chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles diagnosis 1.5 weeks after vaccine.; This is a spontaneous report from a contactable consumer (patient). A 35-years-old (non-pregnant) female patient received bnt162b2 (BNT162B2), Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 25Apr2021 at 16:00 as UNKNOWN, single dose for COVID-19 immunization. The patient was 35-years-old and was not-pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was public Health Clinic Administration facility. No other vaccines received by patient within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID prior to vaccination. The patient has not been tested for COVID since the vaccination. The patient received other medications within 2 weeks of vaccination was valacyclovir. The patient medical history and concomitant medications were not reported. It was reported that on 03May2021, the patient experienced shingles diagnosis 1.5 weeks after vaccine. The adverse event result in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of shingles diagnosis 1.5 weeks after vaccine. Valacyclovir treatment received for the adverse event. The clinical outcome of event was recovering.  Information on the lot/batch number has been requested.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: the vaccine was administered in the Left Gluteus Medius
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: the vaccine was administered in the Left Gluteus Medius
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Back pain, Pain, Sleep disorder
Clinical narrative: Pt was admitted to hospital from ED for Acute pain on chronic pancreatitis 2 days after receiving 2nd dose of vaccine. Per EUA hospitalizations are to be reported.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain, Pancreatitis chronic
Clinical narrative: Pt was admitted to hospital from ED for Acute pain on chronic pancreatitis 2 days after receiving 2nd dose of vaccine. Per EUA hospitalizations are to be reported.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Rash erythematous, Rash papular
Clinical narrative: Symptoms started with a very itchy head (scalp)/very itchy face; A very itchy face that turned into red raised spots that resembled mosquito bites/red itchy bumps on my face; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: EW0171) via an unspecified route of administration, administered into left arm on 25May2021 10:30 (at the age of 41-year-old) as 1st dose, single for COVID-19 immunisation. Medical history included gastrooesophageal reflux disease. Concomitant medications included omeprazole (OMEPRAZOLE). Patient was not pregnant. On 25May2021 12:30, symptoms started with a very itchy head (scalp) then a very itchy face that turned into red raised spots that resembled mosquito bites. Patient took Benadryl for kids 10ml on an unspecified date, since that was all she had. It was reported that the itching stopped and the red itchy bumps on my face went away. Outcome of events recovered on May2021.  Information on the lot/batch number has been requested. Further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Rash maculo-papular
Clinical narrative: Symptoms started with a very itchy head (scalp)/very itchy face; A very itchy face that turned into red raised spots that resembled mosquito bites/red itchy bumps on my face; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: EW0171) via an unspecified route of administration, administered into left arm on 25May2021 10:30 (at the age of 41-year-old) as 1st dose, single for COVID-19 immunisation. Medical history included gastrooesophageal reflux disease. Concomitant medications included omeprazole (OMEPRAZOLE). Patient was not pregnant. On 25May2021 12:30, symptoms started with a very itchy head (scalp) then a very itchy face that turned into red raised spots that resembled mosquito bites. Patient took Benadryl for kids 10ml on an unspecified date, since that was all she had. It was reported that the itching stopped and the red itchy bumps on my face went away. Outcome of events recovered on May2021.  Information on the lot/batch number has been requested. Further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Influenza like illness, Palpitations
Clinical narrative: Shortness of breathe, heart palpitations.; Shortness of breathe, heart palpitations.; This is a spontaneous report. A contactable male consumer (patient) reported a 50-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route in left arm single dose for COVID-19 immunization on 20May2021 11:00, at 50-year-old. No medical history. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive other medications received within 2 weeks of vaccination. The patient previously first dose of received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route in left arm for COVID-19 immunization on 30Apr2021 11:30, at 50-year-old. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced shortness of breathe, heart palpitations; both were on 23May2021 15:00 with outcome of not resolved.  Information lot/batch number has been requested.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Palpitations
