Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Musculoskeletal stiffness, Nausea, Pain in extremity, Pyrexia
Clinical narrative: fever; chills; headache; fatigue; brain fog; nausea; loss of appetite; sore arm; only bruised; only stiff muscle; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 76 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 02Mar2021 14:00 (Lot number: EN6202) at the age of 76 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications.  The following information was reported: PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "fever"; CHILLS (non-serious) with onset 2021, outcome "unknown", described as "chills"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "headache"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "fatigue"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "brain fog"; NAUSEA (non-serious) with onset 2021, outcome "unknown", described as "nausea"; DECREASED APPETITE (non-serious) with onset 2021, outcome "unknown", described as "loss of appetite"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "sore arm"; CONTUSION (non-serious) with onset 2021, outcome "unknown", described as "only bruised"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 2021, outcome "unknown", described as "only stiff muscle".  Additional Information: Minor reactions to 1st and 3rd vaccinations: fever, chills, headache, fatigue, "brain fog". Second vaccination with EP6955 vaccine produced, serious reaction after administration, first reactions occurred evening after injection fever, chills, nausea, headache, following morning, unable to walk or raise arms- muscles (voluntary) flaccid, non-functioning. Had trouble moving eye and focusing. On third day all hearing in both ears lost, Dizzy, Excruciating pain in skin from head to toes, as if I was being electrocuted had sharp pain under right ribs (liver?). Symptoms lasted until 27Mar2021, when all symptoms suddenly stopped except for "brain fog" confusion and fatigue which lasted for several more days.  Patient Had severe reaction only to second vaccination, beginning the day (24Mar2021), Following morning (After a night of fever, chills) Could not sit up or get out bed: No muscle tone flaccid, no muscular control, also pain in one eye when shifting focus. (24Mar); headache too, 25Mar: Total loss of all hearing in both eyes, but now able to walk, but dizzy, and unable to think clearly , speech a little slurred, pain under ribs, right side (liver?) Stomach ache and loss of appetite through 26Mar. 27Mar2021- Recovered except for brain fog. Also, 24hrs after 2nd dose, experienced excruciating body pain!! 24Mar body pain from scalp down to feet, like being electrocuted with 1st and 3rd vaccinations, only reactions were sore injection site, fever, chills and loss of appetite for 24hrs "brain fog" lasted for 48 hours. Full recovery.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information currently available, The casual association between the reported event Hearing loss with 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate