chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Dizziness, Dysgeusia, Electrocardiogram, Fatigue
Clinical narrative: Nausea; Fatigue; Tingling in left arm (both injections in left arm); Headache; Itchy skin all over but no rash; metallic taste in mouth; light headedness; Heart palpitations; This is a spontaneous report from a contactable consumer (patient).  A 61-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EP6955, expiration date was not reported) via an unspecified route of administration, in left arm, on 31Mar2021 15:45 (at the age of 61-years-old), at dose 2, single for covid-19 immunization. Medical history included GERD (gastroesophageal reflux disease)/acid reflux. The patient had no known allergies. Concomitant medications included dexlansoprazole (DEXILANT); simvastatin; zolpidem; sertraline hydrochloride (ZOLOFT); ibuprofen (ADVIL). Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EN6204, expiration date was not reported) via an unspecified route of administration, in left arm, on 10Mar2021 16:00 (at the age of 61-years-old), at dose 1, single for covid-19 immunization. Prior to vaccination the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the covid-19 vaccine. The patient has not been tested with covid-19 after the vaccination. After three months (as reported) on 14Apr2021, the patient experienced nausea, fatigue, tingling in left arm (both injections in left arm), headache, itchy skin all over but no rash, metallic taste in mouth, light headedness, heart palpitations. The events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included blood test and EKG (electrocardiogram) with unknown results on an unspecified date. Therapeutic measures taken for the events included: blood work and EKG. The outcome of the events was not recovered.    Follow-up attempts completed. No further information expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Palpitations, Paraesthesia, Pruritus
Clinical narrative: Nausea; Fatigue; Tingling in left arm (both injections in left arm); Headache; Itchy skin all over but no rash; metallic taste in mouth; light headedness; Heart palpitations; This is a spontaneous report from a contactable consumer (patient).  A 61-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EP6955, expiration date was not reported) via an unspecified route of administration, in left arm, on 31Mar2021 15:45 (at the age of 61-years-old), at dose 2, single for covid-19 immunization. Medical history included GERD (gastroesophageal reflux disease)/acid reflux. The patient had no known allergies. Concomitant medications included dexlansoprazole (DEXILANT); simvastatin; zolpidem; sertraline hydrochloride (ZOLOFT); ibuprofen (ADVIL). Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EN6204, expiration date was not reported) via an unspecified route of administration, in left arm, on 10Mar2021 16:00 (at the age of 61-years-old), at dose 1, single for covid-19 immunization. Prior to vaccination the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the covid-19 vaccine. The patient has not been tested with covid-19 after the vaccination. After three months (as reported) on 14Apr2021, the patient experienced nausea, fatigue, tingling in left arm (both injections in left arm), headache, itchy skin all over but no rash, metallic taste in mouth, light headedness, heart palpitations. The events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included blood test and EKG (electrocardiogram) with unknown results on an unspecified date. Therapeutic measures taken for the events included: blood work and EKG. The outcome of the events was not recovered.    Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: vomiting; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported), dose 2 via an unspecified route of administration, on 11Mar2021 (at the age of 43-year-old), as dose 2, single, for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported), via an unspecified route of administration, on an unspecified date, as dose 1, single, for COVID-19 immunisation. The patient experienced vomiting on 16Jun2021. The outcome for the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Pain in leg for a few days, burning sensation developed and rash; diagnosed with the shingles through a swab; This is a spontaneous report from a contactable healthcare professional (patient). A 32-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number and Expiration date were not reported), via an unspecified route of administration on 27May2021 (at the age of 32-years-old) as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took clarithromycin (MACROBID) and experienced allergy. Prior to vaccination, the patient has not been diagnosed with COVID-19. The patient didn't receive any other vaccines within 4 weeks prior to COVID vaccine. On an unspecified date, the patient experienced pain in leg for a few days, burning sensation developed and rash; diagnosed with the shingles through a swab. The event resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event which included valacyclovir (VALTREX). Since the vaccination the patient has not been tested for COVID-19. The outcome of the event was recovering.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Decreased appetite, Dizziness, Fatigue
