chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pyrexia, Vomiting
Clinical narrative: Headache; Fever; Vomiting; This is a spontaneous report from a non-contactable consumer, the patient. A 21-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206), via an unspecified route of administration in the left arm on 13Mar2021 at 14:45 as a second dose, single for COVID-19 immunization. The patient's medical history was not reported. It was not known whether the patient was diagnosed with COVID-19 prior to vaccination. It was reported that the patient was not pregnant at the time of vaccination. The patient did not have any allergies to medications, food, or other products. The patient's past drug history included BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW6200), via an unspecified route of administration in the left arm on 19Feb2021 at 09:45 as a first dose, single for COVID-19 immunization. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. The patient has not tested for COVID-19 since having the vaccine. The patient's concomitant medications taken within two weeks of vaccination included Tylenol (MANUFACTURER UNKNOWN), Advil (MANUFACTURER UNKNOWN), Sambucus (MANUFACTURER UNKNOWN) all from and to an unknown date and for an unknown indication. On 14Mar2021 at 01:00 (as reported), the patient experienced fever, body temperature reported as of 105.7 (unspecified unit), vomiting and headache. Therapeutic measures were not taken for the events (fever, vomiting and headache). The clinical outcome of the events fever, vomiting and headache were not recovered. No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: patient developed COVID; patient developed COVID; This is a spontaneous report from a Pfizer-sponsored program. A contactable Physician reported for a patient that: The patient of unspecified age and gender received first dose of BNT162B2 ( Solution for injection, Batch/Lot Number: Unknown; Expiration Date: Unknown) via an unspecified route of administration, on 13Feb2021 as 1st dose, single for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient developed COVID  on an unspecified date after the administration of the vaccine. It was reported that physician had a patient who already got the first dose of the Pfizer vaccine on 13Feb2021. Subsequently her patient developed COVID and was wondering when the patient can get the 2nd dose or if there is any timeframe. Outcome of events was unknown. On Follow-up (18Mar2021): This is a follow-up spontaneous report received in response to mail trail sent regarding the confirmation of below mentioned query. This report included that: Query received as an Attachment which included as an escalated comment from 15Mar2021. Reference as a source document with a medical inquiry. Response received as This email is to confirm receipt of inquiry. Please see case for details.  Information on the lot/batch number has been requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the Lack of efficacy, COVID-19 Positive and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE)
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for Covid-19 last Friday; This is a spontaneous report from a contactable consumer or other non hcp (patient) via Pfizer. A male patient of an unspecified age received first dose of BNT162B2 (COMIRNATY, solution for injection, lot number and expiration date were not reported) via an unspecified route of administration on 04Mar2021 as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was tested positive for Covid-19 last Friday on 12Mar2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 12Mar2021. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph nodes on head - preauricular nodes.; This is a spontaneous report from a contactable Other healthcare professional. A 44-year-old female patient received BNT162B2 (BNT162B2; Lot number: UNKNOWN) in the left arm on 06Mar2021 at 12:15 (at the age of 44-years-old) as single dose for COVID-19 immunization. Medical history included penicillin allergy. The patient did not receive any vaccination within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19 and had not been tested for COVID-19, since vaccination. Concomitant medication included Levothyroxine (MANUFACTURER: UNKNOWN) from an unknown date to an unknown date for an unknown indication. On 11Mar2021, the patient experienced swollen lymph nodes on head - preauricular nodes, swollen began 5 days post vaccine and still present 11 days later. It was unknown if patient received any treatment for swollen lymph nodes on head - preauricular nodes. The clinical outcome of swollen lymph nodes on head-preauricular nodes was not recovered not resolved. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose increased
