chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Fatigue, Pain in extremity
Clinical narrative: A-fib; sore arm; a little tired; This is a spontaneous report from a contactable consumer or other non hcp (patient sister). A female patient (age 77 unspecified units) received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 07Apr2021 as dose 1, single and 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 May2021 as dose 2, single both for covid-19 immunisation. Medical history included pacemaker (patient has a pacemaker). The patient's concomitant medications were not reported. Patient experienced some symptoms after the vaccine. On an unspecified date in 2021, patient experienced a little bit of a-fib because the pacemaker does monitor for that, sore arm, a little tired. Patient has a pace-maker. Patient got Pfizer, both of them and did not seem to have anything. Just had a sore arm, and was doing great, was just a little tired. Patient had a little bit of A-FIB because the pacemaker does monitor for that. It normally wasn't anything like that. She got her vaccine and she does not know if her A-Fib was related but it was in the back of her mind. She went for her check-up in Jun2021 and everything was ok. She had the first dose 07Apr2021 and the second dose 4 weeks after the first dose. Infrequent episodes showed up early Jun2021 or Jul2021 and they noted A-Fib, her doctor had noted it. When they were doing her regular 3 months check-up for the pacemaker recording information, the doctor noticed infrequent episodes, less than 12 seconds. Patient had an emergency room visit for the event atrial fibrillation. The report was not related to study or program. The outcome of the events was unknown.  Information on Lot/Batch information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: skin abnormality on her left shin disappeared/skin abnormality on her right wrist cleared up and disappeared; This is a spontaneous report from a contactable Physician (patient) reported that. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Soultion for injection) via an unspecified route of administration on Feb2021 (Batch/Lot number was not reported) as first dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. Pfizer Healthcare Rep reported AE which was reported to him during an interaction with a doctor who had the adverse event and was the patient. Rep reported that patient got her first Pfizer COVID-19 vaccine dose in Feb and had zero adverse events. Rep reported that she said that for her second vaccine dose which she got at the beginning of March she had arm soreness. Rep also reported that she said she had a couple of abnormalities on her skin that her dermatologist wanted to cut out and biopsy prior to having the vaccine shots, and after getting both shots the skin abnormality on her left shin disappeared and the other one on her right wrist cleared up and disappeared within a couple months on an unspecified date. Rep mentioned that patient thought it was medically significant, and she did think it was due to the Pfizer vaccine. Rep mentioned that this was a positive effect, so he wanted to report it, and he had no specific dates for the shots. He said that patient wanted to share a positive that was going on, and they thought Pfizer would like to know about it. Rep mentioned that he had no more details to provide for this report. No further details captured, reported, or documented at this time. The outcome of the event was unknown.  Information about lot/Batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: My uncle had a heart attack following receiving his 2nd vaccine with Pfizer; This is a spontaneous report from a contactable consumer (patients relative).  A male patient of an unspecified age 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 an unspecified date as dose 2, single for covid-19 immunization. Medical history included Heath problems, he had underlined health problems. The patients concomitant medications were not reported. On an unspecified date, the patient experienced a heart attack. patients relative reported that uncle had heart attack following receiving his 2nd vaccine with Pfizer. The clinical outcome of event was unknown.  Information about lot/batch number has been requested.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for Covid; Tested positive for Covid; This is a spontaneous report received from a non-contactable other health care professional (patient). A 25-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID 19 VACCINE, Solution for injection, Lot Number: EL1283) dose 2 via an unspecified route of administration on an unspecified date and received BNT162B2 (PFIZER-BIONTECH COVID 19 VACCINE, Solution for injection, Lot Number: EL1284) dose 1 via an unspecified route of administration on 20Dec2020 both as single dose (at the age of 25-year-old) for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient medical history and concomitant medications were not reported. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine or not. Patient did not diagnose with COVID-19 prior to vaccination. Patient was not tested positive for COVID-19 since vaccination. On 14Jul2021, the patient tested positive for covid and the drug was ineffective. The events were reported as non-serous by the reporter. The patient visited physicians office as a result of adverse events. It was unknown if patient received any treatment as a result of adverse events. The patient underwent lab tests and procedures which included sars-cov-2 test (Nasal Swab): positive on 14Jul2021. The outcome of tested positive for covid was not recovered and outcome of drug ineffective was unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events covid-19 and drug ineffective and the suspect drug BNT162B2.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chest discomfort, Drug ineffective, Malaise, Oropharyngeal pain
