chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Insomnia, Rash papular, Rash pruritic, Urticaria
Clinical narrative: itchy rash; itchy rash that looked like hives and was bumpy; itchy rash that looked like hives and was bumpy; she is not comfortable; She cannot sleep/has not gotten enough sleep; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration in the left arm on 12May2021 16:45 (Lot Number: EW0183) as 1st dose, single for covid-19 immunisation (going to be traveling soon and needed it for work). The patient medical history was not reported. Concomitant medications included ongoing vitamin c [ascorbic acid] (VITAMIN C), ongoing vitamins nos (MULTIVITAMINS) and zinc with therapy date not reported, all for unknown indication. The patient has no previous immunization with the Pfizer vaccine considered as suspect or received additional Vaccines Administered on Same Date of the Pfizer vaccine. The patient did not receive other vaccines 4 weeks prior to vaccination. The patient mentioned that she had the vaccine yesterday, 12May2021 at 4:45pm in a hospital. She stayed for the 15 minutes after, and didn't feel anything but when she got home, she had an itchy rash (also reported as 02:30 am), like hives and she took some allergy pills. She further reported that when she got home, she felt something. It looked like hives and were bumpy, when she scratched it, it was like hives. It was in the middle of her body in the back, front and in her neck, that was 2:30 this morning. This afternoon, it was in her armpits, groin and all over. It happened again at 2:30am (13May2021), she had the itch again and took another pill. It has been on and off and is now all over her body and she is not comfortable. After lunch, again she took a pill and it hasn't stopped itching and is continuous. She mentioned that she has never had the flu shot. She was not planning to have this one, but her work said she had to get this. She did not have any allergic reactions to any vaccines in the past. She mentioned that she does not know what to do since the allergy pill does not work and she thinks she needs an injection. She added that her family (daughter is a nurse) is telling her this is not allergies it is the vaccine. The patient mentioned that the treatment used included allergy pills, an antihistamine, diphenhydramine, the generic form of Benadryl. She took the pills 3 times, every 3 hours. The adverse events did not require emergency room or physician office visit. The patient further mentioned that she just needs something stronger. She can't get any medicine for this and she would like to ask if she can get a steroid for this. She is not comfortable and has not gotten enough sleep. The patient is also going to ask for a prescription for Atarax, hydroxyzine. She added that she cannot sleep and the more she scratches it the worse it gets. Daughter told her she had to call because it is not just allergies. She took a shower to help the itchiness and it helped for a little bit. The outcome of the events was not recovered.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Accident, Blindness, Dizziness, Feeling cold, Feeling hot
Clinical narrative: I started to lose my sight, at first it was my entire peripheral vision and it looked like I was looking through a black holed telescope and then I completely lost sight; Crashed into a stand and passed out; I got really dizzy; I sat in a chair where I became incredibly hot; Sweat through all my clothes; Immediately extremely cold; crashed into a stand; This is a spontaneous report from a contactable consumer (the patient). A 21-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0173) via an unspecified route of administration in left arm on 13May2021 18:00 at age of 21-year-old at single dose for COVID-19 immunisation. Prior to vaccination, the patient diagnosed with COVID-19. No known allergies. No other medical history. Concomitant medication included: the patient received birth control medication within 2 weeks of vaccination. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EP7533) via an unspecified route of administration on 19Apr2021 01:15 PM at age of 21-year-old for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had not been tested for COVID-19 since the vaccination. The patient got really dizzy, then as she tried to walk away she started to lose her sight, at first it was her entire peripheral vision and it looked like she was looking through a black holed telescope and then she completely lost sight. She became very dizzy and crashed into a stand and passed out. While she was passed out on the floor she uncontrollably defected. Once someone helped her up, she sat in a chair where she became incredibly hot, sweat through all her clothes and then immediately extremely cold. The events onset date reported as 14May2021 09:00AM. No treatment received for the events. The outcome of the events was recovering. The report was non-serious.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Loss of consciousness
