chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Muscle pain; injection site pain; insomnia and could not sleep the whole night; had a little loss of balance; severe chills and the chills got worse; severe headache; This is a spontaneous report from a contactable physician (patient). A male patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EK9231), via an unspecified route of administration on 13Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received first dose of bnt162b2 (lot EL0140) on an unspecified date for COVID-19 immunization. Patient reported that he wants to give a follow up on the second vaccine. On 13Jan2021 21:00, the patient experienced severe chills and the chills got worse and he had a severe headache. On an unspecified date, the patient had muscle pain and injection site pain. He said that he had insomnia and could not sleep the whole night and he also had a little loss of balance. The patient does not know if he was running a fever or not. He said that he took Tylenol that night and rested the next day and took Tylenol the next day and he was fine now. Patient said that he did not work yesterday, but started working today and physically, he was feeling fine now. The symptoms were similar to the shingles vaccine, but the shingles vaccine symptoms were a little milder. Outcome of events was unknown.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: worst headache; This is a spontaneous report from a contactable consumer. A 43-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: EL3247), via an unspecified route of administration in the left arm on 15Jan2021 at a single dose for covid-19 immunisation. The patient has no medical history. Concomitant medication includes hydrochlorothiazide, lisinopril (LISINOPRIL HCTZ). On 15Jan2021, 1 hour after the shot, the patient experienced worst headache she ever had in her life. The patient took Tylenol which hasn't done anything for it. The outcome of the event was not recovered.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: Nausea; Headache; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3302, expiry date: unknown), via an unspecified route of administration in the left upper arm, on 12Jan2021 at a single dose for covid-19 immunization. Medical history was not reported. Concomitant medications included other medications but declined to provide those medications. The patient previously took azithromycin and amoxicillin, clavulanic acid (AUGMENTIN) and experienced allergies. The patient had no history of previous immunization and no additional vaccines administered on same date of the suspect drug. The patient had no prior vaccination within four weeks. On 13Jan2021, the patient experienced severe nausea and headache. The patient reported she just stayed at home and drinking ginger ale and crackers. The events did not require visit to emergency room or physician office. Therapeutic measures were taken as a result of the events nausea and headache. Outcome of the events nausea and headache was not recovered.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Diarrhoea, Eructation, Nausea, Vomiting
Clinical narrative: Diarrhea; Belching/burping; Significant abdominal pain; Nausea; Vomiting; This is a spontaneous report from a Pfizer-sponsored program received from a contactable consumer (reported for himself). A 27-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL0140; expiry date: not known), via an unspecified route of administration in the left arm on 08Jan2021 07:20 at single dose for COVID-19 immunization. There were no medical history and concomitant medications. No prior vaccinations within 4 weeks. The patient experienced significant abdominal pain, nausea and vomiting last night at 14Jan2021 20:00. Significant abdominal pain was the first symptom he had. Significant abdominal pain and nausea went away and came back in waves. He had not vomited since midnight. The patient experienced diarrhea which started 07:00 this morning (15Jan2021). Now (15Jan2021), he was burping, it was like weird belching. He wanted to know if these were normal side effects from the vaccine. He was looking at the list and saw nausea as a listed potential side effect, but he did not see diarrhea, vomiting. Therefore, he was calling to see if it is plausible these events were related to the COVID vaccine. The patient di not require emergency room or physician office visit. The outcome of the event vomiting was recovered on 15Jan2021; outcome of the events nausea, diarrhea, and significant abdominal pain was not recovered; and outcome of event belching/burping was unknown.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Pyrexia
