chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Flatulence, Fungal test, Neutrophil count decreased, Platelet count decreased, SARS-CoV-2 test
Clinical narrative: suppressed WBC and neutrophils and platelets; suppressed WBC and neutrophils and platelets; suppressed WBC and neutrophils and platelets; Very loose, sticky stool; Very loose, sticky stool; gaseous episodes; This is a spontaneous report from a contactable Other-HCP (patient). A 65-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EL3248), second dose intramuscular, administered in Arm Left on 08Jan2021 08:00 (at 65 years old, not pregnant) single dose for covid-19 immunisation. The patient had no relevant medical history. The patient had her first dose of bnt162b2 (lot number: EJ1685) on 18Dec2020 1500 for covid-19 immunisation, intramuscular on left arm. Concomitant medication(s) included colecalciferol (VIT D3); magnesium; calcium; ascorbic acid, tocopheryl acetate, xantofyl, zeaxanthin, zinc (AREDS); chondroitin sulfate, glucosamine (GLUCOSAMINE CHONDROITIN; monascus purpureus (RED YEAST RICE). On 16Jan2021, patient experienced very loose, sticky stool, gaseous episodes everyday since 2nd shot in Jan2021. Patient still do not have normal solid stool today. Patient went into the hospital 23Mar2021 with suppressed WBC and neutrophils and platelets. Tested for every virus, fungus and autoimmune disease and all came back negative and then had a bone marrow biopsy with negative results. Inflammation was seen in biopsy study. Given Neupogen to increase WBC/neutrophils only once which raised levels. Released 5 days later. Blood test 4/13 showed below normal WBC/neutrophils again but not as severe. Still trying to get healthy again. Adverse event resulted in visit to Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization. Five days of hopitalisation. The outcome of the events was Recovering.Patient was given treatment Bone marrow biopsy, injection of Neupogen, IV antibiotics. No Covid prior vaccination. Patient got Covid tested post vaccination, nasal swab on 21Mar2021, 21Mar2021 and 23Mar2021, all negative. No Known allergies.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events diarrhea, flatulence, abnormal feces, platelet count decreased, neutrophil count decreased and WBC count decreased and the suspect drug.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to  Committees, and Investigators, as appropriate.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Viral test, White blood cell count decreased
Clinical narrative: suppressed WBC and neutrophils and platelets; suppressed WBC and neutrophils and platelets; suppressed WBC and neutrophils and platelets; Very loose, sticky stool; Very loose, sticky stool; gaseous episodes; This is a spontaneous report from a contactable Other-HCP (patient). A 65-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EL3248), second dose intramuscular, administered in Arm Left on 08Jan2021 08:00 (at 65 years old, not pregnant) single dose for covid-19 immunisation. The patient had no relevant medical history. The patient had her first dose of bnt162b2 (lot number: EJ1685) on 18Dec2020 1500 for covid-19 immunisation, intramuscular on left arm. Concomitant medication(s) included colecalciferol (VIT D3); magnesium; calcium; ascorbic acid, tocopheryl acetate, xantofyl, zeaxanthin, zinc (AREDS); chondroitin sulfate, glucosamine (GLUCOSAMINE CHONDROITIN; monascus purpureus (RED YEAST RICE). On 16Jan2021, patient experienced very loose, sticky stool, gaseous episodes everyday since 2nd shot in Jan2021. Patient still do not have normal solid stool today. Patient went into the hospital 23Mar2021 with suppressed WBC and neutrophils and platelets. Tested for every virus, fungus and autoimmune disease and all came back negative and then had a bone marrow biopsy with negative results. Inflammation was seen in biopsy study. Given Neupogen to increase WBC/neutrophils only once which raised levels. Released 5 days later. Blood test 4/13 showed below normal WBC/neutrophils again but not as severe. Still trying to get healthy again. Adverse event resulted in visit to Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization. Five days of hopitalisation. The outcome of the events was Recovering.Patient was given treatment Bone marrow biopsy, injection of Neupogen, IV antibiotics. No Covid prior vaccination. Patient got Covid tested post vaccination, nasal swab on 21Mar2021, 21Mar2021 and 23Mar2021, all negative. No Known allergies.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events diarrhea, flatulence, abnormal feces, platelet count decreased, neutrophil count decreased and WBC count decreased and the suspect drug.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to  Committees, and Investigators, as appropriate.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Deafness, Feeling abnormal, Hyperhidrosis, Pallor
