chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Hypertension, Pain in extremity, Pyrexia, Wrong product administered
Clinical narrative: Patient received casirivimab instead of intended COVID vaccine.  At 48-hour follow up, patient reported Soreness to arm, fever of 99.9 and high blood pressure.  Wife thought he was anxious.  Follow up 2 hrs later and next morning, he reported he was "fine". Received COVID vaccine on December 31
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Follow up to FAERS18694343: Patient received casirivimab instead of intended COVID vaccine. 48-hr follow up didn't identify AEs. Patient received COVID vaccine December 31
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Follow up to FAERS18694343: Patient received casirivimab instead of intended COVID vaccine. 48-hr follow up didn't identify AEs. Patient Patient received COVID vaccine on December 31
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Follow up to FAERS18694343: Patient received casirivimab instead of intended COVID vaccine. 48-hr follow up didn't identify AEs. Patient Patient received COVID vaccine on December 31
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Follow up to FAERS18694343: Patient received casirivimab instead of intended COVID vaccine. 48-hr follow up didn't identify AEs. Patient Patient received COVID vaccine on December 31
Age: 93.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Follow up to FAERS 18694343: Patient received casirivimab instead of intended COVID vaccine. 48-hr follow up didn't identify AEs. Patient received COVID vaccine on December 31
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Follow up to FAERS18694343: Patient received casirivimab instead of intended COVID vaccine. 48-hr follow up didn't identify AEs. Patient Patient received COVID vaccine on December 31
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Wrong product administered
Clinical narrative: Follow up to FAERS18694343: Patient received casirivimab instead of intended COVID vaccine. At 48-hr follow up, patient reported arm soreness. Patient received COVID vaccine on December 31
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Follow up to FAERS18694343: Patient received casirivimab instead of intended COVID vaccine. 48-hr follow up didn't identify AEs. Patient Patient received COVID vaccine on December 31
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Follow up to FAERS18694343: Patient received casirivimab instead of intended COVID vaccine. 48-hr follow up didn't identify AEs. Patient Patient received COVID vaccine on December 31
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Follow up to FAERS18694343: Patient received casirivimab instead of intended COVID vaccine. 48-hr follow up didn't identify AEs. Patient Patient received COVID vaccine on December 31
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Follow up to FAERS18694343: Patient received casirivimab instead of intended COVID vaccine. 48-hr follow up didn't identify AEs. Patient Patient received COVID vaccine on December 31.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Follow up to FAERS18694343: Patient received casirivimab instead of intended COVID vaccine. 48-hr follow up didn't identify AEs. Patient Patient received COVID vaccine on December 31
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient received casirivimab instead of intended COVID vaccine.  48-hr follow up didn't identify AEs. Patient received COVID vaccine on December 31
Age: 70.0
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles in scalp, Forehead  and upper eye
Sex: F
Vaccine: VARZOS
Symptoms: Gait inability, Monoplegia
Clinical narrative: leg that was paralyzed; she could not walk; This case was reported by a consumer via call center representative and described the occurrence of leg paralysis in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced leg paralysis (serious criteria GSK medically significant) and unable to walk. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the leg paralysis and unable to walk were unknown.   The reporter considered the leg paralysis and unable to walk to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient reported that she had a terrible reaction to Shingrix and she could not walk that she had a leg that was paralyzed. Patient took Benadryl and also did not provide any additional information about the reaction to Shingles. The reporter did not consent to follow up.
