chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vomiting, Weight
Clinical narrative: flash pulmonary edema; anaphylaxis; vomiting; shortness of breath; This is a spontaneous report from contactable consumers (one consumer is the patient daughter) and physician. This report was received via a sales representative a from a Pfizer-sponsored program and from internet news. A 58-year-old female patient (non-pregnant) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot # EL9263), via an unspecified route of administration on 30Jan2021 17:00 at single dose at left arm for Covid-19 immunisation. Medical history included obesity, type 2 diabetes, known allergies_Penicillin, sleep apnoea, hypertension. The patient's concomitant medications included cholesterol lowering medication, blood pressure regulation medicine, medication for blood glucose, but oral, not insulin. The patient while back to home, couldn't breathe and started vomiting. They did administer an EpiPen, CPR and oxygen as well. They tried to remove fluid from her lungs. They called it flash pulmonary edema, and it can be caused by anaphylaxis, patient was taken to a hospital where she was diagnosed. Patient died within an hour of receiving the COVID-19 Pfizer vaccine on 30Jan2021 from pulmonary edema. Her reaction was shortness of breath occurred within 30 minutes after receiving the vaccine dose, also had anaphylaxis (life-threatening), flash pulmonary edema, vomiting and couldn't breathe. Outcome of events shortness of breath and vomiting were unknown, outcome of events flash pulmonary edema and anaphylaxis was fatal. Patient was probably around 5 feet 2 inches and probably over 300 pounds. Cause of death were reported as pending. Toxicology tests were requested as the law has other tests. But they did not do a full autopsy. They only did blood work. Reporter confirmed that autopsy was not performed. The adverse events resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  Follow-up (04Feb2021): This is a follow-up report combining information from duplicate reports 2021117416, 2021130543, 2021141606 and 2021116417. The current and all subsequent information will be reported under manufacturer report number 2021116417. The new information reported included new event (shortness of breath), seriousness, and clinical course.; Reported Cause(s) of Death: flash pulmonary edema; anaphylaxis
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cardiac arrest, Death
Clinical narrative: flash pulmonary edema; anaphylaxis; vomiting; shortness of breath; This is a spontaneous report from contactable consumers (one consumer is the patient daughter) and physician. This report was received via a sales representative a from a Pfizer-sponsored program and from internet news. A 58-year-old female patient (non-pregnant) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot # EL9263), via an unspecified route of administration on 30Jan2021 17:00 at single dose at left arm for Covid-19 immunisation. Medical history included obesity, type 2 diabetes, known allergies_Penicillin, sleep apnoea, hypertension. The patient's concomitant medications included cholesterol lowering medication, blood pressure regulation medicine, medication for blood glucose, but oral, not insulin. The patient while back to home, couldn't breathe and started vomiting. They did administer an EpiPen, CPR and oxygen as well. They tried to remove fluid from her lungs. They called it flash pulmonary edema, and it can be caused by anaphylaxis, patient was taken to a hospital where she was diagnosed. Patient died within an hour of receiving the COVID-19 Pfizer vaccine on 30Jan2021 from pulmonary edema. Her reaction was shortness of breath occurred within 30 minutes after receiving the vaccine dose, also had anaphylaxis (life-threatening), flash pulmonary edema, vomiting and couldn't breathe. Outcome of events shortness of breath and vomiting were unknown, outcome of events flash pulmonary edema and anaphylaxis was fatal. Patient was probably around 5 feet 2 inches and probably over 300 pounds. Cause of death were reported as pending. Toxicology tests were requested as the law has other tests. But they did not do a full autopsy. They only did blood work. Reporter confirmed that autopsy was not performed. The adverse events resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  Follow-up (04Feb2021): This is a follow-up report combining information from duplicate reports 2021117416, 2021130543, 2021141606 and 2021116417. The current and all subsequent information will be reported under manufacturer report number 2021116417. The new information reported included new event (shortness of breath), seriousness, and clinical course.; Reported Cause(s) of Death: flash pulmonary edema; anaphylaxis
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Exfoliative rash, Induration, Injection site rash, Injection site reaction
Clinical narrative: 1/29/21 rash at injection site on left arm, feverish, looked blistered, itchy, rash at baseline of neck, rash on right arm from top to below elbow crease inside of arm, very itchy but no blisters. Used benadryl cream on rash & took benadryl tabs at night. Severe itching lasted about 5 to 6 days. No longer needed tabs after that, continued cream about 10 days
