Age: 65.0
Sex: F
Vaccine: COVID19, FLUX, PPV
Symptoms: Lethargy, Mobility decreased, Nausea, Product use issue, Pyrexia
Clinical narrative: Unable to stand up straight or ambulate without help; Unable to stand up straight or ambulate without help; 102 temp; Nausea; Lethargy / As of today the morning lethargy lasts till around noon then subsides; Vertigo; Brain fog; Lack of visual field; Posterior mid back pain; Spent 3 days in bed with these symptoms; Hot to touch at injection site and very painful; Hot to touch at injection site and very painful; The patient received the third/booster dose of BNT162b2; The patient received the third/booster dose of BNT162b2 on 29Sep2021/ The patient received other vaccines "pneumonia, Merck" and "influenza vaccine" on 29Sep2021; This is a spontaneous report from a contactable nurse (patient). This nurse reported events for two separate vaccine doses. This is the first of two reports. This report is for the events related to the third (Booster) vaccine dose.  A 65-year-old non-pregnant female patient received the third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) via an unspecified route of administration in the left arm on 29Sep2021 at 12:00 (Batch/Lot Number: 301308, at the age of 65-years-old at vaccination) as a single dose for COVID-19 immunisation. The patient received other vaccines on the same day which included pneumococcal vaccine polysacch 23v (MERCK; Lot Number: T040202) in the right arm on 29Sep2021 and influenza vaccine (MANUFACTURER UNKNOWN; Lot Number: UNKNOWN) in the right arm on 29Sep2021, both for immunization. Medical history included hypertension (HTN), hypercholesterolemia, hypothyroid, chronic lumbar pain and glaucoma. The patient was allergic to statins. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified concomitant medications within two weeks of vaccination. Historical vaccination information included the patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9261) via an unspecified route of administration in the right arm on 28Jan2021 at 16:00 (at the age of 64-years-old) and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9809) via an unspecified route of administration in the right arm on 16Feb2021 at 12:00 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. On 04Aug2021, the patient underwent SARS-COV-2 test (nasal swab) and the result was negative. On 29Sep2021, the patient received the third BNT162b2 vaccine dose. On 01Oct2021 at 05:00, the patient experienced 102 (unspecified units) temperature, nausea, lethargy, unable to stand up straight or ambulate without help, vertigo, brain fog, lack of visual field, posterior mid back pain and spent 3 days in bed with these symptoms. The morning lethargy lasts till around noon then subsides. She also reported it was hot to the touch at injection site and very painful. She had the same adverse events after the second vaccine dose. The events did not result in a visit to the doctors or other healthcare professional office/clinic, and emergency room/department or urgent care. Therapeutic measures were taken as a result of 102 (unspecified units) temperature included treatment with paracetamol (TYLENOL). The clinical outcome of the events 102 (unspecified units) temperature, nausea, unable to stand up straight or ambulate without help, vertigo, brain fog, lack of visual field, posterior mid back pain, spent 3 days in bed with these symptoms, injection site was hot to touch and very painful was resolved with sequelae on an unknown date in 2021 while event lethargy was resolved with sequelae on 01Nov2021.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the information currently available,The casual association between the reported events and suspected vaccine BNT162B2 cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : PFIZER INC-202101547670 Same reporter/SD, potential/AE