chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: diagnosed with SARS COV-2; he started feeling really ill; his fever at its highest was 101.6 degrees Fahrenheit; lingering cough; This is a spontaneous report from a contactable consumer(patient) or other non hcp. A 54-year-old male patient received bnt162b2 (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 24Aug2021(at the age of 54-year) as DOSE 1, SINGLE for COVID-19 immunisation. The patient had no medical history, and no concomitant medications were reported. Reporter states, the patient was diagnosed with COVID on 04Sep2021 after he had symptoms the day before, where he started feeling really ill on 03Sep2021. He says his wife's diagnosis was when she had surgery, within two days she had COVID and he has been taking care of her at home. He says two days after he was taking care of her he started feeling ill so he went Saturday and it was positive when they did the COVID nose swab test. Caller said that they gave him monoclonal antibodies last Monday. He said he has also treated the COVID, they gave him a nose spray but he was not sure what that is called, and he was taking a zinc supplement, and he takes Quercetin 800mg capsules three times a day, and a vitamin pack, and Tylenol to help keep fever down. The patient said his fever at its highest was 101.6 degrees Fahrenheit. He said his Tylenol dosage was the Quick Gels, he takes 400mg at a whack, he does not have the bottle with him but he thinks it is 200mg a piece, and he takes two each time, usually one in the morning and one at night before bed. The patient said he takes Zinc one a time day, Zinc dose unknown. The patient said he feels better now, there were 2-3 days he was getting worried, it seems like a roller coaster ride, but he was much better the last two days, and today is his best day yet. He said his negative test was on 16Sep2021, and the only real symptom he still has was the lingering cough that he has ever so often, and that has eased up a lot on an unknown date in 2021. The patient lab included body temperature: result was 101.6 degrees Fahrenheit on an unspecified date in 2021, COVID nose swab test/COVID test: positive on 04Sep2021 and negative on 16Sep2021. Patient received treatment for all events. On 16Sep2021, the patient recovered from COVID-19 and feeling ill. The event outcome for fever and cough was recovering.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: received the first dose of the Pfizer BioNTech Covid 19 vaccine on 5Sep2021/A week later they both tested positive for Covid; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 42-year-old male patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: UNKNOWN), via an unspecified route of administration on 05Sep2021 (at the age of 42-years-old) as dose 1, single for COVID-19 immunisation. The medical history and concomitant medications of the patient were not reported. On an unspecified date in Sep2021, the patient received the first dose of the pfizer biontech covid 19 vaccine on 5sep2021/a week later they both tested positive for covid. The event resulted in the emergency room visit. The patient was scheduled for second dose on 26Sep2021, could she push back the appointment. Not let them schedule it past 42 days. The Regeneron pharmacist said they had to restart the series. Asked was there any information on how the second dose may feel after having Covid. Will there be an interaction with the antibodies. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date in Sep2021. Therapeutic measures were taken as a result of event that included patient was given Regeneron antibody infusion, to help fight off the virus in the emergency room on 14Sep2021 and was released from the emergency room after the infusion. He had read conflicting information if she should get the vaccine on that date, after having Covid and the Regeneron infusion. The outcome of the event was reported as unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101227463 same reporter/product/event, different patient
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Discomfort, Headache, Insomnia, Palpitations
Clinical narrative: my heart started pounding fast and hard; my upper left head area above eyebrow hurt and pounded; Could not sleep first 2 days; feel heavy and water-bloated throughout my whole body; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: Unknown, Expiration date: Not reported), via an unspecified route of administration in upper right arm on 10Jul2021 at 15:00 (at the age of 53-years-old) as dose 1, single for COVID-19 immunization. There was no patient's other medical history reported. There were no known allergies reported. The patient's concomitant medications were not reported. No other vaccine was received by the patient within 4 weeks prior to COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and post vaccination, the patient had not been tested for COVID-19. A couple of hours after the vaccination on 10Jul2021 at 18:00, the patient's heart started pounding fast and hard and upper left head area above the eyebrow was hurt and pounded. The patient could not sleep for the first 2 days, pounded hard and fast on and off during the day for 8 days and the patient feels heavy and water-bloated throughout her whole body and went in to an emergency room (ER) for a few blood tests but showed up nothing. Patient was still concerned about her events. No treatment was received by the patient for these events. The outcome of insomnia was recovered on 12Jul2021 while the other events was not recovered at the time of report.   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: Arthralgia, Autoimmune disorder, Deafness, Nodule, Rheumatoid arthritis
