chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: Chills; Achy; This is a spontaneous report from a contactable consumer (patient). A 90-year-old female patient received second dose (PFIZER-BIONTECH COVID-19 VACCINE,  Lot Number: EN6201; Expiration Date: 30Jun2021), via an unspecified route of administration, administered in the right arm on 15Feb2021 (age at vaccination was 90 years) as single dose for COVID-19 immunization. The patient was vaccinated at a hospital. Medical history and concomitant medications were not reported. Historical included first dose of bnt162b2 (lot number: EL9262, expiry date: 31May2021), via an unspecified route of administration, administered in the right arm on 25Jan2021 and experienced diverticulitis. The patient experienced chills and achy on 16Feb2021 12:00 with outcome of recovered on 16Feb2021 19:00. The events were reported as non-serious.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: PPV
Symptoms: Near death experience, Pneumonia, Respiratory failure
Clinical narrative: Pneumonia and Respiratory Failure after Pneumonia Vaccine; Respiratory Failure; Pneumonia and Respiratory Failure after Pneumonia Vaccine; This is a spontaneous report from a contactable nurse (patient).  A female patient of an unspecified age received pneumococcal 13-val conjugate vaccine (diphtheria crm197 protein), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced pneumonia and respiratory failure after pneumonia vaccine on an unspecified date and states that she almost died. The patient was hospitalized due to the events for 42 days (6 weeks). The outcome of the events was unknown.  Pfizer is a marketing authorization holder of pneumococcal 13-val conjugate vaccine (diphtheria crm197 protein) in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of pneumococcal 13-val conjugate vaccine (diphtheria crm197 protein) has submitted the same report to the regulatory authorities.  Information about batch/lot number requested; Sender's Comments: A possible contributory role of the suspect products cannot be excluded for the reported events pneumonia and associated respiratory failure  based on the known safety profile and temporal association
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Caller have received first dose of the vaccine and 10 days later tested positive for Covid; This is a spontaneous report received from Pfizer sponsored program. A contactable female consumer(patient) of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), first dose via an unspecified route of administration on an unspecified date, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  Patient have received first dose of the vaccine and 10 days later tested positive for Covid and wanted to know if they can still get second dose. The outcome of the event was unknown.  Follow up activities are possible; Further information is expected.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Arthropathy, Muscle strain, Thrombosis
Clinical narrative: may be blood clot; Something happened with my knee and it has just got worse; I was thinking maybe it is a pulled muscle or something but it is very bad now; This is a spontaneous report received from a contactable consumer (patient). An 83-year-old female patient (5 feet 1 inches, about 120 pounds) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6198, patient was not sure) via an unspecified route of administration at left arm on 22Feb2021 (83-year-old at time of vaccination), at single dose; the second dose of BNT162B2 (lot number: unknown) via an unspecified route of administration on 15Mar2021 (83-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient stated she has got both the shots of Pfizer (Covid-19 vaccine) and at the end of the first one or it is like eighteen days, just before the second shot, something happened with her knee and it has just got worse (from 12Mar2021). She did not connect that with the Pfizer shot and I was thinking maybe it is a pulled muscle or something but it is very bad now. She would like to know what she can do. Also, she is thinking may be blood clot at this point and she would like to have it checked. She thinks that she should be able to contact somebody to actually get some physical test on this. She tried heat and cold alternate and Absorbine Jr. and Aspirin. It varied with the days, she thinks she has taken Aspirin about twice a day and it is a tablet and it was 325 mg and she took two of those, orally. Therapeutic measures were taken as a result of the event and included "heat and cold alternate and Absorbine Jr. and Aspirin". The outcome of the event was not recovered.  Information on the lot/batch number has been requested.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Intestinal haemorrhage
