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,
Created on
April 29, 2024
Last modified
April 29, 2024
Page views
24540
Download
2
Documentation in PDF
Metadata
DDI/XML
JSON
- Data files
- SHERPA_Safetydata
specify_clinical (specify_clinical)
Data file: SHERPA_Safetydata
Overview
Valid:
497
Type:
Discrete
Width:
255
Range:
-
Format:
character
Questions and instructions
Categories
| Value | Category | Cases | |
|---|---|---|---|
| 24 weeks pregnant, singleton | 1 |
0.2%
|
|
| Abdomen - Reversal of tubaligation | 1 |
0.2%
|
|
| Advised to book an appointment with dermatology. | 1 |
0.2%
|
|
| BP elevated- lifestyle advise given, to repeat BP at local facilities in 1 month. | 1 |
0.2%
|
|
| BREAST- ABNORMAL NCS , BILATERAL MASTECTOMY SCARRING ( OCCURRED IN 2007) | 1 |
0.2%
|
|
| Breast Exam Normal | 1 |
0.2%
|
|
| Breast- mastectomy scars visible bilaterally | 1 |
0.2%
|
|
| Brown discolouration of sclera since childhood. | 1 |
0.2%
|
|
| Central Obese | 1 |
0.2%
|
|
| Central obesity | 17 |
3.4%
|
|
| Central obesity, BP derated | 1 |
0.2%
|
|
| Central obesity; Pallor: conjunctival & palmar | 1 |
0.2%
|
|
| Cesarean Scar | 1 |
0.2%
|
|
| Cholesestectomy Scar | 1 |
0.2%
|
|
| Completed 6 months of TB treatment in 2015 | 1 |
0.2%
|
|
| Digital clubbing, previous TB 2018 | 1 |
0.2%
|
|
| Early pregnancy by dates 6 weeks . LNMP 25 JUL 20022 | 1 |
0.2%
|
|
| Elevated Diastole - known HPT, Asymptomatic NCS | 1 |
0.2%
|
|
| H/o previous lobectomy on right lung in 2003- no abnormality on auscultation. | 1 |
0.2%
|
|
| Hypochondroplasia (dwarfism) noted. | 1 |
0.2%
|
|
| Implanon inserted on left arm. Old scar tissue. Inserted 1 monthago. | 1 |
0.2%
|
|
| Kmown with 'White Coat HPT' - asymptomatic - NCS. Has BP monitor at home to check himself | 1 |
0.2%
|
|
| Laparotomy Scar | 1 |
0.2%
|
|
| Larascopic breast scar | 1 |
0.2%
|
|
| Left knee replacement surgery | 1 |
0.2%
|
|
| Lipoma on forehead. | 1 |
0.2%
|
|
| Mastectomy 2013 | 1 |
0.2%
|
|
| Menstral state/ Mildly anxious | 1 |
0.2%
|
|
| Mildly raised diastolic BP Asymptomatic NCS | 1 |
0.2%
|
|
| Morbid obesity | 1 |
0.2%
|
|
| Mosquito bites over body. | 1 |
0.2%
|
|
| Musculoskeletal - Right hand ganglion surgery | 1 |
0.2%
|
|
| N/A | 5 |
1%
|
|
| NA | 1 |
0.2%
|
|
| Newly diagnosed pregnancy today. | 1 |
0.2%
|
|
| No | 1 |
0.2%
|
|
| OBESE | 17 |
3.4%
|
|
| Obese | 333 |
67%
|
|
| Obesity | 27 |
5.4%
|
|
| Overweight | 2 |
0.4%
|
|
| Overweight - NCS | 1 |
0.2%
|
|
| PV spotting today. LMP 16 - 21 September 2022 | 1 |
0.2%
|
|
| Pallor (conjunctiva and palms) | 2 |
0.4%
|
|
| Participant counselled to repeat BP tomorrow and to go to clinic if high for initiation of treatment. | 1 |
0.2%
|
|
| Participant currently using a crutch- had spinal surgery for nerve impingement on the 6th Feb 2022 | 1 |
0.2%
|
|
| Participant did not take anti-hypertensive meds this morning. Asymptomatic. Will take medication later this morning. | 1 |
0.2%
|
|
| Participant encouraged to recheck BP later this week | 1 |
0.2%
|
|
| Participant feeling anxious about getting vaccinated. | 1 |
0.2%
|
|
| Participant feeling anxious about getting vaccinated. Also just had coffee. Advised to recheck BP later this week. | 1 |
0.2%
|
|
| Participant feeling anxious about vaccine. | 1 |
0.2%
|
|
| Participant feeling anxious which might explain BP. Encouraged to check BP tomorrow. | 1 |