Clinical narrative: Elevated blood sugars minimally affected by insulin intake.; This is a spontaneous report received from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: Unknown), as a single dose via an unspecified route of administration in the left arm on 17Mar2021 at 09:15 AM (at the age of 29 years old) for COVID-19 immunisation. The patient did not have any allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's medical history included type 1 diabetes. The patient concomitant medications Levothyroxine, Errin, Novolog, Wellbutrin within two weeks of vaccination. The patient visited to pharmacy or drug Store for COVID-19 vaccination. Since the vaccination, the patient had not been tested positive for COVID-19. On 17Mar2021, the patient had elevated blood sugars minimally affected by insulin intake. Corrective treatment included highly increased insulin therapy. The clinical outcome of the event was reported as not resolved at the time of report. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Slight soreness in  left arm where the shot was administered; This is a spontaneous report from a non-contactable consumer, patient. A 32- year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch number: EN6208) via unspecified route of administration in the left arm on 16Mar2021 at 11:45 pm as a first dose for COVID-19 immunisation (Age at vaccination: 32 Years). Medical history and concomitant medications were not provided. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 16Mar2021 patient had experienced Slight soreness in his left arm where the shot was administered. The patient did not receive any treatment for the event. The clinical outcome of event was recovering at time of reporting. No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoacusis
Clinical narrative: I have noticed a decrease in hearing acuity. I find myself asking people to repeat things because I didn't hear it clearly.; This is a spontaneous report received from a contactable health care professional.   A 53-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: EL3248) via intramuscular route of administration on the left arm on 20Jan2021 at 12:00 as single dose for COVID-19 vaccination and the patient also received first dose of BNT162B2 (BNT162B2); Lot/batch no: (EL1284) via intramuscular route of administration on the left arm on 31Dec2020 at 11:00 as a single dose for COVID-19 vaccination. Medical history was not reported. Concomitant medications included bupropion for an unknown indication since an unspecified date and is unknown if ongoing. Prior to 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 4 weeks prior to the vaccine. The patient was not allergic to medication, food, or other products. On an unknown date in Feb2021, the patient had noticed a decrease in hearing acuity and she find herself asking people to repeat things because she did not hear it clearly . It was unknown whether the patient received therapeutic measures for the event. The clinical outcome of the event decreased hearing was not resolved at the time of this report. No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: Moderate Back pain; This is a spontaneous report from a contactable other health care professional, the patient. A 44 year old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9262) via an unspecified route of administration, in right arm as 2nd dose, single, on 15MAR2021 (at the age of 44-years-old) 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. Patient past drug history include BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9269) via an unspecified route of administration, in right arm as 1st dose, single, on 22FEB2021 at 14:30 for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine and did not receive other medications within 2 weeks of vaccination. On 16MAR2021 after vaccination, the patient experienced moderate Back pain. Patient was treated with tylenol for event. Clinical outcome of the event moderate back pain was reported as recovered.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Diarrhoea, Dizziness, Hyperhidrosis, Nausea
Clinical narrative: sweating on left arm at injection site; vomitting; nauseous; feeling like to pass out; immediate abdominal pains; Diarrhea; This is a spontaneous report from a non- contactable consumer, a patient.   A 27-year-old Female patient received a single dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE) ( Lot number = not known) via an unspecified route of administration in the left arm on 09Mar2021(at the age of 27-years-old) at 06:30pm as a first dose for COVID-19 vaccination. Medical history included that patient was allergic to penicillin bee. Concomitant medications were not reported. The patient did not receive any other vaccine within four weeks prior to the vaccination. Since the vaccination, patient had not tested positive for covid-19. On 09Mar2021, within two minutes after vaccination, patient experienced sweating and immediate abdominal pain. She also felt like she was going to pass out and was nauseous and sick with vomiting and diarrhea and after putting water on her face and drinking Gatorade it slowly started to pass. she was told it was an anxiety attack. The patient had recovered from the events at the time of reporting. Information about lot/batch number cannot be obtained as it was unable to locate or read the details and no further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: sweating on left arm at injection site; vomitting; nauseous; feeling like to pass out; immediate abdominal pains; Diarrhea; This is a spontaneous report from a non- contactable consumer, a patient.   A 27-year-old Female patient received a single dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE) ( Lot number = not known) via an unspecified route of administration in the left arm on 09Mar2021(at the age of 27-years-old) at 06:30pm as a first dose for COVID-19 vaccination. Medical history included that patient was allergic to penicillin bee. Concomitant medications were not reported. The patient did not receive any other vaccine within four weeks prior to the vaccination. Since the vaccination, patient had not tested positive for covid-19. On 09Mar2021, within two minutes after vaccination, patient experienced sweating and immediate abdominal pain. She also felt like she was going to pass out and was nauseous and sick with vomiting and diarrhea and after putting water on her face and drinking Gatorade it slowly started to pass. she was told it was an anxiety attack. The patient had recovered from the events at the time of reporting. Information about lot/batch number cannot be obtained as it was unable to locate or read the details and no further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Throat irritation
