chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: PPV
Symptoms: Pneumonia
Clinical narrative: she took the Pneumococcal 13 conjugant vaccine and got pneumonia soon after; she took the Pneumococcal 13 conjugant vaccine and got pneumonia soon after; This is a spontaneous report from a contactable consumer (patient). A female patient (Age: 68; Unit was not reported) received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (trade name and manufacturer were not reported; Lot number and expiration date were not reported) on an unspecified date in 2013 as a single dose, with route of administration unspecified, for immunization. Medical history included non-Hodgkin's lymphoma; low immunity; and follicular slow growing lymph node removal in 2006. The patient's concomitant medications were not reported. On an unspecified date in 2013, the patient had received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein), and got pneumonia soon after. The outcome of the event was unknown.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Cystitis noninfective, Pharyngeal swelling, Somnolence
Clinical narrative: Bladder inflammation; Throat swelling; severe drowsiness; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A 35-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number and expiration was not reported), second dose via an unspecified route of administration, administered in arm right on 18Apr2021 10:00 (at the age of 35-year-old) as dose 2, single for COVID-19 immunization. Patient medical history included hidradenitis, migraine from an unknown date and unknown if ongoing followed by Keflex drug hypersensitivity from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient did not have any history of UTIs. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19, prior vaccination and since the vaccination. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number and expiration was not reported), first dose via an unspecified route of administration, administered in arm right on 28Mar2021 9:45 single for COVID-19 immunization. On 19Apr2021 03:00 the patient experienced bladder inflammation, severe burning pain when urinating, frequent urination, lower abdominal pain, throat swelling, severe drowsiness. Adverse events resulted in Emergency room and department or urgent care. Patient received treatment for events included Bactrim. The outcome of the events was resolving.   Information on the lot/batch number has been requested.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Pain, Pruritus, Pyrexia
Clinical narrative: The worst part is my body's itching everywhere.; The first night is not too bad. However, the next day is pretty severe.; Body aching; fever; headache; This is a spontaneous report from a contactable consumer (patient). A 58-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH, COVID-19 vaccine, formulation: solution for injection) via an unspecified route of administration, administered in Arm Left on 16Apr2021 at 16:45 (58-year-old at the time of vaccination) as dose 1, single for covid-19 immunization. Medical history included allergy to shell food like blue crab and urticaria (same symptoms where a lot of hives appeared). The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 17Apr2021, the patient experienced body aching, fever, headache and the worst part was her body's itching everywhere. It was reported that the first night was not too bad, however the next day was pretty severe. Therapeutic measure was taken due to the events included herbal steam hot water & Zyrtec. The patient was recovering from the events.  Information about batch/Lot number has been requested.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Dyspepsia, Headache, Paraesthesia, SARS-CoV-2 antibody test
Clinical narrative: on and off stomach pain and heart burn; Tingling in hand; on and off stomach pain and heart burn; Headache as well a bit.; This is a spontaneous report received from a contactable consumer (patient herself). A 36-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EW0162) via an unspecified route of administration in left arm on 16Apr2021 08:15 as dose 1, single (at the age of 36-years-old) for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Patient medical history and concomitant medications were not reported. Patient did not had any allergies to medications, food, or other products. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19, since the vaccination. On 16Apr2021 at 08:15 patient experienced tingling in hand, on and off stomach pain and heart burn, headache. Patient did not receive any treatment for the adverse events. The outcome of the events was recovering.   No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hypersensitivity, Sinus disorder, Throat tightness