Clinical narrative: Shortness of breathe, heart palpitations.; Shortness of breathe, heart palpitations.; This is a spontaneous report. A contactable male consumer (patient) reported a 50-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route in left arm single dose for COVID-19 immunization on 20May2021 11:00, at 50-year-old. No medical history. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive other medications received within 2 weeks of vaccination. The patient previously first dose of received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route in left arm for COVID-19 immunization on 30Apr2021 11:30, at 50-year-old. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced shortness of breathe, heart palpitations; both were on 23May2021 15:00 with outcome of not resolved.  Information lot/batch number has been requested.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Anti-neuronal antibody, Antinuclear antibody, Arthralgia, Borrelia test, Differential white blood cell count
Clinical narrative: painful left arm/shoulder where shot was administered; painful left arm/shoulder where shot was administered; Hard to lift up arm, nothing noticeable on arm; bloodshot eyes; muscle aches; unable to take full breathes/shortness of breath; minor cough; migraine headache; chills; exhausted; aches; nausea; covid like symptoms; body aches; low energy; This is a spontaneous report from a contactable consumer (patient). A 62-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 03May2021 15:30 (Batch/Lot Number: EW0173) as single dose for covid-19 immunisation. The patient medical history was reported as none. Patient had not any known allergies. Patient had not received any other vaccine in four weeks nor received any other medications in two weeks. The patient did not received concomitant. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: unknown; Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on 05Apr2021 07:30 PM, as single dose for COVID-19 immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. 2nd shot administered on 03May2021 and on 08May2021 09:00 PM six days later developed migraine headache, chills, exhausted, aches, nausea. Chills, migraine, lasted 1 day, night of 08May2021- 09May2021. It was reported that due to lifting weights, vaccine was trapped in the arm/shoulder muscle, released slowly where he developed covid like symptoms 6 days after shot followed by week of covid like symptoms, shortness of breath, body aches, exhausted, low energy. Week of 10May2021 exhausted, bloodshot eyes, muscle aches, unable to take full breathes, developed a minor cough. On 15May2021- 16May2021, painful left arm/shoulder where shot was administered. Hard to lift up arm, nothing noticeable on arm. No treatment was received for the events. The seriousness of events was reported as non serious by the reporter. The outcome of the events chills, migraine were recovered on 09May2021; events painful left arm/shoulder where shot was administered and hard to lift up arm were recovered on 16May2021 and recovering for other events.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Full blood count, Gonococcal infection, HIV test, Pain in extremity, Peripheral swelling
Clinical narrative: painful left arm/shoulder where shot was administered; painful left arm/shoulder where shot was administered; Hard to lift up arm, nothing noticeable on arm; bloodshot eyes; muscle aches; unable to take full breathes/shortness of breath; minor cough; migraine headache; chills; exhausted; aches; nausea; covid like symptoms; body aches; low energy; This is a spontaneous report from a contactable consumer (patient). A 62-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 03May2021 15:30 (Batch/Lot Number: EW0173) as single dose for covid-19 immunisation. The patient medical history was reported as none. Patient had not any known allergies. Patient had not received any other vaccine in four weeks nor received any other medications in two weeks. The patient did not received concomitant. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: unknown; Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on 05Apr2021 07:30 PM, as single dose for COVID-19 immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. 2nd shot administered on 03May2021 and on 08May2021 09:00 PM six days later developed migraine headache, chills, exhausted, aches, nausea. Chills, migraine, lasted 1 day, night of 08May2021- 09May2021. It was reported that due to lifting weights, vaccine was trapped in the arm/shoulder muscle, released slowly where he developed covid like symptoms 6 days after shot followed by week of covid like symptoms, shortness of breath, body aches, exhausted, low energy. Week of 10May2021 exhausted, bloodshot eyes, muscle aches, unable to take full breathes, developed a minor cough. On 15May2021- 16May2021, painful left arm/shoulder where shot was administered. Hard to lift up arm, nothing noticeable on arm. No treatment was received for the events. The seriousness of events was reported as non serious by the reporter. The outcome of the events chills, migraine were recovered on 09May2021; events painful left arm/shoulder where shot was administered and hard to lift up arm were recovered on 16May2021 and recovering for other events.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Red blood cell sedimentation rate, Rheumatoid factor, Treponema test
