chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This is a spontaneous report from a contactable consumer (patient).  A 56-year-old female patient received first dose of bnt162b2 (BNT162B2, lot number EJ1686) , via an unspecified route of administration on 13Jan2021 09:30 at single dose on left arm for covid-19 immunization .  Medical history included breast cancer (hence tamoxifen) , prediabetic.  Concomitant medication included tamoxifen for breast cancer, calcium, vitamin d nos.  The patient experienced diarrhea on 13Jan2021 11:30. The patient stated that, "started diarrhea within 2 hours after the vaccination, stopped 10 hrs later.  I had a toast with peanut butter and hot water 1 hr before the shot (which is something I eat every morning) I skipped lunch and dinner. Just drank water until the diarrhea stopped around 10pm. I had the same thing next morning without issue." No treatment was received. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. Case assessed as non-serious. The outcome of the event was resolved on 13Jan2021 22:00.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on arms, abdomen, and back; This is a spontaneous report from a contactable other HCP. A 42-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), intramuscular in left arm on 15Jan2021 16:00 at a single dose for covid-19 immunization. There were no relevant medical history. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included vitamin d nos (VITAMIN D NOS), ascorbic acid (VITAMIN C), and fish oil (FISH OIL). The patient previously received the first dose of bnt162b2 on 26Dec2020, lot number: EH9899, in left arm for COVID-19 immunization. The patient experienced rash on arms, abdomen, and back on 17Jan2021 08:00. The outcome of the event was unknown. The event was assessed as non-serious. Since the vaccination, the patient has not been tested for COVID-19.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Headache, Pain in extremity
Clinical narrative: achy legs/Sore arm; Weak; very tired; slight headache; This is a spontaneous report from a contactable nurse (patient). A 59-year-old female patient (no pregnancy) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration from 11Jan2021 at site of left arm at 14:45 at single dose for COVID-19 immunization. Medical history included multiple sclerosis and raynauds. The patient had known allergies: celecoxib (CELEXIA), amoxicillin, desipramine and pantoprazole. Concomitant medication included ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS) and natalizumab (TYSABRI) from 30Dec2020. The patient received first dose of BNT162B2 with lot number: EH9899 on 21Dec2020 at 01:30 pm at site of left arm for COVID-19 immunization and experienced sore arm. The patient experienced achy legs at 06:00 on 12Jan2021, and weak and very tired that afternoon on 12Jan2021, slight headache. Much better 13Jan2021. Sore arm also developed on 12Jan2021. Facility type vaccine was in hospital. No other vaccine received within four weeks. No treatment for adverse event. No COVID prior vaccination. No COVID tested post vaccination. The outcome of events was recovered in Jan2021.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Raynaud's phenomenon
Clinical narrative: Sudden onset of first Raynaud's episode bilateral fingers of hands 36 hours after second COVID-19 vaccine; This is a spontaneous report from a contactable physician.  A 50-years-old female patient received second dose  of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot EK9231, expiry date not reported), intramuscular on 12Jan2021 09:45 at a single dose in the right arm for COVID-19 immunization.  Medical history included rheumatoid arthritis and known allergies to macadamia and pistachio nuts. The patient had no prior COVID vaccination. The patient was not pregnant at the time of the vaccination/at the time of the report. The patient had the first dose of BNT162B2 (brand: Pfizer, Lot number EL0142, expiry date not reported) for COVID-19 immunization on 22Dec2020 02:00 PM via intramuscular route in the right arm (age: 50 years). Concomitant medication included naproxen sodium (ALEVE), paracetamol (TYLENOL), gabapentin (NEURONTIN), and hydroxychloroquine sulfate (PLAQUENIL); all taken in the two weeks of vaccination. The patient had no other vaccine in four weeks. The vaccination was administered in the hospital. On 13Jan2021 08:00 PM, patient had sudden onset of first Raynaud's episode bilateral fingers of hands 36 hours after second COVID-19 vaccine. No treatment received in response to the event. Patient was not tested for COVID post vaccination. The outcome of the event Raynaud's episode was recovering.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Metrorrhagia, SARS-CoV-2 antibody test, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: Breakthrough bleeding/spotting menses; soreness at injection site; This is a spontaneous report from a contactable healthcare professional (patient). A 35-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EL0142, expiry: unknown), via an unspecified route of administration in the left arm on 13Jan2021 at a single dose in a hospital for COVID-19 immunization.  Medical history included Alport's, alopecia areata and eczema. The patient has no known allergies. Concomitant medications included lisinopril and cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]). The patient previously had the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EK5730, expiry: unknown) on 23Dec2020 at 10:00 in the left arm for COVID-19 immunization and experienced fatigue, muscle aches, breakthrough bleeding/spotting menses within 12 hours of dose and soreness at injection site within 12 hours of dose. On an unspecified date, the patient experienced breakthrough bleeding/spotting menses within 12 hours of dose and soreness at injection site within 12 hours of dose (worst with first dose, mild with second dose). The patient was tested for Covid post vaccination via nasal swab using SARS-COV-2 BY PCR (2019-NCOV) on 30Dec2020 which was negative. The patient was also tested with SARS-COV-2 IGG (blood test) on 09Jun2020 which was negative as well. The events were not treated. The outcome of the events was unknown.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Hyperhidrosis, Muscular weakness