Clinical narrative: Severe urgent diarrhea; Feels like she might be getting a little fever; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient  received the first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date unknown), via an unspecified route of administration to right deltoid (shoulder) on 15Jan2021 at around 10:30-10:40 AM at a single dose  for COVID-19 immunization.  Medical history included chronic fatigue syndrome, fibromyalgia, problems with her colon, back surgery, and flashes.  Concomitant medications included ibuprofen given on unspecified date for back surgery, and unspecified hormones, vitamins, and laxatives.  The patient previously received the flu vaccine on unspecified date and experienced like she got the flu and relapse of her chronic fatigue syndrome. She also received hepatitis C vaccine, hepatitis B vaccine, pneumonia vaccine, and shingles vaccine; all on unspecified dates. The patient had not received prior vaccinations within four weeks. On 15Jan2021, the patient experienced severe urgent diarrhea and felt like she might be getting a little fever. It was further described as: Patient had an odd reaction within maybe 30 minutes to 1 hour after that dose was administered of severe urgent diarrhea. Patient mentioned she felt like she might be getting a little fever; but she was not sure and did not have a thermometer to check that. Severe urgent diarrhea: She mentioned she had not seen that side effect posted anywhere for the vaccine so she felt it was an odd reaction; although she did see that it was a side effect of the virus, so maybe it was not that odd of a reaction for the vaccine now that she thought about it. She described this event as completely crazy, the urgency to go to the bathroom, she almost did not make it home to the bathroom. It just hit her like she has never experienced before. It cleaned out her colon really well. She also felt like she might be getting a little fever but mentioned that at her age she gets hormone flashes so it could be that; and was humid at the time of report and thought so it could just be from that. The outcome of the events was unknown.  Information regarding Batch/ Lot number has been requested.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2, Nasopharyngitis
Clinical narrative: Cold like symptoms; had close interaction or exposure with the positive COVID-19 coworker; This is a spontaneous report from a contactable consumer. A 33-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EL3302), via an unspecified route of administration on 12Jan2021 reported at about 18:30 at SINGLE DOSE at left arm for COVID-19 immunization. The patient's Medical history was reported as none.  The patient's concomitant medications were not reported. This Dental Hygienist is the patient who was administered her first dose of Pfizer COVID-19 Vaccine on 12Jan2021. She felt fine before being administered that dose. When she woke up 14Jan2021, she felt cold like symptoms. She just found out today: 15Jan2021 that her coworker who previously had a negative Rapid COVID-19 test result is actually positive for COVID-19 as of today: 15Jan2021. Caller reported the last time she herself had close interaction or exposure with the positive COVID-19 coworker was last night: 14Jan2021. Caller is in the line at this time to go get tested for COVID-19; but she wanted to ask if she should still get tested for COVID-19 or still get the second dose of the Pfizer COVID-19 Vaccine. She does not know when the second dose will be scheduled; she is still waiting on the email to tell her when she is supposed to go get the second dose. She does not know if she will or will not get the second dose related to these events yet. The outcome of the event Cold like symptoms was not recovered while unknown for the event exposure.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Headache, Myalgia, Vaccination site pain
Clinical narrative: her body felt uncomfortable; had pain at injection site for a little bit; muscle soreness/muscle soreness in left arm at injection area after receiving the second dose; headache; This is a spontaneous report from a Pfizer-sponsored program. A contactable nurse (patient) reported that a 54-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3302, expiration date: May2021), intramuscular on 12Jan2021 09:00 at 0.3 mL, single on left arm for COVID-19 immunization. The patient medical history was not reported.  There were no concomitant medications. The patient received her first dose of BNT162B2 on 22Dec2020 around 08:15am to 08:30 am, intramuscular injection in left arm. The dose she received was 0.1ml (lot number: EH9899). The patient received flu shot on Nov (no year reported). The patient experienced headache on 12Jan2021 and muscle soreness on 13Jan2021 in left arm at injection area after receiving the second dose. Her headache was not very strong. It was mild headache since she took Tylenol. She clarified it recovered completely as of yesterday (14Jan2021). When querying seriousness, she states it was a normal side effect so she did not think it is serious. She reported her body felt uncomfortable, and she cannot explain what it was happening, she did not have shortness of breath or diarrhea or anything. States it was like she got flu vaccine and had pain at injection site for a little bit. She received the flu vaccine in Nov (no year reported) and she does not know the name of the flu vaccine. The patient recovered from headache and muscle soreness/muscle soreness in left arm at injection area after receiving the second dose on 14Jan2021. Outcome of the rest of the events was unknown.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Headache, Nausea
