chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity, Malaise, Pain in extremity
Clinical narrative: heart hurting; allergic reaction; head felt weird; Arm ached a little bit; chest pain/chest hurting; heart felt uncomfortable/Heart did not feel comfortable; didn't feel good; head hurts; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 55-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported) via an unspecified route of administration on an unspecified date as a Dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The reporter stated that the patient had received his first dose of the Pfizer Covid-19 vaccine and had "an allergic reaction". The reporter stated that his head felt weird, head hurts, didn't feel good and he had other minor side effect, like his arm ached a little bit, stated it was no big deal. He said that what was concerning to him was he had chest pain/chest hurting and his heart did not feel comfortable/ heart felt uncomfortable. The reporter wanted to know if chest/heart hurting was a serious side effect. The pharmacist told the patient that the first shot normally doesn't do anything and since the patient had a reaction already to the first shot; the pharmacist didn't know if the patient should get the second shot. His doctor told him that he should receive the second dose. Reporter asked whether the second shot be as bad or worse than the first. The patient stated that his doctor said he should take it to be protected. Full details not obtained. The patient thought about not taking the second dose. The patient was advised to refer his HCP for further guidance. As noted in the Fact Sheet for Recipients, the patient should not get the Pfizer-BioNTech COVID-19 Vaccine if the patient had a severe allergic reaction after a previous dose of the vaccine or if the patient had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. Pfizer refer the patient to speak to your healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. The patient's healthcare provider knew his health situation and had access to information that can better help inform this decision. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report from a non-contactable other health care professional. A 52-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 16Feb2021 ((at the age of 52 years old)) (Batch/Lot Number: EN5318) as dose 2, single and via an unspecified route of administration on 22Jan2021 (at the age of 52 years old) (Batch/Lot Number: EN5318) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 05Aug2021, the patient was tested positive for covid-19 following completion of covid-19 vaccine series. The adverse event resulted in Doctor or other healthcare professional office or clinic visit. It is unknown if the patient received any treatment for the adverse events. It is unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine and unknown if the patient was diagnosed with COVID-19 prior to the vaccination and has been tested for COVID-19 since the vaccination. The patient underwent lab tests and procedures which included sars-cov-2 test positive on 05Aug2021. Covid test type Unknown. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected. Sender's Comments: Based on known drug safety profile and temporal association, there is reasonable possibility of causal association between the events vaccination failure, covid-19 and the suspect drug BNT162B2.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Sinusitis, Vaccination failure
Clinical narrative: This is a spontaneous report from a non-contactable other health care professional. A 52-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 16Feb2021 ((at the age of 52 years old)) (Batch/Lot Number: EN5318) as dose 2, single and via an unspecified route of administration on 22Jan2021 (at the age of 52 years old) (Batch/Lot Number: EN5318) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 05Aug2021, the patient was tested positive for covid-19 following completion of covid-19 vaccine series. The adverse event resulted in Doctor or other healthcare professional office or clinic visit. It is unknown if the patient received any treatment for the adverse events. It is unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine and unknown if the patient was diagnosed with COVID-19 prior to the vaccination and has been tested for COVID-19 since the vaccination. The patient underwent lab tests and procedures which included sars-cov-2 test positive on 05Aug2021. Covid test type Unknown. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected. Sender's Comments: Based on known drug safety profile and temporal association, there is reasonable possibility of causal association between the events vaccination failure, covid-19 and the suspect drug BNT162B2.