Clinical narrative: painful left arm/shoulder where shot was administered; painful left arm/shoulder where shot was administered; Hard to lift up arm, nothing noticeable on arm; bloodshot eyes; muscle aches; unable to take full breathes/shortness of breath; minor cough; migraine headache; chills; exhausted; aches; nausea; covid like symptoms; body aches; low energy; This is a spontaneous report from a contactable consumer (patient). A 62-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 03May2021 15:30 (Batch/Lot Number: EW0173) as single dose for covid-19 immunisation. The patient medical history was reported as none. Patient had not any known allergies. Patient had not received any other vaccine in four weeks nor received any other medications in two weeks. The patient did not received concomitant. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: unknown; Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on 05Apr2021 07:30 PM, as single dose for COVID-19 immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. 2nd shot administered on 03May2021 and on 08May2021 09:00 PM six days later developed migraine headache, chills, exhausted, aches, nausea. Chills, migraine, lasted 1 day, night of 08May2021- 09May2021. It was reported that due to lifting weights, vaccine was trapped in the arm/shoulder muscle, released slowly where he developed covid like symptoms 6 days after shot followed by week of covid like symptoms, shortness of breath, body aches, exhausted, low energy. Week of 10May2021 exhausted, bloodshot eyes, muscle aches, unable to take full breathes, developed a minor cough. On 15May2021- 16May2021, painful left arm/shoulder where shot was administered. Hard to lift up arm, nothing noticeable on arm. No treatment was received for the events. The seriousness of events was reported as non serious by the reporter. The outcome of the events chills, migraine were recovered on 09May2021; events painful left arm/shoulder where shot was administered and hard to lift up arm were recovered on 16May2021 and recovering for other events.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Asthenia, Chills, Cough, Dyspnoea
Clinical narrative: painful left arm/shoulder where shot was administered; painful left arm/shoulder where shot was administered; Hard to lift up arm, nothing noticeable on arm; bloodshot eyes; muscle aches; unable to take full breathes/shortness of breath; minor cough; migraine headache; chills; exhausted; aches; nausea; covid like symptoms; body aches; low energy; This is a spontaneous report from a contactable consumer (patient). A 62-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 03May2021 15:30 (Batch/Lot Number: EW0173) as single dose for covid-19 immunisation. The patient medical history was reported as none. Patient had not any known allergies. Patient had not received any other vaccine in four weeks nor received any other medications in two weeks. The patient did not received concomitant. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: unknown; Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on 05Apr2021 07:30 PM, as single dose for COVID-19 immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. 2nd shot administered on 03May2021 and on 08May2021 09:00 PM six days later developed migraine headache, chills, exhausted, aches, nausea. Chills, migraine, lasted 1 day, night of 08May2021- 09May2021. It was reported that due to lifting weights, vaccine was trapped in the arm/shoulder muscle, released slowly where he developed covid like symptoms 6 days after shot followed by week of covid like symptoms, shortness of breath, body aches, exhausted, low energy. Week of 10May2021 exhausted, bloodshot eyes, muscle aches, unable to take full breathes, developed a minor cough. On 15May2021- 16May2021, painful left arm/shoulder where shot was administered. Hard to lift up arm, nothing noticeable on arm. No treatment was received for the events. The seriousness of events was reported as non serious by the reporter. The outcome of the events chills, migraine were recovered on 09May2021; events painful left arm/shoulder where shot was administered and hard to lift up arm were recovered on 16May2021 and recovering for other events.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Migraine, Mobility decreased, Myalgia, Nausea
