Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Malaise, Pyrexia
Clinical narrative: Fever; malaise; second dose: pain on the side of injection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 27 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Mar2021 11:00 (Lot number: ER2613) at the age of 27 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Fibromyalgia", start date: 2020 (ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Adult Pfizer Covid 19 Vaccine: , First dose: 27Feb2021, lot: EN6200, Route of administration: left arm), administration date: 27Feb2021, when the patient was 27 years old, for COVID-19 immunization, reaction(s): "pain on the side of injection". The following information was reported: INJECTION SITE PAIN (non-serious) with onset 20Mar2021, outcome "recovered", described as "second dose: pain on the side of injection"; PYREXIA (non-serious), outcome "unknown", described as "Fever"; MALAISE (non-serious), outcome "unknown", described as "malaise".  Additional information: The caller had no side effects with the first and second dose Adult Pfizer Covid 19 Vaccine except for typical side effects: The caller clarifies the caller had pain on the side of injection after receiving both first and second dose Adult Pfizer Covid 19 Vaccine that lasted for a day or two for both first and second dose Adult Pfizer Covid 19 Vaccine. Second dose: Fever and malaise: Specifically with the second dose Adult Pfizer Covid 19 Vaccine the caller had fever and malaise. Pain on the side of injection: The pain began around the same time frame of 7 or 8 hours after second dose. Pain on the side of injection: The pain went away after a day or two for both the first and second dose Adult Pfizer Covid 19 Vaccine. No prior Vaccinations within 4 weeks, no list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine.  Investigation summary and conclusion: For Lot: ER2613, the complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE lot ER2613 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot ER2613, fill lot EP8678, and the formulated drug product lot EP8565. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There was no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. When more than one investigation was found in the family, the Conclusion field could result in repeating rows for the CR in the table. If the Conclusion was blank in the table above, then the investigation record was likely an Offline Contractor Investigation and the conclusion must be obtained directly from the child investigation record(s) of the linked Complaint Record.  Follow-up attempts are completed. No further information is expected.