chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Nausea, Neck pain
Clinical narrative: fatigue; headache; Neckache; Slight nausea; shoulder sorenes; This is a spontaneous report from a contactable consumer reported for herself that. A 40-year-old non-pregnant female received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was 5318) via unspecified route of administration on 17Feb2021 at 8:30 (age at the time of vaccination was 40-year-old) in right arm, as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient had no known allergies. Previously the patient received first dose of bnt162b2 (COMITNATY, Solution for injection, Batch/Lot number was 5318) via intramuscular route in left arm on 27Jan2021 (age at the time of vaccination was 40-year-old) as single dose for COVID-19 immunization. The patient did not have COVID prior to vaccination and was not tested for COVID post vaccination. The patient did not have any other vaccine in 4 weeks and no other medication in 2 weeks. Starting within about 5 hours of the 2nd vaccine. On 17Feb2021 at 13:30, the patient experienced fatigue, Headache, Neckache, Slight nausea and shoulder soreness. The patient did not receive any treatment for the adverse events. Outcome of all the events was recovered in 2021.  Follow-up (07Jul2021): Follow-up attempts completed. No further information expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: teeth chattering chills, fever, severe headache, muscle aches; teeth chattering chills, fever, severe headache, muscle aches; teeth chattering chills, fever, severe headache, muscle aches; teeth chattering chills, fever, severe headache, muscle aches; This is a spontaneous report from a contactable consumer or other non hcp. A 65-years-old non-pregnant female patient received second dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EN6203) via an unspecified route of administration, administered in Arm Left on 23Feb2021 10:30(age at vaccination: 65 years) as DOSE 2, SINGLE for covid-19 immunisation. Patient was not pregnant at the time of vaccination, patient didn't receive other vaccines within 4weeks prior to vaccination. Patient had received other medications Zyrtec, Vitamin D3 within 2weeks of vaccination. Patient didn't had covid prior to vaccination. The patient medical history was not reported. Concomitant medications included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for an unspecified indication, start and stop date were not reported; vitamin d3 (VITAMIN D3) taken for an unspecified indication, start and stop date were not reported. Patient had no allergies. Patient previously received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: unknown) via unspecified route of administration in Arm left on 03Feb2021 10:30 (age at vaccination:65 years) as DOSE 1, SINGLE for covid-19 immunisation. On 23Feb2021 23:00 the patient experienced teeth chattering chills, fever, severe headache, muscle aches. No therapeutic measures were taken for the events. Patient was not tested for covid to post vaccination. The outcome of the events chills, pyrexia, headache, myalgia was recovered.  No follow-up attempts are possible. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Nausea, Pain
Clinical narrative: Nausea; aches; joint pain; chills; This is a spontaneous report from a contactable consumer (patient herself). a 25-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EL3247, expiry date: unknown) via unspecified route of administration in left arm, on17Feb2021 (age at vaccination: 25-years) as dose 2, single for covid-19 immunisation. Patient was not pregnant at the time of vaccination. Historical vaccine included first dose (lot number: EL3247) via unspecified route of administration, in left arm on 27Jan2021 01:00 PM, as dose 1, single for Covid-19 immunisation. Past drug event included known allergies of amoxicillin. Patients medical history and concomitant medications were not reported. No other vaccine in four weeks was administered. In two weeks patient was administered birth control medications. On 18Feb2021, patient experienced nausea, aches, joint pain, chills. No treatment was given as a result of the adverse events. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The outcome of event was recovering.   Follow-up attempts completed. No further information expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Decreased appetite, Fatigue, Headache
Clinical narrative: Lymph node swelling; Fever; Chills; Muscle pain; joint pain; Loss appetite; Fatigue; Headche; Sensetivity to light and sound; Sensetivity to light and sound; This is a spontaneous report from a Non-contactable consumer or other non-HCP (patient). A 42-year-old Adult non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on an unspecified date (Lot number was not reported) (at the age of 42-year-old) as DOSE 1, SINGLE and dose 2 via an unspecified route of administration administered in Arm left on an unspecified date (Lot number was not reported) (at the age of 42-year-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient had no other medical history. The patient had no known allergies. The patient had no covid prior vaccination. The patient concomitant medications were not reported. No other vaccine in four weeks. The patient had not been covid tested post vaccination. On 08Feb2021, the patient experienced Fever, chills, muscle and joint pain, loss of appetite, fatigue, headache, sensitivity to light and sound and lymph node swelling. No treatment was received to treat the events. The patient outcome of the events was Resolved on an unspecified date in 2021.  No follow-up attempts are possible. Information about lot/batch number could not be requested. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperacusis, Lymphadenopathy, Myalgia, Photophobia, Pyrexia
