chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Pain assessment, Pain in extremity, Thrombosis, Ultrasound scan
Clinical narrative: BLOOD CLOT; ARM SORENESS; TIREDNESS; This spontaneous report received from a patient and concerned a 36 year old  female. The patient's weight was 177 pounds and height was 165 centimeters. The patient's past medical history included fibroid surgery (fibroid was taken out 2 months), and concurrent conditions included alcohol drinker (once a week - occasionally), non-smoker, no drug abuse or illicit drug use, no known allergies. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, intramuscular (right deltoid), batch number: 043A21A) dose was not reported, administered on 05-APR-2021 for prevention of covid-19 disease. No concomitant medications were reported.  On 05-APR-2021, an unspecified amount of time after vaccination, the patient experienced arm soreness and tiredness that resolved within 3 days.  On 15-APR-2021, 10 days after vaccination, the patient experienced calf pain and blood clot. It was reported the patient felt a very sharp pain on her right calf while walking, pain scale was 8/10, and it was so painful that she could not put pressure on it. Therefore, she decided to go to the hospital to have it checked. Her attending physician confirmed based on ultrasound that she has a blood clot on her right leg. She was prescribed blood thinner Eliquis (apixaban) however she was still undecided because her insurance denied to cover it and it was out of pocket. Once she returned home, she stated that the sharp pain was gone and it was just achy. After conversation with her physician, her physician postponed the medication for now because he wanted to make sure that her blood was not already thin before prescribing a blood thinner. She will go to the hospital again on 16-APR-2021 to see a hematologist for blood works and her physician advised her not to work until 20-APR-2021 as a preventive measure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm soreness, and tiredness on 08-APR-2021 and had not recovered from blood clot. This report was serious (Other Medically Important Condition, and Life Threatening).; Sender's Comments: V0:  a 36-year-old female experienced a blood clot in her right leg, 10 days after receiving the Janssen COVID-19 vaccine for prevention of COVID-19 infection.  The patient is a non-smoker, her BMI is 34.5; she has no other relevant medical history and reported no concomitant medications.    Ten days after receiving the vaccine, she felt a sharp pain, graded 8/10, in her right calf while walking.  Ultrasound showed a blood clot on her right leg.  She was prescribed Eliquis but did not fill the prescription and the pain subsided; she was to have further blood tests and see a physician the following day.  Additional information is being sought.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test, Fatigue, Gait inability, Muscle spasms, Pain in extremity
Clinical narrative: BLOOD CLOT; ARM SORENESS; TIREDNESS; This spontaneous report received from a patient and concerned a 36 year old  female. The patient's weight was 177 pounds and height was 165 centimeters. The patient's past medical history included fibroid surgery (fibroid was taken out 2 months), and concurrent conditions included alcohol drinker (once a week - occasionally), non-smoker, no drug abuse or illicit drug use, no known allergies. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, intramuscular (right deltoid), batch number: 043A21A) dose was not reported, administered on 05-APR-2021 for prevention of covid-19 disease. No concomitant medications were reported.  On 05-APR-2021, an unspecified amount of time after vaccination, the patient experienced arm soreness and tiredness that resolved within 3 days.  On 15-APR-2021, 10 days after vaccination, the patient experienced calf pain and blood clot. It was reported the patient felt a very sharp pain on her right calf while walking, pain scale was 8/10, and it was so painful that she could not put pressure on it. Therefore, she decided to go to the hospital to have it checked. Her attending physician confirmed based on ultrasound that she has a blood clot on her right leg. She was prescribed blood thinner Eliquis (apixaban) however she was still undecided because her insurance denied to cover it and it was out of pocket. Once she returned home, she stated that the sharp pain was gone and it was just achy. After conversation with her physician, her physician postponed the medication for now because he wanted to make sure that her blood was not already thin before prescribing a blood thinner. She will go to the hospital again on 16-APR-2021 to see a hematologist for blood works and her physician advised her not to work until 20-APR-2021 as a preventive measure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm soreness, and tiredness on 08-APR-2021 and had not recovered from blood clot. This report was serious (Other Medically Important Condition, and Life Threatening).; Sender's Comments: V0:  a 36-year-old female experienced a blood clot in her right leg, 10 days after receiving the Janssen COVID-19 vaccine for prevention of COVID-19 infection.  