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive for Covid-19 with symptoms; tested positive for Covid-19 with symptoms; sinus infection; This is a spontaneous report from a contactable consumer (patient). A 53-year-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration in the arm [does not remember which arm for either dose] on 15Feb2021 (Lot Number: EN5318; Expiration Date: 31May2021) as dose 2, single; and dose 1 via an unspecified route of administration in the arm [does not remember which arm for either dose] on 22Jan2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 vaccination. The patient's medical history and concomitant medications were not reported. On 05Aug2021, the patient experienced tested positive for covid-19. He added that he was on vacation right now and he traveled on 24Jul2021 and then on 06Aug2021 he tested positive for Covid-19. He was placed on quarantine. He clarified that he had a positive test on 05Aug2021 in the afternoon and then had another test that confirmed he was Covid positive on 06Aug2021. He said that he only feels like he has a sinus infection (2021) and that is all he felt aside from a slight headache. He said that he had a Mojito and could not taste it. He mentioned that he has more like sinus infection symptoms. He is starting to feel better. He is starting to get back his sense of taste and smell. He lost it, but it is coming back now. The outcome of the events was unknown. Event occurred in a country different from that of the reporter. This may be a duplicate if the reporter also submitted directly to his/her local agency.   The following information on the batch/lot number has been requested.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Sinusitis, Vaccination failure
Clinical narrative: tested positive for Covid-19 with symptoms; tested positive for Covid-19 with symptoms; sinus infection; This is a spontaneous report from a contactable consumer (patient). A 53-year-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration in the arm [does not remember which arm for either dose] on 15Feb2021 (Lot Number: EN5318; Expiration Date: 31May2021) as dose 2, single; and dose 1 via an unspecified route of administration in the arm [does not remember which arm for either dose] on 22Jan2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 vaccination. The patient's medical history and concomitant medications were not reported. On 05Aug2021, the patient experienced tested positive for covid-19. He added that he was on vacation right now and he traveled on 24Jul2021 and then on 06Aug2021 he tested positive for Covid-19. He was placed on quarantine. He clarified that he had a positive test on 05Aug2021 in the afternoon and then had another test that confirmed he was Covid positive on 06Aug2021. He said that he only feels like he has a sinus infection (2021) and that is all he felt aside from a slight headache. He said that he had a Mojito and could not taste it. He mentioned that he has more like sinus infection symptoms. He is starting to feel better. He is starting to get back his sense of taste and smell. He lost it, but it is coming back now. The outcome of the events was unknown. Event occurred in a country different from that of the reporter. This may be a duplicate if the reporter also submitted directly to his/her local agency.   The following information on the batch/lot number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Illness, SARS-CoV-2 test, Vaccination failure
Clinical narrative: contracted the Delta variant two weeks ago; contracted the Delta variant two weeks ago; very sick; This is a spontaneous report from a Pfizer sponsored program Pfizer via contactable consumer or other non hcp (patient's wife). A 7-decade-old male patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number and Expiry date was not reported) via an unspecified route of administration on an unspecified date as dose 1, single, dose 2 via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient contracted the delta variant two weeks ago and very sick. She was in 60s and fully vaccinated with vaccine 6 months ago and contracted the delta variant two weeks ago and was very sick. Please help out county get the boosters soon. The patient underwent lab tests and procedures which included sars-cov-2 test: contracted on an unspecified date in 2021. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report from a non-contactable other healthcare professional. A 40-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EN5318), via an unspecified route of administration on 24Mar2021 as dose 2, single and bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EN5318), via an unspecified route of administration on 25Feb2021 as dose 1, single for COVID-19 immunization (at the age of 40-years-old). Facility where the recent COVID-19 vaccine was administered was clinic. The patient medical history and concomitant medications were not reported. It was unknown if, patient receive any other vaccines within 4 weeks prior to the COVID vaccine and prior to vaccination, if the patient diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient tested positive for covid-19 after completion of the covid-19 vaccine series on 09Aug2021. The events were assessed as serious (medically significant). The events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included sars-cov-2 test positive on 09Aug2021. It was unknown if patient received any treatment for the events. The clinical outcome for event COVID-19 was not recovered.  No follow-up attempts are possible. No further information is expected. Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the events: Vaccination failure and Covid-19 and the administration of the vaccine cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Pericarditis
