chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Migraine, Neuropathy peripheral, Pain in extremity
Clinical narrative: Worsen neuropathic symptoms- pains on fingers, wrists, feet, toes, back.; migraine headache; Sore arm; fatigue; This is a spontaneous report received from a contactable consumer (patient herself). A 43-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via an unspecified route of administration in left arm on 03Mar2021 at 11:00 at single dose for COVID-19 immunization. Medical history included ovarian cancer, Blood clots, Hypertension and Sulfa: Allergies. Concomitant medications included duloxetine hydrochloride (CYMBALTA) 30 mg; warfarin 1mg and hydrochlorothiazide. On 03Mar2021, the patient experienced sore arm, Worsen neuropathic symptoms (existing side effects from chemo) - pains on fingers, wrists, feet, toes, back (medically significant), fatigue, migrain headache for 15 days after the first dose. No treatment received for AE. The outcome of events was not recovered.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Menstruation irregular
Clinical narrative: irregular menstrual period; headache; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 and experiencing an irregular menstrual period. After the second dose she has a headache that hasn't gone away and an irregular menstrual period, her menstruation comes and goes, she hasn't stopped bleeding (she doesn't bleed much) but for one day and the next it comes back. She would like to know if this is normal or of she need to go with her doctor and gynecologist. The outcome of events was unknown. The events were considered as non-serious from reporter.  No follow-up attempts are needed; information about batch/lot number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021376721 the same patient and product, different doses and partial similar adverse events
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Middle insomnia, Muscle spasms
Clinical narrative: Headache; woke up at 2am with headache due to muscle spasm in left neck and shoulder; woke up at 2 am; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 02Apr2021 (Batch/Lot Number: EP6955) as single dose for covid-19 immunisation. Medical history included migraines and allergy to latex, PCN, neomyocin. Concomitant medications included gabapentin, omeprazole, melatonin and cetirizine hydrochloride (ZYRTEC ALLERGY), all taken for an unspecified indication, start and stop date were not reported. Historical vaccine included 1st dose of BNT162B2 (Lot/Batch No: EL3247) on 12Mar2021 in arm left for COVID-19 immunisation. Patient woke up at 2 am with headache due to muscle spasm in left neck and shoulder on 03Apr2021. Patient received 2 DF paracetamol (TYLENOL), 2 DF ibuprofen (ADVIL) (4am) and icyhot for headache, muscle spasm in left neck and shoulder. Outcome of the events was resolved.   No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: fever/ low grade fever; body aches; low grade fever plus a raging headache; This is a spontaneous report received from a contactable consumer. A 60-year-old female patient (Pregnant at the time of vaccination: No) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 30Mar2021 at single dose for COVID-19 immunization. The relevant medical history included diabetes and hypothyroid disease from unspecified date. Concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on an unspecified date for Covid-19 Immunization. The patient experienced fever, body aches, low grade fever plus a raging headache on 30Mar2021. It was unknown if the patient received treatment for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The outcome of the events was resolved on 02Apr2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test, Vaccination failure
Clinical narrative: After having the vaccine 08Jan2021 and 27Jan2021 I tested positive for COVID-19 on April 4, 2021; After having the vaccine 08Jan2021 and 27Jan2021 I tested positive for COVID-19 on April 4, 2021; This is a spontaneous report received from a contactable consumer (patient herself). A 78-year-old female patient received second dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: El3246) via an unspecified route of administration in arm on 27Jan2021, (at the age of 78-years-old) as single dose for COVID-19 immunization and was previously administered the first dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: El3246) via an unspecified route of administration in left arm on 08Jan2021 10:00 as single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included diabetes, lymphoma, high blood pressure, thyroid from an unknown date and known allergies: Sulfa drugs. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Concomitant medications were not reported. The patient tested positive for COVID-19 on 04Apr2021 after having the vaccine 08Jan2021 and 27Jan2021. The patient was sent to the hospital for the events. The patient received antibody infusion as treatment to the event. The outcome of the events was not resolving.  Information related to batch/Lot no. was requested. .
