Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immunisation, Pain, Poor quality product administered, Product temperature excursion issue, Pyrexia
Clinical narrative: pains/Ache; slight fever; Booster; temperature excursion; temperature excursion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 73 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 16Sep2021 19:00 (Lot number: 301308A) at the age of 73 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing), notes: Verbatim: Rheumatoid arthritis; "Type 2 Diabetes" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Date: 17Feb2021, Lot Number: EL9266, Expiry Date: 31May2021, Route of Administration: Intramuscular , Anatomical Location: 0.3mL, Left arm), administration date: 17Feb2021, when the patient was 72 years old, for Covid-19 immunization, reaction(s): "pains", "aches", "slight fever"; Bnt162b2 (Dose: 2, Date: 10Mar2021, Lot Number / Expiry Date: EN6205/ 30Jun2021, Route of Administration: Intramuscular , Anatomical Location: 0.3mL, Left arm), administration date: 10Mar2021, when the patient was 72 years old, for Covid-19 immunization, reaction(s): "pains", "aches", "slight fever". The following information was reported: IMMUNISATION (non-serious) with onset 16Sep2021 19:00, outcome "unknown", described as "Booster"; PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious) with onset 16Sep2021, outcome "unknown", POOR QUALITY PRODUCT ADMINISTERED (non-serious) with onset 16Sep2021 19:00, outcome "unknown" and all described as "temperature excursion"; PAIN (non-serious), outcome "recovered", described as "pains/Ache"; PYREXIA (non-serious), outcome "recovered", described as "slight fever".  Additional information: The caller tried to do this online but was told it was too early and was concerned because they received a slight temperature, aches and pains with the vaccine and was concerned about having another vaccine. The caller confirms his wife also had pains, aches, and a slight fever, which she also had with the first two shots. When probed for outcome of the pains, aches, and slight fever, he confirms his wife's symptoms were gone in two days just like it was previously. He verifies the booster dose was given on 16Sep2021. He verifies his wife's Lot number was the same as his. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s): None; other than she takes injections with Enbrel every couple of weeks for her Rheumatoid Arthritis Complete only if a 3rd dose was administered, check one option: Other, please specify: Type II Diabetes. CVS called several days after vaccine and advised vaccine was exposed to colder than required temperature, please get booster revaccinated.   Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101588073 same reporter/drug/event, different pt