Clinical narrative: Feel tightness in throat; its my sinus; I was just fatigued for 2 days; slight headache; Feel tightness in throat; its my sinus; an allergic reaction and I want to know if it is reported for people to have that tightness in their throat after that shot after this long; This is a spontaneous report from a contactable consumer or other non hcp.  A 46-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) dose 2 via an unspecified route of administration on an unspecified date (Age at vaccination is 46 years) (Batch/Lot Number: EL9267, expiration date: 30 Jun 2021) as 2nd DOSE, SINGLE for covid-19 immunisation. Historical Vaccine includes bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) for covid-19 immunisation. Medical history included autoimmune thyroiditis from an unknown date (Hashimoto's thyroiditis). Concomitant medication included levothyroxine sodium (TIROSINT) taken for thyroid pain, start and stop date were not reported. Patient stated that she was wondering if it is a side effect like 5 or 6 weeks after your second Pfizer shot to feel tightness in throat some say maybe it is an allergic reaction. Patient took Tylenol, in his second shot she was just fatigued for 2 days and had a slight headache and then took Tylenol and it was gone away and after that she was fine. In 10 days, she had this tightness in his throat, and she is thinking it an allergic reaction and she went to doctor and they are saying it is sinus give antibiotics (Unspecified medications) that did not help so that tells it is not that doctor asking me to go to allergist because they think it is an allergic reaction and she want to know if it is reported for people to have that tightness in their throat after that shot after this long. . The patient underwent lab tests and procedures which included blood work done but was  waiting for report. Outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: I experienced a nose bleed on 14Mar2021 the day after my second vaccine dose.; This is a spontaneous report from a contactable consumer (patient).  A 51-years-old non-pregnant female patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number EW0150, expiration date unspecified), via an unspecified route of administration, administered in Arm Left on 13Apr2021 at 08:00 (51-years-old at the time of vaccination) as dose 2, single for covid-19 immunization. Medical history included allergy to sulfur drugs. Concomitant medications were not reported. The patient previously received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number ER2613, expiration date unspecified), via an unspecified route of administration, administered in Arm Left on 23Mar2021 at 08:00 (51-years-old at the time of vaccination) as dose 1, single for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient did not received any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 14Apr2021 (day after second vaccine dose) at 12:30, the patient experienced nosebleed. The reporter assessed event as non-serious. No therapeutic measures were taken for the event.The patient recovered from event in 2021.  Information about lot/batch number is available. Follow-up attempts are needed.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain in jaw, Visual impairment
Clinical narrative: seeing black moving spots in my right eye; jaw & neck are achy on my right side; jaw & neck are achy on my right side; This is a spontaneous report from a contactable consumer (patient). A 61-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: ER8737), via an unspecified route of administration, administered in arm left on 19Apr2021 at 13:45 (at an age of 61-years-old) as dose1, single for covid-19 immunization. Medical history included hysterectomy on an unspecified date in 2011. Patient was not diagnosed with covid-19 prior to vaccination. Concomitant medications included Calcium (MANUFACTURER UNKNOWN), via an unspecified date on an unspecified date at unknown dose and frequency for unknown indication; levothyroxine, liothyronine (NP THYROID) (MANUFACTURER UNKNOWN), via an unspecified date on an unspecified date at 60 mg, unknown frequency for unknown indication; vitamin d3 (VITAMIN D3) (MANUFACTURER UNKNOWN), via an unspecified date on an unspecified date at unknown dose and frequency for unknown indication; cyanocobalamin (VITAMIN B12 AAA) (MANUFACTURER UNKNOWN), via an unspecified date on an unspecified date at unknown dose and frequency for unknown indication; fish O (MANUFACTURER UNKNOWN), via an unspecified date on an unspecified date at unknown dose and frequency for unknown indication. The patient previously took ampicillin for hypersensitivity and experienced allergy. Patient did not received any other vaccine prior four weeks of vaccination. On 20Apr2021 at 17:00, the patient experienced seeing black moving spots in my right eye since tuesday evening and jaw & neck are achy on my right side. Since vaccination patient not tested for covid-19. No therapeutic measures were taken as a result of the events. The clinical outcome of the seeing black moving spots in my right eye, jaw & neck are achy on my right side were not recovered.  Batch/Lot number was obtained. Further information has been requested.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Epistaxis, Headache
