chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Weight decreased, Wound
Clinical narrative: he has severe rheumatoid arthritis; he was having problems with his feet.; he had scratched himself so much that he has open wounds on himself; he had scratched himself so much that he has open wounds on himself; down to 135 a couple of week before; This is a spontaneous report from a contactable consumer reporting for a patient. A 70-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number unknown), second dose via an unspecified route of administration on 16Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation, at 70 years old. The patient medical history included "he had complication from egg and orange" from an unspecified date and unspecified health conditions. The patient takes unspecified concomitant medications. The patient received the first dose of BNT162B2 on Feb2021 for covid-19 immunisation, at 70 years old and experienced itching and rash. It was reported that patient has serious health issues already. He has severe rheumatoid arthritis on an unspecified date. He has been given every rheumatoid arthritis medication (unspecified) on the market but none of them really helped him. Patient is now on an infusion of some kind of drugs (unspecified). He is on so many different unspecified medications and then he was having problems with his feet on an unspecified date, so the reporter bought the patient "Gold Bond Diabetic Lotion" (product name as reported), to put on his feet. The reporter does not know if this was all related because he is on so many medications. After the second shot, patient woke up on the morning of 19Mar2021 and he had scratched himself so much that he has open wounds on himself. The reporter talked with the patient regarding the cause of the event so the reporter said to stop using "Gold Bond Diabetic Lotion". The patient had had done that for several days and it did not seem to make a difference. Reporter stated they do not know if this is related to the COVID immunization, but they are trying to eliminate things and he is in touch with his doctor right now. The reporter stated that since the patient has rheumatoid arthritis and he is having a lot of health problems. The patient was down to 135 a couple of week before reporting time (2021). It has been about a month since he had extensive lab test because he has to go for extensive lab test every time before he has that infusion of those drugs on 03Mar2021. Patient would have gone for lab test the Friday before that, 26Feb2021 when he had extensive lab test. No treatment for events "he had scratched himself so much that he has open wounds on himself" and " down to 135 a couple of week before". Treatment was given for rheumatoid arthritis and problems with his feet (unspecified infusions and Gold Bond Diabetic Lotion). Outcome of the events was unknown.  Information about Lot/Batch number is requested.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: C-reactive protein, C-reactive protein increased, Erythema, Microembolism, Pain in extremity
Clinical narrative: microemboli.; some splinter hemorrhages; erythema and tenderness progressively over weeks of all her finger pads; erythema and tenderness progressively over weeks of all her finger pads; crop is elevated; This is a spontaneous report from a contactable physician. A 67-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in left arm on 25Feb2021 12:00 (Lot number was not reported) as single dose for covid-19 immunization at age 67 years old. The vaccine was given in a Pharmacy or Drug Store. Medical history included APLA, hypothyroid, obesity, and allergies. The patient was not pregnant. No covid prior to vaccination and was not tested for covid post vaccination. Concomitant medications included warfarin sodium (COUMADIN); levothyroxine sodium (SYNTHROID); cetirizine hydrochloride (ZYRTEC); all taken for unspecified indications, start and stop date were not reported. No other vaccines administered in four weeks. The patient previously took erythromycin and PCP and experienced allergies to both. The patient previously received the first dose of bnt162b2 intramuscular in left arm on 04Feb2021 12:00 PM (at age 67 years old) for covid-19 immunisation. The patient with APLA on coumadin 1-2 days after receiving the vaccine developed erythema and tenderness progressively over weeks of all her finger pads, crop is elevated (as reported) and some splinter hemorrhages suspect microemboli. Just to left hand, systemically well. The adverse evemts occurred on 26Feb2021 12:00 PM. The AE resulted in: Doctor or other healthcare professional office/clinic visit. No treatment was given to patient for the events. The patient had not recovered from the events.  Information on the lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events 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: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Splinter haemorrhages
