chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pustule, Vaccination site discolouration
Clinical narrative: Discoloration on and under the spot on the left arm,; blister that keeps getting bigger with pus in it.; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 16Jun2021 at 14:30 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history included none. Patient had no known allergies. Concomitant medications included loratadine (CLARITIN) from an unknown date for an unspecified indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17Jun2021 at 00:00, the patient experienced discoloration on and under the spot on the left arm, blister that kept getting bigger with pus in it. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. The clinical outcome of the events discoloration on and under the spot on the left arm, blister that kept getting bigger with pus in it was unknown.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Productive cough
Clinical narrative: mucous; Cough; she didn't feel bad or have an shortness of breath; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 72-years-old female patient received bnt162b2 (BNT162B2, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 04May2021 11:00 (Batch/Lot Number: EW0175; Expiration Date: Aug2021) as DOSE 2, SINGLE for covid-19 immunisation. Patient Age at Time of Vaccination was 72 years. Medical history mentions that she had a fainting spell a couple of years ago, before she got the shot she saw a cardiologist for a check up; and he listened to her lungs; she had no heart problems and she has high cholesterol. Family Medical History Relevant to AE stated that one sister and she got the Moderna and had no reaction at all. There were no concomitant medications. Caller stated she was not on any other prescription medications. Previously patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 04May2021 Time: 12:00 Noon (Batch/Lot Number: EW0161; Expiration Date: Jul2021) as DOSE 1, SINGLE for covid-19 immunisation. On an unknown date three weeks after second dose in Jun2021, the patient experienced mucous and cough. It was stated that she had made an appointment for a pulmonologist, she didn't feel bad or have a shortness of breath.Patient on the line calling regarding side effects after the second dose of the vaccine, the Pfizer COVID 19 vaccine. She had a lot of mucus and coughing for a few weeks. Wanted to know if there were reports about this side effect. She consulted a pulmonologist who required her to use an inhaler which will be for a lifetime. Caller confirmed information provided by transfer agent but states she ended up not using the inhaler. It was probably about three weeks after the vaccine that she realized she had mucous, it built up gradually. She went to a pulmonologist in the middle of Jun2021. Adds she had gotten the second shot in May2021. Then she made the appointment in Jun2021 and was seen about three days later. Reported for about two or three weeks it was not just a cough but spitting up mucus too. Stated the doctor wanted her to use the inhaler but when she read about it she decided not to start it. By the middle of Jun2021 she was already getting over it and after another week or two weeks she was fine. Added it was noticeable at three weeks; then for two weeks bad it was bad; and then it went away; it was about a month total. Added she did research online about this. She just wants to make sure she will be okay not using the inhaler. Added a few weeks ago she reported her event to VAERS. Patient was not in emergency room. The outcome of the event was recovered.   Follow-up attempts are completed. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Dyspnoea, Secretion discharge
Clinical narrative: mucous; Cough; she didn't feel bad or have an shortness of breath; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 72-years-old female patient received bnt162b2 (BNT162B2, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 04May2021 11:00 (Batch/Lot Number: EW0175; Expiration Date: Aug2021) as DOSE 2, SINGLE for covid-19 immunisation. Patient Age at Time of Vaccination was 72 years. Medical history mentions that she had a fainting spell a couple of years ago, before she got the shot she saw a cardiologist for a check up; and he listened to her lungs; she had no heart problems and she has high cholesterol. Family Medical History Relevant to AE stated that one sister and she got the Moderna and had no reaction at all. There were no concomitant medications. Caller stated she was not on any other prescription medications. Previously patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 04May2021 Time: 12:00 Noon (Batch/Lot Number: EW0161; Expiration Date: Jul2021) as DOSE 1, SINGLE for covid-19 immunisation. On an unknown date three weeks after second dose in Jun2021, the patient experienced mucous and cough. It was stated that she had made an appointment for a pulmonologist, she didn't feel bad or have a shortness of breath.Patient on the line calling regarding side effects after the second dose of the vaccine, the Pfizer COVID 19 vaccine. She had a lot of mucus and coughing for a few weeks. Wanted to know if there were reports about this side effect. She consulted a pulmonologist who required her to use an inhaler which will be for a lifetime. Caller confirmed information provided by transfer agent but states she ended up not using the inhaler. It was probably about three weeks after the vaccine that she realized she had mucous, it built up gradually. She went to a pulmonologist in the middle of Jun2021. Adds she had gotten the second shot in May2021. Then she made the appointment in Jun2021 and was seen about three days later. Reported for about two or three weeks it was not just a cough but spitting up mucus too. Stated the doctor wanted her to use the inhaler but when she read about it she decided not to start it. By the middle of Jun2021 she was already getting over it and after another week or two weeks she was fine. Added it was noticeable at three weeks; then for two weeks bad it was bad; and then it went away; it was about a month total. Added she did research online about this. She just wants to make sure she will be okay not using the inhaler. Added a few weeks ago she reported her event to VAERS. Patient was not in emergency room. The outcome of the event was recovered.   Follow-up attempts are completed. No further information is expected.