Clinical narrative: Lymph node swelling; Fever; Chills; Muscle pain; joint pain; Loss appetite; Fatigue; Headche; Sensetivity to light and sound; Sensetivity to light and sound; This is a spontaneous report from a Non-contactable consumer or other non-HCP (patient). A 42-year-old Adult non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on an unspecified date (Lot number was not reported) (at the age of 42-year-old) as DOSE 1, SINGLE and dose 2 via an unspecified route of administration administered in Arm left on an unspecified date (Lot number was not reported) (at the age of 42-year-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient had no other medical history. The patient had no known allergies. The patient had no covid prior vaccination. The patient concomitant medications were not reported. No other vaccine in four weeks. The patient had not been covid tested post vaccination. On 08Feb2021, the patient experienced Fever, chills, muscle and joint pain, loss of appetite, fatigue, headache, sensitivity to light and sound and lymph node swelling. No treatment was received to treat the events. The patient outcome of the events was Resolved on an unspecified date in 2021.  No follow-up attempts are possible. Information about lot/batch number could not be requested. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Pyrexia
Clinical narrative: Fatigue; chills; headache; fever 100.5 F; This is a spontaneous report from a non-contactable consumer. A 54-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot Number: EL3247), dose 2 via an unspecified route of administration, administered in left arm on 17Feb2021 at 01:00 (at the age of 54-years-old) as DOSE 2, SINGLE for COVID-19 immunization. The patient medical and concomitant medication history were reported. Historical vaccine included: first dose of COVID-19 (Lot Number: Unknown) as dose 1, single. No other vaccine in four weeks. No COVID prior vaccination. On 18Feb2021 at 04:00 AM, the patient experienced fatigue, chills, headache and fever 100.5 F. The patient underwent lab tests and procedures which included body temperature: 100.5. No COVID tested post vaccination. No treatment received. The outcome of the events were recovering.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Chills, Nasopharyngitis, Pain
Clinical narrative: lost sense of taste and sense; cold; fever; chills; aches and pain during the night; lose of smell; This is a spontaneous report from a contactable consumer (patient herself). A 30-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiration date was not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that, the patient had got 1st dose on Sunday, after couple of hours on an unspecified date patient had lost sense of taste and sense. Also had a cold, fever and chills. Then aches and pain during the night. Everything was gone except still no sense and no taste. Patient enquired was lose of smell/taste side effect from the vaccine or not. The outcome of event lost sense of taste and sense, lose of smell was not recovered while it was resolved for all other events on an unspecified date.  Information about Lot/batch number has been requested.  Follow-up (13May2021): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: lost sense of taste and sense; cold; fever; chills; aches and pain during the night; lose of smell; This is a spontaneous report from a contactable consumer (patient herself). A 30-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiration date was not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that, the patient had got 1st dose on Sunday, after couple of hours on an unspecified date patient had lost sense of taste and sense. Also had a cold, fever and chills. Then aches and pain during the night. Everything was gone except still no sense and no taste. Patient enquired was lose of smell/taste side effect from the vaccine or not. The outcome of event lost sense of taste and sense, lose of smell was not recovered while it was resolved for all other events on an unspecified date.  Information about Lot/batch number has been requested.  Follow-up (13May2021): Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Insomnia, Pain, Snapping hip syndrome
