chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy
Clinical narrative: Developed Bells Palsy; This is a spontaneous report received a contactable consumer, the patient. A 58-year-old adult male received the first dose of BNT162b2 (solution for injection; Lot provided as unknown and expiry information not reported) as a single dose via unspecified route in the left  arm on 25Mar2021 at 13:00 (at 58-years-old), for COVID-19 immunisation. Relevant medical history allergies to [unspecified] medications, food and/or other products. Concomitant medications included tetanus vaccine (lot unknown) dose 1 in right arm on 12Mar2021. The patient denied any COVID diagnosis prior to the vaccine. The patient reported that on 27Mar2021 at 12:00 he developed Bell's palsy; which was classified non-serious by the reporter. The patient has not been tested for COVID since the vaccine. Treatment for the event included prednisone regimen. The outcome of the event Bell's palsy was recovering.   Information on the lot/batch number has been requested.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Discomfort, Fatigue, Feeling abnormal, Food refusal, Headache
Clinical narrative: Sleep for a few minutes, I didn't pass out but it was similar; Was  pulled over "for minor traffic violation." He was told  "to get out of the car and had a field sobriety test, and I looked  intoxicated."; Felt heavy and tired/Run down; Had a headache; Upset stomach; sleep for a few minutes, I didn't pass out but it was similar/crashed for 4-5 hours in the middle of the day which I never do; aching; Over all weakness; Started feeling sick again at dinner; Woke up feeling really bad; Bad diarrhea; This is a spontaneous report from a contactable consumer or other non hcp. A 41-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 25Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. Medical history included drug hypersensitivity from an unknown date and unknown if ongoing Allergic to sulfa, PCN and amoxicillin. The patients concomitant medications were not reported. On an unspecified date the patient experienced sleep for a few minutes, I didnt pass out but it was similar, was pulled over for minor traffic violation. He was told to get out of the car and had a field sobriety test, and I looked intoxicated, felt heavy and tired/run down, had a headache, bad diarrhea, upset stomach, sleep for a few minutes, I didnt pass out but it was similar, crashed for 4 to 5 hours in the middle of the day which I never do, aching, overall weakness, started feeling sick again at dinner, he went to the bathroom a few times, woke up feeling really bad. The patient was worried because everything was coming to a head right now. The caller got the first shot, he waited for 15 minutes and felt fine. As the caller walked to his car he began feeling heavy, had severe diarrhea, headache, aching, it was almost like he passed out, it felt like he went to sleep. The patient got home and crashed 4 to 5 hours in the middle of the day and woke up feeling really bad. The patient went to a very important dinner meeting that night. While the patient was at the meeting he went to the bathroom a few times and then excused himself because he felt so bad. The patient did not even finish one cocktail with dinner. The caller got pulled over for a minor traffic stop, cutting the corner and crossing the line or something small. The officers believed the caller was driving under the influence and started making him do a sobriety test with 40 degree wind gusts, the patient was miserable. The caller told the officers that he needed to seek medical attention but they ignored him. The officers forced the caller to do the urine test. It has been 5 days since his vaccination and he is just now feeling better. The outcome of events was recovering.  No follow-up attempts are needed.  No further information is expected.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain
Clinical narrative: Sleep for a few minutes, I didn't pass out but it was similar; Was  pulled over "for minor traffic violation." He was told  "to get out of the car and had a field sobriety test, and I looked  intoxicated."; Felt heavy and tired/Run down; Had a headache; Upset stomach; sleep for a few minutes, I didn't pass out but it was similar/crashed for 4-5 hours in the middle of the day which I never do; aching; Over all weakness; Started feeling sick again at dinner; Woke up feeling really bad; Bad diarrhea; This is a spontaneous report from a contactable consumer or other non hcp. A 41-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 25Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. Medical history included drug hypersensitivity from an unknown date and unknown if ongoing Allergic to sulfa, PCN and amoxicillin. The patients concomitant medications were not reported. On an unspecified date the patient experienced sleep for a few minutes, I didnt pass out but it was similar, was pulled over for minor traffic violation. He was told to get out of the car and had a field sobriety test, and I looked intoxicated, felt heavy and tired/run down, had a headache, bad diarrhea, upset stomach, sleep for a few minutes, I didnt pass out but it was similar, crashed for 4 to 5 hours in the middle of the day which I never do, aching, overall weakness, started feeling sick