chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Contusion, Limb mass
Clinical narrative: This is a spontaneous report from a contactable consumer or other non-HCP. An 81-year-old female patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# was not reported), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The HCP whose title she cannot remember said "when they put the needle in her arm, it may have hit a vein" thus causing a "bruising/contusion" (circumstance or information capable of leading to medication error) and a lump in her arm on an unspecified date; with outcome of unknown. No follow-up attempts possible. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: 1 hive on her back; This is a spontaneous report from a non-contactable consumer or other non-health care professional (Patient). A female patient of an unspecified age received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 22Mar2021 as dose 1, single for -19 immunization. Patient's relevant medical history and concomitant medications were not reported. On an unspecified date in Mar2021, patient reported that she had 1 hive on her back that didn't stay there long, stating " It could have been a mosquito bite". Outcome of the event was recovered on an unspecified date in Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Body temperature decreased, Chest discomfort, Dizziness
Clinical narrative: two days later and it was 90 degrees/She checked her temperature and it was 90 degree; throwing up; dizziness; weakness; tightening of her chest and was breathing shallow; woke her up out of a dead sleep; felt really terrible / Had a bad reaction to the first dose of the vaccine; tightening of her chest and was breathing shallow; This is a spontaneous report from a contactable consumer (patient) from Pfizer. A female patient of age 49 (units: unknown) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 11Mar2021 (at the age of 49 (units: unknown)) as single dose for COVID-19 immunization. Medical history included motion sickness. The patient's concomitant medications were not reported. The patient reported that she received the first dose of the pfizer covid 19 vaccine on 11Mar2021. One hour after the shot she started throwing up and she checked her temperature at night and it was 90 degree. She threw up for three to four days. Patient stated that she gets motion sickness. She had dizziness and weakness. Two days later, she took her temperature again and it was 90 degrees. She had tightening of her chest and was breathing shallow and it woke her up out of a dead sleep. She felt really terrible. The patient wanted to know if this had been reported and whether or not it would be safe for her to get other dose because she had the side effects. Outcome of the event throwing up was recovered in Mar2021; other events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Hypopnoea, Sleep disorder, Vomiting
Clinical narrative: two days later and it was 90 degrees/She checked her temperature and it was 90 degree; throwing up; dizziness; weakness; tightening of her chest and was breathing shallow; woke her up out of a dead sleep; felt really terrible / Had a bad reaction to the first dose of the vaccine; tightening of her chest and was breathing shallow; This is a spontaneous report from a contactable consumer (patient) from Pfizer. A female patient of age 49 (units: unknown) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 11Mar2021 (at the age of 49 (units: unknown)) as single dose for COVID-19 immunization. Medical history included motion sickness. The patient's concomitant medications were not reported. The patient reported that she received the first dose of the pfizer covid 19 vaccine on 11Mar2021. One hour after the shot she started throwing up and she checked her temperature at night and it was 90 degree. She threw up for three to four days. Patient stated that she gets motion sickness. She had dizziness and weakness. Two days later, she took her temperature again and it was 90 degrees. She had tightening of her chest and was breathing shallow and it woke her up out of a dead sleep. She felt really terrible. The patient wanted to know if this had been reported and whether or not it would be safe for her to get other dose because she had the side effects. Outcome of the event throwing up was recovered in Mar2021; other events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Flushing, Headache
Clinical narrative: flushed; tiredness; headache; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EN6202 and expiration date: not reported), via an unspecified route of administration, on 06Mar2021 (at the age of 60-year-old) as DOSE 1, SINGLE for covid-19 immunization. Relevant medical history reported as none. The patient's concomitant medications were not reported. On 06Mar2021, 20 minutes after receiving the 1st dose of the Vaccine, patient started to feel flushed. The patient said it felt like she sat out in the sun for too long. And when patient looked in the mirror, she saw that her face was indeed flushed. It eventually went away after 10-15 minutes. The patient also mentioned that she experienced tiredness and headache after the 1st dose. The patient wants to know if this is a normal reaction to the vaccine and if it would still be safe for her to receive the 2nd dose. The outcome of the event Flushed was recovered in 06Mar2021, while other events was unknown at time of report.   No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Hot flush, Malaise
