chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy, Muscle fatigue, Myalgia, Neuropathy peripheral, Paraesthesia oral
Clinical narrative: Peripheral neuropathy; Arthritis in neck hips and shoulders; Arthritis in neck hips and shoulders; Metallic taste on tongue; tingling on tongue; stomach muscle fatigue; itchy head; inability to clear ears; burning sensation in stomach; generalized sore muscles; generalized achy joints; enlarged or swollen lymph nodes; testicular pain; This is a spontaneous report from a contactable consumer (patient). A 63-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8730 and expiration date not provided) via an unspecified route of administration, administered in left arm on 22Mar2021 10:45 as a single dose for COVID-19 immunization. Medical history included pinched nerve in neck and allergies to Penicillin. The patient did not receive any other vaccine in 4 weeks prior to the COVID vaccine and no other medications in two weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. On 22Mar2021 18:00, the patient experienced peripheral neuropathy, arthritis in neck hips and shoulders, metallic taste on tongue, tingling on tongue, stomach muscle fatigue, itchy head, inability to clear ears, burning sensation in stomach, generalized sore muscles, generalized achy joints, enlarged or swollen lymph nodes, and testicular pain. The events resulted in Doctor or other healthcare professional office/clinic visit and Disability or permanent damage. No treatment was given in response to the events. The outcome of the events was not recovered. The patient has not been tested for COVID-19 since having the vaccine.
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Spondylitis, Testicular pain
Clinical narrative: Peripheral neuropathy; Arthritis in neck hips and shoulders; Arthritis in neck hips and shoulders; Metallic taste on tongue; tingling on tongue; stomach muscle fatigue; itchy head; inability to clear ears; burning sensation in stomach; generalized sore muscles; generalized achy joints; enlarged or swollen lymph nodes; testicular pain; This is a spontaneous report from a contactable consumer (patient). A 63-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8730 and expiration date not provided) via an unspecified route of administration, administered in left arm on 22Mar2021 10:45 as a single dose for COVID-19 immunization. Medical history included pinched nerve in neck and allergies to Penicillin. The patient did not receive any other vaccine in 4 weeks prior to the COVID vaccine and no other medications in two weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. On 22Mar2021 18:00, the patient experienced peripheral neuropathy, arthritis in neck hips and shoulders, metallic taste on tongue, tingling on tongue, stomach muscle fatigue, itchy head, inability to clear ears, burning sensation in stomach, generalized sore muscles, generalized achy joints, enlarged or swollen lymph nodes, and testicular pain. The events resulted in Doctor or other healthcare professional office/clinic visit and Disability or permanent damage. No treatment was given in response to the events. The outcome of the events was not recovered. The patient has not been tested for COVID-19 since having the vaccine.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiac flutter, Chest discomfort, Chest pain, Electrocardiogram, Pain in extremity
Clinical narrative: Heart was racing/ pounding heart; chest pain; chest pressure; shortness of breath; heart palpitations and fluttering; Two EKGs have shown shortened PR interval of 110; This is a spontaneous report from a contactable consumer (patient).  A 41-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number not reported) via an unspecified route of administration, administered in Arm Left, at the age of 41-year-old, on 26Mar2021 11:45 as SINGLE DOSE for covid-19 immunisation. Medical history included Pituitary adenoma, seasonal and penicillin allergy. The patient is not pregnant at the time of vaccination. The patient was not diagnosed nor tested for COVID prior vaccination. Concomitant medication included fluticasone propionate (FLONASE). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number not reported), via an unspecified route of administration, administered in Arm Left on Mar2021 as SINGLE DOSE for covid-19 immunisation; and Amoxycillin and Clindamycin and experience allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 26Mar2021 at 12:15pm, her heart was racing about 30 minutes following vaccination. The patient felt pounding heart throughout the night as well as chest pain and pressure. Over the next several days in 2021, the patient felt heart palpitations and fluttering, intermittent chest pain, and shortness of breath. Two EKGs in 2021 have shown shortened PR interval of 110. No other testing has been done. The patient is currently wearing a Ziopatch. The patient did not receive treatments and required physician office visit in response to the events. Outcome was recovering at the time of the report.  Information on the lot/batch number has been requested.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Palpitations
Clinical narrative: Heart was racing/ pounding heart; chest pain; chest pressure; shortness of breath; heart palpitations and fluttering; Two EKGs have shown shortened PR interval of 110; This is a spontaneous report from a contactable consumer (patient).  A 41-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number not reported) via an unspecified route of administration, administered in Arm Left, at the age of 41-year-old, on 26Mar2021 11:45 as SINGLE DOSE for covid-19 immunisation. Medical history included Pituitary adenoma, seasonal and penicillin allergy. The patient is not pregnant at the time of vaccination. The patient was not diagnosed nor tested for COVID prior vaccination. Concomitant medication included fluticasone propionate (FLONASE). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number not reported), via an unspecified route of administration, administered in Arm Left on Mar2021 as SINGLE DOSE for covid-19 immunisation; and Amoxycillin and Clindamycin and experience allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 26Mar2021 at 12:15pm, her heart was racing about 30 minutes following vaccination. The patient felt pounding heart throughout the night as well as chest pain and pressure. Over the next several days in 2021, the patient felt heart palpitations and fluttering, intermittent chest pain, and shortness of breath. Two EKGs in 2021 have shown shortened PR interval of 110. No other testing has been done. The patient is currently wearing a Ziopatch. The patient did not receive treatments and required physician office visit in response to the events. Outcome was recovering at the time of the report.  Information on the lot/batch number has been requested.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiac flutter, Chest discomfort, Chest pain, Dyspnoea, Electrocardiogram