Clinical narrative: This is a solicited report from a contactable consumer (patient) via a non-Pfizer sponsored program received by Pfizer. (Mfr. Control No.: 21K-163-3852938-00). A 60-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot and expiry were not reported), intramuscular on an unspecified date (at the age of 60-year-old) as single dose for covid-19 immunisation and adalimumab (HUMIRA, solution for injection in pre-filled pen), subcutaneous from an unspecified date at unspecified dose and frequency for moderate to severe ulcerative colitis. The patient received first dose of bnt162b2 (manufactured by Pfizer) intramuscular on an unspecified date as single dose for Covid-19 immunisation. The patient's medical history was not reported. The patient had no known allergies. There were no concomitant medications. The patient experienced intestinal bleeding on an unspecified date. He had Intestinal bleeding after second dose of bnt162b2. The patient never had bleeding since taking adalimumab. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Blood was hardly noticeable after ten days. He had no pain and no cramping. The event was considered serious as other medically important condition. The action taken in response to the event for bnt162b2 was not applicable while for adalimumab was unknown. The outcome of the event was recovering. The patient's causality for the event intestinal bleeding was probable for bnt162b2. AbbVie's opinion was that there was no reasonable possibility that the event of intestinal bleeding is related to Humira.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: The 60-year-old male patient had underlying disease of severe ulcerative colitis and was with treatment of adalimumab (HUMIRA). The reported intestinal bleeding after second dose of bnt162b2 was most likely due to his underlying disease of ulcerative colitis, and unlikely causally related to bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE).  The case will be reassessed should additional information become available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
Age: 92.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Autoimmune disorder, Condition aggravated, Urticaria
Clinical narrative: condition aggravavated; Breaking out in my auto-immune; since February and all through March until today has broken out into red welts; This is a spontaneous report from a contactable consumer.   A 92-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in right arm on 21Feb2021 at 12:30 (Batch/Lot Number: EN6201; Expiration Date: 30Jun2021) as a single dose for covid-19 immunisation. First dose: Date: 24Jan2021; Lot Number: EL9261; Expiry Date: 31May2021; Anatomical Location: Right arm. Medical history included neuropathy in hands for 3 years at least , ongoing autoimmune disorder she was diagnosed with the auto-immune condition at least 5 years ago. Concomitant medications included quinapril (QUINAPRIL) taken for high blood pressure for at least 5 years; apixaban (ELIQUIS) taken for blood clots in lungs for at leat 5 years and ongoing; vitamin d3 (VITAMIN D3) for at least 5 years taken to keep bones in order and ongoing; prednisone (PREDNISONE) taken for autoimmune condition, for about 5 years, start and stop date were not reported and gabapentin for at least 5 years.  The patient reported that she has been vaccinated with the Pfizer Covid-19 vaccine and that she has received both doses. Patient reported that she has the auto immune system and that since Feb2021 when she had her Covid-19 vaccine, she has been broken out.  Patient reported that she wanted to know if there was a possible relation between getting the Covid-19 vaccine and breaking out in her auto-immune. Patient reported that the red welts have come out on different parts of her body since Feb2021.  Patient reported that she has had the welts on her neck and on her face.  Patient reported on 19Apr2021, she was breaking out in welts on her arms.  Patient reported that she has had welts behind her legs and that the welts break out anywhere.Patient reported that the welts are just ongoing.  Patient reported that the welts are breaking out the same as when they first started. The patient was not hospitalized for the events. The outcome of the welts was not recovered and remaining events was not reported.   Follow-up attempts are completed. No further information is expected.
