chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Anal incontinence, Death, Drug screen negative, Toxicologic test normal
Clinical narrative: she died; This is a spontaneous report from a contactable physician. A 33-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/lot number: EL3247, expiration date: 31May2021) via an unspecified route of administration in left deltoid on 28Jan2021 13:20 at single dose for COVID-19 immunization. Medical history included asthma; optic neuritis. Concomitant medication included glatiramer acetate (COPAXONE) for optic neuritis, at the scene there was an injectable for optic neuritis, physician believed it was glatiramer acetate, he did not know the dosage, but it was three times per week. Sixteen hours after receiving the vaccine patient was found dead at her home. The cause of death was unknown. They just knew within 24 hours of receiving the vaccine in her left deltoid she died. Patient did not indicate she had any allergies or co-morbidities. One autopsy had been done, but it was pending. The actual date patient away if it was 28Jan2021 or 29Jan2021 was unknown as well at this time. The physician only knew she was found dead in home 16 hours after getting the vaccine. The physician stated he did not know what that dose was and questioned if it was 0.5ml. At end of call, physician stated he expected someone to call him back so they can determine the relationship of this to the vaccine. There were no additional vaccines administered on the same date of the Pfizer suspect. No vaccinations within 4 weeks. The outcome of the event was fatal.; Sender's Comments: The causal relationship between BNT162B2and the event death cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: she died
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Autopsy, Hyponatraemia, Immunomodulatory therapy, Laboratory test, Myocardial fibrosis
Clinical narrative: she died; This is a spontaneous report from a contactable physician. A 33-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/lot number: EL3247, expiration date: 31May2021) via an unspecified route of administration in left deltoid on 28Jan2021 13:20 at single dose for COVID-19 immunization. Medical history included asthma; optic neuritis. Concomitant medication included glatiramer acetate (COPAXONE) for optic neuritis, at the scene there was an injectable for optic neuritis, physician believed it was glatiramer acetate, he did not know the dosage, but it was three times per week. Sixteen hours after receiving the vaccine patient was found dead at her home. The cause of death was unknown. They just knew within 24 hours of receiving the vaccine in her left deltoid she died. Patient did not indicate she had any allergies or co-morbidities. One autopsy had been done, but it was pending. The actual date patient away if it was 28Jan2021 or 29Jan2021 was unknown as well at this time. The physician only knew she was found dead in home 16 hours after getting the vaccine. The physician stated he did not know what that dose was and questioned if it was 0.5ml. At end of call, physician stated he expected someone to call him back so they can determine the relationship of this to the vaccine. There were no additional vaccines administered on the same date of the Pfizer suspect. No vaccinations within 4 weeks. The outcome of the event was fatal.; Sender's Comments: The causal relationship between BNT162B2and the event death cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: she died
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Myocardial ischaemia, Obesity, Pericardial effusion, Sudden death, Syncope
Clinical narrative: she died; This is a spontaneous report from a contactable physician. A 33-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/lot number: EL3247, expiration date: 31May2021) via an unspecified route of administration in left deltoid on 28Jan2021 13:20 at single dose for COVID-19 immunization. Medical history included asthma; optic neuritis. Concomitant medication included glatiramer acetate (COPAXONE) for optic neuritis, at the scene there was an injectable for optic neuritis, physician believed it was glatiramer acetate, he did not know the dosage, but it was three times per week. Sixteen hours after receiving the vaccine patient was found dead at her home. The cause of death was unknown. They just knew within 24 hours of receiving the vaccine in her left deltoid she died. Patient did not indicate she had any allergies or co-morbidities. One autopsy had been done, but it was pending. The actual date patient away if it was 28Jan2021 or 29Jan2021 was unknown as well at this time. The physician only knew she was found dead in home 16 hours after getting the vaccine. The physician stated he did not know what that dose was and questioned if it was 0.5ml. At end of call, physician stated he expected someone to call him back so they can determine the relationship of this to the vaccine. There were no additional vaccines administered on the same date of the Pfizer suspect. No vaccinations within 4 weeks. The outcome of the event was fatal.; Sender's Comments: The causal relationship between BNT162B2and the event death cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: she died
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscle twitching, Pain in extremity, Paraesthesia