Sex: F
Vaccine: COVID19
Symptoms: Tooth abscess
Clinical narrative: Dental abscess; This is a spontaneous report received from a contactable consumer. This contactable consumer (patient) reported for herself that a female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient said she got the first dose of the Pfizer vaccine and she has to take an antibiotic that the that dentist recommended because of a dental abscess. She was asking if it was ok to take the antibiotic or if she shouldn't. Patient stated that after this shot everything was normal, she hadn't started taking the antibiotic, she was just calling to see if she should. Patient referred to her physician for medical decisions. Outcome of the event was unknown.   No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 29-year-old female patient (Non pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Left on 16Mar2021 12:30 (Lot Number: EP6955) as single dose for covid-19 immunisation. Medical history included migraine headaches. The patient did not have COVID prior vaccination. No Known allergies. No COVID tested post vaccination. Concomitant medications included propranolol and rimegepant (NURTEC ODT) for migraine. No other vaccine received in four weeks. The consumer reported that headache was not an adverse event of the 1st dose of vaccine. She had woken up the morning of 05Apr with a headache. The outcome of the event was unknown.   No follow-up attempts are needed. No further information is expected.; Sender's Comments: Event headache is likely an intercurrent condition and unrelated to BNT162B2.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: On 01Apr2021 patient experinced Headache, noise running, Fever, sore throat, difficulty breathing and took a test covid19 and came positive; On 01Apr2021 patient experinced Headache, noise running, Fever, sore throat, difficulty breathing and took a test covid19 and came positive; This is a spontaneous case from a contactable consumer (patient). A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number unknown), via an unknown route on 25Jan2021 and second dose on 19Feb2021 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On 01Apr2021, the patient had symptoms like headache, noise running, fever, sore throat, difficulty breathing. On 03Apr2021 the patient was tested positive for covid19. Outcome of the events On 01Apr2021 patient experienced Headache, noise running, Fever, sore throat, difficulty breathing and took a test covid19 and came positive was unknown.  Information related to lot/batch number has been requested.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis
Clinical narrative: DVT's in right calf; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, in left arm on 16Mar2021 02:00 (at 57-years age) as single dose for covid-19 immunisation. Medical history included ongoing high blood pressure diagnosed in 2002 and it is under control with medications, ongoing diabetes diagnosed in 2000, neuropathy, allergies. The patient previously took first dose of BNT162B2 for Covid-19 immunization as Covid-19 vaccine first dose. Concomitant medications included metformin taken for diabetes mellitus from 2010 and ongoing at 1000 mg, twice a day; hydroxyzine (HYDROXYZINE) taken for allergies and ongoing at 25 mg, once a day; omeprazole (OMEPRAZOLE) taken for high blood pressure and ongoing at 40 mg, once a day; losartan (LOSARTAN) taken for hypertension and ongoing at 100 mg, once a day; carvedilol (CARVEDILOL) taken for high blood pressure and ongoing at 6.25 mg, twice a day; gabapentin (GABAPENTIN) taken for neuropathy and ongoing at 800 mg, twice a day; trazodone (TRAZODONE) taken for sleep and ongoing at 100 mg, once a day; simvastatin (SIMVASTATIN) at 20 mg, once a day taken for blood cholesterol and ongoing; insulin detemir (LEVEMIR) taken for diabetes mellitus and ongoing at 30 uL, once a day. Patient hopes he was not going to die. States on Saturday 3Apr2021 he went to the ER because he had DVT's in his right calf and they gave him the pneumonia vaccine there and he was under the influence because he was on pain medications. Patient received the pneumonia vaccine on Sunday 04Apr2021. NDC, lot number, or expiry date unknown. Caller states he got the second dose of the Pfizer vaccine today 6Apr2021. patient hopes he was not going to die because he took the two vaccines so close to each other. Patient has had DVT's since 2014 but flared up this Saturday 03Apr2021. States it was under control and it is recovering slowly, blood is flowing, INR is flowing, and it is therapeutic. they gave him a heparin drip to dissolve it in the ER. Patient was admitted to hospital at 12 midnight on 04Apr2021 and got out on 05Apr2021. The outcome of the event was resolving.  Information on the lot/batch number has been requested.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Colitis ulcerative, Condition aggravated, Diarrhoea haemorrhagic, Hypokalaemia, SARS-CoV-2 test
