Safety, Effectiveness and Immunogenicity of heterologous mRNA-1273 Boost
South Africa
Nigel Garrett, Tarylee Reddy, Nonhlanhla Yende-Zuma, Azwidhwi Takalani, Kubashni Woeber, Annie Bodenstein, Phumeza Jonas, Imke Engelbrecht, Waasila Jassat, Harry Moultrie, Debbie Bradshaw, Ishen Seocharan, Jackline Odhiambo, Kentse Khuto, Simone I. Richardson, Millicent A. Omondi, Rofhiwa Nesamari,
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April 29, 2024
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April 29, 2024
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Data file: SHERPA_Safetydata
Overview
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124
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Questions and instructions
Categories
| Value | Category | Cases | |
|---|---|---|---|
| -Called the participant , she has been having flu- symptoms since Friday afternoon. She states, she only took Benelyn and Paracetamol on Sunday 11 Sep 2022, she has been able to carry on with daily duties =, she is due to work night shift today. She will continue to observe all Covid-19 regulations, musk and PPE. Need to notify the disease. | 1 |
0.8%
|
|
| 19 Aug 2022- Patient's nasal swab COVID 19 PCR received as positive. At 09:56 & 09:57 patient was contacted there was no answer. Tried again at 13:13. SMS was sent to patient on 19 Aug 2022 no answer Patient was contacted on 22 Aug 2022 and patient was reached. | 1 |
0.8%
|
|
| 1st follow up and results update to participant (20/10/2022), participant asymptomatic. Dr ST Buthelezi | 1 |
0.8%
|
|
| Assymptomatic patient with a positive swab at entry | 1 |
0.8%
|
|
| Asymptomatic | 4 |
3.2%
|
|
| Asymptomatic and reports to be feeling well. | 1 |
0.8%
|
|
| Asymptomatic and reports to be fine. | 1 |
0.8%
|
|
| Asymptomatic at enrolment. Participant notified of positive result. Remains asymptomatic. | 1 |
0.8%
|
|
| Asymptomatic on screening & enrolment visit. Contacted patient 24/10/2022, had no symptoms of Covid-19 since positive PCR. | 1 |
0.8%
|
|
| Asymptomatic, reports to be fine. | 1 |
0.8%
|
|
| Asymptomatic, was not even aware of diagnosis. | 1 |
0.8%
|
|
| Asymptomatic, working as per her daily routine. | 1 |
0.8%
|
|
| Asymptomatic- No symptoms and continuing with her daily routine. | 1 |
0.8%
|
|
| Asymptomatic- Notified late as she was unreachable. | 1 |
0.8%
|
|
| Asymptomatic.. Feeling well and continuing with his daily routine. | 1 |
0.8%
|
|
| Called participant , she is only planning to work night shift been using mask and advised to continue using mask and continue with safety measure's. She must visit her doctor or helpline for further management should she be symptomatic and ill. | 1 |
0.8%
|
|
| Called participant she states she has no symptoms and has not experienced any post vaccination reactogenicity. She is at home and well. Advised her to follow the COVID 19 precautions and regulations. | 1 |
0.8%
|
|
| Called participant, he has generalized body pains used Allergex and Panado. He is informed of his Covid-19 Positive results. | 1 |
0.8%
|
|
| Called participant, she has cough with nasal congestion. She used Benylin syrup, has been working night shift. She is notified of Positive Covid-19 results. She requested the the confirmation document of the Covid-19 positive results. | 1 |
0.8%
|
|
| Called participant, she has headache, dizziness and fatigue on Monday and missed work. Tuesday she was at work. She has not had any medication. She said she will call the site if anything happen. | 1 |
0.8%
|
|
| Called participant, she is Asymptomatic. Notified her of the results. Advice her to use mask and the regulation. | 1 |
0.8%
|
|
| Called participant, she is at home and stay alone. She has no symptom's. Results were communicated on the phone. She's advised to follow Covid-19 regulations including wearing of mask. Also to make sure of the safety desk contact for updates. | 1 |