Clinical narrative: Pericarditis; This is a spontaneous report from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). A contactable consumer reported herself that a female patient received the BNT162B2 (Pfizer Covid-19 vaccine), via an unspecified route of administration on an unspecified in 2021 (Batch/Lot Number: not provided) as single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient had been hospitalized twice due to fluid on heart and lung, chest pains and difficulty in breathing. These issues were ongoing. The patient had been diagnosed with pericarditis from cardiologist where the outer wall of heart was damaged because of the COVID vaccine. The patient stated that because of this shot, her life has changed and now she was susceptible to more breathing issues and chronic chest/heart pains. The patient did not recover.  The lot number for [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a contactable consumer or other non-health care professional from a program. A male patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, batch/lot number was not reported) via an unspecified route of administration on 29Jun2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that the patient received first dose of vaccine on 29Jun2021 was diagnosed with COVID 19 after wards on an unspecified date in 2021. Patient remains in critical condition in the hospital. He has spent 35 days in the hospital. The patient underwent lab tests and procedures which included sars-cov-2 test which was positive on an unspecified date in 2021. The patient was not recovered from the events.  The lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow up.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure increased, Blood pressure measurement, Chills, Dizziness
Clinical narrative: Headache; Nausea; Chills; His head gets very lightheaded like he is going to faint/feel like I will pass out; Weakness; Brain fog; Fatigue; Increase in BP; This is a spontaneous report from a contactable consumer (patient)  A 38-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on 24Jul2021 at 10:30 at single dose via an unspecified route of administration  for COVID-19 immunization. Relevant medical history included diabetes Type 2, Seasonal allergy, he was sick on Dec2019 (with very similar s/s he experienced after the 1st vaccine dose) and suspected COVID-19 on Dec20219 (pharmacist told him he 'probably had Covid-19 in 12/2019 and that is why his symptoms are worse with the 1st dose). Concomitant medications were not reported. On 25Jul2021 nausea started and  since 26Jul2021 headache occurred. On an unspecified date he experienced  weakness and patient also reported that when he went into a crowded room he had to leave because he felt like I will pass out. Since an unspecified date he had brain fog, it was like his equilibrium was off in which he was dizzy (as reported), he had chills and is just really fatigued like he didn't want to get up. Patient also reported an increase in BP appeared since an unspecified date. The symptoms happened in morning and evening not all day. Patient informed that when he lied down, felt better. Patient also commented it's not like it's steady, the side effects usually occur in the morning when he first is waking up and at night. All the side effects are about the same, consistent. This freaks him out because his head gets very lightheaded like he is going to faint, and his Blood pressure rises, which then makes him anxious and stressing out.  He was due for his second dose on 13Aug2021. At the time of the reporting the patient had not recovered from nausea and chills, while outcome of other reported events was unknown.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Nausea
Clinical narrative: Headache; Nausea; Chills; His head gets very lightheaded like he is going to faint/feel like I will pass out; Weakness; Brain fog; Fatigue; Increase in BP; This is a spontaneous report from a contactable consumer (patient)  A 38-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on 24Jul2021 at 10:30 at single dose via an unspecified route of administration  for COVID-19 immunization. Relevant medical history included diabetes Type 2, Seasonal allergy, he was sick on Dec2019 (with very similar s/s he experienced after the 1st vaccine dose) and suspected COVID-19 on Dec20219 (pharmacist told him he 'probably had Covid-19 in 12/2019 and that is why his symptoms are worse with the 1st dose). Concomitant medications were not reported. On 25Jul2021 nausea started and  since 26Jul2021 headache