Clinical narrative: Have Rheumatoid arthritis, have had a very bad flare since first of Apr2021.; joint pain; nodules on both hands; hearing loss; autoimmune disease; This is a spontaneous report from a contactable consumer (patient). A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiration date were not reported), via an unspecified route of administration in left arm on 02Mar2021 at 01:00 (at the age of 53-years-old) as dose 1, single for COVID-19 immunization in a public health clinic/veterans administration facility. Medical history included rheumatoid arthritis, high blood pressure (BP) and gout. There were no known allergies reported. The patient had unspecified rheumatoid arthritis medications and were stopped 2 weeks prior to the COVID vaccine. There were no concomitant medications. No other vaccines was received by the patient within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and post-vaccination, the patient had not been tested for COVID-19. The patient experienced rheumatoid arthritis which had a very bad flare since 01Apr2021. The patient had joint pain, nodules on both hands which were not present before and had hearing loss due to autoimmune disease in 2021. Patient received steroid treatment via unspecified oral medications and injection for these events which resulted in doctor or other healthcare professional office/clinic visit and disability or permanent damage. The outcome of events was not recovered at the time of report.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Rosacea, Ventricular extrasystoles
Clinical narrative: Premature Ventricular Contractions; rosacea; This is a spontaneous report from a contactable consumer(patient). A 50-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Ew0151) via an unspecified route of administration, administered in arm right on 01Apr2021 (at the age of 50-year-old) as DOSE 2, SINGLE for COVID-19 immunisation. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: unknown) via an unspecified route of administration on an unspecified date (age at vaccination 50-year-old) as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history was not reported. Patient had no known drug allergies. Concomitant medications included measles vaccine, mumps vaccine, rubella vaccine (MMR) taken for an unspecified indication from 2021 to 2021 and cholecalciferol (VITAMIN D) taken for an unspecified indication, start and stop date were not reported. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested post vaccination. On an unspecified date in May2021, the patient experienced premature ventricular contractions and rosacea. It was reported that, premature ventricular contractions starting a few weeks after second vaccination, becoming worst mid-may and nearly gone by July. Also had a new case of rosacea diagnosed around the same time. The adverse events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient did not received treatment for the events. Outcome of the event premature ventricular contractions was recovered on an unspecified date in Jul2021 and other event rosacea was recovered on an unspecified date in 2021.  Follow-up attempts are completed. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Acute kidney injury, Blood creatinine, Blood creatinine increased
Clinical narrative: serum creatinine elevated from previous baseline of 1.8 to 4.0 plus/minus 10 percent; acute kidney injury; This is a spontaneous report from a contactable consumer (patient). A 58-year-old male patient received (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Batch/Lot Number: EN6208) via an unspecified route of administration in right arm on 14Mar2021 at 12:00 (at the age of 58-year-old) as Dose 1,Single and received  (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Batch/Lot Number: ER8733) via an unspecified route of administration, administered in left arm on 04Apr2021 at 12:00 as Dose 2,Single for COVID-19 immunization. The patient's medical history was not reported. The patient previously took levaquin and ACE inhibitors and experienced known drug allergy. Concomitant medications included varicella zoster vaccine rge (cho) (SHINGRIX) taken for an unspecified indication on left arm from Mar2021 to an unspecified stop date; diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) taken for an unspecified indication on right arm from Mar2021 to an unspecified stop date. The patient experienced serum creatinine elevated from previous baseline of 1.8 to 4.0 plus/minus 10 percent and acute kidney injury in Jul2021 (disability). The patient underwent lab tests which included blood creatinine: serum creatinine elevated from previous baseline of 1.8 to 4.0 plus/minus 10 percent in Jul2021. Therapeutic measures were taken as a result of serum creatinine elevated from previous baseline of 1.8 to 4.0 plus/minus 10 percent and acute kidney injury. Outcome of the events not recovered.   No follow-up attempts possible. No further information expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Illness, Tinnitus