0.8%
|
|
| Contacted telephonically for follow-up. Reported that she has been asymptomatic since the day of diagnosis. | 1 |
0.8%
|
|
| DR tarrny reported on behalf of participant, she tested covid positive a day after vaccination , she verbalized that participant was okay when they left the center and she has not been able to get ahold of the participant to find out if they have any symptoms | 1 |
0.8%
|
|
| Date of recovery unknown as participant was asymptomatic and did not retest. | 1 |
0.8%
|
|
| Had the vaccine on 10 Jun 2022, went home after not feeling well, had symptoms of myalgia, malaise and severe headache. Went back to the site and had PCR (nasal swab) test done at Isipingo Research Site. Got the results on 13 Jun 2022 and it was POSITIVE. Feels much better and fully recovered. | 1 |
0.8%
|
|
| Multiple telephonic contacts to the participant on 04 and 07 Nov 2022 without any success. Participant only reached today 08 Nov 2022. She recovered well from Covid. She was symptomatic from 30 Oct 2022 until 01 Nov 2022 but didn't disclose it to the investigator when she was on site. Conmeds reported for the same period. | 1 |
0.8%
|
|
| No answer at 08:29. NM1 | 1 |
0.8%
|
|
| No symptoms feeling fine. Not even aware had Covid reports to be continuing with activities of daily living. To quarantine if symptoms according to Covid-19 guidelines. | 1 |
0.8%
|
|
| None | 3 |
2.4%
|
|
| Participant Asymptomatic. Reports to be fine. | 1 |
0.8%
|
|
| Participant called 01 November 2022, has never been ill. Currently well and from the gym. Asymptomatic | 1 |
0.8%
|
|
| Participant confirmed during a telephonic call that he has been asymptomatic since the day of diagnosis. Did not seek medical care. | 1 |
0.8%
|
|
| Participant confirmed during a telephonic call that she has been asymptomatic since the day of diagnosis. | 1 |
0.8%
|
|
| Participant confirmed telephonically that he has been asymptomatic since day of diagnosis. Therefore, did not seek medical care. | 1 |
0.8%
|
|
| Participant confirmed telephonically that he has been asymptomatic since the day of diagnosis. Therefore, did not seek any medical care. | 1 |
0.8%
|
|
| Participant confirmed telephonically that he has been asymptomatic since the day of diagnosis. Therefore, he did not seek medical care. | 1 |
0.8%
|
|
| Participant confirmed telephonically that she has been asymptomatic since the day of diagnosis and did not seek any medical care. | 3 |
2.4%
|
|
| Participant confirmed telephonically that she has been asymptomatic since the day of diagnosis and did not seek medical care. | 2 |
1.6%
|
|
| Participant confirmed telephonically that she has been asymptomatic since the day of diagnosis and is feeling well. Advised to isolate and seek medical care when necessar. | 1 |
0.8%
|
|
| Participant confirmed telephonically that she has been asymptomatic since the day of diagnosis, and therefore did not seek any medical care. | 2 |
1.6%
|
|
| Participant confirmed telephonically that she is fine and has been asymptomatic since date of diagnosis. | 1 |
0.8%
|
|
| Participant confirmed to be asymptomatic since the day of diagnosis and did not seek any medical care. | 1 |
0.8%
|
|
| Participant contacted 26Oct22 when she reported she was asymptomatic | 1 |
0.8%
|
|
| Participant contacted 28Nov22 and confirms that she has remained asymptomatic | 1 |
0.8%
|
|
| Participant contacted 3 times on 01 Sep 2022, No answer or response. 02/09/2022- Participant informed about COVID-19 results. Participant reports no symptoms. | 1 |
0.8%
|
|
| Participant contacted with regard to her positive covid-19 Results, she was asked if she has Any symptoms and she verbalised that she never experienced any COVID-19 symptoms. She also added that She never had flu or any respiratory illnesses as long as She Remembers. Her results were signed and send to her via her emails. | 1 |