Clinical narrative: I started to lose my sight, at first it was my entire peripheral vision and it looked like I was looking through a black holed telescope and then I completely lost sight; Crashed into a stand and passed out; I got really dizzy; I sat in a chair where I became incredibly hot; Sweat through all my clothes; Immediately extremely cold; crashed into a stand; This is a spontaneous report from a contactable consumer (the patient). A 21-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0173) via an unspecified route of administration in left arm on 13May2021 18:00 at age of 21-year-old at single dose for COVID-19 immunisation. Prior to vaccination, the patient diagnosed with COVID-19. No known allergies. No other medical history. Concomitant medication included: the patient received birth control medication within 2 weeks of vaccination. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EP7533) via an unspecified route of administration on 19Apr2021 01:15 PM at age of 21-year-old for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had not been tested for COVID-19 since the vaccination. The patient got really dizzy, then as she tried to walk away she started to lose her sight, at first it was her entire peripheral vision and it looked like she was looking through a black holed telescope and then she completely lost sight. She became very dizzy and crashed into a stand and passed out. While she was passed out on the floor she uncontrollably defected. Once someone helped her up, she sat in a chair where she became incredibly hot, sweat through all her clothes and then immediately extremely cold. The events onset date reported as 14May2021 09:00AM. No treatment received for the events. The outcome of the events was recovering. The report was non-serious.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Deafness unilateral, SARS-CoV-2 test
Clinical narrative: deaf in left ear; Could not keep balance; This is a spontaneous report from a contactable healthcare professional (patient). A 57-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at age 57-year-old, via an unspecified route of administration, administered in arm left on 07Apr2021 16:30 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. The patient's medical history was reported. There were no concomitant medication and no other vaccine received within 4 weeks. The patient could not keep balance and went deaf in left ear on 08Apr2021 12:00. The events resulted in doctor or other healthcare professional office/clinic visit. Unspecified treatment was given for the events. Patient recovered on an unspecified date. Patient was not diagnosed with COVID prior to vaccination and has been tested post vaccination on 13Apr2021 (nasal swab) with negative results.  Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported events of balance disorder and deaf in left ear due to temporal relationship.  Case will be re-assessed upon the additional information provided. 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: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Eye swelling, Fatigue, Headache, Product administered to patient of inappropriate age
Clinical narrative: Swollen eye; low grade fever; slight headache; fatigue; 13-year-old female patient received BNT162B2; This is a spontaneous report from a contactable consumer (patient). A 13-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm on 13May2021 14:15 (batch/lot number: PFIZEREW0179) as 1st dose, single for COVID-19 immunization. Medical history included known allergies to amoxicillin. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No Covid prior to vaccination and was not Covid tested post vaccination. The patient experienced swollen eye, low grade fever (99.5 F), slight headache, fatigue; all on 14May2021 14:00. Treatment was received for the adverse events which included diphenhydramine hcl (BENADRYL). The outcome of the events was recovering.  Information on lot/batch number was available. Follow-up attempts are completed. No further information is expected.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Swollen eye; low grade fever; slight headache; fatigue; 13-year-old female patient received BNT162B2; This is a spontaneous report from a contactable consumer (patient). A 13-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm on 13May2021 14:15 (batch/lot number: PFIZEREW0179) as 1st dose, single for COVID-19 immunization. Medical history included known allergies to amoxicillin. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No Covid prior to vaccination and was not Covid tested post vaccination. The patient experienced swollen eye, low grade fever (99.5 F), slight headache, fatigue; all on 14May2021 14:00. Treatment was received for the adverse events which included diphenhydramine hcl (BENADRYL). The outcome of the events was recovering.  Information on lot/batch number was available. Follow-up attempts are completed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, SARS-CoV-2 test, Tongue discomfort
Clinical narrative: Persistent nausea; tongue often feels different; This is a spontaneous report from a contactable health care professional (patient). A 42-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration on 24Feb2021 as an unknown dose number, as a single dose for COVID-19 immunization.  Medical history included familial hypercholesterolemia and hashimotos antibodies both from an unknown date and unknown if ongoing. Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medications included trazodone (manufacturer unknown) and hydroxyzine (manufacturer unknown), both taken for an unspecified indication, start and stop date were not reported.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced persistent nausea and tongue often feels different on 27Feb2021. The events resulted to a doctor or other healthcare professional office/clinic visit. As treatment for the events, the patient's gall bladder was removed (as reported). The events were reported with a seriousness of disability. The outcome of the events was not recovered. The patient had a nasal swab SARS-COV-2 test on 07May2021 with a result of negative.; Sender's Comments: Events represent intercurrent medical conditions and unrelated to BNT162B2 .  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.