Clinical narrative: Exhaustion; lack of appetite for 3 days pounding headaches; pounding headaches; light headedness; fevers 1st fever 99.8 second fever was 102.3; vomiting; seeing stars weakness; I could barely walk or move; This is a spontaneous report from a contactable consumer or other non hcp. A 30-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0173), dose 2 via an unspecified route of administration, administered in Arm Left on 13Jun2021 at 08:15 (at the age of 30-years-old) as dose 2, single for covid-19 immunisation. Medical history included Tetrology of Fallot with pulmonary atresia and known allergies. Historical Vaccine included BNT162B2 (lot number: Ew0177) on 23May2021 at 08:15 AM (at the age of 30-years-old) as dose 1, for Covid-19 Immunisation. Patient received no other vaccine in four weeks. Other medications in two weeks was reported as yes. On 13Jun2021, the patient experienced exhaustion, lack of appetite for 3 days pounding headaches, pounding headaches, light headedness, fevers 1st fever 99.8 second fever was 102.3, vomiting, seeing stars weakness and i could barely walk or move. The patient underwent lab tests and procedures which included body temperature: 1st fever 99.8, body temperature: second fever was 102.3. Treatment drug included advil/Tylenol for the events and also included hot baths, sleep and cooling cloth. Patient was not covid prior vaccination. Patient did not test covid post vaccination. Outcome of the events were recovering.   Follow-Up (19Jul2021): Follow-up attempts are completed. No further information is expected.  Follow-Up (04Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypokinesia, Pyrexia, Vomiting
Clinical narrative: Exhaustion; lack of appetite for 3 days pounding headaches; pounding headaches; light headedness; fevers 1st fever 99.8 second fever was 102.3; vomiting; seeing stars weakness; I could barely walk or move; This is a spontaneous report from a contactable consumer or other non hcp. A 30-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0173), dose 2 via an unspecified route of administration, administered in Arm Left on 13Jun2021 at 08:15 (at the age of 30-years-old) as dose 2, single for covid-19 immunisation. Medical history included Tetrology of Fallot with pulmonary atresia and known allergies. Historical Vaccine included BNT162B2 (lot number: Ew0177) on 23May2021 at 08:15 AM (at the age of 30-years-old) as dose 1, for Covid-19 Immunisation. Patient received no other vaccine in four weeks. Other medications in two weeks was reported as yes. On 13Jun2021, the patient experienced exhaustion, lack of appetite for 3 days pounding headaches, pounding headaches, light headedness, fevers 1st fever 99.8 second fever was 102.3, vomiting, seeing stars weakness and i could barely walk or move. The patient underwent lab tests and procedures which included body temperature: 1st fever 99.8, body temperature: second fever was 102.3. Treatment drug included advil/Tylenol for the events and also included hot baths, sleep and cooling cloth. Patient was not covid prior vaccination. Patient did not test covid post vaccination. Outcome of the events were recovering.   Follow-Up (19Jul2021): Follow-up attempts are completed. No further information is expected.  Follow-Up (04Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Fatigue, Headache, Heavy menstrual bleeding, Hot flush
Clinical narrative: headaches; hot flashes; cramping; fatigue; 2 weeks after getting my second shot I got an unusually heavy period that last 2 weeks along with hot flashes, cramping, fatigue, and headaches. I got the Mirena IUD in Sept 2020 and hadn't had any pe; 2 weeks after getting my second shot I got an unusually heavy period that last 2 weeks along with hot flashes, cramping, fatigue, and headaches. I got the Mirena IUD in Sept 2020 and hadn't had any pe; Other vaccine same date vaccine date: 01Mar2021; This is a spontaneous report from a contactable consumer (patient). A 24-years-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6204), via an unspecified route of administration in left arm on 01Mar2021 (at the age of 24-years-old) as DOSE 2, SINGLE for covid-19 immunisation and received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: E N6204), via an unspecified route of administration in left arm on 01Mar2021 at 02:00 (at the age of 24-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The medical history included known allergy to Penicillin and Mirena IUD in Sep2020 and hadn't had any periods since then or had any after, birth control for 5 years and never had a surprise period like this. Patient's concomitant medications were not reported. Patient had no other vaccine in four weeks or no other medications in two weeks. On 05Apr2021, at 12:00, 2 weeks after getting second shot the patient experienced an unusually heavy period that last 2 weeks along with hot flashes, cramping, fatigue, and headaches. Patient stated I got the Mirena IUD in Sep2020 and hadn't had any periods since then or had any after. I never had a period that heavy or with those symptoms before. I had been on birth control for 5 years and never had a surprise period like that before. Patient had not covid prior vaccination and tested COVID tested post vaccination. The patient underwent lab tests and procedures which included Nasal swab resulted negative on 21Apr2021 COVID test post vaccination. The patient did not receive any treatment for events. The  outcome of event were recovered on unspecified date on 2021.  Follow-up attempts are completed. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Menstruation irregular, SARS-CoV-2 test
