chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Paraesthesia oral
Clinical narrative: Fatigue; Tingling in face, neck and hands; Tingling in face, neck and hands; Dryness in lips and hands; Dryness in lips and hands; Temperature 99.8; This is a spontaneous report from a contactable consumer or other non-HCP (patient herself). A 44-years-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN6199) via an unspecified route of administration in left arm on 12Mar2021 10:30 as dose 1, single (at the age of 44 years-old) for COVID-19 immunization. Patient was not a pregnant at the time of vaccination. The patient was allergic to Cipro, Sulfa, Flagyl, Percocet. There were no concomitant medications. The vaccination facility type is reported as Pharmacy or Drug Store. Patient did not receive any other vaccine in four weeks and any other medications in two weeks. Patient did not have COVID-19, prior to vaccination and was not tested for COVID-19, post vaccination. The patient underwent lab tests and procedures which included body temperature: 99.8 on 12Mar2021. The patient experienced fatigue, tingling in face, neck and hands, dryness in lips and hands, temperature: 99.8 on 12Mar2021 17:00. No treatment received for the adverse events. The outcome of the adverse events was unknown.   No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Body temperature increased, Dry skin, Fatigue, Lip dry
Clinical narrative: Fatigue; Tingling in face, neck and hands; Tingling in face, neck and hands; Dryness in lips and hands; Dryness in lips and hands; Temperature 99.8; This is a spontaneous report from a contactable consumer or other non-HCP (patient herself). A 44-years-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN6199) via an unspecified route of administration in left arm on 12Mar2021 10:30 as dose 1, single (at the age of 44 years-old) for COVID-19 immunization. Patient was not a pregnant at the time of vaccination. The patient was allergic to Cipro, Sulfa, Flagyl, Percocet. There were no concomitant medications. The vaccination facility type is reported as Pharmacy or Drug Store. Patient did not receive any other vaccine in four weeks and any other medications in two weeks. Patient did not have COVID-19, prior to vaccination and was not tested for COVID-19, post vaccination. The patient underwent lab tests and procedures which included body temperature: 99.8 on 12Mar2021. The patient experienced fatigue, tingling in face, neck and hands, dryness in lips and hands, temperature: 99.8 on 12Mar2021 17:00. No treatment received for the adverse events. The outcome of the adverse events was unknown.   No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia
Clinical narrative: Fatigue; Tingling in face, neck and hands; Tingling in face, neck and hands; Dryness in lips and hands; Dryness in lips and hands; Temperature 99.8; This is a spontaneous report from a contactable consumer or other non-HCP (patient herself). A 44-years-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN6199) via an unspecified route of administration in left arm on 12Mar2021 10:30 as dose 1, single (at the age of 44 years-old) for COVID-19 immunization. Patient was not a pregnant at the time of vaccination. The patient was allergic to Cipro, Sulfa, Flagyl, Percocet. There were no concomitant medications. The vaccination facility type is reported as Pharmacy or Drug Store. Patient did not receive any other vaccine in four weeks and any other medications in two weeks. Patient did not have COVID-19, prior to vaccination and was not tested for COVID-19, post vaccination. The patient underwent lab tests and procedures which included body temperature: 99.8 on 12Mar2021. The patient experienced fatigue, tingling in face, neck and hands, dryness in lips and hands, temperature: 99.8 on 12Mar2021 17:00. No treatment received for the adverse events. The outcome of the adverse events was unknown.   No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Pain in extremity, Rash
Clinical narrative: bright red rash on face; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported), via an unspecified route of administration, administered in arm left on 06Mar2021 08:00 (at the age of 59-years-old) as dose 1, single for covid-19 immunisation. The vaccine was administered at the hospital. The patient was not pregnant at the time of vaccination. The patient had no known medical history. There were no concomitant medications. On 12Mar2021 at 08:00 AM, the patient experienced bright red rash on face. The patient underwent lab tests and procedures which included sars-cov-2 test: unknown result on 11Mar2021. No treatment was received for the reported event. The outcome of the event was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash erythematous, SARS-CoV-2 test
Clinical narrative: bright red rash on face; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported), via an unspecified route of administration, administered in arm left on 06Mar2021 08:00 (at the age of 59-years-old) as dose 1, single for covid-19 immunisation. The vaccine was administered at the hospital. The patient was not pregnant at the time of vaccination. The patient had no known medical history. There were no concomitant medications. On 12Mar2021 at 08:00 AM, the patient experienced bright red rash on face. The patient underwent lab tests and procedures which included sars-cov-2 test: unknown result on 11Mar2021. No treatment was received for the reported event. The outcome of the event was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Lip erythema, Lip swelling