Clinical narrative: chills; fatigue; nausea; aches in body; weak muscles; Fever; dizzy; sweating; This is a spontaneous report from a contactable nurse (patient). A 34-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: not reported), via intramuscular route of administration on 13Jan2021 at 08:30 at a single dose on the right arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took lamotrigine (LAMICTAL) and experienced allergies and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: not reported) on an unspecified date for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination. On 13Jan2021 at 18:00, the patient experienced chills, fatigue, nausea, aches in body, weak muscles, and fever. On the same day, patient was feeling dizzy and sweating. The patient did not receive any treatment for the reported events. Since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The outcome of the events was not recovered.  Information about lot/batch number has been requested.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: chills; fatigue; nausea; aches in body; weak muscles; Fever; dizzy; sweating; This is a spontaneous report from a contactable nurse (patient). A 34-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: not reported), via intramuscular route of administration on 13Jan2021 at 08:30 at a single dose on the right arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took lamotrigine (LAMICTAL) and experienced allergies and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: not reported) on an unspecified date for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination. On 13Jan2021 at 18:00, the patient experienced chills, fatigue, nausea, aches in body, weak muscles, and fever. On the same day, patient was feeling dizzy and sweating. The patient did not receive any treatment for the reported events. Since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The outcome of the events was not recovered.  Information about lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph nodes; This is a spontaneous report from a contactable other healthcare professional (patient) via a manufacturer Sales Representative. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: not provided), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced swollen lymph nodes after getting the vaccine. It resolved and then came back. Event took place after use of product. Outcome of the event was resolved on an unspecified date.  Information on the lot/batch number has been requested.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Chills, Malaise, Pain, Pyrexia
Clinical narrative: Feeling sick; fever; chills; Body aches; back pain; This is a spontaneous report from a contactable other healthcare professional (patient). A 58-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EK9231), intramuscular (left arm), on 12Jan2021 15:00 at single dose, for covid-19 immunization. Medical history included had Covid prior vaccination, high blood pressure, high cholesterol, and myocarditis. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EJ1685), intramuscular (site: left arm), on 22Dec2020 15:00 for covid-19 immunization at 58-years-old. The patient experienced feeling sick, fever, chills, body aches and back pain - all on 13Jan2021 06:00AM. No treatment was received for these adverse events. The patient had no other vaccine in four weeks, and had not been Covid-tested post vaccination. The outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: lymphadenopathy; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown) via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced developed lymphadenopathy 1 day after dose 2 of the vaccine. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Peripheral swelling, Pyrexia
Clinical narrative: fever; chills; His arm also swelled so badly that it looked like he had an extra muscle; This is a spontaneous report received from a contactable other healthcare professional. A male patient of an unspecified age received the second dose of BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration, on an unspecified date, at single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced fever, chills and his arm also swelled so badly that it looked like he had an extra muscle on an unspecified date after use of the vaccine. The outcome of the events was unknown.   No follow up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Fever; chills; This is a spontaneous report from a non-contactable other health professional via a sale representative. A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on an unspecified date at a SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 for covid-19 immunization (first dose). The patient experienced fever and chills. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain, Pyrexia
Clinical narrative: Temp of 103 F; chills; body aches; This is a spontaneous report from a contactable nurse via a Pfizer Sales Representative. A patient (medical director) of unspecified age and gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number and expiry date unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient took the first dose of BNT162B2 (lot/ batch number and expiry date were unknown) on an unspecified date at a single dose for COVID-19 immunization and had no adverse effect. The patient had the second shot and spent Wednesday in bed with a temperature of 103F, chills, and body aches on an unspecified date. Outcome of the events was unknown.    Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: joint pain; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number and expiration date unknown, via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the covid-19 vaccine two weeks ago and had a side effect of joint pain. The patient asked if she can anticipate having the same reaction after the second dose. The outcome of the event was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Myalgia
