chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site pruritus
Clinical narrative: she went into panic mode; She said that it started to swell and itch and was lower than the original place; red circle rash is larger/is further down on her arm; she did have black and blue mark; She said that she had a huge bump that was itchy and the bump looked like it had spread in height and circumference; redness/redness at the injection site; bump at the injection site; allergic reaction; This is a spontaneous report from a contactable consumer (patient).   A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 17Feb2021 as dose 1, single for COVID-19 immunisation.  Medical history included known allergies to latex, sporins, chromium. The patient's concomitant medications were not reported.  Patient was given the shot on 17Feb2021 and she was well on that day. On the next day, 18Feb2021, she had a little redness and bump at the injection site. It got a little bit larger on 19Feb2021. She said that then it got a little flatter, but the bump did not quite go away.  Then on Wednesday, 24Feb2021, she had a huge flare up. Her huge bump was itchy and the bump looked like, it had spread in height and circumference. She had a telehealth visit with her doctor. He said that it looked like an allergic reaction and she was supposed to take Benadryl and hydrocortisone cream 1%. The following day it got better and by Sunday, on 28Feb2021 she felt as though she did not need the medication anymore, but she had a little bit of black and blue mark. On Monday, 01Mar2021 it started to itch a little bit, redness returned, and was getting bigger, and Tuesday, on 02Mar2021 it started all over again.  Also, started to swell and itch and that was lower than the original place, travelled down her arm.  On Wednesday, 03Mar2021, she went into panic mode. She returned to the doctor, he informed, that it was an allergic reaction. He said that she should not get the second dose or if she did, then it would have to be under a medical setting, or else may have another reaction and would be more difficult to handle. It was reported, at the time of report, all of this is 2 weeks old. Therapeutic measures in response to the events included benadryl and hydrocortisone cream . 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: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chills, Cough, Decreased appetite, Headache
Clinical narrative: The following morning I woke up with a migraine that by mid-day was a regular headache; Late morning I began experiencing flu-like symptoms; Muscle and joint aches; Muscle and joint aches; Slight cough; Fever; Chills; Loss of appetite; Approximately 6 hours after vaccine I became nauseous; Migraine, ocular migraine began approximately 4 hours after vaccine. Ocular migraine went away after an hour.  Migraine remained; Migraine, ocular migraine began approximately 4 hours after vaccine. Ocular migraine went away after an hour.  Migraine remained; This is a spontaneous report from a non-contactable consumer (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Mar2021 11:00 (at the age of 52-year-old) (Lot number and expiration date was not reported) as dose number unknown, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included none. The patient did not have any known allergies. The patient's concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. On 02Mar2021 16:00, the patient experienced migraine, ocular migraine began approximately 4 hours after vaccine. Ocular migraine went away after an hour. Migraine remained, and approximately 6 hours after vaccine, the patient became nauseous. The following morning (03Mar2021), patient woke up with a migraine that by mid-day was a regular headache and late morning the patient began experiencing flu-like symptoms and had muscle and joint aches, slight cough, fever, chills, and loss of appetite. The patient did not receive any treatment for the events. The outcome of ocular migraine was recovered and all other events were recovering.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Influenza like illness, Migraine, Myalgia, Nausea, Ophthalmic migraine
Clinical narrative: The following morning I woke up with a migraine that by mid-day was a regular headache; Late morning I began experiencing flu-like symptoms; Muscle and joint aches; Muscle and joint aches; Slight cough; Fever; Chills; Loss of appetite; Approximately 6 hours after vaccine I became nauseous; Migraine, ocular migraine began approximately 4 hours after vaccine. Ocular migraine went away after an hour.  Migraine remained; Migraine, ocular migraine began approximately 4 hours after vaccine. Ocular migraine went away after an hour.  Migraine remained; This is a spontaneous report from a non-contactable consumer (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Mar2021 11:00 (at the age of 52-year-old) (Lot number and expiration date was not reported) as dose number unknown, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included none. The patient did not have any known allergies. The patient's concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. On 02Mar2021 16:00, the patient experienced migraine, ocular migraine began approximately 4 hours after vaccine. Ocular migraine went away after an hour. Migraine remained, and approximately 6 hours after vaccine, the patient became nauseous. The following morning (03Mar2021), patient woke up with a migraine that by mid-day was a regular headache and late morning the patient began experiencing flu-like symptoms and had muscle and joint aches, slight cough, fever, chills, and loss of appetite. The patient did not receive any treatment for the events. The outcome of ocular migraine was recovered and all other events were recovering.