chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Fatigue, Pain, Pain in extremity
Clinical narrative: tested positive with Covid-19 after she got her first dose and said she can't remember the exact date of her 1st dose but it was 3 weeks ago; tested positive with Covid-19 after she got her first dose and said she can't remember the exact date of her 1st dose but it was 3 weeks ago; This is a spontaneous report from a Pfizer sponsored Program. A contactable female consumer (patient) reported that: A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on unspecified date in Mar2021 (reported as 3 weeks ago) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient tested positive with COVID-19 after she got her first dose and said she can't remember the exact date of her 1st dose, but it was 3 weeks ago. She was scheduled to get her 2nd dose today, 09Apr2021 and she wanted to know if it's ok for her to take the 2nd dose of the vaccine today or if she needs to wait and cancel her schedule for today. She said she's not feeling any symptoms. On an unspecified date, the patient underwent lab tests and procedures which included tested with COVID-19: positive. The outcome of events was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: tested positive with Covid-19 after she got her first dose and said she can't remember the exact date of her 1st dose but it was 3 weeks ago; tested positive with Covid-19 after she got her first dose and said she can't remember the exact date of her 1st dose but it was 3 weeks ago; This is a spontaneous report from a Pfizer sponsored Program. A contactable female consumer (patient) reported that: A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on unspecified date in Mar2021 (reported as 3 weeks ago) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient tested positive with COVID-19 after she got her first dose and said she can't remember the exact date of her 1st dose, but it was 3 weeks ago. She was scheduled to get her 2nd dose today, 09Apr2021 and she wanted to know if it's ok for her to take the 2nd dose of the vaccine today or if she needs to wait and cancel her schedule for today. She said she's not feeling any symptoms. On an unspecified date, the patient underwent lab tests and procedures which included tested with COVID-19: positive. The outcome of events was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive with Covid-19 after she got her first dose and said she can't remember the exact date of her 1st dose but it was 3 weeks ago; tested positive with Covid-19 after she got her first dose and said she can't remember the exact date of her 1st dose but it was 3 weeks ago; This is a spontaneous report from a Pfizer sponsored Program. A contactable female consumer (patient) reported that: A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on unspecified date in Mar2021 (reported as 3 weeks ago) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient tested positive with COVID-19 after she got her first dose and said she can't remember the exact date of her 1st dose, but it was 3 weeks ago. She was scheduled to get her 2nd dose today, 09Apr2021 and she wanted to know if it's ok for her to take the 2nd dose of the vaccine today or if she needs to wait and cancel her schedule for today. She said she's not feeling any symptoms. On an unspecified date, the patient underwent lab tests and procedures which included tested with COVID-19: positive. The outcome of events was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive; This is a spontaneous report from a contactable consumer vis a Pfizer-sponsored program COVAX US Support. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration on 28Mar2021, as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was supposed to get her 2nd dose on 18Apr2021. On an unspecified date, the patient was tested positive to COVID-19 and was in quarantine up to an unspecified date. The patient underwent lab test and procedure which included SARS-COV-2 test: positive, on an unspecified date. The clinical outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive; This is a spontaneous report from a contactable consumer vis a Pfizer-sponsored program COVAX US Support. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration on 28Mar2021, as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was supposed to get her 2nd dose on 18Apr2021. On an unspecified date, the patient was tested positive to COVID-19 and was in quarantine up to an unspecified date. The patient underwent lab test and procedure which included SARS-COV-2 test: positive, on an unspecified date. The clinical outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: C-reactive protein normal, Chills, Fatigue, Headache, Insomnia