Clinical narrative: hospitalization due to blood diarrhea, vomiting and hypokalemia; hospitalization due to blood diarrhea, vomiting and hypokalemia; hospitalization due to blood diarrhea, vomiting and hypokalemia; Worsening ulcerative colitis; Worsening ulcerative colitis; This is a spontaneous report from a contactable consumer (patient). A 43 years old female patient received BNT162B2 (lot number: EL3248) second dose on 25Mar2021 (vaccination age 43 years old) on left arm for COVID-19 immunisation. Medical history included Colitis ulcerative. Patient was not Pregnant at the time of vaccination. No other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously received BNT162B2 (lot number: EP6955) first dose on 04Mar2021 (vaccination age 43 years old) on left arm for COVID-19 immunisation. Patient had Worsening ulcerative colitis and hospitalization (for 3 days) due to blood diarrhea, vomiting and hypokalemia. Events occurred on 26Mar2021. Patient received Potassium, Prednisone, Lialda as treatment for the events. Lab test included Nasal Swab on 30Mar2021 with result of negative. The outcome of the events was recovering.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: hospitalization due to blood diarrhea, vomiting and hypokalemia; hospitalization due to blood diarrhea, vomiting and hypokalemia; hospitalization due to blood diarrhea, vomiting and hypokalemia; Worsening ulcerative colitis; Worsening ulcerative colitis; This is a spontaneous report from a contactable consumer (patient). A 43 years old female patient received BNT162B2 (lot number: EL3248) second dose on 25Mar2021 (vaccination age 43 years old) on left arm for COVID-19 immunisation. Medical history included Colitis ulcerative. Patient was not Pregnant at the time of vaccination. No other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously received BNT162B2 (lot number: EP6955) first dose on 04Mar2021 (vaccination age 43 years old) on left arm for COVID-19 immunisation. Patient had Worsening ulcerative colitis and hospitalization (for 3 days) due to blood diarrhea, vomiting and hypokalemia. Events occurred on 26Mar2021. Patient received Potassium, Prednisone, Lialda as treatment for the events. Lab test included Nasal Swab on 30Mar2021 with result of negative. The outcome of the events was recovering.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer (patient) reported that a patient of an unspecified age and gender received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration on an unknown date (Lot Number: Unknown) as single dose, dose 1 via an unspecified route of administration on an unknown date (Lot Number: Unknown) as single dose; both for covid-19 immunization. Medical history and concomitant medications were not reported. After 10 days of the second shot, the patient underwent COVID 19 test which showed positive result. The outcome of the events were unknown.  Forwarded as an Adverse Event by the Epsilon Escalation team on 04May2021. Reporter provided verification of contact address on 04Mar2021.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: positive COVID test occurred 7-10 after second vaccination injection; positive COVID test occurred 7-10 after second vaccination injection; This is a spontaneous report from a contactable consumer (Patient). An adult male patient of unknown age received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, batch number/ Lot Number was unknown and expiry date was not provided), via an unspecified route of administration, in Mar2021 at as a single dose for covid-19 immunisation. Patient's medical history and concomitant medications were not reported. As reported, it was unknown whether other vaccine received in four weeks of vaccination, allergies. The patient previously received first dose of BNT162B2 in 2021. In Mar2021, patient had positive covid test occurred 7-10 after second vaccination injection. It was unknown whether treatment received or not. Patient does not have COVID, prior vaccination. Patient has tested for COVID, post vaccination (test type: unknown, in Mar2021, result was positive). The outcome of the event was not resolved.  No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, COVID-19, Chills, Erythema, Fatigue
Clinical narrative: arm being sore for a couple of days/Arm mildly sore; arm got a little warm; Really small red spot to arm; tired/exhausted; fell asleep; fever; chills; headache; vomiting; lower GI issues; Sick to stomach; Quite sick for a day/weak; sore; This is a spontaneous report from a contactable consumer (patient). This 58-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: ER2613) in the right arm on 24Mar2021 at single dose for COVID-19 immunization. Medical history included ongoing Shellfish Allergy. Concomitant medications were not reported. The patient previously received first dose of BNT162B2 (Lot EN6203) on 03Mar2021 for COVID-19 Immunization, and experienced sore arm that was a little pink, and warm. The red arm after first shot was very small spot, slightly raised, sort of pink, and probably the size of a half dollar. She was tired for a couple of hours that day, but didn't experience anything big. The patient previously experienced very swollen and red arm on 2 occasions with 2 flu vaccines. The Flu Vaccine was vaccinated about 10 years ago (2010) for immunization, her doctor told her it was cellulitis twice from the flu vaccine and she stopped getting them for a while.  After the second dose of BNT162B2, patient reported her arm being sore for a couple of days, but less sore than experienced with the first dose. Really small red spot to arm after second vaccine. The red arm with her second shot was really small, her arm was mildly sore for 2 days. Her arm got a little warm as well. She reported being tired for the first day, fell asleep, and was okay.  