Clinical narrative: coming down with COVID; coming down with COVID; has not been feeling well; sore throat and chest congestion; sore throat and chest congestion; This is a spontaneous report from a contactable consumer (patient) via Pfizer. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown, Expiration date: Unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient was coming down with covid and experienced has not been feeling well, sore throat and chest congestion. Patient believes he was coming down with COVID. Patient was is in a clinical Trial. He was still enrolled in the clinical trial and he was told he was going to continue his trial in with a new center, however he does not have the location or phone number. Clinical Trial. He wanted someone to pick up his test kit and wanted information on that new clinical trial center. The events COVID-19 and drug ineffective considered as medically significant. The outcome of the events was unknown.  Follow up attempts are possible. Further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: patient has been exposed to COVID-19 and has been tested positive; patient has been exposed to COVID-19 and has been tested positive; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient's parent) reported for a female patient. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date were not reported), via unspecified route of administration, on an unspecified date as dose1, single and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date were not reported), via unspecified route of administration, on an unspecified date as dose2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Reporter's daughter took both doses of Pfizer covid vaccine on an unspecified date. Patient may need to travel; that country doesn't have in their system that patient got vaccinated. Patient would need to get Pfizer Covid vaccine in another country. Reporter wants to know if it's safe to get 4 doses. Reporter mentioned that, patient has received Pfizer and was very happy she did, said patient had side effects, but that it's better than having COVID. Reporter said that, patient has been exposed to COVID-19 and has been tested positive. Reporter did not want information anymore with Pfizer since patient has already been exposed to COVID-19 and they already resolved their problem. The patient underwent lab tests and procedures which included SARS-CoV-2 test and result was positive on an unspecified date.  Information about batch/ lot number has been requested.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Chest discomfort, Chest pain, Dyspnoea, Pain
Clinical narrative: chest and heart pain; Short of breath; chest and heart pain; sore arm; tremendous pain; The chest pain is pinching and tightening like a poking of a needle or tightening of the chest; This is a spontaneous report from a contactable consumer. This consumer reported for an 18-year-old female patient (reporter's daughter). An 18-year-old female patient received BNT162b2 (BNT162B2), first dose, intramuscularly, administered in arm left on 11Jul2021 15:30 at the age of 18 years old, at 0.3 ml single dose for covid-19 immunisation. Medical history was none. History of all previous immunization with the Pfizer vaccine considered as suspect was none. The patient's Mother in law has a heart problem, the patient's brother was born with a hole in his heart. There were no concomitant medications. There was no other vaccine in four weeks. The patient experienced chest and heart pain on 12Jul2021, short of breath on 12Jul2021, sore arm on 11Jul2021, tremendous pain in Jul2021, the chest pain is pinching and tightening like a poking of a needle or tightening of the chest in Jul2021. The reporter was calling on behalf of his daughter. The vaccine didn't sit right with the patient. The patient had chest and heart pain and was short of breath. The patient went to her primary care provider and they checked her out and gave them a cardiologist's name to go see tomorrow. The doctor prescribed some ointment to rub on the chest. The doctor recommend that the patient not get her second shot because there was a heart condition that runs in the reporter 's wife's side of the family. The cardiologist was going to do an ultrasound on the patient. The patient was going through tremendous pain and colleges are requiring the vaccine, which was why she got it. The chest pain started Monday (12Jul2021) night at midnight. First came the chest pain and then the shortness of breath. The patient had arm pain and they recommended that she take Tylenol. Tuesday (13Jul2021) the patient had chest pain and took Tylenol and recommended that she see a cardiologist. The patient took Tylenol for her sore arm. The chest pain was pinching and tightening like a poking of a needle or tightening of the chest. The patient is going to be getting an MRI and sonogram tomorrow at the Cardiologist. The doctor is not advising the patient to take the second shot because the symptoms are worse with the second shot. The outcome of the events chest and heart pain, short of breath was not recovered, of the event sore arm was recovering, of the other events was unknown.  