Age: 76.0
Sex: F
Vaccine: FLUA4
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Arm and shoulder pain; Arm and shoulder pain; This spontaneous case was retrieved on 21-Dec-2020 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 896297-1) with additional information (being processed together) received on 12-Jan-2021, reported by other health professional and concerned a 76-year-old female patient.   The patient's medical history and concomitant medications were not reported.  On 22-Oct-2020, the patient was vaccinated with Fluad Quadrivalent vaccine (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; route of administration: intramuscular, anatomical location: left arm, dose and indication: not reported). The batch number reported was 279822.  On the same day, after receiving Fluad Quadrivalent, the patient developed arm and shoulder pain. The patient visited physician's office, however further details were not provided.  At the time of initial reporting, the patient had not recovered from the events.  The reporter did not provide causality assessment.   The case was assessed as non-serious.  Company comment: The patient developed pain in extremity and arthralgia on the same day after receiving the suspect product, Fluad Quadrivalent. Chronology is suggestive. The patient's medical history and concomitant medications were not reported. Considering all above mentioned, causal relationship for both events is assessed as possibly related (defaults to ''related'' in the safety database for reporting purposes).; Sender's Comments: The patient developed pain in extremity and arthralgia on the same day after receiving the suspect product, Fluad Quadrivalent. Chronology is suggestive. The patient's medical history and concomitant medications were not reported. Considering all above mentioned, causal relationship for both events is assessed as possibly related (defaults to ''related'' in the safety database for reporting purposes).
Age: 77.0
Sex: U
Vaccine: FLUA4, PPV
Symptoms: Peripheral swelling, Swelling
Clinical narrative: Pt was given flu vaccine LD SITE Immediately started to swell; This spontaneous case was retrieved on 22-Dec-2020 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 897205-1), reported by other health professional with additional information received on 14-Jan-2021 from Seqirus' manufacturing quality assurance department (being processed together) and concerned a 77-year-old patient of unreported gender.       The patient's concurrent condition included allergy to Skelaxin (metaxalone). The patient's concomitant medications were not reported.   On 17-Nov-2020, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose reported as one, anatomical location: left deltoid, route of administration: intramuscular, indication: not reported). The batch number reported was 279823.   On the same date, the patient was vaccinated with non-company co-suspect vaccine, Pneumovax (pneumococcal vaccine polysacch 23v, anatomical location: right arm, dose, indication, route of administration: not reported). The batch number reported was T010639.   On the same date, immediately after receiving Fluad Quadrivalent and co-suspect vaccine Pneumovax, the patient's left deltoid site started to swell. Doctor was notified and ice was applied. Patient's swelling improved throughout her appointment and showed noticeable improvement in the 45 minutes of giving vaccine.   On 17-Nov-2020, the patient recovered from the event.   The reporter did not provide a causality assessment.    The case was assessed as non-serious.   Company comment: The event of 'vaccination site swelling' is assessed as related to Fluad Quadrivalent.; Sender's Comments: The event of 'vaccination site swelling' is assessed as related to Fluad Quadrivalent.
Age: 80.0
Sex: M
Vaccine: FLUA4
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient hadn't recovered the full motion of the arm; Sore arm; This spontaneous case was retrieved on 22-Dec-2020 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 897275-1), reported by other health professional and concerned an 80-year-old, male patient.  The patient's medical history and concomitant medications were not reported.   On 21-Sep-2020, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose: reported as one, anatomical location: right arm, route of administration: injection and indication: not reported). The batch number reported was 279807.  On 22-Sep-2020, one day after receiving Fluad Quadrivalent, the patient's arm was sore .The patient had not a full motion of arm and was unable to recovered it. The sore arm was presented for the first few days and pain had not subsided. The patient visited physician's office and was undergoing physical therapy.  At the time of initial reporting, the patient had not recovered from both events.  The reporter did not provide causality assessment.  This case was assessed as non-serious.  Company comment:The patient developed mobility decreased and pain in extremity one day after receiving the suspect product, Fluad Quadrivalent. Chronology is plausible. The patient's medical history and concomitant medications were not reported. Considering all above mentioned, causal relationship for both events is assessed as possibly related (defaults to ''related'' in the safety database for reporting purposes).; Sender's Comments: The patient developed mobility decreased and pain in extremity one day after receiving the suspect product, Fluad Quadrivalent. Chronology is plausible. The patient's medical history and concomitant medications were not reported. Considering all above mentioned, causal relationship for both events is assessed as possibly related (defaults to ''related'' in the safety database for reporting purposes).
