chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site mass
Clinical narrative: all of his lymph nodes were swollen under his arm and in his neck; joints were swollen; Huge bump on his arm at the injection site; his fingers are swollen; fever of 101; General feeling of unwell and malaise; This is a spontaneous report from a contactable healthcare professional (patient's wife). A 68-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration in the left arm on 03Mar2021 at about 15:00 (lot number: EN6201 and expiration date: 30Jun2021) at a single dose, received at the hospital for COVID-19 vaccination. Medical history included chronic inflammatory demyelinating polyradiculoneuropathy and patient was immunocompromised. The patient's concomitant medications included immunoglobulin human normal (IMMUNOGLOBULIN [IMMUNOGLOBULIN HUMAN NORMAL]) from 02Mar2021 to 02Mar2021 for chronic inflammatory demyelinating polyradiculoneuropathy. The patient previously received flu vaccine on 15Oct2020. The patient's wife called to report on the side effects that the patient was experiencing after he received the Covid-19 Vaccine. The patient had a fever of 101 started at about 23:00 on 03Mar2021 (his regular base temp is about 97). At midnight of 04Mar2021, all of his lymph nodes were swollen under his arm and in his neck; even in his fingers were swollen. Also noticed that his joints were swollen and had a huge bump on his arm at the injection site on 04Mar2021 after midnight last night. The reported added that patient also had a general feeling of unwell and malaise on 03Mar2021. The patient received treatment for the events. Outcome of the events was not recovered. The events were reported as serious (other medically important condition) and considered related to COVID-19 vaccine (source of assessment was primary source reporter and method of assessment was global introspection).; Sender's Comments: Based on available information, a possible contributory role between BNT162B2 vaccine and the reported events can not be excluded due to temporal relationship and current known drug safety profile.   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.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Dizziness, Erythema, Feeling hot, Paraesthesia
Clinical narrative: right cheek redness; right cheek redness and rash with burning; right cheek redness and rash with burning; itching; tingling sensations; felt hot; dizzy; This is a spontaneous report from a contactable consumer. A 67-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, lot EL3247, expiry date not reported), via an unspecified route of administration, administered in the left arm on 28Jan2021 as a single dose for COVID-19 immunisation. Medical history included hypertension and hypothyroidism, both from an unknown date and unknown if ongoing. The patient had COVID prior vaccination (dates unspecified). The patient was not pregnant at the time of the vaccination and report. The patient's concomitant medications were not reported. The patient had known allergies to aspirin, codeine, metoclopramide, morphine, hydromorphone, tramadol, hydrocodone, and prochloperazine maleate (COMPAZINE). The vaccination was done in the hospital. In Jan2021 (also reported as 18Jan2021), patient experienced right cheek redness and rash with burning, itching, tingling sensations. The patient also felt hot and dizzy. The events caused hospitalization from an unspecified date in 2021. The patient was not tested for COVID post vaccination. The outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: right cheek redness; right cheek redness and rash with burning; right cheek redness and rash with burning; itching; tingling sensations; felt hot; dizzy; This is a spontaneous report from a contactable consumer. A 67-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, lot EL3247, expiry date not reported), via an unspecified route of administration, administered in the left arm on 28Jan2021 as a single dose for COVID-19 immunisation. Medical history included hypertension and hypothyroidism, both from an unknown date and unknown if ongoing. The patient had COVID prior vaccination (dates unspecified). The patient was not pregnant at the time of the vaccination and report. The patient's concomitant medications were not reported. The patient had known allergies to aspirin, codeine, metoclopramide, morphine, hydromorphone, tramadol, hydrocodone, and prochloperazine maleate (COMPAZINE). The vaccination was done in the hospital. In Jan2021 (also reported as 18Jan2021), patient experienced right cheek redness and rash with burning, itching, tingling sensations. The patient also felt hot and dizzy. The events caused hospitalization from an unspecified date in 2021. The patient was not tested for COVID post vaccination. The outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Transient ischaemic attack
Clinical narrative: TIA- mini stroke; This is a spontaneous report from a contactable consumer. An 85-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 25Feb2021 12:00 PM (Batch/Lot Number: EN6202) as SINGLE DOSE for covid-19 immunisation. Medical history included high blood pressure. Concomitant medication included lisinopril. On 27Feb2021 14:00, the patient experienced TIA- mini stroke. The AE resulted in Emergency room/department or urgent care, Hospitalization. The patient was hospitalized for 2 days. The patient underwent lab tests and procedures which included sars-cov-2 test: negative   on 27Feb2021.  Therapeutic measures were taken as a result of tia- mini stroke. The outcome of the event was recovered.
