chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Body temperature, Chills, Pain
Clinical narrative: severe hip right hip and lower back pain; severe hip right hip and lower back pain; Chills; body aches; fever of 100.4; This is a spontaneous report from a contactable Other HCP (patient herself). A 33-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: unknown, expiry date: unknown) via unspecified route of administration, in left arm on 20Aug2021 17:30 (age at vaccination: 33-years) as dose 2, single for covid-19 immunisation. Historical vaccine included first dose of BNT162B2 via unspecified route of administration, on an unspecified date as dose 1, single for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was pharmacy or drug store. Medical history included asthma, heart murmurs, prediabetes, high blood pressure, pcos, known allergies: Avocados, from an unspecified date and unknown if ongoing. Other medications the patient received within 2 weeks of vaccination was multivitamin, hydrochlorothiazide, metformin, which were concomitant medications, taken for unspecified indication, start and stop date not reported. On 21Aug2021 13:00, patient experienced chills, body aches, severe hip right hip and lower back pain, fever of 100.4. No treatment was received as a result of the adverse events. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Device date was reported as 23Aug2021. The patient underwent lab test which included fever, with results: 100.4, on 21AUg2021. The outcome of event was recovering.   Follow-up attempts have been completed. Batch/lot number not available for BNT162B2. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: severe hip right hip and lower back pain; severe hip right hip and lower back pain; Chills; body aches; fever of 100.4; This is a spontaneous report from a contactable Other HCP (patient herself). A 33-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: unknown, expiry date: unknown) via unspecified route of administration, in left arm on 20Aug2021 17:30 (age at vaccination: 33-years) as dose 2, single for covid-19 immunisation. Historical vaccine included first dose of BNT162B2 via unspecified route of administration, on an unspecified date as dose 1, single for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was pharmacy or drug store. Medical history included asthma, heart murmurs, prediabetes, high blood pressure, pcos, known allergies: Avocados, from an unspecified date and unknown if ongoing. Other medications the patient received within 2 weeks of vaccination was multivitamin, hydrochlorothiazide, metformin, which were concomitant medications, taken for unspecified indication, start and stop date not reported. On 21Aug2021 13:00, patient experienced chills, body aches, severe hip right hip and lower back pain, fever of 100.4. No treatment was received as a result of the adverse events. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Device date was reported as 23Aug2021. The patient underwent lab test which included fever, with results: 100.4, on 21AUg2021. The outcome of event was recovering.   Follow-up attempts have been completed. Batch/lot number not available for BNT162B2. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Groin pain, Nausea, Renal pain
Clinical narrative: Extremely bad back pain; Extremely bad back pain at right kidney and groin.; Extremely bad back pain at right kidney and groin.; Kept feeling like he was going to throw up, but a cold rag helped him from doing that,; This is a spontaneous report from a contactable consumer. A 62-year old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number :FA7485) on 05Aug2021 at 07:45 PM via an unspecified route of  administration, administered in left arm as DOSE 2, SINGLE for COVID-19 immunization(age 62-years-old). No covid prior vaccination and history of allergy was reported. No other vaccine in four weeks. The patients medical history includes cancer free for 3 years no other issues reported. The patients concomitant medication in two weeks includes Centrum Silver / Biotin. Historical vaccination includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number :F46780) on 15Jul2021 at 07:45 PM via an unspecified route of  administration, administered in left arm as DOSE 1, SINGLE for COVID-19 immunization. On 06Aug2021 the patient experienced Extremely bad back pain at right kidney and groin. Kept feeling like he was going to throw up, but a cold rag helped him from doing that, so never actually threw up. Lasted 3 days, almost sending him to the hospital in so much pain. No Covid was tested post vaccination. No treatment was received. The outcome of the event was recovered.  Follow-Up (07Sep2021): Follow-up attempts are completed. No further information is expected.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Fatigue, Feeling abnormal, Off label use, SARS-CoV-2 test