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure decreased, Chills, Dizziness postural, Fall, Migraine
Clinical narrative: Twelve hours after receiving vaccine patient began experiencing chills & body aches.  The next morning (24 hours post-vaccine) the patient had a very bad migraine, chills, and body aches.  Upon standing felt nauseous & dizzy, then saw black dots and vision went black for several minutes and fell to floor.  Relative called 911  and vision had returned by the time medics arrived.  Vitals were normal, except for low blood pressure.  She took Advil and felt better by the evening.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Visual impairment
Clinical narrative: Twelve hours after receiving vaccine patient began experiencing chills & body aches.  The next morning (24 hours post-vaccine) the patient had a very bad migraine, chills, and body aches.  Upon standing felt nauseous & dizzy, then saw black dots and vision went black for several minutes and fell to floor.  Relative called 911  and vision had returned by the time medics arrived.  Vitals were normal, except for low blood pressure.  She took Advil and felt better by the evening.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Rash macular, Rash pruritic, Sensation of foreign body, Throat irritation
Clinical narrative: Itchy blotchy rash, scratchy throat, lump in throat
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Eyelid function disorder, Facial paresis, Paraesthesia
Clinical narrative: tingling sensation in right eye and mid cheek area,Unable to wink, or scrunch right eye; muscles on the right side of my face were noticeably weaker; This is a spontaneous report from a contactable nurse (patient).  This 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot # EH9899), via an unspecified route of administration, on 23Dec2020 at 04:00 PM at single dose for COVID-19 immunisation. Vaccine location was right arm.  The patient was vaccinated at Public Health Clinic/Veterans Administration facility, age at vaccination was 48-years-old. No other vaccine was received in four weeks. Medical history included gastrooesophageal reflux disease (GERD). Known allergies included levofloxacin (LEVOFLOXACIN), pethidine hydrochloride (DEMEROL), phenobarbital, cefalexin monohydrate (KEFLEX), charithromycin (BIAXIN). Concomitant medications included dexlansoprazole (DEXILANT), estradiol, phentermine, ergocalciferol (VIT D), calcium. The patient was not tested for covid prior or post vaccination.  On 23Dec2020 at 04:45 PM, after leaving the clinic, the patient felt tingling sensation in right eye and mid cheek area. Within 1.5 hours, muscles on the right side of her face were noticeably weaker. Unable to wink, or scrunch right eye. The events resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient was treated with prednisone. Outcome was recovering.; Sender's Comments: Based on a close temporal relationship causality between events "tingling sensation in right eye and mid cheek area" and "muscles on the right side of her face were noticeably weaker" and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) 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: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tachycardia
Clinical narrative: Reporter received the Pfizer Covid-19 vaccine on Dec 28 around 7:55 am. That afternoon ~12:55, she started experiencing tachycardia. EMS was called to her home. She was evaluated and transported by car to the ER. EKG and labs were done (normal). It could not be determine if the vaccine was the cause.  Dec 29th she went back to the ER for tachycardia and shortness of breath. Once again labs and EKG performed (normal).  She had an appointment with a cardiologist that evening; a Holter monitor and an echo were ordered. She continued to have bouts of shortness of breath, tachycardia, muscle aches, and intermittent twitching. Went back to the ER Dec 31st
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood potassium decreased, Decreased appetite, Dizziness, Dyspnoea, Echocardiogram
Clinical narrative: Reporter received the Pfizer Covid-19 vaccine on Dec 28 around 7:55 am. That afternoon ~12:55, she started experiencing tachycardia. EMS was called to her home. She was evaluated and transported by car to the ER. EKG and labs were done (normal). It could not be determine if the vaccine was the cause.  Dec 29th she went back to the ER for tachycardia and shortness of breath. Once again labs and EKG performed (normal).  She had an appointment with a cardiologist that evening; a Holter monitor and an echo were ordered. She continued to have bouts of shortness of breath, tachycardia, muscle aches, and intermittent twitching. Went back to the ER Dec 31st
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram, Electrocardiogram ambulatory, Fatigue, Heart rate increased, Incomplete course of vaccination