Clinical narrative: Diagnosed with PMR; arthralgia/ pain in joints; unable to move; severe myalgia/ muscle aches/ developed generalized pains in muscle; severe chills; This is a spontaneous report from a contactable physician (patient). A 53-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: EJ1686), dose 2 via an unspecified route of administration on 13Jan2021 (at the age of 53 years) as dose 2, single for COVID-19 immunisation. The patient had no other medical history and no known allergies. The patient concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number was not reported), administered on an unknown date as single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID. The patient did not receive other vaccine in four weeks. Post vaccination, the patient had not been tested for COVID. The patient healthy before the vaccination. On 01Mar2021, the patient had severe myalgia, arthralgia/pain in joints shoulders, gluteus muscles, thighs. Within 8 hours after the 2nd injection developed severe chills, muscle aches, was unable to move. It was lasted to 48 hours and went away. Two weeks later developed generalized pains in muscle and joints. Diagnosed with PMR (Polymyalgia rheumatica). The patient received steroid injection and oral steroids. steroids worked for 2 weeks and now all symptoms back (at the time of report). Therapeutic measures were taken for the event and treatment with steroids injection and oral steroids. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. Patient never had any similar symptoms in the past. The outcome of the events was not resolved.  No follow up attempts are possible. No further information is expected. ; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 in triggering the onset of polymyalgia rheumatica cannot be excluded. 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: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Joint range of motion decreased, Muscle spasms, Myalgia, Pain
Clinical narrative: Diagnosed with PMR; arthralgia/ pain in joints; unable to move; severe myalgia/ muscle aches/ developed generalized pains in muscle; severe chills; This is a spontaneous report from a contactable physician (patient). A 53-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: EJ1686), dose 2 via an unspecified route of administration on 13Jan2021 (at the age of 53 years) as dose 2, single for COVID-19 immunisation. The patient had no other medical history and no known allergies. The patient concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number was not reported), administered on an unknown date as single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID. The patient did not receive other vaccine in four weeks. Post vaccination, the patient had not been tested for COVID. The patient healthy before the vaccination. On 01Mar2021, the patient had severe myalgia, arthralgia/pain in joints shoulders, gluteus muscles, thighs. Within 8 hours after the 2nd injection developed severe chills, muscle aches, was unable to move. It was lasted to 48 hours and went away. Two weeks later developed generalized pains in muscle and joints. Diagnosed with PMR (Polymyalgia rheumatica). The patient received steroid injection and oral steroids. steroids worked for 2 weeks and now all symptoms back (at the time of report). Therapeutic measures were taken for the event and treatment with steroids injection and oral steroids. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. Patient never had any similar symptoms in the past. The outcome of the events was not resolved.  No follow up attempts are possible. No further information is expected. ; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 in triggering the onset of polymyalgia rheumatica cannot be excluded. 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: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chills, Hypokinesia, Myalgia, Polymyalgia rheumatica
Clinical narrative: Diagnosed with PMR; arthralgia/ pain in joints; unable to move; severe myalgia/ muscle aches/ developed generalized pains in muscle; severe chills; This is a spontaneous report from a contactable physician (patient). A 53-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: EJ1686), dose 2 via an unspecified route of administration on 13Jan2021 (at the age of 53 years) as dose 2, single for COVID-19 immunisation. The patient had no other medical history and no known allergies. The patient concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number was not reported), administered on an unknown date as single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID. The patient did not receive other vaccine in four weeks. Post vaccination, the patient had not been tested for COVID. The patient healthy before the vaccination. On 01Mar2021, the patient had severe myalgia, arthralgia/pain in joints shoulders, gluteus muscles, thighs. Within 8 hours after the 2nd injection developed severe chills, muscle aches, was unable to move. It was lasted to 48 hours and went away. Two weeks later developed generalized pains in muscle and joints. Diagnosed with PMR (Polymyalgia rheumatica). The patient received steroid injection and oral steroids. steroids worked for 2 weeks and now all symptoms back (at the time of report). Therapeutic measures were taken for the event and treatment with steroids injection and oral steroids. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. Patient never had any similar symptoms in the past. The outcome of the events was not resolved.  No follow up attempts are possible. No further information is expected. ; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 in triggering the onset of polymyalgia rheumatica cannot be excluded. 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.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive; This is a spontaneous report from a contactable consumer reported for a female patient via a Pfizer-sponsored program. A female patient of an unspecified age received bnt162b2 (BNT162B2 Formulation: Solution for injection), dose 1 via an unspecified route of administration on 02Apr2021 as DOSE 1, SINGLE for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient experienced tested positive on 08Apr2021. Patient tested positive last 08Apr2021. asked if they can still get the 2nd dose today or not. also mentioned she finished quarantine last 18Mar2021 and her husband finished his quarantine yesterday. The patient underwent lab tests and procedures which included covid-19: positive on 08Apr2021. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19
Clinical narrative: tested positive; This is a spontaneous report from a contactable consumer reported for a female patient via a Pfizer-sponsored program. A female patient of an unspecified age received bnt162b2 (BNT162B2 Formulation: Solution for injection), dose 1 via an unspecified route of administration on 02Apr2021 as DOSE 1, SINGLE for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient experienced tested positive on 08Apr2021. Patient tested positive last 08Apr2021. asked if they can still get the 2nd dose today or not. also mentioned she finished quarantine last 18Mar2021 and her husband finished his quarantine yesterday. The patient underwent lab tests and procedures which included covid-19: positive on 08Apr2021. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Deep vein thrombosis
Clinical narrative: Blood clot left leg.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Thrombosis
Clinical narrative: Blood clot left leg.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Dyspnoea, Fatigue, Headache, Impaired work ability
Clinical narrative: ELEVATED HEART RATE; DISCOMFORT SLEEPING ON THE LEFT  SIDE; 4 EPISODES OF CAPILLARY BURSTING, 2 IN EACH EYE; CHRONIC DIARRHEA 2-3 TIMES DAY; RIGHT HAND/FINGERS JOINTS ACHY; SEVERE HEADACHE; INJECTION SITE SWELLING; This spontaneous report received from a patient concerned a 57 year old male. The patient's weight was 172 pounds, and height was 71 inches. The patient's past medical history included covid-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 12-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On OCT-2020, Laboratory data included: COVID-19 virus test (NR: not provided) Positive. On 12-MAY-2021, the subject experienced right hand/fingers joints achy. On 12-MAY-2021, the subject experienced severe headache. On 12-MAY-2021, the subject experienced injection site swelling. On 15-MAY-2021, the subject experienced chronic diarrhea 2-3 times day. On 19-MAY-2021, the subject experienced 4 episodes of capillary bursting, 2 in each eye. On an unspecified date, the subject experienced elevated heart rate, and discomfort sleeping on the left side. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from right hand/fingers joints achy, and injection site swelling on 15-MAY-2021, 4 episodes of capillary bursting, 2 in each eye on 29-MAY-2021, and severe headache on 12-JUN-2021, had not recovered from chronic diarrhea 2-3 times day, and the outcome of elevated heart rate and discomfort sleeping on the left side was not reported. This report was non-serious.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: ELEVATED HEART RATE; DISCOMFORT SLEEPING ON THE LEFT  SIDE; 4 EPISODES OF CAPILLARY BURSTING, 2 IN EACH EYE; CHRONIC DIARRHEA 2-3 TIMES DAY; RIGHT HAND/FINGERS JOINTS ACHY; SEVERE HEADACHE; INJECTION SITE SWELLING; This spontaneous report received from a patient concerned a 57 year old male. The patient's weight was 172 pounds, and height was 71 inches. The patient's past medical history included covid-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 12-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On OCT-2020, Laboratory data included: COVID-19 virus test (NR: not provided) Positive. On 12-MAY-2021, the subject experienced right hand/fingers joints achy. On 12-MAY-2021, the subject experienced severe headache. On 12-MAY-2021, the subject experienced injection site swelling. On 15-MAY-2021, the subject experienced chronic diarrhea 2-3 times day. On 19-MAY-2021, the subject experienced 4 episodes of capillary bursting, 2 in each eye. On an unspecified date, the subject experienced elevated heart rate, and discomfort sleeping on the left side. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from right hand/fingers joints achy, and injection site swelling on 15-MAY-2021, 4 episodes of capillary bursting, 2 in each eye on 29-MAY-2021, and severe headache on 12-JUN-2021, had not recovered from chronic diarrhea 2-3 times day, and the outcome of elevated heart rate and discomfort sleeping on the left side was not reported. This report was non-serious.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Diarrhoea, Eye haemorrhage, Headache, Heart rate increased
