chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Menstrual disorder, Muscle spasms, Pain, Peripheral swelling
Clinical narrative: Onset of menstruation after only 14 days (instead of 28 days)  - 3 days after the first shot and then the same 3 days after the 2nd shot (so 21 days exactly).  Not a normal cycle; severe debilitating cramps like giving birth; headache; pain; Gained 5 lbs the day of the vaccination each time; swollen legs; This is a spontaneous report from a Non-contactable Consumer. A 46-year-old non-pregnant 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, administrated in left arm on 26Mar2021 14:30 (age at the time of vaccination 46-years-old), as a single dose; and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration, administrated in left arm on 16Apr2021 14:30 (age at the time of vaccination 46-years-old), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient had known allergies to CYP2D6 (ultra-fast metabolizer), codeine cannot take codeine, and doxycycline. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. On 26Mar2021 17:00, the patient experienced Onset of menstruation after only 14 days (instead of 28 days) - 3 days after the first shot and then the same 3 days after the 2nd shot (so 21 days exactly), Not a normal cycle, severe debilitating cramps like giving birth, headache, pain, Gained 5 lbs the day of the vaccination each time, and swollen legs. On an unspecified date, the patient underwent lab tests and procedures which included Weight increased: 5lbs. Adverse event resulted in doctor or other healthcare professional office/clinic visit. Patient received treatment as a result of adverse events which included pain medication and rest. The outcome for all the events was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Weight increased
Clinical narrative: Onset of menstruation after only 14 days (instead of 28 days)  - 3 days after the first shot and then the same 3 days after the 2nd shot (so 21 days exactly).  Not a normal cycle; severe debilitating cramps like giving birth; headache; pain; Gained 5 lbs the day of the vaccination each time; swollen legs; This is a spontaneous report from a Non-contactable Consumer. A 46-year-old non-pregnant 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, administrated in left arm on 26Mar2021 14:30 (age at the time of vaccination 46-years-old), as a single dose; and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration, administrated in left arm on 16Apr2021 14:30 (age at the time of vaccination 46-years-old), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient had known allergies to CYP2D6 (ultra-fast metabolizer), codeine cannot take codeine, and doxycycline. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. On 26Mar2021 17:00, the patient experienced Onset of menstruation after only 14 days (instead of 28 days) - 3 days after the first shot and then the same 3 days after the 2nd shot (so 21 days exactly), Not a normal cycle, severe debilitating cramps like giving birth, headache, pain, Gained 5 lbs the day of the vaccination each time, and swollen legs. On an unspecified date, the patient underwent lab tests and procedures which included Weight increased: 5lbs. Adverse event resulted in doctor or other healthcare professional office/clinic visit. Patient received treatment as a result of adverse events which included pain medication and rest. The outcome for all the events was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Chest pain
Clinical narrative: I am having pains in my chest in yet; This is a spontaneous report received from contactable consumer (Patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on 21Apr2021 as dose number unknown, single for COVID-19 immunisation and ibuprofen (MOTRIN MIGRAINE PAIN), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date for chest pain. The patient medical history included on going, chest pain from an unknown date. The patient's concomitant medications were not reported. Consumer stated, "Okay, I had the Pfizer vaccine shot on "yesterday". Okay, prior to that I was at emergency room, and they put me on some Motrin's for, because I have pains in my chest, the walls of my chest it shows the report and I take the Motrin. So, after taking the shot yesterday and I am up today, and I am having pains in my chest in yet. So, I was wondering is it alright for me to take the Motrin after taking the Pfizer shot. Can I still take a Motrin because the Tylenol don't help my chest?". Consumer confirmed vaccine shot name as Pfizer COVID Vaccine. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dysgeusia