Clinical narrative: could barely feel anything; 45 min after vaccine my left arm and left leg got tingly, throughout the day, my right hand tingly, face, neck and chest, then stomach/electrical impulse feeling; I was getting nerve/muscle spasms; I was getting nerve/muscle spasms; twitching and electrical impulse feeling; This is a spontaneous report from a contactable healthcare professional (patient). A 41-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL1284, expiration date unspecified), via an unspecified route of administration on 13Jan2021 09:30 at single dose (left arm) for COVID-19 immunization.  Medical history included Graves's disease, celiac disease, fibromyalgia, and Allergies: Sulfa.  The patient was not pregnant. Concomitant medications included ibuprofen (MOTRIN), zinc, ascorbic acid (VITAMIN C), vitamin d3, levothyroxine sodium (LEVOTHYROX), and lidocaine, prilocaine (LEVA SET). The patient previously took sulfamethoxazole and trimethoprim (BACTRIM) and venlafaxine (EFFEXOR) and experienced allergies. On 13Jan2021, 10:15, 45 min after vaccine, her left arm and left leg got tingly, throughout the day, her right hand was tingly, face, neck and chest, then stomach and she was getting nerve/muscle spasms, twitching and electrical impulse feeling. By the end of the day, it started getting better. It was reported that on Sunday, 17Jan2021 , she could barely feel anything. Then, through Monday and Tuesday, it started up again. It has been continuing until today, 6 days after the vaccine. The patient had no therapy for the events. The patient was asking if she should get the second dose after she had events. The patient had no other vaccine in 4 weeks; patient did not had Covid prior to vaccination and was Covid tested post vaccination. The patient underwent lab tests and procedures which included nasal swab which was negative on 10Jan2021. Outcome of event could barely feel anything was unknown; outcome of the rest of events was not recovered.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Muscle spasms, Muscle twitching, Nervous system disorder, Paraesthesia
Clinical narrative: could barely feel anything; 45 min after vaccine my left arm and left leg got tingly, throughout the day, my right hand tingly, face, neck and chest, then stomach/electrical impulse feeling; I was getting nerve/muscle spasms; I was getting nerve/muscle spasms; twitching and electrical impulse feeling; This is a spontaneous report from a contactable healthcare professional (patient). A 41-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL1284, expiration date unspecified), via an unspecified route of administration on 13Jan2021 09:30 at single dose (left arm) for COVID-19 immunization.  Medical history included Graves's disease, celiac disease, fibromyalgia, and Allergies: Sulfa.  The patient was not pregnant. Concomitant medications included ibuprofen (MOTRIN), zinc, ascorbic acid (VITAMIN C), vitamin d3, levothyroxine sodium (LEVOTHYROX), and lidocaine, prilocaine (LEVA SET). The patient previously took sulfamethoxazole and trimethoprim (BACTRIM) and venlafaxine (EFFEXOR) and experienced allergies. On 13Jan2021, 10:15, 45 min after vaccine, her left arm and left leg got tingly, throughout the day, her right hand was tingly, face, neck and chest, then stomach and she was getting nerve/muscle spasms, twitching and electrical impulse feeling. By the end of the day, it started getting better. It was reported that on Sunday, 17Jan2021 , she could barely feel anything. Then, through Monday and Tuesday, it started up again. It has been continuing until today, 6 days after the vaccine. The patient had no therapy for the events. The patient was asking if she should get the second dose after she had events. The patient had no other vaccine in 4 weeks; patient did not had Covid prior to vaccination and was Covid tested post vaccination. The patient underwent lab tests and procedures which included nasal swab which was negative on 10Jan2021. Outcome of event could barely feel anything was unknown; outcome of the rest of events was not recovered.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 antibody test
Clinical narrative: could barely feel anything; 45 min after vaccine my left arm and left leg got tingly, throughout the day, my right hand tingly, face, neck and chest, then stomach/electrical impulse feeling; I was getting nerve/muscle spasms; I was getting nerve/muscle spasms; twitching and electrical impulse feeling; This is a spontaneous report from a contactable healthcare professional (patient). A 41-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL1284, expiration date unspecified), via an unspecified route of administration on 13Jan2021 09:30 at single dose (left arm) for COVID-19 immunization.  Medical history included Graves's disease, celiac disease, fibromyalgia, and Allergies: Sulfa.  