Age: 92.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Urticaria
Clinical narrative: condition aggravavated; Breaking out in my auto-immune; since February and all through March until today has broken out into red welts; This is a spontaneous report from a contactable consumer.   A 92-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in right arm on 21Feb2021 at 12:30 (Batch/Lot Number: EN6201; Expiration Date: 30Jun2021) as a single dose for covid-19 immunisation. First dose: Date: 24Jan2021; Lot Number: EL9261; Expiry Date: 31May2021; Anatomical Location: Right arm. Medical history included neuropathy in hands for 3 years at least , ongoing autoimmune disorder she was diagnosed with the auto-immune condition at least 5 years ago. Concomitant medications included quinapril (QUINAPRIL) taken for high blood pressure for at least 5 years; apixaban (ELIQUIS) taken for blood clots in lungs for at leat 5 years and ongoing; vitamin d3 (VITAMIN D3) for at least 5 years taken to keep bones in order and ongoing; prednisone (PREDNISONE) taken for autoimmune condition, for about 5 years, start and stop date were not reported and gabapentin for at least 5 years.  The patient reported that she has been vaccinated with the Pfizer Covid-19 vaccine and that she has received both doses. Patient reported that she has the auto immune system and that since Feb2021 when she had her Covid-19 vaccine, she has been broken out.  Patient reported that she wanted to know if there was a possible relation between getting the Covid-19 vaccine and breaking out in her auto-immune. Patient reported that the red welts have come out on different parts of her body since Feb2021.  Patient reported that she has had the welts on her neck and on her face.  Patient reported on 19Apr2021, she was breaking out in welts on her arms.  Patient reported that she has had welts behind her legs and that the welts break out anywhere.Patient reported that the welts are just ongoing.  Patient reported that the welts are breaking out the same as when they first started. The patient was not hospitalized for the events. The outcome of the welts was not recovered and remaining events was not reported.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Infection, Tooth abscess
Clinical narrative: major infection; molar abscess; This is a spontaneous report from a contactable consumer reporting on behalf of her friend. A 63-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 24Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included oral surgery. Concomitant medications included clindamycin hcl taken for an unspecified indication, start and stop date were not reported; glucose, metronidazole (METRONIDAZOLE & DEXTROSE) taken for an unspecified indication, start and stop date were not reported. The patient experienced she was having major infection on an unspecified date. Clinical course reported as: Patient had an oral surgery done and had a implant placed on March 17, she was on antibiotic and on March 24 she received her first dose of the Pfizer covid vaccine. Patient was having problem her implant, it had to be removed, she was having major infection, had to drain the abases in the moth. She had another molar abscess that would be extracted. Outcome of event was unknown.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested Positive for Covid; Tested Positive for Covid, Experienced congestion, loss of smell and taste.; This is a spontaneous report from a contactable nurse. A 54-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular, administered in Arm Left on 23Feb2021 06:00 (Lot Number: EL3247) (at the age of 54-year-old) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had not had Covid prior vaccination. The patient tested positive for covid, experienced congestion, loss of smell and taste. The adverse events were occurred on 09Apr2021. No treatment was received. The patient had covid tested post vaccination. The patient underwent lab tests and procedures which included Covid test Nasal swab (Saliva) on 11Apr2021 with result of positive. The outcome of the events was recovered in Apr2021.; Sender's Comments: Based on available information, a possible contributory role of the subject product,  BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 and suspected LOE.   There is limited information provided in this report.  This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Feeling of body temperature change, Gait disturbance
Clinical narrative: dizzy; having a hard time to breathe; hard to control walking; kept going from cold and hot; This is a spontaneous report from a contactable consumer (patient's husband).   A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 18Apr2021 10:00 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included 1st dose of BNT162B2 for Covid-19 immunization. Around 19:00 on 18Apr2021, patient was dizzy, having a hard time to breathe, hard to control walking and kept going from cold and hot. Caller stated they put ice on her head, she took ibuprofen and they put two to three pillows on her head to help her breathe. Outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Brain oedema, Diarrhoea, Fatigue, Nausea, Vomiting