Clinical narrative: Tiredness/severe tiredness and fatigue; feeling wiped out; Patient experienced side effects 5 days later after the third dose; Patient experienced side effects 5 days later after the third dose; This is a spontaneous report from a contactable consumer or other non hcp.   A 67-years-old male patient received bnt162b2 (BNT162B2(PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection), dose 3 via an unspecified route of administration, administered in Arm Left on 17Aug2021 11:00 (Batch/Lot Number: EW0172) as dose 3, single for covid-19 immunisation. Medical history included ongoing type 2 diabetes mellitus, Diagnosed five years ago Type 2. There were no concomitant medications. It was reported that, Patient experienced side effects 5 days later after the third dose, the booster, of the Pfizer COVID-19 Vaccine, the patient experienced patient experienced side effects 5 days later after the third on 17Aug2021 with outcome of unknown, tiredness/severe tiredness and fatigue, feeling wiped out on 24Aug2021 16:00 with outcome of recovering. The patient underwent lab tests and procedures which included sars-cov-2 test negative on. Spoke from press release from 25Aug2021 "PFIZER AND BIONTECH INITIATE ROLLING SUBMISSION OF SUPPLEMENTAL BIOLOGICS LICENSE APPLICATION TO U.S. FDA FOR BOOSTER DOSE OF COMIRNATY® IN INDIVIDUALS 16 AND OLDER" The reactogenicity profile within seven days after the booster (third) dose was typically mild to moderate. The most common events included injection site pain, fatigue, headache, muscle and joint pain, and chills. The frequency of any severe systemic event after the booster dose was low. The frequency of reactogenicity was similar to or better than after dose two of the primary series. The adverse event profile was generally consistent with other clinical data for COMIRNATY Follow up(25Aug2021): This is a follow up spontaneous report from a contactable consumer reported information included. Follow-Up (02Sep2021): Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac disorder, Injury
Clinical narrative: She's seen serious injuries occur following receipt of the covid vaccine/knows of a 30 year old who now has a heart condition; She's seen serious injuries occur following receipt of the covid vaccine/knows of a 30 year old who now has a heart condition; This is a spontaneous report from a non-contactable Other HCP from a Pfizer sponsored program. A 30-years-old patient of unspecified gender received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On unspecified date, the patient experienced and states that she's seen serious injuries occur following receipt of the covid vaccine and reported that the knows of a 30-year-old who now had a heart condition and was denied help by Pfizer. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Myalgia, Nausea
Clinical narrative: headaches.; Nausea; chills; joint pain; muscle pain; This is a spontaneous report from a non-contactable consumer (patient) via Regulatory Authority Reporting Solution. A 33-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 27Aug2021 17:00 (lot number: FC3184; expiry date: unknown) at the age of 33-years-old as dose 2, single for COVID-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), in left arm for COVID-19 immunisation. The patient did not receive other vaccines in four weeks. The patient was not diagnosed with Covid-19 prior vaccination. On 28Aug2021, at 17:00, the patient experienced nausea, chills, joint pain, muscle pain, and headaches. The patient did not receive treatment for the events. The patient was recovering from the events. The patient has not been tested for Covid-19 post vaccination.   No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pruritus, Rash, SARS-CoV-2 test
Clinical narrative: 2 days after vaccination all body skin rush and itching. Over time got less and less but still coming in patches on knee arm hand and feet.; 2 days after vaccination all body skin rush and itching. Over time got less and less but still coming in patches on knee arm hand and feet; 2 days after vaccination all body skin rush and itching. Over time got less and less but still coming in patches on knee arm hand and feet; Dose 1 administration date: 28Jan2021 + Dose 2 administration date: 28Jan2021; This is a spontaneous report from a contactable consumer. This 73-Year-old female consumer (Patient) reported. A 73-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL 8982), via an unspecified route of administration, administered in Left arm on 28Jan2021 14:00 (70-year-old at the time of vaccination) as dose 1, single and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN 6201), via an unspecified route of administration, administered in Left arm on 28Jan2021 as dose 2, single for covid-19 immunisation. The patient medical history included elevated blood pressure from an unknown date and unknown if ongoing. The patient concomitant medications included amlodipine (AMLODIPINE) taken for an unspecified indication, start and stop date were not reported. There was no vaccine administered in four weeks. There was no COVID prior the vaccination. The patient had no known allergies. The covid was tested post vaccination. On 20Feb2021 22:00, 2 days after vaccination all body skin rush and itching (over time got less and less but still coming in patches on knee arm hand and feet). The patient received treatment Antihistamine / Allergy Relief. The patient underwent lab tests and procedures which included sars-cov-2 test (Covid test name post vaccination=PCR) which was negative, on 09Aug2021. The outcome of events body skin rush and itching (over time got less and less but still coming in patches on knee arm hand and feet) were resolving.  Follow-up attempts are completed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Arthralgia, Fatigue, Feeling abnormal, Inflammation
