chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Bacterial infection, Blood pressure abnormal, Blood pressure measurement, Burning sensation
Clinical narrative: CELLULITIS; Bacterial infection; SWELLING; ITCHING; burning; couldn't lift her arm; JOINT PAIN; dry cough; nausea; diarrhea after drinking milk; improvement in blood pressure; This is a spontaneous report from a contactable consumer and a nurse, based on information received by Pfizer from clinic  (manufacturer control number: EC-2021-090067) for BNT162B2.  A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route single dose for COVID-19 immunization on unknown date; lenvatinib mesilate (LENVIMA, Lot number: 1265576, Expiration date: 31Oct2023) oral 14mg (10mg/4mg) daily for malignant neoplasm of endometrium from 12Mar2021. Medical history included: metastatic uterine cancer (to left fallopian tube and lymph nodes), hyperlipidemia, thrombocytopenia; allergies: diphenhydramine hydrochloride (BENADRYL), sumatriptan succinate (IMITREX), hydrocodone bitartrate, paracetamol (NORCO). Concomitant medication included: magnesium, amlodipine; levothyroxine sodium; ondansetron; echinacea; paracetamol (TYLENOL); ascorbic acid (VITAMIN C); Vitamin D3; trazodone; prochlorperazine maleate; cyclobenzaprine; lidocaine hydrochloride, prilocaine hydrochloride (LIDOCAINE PRILOCAINE BIOGARAN); doxycyline hyclate. Patient had a bacterial infection, cellulitis in her arm that started 2 days after 1st vaccination. She had swelling, itching, burning and couldn't lift her arm; missed lenvatinib mesilate 1 day to see if pain was due to LENVIMA or the vaccine; stated some joint pain improved on the day off, but other symptoms persisted so she went to the urgent care and was put on antibiotics; also reported 'joints', dry cough, nausea, diarrhea after drinking milk; improvement in blood pressure. Action taken for lenvatinib mesilate was temporarily withdrawn on unknown date. Outcome of the events joint pain and blood pressure abnormal was resolving, outcome of the events dry cough, nausea, diarrhea after drinking milk was unknown; outcome of the other events was not resolved.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Cellulitis, Cough, Diarrhoea, Hypokinesia, Nausea
Clinical narrative: CELLULITIS; Bacterial infection; SWELLING; ITCHING; burning; couldn't lift her arm; JOINT PAIN; dry cough; nausea; diarrhea after drinking milk; improvement in blood pressure; This is a spontaneous report from a contactable consumer and a nurse, based on information received by Pfizer from clinic  (manufacturer control number: EC-2021-090067) for BNT162B2.  A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route single dose for COVID-19 immunization on unknown date; lenvatinib mesilate (LENVIMA, Lot number: 1265576, Expiration date: 31Oct2023) oral 14mg (10mg/4mg) daily for malignant neoplasm of endometrium from 12Mar2021. Medical history included: metastatic uterine cancer (to left fallopian tube and lymph nodes), hyperlipidemia, thrombocytopenia; allergies: diphenhydramine hydrochloride (BENADRYL), sumatriptan succinate (IMITREX), hydrocodone bitartrate, paracetamol (NORCO). Concomitant medication included: magnesium, amlodipine; levothyroxine sodium; ondansetron; echinacea; paracetamol (TYLENOL); ascorbic acid (VITAMIN C); Vitamin D3; trazodone; prochlorperazine maleate; cyclobenzaprine; lidocaine hydrochloride, prilocaine hydrochloride (LIDOCAINE PRILOCAINE BIOGARAN); doxycyline hyclate. Patient had a bacterial infection, cellulitis in her arm that started 2 days after 1st vaccination. She had swelling, itching, burning and couldn't lift her arm; missed lenvatinib mesilate 1 day to see if pain was due to LENVIMA or the vaccine; stated some joint pain improved on the day off, but other symptoms persisted so she went to the urgent care and was put on antibiotics; also reported 'joints', dry cough, nausea, diarrhea after drinking milk; improvement in blood pressure. Action taken for lenvatinib mesilate was temporarily withdrawn on unknown date. Outcome of the events joint pain and blood pressure abnormal was resolving, outcome of the events dry cough, nausea, diarrhea after drinking milk was unknown; outcome of the other events was not resolved.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pruritus, Swelling
Clinical narrative: CELLULITIS; Bacterial infection; SWELLING; ITCHING; burning; couldn't lift her arm; JOINT PAIN; dry cough; nausea; diarrhea after drinking milk; improvement in blood pressure; This is a spontaneous report from a contactable consumer and a nurse, based on information received by Pfizer from clinic  (manufacturer control number: EC-2021-090067) for BNT162B2.  