Clinical narrative: Bloody nose; Have a small bruise on my neck; Have pretty much a constant headache; This is a spontaneous report from a contactable consumer (patient). A 62-years-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: ER8732, Expiration date was not reported), via an unspecified route of administration, administered in left arm on 23Mar2021 at 16:30 hours as dose 1, single (at the age of 62-years-old) for covid-19 immunisation. Medical history included ongoing diabetic and slight high blood pressure, elevated triglycerides, three caesarean section, appendicectomy, both knees have been replaced, shoulder surgery and allergies to statins (from an unknown date and unknown if ongoing). The patient previously took Jardiance, Farxiga and statins and had allergies to Jardiance, Farxiga and statins. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received other medications within 2 weeks of vaccination. Patient was not diagnosed with COVID-19, prior to vaccination. Patient had not been tested for COVID-19, since the vaccination. Patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EW0162, Expiration date was not reported), via an unspecified route of administration, administered in left arm on 14Apr2021 as dose 2, single (at the age of 62-years-old) for covid-19 immunisation. On 30Mar2021 at 05:45 hours (one week to the day of my first vaccine), patient got a bloody nose and stated that she had not had one for several years, so it was alarming. Since then, patient had a bloody nose if not every day, every other day. On unspecified date of 2021, patient had a small bruise on her neck that appeared over the weekend and also had pretty much a constant headache. Patient had received no treatment for all the events. The outcome of all the events was not recovered.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: Cramps on left leg between Soleus and Tendons; This is a spontaneous report received from a contactable consumer, the patient. A 45-year-old non pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EW0161) via an unspecified route of administration on left arm 20Apr2021 at 08:15 (at the age of 45-year-old) as a single dose for COVID-19 immunisation. No relevant medical history was reported by the patient. The patient had no known allergies. Concomitant medications included norethisterone (DEBLITANE) and amlodipine (MANUFACTURER UNKNOWN) since an unknown date for an unknown indication. 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. The patient had not been tested for COVID-19 since the vaccination. On 22Apr2021 at 10:30, the patient experienced cramps on left leg between soleus and tendons. The cramps started 2 days after the vaccination and remained for 3 days. It was still present and was not getting worse or better and normal muscle pain should have gone away. Therapeutic measures included acupuncture for the reported event cramps leg. The adverse events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event was not recovered at the time of report.   No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Presyncope
Clinical narrative: dizziness; shortness of breath; near fainting; This is a follow up-spontaneous report from a contactable Pharmacist.   A 46-year-old non-Pregnant female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot No: ER8735), via an Intramuscular route of administration on 24Apr2021 at 16:30 pm into Left arm as a single dose for COVID-19 immunization at Pharmacy or Drug Store. The patient medical history and concomitant medications were not reported. Patient did not receive any other vaccine in four weeks. Prior the vaccination, patient was not diagnosed with COVID. Post vaccination, Patient was not tested with COVID. Patient had no allergies. On an unknown date Apr2021 at 16:30 pm, the patient experienced dizziness, shortness of breath, near fainting. The patient received lay on floor with feet elevated as a treatment. The outcome of the events was recovered (In Apr2021)   No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site discomfort, Vaccination site pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: itching; noticeable discomfort; small rash-like bumps; swelling, injection puncture (raised edges, "Donut"; This is a spontaneous report from a contactable consumer, the patient. An elderly male patient of an unknown age received second dose of BNT162b2 (PFIZER COVID-19 mRNA VACCINE BIONTECH, Lot number: ER8731) via an unknown route of administration at Arm right on 13Apr2021 at 07:45 as single dose indicated for COVID-19 immunisation. The patient previously received first dose of BNT162b2 (PFIZER COVID-19 mRNA VACCINE BIONTECH, Lot number: Unknown) via an unknown route of administration on 23Mar2021 at 07:45 as single indicated for COVID-19 immunisation. The medical history of the patient included Atrial fibrillation (Aib), and penicillin allergy. The patient did not take any concomitant medication. The patient did not receive any other vaccine in last four weeks. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested positive for COVID-10 since having the vaccine. On 15Apr2021 (Thursday), the patient started to notice swelling, by Friday or Saturday, noticed change in injection puncture which had raised edges like a Donut. By Tuesday 20Apr2021, small rash-like bumps appeared, which had itching and noticeable discomfort. The treatment given for the events was unknown. The clinical outcomes of all the events were not recovered at the time of this report.   No follow-up attempts are possible; No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Antinuclear antibody, Antinuclear antibody increased, C-reactive protein, Pain in extremity, Red blood cell sedimentation rate
