chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Swelling face
Clinical narrative: Anaphylactic reaction: other; This is a spontaneous report received from a contactable consumer (patient). A 49-year-old female patient (not pregnant) received BNT162B2 (lot number: EN6205) second dose on 06Mar202111:00 on Right arm at single dose for COVID-19 immunization. Medical history included Asthma, allergies to Sulfa, CT dye, Reglan, Morphine, and Gastrointestinal issues. Concomitant medications within 2 weeks of vaccination included Omeprezole, metformin, fluticasone propionate, salmeterol xinafoate (ADVAIR), cetirizine hydrochloride (ZYRTEC), galcanezumab (EMGALITY). No other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took BNT162B2 first dose on 13Feb2021 13:00 (age at vaccination was 49-year-old) on Right arm for COVID-19 immunization. Patient had Adverse events: Anaphylactic reaction: rash, itching, cough, throat swelling and closing, difficulty breathing, rapid heart rate, face swelling, eye problems, dizziness, nausea, headache on 06Mar2021 11:15. The events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Patient received treatment included Epinephrine, Benadryl injections, O2, Breathing Tx. Prior to vaccination,was the patient was not diagnosed with COVID-19, Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was Recovered with lasting effects.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Heart rate
Clinical narrative: Anaphylactic reaction: other; This is a spontaneous report received from a contactable consumer (patient). A 49-year-old female patient (not pregnant) received BNT162B2 (lot number: EN6205) second dose on 06Mar202111:00 on Right arm at single dose for COVID-19 immunization. Medical history included Asthma, allergies to Sulfa, CT dye, Reglan, Morphine, and Gastrointestinal issues. Concomitant medications within 2 weeks of vaccination included Omeprezole, metformin, fluticasone propionate, salmeterol xinafoate (ADVAIR), cetirizine hydrochloride (ZYRTEC), galcanezumab (EMGALITY). No other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took BNT162B2 first dose on 13Feb2021 13:00 (age at vaccination was 49-year-old) on Right arm for COVID-19 immunization. Patient had Adverse events: Anaphylactic reaction: rash, itching, cough, throat swelling and closing, difficulty breathing, rapid heart rate, face swelling, eye problems, dizziness, nausea, headache on 06Mar2021 11:15. The events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Patient received treatment included Epinephrine, Benadryl injections, O2, Breathing Tx. Prior to vaccination,was the patient was not diagnosed with COVID-19, Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was Recovered with lasting effects.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Dysphagia, Throat irritation, Throat tightness
Clinical narrative: 2:42 Complained of itchy throat , slight cough BP 146/105, P88 02 98 Progessed to dysphagia, worsening cough, sensation of throat closure 2:47 Epi 0.3mg IM  EMS - IV started, Solumedrol 125mg 2:54 BP 184/115 P 89 02- 97 Transferred to Emergency room
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Emergency room for emergent treatment of anaphylaxis; This is a spontaneous report from a contactable physician.  A 38-years-old non-pregnant female patient (nurse) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: Not Reported ), intramuscular, administered in Leg Left on 10Mar2021 at 18:00as a single dose, for COVID-19 vaccination.  Medical history included hysterectomy.  There were no concomitant medications. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19  The patient previously took cephalexin [cefalexin] and experienced drug hypersensitivity.  On 10Mar2021 at 20:00, The patient went  to the emergency room for emergent treatment of anaphylaxis (medically significant). Treatment included' Epi/Decadron/Benadryl/Pepcid IV'. The clinical outcome of the event anaphylaxis was recovered.     Information on the lot/batch number has been requested.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Emergency room for emergent treatment of anaphylaxis; This is a spontaneous report from a contactable physician.  A 38-years-old non-pregnant female patient (nurse) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: Not Reported ), intramuscular, administered in Leg Left on 10Mar2021 at 18:00as a single dose, for COVID-19 vaccination.  Medical history included hysterectomy.  There were no concomitant medications. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19  The patient previously took cephalexin [cefalexin] and experienced drug hypersensitivity.  On 10Mar2021 at 20:00, The patient went  to the emergency room for emergent treatment of anaphylaxis (medically significant). Treatment included' Epi/Decadron/Benadryl/Pepcid IV'. The clinical outcome of the event anaphylaxis was recovered.     Information on the lot/batch number has been requested.
