chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Blood pressure measurement, Chest pain, Condition aggravated, Epistaxis
Clinical narrative: bloody nose/HBP; bloody nose/HBP; This is a spontaneous report from a contactable consumer (patient). A 79-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), intramuscularly, administered in the left arm on 13Mar2021 at 11:30 (Batch/Lot Number: EN9262, Expiration date: unknown) as the 2nd dose, single for COVID-19 immunization. The patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly, administered in the left arm on 19Feb2021 at 10:30 AM at the age of 79 years old (Batch/Lot number: EN6198) for COVID-19 immunization. The vaccine facility type was reported as the urgent care center. Relevant medical history included some digestive issues on an unspecified date in the past, skin cancer (CA) in 1985/1993, and basal cell on an unspecified date with ongoing basal cell on face biopsy from 14Feb2021. There were no concomitant medications. The patient was very healthy and never had any high blood pressure (HBP) and no prescription (Rx) needed or medicine. The patient had no prior vaccination. On 17Mar2021 at 18:30, the patient experienced bloody nose/HBP, which were considered as important medical events. The patient also had bloody nose/HBP on 21Mar2021 at 18:30 and on 28Mar2021 at 19:00. The adverse events (AE) required the patient to visit the emergency room and then to the physician office. The patient underwent lab tests and procedures, which included COVID-19 test: negative on 12Feb2021. Therapeutic measures were taken as a result of HBP, which included Rx for high blood pressure including amlodipine 10 mg. The patient did not receive any treatment for bloody nose. The patient was advised to stop Rx if electrocardiogram (EKG) was abnormal. The patient recovered from the events on an unspecified date in 2021.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Feeling cold, Feeling hot, Headache, Hyperhidrosis
Clinical narrative: bloody nose/HBP; bloody nose/HBP; This is a spontaneous report from a contactable consumer (patient). A 79-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), intramuscularly, administered in the left arm on 13Mar2021 at 11:30 (Batch/Lot Number: EN9262, Expiration date: unknown) as the 2nd dose, single for COVID-19 immunization. The patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly, administered in the left arm on 19Feb2021 at 10:30 AM at the age of 79 years old (Batch/Lot number: EN6198) for COVID-19 immunization. The vaccine facility type was reported as the urgent care center. Relevant medical history included some digestive issues on an unspecified date in the past, skin cancer (CA) in 1985/1993, and basal cell on an unspecified date with ongoing basal cell on face biopsy from 14Feb2021. There were no concomitant medications. The patient was very healthy and never had any high blood pressure (HBP) and no prescription (Rx) needed or medicine. The patient had no prior vaccination. On 17Mar2021 at 18:30, the patient experienced bloody nose/HBP, which were considered as important medical events. The patient also had bloody nose/HBP on 21Mar2021 at 18:30 and on 28Mar2021 at 19:00. The adverse events (AE) required the patient to visit the emergency room and then to the physician office. The patient underwent lab tests and procedures, which included COVID-19 test: negative on 12Feb2021. Therapeutic measures were taken as a result of HBP, which included Rx for high blood pressure including amlodipine 10 mg. The patient did not receive any treatment for bloody nose. The patient was advised to stop Rx if electrocardiogram (EKG) was abnormal. The patient recovered from the events on an unspecified date in 2021.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Hypertension, Malaise, Nausea, Pyrexia
Clinical narrative: bloody nose/HBP; bloody nose/HBP; This is a spontaneous report from a contactable consumer (patient). A 79-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), intramuscularly, administered in the left arm on 13Mar2021 at 11:30 (Batch/Lot Number: EN9262, Expiration date: unknown) as the 2nd dose, single for COVID-19 immunization. The patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly, administered in the left arm on 19Feb2021 at 10:30 AM at the age of 79 years old (Batch/Lot number: EN6198) for COVID-19 immunization. The vaccine facility type was reported as the urgent care center. Relevant medical history included some digestive issues on an unspecified date in the past, skin cancer (CA) in 1985/1993, and basal cell on an unspecified date with ongoing basal cell on face biopsy from 14Feb2021. There were no concomitant medications. The patient was very healthy and never had any high blood pressure (HBP) and no prescription (Rx) needed or medicine. The patient had no prior vaccination. On 17Mar2021 at 18:30, the patient experienced bloody nose/HBP, which were considered as important medical events. The patient also had bloody nose/HBP on 21Mar2021 at 18:30 and on 28Mar2021 at 19:00. The adverse events (AE) required the patient to visit the emergency room and then to the physician office. The patient underwent lab tests and procedures, which included COVID-19 test: negative on 12Feb2021. Therapeutic measures were taken as a result of HBP, which included Rx for high blood pressure including amlodipine 10 mg. The patient did not receive any treatment for bloody nose. The patient was advised to stop Rx if electrocardiogram (EKG) was abnormal. The patient recovered from the events on an unspecified date in 2021.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Oropharyngeal discomfort, Paraesthesia oral