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Fainting episode upon rising from a chair; This is a spontaneous report from a contactable consumer (patient). A 12-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on May2021 (Batch/Lot Number: EW0183) as 1st dose, single dose for covid-19 immunisation. The patient received the vaccine in a Public Health Clinic.   Medical history included juvenile idiopathic arthritis from an unknown date and unknown if ongoing (Previously diagnosed with JIA, but resolved with diet change), mold, gluten and lactose intolerance from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took gluten for food allergy and experienced food allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced fainting episode upon rising from a chair on May2021. No treatment was received in response to the event. The patient was recovering from the event.    Follow-up attempts are needed. Additional information has been requested.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, SARS-CoV-2 test
Clinical narrative: My second dose of the vaccine was 10Jan2021. I conceived around 24Jan2021. I suffered a missed miscarriage detected 10May2021, then an incomplete miscarriage 14May2021.; This is a spontaneous report from a contactable physician (patient). A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm, on 10Jan2021 10:00 (lot number not reported), as 2nd dose, single dose, at age 34 years old, for covid-19 immunisation, at a workplace clinic. The patient was not pregnant at the time of vaccination. The patient medical history was not reported. The patient was not diagnosed with COVID-19 prior to vaccination. There were no concomitant medications (other medications received within 2 weeks of vaccination: no). Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in the left arm, on 20Dec2021 at 10:00 (lot number not reported), at age 34 years old, for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported, "My second dose of the vaccine was 10Jan2021. I conceived around 24Jan2021. I suffered a missed miscarriage detected 10May2021, then an incomplete miscarriage 14May2021." The event resulted to emergency room and physician office visits, and hospitalization (date not reported, duration: 1 day). Treatment was reported as "incomplete miscarriage, hemorrhaged, D&C". The patient tested negative to COVID-19 via nasal swab on 14May2021. The outcome of the event was recovered with sequel in May2021.   Information on batch/lot number has been requested.; Sender's Comments: Based on the temporal relationship, the association between the event miscarriage with BNT162b2 can not be fully 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: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Heart rate, Heart rate increased
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on the left arm on 13May2021 (15:30) as a 1st dose, single dose, with route of administration unspecified, for COVID-19 immunization. Medical history included sulfa allergy. There were no concomitant medications. The patient was not pregnant at the time of vaccination. The patient previously took hydrocodone, acetaminophen (VICODIN), and had drug allergy. On 14May2021 (20:30), the patient had a feeling of heart pain; and heart was beating fast. The patient did not receive any treatment for the reported events. The outcome of the events was unknown. The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested for COVID-19 since the vaccination.  Information on the lot/batch number has been requested.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Appendicitis, Computerised tomogram
Clinical narrative: acute appendicitis; intense abdominal pain; This is a spontaneous report from a contactable nurse. A 52-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 25Jan2021 (Batch/Lot Number: EJ1686; Expiration Date: May2021) as 2nd dose, single dose (at the age of 52 years) for covid-19 immunization. The patient's medical history included acute lymphoblastic leukemia and s/p BMT (s/p BMT 1993, no chronic health conditions). Thepatkent didi not receive any other vaccines within 4 weeks prior to the Covid-19 vaccine. Concomitant medications included estradiol (ESTRADIOL); norethindrone acetate (NORETHINDRONE ACETATE) taken for an unspecified indication, start and stop date were not reported. The patient received the first dose of BNT162B2 on 05Jan2021, 10:00am (lot:EJ1686, expiration: Mar2021) at the age of 52 years for Covid-19 immunisation. Wednesday morning around 9am on27Jan2021, patient went home early from work with intense abdominal pain. She was admitted to the hospital Thursday(28Jan) around 2am and was diagnosed (on CT) with acute appendicitis. Patient had an appendectomy on 28Jan2021 around 11am. The outcome of the events was recovered on 28Jan2021.   Information on Lot/Batch number was available. Additional information has been requested