Clinical narrative: flushed; tiredness; headache; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EN6202 and expiration date: not reported), via an unspecified route of administration, on 06Mar2021 (at the age of 60-year-old) as DOSE 1, SINGLE for covid-19 immunization. Relevant medical history reported as none. The patient's concomitant medications were not reported. On 06Mar2021, 20 minutes after receiving the 1st dose of the Vaccine, patient started to feel flushed. The patient said it felt like she sat out in the sun for too long. And when patient looked in the mirror, she saw that her face was indeed flushed. It eventually went away after 10-15 minutes. The patient also mentioned that she experienced tiredness and headache after the 1st dose. The patient wants to know if this is a normal reaction to the vaccine and if it would still be safe for her to receive the 2nd dose. The outcome of the event Flushed was recovered in 06Mar2021, while other events was unknown at time of report.   No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Flushing, Headache
Clinical narrative: tired; really not so great feeling; felt flushed and very warm; felt a ZING all over, almost like it took off, it didn't hurt, not pain; headaches; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (BNT162B2; Lot Number: EN6202), via an unspecified route of administration in left arm on 06Mar2021 15:35 (at the age of 60-years-old) as dose 1, single for COVID-19 immunization. The patient medical history included reaction to sulfa (about 40 years ago she had a reaction to sulfa, she doesn't know what they call the reaction, but she had to go to the emergency room (ER); it was hard to breathe, she had what was like a sunburn rash on her arms, legs, and face). The patient's concomitant medications were not reported. Prior to vaccination, the patient did not receive any vaccines within four weeks. The patient previously received penicillin (takes penicillin all the time, well, over the years she has taken it). The patient experienced felt a zing all over, almost like it took off, it didn't hurt, not pain on 06Mar2021 15:40 (within 5 minutes of her vaccination or around there), felt flushed and very warm on 06Mar2021 15:50, tired and really not so great feeling on 10Mar2021 and headaches on an unspecified date in Mar2021. It was reported that the day of, she waited 15 minutes and they were very nice, it went smoothly. After the shot, she felt a ZING, about 20 mins she was out in the car, she waited 15, walked out to the car, about 2 mins after that her husband looked at her and asked if she is warm. She felt flush, looked in mirror it looked like she had been out in the sun, she was flush and very warm, she didn't' recognize right away. She had a small headache, she was tired and for a couple days she was really not so great feeling, but she added that the alternative was horrific. Patient thinks the not-so-great feeling was her getting too tired. Patient talked to a friend and she didn't sound like whatever, they said it should not happen 5 days after. She usually doesn't have headaches. Outcome of events felt a ZING all over, almost like it took off, it didn't hurt, not pain and felt flushed and very warm were resolved on 06Mar2021. Events tired, really not so great feeling and headaches were resolved on an unspecified date in Mar2021.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Hot flush, Malaise
Clinical narrative: tired; really not so great feeling; felt flushed and very warm; felt a ZING all over, almost like it took off, it didn't hurt, not pain; headaches; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (BNT162B2; Lot Number: EN6202), via an unspecified route of administration in left arm on 06Mar2021 15:35 (at the age of 60-years-old) as dose 1, single for COVID-19 immunization. The patient medical history included reaction to sulfa (about 40 years ago she had a reaction to sulfa, she doesn't know what they call the reaction, but she had to go to the emergency room (ER); it was hard to breathe, she had what was like a sunburn rash on her arms, legs, and face). The patient's concomitant medications were not reported. Prior to vaccination, the patient did not receive any vaccines within four weeks. The patient previously received penicillin (takes penicillin all the time, well, over the years she has taken it). The patient experienced felt a zing all over, almost like it took off, it didn't hurt, not pain on 06Mar2021 15:40 (within 5 minutes of her vaccination or around there), felt flushed and very warm on 06Mar2021 15:50, tired and really not so great feeling on 10Mar2021 and headaches on an unspecified date in Mar2021. It was reported that the day of, she waited 15 minutes and they were very nice, it went smoothly. After the shot, she felt a ZING, about 20 mins she was out in the car, she waited 15, walked out to the car, about 2 mins after that her