Clinical narrative: unable to hear anything; Feeling funny; pale; diaphoretic; This is a spontaneous report from a contactable healthcare professional. An 18-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in Arm Left on 15Apr2021 (Lot Number: EW0164) as single dose for covid-19 immunisation, administered at the hospital. The patient's medical history and concomitant medications were not reported. On 15Apr2021, the patient started "feeling funny", "was unable to hear anything", opened his eyes with a bunch of people standing in front of him; pale, diaphoretic, brought to the emergency department for evaluation. The patient did not receive treatment for the events. Outcome of the events was recovered in Apr2021.; Sender's Comments: Based on the limited information provided and plausible temporal association, the Company (Pfizer) cannot exclude that the suspect medication may have contributed to the reported serious event in this patient. Additional information regarding relevant medical history, underlying conditions  and concomitant medications will aid in the comprehensive assessment of the case. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, ethics committees. and investigators, as appropriate.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Loss of consciousness
Clinical narrative: loss of conscientiousness; patient as he was falling; This is a spontaneous report from a contactable other health professional (HCP). A 20-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in Arm Left on 15Apr2021 (Batch/Lot Number: EW0164) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 15Apr2021, the patient was brought to emergency department (ED) immediately after vaccination. The patient had two minutes of loss of conscientiousness. As per his father who caught the patient as he was falling. The patient did not hit his head and the patient was stable. The patient did not receive treatment for the events. The outcome of the events was recovered on an unspecified date. It was unknown if the patient had COVID prior to vaccination and was unknown if tested for COVID post vaccination.; Sender's Comments: Based on the information currently available, a possible contribution of the suspect drug administration to the reported event cannot be excluded, due to a plausible temporal relationship. 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: 38.0
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).  A 38-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8734; Expiration Date: Jul2021), via an unspecified route of administration, administered in Arm Right first dose on 30Mar2021 at single dose for covid-19 immunisation. There were no medical history and concomitant medications. It was reported that patient positive between the first and second doses of the Pfizer Covid 19 vaccine. The patient was scheduled to receive the second dose today. The patient was outside the 10 day quarantine window, doesn't think he is contagious, has a little cough that he doesn't think is going away anytime soon, and his taste and smell are returning. The patient wanted to know if he can get the second dose today. He doesn't want to show up to get the vaccine and be turned away. The patient tested positive for COVID on 12Apr2021. His symptoms started around the 08Apr2021, but he tested positive on 12Apr2021.  The outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: got the virus after her first shot/ had a positive nasal swab COVID test; got the virus after her first shot/ had a positive nasal swab COVID test; This is a spontaneous report from a contactable consumer (the patient). A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration in the right arm on an unspecified date in Mar2021 at 12AM (age at vaccination unknown) as a single dose for COVID-19 immunization. The patient had no medical history. The patient was not pregnant at the time of vaccination. The patient did not have any known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient stated she got the virus after her first shot (reported as 28Mar2021 12:30). The patient had a positive nasal swab COVID test on 31Mar2021. The patient received the second dose of the vaccine on 13Apr2021. The outcome of got the virus after her first shot/ had a positive nasal swab COVID test was unknown.   Information about the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021457391 same patient and reporter, different dose and event
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: tested positive for Covid virus; tested positive for Covid virus; This is a spontaneous report from a contactable consumer (patient). A 29-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration in the left arm in Mar2021 (at 09:15AM) (Batch/Lot Number: EL3247) as a single dose for COVID-19 immunization. Medical history included asthma, and allergies to grass, mold, pollen, and cat. Concomitant medications included sertraline (SERTRALINE) taken for an unspecified indication, start and stop date were not reported; clobetasol (CLOBETASOL) taken for an unspecified indication, start and stop date were not reported; ketoconazole (KETOCONAZOLE) taken for an unspecified indication, start and stop date were not reported; aloe vera, malus domestica (VINEGAR APPLE CIDER PLUS) taken for an unspecified indication, start and stop date were not reported. The patient tested positive for COVID virus on 19Apr2021 at 17:00. Treatment for the event included OTC medication. The patient had no Covid prior vaccination and had tested post vaccination. The patient underwent lab tests and procedures which included nasal swab (PCR): negative on 13Apr2021 and positive on 19Apr2021. The outcome of the events resolving.