Clinical narrative: Odd metallic taste in mouth; Severe diarrhea; This is a spontaneous report from a contactable consumer. This 39-Year-Old female consumer (patient) reported that.  A 39-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 22Apr2021 14:00 as (At the age of 39-years) dose 2, single for covid-19 immunisation. None Other medical history and None Known allergies ware reported. The patient concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 01Apr2021 02:15 PM as dose 1, single for covid-19 immunisation. Patient was not pregnant at the time vaccination. No other vaccine in four weeks. No other medications in two weeks. No COVID tested post vaccination. The patient experienced odd metallic taste in mouth, and severe diarrhea on 22Apr2021 14:30. Patient did not receive any treatment for events. The outcome of events was recovering at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Bone pain, Somnolence
Clinical narrative: Sleepy; Pain started in both hips and bottom of tail bone.; Pain started in both hips and bottom of tail bone.; This is a spontaneous report from a contactable consumer(patient) via Pfizer sponsored program COVAX US support. A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on 02Mar2021 as dose 2, single for covid-19 immunisation. Medical history included arthritis, intervertebral disc degeneration from an unknown date and unknown if ongoing. The patient's concomitant medication include NAPROXEN from unknown date to unknown if onoing for an unspecified indication. The patient previously took first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on an unknown date as dose 1, single for covid-19 immunisation. On an unknown date the patient had experienced after vaccine she felt sleepy and pain in both hips and bottom of tail bone. The patient reported Clarified has had them way before 1st dose of vaccine. HCP prescribed Naproxen. The patient was wondering if vaccine made her condition worse and what can she do to minimize effects she had. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Duodenogastric reflux, Fatigue, Lethargy
Clinical narrative: Lethargy; severe left arm pain; chills; diarrhea; severe violent vomiting on empty stomach (black bile) for 2-4 hours; unable to keep food down for another 12 hours;; severe violent vomiting on empty stomach (black bile) for 2-4 hours; unable to keep food down for another 12 hours;; severe body aches and chills; diarrhea 48 hours after; tiredness; This is a spontaneous report from a contactable (patient). A 32-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW 0175), dose 2 via an unspecified route of administration, administered in Arm Left on 27Apr2021 at 14:15 (at the age of 32-years-old) as dose 2, single for covid-19 immunisation. Medical history included , covid-19, breathing issues, fatigue, brain fog, "COVID long hauler" - extended  effects including brain fog, fatigue and breathing issues. Historical Vaccine included BNT162B2 (Lot/batch Number: EW0150) administered on 06Apr2021 at 14:15 in Left arm as dose 1 for covid-19 immunisation (at the age of 32-years-old). The patient's concomitant medications were not reported.  On 29Apr2021 at 05:00, the patient experienced lethargy, severe left arm pain, tiredness, chills, diarrhea, severe violent vomiting on empty stomach (black bile) for 2-4 hours; unable to keep food down for another 12 hours, severe body aches and chills; diarrhea 48 hours after. It was reported the patient had 0-24 hours after injection general lethargy and 39 hours after vaccination severe violent vomiting. The patient received no other vaccine in four weeks. No treatment was given for the events. Patient was covid prior vaccination and did not test for covid post vaccination. Outcome of the events were recovering.   No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Vomiting
Clinical narrative: Lethargy; severe left arm pain; chills; diarrhea; severe violent vomiting on empty stomach (black bile) for 2-4 hours; unable to keep food down for another 12 hours;; severe violent vomiting on empty stomach (black bile) for 2-4 hours; unable to keep food down for another 12 hours;; severe body aches and chills; diarrhea 48 hours after; tiredness; This is a spontaneous report from a contactable (patient). A 32-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW 0175), dose 2 via an unspecified route of administration, administered in Arm Left on 27Apr2021 at 14:15 (at the age of 32-years-old) as dose 2, single for covid-19 immunisation. Medical history included , covid-19, breathing issues, fatigue, brain fog, "COVID long hauler" - extended  effects including brain fog, fatigue and breathing issues. Historical Vaccine included BNT162B2 (Lot/batch Number: EW0150) administered on 06Apr2021 at 14:15 in Left arm as dose 1 for covid-19 immunisation (at the age of 32-years-old). The patient's concomitant medications were not reported.  On 29Apr2021 at 05:00, the patient experienced lethargy, severe left arm pain, tiredness, chills, diarrhea, severe violent vomiting on empty stomach (black bile) for 2-4 hours; unable to keep food down for another 12 hours, severe body aches and chills; diarrhea 48 hours after. It was reported the patient had 0-24 hours after injection general lethargy and 39 hours after vaccination severe violent vomiting. The patient received no other vaccine in four weeks. No treatment was given for the events. Patient was covid prior vaccination and did not test for covid post vaccination. Outcome of the events were recovering.   No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Joint stiffness, Joint swelling