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: The following morning I woke up with a migraine that by mid-day was a regular headache; Late morning I began experiencing flu-like symptoms; Muscle and joint aches; Muscle and joint aches; Slight cough; Fever; Chills; Loss of appetite; Approximately 6 hours after vaccine I became nauseous; Migraine, ocular migraine began approximately 4 hours after vaccine. Ocular migraine went away after an hour.  Migraine remained; Migraine, ocular migraine began approximately 4 hours after vaccine. Ocular migraine went away after an hour.  Migraine remained; This is a spontaneous report from a non-contactable consumer (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Mar2021 11:00 (at the age of 52-year-old) (Lot number and expiration date was not reported) as dose number unknown, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included none. The patient did not have any known allergies. The patient's concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. On 02Mar2021 16:00, the patient experienced migraine, ocular migraine began approximately 4 hours after vaccine. Ocular migraine went away after an hour. Migraine remained, and approximately 6 hours after vaccine, the patient became nauseous. The following morning (03Mar2021), patient woke up with a migraine that by mid-day was a regular headache and late morning the patient began experiencing flu-like symptoms and had muscle and joint aches, slight cough, fever, chills, and loss of appetite. The patient did not receive any treatment for the events. The outcome of ocular migraine was recovered and all other events were recovering.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Migraine, Nausea, Ophthalmic migraine
Clinical narrative: The following morning I woke up with a migraine that by mid-day was a regular headache; Late morning I began experiencing flu-like symptoms; Muscle and joint aches; Muscle and joint aches; Slight cough; Fever; Chills; Loss of appetite; Approximately 6 hours after vaccine I became nauseous; Migraine, ocular migraine began approximately 4 hours after vaccine. Ocular migraine went away after an hour.  Migraine remained; Migraine, ocular migraine began approximately 4 hours after vaccine. Ocular migraine went away after an hour.  Migraine remained; This is a spontaneous report from a non-contactable consumer (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Mar2021 11:00 (at the age of 52-year-old) (Lot number and expiration date was not reported) as dose number unknown, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included none. The patient did not have any known allergies. The patient's concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. On 02Mar2021 16:00, the patient experienced migraine, ocular migraine began approximately 4 hours after vaccine. Ocular migraine went away after an hour. Migraine remained, and approximately 6 hours after vaccine, the patient became nauseous. The following morning (03Mar2021), patient woke up with a migraine that by mid-day was a regular headache and late morning the patient began experiencing flu-like symptoms and had muscle and joint aches, slight cough, fever, chills, and loss of appetite. The patient did not receive any treatment for the events. The outcome of ocular migraine was recovered and all other events were recovering.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Insomnia, Pruritus, Thermal burn
Clinical narrative: Full Body itching; mouth burns; intense joint aching; no sleep for 3 nights; This is a spontaneous report from a contactable consumer (parent).  An 83-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EN6202, expiration date was not reported) via an unspecified route of administration, in right arm, on 26Feb2021 14:00 (at the age of 83-years-old), at dose 1, single for covid-19 immunization. The patient had no medical history and no known allergies. There were no concomitant medications. Prior to vaccination the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the covid-19 vaccine. The patient has not been tested with covid-19 after the vaccination. The patient experienced full body itching, mouth burns, intense joint aching, no sleep for three nights on 27Feb2021 20:00. No treatment was administered for the events. The outcome of the events was not recovered.    No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Eye irritation, Eye pain, Ocular discomfort, Ocular hyperaemia
Clinical narrative: left eye been bothering "me"; left eye been bothering "me", been aching burning, and blood shot; left eye been bothering "me", been aching burning, and blood shot; left eye been bothering "me", been aching burning, and blood shot; This is a spontaneous report from a contactable consumer (patient) received from medical information team. A female patient of an unspecified age (also reported as, age: 37; unit: unknown) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number, expiry date not reported) via an unspecified route of administration, in left arm, on 01Mar2021, at dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced left eye been bothering (as reported); been aching, burning and blood shot on Mar2021. The patient had visited the eye doctor. 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.