Clinical narrative: Lip Swelling; Nausea; Jittery; Lip Burning; This is a spontaneous report from a contactable other HCP reported for herself. A 41-year-old non-pregnant female patient received first dose of bnt162b2 (Pfizer covid-19 vaccine, Solution for injection, Lot unknown reason: misplaced/discarded), via an intramuscular route in the left arm on 12Mar2021 at 09:30 (age at vaccination: 41-year-old), as a single dose for covid-19 immunization. Medical history included emphysema, PVC, fibromyalgia and known allergy to gluten. Concomitant medications included omeprazole (PROTONIX), ondansetron (ZOFRAN), diazepam (VALIUM), zinc, ascorbic acid (VITAMIN C) and multivitamin. Past drug event included last Juvederm Ultra XC filler injections in lips was beginning of November (Nov2020). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. On 13Mar2021 at 17:30, patient experienced minor side effects: jittery and nausea. Today, her lips started swelling slowly and burning. She called doctor immediately and directed to take Benadryl and see him in the morning. Adverse events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures taken as a result of the events included Benadryl. The clinical outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lip swelling, Nausea, Nervousness, Oral discomfort
Clinical narrative: Lip Swelling; Nausea; Jittery; Lip Burning; This is a spontaneous report from a contactable other HCP reported for herself. A 41-year-old non-pregnant female patient received first dose of bnt162b2 (Pfizer covid-19 vaccine, Solution for injection, Lot unknown reason: misplaced/discarded), via an intramuscular route in the left arm on 12Mar2021 at 09:30 (age at vaccination: 41-year-old), as a single dose for covid-19 immunization. Medical history included emphysema, PVC, fibromyalgia and known allergy to gluten. Concomitant medications included omeprazole (PROTONIX), ondansetron (ZOFRAN), diazepam (VALIUM), zinc, ascorbic acid (VITAMIN C) and multivitamin. Past drug event included last Juvederm Ultra XC filler injections in lips was beginning of November (Nov2020). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. On 13Mar2021 at 17:30, patient experienced minor side effects: jittery and nausea. Today, her lips started swelling slowly and burning. She called doctor immediately and directed to take Benadryl and see him in the morning. Adverse events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures taken as a result of the events included Benadryl. The clinical outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Dyspnoea, Lymphadenopathy, Nausea, Pyrexia
Clinical narrative: tightness in chest; swollen neck glands; rapid heartbeat; nausea; fever; dizziness; tounge felt swollen; This is a spontaneous report from a contactable consumer or other non hcp.   A 54-years-old female patient received BNT162b2 (CONMINTARY, Solution for injection, Lot No: EN6204), via an unspecified route of administration, administered in Arm Right on 13Mar2021 12:30 as 1st dose, single for covid-19 immunisation (Age at Vaccination was 54 years). Patient was not pregnant at time of Vaccination. Medical history included hypothyroidism from an unknown date and unknown if ongoing, asthma from an unknown date and unknown if ongoing, covid-19 from an unknown date and unknown if ongoing. Concomitant medication(s) included montelukast (MONTELUKAST) taken for an unspecified indication, start and stop date were not reported; thyroid (THYROID) taken for an unspecified indication, start and stop date were not reported; cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for an unspecified indication, start and stop date were not reported.  The patient experienced tightness in chest, swollen neck glands, rapid heartbeat, nausea, fever, dizziness, tounge felt swollen on 13Mar2021 12:45.  The patient underwent lab tests and procedures which included body temperature: 101- 102   on 13Mar2021, heart rate: rapid   on 13Mar2021. No treatment was received. Yes, covid prior vaccination. Covid tested post vaccination was no. Outcome of the events was recovering.  No follow up attempts are possible. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Chest discomfort, Dizziness, Heart rate, Heart rate increased
Clinical narrative: tightness in chest; swollen neck glands; rapid heartbeat; nausea; fever; dizziness; tounge felt swollen; This is a spontaneous report from a contactable consumer or other non hcp.   A 54-years-old female patient received BNT162b2 (CONMINTARY, Solution for injection, Lot No: EN6204), via an unspecified route of administration, administered in Arm Right on 13Mar2021 12:30 as 1st dose, single for covid-19 immunisation (Age at Vaccination was 54 years). Patient was not pregnant at time of Vaccination. Medical history included hypothyroidism from an unknown date and unknown if ongoing, asthma from an unknown date and unknown if ongoing, covid-19 from an unknown date and unknown if ongoing. Concomitant medication(s) included montelukast (MONTELUKAST) taken for an unspecified indication, start and stop date were not reported; thyroid (THYROID) taken for an unspecified indication, start and stop date were not reported; cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for an unspecified indication, start and stop date were not reported.  The patient experienced tightness in chest, swollen neck glands, rapid heartbeat, nausea, fever, dizziness, tounge felt swollen on 13Mar2021 12:45.  The patient underwent lab tests and procedures which included body temperature: 101- 102   on 13Mar2021, heart rate: rapid   on 13Mar2021. No treatment was received. Yes, covid prior vaccination. Covid tested post vaccination was no. Outcome of the events was recovering.  No follow up attempts are possible. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy, Nausea, Pyrexia, Swollen tongue