Clinical narrative: Heart was racing/ pounding heart; chest pain; chest pressure; shortness of breath; heart palpitations and fluttering; Two EKGs have shown shortened PR interval of 110; This is a spontaneous report from a contactable consumer (patient).  A 41-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number not reported) via an unspecified route of administration, administered in Arm Left, at the age of 41-year-old, on 26Mar2021 11:45 as SINGLE DOSE for covid-19 immunisation. Medical history included Pituitary adenoma, seasonal and penicillin allergy. The patient is not pregnant at the time of vaccination. The patient was not diagnosed nor tested for COVID prior vaccination. Concomitant medication included fluticasone propionate (FLONASE). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number not reported), via an unspecified route of administration, administered in Arm Left on Mar2021 as SINGLE DOSE for covid-19 immunisation; and Amoxycillin and Clindamycin and experience allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 26Mar2021 at 12:15pm, her heart was racing about 30 minutes following vaccination. The patient felt pounding heart throughout the night as well as chest pain and pressure. Over the next several days in 2021, the patient felt heart palpitations and fluttering, intermittent chest pain, and shortness of breath. Two EKGs in 2021 have shown shortened PR interval of 110. No other testing has been done. The patient is currently wearing a Ziopatch. The patient did not receive treatments and required physician office visit in response to the events. Outcome was recovering at the time of the report.  Information on the lot/batch number has been requested.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram PR shortened, Palpitations
Clinical narrative: Heart was racing/ pounding heart; chest pain; chest pressure; shortness of breath; heart palpitations and fluttering; Two EKGs have shown shortened PR interval of 110; This is a spontaneous report from a contactable consumer (patient).  A 41-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number not reported) via an unspecified route of administration, administered in Arm Left, at the age of 41-year-old, on 26Mar2021 11:45 as SINGLE DOSE for covid-19 immunisation. Medical history included Pituitary adenoma, seasonal and penicillin allergy. The patient is not pregnant at the time of vaccination. The patient was not diagnosed nor tested for COVID prior vaccination. Concomitant medication included fluticasone propionate (FLONASE). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number not reported), via an unspecified route of administration, administered in Arm Left on Mar2021 as SINGLE DOSE for covid-19 immunisation; and Amoxycillin and Clindamycin and experience allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 26Mar2021 at 12:15pm, her heart was racing about 30 minutes following vaccination. The patient felt pounding heart throughout the night as well as chest pain and pressure. Over the next several days in 2021, the patient felt heart palpitations and fluttering, intermittent chest pain, and shortness of breath. Two EKGs in 2021 have shown shortened PR interval of 110. No other testing has been done. The patient is currently wearing a Ziopatch. The patient did not receive treatments and required physician office visit in response to the events. Outcome was recovering at the time of the report.  Information on the lot/batch number has been requested.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Burning sensation, Chest discomfort, Dizziness, Loss of consciousness
Clinical narrative: Approximately 10 minutes after immunization she began experiencing waves of light-headedness and a racing heart.  No rash, no swelling, no wheezing, no difficulty breathing.  She stated that her skin was feeling flushed, intermittently.  Dr on site and evaluated her.  Initial heart rate was 90/minute, cap refill <2 sec.  No wheezing, no retractions.  About 10 minutes later she experienced a second wave of light-headedness.  Ambulance was called and about 5 minutes later she experienced an episode of vomiting.  She was then transported to the local ER.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: Approximately 10 minutes after immunization she began experiencing waves of light-headedness and a racing heart.  No rash, no swelling, no wheezing, no difficulty breathing.  She stated that her skin was feeling flushed, intermittently.  Dr on site and evaluated her.  Initial heart rate was 90/minute, cap refill <2 sec.  No wheezing, no retractions.  About 10 minutes later she experienced a second wave of light-headedness.  Ambulance was called and about 5 minutes later she experienced an episode of vomiting.  She was then transported to the local ER.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Flushing, Palpitations, Vomiting
Clinical narrative: Approximately 10 minutes after immunization she began experiencing waves of light-headedness and a racing heart.  No rash, no swelling, no wheezing, no difficulty breathing.  She stated that her skin was feeling flushed, intermittently.  Dr on site and evaluated her.  Initial heart rate was 90/minute, cap refill <2 sec.  No wheezing, no retractions.  About 10 minutes later she experienced a second wave of light-headedness.  Ambulance was called and about 5 minutes later she experienced an episode of vomiting.  She was then transported to the local ER.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Injection site erythema, Injection site induration, Injection site swelling, Rash papular
Clinical narrative: Patient got a reaction-rash. Her PCP told her not to get the second dose.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: Patient got a reaction-rash. Her PCP told her not to get the second dose.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash
Clinical narrative: Patient got a reaction-rash. Her PCP told her not to get the second dose.