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Loss of consciousness, Nausea, Road traffic accident, Sluggishness
Clinical narrative: blacked out; lost control of the car and had an accident; I felt sluggish/dizzy and a bit nauseous/It was the same dizzy and nauseous feeling but more intense; I felt sluggish/dizzy and a bit nauseous/It was the same dizzy and nauseous feeling but more intense; I felt sluggish/dizzy and a bit nauseous/It was the same dizzy and nauseous feeling but more intense; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 07May2021 08:30 (Batch/Lot Number: EW0179) as 2nd dose, single for covid-19 immunization at a hospital. Medical history included allergy to some animal. Prior to vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and has no other medications received within 2 weeks of vaccination. The patient had the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EN6199) on 16Apr2021 at 08:30 in the left arm for COVID-19 immunization. The patient felt sluggish/dizzy and a bit nauseous the evening of the vaccine (07May2021). The next day (08May2021 08:00), the patient felt the same way while driving. It was the same dizzy and nauseous feeling but more intense. Then a few seconds later, she blacked out, lost control of the car and had an accident. The events resulted in emergency room/department or urgent care. The patient was treated with stitches and painkillers for the injuries. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered on May2021.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Chest pain, Costochondritis, Dyspnoea, SARS-CoV-2 test
Clinical narrative: Unexplained chest pain; Breathing difficulties; Weakness; Costochondritis; This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), on 11Feb2021 12:00 (Lot: EL9267) (at the age of 77-years-old) as 1 st dose, single then on 11Mar2021 11:00 (Lot: EL6204) as 2 nd dose, single; both via an unspecified route of administration in left arm for covid-19 immunisation. The vaccination facility type was reported as other. No other vaccines within 4 weeks prior to the COVID vaccine. Medical history included Parkinson's disease, high BP, high cholesterol and known allergies: penicillin. Concomitant medications included allopurinol; esomeprazole magnesium (NEXIUM); pravastatin and propranolol. The patient previously took sulfamethoxazole, trimethoprim (BACTRIM) and experienced known allergies: Bactrim. The reported events unexplained chest pain, breathing difficulties, weakness and initially diagnosed costochondritis, all in Feb2021. The patient considered the case as serious due to caused/prolonged hospitalization, did not results in death, not life threatening, non-disabling/incapacitating and no congenital anomaly/birth defect. 3 more incidents of increasing intensity led to 3 ER visits and 2 hospitalizations. The events resulted doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care and hospitalization for 5 days. Treatment for the events included IV antibiotic, furosemide (LASIX), prednisone. Prior to vaccination, patient was not diagnosed with COVID-19and since vaccination, patient was tested for COVID-19 with nasal swab on 29Apr2021 with result of negative. The outcome of the events was recovering.
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal distension, Asthenia, COVID-19, Chest pain, Costochondritis
Clinical narrative: Unexplained chest pain; Breathing difficulties; Weakness; Costochondritis; This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), on 11Feb2021 12:00 (Lot: EL9267) (at the age of 77-years-old) as 1 st dose, single then on 11Mar2021 11:00 (Lot: EL6204) as 2 nd dose, single; both via an unspecified route of administration in left arm for covid-19 immunisation. The vaccination facility type was reported as other. No other vaccines within 4 weeks prior to the COVID vaccine. Medical history included Parkinson's disease, high BP, high cholesterol and known allergies: penicillin. Concomitant medications included allopurinol; esomeprazole magnesium (NEXIUM); pravastatin and propranolol. The patient previously took sulfamethoxazole, trimethoprim (BACTRIM) and experienced known allergies: Bactrim. The reported events unexplained chest pain, breathing difficulties, weakness and initially diagnosed costochondritis, all in Feb2021. The patient considered the case as serious due to caused/prolonged hospitalization, did not results in death, not life threatening, non-disabling/incapacitating and no congenital anomaly/birth defect. 3 more incidents of increasing intensity led to 3 ER visits and 2 hospitalizations. The events resulted doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care and hospitalization for 5 days. Treatment for the events included IV antibiotic, furosemide (LASIX), prednisone. Prior to vaccination, patient was not diagnosed with COVID-19and since vaccination, patient was tested for COVID-19 with nasal swab on 29Apr2021 with result of negative. The outcome of the events was recovering.
