chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Rash
Clinical narrative: shingles; broke out in a rash; =This is a spontaneous report from a contactable consumer (patient). This 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 17Mar2021 at single dose for COVID-19 immunization.  The patient age at vaccination was 64-year-old. Medical history was none. The patient's concomitant medications were not reported.  The patient was due to take her second Pfizer covid vaccine on Wednesday.  Her first was 17Mar2021. Last Sunday, 28Mar2021, she broke out in a rash.  She had a telehealth appointment with her doctor who gave her cephalexin and said if it didn't resolve in 7-10 days, to let her know.  Patient stated it has gotten worse and she thought it was shingles. She had an appointment with her doctor Wednesday morning at 7:45 and was supposed to get her second covid vaccine at 1:15. Doctor said she thought it would be okay to get it. Therapeutic measures were taken as a result of broke out in a rash. The outcome of the event broke out in a rash was not recovered, of other event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: a little tired; This is a spontaneous report received from a contactable consumer (patient). This male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization.  The patient medical history included shingles complications. Concomitant medication included pregabalin (LYRICA) taken for shingles complications. The patient reported receiving the first dose of the Pfizer covid-19 vaccine and not having any side effects other than feeling a little tired. The consumer reported he had been taking LYRICA for the past 2 months for treatment of shingles complications and his current dose was down to LYRICA 100 mg twice a day. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: UTI; This is a spontaneous report from a contactable consumer (patient). This female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 09Mar2021 at single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  The patient received the first dose of Pfizer's COVID vaccine on 09Mar2021 and was scheduled for her second dose on 06Apr2021. Patient had a UTI (Urinary tract infection) and stated her doctor will most likely put her on antibiotics.  The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect route of product administration, White blood cell count, White blood cell count increased
Clinical narrative: WBC count has gone up; via subcutaneous; This is a spontaneous report from a contactable consumer reported for himself. This 75-year-old male patient received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via subcutaneous on 17Feb2021 at single dose for COVID-19 immunisation. Medical history included prostrate operation 11 years ago, psoriasis and hypertension which was controlled. The patient did not have any blood disorders. Concomitant medications were unknown. The patient had his second dose of the pfizer Covid 19 vaccine on 17Feb2021. and something that had never happened to him before, he had 3 blood test and on all 3 his WBC count had gone up since the Pfizer vaccine dose. The patient asked if the vaccine caused this. He had asked his doctor but he was not able to answer the question. Outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Ageusia, Anosmia, COVID-19, SARS-CoV-2 test
Clinical narrative: loss of taste and smell; loss of taste and smell; tested positive for Covid; This is a spontaneous report from a contactable consumer via the Pfizer-sponsored program. This consumer reported similar events for two patients. This is the first of two reports.   An 82-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 04Mar2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient received the first dose of Pfizer BioNTech Covid 19 vaccine, along with his wife on 04Mar2021 and three to four days later, they developed symptoms including loss of taste and smell and both tested positive for COVID. They were unable to receive the second dose on 25Mar2021 due to quarantining. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021377390 same reporter/drug, similar events, different patients
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ageusia, Anosmia, COVID-19, SARS-CoV-2 test
Clinical narrative: loss of taste and smell; loss of taste and smell; tested positive for Covid; This is a spontaneous report from a contactable consumer via the Pfizer-sponsored program. This consumer reported similar events for two patients. This is the second of two reports.  A 75-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 04Mar2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient received first dose of Pfizer BioNTech Covid 19 vaccine, along with her husband on 04Mar2021 and three to four days later, they developed symptoms including loss of taste and smell and both tested positive for COVID. They were unable to receive second dose on 25Mar2021 due to quarantining. The outcome of the events was unknown.  The information about the batch number has been requested.; Sender's Comments: Linked Report( same reporter/drug, similar events, different patients
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Bone pain, Dyspnoea, Fatigue