A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route single dose for COVID-19 immunization on unknown date; lenvatinib mesilate (LENVIMA, Lot number: 1265576, Expiration date: 31Oct2023) oral 14mg (10mg/4mg) daily for malignant neoplasm of endometrium from 12Mar2021. Medical history included: metastatic uterine cancer (to left fallopian tube and lymph nodes), hyperlipidemia, thrombocytopenia; allergies: diphenhydramine hydrochloride (BENADRYL), sumatriptan succinate (IMITREX), hydrocodone bitartrate, paracetamol (NORCO). Concomitant medication included: magnesium, amlodipine; levothyroxine sodium; ondansetron; echinacea; paracetamol (TYLENOL); ascorbic acid (VITAMIN C); Vitamin D3; trazodone; prochlorperazine maleate; cyclobenzaprine; lidocaine hydrochloride, prilocaine hydrochloride (LIDOCAINE PRILOCAINE BIOGARAN); doxycyline hyclate. Patient had a bacterial infection, cellulitis in her arm that started 2 days after 1st vaccination. She had swelling, itching, burning and couldn't lift her arm; missed lenvatinib mesilate 1 day to see if pain was due to LENVIMA or the vaccine; stated some joint pain improved on the day off, but other symptoms persisted so she went to the urgent care and was put on antibiotics; also reported 'joints', dry cough, nausea, diarrhea after drinking milk; improvement in blood pressure. Action taken for lenvatinib mesilate was temporarily withdrawn on unknown date. Outcome of the events joint pain and blood pressure abnormal was resolving, outcome of the events dry cough, nausea, diarrhea after drinking milk was unknown; outcome of the other events was not resolved.   Information on the lot/batch number has been requested.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Heart rate, Heart rate increased, SARS-CoV-2 test
Clinical narrative: Intermittent chest pain. Very sharp and shooting. Intermittent racing pulse when at rest. Events are completely random and not identified or brought on by any factors. Was hospitalized; Intermittent chest pain. Very sharp and shooting. Intermittent racing pulse when at rest. Events are completely random and not identified or brought on by any factors. Was hospitalized; This is a spontaneous report from a contactable nurse (patient). A 36-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 01Mar2021 10:00 (Batch/Lot number was not reported) (at age of 36 years) as 2ND DOSE, SINGLE for COVID-19 immunisation. The patient medical history was none. There were no concomitant medications. No other vaccines in four weeks. No other medications in two weeks. No COVID prior vaccination. Patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 on unknown date (Batch/Lot number unknown) for COVID-19 immunisation. Vaccine facility type was in workplace clinic. The patient experienced intermittent chest pain, very sharp and shooting, intermittent racing pulse when at rest on 31Mar2021. Events were completely random and not identified or brought on by any factors. Patient was hospitalized. Covid was tested post vaccination (unknown results), covid test type post vaccination was no. Events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The outcome of events was not recovered. It was unknown if treatment was used for events.  Information about the Lot/batch number has been requested.; Sender's Comments: Based on the temporal relationship, the association between the events "intermittent chest pain, very sharp and shooting, intermittent racing pulse when at rest" with BNT162b2 can not be completely excluded in this patient that is relatively young and has no reported known illnesses.  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: 60.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a contactable consumer (patient). A 60-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 on 13Apr2021 08:00 (Lot Number: Ew0151) at 60-year-old as 1ST DOSE, SINGLE for covid-19 immunisation. Facility type vaccine was Pharmacy or Drug Store. Medical history included Known allergies: Sulfur drug, Avocado. There were no concomitant medications.  No other vaccine in four weeks. No Other mediation in two weeks. No Covid prior vaccination. The patient developed covid on 31May2021 with outcome of recovering.  The event resulted in Doctor or other healthcare professional office/clinic visit. No treatment received. Covid test post vaccination included Nasal swab (Saliva) on 01Jun2021 with Positive result.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chest discomfort, Chills, Cough, Dizziness
Clinical narrative: tired; chest heaviness; asthma like cough; shortness of breath; aches; sweating; shivering; feeling like she was "thinking really weirdly" like she was "dreaming but awake" during the night; dizzy; her heart feels really fast and pulse this morning; fever at 6am this morning 101.2. Now down to 99.7 after taking tylenol at 6am; She was up a lot of the night; headache; This is a spontaneous report from a contactable consumer (Patient Mother) reported for a 13-year-old patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 03Jun2021 09:30 (At the age of 13 year) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included, thrombosis (blood clots but not DVT's), mast cell activation syndrome (mast cell activation stuff especially near her periods), device malfunction, she also has a VP shunt. There were no concomitant medications. The patient previously took first dose of BNT162B2 for COVID-19 immunization. It was reported that Consumer calling on behalf of her 13-year-old daughter, birthday of DOB, who received the second dose of the Pfizer Covid 19 vaccine yesterday at 9:30am. She reports the following side affects her