husband looked at her and asked if she is warm. She felt flush, looked in mirror it looked like she had been out in the sun, she was flush and very warm, she didn't' recognize right away. She had a small headache, she was tired and for a couple days she was really not so great feeling, but she added that the alternative was horrific. Patient thinks the not-so-great feeling was her getting too tired. Patient talked to a friend and she didn't sound like whatever, they said it should not happen 5 days after. She usually doesn't have headaches. Outcome of events felt a ZING all over, almost like it took off, it didn't hurt, not pain and felt flushed and very warm were resolved on 06Mar2021. Events tired, really not so great feeling and headaches were resolved on an unspecified date in Mar2021.  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Coagulation test, Contusion, Eyelid disorder, Lymphadenopathy, Pain
Clinical narrative: bruising on his abdomen on day 7-10 after administration/bruises on his belly; large bump/swollen lymphnodes behind right ear; Pain in whole body; spot on eyelid; This is a spontaneous report from a contactable consumer (patient) via medical information team.  A 45-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6199) via an unspecified route of administration in right arm on 10Mar2021 (at the age of 45-years-old) as dose 1, single for COVID-19 immunization. The patient medical history included ongoing high risk High blood pressure (Diagnosed 27 years ago), Overweight (Diagnosed 25 years ago), and Asthma (Diagnosed as a child). The patients concomitant medications were not reported. Reporter stated that he received the first dose of the Covid vaccine on 10Mar2021 and was scheduled to receive the second dose 31Mar2021. Reporter stated that he was having reactions to the vaccine, on 17Mar2021 specifically bruising on his abdomen on day 7-10 after administration. Patient consulted with his health care professional, but he was not sure if he should get the second dose. Reporter queried for if there was any information regarding the side effect he was experiencing. Reporter stated that he wanted to report side effects for first shot. Stated that he had to have the second one on the 31st. Stated that after 10 days after that he had bruises on his belly. Wanted to know if he should get the second shot. Stated that he went to the doctor Monday and he did blood work to see coagulation and all related. Stated that everything came back on the normal range. On unspecified date Mar2021 third day developed spot on eyelid, large bump/swollen lymph nodes behind right ear, pain in whole body. On tenth day bruises on stomach after sleeping. Health care professional ran coagulation test that came back normal, reporter still concerned. Patient had not received any treatment for the events bruising on his abdomen on day 7-10 after administration/bruises on his belly. Outcome of events bruising on his abdomen on day 7-10 after administration/bruises on his belly was recovering and all other events was unknown.  No follow-up attempts are possible. No further information is expected
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Finger deformity, Vaccination site pain, X-ray limb
Clinical narrative: Some arthritis/Arthritis in both hands; The "needle did hurt"; The fingers on her right hand started flexing in the wrong direction/her right middle finger was still uncomfortable; This is a spontaneous report from a contactable consumer (patient) from medical information team. A 72-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EN6205, expiration date was not reported) via intramuscular route, in right arm, on 06Mar2021 11:50 (at the age of 72-year-old) at dose 1, single for covid-19 immunization. Medical history included blood pressure high for a couple years, left knee was bone-on-bone (as reported). There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the covid-19 vaccine. No history of previous immunization with the bnt162b2 vaccine and no additional vaccines administered on same date. The patient experienced some arthritis/arthritis in both hands, the vaccine needle going into her arm was uncomfortable, kind of hurt/ needle did hurt, the fingers on her right hand started flexing in the wrong direction/her right middle finger was still uncomfortable on 06Mar2021. The patient underwent lab tests and procedures which included X-ray of left and right hand: arthritis in both hands on 23Mar2021. The events resulted in Physician office visit. No treatment was received for the events. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: rash; itching allover the body; This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on an unspecified date for COVID-19 immunisation. The patient experienced rash and itching all over the body. The patient was fine after the first dose but after second dose she was having itching and rash, no breathing problems. Patient is taking loratadine (CLARITIN) for it. The outcome of the events was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Swelling