The patient is a non-smoker, her BMI is 34.5; she has no other relevant medical history and reported no concomitant medications.    Ten days after receiving the vaccine, she felt a sharp pain, graded 8/10, in her right calf while walking.  Ultrasound showed a blood clot on her right leg.  She was prescribed Eliquis but did not fill the prescription and the pain subsided; she was to have further blood tests and see a physician the following day.  Additional information is being sought.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Thrombosis, Ultrasound Doppler abnormal
Clinical narrative: BLOOD CLOT; ARM SORENESS; TIREDNESS; This spontaneous report received from a patient and concerned a 36 year old  female. The patient's weight was 177 pounds and height was 165 centimeters. The patient's past medical history included fibroid surgery (fibroid was taken out 2 months), and concurrent conditions included alcohol drinker (once a week - occasionally), non-smoker, no drug abuse or illicit drug use, no known allergies. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, intramuscular (right deltoid), batch number: 043A21A) dose was not reported, administered on 05-APR-2021 for prevention of covid-19 disease. No concomitant medications were reported.  On 05-APR-2021, an unspecified amount of time after vaccination, the patient experienced arm soreness and tiredness that resolved within 3 days.  On 15-APR-2021, 10 days after vaccination, the patient experienced calf pain and blood clot. It was reported the patient felt a very sharp pain on her right calf while walking, pain scale was 8/10, and it was so painful that she could not put pressure on it. Therefore, she decided to go to the hospital to have it checked. Her attending physician confirmed based on ultrasound that she has a blood clot on her right leg. She was prescribed blood thinner Eliquis (apixaban) however she was still undecided because her insurance denied to cover it and it was out of pocket. Once she returned home, she stated that the sharp pain was gone and it was just achy. After conversation with her physician, her physician postponed the medication for now because he wanted to make sure that her blood was not already thin before prescribing a blood thinner. She will go to the hospital again on 16-APR-2021 to see a hematologist for blood works and her physician advised her not to work until 20-APR-2021 as a preventive measure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm soreness, and tiredness on 08-APR-2021 and had not recovered from blood clot. This report was serious (Other Medically Important Condition, and Life Threatening).; Sender's Comments: V0:  a 36-year-old female experienced a blood clot in her right leg, 10 days after receiving the Janssen COVID-19 vaccine for prevention of COVID-19 infection.  The patient is a non-smoker, her BMI is 34.5; she has no other relevant medical history and reported no concomitant medications.    Ten days after receiving the vaccine, she felt a sharp pain, graded 8/10, in her right calf while walking.  Ultrasound showed a blood clot on her right leg.  She was prescribed Eliquis but did not fill the prescription and the pain subsided; she was to have further blood tests and see a physician the following day.  Additional information is being sought.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Deep vein thrombosis, Pain in extremity, Ultrasound Doppler abnormal
Clinical narrative: BLOOD CLOT; ARM SORENESS; TIREDNESS; This spontaneous report received from a patient and concerned a 36 year old  female. The patient's weight was 177 pounds and height was 165 centimeters. The patient's past medical history included fibroid surgery (fibroid was taken out 2 months), and concurrent conditions included alcohol drinker (once a week - occasionally), non-smoker, no drug abuse or illicit drug use, no known allergies. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, intramuscular (right deltoid), batch number: 043A21A) dose was not reported, administered on 05-APR-2021 for prevention of covid-19 disease. No concomitant medications were reported.  On 05-APR-2021, an unspecified amount of time after vaccination, the patient experienced arm soreness and tiredness that resolved within 3 days.  