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dyspnoea, Inflammatory marker increased, Painful respiration, Pericardial effusion, Pleurisy
Clinical narrative: Unexplained chest pain; Breathing difficulties; Weakness; Costochondritis; This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), on 11Feb2021 12:00 (Lot: EL9267) (at the age of 77-years-old) as 1 st dose, single then on 11Mar2021 11:00 (Lot: EL6204) as 2 nd dose, single; both via an unspecified route of administration in left arm for covid-19 immunisation. The vaccination facility type was reported as other. No other vaccines within 4 weeks prior to the COVID vaccine. Medical history included Parkinson's disease, high BP, high cholesterol and known allergies: penicillin. Concomitant medications included allopurinol; esomeprazole magnesium (NEXIUM); pravastatin and propranolol. The patient previously took sulfamethoxazole, trimethoprim (BACTRIM) and experienced known allergies: Bactrim. The reported events unexplained chest pain, breathing difficulties, weakness and initially diagnosed costochondritis, all in Feb2021. The patient considered the case as serious due to caused/prolonged hospitalization, did not results in death, not life threatening, non-disabling/incapacitating and no congenital anomaly/birth defect. 3 more incidents of increasing intensity led to 3 ER visits and 2 hospitalizations. The events resulted doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care and hospitalization for 5 days. Treatment for the events included IV antibiotic, furosemide (LASIX), prednisone. Prior to vaccination, patient was not diagnosed with COVID-19and since vaccination, patient was tested for COVID-19 with nasal swab on 29Apr2021 with result of negative. The outcome of the events was recovering.
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pneumonia, Presyncope, Pyrexia, Weight increased, Wheezing
Clinical narrative: Unexplained chest pain; Breathing difficulties; Weakness; Costochondritis; This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), on 11Feb2021 12:00 (Lot: EL9267) (at the age of 77-years-old) as 1 st dose, single then on 11Mar2021 11:00 (Lot: EL6204) as 2 nd dose, single; both via an unspecified route of administration in left arm for covid-19 immunisation. The vaccination facility type was reported as other. No other vaccines within 4 weeks prior to the COVID vaccine. Medical history included Parkinson's disease, high BP, high cholesterol and known allergies: penicillin. Concomitant medications included allopurinol; esomeprazole magnesium (NEXIUM); pravastatin and propranolol. The patient previously took sulfamethoxazole, trimethoprim (BACTRIM) and experienced known allergies: Bactrim. The reported events unexplained chest pain, breathing difficulties, weakness and initially diagnosed costochondritis, all in Feb2021. The patient considered the case as serious due to caused/prolonged hospitalization, did not results in death, not life threatening, non-disabling/incapacitating and no congenital anomaly/birth defect. 3 more incidents of increasing intensity led to 3 ER visits and 2 hospitalizations. The events resulted doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care and hospitalization for 5 days. Treatment for the events included IV antibiotic, furosemide (LASIX), prednisone. Prior to vaccination, patient was not diagnosed with COVID-19and since vaccination, patient was tested for COVID-19 with nasal swab on 29Apr2021 with result of negative. The outcome of the events was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discolouration
Clinical narrative: Arm,  injection site now has pigmentation gone where the injection went in, the size of 3 peas put together; This is a spontaneous report from Pfizer-sponsored program..  A contactable Consumer (patient), a female patient of an unspecified age, received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) in arm as single dose for covid-19 immunisation.  The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient experienced arm, injection site now has pigmentation gone where the injection went in, the size of 3 peas put together (non-serious) on an unspecified date with outcome of unknown. No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Depression, Hallucination, Intentional self-injury, Mood altered
Clinical narrative: Hallucinations; Urge to self harm; Severe mood swings; Depressive state; This is a spontaneous report from a contactable consumer. A 23-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 15May2021 08:30 (Batch/Lot Number: EW0185), at the age of 23-years-old as 2nd dose, single for COVID-19 immunization. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 24Apr2021 08:30 (lot number: EW0151) at the age of 23-years-old in the left arm. Medical history included Chronic ear pain and allergies with Gorgonzola cheese. The patient's concomitant medications were not reported.  Most recent COVID-19 vaccine was administered at the Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications were received within 2 weeks of vaccination. The patient experienced severe mood swings and depressive state, urge to self-harm (medically significant) and hallucinations (medically significant) on 15May2021 11:45. No treatment was given. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered.    Information on Lot/Batch number was available. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Eczema