Clinical narrative: Headache; Nausea/feels like he wants to throw up; his stomach hurts; This is a spontaneous report from a contactable consumer (patient's wife). An 84-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231), intramuscularly on 10Jan2021 10:00 at a single dose for covid-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. The patient was previously administered with flu shot  (INFLUENZA VACCINE) for immunization and he got sick. The patient experienced headache, nausea; further reported as he feels like he wants to throw up and his stomach hurts; all on an unspecified date. Outcome of the event "headache" recovered on an unspecified date, event "nausea" was not recovered while the event "his stomach hurts" was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: Massive headache and arm pain at injection site; Massive headache and arm pain at injection site; This is a spontaneous report from a contactable physician (wife of the patient).  This Physician reported similar events for two patients. This is the first of two reports.   A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection), via an unspecified route of administration on unspecified date at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported.  After receiving COVID-19 Vaccine, it was reported that the husband had a massive headache and pain at the injection site. The outcome of the events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021047955 same reporter, drug, different patient and similar event
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Blood count, Coagulation time, Fatigue, Investigation, Metabolic function test
Clinical narrative: Petechia; felt fatigued; This is a spontaneous report from a contactable physician. A 52-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), intramuscular on deltoid left from 05Jan2021 to 05Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical history included ongoing blood cholesterol increased/high cholesterol and allergy to sulfa drugs. Concomitant medication included ongoing rosuvastatin calcium (CRESTOR) for blood cholesterol increased. The reporter stated that about 5 days later she noticed petechiae on her hands (10Jan2021). The patient also felt fatigue on Jan2021. She went to see her primary care doctor. She had lab work, blood count, clotting factors, and CMP done and states her labs were ok and the other test had unknown results on an unspecified date. The patient's weight ranges from 140-145 lbs. The petechiae has slowly faded. Outcome of the event petechia was recovering while outcome of the event fatigue was unknown.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Petechiae, Weight
Clinical narrative: Petechia; felt fatigued; This is a spontaneous report from a contactable physician. A 52-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), intramuscular on deltoid left from 05Jan2021 to 05Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical history included ongoing blood cholesterol increased/high cholesterol and allergy to sulfa drugs. Concomitant medication included ongoing rosuvastatin calcium (CRESTOR) for blood cholesterol increased. The reporter stated that about 5 days later she noticed petechiae on her hands (10Jan2021). The patient also felt fatigue on Jan2021. She went to see her primary care doctor. She had lab work, blood count, clotting factors, and CMP done and states her labs were ok and the other test had unknown results on an unspecified date. The patient's weight ranges from 140-145 lbs. The petechiae has slowly faded. Outcome of the event petechia was recovering while outcome of the event fatigue was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: her arm was a little sore; This is a spontaneous report from a contactable consumer reporting for herself. A 25-year-old female patient received bnt162b2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration, on 10Jan2021, at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient reported that she and her husband both took the Covid-19 vaccine on the 10Jan2021. She stated that she did not really have any problems after the receiving the vaccine, but her arm was a little sore on an unspecified date. Outcome of the event was unknown.  Information regarding lot/batch number has been requested.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Nasal congestion, Pyrexia
Clinical narrative: fever of 100 to 101; Congestion; This is a spontaneous report from a contactable consumer (patient's wife). This consumer reported similar events for two patients. This is the 2nd of the two reports.   A 79-years-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283, expiration date: unknown), via an unspecified route of administration on 09Jan2021 at a single dose for COVID-19 Immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of the COVID-19 vaccine on 09Jan2021 and started having fever and congestion on 14Jan2021. The patient began to have a fever of 100 to 101 and congestion yesterday, 14Jan2021. The reporter stated she is giving her husband Coricidin and Vit C with Zinc and is taking her husband to see a healthcare professional (HCP). The outcome of the events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021046098 Same reporter/drug/event; different patient.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Headache, Vaccination site pain
Clinical narrative: pain on injection site; slight little headache; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a patient of unspecified age and gender received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine), via an unspecified route of administration on 16Jan2021 at single dose for COVID-19 immunization. Medical history included covid, diagnosed from Aug2020 (mild symptoms). The patient's concomitant medications were not reported. The patient experienced pain on the injection site, and a slight little headache. The outcome of events was unknown.  Information on the lot/batch number has been requested.