again at dinner, he went to the bathroom a few times, woke up feeling really bad. The patient was worried because everything was coming to a head right now. The caller got the first shot, he waited for 15 minutes and felt fine. As the caller walked to his car he began feeling heavy, had severe diarrhea, headache, aching, it was almost like he passed out, it felt like he went to sleep. The patient got home and crashed 4 to 5 hours in the middle of the day and woke up feeling really bad. The patient went to a very important dinner meeting that night. While the patient was at the meeting he went to the bathroom a few times and then excused himself because he felt so bad. The patient did not even finish one cocktail with dinner. The caller got pulled over for a minor traffic stop, cutting the corner and crossing the line or something small. The officers believed the caller was driving under the influence and started making him do a sobriety test with 40 degree wind gusts, the patient was miserable. The caller told the officers that he needed to seek medical attention but they ignored him. The officers forced the caller to do the urine test. It has been 5 days since his vaccination and he is just now feeling better. The outcome of events was recovering.  No follow-up attempts are needed.  No further information is expected.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Asthenia, Diarrhoea, Fatigue, Feeling abnormal
Clinical narrative: Sleep for a few minutes, I didn't pass out but it was similar; Was  pulled over "for minor traffic violation." He was told  "to get out of the car and had a field sobriety test, and I looked  intoxicated."; Felt heavy and tired/Run down; Had a headache; Upset stomach; sleep for a few minutes, I didn't pass out but it was similar/crashed for 4-5 hours in the middle of the day which I never do; aching; Over all weakness; Started feeling sick again at dinner; Woke up feeling really bad; Bad diarrhea; This is a spontaneous report from a contactable consumer or other non hcp. A 41-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 25Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. Medical history included drug hypersensitivity from an unknown date and unknown if ongoing Allergic to sulfa, PCN and amoxicillin. The patients concomitant medications were not reported. On an unspecified date the patient experienced sleep for a few minutes, I didnt pass out but it was similar, was pulled over for minor traffic violation. He was told to get out of the car and had a field sobriety test, and I looked intoxicated, felt heavy and tired/run down, had a headache, bad diarrhea, upset stomach, sleep for a few minutes, I didnt pass out but it was similar, crashed for 4 to 5 hours in the middle of the day which I never do, aching, overall weakness, started feeling sick again at dinner, he went to the bathroom a few times, woke up feeling really bad. The patient was worried because everything was coming to a head right now. The caller got the first shot, he waited for 15 minutes and felt fine. As the caller walked to his car he began feeling heavy, had severe diarrhea, headache, aching, it was almost like he passed out, it felt like he went to sleep. The patient got home and crashed 4 to 5 hours in the middle of the day and woke up feeling really bad. The patient went to a very important dinner meeting that night. While the patient was at the meeting he went to the bathroom a few times and then excused himself because he felt so bad. The patient did not even finish one cocktail with dinner. The caller got pulled over for a minor traffic stop, cutting the corner and crossing the line or something small. The officers believed the caller was driving under the influence and started making him do a sobriety test with 40 degree wind gusts, the patient was miserable. The caller told the officers that he needed to seek medical attention but they ignored him. The officers forced the caller to do the urine test. It has been 5 days since his vaccination and he is just now feeling better. The outcome of events was recovering.  No follow-up attempts are needed.  No further information is expected.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Feeling drunk, Headache, Loss of consciousness, Malaise, Pain
Clinical narrative: Sleep for a few minutes, I didn't pass out but it was similar; Was  pulled over "for minor traffic violation." He was told  "to get out of the car and had a field sobriety test, and I looked  intoxicated."; Felt heavy and tired/Run down; Had a headache; Upset stomach; sleep for a few minutes, I didn't pass out but it was similar/crashed for 4-5 hours in the middle of the day which I never do; aching; Over all weakness; Started feeling sick again at dinner; Woke up feeling really bad; Bad diarrhea; This is a spontaneous report from a contactable consumer or other non hcp. A 41-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 25Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. Medical history included drug hypersensitivity from an unknown date and unknown if ongoing Allergic to sulfa, PCN and amoxicillin. The patients concomitant medications were not reported. On an unspecified date the patient experienced sleep for a few minutes, I didnt pass out but it was similar, was pulled over for minor traffic violation. He was told