Clinical narrative: weekly I get 2 days that may be functional and able to follow through with planned commitments; Raging inflammation throughout my body; throat collapses onto itself preventing me from exhaling; throat collapses onto itself preventing me from exhaling; muscles and joint pains that vary in location of my body from day to day thus being difficult to explain to a physician; muscles and joint pains that vary in location of my body from day to day thus being difficult to explain to a physician; Chronic fatigue; memory loss; brain fog; This is a spontaneous report from a contactable consumer (patient). A 62-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: Ew0150) via an unspecified route of administration, administered in Arm Right on 12Apr2021 12:45 (at the age of 62 years old) as dose 2, single for COVID-19 immunisation at Public Health Clinic. Medical history included benign essential blephrospasms from an unknown date and unknown if ongoing, drug allergy (Known allergies: Yes). Concomitant medication taken within two weeks included cyanocobalamin (VIT B12), colecalciferol (D3), magnesium (MAGNESIUM), all taken for an unspecified indication, start and stop date were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: En6207) via an unspecified route of administration, administered in Arm Right on 15Mar2021 (at the age of 62 years old) as single for COVID-19 immunisation. Patient did not received other vaccine within four weeks of COVID vaccine. Patient did not have COVID prior to vaccination. The patient experienced raging inflammation throughout my body, throat collapses onto itself preventing me from exhaling, muscles and joint pains that vary in location of my body from day to day thus being difficult to explain to a physician, chronic fatigue, memory loss, brain fog on 15Apr2021, weekly i get 2 days that may be functional and able to follow through with planned commitments on an unspecified date. Adverse event reported as, Raging inflammation throughout my body - throat collapses onto itself preventing me from exhaling - multiple muscles and joint pains that vary in location of my body from day to day thus being difficult to explain to a physician - Chronic fatigue - memory loss - brain fog - weekly I get 2 days that may be functional and able to follow through with planned commitments. Adverse event resulted in doctor or other healthcare professional office/clinic visit. Patient did not tested for COVID post vaccination. Outcome of all the events were not resolved.  Follow-up attempts are completed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Movement disorder, Myalgia, Oropharyngeal discomfort, Throat tightness
Clinical narrative: weekly I get 2 days that may be functional and able to follow through with planned commitments; Raging inflammation throughout my body; throat collapses onto itself preventing me from exhaling; throat collapses onto itself preventing me from exhaling; muscles and joint pains that vary in location of my body from day to day thus being difficult to explain to a physician; muscles and joint pains that vary in location of my body from day to day thus being difficult to explain to a physician; Chronic fatigue; memory loss; brain fog; This is a spontaneous report from a contactable consumer (patient). A 62-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: Ew0150) via an unspecified route of administration, administered in Arm Right on 12Apr2021 12:45 (at the age of 62 years old) as dose 2, single for COVID-19 immunisation at Public Health Clinic. Medical history included benign essential blephrospasms from an unknown date and unknown if ongoing, drug allergy (Known allergies: Yes). Concomitant medication taken within two weeks included cyanocobalamin (VIT B12), colecalciferol (D3), magnesium (MAGNESIUM), all taken for an unspecified indication, start and stop date were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: En6207) via an unspecified route of administration, administered in Arm Right on 15Mar2021 (at the age of 62 years old) as single for COVID-19 immunisation. Patient did not received other vaccine within four weeks of COVID vaccine. Patient did not have COVID prior to vaccination. The patient experienced raging inflammation throughout my body, throat collapses onto itself preventing me from exhaling, muscles and joint pains that vary in location of my body from day to day thus being difficult to explain to a physician, chronic fatigue, memory loss, brain fog on 15Apr2021, weekly i get 2 days that may be functional and able to follow through with planned commitments on an unspecified date. Adverse event reported as, Raging inflammation throughout my body - throat collapses onto itself preventing me from exhaling - multiple muscles and joint pains that vary in location of my body from day to day thus being difficult to explain to a physician - Chronic fatigue - memory loss - brain fog - weekly I get 2 days that may be functional and able to follow through with planned commitments. Adverse event resulted in doctor or other healthcare professional office/clinic visit. Patient did not tested for COVID post vaccination. Outcome of all the events were not resolved.  Follow-up attempts are completed. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site discolouration