Clinical narrative: ELEVATED HEART RATE; DISCOMFORT SLEEPING ON THE LEFT  SIDE; 4 EPISODES OF CAPILLARY BURSTING, 2 IN EACH EYE; CHRONIC DIARRHEA 2-3 TIMES DAY; RIGHT HAND/FINGERS JOINTS ACHY; SEVERE HEADACHE; INJECTION SITE SWELLING; This spontaneous report received from a patient concerned a 57 year old male. The patient's weight was 172 pounds, and height was 71 inches. The patient's past medical history included covid-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 12-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On OCT-2020, Laboratory data included: COVID-19 virus test (NR: not provided) Positive. On 12-MAY-2021, the subject experienced right hand/fingers joints achy. On 12-MAY-2021, the subject experienced severe headache. On 12-MAY-2021, the subject experienced injection site swelling. On 15-MAY-2021, the subject experienced chronic diarrhea 2-3 times day. On 19-MAY-2021, the subject experienced 4 episodes of capillary bursting, 2 in each eye. On an unspecified date, the subject experienced elevated heart rate, and discomfort sleeping on the left side. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from right hand/fingers joints achy, and injection site swelling on 15-MAY-2021, 4 episodes of capillary bursting, 2 in each eye on 29-MAY-2021, and severe headache on 12-JUN-2021, had not recovered from chronic diarrhea 2-3 times day, and the outcome of elevated heart rate and discomfort sleeping on the left side was not reported. This report was non-serious.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Injection site swelling, Insomnia, SARS-CoV-2 test
Clinical narrative: ELEVATED HEART RATE; DISCOMFORT SLEEPING ON THE LEFT  SIDE; 4 EPISODES OF CAPILLARY BURSTING, 2 IN EACH EYE; CHRONIC DIARRHEA 2-3 TIMES DAY; RIGHT HAND/FINGERS JOINTS ACHY; SEVERE HEADACHE; INJECTION SITE SWELLING; This spontaneous report received from a patient concerned a 57 year old male. The patient's weight was 172 pounds, and height was 71 inches. The patient's past medical history included covid-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 12-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On OCT-2020, Laboratory data included: COVID-19 virus test (NR: not provided) Positive. On 12-MAY-2021, the subject experienced right hand/fingers joints achy. On 12-MAY-2021, the subject experienced severe headache. On 12-MAY-2021, the subject experienced injection site swelling. On 15-MAY-2021, the subject experienced chronic diarrhea 2-3 times day. On 19-MAY-2021, the subject experienced 4 episodes of capillary bursting, 2 in each eye. On an unspecified date, the subject experienced elevated heart rate, and discomfort sleeping on the left side. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from right hand/fingers joints achy, and injection site swelling on 15-MAY-2021, 4 episodes of capillary bursting, 2 in each eye on 29-MAY-2021, and severe headache on 12-JUN-2021, had not recovered from chronic diarrhea 2-3 times day, and the outcome of elevated heart rate and discomfort sleeping on the left side was not reported. This report was non-serious.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; EXPIRED VACCINE WAS GIVEN; This spontaneous report received from a health care professional concerned a 43 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid 19 sars-cov2-igg, igm and iga (Immunoglobulin G  Immunoglobulin M, Immunoglobulin A) The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018 and expiry: 25/MAY/2021) dose was not reported, 1 total dose administered on 27-MAY-2021 on left deltoid for prophylactic vaccination. No concomitant medications were reported. Vaccine stored in appropriate temperature condition and 30 minutes to an hour as an estimation removed from storage On 27-MAY-2021, the patient administered the expired vaccine was given and had a negative antibody test (unspecified date),  Laboratory data (dates unspecified) included: COVID-19 antibody test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the expired vaccine was given and suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000184136 The suspected product quality complaint has been confirmed to be void:y based on the PQC evaluation/investigation performed.; Sender's Comments: V0: 20210660757 -COVID-19 VACCINE AD26.COV2.S-Suspected Immunological vaccine failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; EXPIRED VACCINE WAS GIVEN; This spontaneous report received from a health care professional concerned a 43 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid 19 sars-cov2-igg, igm and iga (Immunoglobulin G  Immunoglobulin M, Immunoglobulin A) The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018 