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Urticaria, Vomiting
Clinical narrative: VOMITTED BEFORE LEAVING THE PHARMACY (15 MINUTES AFTER INJECTION) FREEZING CHILLS (6 HOURS AFTER INJECTION LASTING 12 HOURS) MUSCLE SPASMS (6 HOURS AFTER INJECTION LASTING 24 HOURS) MUSCLE ACHES (6 HOURS AFTER INJECTION LASTIN 6 DAYS) SHORTNESS OF BREATH CAUSING ASTHMA SYMPTOMS NEEDING RESCUE INHALER EVERY 4 HOURS (17 HOURS AFTER INJECTION LASTING 4 DAYS) HIVES (17 HOURS AFTER INJECTION LASTING 4 DAYS AND NOW REOCCURING) CALLED PHARMACY MORNING FOLLOWING THE INJECTION TO REPORT PROBLEMS, PHARMACY STATED TO CONTINUE TO USE ADVIL/TYLENOL. CALLED PHARMACY TO REPORT HIVES, PHARMACY STATED TO TAKE DIMENHYDRINATE 50 MG EVERY 4 HOURS PRN UNTIL HIVES DISSAPATE TO GO TO ER IF OBSTRUCTING AIRWAY.
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthma, Chills, Dyspnoea, Feeling cold, Muscle spasms
Clinical narrative: VOMITTED BEFORE LEAVING THE PHARMACY (15 MINUTES AFTER INJECTION) FREEZING CHILLS (6 HOURS AFTER INJECTION LASTING 12 HOURS) MUSCLE SPASMS (6 HOURS AFTER INJECTION LASTING 24 HOURS) MUSCLE ACHES (6 HOURS AFTER INJECTION LASTIN 6 DAYS) SHORTNESS OF BREATH CAUSING ASTHMA SYMPTOMS NEEDING RESCUE INHALER EVERY 4 HOURS (17 HOURS AFTER INJECTION LASTING 4 DAYS) HIVES (17 HOURS AFTER INJECTION LASTING 4 DAYS AND NOW REOCCURING) CALLED PHARMACY MORNING FOLLOWING THE INJECTION TO REPORT PROBLEMS, PHARMACY STATED TO CONTINUE TO USE ADVIL/TYLENOL. CALLED PHARMACY TO REPORT HIVES, PHARMACY STATED TO TAKE DIMENHYDRINATE 50 MG EVERY 4 HOURS PRN UNTIL HIVES DISSAPATE TO GO TO ER IF OBSTRUCTING AIRWAY.