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for Covid-19 virus; tested positive for Covid-19 virus; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL3247) via an unspecified route of administration, administered on the right arm on 31Mar2021 21:15 at a single dose for COVID-19 immunisation. Medical history included diabetes. Concomitant medications included insulin lispro (HUMALOG), lisinopril, simvastatin, amitriptyline and semaglutide (OZEMPIC). On 13Apr2021 10:00, the patient tested positive for Covid virus. Nasal swab done post vaccination on 13Apr2021: COVID test result: Positive. The event resulted to a Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Prior to vaccination, the patient was not diagnosed with COVID-19. The facility where the vaccine was administered was in a workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Therapeutic measures were taken as a result of the events which included hydrocodone/chlorphen Suspension, Tylenol. Outcome of the event was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Haemorrhage urinary tract, Headache, Hyperhidrosis
Clinical narrative: passing blood clots/having a total of 4 of them she has passed/noticing one when she went to the bathroom to urinate; she went into the bathroom and wiped, without actually going to the bathroom, she noticed the blood clot(s); felt like she needed to go to the bathroom/felt weird like something needed to come out; headache; dizziness; hot and cold sweats; This is a spontaneous report from a contactable consumer (who is also the patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration, on 16Apr2021, as single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. In Apr2021, after the first vaccination, the patient experienced "some of the usual side effects" described further as headache, dizziness, and hot and cold sweats. On 18Apr2021, 2 days after the first vaccination, the patient experienced passing blood clots having a total of 4 of them she has passed. She reported noticing one when she went to the bathroom to urinate. For the other blood clots, she reported it felt like she needed to go to the bathroom further described as "felt weird like something needed to come out." When she went into the bathroom and wiped, without actually going to the bathroom, she noticed the blood clot(s). The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: passing blood clots/having a total of 4 of them she has passed/noticing one when she went to the bathroom to urinate; she went into the bathroom and wiped, without actually going to the bathroom, she noticed the blood clot(s); felt like she needed to go to the bathroom/felt weird like something needed to come out; headache; dizziness; hot and cold sweats; This is a spontaneous report from a contactable consumer (who is also the patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration, on 16Apr2021, as single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. In Apr2021, after the first vaccination, the patient experienced "some of the usual side effects" described further as headache, dizziness, and hot and cold sweats. On 18Apr2021, 2 days after the first vaccination, the patient experienced passing blood clots having a total of 4 of them she has passed. She reported noticing one when she went to the bathroom to urinate. For the other blood clots, she reported it felt like she needed to go to the bathroom further described as "felt weird like something needed to come out." When she went into the bathroom and wiped, without actually going to the bathroom, she noticed the blood clot(s). The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report from a contactable nurse via Medical information team. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient tested positive for COVID-19 in between doses. The person who tested positive has not yet received the second dose. The patient tested positive for COVID-19 after receiving the first dose of BNT162B2 on unspecified date. The outcome of the event was unknown.  information on about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Malignant melanoma
