chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Somnolence, Vaccination site pain
Clinical narrative: Moderately sore arm; very mild drowsiness; Mildly sore arm at injection site; This is a spontaneous report from a contactable consumer (patient). A 22-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EP6955; Expiration date was not reported), via an unspecified route of administration in the left arm on 22Apr2021 15:30 (at the age of 22-years-old) as first dose, single dose for COVID-19 immunization at a facility or Health Clinic. Medical history included grass allergy, pollen allergy and other allergy (reported as etc.); all from an unknown date and unknown if ongoing. Concomitant medications included fluticasone nasal spray taken for an unspecified indication, start and stop date were not reported. No other vaccine was received by the patient in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient has not been tested for COVID-19. The patient experienced mildly sore arm at injection site on 22Apr2021 and moderately sore arm and very mild drowsiness on 23Apr2021. The outcome of the events was unknown. The patient was vaccinated with BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: ER8731; Expiration date was not reported), via an unspecified route of administration in the left arm on 13May2021 15:30 (at the age of 22-years-old) as second dose, single dose for COVID-19 immunization at a facility or Health Clinic.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report from a contactable consumer or other non hcp. A 32-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number, and Expiration date not reported), via an unspecified route of administration on an unspecified date, as first dose, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced sore arm on an unspecified date. The outcome of event was unknown.   Information on the lot/batch number has been requested.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Vaccination site erythema, Vaccination site pruritus, Vaccination site rash
Clinical narrative: formed a rash at the injection site on left arm,neck, face,chest and stomach. Rash is itchy and is red.; formed a rash at the injection site on left arm,neck, face,chest and stomach. Rash is itchy and is red.; formed a rash at the injection site on left arm,neck, face,chest and stomach. Rash is itchy and is red.; formed a rash at the injection site on left arm,neck, face,chest and stomach. Rash is itchy and is red.; 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; Batch/Lot number and Expiration Date: not reported), via an unspecified route of administration, administered in left arm on 11May2021 at 17:15 (at the age of 66 years old) as first dose, single for COVID-19 immunisation in a Pharmacy or Drug Store. The patient has no other medical history. The patient was not pregnant at the time of vaccination, has no allergies and prior to vaccine the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient has no list of any other medications the patient received within 2 weeks of vaccination and did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 11May2021 at 19:00, the patient experienced a rash at the injection site on left arm, neck, face, chest and stomach. Rash was itchy and was red. No treatment was received for the adverse event. Since vaccination, the patient has not been tested for COVID-19. Outcome of all events was not recovered.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever; This is a spontaneous report from a contactable consumer (wife). A 49-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number and expiration date were not reported), via an unspecified route of administration on 08May2021 as first dose, single dose for COVID-19 immunization. The patient's medical history was not reported. The patient has no concomitant medications. The patient experienced fever on an unspecified date. The outcome of the event was not recovered; patient still has fever after 8 days. It was reported that they don't have health insurance, and in the hospital they didn't want to prescribe anything other than Tylenol and Ibuprofen. At the clinic where the patient got the vaccine, the reporter was recommended to call one of the phones on the papers they were given after the vaccine and that the reporter could get medical assistance there. The reporter just wanted to get medical assistance for the patient (her husband).  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Anosmia
Clinical narrative: able to smell thing but not tell what it was; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number and Expiration date were not reported), via an unspecified route of administration on an unspecified date as 1st dose, single dose for COVID-19 immunisation. Medical history included COVID-19 (my taste and smell went away and came back different) from Dec2020 to an unknown date. It was reported that post COVID 1 month the patient's smell started to return some and somewhat went back to normal. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced able to smell thing but not tell what it was. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Dysphagia, Odynophagia