Age: 83.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cardiac arrest, Death, Resuscitation
Clinical narrative: Pt found unresponsive at 2245 (no pulse) and CPR initiated. Emergency services arrived and took over CPR. Pt intubated and transported pt to  ER at 2330
Age: 83.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Endotracheal intubation, Pulse absent, Resuscitation, Unresponsive to stimuli
Clinical narrative: Pt found unresponsive at 2245 (no pulse) and CPR initiated. Emergency services arrived and took over CPR. Pt intubated and transported pt to  ER at 2330
Age: 83.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Acute left ventricular failure, Angioplasty, Coronary arterial stent insertion, Death, Endarterectomy
Clinical narrative: Pt found unresponsive at 2245 (no pulse) and CPR initiated. Emergency services arrived and took over CPR. Pt intubated and transported pt to  ER at 2330
Age: 83.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Peripheral ischaemia, Peripheral swelling, Skin weeping, Stent placement
Clinical narrative: Pt found unresponsive at 2245 (no pulse) and CPR initiated. Emergency services arrived and took over CPR. Pt intubated and transported pt to  ER at 2330
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anaphylactic reaction, Chest pain, Dizziness, Eye swelling, Immediate post-injection reaction
Clinical narrative: SHORTNESS OF BREATH; THROAT SWELLING; This spontaneous report received from a patient concerned a 62 year old female.  The patient's weight was 185 pounds, and height was 67 inches. The patient's concurrent conditions included skin irritation to tape. The patient had no history of illness at the time of vaccination. The patient had no history of allergy to vaccines, drug or food and no family history of any disease. Patient had passed age of conception and was not pregnant at the time of reporting.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on right arm on 10-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On MAR-2021, the patient experienced shortness of breath, and was hospitalized. On MAR-2021, the patient experienced throat swelling and was given Epipen (epinephrine). The patient was treated every 4 hours. The patient had Covid-19 test while in the hospital 2 weeks ago and test was negative. The patient did not suspect any causes including co-administered vaccines/risk factors. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the throat swelling and shortness of breath was not reported. The reporter causality between covid-19 vaccine ad26.cov2.s and throat swelling and shortness of breath was not related. This report was serious (Hospitalization Caused / Prolonged). Additional information was received from patient on 23-MAR-2021. The following information was updated and incorporated in to the case narrative: Patient demographic details (Date of birth-13-FEB-1959, height-5'7", Weight-185 lbs), reporter details (address, state code, zip code), reporter causality (not related), patient history and disease tab, lab data (Covid-19 test).; Sender's Comments: v1: The following information received updates Patient demographic details  reporter details, reporter causality (not related), patient history and disease tab, lab data (Covid-19 test). This updated information does not alter prior causality assessment. 20210331224-JANSSEN COVID-19 VACCINE Ad26.COV2.S-Shortness of breath, Throat 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).
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Lip swelling, Loss of consciousness, Pharyngeal swelling, Swollen tongue
Clinical narrative: SHORTNESS OF BREATH; THROAT SWELLING; This spontaneous report received from a patient concerned a 62 year old female.  The patient's weight was 185 pounds, and height was 67 inches. The patient's concurrent conditions included skin irritation to tape. The patient had no history of illness at the time of vaccination. The patient had no history of allergy to vaccines, drug or food and no family history of any disease. Patient had passed age of conception and was not pregnant at the time of reporting.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on right arm on 10-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On MAR-2021, the patient experienced shortness of breath, and was hospitalized. On MAR-2021, the patient experienced throat swelling and was given Epipen (epinephrine). The patient was treated every 4 hours. The patient had Covid-19 test while in the hospital 2 weeks ago and test was negative. The patient did not suspect any causes including co-administered vaccines/risk factors. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the throat swelling and shortness of breath was not reported. The reporter causality between covid-19 vaccine ad26.cov2.s and throat swelling and shortness of breath was not related. This report was serious (Hospitalization Caused / Prolonged). Additional information was received from patient on 23-MAR-2021. The following information was updated and incorporated in to the case narrative: Patient demographic details (Date of birth-13-FEB-1959, height-5'7", Weight-185 lbs), reporter details (address, state code, zip code), reporter causality (not related), patient history and disease tab, lab data (Covid-19 test).; Sender's Comments: v1: The following information received updates Patient demographic details  reporter details, reporter causality (not related), patient history and disease tab, lab data (Covid-19 test). This updated information does not alter prior causality assessment. 20210331224-JANSSEN COVID-19 VACCINE Ad26.COV2.S-Shortness of breath, Throat 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).
