chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Herpes zoster
Clinical narrative: I know of someone else who suddenly got shingles some time after getting vaccinated; I developed a rash with small blisters on my back, on the left shoulder blade close to the spine.; I developed a rash with small blisters on my back, on the left shoulder blade close to the spine.; It's itchy and has a slight burning sensation.; It's itchy and has a slight burning sensation.; This is a spontaneous report from a contactable consumer. This consumer (patient) reported for herself that a 38-years-old female patient received second dose of bnt162b2 (Pfizer-Biontech COVID-19 vaccine, solution for injection, Batch/Lot Number: EP0161), (at the age of 38-years-old) via an unspecified route of administration on 08Apr2021 14:45 left arm as single dose for COVID-19 immunisation. The patient's medical history had chicken pox as a child. She had no known allergies and no other medical history. Concomitant medications were not reported. Patient neither receive any other vaccines within 4 weeks prior to the COVID vaccine nor any other medications within 2 weeks of vaccination. The patient received first dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, Batch/Lot Number: EP7534), via an unspecified route of administration on 18Mar2021 13:00 as historical vaccination on left arm as single dose for COVID-19 immunisation. On 30Apr2021, about a week ago (late Apr), the patient developed a rash with small blisters on my back, on the left shoulder blade close to the spine. It's itchy and has a slight burning sensation. From an online search I believe it's shingles. I'm 38 and never had shingles before. Now it seems that it started to dry out. If needed, I can provide photos of the rash from different stages. Of course, don't know if it is related to the vaccine, but I know of someone else who suddenly got shingles sometime after getting vaccinated, so I thought I'd report it just in case. The patient did not receive any treatment for adverse events. The patient did not test COVID prior to vaccination and post vaccination. The outcome of the events was recovering.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Red bumps that are itchy/started getting worse/has about 20 to 30 areas that exhibit the rash; Red bumps that are itchy/started getting worse/has about 20 to 30 areas that exhibit the rash; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6205; Expiration date was not reported) on the left arm on 08Mar2021 (12:15) as a 2nd dose, single, with route of administration unspecified, for COVID-19 immunization. Medical history included ongoing diabetes mellitus from 2018; bad eye sight; ongoing vasculitis; ongoing abnormal cholesterol; ongoing essential tremor; ongoing prostatomegaly; and ongoing abnormal blood pressure. Concomitant medications included ongoing losartan; ongoing atenolol; azathioprine for vasculitis from 2017 and ongoing; hydroxychloroquine for vasculitis from 2017 and ongoing; sitagliptin (JANUVIA) for blood cholesterol abnormal from May2019 and ongoing; primidone for essential tremor from Apr2020 and ongoing; tamsulosin for prostatomegaly from May2017 and ongoing; ongoing insulin for diabetes mellitus; and ongoing atorvastatin for blood pressure abnormal. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9267; Expiration date was not reported) on 15Feb2021 (when the patient was 72 years old) (11:00) for COVID-19 immunization, and had red bumps that were itchy. On an unspecified date in 2021, after the second dose of vaccination, the patient's itchy red bumps started getting worse. Some of them seem to be going away, but he probably had about 20 to 30 areas that exhibited the rash. The rash itched "like crazy", and the patient has never had itched this bad in his entire life. A week and a half prior to reporting, the patient had started taking diphenhydramine (BENARYL), but it did not seem to make a difference. The outcome of the events was not recovered.  Information on lot/batch number was available. Additional information has been requested.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation delayed