Clinical narrative: she experienced severe muscle and joint pain; she experienced severe muscle and joint pain; severe chills; This is a spontaneous report from a contactable healthcare professional (patient) via a sales representative. A female patient of an unspecified age received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiry date unknown) via an unspecified route of administration on 12Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 for COVID-19 immunization with minor symptoms. The second shot was taken and patient experienced severe muscle and joint pain and severe chills on 12Jan2021. Events took place after use of product. After 24 hours of symptoms she took ibuprofen and symptoms lessened. The outcome of the events was recovering.  Information on the lot/batch number has been requested.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site movement impairment, Vaccination site pain
Clinical narrative: patient's left arm (injection site) got very sore and painful and it was difficult to lift; patient's left arm (injection site) got very sore and painful and it was difficult to lift; This is a spontaneous report from a non-contactable pharmacist (patient). A 57-year-old male received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3248), via intramuscular route of administration on 13Jan2021 at 19:00 at a single dose on the left arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. On 13Jan2021, after the vaccination, the patient's left arm (injection site) got very sore and painful and it was difficult to lift the next day (14Jan2021). The patient did not receive any treatment for the events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered from an unspecified date.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Illness, Influenza like illness
Clinical narrative: sick; It was like a bad flu; This is a spontaneous report from a Pfizer-sponsored program, COVID 19 from a contactable consumer. This consumer reported same events for 3 patients. This is 2nd of 3 reports.   A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Everyone that the reporter knew that has gotten the vaccine so far have all gotten sick for 24 to 48 hours. The patient was one of them. The way they described it was it was like a bad flu. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : same reporter, suspect drug and event; different patient; same reporter, suspect drug and event; different patient
Sex: U
Vaccine: COVID19
Symptoms: Illness, Influenza like illness
Clinical narrative: sick; It was like a bad flu; This is a spontaneous report from Pfizer-sponsored program, COVID 19  from a contactable consumer. This consumer reported same events for 3 patients. This is 3rd of 3 reports.   A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Everyone that the reporter knew that has gotten the vaccine so far has all gotten sick for 24 to 48 hours. The patient was one of them. The way they described it was it was like a bad flu. The outcome of the events was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) :  same reporter,event, suspect and diferent patient.;same reporter,event, suspect and diferent patient.
Sex: M
Vaccine: COVID19
Symptoms: Hypogeusia, SARS-CoV-2 test
Clinical narrative: loss of some taste; This is a spontaneous report from a contactable consumer received from the Pfizer Sponsored Program. A male patient of an unspecified age receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot and expiration date unknown), via an unspecified route of administration on 13Jan2021 at a single dose for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient was being tested weekly and he tested negative but at the same time, he was showing symptoms like loss of some taste but has no fever. Caller would like to know if ever he tested positive, if it's ok that he take typical medications. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness at the injection site; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (BNT162B2) via an unspecified route of administration on 14Jan2021 at a single dose for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient experienced soreness at the injection site on 14Jan2021, developed 6 hours after vaccination. The patient had not recovered from the event at the time of report.  Information on the lot/batch number has been requested.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Tachyphrenia
Clinical narrative: rapid heart rate and racing thoughts; rapid heart rate and racing thoughts; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received the first dose of BNT162B2 (Lot number: EL3246), via an unspecified route of administration on 14Jan2021 08:00 at single dose in the left arm for COVID-19 immunization. Medical history included peptic ulcers and acid reflux. Concomitant medication included sucralfate (CARAFATE) and esomeprazole sodium (NEXIUM). On 14Jan2021 09:00, the patient experienced rapid heart rate and racing thoughts. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of rapid heart rate and racing thoughts includes Benadryl. The outcome of the events was unknown.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: intermittent palpitations; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received the first dose of bnt162b2 (Covid vaccine, reported as Pfizer product) lot no: EL0142, via an unspecified route of administration in left arm on 12Jan2021 at a single dose for COVID-19 immunization. There were no relevant medical history and concomitant medications. The patient experienced intermittent palpitations on 12Jan2021. She has been having palpitations since she received the vaccine, did not start having them until about 8 hours after, stated she has had palpitations on and off since then. The patient had not recovered from the event.