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dyspnoea, Pharyngeal swelling, SARS-CoV-2 test
Clinical narrative: SHORTNESS OF BREATH; THROAT SWELLING; This spontaneous report received from a patient concerned a 62 year old female.  The patient's weight was 185 pounds, and height was 67 inches. The patient's concurrent conditions included skin irritation to tape. The patient had no history of illness at the time of vaccination. The patient had no history of allergy to vaccines, drug or food and no family history of any disease. Patient had passed age of conception and was not pregnant at the time of reporting.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on right arm on 10-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On MAR-2021, the patient experienced shortness of breath, and was hospitalized. On MAR-2021, the patient experienced throat swelling and was given Epipen (epinephrine). The patient was treated every 4 hours. The patient had Covid-19 test while in the hospital 2 weeks ago and test was negative. The patient did not suspect any causes including co-administered vaccines/risk factors. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the throat swelling and shortness of breath was not reported. The reporter causality between covid-19 vaccine ad26.cov2.s and throat swelling and shortness of breath was not related. This report was serious (Hospitalization Caused / Prolonged). Additional information was received from patient on 23-MAR-2021. The following information was updated and incorporated in to the case narrative: Patient demographic details (Date of birth-13-FEB-1959, height-5'7", Weight-185 lbs), reporter details (address, state code, zip code), reporter causality (not related), patient history and disease tab, lab data (Covid-19 test).; Sender's Comments: v1: The following information received updates Patient demographic details  reporter details, reporter causality (not related), patient history and disease tab, lab data (Covid-19 test). This updated information does not alter prior causality assessment. 20210331224-JANSSEN COVID-19 VACCINE Ad26.COV2.S-Shortness of breath, Throat 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).
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dyspnoea, Pharyngeal swelling
Clinical narrative: SHORTNESS OF BREATH; THROAT SWELLING; This spontaneous report received from a patient concerned a 62 year old female.  The patient's weight was 185 pounds, and height was 67 inches. The patient's concurrent conditions included skin irritation to tape. The patient had no history of illness at the time of vaccination. The patient had no history of allergy to vaccines, drug or food and no family history of any disease. Patient had passed age of conception and was not pregnant at the time of reporting.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on right arm on 10-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On MAR-2021, the patient experienced shortness of breath, and was hospitalized. On MAR-2021, the patient experienced throat swelling and was given Epipen (epinephrine). The patient was treated every 4 hours. The patient had Covid-19 test while in the hospital 2 weeks ago and test was negative. The patient did not suspect any causes including co-administered vaccines/risk factors. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the throat swelling and shortness of breath was not reported. The reporter causality between covid-19 vaccine ad26.cov2.s and throat swelling and shortness of breath was not related. This report was serious (Hospitalization Caused / Prolonged). Additional information was received from patient on 23-MAR-2021. The following information was updated and incorporated in to the case narrative: Patient demographic details (Date of birth-13-FEB-1959, height-5'7", Weight-185 lbs), reporter details (address, state code, zip code), reporter causality (not related), patient history and disease tab, lab data (Covid-19 test).; Sender's Comments: v1: The following information received updates Patient demographic details  reporter details, reporter causality (not related), patient history and disease tab, lab data (Covid-19 test). This updated information does not alter prior causality assessment. 20210331224-JANSSEN COVID-19 VACCINE Ad26.COV2.S-Shortness of breath, Throat 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: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy
Clinical narrative: Facial Muscle Weakness; This is a spontaneous report from a contactable consumer (patient). A 69-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN 6202) via an unspecified route of administration administered in left arm on 26Feb2021 17:45 as single dose for COVID-19 immunisation. The patient had known allergies to NSAIDS. There was no other medical history. The patient's concomitant medications were not reported. It reported that there were other medications in two weeks. No COVID prior vaccination. No COVID tested post vaccination. The patient did not other vaccine in four weeks. The patient experienced facial muscle weakness on 27Feb2021 18:00. The patient did not receive treatment for event. The outcome of event was not recovered.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Facial paresis