Clinical narrative: Missed period/10th day of late period; This is a spontaneous report received from a contactable consumer (patient). This 39-year-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EW0158) via an unspecified route of administration on 05May2021 at 15:45 (at the age of 39-years-old) and dose 1 of BNT162B2 (lot number EW0151) via an unspecified route of administration on 05May2021 at 16:00 (as reported) as single doses in the left arm for COVID-19 immunization. Medical history included miscarriage in Nov2020 and allergy to cephalosporins. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. Concomitant medications were not reported. On an unspecified date the patient experienced missed period. Today (30May2021) was the tenth day of late period. The patient had a pretty regular menstrual cycle. She had a miscarriage in Nov2020 but not event that affected her cycle. There was zero percent chance of being pregnant again. She had not had sex in months. The patient did not receive any treatment for the event. The outcome of late period was unknown. It was also reported that since the vaccination the patient had not been tested for COVID-19.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: unable to use my arm as it is still swollen; unable to use my arm as it is still swollen and painful; This is a spontaneous report from a contactable consumer (patient). This 57-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration in the left arm on 03Apr2021 at 12:15 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included suspected COVID-19 in Jan2021; the patient stated she probably had COVID at New Year but was not tested and she spent a few days in bed and was exhausted for all of Jan2021. The patient had not received any other vaccines in the four weeks prior to the COVID vaccine. Concomitant medications were not reported. The patient previously received some antibiotics from unknown dates for unknown indications and experienced allergies; the second dose of shingles vaccine on 09Feb2021 in the left arm (at 57-years-old) for immunisation and experienced a bad reaction; and the first dose of BNT162B2 (lot number unknown) in the right arm on 13Mar2021 at 12:15 (at 57-years-old) for COVID-19 immunisation and experienced very painful and swelled up. The patient reported that since getting the second shot in her left arm on 03Apr2021 she had been unable to use her arm as it was still swollen and painful. Her doctor put her on a week of steroids, anti-inflammatory medications and muscle relaxers to try and reduce the swelling. The patient reported having had a shingles shot in that arm in early Feb2021 with a bad reaction that went away after a week; which was why she had the first shot of BNT162B2 in her right arm , which swelled up immediately and was very painful but started feeling better the next day. The events were reported as non-serious and did not require hospitalization; the event resulted in a physician office visit. The clinical outcomes of unable to use her arm as it was still swollen and painful were not recovered. It was also reported that since vaccination the patient had not been tested for COVID-19.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: unable to use their arm as it was still swollen and painful; unable to use their arm as it was still swollen and painful; unable to use their arm as it was still swollen and painful; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The reporter stated that since getting the second shot in their left arm they had been unable to use their arm as it was still swollen and painful. The reporter's doctor stated she had seen another patient who had a long-term reaction to the vaccine like that of the reporter. The clinical outcomes of unable to use their arm as it was still swollen and painful were unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Alanine aminotransferase increased
Clinical narrative: Mildly elevated ALT of 40 (highest range is 32 for this particular lab that was run).; This is a spontaneous report from a contactable consumer (herself as patient). A 41-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration, administered in Arm Left on 01May2021 10:00 22May2021 14:00 (Batch/Lot Number: EW0170), as single dose and then again the second dose via an unspecified route of administration, administered in Arm Left on 22May2021 14:00 (Batch/Lot Number: EW0187) as single dose; both for COVID-19 immunisation. Medical history included GERD, Anxiety, Allergies; all since from an unknown date and unknown if ongoing. Concomitant medications included famotidine, fexofenadine, paracetamol (TYLENOL) and ibuprofen. On 28May2021 16:15, the patient experienced mildly elevated alanine aminotransferase of 40 (highest range is 32 for this particular lab that was run). 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 the vaccination and has not been tested for COVID-19 since the vaccination. The patient underwent lab tests and procedures which included ALT (highest range is 32): 40 (increased) on 28May2021. The clinical outcome of the event was unknown.  Follow-up attempts are needed. Further information can be expected.; Sender's Comments: Based on the current available information and the consistency with the known safety profile of the suspect product BNT162B2, there is a reasonable possibility that event alanine aminotransferase increased were related to suspect drug based on the temporal relation between the vaccination and onset of events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Colitis ulcerative, Colonoscopy