Clinical narrative: Extremely sore and swollen glands; Itchy throat; This is a spontaneous report received from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 12Mar2021 at 04:30 PM (at the age of 50-years-old) as a single dose for COVID-19 immunisation. No relevant medical history given. The patient reported of no known allergies. Concomitant medications include Magnesium (MANUFACTURER UNKNOWN), Levoxyl (MANUFACTURER UNKNOWN), Advil (MANUFACTURER UNKNOWN), Tylenol (MANUFACTURER UNKNOWN), Benedryl (MANUFACTURER UNKNOWN) for an unknown indication and unknown date. Patient had no symptoms associated with COVID-19 and not had a COVID-19 test. On 12Mar2021, the patient experienced itchy throat approximately 30-35 minutes after receiving the vaccination. On 14Mar2021, the patient experienced extremely sore and swollen glands on the back of neck. No treatment was received for the itchy throat and extremely sore and swollen glands. The clinical outcome of the event itchy throat & extremely sore and swollen glands was not recovered. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Migraine, Neck pain
Clinical narrative: Moderate fatigue (greater than 36 hours); Muscle aches on left side of neck; Migraine-like headache (great than 36 hours); This is a spontaneous report from a contactable pharmacist. A 47-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE); Lot/batch no: EN6208) via unspecified route of administration in the left arm, as a single dose on 14Mar2021 at 15:15 (at the age of 47-years-old) for COVID-19 immunisation. The patients medical history included migraines, depression and anxiety. The patient was allergic to erythromycin. Concomitant medications included Prozac, Claritin, Alprazolam and glucosamine taken within two weeks of vaccination for unknown indications. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not been tested for COVID-19. On 14Mar2021, the patient developed migraine-like headache (greater than 36 hours), muscle aches on left side of neck (injection in left arm) and moderate fatigue (greater than 36 hours). The patient received Motrin as treatment for the adverse events. The clinical outcome of the events migraine-like headache, muscle aches on left side of neck and fatigue was resolving at the time of report. Action taken with BNT162B2 was not applicable No follow-up attempts are needed. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Swelling face
Clinical narrative: facial swelling; face rash; This is a spontaneous report from a non- contactable consumer, the patient. A 26 -year-old non pregnant female patient received BNT162B2 (PFIZER -BIONTECH COVID-19 mRNA VACCINE; Lot/Batch number: Ep-7534), via an unspecified route of administration on left arm on 15March2021 at 4.30 pm as second dose of COVID-19 immunization. The patient past drug history included BNT162B2(PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot/Batch Number: En6203) on 23Feb2021 at 4.30 pm. No concomitant medications were reported. Prior to the vaccination patient was not diagnosed with COVID-19. Since the vaccination patient was not tested for COVID-19. On 16March 2021 the patient experienced face rash and facial swelling. Therapeutic measures taken for the adverse events was unknown. Clinical outcome of the events face rash and facial swelling was recovering/resolving at the time of reporting. No follow up attempts are needed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Vomiting
Clinical narrative: Vomiting; Sudden onset Diarrhea; Chills; This is a spontaneous report from a non-contactable consumer, the patient. A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via unspecified route of administration on 12 Mar 2021 (at the age of 39-years-old) at 12:00 in the right arm for COVID-19 immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included birth control and celexa medications. Patient was allergic to sulfa drugs. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 15 Mar2021, the patient experienced sudden onset diarrhea for several hours, chills and vomiting (once). The patient did not receive any treatment for the adverse events. The clinical outcome of the events was recovered. Information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: she had the symptoms of COVID after the vaccination; This is a spontaneous report from a contactable consumer, the patient received via a Pfizer-sponsored program. A female patient of an unspecified age received first dose of BNT162B2 (Pfizer-Biontech COVID-19 mRNA vaccine, solution for injection) via an unspecified route of administration on 10Mar2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that patient had 1st dose of Pfizer COVID-19 vaccine last Wednesday which was 10Mar2021 and she had the symptoms of COVID after the vaccination. Now she was asking if how long the symptoms would last. The outcome for the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Menstruation irregular, Muscle spasms, Pain in extremity