Clinical narrative: cerebral edema; diarrhea; fatigue; nausea; vomiting; This is a spontaneous report from a contactable pharmacist. A 52-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), intramuscularly administered in left deltoid on 18Apr2021 (at age of 52 years old, Lot Number: EW0161) as single dose for covid-19 immunization. Medical history included hypertension, hyperlipidaemia, depression, anxiety. Concomitant medications included amlodipine, baclofen. The patient previous took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) on 28Mar2021 (at age of 52 years old) as single dose for covid-19 immunization. The patient not took any other vaccine. The patient took some medication (prescribed regularly) for there disease state prior to the event being reported. No allergies reported. Pharmacist stated, "Cerebral edema following within less than 24 hours of the second dose of vaccine. There was no anaphylactic reaction reported. The patient had fatigue, nausea, vomiting, diarrhea. Patient enter ER and was now requiring ICU level of care, intubated for respiratory support. They came in overnight emergency, they do have lab. He had done a whole work up he came in to the ICU. Pharmacist stated, "He did not take anything and ended up into the hospital. So they are requiring antibiotic and they also require intubation. So he needs to be intubated for respiratory support. Duration of stay was undefined and they arrived to the ER at 9:11 AM today (19Apr2021) this morning. That is the time of admission. Before 19, today's date. The events required the initiation of new medication or other treatment or procedure. The outcome of the events was unknown.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the Cerebral edema and other reported events  due to temporal relationship.  However, the reported event of Cerebral edema may possibly represent intercurrent medical condition in this patient.   There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including head CT/MRI, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis
Clinical narrative: DVT developed in Right Calf approx 24 hours after the vaccine administration; This is a spontaneous report from a contactable physician. This Physician reported for a 51-year-old male patient who received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 intramuscular on 11Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.  Medical history included kidney stone from an unknown date and unknown if ongoing.    There were no concomitant medications.  Patient did not receive any vaccine in four weeks. Patient did not receive any vaccine in four weeks. The patient developed DVT in right calf approximately 24 hours after the vaccine administration on 12Mar2021 with outcome of recovering.  Therapeutic measures were taken as a result of event included Xarelto. Patient was not tested for covid post vaccination.   Information on the lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event DVT cannot be excluded.  The case will be reassessed if additional information becomes 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: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Blindness, Deafness, Dizziness, Unresponsive to stimuli
Clinical narrative: lost my vision; lost my vision and hearing; essentially unresponsive; feel light-headed; This is a spontaneous report from a contactable consumer (patient).  A 27-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EW0161), dose 1 via an unspecified route of administration, administered in the left arm on 16Apr2021 at 14:30 as SINGLE DOSE (at the age of 27 years-old) for covid-19 immunisation. Medical history included coarctation of the aorta from an unknown date and unknown if ongoing coarctation of aorta (age: 3 months), only requires bi-annual cardiologist visits, loss of consciousness from an unknown date and unknown if ongoing, covid-19 from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient had no know allergies. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. The patient lost his vision and hearing, essentially unresponsive and light-headed on 16Apr2021 at 14:30. Circulation issues leading to a black out. Within 60 seconds of getting the shot, he began to feel light-headed. Within 30 seconds of that, he knew he needed help, so alerted the emergency medical technicians (EMTs) via car horn/flashers. By the time they arrived (120 seconds from the initial shot), he lost his vision and hearing and was essentially unresponsive. They woke him enough to unlock my car door, at which point they had him lay back to improve his circulation. That ultimately worked and got him back to normal within about 5 minutes. The patient had issues like this before relating to a coarctation of his aorta which he had done at 3 months of age. Over the years, he has "blacked out" like this from weight lifting and other high exertion things. This was the first time it was induced without him overexerting himself, and the onset of the "blackout" was much quicker than what he had experienced from weightlifting. Normally, he could tell 1-3 minutes in advance that he would black out. This time, it was about 30 seconds. Therapeutic measures were taken as a result of lost vision and hearing, essentially unresponsive and feel light-headed. EMTs did an electrocardiogram (EKG) and blood glucose check. The outcome of lost his vision and hearing, essentially unresponsive and light-headed was recovered on an unknown date. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstrual disorder