daughter has experienced: headache that started within an hour of getting the vaccine, by lunch she was tired, chest heaviness, an asthma like cough, a little bit of shortness of breath but her pulse ox is 98%, aches started when going to bed last night, sweating, shivering and feeling like she was "thinking really weirdly" like she was "dreaming but awake" during the night, very dizzy, head feels like it has a heart beat in it, her heart feels really fast and pulse this morning was 130 on the pulse ox, right now standing her pulse is 150, fever at 6am this morning 101.2. Now down to 99.7 after taking tylenol at 6am. It was reported that "She was up a lot of the night but did not want to bother us. It was reported that She has a history of "blood clots but not DVT's, mast cell activation stuff especially near her periods and she also have a VP shunt. Reporter want to know Is this an allergic reaction or could it be. Post Covid vaccine is anyone reporting pericarditis or chest heaviness, when would pericarditis occur. The patient underwent lab tests and procedures which included body temperature: abnormal Fever at 6am this morning 101.2. Now down to 99.7 after taking tylenol at 6 am, oxygen saturation: abnormal pulse this morning was 130 on the pulse ox, right now standing her pulse is 150. The outcome of events was unknown.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Feeling abnormal, Headache, Heart rate irregular
Clinical narrative: tired; chest heaviness; asthma like cough; shortness of breath; aches; sweating; shivering; feeling like she was "thinking really weirdly" like she was "dreaming but awake" during the night; dizzy; her heart feels really fast and pulse this morning; fever at 6am this morning 101.2. Now down to 99.7 after taking tylenol at 6am; She was up a lot of the night; headache; This is a spontaneous report from a contactable consumer (Patient Mother) reported for a 13-year-old patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 03Jun2021 09:30 (At the age of 13 year) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included, thrombosis (blood clots but not DVT's), mast cell activation syndrome (mast cell activation stuff especially near her periods), device malfunction, she also has a VP shunt. There were no concomitant medications. The patient previously took first dose of BNT162B2 for COVID-19 immunization. It was reported that Consumer calling on behalf of her 13-year-old daughter, birthday of DOB, who received the second dose of the Pfizer Covid 19 vaccine yesterday at 9:30am. She reports the following side affects her daughter has experienced: headache that started within an hour of getting the vaccine, by lunch she was tired, chest heaviness, an asthma like cough, a little bit of shortness of breath but her pulse ox is 98%, aches started when going to bed last night, sweating, shivering and feeling like she was "thinking really weirdly" like she was "dreaming but awake" during the night, very dizzy, head feels like it has a heart beat in it, her heart feels really fast and pulse this morning was 130 on the pulse ox, right now standing her pulse is 150, fever at 6am this morning 101.2. Now down to 99.7 after taking tylenol at 6am. It was reported that "She was up a lot of the night but did not want to bother us. It was reported that She has a history of "blood clots but not DVT's, mast cell activation stuff especially near her periods and she also have a VP shunt. Reporter want to know Is this an allergic reaction or could it be. Post Covid vaccine is anyone reporting pericarditis or chest heaviness, when would pericarditis occur. The patient underwent lab tests and procedures which included body temperature: abnormal Fever at 6am this morning 101.2. Now down to 99.7 after taking tylenol at 6 am, oxygen saturation: abnormal pulse this morning was 130 on the pulse ox, right now standing her pulse is 150. The outcome of events was unknown.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Insomnia, Oxygen saturation, Pain, Pyrexia
Clinical narrative: tired; chest heaviness; asthma like cough; shortness of breath; aches; sweating; shivering; feeling like she was "thinking really weirdly" like she was "dreaming but awake" during the night; dizzy; her heart feels really fast and pulse this morning; fever at 6am this morning 101.2. Now down to 99.7 after taking tylenol at 6am; She was up a lot of the night; headache; This is a spontaneous report from a contactable consumer (Patient Mother) reported for a 13-year-old patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 03Jun2021 09:30 (At the age of 13 year) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included, thrombosis (blood clots but not DVT's), mast cell activation syndrome (mast cell activation stuff especially near her periods), device malfunction, she also has a VP shunt. There were no concomitant medications. The patient previously took first dose of BNT162B2 for COVID-19 immunization. It was reported that Consumer calling on behalf of her 13-year-old daughter, birthday of DOB, who received the second dose of the Pfizer Covid 19 vaccine yesterday at 9:30am. She reports the following side affects her