Clinical narrative: severe cramping; early start of mensuration; Burning sensation on left side of face; pain in leg; This is a spontaneous report received from a contactable consumer (patient) reported for herself. This contactable 27 year-old female patient received the first dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in arm left on 26Mar2021 09:00 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included attention deficit disorder (ADD) and anxiety. The patient did not have allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included amfetamine aspartate / amfetamine sulfate / dexamfetamine saccharate / dexamfetamine sulfate (ADDERALL); piroxicam (PAXIL); lorazepam. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced burning sensation on left side of face and pain in leg, both approximate 20 minutes after shot on 26Mar2021. The patient also had severe cramping and early start of mensuration  on 27Mar2021 13:00. No treatment was received for the adverse event. The outcome of the events was not recovered. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Herpes zoster, Lymphadenopathy, Malaise
Clinical narrative: tiredness; headache; muscle pain; feeling unwell; swollen lymph nodes; hives with pain in them; pain; I got Shingles; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received bnt162b2 (BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in right arm on 03Mar2021 13:15 (also reported 15Mar2021 13:30) (Batch/Lot Number: ENG198) (at the age of 60 years old) as 1st dose, single for COVID-19 immunisation. Medical history included stage 3 kidney disease and thyroid disorder. The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was in doctor's office/urgent care. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that patient had other medications received within 2 weeks of vaccination (unspecified). On 03Mar2021, the patient experienced tiredness, headache, muscle pain, feeling unwell, swollen lymph nodes, hives with pain in them, pain and she got shingles. The events resulted in doctor or other healthcare professional office/clinic visit. The treatment received for the adverse event included Valtrex, anti biotic and creme. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the event shingles was unknown; and not recovered outcome for the other events.  No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain, Urticaria
Clinical narrative: tiredness; headache; muscle pain; feeling unwell; swollen lymph nodes; hives with pain in them; pain; I got Shingles; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received bnt162b2 (BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in right arm on 03Mar2021 13:15 (also reported 15Mar2021 13:30) (Batch/Lot Number: ENG198) (at the age of 60 years old) as 1st dose, single for COVID-19 immunisation. Medical history included stage 3 kidney disease and thyroid disorder. The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was in doctor's office/urgent care. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that patient had other medications received within 2 weeks of vaccination (unspecified). On 03Mar2021, the patient experienced tiredness, headache, muscle pain, feeling unwell, swollen lymph nodes, hives with pain in them, pain and she got shingles. The events resulted in doctor or other healthcare professional office/clinic visit. The treatment received for the adverse event included Valtrex, anti biotic and creme. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the event shingles was unknown; and not recovered outcome for the other events.  No follow-up attempts are needed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Dizziness, Ear disorder, Fatigue, Headache
Clinical narrative: pressure behind ears; Jaw pain; sore throat; fatigue; lightheaded; headache; clammy feeling.; syncopal; This is a spontaneous report from a contactable Nurse. The nurse reported that a 65-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number and expiration date were UNKNOWN), first dose via an intramuscular route of administration in the right arm on 26Feb2021 as a single dose for COVID-19 immunisation. The patient's medical history includes artificial heart valve, transcatheter aortic valve replacement and penicillin allergy. Concomitant medications included ramipril, carvedilol and acetylsalicylic acid (ASPIRIN). Patient not received other vaccine in four weeks. Other medications in two weeks: ramipril, carvedilol, aspirin. Immediately following the injection. On 26Feb2021 patient had pressure behind ears, jaw pain, sore throat, fatigue, lightheaded, headache, and clammy feeling. Not received any treatment. Patient not had covid prior vaccination; covid not tested post vaccination. patient had the first vaccine and had syncopal in 2021, dizzy, episodes that lasted for 5 weeks. persistent dizziness, almost immediately, and it has lasted for multiple weeks. she did not have throat tightness, cough or shortness of breath. The outcome of the event syncopal was recovered in 2021. For other events outcome was resolved with sequel.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event syncope and the suspect drug.  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: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain in jaw, Syncope