Clinical narrative: Inability to swallow food to my stomach/ Inability to drink over 1/2 cup; Inability to swallow food to my stomach. Much discomfort. Inability to drink over 1/2 cup. Much discomfort; This is a spontaneous report from a contactable consumer (patient). A 65-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number: ew0171, Expiration Date: not reported), via an unspecified route of administration, administered in left arm on 29Apr2021 at 12:15 (at the age of 65 years old) as second dose, single for COVID-19 immunisation in a Pharmacy or Drug Store. The patient has no other medical history. The patient has no known allergies and prior to vaccine the patient was not diagnosed with COVID-19. The patient previously received the first dose of BNT162B2 (lot number: er8737), via an unspecified route of administration administered in left arm on 08Apr2021 at 12:15 (at the age of 65 years old) as single dose for COVID-19 immunisation. The patient's concomitant medications were not reported.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient has no list of any other medications the patient received within 2 weeks of vaccination. On 02May2021, the patient experienced inability to swallow food to his stomach with much discomfort and inability to drink over 1/2 cup with much discomfort. At the time of report, it was the second week the patient experienced the events. The patient stated that he needed to eat. The patient was able to eat only ice cream slowly. No treatment was received for the adverse event. Since vaccination, the patient has not been tested for COVID-19. Outcome of all events was not recovered.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: vertigo; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EW0167; Expiration date were not reported), via an unspecified route of administration in the left arm on 29Apr2021 12:00 PM (at the age of 60-years-old) as second dose, single dose for COVID-19 immunisation. Medical history hypothyroid and overweight; both from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine sodium (LEVOTHYROXIN), cetirizine hydrochloride (ZYRTEC) and fluoxetine; all taken for an unspecified indication, start and stop dates were not reported. The patient was previously vaccinated with BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EP7533; Expiration date was not reported), via an unspecified route of administration in the left arm on 01Apr2021 12:00 PM (at the age of 60-years-old) as first dose, single dose for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. No other vaccine was received by the patient in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient has not been tested for COVID-19. The patient has no known allergies. On 03May2021 06:30 AM (reported as 4 days later), the patient experienced woke up with vertigo and had a bad case that day. Since then the patient experienced several spells throughout the day. No treatment was given for the event. The outcome of the event was recovering; it (vertigo) got better as the day went on Tuesday.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain
Clinical narrative: She has abdominal pain every time she eats; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number, and Expiration date not reported), via an unspecified route of administration on 12May2021, as second dose, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced she has abdominal pain every time she eats on an unspecified date. Patient stated she is afraid to eat because she has abdominal pain every time she eats. Patient wanted to know how long symptoms last. Patient stated she has a call in to her HCP. The outcome of event was unknown.   Information on the lot/ batch number has been requested.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Nipple pain, Nipple swelling
Clinical narrative: Soreness, redness and slight swelling of left nipple; Soreness, redness and slight swelling of left nipple; Soreness, redness and slight swelling of left nipple; This is a spontaneous report from a contactable consumer (patient). A 26-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number: EW0183, Expiration date was not reported), via an unspecified route of administration (administered on the left arm) on 14May2021 09:00 (at the age of 26-years-old) as 2nd dose, single dose for COVID-19 immunisation. The patient's medical history was not reported. The patient has no concomitant medications. The patient was previously vaccinated with the first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number: ER8736, Expiration date was not reported), via an unspecified route of administration (administered on the left arm) on 21Apr2021 (at the age of 25-years-old) for COVID-19 immunisation. Prior to vaccination, the patient has not been diagnosed with COVID-19. The patient didn't receive any other vaccines within 4 weeks prior to COVID vaccine. On 15May2021, the patient experienced soreness, redness, and slight swelling of left nipple. The events were assessed as non-serious. No treatment was received for the events. Since the vaccination the patient has not been tested for COVID-19. The outcome of the events was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: Caller states sister had second dose and reports a bruise a month later on arm.; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number and Expiration Date: not reported), via an unspecified route of administration on an unspecified date as second dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced a bruise on arm a month later after the second dose of BNT162B2. The patient indicated that she did not know if she could have acquired it working in the yard but asked if it is a reported adverse event. Outcome of the event was unknown.   Information on the Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: sleepy but was generally fine; This is a spontaneous report from a contactable nurse (patient's girlfriend). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number and expiration date were not reported), via an unspecified route of administration on an unspecified date as unknown, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced sleepy but was generally fine. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Nervousness
Clinical narrative: she was not able to sleep, possibly due to nervousness; she was not able to sleep, possibly due to nervousness; This is a spontaneous report from a contactable nurse (patient's sister). A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number, and Expiration date not reported), via an unspecified route of administration on 16May2021, as unknown, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced she was not able to sleep, possibly due to nervousness on an unspecified date in May2021. The outcome of events was unknown.  Information on the Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Pain in extremity