to get out of the car and had a field sobriety test, and I looked intoxicated, felt heavy and tired/run down, had a headache, bad diarrhea, upset stomach, sleep for a few minutes, I didnt pass out but it was similar, crashed for 4 to 5 hours in the middle of the day which I never do, aching, overall weakness, started feeling sick again at dinner, he went to the bathroom a few times, woke up feeling really bad. The patient was worried because everything was coming to a head right now. The caller got the first shot, he waited for 15 minutes and felt fine. As the caller walked to his car he began feeling heavy, had severe diarrhea, headache, aching, it was almost like he passed out, it felt like he went to sleep. The patient got home and crashed 4 to 5 hours in the middle of the day and woke up feeling really bad. The patient went to a very important dinner meeting that night. While the patient was at the meeting he went to the bathroom a few times and then excused himself because he felt so bad. The patient did not even finish one cocktail with dinner. The caller got pulled over for a minor traffic stop, cutting the corner and crossing the line or something small. The officers believed the caller was driving under the influence and started making him do a sobriety test with 40 degree wind gusts, the patient was miserable. The caller told the officers that he needed to seek medical attention but they ignored him. The officers forced the caller to do the urine test. It has been 5 days since his vaccination and he is just now feeling better. The outcome of events was recovering.  No follow-up attempts are needed.  No further information is expected.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Somnolence
Clinical narrative: Sleep for a few minutes, I didn't pass out but it was similar; Was  pulled over "for minor traffic violation." He was told  "to get out of the car and had a field sobriety test, and I looked  intoxicated."; Felt heavy and tired/Run down; Had a headache; Upset stomach; sleep for a few minutes, I didn't pass out but it was similar/crashed for 4-5 hours in the middle of the day which I never do; aching; Over all weakness; Started feeling sick again at dinner; Woke up feeling really bad; Bad diarrhea; This is a spontaneous report from a contactable consumer or other non hcp. A 41-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 25Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. Medical history included drug hypersensitivity from an unknown date and unknown if ongoing Allergic to sulfa, PCN and amoxicillin. The patients concomitant medications were not reported. On an unspecified date the patient experienced sleep for a few minutes, I didnt pass out but it was similar, was pulled over for minor traffic violation. He was told to get out of the car and had a field sobriety test, and I looked intoxicated, felt heavy and tired/run down, had a headache, bad diarrhea, upset stomach, sleep for a few minutes, I didnt pass out but it was similar, crashed for 4 to 5 hours in the middle of the day which I never do, aching, overall weakness, started feeling sick again at dinner, he went to the bathroom a few times, woke up feeling really bad. The patient was worried because everything was coming to a head right now. The caller got the first shot, he waited for 15 minutes and felt fine. As the caller walked to his car he began feeling heavy, had severe diarrhea, headache, aching, it was almost like he passed out, it felt like he went to sleep. The patient got home and crashed 4 to 5 hours in the middle of the day and woke up feeling really bad. The patient went to a very important dinner meeting that night. While the patient was at the meeting he went to the bathroom a few times and then excused himself because he felt so bad. The patient did not even finish one cocktail with dinner. The caller got pulled over for a minor traffic stop, cutting the corner and crossing the line or something small. The officers believed the caller was driving under the influence and started making him do a sobriety test with 40 degree wind gusts, the patient was miserable. The caller told the officers that he needed to seek medical attention but they ignored him. The officers forced the caller to do the urine test. It has been 5 days since his vaccination and he is just now feeling better. The outcome of events was recovering.  No follow-up attempts are needed.  No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pityriasis rosea
Clinical narrative: pityriasis rosea; This is a spontaneous report received from a contactable consumer (patient). A 33-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6207), via an unspecified route of administration in left arm on 12Mar2021 18:00 as single dose for covid-19 immunization. The patient was not pregnant at the time of vaccination. Vaccination facility type- Clinic. The patient medical history and concomitant medications were not reported. The patient not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 19Mar2021, the patient experienced Pityriasis rosea, assessed as non-serious. Steroid cream was given as a treatment for the adverse event. The adverse event resulted for Doctor or other healthcare professional office/clinic visit. The outcome of the event was recovering.   No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acoustic stimulation tests normal, Chills, Dry throat, Hyperacusis, Injection site pain