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: UTI; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported by the patient that she currently has a UTI. She is ready for her second dose of the COVID Vaccine on 26Jan2021. The outcome of the event was unknown.  No follow-up attempts are possible, information about lot/batch cannot be obtained. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Injection site pain with 1st dose; This is a spontaneous report from a non-contactable other healthcare professional. A 28-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EL3248, intramuscular on 22Dec2020 07:00 at a single dose on left arm for COVID-19 immunization. There were no medical history or concomitant medications. The patient is not pregnant and had no known allergies. The patient had no prior vaccination and not tested post vaccination. The patient experienced injection site pain with 1st dose. There was no treatment received. The outcome of the event was recovering.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Fatigue; Headache; This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced fatigue and headache. It was reported that the patient did not have Covid prior to vaccination and it was unknown if patient was Covid tested post vaccination and unknown if there were other vaccine in 4 weeks. Outcome of events was recovered on an unspecified date.  No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Influenza like illness, Investigation, Myalgia
Clinical narrative: Chills; flu like symptoms; Nausea; Myalgia; Headache; Fever; This is a spontaneous report from a contactable consumer. A 26-year-old male patient received his second dose of bnt162b2 (BNT162B2 reported as Pfizer BioNtech COVID 19 Vaccine; lot number: EK9231; expiration date: unknown), via an unspecified route of administration left arm on 13Jan2021 20:00 at a single dose for covid-19 immunization. He received his first dose (age of vaccination was 26-year-old) of bnt162b2 (BNT162B2 reported as Pfizer BioNtech COVID 19 Vaccine; lot number: EH9899; expiration date: unknown), via an unspecified route of administration on 24Dec2020 at a single dose for covid-19 immunization. The patient medical history was not reported. The patient's family history included his father has hypertension and hyperlipidemia. There were no concomitant medications. The patient received the vaccine in a university hospital which set up a clinic. The patient reported that he thought he got his second dose last night at about 8 pm and since then in the morning around 8 am, so about 12 hours after he started having flu like symptoms that got pretty bad one point. He took some acetaminophen (TYLENOL) so it has gotten better but he was having myalgia, headache, fever, chills and nausea. The patient further mentioned that first, he started having chills around 8 am in the morning. He had chills before but now he kind of overheated and now he is not under a blanket anymore, so he thinks that is improved. He then started having nausea, then myalgia and then everything kind of got bad all at once. He mentioned that over all everything has improved except the headache. He further added that everything has not gone away complete but improved significantly. Earlier today (14Jan2021) like 2-3 hours ago he would say it was a 7 or 8 on a scale of 0-10 but right now it is about 4 on a scale of 0-10 and that goes for everything. He does not think anything else is confounding, he is not on any medications and has no chronic health problems, there has been no labs drawn. The patient did not visit an emergency room and physician office. The outcome of the outcome of the event headache was unknown while the outcome of the other events was recovering.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: Chills; flu like symptoms; Nausea; Myalgia; Headache; Fever; This is a spontaneous report from a contactable consumer. A 26-year-old male patient received his second dose of bnt162b2 (BNT162B2 reported as Pfizer BioNtech COVID 19 Vaccine; lot number: EK9231; expiration date: unknown), via an unspecified route of administration left arm on 13Jan2021 20:00 at a single dose for covid-19 immunization. He received his first dose (age of vaccination was 26-year-old) of bnt162b2 (BNT162B2 reported as Pfizer BioNtech COVID 19 Vaccine; lot number: EH9899; expiration date: unknown), via an unspecified route of administration on 24Dec2020 at a single dose for covid-19 immunization. The patient medical history was not reported. The patient's family history included his father has hypertension and hyperlipidemia. There were no concomitant medications. The patient received the vaccine in a university hospital which set up a clinic. The patient reported that he thought he got his second dose last night at about 8 pm and since then in the morning around 8 am, so about 12 hours after he started having flu like symptoms that got pretty bad one point. He took some acetaminophen (TYLENOL) so it has gotten better but he was having myalgia, headache, fever, chills and nausea. The patient further mentioned that first, he started having chills around 8 am in the morning. He had chills before but now he kind of overheated and now he is not under a blanket anymore, so he thinks that is improved. He then started having nausea, then myalgia and then everything kind of got bad all at once. He mentioned that over all everything has improved except the headache. He further added that everything has not gone away complete but improved significantly. Earlier today (14Jan2021) like 2-3 hours ago he would say it was a 7 or 8 on a scale of 0-10 but right now it is about 4 on a scale of 0-10 and that goes for everything. He does not think anything else is confounding, he is not on any medications and has no chronic health problems, there has been no labs drawn. The patient did not visit an emergency room and physician office. The outcome of the outcome of the event headache was unknown while the outcome of the other events was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue
