chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Autoscopy, Dissociation, Malaise, Paraesthesia
Clinical narrative: History of mast cell activation, felt tightness in throat and out of body experience 10 minutes after covid shot. Received Benadryl and famotidine at clinic. Received IM epi and solumedrol from ED. Arrived 1407, discharged 1611 Narrative:  38F w/ MAST sndrome as well as other pmhx as noted, p/w malaise, tingling in arms, feeling of dissociation, and some tightness in her throat after receiving the covid vaccine. She was given benadryl and famotidine in the clinic prior to arrival. No n/v/sob/rash. 38F p/w multiple symptoms after covid vaccine. Vitals wnl; exam non-focal. Given her throat tightness, I felt it was safest to treat her for anaphylaxis. She was given solumedrol and IM epinephrine. We will obs her here until ~ 2 hours after onset of symptoms. Care signed out to oncoming MD for further obs and anticipated discharge. Pt Arrived 1407, discharged 1611.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: History of mast cell activation, felt tightness in throat and out of body experience 10 minutes after covid shot. Received Benadryl and famotidine at clinic. Received IM epi and solumedrol from ED. Arrived 1407, discharged 1611 Narrative:  38F w/ MAST sndrome as well as other pmhx as noted, p/w malaise, tingling in arms, feeling of dissociation, and some tightness in her throat after receiving the covid vaccine. She was given benadryl and famotidine in the clinic prior to arrival. No n/v/sob/rash. 38F p/w multiple symptoms after covid vaccine. Vitals wnl; exam non-focal. Given her throat tightness, I felt it was safest to treat her for anaphylaxis. She was given solumedrol and IM epinephrine. We will obs her here until ~ 2 hours after onset of symptoms. Care signed out to oncoming MD for further obs and anticipated discharge. Pt Arrived 1407, discharged 1611.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: dypsnea Narrative:
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: Narrative:  Patient was seen in urgent care several times recently for itchy rash that reportedly started about 3-4d after his first COVID 19 vaccine on 2/6/21. Pt reported itchy rash to bilateral arms, chest, and back. Pt did get 2nd COVID-19 vaccine on 3/3/21 and still reports the rash on 3/5/21.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: shortness of breath Narrative: Patient experienced some mild shortness of breath while sitting in the post-vaccine observation area. BP 129/83, O2 100% on RA, 81 bpm heart rate. Mild SOB disappeared after about 1-2 minutes. Patient then reported no S/S.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Condition aggravated
Clinical narrative: bell's palsy Narrative:  Patient had history of Bell's Palsy prior to receiving Moderna vaccine. Sx after vaccination occurred on opposite side from previous episode and onset was 5 days after vaccination.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Neck pain, Pain, Pain in jaw, Rash
Clinical narrative: Shingles Narrative: Patient presented to urgent care with a rash 7 days after getting COVID vaccine. Patient's rash was mildly painful ranging from his neck/jaw line to side of the left skull. Patient did have chicken pox a child.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity, Peripheral swelling, Pruritus
Clinical narrative: History of mast cell activation, had swelling of hands and itchiness after vaccine. Got Benadryl and famotidine at clinic. Arrived in ED 1047 discharged 1140. Narrative: 32M w/ MAST cell activation syndrome, p/w swelling of hands and itchiness after receiving covid vaccine. Denies SOB/CP/facial swelling/n/v/syncope. Was given benadryl and famotidine at the clinic and symptoms have significantly improved. 32M w/ pmhx as noted p/w possible allergic reaction. Vitals as above. Non-focal exam. Overall this appears consistent with allergy; pt has no signs/symptoms of anaphylaxis. I think it is reasonable to start him on a steroid burst. As his sx had significantly improved, I did not feel that an extended period of monitoring was necessary in the ED. He does have EpiPens that he carries on his person in the event of any severe reaction.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Extra dose administered
Clinical narrative: pt received 2 doses same day Narrative: Unknow if any symptoms yet. Pt received 2 COVID doses on same day. First one at 9:13 am and second at 9:33 am
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Dizziness, Dysgeusia, Peripheral swelling