Age: 38.0
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: Fatigue; Body aches; This is a spontaneous report from a non-contactable other health professional (HCP). A 38-year-old patient of an unspecified gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot and expiry not reported), via an unspecified route of administration on 13Jan2021 at 14:30 on left arm at a single dose for COVID-19 immunization. Medical history included known allergies to penicillin from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162B2 on 24Dec2020 at 12:30 PM on left arm. Concomitant medication included cetirizine hydrochloride (ZYRTEC). The patient experienced fatigue and body aches on 13Jan2021 at 21:00. The patient did not receive treatment for the events. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Influenza like illness, Pain in extremity
Clinical narrative: Sore arm near injection site; Headache; flu like symptoms; This is a spontaneous report from a contactable other healthcare professional (patient). A 22-year-old female patient (not pregnant), received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date unknown (unable to locate or read the details)), intramuscular (left arm) on 13Jan2021 16:30, at single dose, for covid-19 immunization. Medical history included asthma and, had Covid prior vaccination. Concomitant medication in two weeks included cetirizine hydrochloride (ZYRTEC). The patient experienced sore arm near injection site for one day, headache, and flu like symptoms for one day - all on 14Jan2021 12:00 PM. The patient recovered from the events on 15Jan2021. No treatment was received for these adverse events. The patient had no other vaccination in four weeks and had not been Covid-tested post vaccination.   Information about the lot/batch number has been requested.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes virus infection
Clinical narrative: Reactivating of herpes virus; This is a spontaneous report from a contactable Pharmacist. This Pharmacist reported for similar events for two patients. This is the second of two reports.   A 45-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3249), via an unspecified route of administration on left arm on 13Jan2021 05:30 at a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Facility type vaccine was in nursing home/senior living facility. No other vaccine in four weeks. No COVID prior vaccination. The patient had no known allergies. The patient medical history was not reported. Concomitant medications (medications in two weeks) included calcium and colecalciferol (VIT D3). The patient experienced reactivating of herpes virus on 15Jan2021 05:30. No treatment was administered for the event. The patient was not COVID tested post vaccination. The outcome of the event was recovering.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021032647 same report/drug/event, different patient
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Slight nausea; This is a spontaneous report from a non-contactable other HCP. A 37-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on arm left from 24Dec2020 12:30 to 24Dec2020 12:30 at SINGLE DOSE for covid-19 immunisation. Medical history included known allergies: Penicillin. Concomitant medication included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]). On 25Dec2020, the patient experienced slight nausea. The patient did not received any treatment for the event. The patient was not pregnant at the time of the report. Outcome of the event was recovered on 25Dec2020.   No follow-up attempts are possible. Information on lot number, batch number cannot be obtained.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: flu like symptoms; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration in right arm on 28Dec2020 at single dose for COVID-19 immunization. Medical history was reported as none. There were no concomitant medications. On the first round of the vaccine the patient experienced flu like symptoms on an unspecified date. The outcome of the event was unknown. The facility where the most recent COVID-19 vaccine was administered was in the hospital.
Sex: M
Vaccine: COVID19
Symptoms: Contusion, Pain in extremity
Clinical narrative: sore arm; feels like a deep bruise that doesn't seem to go away; sore arm; feels like a deep bruise that doesn't seem to go away; This is a spontaneous report from a contactable nurse. A 47-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Dec2020 at a single dose COVID-19 immunization.  The patient medical history was not reported.  The patient's concomitant medications were not reported.  The patient experienced a sore arm. The patient stated that his arm right after the injection wasn't sore at all. He's had flu shots and stuff and the next day, his arm was pretty sore but it seemed to go away. However, if one pushes on his arm or punches on his arm, he can probably feel it. It's not aggravating or anything, it's just sore. He wanted to know if this was unusual to have this condition, a sore arm, this long after receiving the first vaccination. He was to receive his second vaccine on Monday, unknown date. His arm was not super sore but was still sore. It felt like a deep bruise, that doesn't seem to go away. The outcome of the events was not recovered.  Information on the Batch/Lot number has been requested.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Hot flush, Pain
