Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthropod sting, Pain
Clinical narrative: soreness; sting; This is a spontaneous report from a Pfizer sponsored program. A contactable 68-year-old female consumer (patient) reported that: A 68-years-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9262, Expiry: unknown) via unspecified route of administration in arm left on 26Feb2021 (at the age of 68-year-old) as dose 2, single COVID-19 immunization. Medical history included immunocompromised from and unknown date and ongoing, primary immune deficiency disease from 2017 (Spring of 2017) and ongoing, Mycobacterium avium complex infection (has been fighting it for 4 years) from 2017 and ongoing and diagnosed with something else that was related to her being immunocompromised. Family history includes to relevant AE: none and mother died due to Cancer. Patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EB5313, Expiry: unknown) via unspecified route of administration in arm right on 05Feb2021 (at the age of 68-year-old) as dose 1, single and also received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: FD8448, Expiry: Oct2021) via unspecified route of administration in arm right on 24Aug2021 (at the age of 68-year-old) as dose 3, single for COVID-19 immunization. Additional vaccine administered on same date of Pfizer suspect: None. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Historical vaccine includes Shingrix vaccine (no problem, were not painful), on 24Aug2018 received Prevnar 13 (does not have Lot number and expiration date of the product) and Pneumovax vaccine both for immunisation and had no problems with either of them. Concomitant medications included immunoglobulin human normal (Cuvitru) taken 14 g (every 2 weeks) subcutaneous for immunodeficiency from Jun2017 and ongoing (takes the medication at least 48 hours apart from her vaccines, as she will be on it for life). Patient weight was 100-102lbs. On Feb2021 patient experienced soreness and did sting a little. No relevant tests were performed. Patient had no physician office and emergency room visit. Patient weight was 100-102lbs. The outcome of the event was unknown.  Description of Product Complaint: Description of complaint: caller on the line calling about the Covid-19 Vaccine and reported that she had the 3rd dose yesterday and had a unusual reaction. While being vaccinated the dose it really hurt and it was like the vaccine was thick, unlike the previous doses. Product strength and count size dispensed: Covid-19 Vaccine Additional lot numbers: Not applicable. Is a sample of the product available to be returned, if requested (Y/N): No Packaging sealed and intact? Not provided.  Follow-up (30Aug2021): This is a follow-up spontaneous report from Product Quality Complaints group. This report included that: Agency report received from Product Quality Complaint with investigation result, Additional reporter added.  A brief summary of this Agency / Complaint Contact is listed below: Pfizer Receipt Date (PRD): 27Aug2021, Responsible Person: (Withheld), Triage Location / Country: AE Reference Number: N/A (Reported to Drug Safety Unit), Status: Approved. Additional Information: 30Aug2021 10:58 AM (4:00) added by (Withheld) (PID-#): Received a voicemail message from the reporter stating that she did not feel the first injection and the second injection did sting a little. Stated that she received her 3rd shoot on 24Aug2021. A reporter did not provide any information about appearance in the voicemail message. Advised initial triaging associate. 26Aug2021 02:38 PM (4:00) added by (Withheld) (PID-#): Called and left voicemail with the reporter asking if she was describing a visual difference in the thickness of the product, or if they were just referring to the reaction they had noticed once the product was administered. Requested return call.  No follow-up attempts are needed. No further information is expected.