Clinical narrative: Reporter received the Pfizer Covid-19 vaccine on Dec 28 around 7:55 am. That afternoon ~12:55, she started experiencing tachycardia. EMS was called to her home. She was evaluated and transported by car to the ER. EKG and labs were done (normal). It could not be determine if the vaccine was the cause.  Dec 29th she went back to the ER for tachycardia and shortness of breath. Once again labs and EKG performed (normal).  She had an appointment with a cardiologist that evening; a Holter monitor and an echo were ordered. She continued to have bouts of shortness of breath, tachycardia, muscle aches, and intermittent twitching. Went back to the ER Dec 31st
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Laboratory test, Muscle twitching, Myalgia, Nausea, Oxygen saturation decreased
Clinical narrative: Reporter received the Pfizer Covid-19 vaccine on Dec 28 around 7:55 am. That afternoon ~12:55, she started experiencing tachycardia. EMS was called to her home. She was evaluated and transported by car to the ER. EKG and labs were done (normal). It could not be determine if the vaccine was the cause.  Dec 29th she went back to the ER for tachycardia and shortness of breath. Once again labs and EKG performed (normal).  She had an appointment with a cardiologist that evening; a Holter monitor and an echo were ordered. She continued to have bouts of shortness of breath, tachycardia, muscle aches, and intermittent twitching. Went back to the ER Dec 31st
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Palpitations, SARS-CoV-2 test negative, Tachycardia
Clinical narrative: Reporter received the Pfizer Covid-19 vaccine on Dec 28 around 7:55 am. That afternoon ~12:55, she started experiencing tachycardia. EMS was called to her home. She was evaluated and transported by car to the ER. EKG and labs were done (normal). It could not be determine if the vaccine was the cause.  Dec 29th she went back to the ER for tachycardia and shortness of breath. Once again labs and EKG performed (normal).  She had an appointment with a cardiologist that evening; a Holter monitor and an echo were ordered. She continued to have bouts of shortness of breath, tachycardia, muscle aches, and intermittent twitching. Went back to the ER Dec 31st
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Eye swelling, Fatigue, Hypoaesthesia oral, In vitro fertilisation
Clinical narrative: One of the nurses noticed I was bright red, I got hives everywhere, the itching intensified, it was red and itching everywhere. My tongue was tingling and numb, they gave me something, I believe it was Benadryl, twice, 2 shots. I can't recall. I was like in shock, maybe after 4 hours later I started feeling a little better and returned to work.  The next day my eyes and lips were swollen, a little bit puffy. I kept taking more Benadryl and I felt like I was hit by a semi truck for a week afterwards, it was awful. I was beyond exhausted.  Mid week last week I finally started having my energy back.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Paraesthesia oral, Pruritus, Shock, Urticaria
Clinical narrative: One of the nurses noticed I was bright red, I got hives everywhere, the itching intensified, it was red and itching everywhere. My tongue was tingling and numb, they gave me something, I believe it was Benadryl, twice, 2 shots. I can't recall. I was like in shock, maybe after 4 hours later I started feeling a little better and returned to work.  The next day my eyes and lips were swollen, a little bit puffy. I kept taking more Benadryl and I felt like I was hit by a semi truck for a week afterwards, it was awful. I was beyond exhausted.  Mid week last week I finally started having my energy back.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling
Clinical narrative: 1/8/21 Rt arm swelling, warm. Dx'd localized vaccine reaction
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, C-reactive protein, Chills, Computerised tomogram abdomen, Culture stool
Clinical narrative: Blood in stool; Fever; Night sweats; Chills; Ache; This is a spontaneous report from a contactable physician reporting for herself. An adult (reported as 30-something year old) female patient received the 1st dose of bnt162b2 (BNT162B2), via an unspecified route of administration, on 30Dec2020, at single dose, for COVID-19 immunisation. The patient's medical history was none. Concomitant medications were not reported. The patient experienced blood in stool in Jan2021 with outcome of unknown, chills on 31Dec2020 with outcome of unknown, ache on 31Dec2020 with outcome of unknown, fever in Jan2021 with outcome of unknown, night sweats in Jan2021 with outcome of unknown. The patient reported that 24 hours after vaccination she experienced chills and aches, and after the 24 hours experienced some significant fevers that wouldn't break and chills. Then, after about 2 hours, the fever would break and come back and it was like a cycle. Also had night sweats and blood in her stools after that.  The information on the lot/batch number has been requested.; Sender's Comments: The female patient received the 1st dose of bnt162b2 (BNT162B2) on 30Dec2020, and experienced blood in stool in Jan2021 with outcome of unknown.  The information available is limited, and case will be reassessed should additional information become available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Full blood count, Haematochezia, Hyperhidrosis, Metabolic function test, Night sweats
