chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Movement disorder, Pyrexia
Clinical narrative: First two doses of the shot did not affect her, this one threw her for a loop; Was not aware it would affect her so badly; have no appetite; exhausted; headache; low grade fever; dizziness; inner ear violent dizziness where the room went up and down; she received her booster dose; I was wired; Drenched in sweat; couldn't move the next day; Sick ever since; Did not sleep that night; This is a spontaneous report from a contactable consumer or other non hcp.   An 84-years-old female patient received bnt162b2 (BNT162B2 PFIZER BIOTECH MRNA COVID 19 SOLUTION FOR INJECTION (Batch/Lot number was not reported), dose 3 via an unspecified route of administration on 01Nov2021 (Batch/Lot number was not reported) as dose 3 (booster), single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that, The patient experienced sick ever since on 01Nov2021 with outcome of recovering , drenched in sweat on an unspecified date with outcome of not recovered , did not sleep that night on 01Nov2021 with outcome of recovering , couldn't move the next day on 02Nov2021 with outcome of recovering , first two doses of the shot did not affect her, this one threw her for a loop on an unspecified date with outcome of recovering , was not aware it would affect her so badly an unspecified date with outcome of recovering , have no appetite, exhausted, headache, low grade fever, dizziness, inner ear violent dizziness where the room went up and down, she received her booster dose, i was wired on an unspecified date with outcome of unknown.  The patient underwent lab tests and procedures which included body temperature: unknown results on low grade fever.    Follow up (10Nov2021): This is a follow up spontaneous report from a contactable consumer. This consumer reported in response to Non-HCP telephonic follow up activity which included the information.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Blister, Erythema, Interchange of vaccine products, Off label use
Clinical narrative: When he took off the band aid there was a blister under the band aid; towards the edge, not on the injection site.; The blister has popped and the area is red; Received Pfizer Covid 19 Vaccine Booster after one dose of Johnson and Johnson Covid Vaccine; Received Pfizer Covid 19 Vaccine Booster after one dose of Johnson and Johnson Covid Vaccine; This is a spontaneous report from a contactable consumer or other non hcp (patient's wife). A 48-years-old male patient received bnt162b2 (COMIRNATY, solution for injection, Lot number was not reported), via an unspecified route of administration on 04Nov2021 (at the age of 48 years) as dose 2 (booster), single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient illness at time of vaccination was none.  The patient received steroid injection in hip 2 weeks prior to Pfizer Covid Vaccine. Historical vaccine included Johnson and Johnson Covid 19 Vaccine on 07Apr2021 for covid-19 immunization, Lot Number: Provided as being either 042A21A or 042AZ1A and flu vaccine 2 weeks prior to Pfizer covid vaccine on Oct-21. On 05Nov2021, the patient experienced "when he took off the band aid there was a blister under the band aid; towards the edge, not on the injection site, the blister has popped and the area is red, received pfizer covid 19 vaccine booster after one dose of johnson and johnson covid vaccine on 04Nov2021. The area is red and is wondering if this is a normal side effect. Caller stated that she has no information available for the Pfizer Covid 19 Vaccine booster that her husband received yesterday.  She does not have the NDC, Lot Number, or Expiry Date. She reported that her husband's previous Covid 19 Vaccine was the Johnson and Johnson Vaccine.  Her husband was told that he could go ahead and get the Pfizer Vaccine as his booster. Event did not cause Emergency Room or Physician Office visit. Clinical outcome of the events was reported as unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Menstruation delayed, SARS-CoV-2 test
Clinical narrative: I am currently 10 days late following dose 3; I am currently 10 days late following dose 3; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 38-years-old non pregnant female patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Lot/Batch number was not reported), via an unspecified route of administration, administered in left arm on 26Oct2021 12:00 (at age of 38 years-old ) as dose 3 (Booster), single for COVID-19 immunisation. The patient also received first dose of Flu shot (FLU VACCINE VII, formulation: unspecified, Lot/Batch number was not reported) via an unspecified route of administration, administered in right arm on 26Oct2021 as dose 1, Single for unspecified indication.Patient medical history included: ADHD, anxiety disorder, smoker. Known allergies were reported as none. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Lot/Batch number was not reported), via an unspecified route of administration, administered in left arm on an unspecified date (at age of 38 years-old )as dose 1, single for COVID-19 immunisation and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Lot/Batch number was not reported), via an unspecified route of administration, administered in left arm on 21Apr2021 as dose 2, single for COVID-19 immunisation. Concomitant medication(s) included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) taken for an unspecified indication, start and stop date were not reported; citalopram (CITALOPRAM) taken for an unspecified indication, start and stop date were not reported; marijuana (MARIJUANA) taken for an unspecified indication, start and stop date were not reported.Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient been tested for COVID-19.The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On an unspecified date in 2021 the patient experienced that she was currently 10 days late following dose 3.The reporter assessed the case as non serious.No treatment was received for the events. The patient underwent lab tests and procedures which included COVID test (nasal swab): results was unknown in 2021. Outcome of the event was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Immunisation, Vaccination site erythema, Vaccination site mass, Vaccination site pain
Clinical narrative: "Covidarm" day two injection site red itchy swollen lump; "Covidarm" day two injection site red itchy swollen lump; "Covidarm" day two injection site red itchy swollen lump, getting larger; "Covidarm" day two injection site red itchy swollen lump, getting larger, hot to touch; "Covidarm" day two injection site red itchy swollen lump, getting larger, hot to touch and painful; Fatigue; The patient received the third/booster dose of BNT162b2; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the third (booster) dose of BNT162b2 (BNT162B2) (PFIZER-BIONTECH COVID-19 mRNA VACCINE Formulation: Solution for injection, Lot Number: FF2588) via an unspecified route of administration in the left arm on 03Nov2021 at 14:00 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included multiple sclerosis (MS) and hypothyroidism. The patient was allergic to sulfa, cooking oils and red dye. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included levothyroxine, lisinopril and hydrochlorothiazide (HCTZ), carbamazepine all for an unknown indication from an unknown date and unknown if ongoing. The patient previously received gabapentin and prednisone and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0187) via an unspecified route of administration in the right arm on 03Jul2021 at 17:00 (at the age of 45-years-old) and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FAC780) via an unspecified route of administration in the left arm on 21Jul2021 at 16:00 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. On 05Nov2021 at 07:00, the patient experienced covid arm injection site red itchy swollen lump, was getting larger, hot to touch and painful and had fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events were unknown at the time of this report.  Follow-Up (12Nov2021): Follow-up attempts are completed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site warmth
Clinical narrative: "Covidarm" day two injection site red itchy swollen lump; "Covidarm" day two injection site red itchy swollen lump; "Covidarm" day two injection site red itchy swollen lump, getting larger; "Covidarm" day two injection site red itchy swollen lump, getting larger, hot to touch; "Covidarm" day two injection site red itchy swollen lump, getting larger, hot to touch and painful; Fatigue; The patient received the third/booster dose of BNT162b2; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the third (booster) dose of BNT162b2 (BNT162B2) (PFIZER-BIONTECH COVID-19 mRNA VACCINE Formulation: Solution for injection, Lot Number: FF2588) via an unspecified route of administration in the left arm on 03Nov2021 at 14:00 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included multiple sclerosis (MS) and hypothyroidism. The patient was allergic to sulfa, cooking oils and red dye. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included levothyroxine, lisinopril and hydrochlorothiazide (HCTZ), carbamazepine all for an unknown indication from an unknown date and unknown if ongoing. The patient previously received gabapentin and prednisone and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0187) via an unspecified route of administration in the right arm on 03Jul2021 at 17:00 (at the age of 45-years-old) and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FAC780) via an unspecified route of administration in the left arm on 21Jul2021 at 16:00 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. On 05Nov2021 at 07:00, the patient experienced covid arm injection site red itchy swollen lump, was getting larger, hot to touch and painful and had fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events were unknown at the time of this report.  Follow-Up (12Nov2021): Follow-up attempts are completed. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Immunisation, Lymphadenopathy