Clinical narrative: Tingling in mouth, lips; Slight swelling of lips; Weird feeling in throat; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EW0171, at the age of 33-year, on 06May2021 12:30 at single dose in left arm for COVID-19 immunization. Medical history included Irritable bowel syndrome (IBS). The patient was not diagnosed with COVID-19 Prior to vaccination. The patient had not been tested for COVID-19 Since the vaccination. Concomitant medications included ergocalciferol (VIT D), ascorbic acid (VIT C), vitamin b complex (VIT B COMPLEX) and zinc chloride. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received Hyoscyamine and Gantrisin and experienced allergy. On 06May2021 12:45, the patient experienced Tingling in mouth, lips; Weird feeling in throat; Slight swelling of lips. Nurses administered Benadryl on site. The outcome of the events was resolved in May2021.
Sex: F
Vaccine: COVID19
Symptoms: Pneumonia
Clinical narrative: Pneumonia; This is a spontaneous report from a contactable consumer (patient).  A 66-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 24Feb2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported.  The patient stated she received the first dose of Pfizer COVID-19 vaccine on 24Feb2021 and then got Pneumonia and was unable to get second dose until 06May2021. She had three doctors telling her she needed to repeat the series. She would like to know if this was true. She also asked if there was any information on the efficacy of getting the second dose outside of the 6week mark and if there was any information about receiving a third dose. She stated looking forward to receiving the booster when it was available. The outcome of the event was unknown.  Information about batch/lot number has been requested.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Autoimmune disorder
Clinical narrative: autoimmune issues have been escalating; arthritis; This is a spontaneous report from a non-contactable consumer (patient). A 52 years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 52-year, on 26Apr2021 at single dose for COVID-19 immunisation. Medical history included Behcet's, arthritis. Concomitant medication was not reported. The patient previously received first dose of BNT162B2 on 05Apr2021. On 27Apr2021, the patient experienced arthritis and autoimmune issues had been escalating since her second vaccination. She had told her doctor. Both events resulted in Doctor or other healthcare professional office/clinic visit. The outcome of both events was unknown.  Information on the lot/batch number has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Electroencephalogram, Magnetic resonance imaging head, Seizure
Clinical narrative: seizure; This is a spontaneous report from a contactable consumer (patient).  A 65-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm right on 16Feb2021 14:00 at the age of 65-years-old (Batch/Lot Number: EN6201) as 1ST DOSE, SINGLE for covid-19 immunisation.  Medical history included Stage 4 cancer from an unknown date, known allergies: Sulfa, Emcin. Concomitant medications included osimertinib mesilate (TAGRISSO); levothyroxine sodium (SYNTHROID) and paracetamol (TYLENOL) all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not Pregnant at time of Vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient stated 10 days after vaccine (as reported) she had a seizure on 21Feb2021 19:30. She was not saying it was related to vaccine but she had heard other people have had this happen and she should report it. The patient was hospitalized for seizure for 3 days. The event resulted in emergency room/department or urgent care. The patient underwent lab tests and procedures which included Brain EEG (electroencephalogram), Brain MRI (magnetic resonance imaging) with unknown results on an unspecified date. Therapeutic measures were taken as a result of seizure. The outcome of the event was resolved in 2021.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Headache, SARS-CoV-2 test positive
Clinical narrative: tested positive for COVID; Headache; This is a spontaneous report from a contactable pharmacist. A 17-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 29Apr2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had the first dose last 29Apr2021 and scheduled to have the second dose on 20May2021. The patient had symptoms last 04May2021 and tested positive for COVID on 06MAY2021. The patient wants to cancel her second dose schedule since the doctor advised that she should wait for 60-90 days and she should start all over again. She already tested negative for the COVID-19 on an unspecified date and reporter wanted to know how to handle this concern. Patient also experience headache on 04May2021. On Tuesday night, (04May2021,) they thought she was having allergies. On Wednesday 05May2021, she found out she had contact with someone who tested positive for covid-19. She tested on Wednesday and received positive result on Thursday (06May2021). They believe she had contact on the same day as the vaccine on the 29th of APR 2021. She had a negative rapid test on Monday and Tuesday (unknown dates). Outcome of the events was unknown.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, SARS-CoV-2 test