Clinical narrative: skin melanoma; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient said she had surgery for her skin melanoma on Monday (unspecified date), and received her second dose of the Pfizer-BioNTech Covid-19 Vaccine on Friday. She wants to know if the Novocaine they gave her during the surgery affected the vaccine. They told the patient that there is no information in the Pfizer-BioNTech Covid-19 Vaccine Prescribing Information about a potential interaction or administration with Novocaine. They also referred the patient to her HCP for more guidance. Patient said she had no problems with the first dose of the Pfizer-BioNTech Covid-19 Vaccine. On 20Apr2021, the patient was calling about the COVID 19 vaccine. She had the vaccine 3 weeks ago and she had no side effects or symptoms and she had received text messages everyday to see how she was feeling everything and she always answered none or no. Patient declined to complete report at this time wished to be transferred to MI for her question. The outcome of the event was unknown. Therapeutic measures were taken as a result of skin melanoma.  Information on the lot/batch number has been requested.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests abnormal, Nerve injury, Sudden hearing loss
Clinical narrative: Hearing loss due to nerve damage; sudden and unexpected hearing loss in her left ear; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EN6200), via an unspecified route of administration on 22Feb2021 (at the age of 68-years-old) as a single dose for COVID-19 immunization. Medical history was not reported. Concomitant medications were reported as none. There were no other vaccines administered within 4 weeks or on the same date as the COVID-19 vaccine. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EL9263) on 01Feb2021 (at the age of 68-years-old) for COVID-19 immunization. On 08Mar2021, the patient had a cataract extraction in both eyes after which she started taking prednisolone acetate USP 1% (UPC: 6075811910, Lot: T0557, Expiry: Jun2023) steroid eye drops on approximately 10Mar2021 for an unspecified length of treatment. On 11Apr2021, the patient experienced sudden and unexpected hearing loss in the left ear only, which worsened. Per the appointment with the ear, nose, and throat (ENT) doctor, there was no reason for the unexpected hearing loss in her left ear, and the hearing loss was not related to anything medical. The ENT doctor started the patient on a steroid treatment (prednisone) for 10 days. On 20Apr2021, the patient had an abnormal hearing test which showed left ear hearing loss due to nerve damage (as of an unspecified date). The events did not require an emergency room visit. The clinical outcome of sudden and unexpected hearing loss in her left ear was not resolved, while of hearing loss due to nerve damage was unknown.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Loss of consciousness, Syncope
Clinical narrative: Experienced syncope approximately a half hour after getting out of bed; Passed out on kitchen floor; Dizziness episode lasted for approximately an hour, of which half was spent on the floor.; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 46 years of age), via an unspecified route of administration, administered in arm left on 19Apr2021 17:00 (Batch/Lot Number: EW0164) as a single dose for COVID-19 immunisation. Medical history included covid-19 from an unknown date and unknown if ongoing as it was reported that the patient had covid prior vaccination. The patient's concomitant medications were not reported. The patient had not been given any other vaccine in four weeks prior to covid vaccine. The patient was not pregnant. On 20Apr2021 12:15 PM, the patient experienced syncope approximately a half hour after getting out of bed. She passed out on kitchen floor. Dizziness episode lasted for approximately an hour, of which half was spent on the floor. The outcome of 'Experienced syncope approximately a half hour after getting out of bed' and 'Passed out on kitchen floor' was recovering while Dizziness was recovered on 20Apr2021 13:15 (lasted for approximately an hour). No treatment received for the events. The patient had not been tested for covid post vaccination.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Dyspnoea exertional, Feeling jittery, Heart rate, Heart rate increased
Clinical narrative: Experiencing A-Fib symptoms for last 3 weeks; Jittery; high HR (normally very low); palpitations; shortness of breath with any exertion; This is a spontaneous report from a contactable consumer.  A non-pregnant 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered on left arm on 29Mar2021 09:30 (Batch/Lot Number: ER8737) as single dose for COVID-19 immunisation.  Medical history included fibromyalgia, gastrooesophageal reflux disease, IBS, Ehlers Danlos Hypermobility Symdrome, POTS, hypothyroidism and hyperparathyroidism. Patient has no known drug allergies. Concomitant medications included duloxetine hydrochloride (CYMBALTA), buspirone hydrochloride (BUSPAR) and levothyroxine sodium, all taken for an unspecified indication, start and stop date were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 dose 1 (Lot number: EN6199), ON 08Mar2021 08:45 AM, on left arm for COVID-19 immunisation. The patient has no COVID prior vaccination and not tested post vaccination. 3 weeks (2nd vaccine was on 29Mar) and just put 2 and 2 together. 7+ A-Fib instances recorded on smartwatch. Jittery, high HR (normally very low), palpitations and shortness of breath with any exertion, all on 01Apr2021 06:30. It was unknown if treatment was received. The outcome of the events was not recovered.