Clinical narrative: microemboli.; some splinter hemorrhages; erythema and tenderness progressively over weeks of all her finger pads; erythema and tenderness progressively over weeks of all her finger pads; crop is elevated; This is a spontaneous report from a contactable physician. A 67-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in left arm on 25Feb2021 12:00 (Lot number was not reported) as single dose for covid-19 immunization at age 67 years old. The vaccine was given in a Pharmacy or Drug Store. Medical history included APLA, hypothyroid, obesity, and allergies. The patient was not pregnant. No covid prior to vaccination and was not tested for covid post vaccination. Concomitant medications included warfarin sodium (COUMADIN); levothyroxine sodium (SYNTHROID); cetirizine hydrochloride (ZYRTEC); all taken for unspecified indications, start and stop date were not reported. No other vaccines administered in four weeks. The patient previously took erythromycin and PCP and experienced allergies to both. The patient previously received the first dose of bnt162b2 intramuscular in left arm on 04Feb2021 12:00 PM (at age 67 years old) for covid-19 immunisation. The patient with APLA on coumadin 1-2 days after receiving the vaccine developed erythema and tenderness progressively over weeks of all her finger pads, crop is elevated (as reported) and some splinter hemorrhages suspect microemboli. Just to left hand, systemically well. The adverse evemts occurred on 26Feb2021 12:00 PM. The AE resulted in: Doctor or other healthcare professional office/clinic visit. No treatment was given to patient for the events. The patient had not recovered from the events.  Information on the lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events 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.
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter, Oesophageal disorder, Pharyngeal disorder
Clinical narrative: Heart fluttering felt like it was going down esophagus; Heart fluttering felt like it was going down esophagus; The heart fluttering felt like it was in esophagus at first. It felt like it was going down her throat; This is a spontaneous report from a contactable consumer (patient's sister). This consumer reported similar events for two patients. This is the second of two reports. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (Lot number was not reported) as single dose for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported. The reporter while reporting for herself, mentioned that her sister (patient) also had the same symptom as one of hers. The patient also had heart fluttering felt like it was in esophagus at first. It felt like it was going down her throat. It only lasted a couple of hours. She heard that from other people. It was her sister and she is older, and she did not wish to create report for her. No further details provided. Outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) Same reporter, same drug and similar event, different patient.
Sex: F
Vaccine: COVID19
Symptoms: Blood creatinine increased, Chills, Decreased activity, Diarrhoea, Fatigue
Clinical narrative: cancer has spread to pelvic area and possibly kidneys; ureter stenosis; fever; chills; diarrhea; increased muscle weakness; fatigue; decreased activity; elevated creatinine; i don't feel that great; This is a spontaneous report received from Pfizer sponsored program student. A contactable other HCP and a contactable consumer (patient herself) reported that a 72-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunisation; sunitinib malate (SUTENT), via oral route of administration from 03Mar2020 and ongoing, at 25 mg, daily (once daily) for renal cell carcinoma. The patient's medical history and concomitant medications were not reported. It was reported that after COVID vaccine, the patient experienced fever and chills, diarrhea, increased muscle weakness, fatigue, decreased activity, elevated creatinine, ureter stenosis on an unspecified date. The PET scan today showed cancer has spread to pelvic area and possibly kidneys and patient stated "I don't feel that great.'' md aware. The patient underwent stent placement for the event ureter stenosis, and it was resolved after stent placement. The action taken in response to the events for sunitinib malate was dose not changed. The outcome of the events ureter stenosis, fever, chills, diarrhea was recovered on an unspecified date and it was unknown for other events.   Information on the lot/batch number has been requested.; Sender's Comments: Based on known disease pathophysiology, the event of Neoplasm progression, stenosis ureteral are assessed as not related to BNT162B2, and more likely due to underlying medical condition of kidney cancer.  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: F
Vaccine: COVID19
Symptoms: Malaise, Muscular weakness, Neoplasm progression, Positron emission tomogram, Pyrexia