0.8%
|
|
| Participant contacted with regard to his positive covid-19 Results, he was asked if he has Any symptoms and he verbalised that he never experienced any COVID-19 symptoms. he also added that he never had flu or any respiratory illnesses as long as he Remembers. His results were signed and send to him via his emails. | 1 |
0.8%
|
|
| Participant did not have any symptom's, he was not even aware of the diagnosis and that he is clinically well doing all his activities of daily living. | 1 |
0.8%
|
|
| Participant fully recovered . Had mild symptoms. There was no need of hospitalization. | 1 |
0.8%
|
|
| Participant had blocked nose for a week in the beginning of August and his symptoms were resolved by the second week of AUG 2022.when he came to the site, he was fully recovered already without symptoms. | 1 |
0.8%
|
|
| Participant had mild flu like symptoms. | 1 |
0.8%
|
|
| Participant had mild myalgia and joint pain. Participant still has intermittent joint pain. | 1 |
0.8%
|
|
| Participant has fully recovered from Covid-19 | 1 |
0.8%
|
|
| Participant has no symptoms -PV001BS | 1 |
0.8%
|
|
| Participant has sore throat, dizziness, light headache and cough. She is asthmatic. was taking only Paracetamol. PV0014JM | 1 |
0.8%
|
|
| Participant is asymptomatic | 2 |
1.6%
|
|
| Participant is currently asymptomatic, therefore Covid outcome listed as 'fully recovered. Participant and NICD notified of Covid-19 result | 1 |
0.8%
|
|
| Participant remains asymptomatic on Day 7. | 1 |
0.8%
|
|
| Participant reported a tight chest for 3 days but then resolved. She denied any other symptoms and has been well since then. | 1 |
0.8%
|
|
| Participant reported being well and remained asymptomatic. She has been well since she was enrolled and received the booster vaccine. | 1 |
0.8%
|
|
| Participant reported feeling tired with loss of appetite for one week. She says she is now well and has no residual symptoms. | 1 |
0.8%
|
|
| Participant reported no Covid - 19 symptoms | 1 |
0.8%
|
|
| Participant reports that he has no symptoms at all only got test for the vaccination - PV001BS | 1 |
0.8%
|
|
| Participant reports to be fine, she is asymptomatic she is currently continuing with her routine ADL's. Never had ant symptom's. | 1 |
0.8%
|
|
| Participant reports to be fine. No Covid-19 symptoms. | 1 |
0.8%
|
|
| Participant seek medical attention from her doctor on 13 Oct 2022. When she was on site on 12 Oct 2022, she mentioned no COVID19 related symptoms. She was clinically well and no active illness noted. She received conmeds from her Dr from 13 Oct 2022. She was contacted again today (17 Oct 2022), she is still symptomatic but improving. Multiple telephonic contact attempts made from 24-26 Oct 2022 to follow up regarding symptoms. No answer. | 1 |
0.8%
|
|
| Participant tested positive at entry, informed of result and confirmed that there have been no symptoms | 1 |
0.8%
|
|
| Participant tested positive at entry. Participant was informed of results and confirmed that there were no symptoms. | 1 |
0.8%
|
|
| Participant to be followed up today with a phone call and assess clinical stability. | 1 |
0.8%
|
|
| Participant unreachable after many attempts. | 1 |
0.8%
|
|
| Participant was asymptomatic | 1 |
0.8%
|
|
| Participant was called on 07 Oct 2022 at 09:45 to inform about positive result. Did not answer-left voice note. Will follow-up again. No alternative phone number. Participant called back. Informed about COVID Pos result. Confirmed was Asymptomatic yesterday, not feeling well today. | 1 |
0.8%
|
|
| Participant was contacted 26Oct22 and attended site today 27Oct22 and is asymptomatic | 1 |