Clinical narrative: Facial Muscle Weakness; This is a spontaneous report from a contactable consumer (patient). A 69-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN 6202) via an unspecified route of administration administered in left arm on 26Feb2021 17:45 as single dose for COVID-19 immunisation. The patient had known allergies to NSAIDS. There was no other medical history. The patient's concomitant medications were not reported. It reported that there were other medications in two weeks. No COVID prior vaccination. No COVID tested post vaccination. The patient did not other vaccine in four weeks. The patient experienced facial muscle weakness on 27Feb2021 18:00. The patient did not receive treatment for event. The outcome of event was not recovered.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anxiety, Dizziness, Electrocardiogram normal, Paraesthesia
Clinical narrative: FEELING ANXIOUS; HYPERTENSION; LIGHT HEADED; CHEST PAIN; SHORTNESS OF BREATH; HEART RATE 120; This spontaneous report received from a pharmacist concerned a 58 year old female. The patient's height, and weight were not reported. The patient's past medical history included hormone replacement therapy, and concurrent conditions included hypertension, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and  expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 1:04 PM on left deltoid for prophylactic vaccination. The pharmacist reports on 3/11 and 3/12 they combined volume from separate vials, most likely did not do so for this specific patient though.  No concomitant medications were reported.  On 11-MAR-2021, the patient experienced hypertension, light headed, chest pain, shortness of breath, heart rate 120 about 2 minutes after the shot. EMS was called, took BP 170/110 and HR 120 O2 97%, mobile EKG normal. She requested to be taken ER, feeling anxious. Patient reported she's been to the ER for same complaints prior to vaccination, they couldn't figure out what was wrong. Laboratory data included: Blood pressure (NR: not provided) 170/110 mmHg, EKG (NR: not provided) Normal, Heart rate (NR: not provided) 120 {beats}/min, and Oxygen saturation (NR: not provided) 97 %. On an unspecified date, the subject experienced feeling anxious. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the light headed, chest pain, shortness of breath, heart rate 120, feeling anxious and hypertension was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210334020- Covid-19 vaccine ad26.cov2.s-Hypertension. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: UNDERLYING DISEASE
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anxiety, Blood pressure measurement, Chest pain, Dizziness, Dyspnoea
Clinical narrative: FEELING ANXIOUS; HYPERTENSION; LIGHT HEADED; CHEST PAIN; SHORTNESS OF BREATH; HEART RATE 120; This spontaneous report received from a pharmacist concerned a 58 year old female. The patient's height, and weight were not reported. The patient's past medical history included hormone replacement therapy, and concurrent conditions included hypertension, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and  expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 1:04 PM on left deltoid for prophylactic vaccination. The pharmacist reports on 3/11 and 3/12 they combined volume from separate vials, most likely did not do so for this specific patient though.  No concomitant medications were reported.  On 11-MAR-2021, the patient experienced hypertension, light headed, chest pain, shortness of breath, heart rate 120 about 2 minutes after the shot. EMS was called, took BP 170/110 and HR 120 O2 97%, mobile EKG normal. She requested to be taken ER, feeling anxious. Patient reported she's been to the ER for same complaints prior to vaccination, they couldn't figure out what was wrong. Laboratory data included: Blood pressure (NR: not provided) 170/110 mmHg, EKG (NR: not provided) Normal, Heart rate (NR: not provided) 120 {beats}/min, and Oxygen saturation (NR: not provided) 97 %. On an unspecified date, the subject experienced feeling anxious. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the light headed, chest pain, shortness of breath, heart rate 120, feeling anxious and hypertension was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210334020- Covid-19 vaccine ad26.cov2.s-Hypertension. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: UNDERLYING DISEASE
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Electrocardiogram, Heart rate, Heart rate increased, Hypertension, Oxygen saturation