Clinical narrative: tightness in chest; swollen neck glands; rapid heartbeat; nausea; fever; dizziness; tounge felt swollen; This is a spontaneous report from a contactable consumer or other non hcp.   A 54-years-old female patient received BNT162b2 (CONMINTARY, Solution for injection, Lot No: EN6204), via an unspecified route of administration, administered in Arm Right on 13Mar2021 12:30 as 1st dose, single for covid-19 immunisation (Age at Vaccination was 54 years). Patient was not pregnant at time of Vaccination. Medical history included hypothyroidism from an unknown date and unknown if ongoing, asthma from an unknown date and unknown if ongoing, covid-19 from an unknown date and unknown if ongoing. Concomitant medication(s) included montelukast (MONTELUKAST) taken for an unspecified indication, start and stop date were not reported; thyroid (THYROID) taken for an unspecified indication, start and stop date were not reported; cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for an unspecified indication, start and stop date were not reported.  The patient experienced tightness in chest, swollen neck glands, rapid heartbeat, nausea, fever, dizziness, tounge felt swollen on 13Mar2021 12:45.  The patient underwent lab tests and procedures which included body temperature: 101- 102   on 13Mar2021, heart rate: rapid   on 13Mar2021. No treatment was received. Yes, covid prior vaccination. Covid tested post vaccination was no. Outcome of the events was recovering.  No follow up attempts are possible. No further information is expected.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Headache, Insomnia, Pain
Clinical narrative: 102F fever; Chills; Headache; Joint pain; was unable to sleep; This is a spontaneous report from a contactable consumer (Patient). A 34-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EN6204), via an unspecified route of administration, administered in left arm on 13Mar2021 at 09:00 AM as dose 2, single (at the age of 34-years-old) for COVID-19 immunisation in Hospital. Medical history included lobster allergy. Concomitant medications included atorvastatin (LIPITOR), cetirizine hydrochloride (ZYRTEC). The patient previously received first dose of BNT162B2, (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: unknown) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. Patient has not taken any other vaccine in four weeks. The patient not had COVID-19 prior vaccination. On 13Mar2021 at 10:00 PM (same day of vaccination), patient had a 102F fever, chills, headache, joint pain and was unable to sleep. The fever broke around 5am and came back around 7pm. Patient had not been tested COVID post vaccination. Patient had not received any treatment for the events. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: 102F fever; Chills; Headache; Joint pain; was unable to sleep; This is a spontaneous report from a contactable consumer (Patient). A 34-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EN6204), via an unspecified route of administration, administered in left arm on 13Mar2021 at 09:00 AM as dose 2, single (at the age of 34-years-old) for COVID-19 immunisation in Hospital. Medical history included lobster allergy. Concomitant medications included atorvastatin (LIPITOR), cetirizine hydrochloride (ZYRTEC). The patient previously received first dose of BNT162B2, (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: unknown) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. Patient has not taken any other vaccine in four weeks. The patient not had COVID-19 prior vaccination. On 13Mar2021 at 10:00 PM (same day of vaccination), patient had a 102F fever, chills, headache, joint pain and was unable to sleep. The fever broke around 5am and came back around 7pm. Patient had not been tested COVID post vaccination. Patient had not received any treatment for the events. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chills, Headache, Insomnia, Pyrexia
Clinical narrative: 102F fever; Chills; Headache; Joint pain; was unable to sleep; This is a spontaneous report from a contactable consumer (Patient). A 34-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EN6204), via an unspecified route of administration, administered in left arm on 13Mar2021 at 09:00 AM as dose 2, single (at the age of 34-years-old) for COVID-19 immunisation in Hospital. Medical history included lobster allergy. Concomitant medications included atorvastatin (LIPITOR), cetirizine hydrochloride (ZYRTEC). The patient previously received first dose of BNT162B2, (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: unknown) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. Patient has not taken any other vaccine in four weeks. The patient not had COVID-19 prior vaccination. On 13Mar2021 at 10:00 PM (same day of vaccination), patient had a 102F fever, chills, headache, joint pain and was unable to sleep. The fever broke around 5am and came back around 7pm. Patient had not been tested COVID post vaccination. Patient had not received any treatment for the events. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eye swelling, Mouth swelling, Swelling face, Swollen tongue