Clinical narrative: My knuckles on my left hand were swollen/right hand knuckles began to swell and ache; My knuckles on my left hand were swollen and sore//right hand knuckles began to swell and ache; The pain and tightness in my knuckles has increased over time; I was having trouble making a fist; I slept most of the day Monday and Tuesday; Chills; Tiredness; This is a spontaneous report from a contactable consumer or other non hcp. A 51-year-old female patient received bnt162b2 (BNT162B2, solution for injection, Lot Number: ER8729), via an unspecified route of administration, administered in Arm Left on 18Apr2021 13:45 (at the age of 51-year-old) as dose 2, single for COVID-19 immunisation. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination:175 levothyroxine. Medical history included hypothyroidism. Concomitant medication(s) included levothyroxine. Patient previously received comirnaty, dose 1 on 28Mar2021 (Batch/Lot Number: ER8727) on Left arm for covid-19 immunisation. On 18Apr2021, the patient experienced chills, fatigue and on 19Apr2021 ptaient experienced, joint swelling, arthralgia, somnolence, joint stiffness, loss of personal independence in daily activities. Adverse event: Had the normal reaction of chills and tiredness close to 10 hours after 2nd dose on Sunday 18Apr2021. On Monday patient noticed her knuckles on her left hand were swollen and sore. On Tuesday 20Apr2021 her right hand knuckles began to swell and ache. She slept most of the day Monday and Tuesday. She has waited the 2-week mark, as she has read some symptoms can linger up to 2 weeks. The pain and tightness in her knuckles have increased over time and today it hurt just to straighten her fingers and she was having trouble making a fist. She also experiencing pain in her ankles when she gets out of bed in the mornings. Prior to the vaccine she has never had any of these symptoms. The only health issue she has is hypothyroidism. She called her doctor, tonight to tell him about her symptoms. He told patient to take some Aleve and Pepcid tonight and he was calling in an order of prednisone for patient to start tomorrow, 02May2021. He told patient to report her reaction and follow up with him in 3 days. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Somnolence
Clinical narrative: My knuckles on my left hand were swollen/right hand knuckles began to swell and ache; My knuckles on my left hand were swollen and sore//right hand knuckles began to swell and ache; The pain and tightness in my knuckles has increased over time; I was having trouble making a fist; I slept most of the day Monday and Tuesday; Chills; Tiredness; This is a spontaneous report from a contactable consumer or other non hcp. A 51-year-old female patient received bnt162b2 (BNT162B2, solution for injection, Lot Number: ER8729), via an unspecified route of administration, administered in Arm Left on 18Apr2021 13:45 (at the age of 51-year-old) as dose 2, single for COVID-19 immunisation. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination:175 levothyroxine. Medical history included hypothyroidism. Concomitant medication(s) included levothyroxine. Patient previously received comirnaty, dose 1 on 28Mar2021 (Batch/Lot Number: ER8727) on Left arm for covid-19 immunisation. On 18Apr2021, the patient experienced chills, fatigue and on 19Apr2021 ptaient experienced, joint swelling, arthralgia, somnolence, joint stiffness, loss of personal independence in daily activities. Adverse event: Had the normal reaction of chills and tiredness close to 10 hours after 2nd dose on Sunday 18Apr2021. On Monday patient noticed her knuckles on her left hand were swollen and sore. On Tuesday 20Apr2021 her right hand knuckles began to swell and ache. She slept most of the day Monday and Tuesday. She has waited the 2-week mark, as she has read some symptoms can linger up to 2 weeks. The pain and tightness in her knuckles have increased over time and today it hurt just to straighten her fingers and she was having trouble making a fist. She also experiencing pain in her ankles when she gets out of bed in the mornings. Prior to the vaccine she has never had any of these symptoms. The only health issue she has is hypothyroidism. She called her doctor, tonight to tell him about her symptoms. He told patient to take some Aleve and Pepcid tonight and he was calling in an order of prednisone for patient to start tomorrow, 02May2021. He told patient to report her reaction and follow up with him in 3 days. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Rash