Clinical narrative: Headache; Fatigue; Tinnitus; Sick; This is a spontaneous report from a contactable consumer or other Non-HCP.  A 55-years-old male received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 04May2021 at 10:30, administered in right arm (age at the time of vaccination was 55-years-old) as a DOSE 2 , SINGLE dose for COVID-19 immunization. The patient had Augmentin allergy. The patient had no other medical history. The patient's concomitant medications were not reported. Previously, the patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 14Apr2021 at 10:00, administered in right arm (age at the time of vaccination was 55-years-old) as a DOSE 1 , SINGLE dose for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19 and since or post the vaccination, the patient had not been tested for COVID-19. On 05May2021, the patient experienced Headache, Fatigue, Tinnitus and Sick. The adverse event treatment was visited my primary, then eye doctor, CT Scan. The clinical outcome of the event Fatigue was recovered on an unspecified date in 2021, while the clinical outcome of the events Headache, Tinnitus and Sick was not recovered  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Haemorrhage, Heavy menstrual bleeding, Menstruation irregular
Clinical narrative: Severe bleeding (passing lots of large clots with heaviest bleeding); Menstrual irregularity; Chills; Fatigue; Severe bleeding (passing lots of large clots with heaviest bleeding); This is a spontaneous report from a contactable consumer. This female consumer (patient) reported for herself.  A 24-years-old female patient (pregnant at time of vaccination; unknown) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Batch/Lot Number: FC3181), via an unspecified route of administration, administered in Arm Left on 10Aug2021 at 16:00 pm (24-year-old at the time of vaccination) as dose 1, single for covid-19 immunisation. Medical history included epilepsy from an unknown date and unknown if ongoing. The patient previously took skin lotions and experienced allergies. Concomitant medication included levetiracetam (KEPPRA [LEVETIRACETAM]) (patient received within 2 weeks of vaccination) for unknown indications from unknown dates and unknown if ongoing. The patient had not received any vaccine within four weeks. The patient had no covid prior to vaccination. The patient was not tested since vaccination. On 10Aug2021 22:00, the patient experienced Menstrual irregularity and severe bleeding both after the first and 2nd dose (passing lots of large clots with heaviest bleeding than ever experienced in my life), chills and fatigue. No prolonged hospitalization for the events. No treatment received for the events. The outcome of the events were not recovered.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Chest pain, Dyspnoea, Fatigue, Headache
Clinical narrative: I thought I was having a heart attack; chest pain; shortness of breath; pounding; rapid heart rate; high BP; headache; malaise; fatigue; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 48-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0176), via an unspecified route of administration, administered in Arm Right on 20Aug2021 (at the age of 48-year-old) as dose 2, single for covid-19 immunisation. Medical history included fibromyalgia, cystitis, palpitations (heart palpitations that I take medicine for), Known allergy: sulfa (sulfa). Patient took concomitant medications (other medications the patient received within 2 weeks of vaccination). Patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: FA6780), via an unspecified route of administration, administered in Arm left on 30Jul2021 (at the age of 48-year-old) as dose 1, single for covid-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 23Aug2021 03:00, the patient experienced i thought i was having a heart attack, chest pain, shortness of breath, pounding, rapid heart rate, high bp, headache, malaise, fatigue. The patient underwent lab tests and procedures which included blood pressure measurement: high on 23Aug2021, heart rate: rapid on 23Aug2021, sars-cov-2 test: negative on 23Aug2021 (Post vaccination). Clinical course: Within 48 hours of my second vaccine patient woke up at about 3:00 am with chest pain, shortness of breath, pounding and rapid  heart rate, high BP, headache, malaise, fatigue. Patient husband took her to the ER. Patient thought she was having a heart attack. Therapeutic measures taken as a result of events included steroids. The events resulted in emergency room and physician office visit. The events were reported as non serious. The outcome of the events was unknown.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Hypertension, Malaise, Myocardial infarction