and expiry: 25/MAY/2021) dose was not reported, 1 total dose administered on 27-MAY-2021 on left deltoid for prophylactic vaccination. No concomitant medications were reported. Vaccine stored in appropriate temperature condition and 30 minutes to an hour as an estimation removed from storage On 27-MAY-2021, the patient administered the expired vaccine was given and had a negative antibody test (unspecified date),  Laboratory data (dates unspecified) included: COVID-19 antibody test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the expired vaccine was given and suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000184136 The suspected product quality complaint has been confirmed to be void:y based on the PQC evaluation/investigation performed.; Sender's Comments: V0: 20210660757 -COVID-19 VACCINE AD26.COV2.S-Suspected Immunological vaccine failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Lip swelling, Pruritus, Rash, SARS-CoV-2 test negative, Urticaria
Clinical narrative: After shot there was a soreness in the left arm that slowly radiated out to the rest of the body. Morning of 4/4/2021 body was covered with an itchy rash, Dr. tried OTC antihistamines.  4/7/2021 Dr. prescribed steroids and stronger antihistamines. 4/20/2021 ER visit had more steroids and antihistamines prescribed.  4/292021 Dr. prescribed steroids and stronger antihistamines.  5/10/2021 Dr. stopped steroids and tried new cocktail of antihistamines.  6/1/2021 Dr. prescribed visiting allergy clinic and had blood test run.  6/9/2021 Allergy clinic Dr. could not run test as i am on a coattail of antihistamines, have to wait until i can go 5 days without antihistamine and hives before testing can start.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Eye swelling, Lip swelling, Pain, Pain in extremity
Clinical narrative: After shot there was a soreness in the left arm that slowly radiated out to the rest of the body. Morning of 4/4/2021 body was covered with an itchy rash, Dr. tried OTC antihistamines.  4/7/2021 Dr. prescribed steroids and stronger antihistamines. 4/20/2021 ER visit had more steroids and antihistamines prescribed.  4/292021 Dr. prescribed steroids and stronger antihistamines.  5/10/2021 Dr. stopped steroids and tried new cocktail of antihistamines.  6/1/2021 Dr. prescribed visiting allergy clinic and had blood test run.  6/9/2021 Allergy clinic Dr. could not run test as i am on a coattail of antihistamines, have to wait until i can go 5 days without antihistamine and hives before testing can start.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Rash, Rash pruritic, Urticaria
Clinical narrative: After shot there was a soreness in the left arm that slowly radiated out to the rest of the body. Morning of 4/4/2021 body was covered with an itchy rash, Dr. tried OTC antihistamines.  4/7/2021 Dr. prescribed steroids and stronger antihistamines. 4/20/2021 ER visit had more steroids and antihistamines prescribed.  4/292021 Dr. prescribed steroids and stronger antihistamines.  5/10/2021 Dr. stopped steroids and tried new cocktail of antihistamines.  6/1/2021 Dr. prescribed visiting allergy clinic and had blood test run.  6/9/2021 Allergy clinic Dr. could not run test as i am on a coattail of antihistamines, have to wait until i can go 5 days without antihistamine and hives before testing can start.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Bedridden, Cerebral disorder, Dizziness, Dysarthria
Clinical narrative: Immediate: Dizziness, Light headed, Drowsy, Unsteady, weak, hot and cold flashes Reported to staff: asked twice for water, chairs were limited, sat in car... due to confusion, vision issues, and above symptoms Called parents after 45 minutes: speech was slurred like a stroke symptom Remained in parking lot for 2 hours  before driving home, have not driven since Upon arriving home: experienced nausea, wooziness, severe chills, breathing irregularities, sore arm Next morning: migraine, nausea, chills, stiff muscles, fatigue, total body ache, confusion, memory loss, slurred speech, dizziness, delayed speech, stuttering  Continued Continued symptoms: all above symptoms, short term memory loss, difficulty with productive language, processing speed and severe impairment with focus and concentration, extreme fatigue, slurry and stuttered speech, at times no speech ability at all, extreme body pain, difficulty walking without assistance, 24/7 headache, dizziness, nausea, vision issues, muscle spasms and tightness, joint and nerve pain, chest pains, changes in menstruation, in and out of awareness, seizure like episodes, extreme weakness The Covid19 vaccine has left pt. both physically and mentally incapacitated. She is unable to work and is on disability, unable to drive or preform normal daily activities. Please See: VSAFE Survey Response Details and Pfizer Complaint dated 5-18-21
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Feeling abnormal, Gait disturbance, Headache, Inappropriate schedule of product administration