Clinical narrative: Eustachian tube dysfunction; Eustachian tube dysfunction and tinnitus (constant high pitch squeal) in both ears/ It was sometimes louder than other times/ It becomes piercingly loud and painful when exposed to other loud noises; Eustachian tube dysfunction and tinnitus (constant high pitch squeal) in both ears/ It was sometimes louder than other times/ It becomes piercingly loud and painful when exposed to other loud noises; Soreness at the injection site; Frequent headaches (every 2 or 3 days); Sore throat started 2 days after injection; Dry throat and chills started a week after injection and current; Dry throat and chills started a week after injection; This is spontaneous report received from a contactable consumer (patient himself). A 43-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8730), via an unspecified route of administration in left arm on 20Mar2021 at 16:00 (at the age of 43-year-old) as a single dose for COVID-19 immunization. The patient's medical history was none. Concomitant medications were not reported. The patient did not have allergies to medications, food, or other products and no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Eustachian tube dysfunction and tinnitus (constant high pitch squeal) in both ears on 21Mar2021. It was sometimes louder than other times. It becomes piercingly loud and painful when exposed to other loud noises, started the day after the vaccine injection. Frequent headaches (every 2 or 3 days) started the day of the injection (20Mar2021) and current. Sore throat started 2 days after injection (on an unspecified date in Mar2021) and has decreased in the last few days. Dry throat and chills started a week after injection (on an unspecified date in Mar2021) and current. Soreness at the injection site on 21Mar2021 that went away after a few days. The adverse events resulted in doctor or other healthcare professional office/clinic visit. No treatment was received for the adverse events. The outcome of the event soreness at the injection site was recovered on an unspecified date in 2021, recovering for the event sore throat and not recovered for the other events.   No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Oropharyngeal pain, Tinnitus
Clinical narrative: Eustachian tube dysfunction; Eustachian tube dysfunction and tinnitus (constant high pitch squeal) in both ears/ It was sometimes louder than other times/ It becomes piercingly loud and painful when exposed to other loud noises; Eustachian tube dysfunction and tinnitus (constant high pitch squeal) in both ears/ It was sometimes louder than other times/ It becomes piercingly loud and painful when exposed to other loud noises; Soreness at the injection site; Frequent headaches (every 2 or 3 days); Sore throat started 2 days after injection; Dry throat and chills started a week after injection and current; Dry throat and chills started a week after injection; This is spontaneous report received from a contactable consumer (patient himself). A 43-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8730), via an unspecified route of administration in left arm on 20Mar2021 at 16:00 (at the age of 43-year-old) as a single dose for COVID-19 immunization. The patient's medical history was none. Concomitant medications were not reported. The patient did not have allergies to medications, food, or other products and no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Eustachian tube dysfunction and tinnitus (constant high pitch squeal) in both ears on 21Mar2021. It was sometimes louder than other times. It becomes piercingly loud and painful when exposed to other loud noises, started the day after the vaccine injection. Frequent headaches (every 2 or 3 days) started the day of the injection (20Mar2021) and current. Sore throat started 2 days after injection (on an unspecified date in Mar2021) and has decreased in the last few days. Dry throat and chills started a week after injection (on an unspecified date in Mar2021) and current. Soreness at the injection site on 21Mar2021 that went away after a few days. The adverse events resulted in doctor or other healthcare professional office/clinic visit. No treatment was received for the adverse events. The outcome of the event soreness at the injection site was recovered on an unspecified date in 2021, recovering for the event sore throat and not recovered for the other events.   No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Dry throat, Ear pain, Eustachian tube dysfunction, Headache