The patient was not pregnant. Concomitant medications included ibuprofen (MOTRIN), zinc, ascorbic acid (VITAMIN C), vitamin d3, levothyroxine sodium (LEVOTHYROX), and lidocaine, prilocaine (LEVA SET). The patient previously took sulfamethoxazole and trimethoprim (BACTRIM) and venlafaxine (EFFEXOR) and experienced allergies. On 13Jan2021, 10:15, 45 min after vaccine, her left arm and left leg got tingly, throughout the day, her right hand was tingly, face, neck and chest, then stomach and she was getting nerve/muscle spasms, twitching and electrical impulse feeling. By the end of the day, it started getting better. It was reported that on Sunday, 17Jan2021 , she could barely feel anything. Then, through Monday and Tuesday, it started up again. It has been continuing until today, 6 days after the vaccine. The patient had no therapy for the events. The patient was asking if she should get the second dose after she had events. The patient had no other vaccine in 4 weeks; patient did not had Covid prior to vaccination and was Covid tested post vaccination. The patient underwent lab tests and procedures which included nasal swab which was negative on 10Jan2021. Outcome of event could barely feel anything was unknown; outcome of the rest of events was not recovered.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram, Electrocardiogram ambulatory, Palpitations
Clinical narrative: Heart palpitations; This is a spontaneous report from a contactable consumer (patient herself). A 46-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EL3247), via an unspecified route of administration (left arm), on 18Jan2021 10:30, at single dose, for covid-19 immunization. The patient has no medical history and has no known allergies. There were no concomitant medications. The patient experienced heart palpitations which began on 18Jan2021 the evening of taking the vaccine and have continued until now. Further reported that this adverse event started on 18Jan2021 10:00 AM. No treatment was received for the event reported. The patient was recovering from the event. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID prior vaccination and have not been COVID tested post vaccination.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Palpitations
Clinical narrative: Heart palpitations; This is a spontaneous report from a contactable consumer (patient herself). A 46-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EL3247), via an unspecified route of administration (left arm), on 18Jan2021 10:30, at single dose, for covid-19 immunization. The patient has no medical history and has no known allergies. There were no concomitant medications. The patient experienced heart palpitations which began on 18Jan2021 the evening of taking the vaccine and have continued until now. Further reported that this adverse event started on 18Jan2021 10:00 AM. No treatment was received for the event reported. The patient was recovering from the event. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID prior vaccination and have not been COVID tested post vaccination.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Blood pressure decreased, Blood test, Computerised tomogram head, Electrocardiogram abnormal
Clinical narrative: Syncopal Episode 11 hrs post vaccination
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Head injury, Headache, Heart rate decreased, Loss of consciousness, Malaise
Clinical narrative: Syncopal Episode 11 hrs post vaccination
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Skin laceration, Spinal X-ray, Suture insertion, Syncope
Clinical narrative: Syncopal Episode 11 hrs post vaccination
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urine analysis, Vertigo
Clinical narrative: Syncopal Episode 11 hrs post vaccination
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Syncope
Clinical narrative: Syncopal Episode 11 hrs post vaccination
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: She tested positive for Covid; She tested positive for Covid; This is a spontaneous report from a contactable nurse. A 62-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection, lot number: EJ1686), via an unspecified route of administration from 28Dec2020 to 28Dec2020 at SINGLE DOSE for COVID-19 immunisation. Medical history was not reported. There were no concomitant medications. The nurse that stated that the patient got the first Covid-19 injection on the 28Dec2020 and reported that on the 04Jan2021, she tested positive for Covid. She said that she has been quarantining and was totally asymptomatic. She said that she is due to get the second vaccine on 18Jan2021. The outcome of the events was unknown.; Sender's Comments: Based on the information provided, the lack of efficacy cannot be excluded for vaccine BNT162B2 .
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Asymptomatic COVID-19, SARS-CoV-2 test positive
Clinical narrative: She tested positive for Covid; She tested positive for Covid; This is a spontaneous report from a contactable nurse. A 62-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection, lot number: EJ1686), via an unspecified route of administration from 28Dec2020 to 28Dec2020 at SINGLE DOSE for COVID-19 immunisation. Medical history was not reported. There were no concomitant medications. The nurse that stated that the patient got the first Covid-19 injection on the 28Dec2020 and reported that on the 04Jan2021, she tested positive for Covid. She said that she has been quarantining and was totally asymptomatic. She said that she is due to get the second vaccine on 18Jan2021. The outcome of the events was unknown.; Sender's Comments: Based on the information provided, the lack of efficacy cannot be excluded for vaccine BNT162B2 .