Clinical narrative: cancer has spread to pelvic area and possibly kidneys; ureter stenosis; fever; chills; diarrhea; increased muscle weakness; fatigue; decreased activity; elevated creatinine; i don't feel that great; This is a spontaneous report received from Pfizer sponsored program student. A contactable other HCP and a contactable consumer (patient herself) reported that a 72-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunisation; sunitinib malate (SUTENT), via oral route of administration from 03Mar2020 and ongoing, at 25 mg, daily (once daily) for renal cell carcinoma. The patient's medical history and concomitant medications were not reported. It was reported that after COVID vaccine, the patient experienced fever and chills, diarrhea, increased muscle weakness, fatigue, decreased activity, elevated creatinine, ureter stenosis on an unspecified date. The PET scan today showed cancer has spread to pelvic area and possibly kidneys and patient stated "I don't feel that great.'' md aware. The patient underwent stent placement for the event ureter stenosis, and it was resolved after stent placement. The action taken in response to the events for sunitinib malate was dose not changed. The outcome of the events ureter stenosis, fever, chills, diarrhea was recovered on an unspecified date and it was unknown for other events.   Information on the lot/batch number has been requested.; Sender's Comments: Based on known disease pathophysiology, the event of Neoplasm progression, stenosis ureteral are assessed as not related to BNT162B2, and more likely due to underlying medical condition of kidney cancer.  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: F
Vaccine: COVID19
Symptoms: Ureteric stenosis
Clinical narrative: cancer has spread to pelvic area and possibly kidneys; ureter stenosis; fever; chills; diarrhea; increased muscle weakness; fatigue; decreased activity; elevated creatinine; i don't feel that great; This is a spontaneous report received from Pfizer sponsored program student. A contactable other HCP and a contactable consumer (patient herself) reported that a 72-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunisation; sunitinib malate (SUTENT), via oral route of administration from 03Mar2020 and ongoing, at 25 mg, daily (once daily) for renal cell carcinoma. The patient's medical history and concomitant medications were not reported. It was reported that after COVID vaccine, the patient experienced fever and chills, diarrhea, increased muscle weakness, fatigue, decreased activity, elevated creatinine, ureter stenosis on an unspecified date. The PET scan today showed cancer has spread to pelvic area and possibly kidneys and patient stated "I don't feel that great.'' md aware. The patient underwent stent placement for the event ureter stenosis, and it was resolved after stent placement. The action taken in response to the events for sunitinib malate was dose not changed. The outcome of the events ureter stenosis, fever, chills, diarrhea was recovered on an unspecified date and it was unknown for other events.   Information on the lot/batch number has been requested.; Sender's Comments: Based on known disease pathophysiology, the event of Neoplasm progression, stenosis ureteral are assessed as not related to BNT162B2, and more likely due to underlying medical condition of kidney cancer.  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: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis
Clinical narrative: DVT Lower Right Leg; This is a spontaneous report from a non-contactable consumer (patient). A 58-year-old male patient received the first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE), via an unspecified route of administration in the left arm on 04Mar2021 16:15 (lot number: EN6199) as a single dose for covid-19 immunization. The patient's medical history concomitant medications were not reported. The patient was not diagnosed with covid prior vaccination. On 13Mar2021, the patient had DVT lower right leg which resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment for the adverse event which included Warfarin/Enoxaparin. The patient has not been covid tested post vaccination. The outcome of the event was not recovered.  No follow up attempts are possible. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Transverse Myelitis; spastic twitching in thighs; severe back and leg pain; severe back and leg pain; This is a spontaneous report from a contactable physician (patient). A 60-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284 and expiration date not provided) via an unspecified route of administration, administered in left arm on 07Jan2021 15:00 as a single dose for COVID-19 immunisation. Medical history includes Hypertension, Gastrooesophageal reflux disease (GERD), prostate cancer and broncholith left lung. The patient has no known allergy. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included amlodipine, losartan, pantoprazole, hctz, and acetylsalicylic acid (ASPIRIN). The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730) on 17Dec2020 and experienced mild numbness and tingling in arms and legs following first dose of vaccine, followed by progressive weakness in legs. On 19Jan2021, the patient developed severe back and leg pain resulting in spinal fusion surgery on 25Jan2021. Postoperatively, the patient developed spastic twitching in thighs on 31Jan2021. On 07Feb2021, he woke up with weakness and clumsiness in left hand. At post-op check for spinal surgery on 10Feb2021, the neurosurgeon recommended another MRI and mentioned possibility of Transverse Myelitis. Following this MRI on 15Feb2021, he was again admitted to hospital for more extensive work up and was admitted for 6 days. Diagnosis made of Transverse Myelitis and was started on high dose steroid treatment and was discharged to home on 17Feb2021. Since then have had profound leg weakness, right side greater than left, which severely impairs mobility, especially stairs. He completed 5 day course of 1000 mg methylprednisolone per day as an outpatient on 20Feb2021. He is in PT and is unable to predict date of return to work. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Disability or permanent damage. Treatment for the events included high dose steroid therapy, PT and exercise. The patient underwent COVID test post vaccination via nasal swab on 24Jan2021 and was negative. The outcome of the events was recovering.; Sender's Comments: Based on available information the reported events are unlikely related to BNT162B2.  These are intercurrent medical conditions.  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.
Sex: F
Vaccine: COVID19
Symptoms: Crying, Decreased appetite, Depression, Feeling abnormal, Suicidal ideation
Clinical narrative: she doesn't want to live/she was feeling suicidal last night; depressed; continuously crying; no appetite; she feels like she doesn't want to live, it feels like her head is going to fall of; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration on an unspecified date (batch/lot number was not reported) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 for COVID-19 immunization. The patient was suffering, she was experiencing depression, she was continuously crying, she has no appetite. She was just very depressed and cannot stop crying. She just wanted to know of these were normal side effects. She has only been a caregiver to her husband before because he had Alzheimer's. She feels like she doesn't want to live, it feels like her head was going to fall off. It takes a strong person to feel like how she was feeling, she asked herself why should she be feeling this way. She was formally asked, that she mentioned she feels like she doesn't want to live, does she feel suicidal at the moment. She stated that she was feeling suicidal last night, it went through her mind when she couldn't sleep but she was not suicidal right now at this moment. It was just a depressed feeling of crying, all the bad stuff that ever happened comes up in the mind. The outcome was not recovered for the event crying; and unknown for the rest of the events.   Information on lot/batch has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Malaise, Pain, Sinus disorder
Clinical narrative: experiencing profuse nose bleeding; not feeling well; had some issues like sinus in her eyes; lot of pain; This is a spontaneous report from a contactable consumer via Pfizer-sponsored program.  A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 27Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included diabetic.   The patient's concomitant medications were not reported. The reporter was calling for a reschedule on behalf of her sister, who was supposed to be due for her second dose of the vaccine today, 20Mar2021 but cannot make it since the patient is not feeling well. According to the reporter, the patient is experiencing profuse nose bleeding. The patient is not feeling well today and she doesn't have Covid or anything but she just had some issues like sinus in her eyes. She is in lot of pain and so she was wondering if she cancel her Covid appointment, can she get another one or you have to have it that is 3 weeks after they did the first shot. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Haematuria, Urinary tract infection
Clinical narrative: UTI; passing a lot of blood; This is a spontaneous case received from a contactable consumer. A 76-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EJ1688), dose 2 via an unspecified route of administration on 17Mar2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 24Feb2021 at Single dose for COVID-19 immunization. The patient received both doses of the Pfizer-BioNTech COVID-19 Vaccine (first dose last 24Feb2021 and second dose on 17Mar2021). On the 18Mar2021, patient had UTI (Urinary Tract Infection) and was admitted in the emergency Room on the 19Mar2021. She was passing a lot of blood and was put on heavy duty antibiotic (cefuroxamine Possibly cefuroxime). The patient experienced uti on 18Mar2021 and passing a lot of blood on Mar2021. The event was assessed as medically significant. Outcome of the event was unknown.  Information about batch/lot number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Ankylosing spondylitis, Aphthous ulcer