Clinical narrative: painful left arm/shoulder where shot was administered; painful left arm/shoulder where shot was administered; Hard to lift up arm, nothing noticeable on arm; bloodshot eyes; muscle aches; unable to take full breathes/shortness of breath; minor cough; migraine headache; chills; exhausted; aches; nausea; covid like symptoms; body aches; low energy; This is a spontaneous report from a contactable consumer (patient). A 62-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 03May2021 15:30 (Batch/Lot Number: EW0173) as single dose for covid-19 immunisation. The patient medical history was reported as none. Patient had not any known allergies. Patient had not received any other vaccine in four weeks nor received any other medications in two weeks. The patient did not received concomitant. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: unknown; Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on 05Apr2021 07:30 PM, as single dose for COVID-19 immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. 2nd shot administered on 03May2021 and on 08May2021 09:00 PM six days later developed migraine headache, chills, exhausted, aches, nausea. Chills, migraine, lasted 1 day, night of 08May2021- 09May2021. It was reported that due to lifting weights, vaccine was trapped in the arm/shoulder muscle, released slowly where he developed covid like symptoms 6 days after shot followed by week of covid like symptoms, shortness of breath, body aches, exhausted, low energy. Week of 10May2021 exhausted, bloodshot eyes, muscle aches, unable to take full breathes, developed a minor cough. On 15May2021- 16May2021, painful left arm/shoulder where shot was administered. Hard to lift up arm, nothing noticeable on arm. No treatment was received for the events. The seriousness of events was reported as non serious by the reporter. The outcome of the events chills, migraine were recovered on 09May2021; events painful left arm/shoulder where shot was administered and hard to lift up arm were recovered on 16May2021 and recovering for other events.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Ocular hyperaemia, Pain, Suspected COVID-19, Vaccination site pain
Clinical narrative: painful left arm/shoulder where shot was administered; painful left arm/shoulder where shot was administered; Hard to lift up arm, nothing noticeable on arm; bloodshot eyes; muscle aches; unable to take full breathes/shortness of breath; minor cough; migraine headache; chills; exhausted; aches; nausea; covid like symptoms; body aches; low energy; This is a spontaneous report from a contactable consumer (patient). A 62-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 03May2021 15:30 (Batch/Lot Number: EW0173) as single dose for covid-19 immunisation. The patient medical history was reported as none. Patient had not any known allergies. Patient had not received any other vaccine in four weeks nor received any other medications in two weeks. The patient did not received concomitant. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: unknown; Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on 05Apr2021 07:30 PM, as single dose for COVID-19 immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. 2nd shot administered on 03May2021 and on 08May2021 09:00 PM six days later developed migraine headache, chills, exhausted, aches, nausea. Chills, migraine, lasted 1 day, night of 08May2021- 09May2021. It was reported that due to lifting weights, vaccine was trapped in the arm/shoulder muscle, released slowly where he developed covid like symptoms 6 days after shot followed by week of covid like symptoms, shortness of breath, body aches, exhausted, low energy. Week of 10May2021 exhausted, bloodshot eyes, muscle aches, unable to take full breathes, developed a minor cough. On 15May2021- 16May2021, painful left arm/shoulder where shot was administered. Hard to lift up arm, nothing noticeable on arm. No treatment was received for the events. The seriousness of events was reported as non serious by the reporter. The outcome of the events chills, migraine were recovered on 09May2021; events painful left arm/shoulder where shot was administered and hard to lift up arm were recovered on 16May2021 and recovering for other events.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Administration site bruise, Body temperature, Hot flush, Malaise, Night sweats
Clinical narrative: This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 86-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration on an unspecified date as unknown, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient stated that the injection site went blue black. The seriousness of the event was reported as non-serious. The clinical outcome of the event was unknown. Information about lot/batch number has been requested. Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site discolouration, Vaccination site haemorrhage, Vaccination site swelling
Clinical narrative: This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 86-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration on an unspecified date as unknown, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient stated that the injection site went blue black. The seriousness of the event was reported as non-serious. The clinical outcome of the event was unknown. Information about lot/batch number has been requested. Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site discolouration
