chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cold sweat, Cough, Headache, Rhinorrhoea
Clinical narrative: Runny Nose; Coughing; Cold Sweats; Pounding Headache; This is a spontaneous report from a contactable consumer (patient). A 31-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered in deltoid left on 07Apr2021 13:30 (Batch/Lot Number: EW0158) as single dose for COVID-19 immunization. The patient medical history included COVID 19 in December and had serious side effects. Patient denied any medications, medical conditions, labs, testing, or treatments. Stated he was the healthiest person. The patient's concomitant medications were none. No prior vaccinations (within 4 weeks). Patient took COVID 19 Shot because he wanted to stop wearing a mask and wanted to travel. The patient experienced pounding headache (reported as worsened) from 09Apr2021 with outcome of not recovered, cold sweats from 11Apr2021 with outcome of recovered on 11Apr2021, runny nose from 12Apr2021 with outcome of not recovered, coughing from 12Apr2021 with outcome of not recovered. AEs did not require a visit to Emergency Room and Physician Office. No family medical history relevant to AEs. No relevant tests. The patient underwent lab tests and procedures which included covid-19: positive on an unspecified date. Clinical course reported as follow: Patient stated the Friday after his vaccine he had a pounding headache. He had take off from work today due to his headache. Said it had eased off, but it came back today worse. Patient said he woke up with cold sweats on Sunday. Has not experienced this symptom since then. Runny nose and coughing started on Monday and was ongoing about the same as when it started.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: who got the first dose of the vaccine then tested positive for COVID-19 afterwards; who got the first dose of the vaccine then tested positive for COVID-19 afterwards; This is a spontaneous report from a Pfizer-sponsored program,  received from a contactable pharmacist. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not reported), on unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that they had a patient who got first dose of the vaccine then tested positive for COVID-19 afterwards. Reporter wanted to know if the patient had to wait 10 or 90 days before he/she could get the second dose. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Nausea
Clinical narrative: nausea; headache; joint pain; fatigue; This is a spontaneous report from a contactable health care professional for a patient enrolled in a Pfizer-sponsored program; this report regards events occurred with suspect product BNT162B2 not included in current Pfizer-sponsored program. A 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not reported), on unspecified date at single dose for COVID-19 immunization. The patient's medical history included cardiomyopathy from 2000 (defibrillator was place due to diagnosis of cardiomyopathy 21 years before the present report) and breast cancer. The patient's concomitant medications included palbociclib (IBRANCE) 125 mg, oral from 13Jan2021 and ongoing at 125 mg, cyclic (21 days on, then days 7 off) for breast cancer. The patient previously received first dose (1st shot) of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not reported), on unspecified date at single dose for COVID-19 immunization. It was reported that IBRANCE for 21 days on, then days 7 off. Patient reported symptoms after IBRANCE the month of the present report (Apr2021) that lasted for a couple days and have all resolved at the time of this report: nausea, headache, joint pain, and fatigue. Patient said that she noticed these symptoms started after her second (2nd) COVID vaccine (date unspecified) and lasted for a couple days after the vaccine, but she felt fine the day of the present report. Medical doctor (MD) was not made aware. Patient agreed to inform MD. Patient stated that she started the last cycle of IBRANCE one day later than usual in Mar2021 due to planned surgery to place a defibrillator (date unspecified), but patient said that she spent one night at hospital after procedure. Patient said that defibrillator was place due to diagnosis of cardiomyopathy 21 years before the present report (2000) (before IBRANCE) patient denied any symptoms that prompted surgery and she said it was planned for a long time prior to IBRANCE start. No other info known about this history. No adverse event reported from missed dose (as reported). The events were reported as serious with hospitalization criteria (reported as initial or prolonged hospitalization). The outcome of the events was resolved.  Information about lot/batch number has been requested.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Appendicitis, SARS-CoV-2 test
