Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Limb injury, Retching
Clinical narrative: This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (Not Available). The reporter is the patient. Other Case identifier(s): 21K-163-4108585-00 (RA). A 72 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 12Feb2021 (Batch/Lot number: unknown) at the age of 72 years as dose 2, single for Covid-19 immunisation; adalimumab (HUMIRA), first regimen subcutaneous (ongoing) (Batch/Lot number: unknown) at unknown (citrate free) and second regimen subcutaneous (Batch/Lot number: unknown) at unknown (citrate free) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st Dose , Intramuscular), administration date: 03Jan2021, when the patient was 72 years old, for COVID-19 vaccination, reaction(s): "Felt sick", "Injury/right shoulder", "Weakness". The following information was reported: ASTHENIA (medically significant) with onset Feb2021, outcome "recovered" (Feb2021), described as "Weakness"; FATIGUE (medically significant) with onset Feb2021, outcome "recovered" (Feb2021), described as "Fatigue"; INFLUENZA LIKE ILLNESS (medically significant) with onset Feb2021, outcome "recovered" (Feb2021), described as "had flu like symptoms"; RETCHING (medically significant) with onset Feb2021, outcome "recovered" (Feb2021), described as "had dry heaves"; BACK PAIN (medically significant) with onset 2021, outcome "not recovered", described as "back pain"; ARTHRALGIA (medically significant), LIMB INJURY (medically significant) all with onset 2021, outcome "not recovered" and all described as "Injury/ right shoulder soreness". The action taken for adalimumab was dosage not changed. Causality by the reporter's, for events "weakness, fatigue, had flu like symptoms and had dry heaves" with adalimumab were "no reasonable possibility" and injury/right shoulder soreness and back pain were injury/right shoulder soreness and back pain. Causality by the reporter's, for events "weakness, fatigue, had flu like symptoms and had dry heaves", right shoulder soreness and back pain with bnt162b2 were Not Reported. The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. Follow up (23Mar2022): This is a follow-up solicited report from a Non-Interventional Study (MARKETING PROGRAM NAME NOT AVAILABLE) based on information received by Pfizer from Regulatory Authority, MFR Control No. 21K-163-4108585-00). A contactable 72-year-old female consumer (patient) reported for herself that: Updated information: Study description added in general tab, Department added in reporter as slider#02, In historical vaccine first dose vaccination date with events added. Biological product added. Co-Suspect product 2nd dosage regimen and route of administration added, New events added, Event onset date added. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Based on plausible dose- event relationship post-vaccination the causal role of BNT162B2 vaccine cannot be excluded for the reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.