Clinical narrative: I thought I was having a heart attack; chest pain; shortness of breath; pounding; rapid heart rate; high BP; headache; malaise; fatigue; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 48-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0176), via an unspecified route of administration, administered in Arm Right on 20Aug2021 (at the age of 48-year-old) as dose 2, single for covid-19 immunisation. Medical history included fibromyalgia, cystitis, palpitations (heart palpitations that I take medicine for), Known allergy: sulfa (sulfa). Patient took concomitant medications (other medications the patient received within 2 weeks of vaccination). Patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: FA6780), via an unspecified route of administration, administered in Arm left on 30Jul2021 (at the age of 48-year-old) as dose 1, single for covid-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 23Aug2021 03:00, the patient experienced i thought i was having a heart attack, chest pain, shortness of breath, pounding, rapid heart rate, high bp, headache, malaise, fatigue. The patient underwent lab tests and procedures which included blood pressure measurement: high on 23Aug2021, heart rate: rapid on 23Aug2021, sars-cov-2 test: negative on 23Aug2021 (Post vaccination). Clinical course: Within 48 hours of my second vaccine patient woke up at about 3:00 am with chest pain, shortness of breath, pounding and rapid  heart rate, high BP, headache, malaise, fatigue. Patient husband took her to the ER. Patient thought she was having a heart attack. Therapeutic measures taken as a result of events included steroids. The events resulted in emergency room and physician office visit. The events were reported as non serious. The outcome of the events was unknown.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, SARS-CoV-2 test
Clinical narrative: I thought I was having a heart attack; chest pain; shortness of breath; pounding; rapid heart rate; high BP; headache; malaise; fatigue; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 48-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0176), via an unspecified route of administration, administered in Arm Right on 20Aug2021 (at the age of 48-year-old) as dose 2, single for covid-19 immunisation. Medical history included fibromyalgia, cystitis, palpitations (heart palpitations that I take medicine for), Known allergy: sulfa (sulfa). Patient took concomitant medications (other medications the patient received within 2 weeks of vaccination). Patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: FA6780), via an unspecified route of administration, administered in Arm left on 30Jul2021 (at the age of 48-year-old) as dose 1, single for covid-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 23Aug2021 03:00, the patient experienced i thought i was having a heart attack, chest pain, shortness of breath, pounding, rapid heart rate, high bp, headache, malaise, fatigue. The patient underwent lab tests and procedures which included blood pressure measurement: high on 23Aug2021, heart rate: rapid on 23Aug2021, sars-cov-2 test: negative on 23Aug2021 (Post vaccination). Clinical course: Within 48 hours of my second vaccine patient woke up at about 3:00 am with chest pain, shortness of breath, pounding and rapid  heart rate, high BP, headache, malaise, fatigue. Patient husband took her to the ER. Patient thought she was having a heart attack. Therapeutic measures taken as a result of events included steroids. The events resulted in emergency room and physician office visit. The events were reported as non serious. The outcome of the events was unknown.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Nodule, Pulmonary mass, SARS-CoV-2 test
Clinical narrative: Multiple nodules found in my lungs and clavicle(s); Multiple nodules found in my lungs and clavicle(s); first dose on 23Jun2021 and second dose on 23Jun2021; This is a spontaneous report from a contactable consumer (patient) reporting for himself. A 33-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0181), via an unspecified route of administration, administered in Right arm on 23Jun2021 15:00 at the age of 33-years-old as dose 1, single and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0177), via an unspecified route of administration, administered in Left arm on 23Jun2021 at the age of 33-years-old as dose 2, single for covid-19 immunisation. Medical history included asthma from an unknown date, known allergies to shellfish from an unknown date. Concomitant medications included vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]) taken for an unspecified indication, vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]) taken for an unspecified indication and zinc (ZINC) taken for an unspecified indication from unspecified date received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has been tested for COVID-19 since the vaccination. Device Date: 18Sep2021. On 26Aug2021 at 12:00, the patient experienced Multiple nodules found in his lungs and clavicle(s). Adverse events resulted in Doctor or other healthcare professional office/clinic visit. No treatment was received for adverse events. The patient underwent lab tests and procedures which included COVID 19 test (sars-cov-2 test) (Nasal Swab): negative on 26Aug2021. The case was reported as non-serious with no seriousness criteria of resulting in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect. The outcome of events was unknown.  Follow-Up (21Sep2021): Follow-up attempts are completed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Dizziness, Fatigue, Inappropriate schedule of product administration, Insomnia
