chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electroencephalogram abnormal, Encephalopathy, Endotracheal intubation, Enterovirus test negative, Herpes simplex test negative
Clinical narrative: This is an 84-year-old woman who several weeks ago began having issues with weakness, nausea vomiting and abdominal discomfort.  She had at least 2 hospitalizations at another facility.  About 6 weeks ago she received her 1st SARS-CoV-2 vaccine and apparently had fever and malaise following the vaccination.  She continued to have ongoing weakness and failure to thrive. Three weeks ago she received her 2nd vaccine.  At about the same time she began to have worsening of her overall weakness and then for the last several days prior to admission she has had deteriorating mental status, weakness and was brought to the hospital on March 27th with severe altered mental status and possible seizures. Following her admission here she developed worsening respiratory failure and bilateral pulmonary infiltrates requiring intubation and mechanical ventilation.  She is currently ventilated and has been on broad-spectrum antibiotic therapy. Magnetic resonance imaging scanning of the brain with contrast demonstrates areas of restricted diffusion suggesting diffuse areas of encephalomyelitis.  Lumbar puncture demonstrated 1 white blood cell and 9 red blood cells with normal glucose and normal protein.  Cultures have been no growth.  A cerebral spinal fluid meningitis panel has shown no evidence of the presence of DNA to common bacterial pathogens.  PCR is further negative for HSV 1 and 2, varicella zoster, enterovirus and cryptococcus.  West Nile virus antibodies have not been sent on either serum or cerebral spinal fluid. Blood cultures have been no growth.  Urine culture had a light growth of Enterococcus.  Fiberoptic bronchoscopy was done and bronchoalveolar lavage cultures and studies are all negative. She has been started on plasma exchange but so far has had no clinical improvement. Electroencephalogram demonstrates diffuse generalized slowing consistent with encephalopathy as well as a single area that may be epileptiform. I do not have any history of travel or obvious recent exposures to ticks or mosquitos. The question of this being a vaccine related encephalomyelitis following SARS-CoV-2 vaccination has been raised. The question of this being a vaccine related encephalomyelitis following SARS-CoV-2 vaccination has been raised.
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lumbar puncture normal, Magnetic resonance imaging head abnormal, Malaise, Mechanical ventilation, Mental impairment
Clinical narrative: This is an 84-year-old woman who several weeks ago began having issues with weakness, nausea vomiting and abdominal discomfort.  She had at least 2 hospitalizations at another facility.  About 6 weeks ago she received her 1st SARS-CoV-2 vaccine and apparently had fever and malaise following the vaccination.  She continued to have ongoing weakness and failure to thrive. Three weeks ago she received her 2nd vaccine.  At about the same time she began to have worsening of her overall weakness and then for the last several days prior to admission she has had deteriorating mental status, weakness and was brought to the hospital on March 27th with severe altered mental status and possible seizures. Following her admission here she developed worsening respiratory failure and bilateral pulmonary infiltrates requiring intubation and mechanical ventilation.  She is currently ventilated and has been on broad-spectrum antibiotic therapy. Magnetic resonance imaging scanning of the brain with contrast demonstrates areas of restricted diffusion suggesting diffuse areas of encephalomyelitis.  Lumbar puncture demonstrated 1 white blood cell and 9 red blood cells with normal glucose and normal protein.  Cultures have been no growth.  A cerebral spinal fluid meningitis panel has shown no evidence of the presence of DNA to common bacterial pathogens.  PCR is further negative for HSV 1 and 2, varicella zoster, enterovirus and cryptococcus.  West Nile virus antibodies have not been sent on either serum or cerebral spinal fluid. Blood cultures have been no growth.  Urine culture had a light growth of Enterococcus.  Fiberoptic bronchoscopy was done and bronchoalveolar lavage cultures and studies are all negative. She has been started on plasma exchange but so far has had no clinical improvement. Electroencephalogram demonstrates diffuse generalized slowing consistent with encephalopathy as well as a single area that may be epileptiform. I do not have any history of travel or obvious recent exposures to ticks or mosquitos. The question of this being a vaccine related encephalomyelitis following SARS-CoV-2 vaccination has been raised. The question of this being a vaccine related encephalomyelitis following SARS-CoV-2 vaccination has been raised.
