chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Vaginal haemorrhage
Clinical narrative: I was believed to be about six weeks pregnant (first trimester) and have started having heavy vaginal bleeding the day after I was given the vaccine. The day I got the vaccine I felt fine beyond arm pain until 2:30 PM when I began feeling chills and sweaty. I measured my temperature and did not have a fever but took Tylenol as advised due to being pregnant.  I felt poor through today and this evening began having heavy vaginal bleeding most consistent with a miscarriage. I have never miscarried before. I will go get labs drawn at the earliest time when I call my provider tomorrow.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling hot, Full blood count, Hyperhidrosis, Metabolic function test
Clinical narrative: 39 yo female scheduled for COVID vaccine. Reports only incident of anaphylaxis d/t pineapple allergy 4 years ago; medication allergies limited to migraine s/s, not anaphylaxis. Denies possibility of pregnancy. Tolerated injection well. Upon standing ~5 min after injection, pt began experiencing lightheadedness and warmth/diaphoresis. Pt's monitoring and care transferred to clinic.  Pt given Benadryl 25mg, famotidine 20mg, 1000ml NaCl IV, Solumedrol 125mg IV.  Pt symptoms resolved and sent home with  Epipen 2-Pak, Loratadine 10mg, prednisone 20mg, Benadryl 25mg/
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Headache, Rhinorrhoea
Clinical narrative: Runny nose headache lost taste and smell
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Flushing, Pruritus, Rash, Rash papular
Clinical narrative: 1 hour after vaccine itching, redness, elevated small bumps in arms. 6.5 hours after the vaccine had flushing and tachycardia up to 130. Had to call FIRE  RESCUE .,Took tachycardia meds
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: 1 hour after vaccine itching, redness, elevated small bumps in arms. 6.5 hours after the vaccine had flushing and tachycardia up to 130. Had to call FIRE  RESCUE .,Took tachycardia meds
Age: 80.0
Sex: M
Vaccine: FLUA3, FLUA4
Symptoms: Guillain-Barre syndrome, Immunoglobulin therapy, Muscular weakness, Paralysis
Clinical narrative: Paralysis; Distal UE and LE weakness; GBS; This spontaneous case was retrieved on 21-Dec-2020 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 895156-1), reported by other health professional and concerned an 80-year-old male patient.  The patient's medical history included unintended weight loss, dementia/impaired cognition, allergy to latex, sulfa, penicillin (PCN), Rocephin (ceftriaxone) and tamsulosin. The patient's 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; dose: reported as one, anatomical location: right arm, route of administration: intramuscular and indication: not reported). The batch number reported was 279821.  On 26-Oct-2020, four days after receiving Fluad Quadrivalent, the patient experienced Guillain-Barre syndrome (GBS), distal upper extremities (UE) and lower extremities (LE) weakness and paralysis.  On an unspecified date in Oct-2020, the patient was hospitalized.The patient was treated with intravenous immunoglobulin.  On an unspecified date in 2020, after eight days, the patient was discharged from the hospital.  At the time of initial reporting, the patient was recovering from the events.  The reporter did not provide a causality assessment.  The events of 'Guillain-Barre syndrome' and paralysis were considered as serious due to seriousness criteria of hospitalization and medically significance, while the event of 'weakness in extremity' was considered as serious due to the seriousness criterion of hospitalization.  Company comment: A 80-year-old male patient experienced paralysis, muscular weakness and Guillain-Barre syndrome 4 days after administration of Fluad Quadrivalent. The patient's medical history included unintended weight loss, dementia/impaired cognition, allergy to latex, sulfa, penicillin (PCN), ceftriaxone and tamsulosin. The patient's concomitant medications were not reported. Causality is assessed as possibly related for all events due to chronological and biological plausibility. Brighton collaboration criteria for Guillain-Barre syndrome could not be assessed due to insufficient information provided.; Sender's Comments: A 80-year-old male patient experienced paralysis, muscular weakness and Guillain-Barre syndrome 4 days after administration of Fluad Quadrivalent. The patient's medical history included unintended weight loss, dementia/impaired cognition, allergy to latex, sulfa, penicillin (PCN), ceftriaxone and tamsulosin. The patient's concomitant medications were not reported. Causality is assessed as possibly related for all events due to chronological and biological plausibility. Brighton collaboration criteria for Guillain-Barre syndrome could not be assessed due to insufficient information provided.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Electrocardiogram normal, Feeling abnormal, Nausea, Retching, Skin discolouration
