chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pyrexia, Tremor
Clinical narrative: allergic reactions; had a rash on the chest; it kind of looked like measles; she was like Parkinson's patient; entire body was shaking violently/left leg was going up and down; body aches; wicked headache; right eye had felt like it was burning from the inside; nauseous; her heart started racing for 4 hours; could not get warm from the chills; could still not get warm; fever/a fever that went up to 103 Fahrenheit; This is a spontaneous report from a Pfizer-sponsored program via Medical information team received by a contactable consumer reported for self. A 55-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration on 22Apr2021 as 2nd dose, single for covid-19 immunisation. Medical history included an underactive thyroid, to which she took low dose levothyroxine in the morning. The patient was reportedly healthy as she was a retired fitness and kick boxing instructor. The patient's concomitant medications were not reported. The patient previously took levothyroxine for underactive thyroid. Historical Vaccine included first dose of BNT162B2 for COVID-19 immunisation. The patient experienced some awful side effects from the Pfizer COVID Vaccine on Thursday, 22Apr2021, she took her 2nd dose of the vaccine and she felt like that she was going to have a fever which was expected. The next morning, Friday, on 23Apr2021, she mentioned that her entire body was shaking violently. Her left leg was going up and down, she could not hold a cup of tea on her right hand because it was shaking too much. She thought that she was like Parkinsons patient. She recorded a video of her symptoms. She mentioned that she had body aches, a fever that went up to 103 Fahrenheit, a wicked headache, her right eye had felt like it was burning from the inside, she was nauseous, and her heart started racing for 4 hours. She also could not get warm from the chills. She mentioned that she had to wear several layers and sit in a hot car but could still not get warm. She mentioned that she thought she was going to feel better by Saturday evening, but on 25Apr2021, Sunday, upon waking up she had a rash on the chest, between her boobs and under the bra line. She mentioned that it was kind of looked like measles. On 25Apr2021, Monday, she finally feels like herself. Nothing in her life has ever side-lined her like this and is kind of regretting getting vaccinated. According to what she had read, rashes and racing heartbeats within 4 hours are considered allergic reactions and if it occurred after those 4 hours, it will be fine.  Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Chills, Eye irritation, Feeling cold, Headache
Clinical narrative: allergic reactions; had a rash on the chest; it kind of looked like measles; she was like Parkinson's patient; entire body was shaking violently/left leg was going up and down; body aches; wicked headache; right eye had felt like it was burning from the inside; nauseous; her heart started racing for 4 hours; could not get warm from the chills; could still not get warm; fever/a fever that went up to 103 Fahrenheit; This is a spontaneous report from a Pfizer-sponsored program via Medical information team received by a contactable consumer reported for self. A 55-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration on 22Apr2021 as 2nd dose, single for covid-19 immunisation. Medical history included an underactive thyroid, to which she took low dose levothyroxine in the morning. The patient was reportedly healthy as she was a retired fitness and kick boxing instructor. The patient's concomitant medications were not reported. The patient previously took levothyroxine for underactive thyroid. Historical Vaccine included first dose of BNT162B2 for COVID-19 immunisation. The patient experienced some awful side effects from the Pfizer COVID Vaccine on Thursday, 22Apr2021, she took her 2nd dose of the vaccine and she felt like that she was going to have a fever which was expected. The next morning, Friday, on 23Apr2021, she mentioned that her entire body was shaking violently. Her left leg was going up and down, she could not hold a cup of tea on her right hand because it was shaking too much. She thought that she was like Parkinsons patient. She recorded a video of her symptoms. She mentioned that she had body aches, a fever that went up to 103 Fahrenheit, a wicked headache, her right eye had felt like it was burning from the inside, she was nauseous, and her heart started racing for 4 hours. She also could not get warm from the chills. She mentioned that she had to wear several layers and sit in a hot car but could still not get warm. She mentioned that she thought she was going to feel better by Saturday evening, but on 25Apr2021, Sunday, upon waking up she had a rash on the chest, between her boobs and under the bra line. She mentioned that it was kind of looked like measles. On 25Apr2021, Monday, she finally feels like herself. Nothing in her life has ever side-lined her like this and is kind of regretting getting vaccinated. According to what she had read, rashes and racing heartbeats within 4 hours are considered allergic reactions and if it occurred after those 4 hours, it will be fine.  Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypersensitivity, Measles, Nausea, Pain, Palpitations
