chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Cystitis escherichia, Escherichia urinary tract infection
Clinical narrative: bladder and urinary tract infection/ first one was E.coli; bladder and urinary tract infection/ first one was E.coli; This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient received the first dose of bnt162b2 (BNT162B2, lot number: EN6205), via an unspecified route of administration on 01Mar2021 (received at 64-years-old) as single dose for covid-19 immunization. Medical history included diabetes mellitus (patient takes Metformin and Insulin), blood cholesterol (patient takes Lipitor for cholesterol), partially deaf. Concomitant medications included isosorbide mononitrate (ISOSORBIDE MONONITRATE) taken for an unspecified indication, start and stop date were not reported; metformin (METFORMIN) taken for diabetes mellitus, start and stop date were not reported; insulin (INSULIN) taken for diabetes mellitus, start and stop date were not reported; atorvastatin (LIPITOR [ATORVASTATIN]) taken for blood cholesterol, start and stop date were not reported; metoprolol (METOPROLOL) taken for an unspecified indication, start and stop date were not reported. The patient stated that in his whole life, he never had a bladder or urinary tract infection and each time after getting the shot he got a bladder, urinary tract infection. He was hospitalized once, the second time they treated him in ER (emergency room). The patient explained that he took the first dose of the Pfizer vaccine on 01Mar2021 while he took the second dose on 23Mar2021. He got hospitalized two days after he got the first shot (03Mar2021). He first went to the hospital because his symptoms were gone and were already up going on for two days (since 01Mar2021) when he checked. They checked him and they were wondering why he was getting fever and chills and they find out that he had a bladder and urinary tract infection. When probed for second dose and causes after that, the patient stated that on 23Mar2021,  he got some symptoms but the result was from a urinary track and bladder infection, the first one was E.coli and the second one they did not tell him what kind of infection it was. The patient was hospitalized for three days, from 03Mar2021 to 06Mar2021 due to the bladder and urinary tract infection. Outcome of the events was unknown.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: bell's palsy; This is a spontaneous report from a contactable consumer (patient) reported for himself. This 69-years-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration 26Mar2021 at 13:15 (lot number: er8723) on the left arm as single dose for COVID-19 immunization. Medical history included severe arthritis. No known allergies. Concomitant medications were not provided. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Mar2021 at 11:45 AM (lot number: en6205) on the right arm as single dose for COVID-19 immunization. The patient did not receive other vaccine in four weeks. The patient did not have Covid prior vaccination and did not have Covid test post vaccination. The patient experienced bell's palsy on unspecified date (reported as 07Mar2021 at 01:15PM) that resulted in emergency room/department or urgent care. Treatment received including unspecified medication for the event. The outcome of the event was unknown.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Disease recurrence
Clinical narrative: stroke; stroke; This is a spontaneous report from a contactable nurse (reporting for her husband). A 65-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6202), dose 1 via an unspecified route of administration, administered in Arm Left on 11Mar2021 (at the age of 65years) as single dose for Covid-19 immunization. Medical history included diabetes from an unknown date and unknown if ongoing, stroke from 03Dec2018 to an unknown date, and cancer from an unknown date and unknown if ongoing. Concomitant medication included unspecified medication (He is taking medication for his diabetes, his stroke the 2nd stoke that he had in last 2 weeks he is taking medication). It was reported that the patient had a Covid vaccine this month on 11Mar2021. That was the 1st vaccine the patient had. Next day on the 12Mar2021, the patient stated having some unbalanced in walking and in his train of thinking. The reporter (nurse) ended up on 15Mar2021 taking the patient to Emergency room, and he had a stroke. The reporter stated, "Now, he had a stroke 2 year before. I called to let you know I talked to the neurologist he has sent him to his family doctor for checkup and his family doctor wanted me to let you know that this happen. Does not know if there is any relation or not but just to let you all know and this coming Thursday, he is supposed to get his 2nd vaccine. I am, just calling to let you know". The patient was taking medication for his 1st stroke and now he is taking medication for his 2nd stroke (treatment). He is taking physical therapy and occupational therapy and for his cancer, he is taking medication for that. The patient was hospitalized for stroke from 15Mar2021 to 17Mar2021, then he was discharged. The outcome of event was not recovered.  Follow-up needed; further information has been requested.; Sender's Comments: Event stroke represents an intercurrent medical condition 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.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Feeling hot, Headache, Presyncope, Syncope