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Asthenia, Chills, Expired product administered, Illness
Clinical narrative: exaggerated arthritis; Expired vaccine used; chills; weak; sick; hurting all over; Sleepy; This is a spontaneous report from a contactable nurse (patient). A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE),  via an unspecified route of administration on 21Feb2021 as dose 1, single for COVID-19 immunisation.  Medical history included CHF and arthritis, both from an unknown date. The patient's concomitant medications were not reported. On 21Feb2021, patient was given expired COVID vaccine by pharmacy student. It was reported that patient believed that she was given expired one. She was looking at the vaccine paperwork and the expiration date looked like, 13Feb2021. All of the numbers were yellow, but it seemed someone scratched through it and crossed it out the day on the date and put the 24th on there in pen. She made a call to the CDC and was told, whether they can take it on the date listed all day, but couldn't take after then. She mentioned that, after a week, the CDC followed up with her and sent a message saying that there was a problem with the expiration. Also, on an unspecified date in Feb2021, she was feeling sick, sleepy, weak, chills at night and that lasted for a few minutes, and was hurting all over. The patient's arthritis which was worst, had been exaggerated. Patient enquired that whether she would get the vaccine again as it was expired.  She mentioned that she had reactions to drugs and does not want to take anything extra, where she already feels really bad. The outcome of the event was recovered and of all other events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Somnolence
Clinical narrative: exaggerated arthritis; Expired vaccine used; chills; weak; sick; hurting all over; Sleepy; This is a spontaneous report from a contactable nurse (patient). A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE),  via an unspecified route of administration on 21Feb2021 as dose 1, single for COVID-19 immunisation.  Medical history included CHF and arthritis, both from an unknown date. The patient's concomitant medications were not reported. On 21Feb2021, patient was given expired COVID vaccine by pharmacy student. It was reported that patient believed that she was given expired one. She was looking at the vaccine paperwork and the expiration date looked like, 13Feb2021. All of the numbers were yellow, but it seemed someone scratched through it and crossed it out the day on the date and put the 24th on there in pen. She made a call to the CDC and was told, whether they can take it on the date listed all day, but couldn't take after then. She mentioned that, after a week, the CDC followed up with her and sent a message saying that there was a problem with the expiration. Also, on an unspecified date in Feb2021, she was feeling sick, sleepy, weak, chills at night and that lasted for a few minutes, and was hurting all over. The patient's arthritis which was worst, had been exaggerated. Patient enquired that whether she would get the vaccine again as it was expired.  She mentioned that she had reactions to drugs and does not want to take anything extra, where she already feels really bad. The outcome of the event was recovered and of all other events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Myalgia, Nausea
Clinical narrative: Extreme joint pains; muscle aches; chills; headaches; nausea; This is a spontaneous report from a contactable consumer (patient). A 24-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported), via an unspecified route of administration, administered in Arm Left on 20Feb2021 16:00 (at the age of 24-year-old), as dose 2, single, for COVID-19 immunisation in hospital. Patient was not pregnant at the time of vaccination. Medical history included vasovagal syncope, chronic migraines, hypersomnia, IBS, exercise induced asthma, depression, anxiety, eating disorder. The allergies included shellfish allergy, pollen allergy and allergic to cats. Concomitant medications included colecalciferol (VITAMIN D [COLECALCIFEROL]); escitalopram oxalate (LEXAPRO); hydroxyzine; ethinylestradiol, etynodiol diacetate (ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL) and birth control pill. Historical vaccine included flu shot on 15Jan2021 for immunization and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported), via an unspecified route of administration, administered in Arm Left on 30Jan2021 (at the age of 24-year-old), as dose 1, single, for COVID-19 immunisation in hospital. Patient was not diagnosed with COVID prior vaccination. Patient was not tested for COVID post vaccination. The patient experienced extreme joint pains, muscle aches, chills, headaches, and nausea on 21Feb2021. Patient received no treatment due to the events. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Lacrimation increased, Nasal congestion, Nasopharyngitis, Oropharyngeal pain, Sneezing