Clinical narrative: FEELING ANXIOUS; HYPERTENSION; LIGHT HEADED; CHEST PAIN; SHORTNESS OF BREATH; HEART RATE 120; This spontaneous report received from a pharmacist concerned a 58 year old female. The patient's height, and weight were not reported. The patient's past medical history included hormone replacement therapy, and concurrent conditions included hypertension, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and  expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 1:04 PM on left deltoid for prophylactic vaccination. The pharmacist reports on 3/11 and 3/12 they combined volume from separate vials, most likely did not do so for this specific patient though.  No concomitant medications were reported.  On 11-MAR-2021, the patient experienced hypertension, light headed, chest pain, shortness of breath, heart rate 120 about 2 minutes after the shot. EMS was called, took BP 170/110 and HR 120 O2 97%, mobile EKG normal. She requested to be taken ER, feeling anxious. Patient reported she's been to the ER for same complaints prior to vaccination, they couldn't figure out what was wrong. Laboratory data included: Blood pressure (NR: not provided) 170/110 mmHg, EKG (NR: not provided) Normal, Heart rate (NR: not provided) 120 {beats}/min, and Oxygen saturation (NR: not provided) 97 %. On an unspecified date, the subject experienced feeling anxious. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the light headed, chest pain, shortness of breath, heart rate 120, feeling anxious and hypertension was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210334020- Covid-19 vaccine ad26.cov2.s-Hypertension. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: UNDERLYING DISEASE
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anxiety, Chest pain, Condition aggravated, Dizziness, Dyspnoea
Clinical narrative: FEELING ANXIOUS; HYPERTENSION; LIGHT HEADED; CHEST PAIN; SHORTNESS OF BREATH; HEART RATE 120; This spontaneous report received from a pharmacist concerned a 58 year old female. The patient's height, and weight were not reported. The patient's past medical history included hormone replacement therapy, and concurrent conditions included hypertension, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and  expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 1:04 PM on left deltoid for prophylactic vaccination. The pharmacist reports on 3/11 and 3/12 they combined volume from separate vials, most likely did not do so for this specific patient though.  No concomitant medications were reported.  On 11-MAR-2021, the patient experienced hypertension, light headed, chest pain, shortness of breath, heart rate 120 about 2 minutes after the shot. EMS was called, took BP 170/110 and HR 120 O2 97%, mobile EKG normal. She requested to be taken ER, feeling anxious. Patient reported she's been to the ER for same complaints prior to vaccination, they couldn't figure out what was wrong. Laboratory data included: Blood pressure (NR: not provided) 170/110 mmHg, EKG (NR: not provided) Normal, Heart rate (NR: not provided) 120 {beats}/min, and Oxygen saturation (NR: not provided) 97 %. On an unspecified date, the subject experienced feeling anxious. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the light headed, chest pain, shortness of breath, heart rate 120, feeling anxious and hypertension was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210334020- Covid-19 vaccine ad26.cov2.s-Hypertension. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: UNDERLYING DISEASE
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Electrocardiogram normal, Hypertension
Clinical narrative: FEELING ANXIOUS; HYPERTENSION; LIGHT HEADED; CHEST PAIN; SHORTNESS OF BREATH; HEART RATE 120; This spontaneous report received from a pharmacist concerned a 58 year old female. The patient's height, and weight were not reported. The patient's past medical history included hormone replacement therapy, and concurrent conditions included hypertension, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and  expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 1:04 PM on left deltoid for prophylactic vaccination. The pharmacist reports on 3/11 and 3/12 they combined volume from separate vials, most likely did not do so for this specific patient though.  No concomitant medications were reported.  On 11-MAR-2021, the patient experienced hypertension, light headed, chest pain, shortness of breath, heart rate 120 about 2 minutes after the shot. EMS was called, took BP 170/110 and HR 120 O2 97%, mobile EKG normal. She requested to be taken ER, feeling anxious. Patient reported she's been to the ER for same complaints prior to vaccination, they couldn't figure out what was wrong. Laboratory data included: Blood pressure (NR: not provided) 170/110 mmHg, EKG (NR: not provided) Normal, Heart rate (NR: not provided) 120 {beats}/min, and Oxygen saturation (NR: not provided) 97 %. On an unspecified date, the subject experienced feeling anxious. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the light headed, chest pain, shortness of breath, heart rate 120, feeling anxious and hypertension was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210334020- Covid-19 vaccine ad26.cov2.s-Hypertension. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: UNDERLYING DISEASE
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Body temperature, Chills, Diarrhoea, Dizziness