Clinical narrative: marked elevation of Antinuclear antibody; severe bilateral upper extremity pain at both shoulders and deltoid muscles; This is a spontaneous report received from a contactable physician (patient) .   A 64-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) intramuscularly in the left arm on 09Apr2021 as a single dose for COVID-19 immunization, when the patient was 64-years-old.  Medical history included hypertension and migraine from an unknown date and unknown if ongoing. The patient had allergies to medications, food, or other products was reported, which was not specified. The patient receive other vaccines within 4 weeks prior to the COVID vaccine.  The patient had received other unspecified medications within 2 weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via unspecified route of administration on 17Mar2021, as a single dose for COVID-19 immunization.  The patient experienced severe bilateral upper extremity pain at both shoulders and deltoid muscles on in Apr2021 (reported as 08Apr2021, at 06:00) with outcome of recovering and marked elevation of antinuclear antibody on an unspecified date with outcome of unknown.  Details were as follows: severe bilateral upper extremity pain at both shoulders and deltoid muscles was noted. Patent labs included marked elevation of ANA 1:1280 - nuclear, fine speckled pattern, mild elevation of C-reactive protein (C-RP) 14, normal White blood cell count (WBC), Red blood cell sedimentation rate (ESR) 11, Rheum Factor was within normal limits. Reported event included severe bilateral upper extremity pain at both shoulders and deltoid muscles. Prior to vaccination, the patient was not diagnosed with COVID-19.  Since the vaccination, the patient has not been tested for COVID-19. Therapeutic measures were taken as a result of severe bilateral upper extremity pain at both shoulders and deltoid muscles in form of treatment with tramadol (MANUFACTURER UNKNOWN). The outcome of severe bilateral upper extremity pain at both shoulders and deltoid muscles was recovering; the outcome of marked elevation of Antinuclear antibody was unknown.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Rheumatoid factor, White blood cell count
Clinical narrative: marked elevation of Antinuclear antibody; severe bilateral upper extremity pain at both shoulders and deltoid muscles; This is a spontaneous report received from a contactable physician (patient) .   A 64-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) intramuscularly in the left arm on 09Apr2021 as a single dose for COVID-19 immunization, when the patient was 64-years-old.  Medical history included hypertension and migraine from an unknown date and unknown if ongoing. The patient had allergies to medications, food, or other products was reported, which was not specified. The patient receive other vaccines within 4 weeks prior to the COVID vaccine.  The patient had received other unspecified medications within 2 weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via unspecified route of administration on 17Mar2021, as a single dose for COVID-19 immunization.  The patient experienced severe bilateral upper extremity pain at both shoulders and deltoid muscles on in Apr2021 (reported as 08Apr2021, at 06:00) with outcome of recovering and marked elevation of antinuclear antibody on an unspecified date with outcome of unknown.  Details were as follows: severe bilateral upper extremity pain at both shoulders and deltoid muscles was noted. Patent labs included marked elevation of ANA 1:1280 - nuclear, fine speckled pattern, mild elevation of C-reactive protein (C-RP) 14, normal White blood cell count (WBC), Red blood cell sedimentation rate (ESR) 11, Rheum Factor was within normal limits. Reported event included severe bilateral upper extremity pain at both shoulders and deltoid muscles. Prior to vaccination, the patient was not diagnosed with COVID-19.  Since the vaccination, the patient has not been tested for COVID-19. Therapeutic measures were taken as a result of severe bilateral upper extremity pain at both shoulders and deltoid muscles in form of treatment with tramadol (MANUFACTURER UNKNOWN). The outcome of severe bilateral upper extremity pain at both shoulders and deltoid muscles was recovering; the outcome of marked elevation of Antinuclear antibody was unknown.