Clinical narrative: Blood in stool; Fever; Night sweats; Chills; Ache; This is a spontaneous report from a contactable physician reporting for herself. An adult (reported as 30-something year old) female patient received the 1st dose of bnt162b2 (BNT162B2), via an unspecified route of administration, on 30Dec2020, at single dose, for COVID-19 immunisation. The patient's medical history was none. Concomitant medications were not reported. The patient experienced blood in stool in Jan2021 with outcome of unknown, chills on 31Dec2020 with outcome of unknown, ache on 31Dec2020 with outcome of unknown, fever in Jan2021 with outcome of unknown, night sweats in Jan2021 with outcome of unknown. The patient reported that 24 hours after vaccination she experienced chills and aches, and after the 24 hours experienced some significant fevers that wouldn't break and chills. Then, after about 2 hours, the fever would break and come back and it was like a cycle. Also had night sweats and blood in her stools after that.  The information on the lot/batch number has been requested.; Sender's Comments: The female patient received the 1st dose of bnt162b2 (BNT162B2) on 30Dec2020, and experienced blood in stool in Jan2021 with outcome of unknown.  The information available is limited, and case will be reassessed should additional information become available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pyrexia, Red blood cell sedimentation rate, SARS-CoV-2 test
Clinical narrative: Blood in stool; Fever; Night sweats; Chills; Ache; This is a spontaneous report from a contactable physician reporting for herself. An adult (reported as 30-something year old) female patient received the 1st dose of bnt162b2 (BNT162B2), via an unspecified route of administration, on 30Dec2020, at single dose, for COVID-19 immunisation. The patient's medical history was none. Concomitant medications were not reported. The patient experienced blood in stool in Jan2021 with outcome of unknown, chills on 31Dec2020 with outcome of unknown, ache on 31Dec2020 with outcome of unknown, fever in Jan2021 with outcome of unknown, night sweats in Jan2021 with outcome of unknown. The patient reported that 24 hours after vaccination she experienced chills and aches, and after the 24 hours experienced some significant fevers that wouldn't break and chills. Then, after about 2 hours, the fever would break and come back and it was like a cycle. Also had night sweats and blood in her stools after that.  The information on the lot/batch number has been requested.; Sender's Comments: The female patient received the 1st dose of bnt162b2 (BNT162B2) on 30Dec2020, and experienced blood in stool in Jan2021 with outcome of unknown.  The information available is limited, and case will be reassessed should additional information become available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chills, Haematochezia, Night sweats, Pain, Pyrexia
Clinical narrative: Blood in stool; Fever; Night sweats; Chills; Ache; This is a spontaneous report from a contactable physician reporting for herself. An adult (reported as 30-something year old) female patient received the 1st dose of bnt162b2 (BNT162B2), via an unspecified route of administration, on 30Dec2020, at single dose, for COVID-19 immunisation. The patient's medical history was none. Concomitant medications were not reported. The patient experienced blood in stool in Jan2021 with outcome of unknown, chills on 31Dec2020 with outcome of unknown, ache on 31Dec2020 with outcome of unknown, fever in Jan2021 with outcome of unknown, night sweats in Jan2021 with outcome of unknown. The patient reported that 24 hours after vaccination she experienced chills and aches, and after the 24 hours experienced some significant fevers that wouldn't break and chills. Then, after about 2 hours, the fever would break and come back and it was like a cycle. Also had night sweats and blood in her stools after that.  The information on the lot/batch number has been requested.; Sender's Comments: The female patient received the 1st dose of bnt162b2 (BNT162B2) on 30Dec2020, and experienced blood in stool in Jan2021 with outcome of unknown.  The information available is limited, and case will be reassessed should additional information become available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray normal, Chest pain, Culture urine negative, Electrocardiogram PR shortened, Electrocardiogram normal