Clinical narrative: Cold like symptoms on 3rd day after vaccination/cold; some congestion.; Sneezing; watery eyes; little bit of sore throat; This is a spontaneous report from a contactable consumer (patient). A 58-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, administered in Left Arm, on 28Feb2021 at 08:15 (at the age of 58-year-old) as DOSE 1, SINGLE for covid-19 immunization. The patient medical history was not reported. Concomitant medications included hydrochlorothiazide and irbesartan and amlodipine. The patient had no Allergies to medications, food, or other products. The patient was not pregnant at time of vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID -19 vaccine. The Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. On 03Mar2021 at 08:00, 3rd day after vaccination, the patient experienced Cold like symptoms, Sneezing, watery eyes, little bit of sore throat and some congestion. No treatment was received for the adverse event. The outcome of the events was not recovered at time of report.  No follow-up attempts are needed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dizziness, Headache, Lymphadenopathy, Muscle spasms
Clinical narrative: Horrible leg cramp; it's the calf and it's under my knee in the back, like 7 or 8 times I was in agony/Horrible leg cramps (i have never had them before and constant trips to the bathroom; Fever/temperature i know of; My throat, it feels like it's completely swollen and glands are like they are swollen; Massive headache; Dizziness; My throat, it feels like it's completely swollen and glands are like they are swollen; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9267), via an unspecified route of administration on 26Feb2021 at 12:00 (at the age of 66-year-old), as dose 1, single in left arm for COVID-19 immunization. The patients medical history included Crohns disease and she was immunosuppressed. The patients past drug included Augmentin and experienced allergies. Concomitant medications included mercaptopurine (PURINETHOL, 50 mg); bupropion hydrochloride (WELLBUTRIN); Famotidine; Omeprazole; pregabalin (LYRICA); Buspirone; Venlafaxine; Glycopyrrolate; Infliximab (REMICADE, 2 mg) received every 7 weeks; and Denosumab (PROLIA) received twice a year; all taken for unspecified indications; start and stop dates were not reported. On 26Feb2021 at 15:00, 15 hours after the first dose of vaccine, the patient experienced a horrible leg cramp; it was the calf and it was under her knee in the back, like 7 or 8 times she was in agony, with fever, throat, it felt like it was completely swollen and glands are like they are swollen, massive headache and dizziness. Patient had Crohns but she reported that this was not Crohns, for which she was going to bathroom and this was completely different. Fever stopped immediately; it was 101.7 at 9 morning. Patient had more symptoms in her throat, it felt like it was completely swollen, and glands are like they are swollen. Patient received treatment with Tylenol. The patient underwent lab test and procedure which included body temperature: 101.7 at 09:00 AM, on an unspecified date in Feb2021. The clinical outcome of fever was resolved. The clinical outcome of all other events was unknown. No follow-up attempts are needed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling, Pyrexia
Clinical narrative: Horrible leg cramp; it's the calf and it's under my knee in the back, like 7 or 8 times I was in agony/Horrible leg cramps (i have never had them before and constant trips to the bathroom; Fever/temperature i know of; My throat, it feels like it's completely swollen and glands are like they are swollen; Massive headache; Dizziness; My throat, it feels like it's completely swollen and glands are like they are swollen; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9267), via an unspecified route of administration on 26Feb2021 at 12:00 (at the age of 66-year-old), as dose 1, single in left arm for COVID-19 immunization. The patients medical history included Crohns disease and she was immunosuppressed. The patients past drug included Augmentin and experienced allergies. Concomitant medications included mercaptopurine (PURINETHOL, 50 mg); bupropion hydrochloride (WELLBUTRIN); Famotidine; Omeprazole; pregabalin (LYRICA); Buspirone; Venlafaxine; Glycopyrrolate; Infliximab (REMICADE, 2 mg) received every 7 weeks; and Denosumab (PROLIA) received twice a year; all taken for unspecified indications; start and stop dates were not reported. On 26Feb2021 at 15:00, 15 hours after the first dose of vaccine, the patient experienced a horrible leg cramp; it was the calf and it was under her knee in the back, like 7 or 8 times she was in agony, with fever, throat, it felt like it was completely swollen and glands are like they are swollen, massive headache and dizziness. Patient had Crohns but she reported that this was not Crohns, for which she was going to bathroom and this was completely different. Fever stopped immediately; it was 101.7 at 9 morning. Patient had more symptoms in her throat, it felt like it was completely swollen, and glands are like they are swollen. Patient received treatment with Tylenol. The patient underwent lab test and procedure which included body temperature: 101.7 at 09:00 AM, on an unspecified date in Feb2021. The clinical outcome of fever was resolved. The clinical outcome of all other events was unknown. No follow-up attempts are needed. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Heart rate increased, Rash