Clinical narrative: tongue swelled/after her first dose she had a mild reaction with her tongue and lips swelled up; lips swelled up/after her first dose she had a mild reaction with her tongue and lips swelled up; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: EP6955), via an unspecified route of administration, administered in right arm on 18Mar2021 as dose 1, single for COVID-19 immunisation. Medical history included Controlled diabetes, High blood pressure, Neuropathy, bad back, uterine cancer and did surgery, cancer of uterus but had surgery and removed it all. Concomitant medications included vitamin b6 (VITAMIN B6); cyanocobalamin (VITAMIN B12); folic acid; gabapentin; methocarbamol (ROBAXIN); losartan; amlodipine; metformin; hydrochlorothiazide and PAD (as reported). After the first dose the patient had a mild reaction with her tongue and lips swelled up and tongue swelled in 2021. The patient underwent lab tests and procedures which included blood cholesterol: result unknown, carbohydrate antigen 125 (CA125): result unknown, full blood count (CBC): result unknown, glycosylated haemoglobin (HbA1C): result unknown, metabolic function test (CMC): result unknown, all the tests were done on an unknown date. The patient went to the emergency room for the reported events, and she was given Benadryl as treatment and monitored in the emergency room before her symptoms resolved but she said her tongue was never the same since. The outcome was recovered for swollen lips in 2021 and recovered with sequel for swelling of tongue.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood cholesterol, Carbohydrate antigen 125, Full blood count, Glycosylated haemoglobin, Lip swelling
Clinical narrative: tongue swelled/after her first dose she had a mild reaction with her tongue and lips swelled up; lips swelled up/after her first dose she had a mild reaction with her tongue and lips swelled up; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: EP6955), via an unspecified route of administration, administered in right arm on 18Mar2021 as dose 1, single for COVID-19 immunisation. Medical history included Controlled diabetes, High blood pressure, Neuropathy, bad back, uterine cancer and did surgery, cancer of uterus but had surgery and removed it all. Concomitant medications included vitamin b6 (VITAMIN B6); cyanocobalamin (VITAMIN B12); folic acid; gabapentin; methocarbamol (ROBAXIN); losartan; amlodipine; metformin; hydrochlorothiazide and PAD (as reported). After the first dose the patient had a mild reaction with her tongue and lips swelled up and tongue swelled in 2021. The patient underwent lab tests and procedures which included blood cholesterol: result unknown, carbohydrate antigen 125 (CA125): result unknown, full blood count (CBC): result unknown, glycosylated haemoglobin (HbA1C): result unknown, metabolic function test (CMC): result unknown, all the tests were done on an unknown date. The patient went to the emergency room for the reported events, and she was given Benadryl as treatment and monitored in the emergency room before her symptoms resolved but she said her tongue was never the same since. The outcome was recovered for swollen lips in 2021 and recovered with sequel for swelling of tongue.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Metabolic function test, Swollen tongue
Clinical narrative: tongue swelled/after her first dose she had a mild reaction with her tongue and lips swelled up; lips swelled up/after her first dose she had a mild reaction with her tongue and lips swelled up; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: EP6955), via an unspecified route of administration, administered in right arm on 18Mar2021 as dose 1, single for COVID-19 immunisation. Medical history included Controlled diabetes, High blood pressure, Neuropathy, bad back, uterine cancer and did surgery, cancer of uterus but had surgery and removed it all. Concomitant medications included vitamin b6 (VITAMIN B6); cyanocobalamin (VITAMIN B12); folic acid; gabapentin; methocarbamol (ROBAXIN); losartan; amlodipine; metformin; hydrochlorothiazide and PAD (as reported). After the first dose the patient had a mild reaction with her tongue and lips swelled up and tongue swelled in 2021. The patient underwent lab tests and procedures which included blood cholesterol: result unknown, carbohydrate antigen 125 (CA125): result unknown, full blood count (CBC): result unknown, glycosylated haemoglobin (HbA1C): result unknown, metabolic function test (CMC): result unknown, all the tests were done on an unknown date. The patient went to the emergency room for the reported events, and she was given Benadryl as treatment and monitored in the emergency room before her symptoms resolved but she said her tongue was never the same since. The outcome was recovered for swollen lips in 2021 and recovered with sequel for swelling of tongue.   No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dermatitis acneiform