Clinical narrative: allergic reactions; had a rash on the chest; it kind of looked like measles; she was like Parkinson's patient; entire body was shaking violently/left leg was going up and down; body aches; wicked headache; right eye had felt like it was burning from the inside; nauseous; her heart started racing for 4 hours; could not get warm from the chills; could still not get warm; fever/a fever that went up to 103 Fahrenheit; This is a spontaneous report from a Pfizer-sponsored program via Medical information team received by a contactable consumer reported for self. A 55-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration on 22Apr2021 as 2nd dose, single for covid-19 immunisation. Medical history included an underactive thyroid, to which she took low dose levothyroxine in the morning. The patient was reportedly healthy as she was a retired fitness and kick boxing instructor. The patient's concomitant medications were not reported. The patient previously took levothyroxine for underactive thyroid. Historical Vaccine included first dose of BNT162B2 for COVID-19 immunisation. The patient experienced some awful side effects from the Pfizer COVID Vaccine on Thursday, 22Apr2021, she took her 2nd dose of the vaccine and she felt like that she was going to have a fever which was expected. The next morning, Friday, on 23Apr2021, she mentioned that her entire body was shaking violently. Her left leg was going up and down, she could not hold a cup of tea on her right hand because it was shaking too much. She thought that she was like Parkinsons patient. She recorded a video of her symptoms. She mentioned that she had body aches, a fever that went up to 103 Fahrenheit, a wicked headache, her right eye had felt like it was burning from the inside, she was nauseous, and her heart started racing for 4 hours. She also could not get warm from the chills. She mentioned that she had to wear several layers and sit in a hot car but could still not get warm. She mentioned that she thought she was going to feel better by Saturday evening, but on 25Apr2021, Sunday, upon waking up she had a rash on the chest, between her boobs and under the bra line. She mentioned that it was kind of looked like measles. On 25Apr2021, Monday, she finally feels like herself. Nothing in her life has ever side-lined her like this and is kind of regretting getting vaccinated. According to what she had read, rashes and racing heartbeats within 4 hours are considered allergic reactions and if it occurred after those 4 hours, it will be fine.  Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Parkinson's disease, Pyrexia, Rash, Tremor
Clinical narrative: allergic reactions; had a rash on the chest; it kind of looked like measles; she was like Parkinson's patient; entire body was shaking violently/left leg was going up and down; body aches; wicked headache; right eye had felt like it was burning from the inside; nauseous; her heart started racing for 4 hours; could not get warm from the chills; could still not get warm; fever/a fever that went up to 103 Fahrenheit; This is a spontaneous report from a Pfizer-sponsored program via Medical information team received by a contactable consumer reported for self. A 55-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration on 22Apr2021 as 2nd dose, single for covid-19 immunisation. Medical history included an underactive thyroid, to which she took low dose levothyroxine in the morning. The patient was reportedly healthy as she was a retired fitness and kick boxing instructor. The patient's concomitant medications were not reported. The patient previously took levothyroxine for underactive thyroid. Historical Vaccine included first dose of BNT162B2 for COVID-19 immunisation. The patient experienced some awful side effects from the Pfizer COVID Vaccine on Thursday, 22Apr2021, she took her 2nd dose of the vaccine and she felt like that she was going to have a fever which was expected. The next morning, Friday, on 23Apr2021, she mentioned that her entire body was shaking violently. Her left leg was going up and down, she could not hold a cup of tea on her right hand because it was shaking too much. She thought that she was like Parkinsons patient. She recorded a video of her symptoms. She mentioned that she had body aches, a fever that went up to 103 Fahrenheit, a wicked headache, her right eye had felt like it was burning from the inside, she was nauseous, and her heart started racing for 4 hours. She also could not get warm from the chills. She mentioned that she had to wear several layers and sit in a hot car but could still not get warm. She mentioned that she thought she was going to feel better by Saturday evening, but on 25Apr2021, Sunday, upon waking up she had a rash on the chest, between her boobs and under the bra line. She mentioned that it was kind of looked like measles. On 25Apr2021, Monday, she finally feels like herself. Nothing in her life has ever side-lined her like this and is kind of regretting getting vaccinated. According to what she had read, rashes and racing heartbeats within 4 hours are considered allergic reactions and if it occurred after those 4 hours, it will be fine.  Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Attention deficit hyperactivity disorder, Dysphagia, Electric shock sensation, Laboratory test, Nervousness