Clinical narrative: I was diagnosed with acute appendicitis /it did not rupture but it was puss filled; This is a spontaneous report from a contactable consumer patient. A 30-year-old female patient (age at vaccination: 29-years-old) received the first dose of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine), via an unspecified route of administration in the left arm on 26Mar2021 at 13:00 (Batch/Lot Number: PAA165969) as a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient was not pregnant, had no other vaccines in four weeks, and did not have COVID prior to vaccination. Concomitant medication included birth control (unspecified; reported as other medication in two weeks). Four days after the patient's vaccine, on 30Mar2021, she was diagnosed with acute appendicitis and had to have it removed. She was told that it did not rupture but it was pus filled. The event resulted in a doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, and hospitalization (for 2 days). The patient underwent lab tests and procedures which included SARS-CoV-2 test (via nasal swab): negative on 30Mar2021. As treatment, the patient's appendix was removed. Outcome of the event was recovering.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Magnetic resonance imaging, Nasal congestion, Nasal discomfort, Oral discomfort
Clinical narrative: Severe inflammation of tendons in right ankle (esp. primary tendon); Nose bleeds; Stuffy nose with little mucus present; Burning in nose; Burning top of mouth; This is a spontaneous report from a contactable healthcare professional (patient). A 69-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number was not reported), via an unspecified route of administration, administered in the right arm on 08Feb2021 (at the age of 69-years-old) as single dose for COVID-19 immunization. Medical history included multiple seasonal allergies, possible Crohn's disease, gluten sensitivity, allergic or sensitive to all antibiotics and prescription pain killers. The patient was not pregnant at the time of vaccination. The patient did not have COVID prior vaccination and was not COVID tested post vaccination. Concomitant medications included sertraline hydrochloride (ZOLOFT), hydrochlorothiazide, montelukast, and cetirizine hydrochloride (ZYRTEC). The patient previously received BNT162B2 (batch/lot number was not reported), dose 1, administered in the right arm on 12Jan2021 (at the age of 69-years-old) 12:00 PM for COVID-19 immunization. The patient did not have other vaccines in four weeks. In Mar2021, the patient experienced severe inflammation of tendons in right ankle (especially primary tendon identified in MRI), nose bleeds, stuffy nose with little mucus present, burning in nose, and burning top of mouth. The events resulted in doctor or other healthcare professional office/clinic visit and disability or permanent damage. Treatment included antibiotic for sinus and boot for foot/tendon. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information provided, A possible contributory role of the suspect product to the development of severe inflammation of tendons, nose bleed, stuffy nose with little mucus, burning in nose and burning top of mouth cannot be excluded. 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: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Tendonitis
Clinical narrative: Severe inflammation of tendons in right ankle (esp. primary tendon); Nose bleeds; Stuffy nose with little mucus present; Burning in nose; Burning top of mouth; This is a spontaneous report from a contactable healthcare professional (patient). A 69-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number was not reported), via an unspecified route of administration, administered in the right arm on 08Feb2021 (at the age of 69-years-old) as single dose for COVID-19 immunization. Medical history included multiple seasonal allergies, possible Crohn's disease, gluten sensitivity, allergic or sensitive to all antibiotics and prescription pain killers. The patient was not pregnant at the time of vaccination. The patient did not have COVID prior vaccination and was not COVID tested post vaccination. Concomitant medications included sertraline hydrochloride (ZOLOFT), hydrochlorothiazide, montelukast, and cetirizine hydrochloride (ZYRTEC). The patient previously received BNT162B2 (batch/lot number was not reported), dose 1, administered in the right arm on 12Jan2021 (at the age of 69-years-old) 12:00 PM for COVID-19 immunization. The patient did not have other vaccines in four weeks. In Mar2021, the patient experienced severe inflammation of tendons in right ankle (especially primary tendon identified in MRI), nose bleeds, stuffy nose with little mucus present, burning in nose, and burning top of mouth. The events resulted in doctor or other healthcare professional office/clinic visit and disability or permanent damage. Treatment included antibiotic for sinus and boot for foot/tendon. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information provided, A possible contributory role of the suspect product to the development of severe inflammation of tendons, nose bleed, stuffy nose with little mucus, burning in nose and burning top of mouth cannot be excluded. 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: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea haemorrhagic, Dizziness, Hyperhidrosis, Vomiting
Clinical narrative: bloody diarrhea; lightheadedness; vomiting; sweating; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm right on 14Apr2021 at 15:30 (Lot Number: EW0161) (at the age of 44-year-old) as single dose for COVID-19 immunisation.  The patient was not pregnant. Medical history included migraine, thyroid cancer and fruit allergy (kiwi fruit), all from an unknown date and unknown if ongoing. Concomitant medication included gabapentin; gabapentin (NEURONTIN); venlafaxine hydrochloride (EFFEXOR); levothyroxine sodium (SYNTHROID); eletriptan hydrobromide (RELPAX), all concomitants were taken for an unspecified indication, start and stop date were not reported. On 17Apr2021 at 10:00, the patient experienced bloody diarrhea, lightheadedness, vomiting and sweating. No therapeutic measures were taken as a result of the events. The patient outcome of the events was unknown.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Pain, Pyrexia
Clinical narrative: Dizzy; fatigue; chills; aches; fever; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, on 15Apr2021 at 4:00 PM (Batch/Lot number was not reported) at the age of 63-years-old, as a single dose in the left arm for COVID-19 immunisation.  Medical history included low thyroid and allergies to penicillin, both from an unknown date and unknown if ongoing. There were no concomitant medications. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, unknown lot number), dose 1 on 25Mar2021 at 4:00 PM at the age of 63-years-old as a single dose in the left arm for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient experienced dizzy, fatigue, aches, fever and chills on 16Apr2021 at 12:00 PM. The reported adverse events resulted in emergency room/department or urgent care. Treatment received included fluids and test run to rule out any other problems. The patient had no COVID prior vaccination. The patient was tested for COVID post vaccination which was a nasal swab with negative result on 16Apr2021. The outcome of the events was recovering.  Information on the lot/batch number has been requested.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Dizzy; fatigue; chills; aches; fever; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, on 15Apr2021 at 4:00 PM (Batch/Lot number was not reported) at the age of 63-years-old, as a single dose in the left arm for COVID-19 immunisation.  Medical history included low thyroid and allergies to penicillin, both from an unknown date and unknown if ongoing. There were no concomitant medications. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, unknown lot number), dose 1 on 25Mar2021 at 4:00 PM at the age of 63-years-old as a single dose in the left arm for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient experienced dizzy, fatigue, aches, fever and chills on 16Apr2021 at 12:00 PM. The reported adverse events resulted in emergency room/department or urgent care. Treatment received included fluids and test run to rule out any other problems. The patient had no COVID prior vaccination. The patient was tested for COVID post vaccination which was a nasal swab with negative result on 16Apr2021. The outcome of the events was recovering.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: Significant back pain.; This is a spontaneous report from a non-contactable consumer.  An adult female consumer of an unknown age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number unknown), on an unknown date at single dose for COVID-19 immunization.  Medical history included Covid-19 prior vaccination. Concomitant medications were not reported.  The patient experienced significant back pain on 17Apr2021. It is unknown if a treatment was given. The outcome of the event was unknown.    No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Hepatitis C, Hepatitis C antibody, Herpes zoster