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Urticaria, Vomiting
Clinical narrative: VOMITTED BEFORE LEAVING THE PHARMACY (15 MINUTES AFTER INJECTION) FREEZING CHILLS (6 HOURS AFTER INJECTION LASTING 12 HOURS) MUSCLE SPASMS (6 HOURS AFTER INJECTION LASTING 24 HOURS) MUSCLE ACHES (6 HOURS AFTER INJECTION LASTIN 6 DAYS) SHORTNESS OF BREATH CAUSING ASTHMA SYMPTOMS NEEDING RESCUE INHALER EVERY 4 HOURS (17 HOURS AFTER INJECTION LASTING 4 DAYS) HIVES (17 HOURS AFTER INJECTION LASTING 4 DAYS AND NOW REOCCURING) CALLED PHARMACY MORNING FOLLOWING THE INJECTION TO REPORT PROBLEMS, PHARMACY STATED TO CONTINUE TO USE ADVIL/TYLENOL. CALLED PHARMACY TO REPORT HIVES, PHARMACY STATED TO TAKE DIMENHYDRINATE 50 MG EVERY 4 HOURS PRN UNTIL HIVES DISSAPATE TO GO TO ER IF OBSTRUCTING AIRWAY.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Audiogram, Deafness unilateral, Magnetic resonance imaging
Clinical narrative: noticeable rapidly deteriorating hearing loss experienced; This is a spontaneous report from a contactable consumer (patient). A 70-year-old male patient received first dose of BNT162B2, (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection; Lot Number: EL8982) via an unspecified route of administration on 15Jan2021 16:30 (at the age of 70-year-old) as single dose for COVID-19 immunization. Medical history included diabetes, high blood pressure. Concomitant medication(s) included valsartan; nicametate dihydrogen citrate (NICAMETA); dipyridamole. It was reported that around the time of the 1st Pfizer Covid-19 vaccine shot, patient experienced noticeable rapidly deteriorating hearing loss in Jan2021. It was reported that patient was not diagnosed with COVID-19 prior to vaccination. The patient underwent lab tests and procedures which included RT-PCR: negative on 01Apr2021. Therapeutic measures were taken as a result of deafness unilateral included oral steroids, steroid injections into ear drum. Outcome of event was not recovered.   Follow up attempts are completed. No further information is expected.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Deafness unilateral, SARS-CoV-2 test
Clinical narrative: noticeable rapidly deteriorating hearing loss experienced; This is a spontaneous report from a contactable consumer (patient). A 70-year-old male patient received first dose of BNT162B2, (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection; Lot Number: EL8982) via an unspecified route of administration on 15Jan2021 16:30 (at the age of 70-year-old) as single dose for COVID-19 immunization. Medical history included diabetes, high blood pressure. Concomitant medication(s) included valsartan; nicametate dihydrogen citrate (NICAMETA); dipyridamole. It was reported that around the time of the 1st Pfizer Covid-19 vaccine shot, patient experienced noticeable rapidly deteriorating hearing loss in Jan2021. It was reported that patient was not diagnosed with COVID-19 prior to vaccination. The patient underwent lab tests and procedures which included RT-PCR: negative on 01Apr2021. Therapeutic measures were taken as a result of deafness unilateral included oral steroids, steroid injections into ear drum. Outcome of event was not recovered.   Follow up attempts are completed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest pain, Dyspnoea, Throat tightness, Urticaria, Wheezing
Clinical narrative: Immediately following vaccination I experienced tightness in my chest, neck/throat, elevated heart rate and low blood pressure, and hives on my chest. I was given 25mg of Benadryl and observed for 90 minutes then sent home. Took 25mg more of Benadryl at 6PM that evening. The next morning around 11AM I experienced moderate/severe anaphalaxis including tightness in throat, wheezing, numbness in hands and feet, confusion, hives on right side of face/chest, pressure/swelling in my face, tightness in my chest. Called ambulance took epi and benadryl.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: Immediately following vaccination I experienced tightness in my chest, neck/throat, elevated heart rate and low blood pressure, and hives on my chest. I was given 25mg of Benadryl and observed for 90 minutes then sent home. Took 25mg more of Benadryl at 6PM that evening. The next morning around 11AM I experienced moderate/severe anaphalaxis including tightness in throat, wheezing, numbness in hands and feet, confusion, hives on right side of face/chest, pressure/swelling in my face, tightness in my chest. Called ambulance took epi and benadryl.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anaphylactic reaction, Chest discomfort, Confusional state, Heart rate increased, Hypoaesthesia
Clinical narrative: Immediately following vaccination I experienced tightness in my chest, neck/throat, elevated heart rate and low blood pressure, and hives on my chest. I was given 25mg of Benadryl and observed for 90 minutes then sent home. Took 25mg more of Benadryl at 6PM that evening. The next morning around 11AM I experienced moderate/severe anaphalaxis including tightness in throat, wheezing, numbness in hands and feet, confusion, hives on right side of face/chest, pressure/swelling in my face, tightness in my chest. Called ambulance took epi and benadryl.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypotension, Immediate post-injection reaction, Muscle tightness, Swelling face, Throat tightness