Clinical narrative: Severe Sore Throat; Stiff neck; Shortness of breath; Back ache; every bone and every part of her body hurt; every bone and every part of her body hurt; pain under her ribs; weak and shaky; weak and shaky; biceps ached; Fatigue; tremendous headache; This is a spontaneous report from a contactable consumer (patient). An 83-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on 28Mar2021 14:00 (Batch/Lot number was not reported: did not get a card that lists NDC, Lot, Expiration) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had no history of all previous immunization with the Pfizer vaccine considered as suspect. It was also reported that no additional vaccines were administered on the same date. The patient did not require visit to Emergency Room and stated that she was desperate and would've gone but she didn't have a ride and added she is worried about the second. Also, the patient did not required visit to the physician's office. No prior vaccinations (within 4 weeks). No family medical history. The patient reported that she received the first dose of the vaccine and 5 days later she got a terrible reaction. She did not expect it. She had a terrible reaction and thought she was going to die. She stated she wanted to report this because the TV says you should expect some kind of reaction after the second dose but does not say after the first and she said that Pfizer needs to know about this reaction. She stated she heard the second dose is worse. The patient asked if she has to get her second dose and if she needs to report this anywhere else? The patient added "what should I do about side effects?" It was reported that the patient (reported as is almost 84) had the first shot on Sunday 28MAR2021 and everything was fine by Friday she was in terrible trouble really really bad. States she has never heard of this, they say the first is easy and everything was terrible. States every bone and every part of her body hurt on 02Apr2021. She states after 24 hours (03Apr2021) it did go away. The patient asks does this happen to other people? It was stated that her symptoms came on suddenly and she had a severe sore throat, stiff neck, back ache, pain under her ribs, very very weak and shaky, shortness of breath, biceps ached, fatigue, and a tremendous headache. It was stated that started on Friday 02Apr2021 12:00 like a hurricane and after 24 hours they subsided on Saturday 03Apr2021. The patient added that she doesn't remember getting a card and didn't know that she should have a card until she saw something about it on TV, and thought well she didn't get a card. The patient also asked what does she do about that?  The patient states she takes medication but not that affects this. The outcome of the events recovered on 03Apr2021.   Additional information has been requested
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Musculoskeletal chest pain, Musculoskeletal stiffness, Myalgia, Oropharyngeal pain
Clinical narrative: Severe Sore Throat; Stiff neck; Shortness of breath; Back ache; every bone and every part of her body hurt; every bone and every part of her body hurt; pain under her ribs; weak and shaky; weak and shaky; biceps ached; Fatigue; tremendous headache; This is a spontaneous report from a contactable consumer (patient). An 83-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on 28Mar2021 14:00 (Batch/Lot number was not reported: did not get a card that lists NDC, Lot, Expiration) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had no history of all previous immunization with the Pfizer vaccine considered as suspect. It was also reported that no additional vaccines were administered on the same date. The patient did not require visit to Emergency Room and stated that she was desperate and would've gone but she didn't have a ride and added she is worried about the second. Also, the patient did not required visit to the physician's office. No prior vaccinations (within 4 weeks). No family medical history. The patient reported that she received the first dose of the vaccine and 5 days later she got a terrible reaction. She did not expect it. She had a terrible reaction and thought she was going to die. She stated she wanted to report this because the TV says you should expect some kind of reaction after the second dose but does not say after the first and she said that Pfizer needs to know about this reaction. She stated she heard the second dose is worse. The patient asked if she has to get her second dose and if she needs to report this anywhere else? The patient added "what should I do about side effects?" It was reported that the patient (reported as is almost 84) had the first shot on Sunday 28MAR2021 and everything was fine by Friday she was in terrible trouble really really bad. States she has never heard of this, they say the first is easy and everything was terrible. States every bone and every part of her body hurt on 02Apr2021. She states after 24 hours (03Apr2021) it did go away. The patient asks does this happen to other people? It was stated that her symptoms came on suddenly and she had a severe sore throat, stiff neck, back ache, pain under her ribs, very very weak and shaky, shortness of breath, biceps ached, fatigue, and a tremendous headache. It was stated that started on Friday 02Apr2021 12:00 like a hurricane and after 24 hours they subsided on Saturday 03Apr2021. The patient added that she doesn't remember getting a card and didn't know that she should have a card until she saw something about it on TV, and thought well she didn't get a card. The patient also asked what does she do about that?  The patient states she takes medication but not that affects this. The outcome of the events recovered on 03Apr2021.   Additional information has been requested