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Mental status changes, Nausea, Plasmapheresis, Pyrexia, Respiratory failure
Clinical narrative: This is an 84-year-old woman who several weeks ago began having issues with weakness, nausea vomiting and abdominal discomfort.  She had at least 2 hospitalizations at another facility.  About 6 weeks ago she received her 1st SARS-CoV-2 vaccine and apparently had fever and malaise following the vaccination.  She continued to have ongoing weakness and failure to thrive. Three weeks ago she received her 2nd vaccine.  At about the same time she began to have worsening of her overall weakness and then for the last several days prior to admission she has had deteriorating mental status, weakness and was brought to the hospital on March 27th with severe altered mental status and possible seizures. Following her admission here she developed worsening respiratory failure and bilateral pulmonary infiltrates requiring intubation and mechanical ventilation.  She is currently ventilated and has been on broad-spectrum antibiotic therapy. Magnetic resonance imaging scanning of the brain with contrast demonstrates areas of restricted diffusion suggesting diffuse areas of encephalomyelitis.  Lumbar puncture demonstrated 1 white blood cell and 9 red blood cells with normal glucose and normal protein.  Cultures have been no growth.  A cerebral spinal fluid meningitis panel has shown no evidence of the presence of DNA to common bacterial pathogens.  PCR is further negative for HSV 1 and 2, varicella zoster, enterovirus and cryptococcus.  West Nile virus antibodies have not been sent on either serum or cerebral spinal fluid. Blood cultures have been no growth.  Urine culture had a light growth of Enterococcus.  Fiberoptic bronchoscopy was done and bronchoalveolar lavage cultures and studies are all negative. She has been started on plasma exchange but so far has had no clinical improvement. Electroencephalogram demonstrates diffuse generalized slowing consistent with encephalopathy as well as a single area that may be epileptiform. I do not have any history of travel or obvious recent exposures to ticks or mosquitos. The question of this being a vaccine related encephalomyelitis following SARS-CoV-2 vaccination has been raised. The question of this being a vaccine related encephalomyelitis following SARS-CoV-2 vaccination has been raised.
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Varicella virus test negative, Vomiting
Clinical narrative: This is an 84-year-old woman who several weeks ago began having issues with weakness, nausea vomiting and abdominal discomfort.  She had at least 2 hospitalizations at another facility.  About 6 weeks ago she received her 1st SARS-CoV-2 vaccine and apparently had fever and malaise following the vaccination.  She continued to have ongoing weakness and failure to thrive. Three weeks ago she received her 2nd vaccine.  At about the same time she began to have worsening of her overall weakness and then for the last several days prior to admission she has had deteriorating mental status, weakness and was brought to the hospital on March 27th with severe altered mental status and possible seizures. Following her admission here she developed worsening respiratory failure and bilateral pulmonary infiltrates requiring intubation and mechanical ventilation.  She is currently ventilated and has been on broad-spectrum antibiotic therapy. Magnetic resonance imaging scanning of the brain with contrast demonstrates areas of restricted diffusion suggesting diffuse areas of encephalomyelitis.  Lumbar puncture demonstrated 1 white blood cell and 9 red blood cells with normal glucose and normal protein.  Cultures have been no growth.  A cerebral spinal fluid meningitis panel has shown no evidence of the presence of DNA to common bacterial pathogens.  PCR is further negative for HSV 1 and 2, varicella zoster, enterovirus and cryptococcus.  West Nile virus antibodies have not been sent on either serum or cerebral spinal fluid. Blood cultures have been no growth.  Urine culture had a light growth of Enterococcus.  Fiberoptic bronchoscopy was done and bronchoalveolar lavage cultures and studies are all negative. She has been started on plasma exchange but so far has had no clinical improvement. Electroencephalogram demonstrates diffuse generalized slowing consistent with encephalopathy as well as a single area that may be epileptiform. I do not have any history of travel or obvious recent exposures to ticks or mosquitos. The question of this being a vaccine related encephalomyelitis following SARS-CoV-2 vaccination has been raised. The question of this being a vaccine related encephalomyelitis following SARS-CoV-2 vaccination has been raised.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Impaired work ability, Limb discomfort, Spinal pain
Clinical narrative: Patient was evaluated at our ER (04/07/2021) after 1 month post vaccine due to Headache and lower extremity weakness. Patient has been evaluated at another hospital and by her primary physician post vaccine due to this symptoms.  Patient stated since the same day after vaccine started with left side weakness and involuntary twitching .  After leaving ER stated some improvement of symptoms.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Computerised tomogram head, Computerised tomogram neck, Headache, Laboratory test normal