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable nurse (patient). An 84-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231, expiration date: Apr2021), via an unspecified route of administration in the left deltoid on 12Jan2021 14:45 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On Jan2021, her left arm was blue from her shoulder to her elbow and almost the whole circumference going under her arm. On Jan2021, she has a slight left arm swelling and left arm discomfort. The discomfort was bearable. The discoloration of her left arm has become bad. She was at the COVID-19 vaccine clinic, some nurses looked at her arm, and insisted she contact Pfizer and her doctor to report what happened to her arm. She has an appointment with her doctor the afternoon of 20Jan2021. Her second COVID-19 vaccine dose is scheduled on 02Feb2021. Her left arm swelling and discomfort is the same now, but her left arm discoloration is awful. Her left arm discoloration is the only change she has experienced since her first report. Her left arm discoloration is what she calls "puce", clarifying hers is a purple, black, and blue color. The discoloration of her left arm is uncanny. The discoloration stops before her left elbow like a completely straight line drawn by a ruler. The discoloration continues from her left elbow up to her left shoulder for which the discoloration spreads out unevenly. Outcome of the events was not recovered. Sender's Comments: A possible contributory role of the suspect products cannot be excluded for the reported events based on the known safety profile and temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators as appropriate.
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cyanosis, Limb discomfort, Peripheral swelling, Skin discolouration
Clinical narrative: This is a spontaneous report from a contactable nurse (patient). An 84-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231, expiration date: Apr2021), via an unspecified route of administration in the left deltoid on 12Jan2021 14:45 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On Jan2021, her left arm was blue from her shoulder to her elbow and almost the whole circumference going under her arm. On Jan2021, she has a slight left arm swelling and left arm discomfort. The discomfort was bearable. The discoloration of her left arm has become bad. She was at the COVID-19 vaccine clinic, some nurses looked at her arm, and insisted she contact Pfizer and her doctor to report what happened to her arm. She has an appointment with her doctor the afternoon of 20Jan2021. Her second COVID-19 vaccine dose is scheduled on 02Feb2021. Her left arm swelling and discomfort is the same now, but her left arm discoloration is awful. Her left arm discoloration is the only change she has experienced since her first report. Her left arm discoloration is what she calls "puce", clarifying hers is a purple, black, and blue color. The discoloration of her left arm is uncanny. The discoloration stops before her left elbow like a completely straight line drawn by a ruler. The discoloration continues from her left elbow up to her left shoulder for which the discoloration spreads out unevenly. Outcome of the events was not recovered. Sender's Comments: A possible contributory role of the suspect products cannot be excluded for the reported events based on the known safety profile and temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators as appropriate.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Heart rate increased, Pyrexia
Clinical narrative: Patient received first dose of Moderna on 1/29 at 09:00.  Symptoms began around 17:00 and steadily progressed throughout the night.  She had high fever (103), tachycardia and chills.  She eventually blacked out and awoke to her husband saying that he called 911.  She was transported to hospital around midnight,  She spent 4-5 hours in the hospital and was released.  Had a rebound bout with similar symptoms after she returned back home but not as severe and then symptoms subsided completely.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Loss of consciousness, Pyrexia, Tachycardia
Clinical narrative: Patient received first dose of Moderna on 1/29 at 09:00.  Symptoms began around 17:00 and steadily progressed throughout the night.  She had high fever (103), tachycardia and chills.  She eventually blacked out and awoke to her husband saying that he called 911.  She was transported to hospital around midnight,  She spent 4-5 hours in the hospital and was released.  Had a rebound bout with similar symptoms after she returned back home but not as severe and then symptoms subsided completely.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Asymptomatic COVID-19, SARS-CoV-2 test positive
Clinical narrative: tested positive after receiving the first shot of the Covid-19 vaccine; tested positive after receiving the first shot of the Covid-19 vaccine; This is a spontaneous report from a Pfizer-sponsored program, from a contactable nurse. This nurse reported similar events for three patients. This is the second of three reports.   A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL0140; Expiration date: Mar2021), via an unspecified route of administration, on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  On an unspecified date, the patient tested positive after receiving the first shot of the covid-19 vaccine.  The patient underwent lab tests and procedures which included a positive Covid-19 test on an unspecified date.   The outcome of tested positive after receiving the first shot of the covid-19 vaccine was unknown.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported tested positive based on the known safety profile. However the short duration of 3 days since the vaccine first dose is given it is unlikely patient would have fully developed immunity.,Linked Report(s) : US-PFIZER INC-2021050427 Same reporter, drug and event; different patient;US-PFIZER INC-2021104537 Same reporter, drug and event; different patient