Clinical narrative: small (pimple size) red dots on upper, outer legs and lower, outer arms; This is a spontaneous report from a contactable consumer (patient).  A 69-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6208) via an unspecified route of administration in right arm on 15Mar2021 at 12:45 (at the age of 69-year-old) as dose 2, single for COVID-19 immunisation. Medical history included diabetes. Concomitant medication included metformin, losartan, Victoza and lorazepam as needed. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number: EN6203) via an unspecified route of administration in left arm on 22Feb2021 at 14:30 (at the age of 69-year-old) as a single dose for COVID-19 immunisation. Past drug history included Darvon for which patient developed allergy. Prior to the vaccination, the patient did not receive any other vaccines within 4 weeks, and had not diagnosed with COVID-19. On 18Mar2021 at 12:00, the patient developed small (pimple size) red dots on upper, outer legs and lower, outer arms. Since the vaccination, the patient was not tested for COVID-19. No treatment received for the events. The outcome of the event was not resolved.  No follow-up attempts are needed. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Erythema
Clinical narrative: small (pimple size) red dots on upper, outer legs and lower, outer arms; This is a spontaneous report from a contactable consumer (patient).  A 69-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6208) via an unspecified route of administration in right arm on 15Mar2021 at 12:45 (at the age of 69-year-old) as dose 2, single for COVID-19 immunisation. Medical history included diabetes. Concomitant medication included metformin, losartan, Victoza and lorazepam as needed. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number: EN6203) via an unspecified route of administration in left arm on 22Feb2021 at 14:30 (at the age of 69-year-old) as a single dose for COVID-19 immunisation. Past drug history included Darvon for which patient developed allergy. Prior to the vaccination, the patient did not receive any other vaccines within 4 weeks, and had not diagnosed with COVID-19. On 18Mar2021 at 12:00, the patient developed small (pimple size) red dots on upper, outer legs and lower, outer arms. Since the vaccination, the patient was not tested for COVID-19. No treatment received for the events. The outcome of the event was not resolved.  No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Asthenia, Diarrhoea, Dizziness, Fatigue
Clinical narrative: Headache; congestion; fatigue; weakness; nausea; diarrhea; severe muscle and joint pain; severe muscle and joint pain; This is a spontaneous report from a contactable consumer. This 48-Year-old non-pregnant female consumer (patient) reported that she received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: not reported), via an unspecified route of administration, administered in left arm on 03Mar2021 at 08:30 (at the age of 48 years) as dose 1, single for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) in two weeks included buspirone hydrochloride (BUSPAR) taken for an unspecified indication, start and stop date were not reported; sertraline hydrochloride (ZOLOFT) taken for an unspecified indication, start and stop date were not reported; montelukast sodium (SINGULAIR) taken for an unspecified indication, start and stop date were not reported. No other vaccine in four weeks. Facility type vaccine was other. No Covid prior vaccination and no Covid tested post vaccination. On 10Mar2021 at 12:00, (seven days after she received her shot), she began having side effects that lasted 3-4 days. Headache, congestion, fatigue, weakness, nausea, diarrhea, severe muscle and joint pain. Still felt some lingering side effects (muscle and joint pain) but not as severe. Also still felt some fatigue. She was just very concerned about getting the second shot. AE resulted in doctor or other healthcare professional office/clinic visit. No treatment received. The outcome of events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Myalgia, Nasal congestion, Nausea, SARS-CoV-2 test negative
Clinical narrative: Headache; congestion; fatigue; weakness; nausea; diarrhea; severe muscle and joint pain; severe muscle and joint pain; This is a spontaneous report from a contactable consumer. This 48-Year-old non-pregnant female consumer (patient) reported that she received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: not reported), via an unspecified route of administration, administered in left arm on 03Mar2021 at 08:30 (at the age of 48 years) as dose 1, single for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) in two weeks included buspirone hydrochloride (BUSPAR) taken for an unspecified indication, start and stop date were not reported; sertraline hydrochloride (ZOLOFT) taken for an unspecified indication, start and stop date were not reported; montelukast sodium (SINGULAIR) taken for an unspecified indication, start and stop date were not reported. No other vaccine in four weeks. Facility type vaccine was other. No Covid prior vaccination and no Covid tested post vaccination. On 10Mar2021 at 12:00, (seven days after she received her shot), she began having side effects that lasted 3-4 days. Headache, congestion, fatigue, weakness, nausea, diarrhea, severe muscle and joint pain. Still felt some lingering side effects (muscle and joint pain) but not as severe. Also still felt some fatigue. She was just very concerned about getting the second shot. AE resulted in doctor or other healthcare professional office/clinic visit. No treatment received. The outcome of events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swelling