Clinical narrative: Patient was evaluated at our ER (04/07/2021) after 1 month post vaccine due to Headache and lower extremity weakness. Patient has been evaluated at another hospital and by her primary physician post vaccine due to this symptoms.  Patient stated since the same day after vaccine started with left side weakness and involuntary twitching .  After leaving ER stated some improvement of symptoms.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscle twitching, Muscular weakness
Clinical narrative: Patient was evaluated at our ER (04/07/2021) after 1 month post vaccine due to Headache and lower extremity weakness. Patient has been evaluated at another hospital and by her primary physician post vaccine due to this symptoms.  Patient stated since the same day after vaccine started with left side weakness and involuntary twitching .  After leaving ER stated some improvement of symptoms.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Swelling
Clinical narrative: Hairy throat, swollen tongue, ichy eye on the inside, throat close off,     Given 50 mg Benedryl with water before it got worse.  Epi pen was opened and prepared for use.  Not needed  Occurred 10 minutes after injection.  Held at pharmacy for 2.5 hours for reduced symptoms before being allowed to leave.  Took 50 mg Benedryl 4 hours later and at 6:00 am next day.   Primary care physician notified and he prescribed Epi pen for relapse or further need.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Eye pruritus, Immunodeficiency common variable, Oropharyngeal discomfort, Throat tightness
Clinical narrative: Hairy throat, swollen tongue, ichy eye on the inside, throat close off,     Given 50 mg Benedryl with water before it got worse.  Epi pen was opened and prepared for use.  Not needed  Occurred 10 minutes after injection.  Held at pharmacy for 2.5 hours for reduced symptoms before being allowed to leave.  Took 50 mg Benedryl 4 hours later and at 6:00 am next day.   Primary care physician notified and he prescribed Epi pen for relapse or further need.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylactic reaction, throat swelling, tongue swelling, confusion - Epi pen administered 15 minutes after the vaccine and transported to the ER via ambulance.  Gave me Benadryl, zofran, headache medicine, fluids
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anaphylactic reaction, Confusional state, Headache, Pharyngeal swelling, Swollen tongue
Clinical narrative: Anaphylactic reaction, throat swelling, tongue swelling, confusion - Epi pen administered 15 minutes after the vaccine and transported to the ER via ambulance.  Gave me Benadryl, zofran, headache medicine, fluids
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysgeusia, Swollen tongue, Throat tightness
Clinical narrative: Tongue started to enlarge; Throat tighten up; Strange metal taste; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 56-year-old female patient received the first dose of BNT162B2 (PFIZER -BIONTECH COVID-19 VACCINE; Lot Number: ER8727), via an unspecified route of administration in left arm, on 24Mar2021 at 10:45 AM, at a single dose, for COVID-19 immunization. The patient's medical history included allergies to sulfa. The patient's concomitant medication included clopidogrel. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. About 30 minutes after injection (24Mar2021 at 11:15 AM), the patient felt throat tighten up and tongue started to enlarge. Also, the patient had strange metal taste but never lost ability to breathe. After drinking some water and about 15 minutes, the symptoms went away. No treatment was received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The patient recovered from the events on 24Mar2021 at 11:30 AM.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysgeusia, Macroglossia, Throat tightness
Clinical narrative: Tongue started to enlarge; Throat tighten up; Strange metal taste; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 56-year-old female patient received the first dose of BNT162B2 (PFIZER -BIONTECH COVID-19 VACCINE; Lot Number: ER8727), via an unspecified route of administration in left arm, on 24Mar2021 at 10:45 AM, at a single dose, for COVID-19 immunization. The patient's medical history included allergies to sulfa. The patient's concomitant medication included clopidogrel. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. About 30 minutes after injection (24Mar2021 at 11:15 AM), the patient felt throat tighten up and tongue started to enlarge. Also, the patient had strange metal taste but never lost ability to breathe. After drinking some water and about 15 minutes, the symptoms went away. No treatment was received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The patient recovered from the events on 24Mar2021 at 11:30 AM.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: ITCHY BUMPS AND  RASH ON THE CHEST AND EXTENDED ALL OVER THE ANTERIOR, POSTERIOR, LATERAL TORSO, LOWER ABDOMEN, ABOVE THE PUBIC AREA AND LOWER ABDOMEN AND BILATERAL THIGHS; HIVES ITCHY/RED WELTS; FEVER; FATIGUE; This spontaneous report received from a patient concerned a 67 year old female. The patient's weight was 132 pounds, and height was 65 inches. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1608609 expiry: UNKNOWN) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination in left arm. No concomitant medications were reported. On 18-MAR-2021, the subject experienced fever. On 18-MAR-2021, the subject experienced fatigue. Laboratory data included: Body temperature (NR: not provided) 99.3 (not reported), 98.8 (not reported). On 22-MAR-2021, the subject experienced itchy bumps and rash on the chest and extended all over the anterior, posterior, lateral torso, lower abdomen, above the pubic area and lower abdomen and bilateral thighs. On 22-MAR-2021, the subject experienced hives itchy/red welts. On 23-MAR-2021, treatment medications included: diphenhydramine hydrochloride, and famotidine. On 24-MAR-2021 06:30, treatment medications included: prednisone. On 24-MAR-2021 07:30, treatment medications included: diphenhydramine hydrochloride. On 25-MAR-2021 07:30, treatment medications included: prednisone. On 25-MAR-2021 08:30, treatment medications included: cetirizine hydrochloride. On 25-MAR-2021 12:45, treatment medications included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hives itchy/red welts on MAR-2021, fever on 18-MAR-2021, and fatigue on 19-MAR-2021, and was recovering from itchy bumps and rash on the chest and extended all over the anterior, posterior, lateral torso, lower abdomen, above the pubic area and lower abdomen and bilateral thighs. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Fatigue, Pyrexia, Rash pruritic, Urticaria
Clinical narrative: ITCHY BUMPS AND  RASH ON THE CHEST AND EXTENDED ALL OVER THE ANTERIOR, POSTERIOR, LATERAL TORSO, LOWER ABDOMEN, ABOVE THE PUBIC AREA AND LOWER ABDOMEN AND BILATERAL THIGHS; HIVES ITCHY/RED WELTS; FEVER; FATIGUE; This spontaneous report received from a patient concerned a 67 year old female. The patient's weight was 132 pounds, and height was 65 inches. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1608609 expiry: UNKNOWN) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination in left arm. No concomitant medications were reported. On 18-MAR-2021, the subject experienced fever. On 18-MAR-2021, the subject experienced fatigue. Laboratory data included: Body temperature (NR: not provided) 99.3 (not reported), 98.8 (not reported). On 22-MAR-2021, the subject experienced itchy bumps and rash on the chest and extended all over the anterior, posterior, lateral torso, lower abdomen, above the pubic area and lower abdomen and bilateral thighs. On 22-MAR-2021, the subject experienced hives itchy/red welts. On 23-MAR-2021, treatment medications included: diphenhydramine hydrochloride, and famotidine. On 24-MAR-2021 06:30, treatment medications included: prednisone. On 24-MAR-2021 07:30, treatment medications included: diphenhydramine hydrochloride. On 25-MAR-2021 07:30, treatment medications included: prednisone. On 25-MAR-2021 08:30, treatment medications included: cetirizine hydrochloride. On 25-MAR-2021 12:45, treatment medications included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hives itchy/red welts on MAR-2021, fever on 18-MAR-2021, and fatigue on 19-MAR-2021, and was recovering from itchy bumps and rash on the chest and extended all over the anterior, posterior, lateral torso, lower abdomen, above the pubic area and lower abdomen and bilateral thighs. This report was non-serious.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cardiac arrest, Death, Resuscitation, Seizure
Clinical narrative: seizure; not breathing/arrested; no pulse; This is a spontaneous report from a contactable consumer (patient's son). A 70-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, arm right on 25Mar2021 15:00 (batch/lot number ER8730 and expiry date not reported) at 70 years of age as single dose for covid-19 immunization in a pharmacy/drug store. Medical history included diabetes, a cardiac electrical issue, permanent scarring of lungs from Sep2020 from previous covid-19 infection. The patient was diagnosed with COVID-19 prior to vaccination. Concomitant medications included metformin; famotidine; clopidogrel; simvastatin; salbutamol sulfate (PROVENTIL HFA [SALBUTAMOL SULFATE]); ascorbic acid, biotin, chromium, copper, folic acid, magnesium, manganese, nicotinamide, pantothenic acid, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, thiamine, tocopherol, vitamin b12 nos, zinc (MULTI) (for him 50+); curcuma longa rhizome, piper nigrum fruit (TURMERIC +); melatonin; all taken for an unspecified indication, start and stop date were not reported. The patient previously took first dose of BNT162B2 in the left arm on 25Feb2021 15:00 (batch/lot number: EN6202) at 70 years of age as single dose for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The reporter informed that around 4:50 pm on 26Mar2021, the patient had a seizure that lasted approximately 5 to 10 seconds. Immediately following the seizure, it was observed that he was not breathing, and no pulse was detected. The emergency was immediately called, and medical assistance was requested. The patient's wife was on the phone, and the daughter transferred the patient to the floor and began CPR. The fire arrived first and took over CPR, with paramedics arriving just a few minutes later. The reporter informed that "they" started delivering medications, intubated him, and shocked him with an AED device. The