Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Asthenia, Burning sensation, Chills, Dysphonia
Clinical narrative: heart started to pound; she could not stop shaking; Right arm soreness; under arm swollen all the way done; across her midsection under both breasts she felt like she was going to explode; Fatigue/Tired; not being able to pick up her arms; Injection site soreness/right arm soreness; Chills/Intense chills; She was burning up; feel sick; felt like she was going to vomit; Headache; She has a new weird hoarse raspy voice; subjective fever; profound weakness x 24 hours; myalgia; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician). The reporter is the patient.  A 69 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 08Oct2021 11:14 (Lot number: FF8841) at the age of 69 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Diabetes Mellitus Type 2" (ongoing), notes: Illness /AE: Diabetes Mellitus Type 2, Onset date: few years; "Hypertension" (ongoing), notes: Illness /AE: Hypertension, Onset date: few years; "Hyperlipidaemia" (ongoing), notes: Illness /AE: Hyperlipidaemia, Onset date: few years; "Rheumatoid Arthritis" (ongoing), notes: Illness /AE: Rheumatoid Arthritis, Onset date: few years; "GERD" (ongoing), notes: Illness /AE: GERD, Onset date: few years; "Retinal anta's embolism", start date: Jul2021 (ongoing), notes: Illness /AE: Retinal anta's embolism; "Symbiotic stroke" (unspecified if ongoing), notes: Verbatim: Symbiotic stroke. Concomitant medication(s) included: JARDIANCE taken for diabetes mellitus (ongoing); ATENOLOL taken for hypertension (ongoing); AMLODIPINE taken for hypertension (ongoing); ROSUVASTATIN taken for hyperlipidaemia (ongoing); PLAVIX taken for cerebrovascular accident (ongoing); OMEPRAZOLE taken for gastroesophageal reflux disease (ongoing). Vaccination history included: Bnt162b2 (Dose 1, single, Lot: EL3261, Expiration: unknown, First two doses were administered at (withheld)Hospital, Anatomical Site of injection: Right deltoid, Route of administration: Intramuscular), administration date: 22Jan2021, when the patient was 69 years old, for Covid-19 Immunization; Bnt162b2 (Dose 2, single, Lot: EM9810, First two doses were administered at (withheld)Hospital, Anatomical Site of injection: Right Deltoid, Route of administration: Intramuscular), administration date: 12Feb2021, for COVID-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 08Oct2021, outcome "recovering", described as "Right arm soreness"; PERIPHERAL SWELLING (non-serious) with onset 08Oct2021, outcome "recovering", described as "under arm swollen all the way done"; ABDOMINAL DISCOMFORT (non-serious) with onset 08Oct2021, outcome "recovered" (Oct2021), described as "across her midsection under both breasts she felt like she was going to explode"; FATIGUE (non-serious) with onset 08Oct2021, outcome "not recovered", described as "Fatigue/Tired"; LIMB DISCOMFORT (non-serious) with onset 08Oct2021, outcome "recovered" (Oct2021), described as "not being able to pick up her arms"; VOMITING (non-serious) with onset Oct2021, outcome "recovered" (Oct2021), described as "felt like she was going to vomit"; HEADACHE (non-serious) with onset Oct2021, outcome "recovered" (Oct2021), described as "Headache"; VACCINATION SITE PAIN (non-serious) with onset 08Oct2021, outcome "recovering", described as "Injection site soreness/right arm soreness"; MALAISE (non-serious) with onset Oct2021, outcome "unknown", described as "feel sick"; CHILLS (non-serious) with onset 08Oct2021, outcome "recovered" (Oct2021), described as "Chills/Intense chills"; BURNING SENSATION (non-serious) with onset Oct2021, outcome "unknown", described as "She was burning up"; TREMOR (non-serious) with onset 08Oct2021, outcome "unknown", described as "she could not stop shaking"; HEART RATE ABNORMAL (non-serious) with onset 10Oct2021, outcome "recovered" (10Oct2021), described as "heart started to pound"; DYSPHONIA (non-serious) with onset Oct2021, outcome "not recovered", described as "She has a new weird hoarse raspy voice"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "subjective fever"; ASTHENIA (non-serious) with onset 2021, outcome "unknown", described as "profound weakness x 24 hours"; MYALGIA (non-serious) with onset 2021, outcome "unknown", described as "myalgia". Therapeutic measures were not taken as a result of pain in extremity, peripheral swelling, abdominal discomfort, limb discomfort, vomiting, vaccination site pain, malaise, tremor, heart rate abnormal, dysphonia. Therapeutic measures were taken as a result of fatigue, headache, chills, burning sensation, pyrexia, asthenia, myalgia.  Additional Information: Family Medical History Relevant to AE(s) was not reported. Patient took Rosuvastatin Nopletet from months for Hyperlipidaemia oral and ongoing. It was reported that no other vaccines were given to patient within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient stated It was time for her flu shot and pneumonia shot, patient asks if she should wait 3 weeks to get them. Also asks if patient need another booster vaccine. Patient declined to be transferred to hospital and states patient will just ask her doctor. Patient had not visited emergency Room/Physician Office for AEs. Vaccination facility type was at Pharmacy or Drug Store for booster. Vaccine Administered at Facility was not reported. AE Term was 48 hours. For events Intense chills, myalgia, fatigue, headache, subjective fever, especially profound weakness x 24 hours was reported as Rest.  No follow-up attempts are possible. No further information is expected.  No follow-up attempts are possible. No further information is expected.