Clinical narrative: This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 86-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration on an unspecified date as unknown, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient stated that the injection site went blue black. The seriousness of the event was reported as non-serious. The clinical outcome of the event was unknown. Information about lot/batch number has been requested. Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cardiac flutter, Chest discomfort, Palpitations, Rash macular, Tenderness
Clinical narrative: possible clotting; heart fluttering; developed severely blotchy skin on my inner right thigh; palpitations; little sore to the touch in places; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient (non-pregnant at time of vaccination) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the left arm on 25May2021 at 15:00 (lot number: EWO191) as single dose for COVID-19 immunisation. Medical history included supraventricular tachycardia. Concomitant medications included fluoxetine hydrochloride (PROZAC); amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL); ibuprofen (ADVIL [IBUPROFEN]). No other vaccine in four weeks. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EWO179), via an unspecified route of administration in the left arm on 03May2021 at 13:00 (at the age of 40 years old) as single dose for COVID-19 immunisation. The patient previously took amoxicillin, clavulanic acid (AUGMENTIN) and experienced known allergies. No covid prior vaccination. No covid tested post vaccination. On 28May2021 at 19:00, patient developed severely blotchy skin on her inner right thigh on Friday evening. It would not clear up and was subcutaneous (not chafing). It was a little sore to the touch in places. Patient did a Google search and was alarmed when one of the first things to pop up was possible clotting. Patient had also been experiencing strange heart fluttering / palpitations (heart palpitations were not tachycardia event). Patient husband brought home some chewable low dose aspirin. Patient took approx. 600mg (per directions - it said take 4-8 tablets every 4 hrs). Patient took 8 tablets. Within 15 minutes the blotchiness started to fade in her leg, and within one hour it was 90% better. It was 100% better by the next morning. Patient had since been taking one low dose aspirin per day as a precaution. Heart palpitations also stopped with the aspirin. Treatment received for events. The outcome of the event heart fluttering, pain and coagulopathy were unknown, while of the other events was recovered on unspecified date.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cardiac flutter, Coagulopathy, Pain, Palpitations, Rash macular
Clinical narrative: possible clotting; heart fluttering; developed severely blotchy skin on my inner right thigh; palpitations; little sore to the touch in places; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient (non-pregnant at time of vaccination) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the left arm on 25May2021 at 15:00 (lot number: EWO191) as single dose for COVID-19 immunisation. Medical history included supraventricular tachycardia. Concomitant medications included fluoxetine hydrochloride (PROZAC); amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL); ibuprofen (ADVIL [IBUPROFEN]). No other vaccine in four weeks. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EWO179), via an unspecified route of administration in the left arm on 03May2021 at 13:00 (at the age of 40 years old) as single dose for COVID-19 immunisation. The patient previously took amoxicillin, clavulanic acid (AUGMENTIN) and experienced known allergies. No covid prior vaccination. No covid tested post vaccination. On 28May2021 at 19:00, patient developed severely blotchy skin on her inner right thigh on Friday evening. It would not clear up and was subcutaneous (not chafing). It was a little sore to the touch in places. Patient did a Google search and was alarmed when one of the first things to pop up was possible clotting. Patient had also been experiencing strange heart fluttering / palpitations (heart palpitations were not tachycardia event). Patient husband brought home some chewable low dose aspirin. Patient took approx. 600mg (per directions - it said take 4-8 tablets every 4 hrs). Patient took 8 tablets. Within 15 minutes the blotchiness started to fade in her leg, and within one hour it was 90% better. It was 100% better by the next morning. Patient had since been taking one low dose aspirin per day as a precaution. Heart palpitations also stopped with the aspirin. Treatment received for events. The outcome of the event heart fluttering, pain and coagulopathy were unknown, while of the other events was recovered on unspecified date.