The lot number for the vaccine, [BNT162b2], was not provided and will be requested during follow up.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: chest and heart pain; Short of breath; chest and heart pain; sore arm; tremendous pain; The chest pain is pinching and tightening like a poking of a needle or tightening of the chest; This is a spontaneous report from a contactable consumer. This consumer reported for an 18-year-old female patient (reporter's daughter). An 18-year-old female patient received BNT162b2 (BNT162B2), first dose, intramuscularly, administered in arm left on 11Jul2021 15:30 at the age of 18 years old, at 0.3 ml single dose for covid-19 immunisation. Medical history was none. History of all previous immunization with the Pfizer vaccine considered as suspect was none. The patient's Mother in law has a heart problem, the patient's brother was born with a hole in his heart. There were no concomitant medications. There was no other vaccine in four weeks. The patient experienced chest and heart pain on 12Jul2021, short of breath on 12Jul2021, sore arm on 11Jul2021, tremendous pain in Jul2021, the chest pain is pinching and tightening like a poking of a needle or tightening of the chest in Jul2021. The reporter was calling on behalf of his daughter. The vaccine didn't sit right with the patient. The patient had chest and heart pain and was short of breath. The patient went to her primary care provider and they checked her out and gave them a cardiologist's name to go see tomorrow. The doctor prescribed some ointment to rub on the chest. The doctor recommend that the patient not get her second shot because there was a heart condition that runs in the reporter 's wife's side of the family. The cardiologist was going to do an ultrasound on the patient. The patient was going through tremendous pain and colleges are requiring the vaccine, which was why she got it. The chest pain started Monday (12Jul2021) night at midnight. First came the chest pain and then the shortness of breath. The patient had arm pain and they recommended that she take Tylenol. Tuesday (13Jul2021) the patient had chest pain and took Tylenol and recommended that she see a cardiologist. The patient took Tylenol for her sore arm. The chest pain was pinching and tightening like a poking of a needle or tightening of the chest. The patient is going to be getting an MRI and sonogram tomorrow at the Cardiologist. The doctor is not advising the patient to take the second shot because the symptoms are worse with the second shot. The outcome of the events chest and heart pain, short of breath was not recovered, of the event sore arm was recovering, of the other events was unknown.  The lot number for the vaccine, [BNT162b2], was not provided and will be requested during follow up.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dizziness postural, Fear, Malaise
Clinical narrative: When I get up to go to bathroom everything was like going round and round I was very dizzy; I got scared; I don't feel good; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 14Jul2021 11:20 (Batch/Lot number was not reported, at age of 57 years old) as single dose for COVID-19 immunisation. Medical history included high blood pressure and diabetes, patient was a little disabled, she had hard time walking. Concomitant medications included unspecified medications and patient took it every day. On 15Jul2021, when the patient got up to go to bathroom everything was like going round and round she was very dizzy the only time she had no weakness, the patient had no pain nothing else just that very dizzy. The patient just got disabled 4 O' clock in the morning on 15Jul2021. She was fine all day. She didn't get nothing. The patient's blood pressure because she got scared 121/60 on unknown date. The patient didn't feel good to talk. The patient underwent lab tests and procedures which included blood pressure: 121/60 on unknown date. The patient did not receive any treatment for events, she didn't get nothing. The outcome of events was unknown. The patient had not received second dose yet, second one in 04Aug2021.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Swelling of eyelid, Urticaria, Weight
Clinical narrative: Itching; Swollen eyelid; Hives all over her body; This is a spontaneous report from a contactable consumer or other non hcp. This consumer reported for a 62-year-old female patient (mother). A 62-year-old female patient received bnt162b2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date (at the age of 62 years) as dose 1, single for covid-19 immunisation at local drug store. The patient medical history and concomitant medications were not reported. On an unspecified date patient experienced itching, swollen eyelid, hives all over her body. Reporter stated that patient took the Pfizer Covid shot and then she was experiencing side effects ever since she got the shot. She has like swollen eyelids and hives all over her body and she was like itching everywhere and went to the emergency room twice and they gave her the cortisone shots and stuff but reporter think it was not working because it comes and goes and it has been like a month. Reporter think it happened after the first shot, it was not as bad it happened like. The patient underwent lab tests which included weight: 135 About a 135. Therapeutic measures were taken as a result of events, includes went to the emergency room twice and they gave cortisone shots. The outcome for all events was unknown.   Information about Lot/Batch number have been requested.