Clinical narrative: This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received her first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date in 2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. Medical history included ongoing Ankylosing Spondylitis and ongoing canker sores oral. Concomitant medication included etanercept (ENBREL) taken for Ankylosing Spondylitis from 2017. The patient received his first dose of COVID-19 vaccine and his next dose would be on 19Mar2021 (next Friday). Subsequently, the patient stated that he could feel that some of his Ankylosing Spondylitis symptoms were coming back. He added that right now he had a canker sore break out and it had brought back the absolute misery this condition could bring. No treatment information was received. The outcome of the events ankylosing spondylitis, aphthous ulcer were reported as not recovered/not resolved. No follow-up attempts are possible; No further information expected; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Deafness, Illness
Clinical narrative: became deaf in one hair; became extraordinarily sick; This is a spontaneous report from a contactable consumer reported for his wife. A 72-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Historical vaccine included polio vaccination at six years of age for immunization. Patient was to receive second dose on 26Mar2021. She had a concern with polio vaccination at six years of age. She went to get her teeth cleaned and the dentist reported that his wife became extraordinarily sick, became deaf in one hair. Had spoken to HCP. She was asking if there was a website that she can search adverse reactions. Outcome of events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Blood pressure abnormal, Blood pressure measurement, Cardiac disorder, Chest discomfort
Clinical narrative: it felt like she was having a heart attack; anaphylaxis; her blood pressure was 160/110; she had a rash on her neck and chest; chest pain; heart palpitations; chest pressure; her arm was numb; her heartbeat was ridiculous/heartrate went over 150; dizziness could be a symptoms of this type of reaction and she stated she was dizzy; She swelled up the first time but yesterday it felt like she was having a heart attack; She swelled up the first time but yesterday it felt like she was having a heart attack; she got the shakes; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient medical history included Drug allergy (had lot of drug allergies) and anaphylaxis (it was different than what she experienced yesterday). The concomitant medication was not reported. The caller stated she had the first dose of the vaccine and was in the emergency room with chest pain, heart palpitations, and her blood pressure was 160/110 all day. They gave her nitroglycerin and Benadryl because she had a rash on her neck and chest, had chest pressure, her arm was numb, and her heartbeat was ridiculous. They got it under control, and she was sent home. She stated she read that if you have had a severe allergic reaction you should not get the second dose and saw that dizziness could be a symptom of this type of reaction and she stated she was dizzy. She asked what would be considered a severe allergic reaction. she was scared about getting her second dose. She asked how many other people have had a rapid heartbeat, dizziness and a rash and still got their second dose? Is there treatment if you get the second dose and have a reaction? How many got the second dose with these symptoms and survived? How does she know she will live through it if she gets the second dose. It was also reported that patient experienced anaphylaxis. She swelled up the first time but yesterday it felt like she was having a heart attack. She stated the HCP wants her to go to an allergist. She said when they gave her Benadryl she got the shakes and her heartrate went over 150 with this medication. She asked if the second was worse than the first dose. Therapeutic measures were taken for the events it felt like she was having a heart attack, anaphylaxis, her blood pressure was 160/110, she had a rash on her neck and chest, chest pain, heart palpitations, chest pressure, her arm was numb, her heartbeat was ridiculous/heartrate went over 150, dizziness could be a symptom of this type of reaction and she stated she was dizzy, She swelled up the first time but yesterday it felt like she was having a heart attack. The outcome of the events was unknown  Information on the lot/batch number has been requested
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dizziness, Heart rate, Heart rate irregular, Hypoaesthesia