Clinical narrative: About 15 min after the vax, I felt metallic taste and about an hour later uncontrolled dry heaving, nothing came up but it kept going.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dysgeusia, Electrocardiogram, Retching, SARS-CoV-2 test
Clinical narrative: About 15 min after the vax, I felt metallic taste and about an hour later uncontrolled dry heaving, nothing came up but it kept going.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Chills, Condition aggravated, Erythema, Flushing, Hypertension
Clinical narrative: Elevated BP and HR; Elevated BP and HR; dizziness; tingling to feet; chest pain; chills; nausea; This is a spontaneous report from a contactable nurse (patient). A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) via intramuscular on 18Dec2020 13:15 on left arm at a single dose for COVID-19 immunization. The patient medical history included hypertension and no allergy to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine but receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 (PENDING CLARIFICATION) and post vaccination, the patient did test for COVID-19 via nasal swab called Rapid covid on 18Dec2020 and result was negative. The patient Elevated blood pressure and heart rate, dizziness, tingling to feet, chest pain, chills, nausea on 18Dec2020 14:30. The adverse events result in emergency room/department or urgent care. The patient received IV benadryl, zofran, solumedrol, pepcid, fluids for the adverse events. The outcome of the events was recovered in Dec2020.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Nausea, Rash macular
Clinical narrative: Elevated BP and HR; Elevated BP and HR; dizziness; tingling to feet; chest pain; chills; nausea; This is a spontaneous report from a contactable nurse (patient). A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) via intramuscular on 18Dec2020 13:15 on left arm at a single dose for COVID-19 immunization. The patient medical history included hypertension and no allergy to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine but receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 (PENDING CLARIFICATION) and post vaccination, the patient did test for COVID-19 via nasal swab called Rapid covid on 18Dec2020 and result was negative. The patient Elevated blood pressure and heart rate, dizziness, tingling to feet, chest pain, chills, nausea on 18Dec2020 14:30. The adverse events result in emergency room/department or urgent care. The patient received IV benadryl, zofran, solumedrol, pepcid, fluids for the adverse events. The outcome of the events was recovered in Dec2020.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Chest X-ray, Chest discomfort, Dizziness, Electrocardiogram, Flushing
Clinical narrative: Elevated BP and HR; Elevated BP and HR; dizziness; tingling to feet; chest pain; chills; nausea; This is a spontaneous report from a contactable nurse (patient). A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) via intramuscular on 18Dec2020 13:15 on left arm at a single dose for COVID-19 immunization. The patient medical history included hypertension and no allergy to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine but receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 (PENDING CLARIFICATION) and post vaccination, the patient did test for COVID-19 via nasal swab called Rapid covid on 18Dec2020 and result was negative. The patient Elevated blood pressure and heart rate, dizziness, tingling to feet, chest pain, chills, nausea on 18Dec2020 14:30. The adverse events result in emergency room/department or urgent care. The patient received IV benadryl, zofran, solumedrol, pepcid, fluids for the adverse events. The outcome of the events was recovered in Dec2020.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Full blood count, Metabolic function test, Nausea, SARS-CoV-2 test, Troponin
Clinical narrative: Elevated BP and HR; Elevated BP and HR; dizziness; tingling to feet; chest pain; chills; nausea; This is a spontaneous report from a contactable nurse (patient). A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) via intramuscular on 18Dec2020 13:15 on left arm at a single dose for COVID-19 immunization. The patient medical history included hypertension and no allergy to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine but receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 (PENDING CLARIFICATION) and post vaccination, the patient did test for COVID-19 via nasal swab called Rapid covid on 18Dec2020 and result was negative. The patient Elevated blood pressure and heart rate, dizziness, tingling to feet, chest pain, chills, nausea on 18Dec2020 14:30. The adverse events result in emergency room/department or urgent care. The patient received IV benadryl, zofran, solumedrol, pepcid, fluids for the adverse events. The outcome of the events was recovered in Dec2020.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Urine analysis, Vomiting