Clinical narrative: headaches; hot flashes; cramping; fatigue; 2 weeks after getting my second shot I got an unusually heavy period that last 2 weeks along with hot flashes, cramping, fatigue, and headaches. I got the Mirena IUD in Sept 2020 and hadn't had any pe; 2 weeks after getting my second shot I got an unusually heavy period that last 2 weeks along with hot flashes, cramping, fatigue, and headaches. I got the Mirena IUD in Sept 2020 and hadn't had any pe; Other vaccine same date vaccine date: 01Mar2021; This is a spontaneous report from a contactable consumer (patient). A 24-years-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6204), via an unspecified route of administration in left arm on 01Mar2021 (at the age of 24-years-old) as DOSE 2, SINGLE for covid-19 immunisation and received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: E N6204), via an unspecified route of administration in left arm on 01Mar2021 at 02:00 (at the age of 24-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The medical history included known allergy to Penicillin and Mirena IUD in Sep2020 and hadn't had any periods since then or had any after, birth control for 5 years and never had a surprise period like this. Patient's concomitant medications were not reported. Patient had no other vaccine in four weeks or no other medications in two weeks. On 05Apr2021, at 12:00, 2 weeks after getting second shot the patient experienced an unusually heavy period that last 2 weeks along with hot flashes, cramping, fatigue, and headaches. Patient stated I got the Mirena IUD in Sep2020 and hadn't had any periods since then or had any after. I never had a period that heavy or with those symptoms before. I had been on birth control for 5 years and never had a surprise period like that before. Patient had not covid prior vaccination and tested COVID tested post vaccination. The patient underwent lab tests and procedures which included Nasal swab resulted negative on 21Apr2021 COVID test post vaccination. The patient did not receive any treatment for events. The  outcome of event were recovered on unspecified date on 2021.  Follow-up attempts are completed. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Vision blurred, Visual impairment
Clinical narrative: Unable to see things normally; Vision seriously blurred; This is a spontaneous report from a contactable consumer. A 62-year-old male consumer (patient) received bnt162b2, dose 2 via an unspecified route of administration, administered in left arm on 09Jun2021 16:00 as single dose for COVID-19 immunisation. Medical history included chronic bronchitis. There were no concomitant medications in 2 weeks. There was no other vaccine in four weeks. The patient previously took bnt162b2, dose 1, administered in left arm on 19May2021 at 04:00 PM for COVID-19 immunisation. The patient was not tested positive for COVID prior vaccination. The patient experienced vision seriously blurred and unable to see things normally; both after second dose of Pfizer vaccine on 12Jun2021 at 12:00 AM. Outcome of the events was not recovered. The patient was not tested positive for COVID post vaccination.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Glycosylated haemoglobin, Muscle spasms, Pain, Pain in extremity
Clinical narrative: Tuesday the pain was intense and scheduled a appoint with my doctors office they scheduled a ultra sound and blood work no findings of a blood clot; The pain is not as intense but she is still limping around and in pain.; I had severe leg cramping and body cramping; The next day my leg hurt behind the knee in the calf and the thigh. I could hardly walk by Sunday and went to urgent care they check my leg over could not see a reason for my pain.; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A 51-year-old Non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN620A and expiration date was not reported), second dose via an unspecified route of administration, administered in Arm Left on 01Apr2021 (at the age of 51 years) as single for covid-19 immunization. Medical history included ITP and diabetes from an unknown date and unknown if ongoing. Patient also had Penicillin Allergy from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6204 and expiration date was not reported), first dose via an unspecified route of administration, administered in Arm right on 11Mar2021 11.00 as single for covid-19 immunization. Patient was not diagnosed with COVID-19, prior vaccination and since the vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and medications in two weeks. On 02Apr2021 the patient experienced leg hurt behind the knee in the calf and the thigh. she could hardly walk by Sunday and went to urgent care they check my leg over could not see a reason for my pain. They didn't visually see a blood clot and sent me home. she had severe leg cramping and body cramping. Tuesday the pain was intense and scheduled a appoint with my doctors office they scheduled a ultra sound and blood work no findings of a blood clot. she also scheduled an appointment with a chiropractor and had no indication of back or knee injuries. she had severe pain for over two month in leg knee lower leg and thighs. The pain is not as intense but she is still limping around. The patient underwent lab tests and procedures which included glycosylated haemoglobin found to be 5.8 on unspecified date. The outcome the events was recovering.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Blood pressure decreased, Blood pressure measurement, Blood test, Chest X-ray