occurred. On an unspecified date he experienced  weakness and patient also reported that when he went into a crowded room he had to leave because he felt like I will pass out. Since an unspecified date he had brain fog, it was like his equilibrium was off in which he was dizzy (as reported), he had chills and is just really fatigued like he didn't want to get up. Patient also reported an increase in BP appeared since an unspecified date. The symptoms happened in morning and evening not all day. Patient informed that when he lied down, felt better. Patient also commented it's not like it's steady, the side effects usually occur in the morning when he first is waking up and at night. All the side effects are about the same, consistent. This freaks him out because his head gets very lightheaded like he is going to faint, and his Blood pressure rises, which then makes him anxious and stressing out.  He was due for his second dose on 13Aug2021. At the time of the reporting the patient had not recovered from nausea and chills, while outcome of other reported events was unknown.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Inappropriate schedule of product administration, SARS-CoV-2 test positive
Clinical narrative: This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 65-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Right arm on 11Mar2021 (65-year-old at the time of vaccination) as dose 2, single for covid-19 immunisation. Medical history included Asthma and high blood pressure from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Batch/Lot number: EL9266), via an unspecified route of administration, on 23Feb2021 (65-year-old at the time of vaccination) as dose 1, single for covid-19 immunisation and No reaction on previous exposure to vaccine. The patient received the Pfizer covid-19 vaccination in January and February, now tested positive for covid-19 the delta variant on 30Jul2021. They have advised her to get antibody testing 3 weeks from the day they tested positive due to their age. She would like to know what she is to do if they get the antibody testing back and they do not have antibodies. They received it 3 weeks from the day that they tested positive, to see if there were any antibodies. She does not know if they would need a booster. The patient underwent lab tests and procedures which included sars-cov-2 test positive: positive on 30Jul2021. The outcome for both the events was Unknown.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Atrial fibrillation, Vaccination site pain
Clinical narrative: Atrial fibrillation; right arm pain (injection site); Joint pain; This is a spontaneous report from a contactable consumer (patient), received via the Pfizer sponsored program. A 79-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in right arm on 26Jul2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation.  Medical history included Shingles shot (a year ago which had nothing to do with COVID and had Shingles shot months and months before that), allergy to perfumes, cats, dogs, sulfates and penicillin, hip replacement and reaction to titanium which caused chromium and cobalt to build up in her system and had build up of calcium in her right leg in the muscle and in the hip. The patient's concomitant medications were not reported. The patient experienced atrial fibrillation, right arm pain and joint pain. The event atrial fibrillation was treated with blood thinner. Patient reported also that she was due to get her second dose, but she will be having a planned Colonoscopy the day after, and she will also be stopping her blood thinner 3 days before her Colonoscopy per protocol. The outcome of events was unknown.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report from a contactable consumer. A 63-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was EP6955), via an intramuscular route of administration on 24Mar2021 as dose 1, single for COVID-19 immunization. She received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was EP6955) via an intramuscular route of administration on 15Apr2021 for COVID-19 immunization. Medical history includes high cholesterol and high blood pressure. There was no known allergies. Concomitant medications includes rosuvastatin, losartan, amlodipine besylate, multivitamin within two weeks of vaccinations. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had been tested positive for covid-19. On 06Aug2021, 09:00AM patient tested positive for COVID-19 with congestion, runny nose, cough, and mild fever. The patient underwent lab tests and procedures which included SARS-COV-2 RNA, QL, RT PCR COVID 19 positive on 07Aug2021 via Nasal Swab. No treatment received for events.  Follow-up (12Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Hyperhidrosis, SARS-CoV-2 test, Vertigo