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: severe allergic reaction; This is a spontaneous report from a contactable consumer (patient's Sister). A male patient of an unspecified age 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. The patient's medical history and concomitant medications were not reported.  The patient experienced severe allergic reaction on an unspecified date with outcome of unknown. There was an article in the paper about how he almost died and he was called up by a doctor who he talked to this was person was wanting to do a study. The reaction was a couple weeks later, clarified as 3 weeks later after receiving his Pfizer COVID vaccine that the patient had a severe allergic reaction. Reporter seriousness for severe allergic reaction: Hospitalization.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Cardiac failure, Chills, Headache
Clinical narrative: heart failure; got really sick; lungs filled with water; fever; Chills; nauseous; headache; teeth throbbing from headache; blood pressure was skyrocketing; lethargy; This is a spontaneous report from a contactable consumer (patient herself). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 26Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took the dose 1 of bnt162b2 for COVID-19 Immunisation and got nauseated, chills, and felt really lowsy, chronic pain went away, sore arm, vomiting, dehydrated, body aches and got pretty sick for about 4 days. Caller stated that she had called the first time after the first shot about bad and good side effects of chills, body aches, vomiting that lasted about four days that began one day after the first shot. In 2021, she had a second appointment and got really sick and was in hospital six days. Patient stated that she woke up the next morning with fever, chills, nauseous, headache, teeth throbbing from headache, lungs filled with water and went into heart failure and had to be put in the hospital. She stated that her blood pressure was skyrocketing and then normal. She stated that every 12 hours that she would go into this Covid reaction. She never had a headache, but it cycled every 12 hours. She was given narcotics for headache and a paracetamol (TYLENOL) IV drip that killed her fever. There was a case that she read about from testing children about myocarditis and she thought that was what she had but she was never diagnosed with this. She had been coming back from the second vaccine for two months with lethargy and was just starting to get back to where she felt normal. She had called previously about another weird side effect. She stated that her husband called and a guy from laundry called about a side effect. Outcome of blood pressure skyrocketing was recovered in 2021, outcome of other events was unknown.  Information on lot number/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Lethargy, Nausea, Pulmonary oedema, Pyrexia
Clinical narrative: heart failure; got really sick; lungs filled with water; fever; Chills; nauseous; headache; teeth throbbing from headache; blood pressure was skyrocketing; lethargy; This is a spontaneous report from a contactable consumer (patient herself). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 26Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took the dose 1 of bnt162b2 for COVID-19 Immunisation and got nauseated, chills, and felt really lowsy, chronic pain went away, sore arm, vomiting, dehydrated, body aches and got pretty sick for about 4 days. Caller stated that she had called the first time after the first shot about bad and good side effects of chills, body aches, vomiting that lasted about four days that began one day after the first shot. In 2021, she had a second appointment and got really sick and was in hospital six days. Patient stated that she woke up the next morning with fever, chills, nauseous, headache, teeth throbbing from headache, lungs filled with water and went into heart failure and had to be put in the hospital. She stated that her blood pressure was skyrocketing and then normal. She stated that every 12 hours that she would go into this Covid reaction. She never had a headache, but it cycled every 12 hours. She was given narcotics for headache and a paracetamol (TYLENOL) IV drip that killed her fever. There was a case that she read about from testing children about myocarditis and she thought that was what she had but she was never diagnosed with this. She had been coming back from the second vaccine for two months with lethargy and was just starting to get back to where she felt normal. She had called previously about another weird side effect. She stated that her husband called and a guy from laundry called about a side effect. Outcome of blood pressure skyrocketing was recovered in 2021, outcome of other events was unknown.  Information on lot number/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Toothache