Clinical narrative: Bad taste in my mouth (like bad feta cheese); Chills; then hot 98.7; (normal is 97.4); total body muscle aching; headache; This is a spontaneous report from a contactable consumer (patient herself) of 68-year-old female (age at the vaccination) received first dose of BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration on 28Jan2021 09:00 AM as single dose for covid-19 immunisation. Vaccine was administered at facility. Patient was not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the covid-19 vaccine. The patient did not diagnose with covid-19 prior to vaccination and had not been tested for covid-19 since the vaccination. Patient medical history was included Stage IV breast cancer, hypo thyroid, elevated BP, pernicious anemia, low K, glaucoma BP and allergies to fish, shellfish, phenothiazines, cipro, cytoxin, morphine, demerol, codeine, sulfa, ampicillin, vancomycin, xylatan, alphagan. Patient's concomitant medications were included eribulin mesilate (HALAVEN) denosumab (XGEVA), amlodipine besilate (AMLODIPINE BESILATE), levothyroxine sodium (SYNTHROID), potassium (POTASSIUM K 20). On 28Jan2021 10:30 am the patient experienced bad taste in my mouth (like bad feta cheese), chills, total body muscle aching, headache. Patient underwent lab tests included body temperature results as hot 98.7 (normal is 97.4) on 28Jan2021 10:30. Patient had not received treatment for the events. The outcome of event was recovering.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fall, Headache, Hyperhidrosis, Investigation, Loss of consciousness
Clinical narrative: Bad taste in my mouth (like bad feta cheese); Chills; then hot 98.7; (normal is 97.4); total body muscle aching; headache; This is a spontaneous report from a contactable consumer (patient herself) of 68-year-old female (age at the vaccination) received first dose of BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration on 28Jan2021 09:00 AM as single dose for covid-19 immunisation. Vaccine was administered at facility. Patient was not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the covid-19 vaccine. The patient did not diagnose with covid-19 prior to vaccination and had not been tested for covid-19 since the vaccination. Patient medical history was included Stage IV breast cancer, hypo thyroid, elevated BP, pernicious anemia, low K, glaucoma BP and allergies to fish, shellfish, phenothiazines, cipro, cytoxin, morphine, demerol, codeine, sulfa, ampicillin, vancomycin, xylatan, alphagan. Patient's concomitant medications were included eribulin mesilate (HALAVEN) denosumab (XGEVA), amlodipine besilate (AMLODIPINE BESILATE), levothyroxine sodium (SYNTHROID), potassium (POTASSIUM K 20). On 28Jan2021 10:30 am the patient experienced bad taste in my mouth (like bad feta cheese), chills, total body muscle aching, headache. Patient underwent lab tests included body temperature results as hot 98.7 (normal is 97.4) on 28Jan2021 10:30. Patient had not received treatment for the events. The outcome of event was recovering.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pain, Pyrexia, Skin abrasion, Vaccination site pain
Clinical narrative: Bad taste in my mouth (like bad feta cheese); Chills; then hot 98.7; (normal is 97.4); total body muscle aching; headache; This is a spontaneous report from a contactable consumer (patient herself) of 68-year-old female (age at the vaccination) received first dose of BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration on 28Jan2021 09:00 AM as single dose for covid-19 immunisation. Vaccine was administered at facility. Patient was not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the covid-19 vaccine. The patient did not diagnose with covid-19 prior to vaccination and had not been tested for covid-19 since the vaccination. Patient medical history was included Stage IV breast cancer, hypo thyroid, elevated BP, pernicious anemia, low K, glaucoma BP and allergies to fish, shellfish, phenothiazines, cipro, cytoxin, morphine, demerol, codeine, sulfa, ampicillin, vancomycin, xylatan, alphagan. Patient's concomitant medications were included eribulin mesilate (HALAVEN) denosumab (XGEVA), amlodipine besilate (AMLODIPINE BESILATE), levothyroxine sodium (SYNTHROID), potassium (POTASSIUM K 20). On 28Jan2021 10:30 am the patient experienced bad taste in my mouth (like bad feta cheese), chills, total body muscle aching, headache. Patient underwent lab tests included body temperature results as hot 98.7 (normal is 97.4) on 28Jan2021 10:30. Patient had not received treatment for the events. The outcome of event was recovering.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site swelling, Vomiting, Weight, Weight decreased