Clinical narrative: pressure behind ears; Jaw pain; sore throat; fatigue; lightheaded; headache; clammy feeling.; syncopal; This is a spontaneous report from a contactable Nurse. The nurse reported that a 65-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number and expiration date were UNKNOWN), first dose via an intramuscular route of administration in the right arm on 26Feb2021 as a single dose for COVID-19 immunisation. The patient's medical history includes artificial heart valve, transcatheter aortic valve replacement and penicillin allergy. Concomitant medications included ramipril, carvedilol and acetylsalicylic acid (ASPIRIN). Patient not received other vaccine in four weeks. Other medications in two weeks: ramipril, carvedilol, aspirin. Immediately following the injection. On 26Feb2021 patient had pressure behind ears, jaw pain, sore throat, fatigue, lightheaded, headache, and clammy feeling. Not received any treatment. Patient not had covid prior vaccination; covid not tested post vaccination. patient had the first vaccine and had syncopal in 2021, dizzy, episodes that lasted for 5 weeks. persistent dizziness, almost immediately, and it has lasted for multiple weeks. she did not have throat tightness, cough or shortness of breath. The outcome of the event syncopal was recovered in 2021. For other events outcome was resolved with sequel.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event syncope and the suspect drug.  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: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Intermenstrual bleeding, Menstrual disorder, Migraine
Clinical narrative: experience breakthrough menstrual bleeding; continued taking birth control regularly but was still experiencing bleeding 3 days later; experienced migraine headaches; This is a spontaneous report from a contactable consumer (patient). A 41-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm right on 23Mar2021 13:30 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation; ethinylestradiol, norgestimate (TRI-SPRINTEC), route of administration, start and stop date, batch/lot number and dose were not reported to regulate menstrual cycle. Age at vaccination: 41 Years. The patient medical history was not reported. None known allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient regulated her menstrual cycle with birth control pills. She was currently taking ethinylestradiol, norgestimate. At the time of her first vaccine appointment the patient was taking the first week of a new pack. The patient experienced migraine headaches 48 hours after her vaccine appointment. Five days after her vaccine the patient began to experience breakthrough menstrual bleeding. The patient had continued taking birth control regularly but was still experiencing bleeding 3 days later. The bleeding was light, not heavy like a normal period, but appeared dark and viscous. No treatment was received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Action taken of ethinylestradiol, norgestimate was unknown. Outcome of the event was not recovered.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: Mild fever; Slight headache; This is a spontaneous report from a contactable consumer (patient). A female  patient of an unspecified age received a first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Unknown, Batch/Lot number: Unknown), via unknown route of administration on 20Mar2021 as a SINGLE DOSE for covid-19 immunization at other. It is unknown whether the patient was pregnant at the time of vaccination. The patient's medical history and concomitant medications were not reported. It is unknown whether, patient receive any other vaccines within 4 weeks prior to the COVID vaccine or if the patient diagnosed with COVID-19 prior to the vaccination. On an unspecified date, patient experienced Mild fever and slight headache. It is unknown whether any treatment received for the adverse event. Also, it is unspecified since the vaccination, if the patient been tested for COVID-19. Outcome of both the events were unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Erythema, Headache, Pain, Pain in extremity
Clinical narrative: increase in rash on arms/hands/feet; sore arm; Redness; headache; Bodyache; joint pain in knees; This is solicited report received from the specialty pharmacy received from a contactable other HCP and consumers. other HCP reported that, A 73-year-old female patient received BNT162B2 ( Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number: unknown, Expiration date: unknown), via an unspecified route of administration on 18Mar2021 at Unknown dose, single for covid-19 immunization. Patient medical history included loose stools, itchy skin, anaemic with low haemoglobin, shortness of breath at times, tired, joint pain, blood pressure fluctuated with very low reading a few days ago, feeling lightheaded, lethargy, from an unknown date. The patient previously took lisinopril doubled lisinopril dosing (per md protocol) prior to checking it pushed fluids and improved, will notify md. it was reported that patient taking  sutent 25 mg daily for 3 weeks. On an unknown date in Mar2021, the patient experienced rash on arms/hands, sore arms, redness, headache, body ache and joint pain in knees. Since the vaccine the patient reported of increased rash on hands/arms/feet which seems to be stable now but not gone. The patient was treated with cortisone ointment for rash on hands/arms/feet. The outcome of the events increase in rash on arms/hands/feet was not recovered, while other events outcome were unknown.   No follow-up attempts are possible. No information about lot/batch number cannot be obtained; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. 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