Clinical narrative: I was diagnosed with Ulcerative Colitis/Rectosigmoiditis; This is a spontaneous report received from a contactable consumer (Patient). A 45-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0153), via an unspecified route of administration in the right arm on 19Apr2021 at 15:15 (at the age of 45-year-old) as dose 2, 0.3 ml single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: ER8732), via an unspecified route of administration in the right arm on 22Mar2021 at 15:00 (at the age of 45-year-old) as dose 1, 0.3 ml single for COVID-19 immunization. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. It was reported that within 24-36 hours of his second dose on 19Apr2021, the patient developed diarrhea, multiple times per day, which worsened to include blood after several days. These symptoms, along with abdominal cramping and weight loss, continued until he was diagnosed with ulcerative colitis/rectosigmoiditis following a colonoscopy with biopsy on 08Jun2021. The patient had no prior history of GI (Gastrointestinal) symptoms or disease prior to second dose of this vaccine on 19Apr2021. The patient's treatment for the adverse event included screening for diagnosis and medication. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The outcome of the event was as unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: on how to identify the variant she got infected with; on how to identify the variant she got infected with; This is a spontaneous report received from Pfizer sponsored program. A contactable female consumer (patient) reported via medical information team. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on an unspecified date as dose 2, single, via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that She had a breakthrough case "here" and a Pfizer trial participant. She had 100% notified her research location. The patient had 2nd dose. The patient wanted to know what variant she contracted and would love to be of more help. The patient really wished she could talk to someone more about this than at her local study location who could tell her how to get information on how to identify the variant she got infected with. She was assuming it was one of the newer variants because "they" are more sneaky, or a higher viral load. The public health "here" has her sample, but she does not know if they would tell her anything. The events were reported as non-serious. The outcome of the events was unknown.  Information about lot/batch number is requested.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Hypoaesthesia
Clinical narrative: numbness- shoulders, chest, arms, upper back, hands, fingers; joint pain- shoulders, elbows, ankles; This is a spontaneous report from a contactable consumer (patient). A 43-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot/batch no: EW0182) via unspecified route, administered in right arm, as dose 1 single on 06May2021 at 15:30 (at the age of 43-years) for COVID-19 immunization. The most recent COVID-19 vaccine was administered in pharmacy or drug store. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 09May2021 10:00, the patient experienced joint pain- shoulders, elbows, ankles and numbness- shoulders, chest, arms, upper back, hands, fingers. The patient received treatment for the events which included steroids, muscle relaxers, therapy and chiropractor. The clinical outcome of the joint pain- shoulders, elbows, ankles and numbness- shoulders, chest, arms, upper back, hands, fingers were not recovered.  Information on batch/lot no. are available. Further information has been requested.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Dry eye, Eye irritation, SARS-CoV-2 test
Clinical narrative: My eyes have been very dry and burning since I received the vaccine.  I have to breaks often from work etc to close my eyes to get relief.; My eyes have been very dry and burning since I received the vaccine.  I have to breaks often from work etc to close my eyes to get relief.; This is a spontaneous report from a contactable consumer (Patient). A 56-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0170), via an unspecified route of administration, administered in left arm on 29Apr2021 at 16:00 (at the age of 56-years-old) as dose 2, single for COVID-19 immunization, in Pharmacy or drug store. Medical history reported as none. Patient had no known allergies. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not take any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19, prior vaccination. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8734), via an unspecified route of administration, administered in left arm on 08Apr2021 at 16:00 as dose 1, single for COVID-19 immunization. On 29Apr2021 (same day of vaccination), patient eyes have been very dry and burning since received the vaccine. Patient had to breaks often from work etc., to close eyes to get relief. The events were assessed as Serious (Disability or permanent damage). The treatment was not received for the event. The patient has been tested for COVID-19 since the vaccination. The patient underwent lab tests which included SARS-CoV-2 Test (Nasal swab, Quick test): Negative on 02Jun2021 quick test. The outcome of the events was reported as not recovered.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Neuropathy peripheral