Clinical narrative: Severe all over body rash; Elevated heart rate; Tiredness; Chills; This is a spontaneous report from a contactable consumer (patient). A 69-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 02Feb2021 (at the age of 69-year-old) (Lot Number: EL9262) as dose 1, single for COVID-19 immunization. Medical history included heart, kidney, bladder cancer, psoriasis. The patient had known allergy to sulfer. The patient's concomitant medications were not reported. The patient did not receive any other vaccines prior to COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient experienced severe all over body rash, elevated heart rate, tiredness, and chills on 26Feb2021. The patient did not receive treatment for the events. The outcome of events was not recovered.  No follow up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Chills; Aching; Headache; Low grade fever; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received second dose of bnt162b2 (BNT162B2, Solution for injection, Lot number was unknown), via an unspecified route of administration on 27Feb2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported. Historical vaccine included first dose of BNT162B2 for Covid-19 immunisation. It was reported that I had my second shot yesterday morning and then last night before bedtime I started to get chills, aching, headache and a low-grade fever on an unspecified date in 2021 and then it got a little bit worse the night, but it is little bit better now. Therapeutic measures were taken as a result of all events. The outcome of the events was recovering.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Rash
Clinical narrative: Rash; lost her sense of taste; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EL9267, NDC number and Expiry date: unknown) via intramuscularly, administered in right arm on 17Feb2021 10:30 as dose 1, single for covid-19 immunization. Medical history included, ongoing angioplasty (heart stents), ongoing type 2 diabetes mellitus and medical diet. Concomitant medication(s) included dexlansoprazole (DEXILANT) for gastrooesophageal reflux disease, ranolazine (RANEXA) for cardiac disorder, olmesartan medoxomil (BENICAR) for cardiac disorder; levothyroxine sodium (SYNTHROID) for thyroid disorder, clopidogrel bisulfate (PLAVIX) for blood disorder, metoprolol succinate (TOPROL XL) for blood pressure measurement, acetylsalicylic acid (BAYER ASPIRIN) for cardiac disorder, ubidecarenone (COQ-10) for cardiac disorder and vitamin D3 (VITAMIN D3) as a supplementation therapy. The patient had not received any other vaccine within 4 weeks. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9261, expiration date: not reported), via an unspecified route of administration in left arm on 27Jan2021 11:00 (at age of 81 years) as dose 1, single for covid-19 immunization. On 18Feb2021, the patient experienced lost her sense of taste (ageusia) and on 20Feb2021 had rash. Additional information included that the caller is a consumer that was calling about the Covid-19 Vaccine and stated that she had the second one and said that she is having some minor reactions to it. Caller clarified that she had the first dose 27Jan2021 and was just a little tired from it. She said that she had the second one on 17Feb2021 and on the 18Feb2021 she lost her sense of taste and it lasted about 1 days. Stated that she tried something spicy and it just tasted like cardboard. On the 20Feb2021, she got a rash on her legs between her knees and her ankles on both legs. It was an itchy and bumpy rash and stated that it is subsiding but its still there. She takes thyroid medications, and blood thinners and blood pressure medications. She said that takes something to up her thyroid, but also takes something to down it. She does not know which one it is. The adverse events did not result in physician/ emergency room and there were no such events prior to vaccination. There was no family medical history relevant to adverse events but stated that she has sensitive skin, and it has been a dry winter. It has not been responsive to over-the-counter moisturizer creams. Outcome of the ageusia was recovered on 19Feb2021, whereas rash was recovering.  Follow-up attempts completed. No further information expected.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: Left side of my cheek is swelling; This is a spontaneous report from Consumer or other non-health professional via a Pfizer sponsored program, reporting for himself.   