Clinical narrative: Narrative: VACCINE #2 ON 2/19 @ 14:15--HAD TO WAIT IN OBSERVATION FOR 40MINS DUE TO DIZZY, CHILLS AND TONGUE FELT LIKE IT WAS SWELLING AND FUNNY TASTE IN MOUTH. UPPER ARM SWOLLEN, UPPER ARM REMAINED SWOLLEN FOR 35 DAYS AND CONTINUES TO ITCH INTERMITTENTLY TO THIS DAY PER PATIENT REPORT ON 2/26--EXPERIENCED VERTIGO, VOMITING, (DIARRHEA X1 WEEK). WIFE FOUND PATIENT ON THE FLOOR, AMBULANCE CALLED, PATIENT AWAKE THE ENTIRE TIME--TAKEN TO A HOSPITAL.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Swollen tongue, Vertigo, Vomiting
Clinical narrative: Narrative: VACCINE #2 ON 2/19 @ 14:15--HAD TO WAIT IN OBSERVATION FOR 40MINS DUE TO DIZZY, CHILLS AND TONGUE FELT LIKE IT WAS SWELLING AND FUNNY TASTE IN MOUTH. UPPER ARM SWOLLEN, UPPER ARM REMAINED SWOLLEN FOR 35 DAYS AND CONTINUES TO ITCH INTERMITTENTLY TO THIS DAY PER PATIENT REPORT ON 2/26--EXPERIENCED VERTIGO, VOMITING, (DIARRHEA X1 WEEK). WIFE FOUND PATIENT ON THE FLOOR, AMBULANCE CALLED, PATIENT AWAKE THE ENTIRE TIME--TAKEN TO A HOSPITAL.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Feeling cold, Headache, Pyrexia
Clinical narrative: feeling cold Narrative:  Pt called COVID-19 vaccine adverse reaction hotline to report symptoms of cold, fever, dizziness, headache one day following the first dose of the Pfizer COVID-19 vaccine, administered on 3/9/2021. Event has been reported to database system/VAERS.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Injection site pain
Clinical narrative: anorexia, injection site pain Narrative:  Pt called COVID-19 vaccine adverse reaction hotline to report symptoms of decreased appetite and pain at injection site one day following the second dose of the COVID-19 vaccine, administered on 2/24/2021. Pt reports symptoms have improved. Event has been reported to database system/VAERS.
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: Lungs filled with blood; A regulatory report from was received from a consumer concerning a 57-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and reported his lungs were filled with Blood.  The patient's medical history was not included. No concomitant medication was included.  On 05-Mar-2021, prior to the onset of the events, the patient received his first of two planned doses of mRNA-1273 (Lot number: 026A21A) intramuscularly on his left arm for prophylaxis of COVID-19 infection.   On 06-Mar-2021, approximately one day after receiving mRNA-1273, patient was hospitalized due to his lungs was filled with blood. He was treated there and discharged on 08-Mar-2021.  Action taken with mRNA-1273 in response to the events was not reported.   Outcome of the event lungs filled with Blood were considered as resolved on 08-Mar-2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 12.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Alopecia, Anaemia, Antinuclear antibody positive, Arthralgia, Biopsy kidney abnormal
Clinical narrative: Patient felt fatigued after vaccine given and 3 days later developed a facial rash for which he was evaluated in our office on 8/6/2020 and 8/13/2020.   ANA on 8/14/2020 was 1:320.   He  continued to feel poorly, persisted with skin rashes, and was evaluated by 2 different allergists and treated hospitalized overnight with anemia, erythema multiform,, leukopenia, and oral ulcers 11/4/2020.  He was thought to have an allergic condition.   The patient continued with fatigue, nausea, weight loss, rashes, chronic congestion, joint pain, poly arthritis, and hair loss.   Eventually he was evaluated by Pediatric  Rheumatology and diagnosed with Systemic Lupus Erythematosis with an ANA of 1:320 and DS DNA 1:10, 240 on 2/1/2021.   Kidney biopsy on 2/27/2021 revealed Class 4 and Class 5 Lupus glomerulonephritis.
Age: 12.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Double stranded DNA antibody positive, Erythema multiforme, Fatigue, Feeling abnormal, Glomerulonephritis
Clinical narrative: Patient felt fatigued after vaccine given and 3 days later developed a facial rash for which he was evaluated in our office on 8/6/2020 and 8/13/2020.   ANA on 8/14/2020 was 1:320.   He  continued to feel poorly, persisted with skin rashes, and was evaluated by 2 different allergists and treated hospitalized overnight with anemia, erythema multiform,, leukopenia, and oral ulcers 11/4/2020.  He was thought to have an allergic condition.   The patient continued with fatigue, nausea, weight loss, rashes, chronic congestion, joint pain, poly arthritis, and hair loss.   Eventually he was evaluated by Pediatric  Rheumatology and diagnosed with Systemic Lupus Erythematosis with an ANA of 1:320 and DS DNA 1:10, 240 on 2/1/2021.   Kidney biopsy on 2/27/2021 revealed Class 4 and Class 5 Lupus glomerulonephritis.