Clinical narrative: Eczema all over forehead, lips and neck.; This is a spontaneous report from a contactable consumer (patient) reported that a 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was not reported), via an unspecified route of administration, administered in arm left on 20Apr2021 16:00 (at the age of 50-years-old) as 2nd dose, single dose for covid-19 immunisation. The vaccine was administered at the Pharmacy/drug store. The patient was not pregnant at the time of vaccination. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No any other medications the patient received within 2 weeks of vaccination. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was not reported), administered in arm left on 30Mar2021 02:00 PM (at the age of 50-years-old) as 1st dose for covid-19 immunization. On 02May2021 at 12:00 PM, the patient experienced eczema all over forehead, lips and neck. Therapeutic measures were taken as a result of eczema all over forehead, lips and neck as the patient received Cortizone. The outcome of the event was not recovered. Since the vaccination, the patient has not been tested for COVID-19.   Information on the lot/batch number has been requested.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Malaise, Oral mucosal blistering, Oropharyngeal blistering, Respiratory disorder
Clinical narrative: mouth and throat broke out in blisters; mouth and throat broke out in blisters; Tongue is broke out with white sores; tongue is swollen; breathing problems; cough; constantly clearing throat; malaise; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: EN6207), via an unspecified route of administration in left arm on 21Apr2021 10:00 (at the age of 51-years-old) as 2 nd dose, single for covid-19 immunisation. The vaccination facility type was a reported as other. No other vaccines within 4 weeks prior to the COVID vaccine. The patient received first dose of bnt162b2 (lot: EP6955) on 31Mar2021 at 10:00 in left arm (at the age of 51-years-old) for COVID-19 immunization. Medical history included asthma, Ehlers Danlos Syndrome, postural orthostatic tachycardia syndrome (POTS), immune disorder, Medium-chain acyl-coenzyme A dehydrogenase deficiency (MCAD), Irritable bowel syndrome (IBS), Chiari-decompressed, anxiety and depression. The patient had no known allergies. The patient's concomitant medications were not reported. The reported adverse events were mouth and throat broke out in blisters; Tongue was broke out with white sores, tongue was swollen, breathing problems, cough, constantly clearing throat and malaise on 24Apr2021. The events resulted doctor or other healthcare professional office/clinic visit. Treatment received for the adverse events included prednisone, z pack, valacyclovir hcl, nystatin. Prior to vaccination, patient was not diagnosed with COVID-19 and since vaccination (post vaccination), patient has been tested for COVID-19 (nasal swab) on 29Apr2021 with result of negative. The outcome of the events was not recovered.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Stomatitis, Swollen tongue, Throat clearing
Clinical narrative: mouth and throat broke out in blisters; mouth and throat broke out in blisters; Tongue is broke out with white sores; tongue is swollen; breathing problems; cough; constantly clearing throat; malaise; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: EN6207), via an unspecified route of administration in left arm on 21Apr2021 10:00 (at the age of 51-years-old) as 2 nd dose, single for covid-19 immunisation. The vaccination facility type was a reported as other. No other vaccines within 4 weeks prior to the COVID vaccine. The patient received first dose of bnt162b2 (lot: EP6955) on 31Mar2021 at 10:00 in left arm (at the age of 51-years-old) for COVID-19 immunization. Medical history included asthma, Ehlers Danlos Syndrome, postural orthostatic tachycardia syndrome (POTS), immune disorder, Medium-chain acyl-coenzyme A dehydrogenase deficiency (MCAD), Irritable bowel syndrome (IBS), Chiari-decompressed, anxiety and depression. The patient had no known allergies. The patient's concomitant medications were not reported. The reported adverse events were mouth and throat broke out in blisters; Tongue was broke out with white sores, tongue was swollen, breathing problems, cough, constantly clearing throat and malaise on 24Apr2021. The events resulted doctor or other healthcare professional office/clinic visit. Treatment received for the adverse events included prednisone, z pack, valacyclovir hcl, nystatin. Prior to vaccination, patient was not diagnosed with COVID-19 and since vaccination (post vaccination), patient has been tested for COVID-19 (nasal swab) on 29Apr2021 with result of negative. The outcome of the events was not recovered.
Sex: M
Vaccine: COVID19
Symptoms: Haematemesis
Clinical narrative: Thrown up once; it had blood in it; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: ER8736) via an unspecified route of administration on 14May2021 as 2nd dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 on an unknown date for COVID-19 immunization. The patient got his second shot on 14May2021 of the Pfizer and he just threw about 15-20 minutes ago, and it had blood in it. The wife was just wondering is this something that they should be concerned about. "Should I take him to the emergency room? He got his second shot yesterday. He has thrown up once. But it had blood in it." Outcome of the event was unknown.