Clinical narrative: Immediate: Dizziness, Light headed, Drowsy, Unsteady, weak, hot and cold flashes Reported to staff: asked twice for water, chairs were limited, sat in car... due to confusion, vision issues, and above symptoms Called parents after 45 minutes: speech was slurred like a stroke symptom Remained in parking lot for 2 hours  before driving home, have not driven since Upon arriving home: experienced nausea, wooziness, severe chills, breathing irregularities, sore arm Next morning: migraine, nausea, chills, stiff muscles, fatigue, total body ache, confusion, memory loss, slurred speech, dizziness, delayed speech, stuttering  Continued Continued symptoms: all above symptoms, short term memory loss, difficulty with productive language, processing speed and severe impairment with focus and concentration, extreme fatigue, slurry and stuttered speech, at times no speech ability at all, extreme body pain, difficulty walking without assistance, 24/7 headache, dizziness, nausea, vision issues, muscle spasms and tightness, joint and nerve pain, chest pains, changes in menstruation, in and out of awareness, seizure like episodes, extreme weakness The Covid19 vaccine has left pt. both physically and mentally incapacitated. She is unable to work and is on disability, unable to drive or preform normal daily activities. Please See: VSAFE Survey Response Details and Pfizer Complaint dated 5-18-21
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Loss of personal independence in daily activities, Muscle spasms, Nausea, Pain, Tremor
Clinical narrative: Immediate: Dizziness, Light headed, Drowsy, Unsteady, weak, hot and cold flashes Reported to staff: asked twice for water, chairs were limited, sat in car... due to confusion, vision issues, and above symptoms Called parents after 45 minutes: speech was slurred like a stroke symptom Remained in parking lot for 2 hours  before driving home, have not driven since Upon arriving home: experienced nausea, wooziness, severe chills, breathing irregularities, sore arm Next morning: migraine, nausea, chills, stiff muscles, fatigue, total body ache, confusion, memory loss, slurred speech, dizziness, delayed speech, stuttering  Continued Continued symptoms: all above symptoms, short term memory loss, difficulty with productive language, processing speed and severe impairment with focus and concentration, extreme fatigue, slurry and stuttered speech, at times no speech ability at all, extreme body pain, difficulty walking without assistance, 24/7 headache, dizziness, nausea, vision issues, muscle spasms and tightness, joint and nerve pain, chest pains, changes in menstruation, in and out of awareness, seizure like episodes, extreme weakness The Covid19 vaccine has left pt. both physically and mentally incapacitated. She is unable to work and is on disability, unable to drive or preform normal daily activities. Please See: VSAFE Survey Response Details and Pfizer Complaint dated 5-18-21
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Amnesia, Arthralgia, Asthenia, Balance disorder, Blood test
Clinical narrative: Immediate: Dizziness, Light headed, Drowsy, Unsteady, weak, hot and cold flashes Reported to staff: asked twice for water, chairs were limited, sat in car... due to confusion, vision issues, and above symptoms Called parents after 45 minutes: speech was slurred like a stroke symptom Remained in parking lot for 2 hours  before driving home, have not driven since Upon arriving home: experienced nausea, wooziness, severe chills, breathing irregularities, sore arm Next morning: migraine, nausea, chills, stiff muscles, fatigue, total body ache, confusion, memory loss, slurred speech, dizziness, delayed speech, stuttering  Continued Continued symptoms: all above symptoms, short term memory loss, difficulty with productive language, processing speed and severe impairment with focus and concentration, extreme fatigue, slurry and stuttered speech, at times no speech ability at all, extreme body pain, difficulty walking without assistance, 24/7 headache, dizziness, nausea, vision issues, muscle spasms and tightness, joint and nerve pain, chest pains, changes in menstruation, in and out of awareness, seizure like episodes, extreme weakness The Covid19 vaccine has left pt. both physically and mentally incapacitated. She is unable to work and is on disability, unable to drive or preform normal daily activities. Please See: VSAFE Survey Response Details and Pfizer Complaint dated 5-18-21
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Chills, Confusional state, Disturbance in attention, Dizziness