Clinical narrative: pain; soreness; can't sleep at night; the bones don't want to move, it keeps snapping and popping; This is a spontaneous report from a contactable consumer (patient). A 72-years-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on 27Jan2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 29Jan2021, the patient experienced pain and soreness about 2 days afterward and that the pain was ongoing, seems like the bones don't want to move, keeps snapping in a popping and he could not sleep at night so sore. The patient did receive his second dose in his opposite arm on 17Feb2021 and doesn't report any problems with it. His doctor told him that the pain should go away on its own. The outcome of the events was pain was not resolved and other events was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Rash all over body; very itchy; This is a spontaneous report from a non-contactable consumer (patient herself). A 73-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 24Feb2021 (age at vaccination: 73 years) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included hydrochlorothiazide 25mg; rosuvastatin 0.5mg. The patient was allergic to Keflex, Bactrim and Codine. The patient did not have any other vaccine in four weeks. On 24Feb2021 20:15 , the patient experienced rash all over body and was very itchy. The patient received Claritin and Benadryl as treatment for the adverse events. The patient did not have covid prior to vaccination nor was tested positive since vaccination. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Transaminases increased
Clinical narrative: transaminitis; This is a spontaneous report from a contactable consumer reporting for a patient. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The Reporter stated that they received a patient with transaminitis three days after receiving the vaccine on an unspecified date. The reporter asked, are there more reports about this? The patient underwent lab tests and procedures which included transaminitis (transaminases increased): increased on an unspecified date. The outcome of event was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Influenza like illness, Pain, Pyrexia
Clinical narrative: Major flu-like symptoms arising; Chills; fever of 102F; full body ache; This is a spontaneous report from a contactable consumer or other non hcp (patient himself). A 26-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 24Feb2021 08:45 (at the age of 26 years old) (Batch/Lot Number: EN6200) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient has no known allergies. Previously the patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 03Feb2021 08:45 AM (at the age of 26 years old) (Lot Number: EN6200) as single dose for COVID-19 immunisation. On 24Feb2021 07:00 AM, the patient experienced Major flu-like symptoms arising 10 hours after the injection and lasting for 12 hours. Chills, fever of 102F, full body aches. No other vaccines were received in fourweeks. The patient was not diagnosed with COVID-19 prior to the vaccination and has not been tested for COVID-19 since the vaccination. The patient underwent lab tests and procedures which included body temperature: 102 fahrenheit on. The outcome of the events was recovering.  Follow-up attempts completed. No further information expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Swollen right entire armpit  following day; This is a spontaneous report from a non-contactable consumer or other non hcp (patient). A 66-year-old non-pregnant female patient received second dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: UNKNOWN), via an unspecified route of administration in arm right on 17Feb2021 at 09:00 (at the age of 66-years-old) as dose 2, single for COVID-19 immunisation. The medical history and concomitant medications of the patient were not reported. No known allergies were reported. The patient previously received first dose of BNT162B2 (solution for injection), via an unspecified route of administration in arm right on an unspecified date as single dose for COVID-19 immunisation. 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. Prior to vaccination, the patient was not diagnosed with covid-19. Since the vaccination, the patient not been tested with covid-19. On 18Feb2021, the patient experienced swollen right entire armpit following day. Therapeutic measures were not taken as a result of event. The outcome of the event was reported as not resolved.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Hordeolum, Myalgia
Clinical narrative: I woke to a stye inside my left lower eye-lid; fever up to 102; fatigue; muscle aches; chills; This is a spontaneous report from a contactable consumer (patient). A 41-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EL3247, patient was 41-year-old at the time of vaccination), via an unspecified route of administration, administered in Arm Left on 23Feb2021 at 10:30 AM as DOSE 2, SINGLE, for covid-19 immunisation. Medical history included crohn's disease. Concomitant medication(s) included mesalamine (MESALAMINE); vedolizumab (ENTYVIO) taken for an unspecified indication from an unspecified start date to 15Feb2021 (last infusion), both were taken in two weeks of vaccination. No other vaccine received in four weeks, no covid prior vaccination, no tested covid post vaccination. No known allergies. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EL3247), via an unspecified route of administration, administered in Arm Left on 02Feb2021 at 10:30 AM as DOSE 1, SINGLE, for covid-19 immunisation. On 23Feb2021 at 11:00 PM, the patient experienced chills, fever up to 102, fatigue, muscle aches, on 25Feb2021 at 11:00 PM, the patient experienced i woke to a stye inside my left lower eye-lid. The patient underwent lab tests and procedures which included body temperature resulted as 102 on an unspecified date in Feb2021. The patient received treatment for event (fever up to 102) with Tylenol and no treatment were received for other events. It was reported that no adverse reactions with 1st vaccine. Approx. 12 hours after 2nd dose experienced some of the typical adverse events. I am at times prone to styes but considered this an event worth reporting. As all other adverse events have cleared with the exception of the stye, I am continuing to monitor it and would seek medical attention if it doesn't clear as expected. The outcomes of event (I woke to a stye inside my left lower eye-lid) was not recovered and outcomes of events (chills, fever up to 102, fatigue, muscle aches) were recovering.  Follow-up (13May2021): Follow-up attempts completed. No further information expected.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: I woke to a stye inside my left lower eye-lid; fever up to 102; fatigue; muscle aches; chills; This is a spontaneous report from a contactable consumer (patient). A 41-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EL3247, patient was 41-year-old at the time of vaccination), via an unspecified route of administration, administered in Arm Left on 23Feb2021 at 10:30 AM as DOSE 2, SINGLE, for covid-19 immunisation. Medical history included crohn's disease. Concomitant medication(s) included mesalamine (MESALAMINE); vedolizumab (ENTYVIO) taken for an unspecified indication from an unspecified start date to 15Feb2021 (last infusion), both were taken in two weeks of vaccination. No other vaccine received in four weeks, no covid prior vaccination, no tested covid post vaccination. No known allergies. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EL3247), via an unspecified route of administration, administered in Arm Left on 02Feb2021 at 10:30 AM as DOSE 1, SINGLE, for covid-19 immunisation. On 23Feb2021 at 11:00 PM, the patient experienced chills, fever up to 102, fatigue, muscle aches, on 25Feb2021 at 11:00 PM, the patient experienced i woke to a stye inside my left lower eye-lid. The patient underwent lab tests and procedures which included body temperature resulted as 102 on an unspecified date in Feb2021. The patient received treatment for event (fever up to 102) with Tylenol and no treatment were received for other events. It was reported that no adverse reactions with 1st vaccine. Approx. 12 hours after 2nd dose experienced some of the typical adverse events. I am at times prone to styes but considered this an event worth reporting. As all other adverse events have cleared with the exception of the stye, I am continuing to monitor it and would seek medical attention if it doesn't clear as expected. The outcomes of event (I woke to a stye inside my left lower eye-lid) was not recovered and outcomes of events (chills, fever up to 102, fatigue, muscle aches) were recovering.  Follow-up (13May2021): Follow-up attempts completed. No further information expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Inappropriate schedule of product administration, Pyrexia
Clinical narrative: mild headache in the evening; a bit tired; temperature of 99.5-100.4; second dose on 22Feb2021; This is a spontaneous report from a contactable consumer (patient). A 64-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6200) via an unspecified route of administration, administered in Arm Left on 22Feb2021 10:00 (at the age of 64 years old) as dose 2, single for COVID-19 immunisation at hospital. Medical history included allergy to penicillin. There were no concomitant medications. Patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN9581) via an unspecified route of administration, administered in Arm Left on 04Jan2021 10:00 (at the age of 64 years old) as single for COVID-19 immunisation. Patient did not have COVID prior to vaccination. The patient experienced as, second dose on 22Feb2021, mild headache in the evening, a bit tired, temperature of 99.5-100.4 on 23Feb2021. Reported as, day of vaccine 2 - mild headache in the evening. A bit tired. Temperature of 99.5-100.4 on day 2,3,4. No treatment were given for the adverse events. Patient did not tested for COVID post vaccination. The patient underwent lab tests and procedures which included body temperature: 99.5-100.4 on 23Feb2021. Outcome of events mild headache in the evening, a bit tired, temperature of 99.5-100.4 were not recovered.  No follow up attempts are needed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, SARS-CoV-2 test