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus in both ears; This is a spontaneous report received from a contactable consumer, the patient. A 55-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0150) via an unspecified route of administration on 08Apr2021 at 20:30 (at the age of 55-years-old), as a single dose for COVID-19 immunisation. The patient did not have any medical history and past drug history. Prior to the vaccination, it was unknown if the patient had diagnosed with COVID-19. The patient had not tested positive for COVID-19 since the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient experienced tinnitus in both ears, left ear had ringing at one frequency, sometimes a humming or pulsating sound and the right ear had ringing at another frequency, sometimes loud rumbling on 10Apr2021 at 12:00. The clinical outcome of the event tinnitus in both ears was not resolved at the time of report.  No follow up attempts are possible. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Chronic sinusitis
Clinical narrative: Chronic sinusitis; This is a spontaneous report from a contactable healthcare professional, the patient. A 22-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8731) via unspecified route of administration in left arm on 17Apr2021 at 10:15 (at the age of 22-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma. Concomitant medications included SINGULAIR, PROZAC, SYNTHROID and lisinopril (MANUFACTURER UNKNOWN) taken within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613) as a single dose via unspecified route in left arm on 21Mar2021 at 12:15 for COVID-19 immunisation. Past drug history included penicillin and peanut. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. It was reported that the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 18Apr2021, at 13:00, the patient experienced chronic sinusitis. The patient reported that she could not breathe out of nose at all, constant post nasal drip and dried out nasal passages. Corrective treatment included Afrin nasal spray and other nasal sprays for an unspecified date. The clinical outcome of chronic sinusitis was not resolved.   No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dizziness, Nausea, Pain
Clinical narrative: Fever; Chills; Body aches; Dizziness; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0170) via an unspecified route of administration in the left arm on 22Apr2021 at 15:45 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension and thyroidectomy. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), liothyronine (MANUFACTURER UNKNOWN), valsartan (MANUFACTURER UNKNOWN), vitamin D (MANUFACTURER UNKNOWN). Past medical history included penicillin. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 01Apr2021 at 15:45 as a single dose for COVID-19 immunisation. 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 COVID-19 vaccination. On 23Apr2021 at 10:00, the patient experienced fever, chills, body aches, dizziness and nausea. On 23Apr2021 at 10:00, the body temperature was reported as 102 degrees Fahrenheit. The clinical outcome of the events fever, chills, body aches, dizziness and nausea were recovered on an unknown date in Apr2021. No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; Chills; Body aches; Dizziness; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0170) via an unspecified route of administration in the left arm on 22Apr2021 at 15:45 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension and thyroidectomy. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), liothyronine (MANUFACTURER UNKNOWN), valsartan (MANUFACTURER UNKNOWN), vitamin D (MANUFACTURER UNKNOWN). Past medical history included penicillin. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 01Apr2021 at 15:45 as a single dose for COVID-19 immunisation. 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 COVID-19 vaccination. On 23Apr2021 at 10:00, the patient experienced fever, chills, body aches, dizziness and nausea. On 23Apr2021 at 10:00, the body temperature was reported as 102 degrees Fahrenheit. The clinical outcome of the events fever, chills, body aches, dizziness and nausea were recovered on an unknown date in Apr2021. No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Temperature excursion, temperature reached 50.1 degrees Fahrenheit, out of range about 46 degrees for about an hour; Temperature excursion, temperature reached 50.1 degrees Fahrenheit, out of range about 46 degrees for about an hour; This case has been made invalid as there is no indication that the patient experienced and adverse event under BNT162B2.  This is a spontaneous report from a contactable pharmacist received via Pfizer sponsored program. This is 1 of 7 reports.  