Clinical narrative: it felt like she was having a heart attack; anaphylaxis; her blood pressure was 160/110; she had a rash on her neck and chest; chest pain; heart palpitations; chest pressure; her arm was numb; her heartbeat was ridiculous/heartrate went over 150; dizziness could be a symptoms of this type of reaction and she stated she was dizzy; She swelled up the first time but yesterday it felt like she was having a heart attack; She swelled up the first time but yesterday it felt like she was having a heart attack; she got the shakes; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient medical history included Drug allergy (had lot of drug allergies) and anaphylaxis (it was different than what she experienced yesterday). The concomitant medication was not reported. The caller stated she had the first dose of the vaccine and was in the emergency room with chest pain, heart palpitations, and her blood pressure was 160/110 all day. They gave her nitroglycerin and Benadryl because she had a rash on her neck and chest, had chest pressure, her arm was numb, and her heartbeat was ridiculous. They got it under control, and she was sent home. She stated she read that if you have had a severe allergic reaction you should not get the second dose and saw that dizziness could be a symptom of this type of reaction and she stated she was dizzy. She asked what would be considered a severe allergic reaction. she was scared about getting her second dose. She asked how many other people have had a rapid heartbeat, dizziness and a rash and still got their second dose? Is there treatment if you get the second dose and have a reaction? How many got the second dose with these symptoms and survived? How does she know she will live through it if she gets the second dose. It was also reported that patient experienced anaphylaxis. She swelled up the first time but yesterday it felt like she was having a heart attack. She stated the HCP wants her to go to an allergist. She said when they gave her Benadryl she got the shakes and her heartrate went over 150 with this medication. She asked if the second was worse than the first dose. Therapeutic measures were taken for the events it felt like she was having a heart attack, anaphylaxis, her blood pressure was 160/110, she had a rash on her neck and chest, chest pain, heart palpitations, chest pressure, her arm was numb, her heartbeat was ridiculous/heartrate went over 150, dizziness could be a symptom of this type of reaction and she stated she was dizzy, She swelled up the first time but yesterday it felt like she was having a heart attack. The outcome of the events was unknown  Information on the lot/batch number has been requested
Sex: F
Vaccine: COVID19
Symptoms: Myocardial infarction, Palpitations, Rash, Swelling, Tremor
Clinical narrative: it felt like she was having a heart attack; anaphylaxis; her blood pressure was 160/110; she had a rash on her neck and chest; chest pain; heart palpitations; chest pressure; her arm was numb; her heartbeat was ridiculous/heartrate went over 150; dizziness could be a symptoms of this type of reaction and she stated she was dizzy; She swelled up the first time but yesterday it felt like she was having a heart attack; She swelled up the first time but yesterday it felt like she was having a heart attack; she got the shakes; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient medical history included Drug allergy (had lot of drug allergies) and anaphylaxis (it was different than what she experienced yesterday). The concomitant medication was not reported. The caller stated she had the first dose of the vaccine and was in the emergency room with chest pain, heart palpitations, and her blood pressure was 160/110 all day. They gave her nitroglycerin and Benadryl because she had a rash on her neck and chest, had chest pressure, her arm was numb, and her heartbeat was ridiculous. They got it under control, and she was sent home. She stated she read that if you have had a severe allergic reaction you should not get the second dose and saw that dizziness could be a symptom of this type of reaction and she stated she was dizzy. She asked what would be considered a severe allergic reaction. she was scared about getting her second dose. She asked how many other people have had a rapid heartbeat, dizziness and a rash and still got their second dose? Is there treatment if you get the second dose and have a reaction? How many got the second dose with these symptoms and survived? How does she know she will live through it if she gets the second dose. It was also reported that patient experienced anaphylaxis. She swelled up the first time but yesterday it felt like she was having a heart attack. She stated the HCP wants her to go to an allergist. She said when they gave her Benadryl she got the shakes and her heartrate went over 150 with this medication. She asked if the second was worse than the first dose. Therapeutic measures were taken for the events it felt like she was having a heart attack, anaphylaxis, her blood pressure was 160/110, she had a rash on her neck and chest, chest pain, heart palpitations, chest pressure, her arm was numb, her heartbeat was ridiculous/heartrate went over 150, dizziness could be a symptom of this type of reaction and she stated she was dizzy, She swelled up the first time but yesterday it felt like she was having a heart attack. The outcome of the events was unknown  Information on the lot/batch number has been requested
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dyspnoea, Myocardial infarction