Clinical narrative: arm is sore, the injection site there was like a black, and when rubbed my arm a purple fluid came out of the injection site and kept paper towel turned pink and kind of blue; very unusual very weird; arm is sore, the injection site there was like a black, and when rubbed my arm a purple fluid came out of the injection site and kept paper towel turned pink and kind of blue; very unusual very weird; This is a spontaneous report from a contactable consumer (patient)or other non hcp.  A 72-years-old female patient received (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in Arm Right on 31Aug2021 (at the age of 72-years-old) as dose 1, single for COVID-19 immunization. No medical history was reported. The patient's concomitant medications were not reported. No prior vaccination (within four weeks). On 31Aug2021, the patient experienced arm is sore, the patient was having different things going on with it and everything like that, but then on Saturday, the 01Sep2021, the injection site was like a black, and when rubbed my arm a purple fluid came out of the injection site and kept paper towel turned pink and kind of blue; very unusual very weird. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Dysmenorrhoea, Pain in extremity, Postmenopausal haemorrhage
Clinical narrative: menstrual cycle with cramps/have not had a menstrual cycle in about a year; menstrual cycle with cramps; severe back pain with it that is shooting down my leg; severe back pain with it that is shooting down my leg; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: FC3182), via an unspecified route of administration in the left arm on 10Sep2021 at 18:30 (at the age of 46-year-old), dose 2, single for COVID-19 immunisation. Medical history included staying tired but expected on that, going through menopause and have not had a menstrual cycle in about a year. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) and sertraline. The patient had no known allergies. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: FC3181) administered via an unspecified route of administration in the left arm on 16Aug2021 at 15:00 (at the age of 46-year-old), dose 1, single for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19, did not receive other vaccines four weeks prior. The patient was not pregnant at the time of vaccination. On 11Sep2021 at 08:00, the patient had menstrual cycle with extreme cramps. The patient stated she was going through menopause and have not had a menstrual cycle in about a year. The patient also had severe back pain with it that was shooting down her leg. No treatment was received for the events. The patient had not been tested for COVID-19 since vaccination. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Painful left arm, particularly when lying down; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: ER8733), via an unspecified route of administration in the left arm on 15Apr2021 at 11:30 (at the age of 59-year-old), dose 2, single for COVID-19 immunisation. Medical history included tongue cancer in Aug2017 (successfully treated with surgery), hypertension, high cholesterol, arthritis, known allergy/sensitive to NSAIDs (cannot take them). Concomitant medications included fluoxetine; chlorthalidone; pravastatin; esomeprazole sodium (NEXIUM). Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6206) administered via an unspecified route of administration in the left arm on 18Mar2021 at 11:15 (at the age of 59-year-old), dose 1, single for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19, did not receive other vaccines four weeks prior. The patient was not pregnant at the time of vaccination. On 15Apr2021 at 20:00, the patient had painful left arm, particularly when lying down. No apparent bruising, no muscle strain. The event started after second dose in Apr2021 and has lasted through 12Sep2021. The patient took Tylenol for the event. The patient had not been tested for COVID-19 since vaccination. The outcome of the event was not recovered.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Loss of consciousness, Muscle rigidity, Musculoskeletal stiffness, Near death experience