A 70-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch no: not reported/Lot number: EL9765, Expiry date: unknown) via an unspecified route of administration, administered in left shoulder on 19Feb2021 (at the age of 70-years-old) as dose 1, single for COVID-19 immunization. Medical history included blood pressure and diabetes from an unknown date and unknown if ongoing. Concomitant medications included Carvedilol (CARVIDOL), Pravastatin, Amlodipine, Alprazolam, Losartan, Acetylsalicylic acid (ASPIRIN) and Metformin hydrochloride, sitagliptin phosphate monohydrate (JANUMET XR), Hydrochloride (Not further clarified) all were taken for unspecified indication and from an unknown date and unknown if ongoing. The patient reported that he had his first COVID vaccine on 19 Feb 2021 and the last 4-5 days left side of his cheek was swelling, that was going into his cheek bones. Patient was asking if that was a side effect of the vaccine. Investigation Assessment was reported as No. Treatment was included as Tylenol and it's just stated to get little uncomfortable. The outcome of the event was unknown.  Follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Diarrhoea, Dizziness, Fatigue
Clinical narrative: Tiredness / Fatigue; Muscle pain; Chills; Fever; Diarrhea; Dizziness; I have lost some weight; I have been so ill; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 65-year-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EN6200), via an unspecified route of administration on 22Feb2021 (at the age of 65-years-old) as dose 1, single (30 mcg per 0.3 ml) for COVID-19 immunisation. The medical history of the patient included hypertension and COVID. The concomitant medications of the patient were not reported. The patient experienced tiredness / fatigue, muscle pain, chills, fever, diarrhea, dizziness, i have lost some weight, i have been so ill on an unspecified date. The patient stated that she had been so ill. She did not told them that about 5 weeks ago she did actually have Covid, she do not know if that was the reason why she was having such a strong reaction to that vaccine. She did not  ttok treatment because she was told that they should let the body take care of that response. So, she did not even take any kind of fever meds or anything. The patient underwent lab tests and procedures which included body temperature: 102 on and weight: i am about 197 pounds both on unspecified date. The outcome of the events was reported as unknown.  No follow up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Myalgia, Pyrexia, Weight, Weight decreased
Clinical narrative: Tiredness / Fatigue; Muscle pain; Chills; Fever; Diarrhea; Dizziness; I have lost some weight; I have been so ill; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 65-year-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EN6200), via an unspecified route of administration on 22Feb2021 (at the age of 65-years-old) as dose 1, single (30 mcg per 0.3 ml) for COVID-19 immunisation. The medical history of the patient included hypertension and COVID. The concomitant medications of the patient were not reported. The patient experienced tiredness / fatigue, muscle pain, chills, fever, diarrhea, dizziness, i have lost some weight, i have been so ill on an unspecified date. The patient stated that she had been so ill. She did not told them that about 5 weeks ago she did actually have Covid, she do not know if that was the reason why she was having such a strong reaction to that vaccine. She did not  ttok treatment because she was told that they should let the body take care of that response. So, she did not even take any kind of fever meds or anything. The patient underwent lab tests and procedures which included body temperature: 102 on and weight: i am about 197 pounds both on unspecified date. The outcome of the events was reported as unknown.  No follow up attempts are possible. No further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Gingival pain, Pyrexia, Swelling face
Clinical narrative: Tiredness occurred within a few hours of the injection; Approximately 34-36 hours after injection tooth/gum pain/above pain worsened overnight; a temperature of about 99.4 appeared/fever rose to about 100.3; a grossly swollen right cheek appeared; This is a spontaneous report from a contactable consumer (patient). A 79-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6198, expiry date not reported) via an unspecified route of administration, in right arm, on 27Feb2021 11:00 (at the age of 79-years-old), at dose number unknown, single for covid-19 immunization. Medical history included heart disease. The patient had known allergies to sulfa drugs and erythromycin. Concomitant medications included amlodipine; atenolol; benazepril; biotin; fluticasone propionate, salmeterol xinafoate (ADVAIR). Prior to vaccination the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the covid-19 vaccine. The patient was not tested with covid-19 after the vaccination. On 28Feb2021 21:00, a few hours of vaccination, the patient experienced tiredness, approximately 34-36 hours after vaccination, tooth/ gum pain; pain worsened overnight, a temperature of about 99.4 appeared and fever rose to about 100.3 and a grossly swollen right cheek appeared. About 48 hours after vaccination, the fever remained about the same. On 28Feb2021, the patient underwent lab tests and procedures which included body temperature: 99.4 Fahrenheit and 100.3 Fahrenheit, after 48 hours of vaccination (01Mar2021 21:00), body temperature was 100.3 Fahrenheit. Therapeutic measures included aspirin, acetaminophen and Alegra. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Illness, Pyrexia