Age: 12.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Haematocrit decreased, Haemoglobin decreased, Leukopenia, Lupus nephritis, Mouth ulceration
Clinical narrative: Patient felt fatigued after vaccine given and 3 days later developed a facial rash for which he was evaluated in our office on 8/6/2020 and 8/13/2020.   ANA on 8/14/2020 was 1:320.   He  continued to feel poorly, persisted with skin rashes, and was evaluated by 2 different allergists and treated hospitalized overnight with anemia, erythema multiform,, leukopenia, and oral ulcers 11/4/2020.  He was thought to have an allergic condition.   The patient continued with fatigue, nausea, weight loss, rashes, chronic congestion, joint pain, poly arthritis, and hair loss.   Eventually he was evaluated by Pediatric  Rheumatology and diagnosed with Systemic Lupus Erythematosis with an ANA of 1:320 and DS DNA 1:10, 240 on 2/1/2021.   Kidney biopsy on 2/27/2021 revealed Class 4 and Class 5 Lupus glomerulonephritis.
Age: 12.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Nasal congestion, Nausea, Polyarthritis, Rash, Systemic lupus erythematosus
Clinical narrative: Patient felt fatigued after vaccine given and 3 days later developed a facial rash for which he was evaluated in our office on 8/6/2020 and 8/13/2020.   ANA on 8/14/2020 was 1:320.   He  continued to feel poorly, persisted with skin rashes, and was evaluated by 2 different allergists and treated hospitalized overnight with anemia, erythema multiform,, leukopenia, and oral ulcers 11/4/2020.  He was thought to have an allergic condition.   The patient continued with fatigue, nausea, weight loss, rashes, chronic congestion, joint pain, poly arthritis, and hair loss.   Eventually he was evaluated by Pediatric  Rheumatology and diagnosed with Systemic Lupus Erythematosis with an ANA of 1:320 and DS DNA 1:10, 240 on 2/1/2021.   Kidney biopsy on 2/27/2021 revealed Class 4 and Class 5 Lupus glomerulonephritis.
Age: 12.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Weight decreased
Clinical narrative: Patient felt fatigued after vaccine given and 3 days later developed a facial rash for which he was evaluated in our office on 8/6/2020 and 8/13/2020.   ANA on 8/14/2020 was 1:320.   He  continued to feel poorly, persisted with skin rashes, and was evaluated by 2 different allergists and treated hospitalized overnight with anemia, erythema multiform,, leukopenia, and oral ulcers 11/4/2020.  He was thought to have an allergic condition.   The patient continued with fatigue, nausea, weight loss, rashes, chronic congestion, joint pain, poly arthritis, and hair loss.   Eventually he was evaluated by Pediatric  Rheumatology and diagnosed with Systemic Lupus Erythematosis with an ANA of 1:320 and DS DNA 1:10, 240 on 2/1/2021.   Kidney biopsy on 2/27/2021 revealed Class 4 and Class 5 Lupus glomerulonephritis.
Age: 12.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Alopecia, Anaemia, Antinuclear antibody increased, Arthralgia, Biopsy kidney
Clinical narrative: Patient felt fatigued after vaccine given and 3 days later developed a facial rash for which he was evaluated in our office on 8/6/2020 and 8/13/2020.   ANA on 8/14/2020 was 1:320.   He  continued to feel poorly, persisted with skin rashes, and was evaluated by 2 different allergists and treated hospitalized overnight with anemia, erythema multiform,, leukopenia, and oral ulcers 11/4/2020.  He was thought to have an allergic condition.   The patient continued with fatigue, nausea, weight loss, rashes, chronic congestion, joint pain, poly arthritis, and hair loss.   Eventually he was evaluated by Pediatric  Rheumatology and diagnosed with Systemic Lupus Erythematosis with an ANA of 1:320 and DS DNA 1:10, 240 on 2/1/2021.   Kidney biopsy on 2/27/2021 revealed Class 4 and Class 5 Lupus glomerulonephritis.