Clinical narrative: Daily increase of swelling and redness over a four-day period after date of vaccination.; Daily increase of swelling and redness over a four-day period after date of vaccination/ Big red spot; it started getting really red; This is a spontaneous report from a contactable consumer (patient).   A 72-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Lot Number: ER8730) via an unspecified route of administration, administered in Arm Right on 21Mar2021 15:15 at the age of 72-year-old as dose 1, single for covid-19 immunisation from pharmacy or drug store. Medical history included double mastectomy in December 2020 and allergies to penicillin, latex, lactose intolerant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no other medications were received within 2 weeks of vaccination. The patient was not diagnosed with covid prior to vaccination and patient was not tested for COVID-19 post vaccination. On 23Mar2021 12:00 patient had daily increase of redness and swelling it was the size of the palm of hand and the next day it was  3 times the size of the palm of her hand and next day it was all the way down to almost my elbow and wrapping around the back side over a four-day period after date of vaccination. On the 23Mar2021, patient notice the big red spot and then it grew on 24Mar2021 and 25Mar2021 it was huge.  In-person consultation with primary physician on 25Mar2021 at which time he told me not to take the second dose; his opinion was it would be too risky considering the reaction to the first dose. No prescription written. physician want to have anything other than Tylenol and Ibuprofen for pain which she didn't do because he didn't want to mess with the vaccination in anyway by giving me any kind of medication. Patient have an ap-pointment schedule on 11April2021 and want to a second opinion on whether I should or should not take the second dose. The patient did not receive any treatment in response to the events. The outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Pain, Pain in extremity, Pyrexia
Clinical narrative: had fever 100.5 °F for a couple days; had aches and pains, sharp pain; weakness; sharp pains in my stomach, arm; sharp pains in my stomach, arm; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration on 24Mar2021 (age at the time of vaccination 64-years-old), as a single dose for COVID-19 immunization. The patient's medical history included Cancer Remission; COVID-19 virus from an unspecified date Feb2021, had the COVID-19 virus the first part of Feb; noticed hair loss, not from the vaccine, hair loss from COVID, I was not hospitalized or anything like that; and blood thinner, I am on Eliquis blood thinner medication. The patient's concomitant medications included ELIQUIS for Blood thinner. On 24Mar2021, the patient experienced had fever 100.5-degree Fahrenheit for a couple days; had aches and pains, sharp pain; weakness; and sharp pains in my stomach, arm. On an unspecified date, the patient underwent lab tests and procedures which included Pyrexia: 100.5-degree Fahrenheit. Caller wanted to make sure second dose is the same amount, the same quantity of the vaccine on the second scheduled 14Apr2021. Caller wanted to know if she can get a blood clot from taking the vaccine because she is on Eliquis blood thinner. The outcome for all the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity, Inflammation, Lip swelling, Swelling, Swelling face
Clinical narrative: swelling on his face; swelling on his lips; developed inflammation on his neck; neck swelling; presented an allergic reaction; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received 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 in 2021 as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient wants to know if he should receive the second dose of the vaccine, since on an unspecified date in 2021 after first dose, patient developed an allergic reaction and presented swelling on his face and lips from 4 to 6 hours after receiving the vaccine, later that night he developed inflammation on his neck, neck swelling, he never had anaphylaxis. Patient reported he had an appointment to receive the second dose on Thursday (31Mar2021), even though he wants to receive the second dose to be protected he might not receive it. Reporter stated response from PI, regarding contraindications included to not administer Pfizer-BioNTech COVID-19 Vaccine to individuals with known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the Pfizer-BioNTech COVID-19 Vaccine; regarding warnings Appropriate medical treatment to be used to manage immediate allergic reactions must be immediately available in the event when an acute anaphylactic reaction occurs following administration of Pfizer-BioNTech COVID-19 Vaccine; the vaccine was approved as a two dose schedule, the first dose primes the immune system and the second one that boosts the immune system. No information on the efficacy of the first dose. The patient wants to know if he could use Epipen to counteract a severe allergic reaction to second dose of vaccine in case of presenting it. He also wants to know if there was any treatment on development for future allergic reactions due to vaccine also patient wants to know the protection percentage he would have with a single vaccine dose. Patient stated that there were some other patients who reported some symptoms the same as this. He was afraid with the second dose that it would give him a stronger reaction. Outcome of the events was unknown.   No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dyspnoea, Fatigue, Headache