Clinical narrative: General discomfort; Swollen glands beginning in the left armpit; dose number=3; administration date=02Nov2021; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 45-years-old male patient received bnt162b2 (BNT162B2, Formulation: Solution for injection), dose 3 via an unspecified route of administration, administered in Arm Left on 02Nov2021 (Batch/Lot Number: FF2590) as DOSE 3 (BOOSTER), SINGLE (at the age of 45-year-old) for covid-19 immunisation. There was no medical history included. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. The historical vaccine included BNT162B2 (Dose Number: 1, Batch/Lot No: ER8734, Location of injection: Arm Left on 08Apr2021 (at the age of 44-years-old) and Dose Number: 2, Batch/Lot No: EW0171, Location of injection: Arm Left) on 29Apr2021 (at the age of 44-years-old) for Covid-19 immunization. The patient had general discomfort and swollen glands beginning in the left armpit on 03Nov2021. No treatment received for AE. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovering.   Follow-up attempts are completed. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Asthenia, Immunisation, Malaise, Off label use, Pain in extremity
Clinical narrative: Moderate arm pain; lack of energy; generally feeling unwell; Flu shot vaccine date=05Nov2021; Booster; Flu shot vaccine date=05Nov2021; This is a spontaneous report received from a contactable consumer (patient) or other non hcp.   A 34-years-old non pregnant female patient received bnt162b2 (COMIRNATY, Formulation: solution for injection), dose 3 via an unspecified route of administration, administered in Arm Left on 05Nov2021 10:45 (at the age of 34-years-old) (Batch/Lot Number: FF8841) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), via an unspecified route of administration from 05Nov2021 (Batch/Lot number was not reported) to 05Nov2021, at DOSE NUMBER UNKNOWN, SINGLE on left arm for an unspecified indication. Medical history included sulfa allergy. Patient was not pregnant at the time of vaccination. Patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination the patient has not been tested for COVID-19. Historical vaccine included Comirnaty dose 1 Batch/Lot No: EL3247, Location of injection: Arm Left, Vaccine Administration Time 14:00 on 05Feb2021 (at the age of 33-years-old) and dose 2 Batch/Lot No: EL3247 Location of injection: Arm Left Vaccine Administration Time: 14:00 on 26Feb2021 (at the age of 33-years-old). Concomitant medication included NEXPLANON taken for an unspecified indication and patient was received NEXPLANON within 2 weeks of vaccination. The patient had previously taken Morphine and experienced allergy. The patient had taken flu shot and booster dose on same day as on 05Nov2021. Patient experienced moderate arm pain, lack of energy, generally feeling unwell all on 05Nov2021 11:15 AM. Patient was not received treatment for adverse events. The outcome of events Moderate arm pain, lack of energy, generally feeling unwell was Recovering.  Follow-up attempts are completed. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Product use issue
Clinical narrative: Moderate arm pain; lack of energy; generally feeling unwell; Flu shot vaccine date=05Nov2021; Booster; Flu shot vaccine date=05Nov2021; This is a spontaneous report received from a contactable consumer (patient) or other non hcp.   A 34-years-old non pregnant female patient received bnt162b2 (COMIRNATY, Formulation: solution for injection), dose 3 via an unspecified route of administration, administered in Arm Left on 05Nov2021 10:45 (at the age of 34-years-old) (Batch/Lot Number: FF8841) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), via an unspecified route of administration from 05Nov2021 (Batch/Lot number was not reported) to 05Nov2021, at DOSE NUMBER UNKNOWN, SINGLE on left arm for an unspecified indication. Medical history included sulfa allergy. Patient was not pregnant at the time of vaccination. Patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination the patient has not been tested for COVID-19. Historical vaccine included Comirnaty dose 1 Batch/Lot No: EL3247, Location of injection: Arm Left, Vaccine Administration Time 14:00 on 05Feb2021 (at the age of 33-years-old) and dose 2 Batch/Lot No: EL3247 Location of injection: Arm Left Vaccine Administration Time: 14:00 on 26Feb2021 (at the age of 33-years-old). Concomitant medication included NEXPLANON taken for an unspecified indication and patient was received NEXPLANON within 2 weeks of vaccination. The patient had previously taken Morphine and experienced allergy. The patient had taken flu shot and booster dose on same day as on 05Nov2021. Patient experienced moderate arm pain, lack of energy, generally feeling unwell all on 05Nov2021 11:15 AM. Patient was not received treatment for adverse events. The outcome of events Moderate arm pain, lack of energy, generally feeling unwell was Recovering.