Clinical narrative: unconscious; I was almost dying; become extremely stiff; become extremely red; rigid; shaking; I was extremely pale; This is a spontaneous report from a contactable consumer reported for himself. A 19-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 12Sep2021 11:15 AM (Batch/Lot number was not reported) (at the age of 19-years-old) as DOSE 1, SINGLE for covid-19 immunisation.  Medical history included covid-19 from an unknown date, the patient got covid prior vaccination. There were no Known allergies. There were no concomitant medications. There were no other medications in two weeks. There was no other vaccine in four weeks. The patient stated as soon as he got the shot on 12Sep2021 11:15 AM he immediately became unconscious. Not even the slow beginning to faint. His mother said as soon as he pushed the plunger his eyes rolled back and he fell forward out of his chair. After about a minute, according to his mom and the (Name) pharmacist, he started to become extremely stiff and started to become extremely red and rigid, and started shaking according to the pharmacist and his mother. He felt like he was almost dying. He had problems with needles as a kid. But this was nothing to do with anxiety or feeling anxious. He felt completely calm going into the shot. After he woke up he was extremely pale. And had to sit for a prolonged time until he could walk. The patient did not get covid tested post vaccination. There was no treatment received for the events. The outcome of the events was resolving.   The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow-up.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Pallor, Tremor
Clinical narrative: unconscious; I was almost dying; become extremely stiff; become extremely red; rigid; shaking; I was extremely pale; This is a spontaneous report from a contactable consumer reported for himself. A 19-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 12Sep2021 11:15 AM (Batch/Lot number was not reported) (at the age of 19-years-old) as DOSE 1, SINGLE for covid-19 immunisation.  Medical history included covid-19 from an unknown date, the patient got covid prior vaccination. There were no Known allergies. There were no concomitant medications. There were no other medications in two weeks. There was no other vaccine in four weeks. The patient stated as soon as he got the shot on 12Sep2021 11:15 AM he immediately became unconscious. Not even the slow beginning to faint. His mother said as soon as he pushed the plunger his eyes rolled back and he fell forward out of his chair. After about a minute, according to his mom and the (Name) pharmacist, he started to become extremely stiff and started to become extremely red and rigid, and started shaking according to the pharmacist and his mother. He felt like he was almost dying. He had problems with needles as a kid. But this was nothing to do with anxiety or feeling anxious. He felt completely calm going into the shot. After he woke up he was extremely pale. And had to sit for a prolonged time until he could walk. The patient did not get covid tested post vaccination. There was no treatment received for the events. The outcome of the events was resolving.   The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow-up.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Tinnitus
Clinical narrative: Worsening tinnitus; This is a spontaneous report from a non-contactable consumer (patient). A 53-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EW0176), via an unspecified route of administration on Feb2021 (at the age of 53-years-old) at dose 1, single in the left arm for COVID-19 immunisation. The patient's medical history and concomitant medications were reported as none. The patient has no other vaccines received within four weeks and no other medications received within two weeks. The patient had no COVID-19 infection prior to vaccination. The patient has no known allergies. The patient was tested for COVID-19 post-vaccination. On Apr2021, the patient experienced worsening tinnitus. The event resulted in doctor or other healthcare professional office/clinic visit (physician office visit). The event is serious due to disability or permanent damage. No treatment was given for the event. On Sep2021, the patient underwent COVID-19 Nasal Swab Test with negative result. Outcome of the event was not recovered.   No follow-up attempts are possible. No further information is expected.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Investigation, SARS-CoV-2 antibody test, SARS-CoV-2 test
Clinical narrative: elevated heart rate/highest was 210; This is a spontaneous report from a contactable consumer (patient).  A 15-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), (Batch/Lot Number: FA6780), via an unspecified route of administration, administered in Arm Right on 12Jun2021 09:00 at the age of 15-years-old as single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination.  Medical history included Covid-19. Concomitant medications included ascorbic acid, rosa canina fruit (VITAMIN C & ROSEHIP) taken for an unspecified indication, start and stop date were not reported; tazarotene (FABIOR) taken for an unspecified indication, start and stop date were not reported. The patient experienced elevated heart rate/highest was 210 on 02Jul2021 with outcome of recovering. The patient underwent lab tests post vaccination which included sars-cov-2 antibody test: negative and sars-cov-2 nasal swab test: negative on unknown date. Therapeutic measures were taken because of the event: cardiology work-up/testing.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101197640 Same reporter/, same patient, different dose of vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Post-traumatic stress disorder