Clinical narrative: fainted; having an odd taste in my mouth; shortness of breath/breathing took 40 minutes to return to normal; vasovagal syncope response; the expected sore injection site; headache; felt overheated; could quite literally only see stars; This is a spontaneous report from a non-contactable consumer (patient). A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 04Apr2021 10:45 (Lot Number: ER8732) as single dose for covid-19 immunisation. Medical history included hypoglycaemia (she ate before the injection) and fainting. Concomitant medication(s) included Birth control and prednisolone acetate ophthalmic sus. The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine. 5 minutes after the injection, the patient began having an odd taste in mouth, shortness of breath, and she fainted. She had a history of fainting, but it took longer for her to recover than usual (50 minutes instead of 15). When she regained consciousness a few minutes after, she had a headache, felt overheated, and could quite literally only see stars. Her breathing took 40 minutes to return to normal, and her body temperature took 2 hours to feel normal. She assumed this was mostly a vasovagal syncope response, but she wasn't anxious or in pain beforehand. After 6 hours, she still have the odd taste, a headache, and the expected sore injection site. The events resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events included Paramedic took vitals and monitored for an hour. The outcome of the events was recovered with sequelae. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Taste disorder, Vaccination site pain, Visual impairment
Clinical narrative: fainted; having an odd taste in my mouth; shortness of breath/breathing took 40 minutes to return to normal; vasovagal syncope response; the expected sore injection site; headache; felt overheated; could quite literally only see stars; This is a spontaneous report from a non-contactable consumer (patient). A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 04Apr2021 10:45 (Lot Number: ER8732) as single dose for covid-19 immunisation. Medical history included hypoglycaemia (she ate before the injection) and fainting. Concomitant medication(s) included Birth control and prednisolone acetate ophthalmic sus. The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine. 5 minutes after the injection, the patient began having an odd taste in mouth, shortness of breath, and she fainted. She had a history of fainting, but it took longer for her to recover than usual (50 minutes instead of 15). When she regained consciousness a few minutes after, she had a headache, felt overheated, and could quite literally only see stars. Her breathing took 40 minutes to return to normal, and her body temperature took 2 hours to feel normal. She assumed this was mostly a vasovagal syncope response, but she wasn't anxious or in pain beforehand. After 6 hours, she still have the odd taste, a headache, and the expected sore injection site. The events resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events included Paramedic took vitals and monitored for an hour. The outcome of the events was recovered with sequelae. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: diagnosed with Bell's palsy 13 days following her first Pfizer vaccine; This is a spontaneous report from a contactable physician. A 27-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was diagnosed with Bell's palsy 13 days following her first Pfizer vaccine. The patient is reluctant to receive her second dose on schedule. She has had no improvement with steroids and valacyclovir. The event was assessed as serious (medically significant). Therapeutic measures were taken as a result of diagnosed with bell's palsy 13 days following her first pfizer vaccine (facial paralysis). The outcome of the event was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Based on the temporal relationship and known drug safety profile, a causal association between BNT162B2 and the reported Bell's palsy 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Disease recurrence