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: he has symptoms like Guillain-Barre; The initial case was missing the following minimum criteria: unspecified AE. Upon receipt of follow-up information on [10Nov2021], this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient's friend). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation.  The patient medical and concomitant medications were not reported. It was reported that the patient (friend of the reporter) that was hospitalized after receiving the first dose of the Pfizer Biontech covid 19 vaccine. As of 10Nov2021 the reporter noted that she doesnt have much information, the patient is not her son, she just knows he has symptoms like Guillain-Barre for the last 11 days after the booster shot (as reported). The outcome of the event was unknown.   Follow-up attempts completed; information about lot/batch number cannot be obtained. No further information expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Immunisation, Pyrexia
Clinical narrative: Fever; Chills; Headache; The patient received third dose of BNT162b2; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: 301558A) via an unspecified route of administration in the left arm on 13Oct2021 at 16:15 (at the age of 57-years-old) as a dose 3 (booster), single for COVID-19 immunisation. The medical history was not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The concomitant medications received within two weeks of vaccination included losartan (MANUFACTURER UNKNOWN) and colecalciferol (VITAMIN D3) both for unknown indications from unknown dates and unknown if ongoing. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EL1284) via an unspecified route of administration in the left arm on 30Dec2020 at 14:30 as dose 1, single and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EL1283) via an unspecified route of administration in the right arm on 16Jan2021 at 12:00 as dose 2, single for COVID-19 immunization. On 14Oct2021 at 04:30, the patient experienced fever, chills and headache. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of events fever, chills and headache were resolved on an unknown date in 2021.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Immunisation, Pain in extremity
Clinical narrative: Booster dose two weeks ago; Pain in my arm; I am having very bad chills; This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received third dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch number: not reported/ Lot Number: EW0186) via an unspecified route of administration on an unspecified date in Oct2021 (reported as two weeks ago) as dose 3 (booster), single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included, patient previously received dose 1 and dose 2 of COVID-19 Vaccine (unknown manufacturer) via an unspecified route of administration, on unspecified dates for covid-19 immunization. On an unspecified date in Oct2021, booster dose two weeks ago was reported. On an unspecified date in Oct2021, patient experienced pain in the arm and patient was having very bad chills. Patient reported that patient had no reaction from first two shots patient had, patient was still having pain in the arm and patient was having very bad chills, patient had called the primary care doctor. Patient also asked have you ever heard anyone having a reaction last 2 weeks and reported that patient was having a reaction that lasted for 2 weeks. Outcome of the events pain in my arm and I am having very bad chills was not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Immunisation
Clinical narrative: Booster Comirnaty; Tired; Chills; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received bnt162b2 (COMIRNATY, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received dose 1 and dose 2 of COVID-19 Vaccine (unknown manufacturer) on unspecified dates for covid-19 immunisation. The patient reported he became very tired and had chills the day after booster Comirnaty vaccination on an unspecified date. Event took place after use of product. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 59.0
Sex: U
Vaccine: COVID19, UNK
Symptoms: Fatigue, Immunisation