Clinical narrative: heart failure; got really sick; lungs filled with water; fever; Chills; nauseous; headache; teeth throbbing from headache; blood pressure was skyrocketing; lethargy; This is a spontaneous report from a contactable consumer (patient herself). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 26Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took the dose 1 of bnt162b2 for COVID-19 Immunisation and got nauseated, chills, and felt really lowsy, chronic pain went away, sore arm, vomiting, dehydrated, body aches and got pretty sick for about 4 days. Caller stated that she had called the first time after the first shot about bad and good side effects of chills, body aches, vomiting that lasted about four days that began one day after the first shot. In 2021, she had a second appointment and got really sick and was in hospital six days. Patient stated that she woke up the next morning with fever, chills, nauseous, headache, teeth throbbing from headache, lungs filled with water and went into heart failure and had to be put in the hospital. She stated that her blood pressure was skyrocketing and then normal. She stated that every 12 hours that she would go into this Covid reaction. She never had a headache, but it cycled every 12 hours. She was given narcotics for headache and a paracetamol (TYLENOL) IV drip that killed her fever. There was a case that she read about from testing children about myocarditis and she thought that was what she had but she was never diagnosed with this. She had been coming back from the second vaccine for two months with lethargy and was just starting to get back to where she felt normal. She had called previously about another weird side effect. She stated that her husband called and a guy from laundry called about a side effect. Outcome of blood pressure skyrocketing was recovered in 2021, outcome of other events was unknown.  Information on lot number/batch number has been requested.
Age: 81.0
Sex: U
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Chills, Fatigue, Headache
Clinical narrative: chills; tiredness; headache; muscle pain; joint pain; my stomach was flipping but not nauseas; This is a spontaneous report from a contactable consumer (the patient).     A 81-years-old patient of an unspecified gender received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 12Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation  .  Medical history included arthritis. On 22Mar2021 the patient received the first dose of BNT162B2 vaccine and experienced chills.  Concomitant medications included influenza vaccine (INFLUENZA VACCINE) taken for an unspecified indication, start and stop date were not reported.  The patient experienced chills  on 12Apr2021 with outcome of recovered , tiredness  on 12Apr2021 with outcome of recovered , headache  on 12Apr2021 with outcome of recovered , muscle pain on 12Apr2021 with outcome of recovered , joint pain on 12Apr2021 with outcome of recovered , my stomach was flipping but not nauseas  on 12Apr2021 with outcome of recovered. All the reported events were considered non serious.   Therapeutic measures were taken as a result of muscle pain and joint pain included Tylenol  Course of the event according to the patient. With the first shot I got chills four hours after shot on the same day, I had the chills for about three days. . But the second shot, the day of the second shot was 12Apr2021, I had the chills, tiredness, headache, muscle pain, joint pain and my stomach was flipping but not nauseas and I didn't had any swelling with that, I did came down with all those symptoms. I lasted for 1 week. I took Tylenol for pain. I have no such condition now, yes it did help. It wasn't a miracle but it did, you know it did help me to relax and sleep.  Information on lot /batch number has been requested.