Clinical narrative: Elevated BP and HR; Elevated BP and HR; dizziness; tingling to feet; chest pain; chills; nausea; This is a spontaneous report from a contactable nurse (patient). A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) via intramuscular on 18Dec2020 13:15 on left arm at a single dose for COVID-19 immunization. The patient medical history included hypertension and no allergy to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine but receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 (PENDING CLARIFICATION) and post vaccination, the patient did test for COVID-19 via nasal swab called Rapid covid on 18Dec2020 and result was negative. The patient Elevated blood pressure and heart rate, dizziness, tingling to feet, chest pain, chills, nausea on 18Dec2020 14:30. The adverse events result in emergency room/department or urgent care. The patient received IV benadryl, zofran, solumedrol, pepcid, fluids for the adverse events. The outcome of the events was recovered in Dec2020.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Blood pressure increased, Chest pain, Chills, Dizziness, Heart rate increased
Clinical narrative: Elevated BP and HR; Elevated BP and HR; dizziness; tingling to feet; chest pain; chills; nausea; This is a spontaneous report from a contactable nurse (patient). A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) via intramuscular on 18Dec2020 13:15 on left arm at a single dose for COVID-19 immunization. The patient medical history included hypertension and no allergy to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine but receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 (PENDING CLARIFICATION) and post vaccination, the patient did test for COVID-19 via nasal swab called Rapid covid on 18Dec2020 and result was negative. The patient Elevated blood pressure and heart rate, dizziness, tingling to feet, chest pain, chills, nausea on 18Dec2020 14:30. The adverse events result in emergency room/department or urgent care. The patient received IV benadryl, zofran, solumedrol, pepcid, fluids for the adverse events. The outcome of the events was recovered in Dec2020.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Nausea, Paraesthesia, SARS-CoV-2 test negative
Clinical narrative: Elevated BP and HR; Elevated BP and HR; dizziness; tingling to feet; chest pain; chills; nausea; This is a spontaneous report from a contactable nurse (patient). A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) via intramuscular on 18Dec2020 13:15 on left arm at a single dose for COVID-19 immunization. The patient medical history included hypertension and no allergy to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine but receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 (PENDING CLARIFICATION) and post vaccination, the patient did test for COVID-19 via nasal swab called Rapid covid on 18Dec2020 and result was negative. The patient Elevated blood pressure and heart rate, dizziness, tingling to feet, chest pain, chills, nausea on 18Dec2020 14:30. The adverse events result in emergency room/department or urgent care. The patient received IV benadryl, zofran, solumedrol, pepcid, fluids for the adverse events. The outcome of the events was recovered in Dec2020.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Anxiety, Blood test normal, Chills, Dyspnoea, Feeling cold
Clinical narrative: Elevated BP and HR; Elevated BP and HR; dizziness; tingling to feet; chest pain; chills; nausea; This is a spontaneous report from a contactable nurse (patient). A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) via intramuscular on 18Dec2020 13:15 on left arm at a single dose for COVID-19 immunization. The patient medical history included hypertension and no allergy to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine but receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 (PENDING CLARIFICATION) and post vaccination, the patient did test for COVID-19 via nasal swab called Rapid covid on 18Dec2020 and result was negative. The patient Elevated blood pressure and heart rate, dizziness, tingling to feet, chest pain, chills, nausea on 18Dec2020 14:30. The adverse events result in emergency room/department or urgent care. The patient received IV benadryl, zofran, solumedrol, pepcid, fluids for the adverse events. The outcome of the events was recovered in Dec2020.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Feeling hot, Nausea, Paraesthesia, Tremor
Clinical narrative: Elevated BP and HR; Elevated BP and HR; dizziness; tingling to feet; chest pain; chills; nausea; This is a spontaneous report from a contactable nurse (patient). A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) via intramuscular on 18Dec2020 13:15 on left arm at a single dose for COVID-19 immunization. The patient medical history included hypertension and no allergy to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine but receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 (PENDING CLARIFICATION) and post vaccination, the patient did test for COVID-19 via nasal swab called Rapid covid on 18Dec2020 and result was negative. The patient Elevated blood pressure and heart rate, dizziness, tingling to feet, chest pain, chills, nausea on 18Dec2020 14:30. The adverse events result in emergency room/department or urgent care. The patient received IV benadryl, zofran, solumedrol, pepcid, fluids for the adverse events. The outcome of the events was recovered in Dec2020.
