Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Pain, Pruritus, Pyrexia
Clinical narrative: body pain; back itch; joint pain; fever; Dizzy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 65 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Sep2021 13:30 (Lot number: FF2588) at the age of 65 years as dose 1, single for covid-19 immunisation. Family history included: "high blood pressure" (unspecified if ongoing). Concomitant medication(s) included: INFLUENZA VACCINE taken for immunisation, administration date 28Sep2021. The following information was reported: PAIN (non-serious) with onset 08Sep2021, outcome "recovered" (10Sep2021), described as "body pain"; PRURITUS (non-serious) with onset 08Sep2021, outcome "recovered" (10Sep2021), described as "back itch"; ARTHRALGIA (non-serious) with onset 08Sep2021, outcome "recovered" (10Sep2021), described as "joint pain"; DIZZINESS (non-serious) with onset 07Sep2021, outcome "recovered" (07Sep2021), described as "Dizzy"; PYREXIA (non-serious) with onset 08Sep2021, outcome "recovered" (10Sep2021), described as "fever".  The Product investigation results included : The complaint for lack of effect of the Pfizer biontech covid-19 vaccine injectable lot FF2588 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, analytical release test results, and an analysis of the complaint history for the reported lot. The final scope was determined to be the reported finished goods lot FF2588, fill lot FF2557, and the bulk formulated drug product lot FE5319. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.  Additional information: It was reported, the patient got first vaccine dose on 07Sep2021. Got second dose on 28Sep2021. Then did not realize, caller got fever, pains, back itch, severe stuff. Now she has a heart problem after the vaccine. Said it's time to get the booster shot, was supposed to go 07Mar2022 to get booster. Got a physical examination. Had a fluttering and pounding heart and failure of having fast beating. She got the first vaccine 07Sep2021 and then 08Sep2021 had fever, body pain, joint pain, back itch for 2 days. Recovered completely, 10Sep2021, all gone. Heart problem after the vaccine, feels like fast beating just a few seconds and goes from chest to throat, like heart will go out of mouth. When Dizzy, Doctor said to stay 15 minutes, caller sat down, then caller got up and walked to car to drive home. Caller states it is called a site infection. Clarified she is referring to the fever, joint pain, body pain. Caller experienced these adverse events 29Sep2021, after the second dose. Stopped: lasted 2 days, 01Oct2021 recovered completely. On 08Nov2021, caller got a COVID-19 test and was positive. Caller states her husband got COVID-19 too, tested positive 14Nov2021. Husband had a really high fever the same date, 08Nov2021. No Antipyretic Use (around the date(s) of Vaccination). No Prior Vaccinations (within 4 weeks) prior to the first administration date of the suspect vaccine(s).  No follow-up attempts are possible. No further information is expected.