Clinical narrative: Caller received the first dose of Pfizer's COVID vaccine and experienced heavy menstrual bleeding; The caller hasn't had a period in 5 years, she is post menopausal; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 30Mar2021 (Lot Number: ER8734) as SINGLE DOSE for covid-19 immunisation. Medical history included post menopausal for 5 years from 2016, Hashimoto's disease. The patient's concomitant medications were not reported. The patient got her shot on 30Mar2021 and then she didn't notice any side effects, but right now in 2021 she's having menstrual cycles, a lot of bleeding. She experienced heavy menstrual bleeding. The patient hasn't had a period in 5 years, she was post menopausal. The outcome of events was unknown.   No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Depression, Fatigue, Hyperhidrosis, Loss of consciousness
Clinical narrative: unusual and pronounced panic attacks and depression; unusual and pronounced panic attacks and depression; fatigue; fever; sweats; pain in my arm and neck; pain in my arm and neck; swollen lymph nodes; I nearly passed out from an anxiety attack; I nearly passed out from an anxiety attack; This is a spontaneous report from a contactable consumer reporting for herself. A 34-year-old female consumer reported that she received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in arm left on 09Apr2021 01:15PM (at the age of 34-year-old) for COVID-19 immunisation. Relevant medical history included COVID prior vaccination. Past drug history included known allergy to cefaclor (CECLOR) and morphine. Concomitant medications were not reported. The patient nearly passed out from an anxiety attach 15 minutes after the vaccine was administered, on 09Apr2021 01:30PM: this had never happened before. For a week after, she experienced fatigue, fever, sweats, pain in arm and neck, and swollen lymph nodes. She had also experienced unusual and pronounced panic attacks and depression since receiving the vaccine and would be seeking medical attention for those issues. Events resulted in physician or other healthcare professional office/clinic visit. No treatment was received. The patient had not tested for COVID post vaccination. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Neck pain, Pain in extremity, Panic attack, Pyrexia
Clinical narrative: unusual and pronounced panic attacks and depression; unusual and pronounced panic attacks and depression; fatigue; fever; sweats; pain in my arm and neck; pain in my arm and neck; swollen lymph nodes; I nearly passed out from an anxiety attack; I nearly passed out from an anxiety attack; This is a spontaneous report from a contactable consumer reporting for herself. A 34-year-old female consumer reported that she received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in arm left on 09Apr2021 01:15PM (at the age of 34-year-old) for COVID-19 immunisation. Relevant medical history included COVID prior vaccination. Past drug history included known allergy to cefaclor (CECLOR) and morphine. Concomitant medications were not reported. The patient nearly passed out from an anxiety attach 15 minutes after the vaccine was administered, on 09Apr2021 01:30PM: this had never happened before. For a week after, she experienced fatigue, fever, sweats, pain in arm and neck, and swollen lymph nodes. She had also experienced unusual and pronounced panic attacks and depression since receiving the vaccine and would be seeking medical attention for those issues. Events resulted in physician or other healthcare professional office/clinic visit. No treatment was received. The patient had not tested for COVID post vaccination. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Throat tightness, Tremor
Clinical narrative: throat closing; severe shortness of breath; body shakes; chest kind of clamping in my chest; This is a spontaneous report received from a contactable consumer (patient). A 24-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 10Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced throat closing, severe shortness of breath, body shakes, chest kind of clamping in chest 9 days after first dose in Apr2021 with outcome of unknown. The events were reported as non-serious.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Pneumonia