Clinical narrative: Chronic fatigue; trouble sleeping; dizziness; nausea; Symptoms seem to getting worse; Dose 1 on 28Jun2021 06:45PM and Dose 2 on 28Jun2021; This is a spontaneous report from a contactable consumer or other non hcp. A 40-years-old female patient received bnt162b2 (PFIZER BIONTECH, Solution for Injection,Batch/Lot Number: EW0196) via an unspecified route of administration, administered in Arm Left on 28Jun2021 at 18:45 (at the age of 40-year-old)  as Dose 1,Single and received bnt162b2 (PFIZER BIONTECH, Solution for Injection,Batch/Lot Number: CA6780) via an unspecified route of administration, administered in Arm Left on 28Jun2021 as Dose 2,Single for COVID-19 immunization. The patient's medical history included none from an unknown date and unknown if ongoing. There were no concomitant medications. No other vaccines received within 4 weeks prior to the COVID vaccine.No other medications the patient received within 2 weeks of vaccination.On 02Jun2021, the patient experienced chronic fatigue, trouble sleeping, dizziness, nausea symptoms seem to getting worse. Vaccination occurred in inappropriate schedule. Treatment for the adverse events included Prednisone/Atarax. The outcome of the events was not recovered.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Chronic fatigue; trouble sleeping; dizziness; nausea; Symptoms seem to getting worse; Dose 1 on 28Jun2021 06:45PM and Dose 2 on 28Jun2021; This is a spontaneous report from a contactable consumer or other non hcp. A 40-years-old female patient received bnt162b2 (PFIZER BIONTECH, Solution for Injection,Batch/Lot Number: EW0196) via an unspecified route of administration, administered in Arm Left on 28Jun2021 at 18:45 (at the age of 40-year-old)  as Dose 1,Single and received bnt162b2 (PFIZER BIONTECH, Solution for Injection,Batch/Lot Number: CA6780) via an unspecified route of administration, administered in Arm Left on 28Jun2021 as Dose 2,Single for COVID-19 immunization. The patient's medical history included none from an unknown date and unknown if ongoing. There were no concomitant medications. No other vaccines received within 4 weeks prior to the COVID vaccine.No other medications the patient received within 2 weeks of vaccination.On 02Jun2021, the patient experienced chronic fatigue, trouble sleeping, dizziness, nausea symptoms seem to getting worse. Vaccination occurred in inappropriate schedule. Treatment for the adverse events included Prednisone/Atarax. The outcome of the events was not recovered.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid-19; covid-19; This is a spontaneous report from a contactable Physician via Pfizer sales representative. This Physician reported for a 48-year-old-male patient received a dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EY0572 and expiry date was not reported), via an unspecified route of administration, on 29Jul2021 (age at vaccination: 47 years), as unknown, a single dose for COVID-19 immunization at workplace clinic. The patient's medical history and concomitant medications were not reported. The patient did not have any known allergies. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. On 17Sep2021, the patient experienced Covid-19. Prior to vaccination, the patient was not diagnosed with Covid-19. Since the vaccination, the patient was tested for Covid-19. There was no hospitalization prolonged. The patient did not receive any treatment. The patient underwent lab test and procedure Covid test with Negative result (Other, Covid test name post vaccination: Saliva) on 05Sep2021. Outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.; 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 serious events Drug ineffective and COVID-19 cannot be totally excluded.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Colitis, Computerised tomogram, Gastritis, Intestinal obstruction, Pharyngeal inflammation
Clinical narrative: Blockage in colon; Acute inflammation of colon, rectum, vagina, stomach and throat; Acute inflammation of colon, rectum, vagina, stomach and throat; Acute inflammation of colon, rectum, vagina, stomach and throat; Acute inflammation of colon, rectum, vagina, stomach and throat; Acute inflammation of colon, rectum, vagina, stomach and throat; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 03Jul2021 13:15 (Lot Number: EW0196) as single dose (at the age of 63-years-old) for COVID-19 immunization. The patient's medical history was not reported. The patient was not pregnant. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID prior vaccination. Concomitant medication included metformin. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 11Jun2021 13:15 (Lot Number: EW0196) as single dose (at the age of 63-years-old) for COVID-19 immunization. The patient experienced blockage in colon on 16Aug2021, acute inflammation of colon, rectum, vagina, stomach and throat on 16Aug2021. Events resulted in Doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included computerised tomogram: results unknown on 2021. Therapeutic measures were taken as a result of the events which included Antibiotics. The outcome of the events was recovering. Not tested for COVID post vaccination. The reporter assessed the events as not serious. Facility where the most recent COVID-19 vaccine was administered was in Pharmacy or Drug Store.  Follow-up attempts are completed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Proctitis, Vulvovaginal inflammation
