Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Nervous system disorder, Paraesthesia, Vaccination site pain
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 41 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Feb2021 (Lot number: EN9581) at the age of 41 years as dose 2, single for COVID-19 immunisation at a hospital (non-military facility). Relevant medical history included: "autoimmune issues", start date: 2016 (ongoing), notes: she has had questionable autoimmune issues for about 5 years. The patient's concomitant medications were not reported. No additional vaccines were administered within 4 weeks or on the same date as the BNT162B2 vaccine. Vaccination history included: Bnt162b2 (Dose:1, Lot Number: EL3246), administration date: 19Jan2021, when the patient was 41 years old, for COVID-19 Immunization. The following information was reported: GUILLAIN-BARRE SYNDROME (medically significant) with onset 09Feb2021, outcome "not recovered", described as "Guillain Barre syndrome"; HEADACHE (non-serious) with onset 09Feb2021, outcome "not recovered", described as "severe headaches / sharp stabbing pain on the side of the injection that went all the way up to her neck and head"; NECK PAIN (non-serious) with onset 09Feb2021, outcome "not recovered", described as "sharp stabbing pain on the side of the injection that went all the way up to her neck and head"; VACCINATION SITE PAIN (non-serious) with onset 09Feb2021, outcome "not recovered", described as "sharp stabbing pain on the side of the injection"; NERVOUS SYSTEM DISORDER (non-serious) with onset 09Feb2021, outcome "not recovered", described as "nerve problems throughout the rest of her body"; PARAESTHESIA (non-serious) with onset 09Feb2021, outcome "not recovered", described as "tingling"; HYPOAESTHESIA (non-serious) with onset 09Feb2021, outcome "not recovered", described as "numbness"; FEELING HOT (non-serious) with onset 09Feb2021, outcome "unknown", described as "ears got warm, lips got warm, she was warm all over". The events "guillain barre syndrome", "severe headaches / sharp stabbing pain on the side of the injection that went all the way up to her neck and head", "sharp stabbing pain on the side of the injection that went all the way up to her neck and head", "sharp stabbing pain on the side of the injection ", "nerve problems throughout the rest of her body", "tingling", "numbness" and "ears got warm, lips got warm, she was warm all over" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of guillain-barre syndrome, headache, neck pain, vaccination site pain, nervous system disorder, paraesthesia, hypoaesthesia, feeling hot. Clinical Course: The nurse reported that immediately after vaccination on 09Feb2021 she had a sharp stabbing pain on the side of the injection that went all the way up to her neck and head. Her ears and lips got warm and she was warm all over.  Then for probably 3-4 weeks she had nerve problems throughout the rest of her body.  She had tingling and numbness. She still has those side effects off and on. Her doctor said that it could be Guillain Barre Syndrome and she agrees with that.  She was not hospitalized.  The events interfered with her job activities and she still had nerve symptoms, numbness and tingling which she never had before and severe headaches.  The events were significant and it was limiting to her. The nurse stated that she doesn't want to diagnose herself but says her reaction was Guillain Barre Syndrome. The nurse reported that the COVID vaccine was the cause of her symptoms because it all started immediately after the vaccine. The nurse denied any other medications, labs, testing, or treatments relevant to these events.  The nurse reported that her doctor has recommended that she does not to get any booster shots or other mRNA vaccines.; Sender's Comments: As there is limited information in the case provided, the causal association between the events guillain-barre syndrome, headache, neck pain, vaccination site pain, nervous system disorder, paraesthesia, hypoaesthesia and feeling hot with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.