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site swelling, Peripheral swelling, Urticaria
Clinical narrative: 1/29/21 rash at injection site on left arm, feverish, looked blistered, itchy, rash at baseline of neck, rash on right arm from top to below elbow crease inside of arm, very itchy but no blisters. Used benadryl cream on rash & took benadryl tabs at night. Severe itching lasted about 5 to 6 days. No longer needed tabs after that, continued cream about 10 days
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site pruritus, Injection site rash, Injection site vesicles, Injection site warmth, Rash
Clinical narrative: 1/29/21 rash at injection site on left arm, feverish, looked blistered, itchy, rash at baseline of neck, rash on right arm from top to below elbow crease inside of arm, very itchy but no blisters. Used benadryl cream on rash & took benadryl tabs at night. Severe itching lasted about 5 to 6 days. No longer needed tabs after that, continued cream about 10 days
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash pruritic
Clinical narrative: 1/29/21 rash at injection site on left arm, feverish, looked blistered, itchy, rash at baseline of neck, rash on right arm from top to below elbow crease inside of arm, very itchy but no blisters. Used benadryl cream on rash & took benadryl tabs at night. Severe itching lasted about 5 to 6 days. No longer needed tabs after that, continued cream about 10 days
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hot flush, Pruritus, Swelling face
Clinical narrative: First dose reaction was itchiness lips and face swelled was told by nurse to take benadryl . Before hand was told to take a benadryl Second dose reaction my body started to get tingly like 20 minutes after dose then got itchy and chest got tight skin got clammy nurse took my vitals heartbeat was a little elevated sat for a little bit longer checked vitals again all was well so left site did okay until about 6pm that evening my mouth started getting numb got itchy again called to IHS talked to doctor on call she told me to take 2 benadryls about half and hour later went away next few days. Unknown if this was documented in my hospital chart or not.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Cold sweat, Heart rate increased, Hypoaesthesia oral, Paraesthesia
Clinical narrative: First dose reaction was itchiness lips and face swelled was told by nurse to take benadryl . Before hand was told to take a benadryl Second dose reaction my body started to get tingly like 20 minutes after dose then got itchy and chest got tight skin got clammy nurse took my vitals heartbeat was a little elevated sat for a little bit longer checked vitals again all was well so left site did okay until about 6pm that evening my mouth started getting numb got itchy again called to IHS talked to doctor on call she told me to take 2 benadryls about half and hour later went away next few days. Unknown if this was documented in my hospital chart or not.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus
Clinical narrative: First dose reaction was itchiness lips and face swelled was told by nurse to take benadryl . Before hand was told to take a benadryl Second dose reaction my body started to get tingly like 20 minutes after dose then got itchy and chest got tight skin got clammy nurse took my vitals heartbeat was a little elevated sat for a little bit longer checked vitals again all was well so left site did okay until about 6pm that evening my mouth started getting numb got itchy again called to IHS talked to doctor on call she told me to take 2 benadryls about half and hour later went away next few days. Unknown if this was documented in my hospital chart or not.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: The first shot caused swelling at injection site.  3 hours after second shot was admitted through the ER because my right arm was "on fire" and there was swelling in my left arm.  Was admitted for 3 days to the ICU.  I have developed a heart murmur.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Burning sensation, Cardiac murmur, Injection site swelling, Intensive care, Laboratory test
Clinical narrative: The first shot caused swelling at injection site.  3 hours after second shot was admitted through the ER because my right arm was "on fire" and there was swelling in my left arm.  Was admitted for 3 days to the ICU.  I have developed a heart murmur.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Lymphoedema, Peripheral swelling
Clinical narrative: The first shot caused swelling at injection site.  3 hours after second shot was admitted through the ER because my right arm was "on fire" and there was swelling in my left arm.  Was admitted for 3 days to the ICU.  I have developed a heart murmur.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Allergy to vaccine, Hypoaesthesia, Nerve stimulation test abnormal, Sensory loss