Clinical narrative: an allergic reaction; she had trouble moving her tongue to speak; increases thirst within 5 minutes of shot; awareness of throat; creeping headache starting at the base of the neck across the entire head; along with lowering blood pressure; I started feeling floaty; my motor skills decreased; I had trouble standing up; I had trouble standing up & walking; I had trouble speaking forming the words & sentences; This is a spontaneous report from a contactable consumer (patient). A 42-year-old non-pregnant female patient received first dose of bnt162b2 (Pfizer-BioNTech covid-19 vaccine, Solution for injection, Lot number: EW0153), via an unspecified route in the right arm on 14Apr2021 at 12:45 (age at vaccination: 42-year-old), as a single dose for covid-19 immunization. Medical history included covid prior to vaccination. Known allergies included Biaxin and penicillin. Concomitant medications included Vitamin D and Iron. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if patient was tested for covid post vaccination. On 05May2021 at 00:45, after the first shot, patient experienced increases thirst within 5 minutes of shot, awareness of throat, creeping headache starting at the base of the neck across the entire head. The throat/headache, along with lowering blood pressure was how she react during an allergic reaction, so she asked the nurse to check her blood pressure. She checked every 15 minutes. Instead of going down, it steadily went up. At this time, she started feeling floaty, her motor skills decreased (She couldn't aim her hand in my bag, she had trouble standing up & walking, and she had trouble moving her tongue to speak), and she had trouble speaking forming the words & sentences. When her blood pressure got to a certain level, the nurse called the paramedics. She was brought to the ER. The patient underwent lab tests and procedures which included blood pressure: it steadily went up and went down, bloodwork, a chest Xray & a CT scan with & without contrast. Patient blood pressure went down as she waited & the results of all tests taken didn't have anything that were of concern to the doctors, so she went home. Adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Patient did not receive any treatment for the events. The clinical outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Dysstasia, Feeling abnormal, Fine motor skill dysfunction, Gait disturbance
Clinical narrative: an allergic reaction; she had trouble moving her tongue to speak; increases thirst within 5 minutes of shot; awareness of throat; creeping headache starting at the base of the neck across the entire head; along with lowering blood pressure; I started feeling floaty; my motor skills decreased; I had trouble standing up; I had trouble standing up & walking; I had trouble speaking forming the words & sentences; This is a spontaneous report from a contactable consumer (patient). A 42-year-old non-pregnant female patient received first dose of bnt162b2 (Pfizer-BioNTech covid-19 vaccine, Solution for injection, Lot number: EW0153), via an unspecified route in the right arm on 14Apr2021 at 12:45 (age at vaccination: 42-year-old), as a single dose for covid-19 immunization. Medical history included covid prior to vaccination. Known allergies included Biaxin and penicillin. Concomitant medications included Vitamin D and Iron. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if patient was tested for covid post vaccination. On 05May2021 at 00:45, after the first shot, patient experienced increases thirst within 5 minutes of shot, awareness of throat, creeping headache starting at the base of the neck across the entire head. The throat/headache, along with lowering blood pressure was how she react during an allergic reaction, so she asked the nurse to check her blood pressure. She checked every 15 minutes. Instead of going down, it steadily went up. At this time, she started feeling floaty, her motor skills decreased (She couldn't aim her hand in my bag, she had trouble standing up & walking, and she had trouble moving her tongue to speak), and she had trouble speaking forming the words & sentences. When her blood pressure got to a certain level, the nurse called the paramedics. She was brought to the ER. The patient underwent lab tests and procedures which included blood pressure: it steadily went up and went down, bloodwork, a chest Xray & a CT scan with & without contrast. Patient blood pressure went down as she waited & the results of all tests taken didn't have anything that were of concern to the doctors, so she went home. Adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Patient did not receive any treatment for the events. The clinical outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypersensitivity, Oropharyngeal discomfort, Thirst, Tongue movement disturbance