Clinical narrative: Was diagnosed with Bell's Palsy on 11May2021; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: EN6205), at the age of 51-year-old, via an unspecified route of administration, administered in Arm Right on 08Mar2021 08:30 at single dose for COVID-19 immunisation. Medical history included migraines, low thyroid, high blood pressure (BP)/cholesterol and mild depression/anxiety. Known allergies: ciprofloxacin (CIPRO). Concomitant medications included levothyroxine; atorvastatin (reported as gen Lipitor's); propranolol; doxepin. The patient also received unspecified CY within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: EN5318) on 15Feb2021 at 08:00 AM, at the age of 51-year-old, via an unspecified route of administration, administered in Right arm, for COVID-19 immunisation. The patient was diagnosed with bell's palsy on 11May2021, and the event onset date reported as 10May2021 13:00. The patient underwent lab tests and procedures which included Nasal Swab: negative (COVID test post vaccination). The event resulted in Emergency room/department or urgent care. Treatment received for the event that included steroids and anti-virals. The patient had doctor (DR) appointment on 21May2021. The outcome of the event was not recovered.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for Covid; Tested positive for Covid; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Mar2021 (Batch/Lot number was not reported) as 1st dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient tested positive for COVID on Apr2021. Patient already had the first dose of the vaccine which was on 17Mar2021 and after 28 days (also reported as 20 days) he tested positive for COVID. So he just wanted to know how he can get second dose since he hasn't received the second dose yet. He was beyond his 40th day and would like to know if it is okay for him to get vaccinated with the second dose tomorrow. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on Apr2021. The outcome of the events was unknown. The events were considered as serious (medically significant).  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Haemorrhage, Rash
Clinical narrative: bleeding on one side; rare rash; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT/Batch number and expiration date unknown) via unspecified route of administration at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient had the COVID first shot and was getting some rare rash, some rare side effects. Patient was bleeding on one side and then it stopped and patient was totally fine for a couple of days and then all of a sudden, it all started up again. Patient reported that this morning, patient was bleeding again. Outcome of the events was recovered with sequel.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Cerebral thrombosis, Cerebrovascular accident, Pulmonary thrombosis, Thrombosis
Clinical narrative: stroke; blood clots on her legs, lungs and head; blood clots on her legs, lungs and head; blood clots on her legs, lungs and head; This is a spontaneous report from a contactable consumer (patient son). A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 31Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history was none. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) as 1st dose on 10Mar2021 for Covid-19 immunization. After having the first dose she told him that she could not make a whole 20 minute walk as she used to, she could for 10 minutes as she felt tired. She presented a consistent cough, that was not "bad". The patient's concomitant medications were not reported. Caller stated that he would like to consult about side effects of the Pfizer Covid-19 vaccine that may have caused his mother to be passing away right now. Stated that they both received the first dose on 10Mar2021 and the second dose on 31Mar2021. A month and a week later she went to her sister's house and this Tuesday he received a phone call where they stated that she had a stroke due to blood clots on her legs, lungs and head. They just left the hospital and the nurse stated that she could have hours or a couple of days left. He would like to consult if there are any reports of these side effects. The outcome of events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021568883 same patient, different dose/events
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Numbness and tingling down left shoulder, arm and into hand.  Numbness and tingling of left side of face (forehead, cheek, mouth, chin).; Numbness and tingling down left shoulder, arm and into hand.  Numbness and tingling of left side of face (forehead, cheek, mouth, chin).; This is a spontaneous report from a contactable other healthcare professional (patient). A 43-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: EW0169), at the age of 43-year-old, via an unspecified route of administration, administered in Arm Left on 18May2021 10:00 at single dose for COVID-19 immunisation. Medical history included endometriosis, dermatographic urticaria (autoimmune condition), and nonallergic rhinitis. Concomitant medications included progesteron; estradiol (ESTROGEN); diltiazem. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient had numbness and tingling down left shoulder, arm and into hand. Numbness and tingling of left side of face (forehead, cheek, mouth, chin) on 18May2021 16:00. Been in contact with her physician. Has not resolved in 24 hrs. Treatment received for the events and included antihistamines, anti-inflammatories. The event resulted in physician office visit. The outcome of the event was not recovered.; Sender's Comments: The causal association between the reported events and vaccine administered cannot be excluded based on a plausible temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: left arm breaking out in hives; left arm broke out in hives: Was in his left arm all the way into his wrist and has gotten worse; This is a spontaneous report from a contactable consumer (patient). A 53-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 18May2021 at 09:05 (at the age of 53 years old)(Batch/Lot Number: EW0185) as 2ND DOSE, SINGLE for covid-19 immunization. Medical history included Heart problems, Stent Placement (Has had 4 stents), blood pressure. Concomitant medication include blood pressure pills which he takes every day (Product Name not provided). No relevant family history was reported. Facility in which the vaccine was administered was a pharmacy. Historical Vaccine includes BNT162B2 dose 1 Lot #: EW0167 on 25Apr2021 in Left Arm and experienced Allergic reaction. No other vaccines were given within 4 weeks. In the morning on 19Mar2021, The patient experienced left arm broke out in hives, left arm broke out in hives: Was in his left arm all the way into his wrist and has gotten worse.  Patient stated he  was worried about breaking out in hives. He has heart problems. Treatment was given for the events. Patient took some Benadryl and stated if this does not clear he is going to the Emergency Room. The clinical outcome of the events was not recovered.    Follow-up attempts completed. No further information expected.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypersensitivity
Clinical narrative: left arm breaking out in hives; left arm broke out in hives: Was in his left arm all the way into his wrist and has gotten worse; This is a spontaneous report from a contactable consumer (patient). A 53-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 18May2021 at 09:05 (at the age of 53 years old)(Batch/Lot Number: EW0185) as 2ND DOSE, SINGLE for covid-19 immunization. Medical history included Heart problems, Stent Placement (Has had 4 stents), blood pressure. Concomitant medication include blood pressure pills which he takes every day (Product Name not provided). No relevant family history was reported. Facility in which the vaccine was administered was a pharmacy. Historical Vaccine includes BNT162B2 dose 1 Lot #: EW0167 on 25Apr2021 in Left Arm and experienced Allergic reaction. No other vaccines were given within 4 weeks. In the morning on 19Mar2021, The patient experienced left arm broke out in hives, left arm broke out in hives: Was in his left arm all the way into his wrist and has gotten worse.  Patient stated he  was worried about breaking out in hives. He has heart problems. Treatment was given for the events. Patient took some Benadryl and stated if this does not clear he is going to the Emergency Room. The clinical outcome of the events was not recovered.    Follow-up attempts completed. No further information expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Polymerase chain reaction
Clinical narrative: sore arm; This is a spontaneous report from a contactable consumer (patient). A 57-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN 6206, expiration date not provided), 1st dose via an unspecified route of administration, administered in arm left on 05Mar2021 15:00 at age of 57 years old as a single dose for COVID-19 immunisation.  Medical history included Hashimoto's Thyroiditis, migraine. Concomitant medications included levothyroxine sodium (SYNTHROID); liothyronine sodium (CYTOMEL); ethinylestradiol, norethisterone acetate (FEMHRT); meloxicam taken for Knee injury; magnesium. The patient previously took amoxycillin, celebrex, clindamycin and known allergies. The patient experienced sore arm on an unspecified date. After first dose, just a sore arm but patient was taking meloxicam for a knee injury and wondered if the anti-inflammatory tempered the reaction. The patient underwent lab tests and procedures which included polymerase chain reaction (PCR): negative (nasal swab) on 15May2021.  The outcome of the event was resolving. The patient was not pregnancy at time of vaccination. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The report was reported as non-serious by reporter.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Dizziness, Fatigue, Feeling abnormal, Head discomfort
Clinical narrative: severe headache; severe vertigo; Bed was spinning out of control and I was hanging on for life; Could not sleep laying down; Intermittent dizziness; motion sickness; ear and head feeling full, brain fog; head feeling full; ear and head feeling full, brain fog; This is a spontaneous report from a contactable consumer (patient). A 57-years-old female patient (not pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in arm right at age of 57 years on 02Apr2021 11:30  (Batch/Lot Number: ER 8730) as single dose for covid-19 immunisation. Medical history included hashimoto's thyroiditis, migraine. The patient's concomitant medications were not reported. The patient previous took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration, administered in arm left at age of 57 years on 05Mar2021 15:00 (Batch/lot number: EN 6206) as single dose for covid-19 immunisation. After first dose, just a sore arm but patient was taking meloxicam (since unknown date) for a knee injury and wondered if the anti-inflammatory tempered the reaction. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent covid-19 vaccine was administered was pharmacy or drug store.12 days after second dose (no longer taking meloxicam) had a severe headache that lasted for 5 days. The day it eased, patient woke up in the middle of the night with sudden onset of severe vertigo.  