Clinical narrative: Death; Heart attack; Shortness of breath; This is a spontaneous report from a contactable consumer. A 72-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at age of 72 years, at single dose on 23Mar2021 at 10:00 (Lot number was not reported) for COVID-19 immunisation. Medical history included asthma, penicillin allergy and she was diagnosed with COVID-19 prior to vaccination. Concomitant medications were not reported. The patient experienced death, shortness of breath and heart attack on 23Mar2021 at 20:30. And it was reported that the adverse event result in "Emergency room/department or urgent care" and patient was treatment with CPR. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not been tested for COVID-19 since the vaccination. Event outcome of events shortness of breath and heart attack was not recovered. The patient died on 23Mar2021 at 20:30. It was unknown if an autopsy was performed.  Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Death
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Death, Dyspnoea, Myocardial infarction, Resuscitation, Vomiting
Clinical narrative: Death; Heart attack; Shortness of breath; This is a spontaneous report from a contactable consumer. A 72-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at age of 72 years, at single dose on 23Mar2021 at 10:00 (Lot number was not reported) for COVID-19 immunisation. Medical history included asthma, penicillin allergy and she was diagnosed with COVID-19 prior to vaccination. Concomitant medications were not reported. The patient experienced death, shortness of breath and heart attack on 23Mar2021 at 20:30. And it was reported that the adverse event result in "Emergency room/department or urgent care" and patient was treatment with CPR. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not been tested for COVID-19 since the vaccination. Event outcome of events shortness of breath and heart attack was not recovered. The patient died on 23Mar2021 at 20:30. It was unknown if an autopsy was performed.  Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Death
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dysstasia, Malaise, Syncope, Unresponsive to stimuli
Clinical narrative: Death; Heart attack; Shortness of breath; This is a spontaneous report from a contactable consumer. A 72-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at age of 72 years, at single dose on 23Mar2021 at 10:00 (Lot number was not reported) for COVID-19 immunisation. Medical history included asthma, penicillin allergy and she was diagnosed with COVID-19 prior to vaccination. Concomitant medications were not reported. The patient experienced death, shortness of breath and heart attack on 23Mar2021 at 20:30. And it was reported that the adverse event result in "Emergency room/department or urgent care" and patient was treatment with CPR. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not been tested for COVID-19 since the vaccination. Event outcome of events shortness of breath and heart attack was not recovered. The patient died on 23Mar2021 at 20:30. It was unknown if an autopsy was performed.  Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Death
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dyspnoea, Myocardial infarction
Clinical narrative: Severe vomiting, shortness of breath, heart attack and death
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Death, Dyspnoea, Myocardial infarction, Resuscitation, Vomiting
Clinical narrative: Severe vomiting, shortness of breath, heart attack and death
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dysstasia, Malaise, Syncope, Unresponsive to stimuli
Clinical narrative: Severe vomiting, shortness of breath, heart attack and death
Sex: F
Vaccine: COVID19
Symptoms: Rheumatoid arthritis
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 16Mar2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported that she received first dose of vaccine on 16Mar2021 and Second dose scheduled for 06Apr2021. The patient reported that she has Rheumatoid Arthritis and takes Humira. The patient reported that she is not currently taking it. She would like to know if there is any information on taking Humeral and getting the vaccine or if there is a time period she should pause her medication. The outcome of the event was unknown.  Information on the lot/batch number has been requested
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Cerebrovascular accident, Somnolence, Vaccination site pain