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Tremor
Clinical narrative: Severe Sore Throat; Stiff neck; Shortness of breath; Back ache; every bone and every part of her body hurt; every bone and every part of her body hurt; pain under her ribs; weak and shaky; weak and shaky; biceps ached; Fatigue; tremendous headache; This is a spontaneous report from a contactable consumer (patient). An 83-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on 28Mar2021 14:00 (Batch/Lot number was not reported: did not get a card that lists NDC, Lot, Expiration) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had no history of all previous immunization with the Pfizer vaccine considered as suspect. It was also reported that no additional vaccines were administered on the same date. The patient did not require visit to Emergency Room and stated that she was desperate and would've gone but she didn't have a ride and added she is worried about the second. Also, the patient did not required visit to the physician's office. No prior vaccinations (within 4 weeks). No family medical history. The patient reported that she received the first dose of the vaccine and 5 days later she got a terrible reaction. She did not expect it. She had a terrible reaction and thought she was going to die. She stated she wanted to report this because the TV says you should expect some kind of reaction after the second dose but does not say after the first and she said that Pfizer needs to know about this reaction. She stated she heard the second dose is worse. The patient asked if she has to get her second dose and if she needs to report this anywhere else? The patient added "what should I do about side effects?" It was reported that the patient (reported as is almost 84) had the first shot on Sunday 28MAR2021 and everything was fine by Friday she was in terrible trouble really really bad. States she has never heard of this, they say the first is easy and everything was terrible. States every bone and every part of her body hurt on 02Apr2021. She states after 24 hours (03Apr2021) it did go away. The patient asks does this happen to other people? It was stated that her symptoms came on suddenly and she had a severe sore throat, stiff neck, back ache, pain under her ribs, very very weak and shaky, shortness of breath, biceps ached, fatigue, and a tremendous headache. It was stated that started on Friday 02Apr2021 12:00 like a hurricane and after 24 hours they subsided on Saturday 03Apr2021. The patient added that she doesn't remember getting a card and didn't know that she should have a card until she saw something about it on TV, and thought well she didn't get a card. The patient also asked what does she do about that?  The patient states she takes medication but not that affects this. The outcome of the events recovered on 03Apr2021.   Additional information has been requested
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: a rapid heartbeat; This is a spontaneous report from a contactable consumer (patient). This 62-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 30Mar2021 at single dose for COVID-19 immunisation. Medical history included pneumonia for 5 days which was really bad, not sure whether this was caused by the covid vaccine and blood pressure abnormal. Concomitant medications included lisinopril in the middle of March for blood pressure. The patient received the 1st dose of the covid vaccine on 30Mar2021. Her neighbor was sneezing and all of a sudden through the night he started coughing and hacking. She was exposed to him last night. He had not received his result of the viral test yet. She had not taken a viral test. The patient asked if she was still susceptible to the covid virus if having the 1st shot. She also reported that she had a little reaction from the vaccine but had subsided which included a rapid heartbeat. Outcome of the event was recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Anosmia, COVID-19, Drug ineffective, Ear congestion, Fatigue
