chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Extra dose administered
Clinical narrative: his third dose  was out of the limits on storage outside of refrigerator/"it sat out too long"; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (his third dose  was out of the limits on storage outside of refrigerator/"it sat out too long") in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     The patient's past medical history included Chronic myeloid leukemia (I have chronic myeloid leukemia I am immunosuppressed). Previously administered products included for an unreported indication: IMMUNOSUPPRESSANTS. Concomitant products included VITAMINS NOS for Supplementation therapy, Strycel, protonix, AMLODIPINE, LOSARTAN, ATORVASTATIN, TAMSULOSIN HYDROCHLORIDE (FLOMAX [TAMSULOSIN HYDROCHLORIDE]), ESCITALOPRAM OXALATE (LEXAPRO), SPIRONOLACTONE and BUPROPION for an unknown indication.    On 27-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (his third dose  was out of the limits on storage outside of refrigerator/"it sat out too long"). At the time of the report, EXPIRED PRODUCT ADMINISTERED (his third dose  was out of the limits on storage outside of refrigerator/"it sat out too long") outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: his third dose  was out of the limits on storage outside of refrigerator/"it sat out too long"; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (his third dose  was out of the limits on storage outside of refrigerator/"it sat out too long") in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     The patient's past medical history included Chronic myeloid leukemia (I have chronic myeloid leukemia I am immunosuppressed). Previously administered products included for an unreported indication: IMMUNOSUPPRESSANTS. Concomitant products included VITAMINS NOS for Supplementation therapy, Strycel, protonix, AMLODIPINE, LOSARTAN, ATORVASTATIN, TAMSULOSIN HYDROCHLORIDE (FLOMAX [TAMSULOSIN HYDROCHLORIDE]), ESCITALOPRAM OXALATE (LEXAPRO), SPIRONOLACTONE and BUPROPION for an unknown indication.    On 27-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (his third dose  was out of the limits on storage outside of refrigerator/"it sat out too long"). At the time of the report, EXPIRED PRODUCT ADMINISTERED (his third dose  was out of the limits on storage outside of refrigerator/"it sat out too long") outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiac flutter, Chest pain, Dyspnoea, Heart rate increased
Clinical narrative: Caller thinks it is Myocarditis.; Chest pain; Shortness of breath; felt like her lungs couldn't fill up; This is a spontaneous report from a contactable Nurse (patient)   A 41-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number not provided), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation.  Relevant medical history and concomitant medications were not reported.  Immediately after receiving the vaccine patient began having chest pain, shortness of breath and felt like her lungs couldn't fill up. She has not gotten better in two weeks. She thought it sounds like Myocarditis (as reported). The patient  went to urgent care center, they told her not to go to the Emergency Room for risk of getting Covid.Stated they did an office EKG and said they would send it to cardiologist. (as reported). The patient underwent lab tests and procedures which included electrocardiogram abnormal on an unspecified date. At the time of the reporting the patient had not yet recovered from chest pain and Shortness of breath, outcome of other reported events was unknown.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug in the reported serious event Myocarditis cannot be completely ruled out given the known suspect drug profile and/or implied 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 Regul atory Authorities, Ethics Committees and Investigators, as appropriate
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Dyspnoea, Electrocardiogram, Feeling abnormal, Myocarditis
Clinical narrative: Caller thinks it is Myocarditis.; Chest pain; Shortness of breath; felt like her lungs couldn't fill up; This is a spontaneous report from a contactable Nurse (patient)   A 41-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number not provided), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation.  Relevant medical history and concomitant medications were not reported.  Immediately after receiving the vaccine patient began having chest pain, shortness of breath and felt like her lungs couldn't fill up. She has not gotten better in two weeks. She thought it sounds like Myocarditis (as reported). The patient  went to urgent care center, they told her not to go to the Emergency Room for risk of getting Covid.Stated they did an office EKG and said they would send it to cardiologist. (as reported). The patient underwent lab tests and procedures which included electrocardiogram abnormal on an unspecified date. At the time of the reporting the patient had not yet recovered from chest pain and Shortness of breath, outcome of other reported events was unknown.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug in the reported serious event Myocarditis cannot be completely ruled out given the known suspect drug profile and/or implied 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 Regul atory Authorities, Ethics Committees and Investigators, as appropriate