Clinical narrative: felt faintness; a quick electric shock across top of head; momentary faintness; having trouble swallowing/uncomfortable to swallow; throat felt sore; Throat remained irritated; mild discomfort in her shoulder; stuffy ears; This is a spontaneous report from a Pfizer-sponsored program  by a contactable consumer (patient).     This 58-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 26Mar2021 12:45 (Lot Number: EN6205) as single dose for COVID-19 immunisation. Medical history included hypertension, asthma, chronic obstructive pulmonary disease (COPD), allergies: Penicillin, environmental allergies. Concomitant medications included lisinopril; montelukast sodium (SINGULAIR); cetirizine hydrochloride (ZYRTEC ALLERGY); bupropion; fluticasone propionate, salmeterol xinafoate (ADVAIR); prednisolone (SPIRICORT).  On 26Mar2021 13:00, the patient experienced felt faintness, a quick electric shock across top of head, momentary faintness, having trouble swallowing/uncomfortable to swallow, throat felt sore, throat remained irritated, mild discomfort in her shoulder, stuffy ears.  No treatment required for the events. The outcome of the event felt faintness was recovered and the outcome for the other events was unknown.  The clinical course was reported as follows: She received her first Pfizer Covid vaccine on 26Mar2021. Within a few minutes, she felt faintness and had difficulty swallowing. She stayed for 30 minutes, it didn't go away but it didn't get worse and she left and went home. She a reports a history of allergies, asthma, COPD. She reports that she did not have compromised breathing. She states she could eat or drink but had a perpetual feeling of difficulty swallowing. She also had mild discomfort in her shoulder, sore throat, and stuffy ears. She reports her difficulty swallowing went away after 10 hours. She took Zyrtex, Singulair, and 3 different inhalers before the vaccine. She is wondering if it is possible that these medications blunted an anaphylactic reaction? Her MD gave her an epipen to take with her for her second dose. She takes lisinopril also.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Oropharyngeal pain, Syncope, Throat clearing, Throat tightness
Clinical narrative: felt faintness; a quick electric shock across top of head; momentary faintness; having trouble swallowing/uncomfortable to swallow; throat felt sore; Throat remained irritated; mild discomfort in her shoulder; stuffy ears; This is a spontaneous report from a Pfizer-sponsored program  by a contactable consumer (patient).     This 58-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 26Mar2021 12:45 (Lot Number: EN6205) as single dose for COVID-19 immunisation. Medical history included hypertension, asthma, chronic obstructive pulmonary disease (COPD), allergies: Penicillin, environmental allergies. Concomitant medications included lisinopril; montelukast sodium (SINGULAIR); cetirizine hydrochloride (ZYRTEC ALLERGY); bupropion; fluticasone propionate, salmeterol xinafoate (ADVAIR); prednisolone (SPIRICORT).  On 26Mar2021 13:00, the patient experienced felt faintness, a quick electric shock across top of head, momentary faintness, having trouble swallowing/uncomfortable to swallow, throat felt sore, throat remained irritated, mild discomfort in her shoulder, stuffy ears.  No treatment required for the events. The outcome of the event felt faintness was recovered and the outcome for the other events was unknown.  The clinical course was reported as follows: She received her first Pfizer Covid vaccine on 26Mar2021. Within a few minutes, she felt faintness and had difficulty swallowing. She stayed for 30 minutes, it didn't go away but it didn't get worse and she left and went home. She a reports a history of allergies, asthma, COPD. She reports that she did not have compromised breathing. She states she could eat or drink but had a perpetual feeling of difficulty swallowing. She also had mild discomfort in her shoulder, sore throat, and stuffy ears. She reports her difficulty swallowing went away after 10 hours. She took Zyrtex, Singulair, and 3 different inhalers before the vaccine. She is wondering if it is possible that these medications blunted an anaphylactic reaction? Her MD gave her an epipen to take with her for her second dose. She takes lisinopril also.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dysphagia, Ear discomfort, Electric shock, Musculoskeletal discomfort
Clinical narrative: felt faintness; a quick electric shock across top of head; momentary faintness; having trouble swallowing/uncomfortable to swallow; throat felt sore; Throat remained irritated; mild discomfort in her shoulder; stuffy ears; This is a spontaneous report from a Pfizer-sponsored program  by a contactable consumer (patient).     This 58-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 26Mar2021 12:45 (Lot Number: EN6205) as single dose for COVID-19 immunisation. Medical history included hypertension, asthma, chronic obstructive pulmonary disease (COPD), allergies: Penicillin, environmental allergies. Concomitant medications included lisinopril; montelukast sodium (SINGULAIR); cetirizine hydrochloride (ZYRTEC ALLERGY); bupropion; fluticasone propionate, salmeterol xinafoate (ADVAIR); prednisolone (SPIRICORT).  On 26Mar2021 13:00, the patient experienced felt faintness, a quick electric shock across top of head, momentary faintness, having trouble swallowing/uncomfortable to swallow, throat felt sore, throat remained irritated, mild discomfort in her shoulder, stuffy ears.  