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: tested positive after receiving the first shot of the Covid-19 vaccine; tested positive after receiving the first shot of the Covid-19 vaccine; This is a spontaneous report from a Pfizer-sponsored program, from a contactable nurse. This nurse reported similar events for three patients. This is the second of three reports.   A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL0140; Expiration date: Mar2021), via an unspecified route of administration, on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  On an unspecified date, the patient tested positive after receiving the first shot of the covid-19 vaccine.  The patient underwent lab tests and procedures which included a positive Covid-19 test on an unspecified date.   The outcome of tested positive after receiving the first shot of the covid-19 vaccine was unknown.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported tested positive based on the known safety profile. However the short duration of 3 days since the vaccine first dose is given it is unlikely patient would have fully developed immunity.,Linked Report(s) : US-PFIZER INC-2021050427 Same reporter, drug and event; different patient;US-PFIZER INC-2021104537 Same reporter, drug and event; different patient
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardio-respiratory arrest, Death, Unresponsive to stimuli
Clinical narrative: Systemic: Other- Patient died two days after vaccination. Not attributable to vaccination.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Death
Clinical narrative: Systemic: Other- Patient died two days after vaccination. Not attributable to vaccination.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dry mouth
Clinical narrative: dry mouth; This is a spontaneous report from a contactable physician reporting for herself. A female patient of unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration, on Dec2020 (29th or 30Dec2020) at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced dry mouth on an unspecified date. The patient asked if dry mouth was a side effect from the COVID-19 Vaccine. She explained that she got the first dose of the Pfizer Covid vaccine on the 29th or 30Dec2020. She is due for second one, but she wants to know if anyone has reported xerostomia or dry mouth. Outcome of the event was unknown.   Information on lot/batch number has been requested.
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: No adverse event
Clinical narrative: 17 Y.O. inadvertently administered moderna cov 19 vaccine
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17 Y.O. inadvertently administered moderna cov 19 vaccine
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Rash, Rash erythematous
Clinical narrative: Allergic Reaction had to be taken to The ER. Treatment Benadryl IV and monitored
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypersensitivity
Clinical narrative: Allergic Reaction had to be taken to The ER. Treatment Benadryl IV and monitored
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Death, Impaired work ability, Injection site pain, Malaise
Clinical narrative: Site: Pain at Injection Site-Medium
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain
Clinical narrative: Site: Pain at Injection Site-Medium
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site pain
Clinical narrative: Site: Pain at Injection Site-Medium
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Swelling face
Clinical narrative: PER MD: HIGH FEVER, TACHYCARDIA, HALUCINATIONS, CHANGE IN MENTAL STATUS
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hallucination, Mental status changes, Pyrexia, Tachycardia
Clinical narrative: PER MD: HIGH FEVER, TACHYCARDIA, HALUCINATIONS, CHANGE IN MENTAL STATUS
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysphagia, Oropharyngeal discomfort, Tinnitus
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on left arm on 16Jan2021 11:30 at a single dose as the patient is a counselor, essential worker, in the health field but she got in because of age (COVID-19 immunization). Medical history included Subclinical hypothyroid (she takes no meds. Was diagnosed 10 years ago), allergies to Sulfa drug, seasonal allergies and sprained wrist. A couple antibiotics bother her stomach but she was not allergic. The patient was not pregnant at the time of vaccination. Concomitant medications included estradiol, B12, calcium and glucosamine. Other medications included estrogen, vitamins, glucosamine supplements, and takes a cream for injury: sprained wrist, she doesn't know the name of it, it is an anti-inflammatory cream, she doesn't think any of that will do anything. No other vaccine in four weeks. The patient had the vaccine on 16Jan2021 Saturday and within 15 minutes (also reported as 20 minutes after shot and