Clinical narrative: Blockage in colon; Acute inflammation of colon, rectum, vagina, stomach and throat; Acute inflammation of colon, rectum, vagina, stomach and throat; Acute inflammation of colon, rectum, vagina, stomach and throat; Acute inflammation of colon, rectum, vagina, stomach and throat; Acute inflammation of colon, rectum, vagina, stomach and throat; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 03Jul2021 13:15 (Lot Number: EW0196) as single dose (at the age of 63-years-old) for COVID-19 immunization. The patient's medical history was not reported. The patient was not pregnant. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID prior vaccination. Concomitant medication included metformin. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 11Jun2021 13:15 (Lot Number: EW0196) as single dose (at the age of 63-years-old) for COVID-19 immunization. The patient experienced blockage in colon on 16Aug2021, acute inflammation of colon, rectum, vagina, stomach and throat on 16Aug2021. Events resulted in Doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included computerised tomogram: results unknown on 2021. Therapeutic measures were taken as a result of the events which included Antibiotics. The outcome of the events was recovering. Not tested for COVID post vaccination. The reporter assessed the events as not serious. Facility where the most recent COVID-19 vaccine was administered was in Pharmacy or Drug Store.  Follow-up attempts are completed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Tinnitus
Clinical narrative: Constant ringing in my ears; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 07Apr2021 13:30 at the age of 48 years old (Lot Number: ER8733) as DOSE 1, SINGLE for COVID-19 immunisation. The patient was not pregnant at time of vaccination. Medical history included achalasia from an unknown date. There were no concomitant medications. The patient stated, "constant ringing in my ears" on 07Apr2021 22:00. The patient has been COVID-9 tested since the vaccination, COVID-19 rapid nasal swab test: unknown on 13Sep2021. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The events resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage.  The outcome of the event was not recovered. Treatment oral appliance received for the event.  Follow-up attempts are completed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Menstrual disorder, SARS-CoV-2 test
Clinical narrative: myself had the virus at the end of Jul; myself had the virus at the end of Jul; menstrual period disappeared /came back again in May and I have not had it ever again; This is a spontaneous report from a contactable pharmacist (patient). A 43-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot/batch number was not reported) via an unspecified route of administration on 27Jan2021 (age at vaccination was 43 years) as dose number unknown, single for covid-19 immunisation. The patient's medical history included diabetes type l. The patient's concomitant medications were not reported. She received Insulin pump within 2 weeks of vaccination. She did not receive any other vaccines within 4 weeks prior to the covid vaccine. After receiving the vaccine, her menstrual period disappeared. She used to have a stable cycle. After the vaccine, it went away for two months, came back again in May and she had not had it ever again on 01Feb2021. There had been no stress related to Covid in her case. She had not stopped working or lost a relative or close friend because of the virus. She herself had the virus at the end of July with no major complications just as her unvaccinated husband and three children. The adverse event resulted into doctor or other healthcare professional office/clinic visit. The patient underwent lab test and procedure included nasal swab (SARS-CoV-2 test) and resulted into positive. She did not receive treatment for adverse events. There were no known allergies. She had not diagnosed for covid-19 prior vaccination and not tested for covid-19 since the vaccination. The outcome of events was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and would be requested during follow up.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, SARS-CoV-2 test
Clinical narrative: Heart palpitations; This is a spontaneous report from a contactable nurse (patient). A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: 9810), via an unspecified route of administration, administered in the left arm on 25Feb2021 (at the age of 38 years old) as dose 2, single for COVID-19 immunization. Medical history included hypothyroidism, obesity, high cholesterol and cholecystectomy, all from an unknown date and unknown if ongoing. The patient is not pregnant. The patient's concomitant medications were not reported. The patient previously took ASA, erythromycin, Keflex, sertraline, ibuprofen and experienced allergies. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: 9264), via an unspecified route of administration, administered in the left arm on an unspecified date (pending clarification; at the age of 38 years old) as dose 1, single for COVID-19 immunization. The patient experienced heart palpitations on 20Mar2021. It was reported that the patient experienced heart palpitations starting in March and continues now to present date. No treatment was received. There was no other vaccine in four weeks. There was no COVID prior vaccination. The patient underwent lab tests and procedures which included Lumira Ag: negative (nasal swab) on 26Aug2021. The outcome of the event was not recovered.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Deafness unilateral, Dizziness, Labyrinthitis, Loss of personal independence in daily activities