Clinical narrative: little red rash all over face; little red rash all over face; This is a spontaneous report from a contactable consumer or other non-hcp. A 17-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration (age at vaccination 17-year) on 28Apr2021 as dose 2, single for COVID-19 immunization; patient received paroxetine, an antidepressant type drug (Batch/Lot number: unknown; Expiration date: unknown) via an unspecified route of administration from 28Apr2021 to 28Apr2021, at unspecified dose for depression. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 administered on an unspecified date for COVID-19 immunization. On 28Apr2021 the patient experienced little red rash all over face. It was reported that "caller, (Name), was calling on behalf of her granddaughter (Name), 17 years old who received her 2nd dose yesterday (28April). Caller said that her granddaughter took Paroxetine, an antidepressant type drug yesterday however she had a little red rash all over face. Caller was asking if the vaccine interacts with the Paroxetine that she took." The action taken in response to the events for paroxetine was unknown. The clinical outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Arm soreness; Rash at injection site; above and below is redness; rash and redness on the arm; Rash at injection site; above and below is redness; rash and redness on the arm; experienced redness and itchiness on the same injection site; This is a spontaneous report from a contactable consumer or other non hcp.A 17-years-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: Not reported) via an unspecified route of administration, administered on 30Apr2021  as DOSE 1, SINGLE for COVID-19 immunization(age at vaccination17 years).The co-suspect drug included as Ibuprofen (IBUPROFEN), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. The patient medical history was not reported. Concomitant medication(s) included ethinylestradiol, norethisterone acetate (JUNEL) taken for Birth control, It just says 28 days and does not says any mg or anything, daily just once a day orally. start and stop date were not reported. on 02May2021 the patient experienced arm soreness, rash at injection site above and below is redness, rash and redness, experienced redness and itchiness on the same injection site. The patient has not received any treatment Caller would like to know if her daughter can take anything for the redness, soring like anti-inflammatory and antihistamine? Or if she can put any topical cream on the site following getting the vaccinated. Caller would like to have recommendations about letting her daughter get the 2nd dose of the vaccine. The outcome of the events was unknown.  Information about lot/batch number cannot be obtained. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chest discomfort, Cough, Illness, Oropharyngeal pain
Clinical narrative: I am very sick now; Fever; Cough; lot of pain in the body; Sore throat; Could breathe good, it was like (voice not clear) in my chest (not clear); This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER8736), via an unspecified route of administration on 24Apr2021 as SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 24Apr2021, the patient was very sick now, fever, cough, lot of pain in the body and sore throat. The patient reported could breathe, could breathe good, it was like (voice not clear) in the chest (not clear). The patient wanted to know whether it was okay to take like cold medicine or something like that because the patient took Tylenol and wanted to know whether could take Alka-Seltzer. The patient's second dose was due on 13May2021. The patient underwent lab tests and procedures which included body temperature on 24Apr2021. The outcome of events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: I am very sick now; Fever; Cough; lot of pain in the body; Sore throat; Could breathe good, it was like (voice not clear) in my chest (not clear); This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER8736), via an unspecified route of administration on 24Apr2021 as SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 24Apr2021, the patient was very sick now, fever, cough, lot of pain in the body and sore throat. The patient reported could breathe, could breathe good, it was like (voice not clear) in the chest (not clear). The patient wanted to know whether it was okay to take like cold medicine or something like that because the patient took Tylenol and wanted to know whether could take Alka-Seltzer. The patient's second dose was due on 13May2021. The patient underwent lab tests and procedures which included body temperature on 24Apr2021. The outcome of events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Dyspnoea, Myalgia, Pyrexia