Age: 12.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Pyrexia, Vomiting
Clinical narrative: Fever 101.3; Chills; vomiting; This is a spontaneous report from a contactable consumer, the patient. A 12-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0196) via an unspecified route of administration in the left arm on 19Jun2021 at 14:30 (at the age of 12-years-old) as a single dose for COVID-19 immunisation. Medical history included General Anxiety Disorder (GAD) and depression. Concomitant medications included fluoxetine (MANUFACTURER UNKNOWN) and trazodone (MANUFACTURER UNKNOWN), both taken for unspecified indications from unknown dates. The patient previously took septra and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0191) via an unspecified route of administration in the left arm on 29May2021 at 14:30 (at the age of 12-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Jun2021 at 04:45, the patient experienced fever 101.3 and chills, on the same day at 05:15, 07:30 and 09:15 the patient experienced vomiting. The patient had skipped fluoxetine that morning due to vomiting. Therapeutic measures were taken as a result of fever and included treatment with Motrin. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events fever and projectile vomiting were resolved on 20Jun2021 and chills was resolved on an unspecified date in Jun2021.
Age: 12.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Chills, Pyrexia, Vomiting
Clinical narrative: Fever 101.3; Chills; vomiting; This is a spontaneous report from a contactable consumer, the patient. A 12-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0196) via an unspecified route of administration in the left arm on 19Jun2021 at 14:30 (at the age of 12-years-old) as a single dose for COVID-19 immunisation. Medical history included General Anxiety Disorder (GAD) and depression. Concomitant medications included fluoxetine (MANUFACTURER UNKNOWN) and trazodone (MANUFACTURER UNKNOWN), both taken for unspecified indications from unknown dates. The patient previously took septra and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0191) via an unspecified route of administration in the left arm on 29May2021 at 14:30 (at the age of 12-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Jun2021 at 04:45, the patient experienced fever 101.3 and chills, on the same day at 05:15, 07:30 and 09:15 the patient experienced vomiting. The patient had skipped fluoxetine that morning due to vomiting. Therapeutic measures were taken as a result of fever and included treatment with Motrin. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events fever and projectile vomiting were resolved on 20Jun2021 and chills was resolved on an unspecified date in Jun2021.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Urticaria
Clinical narrative: headache; tiredness; large outbreak of hives on my legs; After a week a sudden pain came to the back of my right leg; Sore in joints; tingling/numbness in legs/tingling in hands; numbness in legs; Pain had been intense and made it hard to walk, take stairs, bend, etc.; Pain had been intense and made it hard to walk, take stairs, bend, etc.; Feels like arthritis overnight; This is a spontaneous report from a contactable consumer (patient). A 38-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0185, Expiration date: Unknown), via an unspecified route of administration, administered in right arm on 16May2021 18:30 (at the age of 38-years-old) as dose 1, single for covid-19 immunisation in other facility. No other vaccine was administered in four weeks. No other medications were given in two weeks. The patient did not have covid prior vaccination. The patient was not tested for covid post vaccination. The patient did not have known allergies. Medical history included covid-19 from Mar2020 to an unknown date. There were no concomitant medications. On 17May2021 at 07:00, the patient experienced headache, tiredness, large outbreak of hives on her legs, after a week a sudden pain came to the back of her right leg, sore in joints, tingling/numbness in legs/tingling in hands, numbness in legs, pain had been intense and made it hard to walk, take stairs, bend, etc and feels like arthritis overnight. The events result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No treatment was given for the events. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Arthritis, Fatigue, Gait disturbance, Headache
Clinical narrative: headache; tiredness; large outbreak of hives on my legs; After a week a sudden pain came to the back of my right leg; Sore in joints; tingling/numbness in legs/tingling in hands; numbness in legs; Pain had been intense and made it hard to walk, take stairs, bend, etc.; Pain had been intense and made it hard to walk, take stairs, bend, etc.; Feels like arthritis overnight; This is a spontaneous report from a contactable consumer (patient). A 38-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0185, Expiration date: Unknown), via an unspecified route of administration, administered in right arm on 16May2021 18:30 (at the age of 38-years-old) as dose 1, single for covid-19 immunisation in other facility. No other vaccine was administered in four weeks. No other medications were given in two weeks. The patient did not have covid prior vaccination. The patient was not tested for covid post vaccination. The patient did not have known allergies. Medical history included covid-19 from Mar2020 to an unknown date. There were no concomitant medications. On 17May2021 at 07:00, the patient experienced headache, tiredness, large outbreak of hives on her legs, after a week a sudden pain came to the back of her right leg, sore in joints, tingling/numbness in legs/tingling in hands, numbness in legs, pain had been intense and made it hard to walk, take stairs, bend, etc and feels like arthritis overnight. The events result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No treatment was given for the events. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Pain, Pain in extremity, Paraesthesia, Urticaria