Clinical narrative: sleeping a lot; he was tested positive for covid; he was tested positive for covid; experiencing mild congestion in the head/congested in his head; sense of smell is pretty much  gone; decided since his throat was scratchy; congestion in his ears; Exhaustion/ Fatigue; This is a spontaneous report from a contactable consumer (patient). A 55 year old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 19Mar2021 (Batch/Lot Number: ER2613) as SINGLE DOSE for covid-19 immunisation, age at vaccination 55 years old. Medical history included Diabetic from 2013 (Diabetes is fairly under control. He has no super high readings. His diet is better); blood pressure (blood pressure abnormal) from 2013; ongoing overweight (obviously he is overweight) from an unknown date; and heart (disorder) from an unspecified date. Concomitant medications included metformin taken for an unspecified indication; lisinopril for blood pressure (abnormal); and lovastatin for heart (disorder), start and stop dates were not reported. Patient is taking an unspecified over the counter multivitamin. There were no other recent vaccinations or started any new medications. The patient is due for the second dose on 9April2021, but he tested positive for COVID-19 on 01Apr2021 with a PCR test described as oral saliva test. Patient was negative on a rapid test on an unspecified date. Patient wanted to know if he could reschedule the shot and when is it recommended. The patient had a coworker who tested positive, he decided since his throat was scratchy that maybe he had got it, then two more employees had gotten COVID-19 so he got a rapid test that was negative. On Mar2021, he stated he stayed home because he was experiencing mild congested in his head/congested in his head, which it still actually was, and he lost sense of smell completely. He was really tired, sleeping a lot, had congestion in his ears, and he can't smell anything. Patient had no fever, and his lungs were clear (unspecified date), so he commented it was deceiving since he feels fine like he can do whatever he wants, then he gets exhausted and sleeps. He stated he can't work for a whole week. He stated he is assuming his first dose of the shot is helping with it. Patient stated he is doing well, he has it (COVID-19), but he feels pretty good. Outcome of congested in his head was not recovered, while unknown for the other events.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersomnia, Investigation, SARS-CoV-2 test, SARS-CoV-2 test positive, Throat irritation
Clinical narrative: sleeping a lot; he was tested positive for covid; he was tested positive for covid; experiencing mild congestion in the head/congested in his head; sense of smell is pretty much  gone; decided since his throat was scratchy; congestion in his ears; Exhaustion/ Fatigue; This is a spontaneous report from a contactable consumer (patient). A 55 year old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 19Mar2021 (Batch/Lot Number: ER2613) as SINGLE DOSE for covid-19 immunisation, age at vaccination 55 years old. Medical history included Diabetic from 2013 (Diabetes is fairly under control. He has no super high readings. His diet is better); blood pressure (blood pressure abnormal) from 2013; ongoing overweight (obviously he is overweight) from an unknown date; and heart (disorder) from an unspecified date. Concomitant medications included metformin taken for an unspecified indication; lisinopril for blood pressure (abnormal); and lovastatin for heart (disorder), start and stop dates were not reported. Patient is taking an unspecified over the counter multivitamin. There were no other recent vaccinations or started any new medications. The patient is due for the second dose on 9April2021, but he tested positive for COVID-19 on 01Apr2021 with a PCR test described as oral saliva test. Patient was negative on a rapid test on an unspecified date. Patient wanted to know if he could reschedule the shot and when is it recommended. The patient had a coworker who tested positive, he decided since his throat was scratchy that maybe he had got it, then two more employees had gotten COVID-19 so he got a rapid test that was negative. On Mar2021, he stated he stayed home because he was experiencing mild congested in his head/congested in his head, which it still actually was, and he lost sense of smell completely. He was really tired, sleeping a lot, had congestion in his ears, and he can't smell anything. Patient had no fever, and his lungs were clear (unspecified date), so he commented it was deceiving since he feels fine like he can do whatever he wants, then he gets exhausted and sleeps. He stated he can't work for a whole week. He stated he is assuming his first dose of the shot is helping with it. Patient stated he is doing well, he has it (COVID-19), but he feels pretty good. Outcome of congested in his head was not recovered, while unknown for the other events.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Upper respiratory tract infection
Clinical narrative: sleeping a lot; he was tested positive for covid; he was tested positive for covid; experiencing mild congestion in the head/congested in his head; sense of smell is pretty much  gone; decided since his throat was scratchy; congestion in his ears; Exhaustion/ Fatigue; This is a spontaneous report from a contactable consumer (patient). A 55 year old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 19Mar2021 (Batch/Lot Number: ER2613) as SINGLE DOSE for covid-19 immunisation, age at vaccination 55 years old. Medical history included Diabetic from 2013 (Diabetes is fairly under control. He has no super high readings. His diet is better); blood pressure (blood pressure abnormal) from 2013; ongoing overweight (obviously he is overweight) from an unknown date; and heart (disorder) from an unspecified date. Concomitant medications included metformin taken for an unspecified indication; lisinopril