Clinical narrative: suffered from atrial fibrillation and she has not had atrial fibrillation in over 13 months; suffered from atrial fibrillation and she has not had atrial fibrillation in over 13 months; This is a spontaneous report from a contactable consumer. A 82-year-old female patient (reporter's mother) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6208), via an unspecified route of administration on 12Mar2021 at the age of 82-years-old as single dose for COVID-19 immunisation. The patient took the shot at the regional vaccination center and she had an appointment of course set up by her doctor, but they don't have any specific name. The patient's medical history included blood pressure and atrial fibrillation. Concomitant medication included metoprolol taken for an unspecified indication, start and stop date were not reported. The reporter stated that his/her mother experienced a reaction after having the shot. She took the shot on 12Mar2021 and suffered from atrial fibrillation and she has not had atrial fibrillation in over 13 months and once she took the shot on the very next day (13Mar2021) she had atrial fibrillation which lasted about two and a half day. They went to her heart doctor and they checked her out and they said that other people that had taken the vaccine had experience the same thing so, the reporter was calling to see if that was something Pfizer has heard before or not. It was reported that the patient was scheduled to take the second shot this coming Friday and after speaking with her doctor they indicated to go ahead and take the second shot but again the reporter wanted to report this because the reporter knew the company was keeping a record of this information. It was reported that the patient was about 5 feet 7 inches and probably 140 pounds. The outcome of the event was recovered on 15Mar2021.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis
Clinical narrative: Dermatitis; This is a spontaneous report received from a contactable consumer reporting for herself. A 48-year-old female patient received 1 dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number # EN5318 via an unspecified route of administration, administered in Arm Left on 29Jan2021 12:30 at the age of 48 years as SINGLE DOSE for covid-19 immunisation. Vaccine administered facility type: Skill nursing facility(clinic). The patient medical history and concomitant medications were not reported. The patient experienced dermatitis on 29Jan2021 16:00 with outcome of recovered on unspecified date. Seriousness criteria: Important medical event. Therapeutic measures were taken as a result of the event.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Neoplasm malignant
Clinical narrative: diagnosed with cancer; Caller received the first dose of the Pfizer-BioNTech COVID-19 Vaccine, and is scheduled to receive the second dose on Sunday, 11Apr2021. Caller mentioned that she was recently diagnosed with cancer.; This is a spontaneous report received from a contactable female consumer (patient). A 73-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE;( solution for injection, Lot number unknown, expiration date: unknown) via an unspecified route of administration on unspecified date at single dose for COVID-19 immunization. Patient medical history and concomitant medication were not reported. On an unspecified date patient was diagnosed with cancer and would need an implant- a port in the chest for IV access. Patient received the first dose of the Pfizer-BioNTech COVID-19 Vaccine, and is scheduled to receive the second dose on Sunday 11Apr2021. The outcome of event was unknown.  Information on Lot/Batch number has been requested
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cerebrovascular accident, SARS-CoV-2 test
Clinical narrative: On 31 Mar he suffered a stroke and was admitted to the hospital until 2 Apr 2021; He tested positive for Covid19 on 30Mar2021; This is a spontaneous report from a contactable consumer. A 52-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6199), via an unspecified route of administration, administered in arm left on 19Mar2021 (at the age of 52-years-old) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient tested positive for Covid19 on 30Mar2021. On 31Mar2021, the patient suffered a stroke and was admitted to the hospital until 2Apr2021. He was scheduled for second dose and he got COVID, so would like to know the protocol and ins and outs and steps for that. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 30Mar2021. The patient did not receive any treatment for the events. The clinical outcome of the On 31 Mar he suffered a stroke and was admitted to the hospital until 2 Apr 2021 and He tested positive for Covid19 on 30Mar2021 were unknown. No follow up attempts are possible.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac arrest
Clinical narrative: Died from cardiac arrest; This is a spontaneous report from a contactable consumer. A 63-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration, administered in left arm on 24Mar2021 as single dose for COVID-19 immunization. Medical history included heart disease, kidney issues, and physical disability from an unknown date. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medication included atorvastatin; spironolactone; lisinopril; and ubidecarenone, vitamin e NOS (COQ10 COMPLEX) taken for an unspecified indication. The patient previously received the first dose of BNT162B2 on 03Mar2021 11:00 AM, on Left arm, for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was reported to have died from cardiac arrest on 26Mar2021. The reporter did not know if it was related to vaccine. The patient died on 26Mar2021. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: It appears he died from cardiac arrest.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Eye swelling, Muscle twitching, Paraesthesia oral