Clinical narrative: mild case of Bell's Palsy.; skin of the patient's jaw and chin started to feel numb/numbness of her cheeks, eyebrows, and ears; headache; This is a spontaneous report from a contactable consumer (patient). This 40-year-old female patient received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248, expiration date: Apr2021) via intramuscular in the upper left arm on 01Feb2021 at 04:30 PM at single dose for COVID-19 immunization. Medical history included asthma (exercise induced) and menstruating. Concomitant medications included Ibuprofen because she was menstruating. No other vaccine in four weeks. The patient previously received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248, expiration date: Apr2021) via intramuscular in the upper right arm on 11Jan2021 at 04:30 PM at single dose for COVID-19 immunization. The patient was not pregnant. The skin of the patient's jaw and chin started to feel numb about 20 minutes after receiving the vaccine, headache came and went rapidly on 01Feb2021 17: 00. The sensation progressed rapidly to include numbness of her cheeks, eyebrows, and ears. The symptoms appeared rapidly after leaving the clinic as the patient was driving away on her from work. Both sides of her face were impacted equally. She went to an urgent care facility to be evaluated. An Urgent Care Physician's Assistant evaluated the patient. They looked inside her throat to see if it was closing up (it wasn't). They used a swab to test her sensory ability on her face by pressing with either the fuzzy-side or the blunt (wooden) side. When the patient asked the PA how she did, she indicated that she failed the test. They gave her Benadryl. At home, the patient went to bed, woke up normally, and did a "frown test" in front of the mirror. Her left side of face wasn't working the same way as the right side. She may have a mild case of Bell's Palsy in the morning of 02Feb2021. The patient had no covid prior vaccination, no covid tested post vaccination. Benadryl was received as treatment for the events. Outcome of the event "skin of the patient's jaw and chin started to feel numb/numbness of her cheeks, eyebrows, and ears" and "mild case of Bell's Palsy" was recovering, of the event "headache" was recovered.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Facial paralysis, Headache, Hypoaesthesia
Clinical narrative: mild case of Bell's Palsy.; skin of the patient's jaw and chin started to feel numb/numbness of her cheeks, eyebrows, and ears; headache; This is a spontaneous report from a contactable consumer (patient). This 40-year-old female patient received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248, expiration date: Apr2021) via intramuscular in the upper left arm on 01Feb2021 at 04:30 PM at single dose for COVID-19 immunization. Medical history included asthma (exercise induced) and menstruating. Concomitant medications included Ibuprofen because she was menstruating. No other vaccine in four weeks. The patient previously received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248, expiration date: Apr2021) via intramuscular in the upper right arm on 11Jan2021 at 04:30 PM at single dose for COVID-19 immunization. The patient was not pregnant. The skin of the patient's jaw and chin started to feel numb about 20 minutes after receiving the vaccine, headache came and went rapidly on 01Feb2021 17: 00. The sensation progressed rapidly to include numbness of her cheeks, eyebrows, and ears. The symptoms appeared rapidly after leaving the clinic as the patient was driving away on her from work. Both sides of her face were impacted equally. She went to an urgent care facility to be evaluated. An Urgent Care Physician's Assistant evaluated the patient. They looked inside her throat to see if it was closing up (it wasn't). They used a swab to test her sensory ability on her face by pressing with either the fuzzy-side or the blunt (wooden) side. When the patient asked the PA how she did, she indicated that she failed the test. They gave her Benadryl. At home, the patient went to bed, woke up normally, and did a "frown test" in front of the mirror. Her left side of face wasn't working the same way as the right side. She may have a mild case of Bell's Palsy in the morning of 02Feb2021. The patient had no covid prior vaccination, no covid tested post vaccination. Benadryl was received as treatment for the events. Outcome of the event "skin of the patient's jaw and chin started to feel numb/numbness of her cheeks, eyebrows, and ears" and "mild case of Bell's Palsy" was recovering, of the event "headache" was recovered.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Exposure to SARS-CoV-2, Headache, Paraesthesia, SARS-CoV-2 test positive
Clinical narrative: sensation change (pins and needles) in left arm; Tested positive for COVID 23Jan2021/headache; Tested positive for COVID 23Jan2021/headache; This is a spontaneous report from a contactable nurse. A 36-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EJ1685), via intramuscular on 05Jan2021 13:00 at single dose in right arm for COVID-19 immunisation. Medical history included known allergies: coconut.  Prior to vaccination, patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. Patient was tested positive for COVID (test name was reported as COVID-19/SARS COV2, PCR (COVOO)) on 23Jan2021. Patient was asymptomatic at the time and was tested due to positive household members. Patient developed symptom (headache) on 25Jan2021. Patient developed sensation change (pins and needles) in left arm on 31Jan2021. Patient was seen in Emergency Room and kept overnight for observation. No obvious cause for symptoms was found. No treatment was received for the events. Outcome of the events was reported as resolving. This case was reported as serious with seriousness criteria: caused/prolonged hospitalization.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation.  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: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Paraesthesia, SARS-CoV-2 test