A 46-year-old male patient received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: ER8735; Expiration Date: Jul2021; NDC number: 58267100-1) via intramuscular on 26Apr2021 (at the age of 46-years-old) in right arm as a single dose for covid-19 immunization. The patient's medical history, investigation assessment and concomitant medications were reported as unknown. The report was not related to a study or programme. The reporter came to work on 26Apr2021 at around 12:30 in afternoon and checked if the Pfizer covid vaccine he had was good or not. He found temperature excursion, the temperature reached 50.1 degrees Fahrenheit, out of range about 46 degrees for about an hour. On 26Apr2021, the consumer reported temperature excursion of a vaccine that was administered to a patient. The vaccine was administered to 6-7 patients. He does not had all the details about each patient, but does had some information. He believed that the event was medically significant but that would depend on the stability of the product. The outcome of the events was unknown.  Follow-up (26Apr2021): This is a spontaneous report from a contactable pharmacist who reported same event under the same suspect product for 7 patients, vaccine start date and other information related to events.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021488392 same reporter/drug/event, different patients.;US-PFIZER INC-2021488410 same reporter/drug/event, different patients.;US-PFIZER INC-2021488361 same reporter/drug/event, different patients.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes simplex reactivation, Oral herpes
Clinical narrative: herpes reactivation; herpes reactivation worsened; this was herpes S1 since it was on her face; broke out on her lower lip and a couple of days later she broke out in the back of her throat next to the uvula; This is a spontaneous report from a contactable consumer reported for herself. A 62-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot Number: EN6208; Expiration date was not reported) via an unspecified route of administration, administered in arm left on 27Mar2021 10:50 (at the age of 62-years old) as dose 1, single and received second dose via an unspecified route of administration, administered in arm left on 17Apr2021 (Lot number: ER8737; at the age of 62-years old) as dose 2, single for COVID-19 immunisation. Medical history included genital herpes that she has had in the past from unknown date and unknown if ongoing. Other medical history or conditions, concomitant products, investigational assessment, test results, history of all previous immunization with the Pfizer vaccine considered as suspect, additional administered vaccines included none. Prior vaccinations (within 4 weeks) were not reported and for adverse events (AE) following prior vaccination, patient stated no not herpes. For family medical history relevant to AE, the patient stated she was not really sure what was relevant to herpes. Patient took COVID 19 vaccine for protection from COVID so she would not have to go to the hospital. No other products taken. On 27Mar2021, the patient experienced herpes reactivation which was reported as worsened, and this was herpes S1 since it was on her face; it broke out on her lower lip and a couple of days later she broke out in the back of her throat next to the uvula. Therapeutic measures were taken because of events. No emergency room visit was done. Clinical course was as follow: The patient calling about the COVID-19 vaccine to report a side effect. The patient saw a nurse practitioner which was an APRN for her side effect. The patient had a herpes reactivation on her face instead of genital herpes that she has had in the past. The patient stated this was herpes S1 since it was on her face. This started the first day that she received the first vaccine, and she broke out on her lower lip and a couple of days later she broke out in the back of her throat next to the uvula. The patient noticed the first day because she knew the symptoms. The patient stated she took ACYCLOVIR, which was recommended, and the herpes reactivation was strong enough it broke out. The patient was treating her symptoms with ACYCLOVIR, 5 times a day which 5 times a day was the maximum. For the second dose of the vaccine, she made sure she had enough to take the extra 5 times a day and she still broke out within hours. She was having to take 5 pills of the ACYCLOVIR to keep her symptoms at bay instead of the normal 2 pills. Relevant tests included none. Clinical outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: sicker than a dog; This is a spontaneous report from a contactable consumer (patient himself).   A 66-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: not reported), via an unspecified route of administration on an unknown date in April2021 (He states he got the first shot of the withheld virus a month ago) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history included blood clots in both sides of his neck, and in both legs before receiving first shot. The patient's concomitant medications were not reported. The reporter stated that, he has blood on both sides of his neck and sides of his legs, and would like to know if he can receive the second dose of the Pfizer BioNTech COVID-19 because of this. Caller did verify that these blood clots were present before he received his first dose of the vaccine. reporter also mentions that when he received the first dose of the vaccine, 4 days later (on an unknown date in Apr2021) he was sicker than a dog but reports that he came out of that. Patient further stated that the Johnson and Johnson vaccine was giving blood clots to people. He states that he already has blood clots in both sides of his neck and both legs. He was asking if it is okay if he goes ahead and gets the second vaccine which was scheduled for tomorrow. The shot is for the withheld virus, clarified as COVID-19. Reporter confirms that he had the blood clots before receiving the vaccine and states he has had them for a few years, but doctors was not care on this. At the time of this report event outcome was recovered on an unknown date in Apr2021.  