Age: 81.0
Sex: U
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: chills; tiredness; headache; muscle pain; joint pain; my stomach was flipping but not nauseas; This is a spontaneous report from a contactable consumer (the patient).     A 81-years-old patient of an unspecified gender received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 12Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation  .  Medical history included arthritis. On 22Mar2021 the patient received the first dose of BNT162B2 vaccine and experienced chills.  Concomitant medications included influenza vaccine (INFLUENZA VACCINE) taken for an unspecified indication, start and stop date were not reported.  The patient experienced chills  on 12Apr2021 with outcome of recovered , tiredness  on 12Apr2021 with outcome of recovered , headache  on 12Apr2021 with outcome of recovered , muscle pain on 12Apr2021 with outcome of recovered , joint pain on 12Apr2021 with outcome of recovered , my stomach was flipping but not nauseas  on 12Apr2021 with outcome of recovered. All the reported events were considered non serious.   Therapeutic measures were taken as a result of muscle pain and joint pain included Tylenol  Course of the event according to the patient. With the first shot I got chills four hours after shot on the same day, I had the chills for about three days. . But the second shot, the day of the second shot was 12Apr2021, I had the chills, tiredness, headache, muscle pain, joint pain and my stomach was flipping but not nauseas and I didn't had any swelling with that, I did came down with all those symptoms. I lasted for 1 week. I took Tylenol for pain. I have no such condition now, yes it did help. It wasn't a miracle but it did, you know it did help me to relax and sleep.  Information on lot /batch number has been requested.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Lymphadenopathy, Pruritus, Rash
Clinical narrative: Of my feet itched like something I have never experienced; rash on my thighs; fatigue; headache; blurry vision; still to this day swollen lymph nodes.; This is a spontaneous report from a contactable consumer.A 42-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 09Apr2021 16:45 (Batch/Lot Number: EW0158) as DOSE 2, SINGLE for covid-19 immunisation.  Medical history included allergy with Sulfa drugs. Concomitant medication(s) included lorazepam (ATIVAN) taken for an unspecified indication, start and stop date were not reported; cetirizine hydrochloride (ZYRTEC ALLERGY) taken for an unspecified indication, start and stop date were not reported. Patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number:ER8736) on 01May2021 administrated in left arm for covid-19 immunization.After second dose, within 5 days , the bottom Of my feet itched like something I have never experienced, rash on my thighs, fatigue, headache, blurry vision, still to this day swollen lymph nodes. Outcome of swollen lymph nodes was not recovered, of others was recovering. Therapeutic measures were taken as a result of  all events.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: Of my feet itched like something I have never experienced; rash on my thighs; fatigue; headache; blurry vision; still to this day swollen lymph nodes.; This is a spontaneous report from a contactable consumer.A 42-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 09Apr2021 16:45 (Batch/Lot Number: EW0158) as DOSE 2, SINGLE for covid-19 immunisation.  Medical history included allergy with Sulfa drugs. Concomitant medication(s) included lorazepam (ATIVAN) taken for an unspecified indication, start and stop date were not reported; cetirizine hydrochloride (ZYRTEC ALLERGY) taken for an unspecified indication, start and stop date were not reported. Patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number:ER8736) on 01May2021 administrated in left arm for covid-19 immunization.After second dose, within 5 days , the bottom Of my feet itched like something I have never experienced, rash on my thighs, fatigue, headache, blurry vision, still to this day swollen lymph nodes. Outcome of swollen lymph nodes was not recovered, of others was recovering. Therapeutic measures were taken as a result of  all events.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenitis, Lymphadenopathy
Clinical narrative: neck and arm glands were inflamed; had swollen lymph node on the left side of his neck; This is a spontaneous report from a contactable consumer. A 50-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date in Apr2021 (at the age of 50-year-old)(Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included ongoing rheumatoid arthritis. Concomitant medication included etanercept (ENBREL, Solution for injection in pre-filled syringe, lot number: 1125680, expiry date: 31Aug2023) taken for rheumatoid arthritis, start and stop date were not reported. On an unknown date in 2021, the patient stated his neck and arm glands were inflamed, when he was vaccinated with COVID-19 vaccine early this year and resolved. It was further reported on an unknown date in 2021, the patient had swollen lymph node on the left side of his neck. The event outcome was recovered in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rheumatoid arthritis