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Experiencing A-Fib symptoms for last 3 weeks; Jittery; high HR (normally very low); palpitations; shortness of breath with any exertion; This is a spontaneous report from a contactable consumer.  A non-pregnant 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered on left arm on 29Mar2021 09:30 (Batch/Lot Number: ER8737) as single dose for COVID-19 immunisation.  Medical history included fibromyalgia, gastrooesophageal reflux disease, IBS, Ehlers Danlos Hypermobility Symdrome, POTS, hypothyroidism and hyperparathyroidism. Patient has no known drug allergies. Concomitant medications included duloxetine hydrochloride (CYMBALTA), buspirone hydrochloride (BUSPAR) and levothyroxine sodium, all taken for an unspecified indication, start and stop date were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 dose 1 (Lot number: EN6199), ON 08Mar2021 08:45 AM, on left arm for COVID-19 immunisation. The patient has no COVID prior vaccination and not tested post vaccination. 3 weeks (2nd vaccine was on 29Mar) and just put 2 and 2 together. 7+ A-Fib instances recorded on smartwatch. Jittery, high HR (normally very low), palpitations and shortness of breath with any exertion, all on 01Apr2021 06:30. It was unknown if treatment was received. The outcome of the events was not recovered.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Thrombophlebitis superficial
Clinical narrative: superficial thrombophlebitis clot behind left knee; chills; headaches; This is a spontaneous report from a contactable consumer reporting for herself. A 36-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in the Left Arm  on 13Apr2021 11:45 (Batch/Lot Number: Ew0162) as single dose for covid-19 immunisation  .  The patient medical history was not reported. Concomitant medication(s) included hydroxychloroquine (HYDROXYCHLOROQUINE) taken for an unspecified indication, start and stop date were not reported; sertraline hydrochloride (ZOLOFT) taken for an unspecified indication, start and stop date were not reported.  The patient experienced superficial thrombophlebitis clot behind left knee  on 14Apr2021 with outcome of recovering , chills  on 14Apr2021 with outcome of recovering , headaches  on 14Apr2021 with outcome of recovering.  The reported events were considered serious because caused the patient to visit  Emergency room/department or urgent care.  Follow up information has been requested. Lot number has already been provided.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness, Tinnitus
Clinical narrative: This is a spontaneous report from a non-contactable consumer (patient).   A 25-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 27Mar2021 (at the age of 25 years old) (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. Concomitant medication(s) included hepatitis b vaccine (HEPATITIS B VACCIN). Other vaccine that was given within 4 weeks included HEPATITIS B VACCINE.   On 30Mar2021, The patient experienced Loss hearing in one ear (medically significant) and now constant ringing in both.  Treatment was given  as a result of loss hearing in one ear, ringing in both which included Anti biotic and  steroid. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. The clinical outcome of the events was not recovered.   No follow up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster infection neurological
Clinical narrative: Herpes Zoster infection; This is a spontaneous report from non-contactable Other healthcare professional (HCP). A 27-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration on Jan2021 (Lot Number: EL9262) as SINGLE DOSE (at age of 27 years old) for covid-19 immunisation.  Medical history included infant chicken pox (positive varicella titer) from an unknown date and unknown if ongoing. The patient did not have a history of allergies. Concomitant medication(s) included escitalopram (ESCITALOPRAM) taken for an unspecified indication, start and stop date were not reported.  Historical vaccine information included BNT162B2 lot number= EL0142, administration date Jan2021, dose number 1 for Covid-19 immunisation (at 27 years old). Prior to the vaccination, the patient was not diagnosed with COVID-19.  The patient received the vaccine at clinic. Approximately 4 weeks following the second dose, he experienced Herpes Zoster infection in Feb2021. He had no prior history of Zoster or any other herpes infection aside from infant chicken pox (positive varicella titer). Therapeutic measures were taken as a result of herpes zoster infection included Valtrex. Outcome of the event was recovered.  It was also reported that since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Amnesia, Fatigue, Feeling abnormal, Feeling cold, Headache