Clinical narrative: swollen eyes; tingling lips; swollen throat; difficulty breathing; chills; involuntary twitching on the right side of her body; This is a spontaneous report from a contactable consumer via a Pfizer-sponsored program. This female patient of unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not provided. The patient spent 4 hours in the hospital experiencing swollen eyes, tingling lips, swollen throat, difficulty breathing, chills, and involuntary twitching on the right side of her body. Treatment measures received including patient was given meds in IV solution and kept for observation. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling
Clinical narrative: swollen eyes; tingling lips; swollen throat; difficulty breathing; chills; involuntary twitching on the right side of her body; This is a spontaneous report from a contactable consumer via a Pfizer-sponsored program. This female patient of unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not provided. The patient spent 4 hours in the hospital experiencing swollen eyes, tingling lips, swollen throat, difficulty breathing, chills, and involuntary twitching on the right side of her body. Treatment measures received including patient was given meds in IV solution and kept for observation. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Haematochezia
Clinical narrative: Bleeding in stool; This is a spontaneous report from a contactable consumer (patient). A 61-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 26Mar2021 10:30 am (Batch/Lot Number: Er8733) as single dose for covid-19 immunisation. The patient medical history was none. Concomitant medications within 2 weeks included amlodipine; cetirizine hydrochloride (CETRIZINE); carvedilol; oxymetazoline hydrochloride (AFRIN); diclofenac; and diclofeafrin, diclofe. Patient previously received first dose of bnt162b2 on 03Mar2021 10:00 AM at age of 61-year-old for covid-19 immunisation. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient had not been tested for COVID-19. The patient experienced bleeding in stool on 26Mar2021 with outcome of not recovered. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Patient didn't receive treatment for the event. The report was considered as non-serious.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Face oedema, Flushing, Incorrect route of product administration, Pericarditis
Clinical narrative: pericarditis; SOB; facial edema; wheezing; flushing; tachycardia; received the first dose of BNT162B2 via subcutaneous; This is a spontaneous report from a contactable nurse (patient). A 33-year-old female patient received the first dose of BNT162B2 (Lot Number: EJ1686), subcutaneous, administered in right arm on 20Jan2021 13:15 (at the age of 33-year-old) as single dose for COVID-19 immunization.  Medical history included penicillin allergy and COVID-19 on 28Dec2020. The patient is not pregnant. The patient's concomitant medications were not reported. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. On 20Jan2021 13:30, the patient experienced SOB, facial edema, wheezing, flushing, tachycardia and pericarditis. The adverse events resulted in Doctor or other healthcare Professional office/clinic visit, Life Threatening illness (immediate risk of death from the event). Therapeutic measures were taken as a result of the events which included Epinephrine, prednisone, albuterol, diphenhydramine. The outcome of the events was recovered with sequelae.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia, Wheezing
Clinical narrative: pericarditis; SOB; facial edema; wheezing; flushing; tachycardia; received the first dose of BNT162B2 via subcutaneous; This is a spontaneous report from a contactable nurse (patient). A 33-year-old female patient received the first dose of BNT162B2 (Lot Number: EJ1686), subcutaneous, administered in right arm on 20Jan2021 13:15 (at the age of 33-year-old) as single dose for COVID-19 immunization.  Medical history included penicillin allergy and COVID-19 on 28Dec2020. The patient is not pregnant. The patient's concomitant medications were not reported. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. On 20Jan2021 13:30, the patient experienced SOB, facial edema, wheezing, flushing, tachycardia and pericarditis. The adverse events resulted in Doctor or other healthcare Professional office/clinic visit, Life Threatening illness (immediate risk of death from the event). Therapeutic measures were taken as a result of the events which included Epinephrine, prednisone, albuterol, diphenhydramine. The outcome of the events was recovered with sequelae.