No treatment required for the events. The outcome of the event felt faintness was recovered and the outcome for the other events was unknown.  The clinical course was reported as follows: She received her first Pfizer Covid vaccine on 26Mar2021. Within a few minutes, she felt faintness and had difficulty swallowing. She stayed for 30 minutes, it didn't go away but it didn't get worse and she left and went home. She a reports a history of allergies, asthma, COPD. She reports that she did not have compromised breathing. She states she could eat or drink but had a perpetual feeling of difficulty swallowing. She also had mild discomfort in her shoulder, sore throat, and stuffy ears. She reports her difficulty swallowing went away after 10 hours. She took Zyrtex, Singulair, and 3 different inhalers before the vaccine. She is wondering if it is possible that these medications blunted an anaphylactic reaction? Her MD gave her an epipen to take with her for her second dose. She takes lisinopril also.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Oropharyngeal pain, Presyncope, Throat irritation
Clinical narrative: felt faintness; a quick electric shock across top of head; momentary faintness; having trouble swallowing/uncomfortable to swallow; throat felt sore; Throat remained irritated; mild discomfort in her shoulder; stuffy ears; This is a spontaneous report from a Pfizer-sponsored program  by a contactable consumer (patient).     This 58-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 26Mar2021 12:45 (Lot Number: EN6205) as single dose for COVID-19 immunisation. Medical history included hypertension, asthma, chronic obstructive pulmonary disease (COPD), allergies: Penicillin, environmental allergies. Concomitant medications included lisinopril; montelukast sodium (SINGULAIR); cetirizine hydrochloride (ZYRTEC ALLERGY); bupropion; fluticasone propionate, salmeterol xinafoate (ADVAIR); prednisolone (SPIRICORT).  On 26Mar2021 13:00, the patient experienced felt faintness, a quick electric shock across top of head, momentary faintness, having trouble swallowing/uncomfortable to swallow, throat felt sore, throat remained irritated, mild discomfort in her shoulder, stuffy ears.  No treatment required for the events. The outcome of the event felt faintness was recovered and the outcome for the other events was unknown.  The clinical course was reported as follows: She received her first Pfizer Covid vaccine on 26Mar2021. Within a few minutes, she felt faintness and had difficulty swallowing. She stayed for 30 minutes, it didn't go away but it didn't get worse and she left and went home. She a reports a history of allergies, asthma, COPD. She reports that she did not have compromised breathing. She states she could eat or drink but had a perpetual feeling of difficulty swallowing. She also had mild discomfort in her shoulder, sore throat, and stuffy ears. She reports her difficulty swallowing went away after 10 hours. She took Zyrtex, Singulair, and 3 different inhalers before the vaccine. She is wondering if it is possible that these medications blunted an anaphylactic reaction? Her MD gave her an epipen to take with her for her second dose. She takes lisinopril also.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Alanine aminotransferase increased, Aspartate aminotransferase increased, Computerised tomogram abdomen normal, Dehydration
Clinical narrative: 2 days after vaccination had severe abdominal pain; could not urinate for 8.5 hours before going to ER; 6 hours later even higher ALT 4359,AST4755; 6 hours later even higher ALT 4359,AST4755; consistent with medication toxicity; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EW0150 and expiration date was not reported), via an unspecified route of administration in right arm on 12Apr2021 (at the age of 49 years) as single dose for COVID-19 immunization at doctor's office/urgent care. Medical history included on von willebrand's disease and sulfa drug allergy. Other medications received by the patient within 2 weeks of vaccination (concomitant medications) was vitamin-D 50,000 IU per week and vitamin-C (ascorbic acid) 1000 IU. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6206 and expiration date was not reported), via an unspecified route of administration in right arm on 16Mar2021 (at the age of 49 years) as single dose for COVID-19 immunization. The patient was not pregnant at the vaccination time. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. Two days after the vaccination (14Apr2021), the patient had severe abdominal pain and could not urinate for 8.5 hours before going to emergency room (ER). The liver enzymes alanine aminotransferase (ALT) was 1,599 (units not reported) and aspartate aminotransferase (AST) was 17,655 (units not reported). Six hours later even higher with ALT 4,359 (units not reported) and AST 4,755 (units not reported). Computerized tomography (CT) and all other liver tests and organ tests were completely normal. The patient was hospitalized for these events. The patient was consistent with medication toxicity and was treated for it (only new med the patient took was COVID vaccine - liver enzymes were checked 6 weeks prior at routine appointment and were completely normal) with intravenous (IV) antibiotics, N-acetylcysteine (NAC) every 4 hours, potassium and fluids. The patient was discharged on 19Apr2021 with a duration of 5 days after supportive care and enzymes consistently going down. The current AST was 34 (units not reported) and ALT was 377(units not reported). These adverse events results in ER visit or urgent care facility. The outcome of these events was recovering at the time of report.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysuria, Electrocardiogram normal, Hepatic enzyme abnormal, Liver function test normal, Nausea