daughter has experienced: headache that started within an hour of getting the vaccine, by lunch she was tired, chest heaviness, an asthma like cough, a little bit of shortness of breath but her pulse ox is 98%, aches started when going to bed last night, sweating, shivering and feeling like she was "thinking really weirdly" like she was "dreaming but awake" during the night, very dizzy, head feels like it has a heart beat in it, her heart feels really fast and pulse this morning was 130 on the pulse ox, right now standing her pulse is 150, fever at 6am this morning 101.2. Now down to 99.7 after taking tylenol at 6am. It was reported that "She was up a lot of the night but did not want to bother us. It was reported that She has a history of "blood clots but not DVT's, mast cell activation stuff especially near her periods and she also have a VP shunt. Reporter want to know Is this an allergic reaction or could it be. Post Covid vaccine is anyone reporting pericarditis or chest heaviness, when would pericarditis occur. The patient underwent lab tests and procedures which included body temperature: abnormal Fever at 6am this morning 101.2. Now down to 99.7 after taking tylenol at 6 am, oxygen saturation: abnormal pulse this morning was 130 on the pulse ox, right now standing her pulse is 150. The outcome of events was unknown.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Investigation, Myocarditis, SARS-CoV-2 test
Clinical narrative: tested positive for Myocarditis; This is a spontaneous report received from a contactable consumer (patient). A 58-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 05May2021 13:00 (at the age of 58-year-old) as single dose for covid-19 immunization. Medical history included gastrointestinal (GI) bleed, murmur and high blood pressure. Concomitant medications included metoprolol and lisinopril. The patient previously took penicillin and acetylsalicylic acid (ASPIRIN) and both experienced allergies. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 12Apr2021 at 12:45 (at the age of 58-year-old) as single dose for covid-19 immunization. Patient ended up in the hospital and tested positive for myocarditis on 08May2021 at 14:00. The adverse event resulted in emergency room/department or urgent care. Treatment received included blood transfusion and antibiotics. Patient hospitalized 5 days. 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. The patient had been tested for COVID-19 on 09May2021 and was negative. The patient was not pregnant. The outcome of the event was recovering.  Information on the lot/batch number has been requested.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Extrasystoles, SARS-CoV-2 test, Ventricular extrasystoles, Ventricular tachycardia
Clinical narrative: Started having frequent episodes of symptomatic non-sustained Vtach, bigeminy, trigeminy, had an increased PVC burden; Started having frequent episodes of symptomatic non-sustained Vtach, bigeminy, trigeminy, had an increased PVC burden; Started having frequent episodes of symptomatic non-sustained Vtach, bigeminy, trigeminy, had an increased PVC burden; This is a spontaneous report from a contactable nurse (patient). A 27-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in arm left on 09Jan2021 (at the age of 27 years old) (Lot Number: EL1283) as 2nd dose, single for COVID-19 immunization. Medical history included Wolf-parkinson-white. No known allergies. No known drug allergy. Concomitant medications included levonorgestrel (MIRENA); melatonin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162B2 (lot number: EH9899) on 18Dec2020 ((at the age of 27 years old) in left arm for COVID-19 immunization. The patient experienced started having frequent episodes of symptomatic non-sustained Vtach, bigeminy, trigeminy, had an increased PVC burden (hospitalization) on 13Jan2021. Duration of hospitalization was 1 day. Treatment received for the events included Metoprolol. The adverse events resulted in Emergency room/department or urgent care & Doctor or other healthcare professional office/clinic visit. This is a serious report with seriousness criteria: Caused/prolonged hospitalization. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19, Nasal Swab on 13Jan2021, 03Mar2021, 10May2021, all with results of negative. The outcome of the events was recovering.; Sender's Comments: The causal association cannot be excluded between the reported events andBNT162b2 use. 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 AE. 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: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Blood pressure increased, Blood pressure measurement, Eating disorder, Heart rate