Age: 54.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Pharyngeal swelling
Clinical narrative: light headache, dizziness, shortness of breath
Age: 54.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dyspnoea, Headache
Clinical narrative: light headache, dizziness, shortness of breath
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Headache, Lymphadenopathy, Pain
Clinical narrative: fevers up to 103.7F/low grade fever was still here (100.2F); vomiting; fatigue; body aches; chills; headache/headaches became severe; neck pain; This is a spontaneous report from a contactable nurse (patient herself). A 24-year-old female patient (non-pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular on 18Dec2020 15:45 in left arm at single dose for covid-19 immunization. There were no medical history and concomitant medications. The patient was not allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The reason for unknown batch/lot was unable to locate or read the details. About 5 hours after the vaccine, patient started getting chills, headache, and neck pain on 18Dec2020 09:00 PM. About 24 hrs later (19Dec2020), headaches became severe, started getting fevers up to 103.7F, vomiting, fatigue, body aches, and chills. Now 5 days after the vaccine (23Dec2020), low grade fever was still here (100.2F). The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The events were reported as non-serious. No treatment was received for all events. The patient underwent lab tests and procedures which included COVID PCR for Nasal Swab: negative on 20Dec2020 and negative on 21Dec2020. Outcome of events were recovering.   Information on the lot/batch number has been requested.
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Swelling, Vomiting
Clinical narrative: fevers up to 103.7F/low grade fever was still here (100.2F); vomiting; fatigue; body aches; chills; headache/headaches became severe; neck pain; This is a spontaneous report from a contactable nurse (patient herself). A 24-year-old female patient (non-pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular on 18Dec2020 15:45 in left arm at single dose for covid-19 immunization. There were no medical history and concomitant medications. The patient was not allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The reason for unknown batch/lot was unable to locate or read the details. About 5 hours after the vaccine, patient started getting chills, headache, and neck pain on 18Dec2020 09:00 PM. About 24 hrs later (19Dec2020), headaches became severe, started getting fevers up to 103.7F, vomiting, fatigue, body aches, and chills. Now 5 days after the vaccine (23Dec2020), low grade fever was still here (100.2F). The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The events were reported as non-serious. No treatment was received for all events. The patient underwent lab tests and procedures which included COVID PCR for Nasal Swab: negative on 20Dec2020 and negative on 21Dec2020. Outcome of events were recovering.   Information on the lot/batch number has been requested.
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Headache, Neck pain, Pain
Clinical narrative: fevers up to 103.7F/low grade fever was still here (100.2F); vomiting; fatigue; body aches; chills; headache/headaches became severe; neck pain; This is a spontaneous report from a contactable nurse (patient herself). A 24-year-old female patient (non-pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular on 18Dec2020 15:45 in left arm at single dose for covid-19 immunization. There were no medical history and concomitant medications. The patient was not allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The reason for unknown batch/lot was unable to locate or read the details. About 5 hours after the vaccine, patient started getting chills, headache, and neck pain on 18Dec2020 09:00 PM. About 24 hrs later (19Dec2020), headaches became severe, started getting fevers up to 103.7F, vomiting, fatigue, body aches, and chills. Now 5 days after the vaccine (23Dec2020), low grade fever was still here (100.2F). The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The events were reported as non-serious. No treatment was received for all events. The patient underwent lab tests and procedures which included COVID PCR for Nasal Swab: negative on 20Dec2020 and negative on 21Dec2020. Outcome of events were recovering.   Information on the lot/batch number has been requested.
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, SARS-CoV-2 test negative, Vomiting
Clinical narrative: fevers up to 103.7F/low grade fever was still here (100.2F); vomiting; fatigue; body aches; chills; headache/headaches became severe; neck pain; This is a spontaneous report from a contactable nurse (patient herself). A 24-year-old female patient (non-pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular on 18Dec2020 15:45 in left arm at single dose for covid-19 immunization. There were no medical history and concomitant medications. The patient was not allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The reason for unknown batch/lot was unable to locate or read the details. About 5 hours after the vaccine, patient started getting chills, headache, and neck pain on 18Dec2020 09:00 PM. About 24 hrs later (19Dec2020), headaches became severe, started getting fevers up to 103.7F, vomiting, fatigue, body aches, and chills. Now 5 days after the vaccine (23Dec2020), low grade fever was still here (100.2F). The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The events were reported as non-serious. No treatment was received for all events. The patient underwent lab tests and procedures which included COVID PCR for Nasal Swab: negative on 20Dec2020 and negative on 21Dec2020. Outcome of events were recovering.   Information on the lot/batch number has been requested.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Herpes zoster, Pain, Penile rash, Rash, Scrotal dermatitis