A week after receiving the second dose on 31Mar2021, she started experiencing a fever that wasn't high, chills, headache, vomiting, lower GI issues for the entire day, and was exhausted, sick to her stomach, weak and sore. She was quite sick for one day, then it just went away. Stated her fever wasn't bad so she didn't take her temperature. Stated she never got headaches, she took two ibuprofen (ADVIL) one time for it. The symptoms she experienced on 31Mar2021 were all resolved on 01Apr2021.   Patient consulted with HCP in which they had her take a COVID test and that came back negative.  The outcome of fell asleep was unknown, outcome of other events was recovered.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Headache, Malaise, Nausea, Pain
Clinical narrative: arm being sore for a couple of days/Arm mildly sore; arm got a little warm; Really small red spot to arm; tired/exhausted; fell asleep; fever; chills; headache; vomiting; lower GI issues; Sick to stomach; Quite sick for a day/weak; sore; This is a spontaneous report from a contactable consumer (patient). This 58-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: ER2613) in the right arm on 24Mar2021 at single dose for COVID-19 immunization. Medical history included ongoing Shellfish Allergy. Concomitant medications were not reported. The patient previously received first dose of BNT162B2 (Lot EN6203) on 03Mar2021 for COVID-19 Immunization, and experienced sore arm that was a little pink, and warm. The red arm after first shot was very small spot, slightly raised, sort of pink, and probably the size of a half dollar. She was tired for a couple of hours that day, but didn't experience anything big. The patient previously experienced very swollen and red arm on 2 occasions with 2 flu vaccines. The Flu Vaccine was vaccinated about 10 years ago (2010) for immunization, her doctor told her it was cellulitis twice from the flu vaccine and she stopped getting them for a while.  After the second dose of BNT162B2, patient reported her arm being sore for a couple of days, but less sore than experienced with the first dose. Really small red spot to arm after second vaccine. The red arm with her second shot was really small, her arm was mildly sore for 2 days. Her arm got a little warm as well. She reported being tired for the first day, fell asleep, and was okay.  A week after receiving the second dose on 31Mar2021, she started experiencing a fever that wasn't high, chills, headache, vomiting, lower GI issues for the entire day, and was exhausted, sick to her stomach, weak and sore. She was quite sick for one day, then it just went away. Stated her fever wasn't bad so she didn't take her temperature. Stated she never got headaches, she took two ibuprofen (ADVIL) one time for it. The symptoms she experienced on 31Mar2021 were all resolved on 01Apr2021.   Patient consulted with HCP in which they had her take a COVID test and that came back negative.  The outcome of fell asleep was unknown, outcome of other events was recovered.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Somnolence, Vomiting
Clinical narrative: arm being sore for a couple of days/Arm mildly sore; arm got a little warm; Really small red spot to arm; tired/exhausted; fell asleep; fever; chills; headache; vomiting; lower GI issues; Sick to stomach; Quite sick for a day/weak; sore; This is a spontaneous report from a contactable consumer (patient). This 58-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: ER2613) in the right arm on 24Mar2021 at single dose for COVID-19 immunization. Medical history included ongoing Shellfish Allergy. Concomitant medications were not reported. The patient previously received first dose of BNT162B2 (Lot EN6203) on 03Mar2021 for COVID-19 Immunization, and experienced sore arm that was a little pink, and warm. The red arm after first shot was very small spot, slightly raised, sort of pink, and probably the size of a half dollar. She was tired for a couple of hours that day, but didn't experience anything big. The patient previously experienced very swollen and red arm on 2 occasions with 2 flu vaccines. The Flu Vaccine was vaccinated about 10 years ago (2010) for immunization, her doctor told her it was cellulitis twice from the flu vaccine and she stopped getting them for a while.  After the second dose of BNT162B2, patient reported her arm being sore for a couple of days, but less sore than experienced with the first dose. Really small red spot to arm after second vaccine. The red arm with her second shot was really small, her arm was mildly sore for 2 days. Her arm got a little warm as well. She reported being tired for the first day, fell asleep, and was okay.  A week after receiving the second dose on 31Mar2021, she started experiencing a fever that wasn't high, chills, headache, vomiting, lower GI issues for the entire day, and was exhausted, sick to her stomach, weak and sore. She was quite sick for one day, then it just went away. Stated her fever wasn't bad so she didn't take her temperature. Stated she never got headaches, she took two ibuprofen (ADVIL) one time for it. The symptoms she experienced on 31Mar2021 were all resolved on 01Apr2021.   