Clinical narrative: The patient is calling it an allergic reaction; patient became very nauseous; had an elevated BP; decreased heart rate.; also vomited a few times; wasn't able to eat for several days; also developed a rash a few days later; vasovagal reaction; panic attack; anxiety; This is a spontaneous case from Pfizer sponsored program. A contactable pharmacist reported that a 57 years old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 13May2021 (Batch/Lot Number: ER8736; Expiration Date: 31Jul2021) as 0.3 mL, SINGLE for covid-19 immunisation. The patient medical history included has a lengthy list of allergies. There were no concomitant medications. The patient had her first Pfizer Covid vaccine dose on 13May2021 and was advised to wait 30 minutes for monitoring afterwards because she has a lengthy list of allergies. While waiting 30 minutes, the patient became very nauseous, had an elevated BP and decreased heart rate. She was taken to the ED and also vomited a few times. Her vomiting continued for a few days after she left the ED. She also developed a rash a few days later. The caller states that the ED diagnosed her with a vasovagal reaction. The caller states that she didn't feel comfortable giving the patient the second dose based off of the reaction and wants to know if we can help her determine if the patient had a severe allergic reaction. She is not sure. The patient is calling it an allergic reaction, but the caller is not so sure. The caller thinks it may have just been a panic attack. The patient ended up in the ER with high blood pressure, low heart rate, and nausea. She was nauseous for 3 days. The patient also said she developed a rash, but the rash was not documented with the ER visit. The caller doesn't know if this constitutes a severe allergic reaction or not. She just knows that the nausea lasted several days. The patient wasn't able to eat for several days because she vomited everything she ate. That was according to the patient. The caller believes that the vaccine caused the reaction, or it at least caused the anxiety. Treatment included steroids. Multiorgan involvement: yes. Cardiovascular, dermatologic, and gastrointestinal involvement. There was no respiratory involvement to the caller's knowledge. Outcome of events was unknown.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation and known safety profile of suspect drug. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate decreased, Hypersensitivity, Nausea, Panic attack, Presyncope
Clinical narrative: The patient is calling it an allergic reaction; patient became very nauseous; had an elevated BP; decreased heart rate.; also vomited a few times; wasn't able to eat for several days; also developed a rash a few days later; vasovagal reaction; panic attack; anxiety; This is a spontaneous case from Pfizer sponsored program. A contactable pharmacist reported that a 57 years old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 13May2021 (Batch/Lot Number: ER8736; Expiration Date: 31Jul2021) as 0.3 mL, SINGLE for covid-19 immunisation. The patient medical history included has a lengthy list of allergies. There were no concomitant medications. The patient had her first Pfizer Covid vaccine dose on 13May2021 and was advised to wait 30 minutes for monitoring afterwards because she has a lengthy list of allergies. While waiting 30 minutes, the patient became very nauseous, had an elevated BP and decreased heart rate. She was taken to the ED and also vomited a few times. Her vomiting continued for a few days after she left the ED. She also developed a rash a few days later. The caller states that the ED diagnosed her with a vasovagal reaction. The caller states that she didn't feel comfortable giving the patient the second dose based off of the reaction and wants to know if we can help her determine if the patient had a severe allergic reaction. She is not sure. The patient is calling it an allergic reaction, but the caller is not so sure. The caller thinks it may have just been a panic attack. The patient ended up in the ER with high blood pressure, low heart rate, and nausea. She was nauseous for 3 days. The patient also said she developed a rash, but the rash was not documented with the ER visit. The caller doesn't know if this constitutes a severe allergic reaction or not. She just knows that the nausea lasted several days. The patient wasn't able to eat for several days because she vomited everything she ate. That was according to the patient. The caller believes that the vaccine caused the reaction, or it at least caused the anxiety. Treatment included steroids. Multiorgan involvement: yes. Cardiovascular, dermatologic, and gastrointestinal involvement. There was no respiratory involvement to the caller's knowledge. Outcome of events was unknown.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation and known safety profile of suspect drug. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vomiting