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiac flutter, Heart rate increased
Clinical narrative: Injection arm was aching; Fever; Chest pain; Heart started racing; Fluttering in her chest; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart started racing), CHEST DISCOMFORT (Fluttering in her chest), VACCINATION SITE PAIN (Injection arm was aching), CHEST PAIN (Chest pain) and PYREXIA (Fever) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Sep-2021, the patient experienced PALPITATIONS (Heart started racing), CHEST DISCOMFORT (Fluttering in her chest) and CHEST PAIN (Chest pain). On 05-Sep-2021, the patient experienced VACCINATION SITE PAIN (Injection arm was aching) and PYREXIA (Fever). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PALPITATIONS (Heart started racing), CHEST DISCOMFORT (Fluttering in her chest), VACCINATION SITE PAIN (Injection arm was aching), CHEST PAIN (Chest pain) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication details were not reported by the reporter.  Treatment details was not reported by the reporter.  Patient stated that she received her 1st dose of the Moderna COVID 19 vaccine on 4SEPT2021 at Pharmacy. 30 minutes after getting the vaccine, her heart started racing, she felt some fluttering in her chest, and she had a chest pain. The symptoms lasted for 2 minutes; she did not get an EKG done. The next day, she had fever, her injection arm was aching, and she had chest pain which was on and off through out the day; it was not persistent that she needed to call 911. She went to her doctor today; her doctor said the vaccine is safe, but she feels her doctor is bias. She took Motrin at the time she was having the symptoms. She was not having the symptoms at the time of the call. She gave a consent for safety to follow-up with her or her healthcare provider. Lot number and date of birth was provided by patient but the information was deleted when system crashed.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Chest pain, Palpitations, Pyrexia, Vaccination site pain
Clinical narrative: Injection arm was aching; Fever; Chest pain; Heart started racing; Fluttering in her chest; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart started racing), CHEST DISCOMFORT (Fluttering in her chest), VACCINATION SITE PAIN (Injection arm was aching), CHEST PAIN (Chest pain) and PYREXIA (Fever) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Sep-2021, the patient experienced PALPITATIONS (Heart started racing), CHEST DISCOMFORT (Fluttering in her chest) and CHEST PAIN (Chest pain). On 05-Sep-2021, the patient experienced VACCINATION SITE PAIN (Injection arm was aching) and PYREXIA (Fever). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PALPITATIONS (Heart started racing), CHEST DISCOMFORT (Fluttering in her chest), VACCINATION SITE PAIN (Injection arm was aching), CHEST PAIN (Chest pain) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication details were not reported by the reporter.  Treatment details was not reported by the reporter.  Patient stated that she received her 1st dose of the Moderna COVID 19 vaccine on 4SEPT2021 at Pharmacy. 30 minutes after getting the vaccine, her heart started racing, she felt some fluttering in her chest, and she had a chest pain. The symptoms lasted for 2 minutes; she did not get an EKG done. The next day, she had fever, her injection arm was aching, and she had chest pain which was on and off through out the day; it was not persistent that she needed to call 911. She went to her doctor today; her doctor said the vaccine is safe, but she feels her doctor is bias. She took Motrin at the time she was having the symptoms. She was not having the symptoms at the time of the call. She gave a consent for safety to follow-up with her or her healthcare provider. Lot number and date of birth was provided by patient but the information was deleted when system crashed.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Rash, Rash erythematous
Clinical narrative: violent diarrhea; Sweating; chills; This is a spontaneous report from a contactable consumer (patient, self reported). A 52-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date was not reported), via an unspecified route of administration, in Arm right, on 12Aug2021 at 02:00 PM (Age at vaccination: 52 years), as a Dose 2, single for COVID-19 immunization. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, in Arm right, on 22Jul2021 at 10:00AM (Age at vaccination: 52 years), as a Dose 1, single for COVID-19 immunization. The medical history was not reported and patient did not had any known allergies. Concomitant medication included clomiphene citrate (Clomiphene). The patient did not receive other vaccine in four weeks. The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. On 12Aug2021 at 6:00PM, the patient experienced violent diarrhea, Sweating and chills. It was unknown that the patient received treatment for the events. Outcome of the events were not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Diarrhoea, Hyperhidrosis