Clinical narrative: Seizure; No recollection of anything that happened between 2000 and 2100 hours; Very foggy, not thinking properly, repetitive in what he was saying; Very foggy, not thinking properly, repetitive in what he was saying; Very foggy, not thinking properly, repetitive in what he was saying; Not comprehending; He was very cold; Very tired; Very Sweaty; Headache; This is a spontaneous report from a contactable consumer (Patient's wife).   A 53-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on 19Apr2021 12:30 (Lot Number: EW0164) as SINGLE DOSE (at age of 53 years old) for covid-19 immunisation.  Medical history included ongoing epilepsy diagnosed with this when he was 15 years old, seizure from an unknown date and unknown if ongoing (then at 2015 he had a seizure). Concomitant medications included levetiracetam (KEPPRA) 1250 mg, daily (250mg; 5 pills a day) taken for epilepsy from an unspecified start date and ongoing; carbamazepine (CARBAMAZEPINE) 1000 mg, daily (200mg; 5 pills a day) taken for an unspecified indication from an unspecified start date and ongoing.  Family Medical History Relevant to events was none. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 19Apr2021, the patient experienced seizure, Very foggy, not thinking properly, repetitive in what he was saying, very distant, like he was looking at his wife but not seeing her or hearing her, Headache, He was very cold, Very tired, Not comprehending, Very Sweaty, No recollection of anything that happened between 2000 and 2100 hours. The patient received his vaccine yesterday 19Apr2021 at 1230.  On 19Apr2021 by 1500 he was very foggy, not thinking properly, and repetitive in what he was saying.  He was very distant, like he was looking at the consumer but not seeing her or hearing what she was saying.  He was very cold, very tired, and not comprehending.  Then at 2015 he had a seizure. She called the paramedics, her husband was very sweaty on 19Apr2021 and that point and had no recollection of anything that happened between 2000 and 2100 hours.   Patient was not taken to the Emergency Room or admitted to the hospital. Her husband is completely aware and recovered now.  Consumer reported on 19Apr2021 he had a headache that is persisting since the seizure. The consumer reported that her husband is epileptic, but he hasn't had a seizure in over 10 years and hasn't missed any doses of his medication. Patient was evaluated by the Paramedics that came to his home but was not taken to the Emergency Room. Relevant Tests were none. Outcome of Seizure was Recovered/Resolved with Sequel on 19Apr2021. Outcome of Very foggy, not thinking properly, repetitive in what he was saying, He was very cold, Very tired, Not comprehending, Very Sweaty was recovered on 19Apr2021. Outcome of headache was not recovered. Outcome of No recollection of anything that happened between 2000 and 2100 hours was unknown.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Mental impairment, Repetitive speech, Seizure, Thinking abnormal
Clinical narrative: Seizure; No recollection of anything that happened between 2000 and 2100 hours; Very foggy, not thinking properly, repetitive in what he was saying; Very foggy, not thinking properly, repetitive in what he was saying; Very foggy, not thinking properly, repetitive in what he was saying; Not comprehending; He was very cold; Very tired; Very Sweaty; Headache; This is a spontaneous report from a contactable consumer (Patient's wife).   A 53-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on 19Apr2021 12:30 (Lot Number: EW0164) as SINGLE DOSE (at age of 53 years old) for covid-19 immunisation.  Medical history included ongoing epilepsy diagnosed with this when he was 15 years old, seizure from an unknown date and unknown if ongoing (then at 2015 he had a seizure). Concomitant medications included levetiracetam (KEPPRA) 1250 mg, daily (250mg; 5 pills a day) taken for epilepsy from an unspecified start date and ongoing; carbamazepine (CARBAMAZEPINE) 1000 mg, daily (200mg; 5 pills a day) taken for an unspecified indication from an unspecified start date and ongoing.  Family Medical History Relevant to events was none. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 19Apr2021, the patient experienced seizure, Very foggy, not thinking properly, repetitive in what he was saying, very distant, like he was looking at his wife but not seeing her or hearing her, Headache, He was very cold, Very tired, Not comprehending, Very Sweaty, No recollection of anything that happened between 2000 and 2100 hours. The patient received his vaccine yesterday 19Apr2021 at 1230.  On 19Apr2021 by 1500 he was very foggy, not thinking properly, and repetitive in what he was saying.  He was very distant, like he was looking at the consumer but not seeing her or hearing what she was saying.  He was very cold, very tired, and not comprehending.  Then at 2015 he had a seizure. She called the paramedics, her husband was very sweaty on 19Apr2021 and that point and had no recollection of anything that happened between 2000 and 2100 hours.   Patient was not taken to the Emergency Room or admitted to the hospital. Her husband is completely aware and recovered now.  Consumer reported on 19Apr2021 he had a headache that is persisting since the seizure. The consumer reported that her husband is epileptic, but he hasn't had a seizure in over 10 years and hasn't missed any doses of his medication. Patient was evaluated by the Paramedics that came to his home but was not taken to the Emergency Room. Relevant Tests were none. Outcome of Seizure was Recovered/Resolved with Sequel on 19Apr2021. Outcome of Very foggy, not thinking properly, repetitive in what he was saying, He was very cold, Very tired, Not comprehending, Very Sweaty was recovered on 19Apr2021. Outcome of headache was not recovered. Outcome of No recollection of anything that happened between 2000 and 2100 hours was unknown.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Headache, Hypoaesthesia oral, Pain, Pain in extremity