Age: 12.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Fatigue, Lupus nephritis, Neutropenia, Rash, Systemic lupus erythematosus
Clinical narrative: Patient felt fatigued after vaccine given and 3 days later developed a facial rash for which he was evaluated in our office on 8/6/2020 and 8/13/2020.   ANA on 8/14/2020 was 1:320.   He  continued to feel poorly, persisted with skin rashes, and was evaluated by 2 different allergists and treated hospitalized overnight with anemia, erythema multiform,, leukopenia, and oral ulcers 11/4/2020.  He was thought to have an allergic condition.   The patient continued with fatigue, nausea, weight loss, rashes, chronic congestion, joint pain, poly arthritis, and hair loss.   Eventually he was evaluated by Pediatric  Rheumatology and diagnosed with Systemic Lupus Erythematosis with an ANA of 1:320 and DS DNA 1:10, 240 on 2/1/2021.   Kidney biopsy on 2/27/2021 revealed Class 4 and Class 5 Lupus glomerulonephritis.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Activated partial thromboplastin time, Activated partial thromboplastin time normal, Asthenia, Blood folate, Blood magnesium
Clinical narrative: having chest pains; On 22Jan, I was having chest pressure; felt lightheaded; fatigue; 2 days later I started headaches; I had a migrane; fever 100.8; chills; This is a spontaneous report from a contactable other health professional (patient).  A 43-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration on 11Jan2021 10:00 in left arm, at single dose for covid-19 immunization. Medical history included menstrual migraines, no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included rizatriptan benzoate. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration on 21Dec2021 10:30 in right arm, at single dose for covid-19 immunization. Immediately the next day on 12Jan2021 05:00 the patient had a fever 100.8 and chills. 2 days later on 13Jan2021 she started having very bad headaches. She had a migraine daily from 13Jan2021 through 23Jan2021. On 22Jan2021, she was having chest pressure, lightheadedness, fatigue and went to the ER for a cardiac work up. Nothing showed up, felt lightheaded daily after. 25Jan2021 saw PCP- having chest pains. 26Jan2021 went back to the ER with chest pressure, lightheadedness, feelings she was going to black out. Admitted to the hospital. Had a stress test while in the hospital nothing showed up. Discharged. Saw PCP on 29Jan2021 because still feeling lightheaded, dizzy. Patient was hospitalized/ clinic visit/ emergency room for all events. Treatment steroids, Aspirin, lots of blood work. stress test was received. She has ordered a 48 hours heart monitor and a neurologist consult. She had not been able to work since 27Jan2021. The patient underwent lab tests and procedures which included, Nasal Swab test by PCR: negative on 26Jan2021. The outcome of the event migraine was recovered on 23Jan2021. The outcome of the other events was not recovered.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 at 2nd injection cannot be excluded for the reported events based on the known safety profile and the plausible temporal relationship.  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: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiac stress test normal, Chest X-ray, Chest discomfort, Chest pain, Chills
Clinical narrative: having chest pains; On 22Jan, I was having chest pressure; felt lightheaded; fatigue; 2 days later I started headaches; I had a migrane; fever 100.8; chills; This is a spontaneous report from a contactable other health professional (patient).  A 43-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration on 11Jan2021 10:00 in left arm, at single dose for covid-19 immunization. Medical history included menstrual migraines, no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included rizatriptan benzoate. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration on 21Dec2021 10:30 in right arm, at single dose for covid-19 immunization. Immediately the next day on 12Jan2021 05:00 the patient had a fever 100.8 and chills. 2 days later on 13Jan2021 she started having very bad headaches. She had a migraine daily from 13Jan2021 through 23Jan2021. On 22Jan2021, she was having chest pressure, lightheadedness, fatigue and went to the ER for a cardiac work up. Nothing showed up, felt lightheaded daily after. 25Jan2021 saw PCP- having chest pains. 26Jan2021 went back to the ER with chest pressure, lightheadedness, feelings she was going to black out. Admitted to the hospital. Had a stress test while in the hospital nothing showed up. Discharged. Saw PCP on 29Jan2021 because still feeling lightheaded, dizzy. Patient was hospitalized/ clinic visit/ emergency room for all events. Treatment steroids, Aspirin, lots of blood work. stress test was received. She has ordered a 48 hours heart monitor and a neurologist consult. She had not been able to work since 27Jan2021. The patient underwent lab tests and procedures which included, Nasal Swab test by PCR: negative on 26Jan2021. The outcome of the event migraine was recovered on 23Jan2021. The outcome of the other events was not recovered.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 at 2nd injection cannot be excluded for the reported events based on the known safety profile and the plausible temporal relationship.  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: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram, Dizziness, Electrocardiogram, Feeling abnormal, Fibrin D dimer