Clinical narrative: Fever; Sickness; can't breathe; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported) via an unspecified route of administration on 21Feb2021 (at the age of 68-year old) as dose 1, single for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported. On 21Feb2021, since the vaccination, he had fever and was sick. It was reported that, he thought that the last couple days had been killing him. He stated that, he also can't breathe, and his next shot is scheduled on 15th. At the time of report, it has been 9-11 days already since he was sick. Patient reported that he has not spoken to his doctor yet, and the patient was referred by call handler to ER or an urgent care if he feels like his life is at risk. He stated that this was the worst he has felt in his life. He mentioned that he would try to get a hold of his doctor and see if they care, as he is so sick. 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: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Balance disorder, Chills, Fatigue, Headache
Clinical narrative: Injection site pain; tiredness; headaches; muscle pain; chills; joint pain; nausea; feeling unwell; a fast heartbeat; off balance; This is a spontaneous report from a contactable consumer (patient). A 78-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: El1283), via an unspecified route of administration, administered in Arm Left on 09Feb2021 as dose 2, single for covid-19 immunisation from hospital. Medical history included Arthritis, Afib, high blood pressure, thyroid and allergy to opioids.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with covid prior to vaccination and patient was not tested for COVID-19 post vaccination. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EL3249), via an unspecified route of administration, administered in Arm Left on 19Jan2021 as dose 1, single for covid-19 immunisation. Concomitant medications included Olmesartan, apixaban (ELIQUIS), metoprolol, levothyroxine all taken for an unspecified indication, start and stop date were not reported. The patient experienced Injection site pain, tiredness, headaches, muscle pain, chills, joint pain, nausea feeling unwell, a fast heartbeat, off balance on 09Feb2021 19:00. The patient did not receive any treatment in response to the events. The outcome of the event was recovering , headaches (headache) (non-serious) on 09Feb2021 19:00 with outcome of recovering , muscle pain.  No follow-up attempts are possible. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Malaise, Myalgia, Nausea
Clinical narrative: Injection site pain; tiredness; headaches; muscle pain; chills; joint pain; nausea; feeling unwell; a fast heartbeat; off balance; This is a spontaneous report from a contactable consumer (patient). A 78-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: El1283), via an unspecified route of administration, administered in Arm Left on 09Feb2021 as dose 2, single for covid-19 immunisation from hospital. Medical history included Arthritis, Afib, high blood pressure, thyroid and allergy to opioids.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with covid prior to vaccination and patient was not tested for COVID-19 post vaccination. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EL3249), via an unspecified route of administration, administered in Arm Left on 19Jan2021 as dose 1, single for covid-19 immunisation. Concomitant medications included Olmesartan, apixaban (ELIQUIS), metoprolol, levothyroxine all taken for an unspecified indication, start and stop date were not reported. The patient experienced Injection site pain, tiredness, headaches, muscle pain, chills, joint pain, nausea feeling unwell, a fast heartbeat, off balance on 09Feb2021 19:00. The patient did not receive any treatment in response to the events. The outcome of the event was recovering , headaches (headache) (non-serious) on 09Feb2021 19:00 with outcome of recovering , muscle pain.  No follow-up attempts are possible. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Injection site pain; tiredness; headaches; muscle pain; chills; joint pain; nausea; feeling unwell; a fast heartbeat; off balance; This is a spontaneous report from a contactable consumer (patient). A 78-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: El1283), via an unspecified route of administration, administered in Arm Left on 09Feb2021 as dose 2, single for covid-19 immunisation from hospital. Medical history included Arthritis, Afib, high blood pressure, thyroid and allergy to opioids.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with covid prior to vaccination and patient was not tested for COVID-19 post vaccination. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EL3249), via an unspecified route of administration, administered in Arm Left on 19Jan2021 as dose 1, single for covid-19 immunisation. Concomitant medications included Olmesartan, apixaban (ELIQUIS), metoprolol, levothyroxine all taken for an unspecified indication, start and stop date were not reported. The patient experienced Injection site pain, tiredness, headaches, muscle pain, chills, joint pain, nausea feeling unwell, a fast heartbeat, off balance on 09Feb2021 19:00. The patient did not receive any treatment in response to the events. The outcome of the event was recovering , headaches (headache) (non-serious) on 09Feb2021 19:00 with outcome of recovering , muscle pain.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Cough, Nasal congestion, Sinus operation