Clinical narrative: pain in her arm; migraine headache; This is a spontaneous report from a contactable consumer (patient's mother) from a Pfizer sponsored program. A 15-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number and Expiration Date: not reported), via an unspecified route of administration on 16May2021 as first dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient developed pain in her arm and has a migraine headache. The reporter was asking if the patient can take parectamol (TYLENOL). Outcome of the event was unknown.  Information on Lot/Batch number has been requested.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Rash pustular
Clinical narrative: red dots on the whole arm  and there is some yellow in the middle; This is a spontaneous report from a contactable consumer or other non hcp (patient himself). A 52-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: EW0153, Expiration date not reported), via an unspecified route of administration on 18Apr2021 (at the age of 52-year-old), as first dose, single dose for COVID-19 immunisation. The patient has reported he doesn't have any medical conditions and is not allergic to anything. The patient has not received any other products. There were no other vaccines administered on the same date of the administration of BNT162B2. The patient experienced red dots on the whole arm and there is some yellow in the middle on 18Apr2021. He called for the reaction he had on his arm. He had a lot of little dots. Patient stated they were not pimples. They were dots on the whole arm. They are red dots and there is some yellow in the middle. He mentioned it to the person that gave him the second injection and they said it was normal. The outcome of event was not recovered.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: after my first vaccination I had a super heavy period that lasted 10 days; This is a spontaneous report from a contactable consumer (patient). A 34-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: EW0161, Expiration date was not reported), via an unspecified route of administration (administered on the light arm, as reported) on 23Apr2021 15:30 (at the age of 34-years-old) as 1st dose, single dose for COVID-19 immunisation. Medical history included sulfer and penicillin allergy from an unknown date. Concomitant medication included ascorbic acid, biotin, boron citrate, calcium pantothenate, calcium phosphate, choline bitartrate, chromium picolinate, colecalciferol, cyanocobalamin, dl-alpha tocopheryl acetate, folic acid, inositol nicotinate, potassium iodide, pyridoxine hydrochloride, retinol palmitate (VITAFUSION WOMEN'S) taken for an unspecified indication, start and stop date were not reported. Prior to vaccination, the patient has not been diagnosed with COVID-19. The patient didn't receive any other vaccines within 4 weeks prior to COVID vaccine. On an unspecified date, the patient experienced after my first vaccination I had a super heavy period that lasted 10 days. No treatment was received for the event. Since the vaccination the patient has not been tested for COVID-19. The outcome of the event was unknown.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: her arm hurt at the injection site; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number and expiration date were not reported), via an unspecified route of administration in the left arm on an unspecified date (at the age of 63-years-old) as first dose, single dose for COVID-19 immunization. Medical history included pain in the arm (from the Allergy shots) from an unknown date and unknown if ongoing.  The patient's concomitant medications were not reported. The patient previously took allergy shot and experienced pain in the arm. It was reported that the patient gets them every 5 weeks and she has been getting them for 30 years. She has had no problems and she has no idea what they gave her. On an unspecified date, after the 1st vaccine, the patient experienced arm hurt at the injection site. It was reported that the reporter knew your arm hurts for 2-3 days after shot because of the allergy shots she got. The outcome of the event was recovered on an unspecified date (reported to be done in the first 24 hours or believes so). The patient was vaccinated with the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 19Feb2021.  Information on the lot/batch number has been requested.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: diarrhea; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number, and Expiration date not reported), via an unspecified route of administration, administered in the left arm on 24Apr2021 12:30 (at the age of 56-years-old), as first dose, single dose for COVID-19 immunisation. Medical history included very low iron, asthma, and COVID-19. Patient reported she is taking "too many to name" unspecified medications. The patient was not pregnant at the time of vaccination. Patient has no known allergies. Prior to vaccination, the patient was diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced diarrhea on 25Apr2021 00:00. Patient reported she had diarrhea since her first dose. She had COVID so she expected to be ill after the first vaccine. Patient took unspecified diarrhea medication as a result of the event reported. The outcome of event was recovering.  Information on the Lot/Batch number has been requested.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). An 86-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number: unknown, Expiration Date: 31Jul2021), via an unspecified route of administration, administered in left arm on 12Mar2021 at 10:00 (at the age of 86 years old) as first dose, single for COVID-19 immunization at a Senior Center. The patient has no medical history (including any illness at time of vaccination) and family medical history relevant to the adverse event. No adverse event prior to vaccination. The patient's concomitant medications were not reported.  