Clinical narrative: headache; tiredness; large outbreak of hives on my legs; After a week a sudden pain came to the back of my right leg; Sore in joints; tingling/numbness in legs/tingling in hands; numbness in legs; Pain had been intense and made it hard to walk, take stairs, bend, etc.; Pain had been intense and made it hard to walk, take stairs, bend, etc.; Feels like arthritis overnight; This is a spontaneous report from a contactable consumer (patient). A 38-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0185, Expiration date: Unknown), via an unspecified route of administration, administered in right arm on 16May2021 18:30 (at the age of 38-years-old) as dose 1, single for covid-19 immunisation in other facility. No other vaccine was administered in four weeks. No other medications were given in two weeks. The patient did not have covid prior vaccination. The patient was not tested for covid post vaccination. The patient did not have known allergies. Medical history included covid-19 from Mar2020 to an unknown date. There were no concomitant medications. On 17May2021 at 07:00, the patient experienced headache, tiredness, large outbreak of hives on her legs, after a week a sudden pain came to the back of her right leg, sore in joints, tingling/numbness in legs/tingling in hands, numbness in legs, pain had been intense and made it hard to walk, take stairs, bend, etc and feels like arthritis overnight. The events result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No treatment was given for the events. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Herpes zoster, Pain in extremity, Rash
Clinical narrative: pain in my left hip and thigh; pain in my left hip and thigh; painful rash developed from the left side of my lower back, left hip/thigh all the way down to my toes; Shingles; This is a spontaneous report form a contactable consumer (patient) reported for herself. A 54-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 18May2021 at 12:00 pm (age at vaccination was 54 years) as dose 1, single for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications included ramipril, simvastatin, acetaminophen and aspirin [acetylsalicylic acid] all taken for an unspecified indication. The patient previously took Penicillin and experienced drug allergy. 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. On 05Jun2021 at 08:00 am, the patient experienced pain in his left hip and thigh, painful rash developed from the left side of his lower back, left hip/thigh all the way down to his toes and shingles. 18 days after receiving the first dose, the patient began having pain in his left hip and thigh then a painful rash developed from the left side of his lower back, left hip/thigh all the way down to his toes. He was diagnosed by two separate doctors as having Shingles. The adverse event resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient received treatment with Valacyclovir, Prednisone and Gabapentin. The outcome of the events was not resolved.  Follow up attempts are needed. Further information has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Chills, Cold sweat, Feeding disorder, Headache
Clinical narrative: Very hurtful arm, barely moving; Throwing up; Chills; Teeth were chattering; Feeling very weak; This is a spontaneous report from a contactable consumer or other non healthcare professional. A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced very hurtful arm, barely moving leading to limb injury, vomiting, chills, teeth were chattering and feeling very weak on an unspecified date with outcome of unknown. She had the shot at 12:20 in the morning and 09:30 at night it start getting very hurtful arm, barely moving and she started throwing up about every 20 minutes she was throwing up until 6 am. she had chills, very big chills, like 97 degrees, she had the blanket like in the winter, she had jacket and was with chills and her teeth was chattering. she was feeling very weak and every 20-30 minutes she was puking and then there was nothing to puke after a while. It lasted until 6 am, she was extremely weak and the chills went away and the stomach was not throwing up and for a whole day she only had 2 cans of sprite sipping because water would not stay down, anything could not stay down, she was extremely weak and that about it and was in pain, Her daughter and husband with the second vaccine were even worse. They had all the symptoms but had but for 4 days.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021758769 Same reporter/drug/AE, different patient;US-PFIZER INC-2021758768 Same reporter/drug/AE, different patient
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Vomiting