Patient consulted with HCP in which they had her take a COVID test and that came back negative.  The outcome of fell asleep was unknown, outcome of other events was recovered.   No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: felt like they were having heart attacks in the middle of the night.; This is a spontaneous report received from a contactable consumer. The consumer reported similar event for two patients, this is the 1st report of 2.  A patient of unspecified age and gender received bnt162b2 (Pfizer BioNTech Covid 19 vaccine), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The consumer stated she knew 2 other people had the Pfizer vaccine that were having same thing, they all felt like they were having heart attacks in the middle of the night. The outcome of the event was unknown.  Follow-up attempts are completed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021378116 Same reporter/product/event, different patient
Sex: U
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: they all felt like they were having heart attacks in the middle of the night; This is a spontaneous report received from a contactable consumer. The consumer reported similar event for two patients, this is the 2nd of 2 reports.  A patient of unspecified age and gender received bnt162b2 (Pfizer BioNTech Covid 19 vaccine), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The consumer stated she knew 2 other people had the Pfizer vaccine that were having same thing, they all felt like they were having heart attacks in the middle of the night. The outcome of the event was unknown.  Follow-up attempts are completed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021378115 Same reporter/product/event, different patient
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Dizziness, Headache, Nausea
Clinical narrative: Since the evening of my vaccine I have been getting extreme dizzy spells that I feel like I'm going to pass out, along with bad headaches and nausea.; Since the evening of my vaccine I have been getting extreme dizzy spells that I feel like I'm going to pass out, along with bad headaches and nausea.; Since the evening of my vaccine I have been getting extreme dizzy spells that I feel like I'm going to pass out, along with bad headaches and nausea.; My blood pressure has been elevated; This is a spontaneous report from a contactable consumer (consumer) reporting herself. A 34-year-old female patient (non-pregnant) received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8730), via an unspecified route of administration at the age of 34-year-old at arm left on 24Mar2021 17:00 at single dose for COVID-19 immunization. Medical history included ulcerative colitis, endometriosis, osteoarthritis, asthma, obesity, allergies bees. Concomitant medications included marijuana and tizanidine hydrochloride (ZANAFLEX). The patient previously allergic to cefalexin monohydrate (KEFLEX), lavender. Since the evening of her vaccine (on 24Mar2021), the patient had been getting extreme dizzy spells that she feel like she was going to pass out, along with bad headaches and nausea. Her blood pressure has been elevated since then  (in 2021) and she have since had to begin blood pressure medication to try and reduce it to a safe level. The patient did not have blood pressure issues prior to her vaccine. My doctor has advised against her getting she second dose. The adverse event result in doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient hasn't diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. The outcome of events was not recovered.  Follow up attempts are possible. Information about lot/batch number was provided.
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rhinorrhoea, Sneezing
Clinical narrative: sneezing; nose was running at a ridiculous pace/ nasal drainage; experienced itchiness in both of his armpits.; This is a spontaneous report from a contactable consumer (patient). A 71-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 18Mar2021 17:00 (Batch/Lot Number: EN6207) as single dose for COVID-19 immunisation. Medical history was none. The patient's concomitant medications were not reported. Historical vaccine included 1st dose of BNT162B2 (Batch/Lot Number: EN6198) on 26Feb2021 at 17:00 for COVID-19 immunization and experienced terrible sneezing/continuous sneezing day and night and runny nose/nose was running profusely/sniffles. He received a second dose on 18Mar2021 and 2 weeks later he began sneezing and nose was running at a ridiculous pace. This was continuing and had been going on for 5-6 days. He wears CPAP (continuous positive airway pressure) at night and it was having trouble keeping it on because of the nasal drainage. It was also reported that he was roughly 2 weeks or 13 days from that 2nd dose of the vaccine and about 3 days before he began profusely sneezing and still was sneezing and his nose was running and was producing the same as the prior time this happened and he tried taking allergy pills to see if it would subdue this and it did not subdue his symptoms. He received his vaccine dose in his left arm and he had experienced itchiness in both of his armpits. Treatment was received for sneezing and nose was running at a ridiculous pace/ nasal drainage. Outcome of sneezing and nose was running at a ridiculous pace/ nasal drainage was not recovered. Outcome of itchiness in both of his armpits was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Blindness, Dyspnoea, Panic attack, Visual impairment