0.8%
|
|
| Participant was contacted by phone on 17Nov22. He reports that he remained asymptomativ | 1 |
0.8%
|
|
| Participant was informed regarding covid 19 test results | 5 |
4%
|
|
| Participants reported no symptoms for this case as such no treatment taken | 1 |
0.8%
|
|
| Patient contacted and she reports to be asymptomatic. | 1 |
0.8%
|
|
| Patient did not report any symptoms, therefore recovery date is unknown. | 1 |
0.8%
|
|
| Patient only has mild flu-like symptoms. No visit to health care/doctor. No conmeds taken. 22 Nov 2022 - Patient reports full recovery. Only self-medicated at home | 1 |
0.8%
|
|
| Patient reports to be doing well and is asymptomatic. | 1 |
0.8%
|
|
| Patient reports to be doing well. Asymptomatic and not taking any conmeds. | 1 |
0.8%
|
|
| Patient reports to be doing well. Asymptomatic and not using any conmeds. | 1 |
0.8%
|
|
| Patient was contacted. He is asymptomatic and doing well. Not using any conmeds. | 1 |
0.8%
|
|
| Ppt Asymptomatic | 1 |
0.8%
|
|
| Ppt tested positive at entry. Ppt informed of the results on 06 Oct 2022 and confirmed that she had no symptoms. | 1 |
0.8%
|
|
| Ppt tested positive at entry. She was informed of the results and confirmed that she is asymptomatic. | 1 |
0.8%
|
|
| Ppt was asymptomatic. | 2 |
1.6%
|
|
| Previous COVID-19 infection 1 month ago. | 1 |
0.8%
|
|
| The participant confirmed telephonically that she has been asymptomatic since the day of diagnosis, and therefore did not seek any medical care. | 1 |
0.8%
|
|
| The participant confirmed that he has been asymptomatic since the day of diagnosis and did not seek any medical care. | 1 |
0.8%
|
|
| The participant confirmed that she has been asymptomatic since the day of diagnosis and did not seek any medical care. | 1 |
0.8%
|
|
| The participant confirmed to be asymptomatic since the day of diagnosis, therefore, did not seek medical care. | 1 |
0.8%
|
|
| The participant says that since the vaccine/COVID-19 diagnosis she feels intermittently ill. Every few days she has symptoms- myalgia, nausea, malaise. She has had to take sick leave several times. | 1 |
0.8%
|
|
| The participant was asymptomatic hence the start date and the outcome date is the same. | 1 |
0.8%
|
|
| To follow-up with ppt. again on Friday 14 OCT 22. He is currently well and asymptomatic. Contacted ppt successfully on 17 OCT 22. He is feeling well, reported episodes of fatigue through the week with no other symptoms. He is at work and uses a mask as prescribed by NDOH guidelines. | 1 |
0.8%
|
|
| participant contacted by phone. Initially unable to contact but on 15NOV were able to get through and participant reported she was asymptomatic for the whole period | 1 |
0.8%
|
|
| participant could initially not contactable but answered phone yesterday and confirms being asymptomatic | 1 |
0.8%
|
|
| participant initially could not be contacted as on voicemail. contacted yesterday afterhours and confirms was asymptomatic | 1 |
0.8%
|
|
| participant never experienced any symptoms | 1 |
0.8%
|
|
| participant remained asymptomatic | 1 |
0.8%
|
|
| participant was contacted by phone on 01Nov22 and confirmed that she remained asymptomatic | 1 |
0.8%
|
|
| participant was contacted previously on voicemail and today confirms she was asymptomatic | 1 |
0.8%
|
|
| participant was initially uncontactable but was phoned on 15Nov22 when she reported she had remained asymptomatic | 1 |
0.8%
|
|
| ppt asymptomatic | 1 |
0.8%
|
|
| ppt contacted on 14Oct2022 and today | 1 |
0.8%
|
|
| ppt contacted on 24 Jun 2022 and reports no symptoms | 1 |
0.8%
|
|
| remained asymptomaic | 1 |
0.8%
|
|
| results disclosed | 1 |
0.8%
|
Warning: these figures indicate the number of cases found in the data file. They cannot be interpreted as summary statistics of the population of interest.