Clinical narrative: Immediate: Dizziness, Light headed, Drowsy, Unsteady, weak, hot and cold flashes Reported to staff: asked twice for water, chairs were limited, sat in car... due to confusion, vision issues, and above symptoms Called parents after 45 minutes: speech was slurred like a stroke symptom Remained in parking lot for 2 hours  before driving home, have not driven since Upon arriving home: experienced nausea, wooziness, severe chills, breathing irregularities, sore arm Next morning: migraine, nausea, chills, stiff muscles, fatigue, total body ache, confusion, memory loss, slurred speech, dizziness, delayed speech, stuttering  Continued Continued symptoms: all above symptoms, short term memory loss, difficulty with productive language, processing speed and severe impairment with focus and concentration, extreme fatigue, slurry and stuttered speech, at times no speech ability at all, extreme body pain, difficulty walking without assistance, 24/7 headache, dizziness, nausea, vision issues, muscle spasms and tightness, joint and nerve pain, chest pains, changes in menstruation, in and out of awareness, seizure like episodes, extreme weakness The Covid19 vaccine has left pt. both physically and mentally incapacitated. She is unable to work and is on disability, unable to drive or preform normal daily activities. Please See: VSAFE Survey Response Details and Pfizer Complaint dated 5-18-21
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysarthria, Dysphemia, Fatigue, Feeling of body temperature change, Gait disturbance
Clinical narrative: Immediate: Dizziness, Light headed, Drowsy, Unsteady, weak, hot and cold flashes Reported to staff: asked twice for water, chairs were limited, sat in car... due to confusion, vision issues, and above symptoms Called parents after 45 minutes: speech was slurred like a stroke symptom Remained in parking lot for 2 hours  before driving home, have not driven since Upon arriving home: experienced nausea, wooziness, severe chills, breathing irregularities, sore arm Next morning: migraine, nausea, chills, stiff muscles, fatigue, total body ache, confusion, memory loss, slurred speech, dizziness, delayed speech, stuttering  Continued Continued symptoms: all above symptoms, short term memory loss, difficulty with productive language, processing speed and severe impairment with focus and concentration, extreme fatigue, slurry and stuttered speech, at times no speech ability at all, extreme body pain, difficulty walking without assistance, 24/7 headache, dizziness, nausea, vision issues, muscle spasms and tightness, joint and nerve pain, chest pains, changes in menstruation, in and out of awareness, seizure like episodes, extreme weakness The Covid19 vaccine has left pt. both physically and mentally incapacitated. She is unable to work and is on disability, unable to drive or preform normal daily activities. Please See: VSAFE Survey Response Details and Pfizer Complaint dated 5-18-21
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immediate post-injection reaction, Impaired driving ability, Impaired work ability, Lumbar puncture, Magnetic resonance imaging
Clinical narrative: Immediate: Dizziness, Light headed, Drowsy, Unsteady, weak, hot and cold flashes Reported to staff: asked twice for water, chairs were limited, sat in car... due to confusion, vision issues, and above symptoms Called parents after 45 minutes: speech was slurred like a stroke symptom Remained in parking lot for 2 hours  before driving home, have not driven since Upon arriving home: experienced nausea, wooziness, severe chills, breathing irregularities, sore arm Next morning: migraine, nausea, chills, stiff muscles, fatigue, total body ache, confusion, memory loss, slurred speech, dizziness, delayed speech, stuttering  Continued Continued symptoms: all above symptoms, short term memory loss, difficulty with productive language, processing speed and severe impairment with focus and concentration, extreme fatigue, slurry and stuttered speech, at times no speech ability at all, extreme body pain, difficulty walking without assistance, 24/7 headache, dizziness, nausea, vision issues, muscle spasms and tightness, joint and nerve pain, chest pains, changes in menstruation, in and out of awareness, seizure like episodes, extreme weakness The Covid19 vaccine has left pt. both physically and mentally incapacitated. She is unable to work and is on disability, unable to drive or preform normal daily activities. Please See: VSAFE Survey Response Details and Pfizer Complaint dated 5-18-21
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Menstrual disorder, Migraine, Muscle spasms, Muscle tightness, Musculoskeletal stiffness
Clinical narrative: Immediate: Dizziness, Light headed, Drowsy, Unsteady, weak, hot and cold flashes Reported to staff: asked twice for water, chairs were limited, sat in car... due to confusion, vision issues, and above symptoms Called parents after 45 minutes: speech was slurred like a stroke symptom Remained in parking lot for 2 hours  before driving home, have not driven since Upon arriving home: experienced nausea, wooziness, severe chills, breathing irregularities, sore arm Next morning: migraine, nausea, chills, stiff muscles, fatigue, total body ache, confusion, memory loss, slurred speech, dizziness, delayed speech, stuttering  Continued Continued symptoms: all above symptoms, short term memory loss, difficulty with productive language, processing speed and severe impairment with focus and concentration, extreme fatigue, slurry and stuttered speech, at times no speech ability at all, extreme body pain, difficulty walking without assistance, 24/7 headache, dizziness, nausea, vision issues, muscle spasms and tightness, joint and nerve pain, chest pains, changes in menstruation, in and out of awareness, seizure like episodes, extreme weakness The Covid19 vaccine has left pt. both physically and mentally incapacitated. She is unable to work and is on disability, unable to drive or preform normal daily activities. Please See: VSAFE Survey Response Details and Pfizer Complaint dated 5-18-21