Clinical narrative: pain at the injection site; swelling at the injection site; tired; headache; nausea; Chills; Muscle pain; Shortness of breath; Fever; This is a spontaneous report from a contactable consumer (patient's husband) received via medical information team. A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ER2613; Expiration Date: Jul2021), via an unspecified route of administration in left arm on 25Mar2021 12:45 (at the age of 66-years-old) as dose 1, single for COVID-19 immunization.  Medical history included allergy to penicillin, ongoing diabetes from 2018, ongoing HIV and ongoing neuropathy. Concomitant medications included atorvastatin taken orally as 10 mg, 1x/day and ongoing; emtricitabine, tenofovir alafenamide fumarate (DESCOVY) taken orally for HIV as 25 mg, 1x/day, taking for four years and ongoing; gabapentin taken orally for neuropathy as 100 mg, 2x/day, taking for several years and ongoing; dolutegravir sodium (TIVICAY) taken orally for HIV as 50 mg; taken once daily by mouth; taking for four years and ongoing; insulin aspart (NOVOLOG) taken 100 Units; taken by injection as needed with meals; taking for four years and ongoing; insulin glargine (BASAGLAR) taken 100 units; taken by injection daily; taking over four years and ongoing. The patient seemed alright for the first 15 minutes after vaccination. No additional vaccines administered on same date of BNT162B2. Prior to vaccination, the patient did not receive any vaccines within four weeks. The patient experienced pain at the injection site, swelling at the injection site, tired, headache, nausea, chills, muscle pain, shortness of breath and fever on 26Mar2021. It was reported that patient is having a severe headache and nausea. Reporter wanted to know how long the side effects will last and if his wife could take her regular medications. It was stated that they thought she could not take aspirin and wanted to know what she could take for her headache. Events pain at the injection site, swelling at the injection site, headache, and nausea were reported as worsened. Patient has been scheduled for the second dose on 15Apr2021. Outcome of events was not resolved.  No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia, Vaccination site pain, Vaccination site swelling
Clinical narrative: pain at the injection site; swelling at the injection site; tired; headache; nausea; Chills; Muscle pain; Shortness of breath; Fever; This is a spontaneous report from a contactable consumer (patient's husband) received via medical information team. A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ER2613; Expiration Date: Jul2021), via an unspecified route of administration in left arm on 25Mar2021 12:45 (at the age of 66-years-old) as dose 1, single for COVID-19 immunization.  Medical history included allergy to penicillin, ongoing diabetes from 2018, ongoing HIV and ongoing neuropathy. Concomitant medications included atorvastatin taken orally as 10 mg, 1x/day and ongoing; emtricitabine, tenofovir alafenamide fumarate (DESCOVY) taken orally for HIV as 25 mg, 1x/day, taking for four years and ongoing; gabapentin taken orally for neuropathy as 100 mg, 2x/day, taking for several years and ongoing; dolutegravir sodium (TIVICAY) taken orally for HIV as 50 mg; taken once daily by mouth; taking for four years and ongoing; insulin aspart (NOVOLOG) taken 100 Units; taken by injection as needed with meals; taking for four years and ongoing; insulin glargine (BASAGLAR) taken 100 units; taken by injection daily; taking over four years and ongoing. The patient seemed alright for the first 15 minutes after vaccination. No additional vaccines administered on same date of BNT162B2. Prior to vaccination, the patient did not receive any vaccines within four weeks. The patient experienced pain at the injection site, swelling at the injection site, tired, headache, nausea, chills, muscle pain, shortness of breath and fever on 26Mar2021. It was reported that patient is having a severe headache and nausea. Reporter wanted to know how long the side effects will last and if his wife could take her regular medications. It was stated that they thought she could not take aspirin and wanted to know what she could take for her headache. Events pain at the injection site, swelling at the injection site, headache, and nausea were reported as worsened. Patient has been scheduled for the second dose on 15Apr2021. Outcome of events was not resolved.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Hyperhidrosis, Myalgia, Pain in extremity