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Chest pain, Dyspnoea, Erythema, Fatigue
Clinical narrative: Passed out; Had troub breathing/couldn't catch breath when went upstairs; Chest pain; Felt like lungs were hurting in back; Weak; Tired; This is spontaneous report received from a contactable consumer (patient). This is the first of two reports with the events related to the first vaccine dose. A 44-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 13Apr2021 at 19:00 (Batch/Lot Number: ew0162) as 1st dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. No other vaccine received in four weeks. After vaccination on 13Apr2021, no issue w/injection site. a week later had trouble breathing, chest pain, felt like lungs were hurting in back, weak, tired, couldn't catch breath when he went upstairs, almost passed out. No treatment received for adverse event. No covid prior vaccination. No covid tested post vaccination. No known allergies. The outcome of events was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021636737 Same reporter/patient/product; different doses/events.
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Headache, Injection site pain, Lymphadenopathy, Neck pain, Pain
Clinical narrative: Passed out; Had troub breathing/couldn't catch breath when went upstairs; Chest pain; Felt like lungs were hurting in back; Weak; Tired; This is spontaneous report received from a contactable consumer (patient). This is the first of two reports with the events related to the first vaccine dose. A 44-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 13Apr2021 at 19:00 (Batch/Lot Number: ew0162) as 1st dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. No other vaccine received in four weeks. After vaccination on 13Apr2021, no issue w/injection site. a week later had trouble breathing, chest pain, felt like lungs were hurting in back, weak, tired, couldn't catch breath when he went upstairs, almost passed out. No treatment received for adverse event. No covid prior vaccination. No covid tested post vaccination. No known allergies. The outcome of events was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021636737 Same reporter/patient/product; different doses/events.
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pruritus, Pulmonary pain, Rash, SARS-CoV-2 test negative, Sensitive skin
Clinical narrative: Passed out; Had troub breathing/couldn't catch breath when went upstairs; Chest pain; Felt like lungs were hurting in back; Weak; Tired; This is spontaneous report received from a contactable consumer (patient). This is the first of two reports with the events related to the first vaccine dose. A 44-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 13Apr2021 at 19:00 (Batch/Lot Number: ew0162) as 1st dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. No other vaccine received in four weeks. After vaccination on 13Apr2021, no issue w/injection site. a week later had trouble breathing, chest pain, felt like lungs were hurting in back, weak, tired, couldn't catch breath when he went upstairs, almost passed out. No treatment received for adverse event. No covid prior vaccination. No covid tested post vaccination. No known allergies. The outcome of events was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021636737 Same reporter/patient/product; different doses/events.
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Back pain, Chest pain, Dyspnoea, Fatigue
Clinical narrative: Passed out; Had troub breathing/couldn't catch breath when went upstairs; Chest pain; Felt like lungs were hurting in back; Weak; Tired; This is spontaneous report received from a contactable consumer (patient). This is the first of two reports with the events related to the first vaccine dose. A 44-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 13Apr2021 at 19:00 (Batch/Lot Number: ew0162) as 1st dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. No other vaccine received in four weeks. After vaccination on 13Apr2021, no issue w/injection site. a week later had trouble breathing, chest pain, felt like lungs were hurting in back, weak, tired, couldn't catch breath when he went upstairs, almost passed out. No treatment received for adverse event. No covid prior vaccination. No covid tested post vaccination. No known allergies. The outcome of events was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021636737 Same reporter/patient/product; different doses/events.
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Loss of consciousness
Clinical narrative: Passed out; Had troub breathing/couldn't catch breath when went upstairs; Chest pain; Felt like lungs were hurting in back; Weak; Tired; This is spontaneous report received from a contactable consumer (patient). This is the first of two reports with the events related to the first vaccine dose. A 44-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 13Apr2021 at 19:00 (Batch/Lot Number: ew0162) as 1st dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. No other vaccine received in four weeks. After vaccination on 13Apr2021, no issue w/injection site. a week later had trouble breathing, chest pain, felt like lungs were hurting in back, weak, tired, couldn't catch breath when he went upstairs, almost passed out. No treatment received for adverse event. No covid prior vaccination. No covid tested post vaccination. No known allergies. The outcome of events was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021636737 Same reporter/patient/product; different doses/events.