for blood pressure (abnormal); and lovastatin for heart (disorder), start and stop dates were not reported. Patient is taking an unspecified over the counter multivitamin. There were no other recent vaccinations or started any new medications. The patient is due for the second dose on 9April2021, but he tested positive for COVID-19 on 01Apr2021 with a PCR test described as oral saliva test. Patient was negative on a rapid test on an unspecified date. Patient wanted to know if he could reschedule the shot and when is it recommended. The patient had a coworker who tested positive, he decided since his throat was scratchy that maybe he had got it, then two more employees had gotten COVID-19 so he got a rapid test that was negative. On Mar2021, he stated he stayed home because he was experiencing mild congested in his head/congested in his head, which it still actually was, and he lost sense of smell completely. He was really tired, sleeping a lot, had congestion in his ears, and he can't smell anything. Patient had no fever, and his lungs were clear (unspecified date), so he commented it was deceiving since he feels fine like he can do whatever he wants, then he gets exhausted and sleeps. He stated he can't work for a whole week. He stated he is assuming his first dose of the shot is helping with it. Patient stated he is doing well, he has it (COVID-19), but he feels pretty good. Outcome of congested in his head was not recovered, while unknown for the other events.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Blood urine present, Vaginal haemorrhage
Clinical narrative: getting cramps in my abdomen; blood in my urine; blood flow/ still getting dark (gross) spotting; This is a spontaneous report from a contactable consumer(patient) reported for herself. A 59-year-old female patient (Non Pregnant at the time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6206), via an unspecified route of administration, administered in Arm Left on 24Mar2021 12:15 PM as single dose for covid-19 immunisation. Medical history included Graves Disease and seasonal allergy. Concomitant medications received within 2 weeks of vaccination included levothyroxine, liothyronine and seasonal allergy, etc. Allergies to medications, food, or other products: penicillin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Late night on Saturday 27Mar2021 23:45, the patient started getting cramps in abdomen, then she noticed blood in urine. Cramps subsided after Advil but work up the next morning with a blood flow. It's been 5 years since her last menstrual period, with very little spotting in those 5 years. It's been a week since the cramping and she was still getting dark (gross) spotting. This was very unusual for her body. Not sure if she should take the 2nd Pfizer shot. No treatment was received for the adverse event (except cramps in abdomen). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of cramps in abdomen was resolved with sequel. The outcome of others was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pyrexia
Clinical narrative: Headache for 48 hrs; Mild fever for 24 hrs highest was 99.9; This is a spontaneous report from a contactable nurse (patient). A 73-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6203), intramuscularly in right arm on 04Mar2021 (at the age of 73-years-old) at 10:19 at single dose for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EM9810) intramuscularly in right arm on 04Feb2021 at 10:40 at single dose for COVID-19 immunization and experienced fever, severe headache, muscle ache, joint pain, weakness, brain fog, lethargy, nausea and confusion. The patient experienced headache for 48 hours treated with Tylenol and mild fever for 24 hours and the highest was 99.9 in Mar2021. The outcome of the events was recovered in Mar2021. The reporter considered that the suspect product had a causal effect to the adverse events.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021154601 Same patient, same drug, different dose
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Migraine, Nausea
Clinical narrative: nauseous; a slight fever of 99.3 degrees F and 100.2 degree F; whole body aches; chills; fatigue; Sore left arm; Sore at injection site; Migraine intensity increased (had a headache already prior to 2nd injection); This is a spontaneous report from a contactable consumer (patient) reported for herself. A 29-year-old female patient (Non pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 05Apr2021 09:30 (Lot Number: EP6955) as single dose for covid-19 immunisation. Medical history included migraine headaches. The patient did not have COVID prior vaccination. No Known allergies. No COVID tested post vaccination. Concomitant medications included propranolol and Nurtec ODT (as needed). No other vaccine received in four weeks. The patient previously received the first dose of BNT162B2 via an unspecified route of administration, administered in Arm Left on 16Mar2021 12:30 (Lot Number: EP6955) as single dose for covid-19 immunisation. The consumer reported that headache was not an adverse event of the 1st dose of vaccine. She had woken up the morning of 05Apr with a headache. The patient experienced sore left arm and at injection site and migraine intensity increased (had a headache already prior to 2nd injection) on 05Apr2021 12:00. About 12 hours post the injection, she became nauseous, had a slight fever of 99.3 degrees F, whole body aches, chills, fatigue, and a constant migraine. Over the course of the following day (06Apr), these symptoms lessened but only some completely went away. Her highest fever was 100.2 degree F during the morning of 06Apr. The body aches, fatigue, and migraine continue through today (07Apr). Treatment included took already prescribed Nurtec for the migraine. The outcome of the events sore left arm and at injection site and migraine intensity increased was not recovered. The outcome of the others was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia, Vaccination site pain