Clinical narrative: 2 days after vaccination had severe abdominal pain; could not urinate for 8.5 hours before going to ER; 6 hours later even higher ALT 4359,AST4755; 6 hours later even higher ALT 4359,AST4755; consistent with medication toxicity; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EW0150 and expiration date was not reported), via an unspecified route of administration in right arm on 12Apr2021 (at the age of 49 years) as single dose for COVID-19 immunization at doctor's office/urgent care. Medical history included on von willebrand's disease and sulfa drug allergy. Other medications received by the patient within 2 weeks of vaccination (concomitant medications) was vitamin-D 50,000 IU per week and vitamin-C (ascorbic acid) 1000 IU. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6206 and expiration date was not reported), via an unspecified route of administration in right arm on 16Mar2021 (at the age of 49 years) as single dose for COVID-19 immunization. The patient was not pregnant at the vaccination time. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. Two days after the vaccination (14Apr2021), the patient had severe abdominal pain and could not urinate for 8.5 hours before going to emergency room (ER). The liver enzymes alanine aminotransferase (ALT) was 1,599 (units not reported) and aspartate aminotransferase (AST) was 17,655 (units not reported). Six hours later even higher with ALT 4,359 (units not reported) and AST 4,755 (units not reported). Computerized tomography (CT) and all other liver tests and organ tests were completely normal. The patient was hospitalized for these events. The patient was consistent with medication toxicity and was treated for it (only new med the patient took was COVID vaccine - liver enzymes were checked 6 weeks prior at routine appointment and were completely normal) with intravenous (IV) antibiotics, N-acetylcysteine (NAC) every 4 hours, potassium and fluids. The patient was discharged on 19Apr2021 with a duration of 5 days after supportive care and enzymes consistently going down. The current AST was 34 (units not reported) and ALT was 377(units not reported). These adverse events results in ER visit or urgent care facility. The outcome of these events was recovering at the time of report.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ultrasound abdomen normal
Clinical narrative: 2 days after vaccination had severe abdominal pain; could not urinate for 8.5 hours before going to ER; 6 hours later even higher ALT 4359,AST4755; 6 hours later even higher ALT 4359,AST4755; consistent with medication toxicity; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EW0150 and expiration date was not reported), via an unspecified route of administration in right arm on 12Apr2021 (at the age of 49 years) as single dose for COVID-19 immunization at doctor's office/urgent care. Medical history included on von willebrand's disease and sulfa drug allergy. Other medications received by the patient within 2 weeks of vaccination (concomitant medications) was vitamin-D 50,000 IU per week and vitamin-C (ascorbic acid) 1000 IU. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6206 and expiration date was not reported), via an unspecified route of administration in right arm on 16Mar2021 (at the age of 49 years) as single dose for COVID-19 immunization. The patient was not pregnant at the vaccination time. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. Two days after the vaccination (14Apr2021), the patient had severe abdominal pain and could not urinate for 8.5 hours before going to emergency room (ER). The liver enzymes alanine aminotransferase (ALT) was 1,599 (units not reported) and aspartate aminotransferase (AST) was 17,655 (units not reported). Six hours later even higher with ALT 4,359 (units not reported) and AST 4,755 (units not reported). Computerized tomography (CT) and all other liver tests and organ tests were completely normal. The patient was hospitalized for these events. The patient was consistent with medication toxicity and was treated for it (only new med the patient took was COVID vaccine - liver enzymes were checked 6 weeks prior at routine appointment and were completely normal) with intravenous (IV) antibiotics, N-acetylcysteine (NAC) every 4 hours, potassium and fluids. The patient was discharged on 19Apr2021 with a duration of 5 days after supportive care and enzymes consistently going down. The current AST was 34 (units not reported) and ALT was 377(units not reported). These adverse events results in ER visit or urgent care facility. The outcome of these events was recovering at the time of report.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Alanine aminotransferase, Alanine aminotransferase increased, Aspartate aminotransferase, Aspartate aminotransferase increased