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: increase in rash on arms/hands/feet; sore arm; Redness; headache; Bodyache; joint pain in knees; This is solicited report received from the specialty pharmacy received from a contactable other HCP and consumers. other HCP reported that, A 73-year-old female patient received BNT162B2 ( Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number: unknown, Expiration date: unknown), via an unspecified route of administration on 18Mar2021 at Unknown dose, single for covid-19 immunization. Patient medical history included loose stools, itchy skin, anaemic with low haemoglobin, shortness of breath at times, tired, joint pain, blood pressure fluctuated with very low reading a few days ago, feeling lightheaded, lethargy, from an unknown date. The patient previously took lisinopril doubled lisinopril dosing (per md protocol) prior to checking it pushed fluids and improved, will notify md. it was reported that patient taking  sutent 25 mg daily for 3 weeks. On an unknown date in Mar2021, the patient experienced rash on arms/hands, sore arms, redness, headache, body ache and joint pain in knees. Since the vaccine the patient reported of increased rash on hands/arms/feet which seems to be stable now but not gone. The patient was treated with cortisone ointment for rash on hands/arms/feet. The outcome of the events increase in rash on arms/hands/feet was not recovered, while other events outcome were unknown.   No follow-up attempts are possible. No information about lot/batch number cannot be obtained; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. 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
Sex: F
Vaccine: COVID19
Symptoms: Headache, Menstruation irregular
Clinical narrative: Headache; Period was not Regular; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age 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 1ST DOSE, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  The patient experienced headache and stated that her period was not regular on an unspecified date. The outcome of the events was unknown.  Information on lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: increased blood flow like a period every day, it doesn't stop; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation. The patient received the 1st dose on an unspecified date and experienced headache and her period was not regular. The patient's medical history and concomitant medications were not reported. Patient reported that after her second dose she has increased blood flow like a period every day, it doesn't stop on an unspecified date. Outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: After not having a period for over 2.5 years I got a period 3 days after the shot; This is a spontaneous report received from a contactable consumer(patient).A 56-years-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 30Mar2021 at 17:30 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunization. Medical history included and concomitant medications were not reported. The patient did not had allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks of vaccination. There was no other medication within two weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 02Apr2021, the patient experienced menstrual disorder. It was reported that patient did not had a period for over 2.5 years, and she got a period 3 days after the shot. No treatment was received for the events. The outcome of the events was reported as recovered on unspecified date 2021.   Information on the lot/batch number has been requested.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis
Clinical narrative: Mycelitis occurred in legs after second dose; This is a spontaneous report from a contactable consumer (patient) reporting herself. A 19-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number: CVS 5195 and Expiry date was not reported) via unspecified route of administration in left arm on 06Apr2021 at 16:45 (at the age of 19-years-old) as a single dose for covid-19 immunisation. Patient's medical history and concomitant medications were not reported. Patient does not have COVID, prior vaccination and has not been tested for COVID, post vaccination. Patient has previously received first dose of vaccine on an unspecified date. It was reported that, on an unspecified date, patient has experienced mycelitis occurred in legs after second dose and visited emergency room and physician office. The outcome of event was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Heavy menstrual bleeding