Clinical narrative: violent diarrhea; Sweating; chills; This is a spontaneous report from a contactable consumer (patient, self reported). A 52-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date was not reported), via an unspecified route of administration, in Arm right, on 12Aug2021 at 02:00 PM (Age at vaccination: 52 years), as a Dose 2, single for COVID-19 immunization. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, in Arm right, on 22Jul2021 at 10:00AM (Age at vaccination: 52 years), as a Dose 1, single for COVID-19 immunization. The medical history was not reported and patient did not had any known allergies. Concomitant medication included clomiphene citrate (Clomiphene). The patient did not receive other vaccine in four weeks. The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. On 12Aug2021 at 6:00PM, the patient experienced violent diarrhea, Sweating and chills. It was unknown that the patient received treatment for the events. Outcome of the events were not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anal haemorrhage, Anal sphincterotomy, Arteriovenous malformation, Basophil count, Basophil percentage decreased
Clinical narrative: Patient experienced significant post-operative GI bleeding after surgery (9/7/21) within two weeks of her vaccination. Patient was using oxycodone and acetaminophen for post-operative pain. Patient did also have ibuprofen on her post-op med list that has since been discontinued. Reporter is unsure if patient was using this medication at the time of event. Patient had additional surgery to repair bleed on 9/12/21.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure decreased, Colonoscopy normal, Dyspepsia, Eosinophil count, Eosinophil percentage decreased
Clinical narrative: Patient experienced significant post-operative GI bleeding after surgery (9/7/21) within two weeks of her vaccination. Patient was using oxycodone and acetaminophen for post-operative pain. Patient did also have ibuprofen on her post-op med list that has since been discontinued. Reporter is unsure if patient was using this medication at the time of event. Patient had additional surgery to repair bleed on 9/12/21.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Gastrointestinal haemorrhage, Haematocrit decreased, Haemoglobin decreased, Haemorrhoid operation
Clinical narrative: Patient experienced significant post-operative GI bleeding after surgery (9/7/21) within two weeks of her vaccination. Patient was using oxycodone and acetaminophen for post-operative pain. Patient did also have ibuprofen on her post-op med list that has since been discontinued. Reporter is unsure if patient was using this medication at the time of event. Patient had additional surgery to repair bleed on 9/12/21.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immature granulocyte count, Lymphocyte count, Lymphocyte percentage, Mean cell haemoglobin concentration normal, Mean cell haemoglobin normal
Clinical narrative: Patient experienced significant post-operative GI bleeding after surgery (9/7/21) within two weeks of her vaccination. Patient was using oxycodone and acetaminophen for post-operative pain. Patient did also have ibuprofen on her post-op med list that has since been discontinued. Reporter is unsure if patient was using this medication at the time of event. Patient had additional surgery to repair bleed on 9/12/21.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Mean cell volume normal, Mean platelet volume normal, Monocyte count, Monocyte percentage, Nausea
Clinical narrative: Patient experienced significant post-operative GI bleeding after surgery (9/7/21) within two weeks of her vaccination. Patient was using oxycodone and acetaminophen for post-operative pain. Patient did also have ibuprofen on her post-op med list that has since been discontinued. Reporter is unsure if patient was using this medication at the time of event. Patient had additional surgery to repair bleed on 9/12/21.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Neutrophil count, Neutrophil percentage, Platelet count, Red blood cell count decreased, Red cell distribution width normal
Clinical narrative: Patient experienced significant post-operative GI bleeding after surgery (9/7/21) within two weeks of her vaccination. Patient was using oxycodone and acetaminophen for post-operative pain. Patient did also have ibuprofen on her post-op med list that has since been discontinued. Reporter is unsure if patient was using this medication at the time of event. Patient had additional surgery to repair bleed on 9/12/21.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Surgery, Syncope, Transfusion, White blood cell count normal