Sex: M
Vaccine: COVID19
Symptoms: Near death experience
Clinical narrative: 23/Life threatening illness (immediate risk of death from the event); This is a spontaneous report from a contactable physician (patient).  An adult male patient of unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular administered in arm left on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization at the pharmacy or drugstore.  Medical history and concomitant medications reported as none. In Apr2021, the patient had near death experience reported as "23/life threatening illness (immediate risk of death from the event)"-PENDING CLARIFICATION which requires doctor or other healthcare professional office/clinic visit. The event was considered as life threatening and causes disability or permanent damage. It was unknown if treatment was received for the event. The patient was not diagnosed with COVID-19 prior to vaccination and not tested for COVID-19 since the vaccination. The patient recovered from the event in Apr2021.    Information regarding the lot/batch has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2  on reported event cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer drug 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: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Appendicitis, SARS-CoV-2 test
Clinical narrative: Appendicitis; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in the left arm on 26Mar2021 at 15:15 (batch/lot number was not reported) as a single dose for COVID-19 immunisation. The patient's medical history was not reported. The patient has no known allergies. The patient was not pregnant at the time of vaccination. Facility type vaccine was public health clinic/veterans administration facility. Concomitant medication included omeprazole (PRILOSEC) taken for an unspecified indication, start and stop date were not reported. Historical vaccine included BNT162B2 first dose on 05Mar2021 at 14:45 in the left arm for COVID-19 immunisation (batch/lot number was not reported). The patient experienced appendicitis the following Tuesday (as reported), reported start date was on 29Mar2021 at 12:00. The adverse event resulted in emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event). The patient was hospitalized for appendicitis for 3 days. Therapeutic measures were taken as a result of appendicitis which included appendectomy. No Covid prior to vaccination. Patient was Covid tested post vaccination. Covid test type post vaccination was nasal swab on 30Mar2021 with negative result. The outcome of the event was recovering.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Dyspnoea, Fatigue, Tremor
Clinical narrative: shortness of breath; diarrhea; chills; fatigue; shaking; This is a spontaneous report from a Pfizer-sponsored program  received by a contactable consumer. A male patient (reporter's husband) of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 22Mar2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had taken the first dose of the Pfizer COVID-19 vaccine on 22Mar2021. The next day, 23Mar2021, the reporter had to take the patient to the hospital as recommended by his doctor. He had experienced shortness of breath, diarrhea, chills, fatigue, and he was shaking. He had been in the hospital for 3 days. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Death, Dementia
Clinical narrative: died; Dementia; This is a spontaneous report from a contactable consumer. This consumer reported similar event for two patients. This is the first of two reports. This is a spontaneous report from a contactable consumer. This consumer reported similar event for two patients. This is the second of two reports.  A 91-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, 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's medical history and concomitant medications were not reported. The patient had no known allergies. The patient had no other vaccines in four weeks. The patient was not pregnant ("AS REPORTED"). It was reported that the patient at the board and care developed dementia like side effects on 22Mar2021 that didn't exist prior. It was also reported that the patient died on an unspecified date. The events required emergency room/department or urgent care and reported as life-threatening illness (immediate risk of death from the event). The patient had no COVID prior the vaccination and was not tested for COVID post vaccination. Therapeutic measures were taken as a result of the events which included hospice. The outcome of the event dementia was not recovered. It was not reported if an autopsy was performed.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021383789 Same reporter/drug/event, different patient.; Reported Cause(s) of Death: died
Sex: U
Vaccine: COVID19
Symptoms: Dementia
Clinical narrative: dementia like side effects; This is a spontaneous report from a contactable consumer. This consumer reported similar event for two patients. This is the first of two reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunisation. The patient medical history included known allergies (unspecified). The patient had no covid prior vaccination. The patient's concomitant medications were not reported. The patient had no other vaccine in four weeks. On 22Mar2021, the patient experienced developed dementia like side effects that didn't exist prior. The event was reported as life threatening illness (immediate risk of death from the event) and resulted in emergency room/department or urgent care. Unspecified treatment was given to the patient in hospice. Patient was not tested for covid post vaccination. The outcome of the event dementia like side effects was not recovered.   Information on batch/lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021382963 Same reporter/drug/event, different patient.