Clinical narrative: Bell's palsy; tongue went numb; body aches; regular sore arm; headache; This is a spontaneous report from a contactable consumer reporting for herself. A 21-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EW0153/expiration date: not provided), via an unspecified route of administration, on 15Apr2021 10:45 (at the age of 21 years old) as a single dose in the right arm for COVID-19 IMMUNIZATION. Relevant medical history and concomitant medication were none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 15Apr2021, the patient experienced regular sore arm, headache. On 16Apr2021, the patient experienced body aches. On 17Apr2021, the patient's tongue went numb. On 20Apr2021, the patient experienced Bell's palsy and described it as getting worse. The outcome of the event regular sore arm was recovered on 16Apr2021. The outcome of the event body aches was recovered on 19Apr2021. The outcome of the events headache, tongue went numb and Bell's palsy was not recovered.
Sex: M
Vaccine: COVID19
Symptoms: Biopsy bone, Plasma cell myeloma
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 79-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 12Mar2021 (Batch/Lot number was not reported) as single dose for Covid-19 immunization. The patient received the 1st dose of BNT162B2 on an unspecified date for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that he had both of the Pfizer Covid 19 vaccines and the last one was on 12Mar2021. The patient stated that on 02Apr2021 he had a bone biopsy and it came out good with one exception, they found a cluster of T-cells that pathology was unable to explain. The patient further stated that he has multiple myeloma. The patient added that they theorized it may have come from the vaccination and was not concerned about it nor did the HCP want to follow up with it. The patient added that in previous years the T-cells did not show up but this time they did. The outcome of event was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: got covid-19 after the first dose; got covid-19 after the first dose; This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 23Mar2021 (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 pharmacist stated having a patient who got COVID-19 after the first dose of the PFIZER-BIONTECH COVID-19 VACCINE on 23Mar2021. The patient got COVID-19 disease after the first dose and went to Urgent Care due to COVID-19 symptoms. The patient has now fully recovered and is planning to get her second dose of the PFIZER-BIONTECH COVID-19 VACCINE at the time of reporting.  Information on the lot/batch number has been requested.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: stated that she has Covid; stated that she has Covid; This is a spontaneous report from a contactable consumer (cousin).   A 52-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06Apr2021 (Batch/Lot number was not reported) (at the age of 52-year-old) as single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient stated that she had COVID on an unspecified date. The patient underwent lab tests and procedures which included COVID-19 test: positive on an unspecified date.  The patient outcome of the event was unknown.  The information on the lot/batch number has been requested.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram, Fatigue, Feeling abnormal, Laboratory test, Loss of consciousness
Clinical narrative: Extreme fatigue; brain fog; Passed out; Told possible seizure; Felt ill shortly after receiving shot; Threw up; This is a spontaneous report from a contactable consumer (the patient) and then from a contactable consumer (the patient's wife). A 59-year-old male patient received the first dose of BNT162B2 (lot number not provided), via an unspecified route of administration in the left arm on 31Mar2021 10:00 (at the age of 59-years-old) as a single dose for COVID-19 immunization. The patient had no medical history. The patient did not have any known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included: fish oil (OMEGA 3 FISH OIL). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021, the patient felt ill shortly after receiving the shot. Told to sit down. Passed out. Awoke on the floor. Told possible seizure. Sat up. Threw up. Told to lie back down. Ambulance came and took him to the hospital. He spent 90 minutes in the Emergency Room. He was unable to work for a couple of days. He had extreme fatigue and brain fog. He was not back to relatively normal for at least 10 days. Treatment received was reported as yes: ran tests including 3 EKGs, on an unspecified date. The outcome of the events was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.   Information on the lot/batch number has been requested.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Seizure, Vomiting