Clinical narrative: Patient experienced significant post-operative GI bleeding after surgery (9/7/21) within two weeks of her vaccination. Patient was using oxycodone and acetaminophen for post-operative pain. Patient did also have ibuprofen on her post-op med list that has since been discontinued. Reporter is unsure if patient was using this medication at the time of event. Patient had additional surgery to repair bleed on 9/12/21.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Gastrointestinal haemorrhage, Gastrointestinal surgery, Haemoglobin decreased, Post procedural haemorrhage
Clinical narrative: Patient experienced significant post-operative GI bleeding after surgery (9/7/21) within two weeks of her vaccination. Patient was using oxycodone and acetaminophen for post-operative pain. Patient did also have ibuprofen on her post-op med list that has since been discontinued. Reporter is unsure if patient was using this medication at the time of event. Patient had additional surgery to repair bleed on 9/12/21.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Heart rate, Heart rate increased, Oxygen saturation, Pain
Clinical narrative: chest pain; patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Mar2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunization; My heart rate now suddenly was topping out at 105 on the minor hill on the way to work after months of maintaining 170s for the same work; Pain in movement; Pain in movement; This is a spontaneous report from a contactable consumer. An adult male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Mar2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunization. Medical history included Covid-19, after months of maintaining 170s (heart rate). Patient had no other vaccine in four weeks. The patient's concomitant medications were not reported.  The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on 23Mar2021 for covid-19 immunization. Shot 1 hit him like a truck, it was like being back with Covid again for a day, and the second shot wasnt a lot better. But about a week after the second shot, he saw DRAMATIC improvement. Without any substantial muscle gain he had access to my general strength again, he did not need help lifting or moving every-day objects, and he could even walk my dog again without issue. Pain in movement was great-ly reduced to almost nothing. His heart rate now suddenly was topping out at 105 on the minor hill on the way to work after months of maintaining 170s for the  same work. O2 has been holding steady in the 97 to 98 range these days. He was certainly not back to normal, the most he have managed at a stretch was about half a mile for a run before chest pain tilted in, but this is a huge improvement from where he was and he did continue to see incremental increases week to week. The outcome of the event chest pain was unknown, while for other events was recovered on an unspecified date. Patient had no treatment. It was unknown if patient was covid tested post vaccination. Case was reported as non-serious.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Heart rate, Heart rate increased, Inappropriate schedule of product administration, Movement disorder
Clinical narrative: chest pain; patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Mar2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunization; My heart rate now suddenly was topping out at 105 on the minor hill on the way to work after months of maintaining 170s for the same work; Pain in movement; Pain in movement; This is a spontaneous report from a contactable consumer. An adult male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Mar2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunization. Medical history included Covid-19, after months of maintaining 170s (heart rate). Patient had no other vaccine in four weeks. The patient's concomitant medications were not reported.  The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on 23Mar2021 for covid-19 immunization. Shot 1 hit him like a truck, it was like being back with Covid again for a day, and the second shot wasnt a lot better. But about a week after the second shot, he saw DRAMATIC improvement. Without any substantial muscle gain he had access to my general strength again, he did not need help lifting or moving every-day objects, and he could even walk my dog again without issue. Pain in movement was great-ly reduced to almost nothing. His heart rate now suddenly was topping out at 105 on the minor hill on the way to work after months of maintaining 170s for the  same work. O2 has been holding steady in the 97 to 98 range these days. He was certainly not back to normal, the most he have managed at a stretch was about half a mile for a run before chest pain tilted in, but this is a huge improvement from where he was and he did continue to see incremental increases week to week. The outcome of the event chest pain was unknown, while for other events was recovered on an unspecified date. Patient had no treatment. It was unknown if patient was covid tested post vaccination. Case was reported as non-serious.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Oxygen saturation, Pain