Clinical narrative: His arm was still really sore; Chills; Fever of 99.1; Injection site swelling; Injection site pain; Sweating; His arm to be swollen; Muscle pain; This is a spontaneous report from a contactable consumer (patient's wife). A 51-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 25Mar2021 13:15 (at the age of 51-year-old) (Lot number and expiration date was not reported) as dose 1, single for COVID-19 immunization. The vaccine was administered in hospital. The patient medical history included slightly elevated prostate. The concomitant medications included (ibuprofen) ADVIL for unknown indication. The patient experienced muscle pain, arm swollen, injection site swelling and injection site pain on 25Mar2021. On 26Mar2021, patient woke up at 1:30 in a sweat. The patient did not check his temperature at the time, but thought his fever was breaking. The patient woke up in the morning with chills, and his arm was still really sore. On same day, the patient was had fever and temperature during the lunch was 99. The patient received ibuprofen 200 mg capsules (Kirkland brand) as treatment for the events. The outcome of event muscle pain and arm sore was unknown. The outcome of event arm swollen and pyrexia was recovering and outcome of other events was recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Pyrexia, Vaccination site pain, Vaccination site swelling
Clinical narrative: His arm was still really sore; Chills; Fever of 99.1; Injection site swelling; Injection site pain; Sweating; His arm to be swollen; Muscle pain; This is a spontaneous report from a contactable consumer (patient's wife). A 51-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 25Mar2021 13:15 (at the age of 51-year-old) (Lot number and expiration date was not reported) as dose 1, single for COVID-19 immunization. The vaccine was administered in hospital. The patient medical history included slightly elevated prostate. The concomitant medications included (ibuprofen) ADVIL for unknown indication. The patient experienced muscle pain, arm swollen, injection site swelling and injection site pain on 25Mar2021. On 26Mar2021, patient woke up at 1:30 in a sweat. The patient did not check his temperature at the time, but thought his fever was breaking. The patient woke up in the morning with chills, and his arm was still really sore. On same day, the patient was had fever and temperature during the lunch was 99. The patient received ibuprofen 200 mg capsules (Kirkland brand) as treatment for the events. The outcome of event muscle pain and arm sore was unknown. The outcome of event arm swollen and pyrexia was recovering and outcome of other events was recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Restlessness, Rhinorrhoea, Sleep disorder
Clinical narrative: Cough; Runny nose; Waking up last night every hour; Feeling restless; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: not reported) via an unspecified route of administration on 25Mar2021 (at the age of 67-year-old) as Dose 2, single for COVID-19 immunization. Patient medical history included COPD from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient historical vaccine included received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: not reported) via an unspecified route of administration on an unspecified date as Dose 1, single for COVID-19 immunization. On 25Mar2021 (at night), the patient woke up to use the bathroom and felt restless every hour and on 26Mar2021, (this morning) patient had cough and runny nose. Patient wanted to know if this would be something to be concerned about. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Body temperature, Eye disorder, Feeling hot, Headache
Clinical narrative: tingling in her head; equilibrium is off; Low grade fever; left side hotter than the rest; making her nervous; electrical zaps behind her left eye; Headache; This is a spontaneous report from a contactable consumer (Patient). A 57-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation: Solution for injection, Lot Number: EP6955), via an unspecified route of administration, administered in Arm Left on 22Mar2021 14:45PM (age at vaccination 57-years-old) as first dose single for covid-19 immunization. The patient medical history included hypertension, asthma (she has an asthma pump she uses as needed, her asthma was diagnosed 7 or more years ago), overweight, surgery from an unknown date and unknown if ongoing (Caller says she has had several surgeries in her lifetime) along with Caller said that she was on disability right now, and has been for the past few years (disability is unknown). Concomitant medications were not reported. On 23Mar2021 patient experienced that when she walks she had zaps or tingling in her head that are throwing her equilibrium off. She says she had a low-grade fever, her left side is hotter than the rest of her head and neck area. She says that the girl that was giving her the injection said oh you are a bleeder, she must have hit a vein. She says that this was making her nervous, she does not like feeling off balance and does not trust herself to drive today. She asks does she need to go to the doctor or emergency room. She says she felt ok on her way home yesterday from getting the vaccine, then when she got home her head started feeling weird, like a tingle. She says she wants to make sure she was not going to die here. She says that her left side, where she was injected in her left arm, feels hotter, and her right side feels normal. She says if she does her temperature on her left side it was 100.8 then sometimes 101. She says she needs to know what to do