Clinical narrative: having chest pains; On 22Jan, I was having chest pressure; felt lightheaded; fatigue; 2 days later I started headaches; I had a migrane; fever 100.8; chills; This is a spontaneous report from a contactable other health professional (patient).  A 43-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration on 11Jan2021 10:00 in left arm, at single dose for covid-19 immunization. Medical history included menstrual migraines, no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included rizatriptan benzoate. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration on 21Dec2021 10:30 in right arm, at single dose for covid-19 immunization. Immediately the next day on 12Jan2021 05:00 the patient had a fever 100.8 and chills. 2 days later on 13Jan2021 she started having very bad headaches. She had a migraine daily from 13Jan2021 through 23Jan2021. On 22Jan2021, she was having chest pressure, lightheadedness, fatigue and went to the ER for a cardiac work up. Nothing showed up, felt lightheaded daily after. 25Jan2021 saw PCP- having chest pains. 26Jan2021 went back to the ER with chest pressure, lightheadedness, feelings she was going to black out. Admitted to the hospital. Had a stress test while in the hospital nothing showed up. Discharged. Saw PCP on 29Jan2021 because still feeling lightheaded, dizzy. Patient was hospitalized/ clinic visit/ emergency room for all events. Treatment steroids, Aspirin, lots of blood work. stress test was received. She has ordered a 48 hours heart monitor and a neurologist consult. She had not been able to work since 27Jan2021. The patient underwent lab tests and procedures which included, Nasal Swab test by PCR: negative on 26Jan2021. The outcome of the event migraine was recovered on 23Jan2021. The outcome of the other events was not recovered.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 at 2nd injection cannot be excluded for the reported events based on the known safety profile and the plausible temporal relationship.  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: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Full blood count, Headache, Lipase, Metabolic function test, Prothrombin time
Clinical narrative: having chest pains; On 22Jan, I was having chest pressure; felt lightheaded; fatigue; 2 days later I started headaches; I had a migrane; fever 100.8; chills; This is a spontaneous report from a contactable other health professional (patient).  A 43-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration on 11Jan2021 10:00 in left arm, at single dose for covid-19 immunization. Medical history included menstrual migraines, no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included rizatriptan benzoate. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration on 21Dec2021 10:30 in right arm, at single dose for covid-19 immunization. Immediately the next day on 12Jan2021 05:00 the patient had a fever 100.8 and chills. 2 days later on 13Jan2021 she started having very bad headaches. She had a migraine daily from 13Jan2021 through 23Jan2021. On 22Jan2021, she was having chest pressure, lightheadedness, fatigue and went to the ER for a cardiac work up. Nothing showed up, felt lightheaded daily after. 25Jan2021 saw PCP- having chest pains. 26Jan2021 went back to the ER with chest pressure, lightheadedness, feelings she was going to black out. Admitted to the hospital. Had a stress test while in the hospital nothing showed up. Discharged. Saw PCP on 29Jan2021 because still feeling lightheaded, dizzy. Patient was hospitalized/ clinic visit/ emergency room for all events. Treatment steroids, Aspirin, lots of blood work. stress test was received. She has ordered a 48 hours heart monitor and a neurologist consult. She had not been able to work since 27Jan2021. The patient underwent lab tests and procedures which included, Nasal Swab test by PCR: negative on 26Jan2021. The outcome of the event migraine was recovered on 23Jan2021. The outcome of the other events was not recovered.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 at 2nd injection cannot be excluded for the reported events based on the known safety profile and the plausible temporal relationship.  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: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Red blood cell sedimentation rate, Red blood cell sedimentation rate normal, SARS-CoV-2 test, Troponin