Clinical narrative: sensation change (pins and needles) in left arm; Tested positive for COVID 23Jan2021/headache; Tested positive for COVID 23Jan2021/headache; This is a spontaneous report from a contactable nurse. A 36-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EJ1685), via intramuscular on 05Jan2021 13:00 at single dose in right arm for COVID-19 immunisation. Medical history included known allergies: coconut.  Prior to vaccination, patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. Patient was tested positive for COVID (test name was reported as COVID-19/SARS COV2, PCR (COVOO)) on 23Jan2021. Patient was asymptomatic at the time and was tested due to positive household members. Patient developed symptom (headache) on 25Jan2021. Patient developed sensation change (pins and needles) in left arm on 31Jan2021. Patient was seen in Emergency Room and kept overnight for observation. No obvious cause for symptoms was found. No treatment was received for the events. Outcome of the events was reported as resolving. This case was reported as serious with seriousness criteria: caused/prolonged hospitalization.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation.  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: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: tinnitus/she had 2 seconds of a very high pitch and then the following morning, she began having a low level, not high pitched, background low level type hum that was unresolved; This is a spontaneous report from a contactable pharmacist (patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EK9231), via intramuscular on 12Jan2021 17:30 at single dose on left arm for prevention. Medical history included hashimoto's hypothyroidism.  Concomitant medication included levothyroxine sodium (SYNTHROID) and liothyronine sodium (CYTOMEL), both for Hashimoto's Hypothyroidism; cyanocobalamin (VIT B12), selenium, VITAMIN D3, ascorbic acid (VITAMIN C), calcium + magnesium, all for many years for vitamin supplementation. She also had a hormone replacement therapy patch that she had been taking for 5 years. She had experienced some tinnitus on 12Jan2021 21:00 and it had not resolved. She went to ENT (ear, nose and throat) for an ear exam. They were fine. They did not think it was the vaccine but did not know. After she received the vaccine, she had 2 seconds of a very high pitch and then the following morning, she began having a low level, not high pitched, background low level type hum that was unresolved. It started the evening of around 9pm. She went after work at 17:30 to get the vaccine. It was further reported that tinnitus started at 21:00 for just 2 seconds and then hearing was normal. However, the following morning, she woke up with this low level like if you leave TV on the like a hum. Very mild. This started at 06:00. No ER (Emergency Room) or physician's office required. On 29Jan2020, patient did an ear exam and hearing exam. Ear exam was perfect. Hearing exam revealed slightly hearing loss consistent with age. It was pretty normal. The part of the hearing that goes first as the age. Outcome of the event was not resolved. This case was reported as serious with seriousness criteria: medically significant.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event tinnitus cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once 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: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acoustic stimulation tests, Ear, nose and throat examination, Tinnitus
Clinical narrative: tinnitus/she had 2 seconds of a very high pitch and then the following morning, she began having a low level, not high pitched, background low level type hum that was unresolved; This is a spontaneous report from a contactable pharmacist (patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EK9231), via intramuscular on 12Jan2021 17:30 at single dose on left arm for prevention. Medical history included hashimoto's hypothyroidism.  Concomitant medication included levothyroxine sodium (SYNTHROID) and liothyronine sodium (CYTOMEL), both for Hashimoto's Hypothyroidism; cyanocobalamin (VIT B12), selenium, VITAMIN D3, ascorbic acid (VITAMIN C), calcium + magnesium, all for many years for vitamin supplementation. She also had a hormone replacement therapy patch that she had been taking for 5 years. She had experienced some tinnitus on 12Jan2021 21:00 and it had not resolved. She went to ENT (ear, nose and throat) for an ear exam. They were fine. They did not think it was the vaccine but did not know. After she received the vaccine, she had 2 seconds of a very high pitch and then the following morning, she began having a low level, not high pitched, background low level type hum that was unresolved. It started the evening of around 9pm. She went after work at 17:30 to get the vaccine. It was further reported that tinnitus started at 21:00 for just 2 seconds and then hearing was normal. However, the following morning, she woke up with this low level like if you leave TV on the like a hum. Very mild. This started at 06:00. No ER (Emergency Room) or physician's office required. On 29Jan2020, patient did an ear exam and hearing exam. Ear exam was perfect. Hearing exam revealed slightly hearing loss consistent with age. It was pretty normal. The part of the hearing that goes first as the age. Outcome of the event was not resolved. This case was reported as serious with seriousness criteria: medically significant.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event tinnitus cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once 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: 38.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Abdominal pain upper, Blood glucose increased, Blood ketone body increased, Chills, Condition aggravated
