Age: 95.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Pain, Pain in extremity, Pre-existing disease, SARS-CoV-2 antibody test
Clinical narrative: a shock like it was an allergic reaction; she received her third dose in 10Sep2021; she received her third dose in 10Sep2021; She slept very long; she was blotto; stinging in whole body; arm pain; the pain and stinging, she does have this already in general; Malaise; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 95 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Sep2021 13:00 (Lot number: FC3182) at the age of 95 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing); "Thyroid removal" (unspecified if ongoing); "Swelling" (unspecified if ongoing), notes: swollen legs, feet, and ankles; "Knee replacement" (unspecified if ongoing); "Fall" (unspecified if ongoing), notes: she had a bad fall several years ago and hurt a lot of the bones on the right side; "stinging" (unspecified if ongoing); "Hypothyroid" (unspecified if ongoing); "sick", start date: 2020 (unspecified if ongoing), notes: for 5 weeks; "respiratory  infection", start date: 2020 (unspecified if ongoing), notes: she lost her sense of taste and smell; "penicillin" (unspecified if ongoing); "antibiotics" (unspecified if ongoing). Concomitant medication(s) included: GABAPENTIN taken for pain; LEVOTHYROXINE taken for hypothyroidism. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Batch/Lot number: E19262, Administered in the left arm), administration date: 22Jan2021, for COVID-19 IMMUNIZATION; Bnt162b2 (DOSE 2, SINGLE, Batch/Lot number: E19266, Administered in the left arm), administration date: 12Feb2021, for COVID-19 IMMUNIZATION. The following information was reported: IMMUNISATION (non-serious), OFF LABEL USE (non-serious) all with onset 10Sep2021 13:00, outcome "unknown" and all described as "she received her third dose in 10Sep2021"; HYPERSENSITIVITY (non-serious) with onset 11Sep2021, outcome "recovered" (Sep2021), described as "a shock like it was an allergic reaction"; PRE-EXISTING DISEASE (non-serious) with onset 10Sep2021, outcome "unknown", described as "stinging in whole body"; PAIN IN EXTREMITY (non-serious) with onset 10Sep2021, outcome "recovered" (Sep2021), described as "arm pain"; MALAISE (non-serious) with onset 2021, outcome "unknown", described as "Malaise"; HYPERSOMNIA (non-serious) with onset 10Sep2021, outcome "unknown", described as "She slept very long"; FEELING DRUNK (non-serious) with onset 10Sep2021, outcome "unknown", described as "she was blotto"; PAIN (non-serious) with onset Sep2021, outcome "unknown", described as "the pain and stinging, she does have this already in general". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reporter stated that she received her Booster shot (third dose) in 10Sep2021 and suspected that the vaccine was given in error. Reporter wanted to clarify if the vaccine no longer needed to be refrigerated as the woman who administered the vaccine mentioned that the vaccine no longer needs to be refrigerated. After the vaccination, by 19:00, the patient couldn't stay awake.  No follow-up attempts are possible. No further information is expected.