Clinical narrative: Very hurtful arm, barely moving; Throwing up; Chills; Teeth were chattering; Feeling very weak; This is a spontaneous report from a contactable consumer or other non healthcare professional. A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced very hurtful arm, barely moving leading to limb injury, vomiting, chills, teeth were chattering and feeling very weak on an unspecified date with outcome of unknown. She had the shot at 12:20 in the morning and 09:30 at night it start getting very hurtful arm, barely moving and she started throwing up about every 20 minutes she was throwing up until 6 am. she had chills, very big chills, like 97 degrees, she had the blanket like in the winter, she had jacket and was with chills and her teeth was chattering. she was feeling very weak and every 20-30 minutes she was puking and then there was nothing to puke after a while. It lasted until 6 am, she was extremely weak and the chills went away and the stomach was not throwing up and for a whole day she only had 2 cans of sprite sipping because water would not stay down, anything could not stay down, she was extremely weak and that about it and was in pain, Her daughter and husband with the second vaccine were even worse. They had all the symptoms but had but for 4 days.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021758769 Same reporter/drug/AE, different patient;US-PFIZER INC-2021758768 Same reporter/drug/AE, different patient
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Chills, Limb injury, Vomiting
Clinical narrative: Very hurtful arm, barely moving; Throwing up; Chills; Teeth were chattering; Feeling very weak; This is a spontaneous report from a contactable consumer or other non healthcare professional. A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced very hurtful arm, barely moving leading to limb injury, vomiting, chills, teeth were chattering and feeling very weak on an unspecified date with outcome of unknown. She had the shot at 12:20 in the morning and 09:30 at night it start getting very hurtful arm, barely moving and she started throwing up about every 20 minutes she was throwing up until 6 am. she had chills, very big chills, like 97 degrees, she had the blanket like in the winter, she had jacket and was with chills and her teeth was chattering. she was feeling very weak and every 20-30 minutes she was puking and then there was nothing to puke after a while. It lasted until 6 am, she was extremely weak and the chills went away and the stomach was not throwing up and for a whole day she only had 2 cans of sprite sipping because water would not stay down, anything could not stay down, she was extremely weak and that about it and was in pain, Her daughter and husband with the second vaccine were even worse. They had all the symptoms but had but for 4 days.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021758769 Same reporter/drug/AE, different patient;US-PFIZER INC-2021758768 Same reporter/drug/AE, different patient
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Pain in extremity, Skin warm, Swelling
Clinical narrative: Swelling, approximately 4.5 cm wide; 6 cm high; warm to the touch, approximately 4.5 cm wide; 6 cm high; Redness, approximately 4.5 cm wide; 6 cm high; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0178) via an unspecified route of administration in the right arm on 15Jun2021 at 13:15 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. It was reported that the patient participated in Non-Pfizer study, phase 1. Received first dose on 15Sep2000; subsequent injections were placebo. Once results were unblinded, she had an COVID antibodies test which was negative. Concomitant medications included duloxetine hydrochloride (duloxetine HCL) (MANUFACTURER UNKNOWN), paracetamol (TYLENOL 8 HR) and diphenhydramine, paracetamol, phenylpropanolamine hydrochloride (BENADRYL). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22Jun2021 at 09:00, the patient experienced swelling, warm to the touch and redness; approximately 4.5 cm wide; 6 cm high. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the events swelling, warm to the touch and redness; approximately 4.5 cm wide; 6 cm high were not recovered at the time of this report.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Swelling, approximately 4.5 cm wide; 6 cm high; warm to the touch, approximately 4.5 cm wide; 6 cm high; Redness, approximately 4.5 cm wide; 6 cm high; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0178) via an unspecified route of administration in the right arm on 15Jun2021 at 13:15 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. It was reported that the patient participated in Non-Pfizer study, phase 1. Received first dose on 15Sep2000; subsequent injections were placebo. Once results were unblinded, she had an COVID antibodies test which was negative. Concomitant medications included duloxetine hydrochloride (duloxetine HCL) (MANUFACTURER UNKNOWN), paracetamol (TYLENOL 8 HR) and diphenhydramine, paracetamol, phenylpropanolamine hydrochloride (BENADRYL). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22Jun2021 at 09:00, the patient experienced swelling, warm to the touch and redness; approximately 4.5 cm wide; 6 cm high. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the events swelling, warm to the touch and redness; approximately 4.5 cm wide; 6 cm high were not recovered at the time of this report.