Sex: U
Vaccine: COVID19
Symptoms: Death, Malaise
Clinical narrative: person didn't get the second shot, got sick and died; person didn't get the second shot, got sick and died; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on an unspecified date (batch/lot number and expiration date was not reported) as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The consumer stated that they had a case where a person didn't get the second shot, got sick and died (pending confirmation). The patient died on an unspecified date. It was unknown if an autopsy was performed.   Information on the lot/batch number has been requested.; Reported Cause(s) of Death: person didn't got the second shot got sick and died
Sex: U
Vaccine: FLU4
Symptoms: Adverse reaction
Clinical narrative: severe reaction; Initial information was received on 21-Mar-2021 regarding an unsolicited valid non-serious case from a consumer or non-healthcare professional (under reference number: US-SA-SAC20210329000112).  This case involves an adult patient who experienced severe reaction, while the patient received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious severe reaction (adverse reaction) unknown latency following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the event outcome was unknown.  There will be no information on batch number for this case.; Sender's Comments:  SanofiPVPortal20210325000507:
Age: 6.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Expired product administered
Clinical narrative: female patient received expired IPOL vaccine/ NO AE; Initial information regarding an unsolicited valid non-serious case was received from a physician and other healthcare professional via call-center via Agency (Reference number- 00527288) and transmitted to Sanofi on 19-Mar-2021.  This case involves a 6-years-old female patient who received expired 0.5 mL IPV (VERO) [IPOL] vaccine  (strength: standard, frequency: once, batch number: R1B251M and expiry date: 13-Mar-2021 via an intramuscular in the route in right deltoid) (expired product administered) on 19-Mar-2021 for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination, family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DAPTACEL) for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used (latency: same day).  The reporter asks if the vaccine was valid and if the patient needs to be revaccinated.  At the time of reporting, no adverse event was reported.  No treatment was needed.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Blood culture negative, Blood test, Chest X-ray, Computerised tomogram abdomen, Culture urine negative
Clinical narrative: bilateral ovarian vein thrombus, thrombocytopenia - Fever, sepsis, altered mental status, nausea, vomiting
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Mental status changes, Nausea, Ovarian vein thrombosis, Pyrexia, Sepsis
Clinical narrative: bilateral ovarian vein thrombus, thrombocytopenia - Fever, sepsis, altered mental status, nausea, vomiting
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombocytopenia, Urine analysis normal, Vomiting
Clinical narrative: bilateral ovarian vein thrombus, thrombocytopenia - Fever, sepsis, altered mental status, nausea, vomiting
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Rash erythematous, Rash pruritic
Clinical narrative: Rash on left arm- a few centimeters from location of vaccine injection.   Rash is oval and large and itches. It is pink/red.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Incorrect disposal of product, Multiple use of single-use product, Needle issue
Clinical narrative: Patient received an injection that was of a needle used on another patient. The vaccinator noticed the plunger did not move so then offered patient another injection with vaccine in it to ensure adequate vaccination. After root cause analysis it was discovered this med student practiced recapping her needles and therefor did not have her work station cleared prior to next patient and inadvertently grabbed the  used needle to inject the patient with.
Age: 18.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Rash erythematous, Rash pruritic, Swelling of eyelid
Clinical narrative: 20-24 hours after the dose got erythematous, itchy rash to left flexural elbow crease and under eyes bilaterally with mild eyelid swelling.  It continued for a week and spread to some other areas of body including around right ear, right groin, left arm, bilateral hands. Itching better after benedryl and hydrocortisone 1% used. no known exposure to poisonous plants (ivy/ oak) but did have some linear erythematous marks within it
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Limb discomfort, Neck pain, Neuralgia, Pain
Clinical narrative: At 4:30 AM approximate 36 hours after vaccine, constant shooting pain and nerve pain in right arm, upper back/neck area on right side,  pain and nerve pain spreading down in to right forearm.  As of now, approximately one week after onset, very little change
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Ear pain, Erythema, Tinnitus