Clinical narrative: PTSD and anxiety; This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, as a single dose, for covid-19 immunisation. Medical history and concomitant medications were not reported.  The patient reported that she has "PTSD and anxiety from getting this because now I definitely need a doctor, not an emergency room." The outcome of the event was not reported.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Inappropriate schedule of product administration, Rash papular, SARS-CoV-2 antibody test
Clinical narrative: elevated heart rate; broke out into a raised rash on shoulders, back and buttocks; the patient received the first dose of vaccine on 12Jun2021 and the second dose on 28Aug2021; This is a spontaneous report from a contactable consumer (patient).  A 15-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), (Batch/Lot Number: FD8498), via an unspecified route of administration, administered in Arm Right on 28Aug2021 at the age of 15-years-old as single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient had received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), (Batch/Lot Number: FA6780), via an unspecified route of administration, administered in Arm Right on 12Jun2021 09:00 at the age of 15-years-old and she had experienced hearth rate elevated. Medical history included Covid-19. Concomitant medications included ascorbic acid, rosa canina fruit (VITAMIN C & ROSEHIP) taken for an unspecified indication, start and stop date were not reported; tazarotene (FABIOR) taken for an unspecified indication, start and stop date were not reported. The patient experienced elevated heart rate/highest was 214 and broke out into a raised rash on shoulders, back and buttocks on Sep2021 with outcome of recovering. The patient underwent lab tests post vaccination which included sars-cov-2 antibody test: negative and sars-cov-2 nasal swab test: negative on unknown date. Therapeutic measures were taken because of the events: received prescription for steroid.   Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101197093 Same reporter/, same patient, different dose of vaccine.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: elevated heart rate; broke out into a raised rash on shoulders, back and buttocks; the patient received the first dose of vaccine on 12Jun2021 and the second dose on 28Aug2021; This is a spontaneous report from a contactable consumer (patient).  A 15-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), (Batch/Lot Number: FD8498), via an unspecified route of administration, administered in Arm Right on 28Aug2021 at the age of 15-years-old as single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient had received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), (Batch/Lot Number: FA6780), via an unspecified route of administration, administered in Arm Right on 12Jun2021 09:00 at the age of 15-years-old and she had experienced hearth rate elevated. Medical history included Covid-19. Concomitant medications included ascorbic acid, rosa canina fruit (VITAMIN C & ROSEHIP) taken for an unspecified indication, start and stop date were not reported; tazarotene (FABIOR) taken for an unspecified indication, start and stop date were not reported. The patient experienced elevated heart rate/highest was 214 and broke out into a raised rash on shoulders, back and buttocks on Sep2021 with outcome of recovering. The patient underwent lab tests post vaccination which included sars-cov-2 antibody test: negative and sars-cov-2 nasal swab test: negative on unknown date. Therapeutic measures were taken because of the events: received prescription for steroid.   Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101197093 Same reporter/, same patient, different dose of vaccine.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Deafness unilateral, Dizziness, Tinnitus
Clinical narrative: Loss of hearing in Right ear with constant ringing.; Loss of hearing in Right ear with constant ringing.; Dizzinessd and lightheadedness; elevated BP.; This is a spontaneous report from a contactable healthcare professional reporting for herself.  A 60-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number FF2588) on 04Sep2021 at 14:00, at the age of 60 years, as the first single dose, in left arm, for COVID-19 immunisation. Medical history included mitral valve prolapse. The patient did not have COVID prior vaccination. Concomitant medications were none (no other vaccines were administered in 4 weeks and no other medications were administered in 2 weeks). On 04Sep2021 at 14:30 the patient experienced loss of hearing in right ear with constant ringing, dizziness and lightheadedness with elevated BP. The events resulted in Doctor or other healthcare professional office/clinic visit and required treatment (flushed ear and told to go to ENT/take Advil). COVID was not tested post vaccination. The events had not yet resolved.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Deafness unilateral  cannot be totally excluded.The impact of this report 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: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Heavy menstrual bleeding, Postmenopausal haemorrhage