Clinical narrative: Immediately following vaccination I experienced tightness in my chest, neck/throat, elevated heart rate and low blood pressure, and hives on my chest. I was given 25mg of Benadryl and observed for 90 minutes then sent home. Took 25mg more of Benadryl at 6PM that evening. The next morning around 11AM I experienced moderate/severe anaphalaxis including tightness in throat, wheezing, numbness in hands and feet, confusion, hives on right side of face/chest, pressure/swelling in my face, tightness in my chest. Called ambulance took epi and benadryl.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Urticaria, Wheezing
Clinical narrative: Immediately following vaccination I experienced tightness in my chest, neck/throat, elevated heart rate and low blood pressure, and hives on my chest. I was given 25mg of Benadryl and observed for 90 minutes then sent home. Took 25mg more of Benadryl at 6PM that evening. The next morning around 11AM I experienced moderate/severe anaphalaxis including tightness in throat, wheezing, numbness in hands and feet, confusion, hives on right side of face/chest, pressure/swelling in my face, tightness in my chest. Called ambulance took epi and benadryl.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cyanosis, Dizziness, Haematoma, Pain in extremity
Clinical narrative: Patient developed palmar digital vein thrombosis in 4th digit of left hand
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Thrombosis
Clinical narrative: Patient developed palmar digital vein thrombosis in 4th digit of left hand
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Angioedema, Blood pressure decreased, Dizziness, Nausea
Clinical narrative: COLLAPSED TO FLOOR; BLOOD PRESSURE 88/40; SWEATING; HEADACHE; NAUSEAOUS; This spontaneous report received from a health care professional concerned a 30 year old male. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular and batch number: 043A21A, expiry: UNKNOWN) dose was not reported, 1 total, administered on 08-APR-2021 at 11:20 to left arm for prophylactic vaccination. No concomitant medications were reported.   On 08-APR-2021 at 11:30, the patient felt nauseous and stood up and collapsed to the floor. The patient did not lose consciousness. Emergency medical services was called for the patient. At 11:30, blood pressure was found 88/40. The patient was sweating and experiencing headache. The oxygen saturation was normal. On 08-APR-2021 at 11:50, the blood pressure became normal. The patient was monitored for another 20 minutes and was allowed to leave.  On 08-APR-2021, Laboratory data included: Oxygen saturation (NR: not provided) Normal, at 11:30, Laboratory data included: Blood pressure (NR: not provided) 88/40. On 08-APR-2021 11:50, Laboratory data included: Blood pressure (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blood pressure 88/40 on 08-APR-2021 11:50 and the outcome of nauseous, collapsed to floor, sweating and headache was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210421741- covid-19 vaccine ad26.cov2.s-Collapsed to floor, blood pressure 88/40. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood pressure abnormal, Dizziness postural, Headache, Hyperhidrosis, Nausea
Clinical narrative: COLLAPSED TO FLOOR; BLOOD PRESSURE 88/40; SWEATING; HEADACHE; NAUSEAOUS; This spontaneous report received from a health care professional concerned a 30 year old male. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular and batch number: 043A21A, expiry: UNKNOWN) dose was not reported, 1 total, administered on 08-APR-2021 at 11:20 to left arm for prophylactic vaccination. No concomitant medications were reported.   On 08-APR-2021 at 11:30, the patient felt nauseous and stood up and collapsed to the floor. The patient did not lose consciousness. Emergency medical services was called for the patient. At 11:30, blood pressure was found 88/40. The patient was sweating and experiencing headache. The oxygen saturation was normal. On 08-APR-2021 at 11:50, the blood pressure became normal. The patient was monitored for another 20 minutes and was allowed to leave.  On 08-APR-2021, Laboratory data included: Oxygen saturation (NR: not provided) Normal, at 11:30, Laboratory data included: Blood pressure (NR: not provided) 88/40. On 08-APR-2021 11:50, Laboratory data included: Blood pressure (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blood pressure 88/40 on 08-APR-2021 11:50 and the outcome of nauseous, collapsed to floor, sweating and headache was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210421741- covid-19 vaccine ad26.cov2.s-Collapsed to floor, blood pressure 88/40. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Oxygen saturation normal, Syncope