Clinical narrative: The patient is calling it an allergic reaction; patient became very nauseous; had an elevated BP; decreased heart rate.; also vomited a few times; wasn't able to eat for several days; also developed a rash a few days later; vasovagal reaction; panic attack; anxiety; This is a spontaneous case from Pfizer sponsored program. A contactable pharmacist reported that a 57 years old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 13May2021 (Batch/Lot Number: ER8736; Expiration Date: 31Jul2021) as 0.3 mL, SINGLE for covid-19 immunisation. The patient medical history included has a lengthy list of allergies. There were no concomitant medications. The patient had her first Pfizer Covid vaccine dose on 13May2021 and was advised to wait 30 minutes for monitoring afterwards because she has a lengthy list of allergies. While waiting 30 minutes, the patient became very nauseous, had an elevated BP and decreased heart rate. She was taken to the ED and also vomited a few times. Her vomiting continued for a few days after she left the ED. She also developed a rash a few days later. The caller states that the ED diagnosed her with a vasovagal reaction. The caller states that she didn't feel comfortable giving the patient the second dose based off of the reaction and wants to know if we can help her determine if the patient had a severe allergic reaction. She is not sure. The patient is calling it an allergic reaction, but the caller is not so sure. The caller thinks it may have just been a panic attack. The patient ended up in the ER with high blood pressure, low heart rate, and nausea. She was nauseous for 3 days. The patient also said she developed a rash, but the rash was not documented with the ER visit. The caller doesn't know if this constitutes a severe allergic reaction or not. She just knows that the nausea lasted several days. The patient wasn't able to eat for several days because she vomited everything she ate. That was according to the patient. The caller believes that the vaccine caused the reaction, or it at least caused the anxiety. Treatment included steroids. Multiorgan involvement: yes. Cardiovascular, dermatologic, and gastrointestinal involvement. There was no respiratory involvement to the caller's knowledge. Outcome of events was unknown.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation and known safety profile of suspect drug. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Haematochezia, Headache, Pyrexia
Clinical narrative: fever; fresh blood in my stools; chills; headache; This is a spontaneous report received from a non contactable consumer (patient). A non-pregnant 18-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 at the age of 18-year-old via an unspecified route of administration, administered in Arm Left on 28May2021 11:00 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation.  Medical history was none.  The patient previously took lactose and experienced drug hypersensitivity.  The patient received no other vaccines within 4 weeks prior to the COVID vaccine. No covid prior vaccination. No covid tested post vaccination. The concomitant medications included centrum multivitamins in two weeks. On 31May2021, patient experienced chills and a headache around noontime but had a fever at 11:30 PM. The fever and chills went away the next morning but still had a headache until the next morning. As of 03Jun2021, patient found herself experiencing, since 3 days ago, fresh blood in her stools which is to be identified by a doctor if the reaction is vaccine related. Adverse event resulted in [Doctor or other healthcare professional office/clinic visit]. Treatment included analgesic and bed rest. Seriousness reported as no.  The outcome was reported as recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Dyskinesia, Eyelid function disorder, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: Eyelid won't close all the way and left side of mouth is numb/not moving. Possibly Bell's Palsy; Eyelid won't close all the way and left side of mouth is numb/not moving. Possibly Bell's Palsy; Eyelid won't close all the way and left side of mouth is numb/not moving. Possibly Bell's Palsy; Eyelid won't close all the way and left side of mouth is numb/not moving. Possibly Bell's Palsy; Eyelid won't close all the way and left side of mouth is numb/not moving. Possibly Bell's Palsy; This is a spontaneous report from a contactable consumer (patient). A 29-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 22Mar2021 (Batch/Lot Number: EW0161) at the age of 29 years old, as 2ND DOSE,SINGLE for covid-19 immunisation. Patient received the first dose on 22Mar2021 at the age of 29 years old (lot number: ER8730). The patient medical history was not reported. Concomitant medications included minerals nos, vitamins nos (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) and sunflower lecithin. The patient experienced mild facial numbness on the left side. Eyelid won't close all the way and left side of mouth is numb/not moving. Possibly Bell's Palsy on 03Jun2021 13:30. Ae resulted in: [Doctor or other healthcare professional office/clinic visit]. Outcome of events was Not recovered.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Insomnia, Pericarditis, SARS-CoV-2 test