Clinical narrative: nauseous; a slight fever of 99.3 degrees F and 100.2 degree F; whole body aches; chills; fatigue; Sore left arm; Sore at injection site; Migraine intensity increased (had a headache already prior to 2nd injection); This is a spontaneous report from a contactable consumer (patient) reported for herself. A 29-year-old female patient (Non pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 05Apr2021 09:30 (Lot Number: EP6955) as single dose for covid-19 immunisation. Medical history included migraine headaches. The patient did not have COVID prior vaccination. No Known allergies. No COVID tested post vaccination. Concomitant medications included propranolol and Nurtec ODT (as needed). No other vaccine received in four weeks. The patient previously received the first dose of BNT162B2 via an unspecified route of administration, administered in Arm Left on 16Mar2021 12:30 (Lot Number: EP6955) as single dose for covid-19 immunisation. The consumer reported that headache was not an adverse event of the 1st dose of vaccine. She had woken up the morning of 05Apr with a headache. The patient experienced sore left arm and at injection site and migraine intensity increased (had a headache already prior to 2nd injection) on 05Apr2021 12:00. About 12 hours post the injection, she became nauseous, had a slight fever of 99.3 degrees F, whole body aches, chills, fatigue, and a constant migraine. Over the course of the following day (06Apr), these symptoms lessened but only some completely went away. Her highest fever was 100.2 degree F during the morning of 06Apr. The body aches, fatigue, and migraine continue through today (07Apr). Treatment included took already prescribed Nurtec for the migraine. The outcome of the events sore left arm and at injection site and migraine intensity increased was not recovered. The outcome of the others was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: low level anaphylactic reaction half an hour after first shot; This is a spontaneous report received from contactable consumer (patient) via medical information team. A 66-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection and Lot Number: UNKNOWN) via an unspecified route of administration on 21Mar2021 (at the age of 66-year-old) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On 21Mar2021, the patient had a low level anaphylactic reaction half an hour after first shot. Patient's second dose was scheduled for 21Apr2021. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia, Tinnitus
Clinical narrative: tinnitus/ tinnitus in his ears, specifically the left ear/describes it as "annoying."; tingling in my right leg only like a nerve issue; his right leg he has been "getting shocks" and describes it as intermittent numbness; This is a spontaneous case received from Pfizer sponsored program from a contactable consumer (patient). This 59-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID -19 VACCINE), first dose on 20FEB2021, second dose (LOT EN6198) on 13MAR2021, both as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient was experiencing a constant/ongoing tinnitus/ringing in his ears, more predominantly/specifically in his left ear, the same side as his shot. It started within the week of receiving the 2nd shot. He was also experiencing tingling in his right leg only like a nerve issue. That is sporadic and it doesn't last but it happens everyday now. He had never experienced any symptoms like this until receiving the vaccine and describes it as annoying. The patient also reported that in his right leg he had been "getting shocks" and describes it as intermittent numbness and tingling that occurs once a day. Reporter would like to know how long he should expect this to last or if it is going to be permanent. He stated that he had read online that tinnitus is a side effect of the Pfizer vaccine. He would like to know if this is an expected side effect with the vaccine. His side effect was not listed as a commonly reported side effect in the clinical trials but also let him know that this list does not include all possible side effects. The outcome of the event tinnitus was Not recovered, of others was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Exposure to SARS-CoV-2, Pyrexia, SARS-CoV-2 test, Sinus headache