Clinical narrative: stomach pain; vomiting; high ketones; high blood sugars and headache; my body could no longer absorb insulin; 12 hours after vaccine experienced a fever (101.9), aches, chills, and a very bad headache; 12 hours after vaccine experienced a fever (101.9), aches, chills, and a very bad headache; chills; 12 hours after vaccine experienced a fever (101.9), aches, chills, and a very bad headache; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 38-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration second dose (lot number: EL0142) on 03Feb2021 14:45 at a single dose in left arm for COVID-19 immunization. Medical history included type 1 diabetes. Concomitant medication included insulin lispro (HUMALOG), celecoxib (CELEXA) within 2 weeks of vaccination. The patient previously took first dose of bnt162b2 (lot number: EL0142) on 13Jan2021 14:45 at age of 38 years old in left arm for COVID-19 immunization. On 04Feb2021 06:00, the patient experienced 12 hours after vaccine experienced a fever (101.9), aches, chills, and a very bad headache, the body could no longer absorb insulin. On 06Feb2021, the patient experienced stomach pain, vomiting, high ketones, high blood sugars. The worst occurred the day after when the body could no longer absorb insulin. The patient increased basal rate by almost 400% and could not bring sugars down. Saturday afternoon, the patient began experiencing symptoms of diabetic ketoacidosis: stomach pain, vomiting, high ketones and very high blood sugars. The patient was able to eventually take in enough water to lower the ketones and sugar and narrowly avoided going to the emergency room (ER), but high blood sugars and headache persisted, and the patient were still experiencing these symptoms. Prior to vaccination, the patient was not diagnosed with COVID-19.  Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The adverse event result in doctor or other healthcare professional office/clinic visit. The treatment (Insulin and hydration) was received for the adverse event. The seriousness of all the events were life threatening. Therapeutic measures were taken as a result of adverse events. The outcome of all the events was not recovered.
Age: 38.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Diabetic ketoacidosis, Headache, Insulin resistance, Ketosis, Pain
Clinical narrative: stomach pain; vomiting; high ketones; high blood sugars and headache; my body could no longer absorb insulin; 12 hours after vaccine experienced a fever (101.9), aches, chills, and a very bad headache; 12 hours after vaccine experienced a fever (101.9), aches, chills, and a very bad headache; chills; 12 hours after vaccine experienced a fever (101.9), aches, chills, and a very bad headache; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 38-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration second dose (lot number: EL0142) on 03Feb2021 14:45 at a single dose in left arm for COVID-19 immunization. Medical history included type 1 diabetes. Concomitant medication included insulin lispro (HUMALOG), celecoxib (CELEXA) within 2 weeks of vaccination. The patient previously took first dose of bnt162b2 (lot number: EL0142) on 13Jan2021 14:45 at age of 38 years old in left arm for COVID-19 immunization. On 04Feb2021 06:00, the patient experienced 12 hours after vaccine experienced a fever (101.9), aches, chills, and a very bad headache, the body could no longer absorb insulin. On 06Feb2021, the patient experienced stomach pain, vomiting, high ketones, high blood sugars. The worst occurred the day after when the body could no longer absorb insulin. The patient increased basal rate by almost 400% and could not bring sugars down. Saturday afternoon, the patient began experiencing symptoms of diabetic ketoacidosis: stomach pain, vomiting, high ketones and very high blood sugars. The patient was able to eventually take in enough water to lower the ketones and sugar and narrowly avoided going to the emergency room (ER), but high blood sugars and headache persisted, and the patient were still experiencing these symptoms. Prior to vaccination, the patient was not diagnosed with COVID-19.  Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The adverse event result in doctor or other healthcare professional office/clinic visit. The treatment (Insulin and hydration) was received for the adverse event. The seriousness of all the events were life threatening. Therapeutic measures were taken as a result of adverse events. The outcome of all the events was not recovered.