Clinical narrative: He woke up panicked; Vision loss; Visual disturbances; Difficulty breathing; This is a spontaneous report from a contactable consumer. A 67-years-old male patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on 31Mar2021 as a single dose for COVID-19 immunization. Medical history included: heart attack a few years ago and takes maintenance drugs for the heart condition and asthmatic and takes medication but the medications come and go depending on how he is physically. Concomitant medications were not reported. This case was from the same reporter; this case is for the husband. On 2Apr2021 he experienced difficulty breathing and they did not know if it was attributed to the vaccine but he did not have any breathing issues until he got the vaccine but it was a general feeling of something was different but did not think it was severe until the vision thing. Reporter stated there is no medication her husband takes that is related directly to the episode he experienced. On 5Apr2021, he woke up from being asleep, asked if the TV was on (which it was) because he could hear it, but could not see it. His symptoms have also resolved. He had no history of anything like that happening previously with the first dose pfizer covid vaccine. Hi wife stated that he experienced visual disturbances since then, with no prior history of vision impairment. The outcome of the events could not see, Visual disturbances was recovered; the outcome of Difficulty breathing was not recovered; the outcome of the event He woke up panicked was unknown.   Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: received the second dose of the vaccine 9 days ago, and 4 days after receiving it, I was diagnosed positive with covid; Received the second dose of the vaccine 9 days ago, and 4 days after receiving it, I was diagnosed positive with covid; This is a spontaneous report from a contactable consumer or other non hcp.     A patient of unspecified age and gender received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant was not reported.The patient experienced received the second dose of the vaccine 9 days ago, and 4 days after receiving it, person was diagnosed positive with covid (drug ineffective) (medically significant) on an unspecified date.The patient underwent lab tests and procedures which included sars-cov-2 test: positive. The outcome of the event was unknown  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Renal failure
Clinical narrative: Renal failure; She then got really sick; This is a spontaneous report from a contactable consumer (patient) via a Pfizer- Sponsored Program. A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection) via an unspecified route of administration on 04Mar2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On unspecified dates the patient experienced renal failure, which was serious for hospitalization, and she then got really sick. The patient called to report that she received the first dose of the COVID-19 vaccine on 04Mar2021 and then got really sick after having 11 teeth pulled. She stated that she went into renal failure and was hospitalized and was unable to receive second dose. She wanted to know if she could still receive the second dose of the vaccine. The patient asked how she could schedule her second dose because she missed her appointment on the 23rd due to being admitted to the hospital with renal failure. She did not believe the side effects were due to the vaccine, but rather due to the extensive dental work. The clinical outcomes of the events renal failure and she then got really sick were both unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: The company considered there was no plausible mechanism implicating suspect BNT162B2 to the reported events based on the drug known safety profile. The patient got really sick after having 11 teeth pulled, due to an underlying condition, and the renal failure was related to an concurrent condition.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Laboratory test
Clinical narrative: Back pain; This is a spontaneous report from a contactable consumer (patient). A 78 year female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot: EN6198) at single dose Intramuscular in left arm on 06Mar2021 for Covid-19 immunization.  Medical history included autoimmune system hepatitis, High Blood Pressure, Lung Cancer in remission, colonoscopy that was done 5-6 years ago. She further stated that she had surgery in the past that messed up her liver and kidneys, her autoimmune system went wacky. She had diabetes previously, but no longer had that.  