On an unspecified date in Mar 2021, the patient started having problems where he would wake up at night and his right hand would be asleep and did not think anything of it since it had happened once in a while over the years. The patient further stated that he has had numbness in his fingers and the right hand only and then would have problems during the daytime where he would be sitting around and notice like the tip of his thumb, whole hand would go numb, or two fingers would go numb that would last several minutes up to 10 mins and then would slowly disappear. The patient also reported that this started getting worse a week in a half ago or 2 weeks. On an unspecified date in Apr 2021, his whole right arm was aching really bad and that lasted for about 15, 20, or 25 minutes and that continued to get worse but had has not happened during daytime. The night before the day of the report, the patient tried using a heating pad, tried sleeping in a chair, and tried to apply vibrations since it was so bad. The patient stated this started at 2 o'clock this morning and was still hurting at 6 o'clock and he thought he would have to go to the emergency room so he got up and showered and shaved and then all the symptoms disappeared. He was back to normal and it was getting pretty bad. The patient stated that his doctor did not think it could be with the vaccine. The patient was calling to see if these symptoms had been reported since he was worried about the extreme pain in his right arm that he had when the numbness happened. The events resulted to a physician office visit. Treatment was done in response to the events which included heating pad, tried sleeping in a chair, and tried to apply vibrations. Outcome of all events was not recovered. The patient received the second dose of BNT162B2 (lot number and expiration date: unknown), via an unspecified route of administration administered in left arm on 02Apr2021 at 10:00 as single dose for COVID-19 immunization. Information on the lot/batch numbers has been requested. Further information was expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Intermenstrual bleeding, Menstrual disorder
Clinical narrative: heavy during the first few days after vaccine; I also discharged heavy blood clots on some days; Since then I have been bleeding every day/ But even after 35 days i spot daily/ It is not stopping even after 35 days; This is a spontaneous report from a non-contactable consumer (patient). A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number and expiration date were not reported), via an unspecified route of administration on 09Apr2021 09:00 (at the age of 44-years-old) as second dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient has not been tested for COVID-19. The second dose was taken during the patient's period. On 09Apr2021, the patient experienced been bleeding every day, heavy during the first few days after vaccine, even after 35 days the patient spot daily, discharged heavy blood clots on some days and it was not stopping even after 35 days. The events resulted in a doctor or other healthcare professional office/clinic visit. The outcome of the event been bleeding every day, even after 35 days the patient spot daily day and was not stopping even after 35 days was not recovered; while outcome of the other events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site pain
Clinical narrative: painful site of injections; Deltoid muscle is sore anytime it's moved; This is a spontaneous report from a non-contactable consumer or other non hcp (patient herself). A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in the left arm on 10Apr2021 09:30 (at the age of 49 years old; Batch/Lot number; Expiration date was not reported) as first dose, single dose and via an unspecified route of administration, administered in the right arm on 29Apr2021 17:30 (at the age of 49 years old; Batch/Lot number; Expiration date was not reported) as second dose, single dose, both for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took metronidazole. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient experienced 19 days post vaccine still painful site of injections and deltoid muscle is sore anytime it's moved on an unspecified date in Apr2021. Treatment was not received as a result of the events. Events resulted to doctor clinic visit. The outcome of events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Lymphadenopathy
Clinical narrative: Severe swelling of lymph node in left arm pit and minor swelling in other lymph nodes; Severe fatigue; This is a spontaneous report from a contactable consumer (patient). A 41-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number: EW0176, Expiration date was not reported), via an unspecified route of administration (administered on the left arm) on 15May2021 17:30 (at the age of 41-years-old) as 2nd dose, single dose for COVID-19 immunisation. The patient's medical history was not reported. The patient has no other medications received within 2 weeks of vaccination. Prior to vaccination, the patient has not been diagnosed with COVID-19.  The patient didn't receive any other vaccines within 4 weeks prior to COVID vaccine. The patient was previously vaccinated with the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number: EW0170, Expiration date was not reported), via an unspecified route of administration (administered on the right arm) on 24Apr2021 17:15 (at the age of 41-years-old) for COVID-19 immunisation. The patient experienced severe fatigue on 16May2021 07:00 and severe swelling of lymph node in left arm pit and minor swelling in other lymph nodes on 17May2021 07:00. The events were assessed as non-serious. No treatment was received for the events. Since the vaccination the patient has not been tested for COVID-19. The outcome of the events was recovering.