Clinical narrative: an allergic reaction; she had trouble moving her tongue to speak; increases thirst within 5 minutes of shot; awareness of throat; creeping headache starting at the base of the neck across the entire head; along with lowering blood pressure; I started feeling floaty; my motor skills decreased; I had trouble standing up; I had trouble standing up & walking; I had trouble speaking forming the words & sentences; This is a spontaneous report from a contactable consumer (patient). A 42-year-old non-pregnant female patient received first dose of bnt162b2 (Pfizer-BioNTech covid-19 vaccine, Solution for injection, Lot number: EW0153), via an unspecified route in the right arm on 14Apr2021 at 12:45 (age at vaccination: 42-year-old), as a single dose for covid-19 immunization. Medical history included covid prior to vaccination. Known allergies included Biaxin and penicillin. Concomitant medications included Vitamin D and Iron. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if patient was tested for covid post vaccination. On 05May2021 at 00:45, after the first shot, patient experienced increases thirst within 5 minutes of shot, awareness of throat, creeping headache starting at the base of the neck across the entire head. The throat/headache, along with lowering blood pressure was how she react during an allergic reaction, so she asked the nurse to check her blood pressure. She checked every 15 minutes. Instead of going down, it steadily went up. At this time, she started feeling floaty, her motor skills decreased (She couldn't aim her hand in my bag, she had trouble standing up & walking, and she had trouble moving her tongue to speak), and she had trouble speaking forming the words & sentences. When her blood pressure got to a certain level, the nurse called the paramedics. She was brought to the ER. The patient underwent lab tests and procedures which included blood pressure: it steadily went up and went down, bloodwork, a chest Xray & a CT scan with & without contrast. Patient blood pressure went down as she waited & the results of all tests taken didn't have anything that were of concern to the doctors, so she went home. Adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Patient did not receive any treatment for the events. The clinical outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain lower, Antibiotic level, Computerised tomogram, Cyst, Ultrasound abdomen
Clinical narrative: Multiple cysts; severe lower abdominal pain; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 43-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via intramuscular route of administration, administered in Arm Right on 02Apr2021 at 10:45 am (Batch/Lot Number: ER8735) as dose 1, single for covid-19 immunization (at the age of 43-years-old). The patient medical history was none. There were no concomitant medications. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19 Since the vaccination, the patient has not been tested for COVID-19. It was reported by the patient that after receiving the first shot of vaccine within one week on 09Apr2021 at 12:00 pm she experienced severe lower abdominal pain in which she visited her doctor, emergency care doctors, received an ultrasound and CT scan to find what was causing the issue but have still not received a diagnosis. She stated that every month since receiving the vaccine she has had extreme lower abdomen pain for at least a week prior to and during her menstrual cycle that also bothers her intermittently all month long and stated that there is a definite link between the vaccine date and the beginning of this pain/issue. She also stated that on 21Apr2021 the vaginal ultrasound showed a multiple cyst. The adverse events resulted in the doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. On 27Apr2021 gastroenterologist suggested that need to get colonoscopy endoscopy. The patient underwent lab tests and procedures which included antibiotic level which showed pain (to treat pain w/ urination, clear antibiotics for pain in lower pelvic region) on 15Apr2021, urine analysis showed urine culture on 20Apr2021, ultrasound scan vagina showed multiple cysts on 21Apr2021, CT scan (computerised tomogram) and ultrasound abdomen (received an ultrasound and CT scan to find what was causing the issue) which results was unknown on an unspecified date in 2021. The patient was treated with antibiotics and birth control and dicyclomine and ultrasound to monitor cysts 3 months later and need to get colonoscopy and endoscopy. Patient received second dose of BNT162B2 via intramuscular route of administration on 02Apr2021 at 11:15 am (Batch/Lot Number: EW0161) as dose 2, single for covid-19 immunization. The patient was not recovered from the events.   Follow-up attempts are completed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound scan vagina, Urine analysis