Clinical narrative: Hepatitis c 0.9 positive; Herpes or shingles on groin; Extreme fatigue; Fever; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in arm right on 24Mar2021 13:30 (Batch/Lot number was not reported) as single dose, for COVID-19 immunisation. Medical history included hypothyroidism from an unknown date. Concomitant medication included sertraline hydrochloride (ZOLOFT) taken for an unspecified indication, start and stop date were not reported. The patient has no known allergies. The patient was not pregnant at the time of vaccination. The patient experienced Hepatitis c 0.9 positive, Herpes or shingles on groin, extreme fatigue, and fever on 11Apr2021. The patient underwent lab tests and procedures which included nasal swab: negative (covid tested post vaccination) on 15Apr2021 and Hepatitis C 0.9 positive on 11Apr2021. Therapeutic measures were taken as a result of the events which included Valtrex, cough syrup, antibiotics as treatment. The patient received the second dose of BNT162B2, administered in arm right on 14Apr2021 08:00. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Hepatitis c 0.9 positive; Herpes or shingles on groin; Extreme fatigue; Fever; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in arm right on 24Mar2021 13:30 (Batch/Lot number was not reported) as single dose, for COVID-19 immunisation. Medical history included hypothyroidism from an unknown date. Concomitant medication included sertraline hydrochloride (ZOLOFT) taken for an unspecified indication, start and stop date were not reported. The patient has no known allergies. The patient was not pregnant at the time of vaccination. The patient experienced Hepatitis c 0.9 positive, Herpes or shingles on groin, extreme fatigue, and fever on 11Apr2021. The patient underwent lab tests and procedures which included nasal swab: negative (covid tested post vaccination) on 15Apr2021 and Hepatitis C 0.9 positive on 11Apr2021. Therapeutic measures were taken as a result of the events which included Valtrex, cough syrup, antibiotics as treatment. The patient received the second dose of BNT162B2, administered in arm right on 14Apr2021 08:00. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Scleritis
Clinical narrative: Left eye scleritis and pain 17 days after vaccine.; Left eye scleritis and pain 17 days after vaccine.; This is a spontaneous report from a contactable nurse (patient herself).  A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in right arm on 22Mar2021 11:00 (Batch/Lot Number: EP7534) (at the age of 58-years-old) as single dose for COVID-19 immunisation. The recent COVID-19 vaccine was administered in public health clinic ddministration facility. The patient medical history included Hashimoto's thyroiditis, high cholesterol, and depression, and allergies to penicillin and sulfa. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included escitalopram oxalate (LEXAPRO), levothyroxine sodium (SYNTHROID); magnesium; ergocalciferol (VIT D); all taken unspecified indications, start and stop dates were not reported.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took cephalosporin (CEPHALOSPORIN C)  and benzalkonium chloride (BAK) and experienced allergies on both. On 08Apr2021, the patient experienced left eye scleritis and pain 17 days after vaccine. The events were reported as serious due to hospitalization. The events also resulted to healthcare professional office/clinic visit and  emergency room/department or urgent care. Therapeutic measures were taken as a result of the events which included methylprednisolone dose pack. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering.; Sender's Comments: Based on the available information and known product information, the causal relationship between the reported left eye scleritis and pain and the BNT162B2 vaccination  cannot be fully excluded. However,  reported scleritis associated with it may be  confounded by the history of thyroid disease  since non-infectious scleritis has been associated with thyroid disorders and autoimmune disease.  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: 42.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Sudden hearing loss
Clinical narrative: Left ear sudden hearing loss; This is a spontaneous report from a contactable physician (patient himself). A 42-year-old male patient received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 05Apr2021 13:30 (Batch/Lot Number: Er8734) as a single dose for COVID-19 immunisation. Medical history included asthma. Allergies were unknown. The patient's concomitant medications were not reported. The patient previously received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 15Mar2021 12:00 PM. The patient experienced left ear sudden hearing loss on 14Apr2021 20:00. Event resulted in Doctor or other healthcare professional office/clinic visit, Disability or permanent damage. Treatment received included high dose steroids. The patient underwent PCR COVID Nasal swab test: negative on 14Apr2021. Outcome of event was recovering.; Sender's Comments: Based on temporal association, a contributory role of BNT162B2 to the event left ear sudden hearing loss cannot be excluded completely. The case will be reassessed once more information become 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: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Disorientation, Headache, Investigation, Pyrexia