Clinical narrative: shortness of breath; This is a spontaneous report from a contactable consumer (patient). A 41-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6201 and Expiry date was not reported), via an unspecified route of administration administered in Arm Left on 20Feb2021 (at the age of 41-years-old) as dose 2, single for COVID-19 immunization. Medical history included, gastroschisis as infant from an unknown date and unknown if ongoing. Concomitant medication(s) included ibuprofen (IBUPROFEN); curcumin (CURCUMIN); colecalciferol (VITAMIN D [COLECALCIFEROL]); magnesium (MAGNESIUM) and daily vitamin all taken for an unspecified indication, start and stop date were not reported.Patient previously received bnt162b2 PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: 9265 and Expiry date was not reported), via an unspecified route of administration administered in Arm Left on 03Jan2021 at 18:00 as dose 1, single for COVID-19 immunization. The patient previously took lortab [loratadine] and experienced drug hypersensitivity (Known allergies). Patient did not receive any other vaccine in four weeks. The patient was not diagnosed with COVID-19 prior to vaccination. Post vaccination the patient tested negative for COVID 19. It was reported that on 22Feb2021 21:30, starting on day two patient had shortness of breath. The shortness of breath would last anywhere from 20 to 30 minutes or be fleeting. It was currently day five and still experiencing symptoms. Patient did not received any treatment for the adverse event. The patient underwent lab tests and procedures which included sars-cov-2 test with a nasal swab was negative on 22Feb2021. The outcome of shortness of breath was not recovered.  No follow up attempts are possible. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: my chest became splotchy and I began itching from head to toe like I had spiders running all over my body.; This is a spontaneous report from a contactable consumer. A 26-years-old female patient received bnt162b2 (Formulation: Solution for injection; Batch/Lot Number: EN 6198), via an unspecified route of administration, administered in Arm Left on 25Feb2021 12:00 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included Severely allergic to dust mites and Allergy-induced asthma from an unknown date and unknown if ongoing. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not received any other medications within 2 weeks of vaccination. On 25Feb2021 12:30 PM patient experienced 30 minutes after the shot, my chest became splotchy, and I began itching from head to toe like I had spiders running all over my body. The patient was not received treatment medication. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the event was recovering.   No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Diarrhoea, Fatigue, Feeling abnormal
Clinical narrative: diarrhea; low grade fever (99.5); chills; Fatigue; brain fog; vomiting; This is a spontaneous report from a contactable other hcp (health care professional, patient reported for self). A 58-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration, administered in arm left on 30Jan2021 (batch/lot number was not reported) as dose 1, single for covid-19 immunization (at the age of 58-years-old). Medical history included hypothyroid from an unknown date and unknown if ongoing. Concomitant medication(s) included levothyroxine sodium (SYNTHROID), vitamins/minerals and herbal remedies all were taken for an unspecified indication, start and stop date were not reported. Patient did not receive any other vaccine in four weeks. The patient had known allergy of Clindamycin. Patient did not have covid prior vaccination. facility type vaccine was reported as other. It was reported that nine days after the vaccination on 08Feb2021 at 17:00 pm the patient experienced vomiting (multiple episodes) then diarrhea, low grade fever (99.5), chills, brain fog. Diarrhea and brain fog lasted 3 days. It was further stated as fever was 2 days, vomiting was just first evening, fatigue first 2 days following vaccine, then felt okay until 8th day. The patient underwent lab tests and procedures which included body temperature which showed low grade fever (99.5) on 08Feb2021, nasal swab PCR test and nasal swab rapid test which result was negative on 09Feb2021. The patient tested for covid post vaccination. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. The patient was recovered from all the events on an unknown date in Feb2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Vomiting
Clinical narrative: diarrhea; low grade fever (99.5); chills; Fatigue; brain fog; vomiting; This is a spontaneous report from a contactable other hcp (health care professional, patient reported for self). A 58-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration, administered in arm left on 30Jan2021 (batch/lot number was not reported) as dose 1, single for covid-19 immunization (at the age of 58-years-old). Medical history included hypothyroid from an unknown date and unknown if ongoing. Concomitant medication(s) included levothyroxine sodium (SYNTHROID), vitamins/minerals and herbal remedies all were taken for an unspecified indication, start and stop date were not reported. Patient did not receive any other vaccine in four weeks. The patient had known allergy of Clindamycin. Patient did not have covid prior vaccination. facility type vaccine was reported as other. It was reported that nine days after the vaccination on 08Feb2021 at 17:00 pm the patient experienced vomiting (multiple episodes) then diarrhea, low grade fever (99.5), chills, brain fog. Diarrhea and brain fog lasted 3 days. It was further stated as fever was 2 days, vomiting was just first evening, fatigue first 2 days following vaccine, then felt okay until 8th day. The patient underwent lab tests and procedures which included body temperature which showed low grade fever (99.5) on 08Feb2021, nasal swab PCR test and nasal swab rapid test which result was negative on 09Feb2021. The patient tested for covid post vaccination. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. The patient was recovered from all the events on an unknown date in Feb2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Chills, Dizziness, Oral herpes, Rash