Clinical narrative: Myocarditis; A spontaneous report was received from a physician, concerning a 18-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced myocarditis.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 30 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot number: 037K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 31 Dec 2020, within 24 hours of vaccine administration, the patient develop symptoms of myocarditis and was admitted to the hospital. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.  The outcome for the event, myocarditis, was not reported.; Reporter's Comments: This case concerns an 18-year-old, male, who experienced a serious unexpected event of myocarditis. The event occurred approximately 2 days after first dose of mRNA-1273, Lot# 037K20A administration. No information available regarding medical history and concomitant medications. Very limited information regarding this event has been provided at this time.  Based on temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache, Immunoglobulin therapy, Malaise, Pain, Pain in extremity
Clinical narrative: Myocarditis; A spontaneous report was received from a physician, concerning a 18-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced myocarditis.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 30 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot number: 037K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 31 Dec 2020, within 24 hours of vaccine administration, the patient develop symptoms of myocarditis and was admitted to the hospital. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.  The outcome for the event, myocarditis, was not reported.; Reporter's Comments: This case concerns an 18-year-old, male, who experienced a serious unexpected event of myocarditis. The event occurred approximately 2 days after first dose of mRNA-1273, Lot# 037K20A administration. No information available regarding medical history and concomitant medications. Very limited information regarding this event has been provided at this time.  Based on temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Pyrexia, SARS-CoV-2 antibody test, SARS-CoV-2 test negative, Troponin increased
Clinical narrative: Myocarditis; A spontaneous report was received from a physician, concerning a 18-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced myocarditis.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 30 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot number: 037K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 31 Dec 2020, within 24 hours of vaccine administration, the patient develop symptoms of myocarditis and was admitted to the hospital. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.  The outcome for the event, myocarditis, was not reported.; Reporter's Comments: This case concerns an 18-year-old, male, who experienced a serious unexpected event of myocarditis. The event occurred approximately 2 days after first dose of mRNA-1273, Lot# 037K20A administration. No information available regarding medical history and concomitant medications. Very limited information regarding this event has been provided at this time.  Based on temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myocarditis
Clinical narrative: Myocarditis; A spontaneous report was received from a physician, concerning a 18-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced myocarditis.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 30 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot number: 037K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 31 Dec 2020, within 24 hours of vaccine administration, the patient develop symptoms of myocarditis and was admitted to the hospital. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.  The outcome for the event, myocarditis, was not reported.; Reporter's Comments: This case concerns an 18-year-old, male, who experienced a serious unexpected event of myocarditis. The event occurred approximately 2 days after first dose of mRNA-1273, Lot# 037K20A administration. No information available regarding medical history and concomitant medications. Very limited information regarding this event has been provided at this time.  Based on temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fear, Feeling abnormal, Flushing
Clinical narrative: Within 1 minute I started feeling a rush in my throat and a metallic taste, then a tingling in both arms.  That subsided for a minute or two, then started again with a flush feeling down my body.  Nurse took blood pressure 140/80.  Breathing fine. Heart rate fine.  Flush feeling started again, and blood pressure dropped  to100/70.  I was then given 50 mg of Benadryl and an ambulance was called.  My blood pressure stabilized but I was very shaky.  It was recommended that I go to the hospital for observation for a couple of hours, which I did.  I only had the flush feeling once at the hospital.  I was released after two hours.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure decreased, Dysgeusia, Flushing, Nervousness, Paraesthesia