Clinical narrative: Peripheral neuropathy; This is a spontaneous report from a Contactable Health Care Professional. A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: EN6199) via unspecified route of administration, on 23Mar2021, 2nd dose, single for COVID-19 Immunisation. Medical history included Epstein-Barr viraemia. The patient's concomitant medications included Nicotine gum. The patient was allergic to Amoxicillin/clavulanic acid. Historical vaccine included 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: EN6200), via unspecified route of administration, on 01Mar2021, as 1st dose, single for COVID-19 immunisation. On 23May2021, the patient experienced Peripheral neuropathy. The patient did not received any treatment for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and Since the vaccination, the patient had not been tested for COVID-19. The outcome of the event was not recovered.   Follow-up attempts are needed. Further information is expected.; Sender's Comments: Based on the information currently available the causal association between the event peripheral neuropathy and the usage of the vaccine BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 12.0
Sex: U
Vaccine: COVID19
Symptoms: Overdose, Product preparation issue
Clinical narrative: Have gotten 6 doses today/patient got 6 doses of unreconstituted Pfizer Covid-19 Vaccine; Have gotten 6 doses today/patient got 6 doses of unreconstituted Pfizer Covid-19 Vaccine; This is a spontaneous report from a contactable pharmacist via Medical Information Team. A 12-year-old received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EW0167, Expiration Date- Aug2021) via an unspecified route of administration on 14Jun2021 14:30 as dose 1, single (at the age of 12-years-old) for COVID-19 immunization. Patient medical history and concomitant medications were not reported. A nurse gave what was believed to be a full dose of un-reconstituted vaccine.  Pharmacist stated there was only a minute amount left in vial, so patient was believed to have gotten 6 doses today (14Jun2021) around 14:30 CST.  It was the patients first dose. Pharmacist stated it looked like he did not see anything much measurable left in it so it looked like they got 6 doses of un-reconstituted Pfizer Covid-19 Vaccine. The reporter seriousness for the adverse events was serious (medically significant). The adverse events resulted in the emergency room visit. The outcome of the events was unknown.   No follow-up attempts are needed. No further information is expected.; Sender's Comments: There might be a causal relationship between patient got 6 doses of un-reconstituted vaccine and Resulting the patient to visit an emergency room visit.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Abdomen scan, Chest pain, Echocardiogram, Electrocardiogram, Erythema
Clinical narrative: extremely sore and red itchy arm, high fever (normal 97.4 had 102.2) for 2 days, fatigue for a week, heart palpitations on and off for 3 weeks and then wound up in emergency room and to hospital by ambulance for overnight (chest pains) which after they did lung, abdomen scans and eco cardiogram and ekg was diagnosed as inflammation of chest cavity
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Inflammation, Pain in extremity, Palpitations, Pruritus
Clinical narrative: extremely sore and red itchy arm, high fever (normal 97.4 had 102.2) for 2 days, fatigue for a week, heart palpitations on and off for 3 weeks and then wound up in emergency room and to hospital by ambulance for overnight (chest pains) which after they did lung, abdomen scans and eco cardiogram and ekg was diagnosed as inflammation of chest cavity
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Ventilation/perfusion scan
Clinical narrative: extremely sore and red itchy arm, high fever (normal 97.4 had 102.2) for 2 days, fatigue for a week, heart palpitations on and off for 3 weeks and then wound up in emergency room and to hospital by ambulance for overnight (chest pains) which after they did lung, abdomen scans and eco cardiogram and ekg was diagnosed as inflammation of chest cavity
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles, presentation: scalp, ongoing. Prednisone & anti-viral two weeks.  Daughter also had shingles after first vaccine shot Her work supervisor also had shingles post vaccination, and urgent care doc had shingles post vaccination.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Site: Swelling at Injection Site-Severe, Additional Details: patient reported "covid arm (left arm) - swelling, itchy, hot upper arm lasted for 5 days"