Clinical narrative: 2 days after receiving vaccine (Pfizer) had left scrotal pain, 3 days after vaccine noted vesicular lesions on left S3 dermatome extending over scrotum, penis and buttock on back. also with left inguinal adenopathy and burning pain. Started on Valtrex 1g TID on evening of day 3 (same day as rash noted) and rash improved with crusted vesicles and no additional pain.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Scrotal pain
Clinical narrative: 2 days after receiving vaccine (Pfizer) had left scrotal pain, 3 days after vaccine noted vesicular lesions on left S3 dermatome extending over scrotum, penis and buttock on back. also with left inguinal adenopathy and burning pain. Started on Valtrex 1g TID on evening of day 3 (same day as rash noted) and rash improved with crusted vesicles and no additional pain.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Groin pain, Lymphadenopathy, Pain, Penile rash, Rash
Clinical narrative: 2 days after receiving vaccine (Pfizer) had left scrotal pain, 3 days after vaccine noted vesicular lesions on left S3 dermatome extending over scrotum, penis and buttock on back. also with left inguinal adenopathy and burning pain. Started on Valtrex 1g TID on evening of day 3 (same day as rash noted) and rash improved with crusted vesicles and no additional pain.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Rash vesicular, Scab, Scrotal dermatitis, Scrotal pain
Clinical narrative: 2 days after receiving vaccine (Pfizer) had left scrotal pain, 3 days after vaccine noted vesicular lesions on left S3 dermatome extending over scrotum, penis and buttock on back. also with left inguinal adenopathy and burning pain. Started on Valtrex 1g TID on evening of day 3 (same day as rash noted) and rash improved with crusted vesicles and no additional pain.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Throat tightness
Clinical narrative: redness on chest as well as left arm; throat and facial swelling; Allergic reaction; left arm went numb to her fingertips/right hand was numb/numbness of her left arm has moved through all of body; coldness to whole left arm/right hand went cold; tingling; Dizziness; rash on chest and left arm; throat and facial swelling; This is a spontaneous report from a contactable consumer (patient herself). A 31-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at site of left arm on 17Dec2020 at single dose for COVID-19 immunization. Medical history included colitis ulcerative from Mar2018 and ongoing. Concomitant medication included mesalazine (LIALDA) from 2017 and ongoing (had been taking for three years) for ulcerative colitis. Clinical course: Patient said the allergic reaction happened five minutes after she got the vaccine, and she had the numbness and coldness to her whole left arm, numbness from her arm to her fingertips, and her right hand went numb and cold. She said that this was still going on. She said that the numbness of her left arm has moved through all of her body, the numbness and tingling, she had dizziness, it came and went and had not gotten better or worse, she had rash on her chest and left arm, it is red but it is not bumpy, she had no hives, just redness on chest as well as left arm. she also had throat facial swelling that has been going on since 17Dec2020 that had been progressing, it went down but it was not going away, her face was swollen then it went down a bit. She said they thought it was because of the steroids, but she was not on the steroids anymore and she is still swollen. She got treatment in the emergency room immediately right after, and took diphenhydramine hydrochloride (BENADRYL, 25mg tablets) and intravenous prednisone (20mg tablets). She also had a prescription for diphenhydramine hydrochloride and prednisone to take by mouth at home, she thought they gave her diphenhydramine hydrochloride dose of 50mg IV there and follow up dosing prescription by mouth for later of 25mg tablets from 18Dec2020 to 20Dec2020. she was supposed to take diphenhydramine hydrochloride every 6 hours by mouth. She says she took all three of the prednisone that prescribed. She was not admitted to the emergency room, and she went home after being treated. on the 17Dec2020, they did a lab for basic metabolic panel CBC auto-differential but all it said lab was completed and did not provide results. She had her vitals from the 17Dec2020. She said her blood pressure was 129/88, her temperature was 98.2 degrees Fahrenheit, her respirations were 18, her oxygen saturation was 100%, her pulse was 72, and her BMI was 23.5. The outcome of event 'allergic reaction and redness on chest as well as left arm' was unknown; of event 'rash on chest and left arm' was recovered on 21Dec2020; of event 'throat and facial swelling' was recovering; of rest events was not recovered.  Information about lot/batch number has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Paraesthesia, Pruritus
Clinical narrative: Development of facial numbness and burning starting 30 minutes after receiving the vaccine.  No clear motor deficit, but now 9 days later, continues to have symptoms of numbness and burning despite course of steroids and antihistamines
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Computerised tomogram head normal, Hypoaesthesia