Clinical narrative: Chills; Fever; Hot flashes; Body aches; Fatigue; This is a spontaneous report from a contactable nurse (patient). A 26-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1283, expiration: 30Apr2021), via injection in left upper arm on 13Jan2021 at 15:00 at a single dose for vaccination.  Medical history and concomitant medication reported as none. No family medical history. The patient received her first dose of COVID-19 vaccine via injection to left upper arm on 23Dec2020 at around 1:00pm-2:00pm (Lot: EK5730, Expiry: 31Mar2021, NDC: 59267-1000-2). The patient received her second dose of COVID-19 vaccine on 13Jan2021 in a public health department. She called to report the side effects she experienced since about 06:30 AM on 14Jan2021 which includes chills, fever, hot flashes, body aches, and having a lot of fatigue. She was sent home from work on 14Jan2021 related to the reported adverse events. Chills continued through most of the night from 14Jan2021 to 15Jan2021. On 14Jan2021, she had fever of 102 degrees Fahrenheit that was ongoing throughout most of days.  The patient is now feeling fine, all events have improved.  She used ice packs for the adverse events and had taken Tylenol 2 rounds of 500mg strength products for total of about 2000mg throughout 14Jan2021 to 15Jan2021. The patient confirmed that there were no concomitant products or other medical conditions to report and has no existing medical condition.  She verified that she has had no testing/investigations/lab work/imaging/diagnostic work done relative to the report.  No additional vaccines administered on same date of the vaccine. The patient did not require emergency room/physician's office visit. The patient has no prior vaccinations within 4 weeks. The patient did not have adverse event prior vaccinations. No relevant test done. The patient was recovering from the events. The events chills, fever, hot flashes, body aches, fatigue were assessed as related by primary source reporter.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Chills; Fever; Hot flashes; Body aches; Fatigue; This is a spontaneous report from a contactable nurse (patient). A 26-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1283, expiration: 30Apr2021), via injection in left upper arm on 13Jan2021 at 15:00 at a single dose for vaccination.  Medical history and concomitant medication reported as none. No family medical history. The patient received her first dose of COVID-19 vaccine via injection to left upper arm on 23Dec2020 at around 1:00pm-2:00pm (Lot: EK5730, Expiry: 31Mar2021, NDC: 59267-1000-2). The patient received her second dose of COVID-19 vaccine on 13Jan2021 in a public health department. She called to report the side effects she experienced since about 06:30 AM on 14Jan2021 which includes chills, fever, hot flashes, body aches, and having a lot of fatigue. She was sent home from work on 14Jan2021 related to the reported adverse events. Chills continued through most of the night from 14Jan2021 to 15Jan2021. On 14Jan2021, she had fever of 102 degrees Fahrenheit that was ongoing throughout most of days.  The patient is now feeling fine, all events have improved.  She used ice packs for the adverse events and had taken Tylenol 2 rounds of 500mg strength products for total of about 2000mg throughout 14Jan2021 to 15Jan2021. The patient confirmed that there were no concomitant products or other medical conditions to report and has no existing medical condition.  She verified that she has had no testing/investigations/lab work/imaging/diagnostic work done relative to the report.  No additional vaccines administered on same date of the vaccine. The patient did not require emergency room/physician's office visit. The patient has no prior vaccinations within 4 weeks. The patient did not have adverse event prior vaccinations. No relevant test done. The patient was recovering from the events. The events chills, fever, hot flashes, body aches, fatigue were assessed as related by primary source reporter.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: tiredness; headache; muscle aches; nausea; dizziness; This is a spontaneous report from a contactable consumer (patient).  A 68-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL1283), via an unspecified route of administration on 11Jan2021 at 11:00 AM at a single dose on the left arm for COVID-19 immunization.  Medical history included Barret's esophagus and glaucoma both from an unknown date and unknown if ongoing. Concomitant medication included dorzolamide;timolol maleate (manufacturer unknown) and pantoprazole (manufacturer unknown).  The patient did not have COVID-19 prior to vaccination. The patient did not have other vaccines in four weeks. The patient previously took codeine and experienced allergies. The patient experienced tiredness, headache, muscle aches, nausea and dizziness all on 12Jan2021 at 03:30 PM. The patient did not receive any treatment for the events. The outcome of the events was recovered.   No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Pyrexia, Rash
Clinical narrative: Fever; joint pain left side; Rash on legs; headache; This is a spontaneous report from a contactable other healthcare professional (hcp; patient for herself). A 53-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot EL3247, expiry date not reported), via an unspecified route of administration in the left arm on 13Jan2021 10:00 at a single dose for COVID-19 immunization. Medical history included hypothyroidism, HTN (hypertension), migraines, and blepharitis. The patient had no known allergies. The patient was not pregnant at the time of the vaccination. The patient had no COVID prior to vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID), metoprolol tartrate, lisinopril, colecalciferol (VIT D3), fish oil, and "mul" as reported. The first dose of BNT162B2 (brand Pfizer, lot EL1284) for COVID-19 immunization was administered on 22Dec2020 at 05:30 pm in the left arm. The patient had no other vaccines in four weeks. On 13Jan2021 08:45 pm, the patient experienced fever, joint pain left side, rash on legs and headache. No treatments received in response to the events reported. The patient was not tested for COVID post vaccination. The events fever, joint pain left side, rash on legs and headache were recovered on an unknown date in Jan2021.