Clinical narrative: her arthritis flared all over, everywhere except for feet; This is a spontaneous report from a contactable consumer reporting information for the same patient. This is the second of two reports. The first report is a solicited report from a non-Pfizer sponsored program (marketing program name not available) based on information received by Pfizer from Amgen (manufacturer control number: AMGEN-USASL2021106605), license party for etanercept (ENBREL). A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on unspecified date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. Medical history included ongoing rheumatoid arthritis. Concomitant medication included etanercept (ENBREL) from 2002 for rheumatoid arthritis. It was reported that patient got covid vaccine, and her arthritis flared all over, everywhere except for feet. Patient HCP had told her that he had heard from other patient's that their conditions flared after getting vaccine. The outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pneumonia
Clinical narrative: He mentioned that he was in respirator for 3 weeks due to pneumonia; This is a spontaneous report received from a non-contactable consumer (patient) via a Pfizer-sponsored program Support. A male patient of an unspecified age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: Unknown), via an unspecified route of administration on an unspecified date as dose 1, single and a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: Unknown), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. Medical history included covid from Nov2020 to an unknown date, and had been in the hospital for 2 or 3 months. Caller said that he was a Covid survivor in November before the vaccine. The patient concomitant medications were not reported. He mentioned that he was in respirator for 3 weeks due to pneumonia on unknown date. The event was assessed as serious (medically significant). Caller was thankful about the vaccine and he was willing to take the booster shot. Call got disconnected before clarifying to the caller if he was tested positive before or after taking the vaccine. The outcome of the event was reported as unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest pain, Dyspnoea, Myocardial infarction
Clinical narrative: Heart attack; Chest pain; Shortness of breath; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received bnt162b2, first single dose via an unspecified route of administration, administered in arm right on an unspecified date (Batch/Lot Number: EW0180) as for covid-19 immunisation. Medical history included heart problem. Concomitant medication included levetiracetam (KEPPRA). The patient had a serious reaction to your product. The patient was started having chest pain and shortness of breath after medical on 14Jul2021. She had lab work done at the hospital to check her heart and stuff on 14Jul2021. The patient was kept in hospital for 15 hours after she had heart 'attack' on 14Jul2021. The patient received 'Retinol' and Nitroglycerin last night and then received the Nitro drip and fluids last night and in this morning and this afternoon. At the time of this report, it's better since she had Nitro drip. Outcome of the events was recovering.   Follow-up attempts are completed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, COVID-19, Cough, Drug ineffective
Clinical narrative: no smell; headache; cough; no taste; congestion; I tested positive for corvid 19 and have mild symptoms congestion, headache, cough, no taste or smell.; 1st dose taken on 05Feb2021 and the 2nd dose was taken on 15Jun2021; 1st dose taken on 05Feb2021 and the 2nd dose was taken on 15Jun2021; This is a spontaneous report from a contactable consumer (patient). A 38-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EL3247 and Expiry date was not reported), dose 2 via an unspecified route of administration in arm right on 15Jun2021 13:00 (age at vaccination was 38-year-old) and dose 1 (Lot Number: EL3247 and Expiry date was not reported) via an unspecified route of administration in arm right on 05Feb2021 13:00 as a single dose for covid-19 immunisation. Medical history included drug hypersensitivity (Sulfur base drugs) from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient tested for COVID-19. Concomitant medications received within 2 weeks of vaccination included birth control pills, OTC, cetirizine hydrochloride (WAL ZYR) and fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 13Jul2021 at 03:00 tested positive for corvid 19 and have mild symptoms congestion, headache, cough, no taste or smell. Due to the events patient visit Doctor or other healthcare professional office/clinic visit. Treatment received for the events was unknown. The patient underwent lab tests and procedures which included sars-cov-2 test post vaccination: negative on 19May2021, negative on 25Jun2021, positive on 15Jul2021 by using nasal swab and covid test name was SARS-CoV-2 (APTIMA). The outcome of the events was unknown.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Inappropriate schedule of product administration, Nasal congestion, SARS-CoV-2 test