Clinical narrative: Multiple cysts; severe lower abdominal pain; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 43-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via intramuscular route of administration, administered in Arm Right on 02Apr2021 at 10:45 am (Batch/Lot Number: ER8735) as dose 1, single for covid-19 immunization (at the age of 43-years-old). The patient medical history was none. There were no concomitant medications. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19 Since the vaccination, the patient has not been tested for COVID-19. It was reported by the patient that after receiving the first shot of vaccine within one week on 09Apr2021 at 12:00 pm she experienced severe lower abdominal pain in which she visited her doctor, emergency care doctors, received an ultrasound and CT scan to find what was causing the issue but have still not received a diagnosis. She stated that every month since receiving the vaccine she has had extreme lower abdomen pain for at least a week prior to and during her menstrual cycle that also bothers her intermittently all month long and stated that there is a definite link between the vaccine date and the beginning of this pain/issue. She also stated that on 21Apr2021 the vaginal ultrasound showed a multiple cyst. The adverse events resulted in the doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. On 27Apr2021 gastroenterologist suggested that need to get colonoscopy endoscopy. The patient underwent lab tests and procedures which included antibiotic level which showed pain (to treat pain w/ urination, clear antibiotics for pain in lower pelvic region) on 15Apr2021, urine analysis showed urine culture on 20Apr2021, ultrasound scan vagina showed multiple cysts on 21Apr2021, CT scan (computerised tomogram) and ultrasound abdomen (received an ultrasound and CT scan to find what was causing the issue) which results was unknown on an unspecified date in 2021. The patient was treated with antibiotics and birth control and dicyclomine and ultrasound to monitor cysts 3 months later and need to get colonoscopy and endoscopy. Patient received second dose of BNT162B2 via intramuscular route of administration on 02Apr2021 at 11:15 am (Batch/Lot Number: EW0161) as dose 2, single for covid-19 immunization. The patient was not recovered from the events.   Follow-up attempts are completed. No further information is expected.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Nasopharyngitis, Pruritus, Rash, Vaccination site pain
Clinical narrative: cold symptoms; rash; itch; pain near site; This is a spontaneous report from a contactable consumer (patient).   An 80-year-old male patient received BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL9269) via intramuscular on 10Feb2021 (at the age of 80 years old) as dose 2, single for COVID-19 immunisation. Medical history included ongoing thyroid disorder, ongoing cholesterol, and gastrooesophageal reflux disease. Concomitant medications included rosuvastatin calcium (CRESTOR) taken for cholesterol, and famotidine (PEPCID [FAMOTIDINE]) taken for gastrooesophageal reflux disease. The patient previously received BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL3247) via intramuscular on 20Jan2021 as dose 1, single for COVID-19 immunisation. On an unspecified date, the patient experienced cold symptoms, rash, itch, pain near site. The vaccination facility type was reported as hospital. Prior vaccination (within 4 weeks) was reported as none. The outcome of pain near site was unknown; outcome of all the other events was recovered on an unspecified date.   No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Menopausal disorder
Clinical narrative: Post Menopausal full menstration days 21-28 after first dose; This is a spontaneous report from a Non-contactable consumer (Patient reported for herself).  A 53-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, Lot Number: Unknown), via unspecified route of administration, in left arm on 31Mar2021 (at the age of 53-year-old) as a dose 1, single for COVID-19 immunization. The patient medical history and concomitant medication was not reported. The patient had not taken other vaccine in four weeks and no other medication in two weeks. Patient had no known allergies and no other medical history. Patient had no COVID prior to vaccination and not tested post COVID vaccination. On19May2021 the patient experienced post-menopausal full menstruation days 21-28 after first dose. Patient does not receive any treatment for the reported event. Outcome for the reported event was unknown. No follow-up attempts are possible: information about lot/batch number/expiry date cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Herpes zoster
Clinical narrative: Shingles; Pain on skin on backside; This is a spontaneous report from a contactable consumer or other non hcp.   A 40-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 27Apr2021 (Batch/Lot Number: EP6955) as DOSE 2, SINGLE for covid-19 immunisation.  Medical history included none from an unknown date and unknown if ongoing. There were no concomitant medications. Historical Vaccine first Dose: Date Administered: 06Apr2021; Lot Number: EP6955; Anatomical Location: Caller reported that she doesn't remember, but probably her left arm for covid-19 immunisation. on 06Jul2021 20:00 Caller reported that she went to her health care provider today because she had a pain on her skin on her backside. 07Jul2021 20:00 Caller reported that she was diagnosed with shingles and the health care provider asked if the caller had gotten the Covid-19 vaccine.  Outcome of the event back pain was not recovered, for the event shingles was unknown.   Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis, Fatigue, Sinusitis