Clinical narrative: About an hour later he was disoriented; headache; seizure; fever was over 103/temperature spiked so quickly; This is a spontaneous report from a contactable consumer. A 16-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in right arm on 16Apr2021 13:00 (Batch/Lot number was not reported) (at the age of 16-years-old) as a single dose for COVID-19 immunisation. Medical history included mental illness and autism from unspecified dates and unknown if ongoing. There were no concomitant medications. Patient previously took the first dose of BNT162B2, administered in right arm on Mar2021 (Lot number was unknown), at the age of 16 years old, for COVID-19 immunisation. There were no other vaccines in four weeks. Several hours after receiving the second dose of Pfizer Covid vaccine on 16Apr2021 20:00, the individual developed a headache and took ibuprofen (ADVIL) and water. About an hour later, he was disoriented and the parent (who was a nurse practitioner) asked him questions and he was having a hard time answering. Patient's fever was over 103 in the ambulance. He was tested for everything at the hospital and all was negative. It was determined to be an adverse reaction to the vaccine and what likely happened is his temperature spiked so quickly that he had a seizure. The events resulted in emergency room/department or urgent care. Treatment for other adverse events was unknown. There was no COVID prior vaccination and patient was not COVID tested post vaccination. The outcome of the events was recovering.  Information about lot/batch has been requested.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: About an hour later he was disoriented; headache; seizure; fever was over 103/temperature spiked so quickly; This is a spontaneous report from a contactable consumer. A 16-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in right arm on 16Apr2021 13:00 (Batch/Lot number was not reported) (at the age of 16-years-old) as a single dose for COVID-19 immunisation. Medical history included mental illness and autism from unspecified dates and unknown if ongoing. There were no concomitant medications. Patient previously took the first dose of BNT162B2, administered in right arm on Mar2021 (Lot number was unknown), at the age of 16 years old, for COVID-19 immunisation. There were no other vaccines in four weeks. Several hours after receiving the second dose of Pfizer Covid vaccine on 16Apr2021 20:00, the individual developed a headache and took ibuprofen (ADVIL) and water. About an hour later, he was disoriented and the parent (who was a nurse practitioner) asked him questions and he was having a hard time answering. Patient's fever was over 103 in the ambulance. He was tested for everything at the hospital and all was negative. It was determined to be an adverse reaction to the vaccine and what likely happened is his temperature spiked so quickly that he had a seizure. The events resulted in emergency room/department or urgent care. Treatment for other adverse events was unknown. There was no COVID prior vaccination and patient was not COVID tested post vaccination. The outcome of the events was recovering.  Information about lot/batch has been requested.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Fainted about 15 to 20 minutes after dose; This is a spontaneous report from a contactable consumer (patient himself). A 24-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in the right arm on 17Apr2021 at 11:15 AM (Batch/Lot Number: ERB8729) as a single dose for COVID-19 immunization. The patient had no medical history. The patient had no known allergies. Concomitant medication included diphenhydramine taken for an unspecified indication, start and stop date were not reported. The patient had no other vaccine in four weeks. The patient had no COVID-19 prior vaccination. The patient was not tested for COVID-19 post vaccination. On 17Apr2021 at 11:30 AM, the patient fainted about 15 to 20 minutes after dose. The patient did not receive any treatment for the adverse event (AE). The patient recovered from the event on an unspecified date.