at 12:00), the patient experienced severe ringing in ears. She had severe ringing in her ears, it was really loud, and was still there. She can't seem to figure out if it was normal, what's causing it and could it be from the vaccine. It may have been anxiety because of that, but right after she heard ringing, there was a lump feeling in her throat on same day, like something was in her throat, she thought she had throat swelling, it lasted a couple of days, but she had no shortness of breath or anything. Ringing in ears was a lot worse in the morning, and gets better during the day, maybe because she was around noise, but it comes and goes, there are two separate sounds, one was a high pitched and continuous, the other one was lower pitched, a little fragmented, if she drew a picture, there would be little dust particles in the air, but the other is constant, she tried really hard to ignore, but it was driving her nuts. She is hoping it will go away. The lump feeling in her throat was gone, she was wondering if it was anxiety. It was mentioned, "She gets nervous, gets a lump in her throat a lot", but this was really severe, but she saw a man being taken away in an ambulance, and that scared her, she was waiting in the waiting area, and saw that, so it scared her. Recovered completely from the lump feeling in her throat. Throat was normal in 2 days but ears ringing still there after 4 days. There was no treatment for the events severe ringing in ears and Lump feeling in throat. The outcome of the events severe ringing in ears was not recovered; event Lump feeling in throat and throat swelling was recovered in 18Jan2021; and unknown outcome for the other event.  Information on lot/batch number has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fear, Pharyngeal swelling, Sensation of foreign body, Tinnitus
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on left arm on 16Jan2021 11:30 at a single dose as the patient is a counselor, essential worker, in the health field but she got in because of age (COVID-19 immunization). Medical history included Subclinical hypothyroid (she takes no meds. Was diagnosed 10 years ago), allergies to Sulfa drug, seasonal allergies and sprained wrist. A couple antibiotics bother her stomach but she was not allergic. The patient was not pregnant at the time of vaccination. Concomitant medications included estradiol, B12, calcium and glucosamine. Other medications included estrogen, vitamins, glucosamine supplements, and takes a cream for injury: sprained wrist, she doesn't know the name of it, it is an anti-inflammatory cream, she doesn't think any of that will do anything. No other vaccine in four weeks. The patient had the vaccine on 16Jan2021 Saturday and within 15 minutes (also reported as 20 minutes after shot and at 12:00), the patient experienced severe ringing in ears. She had severe ringing in her ears, it was really loud, and was still there. She can't seem to figure out if it was normal, what's causing it and could it be from the vaccine. It may have been anxiety because of that, but right after she heard ringing, there was a lump feeling in her throat on same day, like something was in her throat, she thought she had throat swelling, it lasted a couple of days, but she had no shortness of breath or anything. Ringing in ears was a lot worse in the morning, and gets better during the day, maybe because she was around noise, but it comes and goes, there are two separate sounds, one was a high pitched and continuous, the other one was lower pitched, a little fragmented, if she drew a picture, there would be little dust particles in the air, but the other is constant, she tried really hard to ignore, but it was driving her nuts. She is hoping it will go away. The lump feeling in her throat was gone, she was wondering if it was anxiety. It was mentioned, "She gets nervous, gets a lump in her throat a lot", but this was really severe, but she saw a man being taken away in an ambulance, and that scared her, she was waiting in the waiting area, and saw that, so it scared her. Recovered completely from the lump feeling in her throat. Throat was normal in 2 days but ears ringing still there after 4 days. There was no treatment for the events severe ringing in ears and Lump feeling in throat. The outcome of the events severe ringing in ears was not recovered; event Lump feeling in throat and throat swelling was recovered in 18Jan2021; and unknown outcome for the other event.  Information on lot/batch number has been requested.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: REDDISH RASH AND ITCHING A FEW INCHES BELOW INJECTION SITE. ADVERSE EVENT OCCURRED TWO WEEKS AFTER INJECTION
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site pruritus, Injection site rash, Rash erythematous
Clinical narrative: REDDISH RASH AND ITCHING A FEW INCHES BELOW INJECTION SITE. ADVERSE EVENT OCCURRED TWO WEEKS AFTER INJECTION
Age: 50.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Headache
Clinical narrative: shivers that lasted from 9:30pm - 6am extreme headache overnight preventing sleep
Age: 50.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Headache, Insomnia
Clinical narrative: shivers that lasted from 9:30pm - 6am extreme headache overnight preventing sleep
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injected limb mobility decreased, Injection site reaction, Myositis