Clinical narrative: I'm kind of tired; I got the booster shot the third one is it 6 months or it is 8 months; This is a spontaneous report from a contactable consumer (patient). A 59-years-old patient of an unspecified gender received the third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 2021 (Batch/Lot number was not reported,at the age of 59-years-old) as single dose for covid-19 immunisation; estrogens conjugated (PREMARIN), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication.  The patient medical history and concomitant medications were not reported. The patient previously received the first and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number not provided) via an unspecified route of administration on unspecified dates at single dose for covid-19 immunisation. The patient experienced I got the booster shot the third one is it 6 months or it is 8 months on 2021, I'm kind of tired on 08Nov2021. The patient stated, "I got the booster shot the third one is it 6 months or it is 8 months you have to wait?" Advised would have to transfer call to have that answered and patient stated, "No I'm kind of tired today." The outcome of the event I'm kind of tired was unknown.    The lot number for BNT162B2, was not provided and will be requested during follow up.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Immunisation, Menstrual disorder, Menstruation irregular, Pain in extremity
Clinical narrative: booster.; mild headache; sore arm; developed irregular spotting; Periods have stopped; This is a spontaneous report from a contactable Other Healthcare professional (patient). A 40-year-old non-pregnant female patient received third dose of bnt162b2 (FIZER-BIONTECH COVID-19 VACCINE, Lot number: FF8841), via intramuscular route, administered in arm left on 08Oct2021 (at the age of 40-year-old) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EX0904), via intramuscular route, administered in arm left on 06Apr2021 (at the age of 40-year-old) and second dose of bnt162b2 (FIZER-BIONTECH COVID-19 VACCINE, Lot number: FA9091), via intramuscular route, administered in arm left on 26Jun2021 (at the age of 40-year-old), both doses for COVID-19 immunization and after second dose experienced sore arm and fever. The patient had no known allergies. Prior vaccinations within 4 weeks and other medications within 2 weeks were reported as none. The patient was not diagnosed with COVID-19 prior to vaccination. Since vaccination patient was not tested for COVID-19. On 08Oct2021, the patient experienced mild headache, sore arm, developed irregular spotting and periods had stopped. Clinical course: No to-very mild immediate side effects: sore arm, fever (controlled by Tylenol in 2 hours)-second dose mild headache, sore arm-booster. Booster mistakenly was done at 3 months after 2nd dose. Noticing since 2nd dose and especially after booster, I find a connection in affecting my menstrual cycle. Periods have stopped, developed irregular spotting. Adverse events required physician office visit. Treatment received for the adverse events was reported as unknown. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Intermenstrual bleeding, SARS-CoV-2 test, Ultrasound scan, Uterine leiomyoma
Clinical narrative: fibroids on uterus; extremely heavy bleeding; intermittent bleeding; This is a spontaneous report from a contactable consumer(patient).  The 38-years-old non-pregnant female patient received bnt162b2 (Pfizer COVID 19), dose 2 via an unspecified route of administration, administered in Arm Right on 15Feb2021 at her 38-years-old (Lot Number: EL3249) as dose 2, single for covid-19 immunisation.  The patient medical history includes did not menstruate monthly. Concomitant medication included levonorgestrel (MIRENA) taken for did not menstruate monthly, start and stop date were not reported. Historical Vaccine included first dose bnt162b2(dose 1, lot number=EN6201 on Left arm) for COVID-19 immunization on 22Jan2021 at her 38-years-old and experienced menstruating heavily and intermittent bleeding. No other vaccine in four weeks. The patient experienced fibroids on uterus, extremely heavy bleeding, intermittent bleeding and on Feb2021.  The patient underwent lab tests and procedures which included Nasal Swab: negative on unknown date, ultrasound scan: fibroids on uterus on unknown date.  AEs resulted in Emergency Room Visit and Physician Office Visit. Treatment received for all events included Surgery. No Covid prior vaccination. Covid had been tested post vaccination via Nasal Swab with negative result. The clinical course was reported as follows: None of these problems happened prior to getting the first dose of the COVID vaccine. She did not menstruate monthly because of prescription Mirena. She had the first dose of COVID-19 vaccine on 22Jan2021, and 24 hours after the first shot, she began menstruating heavily. She subsequently was intermittingly bleeding every day. On 15Feb2021, she had second dose of COVID-19 vaccine. 24 hours after the second shot, she had very heavy bleeding and in the days after, she had intermittent bleeding that did not stop. She was very concerned because she typically do not have this happened, so she scheduled an appointment with OBGYN for an exam. She had an ultrasound done, found out she had fibroids on uterus. She had to have surgery On 18Aug2021 to try and stop the bleeding. The fibroids were too dense and could not be removed. On 03Nov2021, she ended up in the emergency room for extremely heavy bleeding. She will likely have to have a standard hysterectomy to fix this problem. Outcome of events was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101555770 Same reporter/RA, similiar events, Different dose