Age: 57.0
Sex: U
Vaccine: COVID19
Symptoms: Activated partial thromboplastin time, Blood cholesterol increased, Blood thyroid stimulating hormone, Blood triglycerides, Blood triglycerides increased
Clinical narrative: right vision got more blurry; stroke on the left side of brain; felt weird; tongue started to go numb; Right side of face went numb; Headache; CBCT scan found nothing but calcification; overall cholesterol was 221; LDL was 124; triglyceride was 156; This is a spontaneous report from a contactable consumer (patient). A 57-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 09Apr2021 (lot number: EW0162), as 1st dose, single dose, at age 57 years old, for COVID-19 immunisation. Medical history included asthma, arthritis, environmental allergies, and allergy to grass ragweed, mold, tree pollen which triggers the asthma. Concomitant medications included celecoxib (CELEBREX) taken for arthritis from an unspecified date and ongoing; nicotinamide (VITAMIN B3); vitamin C; and vitamin b complex, taken for unspecified indications, start and stop dates were not reported. On 19Apr2021, between 19:30 to 20:00, the patient had a stroke on the left side of brain. It was also reported that on an unspecified date in Apr2021, the patient felt weird, tongue started to go numb, right side of face went numb, right vision got more blurry, and had headache. These events resulted to hospitalization on 20Apr2021 for 2 and a half days (as reported). In Apr2021, when the patient was in the hospital, laboratory tests were performed which included activated partial thromboplastin time (APTT), blood thyroid stimulating hormone (TSH), Hemoglobin A1C, lipid panel, basic metabolic panel, comprehensive metabolic panel, CBC platelet with automated differential, prothrombin INR, prothrombin time, i-STAT Troponin and Sonogram of carotid bilateral vascular in neck which were all normal; Triglycerides was 156, High density lipoprotein (HDL) was 53, Low density lipoprotein (LDL) was 124, Total cholesterol (overall cholesterol) was 221. On 10Apr2021, the patient underwent CBCT scan of the whole body which showed no aneurysm, no cancer, found nothing but calcification. The outcome of the events was unknown.  Follow-up attempts are needed. Further information is expected.
Age: 57.0
Sex: U
Vaccine: COVID19
Symptoms: Calcinosis, Cerebrovascular accident, Computerised tomogram, Feeling abnormal, Glycosylated haemoglobin increased
Clinical narrative: right vision got more blurry; stroke on the left side of brain; felt weird; tongue started to go numb; Right side of face went numb; Headache; CBCT scan found nothing but calcification; overall cholesterol was 221; LDL was 124; triglyceride was 156; This is a spontaneous report from a contactable consumer (patient). A 57-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 09Apr2021 (lot number: EW0162), as 1st dose, single dose, at age 57 years old, for COVID-19 immunisation. Medical history included asthma, arthritis, environmental allergies, and allergy to grass ragweed, mold, tree pollen which triggers the asthma. Concomitant medications included celecoxib (CELEBREX) taken for arthritis from an unspecified date and ongoing; nicotinamide (VITAMIN B3); vitamin C; and vitamin b complex, taken for unspecified indications, start and stop dates were not reported. On 19Apr2021, between 19:30 to 20:00, the patient had a stroke on the left side of brain. It was also reported that on an unspecified date in Apr2021, the patient felt weird, tongue started to go numb, right side of face went numb, right vision got more blurry, and had headache. These events resulted to hospitalization on 20Apr2021 for 2 and a half days (as reported). In Apr2021, when the patient was in the hospital, laboratory tests were performed which included activated partial thromboplastin time (APTT), blood thyroid stimulating hormone (TSH), Hemoglobin A1C, lipid panel, basic metabolic panel, comprehensive metabolic panel, CBC platelet with automated differential, prothrombin INR, prothrombin time, i-STAT Troponin and Sonogram of carotid bilateral vascular in neck which were all normal; Triglycerides was 156, High density lipoprotein (HDL) was 53, Low density lipoprotein (LDL) was 124, Total cholesterol (overall cholesterol) was 221. On 10Apr2021, the patient underwent CBCT scan of the whole body which showed no aneurysm, no cancer, found nothing but calcification. The outcome of the events was unknown.  Follow-up attempts are needed. Further information is expected.