Clinical narrative: severe chest pain; shortness of breath; severe muscle and  joint pain; severe muscle and  joint pain; Fever the next day; This is a spontaneous report from a contactable consumer (Patient). A 52-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Batch/Lot Number: ER8736), via an unspecified route of administration, administered in Arm Left on 28Apr2021 14:00 as dose 2, single for covid-19 immunisation. Medical history included hypertension (prolonged qt) from an unknown date and unknown if ongoing. Concomitant medications included fish oil, colecalciferol (D3), vitamin b complex (B COMPLEX [VITAMIN B COMPLEX]) and amlodi-pine;Olmesartan taken for an unspecified indication. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration, administered in Arm Left on 07Apr2021 14:00 as dose 1, single for COVID-19 immunisation. It was reported that she was not a pregnant at the time of vaccination. She did not take any other vaccine in four weeks prior COVID -19 vac-cine. She was not diagnosed with COVID prior vaccination and not tested with COVID post vaccination. On 29Apr2021 patient experienced fever and on 30Apr2021 patient experienced second day was a severe chest pain and shortness of breath with severe muscle and joint pain. The patient did not received any treatment for all the events. The outcome of the events was recovering.  No follow up attempt are needed: No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling hot, Headache, Pruritus, Vaccination site pain
Clinical narrative: extreme fatigue (for 4 days after injection); face was hot and itchy; face was hot and itchy; pain at injection site; headache; This is a spontaneous report received from a contactable consumer (patient). A 34-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EN6204, Expiration date: not reported), via an unspecified route of administration in arm left on 12Mar2021 (at the age of 34-year-old) as a dose 1, single for COVID-19 immunization. The patient's medical history included hypothyroid, fibromyalgia. The patient had no known allergies. The patient's concomitant medications in two weeks included fluoxetine hydrochloride (PROZAC), metformin, ethinylestradiol, etonogestrel (NUVARING), levothyroxine sodium (SYNTHROID), all were taken for an unspecified indication. It was reported that, the patient was not pregnant at time of vaccination. Other vaccine in four weeks was reported as no. No covid prior vaccination and no covid tested post vaccination. On 12Mar2021, the patient experienced extreme fatigue (for 4 days after injection), face was hot and itchy (started about 3 hours after injection and lasted until the next morning), pain at injection site, headache (lasted 1 day after injection). Treatment was received for the events. The outcome of the event for headache was recovered on 13Mar2021 while for the other events was not recovered.  No follow up attempts are possible. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Hyperhidrosis, Pyrexia, Rash, Urticaria
Clinical narrative: hives; burning sensation; I just had bad sweat; I got a rash; I got like a burning fever; This is a spontaneous report from a contactable consumer (patient himself).  A 51-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: EW0173 and Expiry date Sep2021), via an unspecified route of administration on 03May2021 (at the age of 51 years old) as dose 2, single for COVID-19 immunization. Patient received co-suspect of diphenhydramine hydrochloride (BENADRYL), via an unspecified route of administration from an unspecified date (Batch/Lot Number: Unknown) to an unspecified date, at unspecified dose for an unspecified indication. The patient medical history was not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EW10153 and Expiry date Jul2021), via an unspecified route of administration on 04Apr2021 as dose 1, single for COVID-19 immunization. Concomitant medications included lisinopril (LISINOPRIL) taken orally for blood pressure abnormal, start and stop date were not reported; rosuvastatin calcium (CRESTOR) taken orally for blood cholesterol, start and stop date were not reported; methadone (METHADONE) taken for back surgery, start and stop date were not reported. On unspecified date in May2021 patient experienced little hives and feel like a burning sensation and he got setup taken second dose and queried for was it all right if he had taken Benadryl. When probed for the dose of vaccine, patient stated, that yes, he had this morning about 9:45 this morning. Patient was informed about the Medical Information and provided with the number and requested to dial the option 3 and informed about timings as 8 AM to 8 PM from Monday to Friday and for Saturday and Sunday timings are 9 AM to 3 PM. Patient's initial was confirmed. Patient reported that, he just had sweat and he just had bad sweat with it and further stated that he knows what he mean that's now he mean that's the first start he had with it and he got a rash, he got like a burning fever. Outcome of events was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hyperhidrosis, Pyrexia, Rash