Clinical narrative: COLLAPSED TO FLOOR; BLOOD PRESSURE 88/40; SWEATING; HEADACHE; NAUSEAOUS; This spontaneous report received from a health care professional concerned a 30 year old male. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular and batch number: 043A21A, expiry: UNKNOWN) dose was not reported, 1 total, administered on 08-APR-2021 at 11:20 to left arm for prophylactic vaccination. No concomitant medications were reported.   On 08-APR-2021 at 11:30, the patient felt nauseous and stood up and collapsed to the floor. The patient did not lose consciousness. Emergency medical services was called for the patient. At 11:30, blood pressure was found 88/40. The patient was sweating and experiencing headache. The oxygen saturation was normal. On 08-APR-2021 at 11:50, the blood pressure became normal. The patient was monitored for another 20 minutes and was allowed to leave.  On 08-APR-2021, Laboratory data included: Oxygen saturation (NR: not provided) Normal, at 11:30, Laboratory data included: Blood pressure (NR: not provided) 88/40. On 08-APR-2021 11:50, Laboratory data included: Blood pressure (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blood pressure 88/40 on 08-APR-2021 11:50 and the outcome of nauseous, collapsed to floor, sweating and headache was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210421741- covid-19 vaccine ad26.cov2.s-Collapsed to floor, blood pressure 88/40. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood pressure measurement, Headache, Hyperhidrosis, Hypotension, Nausea
Clinical narrative: COLLAPSED TO FLOOR; BLOOD PRESSURE 88/40; SWEATING; HEADACHE; NAUSEAOUS; This spontaneous report received from a health care professional concerned a 30 year old male. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular and batch number: 043A21A, expiry: UNKNOWN) dose was not reported, 1 total, administered on 08-APR-2021 at 11:20 to left arm for prophylactic vaccination. No concomitant medications were reported.   On 08-APR-2021 at 11:30, the patient felt nauseous and stood up and collapsed to the floor. The patient did not lose consciousness. Emergency medical services was called for the patient. At 11:30, blood pressure was found 88/40. The patient was sweating and experiencing headache. The oxygen saturation was normal. On 08-APR-2021 at 11:50, the blood pressure became normal. The patient was monitored for another 20 minutes and was allowed to leave.  On 08-APR-2021, Laboratory data included: Oxygen saturation (NR: not provided) Normal, at 11:30, Laboratory data included: Blood pressure (NR: not provided) 88/40. On 08-APR-2021 11:50, Laboratory data included: Blood pressure (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blood pressure 88/40 on 08-APR-2021 11:50 and the outcome of nauseous, collapsed to floor, sweating and headache was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210421741- covid-19 vaccine ad26.cov2.s-Collapsed to floor, blood pressure 88/40. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Oxygen saturation, Syncope
Clinical narrative: COLLAPSED TO FLOOR; BLOOD PRESSURE 88/40; SWEATING; HEADACHE; NAUSEAOUS; This spontaneous report received from a health care professional concerned a 30 year old male. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular and batch number: 043A21A, expiry: UNKNOWN) dose was not reported, 1 total, administered on 08-APR-2021 at 11:20 to left arm for prophylactic vaccination. No concomitant medications were reported.   On 08-APR-2021 at 11:30, the patient felt nauseous and stood up and collapsed to the floor. The patient did not lose consciousness. Emergency medical services was called for the patient. At 11:30, blood pressure was found 88/40. The patient was sweating and experiencing headache. The oxygen saturation was normal. On 08-APR-2021 at 11:50, the blood pressure became normal. The patient was monitored for another 20 minutes and was allowed to leave.  On 08-APR-2021, Laboratory data included: Oxygen saturation (NR: not provided) Normal, at 11:30, Laboratory data included: Blood pressure (NR: not provided) 88/40. On 08-APR-2021 11:50, Laboratory data included: Blood pressure (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blood pressure 88/40 on 08-APR-2021 11:50 and the outcome of nauseous, collapsed to floor, sweating and headache was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210421741- covid-19 vaccine ad26.cov2.s-Collapsed to floor, blood pressure 88/40. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Deep vein thrombosis, Fibrin D dimer normal, Pain in extremity, Peripheral swelling
Clinical narrative: DVT of the right lower extremity
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ultrasound Doppler
Clinical narrative: DVT of the right lower extremity
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram thorax, Deep vein thrombosis, Ultrasound Doppler abnormal
Clinical narrative: DVT of the right lower extremity
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Aphasia, Cardiac failure congestive, Dyspnoea, Gingival pain, Mouth swelling
Clinical narrative: CONGESTIVE HEART FAILURE; FLUID AROUND HEART; HAD TROUBLE BREATHING; TEETH AND GUMS STARTED HURTING; TEETH AND GUMS STARTED HURTING; GUM SWELLING; This spontaneous report received from a pharmacist concerned a 79 year old male. 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: 042A21A, expiry: UNKNOWN) dose was not reported, 1 total administered on 01-APR-2021 for prophylactic vaccination about 1:30 pm in left deltoid. No concomitant medications were reported.  On 02-APR-2021, the patient experienced gum swelling, teeth and gums started hurting, trouble breathing. His tongue and throat did not swell. On 03-APR-2021, the patient visited the emergency room (ER) about 12:30am and was given Solumedrol intravenously and was sent home advised to take Benadryl. The patient took Benadryl 4-6 hourly all day on 03-APR-2021. The patient visited the ER again on 04-APR-2021 about 5:30 am with swollen gums again and was informed that he had fluid around heart and given Lasix. Emergency department (ED) HCP told patient that the vaccine gave him congestive heart failure (according to patient) and he was given Solumedrol at ED again and sent home on Medrol dose pack. On Monday 04-APR-2021, the patient visited his primary care physician and congestive heart failure had resolved.