Clinical narrative: probably had a sinus infection; overly fatigued; He keeps having extreme epistaxis after receiving the vaccine; This is a spontaneous report from a contactable consumer (patient).   A 70-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: not reported), via an unspecified route of administration on Feb2021 as dose 2, single for covid-19 immunization. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1, on Jan2021 for covid-19 immunization. Patient had no known allergies. The patient had relevant medical history of multiple Sclerosis and trigeminal neuralgia. The patient concomitant medications were not reported. Both got the vaccine first dose in Jan and the second dose at the end of Feb. He had extreme epistaxis after receiving the vaccine, with the first episode occurring 12Mar2021 and then 2 times in Apr, once in May and 2 in Jun with the last episode on 22Jun2021. She states he was in the ER for over 6 hours during the first episode and they had a problem getting it stopped. He never had a nose bleed in his life. It was not a normal nose bleed, its like turning on a faucet and projectile out of his nostrils, a significant amount of blood. He saw the ENT in Apr was told he probably had a sinus infection and was given Augmentin, Afrin and nasal rinses. Their was no help and he went back to the ENT. He had two more scopes done. He was already scheduled for an MRI due to be overly fatigued from his MS and no tumors or an increase of plaques were seen. He had been given Augmentin 3 times in total and has also been given Astelin nasal spray. The ENT did not figure out what was causing it. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Gait disturbance, Herpes zoster, Pain in extremity
Clinical narrative: right arm pain; tremendous pain that went down to her elbow; shingles; can't walk; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 23Mar2021 12:00 (Batch/Lot Number: EP7534) at the age of 62 years as single dose for covid-19 immunisation. Medical history included fibromyalgia on the left side from a previous stroke, diagnosed about 5 years ago, stroke diagnosed 8 year ago and pulmonary hypertension from 03Oct2007. Patient had no family medical history relevant to AE. Historical vaccine included a shingles shot 8 to 10 years ago and it didn't protect her from the shingles this time. Unknown lot, NDC, and expiration date for the shingles vaccine. Patient had no concomitant medications. Patient had no additional vaccines administered on same date of the Pfizer Suspect, had no previous immunization with the Pfizer vaccine considered as suspect. Patient reported shingles post first dose and confirmed shingles outbreak started post second vaccination. Patient experienced first shot: right arm pain. The first shot the patient got in the right arm and it was still killing her when she went to get the second dose. Patient right arm had tremendous pain that went down to her elbow and woke her up because that was how bad it was. The pain the patient's arm happened the day of the first shot day or a couple of days later, she can't remember. The shingles pain was so bad she had been in bed and can't walk. Patient had no relevant tests. Outcome of events were not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Coagulopathy, Discomfort, Heavy menstrual bleeding, Menstrual disorder, Pain
Clinical narrative: Significant change in menstrual period. On cycle, Significant increase in bleeding, new (large) clotting; Significant change in menstrual period. On cycle, Significant increase in bleeding, new (large) clotting; Significant change in menstrual period. On cycle, Significant increase in bleeding, new (large) clotting; stronger pain and discomfort; stronger pain and discomfort; This is a spontaneous report from a non-contactable consumer (patient). A 44-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15Apr2021 (Batch/Lot Number: ER8729) at age of 44-years-old as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. Medical history included COVID-19 from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient was not pregnant. The patient experienced significant change in menstrual period. on cycle, significant increase in bleeding, new (large) clotting, stronger pain and discomfort, all on 17Apr2021 with outcome of unknown. No COVID tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, Maternal exposure during pregnancy, No adverse event