Sex: M
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Chest pain and it went away; This is a spontaneous report from a contactable consumer (patient's daughter in law). This consumer reports similar events for 2 patients. This is the second of two reports. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number and Expiration Date: not reported), via an unspecified route of administration on an unspecified date as unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced chest pain and it went away. It was also reported that later on, the patient was okay after the event. Outcome of the event was recovered on an unspecified date.  Information on the lot/batch numbers has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021556550 same reporter and drug, similar events, different patient
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Pain in extremity, Pruritus
Clinical narrative: Blisters; itching; pain on left hand; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: Er8732; Expiration date was not reported), via an unspecified route of administration in the left arm on 07Apr2021 (at the age of 40-years-old) as first dose, single dose for COVID-19 immunization. Medical history included arthritis, colon polyps, PTSD, ADHD, bulging disc and depression; all from unknown date and unknown if ongoing. Concomitant medications included hydrocodone and zolpidem tartrate (AMBIEN); both taken for an unspecified indication, start and stop dates were not reported. The patient previously took metoclopramide (REGLAN) and experienced drug allergy. The patient was not pregnant at the time of vaccination. No other vaccine was received by the patient in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient has not been tested for COVID-19. On 08Apr2021, the patient experienced blisters, itching and pain on left hand. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care visit. Treatment with steroids pills, steroids shot and 4 creams were taken as a result of the events. The outcome of the events was not recovered. The patient was vaccinated with BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: ew0161; Expiration date was not reported), via an unspecified route of administration on 27Apr2021 (at the age of 40-years-old) as second dose, single dose for COVID-19 immunization.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Severe pain in left arm over 2 week; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number and Expiration date were not reported), via an unspecified route of administration (administered on the left arm) on 03May2021 12:00 (at the age of 60-years-old) as 1st dose, single dose for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications included meloxicam, pravastatin and cetirizine all taken for an unspecified indication, start and stop date were not reported. The patient has no known allergies. The patient didn't receive any other vaccines within 4 weeks prior to COVID vaccine. Prior to vaccination, the patient has not been diagnosed with COVID-19. The patient experienced severe pain in left arm over 2 week on 05May2021 08:00. The adverse event resulted in doctor or other healthcare professional office/clinic visit. Unspecified therapeutic measures were taken as a result of the event on 17May2021. Since the vaccination the patient has not been tested for COVID-19. The outcome of the event was unknown.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Breast pain, Pain
Clinical narrative: Sharp/throbbing pain in left underarm/breast area.; Sharp/throbbing pain in left underarm/breast area.; Sharp/throbbing pain in left underarm/breast area.; This is a spontaneous report from a non-contactable consumer (patient) via. This 32-year-old female patient received the second dose of COVID-19 vaccine (TRADE NAME UNSPECIFIED; lot number ER2613) via an unspecified route of administration in the left arm on 17May2021 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination the patient had not been diagnosed with COVID-19 and had not received any other vaccines in the four weeks prior to the COVID vaccine. The patient had no concomitant medications. The patient previously received the first dose of COVID-19 vaccine (lot number ER8733) in the left arm on an unspecified date for COVID-19 immunisation. On 18May2021 the patient experienced sharp/throbbing pain in the left underarm/breast area. She reported it started on day two after getting the second dose. The events were reported as non-serious and did not require hospitalization. No treatment was received for the events. The clinical outcomes of sharp/throbbing pain in the left underarm/breast area were unknown. It was also reported that since vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Patient has experienced a mild rash on both hands/rash on patient's face; This is a spontaneous report from a contactable consumer (Patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 13May2021 12:00 as 1ST DOSE, SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that, Since that time, Patient has experienced a mild rash on both hands. Patient woke up that morning to have the rash on hands gone but the rash was now present on patient's face on an unknown date. The outcome of event was unknown.  Information on the lot/batch number has been requested. Follow up letter has been generated for further information.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstrual disorder
Clinical narrative: struck periods for long duration(15) and gap between monthly periods have reduced from 25 days to 10days; struck periods for long duration(15) and gap between monthly periods have reduced from 25 days to 10days; This is a spontaneous report from a contactable consumer (patient) . This non-pregnant 39-year-old female patient received a dose of COVID-19 vaccine (UNSPECIFIED TRADE NAME; lot number EN6206) via an unspecified route of administration on 04May2021 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination the patient was not diagnosed with COVID-19 and had not received any other vaccines in the four weeks prior to the COVID vaccine. The patient reported that she had "struck periods" for long duration "(15)" and gap between monthly periods had reduced from 25 days to 10 days. The events were reported as non-serious and did not require hospitalization. No treatment was received for the events. The clinical outcomes of "struck periods" for long duration "(15)" and gap between monthly periods had reduced from 25 days to 10 days were unknown. It was also reported that the patient had not been tested for COVID since vaccination.