Clinical narrative: mild diarrhea; fatigue; This is a spontaneous report from a non-contactable consumer.  A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 15Jan2021 as single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  The patient experienced mild diarrhea and fatigue on Jan2021. The outcome of mild diarrhea and fatigue was unknown.   The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Menstrual disorder
Clinical narrative: cramping period; menstrual cycle disorder; This is a spontaneous report from a contactable nurse. A 34-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899 and EK9231, expiration date: 31Mar2021 and 30Apr2021), intramuscular on arm right from 22Dec2020 12:00 to 22Dec2020 12:00 and via an unspecified route of administration on arm left from 12Jan2021 12:00 to 12Jan2021 12:00 both at SINGLE DOSE for covid-19 immunisation. Medical history included IUD Placement from May2019 and ongoing.  The patient's concomitant medications were not reported. The patient said that received the first vaccine on Tuesday 22Dec2020 and on Thursday 24Dec2020 she started having her menstrual cycle disorder period which last for 8 days. The caller said that she had a legit, cramping period that she has not had for a long time (occurred on an unspecified date). She said that it was like being a teenager. She received the 2nd dose on 12Jan2021 and she started her period again on 14Jan2021, this morning. She said that her periods have been 3 weeks apart. She said that she has the IUD because she has irregular periods. Outcome of the events was unknown
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Tongue discolouration, Tongue injury, Vaccination site pain
Clinical narrative: tongue on the side is bruised; it was a big black spot that she noticed this morning while brushing her tooth; right arm being sore started after 1.5 hours after the shot; This is a spontaneous report from a contactable consumer (patient). A 60-years-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot EL3247, expiry date not reported), via an unspecified route of administration on 13Jan2021 at a single dose in the right arm for covid-19 (immunization). There were no medical history and concomitant medications. Patient had got her Pfizer Covid vaccine on 13Jan2021 and thought she had a reaction and wanted to know if anyone had this reaction. On 14Jan2021, patient stated on right side where got shot on that her tongue on the side was bruised. She stated that her arm hurt last night. She stated this was her first dose. She later clarified that it was her right arm. Patient stated that it was a big black spot that she noticed this morning while brushing her tooth (14Jan2021). Her right arm being sore started after 1.5 hours after the shot (13Jan2021). No treatments received in response to the events reported. The events "tongue on the side was bruised" and "it was a big black spot that she noticed this morning while brushing her tooth" were not recovered. The outcome of the event "right arm being sore started after 1.5 hours after the shot" was recovered on 14Jan2021.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Injection site pain, Myalgia, Nausea
Clinical narrative: Some injection site soreness; Joint pain; Muscle aches; A little temporary nausea; This is a spontaneous report from a non-contactable consumer. A 61-years-old male patient started to receive received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number FL1284, via an unspecified route of administration on14Jan2021 09:00 at SINGLE DOSE for COVID-19 immunization. Vaccine location: Left arm Medical history included cardiovascular disorder, colitis ulcerative and depression. Concomitant medication included aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]), colecalciferol (D3), fluoxetine (FLUOXETINE), mesalamine (MESALAMINE), rosuvastatin calcium (ROSUVASTIN), ubidecarenone (COQ10 [UBIDECARENONE]). On 14Jan2021 19:00, patient experienced injection site soreness with outcome of recovered, joint pain with outcome of recovered, muscle aches with outcome of recovered and a little temporary nausea with outcome of recovered. The action taken was not applicable. No follow up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chapped lips, Headache, Muscle tightness, Myalgia, Pain