No family medical history relevant to the event. Concomitant drugs included ongoing metoprolol succinate ER 50mg tablet orally once daily for high blood pressure (patient had been taking 20 years as of 06Apr2021 if not longer), ongoing apixaban (ELIQUIS) 2.5mg tablet orally at 2.5 mg twice per day from an unknown date to an unknown date for about 4 or 5 years as of 06Apr2021 for blood clot, and 5 mg twice a day Mar2021 as she developing another blood clot while on the 2.5mg and raised the dose (AER 2021379982), ongoing azathioprine tablet 50 mg tabs orally once daily (been taking it about a year as of 06Apr2021), ongoing spironolactone 25mg tabs orally once daily from 2020, ongoing escitalopram 10 mg tablets orally once daily from an unknown date (reported as started in 2020 or a little bit longer ago), ongoing azathioprine (IMURAN) from 2017 at 50 mg tablets orally once daily for hepatic cirrhosis, and biotin, carbohydrates nos, fats nos, minerals nos, potassium, proteins nos, sodium, vitamins nos (BOOST) drinks for years. Patient stated one of her medications was to help calm her down, but she did not know which one. She confirmed she did not think she had ever had any other Pfizer vaccines. No additional Vaccines Administered on Same Date of the Pfizer Suspect.  No other vaccinations within four weeks prior to the first administration date of the suspect vaccine. She went to the hospital after her first Pfizer COVID-19 Immunization. She explained that she had previous surgery and she was having trouble with a colonoscopy that was done 5-6 years ago. She went in to have a mesh put in to take away the pain. It was further reported that she could not recall if the surgery to have mesh placed was before or after the first Pfizer COVID-19 vaccination. She later added she thinks she had the surgery on 02Mar2021, but she not sure. She called the doctor about pain in her back and telling the doctor she wasn't sure if it was pain from the surgery or pain from the recent Pfizer COVID-19 immunization. The doctor told him if it got any worse to go to the emergency room, but it got better. Patient stated that it got better and she did not go to the emergency room, and did not go to the hospital. All her tests have been good, no additional details provided. No Relevant Tests performed.  She had recovered from back pain.  The report was considered non- serious.      No follow-up attempts are needed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Ear disorder, Ear pruritus, Exposure to SARS-CoV-2, Nocturnal dyspnoea
Clinical narrative: her husband tested positive on 29MAR 2021 and she was direct exposed; Diarrhea; fluid in ears; tested positive for Covid; tested positive for Covid; runny nose and sneezing; runny nose and sneezing; itchy ears and itchy throat; itchy ears and itchy throat; trouble breathing at night; This is a spontaneous report received from a contactable consumer (patient). A 45-Year-Old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EP3302) via an unspecified route of administration in left arm on 13Jan2021 at around 14:00-15:00 as single dose for COVID-19 immunization. Patient medical history included high blood pressure from 6-7 years ago and still ongoing. Concomitant medications were not reported. Patient received historical vaccination as first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), formulation: Solution for injection, Lot number: EH9899, via an unspecified route of administration in left arm on 23Dec2020 10:30 AM at single dose for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. on 3Apr2021, she started having allergy symptoms like a runny nose and sneezing, itchy ears and itchy throat and had trouble breathing at night with clinical outcome of not recovered. She states that the doctor told her she had fluid in both of her ears on 5Apr2021 with outcome of event not recovered. she has diarrhea on 06Apr2021, with outcome of event not recovered. She reported that not even two months later, she has tested positive for COVID-19 on 05APR2021. She states that her husband tested positive on 29MAR2021 and she was direct exposed (exposure to SARS-COV-2) due to work she had to quarantine for 14 days, states her daughter tested positive two days after her husband, states neither of them had the vaccine. The patient did not receive any treatment for the events. The clinical outcomes of event not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, SARS-CoV-2 test positive, Sneezing, Throat irritation, Vaccination failure
Clinical narrative: her husband tested positive on 29MAR 2021 and she was direct exposed; Diarrhea; fluid in ears; tested positive for Covid; tested positive for Covid; runny nose and sneezing; runny nose and sneezing; itchy ears and itchy throat; itchy ears and itchy throat; trouble breathing at night; This is a spontaneous report received from a contactable consumer (patient). A 45-Year-Old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EP3302) via an unspecified route of administration in left arm on 13Jan2021 at around 14:00-15:00 as single dose for COVID-19 immunization. Patient medical history included high blood pressure from 6-7 years ago and still ongoing. Concomitant medications were not reported. Patient received historical vaccination as first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), formulation: Solution for injection, Lot number: EH9899, via an unspecified route of administration in left arm on 23Dec2020 10:30 AM at single dose for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. on 3Apr2021, she started having allergy symptoms like a runny nose and sneezing, itchy ears and itchy throat and had trouble breathing at night with clinical outcome of not recovered. She states that the doctor told her she had fluid in both of her ears on 5Apr2021 with outcome of event not recovered. she has diarrhea on 06Apr2021, with outcome of event not recovered. She reported that not even two months later, she has tested positive for COVID-19 on 05APR2021. She states that her husband tested positive on 29MAR2021 and she was direct exposed (exposure to SARS-COV-2) due to work she had to quarantine for 14 days, states her daughter tested positive two days after her husband, states neither of them had the vaccine. The patient did not receive any treatment for the events. The clinical outcomes of event not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Epistaxis, Mouth haemorrhage, Musculoskeletal stiffness, Nasal dryness