Clinical narrative: having chest pains; On 22Jan, I was having chest pressure; felt lightheaded; fatigue; 2 days later I started headaches; I had a migrane; fever 100.8; chills; This is a spontaneous report from a contactable other health professional (patient).  A 43-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration on 11Jan2021 10:00 in left arm, at single dose for covid-19 immunization. Medical history included menstrual migraines, no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included rizatriptan benzoate. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration on 21Dec2021 10:30 in right arm, at single dose for covid-19 immunization. Immediately the next day on 12Jan2021 05:00 the patient had a fever 100.8 and chills. 2 days later on 13Jan2021 she started having very bad headaches. She had a migraine daily from 13Jan2021 through 23Jan2021. On 22Jan2021, she was having chest pressure, lightheadedness, fatigue and went to the ER for a cardiac work up. Nothing showed up, felt lightheaded daily after. 25Jan2021 saw PCP- having chest pains. 26Jan2021 went back to the ER with chest pressure, lightheadedness, feelings she was going to black out. Admitted to the hospital. Had a stress test while in the hospital nothing showed up. Discharged. Saw PCP on 29Jan2021 because still feeling lightheaded, dizzy. Patient was hospitalized/ clinic visit/ emergency room for all events. Treatment steroids, Aspirin, lots of blood work. stress test was received. She has ordered a 48 hours heart monitor and a neurologist consult. She had not been able to work since 27Jan2021. The patient underwent lab tests and procedures which included, Nasal Swab test by PCR: negative on 26Jan2021. The outcome of the event migraine was recovered on 23Jan2021. The outcome of the other events was not recovered.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 at 2nd injection cannot be excluded for the reported events based on the known safety profile and the plausible temporal relationship.  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: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vitamin B12, X-ray
Clinical narrative: having chest pains; On 22Jan, I was having chest pressure; felt lightheaded; fatigue; 2 days later I started headaches; I had a migrane; fever 100.8; chills; This is a spontaneous report from a contactable other health professional (patient).  A 43-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration on 11Jan2021 10:00 in left arm, at single dose for covid-19 immunization. Medical history included menstrual migraines, no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included rizatriptan benzoate. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration on 21Dec2021 10:30 in right arm, at single dose for covid-19 immunization. Immediately the next day on 12Jan2021 05:00 the patient had a fever 100.8 and chills. 2 days later on 13Jan2021 she started having very bad headaches. She had a migraine daily from 13Jan2021 through 23Jan2021. On 22Jan2021, she was having chest pressure, lightheadedness, fatigue and went to the ER for a cardiac work up. Nothing showed up, felt lightheaded daily after. 25Jan2021 saw PCP- having chest pains. 26Jan2021 went back to the ER with chest pressure, lightheadedness, feelings she was going to black out. Admitted to the hospital. Had a stress test while in the hospital nothing showed up. Discharged. Saw PCP on 29Jan2021 because still feeling lightheaded, dizzy. Patient was hospitalized/ clinic visit/ emergency room for all events. Treatment steroids, Aspirin, lots of blood work. stress test was received. She has ordered a 48 hours heart monitor and a neurologist consult. She had not been able to work since 27Jan2021. The patient underwent lab tests and procedures which included, Nasal Swab test by PCR: negative on 26Jan2021. The outcome of the event migraine was recovered on 23Jan2021. The outcome of the other events was not recovered.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 at 2nd injection cannot be excluded for the reported events based on the known safety profile and the plausible temporal relationship.  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: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Body temperature, Cardiac stress test, Chest discomfort, Chest pain
Clinical narrative: having chest pains; On 22Jan, I was having chest pressure; felt lightheaded; fatigue; 2 days later I started headaches; I had a migrane; fever 100.8; chills; This is a spontaneous report from a contactable other health professional (patient).  A 43-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration on 11Jan2021 10:00 in left arm, at single dose for covid-19 immunization. Medical history included menstrual migraines, no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included rizatriptan benzoate. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration on 21Dec2021 10:30 in right arm, at single dose for covid-19 immunization. Immediately the next day on 12Jan2021 05:00 the patient had a fever 100.8 and chills. 2 days later on 13Jan2021 she started having very bad headaches. She had a migraine daily from 13Jan2021 through 23Jan2021. On 22Jan2021, she was having chest pressure, lightheadedness, fatigue and went to the ER for a cardiac work up. Nothing showed up, felt lightheaded daily after. 25Jan2021 saw PCP- having chest pains. 