Clinical narrative: chest pain; patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Mar2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunization; My heart rate now suddenly was topping out at 105 on the minor hill on the way to work after months of maintaining 170s for the same work; Pain in movement; Pain in movement; This is a spontaneous report from a contactable consumer. An adult male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Mar2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunization. Medical history included Covid-19, after months of maintaining 170s (heart rate). Patient had no other vaccine in four weeks. The patient's concomitant medications were not reported.  The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on 23Mar2021 for covid-19 immunization. Shot 1 hit him like a truck, it was like being back with Covid again for a day, and the second shot wasnt a lot better. But about a week after the second shot, he saw DRAMATIC improvement. Without any substantial muscle gain he had access to my general strength again, he did not need help lifting or moving every-day objects, and he could even walk my dog again without issue. Pain in movement was great-ly reduced to almost nothing. His heart rate now suddenly was topping out at 105 on the minor hill on the way to work after months of maintaining 170s for the  same work. O2 has been holding steady in the 97 to 98 range these days. He was certainly not back to normal, the most he have managed at a stretch was about half a mile for a run before chest pain tilted in, but this is a huge improvement from where he was and he did continue to see incremental increases week to week. The outcome of the event chest pain was unknown, while for other events was recovered on an unspecified date. Patient had no treatment. It was unknown if patient was covid tested post vaccination. Case was reported as non-serious.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Pain in extremity
Clinical narrative: Diarrhea; Arm uncomfortable; it was sore to the touch and it hurt to move it; Diarrhea was reported as worsened; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 79-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EL9266; Expiration Date: 31May2021), via an unspecified route of administration, administered in arm left on 15Feb2021 at 12:00 PM (at the age of 79-year-old) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced diarrhea was reported as worsened on an unspecified date in Feb2021; arm uncomfortable, it was sore to the touch and it hurt to move it on 15Feb2021; diarrhea on 19Feb2021. Calling about the Covid-19 Vaccine. Stated that she got her 1st dose on 15Feb2021 and for about 1.5 days her arm was uncomfortable; it was sore to the touch and it hurt to move it, but that passed, and now today she has diarrhea. Could that be a side effect of the vaccine. Outcome of the events diarrhea was not recovered; diarrhea was reported as worsened was unknown; it was sore to the touch and it hurt to move it was recovered on an unspecified date in Feb2021; arm uncomfortable was recovered on 16Feb2021.  Follow-up (PRD/SRD 13May2021): Follow-up attempts completed. No further information expected.
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Limb discomfort, Pain in extremity
Clinical narrative: Diarrhea; Arm uncomfortable; it was sore to the touch and it hurt to move it; Diarrhea was reported as worsened; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 79-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EL9266; Expiration Date: 31May2021), via an unspecified route of administration, administered in arm left on 15Feb2021 at 12:00 PM (at the age of 79-year-old) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced diarrhea was reported as worsened on an unspecified date in Feb2021; arm uncomfortable, it was sore to the touch and it hurt to move it on 15Feb2021; diarrhea on 19Feb2021. Calling about the Covid-19 Vaccine. Stated that she got her 1st dose on 15Feb2021 and for about 1.5 days her arm was uncomfortable; it was sore to the touch and it hurt to move it, but that passed, and now today she has diarrhea. Could that be a side effect of the vaccine. Outcome of the events diarrhea was not recovered; diarrhea was reported as worsened was unknown; it was sore to the touch and it hurt to move it was recovered on an unspecified date in Feb2021; arm uncomfortable was recovered on 16Feb2021.  Follow-up (PRD/SRD 13May2021): Follow-up attempts completed. No further information expected.
Age: 13.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Injection site pain, Pyrexia
Clinical narrative: My daughter was mandated to get the vaccine to go to school. She is small for her age and was given the same amount as an adult.  She had significant pain at the injection site and her overall arm was sore. 24 hours later, she suffered a severe headache and a fever of 101.6. She was unable to do anything but stay in bed and drink liquids and apply cold compress to bring down her fever. After sleeping for 12 hours she woke up feeling better. I am concerned about her adverse reaction and having to get another shot. Since she is the size and weight of an 11 year-old- I am consulting with her pediatrician that she is not a good candidate for a second dose at this high level, especially when it is recommended for small children to be given half the dose this week.