Clinical narrative: Development of facial numbness and burning starting 30 minutes after receiving the vaccine.  No clear motor deficit, but now 9 days later, continues to have symptoms of numbness and burning despite course of steroids and antihistamines
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered, No adverse event, Product preparation issue
Clinical narrative: Nurse did not add normal saline diluent to vial; drew up and administered concentrated vaccine of 0.3ml the equivalent of 5 concentrated doses/ it sounds like I got 30 times the regular dose; elevated diastolic BP; This is a spontaneous report from a contactable physician (patient) and nurse. A 38-year-old male patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, lot number: EK5730), intramuscular in the left arm on 21Dec2020 09:30 at a single dose for COVID-19 immunization. The COVID-19 vaccine was administered in a hospital facility. There were no other medical history and no concomitant medications. The patient has no known allergies. The patient has no COVID-19 prior vaccination. It was reported that the nurse did not add normal saline diluent to vial, then drew up and administered concentrated vaccine of 0.3ml the equivalent of 5 concentrated doses. The doctor (patient) stated, "This question is appreciated here because it's a little complicated. I am in the ER, I am an ER doctor and I got my vaccine today. But they made a medication error and they gave me, it sounds like 30 times of concentration, it's 30 times of regular dose." The patient further stated, "This is confirmed by the individual who administered it to me and it sounds like I got 30 times the regular dose. What she told me was that the vial (incomplete sentence) and they said that they called Pfizer about this. The vial should have been reconstituted in 1.8 ml of normal saline and that in some part of that, a fraction of that, instead of one-fifth of 0.3 ml of that should be given. So it sounds like basically she was telling me and she confirmed this that I got 30 times the amount. And when she told me about the math was 25 because it sounded like that was 5 times less the dilution but if I do the math, 3 ml x 1.8 that's I think, 6 times concentrated thing in the vial and then a fraction of that. It just got 1%, so if I am doing the math correctly, it's 30 times the dose. So basically, at about 09:24, I got the 30 times that I shouldn't be getting. No symptoms right now, they are just monitoring me but because this is all new, nobody really knows any of the side effects at this. This is all new information, I wanted to make sure the information is being accurately conveyed and understood by Pfizer authorities. In case there needs to be tracking, antibody response and side effects, at this concentration because 30 times concentration is not insignificant." The patient had no symptoms other than an elevated diastolic BP on 21Dec2020. It was unknown if treatment was received for the adverse event. The adverse event resulted in Emergency room/department or urgent care. The outcome of the event elevated diastolic BP was unknown. The report was considered non-serious.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Incorrect dose administered, Product preparation issue
Clinical narrative: Nurse did not add normal saline diluent to vial; drew up and administered concentrated vaccine of 0.3ml the equivalent of 5 concentrated doses/ it sounds like I got 30 times the regular dose; elevated diastolic BP; This is a spontaneous report from a contactable physician (patient) and nurse. A 38-year-old male patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, lot number: EK5730), intramuscular in the left arm on 21Dec2020 09:30 at a single dose for COVID-19 immunization. The COVID-19 vaccine was administered in a hospital facility. There were no other medical history and no concomitant medications. The patient has no known allergies. The patient has no COVID-19 prior vaccination. It was reported that the nurse did not add normal saline diluent to vial, then drew up and administered concentrated vaccine of 0.3ml the equivalent of 5 concentrated doses. The doctor (patient) stated, "This question is appreciated here because it's a little complicated. I am in the ER, I am an ER doctor and I got my vaccine today. But they made a medication error and they gave me, it sounds like 30 times of concentration, it's 30 times of regular dose." The patient further stated, "This is confirmed by the individual who administered it to me and it sounds like I got 30 times the regular dose. What she told me was that the vial (incomplete sentence) and they said that they called Pfizer about this. The vial should have been reconstituted in 1.8 ml of normal saline and that in some part of that, a fraction of that, instead of one-fifth of 0.3 ml of that should be given. So it sounds like basically she was telling me and she confirmed this that I got 30 times the amount. And when she told me about the math was 25 because it sounded like that was 5 times less the dilution but if I do the math, 3 ml x 1.8 that's I think, 6 times concentrated thing in the vial and then a fraction of that. It just got 1%, so if I am doing the math correctly, it's 30 times the dose. So basically, at about 09:24, I got the 30 times that I shouldn't be getting. No symptoms right now, they are just monitoring me but because this is all new, nobody really knows any of the side effects at this. This is all new information, I wanted to make sure the information is being accurately conveyed and understood by Pfizer authorities. In case there needs to be tracking, antibody response and side effects, at this concentration because 30 times concentration is not insignificant." The patient had no symptoms other than an elevated diastolic BP on 21Dec2020. It was unknown if treatment was received for the adverse event. The adverse event resulted in Emergency room/department or urgent care. The outcome of the event elevated diastolic BP was unknown. The report was considered non-serious.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Feeling hot, Flushing, Throat tightness