Clinical narrative: Bad taste in my mouth (like bad feta cheese); Chills; then hot 98.7; (normal is 97.4); total body muscle aching; headache; This is a spontaneous report from a contactable consumer (patient herself) of 68-year-old female (age at the vaccination) received first dose of BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration on 28Jan2021 09:00 AM as single dose for covid-19 immunisation. Vaccine was administered at facility. Patient was not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the covid-19 vaccine. The patient did not diagnose with covid-19 prior to vaccination and had not been tested for covid-19 since the vaccination. Patient medical history was included Stage IV breast cancer, hypo thyroid, elevated BP, pernicious anemia, low K, glaucoma BP and allergies to fish, shellfish, phenothiazines, cipro, cytoxin, morphine, demerol, codeine, sulfa, ampicillin, vancomycin, xylatan, alphagan. Patient's concomitant medications were included eribulin mesilate (HALAVEN) denosumab (XGEVA), amlodipine besilate (AMLODIPINE BESILATE), levothyroxine sodium (SYNTHROID), potassium (POTASSIUM K 20). On 28Jan2021 10:30 am the patient experienced bad taste in my mouth (like bad feta cheese), chills, total body muscle aching, headache. Patient underwent lab tests included body temperature results as hot 98.7 (normal is 97.4) on 28Jan2021 10:30. Patient had not received treatment for the events. The outcome of event was recovering.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Chills, Feeling hot, Headache, Myalgia
Clinical narrative: Bad taste in my mouth (like bad feta cheese); Chills; then hot 98.7; (normal is 97.4); total body muscle aching; headache; This is a spontaneous report from a contactable consumer (patient herself) of 68-year-old female (age at the vaccination) received first dose of BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration on 28Jan2021 09:00 AM as single dose for covid-19 immunisation. Vaccine was administered at facility. Patient was not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the covid-19 vaccine. The patient did not diagnose with covid-19 prior to vaccination and had not been tested for covid-19 since the vaccination. Patient medical history was included Stage IV breast cancer, hypo thyroid, elevated BP, pernicious anemia, low K, glaucoma BP and allergies to fish, shellfish, phenothiazines, cipro, cytoxin, morphine, demerol, codeine, sulfa, ampicillin, vancomycin, xylatan, alphagan. Patient's concomitant medications were included eribulin mesilate (HALAVEN) denosumab (XGEVA), amlodipine besilate (AMLODIPINE BESILATE), levothyroxine sodium (SYNTHROID), potassium (POTASSIUM K 20). On 28Jan2021 10:30 am the patient experienced bad taste in my mouth (like bad feta cheese), chills, total body muscle aching, headache. Patient underwent lab tests included body temperature results as hot 98.7 (normal is 97.4) on 28Jan2021 10:30. Patient had not received treatment for the events. The outcome of event was recovering.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Taste disorder
Clinical narrative: Bad taste in my mouth (like bad feta cheese); Chills; then hot 98.7; (normal is 97.4); total body muscle aching; headache; This is a spontaneous report from a contactable consumer (patient herself) of 68-year-old female (age at the vaccination) received first dose of BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration on 28Jan2021 09:00 AM as single dose for covid-19 immunisation. Vaccine was administered at facility. Patient was not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the covid-19 vaccine. The patient did not diagnose with covid-19 prior to vaccination and had not been tested for covid-19 since the vaccination. Patient medical history was included Stage IV breast cancer, hypo thyroid, elevated BP, pernicious anemia, low K, glaucoma BP and allergies to fish, shellfish, phenothiazines, cipro, cytoxin, morphine, demerol, codeine, sulfa, ampicillin, vancomycin, xylatan, alphagan. Patient's concomitant medications were included eribulin mesilate (HALAVEN) denosumab (XGEVA), amlodipine besilate (AMLODIPINE BESILATE), levothyroxine sodium (SYNTHROID), potassium (POTASSIUM K 20). On 28Jan2021 10:30 am the patient experienced bad taste in my mouth (like bad feta cheese), chills, total body muscle aching, headache. Patient underwent lab tests included body temperature results as hot 98.7 (normal is 97.4) on 28Jan2021 10:30. Patient had not received treatment for the events. The outcome of event was recovering.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cerebrovascular accident, Magnetic resonance imaging
Clinical narrative: Had a stroke; This is a spontaneous report from a contactable consumer (patient). A 47-years-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 11Jan2021 at 09:00 (age at vaccination: 47-years) at a single dose for COVID-19 immunization. Medical history included diabetes, high blood pressure, kidney disease, Penicillin allergy and Covid-19 prior vaccination. Concomitant medications included venlafaxine hydrochloride (EFFEXOR); trazodone; insulin aspart (NOVOLOG); insulin lispro (HUMALOG); and pantoprazole. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 14Jan2021 at 08:00, the patient had a stroke. The event resulted to hospitalization on an unspecified date. The patient received an unspecified treatment for the event. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was recovering.  