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Myalgia
Clinical narrative: Muscle aches; back pain; This is a spontaneous report from a non-contactable consumer. An adult male patient received first and second dose of  bnt162b2 BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 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 muscle aches and back pain on an unspecified date. The outcome of the events was recovered on an unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Lymphadenopathy, Myalgia, Vaccination site pain
Clinical narrative: weird taste (bitter) in her mouth; Lymphadenopathy; significant myalgias; injection site soreness; This is a spontaneous report from a contactable physician (patient). A 41-year-old female patient received the second dose of BNT162B2 via an unspecified route of administration on 11Jan2021 at a single dose as Covid vaccine. Medical history and concomitant medications were not reported. The patient previously had her first dose of BNT162B2 on an unspecified date as Covid vaccine. The patient experienced significant myalgias and injection site soreness, both on 11Jan2021; weird taste (bitter) in her mouth and lymphadenopathy, both on 13Jan2021. The patient received her second Covid vaccine on Monday and was having a weird taste in her mouth (weird taste as bitterness). She has significant myalgia that resolved and injection site pain (injection site pain as soreness) that was resolving. She looked it up and could not find anything. She wanted to know if this was something that they were getting a lot of. The outcome of the event significant myalgias was recovered with sequelae on 13Jan2021 while of the rest of events was recovering.  Information on the lot/batch number has been requested.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Mild arm tenderness; This is a spontaneous report from a contactable pharmacist reported that a 49-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscular on the left arm on 17Dec2020 09:00 at a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced mild arm tenderness on an unspecified date with outcome of recovered. No treatment received for the reported event.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Decreased appetite, Diarrhoea, Fatigue
Clinical narrative: nausea; malaise; flu-like symptoms; mild fever; chills; body aches; gastritis; diarrhea; Fatigue; loss of appetite; This is a spontaneous report from a contactable pharmacist. A 49-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EL0142), intramuscular on 06Jan2021 09:00 at single dose at left arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 on 17Dec2020 via intramuscular at left arm with lot number: EK5730 for COVID-19 immunization and experienced mild arm tenderness. Second dose administered 21 days after 1st dose resulted in adverse effects (AE) approximately 40-43 Hours after 2nd dose was administered. On 08Jan2021 08:00, AEs involved nausea, malaise, flu-like symptoms, mild fever, chills, body aches, gastritis and diarrhea. AEs lasted approximately 4-5 hours. Fatigue lingered for approx. 12 hours. Patient felt normal upon awakening next morning with no additional or lingering AEs to report since experiencing AEs from 2nd dose of BioNTech vaccine. acetaminophen was taken during first experience with AEs. Acetaminophen did alleviate severity of symptoms slightly. Patient had loss of appetite due to AEs experienced. Patient was able to consume water without complications. No mental effects only tiredness from symptoms were experienced. The patient received treatment for the events. The outcome of the events was recovered in Jan2021.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Gastritis, Influenza like illness, Malaise, Nausea, Pain
Clinical narrative: nausea; malaise; flu-like symptoms; mild fever; chills; body aches; gastritis; diarrhea; Fatigue; loss of appetite; This is a spontaneous report from a contactable pharmacist. A 49-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EL0142), intramuscular on 06Jan2021 09:00 at single dose at left arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 on 17Dec2020 via intramuscular at left arm with lot number: EK5730 for COVID-19 immunization and experienced mild arm tenderness. Second dose administered 21 days after 1st dose resulted in adverse effects (AE) approximately 40-43 Hours after 2nd dose was administered. On 08Jan2021 08:00, AEs involved nausea, malaise, flu-like symptoms, mild fever, chills, body aches, gastritis and diarrhea. AEs lasted approximately 4-5 hours. Fatigue lingered for approx. 12 hours. Patient felt normal upon awakening next morning with no additional or lingering AEs to report since experiencing AEs from 2nd dose of BioNTech vaccine. acetaminophen was taken during first experience with AEs. Acetaminophen did alleviate severity of symptoms slightly. Patient had loss of appetite due to AEs experienced. Patient was able to consume water without complications. No mental effects only tiredness from symptoms were experienced. The patient received treatment for the events. The outcome of the events was recovered in Jan2021.