Clinical narrative: lost taste of coffee - rash on left side of neck - cold sore on left side of lip - chills - Dizzy - Left shoulder blade area on back very sore; Rash on left side of neck; Chills; lost taste of coffee; cold sore on left side of lip; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A 65-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9261 nd Expiry date: Unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 13Feb2021 15:30 at the age of 65-years-old as DOSE 1, SINGLE for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. The patient received other medications of vaccination. The patient was not diagnosed with Covid 19 and has not been tested for Covid-19 Since the vaccination. Medical history included dust allergy , seasonal allergy from an unknown date and unknown if ongoing. On 14Feb2021 07:00 the patient experienced lost taste of coffee - rash on left side of neck - cold sore on left side of lip - chills - dizzy - left shoulder blade area on back very sore , rash on left side of neck, chills, lost taste of coffee, cold sore on left side of lip. The outcome of event was not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia
Clinical narrative: Caller wanted to know if the muscle pain and joint pain side effects will affect her; Caller wanted to know if the muscle pain and joint pain side effects will affect her; This is a spontaneous report from a non-contactable consumer via Pfizer sponsored program COVAX US Support. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Solution for injection Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. Medical history included bone problems she had a reaction to the medication she took for her bones, acid reflux, cirrhosis, all from an unknown date and unknown if ongoing. Concomitant medications were not reported. On an unspecified date, the caller wanted to know if the muscle pain and joint pain side effects will affect her and if the side effects to the second dose are worse than the first dose. Caller had a concern about getting the Pfizer COVID 19 vaccine because she had underlying conditions stating bone problems, acid reflux and cirrhosis. Caller wanted to know when the second dose is given, how people with a liver problem were affected by the vaccine and if the Pfizer COVID 19 vaccine is FDA approved and what is an EUA and if the amount of time the vaccine stays in the body has an effect on how long we have immunity. The clinical outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash, Sensitive skin
Clinical narrative: skin rashes; itchiness; my skin has become very sensitive and remains very red; my skin has become very sensitive and remains very red; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 44-years-old male patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 administered in Arm Left on 30Jan2021 10:45 (Batch/Lot number and Expiry date was not reported) and dose 2 via an unspecified route of administration, administered in Arm Left on 20Feb2021 10:15 (Batch/Lot Number: EN6200) (at the age of 44-years-old) as DOSE 2, SINGLE for covid-19 immunization. Medical history included none. There were no known allergies reported. The patient concomitant medications were not reported. The patient did not have covid prior vaccination and has not been tested for covid post vaccination. On 01Feb2021, the patient experienced skin rashes and itchiness. Since the first dose of the vaccine, the patient had skin rashes and itchiness throughout the body. Also, he reported that my skin has become very sensitive and remains very red for a few minutes when I scratch it, even if lightly. Even just drying off with a towel after a shower makes my skin very red. Side effects continued after the second dose. There was no treatment received. The clinical outcome of the events was not recovered.  Follow-up attempts completed. No further information expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Myalgia, Pyrexia