Age: 13.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Adverse reaction, Headache, Injection site pain, Mobility decreased, Pain in extremity
Clinical narrative: My daughter was mandated to get the vaccine to go to school. She is small for her age and was given the same amount as an adult.  She had significant pain at the injection site and her overall arm was sore. 24 hours later, she suffered a severe headache and a fever of 101.6. She was unable to do anything but stay in bed and drink liquids and apply cold compress to bring down her fever. After sleeping for 12 hours she woke up feeling better. I am concerned about her adverse reaction and having to get another shot. Since she is the size and weight of an 11 year-old- I am consulting with her pediatrician that she is not a good candidate for a second dose at this high level, especially when it is recommended for small children to be given half the dose this week.
Age: 13.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: My daughter was mandated to get the vaccine to go to school. She is small for her age and was given the same amount as an adult.  She had significant pain at the injection site and her overall arm was sore. 24 hours later, she suffered a severe headache and a fever of 101.6. She was unable to do anything but stay in bed and drink liquids and apply cold compress to bring down her fever. After sleeping for 12 hours she woke up feeling better. I am concerned about her adverse reaction and having to get another shot. Since she is the size and weight of an 11 year-old- I am consulting with her pediatrician that she is not a good candidate for a second dose at this high level, especially when it is recommended for small children to be given half the dose this week.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Dysphagia, Dyspnoea
Clinical narrative: Anaphylaxis type reaction,  SOB / difficulty swallowing.  Treated with EPI, diphenhydramine and methylprednisolone.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactoid reaction, Dysphagia, Dyspnoea
Clinical narrative: Anaphylaxis type reaction,  SOB / difficulty swallowing.  Treated with EPI, diphenhydramine and methylprednisolone.
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Back pain, Delirium, Full blood count, Myalgia, Nausea
Clinical narrative: CONVULSIONS; FLU LIKE SYMPTOMS; FEELING YUCKY; This spontaneous report received from a parent concerned an 18 year old white non Hispanic or Latino male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no change in lifestyle and had no allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, expiry: 21-SEP-2021) dose was not reported, 1 total, administered on 16-SEP-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 16-SEP-2021, about an hour or two, patient started to feel yucky. On the same day, patient had convulsions and flu like symptoms throughout the day with a fever brought to the emergency room (ER) at 12:45 AM on 17-SEP-2021 with a temperature 102.4 Degrees Fahrenheit at the triage with severe back pain, vomiting and convulsing. The patient was administered Motrin, Phenergren and IV fluids. The blood works were performed, fast covid-19 screening, CPK and comprehensive metabolic panel. The patient was discharged at 3 AM and returned home. It was reported that flu like symptoms body ache, fever, back ache, nausea, vomiting and convulsing which got progressively worse as the day wore on. The temperature was fluctuating between 99 and 100 Degrees Fahrenheit. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from convulsions, and flu like symptoms, and the outcome of feeling yucky was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210935140- covid-19 vaccine ad26.cov2.s-Convulsion & flu like symptoms. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Seizure, Vomiting
Clinical narrative: CONVULSIONS; FLU LIKE SYMPTOMS; FEELING YUCKY; This spontaneous report received from a parent concerned an 18 year old white non Hispanic or Latino male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no change in lifestyle and had no allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, expiry: 21-SEP-2021) dose was not reported, 1 total, administered on 16-SEP-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 16-SEP-2021, about an hour or two, patient started to feel yucky. On the same day, patient had convulsions and flu like symptoms throughout the day with a fever brought to the emergency room (ER) at 12:45 AM on 17-SEP-2021 with a temperature 102.4 Degrees Fahrenheit at the triage with severe back pain, vomiting and convulsing. The patient was administered Motrin, Phenergren and IV fluids. The blood works were performed, fast covid-19 screening, CPK and comprehensive metabolic panel. The patient was discharged at 3 AM and returned home. It was reported that flu like symptoms body ache, fever, back ache, nausea, vomiting and convulsing which got progressively worse as the day wore on. The temperature was fluctuating between 99 and 100 Degrees Fahrenheit. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from convulsions, and flu like symptoms, and the outcome of feeling yucky was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210935140- covid-19 vaccine ad26.cov2.s-Convulsion & flu like symptoms. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood creatine phosphokinase, Blood test, Body temperature, Feeling abnormal, Influenza like illness