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from events of gum swelling, teeth and gums started hurting, had trouble breathing an unspecified date in Apr-2021, and from fluid around heart, and congestive heart failure on 05-APR-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210420579- covid-19 vaccine ad26.cov2.s-Congestive heart failure, fluid around heart, had trouble breathing, teeth and  gums started hurting, gum swelling. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Toothache
Clinical narrative: CONGESTIVE HEART FAILURE; FLUID AROUND HEART; HAD TROUBLE BREATHING; TEETH AND GUMS STARTED HURTING; TEETH AND GUMS STARTED HURTING; GUM SWELLING; This spontaneous report received from a pharmacist concerned a 79 year old male. 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: 042A21A, expiry: UNKNOWN) dose was not reported, 1 total administered on 01-APR-2021 for prophylactic vaccination about 1:30 pm in left deltoid. No concomitant medications were reported.  On 02-APR-2021, the patient experienced gum swelling, teeth and gums started hurting, trouble breathing. His tongue and throat did not swell. On 03-APR-2021, the patient visited the emergency room (ER) about 12:30am and was given Solumedrol intravenously and was sent home advised to take Benadryl. The patient took Benadryl 4-6 hourly all day on 03-APR-2021. The patient visited the ER again on 04-APR-2021 about 5:30 am with swollen gums again and was informed that he had fluid around heart and given Lasix. Emergency department (ED) HCP told patient that the vaccine gave him congestive heart failure (according to patient) and he was given Solumedrol at ED again and sent home on Medrol dose pack. On Monday 04-APR-2021, the patient visited his primary care physician and congestive heart failure had resolved.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from events of gum swelling, teeth and gums started hurting, had trouble breathing an unspecified date in Apr-2021, and from fluid around heart, and congestive heart failure on 05-APR-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210420579- covid-19 vaccine ad26.cov2.s-Congestive heart failure, fluid around heart, had trouble breathing, teeth and  gums started hurting, gum swelling. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardiac failure congestive, Dyspnoea, Gingival pain, Gingival swelling, Pericardial effusion
Clinical narrative: CONGESTIVE HEART FAILURE; FLUID AROUND HEART; HAD TROUBLE BREATHING; TEETH AND GUMS STARTED HURTING; TEETH AND GUMS STARTED HURTING; GUM SWELLING; This spontaneous report received from a pharmacist concerned a 79 year old male. 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: 042A21A, expiry: UNKNOWN) dose was not reported, 1 total administered on 01-APR-2021 for prophylactic vaccination about 1:30 pm in left deltoid. No concomitant medications were reported.  On 02-APR-2021, the patient experienced gum swelling, teeth and gums started hurting, trouble breathing. His tongue and throat did not swell. On 03-APR-2021, the patient visited the emergency room (ER) about 12:30am and was given Solumedrol intravenously and was sent home advised to take Benadryl. The patient took Benadryl 4-6 hourly all day on 03-APR-2021. The patient visited the ER again on 04-APR-2021 about 5:30 am with swollen gums again and was informed that he had fluid around heart and given Lasix. Emergency department (ED) HCP told patient that the vaccine gave him congestive heart failure (according to patient) and he was given Solumedrol at ED again and sent home on Medrol dose pack. On Monday 04-APR-2021, the patient visited his primary care physician and congestive heart failure had resolved.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from events of gum swelling, teeth and gums started hurting, had trouble breathing an unspecified date in Apr-2021, and from fluid around heart, and congestive heart failure on 05-APR-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210420579- covid-19 vaccine ad26.cov2.s-Congestive heart failure, fluid around heart, had trouble breathing, teeth and  gums started hurting, gum swelling. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: C-reactive protein increased, Chest pain, Chills, Dyspnoea, Monocyte count
Clinical narrative: Patient developed Chest pain 3 days post vaccination and was admitted to the ER and diagnosed with Myopericarditis. he was treated and released the next morning, Patient is doing well with no further symptoms. Expected to make full and uncomplicated recovery after 90 days of colchicine.
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Nausea, Neutrophil count increased, Paraesthesia, Pleurisy, Syncope
Clinical narrative: Patient developed Chest pain 3 days post vaccination and was admitted to the ER and diagnosed with Myopericarditis. he was treated and released the next morning, Patient is doing well with no further symptoms. Expected to make full and uncomplicated recovery after 90 days of colchicine.