0.2%
|
|
| Participant feeling anxious. Encouraged to recheck BP in a few days. | 1 |
0.2%
|
|
| Participant feeling anxious. Encouraged to recheck BP tomorrow. | 1 |
0.2%
|
|
| Participant feeling stressed about work. Encouraged to check BP next week once stress settles. | 1 |
0.2%
|
|
| Participant going to clinic next week, encouraged to repeat BP then. | 1 |
0.2%
|
|
| Participant has just finished drinking a Monster which explains the mildly elevated BP. | 1 |
0.2%
|
|
| Participant has mildly elevated BP. He was given a letter to his doctor to monitor his BP. Participant is asymptomatic. | 1 |
0.2%
|
|
| Participant has not taken BP meds in last few days. Counselled on importance of taking treatment. | 1 |
0.2%
|
|
| Participant has not taken BP meds this morning. Going to clinic on 26 Jun. Counselled to recheck BP. | 1 |
0.2%
|
|
| Participant has not taken BP meds today and just had coffee. | 1 |
0.2%
|
|
| Participant has not taken BP treatment today. | 1 |
0.2%
|
|
| Participant is feeling anxious about getting vaccinated. Also had coffee this morning. Advised to recheck BP later this week. | 1 |
0.2%
|
|
| Participant is feeling stressed. | 1 |
0.2%
|
|
| Participant known with hypertension. She did not take her treatment this morning, She was encouraged to take her treatment as soon as she can. | 1 |
0.2%
|
|
| Participant morbidly obese. Mild tachycardia due to effort of walking. | 1 |
0.2%
|
|
| Patient is a known hypertensive, BP is otherwise well controlled. Currently feeling very anxious. BP 140/96 mmHg | 1 |
0.2%
|
|
| Patient says she was stressed about her children being unable to get into her house. BP dropped to 140/96mmHg after a short rest. On dual therapy. | 1 |
0.2%
|
|
| Previous abscess on left cheek, surgically removed. | 1 |
0.2%
|
|
| Previous c/section x 2 - foetal distress and CPD. | 1 |
0.2%
|
|
| Previously on treatment for hypercholestrolemia, stopped treatment in 2020. | 1 |
0.2%
|
|
| Recurrent abscesses on chin - previously 1 year ago, abscess surgically removed. Now presenting with 1,5cm x 1,5cm small abscess in left submandibular area, non-tender, soft. Patient reports having drained some pus from abscess a week ago. He has this problem when he grows his beard. | 1 |
0.2%
|
|
| Repeat BP on the 24th June 2022: 168/78 which is showing improvement after lifestyle changes, to repeat in 1 month. Participant not on medication. | 1 |
0.2%
|
|
| Scoliosis | 1 |
0.2%
|
|
| Tattoo over left and right bicep/ deltoid area | 1 |
0.2%
|
|
| Tattoo over left bicep/ deltoid area | 1 |
0.2%
|
|
| Tattoo over left wrist along hypothenar border. | 1 |
0.2%
|
|
| White coat increased blood pressure. Measures at work are normal | 1 |
0.2%
|
|
| decreased ROM (L) wrist, radius fracture Oct 2021 | 1 |
0.2%
|
|
| large, hyperpigmented, superficial lesion on right lower abdomen | 1 |
0.2%
|
|
| low BMI, participant reports that she has always been thin, no recent history of weight loss | 1 |
0.2%
|
|
| nil | 1 |
0.2%
|
|
| none | 2 |
0.4%
|
|
| obese | 9 |
1.8%
|
|
| obesity | 3 |
0.6%
|
|
| obesity-BMI 40.5 | 1 |
0.2%
|
|
| osteoarthritis of hands and knees | 1 |
0.2%
|
|
| recent knee replacement- using crutches | 1 |
0.2%
|
|
| right mastectomy | 1 |
0.2%
|
|
| strabismus | 1 |
0.2%
|
|
| underweight | 1 |
0.2%
|
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.