Clinical narrative: 2 days after vaccination had severe abdominal pain; could not urinate for 8.5 hours before going to ER; 6 hours later even higher ALT 4359,AST4755; 6 hours later even higher ALT 4359,AST4755; consistent with medication toxicity; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EW0150 and expiration date was not reported), via an unspecified route of administration in right arm on 12Apr2021 (at the age of 49 years) as single dose for COVID-19 immunization at doctor's office/urgent care. Medical history included on von willebrand's disease and sulfa drug allergy. Other medications received by the patient within 2 weeks of vaccination (concomitant medications) was vitamin-D 50,000 IU per week and vitamin-C (ascorbic acid) 1000 IU. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6206 and expiration date was not reported), via an unspecified route of administration in right arm on 16Mar2021 (at the age of 49 years) as single dose for COVID-19 immunization. The patient was not pregnant at the vaccination time. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. Two days after the vaccination (14Apr2021), the patient had severe abdominal pain and could not urinate for 8.5 hours before going to emergency room (ER). The liver enzymes alanine aminotransferase (ALT) was 1,599 (units not reported) and aspartate aminotransferase (AST) was 17,655 (units not reported). Six hours later even higher with ALT 4,359 (units not reported) and AST 4,755 (units not reported). Computerized tomography (CT) and all other liver tests and organ tests were completely normal. The patient was hospitalized for these events. The patient was consistent with medication toxicity and was treated for it (only new med the patient took was COVID vaccine - liver enzymes were checked 6 weeks prior at routine appointment and were completely normal) with intravenous (IV) antibiotics, N-acetylcysteine (NAC) every 4 hours, potassium and fluids. The patient was discharged on 19Apr2021 with a duration of 5 days after supportive care and enzymes consistently going down. The current AST was 34 (units not reported) and ALT was 377(units not reported). These adverse events results in ER visit or urgent care facility. The outcome of these events was recovering at the time of report.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram, Dysuria, Investigation, Liver function test, Toxicity to various agents
Clinical narrative: 2 days after vaccination had severe abdominal pain; could not urinate for 8.5 hours before going to ER; 6 hours later even higher ALT 4359,AST4755; 6 hours later even higher ALT 4359,AST4755; consistent with medication toxicity; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EW0150 and expiration date was not reported), via an unspecified route of administration in right arm on 12Apr2021 (at the age of 49 years) as single dose for COVID-19 immunization at doctor's office/urgent care. Medical history included on von willebrand's disease and sulfa drug allergy. Other medications received by the patient within 2 weeks of vaccination (concomitant medications) was vitamin-D 50,000 IU per week and vitamin-C (ascorbic acid) 1000 IU. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6206 and expiration date was not reported), via an unspecified route of administration in right arm on 16Mar2021 (at the age of 49 years) as single dose for COVID-19 immunization. The patient was not pregnant at the vaccination time. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. Two days after the vaccination (14Apr2021), the patient had severe abdominal pain and could not urinate for 8.5 hours before going to emergency room (ER). The liver enzymes alanine aminotransferase (ALT) was 1,599 (units not reported) and aspartate aminotransferase (AST) was 17,655 (units not reported). Six hours later even higher with ALT 4,359 (units not reported) and AST 4,755 (units not reported). Computerized tomography (CT) and all other liver tests and organ tests were completely normal. The patient was hospitalized for these events. The patient was consistent with medication toxicity and was treated for it (only new med the patient took was COVID vaccine - liver enzymes were checked 6 weeks prior at routine appointment and were completely normal) with intravenous (IV) antibiotics, N-acetylcysteine (NAC) every 4 hours, potassium and fluids. The patient was discharged on 19Apr2021 with a duration of 5 days after supportive care and enzymes consistently going down. The current AST was 34 (units not reported) and ALT was 377(units not reported). These adverse events results in ER visit or urgent care facility. The outcome of these events was recovering at the time of report.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Headache, Loss of consciousness, Nausea, Pyrexia