Clinical narrative: Extreme fatigue; brain fog; Passed out; Told possible seizure; Felt ill shortly after receiving shot; Threw up; This is a spontaneous report from a contactable consumer (the patient) and then from a contactable consumer (the patient's wife). A 59-year-old male patient received the first dose of BNT162B2 (lot number not provided), via an unspecified route of administration in the left arm on 31Mar2021 10:00 (at the age of 59-years-old) as a single dose for COVID-19 immunization. The patient had no medical history. The patient did not have any known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included: fish oil (OMEGA 3 FISH OIL). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021, the patient felt ill shortly after receiving the shot. Told to sit down. Passed out. Awoke on the floor. Told possible seizure. Sat up. Threw up. Told to lie back down. Ambulance came and took him to the hospital. He spent 90 minutes in the Emergency Room. He was unable to work for a couple of days. He had extreme fatigue and brain fog. He was not back to relatively normal for at least 10 days. Treatment received was reported as yes: ran tests including 3 EKGs, on an unspecified date. The outcome of the events was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.   Information on the lot/batch number has been requested.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Haemarthrosis, Haemorrhage
Clinical narrative: ulcerated ankles bled into her shoe/ bled more; ulcerated ankles bled into her shoe/ bled more; bleeding disorder; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8732), first dose via an unspecified route of administration, administered in Arm Right on 01Apr2021 (at 67 years old), single dose for covid-19 immunisation. Medical history included ongoing ulcerated ankles, joint bleeding diagnosed prior to the vaccine in her 40s. The patient had no concomitant medications. On 04Apr2021,  3 days post-vaccination her ulcerated ankles bled.  She explained this bleeding has happened before, but she bled more, and it reached into her shoes which is "unusual". Patient came home from shopping three days after the vaccine and her shoes were saturated with blood, states this lasted for about a day and resolved two days later around 06Apr2021. She was reading through the paperwork and it said to let them know if you have a bleeding disorder. She is scared. Her ankles have bled like this before, wants to know if this is considered a bleeding disorder, does the vaccine make you bleed more. The outcome of the events was recovered on 06Apr2021.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dyspnoea, Fatigue, Pruritus, SARS-CoV-2 test
Clinical narrative: fainted; weak; tired; itching; trouble breathing; face swelling; unstable vital signs; This is a spontaneous report from a contactable consumer. A 47-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number and expiration date not provided, via an unspecified route of administration, administered in left arm on 05Apr2021 10:00 as single dose for covid-19 immunisation. Medical history included hypothyroidism, high cholesterol, allergies to penicillin and shell seafood.  here were no concomitant medications.  The patient previously took Percocet [oxycodone hydrochloride;paracetamol] and experienced allergies. The patient experienced fainted, weak, tired, itching, trouble breathing, face swelling and unstable vital signs on 05Apr2021 21:30. The patient was hospitalized. It was unknown if the patient received any treatment. The outcome of the events was unknown.   No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face, Syncope, Vital functions abnormal
Clinical narrative: fainted; weak; tired; itching; trouble breathing; face swelling; unstable vital signs; This is a spontaneous report from a contactable consumer. A 47-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number and expiration date not provided, via an unspecified route of administration, administered in left arm on 05Apr2021 10:00 as single dose for covid-19 immunisation. Medical history included hypothyroidism, high cholesterol, allergies to penicillin and shell seafood.  here were no concomitant medications.  The patient previously took Percocet [oxycodone hydrochloride;paracetamol] and experienced allergies. The patient experienced fainted, weak, tired, itching, trouble breathing, face swelling and unstable vital signs on 05Apr2021 21:30. The patient was hospitalized. It was unknown if the patient received any treatment. The outcome of the events was unknown.   No follow-up attempts are possible, information about lot/batch number cannot be obtained.