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Dizziness, Dyspnoea, Echocardiogram, Heart rate
Clinical narrative: Daily fluctuation in BP and pulse; Unable to resume regular day to day activities including office work; 100 degree fever; chills; The blood pressure shot up to 165-95/BP at 165-90/BP shoot up to 170-90/rise in BP; heart rate was around 140/pulse was at 150/pulse 145/rise in BP and pulse; Was feeling breathless; sweaty; Always feeling dizzy; lightheaded; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 43-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported and expiry date: unknown), dose 2 via an unspecified route of administration, administered in Arm Left on 22May2021 at 15:30 as DOSE 2 (age at vaccination: 43-years-old), SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient had no known allergies. Concomitant medications included fish oil (FISH OIL), vitamin b12 [vitamin b12 nos] (VITAMIN B12 [VITAMIN B12 NOS]). After 2nd dose following events occur deteriorating overall health. The patient received dose 1 of bnt162b2 on 27APR2021 for COVID-19 immunization (administration time: 09:30 AM, vaccine location: Left arm). The patient did not have any preexisting health conditions. 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. The patient experienced dose number=2/administration date=22may2021/dose number=1/administration date=27apr2021 on 22May2021 at 15:30, 100 degree fever, chills, the blood pressure shot up to 165-95/bp at 165-90/bp shoot up to 170-90/rise in bp, heart rate was around 140/pulse was at 150/pulse 145/rise in bp and pulse, was feeling breathless, sweaty, always feeling dizzy, lightheaded, daily fluctuation in bp and pulse and unable to resume regular day to day activities including office work on 24May2021 at 00:15. Consulted cardiologist and on Metoprolol medicine as a treatment for the events (IV administered, metoprolol prescribed). The event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient underwent lab tests and procedures which included blood pressure measurement: 165-95 on 24May2021 (The blood pressure shot up to 165-95), blood pressure measurement: 165-90 on 30May2021, blood pressure measurement: 170-90   on 31May2021, blood test: unknown results on an unknown date, cardiac stress test: unknown results on an unknown date, echocardiogram: unknown results on an unknown date, heart rate: 140 on 24May2021, heart rate: 150 on 30May2021, heart rate: 145 on 31May2021, x-ray: unknown results on an unknown date. Outcome of all the events was not recovered.  Information about lot and batch number was requested.  Amendment: This follow-up report is being submitted to amend previously reported information: event Inappropriate dose of vaccine administered was deleted.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Stomatitis, Throat irritation
Clinical narrative: Severe Headache; Fatigue; Mouth sores; Upset stomach; Anxiety; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 21May2021 at 11:00 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Other medical history not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 30Apr2021 at 11:00 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21May2021 at 16:00, the patient experienced severe headache, fatigue, mouth sores, upset stomach and anxiety. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, fatigue, mouth sores, upset stomach and anxiety was not recovered at the time of this report.   The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Anxiety, Fatigue, Headache, Stomatitis
Clinical narrative: Severe Headache; Fatigue; Mouth sores; Upset stomach; Anxiety; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 21May2021 at 11:00 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Other medical history not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 30Apr2021 at 11:00 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21May2021 at 16:00, the patient experienced severe headache, fatigue, mouth sores, upset stomach and anxiety. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, fatigue, mouth sores, upset stomach and anxiety was not recovered at the time of this report.   The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest X-ray normal, Chest pain, Computerised tomogram thorax, Dyspnoea, Echocardiogram