Sex: M
Vaccine: COVID19
Symptoms: Arrhythmia
Clinical narrative: Arrhythmia; This is a spontaneous report from a contactable consumer (patient). A 75-year-old male patient received his first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6198), via an unspecified route of administration at arm left on 26Feb2021 10:30 AM at single dose for COVID-19 immunisation. Medical history included heart disorder. Concomitant medications in two weeks included omeprazole (PRILOSEC), lisinopril, nadolol, rosuvastatin calcium (CRESTOR) and aspirin. There was no other vaccine in four weeks, no covid prior vaccination and no covid tested post vaccination. The patient experienced arrhythmia on 28Feb2021 04:00 PM. The patient was hospitalized for arrhythmia for 2 days. Adverse event (AE) was resulted in emergency room/department or urgent care, hospitalization. There was no treatment for event. The outcome of event was not recovered.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure abnormal, Blood pressure measurement, Chest pain, Hypotension, Loss of consciousness
Clinical narrative: collapse; respiratory distress; hypotension; tongue swelling; throat tightness; blood pressure abnormality; chest pain; increased swelling; skin changes; This is a spontaneous report from a non-contactable other hcp.    A 50-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: EN6205), via an unspecified route of administration on an unspecified date) at SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. During her 15 minute waiting period after the injection, the patient began to experience throat tightness. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality, chest pain, collapse, hypotension, increased swelling, rapid progression of symptoms, respiratory distress, skin changes and tongue swelling. Treatment included: antihistamines. Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: A contributory role of vaccine BNT162B2 to the reported events cannot be excluded based on the plausible temporal relationship and product safety profile.  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, Ehics Committees, and Investigators, as appropriate.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory distress, Skin disorder, Swelling, Swollen tongue, Throat tightness
Clinical narrative: collapse; respiratory distress; hypotension; tongue swelling; throat tightness; blood pressure abnormality; chest pain; increased swelling; skin changes; This is a spontaneous report from a non-contactable other hcp.    A 50-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: EN6205), via an unspecified route of administration on an unspecified date) at SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. During her 15 minute waiting period after the injection, the patient began to experience throat tightness. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality, chest pain, collapse, hypotension, increased swelling, rapid progression of symptoms, respiratory distress, skin changes and tongue swelling. Treatment included: antihistamines. Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: A contributory role of vaccine BNT162B2 to the reported events cannot be excluded based on the plausible temporal relationship and product safety profile.  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, Ehics Committees, and Investigators, as appropriate.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature fluctuation, Chills, Delirium, Dizziness
Clinical narrative: Temp now fluctuates from 95-100; Feeling delirious; Sweating; Dizzy; Left arm is numb; Pins and needles sensation all over my body; Hearing noises in my ears like a throbbing when I stand up; Barely walk to the bathroom; Chills; Everything sore; Sore throat; Began violently shaking around midnight; Fever was 103/Ran fever of 100.5-103 until this morning/Fever is below 100 today; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 03Mar2021 09:30 (Batch/Lot Number: EN6200) as single dose for covid-19 immunisation at a Public Health Clinic/Administration facility. Medical history included Hashimotos. The patient has no Covid prior to vaccination and not tested for Covid post vaccination. The patient has no known allergies. Concomitant medications included levothyroxine sodium (SYNTHROID), lisdexamfetamine mesilate (VYVANSE), venlafaxine, cyanocobalamin (B12 [CYANOCOBALAMIN]), and ergocalciferol (VIT D). The patient had no other vaccine in four weeks. The patient previously had the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EL9269) on 09Feb2021 17:30 in the left arm for Covid-19 immunization. On 03Mar2021, sore throat began around 17:30 and chills began at 21:30. Patient took Tylenol and went to