Clinical narrative: she also had a heavy nose bleed ( not sure of the date) since the 2nd Pfizer vaccine dose.; 5 days later  I got my period and had very heavy bleeding, this never happens to me; This is a spontaneous report from a contactable consumer (patient). This 54-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 25Feb2021 afternoon (Batch/Lot Number: EN6198) as single dose to protect herself against the virus. Medical history included progesterone symptoms of  sleeplessness, hot flashes, and various symptoms; hormone replacement therapy. Concomitant medication included progesterone (UTROGESTAN) and estradiol benzoate (ESTRADIOL) both taken for progesterone. There has no prior vaccinations. She had the first dose of bnt162b2 on 04Feb2021 in her left arm (lot: EL9264) for COVID-19 immunisation. On 02Mar2021, 5 days later she got her period and had very heavy bleeding, this never happens to her. The patient started her 2nd period and bled through her clothing, which never happens to her. She also had a heavy nose bleed (not sure of the date) since the 2nd Pfizer vaccine dose. She only had one nose bleed. She had the second dose on 25Feb2021, and since then she has had 2 menstrual periods. One was 5 days after the vaccine. She didn't think much of it but had extremely heavy bleeding which was not like her. She never had that, usually she had had light periods her entire life. She was at the grocery store, and it literally went through her clothing. She had to go home and wash everything. Her period right after the second dose was also heavy, not as heavy as this, but heavy for her. She went to (Site name) when to be concerned about when a period is heavy, not about the vaccine. It also occurred to her that she also had a nose bleed, and it was a nose bleed. It felt like her nose was running. She hasn't had something like that since she was a child. It really was like a regular nose bleed. Again, she didn't think of the vaccine. Since this is happening she is wondering if there would be a correlation. The bleeding started Tuesday and is very heavy today. It has only been 2 periods and this one was worse. The event did not require a visit to emergency room or physician office. The outcome of very heavy bleeding was not recovered, of other events was unknown.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Hyperhidrosis, Loss of consciousness, Syncope, Vision blurred
Clinical narrative: Fainting; Remained unconscious for a few seconds; Sweating; Minor tightness in the chest; Blurred vision; This is a spontaneous report was received from a contactable consumer (patient). A 44-years-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: ER8734), via an unspecified route on 08Apr2021 at 13:15 as 1st dose, single in the left arm for covid-19 immunisation. The patient's medical history was not reported. The patient's concomitant medications included Betamethasone Dipropionate Cream USP 0.05%. The patient had known allergies with Keflex (cephalexin). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021 (5 minutes after vaccination), the patient experienced sweating, minor tightness in the chest and blurred vision followed by fainting and remained unconscious for a few seconds. After regaining consciousness, continued sweating for maybe 10 minutes. The patient visited emergency room. The patient did not receive any treatment for the events. On an unspecified date in APR-2021, the patient had recovered from the events.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder, SARS-CoV-2 test
Clinical narrative: My period came the day of vaccination around 6:00pm. Started with a clot and stopped, 2 days later it came again. I had my period 5 days before vaccination.; This is a spontaneous report from a contactable other Healthcare Professional (patient). A 51-year-old female patient (not pregnant) received bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine), dose 1 via an unspecified route of administration, administered in Arm Right on 08Apr2021 10:15 AM (Lot Number: EW0150) at single dose for covid-19 immunization. Medical history included hypertension, generalized anxiety and Gel nail enamel allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included propranolol (PROPANOLOL) taken for an unspecified indication, start and stop date were not reported; alprazolam taken for an unspecified indication, start and stop date were not reported; cetirizine hydrochloride (CETRIZINE) taken for an unspecified indication, start and stop date were not reported; fish oil taken for an unspecified indication, start and stop date were not reported. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced her period came the day of vaccination around 6:00pm. Started with a clot and stopped, 2 days later it came again. She had her period 5 days before vaccination. The adverse event resulted in doctor or other healthcare professional office/clinic visit. It was unknown if treatment was received for the adverse event. Outcome of event was not recovered. COVID-19 test post vaccination included nasal swab, Negative.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: stated she had always been extremely regular, since having the vaccine she was two weeks early; This is a spontaneous report received from a non-contactable consumer (patient) from Pfizer-Sponsored Program. A female patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The relevant medical history and concomitant medications were not reported. The patient had her first dose of the covid-19 vaccine this past Saturday and then got her period, she stated she had always been extremely regular, since having the vaccine she was two weeks early. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.