from here, she does not want to croak while being home and she does not trust herself driving. She says having the weird sensation throws her off, when she turns her neck or stretches and gets up she has electrical zaps behind her left eye for her head. It was reported she was on disability right now and has been for the past few years. She asks if the people giving vaccines, are they phlebotomists or certified to give vaccines, she should have asked, they were supposed to hit a muscle, not a vein. It was reported she also has a heavy too headache. She says that the vaccine was given in her non-dominant arm. The patient underwent lab tests and procedures which included body temperature found to be unknown result on unspecified date of 2021. The clinical outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Nervousness, Paraesthesia, Pyrexia
Clinical narrative: tingling in her head; equilibrium is off; Low grade fever; left side hotter than the rest; making her nervous; electrical zaps behind her left eye; Headache; This is a spontaneous report from a contactable consumer (Patient). A 57-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation: Solution for injection, Lot Number: EP6955), via an unspecified route of administration, administered in Arm Left on 22Mar2021 14:45PM (age at vaccination 57-years-old) as first dose single for covid-19 immunization. The patient medical history included hypertension, asthma (she has an asthma pump she uses as needed, her asthma was diagnosed 7 or more years ago), overweight, surgery from an unknown date and unknown if ongoing (Caller says she has had several surgeries in her lifetime) along with Caller said that she was on disability right now, and has been for the past few years (disability is unknown). Concomitant medications were not reported. On 23Mar2021 patient experienced that when she walks she had zaps or tingling in her head that are throwing her equilibrium off. She says she had a low-grade fever, her left side is hotter than the rest of her head and neck area. She says that the girl that was giving her the injection said oh you are a bleeder, she must have hit a vein. She says that this was making her nervous, she does not like feeling off balance and does not trust herself to drive today. She asks does she need to go to the doctor or emergency room. She says she felt ok on her way home yesterday from getting the vaccine, then when she got home her head started feeling weird, like a tingle. She says she wants to make sure she was not going to die here. She says that her left side, where she was injected in her left arm, feels hotter, and her right side feels normal. She says if she does her temperature on her left side it was 100.8 then sometimes 101. She says she needs to know what to do from here, she does not want to croak while being home and she does not trust herself driving. She says having the weird sensation throws her off, when she turns her neck or stretches and gets up she has electrical zaps behind her left eye for her head. It was reported she was on disability right now and has been for the past few years. She asks if the people giving vaccines, are they phlebotomists or certified to give vaccines, she should have asked, they were supposed to hit a muscle, not a vein. It was reported she also has a heavy too headache. She says that the vaccine was given in her non-dominant arm. The patient underwent lab tests and procedures which included body temperature found to be unknown result on unspecified date of 2021. The clinical outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pain in extremity, Pyrexia
Clinical narrative: fever of 101; arm hurt/ arm was very sore; bad headache; This is a spontaneous report from a contactable consumer or other non hcp reporting for a patient (son). A male patient of an unspecified age received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown), dose 2 via an unspecified route of administration on 22Mar2021 as dose 2 , single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient's historical vaccine included BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Lot Number: not reported; expiration date: not reported) administered via unknown route on an unknown date in 2021 as dose 1, single for covid-19 immunization and experienced arm hurt a little bit. On 22Mar2021, the patient experienced arm hurt/ arm was very sore and on 23Mar2021 the patient had fever of 101 and bad headache on an unknown date in Mar2021. Reporter stated that patient had first shot a couple of weeks ago. He was ok, but his arm hurt a little bit and he was fine. Yesterday, his arm hurt about an hour later and was still hurting him. Had a fever of 101 early this morning. Fever went down a little bit. Reporter wanted someone to call her back and let her know what kind of aspirin she should get or should she get Tylenol, Ibuprofen, or Advil. Patient's head hurts now. Reporter further stated it looked like the fever went down and broke. Just has a bad headache and his arm was very sore. The patient underwent lab tests and procedures which included body temperature: 101 on 23Mar2021. The outcome of hurt/ arm was very sore was unknown, the outcome of fever of 101 was recovering and headache was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Feeling abnormal, Feeling of body temperature change, Headache