Clinical narrative: diagnosed me Pericarditis/ a fever around 38-39 C (101 F)/ a mild chest pain/with a strong chest pain that I couldn't sleep at night at all; I couldn't sleep at night at all; This is a spontaneous report received from a contactable consumer (patient) reported for himself. A 18-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 27May2021 13:15 (Batch/Lot Number: EW0167) as 2ND DOSE, SINGLE for covid-19 immunization, at the age at vaccination of 18 years old.  Medical history reported as none. There were no concomitant medications. No known allergies. Historical vaccine included first dose of  BNT162B2 (Product=COVID 19, lot number=EW0179; vaccine location=Right arm) on 06May2021 at 04:15 PM.  The patient experienced diagnosed me pericarditis (medically significant) on 30May2021 with outcome of recovering, a fever around 38-39 c (101 f) on 28May2021 01:00 AM with outcome of recovering, a mild chest pain/with a strong chest pain that i couldn't sleep at night at all on 28May2021 01:00AM  with outcome of recovering, i couldn't sleep at night at all on 29May2021 with outcome of recovering.  The patient underwent lab tests which included body temperature: 101 fahrenheit (38-39 C) on 28May2021 and 29May2021, sars-cov-2 test: negative on 29May2021 (Nasal Swab).  Additional information: "12 hours after 2nd shot I had a fever around 38-39 C (101 F) and a mild chest pain. 24 hours after that I still had the same fever, but with a strong chest pain that I couldn't sleep at night at all. Next day I went to the emergency room and they diagnosed me Pericarditis. I've never had any health problem before, especially heart problem." The events result in: Emergency room/department or urgent care. Treatment received for events included: Colchicine 0.6 mg. 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. Since the vaccination, the patient had not been tested for COVID-19.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Blood test, Postmenopausal haemorrhage, Ultrasound scan
Clinical narrative: 5 years post menopause, 10 days after injection got period/menstruated.  Have to get endometriotic biopsy; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration and administered in left arm at age of 41-years, on 21May2021 08:30 (Lot number was not reported) as single dose for covid-19 immunisation. Medical history included Premature ovarian failure and Menopause 5 years ago in 2016, and penicillin allergy. Patient was not pregnant. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There was no any other medications the patient received within 2 weeks of vaccination. The patient previously took amoxicillin and experienced allergy. The patient post menopause 5 years ago. 10 days after injection, she got period/menstruated on 01Jun2021 20:30. She had to get endometriotic biopsy. The adverse event result in "Doctor or other healthcare professional office/clinic visit". Therapeutic measures were taken for it. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient underwent lab tests and procedures which included biopsy, blood work and ultrasound on an unknown date, all were awaiting results. Event outcome was not recovered.  Information on the lot/batch number has been requested.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Pallor
Clinical narrative: the son felt like he was gonna pass out and was pale; the son felt like he was gonna pass out and was pale; This is a spontaneous report from a contactable consumer. A 15-year-old male patient (reporter's son) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at age of 15-years, on 03Jun2021 18:25 (Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical Vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unknown date as single dose for covid-19 immunisation. The patient experienced felt like he was gonna pass out and was pale on 04Jun2021 01:00. Events outcome was unknown.  Information on the lot/batch number has been requested.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Myocarditis
Clinical narrative: Myocarditis; strong pain/pangs in chest at middle of the night; This is a spontaneous report received from a contactable consumer (patient). A non-pregnant 64-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 at the age of 64-years-old via an unspecified route of administration, administered in Arm Left on 06Apr2021 (Lot Number: EN6208) as 2nd dose, single for covid-19 immunisation.  Medical history included mitral valve prolapse, seasonal allergy, hypotension. No other vaccine in four weeks. No covid prior vaccination.  No covid tested post vaccination.  The patient's concomitant medications were not reported.  The patient previous took fist dose of BNT162B2 on 16Mar2021 at the age of 64-years-old administered in Left arm (Lot number: EL9262) for covid-19 immunisation and experienced chest pains/soreness/pangs. The patient experienced strong pain/pangs in chest at middle of the night of the vaccine. Since then she still had chest pains/soreness/pangs, what she now think is myocarditis. Adverse event start date was 16Apr2021. No treatment was received. The event outcome was not recovered.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Head injury, Nausea, Pyrexia, Syncope