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Error: Patient Too Young for Vaccine Administered-
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Injection site pain
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Additional Details: Injection arm is numb
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray, Confusional state, Dizziness, Lymphadenitis, Magnetic resonance imaging
Clinical narrative: vision was off and even confusion; vision was off and even confusion; dizzy; showed the lymph nodes were inflamed; got hives; arm swelled; This is a spontaneous report from a contactable consumer. A 49-years-old male patient received first dose of BNT162B2 (Formulation: Solution for injection, Batch/Lot Number: ER8735), via an unspecified route of administration, administered in Arm Left on 16May2021 10:00 AM as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history included drug allergy to penicillin from an unknown date and unknown if ongoing. COVID-19 from an unknown date and unknown if ongoing. The patient concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) and sertraline hydrochloride (ZOLOF) taken for an unspecified indication, start and stop date were not reported. The patient was diagnosed with COVID-19 prior to vaccination and not diagnosed since the vaccination. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient received shot on Sunday May 16th at 10 am, slept for 23 or 24 hours and would not eat or drink, second day better but arm swelled and got hives gave Benadryl and missed two day of work went back on Wednesday then on May 23rd, woke up dizzy and vision was off and even confusion, went to ER and started stroke protocol, did all testing including a chest x-ray that showed the lymph nodes were inflamed, kept treating as if a possible stroke, MRI machine down so they admitted and waited for machine next day was released after negative scan. The adverse event result in emergency room/department or urgent care. The patient received treatment with adverse event all testing for stroke protocols. Seriousness criteria was Caused/prolonged hospitalization. Since the vaccination, the patient has not been tested for COVID-19. The patient underwent lab tests and procedures which included chest x-ray: lymph nodes were inflamed on 23May2021, magnetic resonance imaging: negative scan on 23May2021, sars-cov-1 test positive: positive on an unspecified date. On an unspecified date, the events were resolved.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, SARS-CoV-1 test positive, Urticaria, Visual impairment
Clinical narrative: vision was off and even confusion; vision was off and even confusion; dizzy; showed the lymph nodes were inflamed; got hives; arm swelled; This is a spontaneous report from a contactable consumer. A 49-years-old male patient received first dose of BNT162B2 (Formulation: Solution for injection, Batch/Lot Number: ER8735), via an unspecified route of administration, administered in Arm Left on 16May2021 10:00 AM as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history included drug allergy to penicillin from an unknown date and unknown if ongoing. COVID-19 from an unknown date and unknown if ongoing. The patient concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) and sertraline hydrochloride (ZOLOF) taken for an unspecified indication, start and stop date were not reported. The patient was diagnosed with COVID-19 prior to vaccination and not diagnosed since the vaccination. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient received shot on Sunday May 16th at 10 am, slept for 23 or 24 hours and would not eat or drink, second day better but arm swelled and got hives gave Benadryl and missed two day of work went back on Wednesday then on May 23rd, woke up dizzy and vision was off and even confusion, went to ER and started stroke protocol, did all testing including a chest x-ray that showed the lymph nodes were inflamed, kept treating as if a possible stroke, MRI machine down so they admitted and waited for machine next day was released after negative scan. The adverse event result in emergency room/department or urgent care. The patient received treatment with adverse event all testing for stroke protocols. Seriousness criteria was Caused/prolonged hospitalization. Since the vaccination, the patient has not been tested for COVID-19. The patient underwent lab tests and procedures which included chest x-ray: lymph nodes were inflamed on 23May2021, magnetic resonance imaging: negative scan on 23May2021, sars-cov-1 test positive: positive on an unspecified date. On an unspecified date, the events were resolved.