Follow-up attempts are completed; information about lot/batch number cannot be obtained.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Rash, Rash erythematous, Streptococcal infection
Clinical narrative: she has a rash, rash on right cheek and rash on forehead; Stated that she has a rash that is quite red; Is kind of warm to the touch; like if she had a strep infection; This is a spontaneous report from a contactable consumer (patient). This consumer reported for herself that a 57-years-old female patient received second dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, Batch/Lot Number: EW0167), (at the age of 57-years-old) via an unspecified route of administration on left arm on 02May2021 as single dose for COVID-19 immunisation. The patient's medical history includes fibromyalgia for 25 years which was still ongoing. Was not on medication anymore. Those medications gave her problems and made it worse. Concomitant medications were Modafinil (generic version of Provigil) has been taking for 10 years, at least for narcolepsy and Claritin (Clarithromycin) took daily during the spring and fall. Has taken for years but, only in those periods of time with seasonal allergies. The patient received first dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, Batch/Lot Number: EW0151) via an unspecified route of administration on left upper arm on 04Apr2021 10:15 as historical vaccine single dose for COVID-19 immunisation. On 04May2021, the patient had a reaction to the second dose of the Pfizer Covid-19 vaccine which she administered on Sunday. She has a rash that was quite red where it bends, it was warm to the touch, but nothing was raised, looks like a sunburn, it was inside of her left arm on the elbow area, which was the same side as the injection. Her right cheek was red, as if she was slapped, she also has it across her forehead and in the back of her neck. She would like advice on how to treat it. Rash on inside of left arm: Noticed when she woke up this morning. Rash on right cheek: Developed soon after the rash on the arm. Was maybe an hour or so, when the cheek became red. Rash on forehead:  Not as bad but looks very similar to the rash on her arm. Is getting more intense now. Is also on her neck. States that she got up around 06:30. It was a very similar rash to viral rashes. The last time she had it was probably when she had the flu. It was not during the pandemic. It was around Feb 2019. No prior vaccinations within 4 weeks. There were no relevant tests proceed. The outcome of the event was not recovered.  Follow-up (04May2021): This is a follow-up spontaneous report from a contactable consumer (patient). This 57-years-old female consumer reported for herself.  Follow-up attempts are completed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Heavy menstrual bleeding, Lymph node pain
Clinical narrative: Migraine; period started 2 days early the day after the shot and slightly heavier bleeding than usual.; Headache; Fatigue; Mild fever of 99.9; Tenderness of lymph node under left arm; swelling and tenderness of lymph node; This is a spontaneous report received from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in left arm on 22Apr2021 at 11:15 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. Concomitant medications included ZYRTEC and PRILOSEC for unknown indication. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in left arm on 01Apr2021 at 10:45 (at the age of 48-years-old) as a single dose, for COVID-19 immunisation. On 23Apr2021 the body temperature was measured and was found to be 99.9 (unspecified unit). On 23Apr2021 at 07:00 the patient experienced mild fever of 99.9 (unspecified unit), fatigue, swelling, tenderness of lymph node under left arm (lymph node tenderness) and headache. On the same day the patient also reported that period started 2 days early the day after the shot and slightly heavier bleeding (bleeding menstrual heavy) than usual. On 25Apr2021 3 days after the shot the patient had experienced migraine. The clinical outcome of events lymph node tenderness, swelling, bleeding menstrual heavy, headache, pyrexia, fatigue was recovered on an unspecified date in Apr2021; while that of the event migraine was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Migraine, Pyrexia