Age: 19.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Cardiac imaging procedure abnormal, Chest pain, Echocardiogram normal, Electrocardiogram abnormal
Clinical narrative: Got vaccinated on May 22 on a saturday at store/pharmacy with Moderna. This was the second dose of the vaccine. I use a smart watch to monitor my health 24/7. I noticed an unusual elevation in my heart pulse after the first vaccine but that went away in a few days and I was back to normal. After the second vaccine I had the usual expected symptoms of headaches etc which went away the next day. After receiving the second dose on saturday I experienced unusual chest pains on monday which lasted for a few while and I was fine the rest of the day. It was tuesday when things got worse. I had a very sharp chest pain which I had never experienced and it continued till I took Alegra. I thought it was heartburn but when I went to the hospital they did my EKG which showed some abnormalities. I was then diagnosed with Pericarditis. After staying in the hospital for 4 days. I was discharged with anti inflammatory meds. I hope to have a full recovery in a few weeks.
Age: 19.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Inflammation, Myocardial oedema, Myocarditis, Troponin increased
Clinical narrative: Got vaccinated on May 22 on a saturday at store/pharmacy with Moderna. This was the second dose of the vaccine. I use a smart watch to monitor my health 24/7. I noticed an unusual elevation in my heart pulse after the first vaccine but that went away in a few days and I was back to normal. After the second vaccine I had the usual expected symptoms of headaches etc which went away the next day. After receiving the second dose on saturday I experienced unusual chest pains on monday which lasted for a few while and I was fine the rest of the day. It was tuesday when things got worse. I had a very sharp chest pain which I had never experienced and it continued till I took Alegra. I thought it was heartburn but when I went to the hospital they did my EKG which showed some abnormalities. I was then diagnosed with Pericarditis. After staying in the hospital for 4 days. I was discharged with anti inflammatory meds. I hope to have a full recovery in a few weeks.
Age: 19.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Chest pain, Dyspepsia, Echocardiogram, Electrocardiogram abnormal
Clinical narrative: Got vaccinated on May 22 on a saturday at store/pharmacy with Moderna. This was the second dose of the vaccine. I use a smart watch to monitor my health 24/7. I noticed an unusual elevation in my heart pulse after the first vaccine but that went away in a few days and I was back to normal. After the second vaccine I had the usual expected symptoms of headaches etc which went away the next day. After receiving the second dose on saturday I experienced unusual chest pains on monday which lasted for a few while and I was fine the rest of the day. It was tuesday when things got worse. I had a very sharp chest pain which I had never experienced and it continued till I took Alegra. I thought it was heartburn but when I went to the hospital they did my EKG which showed some abnormalities. I was then diagnosed with Pericarditis. After staying in the hospital for 4 days. I was discharged with anti inflammatory meds. I hope to have a full recovery in a few weeks.