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: Her Husband got the 2nd dose of the Pfizer vaccine and he collapsed and after speaking with the V.A; This is a spontaneous report from a non-contactable consumer. A 50-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation The patient medical history was not reported. The patient's concomitant medications were not reported. The patient got the 2nd dose of the vaccine and he collapsed on an unspecified date. The outcome of event was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Neoplasm malignant
Clinical narrative: the patient has been diagnosed with cancer; This is a spontaneous report received from a contactable consumer (patient's wife). A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number, NDC number and Expiry date: unknown), via an unspecified route of administration on 01Mar2021 as DOSE 2, SINGLE for COVID-19 immunization. No medical history and concomitant medications were reported. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: unknown) in Feb2021 as DOSE 1, SINGLE for COVID-19 immunization. On an unspecified date in 2021, the patient was diagnosed with cancer. Outcome of the event was unknown. Investigation Assessment: Not Provided  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Neutropenia
Clinical narrative: After the second dose has findings of neutropenia; This is a spontaneous report from a Pfizer Sponsored Program via a contactable consumer reported for a patient. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unspecified date (age at vaccination was unknown) as 2nd dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unspecified date (age at vaccination was unknown) as 1st dose, single for COVID-19 immunization and had no reaction. The reporter was enquiring about the side effect of the COVID vaccine. On an unspecified date, after the second dose the patient had findings of neutropenia and they were trying to figure it out if it would be a side effect. The reporter stated that they were just investigating neutropenia in a patient that had developed recently and they wondered if they had reports of neutropenia in the Pfizer vaccine. The reporter stated that they were not sure if that's what causing in first place they just wanted to know if there had been any report about it. The reporter confirmed Pfizer Covid-19 vaccine. The reporter was informed about the role of Pfizer drug safety and medical information department. The outcome of the event was unknown.   Information on the lot/batch number has been requested. Follow-up attempts not completed; information about lot/batch number cannot be obtained. No further information expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Loss of consciousness, Pruritus, Tongue disorder
Clinical narrative: I passed out immediately; severe sweating immediately; My tongue felt thick for the next 12+ hours; Itching at the site started the next day and lasted for a week.; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0177, Expiration date: Unknown), via an unspecified route of administration, administered in left arm on 18May2021 12:30 (at the age of 65-years-old) as dose 1, single for COVID-19 immunisation in hospital. Medical history included Crohn's (in remission), Graves (in remission), Hashimoto's and celiac. perfume sensitivity and COVID-19. Concomitant medications included liothyronine sodium (CYTOMEL) taken for an unspecified indication, start and stop date were not reported; levothyroxine sodium (SYNTHROID) 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. The patient previously took sulfa g and experienced drug hypersensitivity, antibiotics and experienced drug hypersensitivity, peppermint bell and experienced drug hypersensitivity, nickel and experienced allergy to metals. On 18May2021 at 12:30, she passed out immediately, severe sweating immediately, her tongue felt thick for the next 12+ hours and itching at the site started the next day and lasted for a week. Since the vaccination, the patient has not been tested for COVID-19. The patient did not received treatment for the events. The clinical outcome of the events was resolved on an unspecified date of May2021.  Information on Lot/Batch number was available. Additional information has been requested
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Rheumatoid arthritis
Clinical narrative: her rheumatoid arthritis has been worse since the shots, flare up with her rheumatoid arthritis; He has left the house because his wife is still in bed; This is a spontaneous report from a contactable consumer (patient husband) via a Pfizer sponsored program.  A 76-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 07Mar2021 and first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 07Feb2021 as a single dose for COVID-19 immunization. The patient medical history included ongoing rheumatoid arthritis. Concomitant medication included tofacitinib citrate (XELJANZ XR) 11mg tablets for Rheumatoid arthritis. She was off of her Xeljanz XR for 7-8 days before and 4-5 days after both COVID shots.On an unspecified date in 2021, the patient experienced rheumatoid arthritis has been worse since the shots and more pain with her rheumatoid arthritis since the shots, she was just having a flare up, her husband has left the house because she was still in bed. He doesn't think this was any different than normal and he just wants to let it go and was needed to speak with her Rheumatoid Arthritis doctor, but he has been off this whole week and usually, they can get Xeljanz XR from the doctor to tide them over until the paperwork is done. The outcome of the events was not recovered.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Basedow's disease, Tachycardia