26Jan2021 went back to the ER with chest pressure, lightheadedness, feelings she was going to black out. Admitted to the hospital. Had a stress test while in the hospital nothing showed up. Discharged. Saw PCP on 29Jan2021 because still feeling lightheaded, dizzy. Patient was hospitalized/ clinic visit/ emergency room for all events. Treatment steroids, Aspirin, lots of blood work. stress test was received. She has ordered a 48 hours heart monitor and a neurologist consult. She had not been able to work since 27Jan2021. The patient underwent lab tests and procedures which included, Nasal Swab test by PCR: negative on 26Jan2021. The outcome of the event migraine was recovered on 23Jan2021. The outcome of the other events was not recovered.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 at 2nd injection cannot be excluded for the reported events based on the known safety profile and the plausible temporal relationship.  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: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Migraine
Clinical narrative: having chest pains; On 22Jan, I was having chest pressure; felt lightheaded; fatigue; 2 days later I started headaches; I had a migrane; fever 100.8; chills; This is a spontaneous report from a contactable other health professional (patient).  A 43-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration on 11Jan2021 10:00 in left arm, at single dose for covid-19 immunization. Medical history included menstrual migraines, no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included rizatriptan benzoate. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration on 21Dec2021 10:30 in right arm, at single dose for covid-19 immunization. Immediately the next day on 12Jan2021 05:00 the patient had a fever 100.8 and chills. 2 days later on 13Jan2021 she started having very bad headaches. She had a migraine daily from 13Jan2021 through 23Jan2021. On 22Jan2021, she was having chest pressure, lightheadedness, fatigue and went to the ER for a cardiac work up. Nothing showed up, felt lightheaded daily after. 25Jan2021 saw PCP- having chest pains. 26Jan2021 went back to the ER with chest pressure, lightheadedness, feelings she was going to black out. Admitted to the hospital. Had a stress test while in the hospital nothing showed up. Discharged. Saw PCP on 29Jan2021 because still feeling lightheaded, dizzy. Patient was hospitalized/ clinic visit/ emergency room for all events. Treatment steroids, Aspirin, lots of blood work. stress test was received. She has ordered a 48 hours heart monitor and a neurologist consult. She had not been able to work since 27Jan2021. The patient underwent lab tests and procedures which included, Nasal Swab test by PCR: negative on 26Jan2021. The outcome of the event migraine was recovered on 23Jan2021. The outcome of the other events was not recovered.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 at 2nd injection cannot be excluded for the reported events based on the known safety profile and the plausible temporal relationship.  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: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: having chest pains; On 22Jan, I was having chest pressure; felt lightheaded; fatigue; 2 days later I started headaches; I had a migrane; fever 100.8; chills; This is a spontaneous report from a contactable other health professional (patient).  A 43-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration on 11Jan2021 10:00 in left arm, at single dose for covid-19 immunization. Medical history included menstrual migraines, no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included rizatriptan benzoate. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration on 21Dec2021 10:30 in right arm, at single dose for covid-19 immunization. Immediately the next day on 12Jan2021 05:00 the patient had a fever 100.8 and chills. 2 days later on 13Jan2021 she started having very bad headaches. She had a migraine daily from 13Jan2021 through 23Jan2021. On 22Jan2021, she was having chest pressure, lightheadedness, fatigue and went to the ER for a cardiac work up. Nothing showed up, felt lightheaded daily after. 25Jan2021 saw PCP- having chest pains. 26Jan2021 went back to the ER with chest pressure, lightheadedness, feelings she was going to black out. Admitted to the hospital. Had a stress test while in the hospital nothing showed up. Discharged. Saw PCP on 29Jan2021 because still feeling lightheaded, dizzy. Patient was hospitalized/ clinic visit/ emergency room for all events. Treatment steroids, Aspirin, lots of blood work. stress test was received. She has ordered a 48 hours heart monitor and a neurologist consult. She had not been able to work since 27Jan2021. The patient underwent lab tests and procedures which included, Nasal Swab test by PCR: negative on 26Jan2021. The outcome of the event migraine was recovered on 23Jan2021. The outcome of the other events was not recovered.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 at 2nd injection cannot be excluded for the reported events based on the known safety profile and the plausible temporal relationship.  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: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Autoimmune disorder, Blood immunoglobulin G decreased, Blood pressure increased, Flank pain