Age: 19.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache, Heart rate increased, Magnetic resonance imaging, Pericarditis
Clinical narrative: Got vaccinated on May 22 on a saturday at store/pharmacy with Moderna. This was the second dose of the vaccine. I use a smart watch to monitor my health 24/7. I noticed an unusual elevation in my heart pulse after the first vaccine but that went away in a few days and I was back to normal. After the second vaccine I had the usual expected symptoms of headaches etc which went away the next day. After receiving the second dose on saturday I experienced unusual chest pains on monday which lasted for a few while and I was fine the rest of the day. It was tuesday when things got worse. I had a very sharp chest pain which I had never experienced and it continued till I took Alegra. I thought it was heartburn but when I went to the hospital they did my EKG which showed some abnormalities. I was then diagnosed with Pericarditis. After staying in the hospital for 4 days. I was discharged with anti inflammatory meds. I hope to have a full recovery in a few weeks.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This is a spontaneous report from a contactable consumer via Medical Information Team. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 03May2021 (NDC number: Not provided, Expiry date: Not supplied) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Caller stated that someone she knows was supposed to get the second Pfizer Covid vaccine dose today 24May2021, but they currently have a shingles infection. She was referred to HCP and make caller aware of contraindications for receiving second dose of the vaccine as per attached fact sheet for HCPs administering vaccine. Caller on the line inquired about another person who was scheduled to get the COVID 19 Vaccine today, the second dose, but the person was having shingles. Patient got first dose on 03May2021 and second dose was scheduled for tonight. However, she wanted to know if it was okay for him to get the second dose being that he was currently having shingles. Caller declined to continue with report. Indicated she went through providing information to previous agent and she did not have time. No PQC present. Outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Chest discomfort, Dysphagia, Dyspnoea, Eye swelling
Clinical narrative: angioedema with need for epinephrine and transportation via 911 to local ER. Additional unknown treatment provided at ED
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Flushing, Hyperhidrosis, Hypertension, Mouth swelling, Swelling face
Clinical narrative: angioedema with need for epinephrine and transportation via 911 to local ER. Additional unknown treatment provided at ED
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swollen tongue, Throat tightness
Clinical narrative: angioedema with need for epinephrine and transportation via 911 to local ER. Additional unknown treatment provided at ED
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angioedema
Clinical narrative: angioedema with need for epinephrine and transportation via 911 to local ER. Additional unknown treatment provided at ED
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Injection site vesicles, Pyrexia
Clinical narrative: RECURRING BLISTER AT INJECTION SITE; SKIN UNDER BLISTERS FELT BURNED; RED CIRCLE AROUND INJECTION SITE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 07-JUN-2021, the subject experienced red circle around injection site. On an unspecified date, the subject experienced recurring blister at injection site, and skin under blisters felt burned. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from recurring blister at injection site, red circle around injection site, and skin under blisters felt burned. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Injection site erythema, Injection site vesicles, Skin burning sensation
Clinical narrative: RECURRING BLISTER AT INJECTION SITE; SKIN UNDER BLISTERS FELT BURNED; RED CIRCLE AROUND INJECTION SITE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 07-JUN-2021, the subject experienced red circle around injection site. On an unspecified date, the subject experienced recurring blister at injection site, and skin under blisters felt burned. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from recurring blister at injection site, red circle around injection site, and skin under blisters felt burned. This report was non-serious.
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acute respiratory failure, COVID-19, COVID-19 pneumonia, Chest X-ray abnormal, Cough
Clinical narrative: DRY COUGH, MALAISE, NAUSE, SORE THROAT, INCREASED SHORTNESS OF BREATH, FATIGUE
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypophagia, Hypoxia, Inappropriate schedule of product administration, Lung opacity, Malaise
Clinical narrative: DRY COUGH, MALAISE, NAUSE, SORE THROAT, INCREASED SHORTNESS OF BREATH, FATIGUE
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Nausea, Oropharyngeal pain, Pneumonia viral, Rheumatoid arthritis, SARS-CoV-2 test positive
Clinical narrative: DRY COUGH, MALAISE, NAUSE, SORE THROAT, INCREASED SHORTNESS OF BREATH, FATIGUE
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Chest X-ray, Cough, Dyspnoea, Fatigue
Clinical narrative: DRY COUGH, MALAISE, NAUSE, SORE THROAT, INCREASED SHORTNESS OF BREATH, FATIGUE
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Malaise, Nausea, Oropharyngeal pain, SARS-CoV-2 test positive
Clinical narrative: DRY COUGH, MALAISE, NAUSE, SORE THROAT, INCREASED SHORTNESS OF BREATH, FATIGUE