Age: 61.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Immunisation, Off label use, Product use issue, Pulmonary embolism
Clinical narrative: Pt had unprovoked pulmonary embolism 3 weeks after booster vaccine with pfizer.; third dose; Also received flu vaccine on the same date; Also received flu vaccine on the same date; This is a spontaneous report from a contactable Physician. A 61-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 3 via an unspecified route of administration on 20Oct2021 (Batch/Lot number was not reported) at the age of 61-years-old as single dose for covid-19 immunisation; influenza vaccine (INFLUENZA), via an unspecified route of administration on 20Oct2021 (Batch/Lot number was not reported) at single dose for immunization. Medical history included type 2 diabetes mellitus. No Covid prior vaccination. No known allergies. The patient's concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 01Mar2021 (Batch/Lot number was not reported) at the age of 60-years-old; dose 2 via an unspecified route of administration on 01May2021 (Batch/Lot number was not reported) at the age of 61-years-old for covid-19 immunisation. On 09Nov2021, patient had unprovoked pulmonary embolism 3 weeks after booster vaccine with Pfizer. Also received flu vaccine on the same date. The event resulted in hospitalization for one day. The patient received treatment: anticoagulation for the event. Outcome of the event pulmonary embolism was recovered with sequel.  The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported events of Immunisation and Pulmonary embolism. 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: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for covid; tested positive for covid; This is a spontaneous report from a contactable consumer (patient) via . A 55-years-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration, administered in Arm Left on 27Jul2021 14:30 (Batch/Lot number was not reported) at the age of 55-years-old as single dose for covid-19 immunisation. Medical history was none. No family medical history relevant to the event. There were no concomitant medications. No prior vaccinations (within 4 weeks). No history of previous immunization with the Pfizer vaccine considered as suspect. The patient got the first dose of the Pfizer Covid-19 vaccine and about a month later she actually got Covid. On 31Aug2021, she thought it was sometime around there, she tested positive for covid. She wanted to know what was the longest time between the first and second dose and if she should get the second dose or start over.  The event did not require a visit to emergency room or physician office. The patient underwent lab tests and procedures which included Covid test on 31Aug2021: positive. Outcome of the events was unknown.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, UNK, COVID19
Symptoms: Blood test, Blood thyroid stimulating hormone decreased, Immunisation, Off label use, Vitamin D increased
Clinical narrative: level of Vitamin D went up a little bit; decrease in her TSH level to 0.408; booster dose; Off label use; This is a spontaneous report from a contactable consumer (patient).   A 73-years-old female patient received BNT162B2 (COMIRNATY, solution for injection), dose 3 via an unspecified route of administration on 02Nov2021 (Batch/Lot number was not reported) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation (Booster) and thyroid (THYROID), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) and ongoing, at unspecified dose for an unspecified indication.  The patient's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (COMIRNATY, solution for injection), dose 1 and dose 2 via an unspecified route of administration on unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE and DOSE 2, single for covid-19 immunisation. Reporter stated on 02Nov2021 she got the booster dose. Also she said that she was not sick after getting the booster. Reporter stated on 08Nov2021, a week later, she got her blood test done, that showed that her level of Vitamin D went up a little bit and a decrease in her TSH level to 0.408, and her doctor said that "It could" due to the vaccine but was not sure. Reporter asked if the vaccine could take her TSH level to go down. Patient underwent lab tests include blood test done, that showed that her level of Vitamin D went up a little bit and a decrease in her TSH level to 0.408 on 08Nov2021. At the time of this report, the outcome of event was unknown.  The lot number for the vaccine, (BNT162B2) was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, UNK, COVID19