Clinical narrative: Vertigo; Heartbeat was high; Sweating; This is a spontaneous report from a contactable consumer (patient).   A 61-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm, on 22Feb2021 at 10:00 (Lot Number: EN6198), at the age of 61 years old, as 1st single dose, for COVID-19 immunisation. Medical history included asthma ongoing since he was an infant, skin cancer from 2018, suspected COVID-19 in Feb2020 (no fever, no test done), and ongoing allergy for which he was getting unspecified allergy shots that he reacts to, but he was supposed to react to them (he stated it is the appropriate response). The patient's concomitant medications were unspecified, with the patient stating that he did not think any of his medication would have anything to do with the reported events. Historical vaccination included the pneumonia shot several months prior to BNT162b2 vaccination. Past drug history included reaction to levofloxacin (LEVAQUIN) in 2009, for which the patient went to ER by ambulance for treatment. The patient stated that on 22Feb202, as soon as they gave him the first shot, his heartbeat was high, he was sweating, and having vertigo that lasted for 3 days. No Emergency Room visit was needed. On 28Apr2020, a COVID-19 test was negative. The patient recovered from vertigo, difficulty breathing, heart beat high, sweating on an unspecified date. The patient received the 2nd single dose of BNT162b2 on 15Mar2021   Follow-up attempts are completed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Urticaria chronic
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 49-year-old non-pregnant female patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration, administered in the left arm on 10Apr2021 at 10:14 (Lot Number: EW0150) as dose 2, single for COVID-19 immunization.  Medical history included ongoing anxiety, ongoing ADHD, and ongoing blepharitis all from an unknown date. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ZOLOFT taken for anxiety, DEXEDRINE taken for ADHD, and ORACEA taken for blepharitism, all from an unspecified start date and ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received BNT162B2 (lot number: EN6206) on 20Mar2021 at 10:19 on the left arm for COVID-19 immunization. The patient previously received bupropion and experienced allergy and hives. Since the vaccination, the patient has not been tested for COVID-19. It was reported that on 11Apr2021, the day after the second dose, at 07:00 AM, the patient woke up with hives all over her legs and stomach. Since then, she has had hives everyday. Some days, not many. Other days, literally her entire legs are covered. Her index (also reported as C4) was measured at >50 (standard is <10) on 14Jul2021. Her doctor said she has chronic urticaria and she believes it is a result of the vaccine. The event resulted in a visit to the doctor's clinic. The patient received antihistamines and prednisone as treatment for the event. The patient has not recovered from the event. The event was reported with a seriousness of persistent/significant disability/incapacity.  Follow-up on 23Aug2021. This case is being submitted to notify that the serious information for this case was first received by the Company on 23Aug2021 and not on 09Aug2021 as previously reported.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a non-contactable physician. A 61-year-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date, it was stated that the patient covid. He had the Delta variant and was very sick. The patient also had a very high fever and had to receive anti-viral. The outcome of the events was recovered.  No follow-up attempts are possible. No further information is expected. The efficacy of a drug varies from patient to patient and can be affected by different factors, however, a contributory role of the suspect product bnt162b2 to the reported drug ineffective. COVID-19 cannot be ruled out.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Anosmia, Decreased appetite, Fatigue, Subdural haematoma
Clinical narrative: Subdural hem; Tiredness; Loss of appetite; Loss of smell; This is a spontaneous report from two contactable consumers (one of was patient's wife). A 76-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular, administered in Deltoid Left on 26Feb2021 16:00 (Lot Number: EN6205) as dose 2, single (at age of 76-year-old) for covid-19 immunisation. Prior Vaccinations was none. Medical history included blood pressure abnormal, chronic obstructive pulmonary disease (COPD), cholesterol abnormal. Concomitant medications included lisinopril taken for blood pressure abnormal from an unspecified date to 22May2021; salbutamol sulfate (PROAIR HFA) via Inhalation route taken for COPD from an unspecified date to 22May2021; pravastatin taken for cholesterol abnormal from 2019 to 21May2021. Historical Vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: EL9265) Intramuscular administered in Right deltoid on 02Feb2021 08:45 AM for COVID-19 immunisation (at age of 76-year-old) and experienced flu like, sweats, chills, fever, vomiting, extreme tiredness, ill. The patient experienced subdural hem (death, medically significant) on 23May2021, week long tiredness on 2021, loss of appetite on 2021, loss of smell on 2021. The second dose resulted in week long tiredness, loss of appetite, loss of smell. The event subdural hem required visit to Emergency room and had no treatment. The patient died on 24May2021. An autopsy was not performed. Outcome of the event subdural hem was fatal, of the events tiredness, loss of appetite, loss of smell was unknown.     Follow-up attempts are completed. No further information is expected.; Reported Cause(s) of Death: Subdural hem