Clinical narrative: rash; got like a burning fever; I just have sweat , I just had bad sweat; This is a spontaneous report from a contactable consumer (patient) or other non HCP.  A 51-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0173; Expiration date: Jul2021), via an unspecified route of administration on 04Apr2021 (age at vaccination was 51 years-old) as Dose 1, SINGLE for covid-19 immunisation; patient received diphenhydramine hydrochloride (BENADRYL), Batch/Lot number: Unknown), via an unspecified route of administration from an unspecified date to an unspecified date for an unspecified indication. The patient medical history was not reported. Concomitant medications included lisinopril taken for blood pressure, rosuvastatin calcium (CRESTOR) taken for cholesterol, methadone taken for back surgery; start and stop date were not reported for all. On an unspecified date in Apr2021, patient experienced rash, got like a burning fever, just had bad sweat. he just had sweat and he just had bad sweat with it and the patient meant that the first start he had with bnt162b2 and he got a rash, he got like a burning fever. The patient's initials was confirmed. Investigation assessment was not reported. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Nasal congestion, Oropharyngeal pain, Respiratory disorder
Clinical narrative: Severe respiratory illness lasting two weeks; sore throat; cough; congestion; This is a spontaneous report from a non-contactable consumer or other non hcp (patient).  A 36-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 05Apr2021 (at the age of 36 years) (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation for Pharmacy or Drug Store. The patient was not pregnant at the time of vaccination. The patient medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Apr2021 the patient experienced Severe respiratory illness lasting two weeks, including sore throat, cough, and congestion. The patient did not receive any treatment for the adverse events. The clinical outcome of the events was recovered on unspecified dates in 2021.   No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Swelling face, Tenderness
Clinical narrative: swelling, warmth and tenderness to the face; swelling, warmth and tenderness to the face; swelling, warmth and tenderness to the face; This is a spontaneous report received by Pfizer from Regulatory Agency (Reference number: GL-O42121-10054) via a contactable Physician reported for a patient. A 58-years-old female patient received an unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unspecified date (age at vaccination was unknown) as dose number unknown, single for COVID-19 immunization. The co-suspect medication included hyaluronic acid (RESTYLANE) via an unspecified route of administration in Feb2020, at unspecified dose for an unspecified indication. The patient's medical history and concomitant medications were not reported. The patient received COVID vaccine approximately 3 weeks ago and on an unspecified date, the patient experienced swelling, warmth and tenderness to the face where Defyne was injected. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 31.0
Sex: U
Vaccine: COVID19
Symptoms: Burning sensation, Chest discomfort, Pain in extremity, Palpitations, Paraesthesia
Clinical narrative: Heart palpitations; chest tightness starting within 12 hours of vaccine.; burning sensations at back of neck and scalp; burning sensations at back of neck and scalp; Tingling in both arms.; pain in legs and pelvis.; pain in legs and pelvis.; This is a spontaneous report from a contactable consumer (patient). A 31-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection) via an unspecified route of administration in arm right on 08Apr2021 09:45 (age at vaccination 31 year) as dose number unknown, single for COVID-19 immunisation. Medical history included latex allergy. The patient's concomitant medication received included ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE]), on an unspecified date for unspecified indication. No other vaccine in four weeks, no covid prior vaccination, not tested for covid post vaccination, no other medical history and other medications in two weeks was prenatal. On 08Apr2021, the patient experience heart palpitations and chest tightness starting within 12 hours of vaccine, burning sensations at back of neck and scalp, tingling in both arms, pain in legs and pelvis. No treatment received. 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: 31.0
Sex: U
Vaccine: COVID19
Symptoms: Pelvic pain, Skin burning sensation