Clinical narrative: Headache; Chapped lips; Body is aching from her groin and going down, especially in both thigh areas; Fever; Tightness in jaw; Sore arm and muscles; Sore arm and muscles; This is a spontaneous report from a contactable consumer. A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302), via an unspecified route of administration on 12Jan2021 08:40 at a SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced tightness in jaw within one hour after vaccination and noticed on her way home, sore arm and muscles on 12Jan2021, fever last night (13Jan2021). Her body was aching from her groin and going down, especially in both thigh areas on 13Jan2021.  It woke her up. She didn't take anything for it. She laid there until she went back to sleep. It was gone now. The patient also experienced a headache on an unspecified date and chapped lips on 14Jan2021. The outcome of the events chapped lips and headache was unknown, tightness in jaw was not recovered, body is aching from her groin and going down, especially in both thigh areas were recovered while other events were recovering.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Headache; Chapped lips; Body is aching from her groin and going down, especially in both thigh areas; Fever; Tightness in jaw; Sore arm and muscles; Sore arm and muscles; This is a spontaneous report from a contactable consumer. A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302), via an unspecified route of administration on 12Jan2021 08:40 at a SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced tightness in jaw within one hour after vaccination and noticed on her way home, sore arm and muscles on 12Jan2021, fever last night (13Jan2021). Her body was aching from her groin and going down, especially in both thigh areas on 13Jan2021.  It woke her up. She didn't take anything for it. She laid there until she went back to sleep. It was gone now. The patient also experienced a headache on an unspecified date and chapped lips on 14Jan2021. The outcome of the events chapped lips and headache was unknown, tightness in jaw was not recovered, body is aching from her groin and going down, especially in both thigh areas were recovered while other events were recovering.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal dreams, Feeling abnormal, Headache, Lethargy, Nausea
Clinical narrative: Nausea; Vomiting; Neck pain; Headache; Mental 'fog'; Lethargic; Vivid dreams upon sleeping; This is a spontaneous report from a non-contactable other health professional reporting for herself. A 36-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: El3248), via an unspecified route of administration on 12Jan2021 09:30, on right arm at single dose for COVID-19 immunization. Facility type vaccine was in Hospital. Medical history was reported as none and patient had no known allergies. Concomitant medications were not reported. Historical vaccine included received her first dose of BNT162B2 (Lot number: EK5730) on 22Dec2020 09:15 on Left arm for COVID-19 immunization and had a headache. The patient experienced nausea, vomiting, neck pain, headache, mental 'fog', lethargic and vivid dreams upon sleeping all on 12Jan2021 15:00. No treatment was received for all events. The outcome of all events were resolved with sequel in Jan2021. Patient did not have Covid prior vaccination and Covid was not tested post vaccination.  No follow-up attempts are possible. No further information expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Vomiting
Clinical narrative: Nausea; Vomiting; Neck pain; Headache; Mental 'fog'; Lethargic; Vivid dreams upon sleeping; This is a spontaneous report from a non-contactable other health professional reporting for herself. A 36-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: El3248), via an unspecified route of administration on 12Jan2021 09:30, on right arm at single dose for COVID-19 immunization. Facility type vaccine was in Hospital. Medical history was reported as none and patient had no known allergies. Concomitant medications were not reported. Historical vaccine included received her first dose of BNT162B2 (Lot number: EK5730) on 22Dec2020 09:15 on Left arm for COVID-19 immunization and had a headache. The patient experienced nausea, vomiting, neck pain, headache, mental 'fog', lethargic and vivid dreams upon sleeping all on 12Jan2021 15:00. No treatment was received for all events. The outcome of all events were resolved with sequel in Jan2021. Patient did not have Covid prior vaccination and Covid was not tested post vaccination.  No follow-up attempts are possible. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Influenza like illness, Pain, Pain in extremity
Clinical narrative: I started getting chills; my whole body was sore; Felt like the Flu minus the respiratory stuff.; Had arm pain that night; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received his second dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 vaccine; lot number: EL1283; expiration date: unknown), via an unspecified route of administration on 11Jan2021 at a single dose for covid-19 immunization. The patient received his first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 vaccine; lot number: EL0140; expiration date: unknown), via an unspecified route of administration on 22Dec2020 at a single dose for covid-19 immunization.  The patient's medical history concomitant medications were not reported. The reporter stated that the second dose was much worse. The patient had arm pain that night (11Jan2021) then about 16 hours post shot (12Jan2021), the patient started getting chills and his whole body was sore. The patient felt like the flu minus the respiratory stuff. The patient got home from work, did zoom meetings in bed, then slept until this morning and still feel kinda like crap but he was starting to feel better. It was mentioned that it was not reported if the patient had covid prior vaccination, if covid tested post vaccination was done or if treatment was received. The outcome of the events was recovering.