Clinical narrative: Chest tightening and warm feeling on chest; throat tightening; warm and flushed feeling in throat; This is a spontaneous report from a contactable healthcare professional (patient). A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0140, expiry date: unknown), via an unspecified route of administration on 22Dec2020 09:15 at a single dose for COVID-19 immunization. Medical history included PCOS and thoracic outlet syndrome. Concomitant medication included acetylsalicylic acid (ASPIRIN 81), fish oil, and alprazolam (XANAX). The patient experienced throat and chest tightening as well as warm and flushed feeling in throat and chest on 22Dec2020 09:15. Treatment of IV BENADRYL and PEPCID was given for the events. Events resulted in the emergency room. Outcome of the events was recovered on an unspecified date in Dec2020. Patient had no COVID prior to vaccination and was not tested for COVID post vaccination. The events was considered non-serious.; Sender's Comments: Based on the compatible time association, the events throat and chest tightening as well as warm and flushed feeling in throat and chest is possibly related to 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: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram head normal, Hypoaesthesia, Laboratory test normal, Paraesthesia, Speech disorder
Clinical narrative: Speech difficulty; bilateral lower extremity with tingling and numbness; bilateral lower extremity with tingling and numbness; This is a spontaneous report from a contactable Pharmacist. A 38-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscularly on left arm at 02:15 PM on 18Dec2020 at single dose for COVID-19 immunization. Medical history included known allergies: urticaria and allergic reaction to vaccines. The patient's concomitant medications were not reported. The patient experienced speech difficulty and bilateral lower extremity with tingling and numbness after COVID-19 vaccine administration at 02:15 PM on 18Dec2020. Events were reported as non-serious. Symptoms improved at ED (Emergency department) with IV hydration. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. The outcome of events was unknown.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysarthria, Hypoaesthesia, Paraesthesia
Clinical narrative: Speech difficulty; bilateral lower extremity with tingling and numbness; bilateral lower extremity with tingling and numbness; This is a spontaneous report from a contactable Pharmacist. A 38-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscularly on left arm at 02:15 PM on 18Dec2020 at single dose for COVID-19 immunization. Medical history included known allergies: urticaria and allergic reaction to vaccines. The patient's concomitant medications were not reported. The patient experienced speech difficulty and bilateral lower extremity with tingling and numbness after COVID-19 vaccine administration at 02:15 PM on 18Dec2020. Events were reported as non-serious. Symptoms improved at ED (Emergency department) with IV hydration. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. The outcome of events was unknown.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Eye inflammation, Eye swelling, Fatigue, Tenderness
Clinical narrative: Swollen and inflamed right eye, tenderness to right axilla; Swollen and inflamed right eye, tenderness to right axilla; Swollen and inflamed right eye, tenderness to right axilla; This is a spontaneous report from a contactable nurse reporting for himself.  A 36-year-old male patient received the 1st dose of bnt162b2 (BNT162B2, Lot # EL0140) intramuscular at single dose at right arm on 19Dec2020 07:30 AM for Covid-19 immunisation, administered at workplace clinic.  The patient medical history was not reported. The concomitant medications were none: no other medications in two weeks. The patient has not received other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced swollen and inflamed right eye, tenderness to right axilla on 21Dec2020 08:00. AE resulted in Emergency room/department or urgent care. The patient received Benadryl as treatment for the adverse event. Therapeutic measures were taken as a result of events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The outcome of not recovered. The reporter assessed the events as non serious.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Axillary pain, Eye inflammation, Eye swelling
Clinical narrative: Swollen and inflamed right eye, tenderness to right axilla; Swollen and inflamed right eye, tenderness to right axilla; Swollen and inflamed right eye, tenderness to right axilla; This is a spontaneous report from a contactable nurse reporting for himself.  A 36-year-old male patient received the 1st dose of bnt162b2 (BNT162B2, Lot # EL0140) intramuscular at single dose at right arm on 19Dec2020 07:30 AM for Covid-19 immunisation, administered at workplace clinic.  The patient medical history was not reported. The concomitant medications were none: no other medications in two weeks. The patient has not received other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced swollen and inflamed right eye, tenderness to right axilla on 21Dec2020 08:00. AE resulted in Emergency room/department or urgent care. The patient received Benadryl as treatment for the adverse event. Therapeutic measures were taken as a result of events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The outcome of not recovered. The reporter assessed the events as non serious.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Activated partial thromboplastin time normal, Asthenia, Blood creatinine normal, Blood electrolytes normal, Blood glucose normal