Information about the lot/batch number has been requested.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Had a stroke; This is a spontaneous report from a contactable consumer (patient). A 47-years-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 11Jan2021 at 09:00 (age at vaccination: 47-years) at a single dose for COVID-19 immunization. Medical history included diabetes, high blood pressure, kidney disease, Penicillin allergy and Covid-19 prior vaccination. Concomitant medications included venlafaxine hydrochloride (EFFEXOR); trazodone; insulin aspart (NOVOLOG); insulin lispro (HUMALOG); and pantoprazole. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 14Jan2021 at 08:00, the patient had a stroke. The event resulted to hospitalization on an unspecified date. The patient received an unspecified treatment for the event. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was recovering.  Information about the lot/batch number has been requested.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angina unstable, Chest pain, Condition aggravated, Dyspnoea, Hypertensive urgency
Clinical narrative: 3/17/21: patient presented and was admitted through ED for chest pain. Patient had recent event of NSTEMI  and stent was placed last Friday.  Per the EUA, hospitalizations are to be reported irrespective of attribution to vaccine.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain in jaw
Clinical narrative: 3/17/21: patient presented and was admitted through ED for chest pain. Patient had recent event of NSTEMI  and stent was placed last Friday.  Per the EUA, hospitalizations are to be reported irrespective of attribution to vaccine.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acute myocardial infarction, Chest pain, Stent placement
Clinical narrative: 3/17/21: patient presented and was admitted through ED for chest pain. Patient had recent event of NSTEMI  and stent was placed last Friday.  Per the EUA, hospitalizations are to be reported irrespective of attribution to vaccine.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Chest discomfort, Dyspnoea, Electrocardiogram, Erythema
Clinical narrative: Full blown allergic reaction to vaccine within minutes of administration/redness all over her body, lip swelling, severe allergic reaction; redness all over her body, lip swelling, severe allergic reaction; redness all over her body, lip swelling, severe allergic reaction; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 11Mar2021 (at the age of 47 years old) at a single dose for COVID-19 immunization. Vaccination was done in a Public Health Clinic/Veterans Administration facility. Medical history included connective tissue disorder, high cholesterol, and chronic hip/labrum issues, all from an unknown date and unknown if ongoing. Patient was not pregnant. There was no COVID prior vaccination and not COVID tested post vaccination. The patient's concomitant medications were not reported. The patient previously received flu vaccine for immunization and experienced known allergies: flu vaccine. The patient experienced full blown allergic reaction to vaccine within minutes of administration/redness all over her body, lip swelling, severe allergic reaction on 11Mar2021. It was reported that the patient was taken to the ER by EMS for observation, treated and released, all on 11Mar2021. She took Benadryl at the vaccination site and was given prednisone treatment at the hospital. The outcome of the event was recovering.  Information on the batch/lot number has been requested.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate increased, Hyperhidrosis, Hypoaesthesia, Hypoaesthesia oral, Lip swelling
Clinical narrative: Full blown allergic reaction to vaccine within minutes of administration/redness all over her body, lip swelling, severe allergic reaction; redness all over her body, lip swelling, severe allergic reaction; redness all over her body, lip swelling, severe allergic reaction; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 11Mar2021 (at the age of 47 years old) at a single dose for COVID-19 immunization. Vaccination was done in a Public Health Clinic/Veterans Administration facility. Medical history included connective tissue disorder, high cholesterol, and chronic hip/labrum issues, all from an unknown date and unknown if ongoing. Patient was not pregnant. There was no COVID prior vaccination and not COVID tested post vaccination. The patient's concomitant medications were not reported. The patient previously received flu vaccine for immunization and experienced known allergies: flu vaccine. The patient experienced full blown allergic reaction to vaccine within minutes of administration/redness all over her body, lip swelling, severe allergic reaction on 11Mar2021. It was reported that the patient was taken to the ER by EMS for observation, treated and released, all on 11Mar2021. She took Benadryl at the vaccination site and was given prednisone treatment at the hospital. The outcome of the event was recovering.  Information on the batch/lot number has been requested.