sleep. Violently shaking began around midnight (Mar2021); the patient was unable to get warm, yet fever was 103 (Mar2021). It was reported that everything sore on 03Mar2021 17:50. The patient ran fever of 100.5-103 until this morning (04Mar2021). Temp now fluctuates from 95-100. Mostly all "ept" until this morning (06Mar2021) waking to drink water and take Tylenol every 4 hours. The patient was still sweating profusely and was feeling delirious and dizzy (06Mar2021). Left arm is numb and has a pins and needles sensation all over her body on 06Mar2021. It was very uncomfortable. The patient was also hearing noises in her ears like a throbbing when she stands up. Fever is below 100 today (unspecified date), after taking a shower this morning, it was 95. The patient can barely walk to the bathroom on 06Mar2021 and she hasn't left her room since this started Wednesday night. Her husband called her doctor and she say this should pass by 9:30 tonight. There were times she prayed to die; she hurts so bad. Fortunately, the pain is not this bad now. But she was suffering greatly from the 2nd shot. The events sore throat and chills were treated, while the other events were not. The outcome of the events was not recovered.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Hyperhidrosis, Hypoaesthesia, Oropharyngeal pain, Pain
Clinical narrative: Temp now fluctuates from 95-100; Feeling delirious; Sweating; Dizzy; Left arm is numb; Pins and needles sensation all over my body; Hearing noises in my ears like a throbbing when I stand up; Barely walk to the bathroom; Chills; Everything sore; Sore throat; Began violently shaking around midnight; Fever was 103/Ran fever of 100.5-103 until this morning/Fever is below 100 today; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 03Mar2021 09:30 (Batch/Lot Number: EN6200) as single dose for covid-19 immunisation at a Public Health Clinic/Administration facility. Medical history included Hashimotos. The patient has no Covid prior to vaccination and not tested for Covid post vaccination. The patient has no known allergies. Concomitant medications included levothyroxine sodium (SYNTHROID), lisdexamfetamine mesilate (VYVANSE), venlafaxine, cyanocobalamin (B12 [CYANOCOBALAMIN]), and ergocalciferol (VIT D). The patient had no other vaccine in four weeks. The patient previously had the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EL9269) on 09Feb2021 17:30 in the left arm for Covid-19 immunization. On 03Mar2021, sore throat began around 17:30 and chills began at 21:30. Patient took Tylenol and went to sleep. Violently shaking began around midnight (Mar2021); the patient was unable to get warm, yet fever was 103 (Mar2021). It was reported that everything sore on 03Mar2021 17:50. The patient ran fever of 100.5-103 until this morning (04Mar2021). Temp now fluctuates from 95-100. Mostly all "ept" until this morning (06Mar2021) waking to drink water and take Tylenol every 4 hours. The patient was still sweating profusely and was feeling delirious and dizzy (06Mar2021). Left arm is numb and has a pins and needles sensation all over her body on 06Mar2021. It was very uncomfortable. The patient was also hearing noises in her ears like a throbbing when she stands up. Fever is below 100 today (unspecified date), after taking a shower this morning, it was 95. The patient can barely walk to the bathroom on 06Mar2021 and she hasn't left her room since this started Wednesday night. Her husband called her doctor and she say this should pass by 9:30 tonight. There were times she prayed to die; she hurts so bad. Fortunately, the pain is not this bad now. But she was suffering greatly from the 2nd shot. The events sore throat and chills were treated, while the other events were not. The outcome of the events was not recovered.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Pyrexia, Tinnitus, Tremor
Clinical narrative: Temp now fluctuates from 95-100; Feeling delirious; Sweating; Dizzy; Left arm is numb; Pins and needles sensation all over my body; Hearing noises in my ears like a throbbing when I stand up; Barely walk to the bathroom; Chills; Everything sore; Sore throat; Began violently shaking around midnight; Fever was 103/Ran fever of 100.5-103 until this morning/Fever is below 100 today; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 03Mar2021 09:30 (Batch/Lot Number: EN6200) as single dose for covid-19 immunisation at a Public Health Clinic/Administration facility. Medical history included Hashimotos. The patient has no Covid prior to vaccination and not tested for Covid post vaccination. The patient has no known allergies. Concomitant medications included levothyroxine sodium (SYNTHROID), lisdexamfetamine mesilate (VYVANSE), venlafaxine, cyanocobalamin (B12 [CYANOCOBALAMIN]), and ergocalciferol (VIT D). The patient had no other vaccine in four weeks. The patient previously had the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EL9269) on 09Feb2021 17:30 in the left arm for Covid-19 immunization. On 03Mar2021, sore throat began around 17:30 and chills began at 21:30. Patient took Tylenol and went to sleep. Violently shaking began around midnight (Mar2021); the patient was unable to get warm, yet fever was 103 (Mar2021). It was reported that everything sore on 03Mar2021 17:50. The patient ran fever of 100.5-103 until this morning (04Mar2021). Temp now fluctuates from 95-100. Mostly all "ept" until this morning (06Mar2021) waking to drink water and take Tylenol every 4 hours. The patient was still sweating profusely and was feeling delirious and dizzy (06Mar2021). Left arm is numb and has a pins and needles sensation all over her body on 06Mar2021. It was very uncomfortable. The patient was also hearing noises in her ears like a throbbing when she stands up. Fever is below 100 today (unspecified date), after taking a shower this morning, it was 95. The patient can barely walk to the bathroom on 06Mar2021 and she hasn't left her room since this started Wednesday night. Her husband called her doctor and she say this should pass by 9:30 tonight. There were times she prayed to die; she hurts so bad. Fortunately, the pain is not this bad now. But she was suffering greatly from the 2nd shot. The events sore throat and chills were treated, while the other events were not. The outcome of the events was not recovered.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Cellulitis, Lymphadenitis, Pyrexia, Swelling
Clinical narrative: cellulitis; lymphadenitis; Fever 103; Still swollen from groin area down to knee; This is a spontaneous report from a contactable other HCP (patient). This 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: not reported), via an unspecified route of administration in the left arm on 26Feb2021 at 12:00 PM at a single dose for COVID-19 immunization. Medical history was unknown. Concomitant medications were none. The patient was not pregnant. The patient had no other vaccine in four weeks or other medications in two weeks. The patient experienced fever 103 white posture on knee that turned into cellulitis and lymphadenitis. The patient had IV antibiotics twice within 5 days of vaccine as treatment for events. The patient still had swollen from groin area down to knee. AE resulted in emergency room/department or urgent care. The patient had no covid prior vaccination, no covid tested post vaccination. Outcome of the events was not recovered.   Information on the batch/lot number has been requested.; Sender's Comments: The event cellulitis is assessed as unrelated to BNT162B2 based on the information provided. The event onset date is not reported, therefore the drug-event temporal relationship is not clear. In addition, the BNT162B2 vaccine was administered in the arm but the reported cellulitis was at knee area. It is very unlikely that the cellulitis was related to BNT162B2.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: massive heart attack; This is a spontaneous report from a contactable consumer or (patient's daughter-in-law).  A 71-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number EL9267) via an unspecified route of administration at single dose in right arm on 19Feb2021 3:30PM for COVID-19 immunisation. Medical history included diabetes, high blood pressure. Concomitant medications included meloxicam at 15 mg one tablet per day in morning by mouth, metformin at 1000 mg twice daily by mouth, hydrochlorothiazide, valsartan (VALSARTAN + HIDROCLOROTIAZIDA) at 320 mg/12.5 mg once a day in morning by mouth, all from unspecified date and ongoing for unknown indication. On 03Mar2021, the patient experienced massive heart attack with outcome of unknown. The event required a visit to the emergency room. The patient was hospitalized for massive heart attack from 03Mar2021 to ongoing. Reporter stated that "Patient is in the hospital right now as he had a massive heart attack on Wednesday 03Mar2021. She reports they do not think its an adverse event related to the COVID-19 vaccine because 3 of his 4 valves were clogged, but she did fill out a form online with the state of (state withheld). The patient's second COVID-19 vaccine was rescheduled to 13Mar2021 and she is asking if the second COVID-19 vaccine can be rescheduled to the 31Mar2021, since the patient will have a long recovery. She's not sure how far they can go with the scheduling of the second vaccine before the 1st one will expire and he will have to start the series all over again".