Clinical narrative: It's not really a cold, it's a congestion. It's like a allergy in my nasal nose; I developed this drainage and cough, it is like an allergy; I developed this drainage and cough, it is like an allergy; This is a spontaneous report from a contactable consumer (patient) reported for self. A patient of unspecified age and gender received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 1 via an unspecified route of administration on 10Feb2021 (Lot Number: EL9261; Expiration Date: 31May2021) as dose 1, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in Feb2021, the patient got developed that drainage and cough, which was like an allergy. The patient asked that the caused event was due to vaccination. The patient also experienced an allergy in his/her nasal nose and then that caused him/her to do some coughing. The outcome of all the events was unknown.  Additional Context: Over the call both the patient (husband) and the reporter (wife) were available. Reporter stated, "I was actually going to put my husband on. It is really his question. We both had the Pfizer COVID-19 vaccine about 2 weeks ago. And coincidently, he felt fine and everything still does feel fine but something odd is going on with his toes. And I know there is something called COVID toes and we looked it up online, that's sort of what it looks like, a mild case but not extreme. But really our question is related to, could this be a side effect from the vaccine. I will put him on." Reporter was informed about the role of Pfizer Drug Safety and Pfizer Medical Information. Reporter was provided with the contact# for Pfizer Medical Information. When requested for permission to probe questions for a safety report, patient stated, "I'm not sure what questions I'm answering. What am I answering? What questions are you talking about?" When informed that the questions would be related to demographic details, medical history, patient stated, "This is taking way too long. I'll have to call back. I have the number and the option. I will call back in a later date."  No follow up attempts are possible. No further information is expected.
Age: 84.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Chest pain, Fatigue, Headache, Malaise
Clinical narrative: stomach aches; chest aches; Exhaustion; Feeling unwell; Headache; This is a spontaneous report from a contactable consumer or other non hcp. This consumer reported that an 84-year-old male patient received bnt162b2 (Pfizer COVID 19 vaccine, BNT162B2, Formulation: Solution for injection, Batch/Lot Number: EL3302), dose 2 via an unspecified route of administration on 12Feb2021 (Age 84-year-old at time of vaccination) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The historical vaccine included, bnt162b2 (BNT162B2, Batch/Lot Number: EL0142), dose 1 via an unspecified route of administration on an unspecified date (Age at time of vaccination was not provided) as DOSE 1, SINGLE for covid-19 immunisation. The reporter stated that her and another best friend of hers went to take the shot last month and they were trying to find out, they still had different abnormal response to the vaccine after the second one. It has been 2 weeks since they had the second one and the still had tiredness and extreme fatigue, feeling unwell in Feb2021 and they were calling to see if there were suggestions, or something take or do after the second shot. She clarified she was calling about the second Pfizer COVID 19 vaccine. She said the patient was also on the line they went to together to get the vaccine and he was the other person; he was also on the call. She confirmed his first dose says EL0142 or the 2 could be a 6. And the second dose says EL3302. And the zero has a slash in the middle and that was on 12Feb2021 and it has AMC-S. She said the dates were the same for them because they went together on the same day to get both doses. She said he had been worse off than her. He was having feeling unwell, exhaustion, he had headache and stomach aches and his chest aches in Feb2021 and still had. Physically there was nothing wrong with him he has been to the doctor and had a physical and the doctor did not seem to be anything wrong with his physical being. The outcome of the event was reported as not recovered.  No follow-up attempts are needed. No further information is expected.