Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Impaired work ability, Nausea, Pyrexia, Tremor
Clinical narrative: inability to function normally; Nausea; vomiting; diarrhea; headache; fever (101); chills; uncontrollable shaking; extreme weakness; fatigue for 36 hours; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Oct2022 at 08:30 as dose 5 (booster), single (Lot number: GH9702) at the age of 73 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Osteoporosis" (unspecified if ongoing); "Known allergies: yes - acrylates (topical)" (unspecified if ongoing); "If covid prior vaccination: Yes" (unspecified if ongoing), notes: If covid prior vaccination: Yes. There were no concomitant medications. Past drug history included: Clindamycin hcl, reaction(s): "Known allergies: Clindamycin HCl", notes: Known allergies: Clindamycin HCl. Vaccination history included: BNT162b2 (Dose Number: 4, Pfizer-BioNTech SARS-CoV-2 Vaccination (Gray Cap), Batch/Lot No: FK9895  Pharmacy 8910, Location of injection: Arm Right, Vaccine Administration Time: 01:15 PM), administration date: 31Mar2022, when the patient was 72-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 3, Pfizer-BioNTech SARS-CoV-2 Vaccination (Purple Cap), Batch/Lot No:  301308A, Location of injection: Arm Right, Vaccine Administration Time: 01:30 PM), administration date: 25Sep2021, when the patient was 72-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 2, Pfizer-BioNTech SARS-CoV-2 Vaccination (Purple Cap), Batch/Lot No:  EN6199, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM), administration date: 05Mar2021, when the patient was 71-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 1, Pfizer-BioNTech SARS-CoV-2 Vaccination (Purple Cap), Batch/Lot No:  EL9267, Location of injection: Arm Right, Vaccine Administration Time: 08:00 AM), administration date: 12Feb2021, when the patient was 71-year-old, for COVID-19 immunization.  The following information was reported: NAUSEA (non-serious) with onset 2022, outcome "recovered" (2022); CHILLS (non-serious) with onset 2022, outcome "recovered" (2022); DIARRHOEA (non-serious) with onset 2022, outcome "recovered" (2022), described as "diarrhea"; ASTHENIA (non-serious) with onset 2022, outcome "recovered" (2022), described as "extreme weakness"; FATIGUE (non-serious) with onset 2022, outcome "recovered" (2022), described as "fatigue for 36 hours"; PYREXIA (non-serious) with onset 2022, outcome "recovered" (2022), described as "fever (101)"; HEADACHE (non-serious) with onset 2022, outcome "recovered" (2022); IMPAIRED WORK ABILITY (non-serious) with onset 2022, outcome "recovered" (2022), described as "inability to function normally"; TREMOR (non-serious) with onset 2022, outcome "recovered" (2022), described as "uncontrollable shaking"; VOMITING (non-serious) with onset 2022, outcome "recovered" (2022). Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of impaired work ability, nausea, vomiting, diarrhoea, headache, pyrexia, chills, tremor, asthenia, fatigue.  Additional information: Patient did not receive any other vaccine in four weeks and not received any medications in two weeks. Patient had COVID prior to vaccination. Patient had not been tested COVID post vaccination. Patient did not received treatment for AEs. Patient received vaccine (Facility type vaccine) at Doctor's office/urgent care. Adverse event: nausea, vomiting, diarrhea, headache, fever (101), chills, uncontrollable shaking, inability to function normally, extreme weakness and fatigue for 36 hours. It was reported that patient was recovered from AEs.