Clinical narrative: Within 15 minutes of receiving the vaccine I started to feel flushed.; My heart began to race; my heart rate was 175; This is a spontaneous report from a contactable nurse (patient) and a contactable other health professional.  A 35-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration at left arm on 22Dec2020 at 10:00 at single dose for COVID-19 immunization. The patient medical history included ongoing birth control pill. The patient's concomitant medication included vitamin C, vitamin D3 and zinc.  The patient reported that: " within 15 minutes of receiving the vaccine I started to feel flushed. My heart began to race. I flagged down a nurse who took my vitals and my heart rate was 175. I was taken to Emergency where I received IV fluids, IV BENADRYL and lab tests. I was monitored, my heart rate came down but still remained high at rest 90s-110s". The patient outcome of the events was recovering.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood urea normal, Brain natriuretic peptide normal, Differential white blood cell count normal, Dizziness, Fibrin D dimer normal
Clinical narrative: Within 15 minutes of receiving the vaccine I started to feel flushed.; My heart began to race; my heart rate was 175; This is a spontaneous report from a contactable nurse (patient) and a contactable other health professional.  A 35-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration at left arm on 22Dec2020 at 10:00 at single dose for COVID-19 immunization. The patient medical history included ongoing birth control pill. The patient's concomitant medication included vitamin C, vitamin D3 and zinc.  The patient reported that: " within 15 minutes of receiving the vaccine I started to feel flushed. My heart began to race. I flagged down a nurse who took my vitals and my heart rate was 175. I was taken to Emergency where I received IV fluids, IV BENADRYL and lab tests. I was monitored, my heart rate came down but still remained high at rest 90s-110s". The patient outcome of the events was recovering.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Flushing, Full blood count normal, Heart rate increased, Human chorionic gonadotropin negative, International normalised ratio normal
Clinical narrative: Within 15 minutes of receiving the vaccine I started to feel flushed.; My heart began to race; my heart rate was 175; This is a spontaneous report from a contactable nurse (patient) and a contactable other health professional.  A 35-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration at left arm on 22Dec2020 at 10:00 at single dose for COVID-19 immunization. The patient medical history included ongoing birth control pill. The patient's concomitant medication included vitamin C, vitamin D3 and zinc.  The patient reported that: " within 15 minutes of receiving the vaccine I started to feel flushed. My heart began to race. I flagged down a nurse who took my vitals and my heart rate was 175. I was taken to Emergency where I received IV fluids, IV BENADRYL and lab tests. I was monitored, my heart rate came down but still remained high at rest 90s-110s". The patient outcome of the events was recovering.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Laboratory test, Troponin I normal, X-ray normal
Clinical narrative: Within 15 minutes of receiving the vaccine I started to feel flushed.; My heart began to race; my heart rate was 175; This is a spontaneous report from a contactable nurse (patient) and a contactable other health professional.  A 35-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration at left arm on 22Dec2020 at 10:00 at single dose for COVID-19 immunization. The patient medical history included ongoing birth control pill. The patient's concomitant medication included vitamin C, vitamin D3 and zinc.  The patient reported that: " within 15 minutes of receiving the vaccine I started to feel flushed. My heart began to race. I flagged down a nurse who took my vitals and my heart rate was 175. I was taken to Emergency where I received IV fluids, IV BENADRYL and lab tests. I was monitored, my heart rate came down but still remained high at rest 90s-110s". The patient outcome of the events was recovering.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Flushing, Heart rate increased, Laboratory test, Palpitations
Clinical narrative: Within 15 minutes of receiving the vaccine I started to feel flushed.; My heart began to race; my heart rate was 175; This is a spontaneous report from a contactable nurse (patient) and a contactable other health professional.  A 35-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration at left arm on 22Dec2020 at 10:00 at single dose for COVID-19 immunization. The patient medical history included ongoing birth control pill. The patient's concomitant medication included vitamin C, vitamin D3 and zinc.  The patient reported that: " within 15 minutes of receiving the vaccine I started to feel flushed. My heart began to race. I flagged down a nurse who took my vitals and my heart rate was 175. I was taken to Emergency where I received IV fluids, IV BENADRYL and lab tests. I was monitored, my heart rate came down but still remained high at rest 90s-110s". The patient outcome of the events was recovering.