Clinical narrative: Grave's disease; tachycardia; This is a spontaneous report from a contactable consumer (Patient's grandfather) via Pfizer sponsored program. A 15-years-old female patient (Reporter's granddaughter) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 15May2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced Grave's disease and tachycardia. He called in because he heard or saw somewhere regarding the myocarditis side effect of the vaccine. With that, wanted to know if could take the second dose of the vaccine due tomorrow. The outcome of the events was unknown.   Information of lot/batch number has been requested.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Electric shock sensation, Fatigue, Paranasal sinus hypersecretion
Clinical narrative: Extremely fatigued; mucus and sinus drainage increased by 500%; electrical shock in muscles and tendons; breathing issues 02 sat is staying between 70 and 90; This is a spontaneous report from a contactable consumer (patient, self-reporting). A 55-years-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine, Formulation: Solution for injection, Lot number: er8729 and Expiration date: unknown), via an unknown route of administration, in left arm on 22Apr2021 at 12:00 (at the age of 55-years-old) as dose number unknown, single for COVID-19 immunisation. Medical history included congestive heart failure, diabetes, bundle bunch blockage, coronary heart disease from an unknown date. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received long list of other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested positive for COVID-19. On 23Apr2021 at 10:00, the patient was extremely fatigued, mucus and sinus drainage increased by 500%, electrical shock in muscles and tendons, breathing issues 02 sat is staying between 70 and 90. The patient still have ongoing symptoms and issues from shot three months later. Doctor requested him not take second dose. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Treatment for events included Steroids and increased treatment for congestive heart. Outcome of events reported as recovered with sequelae on an unknown date in 2021.   Follow up needed, further information has been requested.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Palpitations
Clinical narrative: Racing heart for a month. Over 140 bpm; This is a spontaneous report received from a contactable consumer (reported for herself).  A 39-year-old non-pregnant female consumer (patient) reported for herself that she received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: 240720, and Expiration date: Unknown), via an unspecified route of administration, administered in left arm on 22Apr2021 at 10:00 (at the age of 39-year-old) as dose 1, single and second dose (BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: 240720, and Expiration date: Unknown) via an unspecified route of administration, administered in left arm on 13May2021 at 10:00 at dose 2, single for COVID-19 immunization, in hospital. She was not pregnant at the time of vaccination. The patient medical history and concomitant medications were not reported. on an unspecified date in 2021, the patient experienced racing heart for a month. over 140 bpm. Device date was 15Jun2021. The patient underwent lab tests and procedures which included heart rate: racing heart for a month. over 140 bpm (Racing heart for a month. Over 140 bpm). The outcome of the event was unknown.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Investigation, Loss of consciousness
Clinical narrative: He blacked out; This is a spontaneous report from a contactable consumer reporting for her grandson (patient).  A 14-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number and Expiry Date are unknown) via an unspecified route of administration on 14Jun2021 15:00 at the age of 14-years-old as dose 1, single for COVID-19 immunisation. The Patients Medical History including any illness at time of vaccination were none. The Patients concomitant medications were none. Family Medical History Relevant to AE(s) were none. Relevant Tests were none. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) were none. Additional vaccines administered on same date of the Pfizer suspect if applicable, list all vaccines administered on same date with the Pfizer vaccine considered as suspect were none. Prior Vaccinations within 4 weeks were none. AE(s) following prior vaccinations were none. On 14Jun2021 at 10 PM, 7 hours later, when he got out of his chair, he blacked out stated this morning, she checked on him. The patient underwent lab tests and procedures which included 'vitals (investigation): ok on an unspecified date in 2021, breathing (investigation): ok on an unspecified date in 2021, pulse (heart rate): ok on an unspecified date in 2021. The outcome of event was unknown.  Follow-up attempts are needed. Information on Batch/Lot number has been requested.  Follow up attempts are needed. Additional information has been requested.