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Cardiac failure congestive, Cardiomyopathy, Chest pain, Cough
Clinical narrative: congestive heart failure; Myocardia; I went into afib; Experienced chest pain minutes after shot was administered.; Shortness of breath; Coughing started hours after the dose; High heart rate/heart right went to about 180 bpm; This is a spontaneous report from a contactable consumer (patient). A 31-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in right arm on 17Jul2021 at the age of 31 years as single dose for covid-19 immunisation. Medical history included high blood pressure which he was medicated for and was under control, patient had recent tests done and had no issues with his heart, hypothyroidism, covid-19 prior vaccination. Concomitant medications included metoprolol; amlodipine; hydrochlorothiazide; levothyroxine sodium (LEVOTHYROX). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient experienced chest pain minutes after shot was administered. Chest pain, shortness of breath, and coughing started hours after the dose. Patient was admitted 2 days later to the emergency room with chest pain and high heart rate. Patient went into afib, at the hospital where his heart right went to about 180 bpm. Patient was diagnosed with myocardia and congestive heart failure. Adverse event start time was 17Jul2021 05:00 PM. Duration of hospitalization was 1 day. Treatment received included pill to slow heart rate 3 times, medication change. Adverse events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event), disability or permanent damage. Since the vaccination, the patient had not been tested for COVID-19. Outcome of events were not recovered.  The lot number for BNT162B2 was not provided and will be requested during follow up.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate, Heart rate increased
Clinical narrative: congestive heart failure; Myocardia; I went into afib; Experienced chest pain minutes after shot was administered.; Shortness of breath; Coughing started hours after the dose; High heart rate/heart right went to about 180 bpm; This is a spontaneous report from a contactable consumer (patient). A 31-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in right arm on 17Jul2021 at the age of 31 years as single dose for covid-19 immunisation. Medical history included high blood pressure which he was medicated for and was under control, patient had recent tests done and had no issues with his heart, hypothyroidism, covid-19 prior vaccination. Concomitant medications included metoprolol; amlodipine; hydrochlorothiazide; levothyroxine sodium (LEVOTHYROX). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient experienced chest pain minutes after shot was administered. Chest pain, shortness of breath, and coughing started hours after the dose. Patient was admitted 2 days later to the emergency room with chest pain and high heart rate. Patient went into afib, at the hospital where his heart right went to about 180 bpm. Patient was diagnosed with myocardia and congestive heart failure. Adverse event start time was 17Jul2021 05:00 PM. Duration of hospitalization was 1 day. Treatment received included pill to slow heart rate 3 times, medication change. Adverse events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event), disability or permanent damage. Since the vaccination, the patient had not been tested for COVID-19. Outcome of events were not recovered.  The lot number for BNT162B2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, COVID-19, Drug ineffective, Dyspnoea
Clinical narrative: This is a spontaneous report from a contactable consumer. This consumer reporter for a 77-year-old female patient. A 77-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number unknown) via an unspecified route of administration on an unspecified date in 2021 as DOSE NUMBER UNKNOWN, SINGLE (age at vaccination: 77 years) for COVID-19 immunization. Medical history and concomitant medications were not reported. She was not pregnant at the time of vaccination. 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 had not been tested for COVID-19. Known allergies were unknown. It was reported that it had been vaccinated with the Pfizer Covid vaccine earlier this year. On 03Aug2021, she became sick with 103F fever. On 04Aug2021, patient underwent sars-cov-2 and tested positive for COVID using quick test. She was currently waiting for more accurate Covid test result. On an unspecified date in 2021 she had been short of breath and was very weak. No treatment was received. The patient underwent lab tests and procedures which included fever resulted as 103 Fahrenheit on 03Aug2021, more accurate Covid test result as unknown results on an unknown date covid test type post vaccination: unknown, covid test result pending, sars-cov-2 test resulted as positive on 04Aug2021. The clinical outcome of the event was unknown.  