Clinical narrative: CONVULSIONS; FLU LIKE SYMPTOMS; FEELING YUCKY; This spontaneous report received from a parent concerned an 18 year old white non Hispanic or Latino male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no change in lifestyle and had no allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, expiry: 21-SEP-2021) dose was not reported, 1 total, administered on 16-SEP-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 16-SEP-2021, about an hour or two, patient started to feel yucky. On the same day, patient had convulsions and flu like symptoms throughout the day with a fever brought to the emergency room (ER) at 12:45 AM on 17-SEP-2021 with a temperature 102.4 Degrees Fahrenheit at the triage with severe back pain, vomiting and convulsing. The patient was administered Motrin, Phenergren and IV fluids. The blood works were performed, fast covid-19 screening, CPK and comprehensive metabolic panel. The patient was discharged at 3 AM and returned home. It was reported that flu like symptoms body ache, fever, back ache, nausea, vomiting and convulsing which got progressively worse as the day wore on. The temperature was fluctuating between 99 and 100 Degrees Fahrenheit. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from convulsions, and flu like symptoms, and the outcome of feeling yucky was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210935140- covid-19 vaccine ad26.cov2.s-Convulsion & flu like symptoms. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Metabolic function test, SARS-CoV-2 test, Seizure
Clinical narrative: CONVULSIONS; FLU LIKE SYMPTOMS; FEELING YUCKY; This spontaneous report received from a parent concerned an 18 year old white non Hispanic or Latino male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no change in lifestyle and had no allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, expiry: 21-SEP-2021) dose was not reported, 1 total, administered on 16-SEP-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 16-SEP-2021, about an hour or two, patient started to feel yucky. On the same day, patient had convulsions and flu like symptoms throughout the day with a fever brought to the emergency room (ER) at 12:45 AM on 17-SEP-2021 with a temperature 102.4 Degrees Fahrenheit at the triage with severe back pain, vomiting and convulsing. The patient was administered Motrin, Phenergren and IV fluids. The blood works were performed, fast covid-19 screening, CPK and comprehensive metabolic panel. The patient was discharged at 3 AM and returned home. It was reported that flu like symptoms body ache, fever, back ache, nausea, vomiting and convulsing which got progressively worse as the day wore on. The temperature was fluctuating between 99 and 100 Degrees Fahrenheit. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from convulsions, and flu like symptoms, and the outcome of feeling yucky was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210935140- covid-19 vaccine ad26.cov2.s-Convulsion & flu like symptoms. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Neck pain, Pain
Clinical narrative: low fever, left arm pain, swollen arm , very tired, nausea, neck pain, heavy body ache, headache .
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: low fever, left arm pain, swollen arm , very tired, nausea, neck pain, heavy body ache, headache .
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Hypoaesthesia, Lumbar puncture, Magnetic resonance imaging
Clinical narrative: Fingers began to go numb and tingly, then 2 and a half weeks later both legs became tingly and numb, then other arm. Went to hospital, could barely move legs for about 2 days, had no reflexes in extremities, severe weakness. Sedation to hands/arms has come back but legs are still severely weak. I can walk with assistance of a walker.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Movement disorder, Muscular weakness, Paraesthesia, Walking aid user
Clinical narrative: Fingers began to go numb and tingly, then 2 and a half weeks later both legs became tingly and numb, then other arm. Went to hospital, could barely move legs for about 2 days, had no reflexes in extremities, severe weakness. Sedation to hands/arms has come back but legs are still severely weak. I can walk with assistance of a walker.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Dyspnoea, Exercise tolerance decreased, Fatigue
Clinical narrative: Chills, sweats, headache, body ache, restless legs, dizziness, fatigue, low grade fever, shortness of breath, difficulty walking or performing any type of physical activity. Telephones physician.  Used Tylenol and ibuprofen.  After 12 hours, muscle aches and headache diminished.  Dizziness and chills persist.  No fever 24 hours after vaccine.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance, Headache, Hyperhidrosis, Pain, Pyrexia