Clinical narrative: After second dose-Chest pain lasting for 10 days.; Low grade fever; Shortness of breath; Elevated heart rate (ongoing); This is a spontaneous report from a contactable consumer. This 40-Years-Old female consumer reported for herself that.  A 40-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0187), dose 2 via an unspecified route of administration, administered in Arm Right on 21May2021 11:45 as (At the age of 40-years) DOSE 2, SINGLE for covid-19 immunisation. Medical history included food allergy from an unknown date and unknown if ongoing. No other medical history diagnosed illness/chronic health conditions. The patient's concomitant included Multivitamin (Naturelo One daily Women multi). No covid prior vaccination. No covid tested post vaccination. Patient was not pregnant at the time of vaccination. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0171), dose 1 via an unspecified route of administration, administered in Arm Right on 30Apr2021 11:45 as (At the age of 40-years) DOSE 1, SINGLE for covid-19 immunisation. The patient experienced Chest pain lasting for 10 days, and then intermittent pain. Low grade fever Shortness of breath and Elevated heart rate on 21May2021 19:00. Patient did not receive any treatment for events. The outcome of events was recovering.  Follow-up attempts are completed. No further information is expected
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Electrocardiogram ambulatory, Electrocardiogram normal, Fibrin D dimer increased, Heart rate increased, Lymphadenopathy
Clinical narrative: After second dose-Chest pain lasting for 10 days.; Low grade fever; Shortness of breath; Elevated heart rate (ongoing); This is a spontaneous report from a contactable consumer. This 40-Years-Old female consumer reported for herself that.  A 40-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0187), dose 2 via an unspecified route of administration, administered in Arm Right on 21May2021 11:45 as (At the age of 40-years) DOSE 2, SINGLE for covid-19 immunisation. Medical history included food allergy from an unknown date and unknown if ongoing. No other medical history diagnosed illness/chronic health conditions. The patient's concomitant included Multivitamin (Naturelo One daily Women multi). No covid prior vaccination. No covid tested post vaccination. Patient was not pregnant at the time of vaccination. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0171), dose 1 via an unspecified route of administration, administered in Arm Right on 30Apr2021 11:45 as (At the age of 40-years) DOSE 1, SINGLE for covid-19 immunisation. The patient experienced Chest pain lasting for 10 days, and then intermittent pain. Low grade fever Shortness of breath and Elevated heart rate on 21May2021 19:00. Patient did not receive any treatment for events. The outcome of events was recovering.  Follow-up attempts are completed. No further information is expected
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest pain, Dyspnoea, Heart rate increased, Pyrexia
Clinical narrative: After second dose-Chest pain lasting for 10 days.; Low grade fever; Shortness of breath; Elevated heart rate (ongoing); This is a spontaneous report from a contactable consumer. This 40-Years-Old female consumer reported for herself that.  A 40-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0187), dose 2 via an unspecified route of administration, administered in Arm Right on 21May2021 11:45 as (At the age of 40-years) DOSE 2, SINGLE for covid-19 immunisation. Medical history included food allergy from an unknown date and unknown if ongoing. No other medical history diagnosed illness/chronic health conditions. The patient's concomitant included Multivitamin (Naturelo One daily Women multi). No covid prior vaccination. No covid tested post vaccination. Patient was not pregnant at the time of vaccination. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0171), dose 1 via an unspecified route of administration, administered in Arm Right on 30Apr2021 11:45 as (At the age of 40-years) DOSE 1, SINGLE for covid-19 immunisation. The patient experienced Chest pain lasting for 10 days, and then intermittent pain. Low grade fever Shortness of breath and Elevated heart rate on 21May2021 19:00. Patient did not receive any treatment for events. The outcome of events was recovering.  Follow-up attempts are completed. No further information is expected
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: C-reactive protein increased, Cardiac imaging procedure abnormal, Chest pain, Myocarditis, Pain
Clinical narrative: Inflammation of his heart; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDITIS (Inflammation of his heart) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026D21A and 049C21A) for COVID-19 vaccination.   No Medical History information was reported.   On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Jun-2021, the patient experienced MYOCARDITIS (Inflammation of his heart) (seriousness criteria hospitalization prolonged and medically significant). The patient was hospitalized from 19-Jun-2021 to 23-Jun-2021 due to MYOCARDITIS. At the time of the report, MYOCARDITIS (Inflammation of his heart) outcome was unknown.         No concomitant medications were provided.  No treatment information was provided.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-286631 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Painful respiration, Sleep disorder, Troponin increased