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Pyrexia, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a contactable consumer. This consumer reporter for a 77-year-old female patient. A 77-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number unknown) via an unspecified route of administration on an unspecified date in 2021 as DOSE NUMBER UNKNOWN, SINGLE (age at vaccination: 77 years) for COVID-19 immunization. Medical history and concomitant medications were not reported. She was not pregnant at the time of vaccination. 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 had not been tested for COVID-19. Known allergies were unknown. It was reported that it had been vaccinated with the Pfizer Covid vaccine earlier this year. On 03Aug2021, she became sick with 103F fever. On 04Aug2021, patient underwent sars-cov-2 and tested positive for COVID using quick test. She was currently waiting for more accurate Covid test result. On an unspecified date in 2021 she had been short of breath and was very weak. No treatment was received. The patient underwent lab tests and procedures which included fever resulted as 103 Fahrenheit on 03Aug2021, more accurate Covid test result as unknown results on an unknown date covid test type post vaccination: unknown, covid test result pending, sars-cov-2 test resulted as positive on 04Aug2021. The clinical outcome of the event was unknown.  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac failure congestive, Cardiomyopathy, Myocarditis, SARS-CoV-2 test
Clinical narrative: Cardiomyopathy; myocarditis; congestive heart failure; This is a spontaneous report from a contactable consumer (patient). A 29-years-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine administered at Pharmacy or Drug Store via an unspecified route of administration, in left arm on 22Mar2021, at 29 years of age (Batch/Lot Number: ER8727) as single dose, and the second dose via administered at Pharmacy or Drug Store via an unspecified route of administration, in left arm on 22Mar2021 (to be clarified), at 29 years of age (Batch/Lot Number: EW0151) as single dose for COVID-19 immunization. Medical history included hypersensitivity to sulfa based antibiotics from an unknown date. The patient's concomitant medications were not reported. The patient didn't receive any other vaccine in the previous 4 weeks. The patient was not diagnosed with COVID-19 prior to vaccination. On 20May2021 the patient experienced cardiomyopathy, myocarditis and congestive heart failure, all assessed as medically significant and requiring Emergency Room Visit, Physician office visit and hospitalization for 7 days. The patient underwent lab tests and procedures which included SARS-CoV-2 test via Nasal swab in May2021, which was negative. Unspecified therapeutic measures were taken as a result of the reported events. At the time of the report the reported events had not resolved yet.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Autoimmune encephalopathy, Inappropriate schedule of product administration, SARS-CoV-2 test, Status epilepticus
Clinical narrative: auto-immune encephalopathy; acute respiratory failure; refractory status epilepticus; dose 2: 26Jul2021, dose 1: 05Jun2021; This is a spontaneous report from a contactable nurse. A 40-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular on 26Jul2021 11:15 (lot number: EW0217) at the age of 40 years as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included the first dose of BNT162B2 intramuscular on 05Jun2021 (lot number: EW0191) at the age of 39 years as single dose for covid-19 immunisation. Adverse event concerned for auto-immune encephalopathy, acute respiratory failure, refractory status epilepticus. Adverse event start date was 30Jul2021. AE resulted in emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event). Treatment was received. AE treatment plex for autoimmune encephalitis. Covid tested post vaccination, test type post vaccination=Nasal Swab on 07Aug2021, negative. Outcome of events were not recovered.; Sender's Comments: Based on the available information in the case, the causal association between the events autoimmune encephalitis, acute respiratory failure, status epilepticus and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new 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: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Heavy menstrual bleeding, Menstruation irregular, Reproductive hormone, Thrombosis