Symptoms: Blood thyroid stimulating hormone, Blood thyroid stimulating hormone abnormal, Immunisation
Clinical narrative: level of Vitamin D went up a little bit; decrease in her TSH level to 0.408; booster dose; Off label use; This is a spontaneous report from a contactable consumer (patient).   A 73-years-old female patient received BNT162B2 (COMIRNATY, solution for injection), dose 3 via an unspecified route of administration on 02Nov2021 (Batch/Lot number was not reported) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation (Booster) and thyroid (THYROID), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) and ongoing, at unspecified dose for an unspecified indication.  The patient's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (COMIRNATY, solution for injection), dose 1 and dose 2 via an unspecified route of administration on unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE and DOSE 2, single for covid-19 immunisation. Reporter stated on 02Nov2021 she got the booster dose. Also she said that she was not sick after getting the booster. Reporter stated on 08Nov2021, a week later, she got her blood test done, that showed that her level of Vitamin D went up a little bit and a decrease in her TSH level to 0.408, and her doctor said that "It could" due to the vaccine but was not sure. Reporter asked if the vaccine could take her TSH level to go down. Patient underwent lab tests include blood test done, that showed that her level of Vitamin D went up a little bit and a decrease in her TSH level to 0.408 on 08Nov2021. At the time of this report, the outcome of event was unknown.  The lot number for the vaccine, (BNT162B2) was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: she was diagnosed with COVID 5 month after receiving her second shot of the Pfizer Covid Vaccine; she was diagnosed with COVID 5 month after receiving her second shot of the Pfizer Covid Vaccine; This is a spontaneous report from a contactable consumer (patient). This 65-years-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single, dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported. Historical vaccine included pneumonia vaccine on 23Aug2021 for immunization. Patient stated 5 month after the 2nd dose of the Pfizer Covid Vaccine she got COVID.  She received pneumonia vaccine 23Aug2021 and had the antibody treatment 29Aug2021 and was told she could not get the booster dose until 90 days after antibody treatment. It has been about 73 days since the antibody treatment. Patient stated she was diagnosed with COVID 5 month after receiving her second shot of the Pfizer Covid Vaccine (purple top). The outcome of the events was unknown.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Immunisation, Vertigo
Clinical narrative: weakness which got a little bit worse; dizziness gotten worst; whenever she bends she gets a "sweeney head"/ if she bends over she gets swimmy headed; booster; This is a spontaneous report from a contactable consumer (patient). A 88-year-old female patient received third dose of bnt162b2 (COMIRNATY, Formulation: Solution for injection, Lot number: FF2593), via an unspecified route of administration, administered on 07Nov2021 at 01:30 (at the age of 88-year-old) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization. The patient medical history included cholesterol. Concomitant medication included FENOFIBRATE 160 mg for cholesterol; she is pretty healthy and she only takes one medication for cholesterol, Fenofibrate. Historical vaccine included first dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: EL9269), via an unspecified route of administration, administered on 04Feb2021 (at the age of 88-year-old) as DOSE 1, SINGLE and second dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: EN6205), via an unspecified route of administration, administered on 25Feb2021 (at the age of 88-year-old) as DOSE 2, SINGLE for COVID-19 immunization. On 08Nov2021, the patient experienced weakness which got a little bit worse, dizziness gotten worst and whenever she bends, she gets a "sweeney head"/ if she bends over, she gets swimmy headed. The patient reported that she went and had the 1st and 2nd dose of the vaccine and then she went on Sunday to get the booster and ever since then she has had weakness and dizziness and she is wondering how long it will last. She says that she was even fine up until she got her booster. She has still been going, but her legs are weak, and she gets dizzy when she gets up and bends over. This began when she got up Monday, confirmed to be 08Nov2021. She got her booster at about 1:30 on Sunday, 07Nov2021, and she was doing alright until she got up on Monday morning. She keeps a walker beside her bed that used to belong to her husband, and she had to grab it because she was so dizzy. She believes that she is a little worse today as far as the weakness. The dizziness gets better up in the day but if she bends over, she gets swimmy headed. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Swelling, Urticaria