Age: 38.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Pyrexia, Vomiting
Clinical narrative: stomach pain; vomiting; high ketones; high blood sugars and headache; my body could no longer absorb insulin; 12 hours after vaccine experienced a fever (101.9), aches, chills, and a very bad headache; 12 hours after vaccine experienced a fever (101.9), aches, chills, and a very bad headache; chills; 12 hours after vaccine experienced a fever (101.9), aches, chills, and a very bad headache; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 38-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration second dose (lot number: EL0142) on 03Feb2021 14:45 at a single dose in left arm for COVID-19 immunization. Medical history included type 1 diabetes. Concomitant medication included insulin lispro (HUMALOG), celecoxib (CELEXA) within 2 weeks of vaccination. The patient previously took first dose of bnt162b2 (lot number: EL0142) on 13Jan2021 14:45 at age of 38 years old in left arm for COVID-19 immunization. On 04Feb2021 06:00, the patient experienced 12 hours after vaccine experienced a fever (101.9), aches, chills, and a very bad headache, the body could no longer absorb insulin. On 06Feb2021, the patient experienced stomach pain, vomiting, high ketones, high blood sugars. The worst occurred the day after when the body could no longer absorb insulin. The patient increased basal rate by almost 400% and could not bring sugars down. Saturday afternoon, the patient began experiencing symptoms of diabetic ketoacidosis: stomach pain, vomiting, high ketones and very high blood sugars. The patient was able to eventually take in enough water to lower the ketones and sugar and narrowly avoided going to the emergency room (ER), but high blood sugars and headache persisted, and the patient were still experiencing these symptoms. Prior to vaccination, the patient was not diagnosed with COVID-19.  Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The adverse event result in doctor or other healthcare professional office/clinic visit. The treatment (Insulin and hydration) was received for the adverse event. The seriousness of all the events were life threatening. Therapeutic measures were taken as a result of adverse events. The outcome of all the events was not recovered.
Age: 38.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Abdominal pain upper, Blood glucose increased, Blood ketone body increased, Chills, Diabetic ketoacidosis
Clinical narrative: stomach pain; vomiting; high ketones; high blood sugars and headache; my body could no longer absorb insulin; 12 hours after vaccine experienced a fever (101.9), aches, chills, and a very bad headache; 12 hours after vaccine experienced a fever (101.9), aches, chills, and a very bad headache; chills; 12 hours after vaccine experienced a fever (101.9), aches, chills, and a very bad headache; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 38-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration second dose (lot number: EL0142) on 03Feb2021 14:45 at a single dose in left arm for COVID-19 immunization. Medical history included type 1 diabetes. Concomitant medication included insulin lispro (HUMALOG), celecoxib (CELEXA) within 2 weeks of vaccination. The patient previously took first dose of bnt162b2 (lot number: EL0142) on 13Jan2021 14:45 at age of 38 years old in left arm for COVID-19 immunization. On 04Feb2021 06:00, the patient experienced 12 hours after vaccine experienced a fever (101.9), aches, chills, and a very bad headache, the body could no longer absorb insulin. On 06Feb2021, the patient experienced stomach pain, vomiting, high ketones, high blood sugars. The worst occurred the day after when the body could no longer absorb insulin. The patient increased basal rate by almost 400% and could not bring sugars down. Saturday afternoon, the patient began experiencing symptoms of diabetic ketoacidosis: stomach pain, vomiting, high ketones and very high blood sugars. The patient was able to eventually take in enough water to lower the ketones and sugar and narrowly avoided going to the emergency room (ER), but high blood sugars and headache persisted, and the patient were still experiencing these symptoms. Prior to vaccination, the patient was not diagnosed with COVID-19.  Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The adverse event result in doctor or other healthcare professional office/clinic visit. The treatment (Insulin and hydration) was received for the adverse event. The seriousness of all the events were life threatening. Therapeutic measures were taken as a result of adverse events. The outcome of all the events was not recovered.