Age: 57.0
Sex: U
Vaccine: COVID19
Symptoms: Headache, High density lipoprotein, Hypoaesthesia, Hypoaesthesia oral, Lipids
Clinical narrative: right vision got more blurry; stroke on the left side of brain; felt weird; tongue started to go numb; Right side of face went numb; Headache; CBCT scan found nothing but calcification; overall cholesterol was 221; LDL was 124; triglyceride was 156; This is a spontaneous report from a contactable consumer (patient). A 57-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 09Apr2021 (lot number: EW0162), as 1st dose, single dose, at age 57 years old, for COVID-19 immunisation. Medical history included asthma, arthritis, environmental allergies, and allergy to grass ragweed, mold, tree pollen which triggers the asthma. Concomitant medications included celecoxib (CELEBREX) taken for arthritis from an unspecified date and ongoing; nicotinamide (VITAMIN B3); vitamin C; and vitamin b complex, taken for unspecified indications, start and stop dates were not reported. On 19Apr2021, between 19:30 to 20:00, the patient had a stroke on the left side of brain. It was also reported that on an unspecified date in Apr2021, the patient felt weird, tongue started to go numb, right side of face went numb, right vision got more blurry, and had headache. These events resulted to hospitalization on 20Apr2021 for 2 and a half days (as reported). In Apr2021, when the patient was in the hospital, laboratory tests were performed which included activated partial thromboplastin time (APTT), blood thyroid stimulating hormone (TSH), Hemoglobin A1C, lipid panel, basic metabolic panel, comprehensive metabolic panel, CBC platelet with automated differential, prothrombin INR, prothrombin time, i-STAT Troponin and Sonogram of carotid bilateral vascular in neck which were all normal; Triglycerides was 156, High density lipoprotein (HDL) was 53, Low density lipoprotein (LDL) was 124, Total cholesterol (overall cholesterol) was 221. On 10Apr2021, the patient underwent CBCT scan of the whole body which showed no aneurysm, no cancer, found nothing but calcification. The outcome of the events was unknown.  Follow-up attempts are needed. Further information is expected.
Age: 57.0
Sex: U
Vaccine: COVID19
Symptoms: Low density lipoprotein, Low density lipoprotein increased, Metabolic function test, Platelet count, Prothrombin level
Clinical narrative: right vision got more blurry; stroke on the left side of brain; felt weird; tongue started to go numb; Right side of face went numb; Headache; CBCT scan found nothing but calcification; overall cholesterol was 221; LDL was 124; triglyceride was 156; This is a spontaneous report from a contactable consumer (patient). A 57-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 09Apr2021 (lot number: EW0162), as 1st dose, single dose, at age 57 years old, for COVID-19 immunisation. Medical history included asthma, arthritis, environmental allergies, and allergy to grass ragweed, mold, tree pollen which triggers the asthma. Concomitant medications included celecoxib (CELEBREX) taken for arthritis from an unspecified date and ongoing; nicotinamide (VITAMIN B3); vitamin C; and vitamin b complex, taken for unspecified indications, start and stop dates were not reported. On 19Apr2021, between 19:30 to 20:00, the patient had a stroke on the left side of brain. It was also reported that on an unspecified date in Apr2021, the patient felt weird, tongue started to go numb, right side of face went numb, right vision got more blurry, and had headache. These events resulted to hospitalization on 20Apr2021 for 2 and a half days (as reported). In Apr2021, when the patient was in the hospital, laboratory tests were performed which included activated partial thromboplastin time (APTT), blood thyroid stimulating hormone (TSH), Hemoglobin A1C, lipid panel, basic metabolic panel, comprehensive metabolic panel, CBC platelet with automated differential, prothrombin INR, prothrombin time, i-STAT Troponin and Sonogram of carotid bilateral vascular in neck which were all normal; Triglycerides was 156, High density lipoprotein (HDL) was 53, Low density lipoprotein (LDL) was 124, Total cholesterol (overall cholesterol) was 221. On 10Apr2021, the patient underwent CBCT scan of the whole body which showed no aneurysm, no cancer, found nothing but calcification. The outcome of the events was unknown.  Follow-up attempts are needed. Further information is expected.