Clinical narrative: the patient felt sick 15 hours after the vaccine shot; muscle pain; some fever; This is a spontaneous report from a non-contactable consumer or other non healthcare professional. A 53 year old adult female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER, UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient felt sick 15 hours after the vaccine shot, muscle pain leading to myalgia and fever on an unspecified date with outcome of recovered.  No follow-up attempts are possible. Information about lot/batch cannot be obtained.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Fine pruritic rash over neck, check and upper back.; This is a spontaneous report from a contactable consumer or other non hcp.  A 19-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection), via an unspecified route of administration, administered in left arm on 13Feb2021 16:30 (age at vaccination 19-year-old, Batch/Lot Number: EL9267) as single dose for COVID-19 immunisation. Medical history reported as none. Patient was not pregnant. The patient's concomitant medications were not reported. The patient experienced fine pruritic rash over neck, check and upper back on 15Feb2021 20:00. Therapeutic measures were taken as result of fine pruritic rash over neck, check and upper back. Patient received treatment as Benadryl PO and topical. No other vaccine in four weeks and no other medications in two weeks. Patient has no known drug allergies. No COVID prior vaccination and no COVID tested post vaccination. The outcome of event was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dyspnoea, Headache, Impaired work ability
Clinical narrative: nausea; severe headache; chills; joint pain; shortness of breath; inability to do anything; This is a spontaneous report from a contactable consumer (patient). A 65-years-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19, Solution for injection, Batch/Lot Number: EN6203), via an unspecified route of administration, administered in left arm on 24Feb2021 at 14:45 (at the age of 65-years-old) as DOSE 2, SINGLE for COVID-19 immunisation. The medical history included haemolytic anaemia, G6PD deficiency. The patient has known allergies to sulphur (No sulphur drugs time). The patient's concomitant medications were not reported. The patient had received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19, Solution for injection, Batch/Lot Number: EL3247), via an unspecified route of administration, administered in right arm on 03Feb2021 (at the age of 65-years-old) as DOSE 1, SINGLE for COVID-19 immunisation. The patient reported immediately following the injection, I felt fine. No problems noticed. The next morning on 25Feb2021 at 06:00, the patient experienced nausea, a severe headache, chills, joint pain, shortness of breath, and the inability to do anything. The patient had no Covid prior to vaccination and not COVID tested post vaccination. The patient received treatment of medication for nausea and Tylenol for pain. Seriousness reported as non-serious. The outcome of the events was recovering.   Follow-up attempts completed. No further information expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: nausea; severe headache; chills; joint pain; shortness of breath; inability to do anything; This is a spontaneous report from a contactable consumer (patient). A 65-years-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19, Solution for injection, Batch/Lot Number: EN6203), via an unspecified route of administration, administered in left arm on 24Feb2021 at 14:45 (at the age of 65-years-old) as DOSE 2, SINGLE for COVID-19 immunisation. The medical history included haemolytic anaemia, G6PD deficiency. The patient has known allergies to sulphur (No sulphur drugs time). The patient's concomitant medications were not reported. The patient had received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19, Solution for injection, Batch/Lot Number: EL3247), via an unspecified route of administration, administered in right arm on 03Feb2021 (at the age of 65-years-old) as DOSE 1, SINGLE for COVID-19 immunisation. The patient reported immediately following the injection, I felt fine. No problems noticed. The next morning on 25Feb2021 at 06:00, the patient experienced nausea, a severe headache, chills, joint pain, shortness of breath, and the inability to do anything. The patient had no Covid prior to vaccination and not COVID tested post vaccination. The patient received treatment of medication for nausea and Tylenol for pain. Seriousness reported as non-serious. The outcome of the events was recovering.   Follow-up attempts completed. No further information expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling abnormal, Injection site swelling, Vaccination site pain
Clinical narrative: Swelling at injection site; redness; painful at injection site; warm to the touch; This is a spontaneous report received from a contactable consumer or other non hcp. A 45-years-old female patient received 1st dose of bnt162b2 (COMIRNATY,Batch/Lot Number: EN6198), via an unspecified route of administration, administered in Arm Left on 19Feb2021 12:15  as Dose 1,single for covid-19 immunization.Medical history included anxiety,depression, restless legs syndrome and covid-19 from an unknown date and unknown if ongoing. Concomitant medication(s) included ropinirole, ondansetron (ZOFRAN),prochlorperazine edisylate (COMPAZINE)taken for an unspecified indication, start and stop date were not reported.The patient previously took gantrisine and experienced drug hypersensitivity.The patient experienced swelling at injection site,redness, painful at injection site and warm to the touch on 20Feb2021 06:30.The outcome of the events was not recovered.The patient was diagnosed with covid prior vaccination and not tested for covid19 post vaccination.The patient had not received any other vaccine within 4 weeks.