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: nausea; malaise; flu-like symptoms; mild fever; chills; body aches; gastritis; diarrhea; Fatigue; loss of appetite; This is a spontaneous report from a contactable pharmacist. A 49-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EL0142), intramuscular on 06Jan2021 09:00 at single dose at left arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 on 17Dec2020 via intramuscular at left arm with lot number: EK5730 for COVID-19 immunization and experienced mild arm tenderness. Second dose administered 21 days after 1st dose resulted in adverse effects (AE) approximately 40-43 Hours after 2nd dose was administered. On 08Jan2021 08:00, AEs involved nausea, malaise, flu-like symptoms, mild fever, chills, body aches, gastritis and diarrhea. AEs lasted approximately 4-5 hours. Fatigue lingered for approx. 12 hours. Patient felt normal upon awakening next morning with no additional or lingering AEs to report since experiencing AEs from 2nd dose of BioNTech vaccine. acetaminophen was taken during first experience with AEs. Acetaminophen did alleviate severity of symptoms slightly. Patient had loss of appetite due to AEs experienced. Patient was able to consume water without complications. No mental effects only tiredness from symptoms were experienced. The patient received treatment for the events. The outcome of the events was recovered in Jan2021.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, SARS-CoV-2 test
Clinical narrative: Right axillary tender/painful lymphadenopathy (same arm as injection); This is a spontaneous report from a non-contactable physician.  A 31-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: ek4176, expiry date not reported), intramuscular on 11Jan2021 at a single dose in the left arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had no COVID prior to vaccination. The first dose of BNT162B2 (lot number eh9899) for COVID-19 immunization was administered on 21Dec2020 intramuscularly on the left arm (age 31 years old). On 12Jan2021, patient experienced right axillary tender/painful lymphadenopathy (same arm as injection) 24-72 hrs after vaccination. No treatments received in response to the events reported. Covid test post vaccination included nasal swab (BD) on 15Jan2021 with negative result. The outcome of the event "right axillary tender/painful lymphadenopathy (same arm as injection)" was recovered in Jan2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Crown of head is tender; arm hurting; This is a spontaneous report from a contactable consumer (patient). A 75-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 12Jan2021 04:00 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got the vaccine on 12Jan2021 Tuesday afternoon, other than his arm hurting on 13Jan2021 Wednesday morning, which was gone now (15Jan2021), he had no headache or any other symptoms. Then, he woke up today (15Jan2021), and the crown of his head was tender and he wanted to know if there was a correlation to the vaccine. He was not ill or anything and it may be just a coincidence. The outcome of the event arm hurting was recovered on 15Jan2021 and unknown for the other event.  Information about Lot/Batch number is requested.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pain in extremity, SARS-CoV-2 antibody test, SARS-CoV-2 test
Clinical narrative: The first round of the vaccine she only had a super mild sore arm and a slight headache.; The first round of the vaccine she only had a super mild sore arm and a slight headache.; sore; This is a spontaneous report from a contactable nurse. A 38-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EL1284, expiry date: 30Apr2021), intramuscularly on 28Dec2020 at SINGLE DOSE at left deltoid for covid-19 immunisation. Medical history included ongoing pernicious anaemia, a b12 deficiency. She gives herself B12 shots. She was diagnosed 2-3 years ago. She also had a Myomectomy, 15 cm uterine fibroid , removed this past summer. Concomitant medication included ongoing cyanocobalamin (B12 [CYANOCOBALAMIN]) for pernicious anemia. The first round of the vaccine she only had a super mild sore arm and a slight headache. She was a little suspicious because of the headache after the first one. She hasn't been around anyone in a couple of weeks. She has been working from home. She has not been exposed to people. She keeps feeling like she needs to stretch because she is sore. The patient underwent lab tests and procedures which included COVID 19 test on an unspecified date: negative, COVID-19 antibody test on an Unspecified date, Result: negative. The outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: massive headache; arm pain; This is a spontaneous report from a contactable physician (patient). This physician reported similar events for two patients. This is the second of two reports.   A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 13Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced massive headache and arm pain on an unspecified date. The outcome of the events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021046400 same reporter and drug, different patient, and similar events
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Gait disturbance, Migraine, Muscle tightness, Musculoskeletal stiffness