Clinical narrative: Inflammation of his heart; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDITIS (Inflammation of his heart) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026D21A and 049C21A) for COVID-19 vaccination.   No Medical History information was reported.   On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Jun-2021, the patient experienced MYOCARDITIS (Inflammation of his heart) (seriousness criteria hospitalization prolonged and medically significant). The patient was hospitalized from 19-Jun-2021 to 23-Jun-2021 due to MYOCARDITIS. At the time of the report, MYOCARDITIS (Inflammation of his heart) outcome was unknown.         No concomitant medications were provided.  No treatment information was provided.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-286631 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myocarditis
Clinical narrative: Inflammation of his heart; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDITIS (Inflammation of his heart) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026D21A and 049C21A) for COVID-19 vaccination.   No Medical History information was reported.   On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Jun-2021, the patient experienced MYOCARDITIS (Inflammation of his heart) (seriousness criteria hospitalization prolonged and medically significant). The patient was hospitalized from 19-Jun-2021 to 23-Jun-2021 due to MYOCARDITIS. At the time of the report, MYOCARDITIS (Inflammation of his heart) outcome was unknown.         No concomitant medications were provided.  No treatment information was provided.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-286631 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urinary tract infection
Clinical narrative: developed urinary tract infection 3 days after the vaccine. (this was the 2nd dose.); This is a spontaneous report from a contactable consumer (patient, reported for herself). A 63-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Reason why batch/lot is Unknown: Not available/provided to reporter at the time of report completion), dose 2 via an unspecified route of administration, administered in Arm Left on 16May2021 (Batch/Lot number was not reported) (at the age of 63-year-old) as Dose 2, Single for COVID-19 immunization. Medical history included Known allergies: sulfa, UTI (I have not had a UTI in 10 or 15 years (estimated). Other history: N/A. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient concomitant medications received within 2 weeks of vaccination: multi-vitamin. Historical Vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Reason why batch/lot is Unknown: Unable to locate or read the details), dose 1 via an unspecified route of administration, administered in Arm Left on 25Apr2021 08:30 AM (Batch/Lot number was not reported) (at the age of 63-year-old) as Dose 1, Single for COVID-19 immunization and Urinary Tract Infection came on suddenly 5 days after receiving the vaccine (Start Date/Time: 25Apr2021 08:30 AM. Reason why batch/lot is Unknown: Unable to locate or read the details. Facility where the most recent COVID-19 vaccine was administered included Public Health Clinic/Veterans Administration facility. Reported Event: Urinary Tract Infection came on suddenly 5 days after receiving the vaccine.  (Vaccine on 25Apr2021, UTI on 30Apr2021). This is very unusual; I have not had a UTI in 10 or 15 years (estimated). Adverse event start date and time: 30Apr2021 03:30 AM. If patient recovered: Recovered. If treatment AE: Yes. The adverse event result in Doctor or other healthcare professional office/clinic visit. Treatment received for the adverse event as Doctor prescribed antibiotic. Device Date: 07May2021). On 19May2021, the patient experienced developed urinary tract infection 3 days after the vaccine. (this was the 2nd dose.) (non-serious). Event Verbatim: Developed Urinary Tract Infection 3 days after the vaccine. (This was the 2nd dose.) Note that I also developed a UTI 5 days after the 1st vaccine. I reported this separately. It was extremely unusual for me to have a UTI. Adverse event start date: 19May2021. Facility where the most recent COVID-19 vaccine was administered was provided as Other. The adverse event result in Doctor or other healthcare professional office/clinic visit. Treatment was received for the adverse event. Treatment received for the adverse event as Doctor prescribed antibiotic. The outcome of event was recovered on an unspecified date in 2021.  Information on Lot/Batch number was available. Additional information has been requested.