reporter informed that after getting a pulse (40 minutes later), the patient was transported to the hospital. The patient arrested and was revived two more times before arresting a third time and time of death being called around 8:30 pm on 26Mar2021. The reporter informed that the patient got the 2nd dose on Thursday and on Friday he died. The events resulted in emergency room/department or urgent care. The events were considered serious (resulted in death). The reporter informed that it was unknown if patient been tested for COVID-19 since the vaccination. The patient's treatment received were CPR, defibrillation, medications (epinephrine, norepinephrine, amioderone, etc). The patient died on 26Mar2021. It was not reported if an autopsy was performed. A report was filed earlier this morning with PSCC, but the funeral home was needing to know if Pfizer will want an autopsy prior to cremation.; Reported Cause(s) of Death: not breathing/arrested; seizure; no pulse
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Respiratory arrest, Resuscitation, Seizure
Clinical narrative: seizure; not breathing/arrested; no pulse; This is a spontaneous report from a contactable consumer (patient's son). A 70-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, arm right on 25Mar2021 15:00 (batch/lot number ER8730 and expiry date not reported) at 70 years of age as single dose for covid-19 immunization in a pharmacy/drug store. Medical history included diabetes, a cardiac electrical issue, permanent scarring of lungs from Sep2020 from previous covid-19 infection. The patient was diagnosed with COVID-19 prior to vaccination. Concomitant medications included metformin; famotidine; clopidogrel; simvastatin; salbutamol sulfate (PROVENTIL HFA [SALBUTAMOL SULFATE]); ascorbic acid, biotin, chromium, copper, folic acid, magnesium, manganese, nicotinamide, pantothenic acid, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, thiamine, tocopherol, vitamin b12 nos, zinc (MULTI) (for him 50+); curcuma longa rhizome, piper nigrum fruit (TURMERIC +); melatonin; all taken for an unspecified indication, start and stop date were not reported. The patient previously took first dose of BNT162B2 in the left arm on 25Feb2021 15:00 (batch/lot number: EN6202) at 70 years of age as single dose for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The reporter informed that around 4:50 pm on 26Mar2021, the patient had a seizure that lasted approximately 5 to 10 seconds. Immediately following the seizure, it was observed that he was not breathing, and no pulse was detected. The emergency was immediately called, and medical assistance was requested. The patient's wife was on the phone, and the daughter transferred the patient to the floor and began CPR. The fire arrived first and took over CPR, with paramedics arriving just a few minutes later. The reporter informed that "they" started delivering medications, intubated him, and shocked him with an AED device. The reporter informed that after getting a pulse (40 minutes later), the patient was transported to the hospital. The patient arrested and was revived two more times before arresting a third time and time of death being called around 8:30 pm on 26Mar2021. The reporter informed that the patient got the 2nd dose on Thursday and on Friday he died. The events resulted in emergency room/department or urgent care. The events were considered serious (resulted in death). The reporter informed that it was unknown if patient been tested for COVID-19 since the vaccination. The patient's treatment received were CPR, defibrillation, medications (epinephrine, norepinephrine, amioderone, etc). The patient died on 26Mar2021. It was not reported if an autopsy was performed. A report was filed earlier this morning with PSCC, but the funeral home was needing to know if Pfizer will want an autopsy prior to cremation.; Reported Cause(s) of Death: not breathing/arrested; seizure; no pulse
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pulse absent, Respiratory arrest, Seizure
Clinical narrative: seizure; not breathing/arrested; no pulse; This is a spontaneous report from a contactable consumer (patient's son). A 70-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, arm right on 25Mar2021 15:00 (batch/lot number ER8730 and expiry date not reported) at 70 years of age as single dose for covid-19 immunization in a pharmacy/drug store. Medical history included diabetes, a cardiac electrical issue, permanent scarring of lungs from Sep2020 from previous covid-19 infection. The patient was diagnosed with COVID-19 prior to vaccination. Concomitant medications included metformin; famotidine; clopidogrel; simvastatin; salbutamol sulfate (PROVENTIL HFA [SALBUTAMOL SULFATE]); ascorbic acid, biotin, chromium, copper, folic acid, magnesium, manganese, nicotinamide, pantothenic acid, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, thiamine, tocopherol, vitamin b12 nos, zinc (MULTI) (for him 50+); curcuma longa rhizome, piper nigrum fruit (TURMERIC +); melatonin; all taken for an unspecified indication, start and stop date were not reported. The patient previously took first dose of BNT162B2 in the left arm on 25Feb2021 15:00 (batch/lot number: EN6202) at 70 years of age as single dose for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The reporter informed