Age: 38.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Headache, Insulin resistance, Pain, Pyrexia, Vomiting
Clinical narrative: stomach pain; vomiting; high ketones; high blood sugars and headache; my body could no longer absorb insulin; 12 hours after vaccine experienced a fever (101.9), aches, chills, and a very bad headache; 12 hours after vaccine experienced a fever (101.9), aches, chills, and a very bad headache; chills; 12 hours after vaccine experienced a fever (101.9), aches, chills, and a very bad headache; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 38-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration second dose (lot number: EL0142) on 03Feb2021 14:45 at a single dose in left arm for COVID-19 immunization. Medical history included type 1 diabetes. Concomitant medication included insulin lispro (HUMALOG), celecoxib (CELEXA) within 2 weeks of vaccination. The patient previously took first dose of bnt162b2 (lot number: EL0142) on 13Jan2021 14:45 at age of 38 years old in left arm for COVID-19 immunization. On 04Feb2021 06:00, the patient experienced 12 hours after vaccine experienced a fever (101.9), aches, chills, and a very bad headache, the body could no longer absorb insulin. On 06Feb2021, the patient experienced stomach pain, vomiting, high ketones, high blood sugars. The worst occurred the day after when the body could no longer absorb insulin. The patient increased basal rate by almost 400% and could not bring sugars down. Saturday afternoon, the patient began experiencing symptoms of diabetic ketoacidosis: stomach pain, vomiting, high ketones and very high blood sugars. The patient was able to eventually take in enough water to lower the ketones and sugar and narrowly avoided going to the emergency room (ER), but high blood sugars and headache persisted, and the patient were still experiencing these symptoms. Prior to vaccination, the patient was not diagnosed with COVID-19.  Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The adverse event result in doctor or other healthcare professional office/clinic visit. The treatment (Insulin and hydration) was received for the adverse event. The seriousness of all the events were life threatening. Therapeutic measures were taken as a result of adverse events. The outcome of all the events was not recovered.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Peripheral swelling
Clinical narrative: Suspect delayed hypersensitivity reaction. Patient felt some malaise and pain over injection site for 2-3 days following 2nd SARS-COV-2 vaccine, however developed large targetoid erythematous, pruritic rash over injection site and much of this arm  3-4 days following  vaccination.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site pain, Injection site reaction, Malaise, Rash, Rash erythematous
Clinical narrative: Suspect delayed hypersensitivity reaction. Patient felt some malaise and pain over injection site for 2-3 days following 2nd SARS-COV-2 vaccine, however developed large targetoid erythematous, pruritic rash over injection site and much of this arm  3-4 days following  vaccination.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash pruritic, Type IV hypersensitivity reaction
Clinical narrative: Suspect delayed hypersensitivity reaction. Patient felt some malaise and pain over injection site for 2-3 days following 2nd SARS-COV-2 vaccine, however developed large targetoid erythematous, pruritic rash over injection site and much of this arm  3-4 days following  vaccination.
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Extra dose administered, Unevaluable event
Clinical narrative: Patient was discharged from clinic and presented to the ED with symptoms of feeling like throat was closing; This is a spontaneous report from a contactable other hcp.   An 84-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number EM2810), intramuscular at single dose in the left arm on 10Feb2021 09:45 for covid-19 immunisation. Medical history included diabetes. Concomitant medication included insulin. The patient was discharged from clinic and presented to the ED (Emergency department) with symptoms of feeling like throat was closing on 10Feb2021 with outcome of unknown. Therapeutic measures were taken as a result of the event included insulin, chest Xray, intubation. Seriousness criteria of the event was reported as serious due to hospitalization, life threatening illness (immediate risk of death from the event). Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: Based on a close vaccine-event chronological association (same day) causality between event "symptoms of feeling like throat was closing" and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Throat tightness
Clinical narrative: Patient was discharged from clinic and presented to the ED with symptoms of feeling like throat was closing; This is a spontaneous report from a contactable other hcp.   An 84-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number EM2810), intramuscular at single dose in the left arm on 10Feb2021 09:45 for covid-19 immunisation. Medical history included diabetes. Concomitant medication included insulin. The patient was discharged from clinic and presented to the ED (Emergency department) with symptoms of feeling like throat was closing on 10Feb2021 with outcome of unknown. Therapeutic measures were taken as a result of the event included insulin, chest Xray, intubation. Seriousness criteria of the event was reported as serious due to hospitalization, life threatening illness (immediate risk of death from the event). Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: Based on a close vaccine-event chronological association (same day) causality between event "symptoms of feeling like throat was closing" and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered, Injection site pain, Syringe issue
Clinical narrative: Syringe malfunction and patient did not receive complete dosage. Less than half of the recommended dose is estimated to have been given. Patient monitored x 15 min after injection, no untoward effects. The manufacturer was contacted-  an additional dose was not recommended.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Syringe issue, Underdose
Clinical narrative: Syringe malfunction and patient did not receive complete dosage. Less than half of the recommended dose is estimated to have been given. Patient monitored x 15 min after injection, no untoward effects. The manufacturer was contacted-  an additional dose was not recommended.