Clinical narrative: visual hallucinations; cough; shallow breathing; rash on neck, rash in left abdomen; feeling dizzy like too much oxygen to brain; panic attacks; symptoms of mania; lack of sleep; pressured speech; Temp 101.2; This is a spontaneous report from a contactable Physician (patient). A 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number Ek6730, Intramuscular in left arm on 26Dec2020 14:15 at single dose for COVID-19 immunization. Medical history included Autoimmune hypothyroidism, autoimmune ulcerative colitis, Raynauds phenomenon, mitral valve prolapse mild, right sided kidney stones. Concomitant medications included levothyroxine sodium (SYNTHROID), mesalamine, folic acid (FOLATE) and curcuma longa (TURMERIC). The patient previously received Sulfa and experienced rash. The patient had Temp 101.2, cough, shallow breathing, rash on neck, rash in left abdomen, feeling dizzy like too much oxygen to brain, panic attacks, visual hallucinations, symptoms of mania (lack of sleep, pressured speech) on 02Jan2021 07:30. All events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Treatment received for the events included Lamictal, Zyprexa, clonazepam, propranolol, Norvasc. The patient had no Covid prior vaccination. The patient had covid tested post vaccination. Lab data included Nasal Swab Negative on 07Jan2021. The outcome of all events was resolving.; Sender's Comments: Considering the temporal association, a causal association between administration of BNT162B2 and the onset of visual hallucinations 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: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypopnoea, Mental fatigue, Poor quality sleep, Pyrexia, Rash
Clinical narrative: visual hallucinations; cough; shallow breathing; rash on neck, rash in left abdomen; feeling dizzy like too much oxygen to brain; panic attacks; symptoms of mania; lack of sleep; pressured speech; Temp 101.2; This is a spontaneous report from a contactable Physician (patient). A 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number Ek6730, Intramuscular in left arm on 26Dec2020 14:15 at single dose for COVID-19 immunization. Medical history included Autoimmune hypothyroidism, autoimmune ulcerative colitis, Raynauds phenomenon, mitral valve prolapse mild, right sided kidney stones. Concomitant medications included levothyroxine sodium (SYNTHROID), mesalamine, folic acid (FOLATE) and curcuma longa (TURMERIC). The patient previously received Sulfa and experienced rash. The patient had Temp 101.2, cough, shallow breathing, rash on neck, rash in left abdomen, feeling dizzy like too much oxygen to brain, panic attacks, visual hallucinations, symptoms of mania (lack of sleep, pressured speech) on 02Jan2021 07:30. All events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Treatment received for the events included Lamictal, Zyprexa, clonazepam, propranolol, Norvasc. The patient had no Covid prior vaccination. The patient had covid tested post vaccination. Lab data included Nasal Swab Negative on 07Jan2021. The outcome of all events was resolving.; Sender's Comments: Considering the temporal association, a causal association between administration of BNT162B2 and the onset of visual hallucinations 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: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swelling
Clinical narrative: visual hallucinations; cough; shallow breathing; rash on neck, rash in left abdomen; feeling dizzy like too much oxygen to brain; panic attacks; symptoms of mania; lack of sleep; pressured speech; Temp 101.2; This is a spontaneous report from a contactable Physician (patient). A 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number Ek6730, Intramuscular in left arm on 26Dec2020 14:15 at single dose for COVID-19 immunization. Medical history included Autoimmune hypothyroidism, autoimmune ulcerative colitis, Raynauds phenomenon, mitral valve prolapse mild, right sided kidney stones. Concomitant medications included levothyroxine sodium (SYNTHROID), mesalamine, folic acid (FOLATE) and curcuma longa (TURMERIC). The patient previously received Sulfa and experienced rash. The patient had Temp 101.2, cough, shallow breathing, rash on neck, rash in left abdomen, feeling dizzy like too much oxygen to brain, panic attacks, visual hallucinations, symptoms of mania (lack of sleep, pressured speech) on 02Jan2021 07:30. All events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Treatment received for the events included Lamictal, Zyprexa, clonazepam, propranolol, Norvasc. The patient had no Covid prior vaccination. The patient had covid tested post vaccination. Lab data included Nasal Swab Negative on 07Jan2021. The outcome of all events was resolving.; Sender's Comments: Considering the temporal association, a causal association between administration of BNT162B2 and the onset of visual hallucinations 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.