Clinical narrative: bleeding prolifically with gigantic blood clots coming out; bleeding prolifically with gigantic blood clots coming out; had only 2 menstrual cycles (02May2021 and 24Jul2021) since the vaccine and patient was normally regular with her cycles; This is a spontaneous report from a contactable consumer (patient). A 50-year-old non-pregnant female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL8982, Expiration date was not reported), via an unspecified route of administration, administered in left arm on 05Feb2021 at 17:30 hours as dose 2, single (at the age of 50-year-old) for COVID-19 immunisation. Medical history included penicillin allergy from an unknown date and unknown if ongoing and had no other medical history. Patient was not diagnosed with COVID-19, prior to vaccination and had not been tested for COVID-19, since the vaccination. Patient did not receive concomitant medications within 2 weeks of vaccination. Historical vaccine included patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL3247, Expiration date was not reported), via an unspecified route of administration, administered in left arm on 16Jan2021 at 09:00 hours as dose 1, single (at the age of 50-year-old) for COVID-19 immunisation. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had only 2 menstrual cycles since the vaccine and patient was normally regular with her cycles. Patient last cycle ended 16Feb2021, just after her second dose. The first one, patient had since then was at 02May2021 (the beginning of May) and patient bled for over a month. Then she visited her doctor to get an exam. The next cycle patient had begun 24Jul2021 and by 01Aug2021, patient was bleeding prolifically with gigantic blood clots coming out for over 48 hours. Patient went back to her doctor for another exam and blood work and hormones labs in Aug2021. All of which came out normal. Patient had never in her life experienced menstrual cycles such as these 2 and they were the only one patient had since her second dose of the vaccine. Patient had doctor or other healthcare professional office/clinic visit for all the events. The events were reported as non-serious by the reporter. Patient received no treatment for the events. The outcome of all the event was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report from a contactable Physician. A 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route single dose for COVID-19 immunization, first dose (Lot number: EW0162, expiration date: 31Jul2021) on 24Apr2021, second dose (Lot number: EW0168, expiration date: 31Aug2021) on 15May2021. Medical history included: diabetes, high blood pressure, cholesterol. Concomitant medications included: atorvastatin, glimepiride, lisinopril, hydrochlorothiazide, metformin. The patient was tested positive for COVID-19 after taking the vaccine on 17Jul2021. The reporter assumed that its delta variant but didn't know for sure. The patient was sequencing DNA sample.; Sender's Comments: The possibility of COVI-199, Vaccination failure, being an intercurrent condition cannot be ruled out. The response to the vaccine can vary from one person to another and hence the occurrence of the event post vaccination cannot be completely ruled out.
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Ear pain, Eye pain, Headache, Neck pain
Clinical narrative: occipital neuralgia; Horrible head pain right side from base of scull to forehead and jaws and teeth and eye and ear; Horrible head pain right side from base of scull to forehead and jaws and teeth and eye and ear; Horrible head pain right side from base of scull to forehead and jaws; Horrible head pain right side from base of scull to forehead and jaws and teeth; Horrible head pain right side from base of scull to forehead and jaws and teeth and eye; Pain radiates down neck and trapezoid on right.; Pain radiates down neck and trapezoid on right.; This is a spontaneous report from a contactable consumer (patient). A 61-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EP7534) via an unspecified route of administration in left arm on an unspecified date in Mar2021 as single dose for COVID-19 immunization. Medical history of the patient included diabetes, pulmonary embolisms from trauma, kidney stones. Concomitant (other) medications in two weeks included metformin and glipizide taken for Diabetes and warfarin sodium [COUMADIN] taken for an unspecified indication. Patient did not receive any other vaccine in four weeks of COVID vaccine. Patient did not have COVID prior vaccination and was not tested for COVID post vaccination. Patient has allergy to mushrooms, iodine dye, aloe. On an unspecified date in Mar2021, patient experienced horrible head pain right side from base of skull to forehead and jaws and teeth and eye and ear, originally called occipital neuralgia. Pain was still there after 5 months. 10 on scale of 1 to 10. Pain radiates down neck and trapezoid on right. Patient never had headaches before this shot. Patient was taking oxycodone and gabapenten and Memantine. Adverse event resulted in visit to Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Reporter assessed events as serious causing Disability or permanent damage. Corrective treatment included Pain meds, acupuncture and cupping, TENS. Outcome of the events were not recovered.