Clinical narrative: Blood and clots came out of nose and mouth, first vaccine.; Blood and clots came out of nose and mouth, first vaccine.; Blood and clots came out of nose and mouth, first vaccine.; Face felt tight, first vaccine.; Mouth and nose dry, first vaccine.; Mouth and nose dry, first vaccine.; Sore arm, first vaccine.; This is a spontaneous report received from a contactable consumer(patient). A 73-year-old female patient received first dose of BNT162b2 (Pfizer-BioNTech COVID-19 Vaccine), at the age of 73-years-old, via an unspecified route of administration, administered in Arm Left (in the back of the arm) on 20Jan2021 (maybe at 11:10 am) (Lot Number: EL3246; Expiration Date: Apr2021) as single dose for covid-19 immunisation. Medical history included ongoing Postural vertigo maybe 10 years ago for a day. No family medical history relevant to AE. The patient's concomitant medications were not reported. Patient got the Shingles vaccine years ago and the next day, she had a sore arm and tingles, up and down her arm. She didn't feel food for 7 days and felt achy. It was the first Shingles shot. No prior Vaccinations (within 4 weeks). The patient experienced blood and clots came out of nose and mouth on 21Jan2021 (the same time that she woke up) with outcome of recovered on 21Jan2021. She blew her nose and leaned over and noticed a drop of blood on the rug and grabbed a Kleenex. She blew her nose, easy, and all of a sudden blood and clots came out of her nose and mouth. It lasted for about 8 minutes. Sore arm on 20Jan2021 (started in the evening) with outcome of recovered on 21Jan2021. Face felt tight on 21Jan2021 (around 8:30 or 9:00 am) with outcome of recovered on 21Jan2021. Mouth and nose dry on 21Jan2021 (in the morning) with outcome of recovered on 21Jan2021.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Thrombosis
Clinical narrative: Blood and clots came out of nose and mouth, first vaccine.; Blood and clots came out of nose and mouth, first vaccine.; Blood and clots came out of nose and mouth, first vaccine.; Face felt tight, first vaccine.; Mouth and nose dry, first vaccine.; Mouth and nose dry, first vaccine.; Sore arm, first vaccine.; This is a spontaneous report received from a contactable consumer(patient). A 73-year-old female patient received first dose of BNT162b2 (Pfizer-BioNTech COVID-19 Vaccine), at the age of 73-years-old, via an unspecified route of administration, administered in Arm Left (in the back of the arm) on 20Jan2021 (maybe at 11:10 am) (Lot Number: EL3246; Expiration Date: Apr2021) as single dose for covid-19 immunisation. Medical history included ongoing Postural vertigo maybe 10 years ago for a day. No family medical history relevant to AE. The patient's concomitant medications were not reported. Patient got the Shingles vaccine years ago and the next day, she had a sore arm and tingles, up and down her arm. She didn't feel food for 7 days and felt achy. It was the first Shingles shot. No prior Vaccinations (within 4 weeks). The patient experienced blood and clots came out of nose and mouth on 21Jan2021 (the same time that she woke up) with outcome of recovered on 21Jan2021. She blew her nose and leaned over and noticed a drop of blood on the rug and grabbed a Kleenex. She blew her nose, easy, and all of a sudden blood and clots came out of her nose and mouth. It lasted for about 8 minutes. Sore arm on 20Jan2021 (started in the evening) with outcome of recovered on 21Jan2021. Face felt tight on 21Jan2021 (around 8:30 or 9:00 am) with outcome of recovered on 21Jan2021. Mouth and nose dry on 21Jan2021 (in the morning) with outcome of recovered on 21Jan2021.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Dyspnoea, Headache, Heart rate increased
Clinical narrative: swollen throat; Difficulty breathing; Dizzy; scratching  from head to toe; swollen face; heart rate was faster than normal; more palpitations than normal; light head headache; Shivering; thought she was getting the flu; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1, via an unspecified route of administration on 28Mar2021 at 11:00 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced swollen throat, difficulty breathing, dizzy, scratching  from head to toe, swollen face, heart rate was faster than normal, more palpitations than normal, light head headache, shivering and she thought she was getting the flu on an unknown date, reported as a late reaction after the vaccine (received the vaccine a week ago). The clinical outcome of the events swollen throat, difficulty breathing, dizzy, scratching  from head to toe, swollen face, heart rate was faster, more palpitations, headache, shivering and flu was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.