Bed was spinning out of control and I was hanging on for life.  No prior medical history (hx) of vertigo.  Vertigo was severe when laying on right side for a week.  Could not sleep laying down.  Intermittent dizziness and motion sickness during the day - especially when bending over or turning my head to the right.  It is over 4 weeks since onset of symptoms.  Had intermittent days of strange headache, ear and head feeling full, brain fog, fatigue.  Vertigo is improved but definitely still there when I lay down to the right or rollover.  Have not been able to drive since onset. Adverse event start date/time reported as 14Apr2021 19:00 (as reported). The adverse event result in Doctor or other healthcare professional office/clinic visit. The patient had PCR test via Nasal Swab on 15May2021 and Negative. Prior to vaccination, was the patient was not diagnosed with COVID-19. Treatment received for the adverse event included CT scan w/venogram, prednisone, meclizine (in 2021). Seriousness reported as no. The outcome of the events was recovering.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Loss of personal independence in daily activities, Motion sickness, SARS-CoV-2 test, Sleep disorder
Clinical narrative: severe headache; severe vertigo; Bed was spinning out of control and I was hanging on for life; Could not sleep laying down; Intermittent dizziness; motion sickness; ear and head feeling full, brain fog; head feeling full; ear and head feeling full, brain fog; This is a spontaneous report from a contactable consumer (patient). A 57-years-old female patient (not pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in arm right at age of 57 years on 02Apr2021 11:30  (Batch/Lot Number: ER 8730) as single dose for covid-19 immunisation. Medical history included hashimoto's thyroiditis, migraine. The patient's concomitant medications were not reported. The patient previous took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration, administered in arm left at age of 57 years on 05Mar2021 15:00 (Batch/lot number: EN 6206) as single dose for covid-19 immunisation. After first dose, just a sore arm but patient was taking meloxicam (since unknown date) for a knee injury and wondered if the anti-inflammatory tempered the reaction. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent covid-19 vaccine was administered was pharmacy or drug store.12 days after second dose (no longer taking meloxicam) had a severe headache that lasted for 5 days. The day it eased, patient woke up in the middle of the night with sudden onset of severe vertigo.  Bed was spinning out of control and I was hanging on for life.  No prior medical history (hx) of vertigo.  Vertigo was severe when laying on right side for a week.  Could not sleep laying down.  Intermittent dizziness and motion sickness during the day - especially when bending over or turning my head to the right.  It is over 4 weeks since onset of symptoms.  Had intermittent days of strange headache, ear and head feeling full, brain fog, fatigue.  Vertigo is improved but definitely still there when I lay down to the right or rollover.  Have not been able to drive since onset. Adverse event start date/time reported as 14Apr2021 19:00 (as reported). The adverse event result in Doctor or other healthcare professional office/clinic visit. The patient had PCR test via Nasal Swab on 15May2021 and Negative. Prior to vaccination, was the patient was not diagnosed with COVID-19. Treatment received for the adverse event included CT scan w/venogram, prednisone, meclizine (in 2021). Seriousness reported as no. The outcome of the events was recovering.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Venogram, Vertigo
Clinical narrative: severe headache; severe vertigo; Bed was spinning out of control and I was hanging on for life; Could not sleep laying down; Intermittent dizziness; motion sickness; ear and head feeling full, brain fog; head feeling full; ear and head feeling full, brain fog; This is a spontaneous report from a contactable consumer (patient). A 57-years-old female patient (not pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in arm right at age of 57 years on 02Apr2021 11:30  (Batch/Lot Number: ER 8730) as single dose for covid-19 immunisation. Medical history included hashimoto's thyroiditis, migraine. The patient's concomitant medications were not reported. The patient previous took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration, administered in arm left at age of 57 years on 05Mar2021 15:00 (Batch/lot number: EN 6206) as single dose for covid-19 immunisation. After first dose, just a sore arm but patient was taking meloxicam (since unknown date) for a knee injury and wondered if the anti-inflammatory tempered the reaction. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent covid-19 vaccine was administered was pharmacy or drug store.12 days after second dose (no longer taking meloxicam) had a severe headache that lasted for 5 days. The day it eased, patient woke up in the middle of the night with sudden onset of severe vertigo.  Bed was spinning out of control and I was hanging on for life.  No prior medical history (hx) of vertigo.  Vertigo was severe when laying on right side for a week.  Could not sleep laying down.  Intermittent dizziness and motion sickness during the day - especially when bending over or turning my head to the right.  It is over 4 weeks since onset of symptoms.  