Clinical narrative: Heart palpitations; chest tightness starting within 12 hours of vaccine.; burning sensations at back of neck and scalp; burning sensations at back of neck and scalp; Tingling in both arms.; pain in legs and pelvis.; pain in legs and pelvis.; This is a spontaneous report from a contactable consumer (patient). A 31-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection) via an unspecified route of administration in arm right on 08Apr2021 09:45 (age at vaccination 31 year) as dose number unknown, single for COVID-19 immunisation. Medical history included latex allergy. The patient's concomitant medication received included ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE]), on an unspecified date for unspecified indication. No other vaccine in four weeks, no covid prior vaccination, not tested for covid post vaccination, no other medical history and other medications in two weeks was prenatal. On 08Apr2021, the patient experience heart palpitations and chest tightness starting within 12 hours of vaccine, burning sensations at back of neck and scalp, tingling in both arms, pain in legs and pelvis. No treatment received. 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.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Impaired driving ability
Clinical narrative: headache; Dizziness; have not been able to drive since; This is a spontaneous report from a contactable consumer (patient). A 31-years-old non pregnant female patient received first dose of bnt162b2 (Solution injection; Batch/Lot Number: Er8729), via an unspecified route of administration, administered in Arm Right on 14Apr2021 as single dose and received second dose of bnt162b2 (Solution injection; Batch/Lot Number: Batch/Lot Number: Ew0171) via an unspecified route of administration, administered in Arm Right on 05May2021 as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included iron. Patient was not diagnosed with covid prior vaccination. Patient was not tested for covid post vaccination. Patient did not receive any other vaccine in four weeks. The patient experienced severe dizziness and headache that started 5 days after dose 1 on 19Apr2021. She went to the ER due to severity. She had not been able to drive since. It started to get better before dose 2, but now it was back. The outcome of all the events was not recovered.  No follow up attempts are possible. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, SARS-CoV-2 test
Clinical narrative: Sharp pain in left chest around my heart.; This is a spontaneous report from a contactable consumer (patient himself). A 40-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: Ew0150), via an unspecified route of administration, administered in left arm on 23Apr2021 14:00 (age at vaccination: 40 years) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient had no known allergies. The patient's historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: Ew0150), via an unspecified route of administration, administered in left arm on 02Apr2021 14:00 as DOSE 2, SINGLE for covid-19 immunisation. The vaccine was administered in a Student Health Clinic. The patient did not receive any other vaccine in four weeks nor other medications in 2 weeks. On 01Jun2021, the patient experienced sharp pain in left chest around his heart. The patient underwent lab tests and procedures which included sars-cov-2 test (nasal swab): negative on 01Jan2021. The patient did not receive any treatment for the adverse events. The patient did not have covid prior to vaccination. The outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.  Follow-up attempts are completed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Nerve compression, Pain in extremity, Peripheral swelling
Clinical narrative: pinch nerve on my left leg; leg more frequently with more pain/heat/swollen; leg more frequently with more pain/heat/swollen; leg more frequently with more pain/heat/swollen; This is a spontaneous report from a contactable consumer (Patient). A 58-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EW0183, patient was 58-year-old and not pregnant at the time of vaccination), via an unspecified route of administration, administered in Arm Left on 28May2021 at 11:00 as DOSE 1, SINGLE, and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EW0186, patient was 58-year-old and not pregnant at the time of vaccination), via an unspecified route of administration, administered in Arm Left on 18Jun2021 as DOSE 2, SINGLE both for covid-19 immunisation. Patient received other vaccine in four weeks as Pfizer biontech. Medical history included osteoarthritis on right leg / pinch nerve on left leg. There were no concomitant medications. No covid prior vaccination, no covid tested post vaccination. No known allergies reported. On 28May2021 at 11:00 AM, the patient experienced pinch nerve on my left leg, leg more frequently with more pain/heat/swollen, leg more frequently with more pain/heat/swollen. No treatment received for events. The outcomes of events were not recovered.  Follow-up (21Sep2021): new information received from a  sponsored program  support. A contactable pharmacist reported that: No new event was reported.  Follow-up(24Sep2021) new information received in response to the mail trail sent regarding the confirmation of below mentioned query. The response included: patient DOB was confirmed.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Migraine, Paraesthesia