that around 4:50 pm on 26Mar2021, the patient had a seizure that lasted approximately 5 to 10 seconds. Immediately following the seizure, it was observed that he was not breathing, and no pulse was detected. The emergency was immediately called, and medical assistance was requested. The patient's wife was on the phone, and the daughter transferred the patient to the floor and began CPR. The fire arrived first and took over CPR, with paramedics arriving just a few minutes later. The reporter informed that "they" started delivering medications, intubated him, and shocked him with an AED device. The reporter informed that after getting a pulse (40 minutes later), the patient was transported to the hospital. The patient arrested and was revived two more times before arresting a third time and time of death being called around 8:30 pm on 26Mar2021. The reporter informed that the patient got the 2nd dose on Thursday and on Friday he died. The events resulted in emergency room/department or urgent care. The events were considered serious (resulted in death). The reporter informed that it was unknown if patient been tested for COVID-19 since the vaccination. The patient's treatment received were CPR, defibrillation, medications (epinephrine, norepinephrine, amioderone, etc). The patient died on 26Mar2021. It was not reported if an autopsy was performed. A report was filed earlier this morning with PSCC, but the funeral home was needing to know if Pfizer will want an autopsy prior to cremation.; Reported Cause(s) of Death: not breathing/arrested; seizure; no pulse
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Axillary pain, Lymphadenopathy, Mammogram
Clinical narrative: This spontaneous report received from a patient concerned a 60 year old female. The patient's weight was 192 pounds, and height was 161 centimeters. The patient's concurrent conditions included hypertension, diabetes mellitus, gerd, and lexapro allergy, and other pre-existing medical conditions included unknown. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 04-MAR-2021. No concomitant medications were reported. On 2021, Laboratory date included: Mammogram (NR: not provided) unknown. On 04-MAR-2021, the patient experienced swollen left armpit and pain in left armpit. Patient reported that after covid vaccination in left arm she developed a swollen left armpit and pain in left armpit. Patient had to go to urgent care. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swollen left armpit, and pain in left armpit. This report was serious (Other Medically Important Condition). This case, involving the same patient is linked to 20210313453. Additional information was received from patient on 12/Mar/2021. The following information was updated and incorporated into the case narrative: Patient information (age, age group, weight, height) added, Patient medical history and lab details added.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Axillary pain, Mammogram, Peripheral swelling
Clinical narrative: This spontaneous report received from a patient concerned a 60 year old female. The patient's weight was 192 pounds, and height was 161 centimeters. The patient's concurrent conditions included hypertension, diabetes mellitus, gerd, and lexapro allergy, and other pre-existing medical conditions included unknown. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 04-MAR-2021. No concomitant medications were reported. On 2021, Laboratory date included: Mammogram (NR: not provided) unknown. On 04-MAR-2021, the patient experienced swollen left armpit and pain in left armpit. Patient reported that after covid vaccination in left arm she developed a swollen left armpit and pain in left armpit. Patient had to go to urgent care. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swollen left armpit, and pain in left armpit. This report was serious (Other Medically Important Condition). This case, involving the same patient is linked to 20210313453. Additional information was received from patient on 12/Mar/2021. The following information was updated and incorporated into the case narrative: Patient information (age, age group, weight, height) added, Patient medical history and lab details added.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Back pain, Chills, Fatigue, Feeling abnormal
Clinical narrative: EXHAUSTED; CHILLS; FEVER; HIPS, LOWER BACK AND KNEE ACHED; JOINT PAIN; FATIGUED; ACHY; TIRED; SLEPT ALL DAY; RASH TO BILATERAL ARMS, NECK AND CHEST; LEFT HAND SWOLLEN; LEFT VEIN TO POINTER FINGER WAS SWOLLEN; FELT ODD; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 27-MAR-2021to left arm for prophylactic vaccination. No concomitant medications were reported. On 27-MAR-2021 11:00, the subject experienced left hand swollen. On 27-MAR-2021 11:00, the subject experienced left vein to pointer finger was swollen. On 27-MAR-2021 11:00, the subject experienced felt odd. On 27-MAR-2021 11:00, the subject experienced rash to bilateral arms, neck and chest. On 28-MAR-2021, the subject experienced slept all day. On 28-MAR-2021, the subject experienced tired. On 29-MAR-2021, the subject experienced hips, lower back and knee ached. On 29-MAR-2021, the subject experienced joint pain. On 29-MAR-2021, the subject experienced fatigued. On 29-MAR-2021, the subject experienced achy. On 30-MAR-2021, the subject experienced chills. On 30-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101.6. On 31-MAR-2021, the subject experienced exhausted. Laboratory data included: Body temperature (NR: not provided) 100. Laboratory data (dates unspecified) included: COVID-19 virus test negative (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, chills, tired, exhausted, and fatigued, and the outcome of hips, lower back and knee ached, joint pain, rash to bilateral arms, neck and chest, left hand swollen, felt odd, left vein to pointer finger was swollen, slept all day and achy was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Injection site induration, Injection site nodule, Lethargy, Pain, Peripheral swelling