Had intermittent days of strange headache, ear and head feeling full, brain fog, fatigue.  Vertigo is improved but definitely still there when I lay down to the right or rollover.  Have not been able to drive since onset. Adverse event start date/time reported as 14Apr2021 19:00 (as reported). The adverse event result in Doctor or other healthcare professional office/clinic visit. The patient had PCR test via Nasal Swab on 15May2021 and Negative. Prior to vaccination, was the patient was not diagnosed with COVID-19. Treatment received for the adverse event included CT scan w/venogram, prednisone, meclizine (in 2021). Seriousness reported as no. The outcome of the events was recovering.  Information on Lot/Batch number was available. Additional information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: I am having like severe chest pain; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (Lot number was not reported), via an unspecified route of administration on an unspecified date as 2nd dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of BNT162B2 on an unspecified date as single dose for COVID-19 immunization. The patient got the second dose of Covid vaccine and the patient was having like severe chest pain on an unspecified date. The outcome of the event was unknown.    Information on the lot/batch number has been requested.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Headache, Neck pain, Pharyngeal swelling
Clinical narrative: Throat swelled shut I could not breathe; Throat swelled shut I could not breathe; Throat swelled shut I could not breathe; Chest was extremely tight; The whole left side of my head hurt and down the left side of neck; The whole left side of my head hurt and down the left side of neck; This is a spontaneous report from a non-contactable consumer (patient). A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0167, expiration date not provided), 1st dose via an unspecified route of administration, administered in Arm Left on 30Apr2021 10:30 at age of 39 years old as a single dose for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL); bupropion hcl. The patient previously took morphine, doxycycline, dairy IBS and all experienced drug allergy. The patient experienced throat swelled shut she could not breathe, chest was extremely tight and the whole left side of her head hurt and down the left side of neck, all on 30Apr2021 10:30. The events were reported as being disability. The outcome of the events was recovered with sequel on an unspecified date. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: Throat swelled shut I could not breathe; Throat swelled shut I could not breathe; Throat swelled shut I could not breathe; Chest was extremely tight; The whole left side of my head hurt and down the left side of neck; The whole left side of my head hurt and down the left side of neck; This is a spontaneous report from a non-contactable consumer (patient). A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0167, expiration date not provided), 1st dose via an unspecified route of administration, administered in Arm Left on 30Apr2021 10:30 at age of 39 years old as a single dose for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL); bupropion hcl. The patient previously took morphine, doxycycline, dairy IBS and all experienced drug allergy. The patient experienced throat swelled shut she could not breathe, chest was extremely tight and the whole left side of her head hurt and down the left side of neck, all on 30Apr2021 10:30. The events were reported as being disability. The outcome of the events was recovered with sequel on an unspecified date. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: already had her period and started having heavy bleeding 2 days after the vaccine; This is a spontaneous report from a contactable physician (patient's father). A 15-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration, administered in arm left at age of 15 years on 13May2021 05:30 (Lot Number: EW0173) as single dose for covid-19 immunisation. Medical history reported as none. No know allergies. The patient's concomitant medications were none. No other medications the patient received within 2 weeks of vaccination, the patient did not receive any other vaccines within 4 weeks prior to the COVID. vaccine Facility where the most recent COVID-19 vaccine was administered was other. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient had already had her period and started having heavy bleeding 2 days after the vaccine on 15May2021. No treatment received. The outcome of the event was not recovered.   Follow up attempts are needed. Further information has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Bleeding menstrual heavy  cannot be excluded.  The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Paralysis, Ulnar nerve palsy