Clinical narrative: Headache; congestion; fatigue; weakness; nausea; diarrhea; severe muscle and joint pain; severe muscle and joint pain; This is a spontaneous report from a contactable consumer. This 48-Year-old non-pregnant female consumer (patient) reported that she received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: not reported), via an unspecified route of administration, administered in left arm on 03Mar2021 at 08:30 (at the age of 48 years) as dose 1, single for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) in two weeks included buspirone hydrochloride (BUSPAR) taken for an unspecified indication, start and stop date were not reported; sertraline hydrochloride (ZOLOFT) taken for an unspecified indication, start and stop date were not reported; montelukast sodium (SINGULAIR) taken for an unspecified indication, start and stop date were not reported. No other vaccine in four weeks. Facility type vaccine was other. No Covid prior vaccination and no Covid tested post vaccination. On 10Mar2021 at 12:00, (seven days after she received her shot), she began having side effects that lasted 3-4 days. Headache, congestion, fatigue, weakness, nausea, diarrhea, severe muscle and joint pain. Still felt some lingering side effects (muscle and joint pain) but not as severe. Also still felt some fatigue. She was just very concerned about getting the second shot. AE resulted in doctor or other healthcare professional office/clinic visit. No treatment received. The outcome of events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Asthenia, Diarrhoea, Fatigue, Headache
Clinical narrative: Headache; congestion; fatigue; weakness; nausea; diarrhea; severe muscle and joint pain; severe muscle and joint pain; This is a spontaneous report from a contactable consumer. This 48-Year-old non-pregnant female consumer (patient) reported that she received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: not reported), via an unspecified route of administration, administered in left arm on 03Mar2021 at 08:30 (at the age of 48 years) as dose 1, single for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) in two weeks included buspirone hydrochloride (BUSPAR) taken for an unspecified indication, start and stop date were not reported; sertraline hydrochloride (ZOLOFT) taken for an unspecified indication, start and stop date were not reported; montelukast sodium (SINGULAIR) taken for an unspecified indication, start and stop date were not reported. No other vaccine in four weeks. Facility type vaccine was other. No Covid prior vaccination and no Covid tested post vaccination. On 10Mar2021 at 12:00, (seven days after she received her shot), she began having side effects that lasted 3-4 days. Headache, congestion, fatigue, weakness, nausea, diarrhea, severe muscle and joint pain. Still felt some lingering side effects (muscle and joint pain) but not as severe. Also still felt some fatigue. She was just very concerned about getting the second shot. AE resulted in doctor or other healthcare professional office/clinic visit. No treatment received. The outcome of events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Nasal congestion, Nausea
Clinical narrative: Headache; congestion; fatigue; weakness; nausea; diarrhea; severe muscle and joint pain; severe muscle and joint pain; This is a spontaneous report from a contactable consumer. This 48-Year-old non-pregnant female consumer (patient) reported that she received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: not reported), via an unspecified route of administration, administered in left arm on 03Mar2021 at 08:30 (at the age of 48 years) as dose 1, single for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) in two weeks included buspirone hydrochloride (BUSPAR) taken for an unspecified indication, start and stop date were not reported; sertraline hydrochloride (ZOLOFT) taken for an unspecified indication, start and stop date were not reported; montelukast sodium (SINGULAIR) taken for an unspecified indication, start and stop date were not reported. No other vaccine in four weeks. Facility type vaccine was other. No Covid prior vaccination and no Covid tested post vaccination. On 10Mar2021 at 12:00, (seven days after she received her shot), she began having side effects that lasted 3-4 days. Headache, congestion, fatigue, weakness, nausea, diarrhea, severe muscle and joint pain. Still felt some lingering side effects (muscle and joint pain) but not as severe. Also still felt some fatigue. She was just very concerned about getting the second shot. AE resulted in doctor or other healthcare professional office/clinic visit. No treatment received. The outcome of events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy, Facial paralysis