Clinical narrative: Eustachian tube dysfunction; Eustachian tube dysfunction and tinnitus (constant high pitch squeal) in both ears/ It was sometimes louder than other times/ It becomes piercingly loud and painful when exposed to other loud noises; Eustachian tube dysfunction and tinnitus (constant high pitch squeal) in both ears/ It was sometimes louder than other times/ It becomes piercingly loud and painful when exposed to other loud noises; Soreness at the injection site; Frequent headaches (every 2 or 3 days); Sore throat started 2 days after injection; Dry throat and chills started a week after injection and current; Dry throat and chills started a week after injection; This is spontaneous report received from a contactable consumer (patient himself). A 43-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8730), via an unspecified route of administration in left arm on 20Mar2021 at 16:00 (at the age of 43-year-old) as a single dose for COVID-19 immunization. The patient's medical history was none. Concomitant medications were not reported. The patient did not have allergies to medications, food, or other products and no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Eustachian tube dysfunction and tinnitus (constant high pitch squeal) in both ears on 21Mar2021. It was sometimes louder than other times. It becomes piercingly loud and painful when exposed to other loud noises, started the day after the vaccine injection. Frequent headaches (every 2 or 3 days) started the day of the injection (20Mar2021) and current. Sore throat started 2 days after injection (on an unspecified date in Mar2021) and has decreased in the last few days. Dry throat and chills started a week after injection (on an unspecified date in Mar2021) and current. Soreness at the injection site on 21Mar2021 that went away after a few days. The adverse events resulted in doctor or other healthcare professional office/clinic visit. No treatment was received for the adverse events. The outcome of the event soreness at the injection site was recovered on an unspecified date in 2021, recovering for the event sore throat and not recovered for the other events.   No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Oropharyngeal pain, Tinnitus, Vaccination site pain
Clinical narrative: Eustachian tube dysfunction; Eustachian tube dysfunction and tinnitus (constant high pitch squeal) in both ears/ It was sometimes louder than other times/ It becomes piercingly loud and painful when exposed to other loud noises; Eustachian tube dysfunction and tinnitus (constant high pitch squeal) in both ears/ It was sometimes louder than other times/ It becomes piercingly loud and painful when exposed to other loud noises; Soreness at the injection site; Frequent headaches (every 2 or 3 days); Sore throat started 2 days after injection; Dry throat and chills started a week after injection and current; Dry throat and chills started a week after injection; This is spontaneous report received from a contactable consumer (patient himself). A 43-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8730), via an unspecified route of administration in left arm on 20Mar2021 at 16:00 (at the age of 43-year-old) as a single dose for COVID-19 immunization. The patient's medical history was none. Concomitant medications were not reported. The patient did not have allergies to medications, food, or other products and no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Eustachian tube dysfunction and tinnitus (constant high pitch squeal) in both ears on 21Mar2021. It was sometimes louder than other times. It becomes piercingly loud and painful when exposed to other loud noises, started the day after the vaccine injection. Frequent headaches (every 2 or 3 days) started the day of the injection (20Mar2021) and current. Sore throat started 2 days after injection (on an unspecified date in Mar2021) and has decreased in the last few days. Dry throat and chills started a week after injection (on an unspecified date in Mar2021) and current. Soreness at the injection site on 21Mar2021 that went away after a few days. The adverse events resulted in doctor or other healthcare professional office/clinic visit. No treatment was received for the adverse events. The outcome of the event soreness at the injection site was recovered on an unspecified date in 2021, recovering for the event sore throat and not recovered for the other events.   No follow-up attempts are needed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Erythema, Feeling abnormal, Peripheral swelling
Clinical narrative: She had a horrible rash and cellulitis; patient travelled to Florida and got very sick and went to a clinic there.She had a horrible rash and cellulitis and was treated with antibiotics.She still is not ok but the rash is much better; She had a horrible rash; This is a spontaneous report received from a contactable pharmacist. A 68-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 intramuscular, administered in Arm Left on 17Mar2021 (Batch/Lot Number: ep6955) (at the age of 68-years-old) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was unknown if patient received any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown if patient had been tested for COVID-19. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) dose 1 intramuscular, administered in Arm Left on 25Feb2021 (Batch/Lot Number: EN6200) as a single dose for COVID-19 immunization. On 17Mar2021, the patient travelled to florida and got very sick and went to a clinic there. She had a horrible rash and cellulitis. The events result in doctor or other healthcare professional office/clinic visit. She still was not ok, but the rash was much better. Therapeutic measures were taken as a result of events included antibiotics (unspecified). The outcome of the event rash was recovering, and other events was not recovered.; Sender's Comments: The event cellulitis most likely represents intercurrent medical condition that is assessed as unrelated to BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cellulitis, Illness, Rash