Clinical narrative: was completely in menopause and 2 days after the first shot I started my period heavy for 10 days; was completely in menopause and 2 days after the first shot I started my period heavy for 10 days; diarrhea(liquid); This is a spontaneous report from a contactable consumer (patient).  A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE),  via an unspecified route of administration, administered in left arm on 11Aug2021 12:00 (Batch/Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included menopause and COVID-19 (COVID prior vaccination) on unspecified dates.  The patient was not pregnant at the time of vaccination and no other vaccine was received in four weeks. There were no concomitant medications. The patient previously took amoxicillin and experienced allergies. On 13Aug2021, the patient experienced was completely in menopause and 2 days after the first shot  she started her period heavy for 10 days  (medically significant). On unspecified date in 20201, the patient also had diarrhea (liquid) (medically significant) for three weeks after the first shot.  There were no treatments for the events. Patient had not tested for COVID post vaccination. The outcome of the events completely in menopause and 2 days after the first shot I started my period heavy for 10 days was recovered on 23Aug2021 while diarrhea (liquid) was recovered unspecified date in 2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: I had a breakthrough case of Covid-19. I was exposed on Sunday 05Sep2021 and noticeable symptoms began on Wednesday 08Sep2021.; I had a breakthrough case of Covid-19. I was exposed on Sunday 05Sep2021 and noticeable symptoms began on Wednesday 08Sep2021.; This is a spontaneous report from a contactable consumer. A 32-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: ER8736), via an unspecified route of administration, administered in left arm as dose 2, single on 21Apr2021 (at the age of 31-year-old) for covid-19 immunisation and first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EP7533), via an unspecified route of administration, administered in left arm as dose 1, single on 30Mar2021 (at the age of 31-year-old) for covid-19 immunisation. Facility type vaccine was Pharmacy or Drug Store. Medical history included attention deficit hyperactivity disorder (ADHD), depression, seasonal allergies all from an unknown date and unknown if ongoing and no known allergies. Concomitant medications included cetirizine hydrochloride (ZYRTEC); fluticasone propionate (FLONASE) and bupropion hydrochloride (WELLBUTRIN) at 300 mg all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and received other medications within 2 weeks: wellbutrin XR 300mg, Zyrtec (OTC) and Flonase. Patient was not pregnant at the time of vaccination. As reported, the patient had a breakthrough case of Covid-19 and was exposed on 05Sep2021 (at the time of the report on Sunday) with noticeable symptoms began on 08Sep2021 (at the time of the report on Wednesday). Symptoms included nasal congestion, sinus pressure, mild chest congestion, and aches in the neck and shoulders. All the adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included SARS-COV-2 test: via Nasal Swab (Rapid Antigen Test) resulted positive on 10Sep2021. Therapeutic measures were taken as a result of OTC nasal and chest decongestants. At the time of this report, the outcome of all events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Blood pressure increased, Blood pressure measurement, C-reactive protein increased, Dizziness
Clinical narrative: dizziness; severe musculoskeletal pain, especially upper and lower back pain; Arthritis in wrists, hands and feet; Severe inflammatory and auto-immune response; 20-point rise in Blood pressure; CRP is 6.7 (normal is under 3); This is a spontaneous report from a contactable Other Health Professional (patient). A 79-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 10Mar2021 09:00 (Batch/Lot Number: EN6200) as single dose for COVID-19 immunisation (Age at vaccination was 79-year-old). Medical history included HLaB27 gene and known allergies. Patient was not pregnant. Concomitant medication included other medication in two weeks. Historical vaccine included 1st dose of BNT162B2 on 15Feb2021 at 09:00 am (lot number: EM9809) on left arm for Covid-19 immunization at age of 79-year-old. Patient did not experience COVID prior vaccination. Patient experienced one month of dizziness (first month). 6 months to date of severe musculoskeletal pain, especially upper and lower back pain. Arthritis in wrists, hands and feet. Severe inflammatory and auto-immune response. CRP was 6.7 (normal was under 3). 20-point rise in blood pressure. At this point all symptoms appear chronic. Adverse event start date: 12Mar2021. Adverse event start time: 12:00 am. Adverse event resulted in doctor or other healthcare professional office/clinic visit. Patient received treatment included occupational therapy. COVID tested post vaccination PCR: negative on 20Jul2021. Patient was not recovered from the events. This case was reported as serious with seriousness criteria: disability.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Musculoskeletal pain, SARS-CoV-2 test