Clinical narrative: EXHAUSTED; CHILLS; FEVER; HIPS, LOWER BACK AND KNEE ACHED; JOINT PAIN; FATIGUED; ACHY; TIRED; SLEPT ALL DAY; RASH TO BILATERAL ARMS, NECK AND CHEST; LEFT HAND SWOLLEN; LEFT VEIN TO POINTER FINGER WAS SWOLLEN; FELT ODD; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 27-MAR-2021to left arm for prophylactic vaccination. No concomitant medications were reported. On 27-MAR-2021 11:00, the subject experienced left hand swollen. On 27-MAR-2021 11:00, the subject experienced left vein to pointer finger was swollen. On 27-MAR-2021 11:00, the subject experienced felt odd. On 27-MAR-2021 11:00, the subject experienced rash to bilateral arms, neck and chest. On 28-MAR-2021, the subject experienced slept all day. On 28-MAR-2021, the subject experienced tired. On 29-MAR-2021, the subject experienced hips, lower back and knee ached. On 29-MAR-2021, the subject experienced joint pain. On 29-MAR-2021, the subject experienced fatigued. On 29-MAR-2021, the subject experienced achy. On 30-MAR-2021, the subject experienced chills. On 30-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101.6. On 31-MAR-2021, the subject experienced exhausted. Laboratory data included: Body temperature (NR: not provided) 100. Laboratory data (dates unspecified) included: COVID-19 virus test negative (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, chills, tired, exhausted, and fatigued, and the outcome of hips, lower back and knee ached, joint pain, rash to bilateral arms, neck and chest, left hand swollen, felt odd, left vein to pointer finger was swollen, slept all day and achy was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Rash, Somnolence
Clinical narrative: EXHAUSTED; CHILLS; FEVER; HIPS, LOWER BACK AND KNEE ACHED; JOINT PAIN; FATIGUED; ACHY; TIRED; SLEPT ALL DAY; RASH TO BILATERAL ARMS, NECK AND CHEST; LEFT HAND SWOLLEN; LEFT VEIN TO POINTER FINGER WAS SWOLLEN; FELT ODD; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 27-MAR-2021to left arm for prophylactic vaccination. No concomitant medications were reported. On 27-MAR-2021 11:00, the subject experienced left hand swollen. On 27-MAR-2021 11:00, the subject experienced left vein to pointer finger was swollen. On 27-MAR-2021 11:00, the subject experienced felt odd. On 27-MAR-2021 11:00, the subject experienced rash to bilateral arms, neck and chest. On 28-MAR-2021, the subject experienced slept all day. On 28-MAR-2021, the subject experienced tired. On 29-MAR-2021, the subject experienced hips, lower back and knee ached. On 29-MAR-2021, the subject experienced joint pain. On 29-MAR-2021, the subject experienced fatigued. On 29-MAR-2021, the subject experienced achy. On 30-MAR-2021, the subject experienced chills. On 30-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101.6. On 31-MAR-2021, the subject experienced exhausted. Laboratory data included: Body temperature (NR: not provided) 100. Laboratory data (dates unspecified) included: COVID-19 virus test negative (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, chills, tired, exhausted, and fatigued, and the outcome of hips, lower back and knee ached, joint pain, rash to bilateral arms, neck and chest, left hand swollen, felt odd, left vein to pointer finger was swollen, slept all day and achy was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Body temperature, Chills, Fatigue, Feeling abnormal
Clinical narrative: EXHAUSTED; CHILLS; FEVER; HIPS, LOWER BACK AND KNEE ACHED; JOINT PAIN; FATIGUED; ACHY; TIRED; SLEPT ALL DAY; RASH TO BILATERAL ARMS, NECK AND CHEST; LEFT HAND SWOLLEN; LEFT VEIN TO POINTER FINGER WAS SWOLLEN; FELT ODD; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 27-MAR-2021to left arm for prophylactic vaccination. No concomitant medications were reported. On 27-MAR-2021 11:00, the subject experienced left hand swollen. On 27-MAR-2021 11:00, the subject experienced left vein to pointer finger was swollen. On 27-MAR-2021 11:00, the subject experienced felt odd. On 27-MAR-2021 11:00, the subject experienced rash to bilateral arms, neck and chest. On 28-MAR-2021, the subject experienced slept all day. On 28-MAR-2021, the subject experienced tired. On 29-MAR-2021, the subject experienced hips, lower back and knee ached. On 29-MAR-2021, the subject experienced joint pain. On 29-MAR-2021, the subject experienced fatigued. On 29-MAR-2021, the subject experienced achy. On 30-MAR-2021, the subject experienced chills. On 30-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101.6. On 31-MAR-2021, the subject experienced exhausted. Laboratory data included: Body temperature (NR: not provided) 100. Laboratory data (dates unspecified) included: COVID-19 virus test negative (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, chills, tired, exhausted, and fatigued, and the outcome of hips, lower back and knee ached, joint pain, rash to bilateral arms, neck and chest, left hand swollen, felt odd, left vein to pointer finger was swollen, slept all day and achy was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Hypersomnia, Pain, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: EXHAUSTED; CHILLS; FEVER; HIPS, LOWER BACK AND KNEE ACHED; JOINT PAIN; FATIGUED; ACHY; TIRED; SLEPT ALL DAY; RASH TO BILATERAL ARMS, NECK AND CHEST; LEFT HAND SWOLLEN; LEFT VEIN TO POINTER FINGER WAS SWOLLEN; FELT ODD; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 27-MAR-2021to left arm for prophylactic vaccination. No concomitant medications were reported. On 27-MAR-2021 11:00, the subject experienced left hand swollen. On 27-MAR-2021 11:00, the subject experienced left vein to pointer finger was swollen. On 27-MAR-2021 11:00, the subject experienced felt odd. On 27-MAR-2021 11:00, the subject experienced rash to bilateral arms, neck and chest. On 28-MAR-2021, the subject experienced slept all day. On 28-MAR-2021, the subject experienced tired. On 29-MAR-2021, the subject experienced hips, lower back and knee ached. On 29-MAR-2021, the subject experienced joint pain. On 29-MAR-2021, the subject experienced fatigued. On 29-MAR-2021, the subject experienced achy. On 30-MAR-2021, the subject experienced chills. On 30-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101.6. On 31-MAR-2021, the subject experienced exhausted. Laboratory data included: Body temperature (NR: not provided) 100. Laboratory data (dates unspecified) included: COVID-19 virus test negative (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, chills, tired, exhausted, and fatigued, and the outcome of hips, lower back and knee ached, joint pain, rash to bilateral arms, neck and chest, left hand swollen, felt odd, left vein to pointer finger was swollen, slept all day and achy was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Rash, SARS-CoV-2 test negative, Vasodilatation
Clinical narrative: EXHAUSTED; CHILLS; FEVER; HIPS, LOWER BACK AND KNEE ACHED; JOINT PAIN; FATIGUED; ACHY; TIRED; SLEPT ALL DAY; RASH TO BILATERAL ARMS, NECK AND CHEST; LEFT HAND SWOLLEN; LEFT VEIN TO POINTER FINGER WAS SWOLLEN; FELT ODD; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 27-MAR-2021to left arm for prophylactic vaccination. No concomitant medications were reported. On 27-MAR-2021 11:00, the subject experienced left hand swollen. On 27-MAR-2021 11:00, the subject experienced left vein to pointer finger was swollen. On 27-MAR-2021 11:00, the subject experienced felt odd. On 27-MAR-2021 11:00, the subject experienced rash to bilateral arms, neck and chest. On 28-MAR-2021, the subject experienced slept all day. On 28-MAR-2021, the subject experienced tired. On 29-MAR-2021, the subject experienced hips, lower back and knee ached. On 29-MAR-2021, the subject experienced joint pain. On 29-MAR-2021, the subject experienced fatigued. On 29-MAR-2021, the subject experienced achy. On 30-MAR-2021, the subject experienced chills. On 30-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101.6. On 31-MAR-2021, the subject experienced exhausted. Laboratory data included: Body temperature (NR: not provided) 100. Laboratory data (dates unspecified) included: COVID-19 virus test negative (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, chills, tired, exhausted, and fatigued, and the outcome of hips, lower back and knee ached, joint pain, rash to bilateral arms, neck and chest, left hand swollen, felt odd, left vein to pointer finger was swollen, slept all day and achy was not reported. This report was non-serious.
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Bone pain, Chest X-ray, Computerised tomogram, Electroencephalogram, Feeling abnormal
Clinical narrative: Had grand mal seizure; This is a spontaneous report from a contactable consumer (patient). A 21-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 12Mar2021 08:00 (Lot Number: EN6205) as SINGLE DOSE for COVID-19 immunisation; and pefloxacin mesilate (PEFCID), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. Medical history included, iodine allergy, yellow dye allergy and dysautonomia; all from an unknown date and unknown if ongoing. Concomitant medications included fexofenadine hydrochloride (ALLEGRA) taken for an unspecified indication, start and stop date were not reported. The patient was not pregnant at time of vaccination. The patient previously had first dose of BNT162B2 (lot number: EN6200,) on 19Feb2021 13:15 in left arm for COVID-19 immunization. On 13Mar2021 05:30, the patient had grand mal seizure reported as serious and life threatening since in an immediate risk of death. The event resulted in visit to emergency room/department or urgent care. The facility where the most recent COVID-19 vaccine was administered was in the Vaccine Clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The outcome of the event was recovering. The patient underwent lab tests and procedures which included COVID-19: negative on 13Mar2021. The patient received treatment for the event. The action taken in response to pefloxacin mesylate for the event was unknown.