Clinical narrative: Tinnitus that states a few days after injection, and it is persistent today.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: Pt passed out momentarily after vaccination. He recovered quickly without intervention. BP 136/64, HR 60, SP02 99%. His significant other drove him home. He recovered completely at time of departure.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dry mouth, Headache, Heart rate increased, Hot flush
Clinical narrative: Within minutes of receiving the injection I experienced waves of dizziness to the point of almost passing out, rapid heartbeat, full body hot flashes, sweating, hand tremors,, dry mouth Observed for 30 min and released with no intervention. Waves of vertigo continued  throughout the day, but are decreasing in frequency but not intensity as days go on. Within an hour of injection psoriasis on left leg flared and was raised, red and extremely itchy through Sunday, 4.11.21. Severe headache through end of day on 4.9.21. Treated allergic symptoms with 10ml Benadryl  every 5 hours for 2 days, Ibuprofen PRN for pain. All symptoms subsided  except for headache and dizziness/vertigo but appears to be decreasing in frequency but not intensity.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Psoriasis, Tremor, Vertigo
Clinical narrative: Within minutes of receiving the injection I experienced waves of dizziness to the point of almost passing out, rapid heartbeat, full body hot flashes, sweating, hand tremors,, dry mouth Observed for 30 min and released with no intervention. Waves of vertigo continued  throughout the day, but are decreasing in frequency but not intensity as days go on. Within an hour of injection psoriasis on left leg flared and was raised, red and extremely itchy through Sunday, 4.11.21. Severe headache through end of day on 4.9.21. Treated allergic symptoms with 10ml Benadryl  every 5 hours for 2 days, Ibuprofen PRN for pain. All symptoms subsided  except for headache and dizziness/vertigo but appears to be decreasing in frequency but not intensity.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site pruritus, Stomatitis
Clinical narrative: The next day after my shot I had pain around the area where I took my shot.  Monday 4/12 my arm started itching, particularly around the area where I got my shot.   Tuesday 4/13 I woke up with a sore on my mouth. I?ve never had a sore in my life. It looks like a canker sore after speaking to a doctor.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Hyperhidrosis, Nausea, Pallor
Clinical narrative: client complained of dizziness after receiving 1st Pfizer Covid Vaccine (lot#EW0161 Exp. 4/17/21). Client alerted EMT he was feeling dizzy, nauseous, and sweaty. Other medical staff joined EMT. Upon arrival client was sitting on chair, pale, diaphoretic, holding emesis bag. Alert and oriented. Client stated had been sitting approximately 13 mins when he started feeling tingling sensation to both arms below elbow, dizziness, nausea, and chills. Client denied chest pain, shortness of breath, headache or blurry vision. Vitals 1515: blood pressure: 132/90, pulse 60. Client transfered to gravity chair and given water. 1521 client stated tingling sensation was improving, chills were improving, and nausea had resolved. Medical history: sleep apnea. Medications: for gastritis, name not available, per client has not taken in a couple weeks. Vitals 1523: blood pressure: 130/84, pulse 68. Skin color improving, per client dizziness, chills, nausea all resolved. 1530 client stated tingling sensation had resolved. Medical staff slowly began to reposition client back to a straight chair position. Vitals 1532: blood pressure 132/85, pulse 60. No complaints, everything resolved. Client back in straight sitting position without complaints. Client advised to speak to provider prior to second dose. Last vitals at 1543: blood pressure 130/84, pulse 60. Per client feeling fine, ready to leave. Able to stand up with no dizziness. ER precautions given. Client left facility with steady gait at 1546
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: client complained of dizziness after receiving 1st Pfizer Covid Vaccine (lot#EW0161 Exp. 4/17/21). Client alerted EMT he was feeling dizzy, nauseous, and sweaty. Other medical staff joined EMT. Upon arrival client was sitting on chair, pale, diaphoretic, holding emesis bag. Alert and oriented. Client stated had been sitting approximately 13 mins when he started feeling tingling sensation to both arms below elbow, dizziness, nausea, and chills. Client denied chest pain, shortness of breath, headache or blurry vision. Vitals 1515: blood pressure: 132/90, pulse 60. Client transfered to gravity chair and given water. 1521 client stated tingling sensation was improving, chills were improving, and nausea had resolved. Medical history: sleep apnea. Medications: for gastritis, name not available, per client has not taken in a couple weeks. Vitals 1523: blood pressure: 130/84, pulse 68. Skin color improving, per client dizziness, chills, nausea all resolved. 1530 client stated tingling sensation had resolved. Medical staff slowly began to reposition client back to a straight chair position. Vitals 1532: blood pressure 132/85, pulse 60. No complaints, everything resolved. Client back in straight sitting position without complaints. Client advised to speak to provider prior to second dose. Last vitals at 1543: blood pressure 130/84, pulse 60. Per client feeling fine, ready to leave. Able to stand up with no dizziness. ER precautions given. Client left facility with steady gait at 1546