Clinical narrative: She had a horrible rash and cellulitis; patient travelled to Florida and got very sick and went to a clinic there.She had a horrible rash and cellulitis and was treated with antibiotics.She still is not ok but the rash is much better; She had a horrible rash; This is a spontaneous report received from a contactable pharmacist. A 68-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 intramuscular, administered in Arm Left on 17Mar2021 (Batch/Lot Number: ep6955) (at the age of 68-years-old) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was unknown if patient received any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown if patient had been tested for COVID-19. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) dose 1 intramuscular, administered in Arm Left on 25Feb2021 (Batch/Lot Number: EN6200) as a single dose for COVID-19 immunization. On 17Mar2021, the patient travelled to florida and got very sick and went to a clinic there. She had a horrible rash and cellulitis. The events result in doctor or other healthcare professional office/clinic visit. She still was not ok, but the rash was much better. Therapeutic measures were taken as a result of events included antibiotics (unspecified). The outcome of the event rash was recovering, and other events was not recovered.; Sender's Comments: The event cellulitis most likely represents intercurrent medical condition that is assessed as unrelated to BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cellulitis, Pain, Vaccination site swelling
Clinical narrative: She had a horrible rash and cellulitis; patient travelled to Florida and got very sick and went to a clinic there.She had a horrible rash and cellulitis and was treated with antibiotics.She still is not ok but the rash is much better; She had a horrible rash; This is a spontaneous report received from a contactable pharmacist. A 68-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 intramuscular, administered in Arm Left on 17Mar2021 (Batch/Lot Number: ep6955) (at the age of 68-years-old) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was unknown if patient received any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown if patient had been tested for COVID-19. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) dose 1 intramuscular, administered in Arm Left on 25Feb2021 (Batch/Lot Number: EN6200) as a single dose for COVID-19 immunization. On 17Mar2021, the patient travelled to florida and got very sick and went to a clinic there. She had a horrible rash and cellulitis. The events result in doctor or other healthcare professional office/clinic visit. She still was not ok, but the rash was much better. Therapeutic measures were taken as a result of events included antibiotics (unspecified). The outcome of the event rash was recovering, and other events was not recovered.; Sender's Comments: The event cellulitis most likely represents intercurrent medical condition that is assessed as unrelated to BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: HIV test, HIV test false positive
Clinical narrative: Showed a false positive for HIV; This is a spontaneous report from a contactable consumer (patient). A 35-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6205), via an unspecified route of administration in left arm, on 09Mar2021 at 02:00 PM (14:00), at a single dose, for COVID-19 immunization. The patient had no medical history and concomitant medications. The patient had no known allergies. The patient was not diagnosed with COVID-19 prior vaccination. No other vaccine was administered in four weeks. The most recent vaccine was administered in a public health clinic or Veterans administration facility. On 20Mar2021 at 12:00 PM, the patient donated blood at American Red Cross and showed a false positive result for HIV. The confirmatory test in Mar2021 resulted negative. The patient had not received a false positive previously. No treatment was received for the event. The patient underwent COVID-19 nasal swab test post-vaccination on 12Mar2021 that was negative. The patient recovered from the event in Mar2021.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: HIV test, HIV test false positive, SARS-CoV-2 test
Clinical narrative: Showed a false positive for HIV; This is a spontaneous report from a contactable consumer (patient). A 35-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6205), via an unspecified route of administration in left arm, on 09Mar2021 at 02:00 PM (14:00), at a single dose, for COVID-19 immunization. The patient had no medical history and concomitant medications. The patient had no known allergies. The patient was not diagnosed with COVID-19 prior vaccination. No other vaccine was administered in four weeks. The most recent vaccine was administered in a public health clinic or Veterans administration facility. On 20Mar2021 at 12:00 PM, the patient donated blood at American Red Cross and showed a false positive result for HIV. The confirmatory test in Mar2021 resulted negative. The patient had not received a false positive previously. No treatment was received for the event. The patient underwent COVID-19 nasal swab test post-vaccination on 12Mar2021 that was negative. The patient recovered from the event in Mar2021.