Clinical narrative: Fainted; Bumped my head on the tiles in the bathroom; Nauseous; Fever; Chills; Vomiting; This is a spontaneous report from a contactable consumer (patient). A 43-year-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 02Jun2021 10:00 (Lot Number: EW0186) as single dose for covid-19 immunisation at the age of 43-year-old. The patient was healthy, no illnesses before vaccination. Concomitant medications included calcium carbonate, colecalciferol (VITAMIN D 2000), ascorbic acid, rosa canina fruit (VITAMIN C & ROSEHIP). The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and hasn't been tested for COVID-19 since the vaccination. The patient previously received the dose 1 administered in Arm Left on 12May2021 11:15 (Lot Number: EW0183) at the age of 43-year-old. On 02Jun2021 22:00, the patient felt nauseous, had fever, chills and vomiting. On 03Jun2021 07:00, the patient fainted and bumped the head on the tiles in the bathroom. The events resulted in visit of Emergency room/department or urgent care. Treatment received for the events. The outcome of the events was recovering.  The patient reported, my symptoms began 12 hours after the second dose. I felt nauseous throughout the night and I had fever, chills and vomiting. 21 hours after vaccination I fainted and I bumped my head on the tiles in the bathroom. My husband called 911. Emergency check received from first responders.  Follow up attempts are needed. Further information has been requested
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Fainted; Bumped my head on the tiles in the bathroom; Nauseous; Fever; Chills; Vomiting; This is a spontaneous report from a contactable consumer (patient). A 43-year-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 02Jun2021 10:00 (Lot Number: EW0186) as single dose for covid-19 immunisation at the age of 43-year-old. The patient was healthy, no illnesses before vaccination. Concomitant medications included calcium carbonate, colecalciferol (VITAMIN D 2000), ascorbic acid, rosa canina fruit (VITAMIN C & ROSEHIP). The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and hasn't been tested for COVID-19 since the vaccination. The patient previously received the dose 1 administered in Arm Left on 12May2021 11:15 (Lot Number: EW0183) at the age of 43-year-old. On 02Jun2021 22:00, the patient felt nauseous, had fever, chills and vomiting. On 03Jun2021 07:00, the patient fainted and bumped the head on the tiles in the bathroom. The events resulted in visit of Emergency room/department or urgent care. Treatment received for the events. The outcome of the events was recovering.  The patient reported, my symptoms began 12 hours after the second dose. I felt nauseous throughout the night and I had fever, chills and vomiting. 21 hours after vaccination I fainted and I bumped my head on the tiles in the bathroom. My husband called 911. Emergency check received from first responders.  Follow up attempts are needed. Further information has been requested
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebral thrombosis, Cerebrovascular accident
Clinical narrative: Blood clot to the right side of the brain, resulting in a mini stroke.; Blood clot to the right side of the brain, resulting in a mini stroke.; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 52-year-old female patient received the second dose of bnt162b2 (PFIZER COVID VACCINE), via an unspecified route of administration administered in arm right on 23May2021 10:30 (Batch/Lot Number: EW0185) as single dose for covid-19 immunisation. Medical history included migraine and known allergies to penicillin. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included verapamil ER; valsartan; topiramate; lansoprazole. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took the first dose of bnt162b2 on 02May2021 10:00 AM on arm right (Batch/lot number: EW0176) for covid-19 immunisation. On 28May2021 06:00 PM, the patient experienced blood clot to the right side of the brain, resulting in a mini stroke. Treatment was received for the adverse event included blood thinners, clopidogrel bisulfate (PLAVIX). The adverse event result in Emergency room/department or urgent care. The patient was hospitalized for the events for 6 days, without hospitalization prolonged. The outcome of the events was not recovered. Since the vaccination, the patient had not been tested for COVID-19.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Haemorrhage, Maternal exposure during pregnancy, Muscle spasms
Clinical narrative: Severe cramping massive bleeding; severe cramping massive bleeding on 24May2021; I found out I was pregnant a few days after receiving my first vaccine a few days later, Severe cramping massive bleeding; This is a spontaneous report from a contactable consumer (patient). A 38-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 administered in Arm Left on 30Apr2021 12:15 (Lot Number: Ew1067) at 38-year-old as 1st dose single for covid-19 immunisation. The patient medical history and the concomitant medications were not reported.  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. Since the vaccination, the patient has not been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. The patient found out she was pregnant a few days after receiving her first vaccine a few days later, severe cramping massive bleeding on 24May2021. The patient ended up bleeding for a total of 19 days. The outcome was unknown. The patient became pregnant while taking bnt162b2.  The patient was due to deliver on 07Jan2022.  The lab tests included blood test: negative  on 28May2021. The adverse event result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care.