Age: 47.0
Sex: U
Vaccine: COVID19
Symptoms: Psoriasis, Rash macular
Clinical narrative: Continued psoriasis outbreak; Red dots from plaque over most of my body; This is a spontaneous report from a contactable consumer (patient) via COVAES. This 47-year-old patient of unspecified gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number ER8730) via an unspecified route of administration in the right arm on 27Mar2021 at 16:30 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included psoriatic arthritis from an unknown date and unknown if ongoing, psoriasis from 2001, irritable bowel syndrome (IBS) from an unknown date and unknown if ongoing, Barret's from an unknown date and unknown if ongoing, and spondylitis from an unknown date and unknown if ongoing. The patient had no known allergies, had not been diagnosed with COVID-19 prior to vaccination and had not received any other vaccines in the 4 weeks prior to the COVID vaccine. Concomitant medications included tofacitinib citrate (XELJANZ) from an unknown date for psoriasis; esomeprazole magnesium (NEXIUM) from an unknown date for an unknown indication; alprazolam (XANAX) from an unknown date for an unknown indication; colecalciferol (VITAMIN D) from an unknown date for an unknown indication; and vortioxetine hydrobromide (TRINTELLIX) from an unknown date for an unknown indication. The patient previously received the first dose of BNT162B2 (lot number EN6202) in the right arm on 06Mar2021 at 16:30 (at the age of 47-years-old) for COVID-19 immunisation. The patient reported that on 03Apr2021 they experienced continued psoriasis outbreak. They reported having red dots from plaque over most of their body starting about a week after their second dose. They continued to get worse even after resuming their tofacitinib citrate treatment. The patient reported it was very unusual as they had never had that much red spotting since their diagnosis 20 years ago. The patient was treated with acetylsalicylic acid (ASPIRIN) daily. The clinical outcomes of continued psoriasis outbreak and red dots from plaque over most of their body were not recovered. It was also reported that since vaccination, the patient had not been tested for COVID-19.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Palpitations, Tachycardia
Clinical narrative: tachycardia; Palpitations at night; This is a spontaneous report from a contactable physician (patient). This non-pregnant 47-year-old female patient received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number ER8736) via an unspecified route of administration in the right arm on 06May2021 at 14:30 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes, rheumatoid arthritis, and hypothyroidism, all from unknown dates and unknown if ongoing. The patient had no known allergies, had not been diagnosed with COVID-19 prior to vaccination and had not received any other vaccines in the four weeks prior to the COVID vaccine. Concomitant medications included methotrexate, sulfasalazine, levothyroxine, metformin, and hydroxychloroquine, all from unknown dates for unknown indications. The patient reported that at night of vaccination she had tachycardia around 130 at rest during sleep. After 4 days of vaccination, tachycardia continued ranging from 120-130 per minute, reported as more during sleep. She further reported palpitations at night. The events were reported as non-serious and did not require hospitalization. No treatment was received for the events. The clinical outcome of tachycardia and palpitations at night were not recovered. It was also reported that since vaccination, the patient had not been tested for COVID-19.