Clinical narrative: Within 30 minutes of receiving the 1st dose of the covid19 vaccine in my left shoulder my left hand and wrist became completely paralyzed.; Ulnar Palsy; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6207, expiration date not provided), 1st dose via an unspecified route of administration, administered in arm left on 16May2021 15:30 at age of 43 years old as a single dose for COVID-19 immunisation. Medical history included latex sensitivity. The patient's concomitant medications were not reported. The patient experienced within 30 minutes of receiving the 1st dose of the COVID-19 vaccine in her left shoulder her left hand and wrist became completely paralyzed on 16May2021 16:00. The ER said it was random coincidence and diagnosed it as Ulnar Palsy on 16May2021 16:00.  The events were reported as being disability. Therapeutic measures were taken as a result of all events. The outcome of the events was not recovered. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient had not received any other medications within 2 weeks of vaccination. The adverse event resulted in visiting doctor or other healthcare professional office/clinic. The adverse event result in visiting Emergency room/department or urgent care. Treatment for the adverse event was included ER (emergency room) Exam. The patient was not pregnancy at time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  Information on the lot/batch number has been requested.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Patient contracted COVID-19 2 weeks following 1st vaccine dose; Patient contracted COVID-19 2 weeks following 1st vaccine dose; This is a spontaneous report from a contactable other healthcare professional (HCP). A 45-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), intramuscularly, administered in the left arm on 25Mar2021 at 18:00 at the age of 45 years old (Batch/Lot Number: En8730, Expiration date: Unknown) as the 1st dose, single for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was at the pharmacy or drug store. The patient's medical history was not reported. Concomitant medication included finasteride taken for an unspecified indication, start and stop date were not reported. 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 vaccine. The patient contracted COVID-19 2 weeks following 1st vaccine dose on 08Apr2021 at 12:00 with polymerase chain reaction (PCR), Covid test via nasal swab: positive post vaccination on 10Apr2021. The reporter assessed the event as non-serious. The adverse event (ae) resulted in a doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the adverse event. The patient recovered from the event on an unspecified date in 2021.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 7 days after the second dose.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Inflammation
Clinical narrative: the inflammation multiples by 10; the inflammation multiples by 10; This is a spontaneous report from a contactable consumer (patient). This consumer reported same event for same patient, different vaccine dose. This is the second dose.  A 33-year-old (also reported as 32 years old) non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: Ew0177, expiration date not provided), 2nd dose via an unspecified route of administration, administered in Arm Right on 14May2021 16:00 at age of 33 years old as a single dose for COVID-19 immunisation. Medical history included ankylosing spondylitis. Concomitant medications included diazepam (VALIUM); naproxen (NAPROXEN ). The patient previously took vancomycin, rocephin biochemie, latex, BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: Ew0161, expiration date not provided), 1st dose via an unspecified route of administration, administered in Arm Right on 23Apr2021 15:00 as a single dose for COVID-19 immunisation and experienced severe inflammation in my neck, spine, shoulders, elbow, wrist, fingers, knees, ankles. The patient experienced severe inflammation in her neck, spine, shoulders, elbow, wrist, fingers, knees, ankles. This was present after the first shot. After the second shot on 14May2021 the inflammation multiples by 10 in 2021. Therapeutic measures were taken as a result of the inflammation multiples by 10. The outcome of the event was not recovered. The report was reported as non-serious by reporter. The patient was not pregnancy at time of vaccination. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The adverse event result in visiting doctor or other healthcare professional office/clinic visit. Treatment for the adverse event was included prednisone. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021572514 same patient/event, different vaccine doses
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Hives; rash; This is a spontaneous report from a contactable consumer (patient). A 32-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in arm left at age of 32 years on 17May2021 15:00 (Lot Number: EW0182) as single dose for covid-19 immunisation. The patient medical history was included diagnosed COVID-19 prior to vaccination. No known allergies. Concomitant medications included cefalexin (Cephalexine), sulfamethoxazole, doxycycline. The patient previous took fist dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration at age of 32 years on 26Apr2021 15:00 (Lot Number: ER8736) as single dose for Covid-19 immunization. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent covid-19 vaccine was administered was pharmacy or drug store. Since the vaccination, the patient has not been tested for COVID-19. Hives and a rash started to appear on body roughly 24-26 hours after second shot. The rash started around both arms, mostly above the elbow and slightly on the torso. By the next morning, the rash spread to the rest of body, growing denser in many areas on arms and back and middle of the chest and stomach. The adverse event resulted in Emergency room/department or urgent care. Treatment received for the adverse event included prescribed prednisone, taking Tylenol and Benadryl. Adverse event start date was 18May2021 19:00 PM. Seriousness reported as no. The outcome of the events was recovering.  Follow attempts are needed. Further information is expected