Sex: M
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 consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 29Mar2021 (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 mentioned that he had his first dose of the vaccine last 29Mar2021 and he is due to get his second shot on 19Apr2021. The patient would like to know if he still needs to get the second shot because he has tested positive with COVID on an unspecified date. The outcome of events was unknown.   Information about lot/batch number has been requested.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea haemorrhagic
Clinical narrative: Bloody diarrhea; This is a spontaneous report from a contactable consumer (patient). This 61-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 15Apr2021 13:00 (Batch/Lot Number: ER8731) as a single dose for COVID-19 immunization. Patient has no medical history. Concomitant medication included ibuprofen. 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. Patient has not been tested for COVID-19 since the vaccination. Patient has no known allergies. The patient experienced bloody diarrhea on 17Apr2021 10:00 with outcome of recovering.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Syncope; This is a spontaneous report from a contactable nurse (patient). A 57-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 17Apr2021 11:30 (Batch/Lot Number: ER8735) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. The patient experienced syncope on 17Apr2021 11:45. The event resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of syncope. Outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information currently available and the close temporal relationship, a possible contributory role of suspect product BNT162B2 to the reported 'syncope' cannot be completely excluded. Case will be reassessed if additional information is received. 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: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Agitation, Asthenia, Cardiovascular disorder, Colonoscopy, Discomfort
Clinical narrative: high blood pressure; fast heart beat, fast blood stream; fast heart beat, fast blood stream; weak; shaking; very uncomfortable horrible feeling; very uncomfortable horrible feeling; faint; adrenaline rush; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered on left arm on 15Apr2021 15:30 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included low TSH and high blood pressure. Patient was not pregnant at the time of vaccination and did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine sodium; losartan potassium (LOSARTAN "AGP"); vitamin D3; cissus quadrangularis (CQL); all taken for unspecified indications, start and stop dates were not reported. On 15Apr2021, the patient had three times adrenaline rush at 16:10, 16:30 and 18:20. It came automatically at 16:15 (as reported) with high blood pressure, fast heart beat, fast blood stream, faint, weak, shaking, very uncomfortable horrible feeling. Usually, this feeling will come after something happen and impact the brain, but now it came just by itself. Patient has feeling that she might die. She wanted to know if this vaccine affected her nerve system and if she should take the second dose or not. No treatment received for the adverse events. The patient underwent lab tests and procedures which included on 08Jan2021, colonoscopy: none, nucleic: none and nasal swab: negative; on 08Apr2021, colonoscopy (received within 2 weeks of vaccination): unknown results; and on an unspecified date (since the vaccination, the patient been tested for COVID-19) nucleic acid test: unknown results. Outcome of events were recovered on an unspecified date.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Hypertension, Malaise, Nucleic acid test, Syncope
Clinical narrative: high blood pressure; fast heart beat, fast blood stream; fast heart beat, fast blood stream; weak; shaking; very uncomfortable horrible feeling; very uncomfortable horrible feeling; faint; adrenaline rush; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered on left arm on 15Apr2021 15:30 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included low TSH and high blood pressure. Patient was not pregnant at the time of vaccination and did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine sodium; losartan potassium (LOSARTAN "AGP"); vitamin D3; cissus quadrangularis (CQL); all taken for unspecified indications, start and stop dates were not reported. On 15Apr2021, the patient had three times adrenaline rush at 16:10, 16:30 and 18:20. It came automatically at 16:15 (as reported) with high blood pressure, fast heart beat, fast blood stream, faint, weak, shaking, very uncomfortable horrible feeling. Usually, this feeling will come after something happen and impact the brain, but now it came just by itself. Patient has feeling that she might die. She wanted to know if this vaccine affected her nerve system and if she should take the second dose or not. No treatment received for the adverse events. The patient underwent lab tests and procedures which included on 08Jan2021, colonoscopy: none, nucleic: none and nasal swab: negative; on 08Apr2021, colonoscopy (received within 2 weeks of vaccination): unknown results; and on an unspecified date (since the vaccination, the patient been tested for COVID-19) nucleic acid test: unknown results. Outcome of events were recovered on an unspecified date.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor, Viral test