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: then had a stroke; This is a spontaneous report from a contactable consumer. A female patient (mother) of an unspecified age (Age: 87; Unit: Unknown) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 23Jan2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient received the first dose of the pfizer covid 19 vaccine and then had a stroke on an unspecified date. Reporter wanted to know the maximum amount of time between the first and second dose. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Blood pressure measurement, Depression, Dizziness, Fall
Clinical narrative: visual blurriness/visual disturbances; headaches; tiredness; muscle/joint aches; muscle/joint aches; dizziness; panic attacks; depression got worse; nausea; fell once, almost fell at least 5 times; visual hallucination; My blood pressure has been elevated; This is a spontaneous report from a contactable consumer (patient). A 70-year-old male patient received the second dose of BNT162B2 (lot number: EM9810), via an unspecified route of administration, administered in right arm on 11Feb2021 15:00 (at the age of 70-year-old) at single dose for COVID-19 immunization.  Medical history included depression, diabetes, arterial sclerosis, panic attacks, high cholesterol/ blood pressure, and enlarged prostate. The patient had no knpown allergies. Concomitant medications included clopidogrel bisulfate (CLOPIDROGEL SANDOZ); clonazepam; tamsulosin; and ramipril. The patient previously received the first dose of BNT162B2 (lot number: EL3247) via an unspecified route of administration administered in right arm on 21Jan2021 at 4:00 PM (at the age of 70-year-old) at single dose for COVID-19 immunization. The patient had no other vaccine in four weeks. Soon after the 2nd shot in Feb2021, the patient started having headaches, tiredness, muscle/joint aches. Three (3) days after it on unspecified date in Feb2021, he started having dizziness, panic attacks, visual blurriness, and his depression got worse. This last week on unspecified date in Feb2021, the dizziness with nausea, the visual disturbances increased to the point where the patient fell once, almost fell at least 5 times but caught himself, panic attacks increased, and on unspecified date in 2021 (also reported as yesterday) the patient had what was almost like a visual hallucination while riding in the car. Still dizzy today. His blood pressure has been elevated on unspecified date in 2021- most likely due to the worry about all of this. He does not know if these are related to the shot or something different is going on. There was no treatment for the adverse events. The events required physician office visit. No COVID prior vaccination and was not tested wih COVID post vaccination. The outcome of the events was not recovered.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Hallucination, visual, Headache, Hypertension, Myalgia
Clinical narrative: visual blurriness/visual disturbances; headaches; tiredness; muscle/joint aches; muscle/joint aches; dizziness; panic attacks; depression got worse; nausea; fell once, almost fell at least 5 times; visual hallucination; My blood pressure has been elevated; This is a spontaneous report from a contactable consumer (patient). A 70-year-old male patient received the second dose of BNT162B2 (lot number: EM9810), via an unspecified route of administration, administered in right arm on 11Feb2021 15:00 (at the age of 70-year-old) at single dose for COVID-19 immunization.  Medical history included depression, diabetes, arterial sclerosis, panic attacks, high cholesterol/ blood pressure, and enlarged prostate. The patient had no knpown allergies. Concomitant medications included clopidogrel bisulfate (CLOPIDROGEL SANDOZ); clonazepam; tamsulosin; and ramipril. The patient previously received the first dose of BNT162B2 (lot number: EL3247) via an unspecified route of administration administered in right arm on 21Jan2021 at 4:00 PM (at the age of 70-year-old) at single dose for COVID-19 immunization. The patient had no other vaccine in four weeks. Soon after the 2nd shot in Feb2021, the patient started having headaches, tiredness, muscle/joint aches. Three (3) days after it on unspecified date in Feb2021, he started having dizziness, panic attacks, visual blurriness, and his depression got worse. This last week on unspecified date in Feb2021, the dizziness with nausea, the visual disturbances increased to the point where the patient fell once, almost fell at least 5 times but caught himself, panic attacks increased, and on unspecified date in 2021 (also reported as yesterday) the patient had what was almost like a visual hallucination while riding in the car. Still dizzy today. His blood pressure has been elevated on unspecified date in 2021- most likely due to the worry about all of this. He does not know if these are related to the shot or something different is going on. There was no treatment for the adverse events. The events required physician office visit. No COVID prior vaccination and was not tested wih COVID post vaccination. The outcome of the events was not recovered.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Panic attack, Visual impairment