Clinical narrative: exposed to Covid19; she's had "mild" symptoms of a headache and being "sinus-y" and a low-grade fever of 99 F; she's had "mild" symptoms of a headache and being "sinus-y" and a low-grade feve of 99 F; This is a spontaneous report received from contactable consumer (patient). A 43-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection and Lot Number: unknown) via an unspecified route of administration on 18Mar2021 (at the age of 43-year-old) as a single dose for COVID-19 immunization. Medical history and Concomitant medications were not reported. Family history included Covid-19 (patient 8 y/o daughter tested positive for Covid) on 31Mar2021. On 21Mar2021, patient was exposed to Covid19 at a family gathering with two people tested positive later that week. On 26Mar2021, she had a negative Covid test, but on the evening of 28Mar2021 her 8 y/o daughter started having Covid19 symptoms and later tested positive for Covid on 31Mar2021. Patient indicated that she's had "mild" symptoms of a headache and being "sinus-y" and a low-grade fever of 99F for one day in 2021, but she continued to test negative for Covid19 in 2021. Patient was due to receive her second dose of vaccine 08Apr2021. A member of the local health department told them to quarantine in their house until 19Apr2021. The outcome for the events mild" symptoms of a headache and being "sinus-y" and a low-grade fever of 99 F for one day was recovered on an unspecified date in 2021 and exposed to Covid19 was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash all over my body but this morning it's worst.; This is a spontaneous report from a contactable consumer (patient). This 56-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) second dose (Lot EW0150) on 31Mar2021 (last Wednesday) as single dose at left arm for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose (lot EN6207) on 10Mar2021 12:00pm at left arm for COVID-19 immunization. Patient started with some rash all over his body on 04Apr2021 but 05Apr2021 morning it was worst. He didn't think it was food poisoning and just want to make sure these side effects are related to the vaccine before he call his physician. Originating AE Request: REQ-228433. The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Irritability, Vaccination site pain
Clinical narrative: Irritable; was fatigued; Patient has tenderness at the injection site; This is a spontaneous report from a contactable consumer. A 40-year-old male patient received BNT162B2 first dose on 30Mar2021 17:15 (Age at vaccination was 40 Years old) on left arm at single dose for COVID-19 immunization. Medical history included Pencillin Allergy. Concomitant medications in two weeks included SSRI. No other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient has tenderness at the injection site, and was fatigued and irritable beginning approximately 24 hours after vaccination (31Mar202105:00 PM). Symptoms lasted for approximately 12 hours. At the end of that 12 hour period all symptoms ceased. The outcome of the events was recovered in 2021. No treatment for the events. No covid tested post vaccination.   No follow up attempts are possible. Information on lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: extreme fatigue; chills; aches; Fever; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 24Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced extreme fatigue, chills, aches, fever on an unspecified date. Outcome of events fatigue, chills, aches, was not recovered, fever was recovered.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test positive
Clinical narrative: positive covid result after being vaccinated; positive covid result after being vaccinated; This is a spontaneous report from a contactable consumer reporting for a patient. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation, age at vaccination unknown. The patient medical history and concomitant medications were not reported. The patient experienced positive COVID result after being vaccinated on an unspecified date. Outcome of the events was unknown.  Information on the lot number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site pain
Clinical narrative: The injection site has been sore; The muscle at the spot continually hurts and has not let up; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 24Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced the injection site has been sore and the muscle at the spot continually hurts and has not let up on an unspecified date. Outcome of events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hypertension, Illness, Swollen tongue
Clinical narrative: dizziness; high blood pressure/ at 175/110 when normal BP is at 120/70; swelling of tongue/ tongue swelled but did not close up; felt pretty sick; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on 02Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient was vaccinated at a clinic. Medical history included Lyme disease, bell's palsy and neurological pain all from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient reported that she had her first dose of the PFIZER BIONTECH COVID19 vaccine on 02Mar2021 (reported as a month ago). Also seeking assistance if we had any study as to patients who participated in the clinical trial with co-morbidity specifically to that of the Lyme disease. The patient also reported that she had "bad reaction" towards the vaccine