Clinical narrative: high blood pressure; fast heart beat, fast blood stream; fast heart beat, fast blood stream; weak; shaking; very uncomfortable horrible feeling; very uncomfortable horrible feeling; faint; adrenaline rush; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered on left arm on 15Apr2021 15:30 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included low TSH and high blood pressure. Patient was not pregnant at the time of vaccination and did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine sodium; losartan potassium (LOSARTAN "AGP"); vitamin D3; cissus quadrangularis (CQL); all taken for unspecified indications, start and stop dates were not reported. On 15Apr2021, the patient had three times adrenaline rush at 16:10, 16:30 and 18:20. It came automatically at 16:15 (as reported) with high blood pressure, fast heart beat, fast blood stream, faint, weak, shaking, very uncomfortable horrible feeling. Usually, this feeling will come after something happen and impact the brain, but now it came just by itself. Patient has feeling that she might die. She wanted to know if this vaccine affected her nerve system and if she should take the second dose or not. No treatment received for the adverse events. The patient underwent lab tests and procedures which included on 08Jan2021, colonoscopy: none, nucleic: none and nasal swab: negative; on 08Apr2021, colonoscopy (received within 2 weeks of vaccination): unknown results; and on an unspecified date (since the vaccination, the patient been tested for COVID-19) nucleic acid test: unknown results. Outcome of events were recovered on an unspecified date.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Rash pruritic, Skin haemorrhage
Clinical narrative: Extremely itchy rash on neck from chest to chin and on facial cheeks.; scratching raised blood to the surface. This reaction continues today.; This is a spontaneous report from a contactable consumer (patient). A 56-years-old male patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine at Doctor's office/urgent care, via an unspecified route of administration, administered in left arm on 26Mar2021 17:00, at 56 years of age, (Batch/Lot Number: EP6955) as single dose for COVID-19 immunization. Relevant medical history included seasonal allergies. The patient wasn't diagnosed with COVID prior vaccination and was not tested for COVID post vaccination. Concomitant medication included fluticasone taken for seasonal allergies, start and stop date were not reported. On 27Mar2021 at 06:30 the patient experienced extremely itchy rash on neck from chest to chin and on facial cheeks. It appears during showers and dissipates within 15 minutes of getting out of shower. No change in shampoo, soap, shave soap or razors. The first time the patient could not satisfy the itch and scratching raised blood to the surface. The patient didn't receive any treatment for the event. At the time of the report the events had not resolved yet.
Sex: F
Vaccine: COVID19
Symptoms: Pneumonia
Clinical narrative: pneumonia; This is a spontaneous report from a sponsored program, received from a contactable consumer (patient). A female patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not reported), on unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient said that she was supposed to receive the second dose of the PFIZER-BIONTECH COVID-19 VACCINE within an hour (17Apr2021). However, she said she had pneumonia and she wanted to know if her condition would have an impact to the vaccine. Patient said that she already got the first shot of the vaccine and she was scheduled to get the second dose the day of the present report (17Apr2021), however, she developed pneumonia. She would like to know if she should still get the vaccine today. She said that she wanted to get an answer right away. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Chest discomfort, Dizziness, Eye haemorrhage, Eye pain
Clinical narrative: It feels like an MS flare; left eye blood vessel rupture with pain; left eye blood vessel rupture with pain; pressure emanating to left eye; Dizziness; off-balance; headache and head pressure; headache and head pressure; chest heaviness; exhaustion; nausea; This is a spontaneous report from a contactable consumer (patient). A 44-year-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 31Mar2021 17:45 as single dose  for COVID-19 immunization on an unspecified facility. Medical history included multiple sclerosis, ulcerative colitis, rheumatoid arthritis, and seasonal allergy from an unknown date. The patient took several unspecified concomitant medications taken within two weeks. The patient previously took metoclopramide (REGLAN) for nausea and experienced drug allergy. No other vaccines were taken in four weeks. No COVID-19 prior to vaccination and not tested for COVID-19 post vaccination. On 02Apr2021, the patient had MS flare, left eye blood vessel rupture with pain and pressure emanating to left eye, dizziness, off-balance, headache and head pressure, chest heaviness, exhaustion, and nausea. The patient visited the emergency room and physician's office where she was given an unspecified treatment. The outcome of the events was not recovered.   Information on the lot/batch number has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Head discomfort, Headache, Multiple sclerosis relapse, Nausea