Clinical narrative: . He needed help with ADLs, which is currently provided by HHA and family members; Vomiting bile; unable to stand / Imbalance; loss of hearing right ear /Asymmetrical right sensorineural hearing loss; severe vertigo; Labyrinthitis of Right Ear; Dizziness; This is a spontaneous report from a contactable consumer. A 74-year-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 03Feb2021 14:15 (Batch/Lot Number: EN 5318) as DOSE 2,SINGLE (at the age of 74 years) for covid-19 immunisation. Medical history included radical prostatectomy removing prostate cancer, appendectomy, tonsillectomy, type 2 diabetes, adhesive tape and Covid-19 in May2020. Concomitant medications included acetylsalicylic acid (BABY ASPIRIN); losartan potassium (COZAAR); rosuvastatin calcium (CRESTOR); and dulaglutide (TRULICITY), all taken for an unspecified indication, start and stop date were not reported. The patient previously took morphine, codeine and experienced allergy. The patient received the first dose of BNT162b2 (Lot: EL 3248), on an unknown date, given in arm left for Covid-19 immunisation. The patient experienced vomiting bile, unable to stand/ imbalance, loss of hearing right ear /asymmetrical right sensorineural hearing loss, severe vertigo, labyrinthitis of right ear and dizziness on 12Feb2021 at 01:00. It was further reported that patient was transported by an ambulance to emergency department on 12Feb2021, admitted at 11:27AM. Vomiting bile, unable to stand, loss of hearing right ear, severe vertigo. Admitted as inpatient based on ED Disposition Decision. Discharge: 16Feb2021. Referred to rehabilitation, diagnosis was Labyrinthitis of Right Ear, Asymmetrical right sensorineural hearing loss, dizziness, imbalance. As of the date of this report, he have chronic symptoms. He was receiving services of a Home Health Aide(HHA) and require a cane to maintain stability. He needed help with ADLs, which is currently provided by HHA and family members. The patient underwent lab tests and procedures in May2021 which included Covid-19 Antibody positive test via blood test, and on 20Au2021, Covid -19 Antibody, Total Spike was positive (blood test). The outcome of the events was not recovered at the time of the report.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Vertigo, Vomiting
Clinical narrative: . He needed help with ADLs, which is currently provided by HHA and family members; Vomiting bile; unable to stand / Imbalance; loss of hearing right ear /Asymmetrical right sensorineural hearing loss; severe vertigo; Labyrinthitis of Right Ear; Dizziness; This is a spontaneous report from a contactable consumer. A 74-year-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 03Feb2021 14:15 (Batch/Lot Number: EN 5318) as DOSE 2,SINGLE (at the age of 74 years) for covid-19 immunisation. Medical history included radical prostatectomy removing prostate cancer, appendectomy, tonsillectomy, type 2 diabetes, adhesive tape and Covid-19 in May2020. Concomitant medications included acetylsalicylic acid (BABY ASPIRIN); losartan potassium (COZAAR); rosuvastatin calcium (CRESTOR); and dulaglutide (TRULICITY), all taken for an unspecified indication, start and stop date were not reported. The patient previously took morphine, codeine and experienced allergy. The patient received the first dose of BNT162b2 (Lot: EL 3248), on an unknown date, given in arm left for Covid-19 immunisation. The patient experienced vomiting bile, unable to stand/ imbalance, loss of hearing right ear /asymmetrical right sensorineural hearing loss, severe vertigo, labyrinthitis of right ear and dizziness on 12Feb2021 at 01:00. It was further reported that patient was transported by an ambulance to emergency department on 12Feb2021, admitted at 11:27AM. Vomiting bile, unable to stand, loss of hearing right ear, severe vertigo. Admitted as inpatient based on ED Disposition Decision. Discharge: 16Feb2021. Referred to rehabilitation, diagnosis was Labyrinthitis of Right Ear, Asymmetrical right sensorineural hearing loss, dizziness, imbalance. As of the date of this report, he have chronic symptoms. He was receiving services of a Home Health Aide(HHA) and require a cane to maintain stability. He needed help with ADLs, which is currently provided by HHA and family members. The patient underwent lab tests and procedures in May2021 which included Covid-19 Antibody positive test via blood test, and on 20Au2021, Covid -19 Antibody, Total Spike was positive (blood test). The outcome of the events was not recovered at the time of the report.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Dizziness, Hypersensitivity, Muscle spasms, Pain