Age: 81.0
Sex: U
Vaccine: COVID19
Symptoms: Epistaxis, Fatigue, Pyrexia, Rhinorrhoea, Sinus congestion
Clinical narrative: fatigue; fevers; runny nose; sinus congestion; bloody nose; This is a spontaneous report from a contactable Other HCP. This Other HCP reported for a patient that: An 81-year-old patient of an unspecified gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 18Feb2021 (at the age of 81-year-old) as single dose for covid-19 immunisation. Medical history included Has mild elevated Blood pressure from an unknown date and unknown if ongoing but does not take meds for it. Patient takes no medications. Patient received second dose of Pfizer BioNTech Covid 19 Vaccine on 18Feb2021 and began experiencing fatigue, fevers, runny nose, sinus congestion and had a bloody nose morning of 19Feb2021. All symptoms except bloody nose remain today (20Feb2021), but patient stated it was a little better today. Event took place after use of product. The outcome of the event bloody nose was reported as recovered on an unspecified date in Feb2021 and rest all other events were recovering.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Rash, SARS-CoV-2 test
Clinical narrative: both hands covered in a rash; fatigue; pain at injection site; chills; headache; This is a spontaneous report from a contactable consumer. A 46-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN9581), dose 1 via an unspecified route of administration, administered in Arm Left on 29Jan2021 at 18:45 (at the age of 46 year) as dose 1, single for COVID-19 immunisation. Medical history included none. Patient had known allergies to Reglan. No Covid prior vaccination. Patient had covid tested post vaccination. Concomitant medication(s) included melatonin (MELATONIN). The patient previously took Reglan [metoclopramide hydrochloride] and experienced drug hypersensitivity. On 30Jan2021 at 13:30, first day patient experienced with pain at injection site, by afternoon had chills and then headache started and on 31Jan2021 second day had chills, fatigue, and headache and on 01Feb2021 third day had fatigue and woke up with top of both hands covered in a rash. Worse on left hand, which was arm that patient got the shot in. Because patient hands broke out into a rash and no new body products were introduced and it was occurring during the chills, fatigue and headache of the shot, patient was told to report the reaction to help others. Patient just got second shot last night 19Feb2021 and was also told that if any reactions occur to report the symptoms. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 29Jan2021, sars-cov-2 test: negative on 12Feb2021. AE did not result in physician office and emergency room. Therapeutic measures were taken as a result of all AE which included treatment hydrocortisone for rash, aleve/ Zolmitriptan. The outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: both hands covered in a rash; fatigue; pain at injection site; chills; headache; This is a spontaneous report from a contactable consumer. A 46-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN9581), dose 1 via an unspecified route of administration, administered in Arm Left on 29Jan2021 at 18:45 (at the age of 46 year) as dose 1, single for COVID-19 immunisation. Medical history included none. Patient had known allergies to Reglan. No Covid prior vaccination. Patient had covid tested post vaccination. Concomitant medication(s) included melatonin (MELATONIN). The patient previously took Reglan [metoclopramide hydrochloride] and experienced drug hypersensitivity. On 30Jan2021 at 13:30, first day patient experienced with pain at injection site, by afternoon had chills and then headache started and on 31Jan2021 second day had chills, fatigue, and headache and on 01Feb2021 third day had fatigue and woke up with top of both hands covered in a rash. Worse on left hand, which was arm that patient got the shot in. Because patient hands broke out into a rash and no new body products were introduced and it was occurring during the chills, fatigue and headache of the shot, patient was told to report the reaction to help others. Patient just got second shot last night 19Feb2021 and was also told that if any reactions occur to report the symptoms. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 29Jan2021, sars-cov-2 test: negative on 12Feb2021. AE did not result in physician office and emergency room. Therapeutic measures were taken as a result of all AE which included treatment hydrocortisone for rash, aleve/ Zolmitriptan. The outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.