Clinical narrative: passed out; ran a fever fluctuating between 103F and 106 F (measured on three different thermometers) from 700 to 1030; severe nausea; dizziness; headache that made it impossible to sit up without vomiting; headache that made it impossible to sit up without vomiting, could not keep down liquids other than water; This is a spontaneous report from a contactable consumer or other non hcp. A 39-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) (Batch/Lot Number: ER8735), dose 2, via an unspecified route of administration in the left arm on 24Apr2021 at 16:30 (at the age of 39-years-old) as a single dose for covid-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. No other medications were received within 2 weeks of the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) (batch/lot number: Unknown), dose #1, via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization and experienced no adverse effects. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 25Apr2021, the patient ran a fever fluctuating between 103F and 106F (measured on 3 different thermometers) from 0700 to 1030. She experienced severe nausea, dizziness and a headache that made it impossible to sit up without vomiting. The patient could not keep down liquids other than water. She passed out at 1030 and woke at 1400. Her fever was then at 100.1F at 1400 to 1830 and would not drop further despite cold showers and Tylenol. The patient called urgent care once she could sit up at 1830 and increased the Tylenol dosage. She stated she never had this high of a fever for this sustained time period in her life. The adverse events resulted in an emergency room/department or urgent care visit via Telehealth. The patient underwent lab tests and procedures which included body temperature (25Apr2021): fluctuating between 103F and 106F from 0700 to 1030 and body temperature (25Apr2021): 100.1F at 1400 to 1830. Clinical outcome of events ran a fever fluctuating between 103F and 106F (measured on 3 different thermometers) from 0700 to 1030. She experienced severe nausea, dizziness, headache that made it impossible to sit up without vomiting, could not keep down liquids other than water and passed out at 1030 and woke at 1400 was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  Follow up needed, further information has been requested.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: passed out; ran a fever fluctuating between 103F and 106 F (measured on three different thermometers) from 700 to 1030; severe nausea; dizziness; headache that made it impossible to sit up without vomiting; headache that made it impossible to sit up without vomiting, could not keep down liquids other than water; This is a spontaneous report from a contactable consumer or other non hcp. A 39-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) (Batch/Lot Number: ER8735), dose 2, via an unspecified route of administration in the left arm on 24Apr2021 at 16:30 (at the age of 39-years-old) as a single dose for covid-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. No other medications were received within 2 weeks of the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) (batch/lot number: Unknown), dose #1, via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization and experienced no adverse effects. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 25Apr2021, the patient ran a fever fluctuating between 103F and 106F (measured on 3 different thermometers) from 0700 to 1030. She experienced severe nausea, dizziness and a headache that made it impossible to sit up without vomiting. The patient could not keep down liquids other than water. She passed out at 1030 and woke at 1400. Her fever was then at 100.1F at 1400 to 1830 and would not drop further despite cold showers and Tylenol. The patient called urgent care once she could sit up at 1830 and increased the Tylenol dosage. She stated she never had this high of a fever for this sustained time period in her life. The adverse events resulted in an emergency room/department or urgent care visit via Telehealth. The patient underwent lab tests and procedures which included body temperature (25Apr2021): fluctuating between 103F and 106F from 0700 to 1030 and body temperature (25Apr2021): 100.1F at 1400 to 1830. Clinical outcome of events ran a fever fluctuating between 103F and 106F (measured on 3 different thermometers) from 0700 to 1030. She experienced severe nausea, dizziness, headache that made it impossible to sit up without vomiting, could not keep down liquids other than water and passed out at 1030 and woke at 1400 was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  Follow up needed, further information has been requested.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Dizziness, Headache, Loss of consciousness, Nausea
Clinical narrative: passed out; ran a fever fluctuating between 103F and 106 F (measured on three different thermometers) from 700 to 1030; severe nausea; dizziness; headache that made it impossible to sit up without vomiting; headache that made it impossible to sit up without vomiting, could not keep down liquids other than water; This is a spontaneous report from a contactable consumer or other non hcp. A 39-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) (Batch/Lot Number: ER8735), dose 2, via an unspecified route of administration in the left arm on 24Apr2021 at 16:30 (at the age of 39-years-old) as a single dose for covid-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. No other medications were received within 2 weeks of the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) (batch/lot number: Unknown), dose #1, via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization and experienced no adverse effects. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 25Apr2021, the patient ran a fever fluctuating between 103F and 106F (measured on 3 different thermometers) from 0700 to 1030. She experienced severe nausea, dizziness and a headache that made it impossible to sit up without vomiting. The patient could not keep down liquids other than water. She passed out at 1030 and woke at 1400. Her fever was then at 100.1F at 1400 to 1830 and would not drop further despite cold showers and Tylenol. The patient called urgent care once she could sit up at 1830 and increased the Tylenol dosage. She stated she never had this high of a fever for this sustained time period in her life. The adverse events resulted in an emergency room/department or urgent care visit via Telehealth. The patient underwent lab tests and procedures which included body temperature (25Apr2021): fluctuating between 103F and 106F from 0700 to 1030 and body temperature (25Apr2021): 100.1F at 1400 to 1830. Clinical outcome of events ran a fever fluctuating between 103F and 106F (measured on 3 different thermometers) from 0700 to 1030. She experienced severe nausea, dizziness, headache that made it impossible to sit up without vomiting, could not keep down liquids other than water and passed out at 1030 and woke at 1400 was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  Follow up needed, further information has been requested.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: passed out; ran a fever fluctuating between 103F and 106 F (measured on three different thermometers) from 700 to 1030; severe nausea; dizziness; headache that made it impossible to sit up without vomiting; headache that made it impossible to sit up without vomiting, could not keep down liquids other than water; This is a spontaneous report from a contactable consumer or other non hcp. A 39-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) (Batch/Lot Number: ER8735), dose 2, via an unspecified route of administration in the left arm on 24Apr2021 at 16:30 (at the age of 39-years-old) as a single dose for covid-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. No other medications were received within 2 weeks of the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) (batch/lot number: Unknown), dose #1, via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization and experienced no adverse effects. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 25Apr2021, the patient ran a fever fluctuating between 103F and 106F (measured on 3 different thermometers) from 0700 to 1030. She experienced severe nausea, dizziness and a headache that made it impossible to sit up without vomiting. The patient could not keep down liquids other than water. She passed out at 1030 and woke at 1400. Her fever was then at 100.1F at 1400 to 1830 and would not drop further despite cold showers and Tylenol. The patient called urgent care once she could sit up at 1830 and increased the Tylenol dosage. She stated she never had this high of a fever for this sustained time period in her life. The adverse events resulted in an emergency room/department or urgent care visit via Telehealth. The patient underwent lab tests and procedures which included body temperature (25Apr2021): fluctuating between 103F and 106F from 0700 to 1030 and body temperature (25Apr2021): 100.1F at 1400 to 1830. Clinical outcome of events ran a fever fluctuating between 103F and 106F (measured on 3 different thermometers) from 0700 to 1030. She experienced severe nausea, dizziness, headache that made it impossible to sit up without vomiting, could not keep down liquids other than water and passed out at 1030 and woke at 1400 was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  Follow up needed, further information has been requested.
Age: 82.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Joint stiffness, Joint swelling
Clinical narrative: Left knee started to swell and reports that it is painful; Left knee started to swell and reports that it is painful; It is is stiff; This is a spontaneous report from a contactable consumer (patient). A 82-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiry date unknown), via an unspecified route of administration on an unspecified date (at the age 82-year-old) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient states that about a week and a half to two weeks after, her left knee started to swell and reports that it is painful. She states that it is not an "excruciating" pain but does report that it is really bothering her and that it is stiff. She is concerned that this may be an autoimmune response to the vaccine. She also mentions that she received her second dose of the vaccine the day before yesterday. The patient states that when she took Tylenol and placed ice on it, the swelling seemed to go down a little bit and does not know if she should continue with icing it and resting it, or if she should see her doctor. Outcome of the event was not reported.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pruritus, Rash
Clinical narrative: itchiness last night; eyes are begun swollen a little bit; some hives/red patches; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (Patient's mother) reported for her son. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: Unknown), dose 1 via an unspecified route of administration on 25Apr2021 as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that her son experienced itchiness last night and eyes were begun swollen a little bit, also experienced red patches/ some hives. The outcome of the events reported as unknown.   Follow-up received on 26Apr2021, no new information.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.