Clinical narrative: swelling all over his body for 4 days; developed hives; This is a spontaneous report from a contactable consumer (patient mother). This 12-years-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  Reporter was the mother of a 12 year old boy who received the Pfizer Covid vaccine. 24 hours after he developed hives and swelling all over his body for 4 days. He was seen in the emergency room. The outcome of the events was unknown.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Immunisation
Clinical narrative: Atrial fibrillation; BOOSTER; This is a spontaneous report from a contactable consumer (patient's daughter).  A 69-years-old male patient (reporter's father) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 3 via an unspecified route of administration on 22Oct2021 at age of 69-years-old as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose and second dose of COVID-19 vaccine for Covid-19 immunization (Primary Immunization series complete but unknown manufacturer). The reporter was reporting on the Pfizer Covid 19 vaccine. She explained her father just got the booster about 1-2 weeks ago and less than 2 days had to go to ER for atrial fibrillation and never he had never had this diagnosis before the shot. The booster shot was given on 22Oct2021. Caller stated her father was treated an released on 08Nov2021, he got there about 6am. When he left he was still in atrial fibrillation when he left and was to follow up with the cardiologist. The outcome of the events was unknown.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness, Vision blurred
Clinical narrative: vision loss; 30% of left eye is blurry; This is a spontaneous report from a contactable other hcp (Patient). This 28-year-old female non pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) Arm Left on 10Nov2021 15:30 at age of 28-year-old as DOSE 1, SINGLE (lot number: FG3527) for COVID-19 immunisation. Medical history included Asthma. No covid prior vaccination. Concomitant durg included budesonide (PULMICORT). No other vaccine in four weeks. She experienced Left eye vision loss. 70% of vision was gone for about an hour. What I could see looked like tv static. Currently approximately 30% of left eye is blurry and almost looks like items are moving forward on 10Nov2021 08:45 PM. No covid tested post vaccination. No treatments received. Outcome of the events were not recovered.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the events Blindness ,Vision blurred and suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Immunisation, Tinnitus
Clinical narrative: her tinnitus is really really bad; her tinnitus is really really bad; Booster; This is a spontaneous report from a contactable consumer (patient).   A 73-years-old female patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: 320308D), via an unspecified route of administration, administered in Arm Right on 04Nov2021 at 13:45 (at the age of 73-years-old) as dose 3 (booster), single for covid-19 immunisation. Medical history included ongoing tinnitus. Concomitant medication included influenza vaccine inact sag 4v (FLUAD QUAD, Lot number: 312828), received within 4 weeks prior to the vaccination, administered in right arm taken for an unspecified indication on 18Oct2021. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EK4231), via an unspecified route of administration on 30Jan2021 (at the age of 72-years-old) as dose 1, single and received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: ENU207), via an unspecified route of administration on 20Mar2021 (at the age of 72-years-old) as dose 2, single both doses for covid-19 immunisation. The patient did not receive any other additional vaccine on same date of the pfizer suspect. On 06Nov2021, the patient experienced her tinnitus was really really bad. Her tinnitus WAS really really bad was reported as worsened. Patient stated since she got that shot on 04Nov2021, her tinnitus was really really bad. She has had tinnitus for at least 20 years but it has been mild and then it has increased and was really loud. The patient did not required emergency room or physician office visit. Patient Stated that the tinnitus was ongoing and had been at a steady loud rate and that was noticed on 06Nov2021 after the booster vaccine. The outcome of the event was not recovered.  Follow-up attempts are completed. No further information is expected.