Clinical narrative: Constant chest pain, on the right side and sometimes on the left.; Long lasting migraines; tingling sensation in hands and feet; This is a spontaneous report from a contactable consumer (patient). A 23-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot Number: Unknown) via an unspecified route of administration, administered in arm left on 22May2021 at 09:00 (at the age of 23-year-old) as single dose for COVID-19 immunization at pharmacy or drug store. The patient was not pregnant at the time of vaccination. The patient medical history was not reported. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and not received any other medications within 2 weeks of vaccination. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. On 09Jun2021 at 12:00, patient experienced constant chest pain, on the right side and sometimes on the left. Long lasting migraines and tingling sensation in hands and feet. Patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot Number: Unknown) via an unspecified route of administration, administered in arm left on 14Jun2021 at 17:00 (at the age of 23-year-old) as single dose for COVID-19 immunization. The adverse events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient did not receive any treatment for adverse events. The outcome of all the events was not recovered.  Follow-up attempts are completed. No further information is expected
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: (name) experienced intermittent chest pain (severe at times) starting from 2nd day of vaccination which lasted for about 4 days. At that point I was unaware of any such side effect of the pfizer vacci; This is a spontaneous report from a contactable consumer or other non hcp.   A 13-years-old male patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot Number: ER8727), dose 2 via an unspecified route of administration, administered in Arm Left on 06Jun2021 dose 2, single for covid-19 immunisation. The patient medical history and concomitant were not reported. The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID.It was Reported that, patient experienced intermittent chest pain starting from 2nd day of vaccination which lasted for about 4 days. At that point I was unaware of any such side effect of the Pfizer vaccine, so I did not report it immediately on 07Jun2021 with outcome of recovered.  Follow-up attempts have been completed and no further information is expected
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder, Menstruation irregular, SARS-CoV-2 test
Clinical narrative: issues with uterus, my periods have been super heavy and then super light ever since the vaccine was administered; issues with uterus, my periods have been super heavy and then super light ever since the vaccine was administered; This is a spontaneous report from a contactable consumer or other non hcp.    A 17-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 16Mar2021 as dose 2, single for covid-19 immunisation. Medical history included neuropathy peripheral, food allergy, iodine allergy The patient's concomitant medications were not reported. The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID. It was reported that, the patient experienced issues with uterus, my periods have been super heavy and then super light ever since the vaccine was administered on 16Mar2021 15:00 with outcome of not recovered. The patient underwent lab tests and procedures which included sars-cov-2 test negative on 28May2021.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain
Clinical narrative: Severe neck pain on the same side as vaccination site that is lasting more than two weeks after second dose.; This is a spontaneous report from a non-contactable consumer. This 35-year-old female consumer reported for herself that.  A 35-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 21Jun2021 14:00 as (At the age of 35-years) dose 2, single for covid-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing and Known allergies to Penicillin from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. Patient was not pregnant at the time of vaccination. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 28May2021 04:00 pm as (At the age of 35-years) dose 1, single for covid-19 immunisation. The patient experienced severe neck pain on the same side as vaccination site that is lasting more than two weeks after second dose on 22Jun2021. Patient visit Physician Office for event and received treatment as Physical therapy and pain medication. The outcome of event was not recovered.   No follow-up attempts are possible. Information about Lot/Batch number cannot be obtained.