Clinical narrative: Had to walk bent over; Hands felt tingly; Migraine; Vomiting; Dizziness; Muscles in her back became stiff; stiffness progressed to her whole body; Muscles in her back became tight; Muscles are still very sore; This is a spontaneous report from a contactable consumer (patient who is a medical assistant). A 25-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EK9231), via an unspecified route of administration in left arm, on 13Jan2021 at 08:30, at a single dose, for COVID-19 immunization. The patient's medical history included anxiety. The patient's concomitant medication included escitalopram oxalate (LEXAPRO) from 2018 and ongoing (for two-and-a-half years) for anxiety. The patient previously took the first dose of BNT162B2 (Lot Number: EK5730) on 22Dec2020 at 09:00 AM (in the right arm) for COVID-19 immunization. The patient was calling to report side effects. After the second dose on 13Jan2021, the patient noticed around 18:00 that the muscles in her back became stiff and tight. It got worse overnight and, in the morning (14Jan2021), she had to walk bent over. This stiffness progressed to her whole body. That morning she also noticed her hands felt tingly (like when they fall asleep) and she had a migraine with vomiting and dizziness. All of these effects started to resolve but now her muscles are still very sore (Jan2021). The migraine went away this morning as did the vomiting and dizziness. The patient recovered from "Hands felt tingly", "Migraine", "Vomiting", and "Dizziness" on 15Jan2021. The patient had not recovered from "Muscles are still very sore". The outcome of "Had to walk bent over" was unknown. The patient was recovering from the remaining events.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Paraesthesia, Vomiting
Clinical narrative: Had to walk bent over; Hands felt tingly; Migraine; Vomiting; Dizziness; Muscles in her back became stiff; stiffness progressed to her whole body; Muscles in her back became tight; Muscles are still very sore; This is a spontaneous report from a contactable consumer (patient who is a medical assistant). A 25-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EK9231), via an unspecified route of administration in left arm, on 13Jan2021 at 08:30, at a single dose, for COVID-19 immunization. The patient's medical history included anxiety. The patient's concomitant medication included escitalopram oxalate (LEXAPRO) from 2018 and ongoing (for two-and-a-half years) for anxiety. The patient previously took the first dose of BNT162B2 (Lot Number: EK5730) on 22Dec2020 at 09:00 AM (in the right arm) for COVID-19 immunization. The patient was calling to report side effects. After the second dose on 13Jan2021, the patient noticed around 18:00 that the muscles in her back became stiff and tight. It got worse overnight and, in the morning (14Jan2021), she had to walk bent over. This stiffness progressed to her whole body. That morning she also noticed her hands felt tingly (like when they fall asleep) and she had a migraine with vomiting and dizziness. All of these effects started to resolve but now her muscles are still very sore (Jan2021). The migraine went away this morning as did the vomiting and dizziness. The patient recovered from "Hands felt tingly", "Migraine", "Vomiting", and "Dizziness" on 15Jan2021. The patient had not recovered from "Muscles are still very sore". The outcome of "Had to walk bent over" was unknown. The patient was recovering from the remaining events.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Blood iron, Blood iron decreased, Body temperature, Body temperature decreased, Chills
Clinical narrative: ears have been burning; she checked her temperature and it is lower than normal, her temperature is usually 96 and she just checked it and it was 91 degrees Fahrenheit; feels like her ears are hot; low iron; it feels like someone is pouring ice on her back/ she finds herself so cold; chills; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EK9231, expiration date not reported) intramuscular on 30Dec2020 at, single for COVID. The patient had no medical history. There were no concomitant medications. The patient said that calling she was having a side effect that is not on the list of side effect. She does not know if it was from the chills but her ears have been burning ever since had the shot. She feels like her ears were hot. Can the vaccine cause this to happen? She clarified she was not having chills, it doesn't feel like chills, she said on the second day after the vaccine she had chills but right now it felt like someone was pouring ice on her back and she checked her temperature and it is lower than normal, her temperature is usually 96 and she just checked it and it was 91 degrees Fahrenheit. Her ears have been burning. Her first dose was given 30Dec2020. That was another reason she was calling should she get the second dose if she was feeling this way. She said her ears began burning sometime last week and it has not stopped. Sometimes it will go away and come back but she find herself so cold she has to get under the covers and it takes forever to warm up. Today she put a hat and a scarf around her ears to warm up in doors. She has low iron. She doesn't know with her having low iron all her life and she has never experienced this before. Outcome of the event ears have been burning was not recovered while unknown for the other events.