Clinical narrative: dizziness; severe musculoskeletal pain, especially upper and lower back pain; Arthritis in wrists, hands and feet; Severe inflammatory and auto-immune response; 20-point rise in Blood pressure; CRP is 6.7 (normal is under 3); This is a spontaneous report from a contactable Other Health Professional (patient). A 79-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 10Mar2021 09:00 (Batch/Lot Number: EN6200) as single dose for COVID-19 immunisation (Age at vaccination was 79-year-old). Medical history included HLaB27 gene and known allergies. Patient was not pregnant. Concomitant medication included other medication in two weeks. Historical vaccine included 1st dose of BNT162B2 on 15Feb2021 at 09:00 am (lot number: EM9809) on left arm for Covid-19 immunization at age of 79-year-old. Patient did not experience COVID prior vaccination. Patient experienced one month of dizziness (first month). 6 months to date of severe musculoskeletal pain, especially upper and lower back pain. Arthritis in wrists, hands and feet. Severe inflammatory and auto-immune response. CRP was 6.7 (normal was under 3). 20-point rise in blood pressure. At this point all symptoms appear chronic. Adverse event start date: 12Mar2021. Adverse event start time: 12:00 am. Adverse event resulted in doctor or other healthcare professional office/clinic visit. Patient received treatment included occupational therapy. COVID tested post vaccination PCR: negative on 20Jul2021. Patient was not recovered from the events. This case was reported as serious with seriousness criteria: disability.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Malaise, SARS-CoV-2 test
Clinical narrative: Tested positive for covid on Friday 10Sep; Tested positive for covid on Friday 10Sep; 12-13 days after the vaccine the caller felt sick; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported)  via an unspecified route of administration on 27Aug2021 as dose 1, single for COVID-19 immunisation. The patient medical history  and concomitant medications were not reported. It was reported that the patient received her first dose of the Pfizer covid vaccine on 27Aug and 12-13 days after the vaccine the patient felt sick and tested positive for covid on Friday 10Sep. The caller has stated that she can't find anything online to support her argument about the 10-13 days and she doesn't want to sound like an idiot while trying to support something or someone and also she wanted to know when someone gets their first COVID shot how long afterwards can they expect to experience possible side effects, could it be 10-13 days and then the patient has tested positive for COVID. The patient stated that she wanted to know if its normal to still be feeling the side effects of the vaccine after this long. Outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid positive after the first dose in Mar2021; Covid positive after the first dose in Mar2021; This is a spontaneous report from a contactable consumer (patient) Medical information team. A female patient of an unspecified age received bnt162b2 (Comirnaty, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date in Mar2021 as dose 1, single and bnt162b2 (Comirnaty, Solution for injection) via an unspecified route of administration on an unspecified date in Apr2021 as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient was covid positive, after the first dose. Patient wanted to know if there was a certain time frame that she needs to wait to get a 3rd dose of the Comirnaty vaccine. Response received that 3rd dose was recommended for those with certain types of immune compromise and referred her to speak with her HCP. The patient underwent lab tests and procedures which included sars-cov-2 test result was positive on an unspecified date in 2021. Outcome of the events were unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Blood creatinine, Blood creatinine increased, Renal pain
Clinical narrative: pain near kidneys.; showing 1.06 high creatinine levels.; This is a spontaneous report from a contactable consumer or other non hcp. A 53-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in Arm Right on 08Mar2021 (at the age of 53-years-old) (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation.  Medical history included hashimoto disease. Concomitant medications included thyroid (ARMOUR THYROID); and hydroxychloroquine sulfate (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]). On 12Mar2021, the patient experienced pain near kidneys, showing 1.06 high creatinine levels. The patient did not receive treatment for the events. The events were assessed as serious (medically significant). The patient underwent lab tests and procedures which included blood creatinine: 1.06 on 12Mar2021 High  bloodwork was done on 12Mar2021  showing 1.06 high creatinine levels , blood creatinine: 1.06 on 28Apr2021 High , blood creatinine: 1.03 on 06May2021 High , blood creatinine: 1.16 on 19May2021 High , blood creatinine: 1.10 on 05Aug2021 High, blood creatinine: 1.13 on 16Aug2021 High , blood creatinine: 1.29 on 08Sep2021 High. The outcome of the events was not recovered. The patient did not have COVID prior vaccination, and was not covid tested post vaccination.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.