Age: 24.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Syncope
Clinical narrative: Prior to vaccine or was asked if any severe reactions occurred to pervious vaccines; post vaccination patient states of light headedness and proceeds to faint onto the floor while pharmacy tech assist; Prior to vaccine or was asked if any severe reactions occurred to pervious vaccines; post vaccination patient states of light headedness and proceeds to faint onto the floor while pharmacy tech assist; This is a spontaneous report from a contactable physician. A 24-years-old male patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: Batch/Lot Number: ER2613; Expiration Date: unknown), dose 1 intramuscular, administered in Arm Left on 30Mar2021 14:30 as SINGLE DOSE for COVID-19 immunization. Medical history included syncope, High blood pressure, Prone to fainting during medical procedures, Bell's palsy on 25Mar2021 with the outcome of not recovered. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient was tested for Covid-19 was unknown. The patient was not diagnosed with covid-19 prior to vaccination. The patient's concomitant medications were not reported. No allergies to medications, food, or other products. On 30Mar2021 14:45 the patient experienced light headedness and proceeds to faint onto the floor while pharmacy tech assists to prevent harm. The outcome of the event light headedness and proceeds to faint onto the floor was recovered. No follow-up attempts are needed. No further information is expected.
Age: 24.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Fall
Clinical narrative: Prior to vaccine or was asked if any severe reactions occurred to pervious vaccines; post vaccination patient states of light headedness and proceeds to faint onto the floor while pharmacy tech assist; Prior to vaccine or was asked if any severe reactions occurred to pervious vaccines; post vaccination patient states of light headedness and proceeds to faint onto the floor while pharmacy tech assist; This is a spontaneous report from a contactable physician. A 24-years-old male patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: Batch/Lot Number: ER2613; Expiration Date: unknown), dose 1 intramuscular, administered in Arm Left on 30Mar2021 14:30 as SINGLE DOSE for COVID-19 immunization. Medical history included syncope, High blood pressure, Prone to fainting during medical procedures, Bell's palsy on 25Mar2021 with the outcome of not recovered. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient was tested for Covid-19 was unknown. The patient was not diagnosed with covid-19 prior to vaccination. The patient's concomitant medications were not reported. No allergies to medications, food, or other products. On 30Mar2021 14:45 the patient experienced light headedness and proceeds to faint onto the floor while pharmacy tech assists to prevent harm. The outcome of the event light headedness and proceeds to faint onto the floor was recovered. No follow-up attempts are needed. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Condition aggravated, Tinnitus
Clinical narrative: increase in my tinnitus/ right ear is louder than my left; This is a spontaneous report received from a contactable other healthcare professional (retired dentist/ also the patient). A 65-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in Arm Left on 08Feb2021 16:45 (Batch/Lot Number: EL9264) as SINGLE DOSE for covid-19 immunisation. The patient was vaccinated at a hospital. Medical history included Chronic tinnitus from an unknown date and unknown if ongoing (Patient had chronic tinnitus with mild symptoms, Before the vaccines). The patient was not diagnosed with COVID-19 prior to vaccination, also not been tested for COVID-19 since the vaccination. The patient had no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, and no any other medications the patient received within 2 weeks of vaccination. The patient's concomitant medications were not reported. The patient previously took bnt162b2 first dose on 18Jan2021 (lot number: EK4176) on 18Jan2021 in left arm for covid-19 immunization. It was reported by the patient that: "previous to the vaccines I had chronic tinnitus with mild symptoms. I am a retired dentist. I was not aware of any changes in my tinnitus after the 1st vaccine. But after the 2nd vaccine I noticed a definite profound increase in my tinnitus (on 21Feb2021). It is now on the verge of being debilitating in nature. It is now  pulsating and much louder, very difficult to ignore even during day time activities. Before my tinnitus was bilaterally equal, now I would say my right ear is louder than my left. But both are louder than before. Today marks about 50 days since 2nd vaccine, and I think its actually getting progressively worse! Hopefully this is not permanent." The outcome of the event was not recovered. The case was considered as serious (criteria-Disabling/Incapacitating: Yes). No treatment was received for the adverse event.   Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: increase in my tinnitus/ right ear is louder than my left; This is a spontaneous report received from a contactable other healthcare professional (retired dentist/ also the patient). A 65-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in Arm Left on 08Feb2021 16:45 (Batch/Lot Number: EL9264) as SINGLE DOSE for covid-19 immunisation. The patient was vaccinated at a hospital. Medical history included Chronic tinnitus from an unknown date and unknown if ongoing (Patient had chronic tinnitus with mild symptoms, Before the vaccines). The patient was not diagnosed with COVID-19 prior to vaccination, also not been tested for COVID-19 since the vaccination. The patient had no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, and no any other medications the patient received within 2 weeks of vaccination. The patient's concomitant medications were not reported. The patient previously took bnt162b2 first dose on 18Jan2021 (lot number: EK4176) on 18Jan2021 in left arm for covid-19 immunization. It was reported by the patient that: "previous to the vaccines I had chronic tinnitus with mild symptoms. I am a retired dentist. I was not aware of any changes in my tinnitus after the 1st vaccine. But after the 2nd vaccine I noticed a definite profound increase in my tinnitus (on 21Feb2021). It is now on the verge of being debilitating in nature. It is now  pulsating and much louder, very difficult to ignore even during day time activities. Before my tinnitus was bilaterally equal, now I would say my right ear is louder than my left. But both are louder than before. Today marks about 50 days since 2nd vaccine, and I think its actually getting progressively worse! Hopefully this is not permanent." The outcome of the event was not recovered. The case was considered as serious (criteria-Disabling/Incapacitating: Yes). No treatment was received for the adverse event.   Additional information has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Hypertension
Clinical narrative: high fever; body pain; headache; chills; sore throat; lost appetite; feels weak; This is a spontaneous report received from a Pfizer sponsored program Covax US Support. A contactable consumer (patient) reported a female patient of an unspecified age received a first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and Expiration dates were not reported), via unspecified route of administration on 27Mar2021 as single dose for COVID-19 immunization. The patient had medical history of tested positive for Covid-19 on Dec2020, she was hospitalized and released on 03Jan2021. The concomitant medication was not reported. The patient reported that she woke up at the night of vaccination with high fever, body pain, headache, chills, sore throat and lost appetite. The next day she still feels weak, she still has it but not just like yesterday. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Chills, Decreased appetite, Headache, Oropharyngeal pain
Clinical narrative: high fever; body pain; headache; chills; sore throat; lost appetite; feels weak; This is a spontaneous report received from a Pfizer sponsored program Covax US Support. A contactable consumer (patient) reported a female patient of an unspecified age received a first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and Expiration dates were not reported), via unspecified route of administration on 27Mar2021 as single dose for COVID-19 immunization. The patient had medical history of tested positive for Covid-19 on Dec2020, she was hospitalized and released on 03Jan2021. The concomitant medication was not reported. The patient reported that she woke up at the night of vaccination with high fever, body pain, headache, chills, sore throat and lost appetite. The next day she still feels weak, she still has it but not just like yesterday. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: high fever; body pain; headache; chills; sore throat; lost appetite; feels weak; This is a spontaneous report received from a Pfizer sponsored program Covax US Support. A contactable consumer (patient) reported a female patient of an unspecified age received a first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and Expiration dates were not reported), via unspecified route of administration on 27Mar2021 as single dose for COVID-19 immunization. The patient had medical history of tested positive for Covid-19 on Dec2020, she was hospitalized and released on 03Jan2021. The concomitant medication was not reported. The patient reported that she woke up at the night of vaccination with high fever, body pain, headache, chills, sore throat and lost appetite. The next day she still feels weak, she still has it but not just like yesterday. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.