Clinical narrative: visual blurriness/visual disturbances; headaches; tiredness; muscle/joint aches; muscle/joint aches; dizziness; panic attacks; depression got worse; nausea; fell once, almost fell at least 5 times; visual hallucination; My blood pressure has been elevated; This is a spontaneous report from a contactable consumer (patient). A 70-year-old male patient received the second dose of BNT162B2 (lot number: EM9810), via an unspecified route of administration, administered in right arm on 11Feb2021 15:00 (at the age of 70-year-old) at single dose for COVID-19 immunization.  Medical history included depression, diabetes, arterial sclerosis, panic attacks, high cholesterol/ blood pressure, and enlarged prostate. The patient had no knpown allergies. Concomitant medications included clopidogrel bisulfate (CLOPIDROGEL SANDOZ); clonazepam; tamsulosin; and ramipril. The patient previously received the first dose of BNT162B2 (lot number: EL3247) via an unspecified route of administration administered in right arm on 21Jan2021 at 4:00 PM (at the age of 70-year-old) at single dose for COVID-19 immunization. The patient had no other vaccine in four weeks. Soon after the 2nd shot in Feb2021, the patient started having headaches, tiredness, muscle/joint aches. Three (3) days after it on unspecified date in Feb2021, he started having dizziness, panic attacks, visual blurriness, and his depression got worse. This last week on unspecified date in Feb2021, the dizziness with nausea, the visual disturbances increased to the point where the patient fell once, almost fell at least 5 times but caught himself, panic attacks increased, and on unspecified date in 2021 (also reported as yesterday) the patient had what was almost like a visual hallucination while riding in the car. Still dizzy today. His blood pressure has been elevated on unspecified date in 2021- most likely due to the worry about all of this. He does not know if these are related to the shot or something different is going on. There was no treatment for the adverse events. The events required physician office visit. No COVID prior vaccination and was not tested wih COVID post vaccination. The outcome of the events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Mastitis, Off label use, Product use issue
Clinical narrative: Mastitis; the patient was lactating; the patient was lactating; This is a spontaneous report from a contactable pharmacist (patient). An adult female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 02Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunisation. The patient was not pregnant at time of vaccination. Medical history and concomitant medication were not reported. The patient had no other vaccine in four weeks and has not had COVID tested post vaccination. The patient experienced mastitis after both doses on 02Feb2021. The patient was lactating. The outcome of event was recovered on unspecified date. The event was treated with Dicloxacillin.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of mastitis in this patient who was lactating. 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.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Hallucination, Paranoia
Clinical narrative: hallucinatory trip; fatigue; It was really weird because I've never had anything like that happen to me before; I felt paranoid; This is a spontaneous report from a contactable consumer. A 74-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot and expiration date unknown), via an unspecified route of administration on 04Mar2021 as a single dose for covid-19 immunization. The patient's medical history included visual impairment (reported as visually impaired) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient received the first dose of bnt162b2 on an unknown date for Covid-19 immunisation. On 05Mar2021, unusual side effect . He had a hallucinatory trip, He was seeing people in his room and got very concerned because he live alone. He was seeing movement in his room and felt paranoid. It was really weird because He never had anything like that happen to him before. He has not spoken with his primary care provider yet but he plans to call her next. The outcome of the events was unknown.  Information about the Lot/Batch number has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Choking, Middle insomnia, Oropharyngeal pain
Clinical narrative: Choking; Weakness; Sore throat; I kept waking up from it; This is a spontaneous report from a contactable consumer (patient herself). A 50-year-old female patient (non-pregnant) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EN6199), via an unspecified route of administration on 05Mar2021 15:15 in right arm as single dose for covid-19 immunisation. The patient medical history was not reported. Known allergies was no. The patient had no other vaccine in four weeks. Concomitant medications included fluticasone propionate (FLONASE); vitamin d; cyanocobalamin (VITAMIN B12). On 05Mar2021 16:00, the patient experienced weakness after vaccination, sore throat last night and today, choking when sleeping, she kept waking up from it.  No treatment was received for the events. The patient had no COVID prior vaccination and was not tested COVID post vaccination. Outcome of events were not recovered.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Cognitive disorder, Depression, Suicidal ideation