Clinical narrative: Allergy reaction; Swelled face, from mouth line came all the way down under jaw, all the way down to my chin; face looking really bad; right side face swollen, all the way up and under to my chin; This is a spontaneous report received from a contactable consumer or other non-healthcare professional (patient). A 78-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6206), via an unspecified route of administration on 08Mar2021 (at the age of 78-years-old) as dose 1, single for COVID-19 immunisation. Medical history included contrast media allergy (allergic to IV dye), blood pressure abnormal from an unknown date and unknown if ongoing. Concomitant medications included vitamin d nos (VITAMIN D NOS) taken for an unspecified indication, start and stop date were not reported, water pill use for blood pressure. The patient experienced allergy reaction, swelled face, from mouth line came all the way down under jaw, all the way down to my chin; face looking really bad, right side face swollen, all the way up and under to my chin on 08Mar2021. Consumer stated, I had an allergy reaction. It swelled my face and right from your mouth that line came all the way down under my jaw, got my face you know how it was how clowns look with their mouth, you know with that frown mouth found on their mouth. I did not notice it until I got home later and I called my doctor about it and I got appointment with him next Tuesday. He told me to wait until then but I felt like I need to call you all because that got my face looking really, really, really bad. Side of my face was swollen, you know that long line from your lip come all down to under your chin, that's what I got these looking like how clown face look. I have had looking on my face. When probed for the expiration date, consumer stated, do not see no expiration date. I just see the date that I am supposed to take the shot, the second shot. That's all on here. When probed if still experiencing the problem, consumer stated, that's why I has been calling, so I could talk to someone, yeah my mouth feel like that. I did not really know my mouth like that till night I got ready to wash my face and saw my mouth all that long thing all, my mouth all down like that. I did not know it until I looked into mirror and then I read the paper work that said it will cause your face to swell and all my right side of my face was swollen, all the way up and under to my chin and that line was in my mouth all the way down to my chin. Consumer stated, No, I have not. I told you my doctor told me to wait until I come to his office, Tuesday. Well, I did not want to wait because its not getting any better. Scheduled second dose on 29Mar2021. The outcome of the event allergy reaction was reported as unknown and while for other  No follow up attempts are needed. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypersensitivity, Investigation, Swelling face
Clinical narrative: Allergy reaction; Swelled face, from mouth line came all the way down under jaw, all the way down to my chin; face looking really bad; right side face swollen, all the way up and under to my chin; This is a spontaneous report received from a contactable consumer or other non-healthcare professional (patient). A 78-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6206), via an unspecified route of administration on 08Mar2021 (at the age of 78-years-old) as dose 1, single for COVID-19 immunisation. Medical history included contrast media allergy (allergic to IV dye), blood pressure abnormal from an unknown date and unknown if ongoing. Concomitant medications included vitamin d nos (VITAMIN D NOS) taken for an unspecified indication, start and stop date were not reported, water pill use for blood pressure. The patient experienced allergy reaction, swelled face, from mouth line came all the way down under jaw, all the way down to my chin; face looking really bad, right side face swollen, all the way up and under to my chin on 08Mar2021. Consumer stated, I had an allergy reaction. It swelled my face and right from your mouth that line came all the way down under my jaw, got my face you know how it was how clowns look with their mouth, you know with that frown mouth found on their mouth. I did not notice it until I got home later and I called my doctor about it and I got appointment with him next Tuesday. He told me to wait until then but I felt like I need to call you all because that got my face looking really, really, really bad. Side of my face was swollen, you know that long line from your lip come all down to under your chin, that's what I got these looking like how clown face look. I have had looking on my face. When probed for the expiration date, consumer stated, do not see no expiration date. I just see the date that I am supposed to take the shot, the second shot. That's all on here. When probed if still experiencing the problem, consumer stated, that's why I has been calling, so I could talk to someone, yeah my mouth feel like that. I did not really know my mouth like that till night I got ready to wash my face and saw my mouth all that long thing all, my mouth all down like that. I did not know it until I looked into mirror and then I read the paper work that said it will cause your face to swell and all my right side of my face was swollen, all the way up and under to my chin and that line was in my mouth all the way down to my chin. Consumer stated, No, I have not. I told you my doctor told me to wait until I come to his office, Tuesday. Well, I did not want to wait because its not getting any better. Scheduled second dose on 29Mar2021. The outcome of the event allergy reaction was reported as unknown and while for other  No follow up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal distension, Chronic obstructive pulmonary disease, Dyspnoea, Endoscopy, Illness