Clinical narrative: Within 1 minute I started feeling a rush in my throat and a metallic taste, then a tingling in both arms.  That subsided for a minute or two, then started again with a flush feeling down my body.  Nurse took blood pressure 140/80.  Breathing fine. Heart rate fine.  Flush feeling started again, and blood pressure dropped  to100/70.  I was then given 50 mg of Benadryl and an ambulance was called.  My blood pressure stabilized but I was very shaky.  It was recommended that I go to the hospital for observation for a couple of hours, which I did.  I only had the flush feeling once at the hospital.  I was released after two hours.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Condition aggravated, Cough, Lip swelling, Paraesthesia oral
Clinical narrative: Angioedema, itchy swelling lips Dry, itchy throat Cough  Tightness of throat
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Throat clearing
Clinical narrative: Angioedema, itchy swelling lips Dry, itchy throat Cough  Tightness of throat
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angioedema, Cough, Lip pruritus, Lip swelling, Throat irritation
Clinical narrative: Angioedema, itchy swelling lips Dry, itchy throat Cough  Tightness of throat
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Throat tightness
Clinical narrative: Angioedema, itchy swelling lips Dry, itchy throat Cough  Tightness of throat
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Headache, Myalgia, Pain in extremity, Vomiting
Clinical narrative: 20 hours vomited about 7 times, diarrhea, headache lasted a week, muscle cramps -legs: flu like symptoms: 6 days after vaccine started getting an allergic reaction to the vaccine, red, itchy, hot this has lasted 8 days. Arm pain also.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Erythema, Headache, Influenza like illness, Muscle spasms
Clinical narrative: 20 hours vomited about 7 times, diarrhea, headache lasted a week, muscle cramps -legs: flu like symptoms: 6 days after vaccine started getting an allergic reaction to the vaccine, red, itchy, hot this has lasted 8 days. Arm pain also.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Vomiting
Clinical narrative: 20 hours vomited about 7 times, diarrhea, headache lasted a week, muscle cramps -legs: flu like symptoms: 6 days after vaccine started getting an allergic reaction to the vaccine, red, itchy, hot this has lasted 8 days. Arm pain also.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chills, Fatigue, Hypersomnia, Injection site hypoaesthesia
Clinical narrative: *Other: hip joint pain and sciatica on injection side of body.  Side affects started the following morning after my vaccine with arm pain and stiffness. After about 24 hours I had fatigue and chills with body aches. I slept for about 14 hours that evening then woke up the next morning without chills, body aches, and less arm pain. I then developed joint pain in my elbow and hip, as well as sciatica down my whole leg, that lasted for 2 more days. I also had numbness at the injection site for about 1 day.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pain in extremity, Sciatica
Clinical narrative: *Other: hip joint pain and sciatica on injection side of body.  Side affects started the following morning after my vaccine with arm pain and stiffness. After about 24 hours I had fatigue and chills with body aches. I slept for about 14 hours that evening then woke up the next morning without chills, body aches, and less arm pain. I then developed joint pain in my elbow and hip, as well as sciatica down my whole leg, that lasted for 2 more days. I also had numbness at the injection site for about 1 day.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chills, Fatigue, Hypersomnia, Musculoskeletal stiffness
Clinical narrative: *Other: hip joint pain and sciatica on injection side of body.  Side affects started the following morning after my vaccine with arm pain and stiffness. After about 24 hours I had fatigue and chills with body aches. I slept for about 14 hours that evening then woke up the next morning without chills, body aches, and less arm pain. I then developed joint pain in my elbow and hip, as well as sciatica down my whole leg, that lasted for 2 more days. I also had numbness at the injection site for about 1 day.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: I developed redness, warmth, swelling, and tenderness at the site that has gradually worsened over the past week. Today (1-07-21) I am also experiencing itching at the site. I am going to try some Benadryl and Zyrtec in case this is an allergic reaction.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: I developed redness, warmth, swelling, and tenderness at the site that has gradually worsened over the past week. Today (1-07-21) I am also experiencing itching at the site. I am going to try some Benadryl and Zyrtec in case this is an allergic reaction.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dry mouth, Dysarthria, Full blood count, Limb discomfort, Metabolic function test