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Neuralgia, Neurological symptom, Pain, Pain in extremity
Clinical narrative: Immediate: Dizziness, Light headed, Drowsy, Unsteady, weak, hot and cold flashes Reported to staff: asked twice for water, chairs were limited, sat in car... due to confusion, vision issues, and above symptoms Called parents after 45 minutes: speech was slurred like a stroke symptom Remained in parking lot for 2 hours  before driving home, have not driven since Upon arriving home: experienced nausea, wooziness, severe chills, breathing irregularities, sore arm Next morning: migraine, nausea, chills, stiff muscles, fatigue, total body ache, confusion, memory loss, slurred speech, dizziness, delayed speech, stuttering  Continued Continued symptoms: all above symptoms, short term memory loss, difficulty with productive language, processing speed and severe impairment with focus and concentration, extreme fatigue, slurry and stuttered speech, at times no speech ability at all, extreme body pain, difficulty walking without assistance, 24/7 headache, dizziness, nausea, vision issues, muscle spasms and tightness, joint and nerve pain, chest pains, changes in menstruation, in and out of awareness, seizure like episodes, extreme weakness The Covid19 vaccine has left pt. both physically and mentally incapacitated. She is unable to work and is on disability, unable to drive or preform normal daily activities. Please See: VSAFE Survey Response Details and Pfizer Complaint dated 5-18-21
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Speech disorder developmental, Thinking abnormal, Ultrasound scan, Urine analysis, Visual impairment
Clinical narrative: Immediate: Dizziness, Light headed, Drowsy, Unsteady, weak, hot and cold flashes Reported to staff: asked twice for water, chairs were limited, sat in car... due to confusion, vision issues, and above symptoms Called parents after 45 minutes: speech was slurred like a stroke symptom Remained in parking lot for 2 hours  before driving home, have not driven since Upon arriving home: experienced nausea, wooziness, severe chills, breathing irregularities, sore arm Next morning: migraine, nausea, chills, stiff muscles, fatigue, total body ache, confusion, memory loss, slurred speech, dizziness, delayed speech, stuttering  Continued Continued symptoms: all above symptoms, short term memory loss, difficulty with productive language, processing speed and severe impairment with focus and concentration, extreme fatigue, slurry and stuttered speech, at times no speech ability at all, extreme body pain, difficulty walking without assistance, 24/7 headache, dizziness, nausea, vision issues, muscle spasms and tightness, joint and nerve pain, chest pains, changes in menstruation, in and out of awareness, seizure like episodes, extreme weakness The Covid19 vaccine has left pt. both physically and mentally incapacitated. She is unable to work and is on disability, unable to drive or preform normal daily activities. Please See: VSAFE Survey Response Details and Pfizer Complaint dated 5-18-21
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood culture, Chest X-ray, Computerised tomogram thorax abnormal, Headache, Pleural effusion
Clinical narrative: BILATERAL PULMONARY EMBOLISM; This spontaneous report received from a parent via social media concerned an 18 year old male of unspecified race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced bilateral pulmonary embolism, and was hospitalized on 19-MAY-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bilateral pulmonary embolism was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: This spontaneous report received from a patient's parent via social media concerns an 18-year-old male of specified race/ethnicity who was hospitalized for bilateral pulmonary embolism an unspecified period of time after receiving the Janssen Covid-19 vaccine. Medical history, concomitant medications, clinical symptoms, diagnostic testing (e.g. platelet count, anti-Platelet Factor 4 antibody, d-Dimer, coagulopathy panel), corrective treatment, and outcome were not reported. Based on evolving knowledge of Thrombosis with Thrombocytopenia Syndrome (TTS, per definition from vaccine safety research), the relationship of the pulmonary embolism to vaccination is considered unclassifiable due to insufficient information. Additional information will be requested if contact information becomes available.