Clinical narrative: pregnant female patient received vaccine/no AE; Initial information was received on 01-Sep-2021 regarding an unsolicited valid non-serious case from physician.  This case involves a 25-year-old pregnant female patient who was exposed to INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] (exposure during pregnancy) during third pregnancy trimester.  Data regarding this pregnancy were received prospectively.  The gestation period at onset was 26 weeks.  The date of last menstrual period was reported as 26-Feb-2021.  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  The patient had unknown previous pregnancies.  On 01-Sep-2021, the patient received first dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (suspension for injection, lot GT73255A and expiry date 30-Jun-2022) via an intramuscular route at an unknown administration site for prophylactic vaccination.  It was a case of vaccine exposure during pregnancy (latency-same day).  At the time of report, no adverse event was reported.  The estimated due date is 03-Dec-2021.  Details of laboratory data was not reported.  Additionally, at time of reporting, the outcome of the pregnancy was unknown.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Maternal exposure before pregnancy
Clinical narrative: patient was administered FLUZONE QUADRIVALENT before she got pregnant, with no reported adverse event; Initial information was received on 01-Sep-2021 regarding an unsolicited valid non-serious case from other health professional.  This case is linked to cases 2021SA294755, 2021SA293704, and 2021SA293706(CLUSTER).  This case involves a 26-year-old female patient who was vaccinated with INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] before she got pregnant (maternal exposure before pregnancy).   Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known.   The date of last menstrual period was 30-Apr-2021  The estimated due date is 04-feb-2022.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's past medical treatment(s), vaccination(s) concomitant medications and family history were not provided.  On 09-Jan-2021, the patient received a dose 1 of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number: UT7325JA; expiry date: 30-Jun-2022; form: suspension for injection) via intramuscular route in unknown administration site for prophylactic vaccination.  It was the case of vaccine exposure before pregnancy (same day latency).  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were laboratory data/results available.  At time of reporting, the outcome was unknown for the reported event.  Additionally, at time of reporting, the outcome of the pregnancy was unknown.
Sex: M
Vaccine: FLU3
Symptoms: Anaphylactic reaction, Lymphadenopathy, Swollen tongue
Clinical narrative: swollen lymph nodes; anaphylactic reaction; tongue swelling; Initial information was received on 01-Sep-2021 regarding an unsolicited valid serious case from a consumer/non-healthcare professional.  This case involves male patient (unknown age) who experienced tongue swelling (swollen tongue), anaphylactic reaction and swollen lymph nodes (lymphadenopathy) after receiving INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE].  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date in 2017, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (suspension for injection, lot number and expiry date were not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date in 2017, the patient developed serious anaphylactic reaction (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. This event was assessed as medically significant.  On an unknown date in 2017, the patient developed non-serious tongue swelling (swollen tongue), swollen lymph nodes (lymphadenopathy) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED.  Details of laboratory data was not reported.  It was not reported if the patient received any corrective treatment for the events.  At time of reporting, the outcome was unknown for all the events.  There will be no information on the batch number.; Sender's Comments: This case involves an unknown age male patient who had swollen tongue, anaphylactic reaction and lymphadenopathy after vaccination with INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE]. The time to onset is unknown. There is no further information regarding patient's medical condition at time of vaccination, history and laboratory tests ruling out alternate etiologies. Based upon the reported information, the role of a vaccine cannot be assessed.
Age: 0.33
Sex: U
Vaccine: UNK
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Pentacel at 4 months, 6 months and 15 months, with no adverse event; Initial information received on 02-Sep-2021 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional.  This case involves a 15-month-old (gender unknown) patient who received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] at the age of 4 months, 6 months and 15 months (inappropriate schedule of product administration).  The patient's past vaccination(s) included VAXELIS at the age of 2 months. The patient's medical history, past medical treatment(s), concomitant medications and family history were not provided.  On unknown dates, the patient received the first, second and third doses of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot number and expiry date not reported) via unknown routes in unknown administration sites for prophylactic vaccination (inappropriate schedule of product administration).  It was a case of actual medication error due to inappropriate schedule of vaccine administered (latency- same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the lot number for this case.