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tachycardia, Troponin I increased, White blood cell count increased
Clinical narrative: Patient developed Chest pain 3 days post vaccination and was admitted to the ER and diagnosed with Myopericarditis. he was treated and released the next morning, Patient is doing well with no further symptoms. Expected to make full and uncomplicated recovery after 90 days of colchicine.
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Myocarditis
Clinical narrative: Patient developed Chest pain 3 days post vaccination and was admitted to the ER and diagnosed with Myopericarditis. he was treated and released the next morning, Patient is doing well with no further symptoms. Expected to make full and uncomplicated recovery after 90 days of colchicine.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysphagia, Throat tightness
Clinical narrative: The back of my throat started to tingle, then it started to swell. The staff at the CVS stuck me with an epi-pen. I waited for almost an hour after the epi-pen and the swelling did start going down. It didn't completely go down, back to normal, for several hours later. My airways were never completely restricted, it was just some swelling in the back of my throat.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactoid reaction, Pharyngeal paraesthesia, Pharyngeal swelling
Clinical narrative: The back of my throat started to tingle, then it started to swell. The staff at the CVS stuck me with an epi-pen. I waited for almost an hour after the epi-pen and the swelling did start going down. It didn't completely go down, back to normal, for several hours later. My airways were never completely restricted, it was just some swelling in the back of my throat.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Headache, Nausea, Rash
Clinical narrative: Vaccine was administered on 4/8/2021 and patient stated on vaccine questionnaire that she has had a severe reaction to a vaccine in the past. When interviewed, she indicated that her physician did recommend she receive the vaccine. We confirmed that she should wait 30 minutes, which she did. She was accompanied by her husband at the visit as well. It was later reported that Sunday, 4/11/2021, she began having a rash (hives) and some breathing difficulty which caused her to go to the ER. Her breathing continued to be an issue and she was hospitalized on Wednesday 4/14/2021 (admitted to PCU per husband).
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Rash, Urticaria
Clinical narrative: Vaccine was administered on 4/8/2021 and patient stated on vaccine questionnaire that she has had a severe reaction to a vaccine in the past. When interviewed, she indicated that her physician did recommend she receive the vaccine. We confirmed that she should wait 30 minutes, which she did. She was accompanied by her husband at the visit as well. It was later reported that Sunday, 4/11/2021, she began having a rash (hives) and some breathing difficulty which caused her to go to the ER. Her breathing continued to be an issue and she was hospitalized on Wednesday 4/14/2021 (admitted to PCU per husband).
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Amnesia, Axillary pain, Blood test, Body temperature increased
Clinical narrative: mentally fuzzy/mind was spacey; short term memory loss; body aches; very upset stomach; wiped out /exhausted; hallucinations; chills/shivering; high temp; got hot; my muscles in my neck, back, arms and legs tightened; freezing for a few hours; vomiting; armpit glands felt like they were being twisted and pulled/armpits hurt.; felt very sick; This is a spontaneous report from a contactable consumer (patient). A 58-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in arm left on 26Mar2021 15:15 (Batch/Lot Number: Pfizer ER8730) as single dose for COVID-19 immunisation. Medical history included penicillin allergy and allergies to nitrates, nitrites and sulfites. There were no concomitant medications. The patient previously took and had allergies to MSG (monosodium glutamate). Historical vaccine included BNT162B2 dose 1 for COVID-19 immunisation. The patient had no other vaccine in four weeks prior to covid vaccine. It was reported that 11 hours after shot (Sat 27Mar2021 2:00am), the patient experienced chills, high temp and hallucinations, then got hot, muscles in his neck, back, arms and legs tightened, then freezing for a few hours. At 8:00am, he was wiped out but functioning. At 1:00pm (Sat), he started feeling chills, hot, body aches along with very upset stomach, slept on/off until 4 or 5pm when he started shivering, vomiting and some hallucinating. His armpit glands felt like they were being twisted and pulled. He felt very sick and asked his wife to call #. Paramedics came, took vitals (unknown result), blood (unknown result) and offered to take him to the hospital. They stayed an hour until he felt stable and fell asleep in his bed. Sunday, 28Mar2021 morning, he felt exhausted, slightly better but his mind was spacey, body achy and armpits hurt. At 12:00pm, he noticed short term memory loss. He ate a few crackers and drank water, napped on/ off, went to bed around 900pm. On Mon, 29Mar2021, he was still achy and mentally fuzzy. Side effects diminished after a few more days. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events; vitals, blood draw, observation by paramedics. The outcome of the events was recovered with recovered/resolved with sequel.