Clinical narrative: Felt a little off; Pneumonia; This is a spontaneous report from a contactable consumer (patient's daughter). A 91-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration, administered on the left arm on 16Mar2021 at a single dose for COVID-19 immunisation. The patient's medical history included deaf. Concomitant medications were not reported. Reporter stated that a week and a half after his first vaccine he had pneumonia (Mar2021); but that they didn't think it was related to the vaccine. The patient also felt a little off on 16Mar2021 and required a visit to the emergency room and physician office. The facility where the vaccine was administered was in a clinic. There were no additional vaccines administered on same date of Pfizer suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There was no family medical history relevant to events and no relevant tests done. Outcome of the event pneumonia was unknown while not recovered for the other event. The reporter mentioned that they didn't think that pneumonia was related to the vaccine.   Information about the Lot/batch number has been requested.; Sender's Comments: Based on available information, pneumonia is assessed as unrelated to BNT162B2, this is an intercurrent medical condition. Potential contributors include patient's advanced age as the risk for infections is higher in this population. Case will be  reassessed if additional information is received
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Pneumonia
Clinical narrative: flared up after the first dose of pfizer covid vaccine; States it flared up after the first dose of Pfizer covid vaccine. states this is normal for her. and has nothing to do with the shot; This is a spontaneous report from a non-contactable consumer (patient).  A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number was not reported), on 31Mar2021 at single dose for covid-19 immunisation.  Medical history included a couple of times a year pneumonia from her COPD. The patient's concomitant medications were not reported. Patient was due to have her second shot in Apr2021 however she was taking antibiotics and asked if it was ok to have the second shot of covid vaccine while taking antibiotics. Patient clarified antibiotics were for a pre-existing condition, she had COPD. Patient stated a couple of times a year she gets pneumonia from her COPD. She reported it flared up after the first dose of the vaccine. She stated this was normal for her and has nothing to do with the shot.The outcome of the event was unknown.No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: The event flare up of pneumonia is unrelated to BNT162B2, the event can be attributed to an underlying COPD
Sex: F
Vaccine: COVID19
Symptoms: Dyskinesia
Clinical narrative: Mild jerks for 45 min.; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: en6207), via an unspecified route of administration in the left arm on 21Mar2021 12:00 at a single dose for COVID-19 immunization. The patient medical history was not reported. There were no other vaccines in four weeks. There were no other medications in two weeks. The patient was not pregnant. There were no concomitant medications. The patient experienced mild jerks for 45 min. on an unspecified date in Mar2021 (also reported as 05Mar2021; pending clarification). The event resulted in emergency room/department or urgent care, hospitalization. The patient was hospitalized for mild jerks for 45 min. for 5 days. Treatment was received. The patient had not had COVID prior vaccination.  The patient was not COVID tested post vaccination. The outcome of the event was recovered with sequel on an unspecified date.   The event mild jerks for 45 min. occurred in a country different from that of the reporter. This may be a duplicate report if another reporter from the country where the event occurred has submitted the same information to his/her local agency.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Demyelination, Noninfective encephalitis, Pyrexia, SARS-CoV-2 test, Seizure
Clinical narrative: demyelination with brain inflammation; demyelination with brain inflammation; seizures; Fever; 2 seizures fever vomiting and demyelination with brain inflammation; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route on left arm single dose for COVID-19 immunisation on 01Apr2021, 06:45 PM, at 38-year-old. Medical history included: diabetes and hypertension; known allergies: penicillin. No other vaccine in four weeks and no other medications in two weeks. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization on unknown date, 06:45 PM, at 38-year-old. On 02Apr2021, the patient had 2 seizures, fever, vomiting and demyelination with brain inflammation. Emergency room/department or urgent care visited and hospitalization for 10 days. Treatment included: plasma exchange, steroids, fluids and IV antibiotic. Lab data included: negative COVID test on 02Apr2021. Outcome of the events was resolving.  Information about lot/batch number has been requested.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: demyelination with brain inflammation; demyelination with brain inflammation; seizures; Fever; 2 seizures fever vomiting and demyelination with brain inflammation; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route on left arm single dose for COVID-19 immunisation on 01Apr2021, 06:45 PM, at 38-year-old. Medical history included: diabetes and hypertension; known allergies: penicillin. No other vaccine in four weeks and no other medications in two weeks. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization on unknown date, 06:45 PM, at 38-year-old. On 02Apr2021, the patient had 2 seizures, fever, vomiting and demyelination with brain inflammation. Emergency room/department or urgent care visited and hospitalization for 10 days. Treatment included: plasma exchange, steroids, fluids and IV antibiotic. Lab data included: negative COVID test on 02Apr2021. Outcome of the events was resolving.  Information about lot/batch number has been requested.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Dizziness, Gait inability, Loss of consciousness, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). An 87-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route on left arm single dose for COVID-19 immunisation on 22Feb2021, 02:00 PM, at 87-year-old. No medical history and concomitant medications were not reported. No other vaccine in four weeks and no other medications in two weeks. On 22Mar2021, 03:30 PM, the patient had lost consciousness 10 hours, could not walk, fever 101, extreme dizziness, vomiting, had to crawl when vomiting. No treatment. Outcome of the event was resolved on unknown date.  Information about lot/batch number has been requested.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). An 87-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route on left arm single dose for COVID-19 immunisation on 22Feb2021, 02:00 PM, at 87-year-old. No medical history and concomitant medications were not reported. No other vaccine in four weeks and no other medications in two weeks. On 22Mar2021, 03:30 PM, the patient had lost consciousness 10 hours, could not walk, fever 101, extreme dizziness, vomiting, had to crawl when vomiting. No treatment. Outcome of the event was resolved on unknown date.  Information about lot/batch number has been requested.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular, Thrombosis, Vaginal haemorrhage
Clinical narrative: vaginal bleeding/blood clots at mid-cycle; vaginal bleeding/blood clots at mid-cycle; vaginal bleeding/blood clots at mid-cycle; This is a spontaneous report from a contactable consumer. A 40-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: EN6206, via an unspecified route of administration, administered in left arm on 15Mar2021 10:30 as single dose for Covid-19 immunisation. Medical history included folate deficiency and allergies to sulfa. There were no concomitant medications. After the first dose on 15Mar2021, the patient had vaginal bleeding/blood clots at mid-cycle. No treatment information was provided. The outcome of the events was not recovered.; Sender's Comments: Based on temporal association reported events causal relationship with BNT162B2 cannot be excluded. Case to be re-assessed upon receipt of new information.  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: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Endoscopy, Sjogren's syndrome
Clinical narrative: The result came back positive for Sjogren's; This is a spontaneous report received from a contactable consumer (patient). A 72-year-old female patient received bnt162b2 (Pfizer/BioNTech COVID-19 Vaccine), dose 2 intramuscularly, administered in Arm Left at 72 years old on 09Feb2021 08:00 (Lot Number: EL9265) at single dose for covid-19 immunization. Medical history included pain joint and muscles, autoimmune inflammation. Family history was none. Concomitant medications included ibuprofen (ADVIL) taken for pain joint and muscles from 20Jan2021 to 15Mar2021 at 6 pills a day. No prior vaccine was administered within 4 weeks. The patient previously received the first dose of bnt162b2 (Lot number: EL1283) at 72 years old on 12Jan2021 8:00 AM intramuscularly in left arm for covid-19 immunization. Patient had major aches in muscles (legs & arms) and hip joints-muscle pain, joint pain, tiredness after the first vaccination. Before her present health issue began after her first Pfizer vaccine shot, patient had never been tested for possible autoimmune problems. Within a week (I believe the timing), she began to feel migrating pain and stiffness around her body and was very lethargic. She had aches and often stiffness in her legs and arms, a dry cough, and night sweats. Her mouth became parched. Her eyes had suffered from dryness in the past and became even more acute. At night she had trouble sleeping because of the increasing pain. Again, the pain was strange in that it migrated around her body. At first, her primary care physician, Dr.