Clinical narrative: Bell's Palsy; stroke; Minor injection site soreness; Extreme sleepiness (2 days); This is a spontaneous report received from a contactable consumer (patient). A 62-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6206), first dose via an unspecified route of administration, administered in right arm on 05Mar2021 07:30 as single dose for covid-19 immunisation. Medical history included high blood pressure (HBP) hypertension, Transient ischaemic attack (TIA) twice, pre-diabetic. Known allergies was none. Concomitant medications received within 2 weeks of vaccination included metformin, atorvastatin, losartan, amlodipine, Aspirin (acetylsalicylic acid). The most recent COVID-19 vaccine was administered at work location. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced bell's palsy (17 days after vaccination - confirmed via ER visit vice stroke) and stroke (seriousness crietria was medically significant), minor injection site soreness (2days) and extreme sleepiness (2 days); all events on 22Mar2021 17:30. The adverse event result in emergency room/department or urgent care. Treatment was received for all adverse events including Steroid/anti-viral medication 7 days by neurologist. The event outcome for all events was not recovered.  Follow-up attempts are needed. Information on batch/lot number was available.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Rheumatoid arthritis
Clinical narrative: rheumatoid arthritis which has flared up following vaccination.; This is a spontaneous report received from a contactable nurse (patient). A 61-year-old female patient received BNT162B2 (Pfizer BioNTech COVID-19 vaccine, Formulation: Solution for injection (batch/Lot number: unknown), via an unspecified route of administration on 26Feb2021 at single dose for COVID-19 immunization. Medical history included blindness. Concomitant medications was not reported. Her next dose was in 2 days. The patient reported that she was ok the first few days after vaccination then experienced side effects including joint pains, the patient had numerous autoimmune diseases, specifying one of the as rheumatoid arthritis which has flared up following vaccination. The outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event of RA flare due to temporal relationship. However, the reported event may possibly represent intercurrent medical condition in this patient.   There is limited information provided in this report.  This case will be reassessed once additional information is 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: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Dehydration, Headache, Immune system disorder, Lethargy, Malaise
Clinical narrative: heart attacks; bad immune system; lethargic; mild headache; feeling not well; soreness in the arm initially; may be dehydrated; This is a spontaneous report received from contactable consumer (patient) via medical information team. A 52-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration at the age of 52-years, on 20Mar2021 at a single dose for immunisation. The patient's medical history and concomitant medications were not reported. The patient stated that on 20Mar2021, he had the Pfizer covid vaccine and experienced lethargic, mild headache, feeling not well, soreness in the arm initially on an unspecified date. The patient also stated that he had heart attacks, has a bad immune system on an unspecified date and may be dehydrated. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction, Pain in extremity
Clinical narrative: heart attacks; bad immune system; lethargic; mild headache; feeling not well; soreness in the arm initially; may be dehydrated; This is a spontaneous report received from contactable consumer (patient) via medical information team. A 52-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration at the age of 52-years, on 20Mar2021 at a single dose for immunisation. The patient's medical history and concomitant medications were not reported. The patient stated that on 20Mar2021, he had the Pfizer covid vaccine and experienced lethargic, mild headache, feeling not well, soreness in the arm initially on an unspecified date. The patient also stated that he had heart attacks, has a bad immune system on an unspecified date and may be dehydrated. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Pain in extremity
Clinical narrative: stroke; her arm is still sore since she takes the first dose.; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A 79-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 01Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history included patient was diabetic from an unspecified date and ongoing. The patient's concomitant medications were not reported. The patient reported that she received the first dose on 01Mar2021. Her arm was still sore from an unspecified date in Mar2021 since she took the first dose. The patient reported that she was doing fine but her arm was still sore from the first shot. That was what she was concerned. The patient is a diabetic and had a stroke on an unspecified date. She felt okay. She received the 2nd Pfizer vaccine dose on 26Mar2021 due to the fact that on 19Mar2021 she called to ask what she should or shouldn't doe before 26Mar2021. She mentioned her situation 26Mar2021 and they said it was supposed to be common still having problems and some weren't. She wanted to go out of town and wanted to ask if what if she was to extend the shot but cancelled the trip and she wasn't going without her shot. The outcome of the event sore arm was not recovered, while the outcome of the event stroke was unknown.  Information on the lot/batch number has been requested.