that lead her HCP  to decide that she should no longer take the second dose of the vaccine. The patient said prior to this that she had Lyme disease, bell's palsy and some neurological pain. Also severe adverse events she experienced immediately after taking the first dose (02Mar2021) are dizziness for many hours, high blood pressure taken by paramedic to be at 175/110 when normal BP is at 120/70. Also experienced swelling of tongue after 15-20 mins post vaccination and felt pretty sick after days after. Also she mentioned that she can't have epinephrine for her severe adverse reactions to the vaccine. The patient was recommended not to take the second dose of the vaccine as she had severe adverse reaction during her first dose. The patient is asking assistance if she can be issued a certificate or a form that would state this for the purpose of international travels. The patient also inquires on any studies on the covid-19 vaccine and Lymes disease, as she had Lymes disease several years ago and had bells palsey, states she reacts to vaccines badly, the patient had her first dose of the covid-19 vaccine on 02Mar2021 had immediate dizziness for many hours, blood pressure was elevated, tongue swelled but did not close up, and cannot have epinephrine and was advised not to have the second dose of the vaccine. The patient also needs to travel overseas to visit with her mother and is asking if there is a waiver or something else she will need in order to travel. The outcome of the events was unknown.   Information on Lot/Batch number was not available. No further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Sneezing
Clinical narrative: terrible sneezing/continuous sneezing day and night; runny nose/nose was running profusely/sniffles; This is a spontaneous report from a contactable consumer (patient). A 71-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 26Feb2021 at 17:00 (lot number: EN6198) as single dose for COVID-19 immunization. Medical history reported as none. No allergy medication. Concomitant medications were not provided. Patient received his first Pfizer Covid vaccine dose on 26Feb2021, and the next five days were unremarkable, but he had terrible sneezing, sniffles and runny nose and it resolved after 5 days. Stated when he had the 1st dose of the vaccine, everything went fine but from day 1-5 after the 1st dose he had continuous sneezing day and night and his nose was running profusely after the 1st dose. The patient HCP did not know he had this problem. The outcome of events was recovered on unknown date.   No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Loss of personal independence in daily activities
Clinical narrative: feeling dizzy; cannot got to work and about to get laid off; This is a spontaneous report from a contactable consumer (patient) reported for himself. This male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 31Mar2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not provided. The patient received the Pfizer Covid vaccine on 31Mar2021 since the patient had been feeling dizzy and cannot got to work and about to get laid off. Patient asked who would responsible for getting his life back. The outcome of events was unknown. This report was assessed by the reporting consumer is non-serious.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Influenza
Clinical narrative: Diarrhea; Chills; flu; This is a spontaneous report from a non-contactable consumer (patient). This female patient of unspecified age (reported age was 61, unknown unit) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Apr2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not provided. Patient had her first dose of the PFIZER-BIONTECH COVID19 VACCINE on 02Apr2021 (reported as this past Friday, as of 05Apr2021). Patient reported diarrhea and "chills and whatnot" and wanted to know if this was normal. Never had flu shot before, but patient had the flu. The outcome of events was unknown. This report was assessed by the reporting consumer was non-serious.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Condition aggravated, Pyrexia, Swelling face
Clinical narrative: chill; half face was swelling; fever (99-100F); much stronger pain with the tooth; much stronger pain with the tooth; This is a spontaneous report from a contactable consumer reported for himself. A 44-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 24Mar2021 15:45 (Batch/Lot Number: ER8727) as single dose for covid-19 immunisation. Medical history included one tooth with some inflammation and pain. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  None allergies to medications, food, or other products. The patient's concomitant medications were none. The patient experienced much stronger pain with the tooth on 24Mar2021 18:15 with outcome of recovered, half face was swelling on 25Mar2021 (next morning)with outcome of recovered, fever (99-100f) on 25Mar2021 (next morning)with outcome of unknown, chill on unspecified date with outcome of recovered. The chill, swelling and pain last 3-4 days post injection. Therapeutic measures (Advil) were taken as a result of much stronger pain with the tooth.  Follow-up attempts have been completed and no further information is expected.