Clinical narrative: It feels like an MS flare; left eye blood vessel rupture with pain; left eye blood vessel rupture with pain; pressure emanating to left eye; Dizziness; off-balance; headache and head pressure; headache and head pressure; chest heaviness; exhaustion; nausea; This is a spontaneous report from a contactable consumer (patient). A 44-year-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 31Mar2021 17:45 as single dose  for COVID-19 immunization on an unspecified facility. Medical history included multiple sclerosis, ulcerative colitis, rheumatoid arthritis, and seasonal allergy from an unknown date. The patient took several unspecified concomitant medications taken within two weeks. The patient previously took metoclopramide (REGLAN) for nausea and experienced drug allergy. No other vaccines were taken in four weeks. No COVID-19 prior to vaccination and not tested for COVID-19 post vaccination. On 02Apr2021, the patient had MS flare, left eye blood vessel rupture with pain and pressure emanating to left eye, dizziness, off-balance, headache and head pressure, chest heaviness, exhaustion, and nausea. The patient visited the emergency room and physician's office where she was given an unspecified treatment. The outcome of the events was not recovered.   Information on the lot/batch number has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Ocular discomfort
Clinical narrative: It feels like an MS flare; left eye blood vessel rupture with pain; left eye blood vessel rupture with pain; pressure emanating to left eye; Dizziness; off-balance; headache and head pressure; headache and head pressure; chest heaviness; exhaustion; nausea; This is a spontaneous report from a contactable consumer (patient). A 44-year-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 31Mar2021 17:45 as single dose  for COVID-19 immunization on an unspecified facility. Medical history included multiple sclerosis, ulcerative colitis, rheumatoid arthritis, and seasonal allergy from an unknown date. The patient took several unspecified concomitant medications taken within two weeks. The patient previously took metoclopramide (REGLAN) for nausea and experienced drug allergy. No other vaccines were taken in four weeks. No COVID-19 prior to vaccination and not tested for COVID-19 post vaccination. On 02Apr2021, the patient had MS flare, left eye blood vessel rupture with pain and pressure emanating to left eye, dizziness, off-balance, headache and head pressure, chest heaviness, exhaustion, and nausea. The patient visited the emergency room and physician's office where she was given an unspecified treatment. The outcome of the events was not recovered.   Information on the lot/batch number has been requested.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Rhabdomyolysis, SARS-CoV-2 test
Clinical narrative: rhabdomyolysis; muscle and joint pain; muscle and joint pain; This is a spontaneous report from a contactable consumer (patient). A 71-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Mar2021 (at the age of 71 years old) (Lot Number: en6208, unknown expiration) as a single dose for COVID-19 immunisation.  Medical history included type 1 diabetic. Concomitant medication included insulin. The patient also received first dose of BNT162B2 in right arm for COVID-19 immunization on 25Feb2021 at 02:15 pm (at the age of 71 years old) (lot number: en6198, unknown expiration). The patient experienced bad muscle and joint pain on 25Mar2021 at 19:00. He went to emergency room and was sent to hospital which said rhabdomyolysis. The patient received IVs for the events. The patient did not receive other vaccine in four weeks. The patient has no COVID prior to vaccination and was tested for COVID (nasal swab) on 09Apr2021 with negative result.  The patient had not yet recovered from the events. The events were assessed as serious (hospitalization) for 1 day.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: A week later get a COVID test positive; This is a spontaneous report from a non-contactable consumer (patient himself) and via response to the mail trail sent regarding the confirmation of mentioned query. A 50-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 06Apr2021 at 10:30 (at the age of 50-years-old) as SINGLE DOSE for covid-19 immunization. Medical history included High blood pressure and Hashymoto. The patient had no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. On 13Apr2021 the patient experienced a week later get a covid test positive. The patient underwent lab tests and procedures which included Covid test: positive on 13Apr2021 nasal swab, PCR covid test: positive on 13Apr2021 nasal swab. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient has been tested for COVID-19 and tested positive on post vaccination in Nasal swab test. The Patient did not receive any treatment for the adverse event. At the time of this report event outcome was not recovered.  Information about batch/Lot number has been requested.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.