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis, Pallor
Clinical narrative: Complained of Dizziness , Diaphoretic/ pale
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on left leg, left waist and right leg
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: Wen t home after first shot an immediately fell asleep for 7 hours.  I have never slept/napped in the day before.  In the days since then I have several bouts, every day, of wanting to sleep and spend hours drinking coffee and trying to stay awake.  What those shots have left me with is debilitating and I am afraid that I will be stuck with this for the rest of my life.  I read that  there is no cure for ME  If you can help, you have my contact information.  I would gladly be part of a study.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Fall, Loss of consciousness, Neck pain, Unresponsive to stimuli
Clinical narrative: While walking a patient from urgent care to radiology at approximately 1632 on 4/12/21, I witnessed another patient (patient affected by event) fall to the floor by the pharmacy window. I rushed to the patient's side and began an initial assessment of airway, breathing, and circulation. No active bleeding or head injury detected. The patient was lying to her right side and appeared to be unconscious. No response when called or tapped on the shoulder several times. Patient's eyes appeared to be half-open without apparent movement. I asked for assitance from nearby security officer to call an ERT. Approximately 30-45 seconds into event, patient's daughter appeared on scene and attempted to call patient without response. While daughter assisted with supporting the patient's head, the patient suddenly took a deep breath and appeared to blink eyes several times (approx 5 seconds) before returning to previous unconscious state. No response when called by daughter throughout event. Another staff member appeared on scene at this time and recorded the second unconsciousness episode, which lasted for 90 seconds. ERT, urgent care providers, and other staff members were on scene at this time. 911 called. Vital signs taken and further assessments conducted. A pillow was placed under the patient's head and cervical collar applied. Patient appeared to be confused and in and out of consciousness at this moment. Patient was not able to identify name, date of birth, or current location but did state she had pain in her neck when asked in Spanish by another urgent care staff member. 911 staff on site at approximately 1645. Patient left in stable condition via ambulance gurney to higher level of care, accompanied by daugher and  paramedics.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Chest pain, Chills, Discomfort, Dyspnoea
Clinical narrative: About 3 hours after getting the vaccine I started to feel short of breath. About 5 hours after that I got chills that made me shake all over because I got a fever of 103. Then 2 hours later my heart started to beat very rapidly and got up to 126 beats per minute, my heart was also not only beating vast but very very hard. Then throughout the night and all of the next day, I had pain in my chest on the left side and also pain in my rib area on the left side. The pain lasted for over 24 hours and because of that I went to the emergency room. It turned out they didn't find anything life threatening at the emergency room but all the pain I had was very scary and very uncomfortable. It was a terrible experience and because of it, I am telling people not to get the Johnson and Johnson vaccine.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased, Musculoskeletal chest pain, Pyrexia, Tremor
Clinical narrative: About 3 hours after getting the vaccine I started to feel short of breath. About 5 hours after that I got chills that made me shake all over because I got a fever of 103. Then 2 hours later my heart started to beat very rapidly and got up to 126 beats per minute, my heart was also not only beating vast but very very hard. Then throughout the night and all of the next day, I had pain in my chest on the left side and also pain in my rib area on the left side. The pain lasted for over 24 hours and because of that I went to the emergency room. It turned out they didn't find anything life threatening at the emergency room but all the pain I had was very scary and very uncomfortable. It was a terrible experience and because of it, I am telling people not to get the Johnson and Johnson vaccine.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cerebrovascular accident, Death
Clinical narrative: Patient had a stroke 11 days later(on 4/6/21) and expired
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cerebrovascular accident, Death, Headache
Clinical narrative: Patient had a stroke 11 days later(on 4/6/21) and expired
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Headache, Secretion discharge, Vision blurred
Clinical narrative: Extreme breathing difficulty,  veey bad cough.m, heavy mucous severe headache, blured vision.  Had to have albuteral treatments in nebulizer every 4 hours, started on Adair inhaler and Augmentin 875 mg 2 times daily.