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardiac disorder, Electrocardiogram, Electrocardiogram ambulatory, Heart rate increased, Supraventricular tachycardia
Clinical narrative: I thought I was having a heart attack and went to the hospital; I had an SVT event and called 911 and had an EKG in the ambulance; I was having increased heart rate and SVT after my vaccine; This is a spontaneous report from a contactable consumer consumer(patient) reported for himself that.  A 40-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number Er8727, age at vaccination 40 years), dose 1 via an unspecified route of administration, administered in Arm Right on 25Mar2021at 12:30 as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not diagnose with COVID-19 Prior to vaccination. The patient did not test for COVID-19 since the vaccination. On 27Mar2021 the patient experienced 2 days after 1st dose patient stated that he had an SVT event and called 911 and had an EKG in the ambulance. They said I was not having a heart attack, but we are not surprised that I was having increased heart rate and SVT after my vaccine. I have had several since. I went to the emergency room on 13Jun2021 after another event. I thought I was having a heart attack and went to the hospital. They want to monitor me with a Holter monitor for 15 days to see if they can catch an event when it takes place. The adverse event was resulted in a visit to doctor or other healthcare professional office/clinic or Emergency room/department or urgent care. The patient underwent lab tests and procedures which included (EKG) electrocardiogram on 27Mar2021, (Holter monitor) electrocardiogram ambulatory on 13Jun2021 was unknown. The outcome of the events was not recovered.  Information on batch/lot no. are available. Further information has been requested.
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Confusional state, Electrocardiogram ambulatory, Electrocardiogram normal, Language disorder
Clinical narrative: I thought I was having a heart attack and went to the hospital; I had an SVT event and called 911 and had an EKG in the ambulance; I was having increased heart rate and SVT after my vaccine; This is a spontaneous report from a contactable consumer consumer(patient) reported for himself that.  A 40-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number Er8727, age at vaccination 40 years), dose 1 via an unspecified route of administration, administered in Arm Right on 25Mar2021at 12:30 as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not diagnose with COVID-19 Prior to vaccination. The patient did not test for COVID-19 since the vaccination. On 27Mar2021 the patient experienced 2 days after 1st dose patient stated that he had an SVT event and called 911 and had an EKG in the ambulance. They said I was not having a heart attack, but we are not surprised that I was having increased heart rate and SVT after my vaccine. I have had several since. I went to the emergency room on 13Jun2021 after another event. I thought I was having a heart attack and went to the hospital. They want to monitor me with a Holter monitor for 15 days to see if they can catch an event when it takes place. The adverse event was resulted in a visit to doctor or other healthcare professional office/clinic or Emergency room/department or urgent care. The patient underwent lab tests and procedures which included (EKG) electrocardiogram on 27Mar2021, (Holter monitor) electrocardiogram ambulatory on 13Jun2021 was unknown. The outcome of the events was not recovered.  Information on batch/lot no. are available. Further information has been requested.
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Supraventricular tachycardia
Clinical narrative: I thought I was having a heart attack and went to the hospital; I had an SVT event and called 911 and had an EKG in the ambulance; I was having increased heart rate and SVT after my vaccine; This is a spontaneous report from a contactable consumer consumer(patient) reported for himself that.  A 40-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number Er8727, age at vaccination 40 years), dose 1 via an unspecified route of administration, administered in Arm Right on 25Mar2021at 12:30 as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not diagnose with COVID-19 Prior to vaccination. The patient did not test for COVID-19 since the vaccination. On 27Mar2021 the patient experienced 2 days after 1st dose patient stated that he had an SVT event and called 911 and had an EKG in the ambulance. They said I was not having a heart attack, but we are not surprised that I was having increased heart rate and SVT after my vaccine. I have had several since. I went to the emergency room on 13Jun2021 after another event. I thought I was having a heart attack and went to the hospital. They want to monitor me with a Holter monitor for 15 days to see if they can catch an event when it takes place. The adverse event was resulted in a visit to doctor or other healthcare professional office/clinic or Emergency room/department or urgent care. The patient underwent lab tests and procedures which included (EKG) electrocardiogram on 27Mar2021, (Holter monitor) electrocardiogram ambulatory on 13Jun2021 was unknown. The outcome of the events was not recovered.  Information on batch/lot no. are available. Further information has been requested.