Clinical narrative: no smell; headache; cough; no taste; congestion; I tested positive for corvid 19 and have mild symptoms congestion, headache, cough, no taste or smell.; 1st dose taken on 05Feb2021 and the 2nd dose was taken on 15Jun2021; 1st dose taken on 05Feb2021 and the 2nd dose was taken on 15Jun2021; This is a spontaneous report from a contactable consumer (patient). A 38-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EL3247 and Expiry date was not reported), dose 2 via an unspecified route of administration in arm right on 15Jun2021 13:00 (age at vaccination was 38-year-old) and dose 1 (Lot Number: EL3247 and Expiry date was not reported) via an unspecified route of administration in arm right on 05Feb2021 13:00 as a single dose for covid-19 immunisation. Medical history included drug hypersensitivity (Sulfur base drugs) from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient tested for COVID-19. Concomitant medications received within 2 weeks of vaccination included birth control pills, OTC, cetirizine hydrochloride (WAL ZYR) and fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 13Jul2021 at 03:00 tested positive for corvid 19 and have mild symptoms congestion, headache, cough, no taste or smell. Due to the events patient visit Doctor or other healthcare professional office/clinic visit. Treatment received for the events was unknown. The patient underwent lab tests and procedures which included sars-cov-2 test post vaccination: negative on 19May2021, negative on 25Jun2021, positive on 15Jul2021 by using nasal swab and covid test name was SARS-CoV-2 (APTIMA). The outcome of the events was unknown.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood pressure measurement, Feeling hot, Pain in extremity
Clinical narrative: She had increase in pain in elbows, wrists and hands after each dose.; She had increase in pain in elbows, wrists and hands after each dose.; knee pain and they feel hot; This is a spontaneous report from a contactable Other Health Professional and consumer Specialty Pharmacy. This 54-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on May2021 (at the age of 54-years-old) (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included rheumatoid arthritis from an unknown date and unknown if ongoing, blood pressure readings went high from Nov2020 to an unknown date (patient reports in Nov2020 her blood pressure readings went high in the 180 over102-104 range). Concomitant medication included tofacitinib citrate (XELJANZ) taken for rheumatoid arthritis from 2019 and ongoing. The patient had she had increase in pain in elbows, wrists and hands after each dose on an unspecified date in May2021 and knee pain and they feel hot on an unspecified date in 2021. Patient reports when she was off XELJANZ for 10 days following each covid vaccine in May2021 and Jun2021. She had increase in pain in elbows, wrists and hands after each dose. patient reports in Nov2020 her blood pressure readings went high in the 180 over102-104 range, her md put her on medication and her readings are now 145/77. No other readings given. Patient states md believes it was from XELJANZ. Patient now states she has bilateral knee pain and they feel hot, she reports she ices them and puts on biofreeze. Registered nurse encouraged to update md. Patient agreed. No further details. The patient underwent lab tests and procedures which included blood pressure measurement: 180 on Nov2020 Patient reports in Nov2020 her blood pressure readings went high in the 180 over102-104 range, her md put her on medication and her readings are now 145/77, blood pressure measurement: 145/77 on 2021 Patient reports in Nov2020 her blood pressure readings went high in the 180 over102-104 range, her md put her on medication and her readings are now 145/77. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021906600
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood pressure measurement, Feeling hot, Pain in extremity
Clinical narrative: She had increase in pain in elbows, wrists and hands after each dose/States she has bilateral knee pain and they feel hot; She had increase in pain in elbows, wrists and hands after each dose.; She had increase in pain in elbows, wrists and hands after each dose/States she has bilateral knee pain and they feel hot; This is a spontaneous report from a contactable other health care professional and consumer. A 24-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number& Expiry date not reported) via unspecified route of administration on unspecified date in Jun2021 (at age of 24-year-old) as dose 2, single for COVID-19 Immunisation. Patient medical history includes rheumatoid arthritis, Blood pressure readings went high in Nov2020 (her blood pressure readings went high in the 180 over102-104 range). Concomitant medications include tofacitinib citrate (XELJANZ) taken for rheumatoid arthritis from 2019 and ongoing. Patient previously received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number& Expiry date not reported) via unspecified route of administration (at age of 24-year-old) on unspecified date in May2021 and experienced pain in elbows, wrists and hands after each dose. Patient reports when she was off Xeljanz for 10 days following each covid vaccine in May2021 and Jun2021. She had increase in pain in elbows, wrists and hands after each dose following second dose she was on short course of prednisone due to this once back on Xeljanz, it took 2-2.5 weeks for her to feel less pain and back to normal and MD was aware. Patient underwent lab test and procedures include blood pressure reports in Nov2020 her blood pressure readings went high in the 180 over102-104 range, her MD put her on medication and her readings are now 145/77 on unspecified date. Patient states MD believes it was from Xeljanz. Patient now states she has bilateral knee pain, and they feel hot, she reports she ices them and puts on biofreeze and registered nurse encouraged to update MD. patient agreed. The Outcome of all events was unknown.  Information on the lot/batch number has been requested.  ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021906599