Clinical narrative: slurring speech; rash around his neck and upper chest; his earlobes were bright red, as was his nose; mouth was dry; nose was dry; dry throat; almost "drunk"; Only abnormal finding was BP 159/94; This is a spontaneous report from contactable pharmacist. A 36-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL1283 and Expiration Date unknown) via Intramuscular on 08Jan2021 11:25 at single dose for COVID-19 immunisation. The patient's medical history was reported toradol made him feel lightheaded and foggy (similar to his first Pfizer BioNTech covid vaccine), Attention deficit hyperactivity disorder (ADHD). History vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number =EK5730 and Expiration Date unknown) via Intramuscular on 18Dec2020 at single dose for COVID-19 immunisation. Patient did report that on first vaccine it made him feel a little sluggish, tired and foggy minded. The concomitant medications were reported as amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (Adderall XR) at 25mg twice a day (BID) and escitalopram oxalate (LEXAPRO) oral (PO) at 10mg every day. No other vaccine in four weeks. Patient was vaccinated at 11:25. Patient was observed for 30 minutes. Pharmacist checked on patient at 17 minutes after vaccination - he was fine able to communicate and showed no signs of distress. Pharmacist came back and checked on patient at 25 minutes after vaccination (11:50)  and patient was slurring speech, had developed rash around his neck and upper chest, his earlobes were bright red, as was his nose - mouth was dry, reported dry throat - no visible swelling of the lips or tongue. Patient was transported to ED (2 min) Home meds: Adderall XR 25mg BID [Twice a day], Lexapro 10mg Q [every]PM. Only abnormal finding was BP 159/94 - after initial workup patient was noted to be almost "drunk" as reported by Emergency Room (ER Doc). Patient was offered diphenhydramine declined several times but eventually agreed. Approx 30 min after diphenhydramine patient fully recovered and stated "I'm back". The second dose reaction was much more exaggerated and lasted much longer. No COVID prior vaccination and no COVID tested post vaccination. The adverse event result in Emergency room/department or urgent care. The outcome of events was recovered in Jan2021 after treatment was given.; Sender's Comments: Based on the time association, all events are possibly related to suspect BNT162B2 administration. 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: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Rash
Clinical narrative: slurring speech; rash around his neck and upper chest; his earlobes were bright red, as was his nose; mouth was dry; nose was dry; dry throat; almost "drunk"; Only abnormal finding was BP 159/94; This is a spontaneous report from contactable pharmacist. A 36-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL1283 and Expiration Date unknown) via Intramuscular on 08Jan2021 11:25 at single dose for COVID-19 immunisation. The patient's medical history was reported toradol made him feel lightheaded and foggy (similar to his first Pfizer BioNTech covid vaccine), Attention deficit hyperactivity disorder (ADHD). History vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number =EK5730 and Expiration Date unknown) via Intramuscular on 18Dec2020 at single dose for COVID-19 immunisation. Patient did report that on first vaccine it made him feel a little sluggish, tired and foggy minded. The concomitant medications were reported as amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (Adderall XR) at 25mg twice a day (BID) and escitalopram oxalate (LEXAPRO) oral (PO) at 10mg every day. No other vaccine in four weeks. Patient was vaccinated at 11:25. Patient was observed for 30 minutes. Pharmacist checked on patient at 17 minutes after vaccination - he was fine able to communicate and showed no signs of distress. Pharmacist came back and checked on patient at 25 minutes after vaccination (11:50)  and patient was slurring speech, had developed rash around his neck and upper chest, his earlobes were bright red, as was his nose - mouth was dry, reported dry throat - no visible swelling of the lips or tongue. Patient was transported to ED (2 min) Home meds: Adderall XR 25mg BID [Twice a day], Lexapro 10mg Q [every]PM. Only abnormal finding was BP 159/94 - after initial workup patient was noted to be almost "drunk" as reported by Emergency Room (ER Doc). Patient was offered diphenhydramine declined several times but eventually agreed. Approx 30 min after diphenhydramine patient fully recovered and stated "I'm back". The second dose reaction was much more exaggerated and lasted much longer. No COVID prior vaccination and no COVID tested post vaccination. The adverse event result in Emergency room/department or urgent care. The outcome of events was recovered in Jan2021 after treatment was given.; Sender's Comments: Based on the time association, all events are possibly related to suspect BNT162B2 administration. 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.