Clinical narrative: Chills, sweats, headache, body ache, restless legs, dizziness, fatigue, low grade fever, shortness of breath, difficulty walking or performing any type of physical activity. Telephones physician.  Used Tylenol and ibuprofen.  After 12 hours, muscle aches and headache diminished.  Dizziness and chills persist.  No fever 24 hours after vaccine.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Restless legs syndrome
Clinical narrative: Chills, sweats, headache, body ache, restless legs, dizziness, fatigue, low grade fever, shortness of breath, difficulty walking or performing any type of physical activity. Telephones physician.  Used Tylenol and ibuprofen.  After 12 hours, muscle aches and headache diminished.  Dizziness and chills persist.  No fever 24 hours after vaccine.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Nausea, Oral discomfort
Clinical narrative: Patient stated on the phone she was nauseous right after the vaccine. On Saturday, the day after the vaccine, she states her top lip was tight and red. It was slightly evident Friday, but more apparent on Saturday as it bothered her more.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood testosterone decreased
Clinical narrative: Low T effecting strength and stamina
Age: 34.0
Sex: F
Vaccine: VARCEL
Symptoms: Paraesthesia, Pyrexia, Rash
Clinical narrative: Rash developed on inner thigh. Light fever. Tingling sensation in body.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Condition aggravated, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Prolonged, continuous cardiac arrhythmias, approximately 12-15 hours duration  despite normal medication that usually controls them. Began about 30 hours after injection, resolved at about 48 hours after injection.  Swelling, redness below injection site, warm to touch approximately 6?x 3? area. Began about 30 hours after injection. Swelling has lasted at least 36 hours at current date. No signs of improvement to this point despite repeated application of steroid cream, oral antihistamines and  h2 blockers.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: Heart attack
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Angina pectoris, Discomfort, Loss of personal independence in daily activities, Pain
Clinical narrative: Chest pain centered at the heart. Pain was both consistent (at a level 3/10) and would at times spike in pain level (to 7/10). No chest pain has ever been felt as severe as this before.  The pain started earlier the day after the vaccine and became worse at night. Throughout the rest of that week it took at least 4-5 days before I felt comfortable enough to run and continue my usual physical activities.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Fatigue, Lymphadenopathy, Pain
Clinical narrative: Beginning a few hours after injection I had left arm pain. Then began a fever of 101.4. Then sever body aches and joint pain to the point of near immobility. Swollen lymph nodes. Extreme fatigue. Was prescribed dexamethasone and Toradol for symptoms the day after as I was incapacitated and in tears.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Tearfulness
Clinical narrative: Beginning a few hours after injection I had left arm pain. Then began a fever of 101.4. Then sever body aches and joint pain to the point of near immobility. Swollen lymph nodes. Extreme fatigue. Was prescribed dexamethasone and Toradol for symptoms the day after as I was incapacitated and in tears.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial flutter, Cardiac monitoring, Computerised tomogram head normal, Electrocardiogram abnormal, Hypoaesthesia
Clinical narrative: 1.  Numbness on right side of nose and under right eye.  Amoxicillin followed by Clavulanate starting 5/28/2021.  Clindamycin starting 6/23/2021.  Condition still exists.   2.  Atrial Flutter.  First detected on 7/27/2021.  Condition still exists.  Ablation scheduled for 10/15/2021. Atrial Flutter-Echocardiogram 8/9/2021.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging head normal
Clinical narrative: 1.  Numbness on right side of nose and under right eye.  Amoxicillin followed by Clavulanate starting 5/28/2021.  Clindamycin starting 6/23/2021.  Condition still exists.   2.  Atrial Flutter.  First detected on 7/27/2021.  Condition still exists.  Ablation scheduled for 10/15/2021. Atrial Flutter-Echocardiogram 8/9/2021.
Age: 72.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Feeling abnormal, Headache, Joint swelling, Mobility decreased
Clinical narrative: Swollen shoulder & arm down into armpit Redness around arm at shoulder  Trouble lifting arm, cannot lay on it Headache and fuzzy headed
Age: 72.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Peripheral swelling
Clinical narrative: Swollen shoulder & arm down into armpit Redness around arm at shoulder  Trouble lifting arm, cannot lay on it Headache and fuzzy headed