Clinical narrative: COPD exacerbation; did an endoscopy and found ulcers; bloating; shortness of breath; This is a spontaneous report from a contactable nurse (reporting for husband). A male patient of an unspecified age (Age: 67; unit: unknown) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiration date was not reported), dose 1 via an unspecified route of administration on 22Feb2021 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease and pulmonary fibrosis (got sick with pulmonary fibrosis and COPD, for which he currently required prednisolone) and difficulty breathing (Even if lying down, he had difficulty breathing and he takes SYMBICORT). Concomitant medication(s) included budesonide, formoterol fumarate (SYMBICORT) taken for an unspecified indication, start and stop date were not reported and prednisolone for COPD. The patient experienced received his 1st dose on 22Feb2021. For his COPD exacerbation (start date: unspecified), he was taking prednisolone to lessen the inflammation. Now, he was okay. She read on the prednisolone information that it diminished vaccine efficacy. In 2021 (last weeks), he had complaints of bloating and shortness of breath which was observed until Sunday (unspecified date). Even if lying down, he had difficulty breathing and he takes the SYMBICORT. Reporter rushed him to the emergency on 15Mar2021 (this morning) at 12:00, although he has had similar complaints before, they still did an endoscopy and found ulcers. The 2nd dose of the covid vaccine was supposed to be on 15Mar2021 (today) but was moved. Outcome for COPD exacerbation was recovering, for bloating and shortness of breath was recovered in 2021; and for rest all events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pulmonary fibrosis, Ulcer
Clinical narrative: COPD exacerbation; did an endoscopy and found ulcers; bloating; shortness of breath; This is a spontaneous report from a contactable nurse (reporting for husband). A male patient of an unspecified age (Age: 67; unit: unknown) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiration date was not reported), dose 1 via an unspecified route of administration on 22Feb2021 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease and pulmonary fibrosis (got sick with pulmonary fibrosis and COPD, for which he currently required prednisolone) and difficulty breathing (Even if lying down, he had difficulty breathing and he takes SYMBICORT). Concomitant medication(s) included budesonide, formoterol fumarate (SYMBICORT) taken for an unspecified indication, start and stop date were not reported and prednisolone for COPD. The patient experienced received his 1st dose on 22Feb2021. For his COPD exacerbation (start date: unspecified), he was taking prednisolone to lessen the inflammation. Now, he was okay. She read on the prednisolone information that it diminished vaccine efficacy. In 2021 (last weeks), he had complaints of bloating and shortness of breath which was observed until Sunday (unspecified date). Even if lying down, he had difficulty breathing and he takes the SYMBICORT. Reporter rushed him to the emergency on 15Mar2021 (this morning) at 12:00, although he has had similar complaints before, they still did an endoscopy and found ulcers. The 2nd dose of the covid vaccine was supposed to be on 15Mar2021 (today) but was moved. Outcome for COPD exacerbation was recovering, for bloating and shortness of breath was recovered in 2021; and for rest all events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal distension, Chronic obstructive pulmonary disease, Dyspnoea, Endoscopy, Gastrointestinal ulcer
Clinical narrative: COPD exacerbation; did an endoscopy and found ulcers; bloating; shortness of breath; This is a spontaneous report from a contactable nurse (reporting for husband). A male patient of an unspecified age (Age: 67; unit: unknown) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiration date was not reported), dose 1 via an unspecified route of administration on 22Feb2021 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease and pulmonary fibrosis (got sick with pulmonary fibrosis and COPD, for which he currently required prednisolone) and difficulty breathing (Even if lying down, he had difficulty breathing and he takes SYMBICORT). Concomitant medication(s) included budesonide, formoterol fumarate (SYMBICORT) taken for an unspecified indication, start and stop date were not reported and prednisolone for COPD. The patient experienced received his 1st dose on 22Feb2021. For his COPD exacerbation (start date: unspecified), he was taking prednisolone to lessen the inflammation. Now, he was okay. She read on the prednisolone information that it diminished vaccine efficacy. In 2021 (last weeks), he had complaints of bloating and shortness of breath which was observed until Sunday (unspecified date). Even if lying down, he had difficulty breathing and he takes the SYMBICORT. Reporter rushed him to the emergency on 15Mar2021 (this morning) at 12:00, although he has had similar complaints before, they still did an endoscopy and found ulcers. The 2nd dose of the covid vaccine was supposed to be on 15Mar2021 (today) but was moved. Outcome for COPD exacerbation was recovering, for bloating and shortness of breath was recovered in 2021; and for rest all events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.