Clinical narrative: pain and swelling all over my body; pain and swelling all over my body; spinning out of control with the worst dizziness; tingling in my fingers; lump in my throat; burning sensation and cramping that felt like explosions were going off in my joints in my knees, elbows, ankles and under my rib cage; burning sensation and cramping that felt like explosions were going off in my joints in my knees, elbows, ankles and under my rib cage; tingling in my fingers and my tongue; mild allergic reaction; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 51 years old, via an unspecified route of administration, administered in Arm Right on 22Apr2021 17:30 (Batch/Lot Number: EWO153(7/21)) as DOSE 1, SINGLE for COVID-19 immunization in a Pharmacy or Drug Store. Medical history included allergy to many chemicals and have suffered from mercury poisoning, low thyroid and fibromaialgia (over 10 years ago) from an unknown date. There were no concomitant medications. The patient was not pregnant at time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Immediately after receiving the injection on 22Apr2021, at 07:00 PM the patient stated, "I had some tingling in my fingers and my tongue followed by a little bit of a lump in my throat, assumingly a mild allergic reaction but about 2 hours later, I reached down to pet my dog and started spinning out of control with the worst dizziness I have ever had in my life. Called the hospital but they did not have any answers so I just sat still and slept sitting up. The dizziness resided over the next couple days but on about the third day I had pain and swelling all over my body that lasted at least a month followed by another episode of dizziness. I had a burning sensation and cramping that felt like explosions were going off in my joints in my knees, elbows, ankles and under my rib cage. I did not get the second shot and am still only partially vaccinated". The events resulted in doctor or other healthcare professional office/clinic visit. No treatment given for the events. The patient has not been COVID-9 tested since the vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The outcome of events was recovered on unspecified date.  Follow-up attempts are completed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Paraesthesia oral, Pharyngeal mass, Swelling
Clinical narrative: pain and swelling all over my body; pain and swelling all over my body; spinning out of control with the worst dizziness; tingling in my fingers; lump in my throat; burning sensation and cramping that felt like explosions were going off in my joints in my knees, elbows, ankles and under my rib cage; burning sensation and cramping that felt like explosions were going off in my joints in my knees, elbows, ankles and under my rib cage; tingling in my fingers and my tongue; mild allergic reaction; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 51 years old, via an unspecified route of administration, administered in Arm Right on 22Apr2021 17:30 (Batch/Lot Number: EWO153(7/21)) as DOSE 1, SINGLE for COVID-19 immunization in a Pharmacy or Drug Store. Medical history included allergy to many chemicals and have suffered from mercury poisoning, low thyroid and fibromaialgia (over 10 years ago) from an unknown date. There were no concomitant medications. The patient was not pregnant at time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Immediately after receiving the injection on 22Apr2021, at 07:00 PM the patient stated, "I had some tingling in my fingers and my tongue followed by a little bit of a lump in my throat, assumingly a mild allergic reaction but about 2 hours later, I reached down to pet my dog and started spinning out of control with the worst dizziness I have ever had in my life. Called the hospital but they did not have any answers so I just sat still and slept sitting up. The dizziness resided over the next couple days but on about the third day I had pain and swelling all over my body that lasted at least a month followed by another episode of dizziness. I had a burning sensation and cramping that felt like explosions were going off in my joints in my knees, elbows, ankles and under my rib cage. I did not get the second shot and am still only partially vaccinated". The events resulted in doctor or other healthcare professional office/clinic visit. No treatment given for the events. The patient has not been COVID-9 tested since the vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The outcome of events was recovered on unspecified date.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Erectile dysfunction
Clinical narrative: This is a spontaneous report from a non-contactable consumer (patient)   A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced dick was hard on an unspecified date. The outcome was unknown.    Additional Context: The caller saw where the covid 19 vaccines boosters will be on hold and be recalled, is this true? The vaccine has MRNA and it is going to change your DNA, is that correct? The caller stated that this agent doesn't know shit. The caller's mentioned his dick was hard and that this agent wouldn't know what to do.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.