Clinical narrative: Migraine; period started 2 days early the day after the shot and slightly heavier bleeding than usual.; Headache; Fatigue; Mild fever of 99.9; Tenderness of lymph node under left arm; swelling and tenderness of lymph node; This is a spontaneous report received from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in left arm on 22Apr2021 at 11:15 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. Concomitant medications included ZYRTEC and PRILOSEC for unknown indication. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in left arm on 01Apr2021 at 10:45 (at the age of 48-years-old) as a single dose, for COVID-19 immunisation. On 23Apr2021 the body temperature was measured and was found to be 99.9 (unspecified unit). On 23Apr2021 at 07:00 the patient experienced mild fever of 99.9 (unspecified unit), fatigue, swelling, tenderness of lymph node under left arm (lymph node tenderness) and headache. On the same day the patient also reported that period started 2 days early the day after the shot and slightly heavier bleeding (bleeding menstrual heavy) than usual. On 25Apr2021 3 days after the shot the patient had experienced migraine. The clinical outcome of events lymph node tenderness, swelling, bleeding menstrual heavy, headache, pyrexia, fatigue was recovered on an unspecified date in Apr2021; while that of the event migraine was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Menstrual disorder, Nausea, Pain
Clinical narrative: Abnormal periods; Body aches; Chills; Nausea; This is a spontaneous report from a non-contactable consumer, the patient. A 32-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration, in left arm on 31Mar2021 (at the age of 32-years-old) as single dose for COVID-19 immunisation. The patient had no medical history and did not receive any other medications within 2 weeks of vaccination. The patient had not received any other vaccines within four 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 an unknown date in 2021, the patient experienced chills, body aches, nausea and abnormal periods. The patient did not receive any treatment for the adverse events. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of chills, body aches, nausea and abnormal periods were unknown at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Red, slightly swollen circle around injection site about 1.5 to 2" in diameter.; Red, slightly swollen circle around injection site about 1.5 to 2" in diameter.; Painful when touched and warm to touch the injection site.; Painful when touched and warm to touch the injection site.; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: unknown) via an unspecified route of administration in the left arm on 19Apr2021 (at the age of 22-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient received other medications within 2 weeks of vaccination included bupropion (WELLBUTRIN) for an unspecified indication. The past drug history included amoxicillin for unspecified indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested positive for COVID-19. On 20Apr2021, the patient experienced red, slightly swollen circle around injection site about 1.5 to 2 in diameter and she had painful when touched and warm to touch the injection site. The clinical outcome of red, slightly swollen circle around injection site about 1.5 to 2 in diameter,  painful when touched and warm to touch the injection site were not resolved at the time of this report.  Information about lot/batch number cannot be obtained. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Asthenia, Chills, Decreased appetite, Diarrhoea
Clinical narrative: feels lightheaded; fever; chills; headache; stomach upset; could not eat; diarrhea; aches all over; weak; This is spontaneous report from contactable consumer. This consumer (patient) reported that a 78-years-old female patient received first dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, batch/lot Number: EW0170), (at the age of 78-years-old) via an unspecified route of administration on 28Apr2021 at 15:00 (Wednesday afternoon) on right arm as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated that after received shot she had been sick ever since. She has been taking two Tylenol every six hours. On 28Apr2021, the patient feels lightheaded when she gets up, fever and chills at night, headache, stomach upset, could not eat up until today and stated that she ate jello, diarrhea, stated that she did not known if she can drive or not that she was weak, aches all over and that the other day when she had the headache that Tylenol would not take it away. Stated that she was okay when she got it and it took 4 hours to get sick. Stated that she could not even drive. Stated that she had Covid on 28Jan2021 and waited 90 days to get the shot. The patient treated herself by using cold packs. The outcome of adverse events feels lightheaded, stomach upset, diarrhea, weak and aches all over was not recovered. On 29Apr2021, fever, chills were recovered. On 30Apr2021, headache was recovered. The outcome of adverse event could not eat was unknown.    No follow-up attempts are needed. No further information is expected.