Clinical narrative: Left arm remained sore and warm to touch for several days. On 1/31/21 started having extreme pain with ROM of left should. Went for evaluation on 2/1/21, was diagnosed with left shoulder deltoid myositis after injection.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Joint range of motion decreased, Myositis, Pain in extremity, Skin warm
Clinical narrative: Left arm remained sore and warm to touch for several days. On 1/31/21 started having extreme pain with ROM of left should. Went for evaluation on 2/1/21, was diagnosed with left shoulder deltoid myositis after injection.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Anaphylactic reaction, Chest X-ray, Condition aggravated, Laboratory test
Clinical narrative: anaphylaxis
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Respiratory distress, Stridor
Clinical narrative: anaphylaxis
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: anaphylaxis
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Patient called PCP on 2/1/21 after complaint of rash for the past 3-4 days. Then, patient was also seen in person at urgent care 2/1/21 for rash. She had received Moderna vaccine dose 1 on 1/22/21.  Per her report to urgent care provider, she reported feeling "feverish and chills" on the 27th and then subsequently developed rash after that.  Denies itchiness and had not taken any medications.  Rash started on belly and legs and then on arms and chest. Rash is better on arms/chest. Patient was prescribed hydroxyzine 25mg and TAC 1% cream by PCP on 2/1/21. Repeat COVID test done on 2/2/21 resulted as COVID negative.  Patient was followed up 2 days later on 2/3/21 via telephone and patient reported to provider rash symptoms have improved.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chills, Pyrexia, Rash
Clinical narrative: Patient called PCP on 2/1/21 after complaint of rash for the past 3-4 days. Then, patient was also seen in person at urgent care 2/1/21 for rash. She had received Moderna vaccine dose 1 on 1/22/21.  Per her report to urgent care provider, she reported feeling "feverish and chills" on the 27th and then subsequently developed rash after that.  Denies itchiness and had not taken any medications.  Rash started on belly and legs and then on arms and chest. Rash is better on arms/chest. Patient was prescribed hydroxyzine 25mg and TAC 1% cream by PCP on 2/1/21. Repeat COVID test done on 2/2/21 resulted as COVID negative.  Patient was followed up 2 days later on 2/3/21 via telephone and patient reported to provider rash symptoms have improved.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: C-reactive protein increased, Liver function test increased, Rash, Rash macular, Red blood cell sedimentation rate increased
Clinical narrative: Patient called PCP on 2/1/21 after complaint of rash for the past 3-4 days. Then, patient was also seen in person at urgent care 2/1/21 for rash. She had received Moderna vaccine dose 1 on 1/22/21.  Per her report to urgent care provider, she reported feeling "feverish and chills" on the 27th and then subsequently developed rash after that.  Denies itchiness and had not taken any medications.  Rash started on belly and legs and then on arms and chest. Rash is better on arms/chest. Patient was prescribed hydroxyzine 25mg and TAC 1% cream by PCP on 2/1/21. Repeat COVID test done on 2/2/21 resulted as COVID negative.  Patient was followed up 2 days later on 2/3/21 via telephone and patient reported to provider rash symptoms have improved.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Dizziness, Palpitations, Paraesthesia
Clinical narrative: Dizzy immediately following vaccine, then high blood pressure, funny feeling in mouth and some difficulty easily swallowing, sweating
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dysphagia, Hyperhidrosis, Hypertension, Immediate post-injection reaction
Clinical narrative: Dizzy immediately following vaccine, then high blood pressure, funny feeling in mouth and some difficulty easily swallowing, sweating
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Stomatitis
Clinical narrative: Dizzy immediately following vaccine, then high blood pressure, funny feeling in mouth and some difficulty easily swallowing, sweating
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Fatigue, Headache, Neck pain, Pyrexia
Clinical narrative: Fever from 99 to 101.2 the 2nd 24 hrs. Headache neck ache severe fatigue and increased coughing and congestion
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Respiratory tract congestion
Clinical narrative: Fever from 99 to 101.2 the 2nd 24 hrs. Headache neck ache severe fatigue and increased coughing and congestion
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bronchitis, Fatigue, Pyrexia
Clinical narrative: Fever from 99 to 101.2 the 2nd 24 hrs. Headache neck ache severe fatigue and increased coughing and congestion
Age: 78.0
Sex: U
Vaccine: UNK
Symptoms: Dizziness, Fatigue, Headache, Nausea, Somnolence
Clinical narrative: severe headache, nausea, extreme fatique, I could not wake up, dizzy
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash, Rash erythematous
Clinical narrative: Noticed a red rash with minor itching covering my torso and back. The rash was first noticed about 34 hours after the vaccination.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Pain, Pyrexia