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Acoustic stimulation tests, Balance test, Burning sensation, CSF pressure increased, Computerised tomogram
Clinical narrative: Severe headache on top of head which eventually included pain at base of skull, visual changes, dizziness, tingling, burning, nausea and uncontrollable shaking. This course transpired over several days and is still not resolved. On day 4 post vaccine he saw primary physician who dxed vertigo and prescribed Meclizin. This physician also did blood work that had normal results...he is not sure what the lab tests were. On day 8 post vaccine he saw a physician, with Ear and Balance Institute and underwent comprehensive testing which included CT scan, MRI, CSF pressure test, hearing test. Dr.  concluded he had increased pressure in CSF and brain stem and had suffered rupture of left ear
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Confusional state, Disorientation, Dizziness, Head discomfort, Headache
Clinical narrative: Severe headache on top of head which eventually included pain at base of skull, visual changes, dizziness, tingling, burning, nausea and uncontrollable shaking. This course transpired over several days and is still not resolved. On day 4 post vaccine he saw primary physician who dxed vertigo and prescribed Meclizin. This physician also did blood work that had normal results...he is not sure what the lab tests were. On day 8 post vaccine he saw a physician, with Ear and Balance Institute and underwent comprehensive testing which included CT scan, MRI, CSF pressure test, hearing test. Dr.  concluded he had increased pressure in CSF and brain stem and had suffered rupture of left ear
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypersensitivity, Inner ear disorder, Magnetic resonance imaging, Nausea, Paraesthesia
Clinical narrative: Severe headache on top of head which eventually included pain at base of skull, visual changes, dizziness, tingling, burning, nausea and uncontrollable shaking. This course transpired over several days and is still not resolved. On day 4 post vaccine he saw primary physician who dxed vertigo and prescribed Meclizin. This physician also did blood work that had normal results...he is not sure what the lab tests were. On day 8 post vaccine he saw a physician, with Ear and Balance Institute and underwent comprehensive testing which included CT scan, MRI, CSF pressure test, hearing test. Dr.  concluded he had increased pressure in CSF and brain stem and had suffered rupture of left ear
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Presyncope, Tremor, Vertigo, Vision blurred, Visual field tests
Clinical narrative: Severe headache on top of head which eventually included pain at base of skull, visual changes, dizziness, tingling, burning, nausea and uncontrollable shaking. This course transpired over several days and is still not resolved. On day 4 post vaccine he saw primary physician who dxed vertigo and prescribed Meclizin. This physician also did blood work that had normal results...he is not sure what the lab tests were. On day 8 post vaccine he saw a physician, with Ear and Balance Institute and underwent comprehensive testing which included CT scan, MRI, CSF pressure test, hearing test. Dr.  concluded he had increased pressure in CSF and brain stem and had suffered rupture of left ear
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Acoustic stimulation tests abnormal, Blood test normal, Burning sensation, CSF pressure increased, Computerised tomogram
Clinical narrative: Severe headache on top of head which eventually included pain at base of skull, visual changes, dizziness, tingling, burning, nausea and uncontrollable shaking. This course transpired over several days and is still not resolved. On day 4 post vaccine he saw primary physician who dxed vertigo and prescribed Meclizin. This physician also did blood work that had normal results...he is not sure what the lab tests were. On day 8 post vaccine he saw a physician, with Ear and Balance Institute and underwent comprehensive testing which included CT scan, MRI, CSF pressure test, hearing test. Dr.  concluded he had increased pressure in CSF and brain stem and had suffered rupture of left ear
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Deafness, Dizziness, Headache, Magnetic resonance imaging, Nausea
Clinical narrative: Severe headache on top of head which eventually included pain at base of skull, visual changes, dizziness, tingling, burning, nausea and uncontrollable shaking. This course transpired over several days and is still not resolved. On day 4 post vaccine he saw primary physician who dxed vertigo and prescribed Meclizin. This physician also did blood work that had normal results...he is not sure what the lab tests were. On day 8 post vaccine he saw a physician, with Ear and Balance Institute and underwent comprehensive testing which included CT scan, MRI, CSF pressure test, hearing test. Dr.  concluded he had increased pressure in CSF and brain stem and had suffered rupture of left ear
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Occipital neuralgia, Pain, Paraesthesia, Tremor, Tympanic membrane perforation
Clinical narrative: Severe headache on top of head which eventually included pain at base of skull, visual changes, dizziness, tingling, burning, nausea and uncontrollable shaking. This course transpired over several days and is still not resolved. On day 4 post vaccine he saw primary physician who dxed vertigo and prescribed Meclizin. This physician also did blood work that had normal results...he is not sure what the lab tests were. On day 8 post vaccine he saw a physician, with Ear and Balance Institute and underwent comprehensive testing which included CT scan, MRI, CSF pressure test, hearing test. Dr.  concluded he had increased pressure in CSF and brain stem and had suffered rupture of left ear