Age: 95.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling of body temperature change, Hunger, Hyperhidrosis, Laziness
Clinical narrative: Getting hot and cold; Gets hot and sweaty; Does not feel like doing anything, feels lazy; Hungry and eating like crazy/has been more hungry and eating more; This is a spontaneous report from a contactable consumer (patient). A 95-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL3246, expiration date: 30Jan2021) via an unspecified route of administration on the right arm on 09Jan2021 at a single dose for COVID-19 immunization. Medical history included walks with a walker, both knees replaced a year ago on 11Mar2020 (prior to receiving the vaccine), she had the mucus in her throat and a little bit of a cough prior to getting the vaccine. She had allergies. She normally has the mucus and cough in the morning when she gets up. She is also blowing her nose a lot. There were no concomitant medications. The patient was starting to get hot and cold. She was unsure if she has a fever as she does not have anything to measure it with. She gets hot and sweaty. She feels good but is hungry and eating like crazy on 09Jan2021. She is talking and breathing fine. Getting hot and cold and hot and sweaty: Happened a few days after the vaccine. She was unsure what day, maybe the day before yesterday, or yesterday and today. Yesterday she took a shower and she also took some guaifenesin (MUCINEX). This made her feel better. For example, she had lunch a while ago and she did not feel like doing anything. She felt lazy. She usually swims at 6 AM Monday, Wednesday, and Friday, and she did not go. Her friend said this was not like her. She also did not want to shower yesterday. She kept putting it off and then she finally showered and felt terrific. Her body felt like her body. She has always been a good eater, but since the vaccine she has been more hungry and eating more. Right now, she is starting to get warm as she is talking. It will go away and come back a little while later. Outcome of the events 'getting hot and cold' and 'gets hot and sweaty' was recovering and not recovered for the other events.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue; This is a spontaneous report from a contactable consumer (patient's wife). An 88-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left upper arm on 12Jan2021 at single dose for COVID-19 immunization. Medical history included COVID from 22Nov2020 to an unknown date and coronary artery disease from an unknown date and unknown if ongoing. There were no concomitant medications. The patient experienced fatigue (fatigue) (non-serious) on an unspecified date with outcome of unknown. The patient's wife read that would test positive for 90 days after. She and her husband had their first vaccine on Tuesday, 12Jan2021. She read that was not a good thing to do, to get the vaccine after only 2 months instead of 3 months from diagnoses. The patient has experienced fatigue, slept all day yesterday. The patient had an appointment yesterday but canceled it, it was for blood work but he wasn't feeling up to it. The facility where the most recent COVID-19 vaccine was administered was in an independent living center. The vaccine was not administered at a Facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No emergency room or physician office visit done. The outcome of the event was unknown.  Information about lot/batch number has been requested.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain
Clinical narrative: Headache; fatigue; body aches; This is a spontaneous report from a non-contactable healthcare professional (patient herself). A 19-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration in the left arm on 13Jan2021 15:30 at single dose for COVID-19 immunisation. Medical history and concomitant medications were none. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient had no allergies to medications, food, or other products. On 14Jan2021 06:00, the patient experienced headache, fatigue, and body aches. No therapeutic measure was taken as a result of the events. Clinical outcome of events was recovering.  No follow-up attempts are possible, information about lot/batch cannot be obtained.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Pain in extremity
Clinical narrative: Arm soreness; fatigue; body aches; headache; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 32-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EL0142), intramuscular (left arm), on 12Jan2021 16:30, at single dose, for covid-19 immunization. Medical history included GERD, seasonal allergies (dust, mold), and degenerative disc disease (DDD). The patient had received unspecified concomitant medications in two weeks. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EH9899) intramuscular (left arm) on 21Dec2020 for covid-19 immunization. The patient experienced on 12Jan2021 16:45 arm soreness immediately after up to 48 hours later, significant fatigue, body aches at 20 hours through 36 hours, and headache 8 hours after. The patient had no Covid prior vaccination, had no other vaccine in four weeks and, had not been Covid-tested post vaccination. The patient received Tylenol and naproxen pan as treatment for the events. The patient recovered from the events on Jan2021.