Clinical narrative: hands feel hot then cold; fever of 101.1/fevers; chills; aches/her hair hurt; felt like she had been run over by two cement trucks; her kidneys bothered her too; bothered her stomach too and she felt nauseous; bothered her stomach too and she felt nauseous; watering in the mouth/water in the mouth; her toenails hurt; headache; sores in her mouth; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN6200 and expiry date was Unknown), via an unspecified route of administration, in Arm Left, on 24Mar2021, as dose 2, single for COVID-19 immunization. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: 926P and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 03Feb2021, as dose 1, single for COVID-19 immunization. The patient medical history included that she lost a lot of blood at childbirth. Family history included bone cancer of her husband. Concomitant medications were not reported. On an unspecified date, the patient experienced hands feel hot then cold, fever of 101.1/fevers, chills, aches/her hair hurt, felt like she had been run over by two cement trucks, her kidneys bothered her too, bothered her stomach too and she felt nauseous, watering in the mouth/water in the mouth, her toenails hurt, headache, sores in her mouth. The patient stated that she had side effects that lasted form 12 am to 11 pm and stated she had really bad symptoms afterwards. The patient stated that it was like the flu when her hands feel hot then cold, fever of 101.1 and thought she had COVID. She reported chills, fevers, aches, felt like she had been run over by two cement trucks and hurt everywhere and her kidneys bothered her too. The patient reported that it bothered her stomach too and she felt nauseous and had watering in the mouth. She stated that nausea is common for her but not the water in the mouth and her hair hurt her toenails hurt and had a small headache. The patient also reported that she had sores in her mouth days after that lasted a day. She wanted to know what to tell her daughter about the kidney pain. She told her daughter to place blankets and a heating pad due to being cold, but then get hot.  The patient underwent lab test and procedure included Fever 101.1 on an unspecified date. Outcome of the events were unknown.  Follow-up (26Mar2021): This is a follow-up spontaneous report from a contactable consumer. This consumer (patient) reported information included information about first dose.     No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Onychalgia, Pain, Pyrexia, Renal disorder
Clinical narrative: hands feel hot then cold; fever of 101.1/fevers; chills; aches/her hair hurt; felt like she had been run over by two cement trucks; her kidneys bothered her too; bothered her stomach too and she felt nauseous; bothered her stomach too and she felt nauseous; watering in the mouth/water in the mouth; her toenails hurt; headache; sores in her mouth; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN6200 and expiry date was Unknown), via an unspecified route of administration, in Arm Left, on 24Mar2021, as dose 2, single for COVID-19 immunization. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: 926P and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 03Feb2021, as dose 1, single for COVID-19 immunization. The patient medical history included that she lost a lot of blood at childbirth. Family history included bone cancer of her husband. Concomitant medications were not reported. On an unspecified date, the patient experienced hands feel hot then cold, fever of 101.1/fevers, chills, aches/her hair hurt, felt like she had been run over by two cement trucks, her kidneys bothered her too, bothered her stomach too and she felt nauseous, watering in the mouth/water in the mouth, her toenails hurt, headache, sores in her mouth. The patient stated that she had side effects that lasted form 12 am to 11 pm and stated she had really bad symptoms afterwards. The patient stated that it was like the flu when her hands feel hot then cold, fever of 101.1 and thought she had COVID. She reported chills, fevers, aches, felt like she had been run over by two cement trucks and hurt everywhere and her kidneys bothered her too. The patient reported that it bothered her stomach too and she felt nauseous and had watering in the mouth. She stated that nausea is common for her but not the water in the mouth and her hair hurt her toenails hurt and had a small headache. The patient also reported that she had sores in her mouth days after that lasted a day. She wanted to know what to tell her daughter about the kidney pain. She told her daughter to place blankets and a heating pad due to being cold, but then get hot.  The patient underwent lab test and procedure included Fever 101.1 on an unspecified date. Outcome of the events were unknown.  Follow-up (26Mar2021): This is a follow-up spontaneous report from a contactable consumer. This consumer (patient) reported information included information about first dose.     No follow-up attempts are possible. No further information is expected.