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: developed Shingles after the Pfizer Covid vaccine.; This is a spontaneous report from a contactable consumer. This case is for one of reporter's two friends.   A patient of an unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: Unknown) via an unspecified route of administration on an unspecified date as unknown, single dose for COVID-19 immunization. Medical history, concomitant conditions and past drug history of the patient were not reported. On an unspecified date, after vaccination, patient developed shingles. Reporter stated that she thought that shingles wasn't related to the vaccine, until a coworker, was at a game, and another parent, who was sitting next to this coworker, brought up the fact that two friends of that parent developed shingles after the Pfizer Covid vaccine. Outcome of the event was unknown.  Information about Lot/Batch number has been requested.; Sender's Comments: Linked Report(s) : -PFIZER INC-2021576866 same reporter/drug/event, different patient;-PFIZER INC-2021576816 same reporter/drug/event, different patient
Sex: F
Vaccine: COVID19
Symptoms: Genital herpes
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 62-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0168), via an unspecified route of administration, administered in Arm Left on 21May2021 at 12:30 (Age at vaccination: 62 years) as 1ST DOSE, SINGLE DOSE for COVID-19 immunization. The patient's past medical history included high blood pressure. Allergy to Sulfa-based drug and possibly bee sting. Concomitant medications included Amlodipine, Losartan, Nadolol and Doxycycline Hyclate. The patient did not receive any vaccines within 4 weeks prior to COVID-19 vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. On 21May2021 (12- 18 hours of receiving the first dose), patient had genital herpes which were previously dormant (for years, maybe even a decade or more) but came back with the first dose of the vaccine. Patient's lifestyle habits had not changed so I could not attribute it to any other events. The patient did not receive any other treatment. Outcome of the event genital herpes was recovering.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: urticaria 6 hours after vaccine; This is a spontaneous report from a contactable Physician. A 33-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ER8735), via intramuscular route of administration on 26May2021 (at the age of 33 years) as single dose for covid-19 immunization. Medical history included hypothyroid, hyperlipidemia, allergic rhinitis from an unknown date and unknown if ongoing. The patient had no known allergies. Concomitant medication included levothyroxine (LEVOTHYROXINE) for an unspecified indication, start and stop date were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: ER8735) via intramuscular route of administration on 05May2021 for covid-19 immunization. The patient did not receive any other vaccines in four weeks. It was unknown if covid prior vaccination. Since the vaccination, the patient not been tested for covid-19. On 26May2021, 6 hours after vaccine, patient experienced urticaria. The event resulted in: Doctor or other healthcare professional office/clinic visit. Treatment received: Benadryl. The outcome of events was not recovered.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number and Expiration date were not reported), intramuscularly (administered on the arm) on 23Feb2021 as 1st dose, single dose and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number and Expiration date were not reported), via an unspecified route of administration on 16Mar2021 as 2nd dose, single dose both for COVID-19 immunisation. The patient's medical history was not reported. The patient has no concomitant medications. The patient experienced sore arm on 23Feb2021 and recovered on 25Feb2021, he also experienced sore arm on 16Mar2021 and recovered on 18May2021.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, SARS-CoV-2 test, Vomiting
Clinical narrative: Hospitalized for uncontrollable vomiting, diarrhea and weakness; Hospitalized for uncontrollable vomiting, diarrhea and weakness; Hospitalized for uncontrollable vomiting, diarrhea and weakness; This is a spontaneous report from a contactable consumer (patient). An 18-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in right arm on an unspecified date (Batch/Lot Number: EW0138) as 2ND DOSE, SINGLE for covid-19 immunisation. Patient not diagnosed with COVID-19 Prior to vaccination. Concomitant medication(s) included Bupropion; Sertraline; methylphenidate hydrochloride (CONCERTA). The patient had allergies on Prazosin and amoxicillin. Patient not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was hospitalized for uncontrollable vomiting, diarrhea and weakness on 27May2021 16:00. Patient received 2 liters of IV and potassium treatment. Event outcome was recovering. Emergency Room and Physician Office Visited. Covid Nasal Swab tested Negative on 01Jun2021.  Follow up attempts are needed. Further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Neurological examination, Paraesthesia, Urticaria
Clinical narrative: sensation in her hands & toes like pens/needles; hives; This is a spontaneous report from a contactable other HCP (patient). A 43-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, in Arm Right on 19May2021 18:30 (Batch/Lot Number: EW0177) as single dose for covid-19 immunization. Medical history included thyroidectomy from 2005, gastrooesophageal reflux disease. Concomitant medication(s) included levothyroxine sodium (SYNTHROID) taken for thyroidectomy, start and stop date were not reported; omeprazole (OMEPRAZOLE) taken for gastrooesophageal reflux disease, start and stop date were not reported. On 19May2021 21:30, patient experienced hives, treated with Benadryl, and on 24May2021, sensation in her hands & toes like pens/needles. Caller states she couldn't drive, her hands started to hurt with the pins and needles and they wouldn't go away, it was constant in her fingers and toes. Patient went to a neurologist, did have a neurological work-up and he suggested patient to visit a cardiologist Patient will have a cardiological work-up and probably will have to go to the rheumatologist after that. Outcome of event hives was recovered by the time she woke up the next day, of other events was not recovered.  Information about lot/batch number was obtained. Additional information is requested.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship,  a possible causal relationship between the events and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.