Clinical narrative: Fever up to 101.3, symptoms started around 12 to 14 hours after receiving  the vaccine.  Severe chills and body aches and back pain.  Fever lasted for about 36 hours, still have moderate to severe body aches after 36 hours and a low grade temp at 36 hours
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pruritus, Rash, Swelling
Clinical narrative: Rash, itching, pain, minor swelling a week after vaccination
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Emotional distress, Nausea, Vomiting
Clinical narrative: patient felt nauseated, said she was emotionally distressed from her dog dying this morning and had not had any food yet today.  She vomited but was feeling slightly better within the hour.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Depressed level of consciousness, Headache, Hypoacusis, Hypoaesthesia, Magnetic resonance imaging
Clinical narrative: Faint, decrease level of consciousness, ringing in left ear, numbness of left side of body, decrease hearing in left ear and headaches
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope, Tinnitus, X-ray
Clinical narrative: Faint, decrease level of consciousness, ringing in left ear, numbness of left side of body, decrease hearing in left ear and headaches
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: Within 2 minutes patient sank in chair and passed out
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Dysphonia, Erythema, Paraesthesia, Paraesthesia oral
Clinical narrative: 10-15 minutes after injection splotchy redness forearms, palm of hands. Approximately 1 hour after injection splotchy redness both legs. Approximately 2 hours after injection tingling around neck, tingling in lips and swelling and tingling right side of face and voice change hoarseness.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Rash macular, Swelling face
Clinical narrative: 10-15 minutes after injection splotchy redness forearms, palm of hands. Approximately 1 hour after injection splotchy redness both legs. Approximately 2 hours after injection tingling around neck, tingling in lips and swelling and tingling right side of face and voice change hoarseness.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis bullous
Clinical narrative: Patchy vesicular and bullous rash on the legs, hands, and buttocks. Noticed the morning after the vaccine. New lesions occurring until day 5. No improvement yet day 7. No treatment.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Sensation of foreign body
Clinical narrative: Around 7pm on day 8 after getting my first shot of the Moderna vaccine, my right arm was all swollen and bright red (at the site of injection- upper right arm), and even though I could breathe and was not hyperventilating, I get a lump in my throat.  After consulting with a nurse over the phone, it was recommended to see a doctor, but no appointments available, so I ended up going to the ER. No cellulitis, but it was recommended to monitor and ice my arm. On day 10, it is still swollen, but not as much, and not bright red. Lump in throat disappeared on day 9 in the afternoon.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site rash
Clinical narrative: Rash and pain at injection site 1 1/2 weeks after first shot
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: I received my vaccine this morning and I had no problems until I was getting ready for bed and I noticed the bandaid was very high on my arm. As a certified medical assistant I know that vaccines must be given in the muscle of the deltoid; however my injection of the Covid vaccine was administered roughly 0.25-0.5in below my acromion process on my L arm; therefore not in the muscle of the deltoid.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Crying, Dizziness, Feeling cold, Gait disturbance
Clinical narrative: Sore muscles, chills, freezing cold, hard time walking, headache, light headed, nauseous, pins and needles feeling in legs, sore in injection site, bruising in injection site, pain that caused crying
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site bruising, Injection site pain, Myalgia, Nausea
Clinical narrative: Sore muscles, chills, freezing cold, hard time walking, headache, light headed, nauseous, pins and needles feeling in legs, sore in injection site, bruising in injection site, pain that caused crying
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Sore muscles, chills, freezing cold, hard time walking, headache, light headed, nauseous, pins and needles feeling in legs, sore in injection site, bruising in injection site, pain that caused crying
Age: 47.0
Sex: M
Vaccine: FLU4
Symptoms: Pain
Clinical narrative: Few weeks after shots, pain became unbearable so I needed to rest often. I visited a clinic nearby but they told me to wait as vaccines can cause temporary pain. However, three plus years later, I am in pain often and when such pain occurs, it is acute.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Rash pruritic
Clinical narrative: patient describes itchy rash on arm that she was shot in, but rash did not start until a week after her vaccine
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Pruritus, Rash, Skin warm
Clinical narrative: Itchy, warm rash. Very swollen and sometimes painful lymph nodes under armpit. Same side as injection.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray, Computerised tomogram, Dizziness, Dysphagia, Electrocardiogram
Clinical narrative: Warm , tingly arm, dizziness, lightheaded, tongue swelling, difficulty swallowing, high blood pressure