(name) did not recognise her symptoms, didn't order any tests, and sent her to physical therapy. After a month (after the second vaccination), when the body pains and tiredness got worse, and her ankle swelled, she sent her for blood tests at (name) Diagnostic on 23Feb2021. The result came back positive for Sjogren's, a disease she had never heard of before. Later a Rheumatologist ran a confirmatory test with lab corp. With the same result in return. Dr. (Name withheld) Put her on Meloxicam for inflammation and the issues mostly have subsided except for continuing pain in her arms. Since mid-Jan, Dr. (Name withheld) had referred her to an ophthalmologist, gastroenterologist and rheumatologist. Patient had an appointment schedule with a pneumologist on 21Apr. The gastroenterologist did an endoscopy and has ordered a CT Scan to rule out lymphoma. The rheumatologist was running more test. Relevant tests included: autoimmune testing onset lab  for ANA Sjogren's on 23Feb2021, Result: Positive, Units: 2.4; autoimmune testing onset lab  for Sjogren's on 18Mar2021, Result: Positive, Units: 2.1. Event required visit to Physician office. Treatment received for the event included meloxicam 15 mg from 16Mar2021 and ongoing at 1 pill a day. The outcome of the event was recovering. Seriousness Criteria was reported as Persistent/significant disability/Incapacity.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Electroencephalogram, Investigation, Magnetic resonance imaging, Seizure
Clinical narrative: seizures; This is a spontaneous report from a contactable consumer (Patient's husband).   A 70-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 70-year-old via an unspecified route of administration, administered in Arm Left on 26Feb2021 (Lot Number: EN6203) as single dose, second dose of BNT162B2 via an unspecified route of administration, administered in Arm Left on 19Mar2021 (Lot Number: EN8727) as single dose both for covid-19 immunisation.  Medical history included High blood pressure, atrial fibrillation. No family medical history. No prior vaccination within 4 weeks. Ongoing Concomitant medications included rivaroxaban (XARELTO); losartan taken for hypertension; hydrochlorothiazide taken for blood pressure abnormal, fluid imbalance; diltiazem hydrochloride (CARTIA XT) taken for atrial fibrillation; loratadine.  After the first shot, about a week and a half later, she started having seizures in Mar2021. Since the second shot, it had gotten worse. The event resulted in Emergency Room visit. She was taken in twice. The first time, she was in the hospital for 4 days. This occurred last month, in Mar2021. After the second dose, she had been hospitalized, the end of March, almost April. They took her twice. The first time, they did a bunch of tests and were questioning seizure or a stroke. At the end, they thought it was a seizure. She then came home and had it worse. They put her on medication. The patient underwent lab tests and procedures which included tests: all were negative, computerised tomogram: unknown results, electroencephalogram: unknown results, magnetic resonance imaging: unknown results all in Mar2021.  The events outcome was not recovered.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal faeces, Antibody test, Biopsy bone marrow, Blood test, Diarrhoea
Clinical narrative: suppressed WBC and neutrophils and platelets; suppressed WBC and neutrophils and platelets; suppressed WBC and neutrophils and platelets; Very loose, sticky stool; Very loose, sticky stool; gaseous episodes; This is a spontaneous report from a contactable Other-HCP (patient). A 65-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EL3248), second dose intramuscular, administered in Arm Left on 08Jan2021 08:00 (at 65 years old, not pregnant) single dose for covid-19 immunisation. The patient had no relevant medical history. The patient had her first dose of bnt162b2 (lot number: EJ1685) on 18Dec2020 1500 for covid-19 immunisation, intramuscular on left arm. Concomitant medication(s) included colecalciferol (VIT D3); magnesium; calcium; ascorbic acid, tocopheryl acetate, xantofyl, zeaxanthin, zinc (AREDS); chondroitin sulfate, glucosamine (GLUCOSAMINE CHONDROITIN; monascus purpureus (RED YEAST RICE). On 16Jan2021, patient experienced very loose, sticky stool, gaseous episodes everyday since 2nd shot in Jan2021. Patient still do not have normal solid stool today. Patient went into the hospital 23Mar2021 with suppressed WBC and neutrophils and platelets. Tested for every virus, fungus and autoimmune disease and all came back negative and then had a bone marrow biopsy with negative results. Inflammation was seen in biopsy study. Given Neupogen to increase WBC/neutrophils only once which raised levels. Released 5 days later. Blood test 4/13 showed below normal WBC/neutrophils again but not as severe. Still trying to get healthy again. Adverse event resulted in visit to Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization. Five days of hopitalisation. The outcome of the events was Recovering.Patient was given treatment Bone marrow biopsy, injection of Neupogen, IV antibiotics. No Covid prior vaccination. Patient got Covid tested post vaccination, nasal swab on 21Mar2021, 21Mar2021 and 23Mar2021, all negative. No Known allergies.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events diarrhea, flatulence, abnormal feces, platelet count decreased, neutrophil count decreased and WBC count decreased and the suspect drug.  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  Committees, and Investigators, as appropriate.