Clinical narrative: Two days after the shot, I've had severe depression.  Difficult to think and get out of bed.  Suicidal thoughts; Two days after the shot, I've had severe depression.  Difficult to think and get out of bed.  Suicidal thoughts; Two days after the shot, I've had severe depression.  Difficult to think and get out of bed.  Suicidal thoughts; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), via an unspecified route of administration, administered in left arm on 03Mar2021 17:45 as single dose for covid-19 immunisation at a Pharmacy/Drug Store. Medical history included anxiety and allergies to Penicillin and sulfar drugs. The patient had no Covid prior vaccination and was not tested for Covid post vaccination. Concomitant medication included buspirone hydrochloride (BUSPAR). The patient had no other vaccine in four weeks. On 05Mar2021 17:30, two days after the shot, the patient had severe depression, difficult to think and get out of bed and suicidal thoughts. The events were not treated. The outcome of the events was recovering.  Information on the batch/lot number has been requested.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Hypoaesthesia, Paraesthesia
Clinical narrative: left side of face just under cheek bone feels slightly numb and tingly, left side of mouth appears very, very, very, slightly "drooped" like it does not match the right side of my mouth; left side of face just under cheek bone feels slightly numb and tingly, left side of mouth appears very, very, very, slightly "drooped" like it does not match the right side of my mouth; left side of face just under cheek bone feels slightly numb and tingly, left side of mouth appears very, very, very, slightly "drooped" like it does not match the right side of my mouth; This is a spontaneous report from a contactable consumer (patient himself). A 50-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 06Mar2021 15:45 (at age of 50-year-old) (Lot Number: EN6206) as single dose for COVID-19 immunization.  Medical history included high blood pressure, high cholesterol, obesity. There was known allergies: bee stings and sulfa drugs. Concomitant medications included atorvastatin (LIPITOR); hydrochlorothiazide, lisinopril (LISINOPRIL HCTZ); and emtricitabine, tenofovir disoproxil fumarate (TRUVADA).  The patient reported "left side of face just under cheek bone feels slightly numb and tingly, left side of mouth appears very, very, very, slightly 'drooped' like it does not match the right side of my mouth but you have to stare and look really close to notice it. Should I hold off on getting my second dose in the next 3 or 4 weeks to see how this goes?" The adverse events start time was 06Mar2021 20:45. The events did not result in emergency room visit or physician office visit. It was unknown if treatment received for the events. There was no COVID prior vaccination or COVID tested post vaccination. The outcome of events was not resolved.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dyspnoea, Fatigue, Headache, Heart rate
Clinical narrative: extreme fatigue; faintness; severe headache; fever(100 degrees); nausea; shortness of breath; rapid heart beat; This is a spontaneous report from a non-contactable consumer. A 71-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: EN6205, via an unspecified route of administration, administered in left arm on 04Mar2021 as single dose for COVID-19 immunisation. Medical history included high blood pressure, pre-diabetic, penicillin allergies, allergies to sulfa drugs and bee stings. Concomitant medication included calcium. Historical vaccine included BNT162B2 on 11Feb2021 (lot number: EM9810) for COVID-19 immunization. On 04Mar2021, after 1 hour, the patient experienced shortness of breath and rapid heartbeat. At 12 hours, severe headache, fever (100 degrees) nausea, faintness, extreme fatigue 24 hours later, started to feel normal again 6 hours later. No treatment information was reported. The outcome of the events shortness of breath and rapid heartbeat was recovered on 04Mar2021, For events faintness, severe headache, fever (100 degrees), nausea and extreme fatigue was recovered on 05Mar2021.  No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Nausea, Pyrexia, Syncope
Clinical narrative: extreme fatigue; faintness; severe headache; fever(100 degrees); nausea; shortness of breath; rapid heart beat; This is a spontaneous report from a non-contactable consumer. A 71-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: EN6205, via an unspecified route of administration, administered in left arm on 04Mar2021 as single dose for COVID-19 immunisation. Medical history included high blood pressure, pre-diabetic, penicillin allergies, allergies to sulfa drugs and bee stings. Concomitant medication included calcium. Historical vaccine included BNT162B2 on 11Feb2021 (lot number: EM9810) for COVID-19 immunization. On 04Mar2021, after 1 hour, the patient experienced shortness of breath and rapid heartbeat. At 12 hours, severe headache, fever (100 degrees) nausea, faintness, extreme fatigue 24 hours later, started to feel normal again 6 hours later. No treatment information was reported. The outcome of the events shortness of breath and rapid heartbeat was recovered on 04Mar2021, For events faintness, severe headache, fever (100 degrees), nausea and extreme fatigue was recovered on 05Mar2021.  No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris
Clinical narrative: About two hours after injection experienced heart pain. It lasted about 3 hours; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EN6199), via an unspecified route of administration administered in left arm on 06Mar2021 at 09:00 as SINGLE DOSE for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient had no other vaccine in four weeks. The patient had no COVID prior vaccination and was not COVID tested post vaccination. Medical history included no thyroid, fibrinogen in blood; and known allergies to latex and penicillin. Concomitant medications included levothyroxine sodium (LEVOTHYROXIN), liothyronine, and aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]). On 06Mar2021 at 11:00 AM, the patient experienced about two hours after injection experienced heart pain. It lasted about 3 hours. There was no treatment given for the event. The patient recovered from the event on 06Mar2021 at 14:00.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Glossitis, Lip swelling, Oral discomfort, Oral mucosal erythema, Paraesthesia
Clinical narrative: Sialadenitis (salivary gland inflammation); glossitis (tounge inflammation); inflammation of the mucosal lining of the oral cavity with cherry red discoloration and swelling of the lips; inflammation of the mucosal lining of the oral cavity with cherry red discoloration and swelling of the lips; inflammation of the mucosal lining of the oral cavity with cherry red discoloration and swelling of the lips; Tingling; prickly sensation on tongue when eating; cold items felt opposite of what they should, more like burning sensation; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6202), via an unspecified route of administration in the left arm on 27Feb2021 12:45 as single dose for COVID-19 immunization. Medical history included known allergies to Sulph. The patient was not pregnant. Concomitant medications included aceclofenac (BIOFLEX [ACECLOFENAC]), calcium (CITRICAL [CALCIUM]) and vitamin D (VITAMIN D [VITAMIN D NOS]). On 01Mar2021 08:00, the patient experienced sialadenitis (salivary gland inflammation), glossitis (tounge inflammation), inflammation of the mucosal lining of the oral cavity with cherry red discoloration and swelling of the lips. Tingling, prickly sensation on tongue when eating, cold items felt opposite of what they should, more like burning sensation were also reported. Onset of symptoms Monday morning, symptoms peaked Wednesday evening through midday Thursday, greatly improved by Friday morning. The patient had a COVID test on Friday to be sure and it was negative. There were no treatment for events. No COVID prior vaccination. The patient had a COVID test type post vaccination-Nasal Swab (Covid 2 PCR) on 05Mar2021 which was negative. The patient had The outcome of the events was recovered on unspecified date in Mar2021.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, SARS-CoV-2 test, Sialoadenitis, Stomatitis
Clinical narrative: Sialadenitis (salivary gland inflammation); glossitis (tounge inflammation); inflammation of the mucosal lining of the oral cavity with cherry red discoloration and swelling of the lips; inflammation of the mucosal lining of the oral cavity with cherry red discoloration and swelling of the lips; inflammation of the mucosal lining of the oral cavity with cherry red discoloration and swelling of the lips; Tingling; prickly sensation on tongue when eating; cold items felt opposite of what they should, more like burning sensation; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6202), via an unspecified route of administration in the left arm on 27Feb2021 12:45 as single dose for COVID-19 immunization. Medical history included known allergies to Sulph. The patient was not pregnant. Concomitant medications included aceclofenac (BIOFLEX [ACECLOFENAC]), calcium (CITRICAL [CALCIUM]) and vitamin D (VITAMIN D [VITAMIN D NOS]). On 01Mar2021 08:00, the patient experienced sialadenitis (salivary gland inflammation), glossitis (tounge inflammation), inflammation of the mucosal lining of the oral cavity with cherry red discoloration and swelling of the lips. Tingling, prickly sensation on tongue when eating, cold items felt opposite of what they should, more like burning sensation were also reported. Onset of symptoms Monday morning, symptoms peaked Wednesday evening through midday Thursday, greatly improved by Friday morning. The patient had a COVID test on Friday to be sure and it was negative. There were no treatment for events. No COVID prior vaccination. The patient had a COVID test type post vaccination-Nasal Swab (Covid 2 PCR) on 05Mar2021 which was negative. The patient had The outcome of the events was recovered on unspecified date in Mar2021.
Age: 17.0
Sex: M
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: A 17 year old patient received Flublok, no AE; Initial information was received on 01-Mar-2021 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional.  This case involves a 17-year-old male patient who received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (batch number and expiry date not reported) via an unknown route in an unknown administration site for prophylactic vaccination on an unknown date (a few months from 18th birthday) (product administered to patient of inappropriate age).  The patient's past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  It was unknown if the patient experienced any additional symptoms/events.   The details of medication and reason for taking the medicine was unknown.  It is unknown if there were lab data/results available.  This was a case of actual medication error case due to inappropriate age at vaccine administration (latency same day).  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.