On 15-APR-2021, 10 days after vaccination, the patient experienced calf pain and blood clot. It was reported the patient felt a very sharp pain on her right calf while walking, pain scale was 8/10, and it was so painful that she could not put pressure on it. Therefore, she decided to go to the hospital to have it checked. Her attending physician confirmed based on ultrasound that she has a blood clot on her right leg. She was prescribed blood thinner Eliquis (apixaban) however she was still undecided because her insurance denied to cover it and it was out of pocket. Once she returned home, she stated that the sharp pain was gone and it was just achy. After conversation with her physician, her physician postponed the medication for now because he wanted to make sure that her blood was not already thin before prescribing a blood thinner. She will go to the hospital again on 16-APR-2021 to see a hematologist for blood works and her physician advised her not to work until 20-APR-2021 as a preventive measure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm soreness, and tiredness on 08-APR-2021 and had not recovered from blood clot. This report was serious (Other Medically Important Condition, and Life Threatening).; Sender's Comments: V0:  a 36-year-old female experienced a blood clot in her right leg, 10 days after receiving the Janssen COVID-19 vaccine for prevention of COVID-19 infection.  The patient is a non-smoker, her BMI is 34.5; she has no other relevant medical history and reported no concomitant medications.    Ten days after receiving the vaccine, she felt a sharp pain, graded 8/10, in her right calf while walking.  Ultrasound showed a blood clot on her right leg.  She was prescribed Eliquis but did not fill the prescription and the pain subsided; she was to have further blood tests and see a physician the following day.  Additional information is being sought.
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Ear haemorrhage, Epistaxis, Haematospermia
Clinical narrative: EAR BLEED; BLOOD IN SEMEN; NOSE BLEED WITH CLOT; CHEST PRESSURE; This spontaneous report received from a patient concerned a 56 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: 1805031, expiry: 26-MAY-2021) dose was not reported, 1 total, administered on 16-MAR-2021 at right arm for prophylactic vaccination. No concomitant medications were reported. On 16-MAR-2021, the subject experienced chest pressure. On 23-MAR-2021, the subject experienced nose bleed with clot, ear bleeding and blood in semen within first week after the vaccine, blood in semen lasted around a week that reduced gradually and resolved. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nose bleed with clot on 11-APR-2021, ear bleed on 26-MAR-2021, and blood in semen on 02-APR-2021, and had not recovered from chest pressure. This report was non-serious.
Age: 59.0
Sex: U
Vaccine: COVID19
Symptoms: Burning sensation, Dyspnoea, Limb discomfort, Peripheral swelling, Scan
Clinical narrative: THROMBOSIS ARM; SHORTNESS OF BREATHE; ARM BURNING; ARM DISCOMFORT; SWOLLEN ARM; This spontaneous report received from a patient concerned a 59 year old of unspecified sex. The patient's height, and weight were not reported. The patient's past medical history included blood clots treated with Eliquis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and expiry: UNKNOWN) dose was not reported,1 total administered on 08-MAR-2021, left arm for prophylactic vaccination. No concomitant medications were reported.  On 22-MAR-2021, two weeks after vaccination the patient experienced swollen arm and arm discomfort. On 29-MAR-2021, the patient experienced shortness of breathe and arm burning. On 30-MAR-2021, the patient experienced thrombosis arm. Laboratory data (dates unspecified) included: Scan (NR: not provided) Right Arm Occluded. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from swollen arm, and shortness of breathe, and had not recovered from thrombosis arm, arm discomfort, and arm burning. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:  This 59-year-old of unspecified gender, currently on Eliquis for history of blood clots noted swelling of arm with discomfort and burning (described as "like from a match") as well as shortness of breath 14 days after receiving COVID-19 VACCINE AD26.COV2.S on left arm.  Scan showed right arm was occluded.  Treatment for the events was not reported; the patient is recovering from swelling of arm and shortness of breath; the patient have not recovered from thrombosis of arm and arm discomfort/burning.  The event is confounded by the underlying history of blood clots that is being treated medically.  However, the events are assessed as indeterminate with a causal association to immunization, per the causality classification for adverse events following immunization based on a lack of a definitive plausible biological mechanism.  Considering temporal relationship and recently evolving theories in the literature about COVID infections and vaccinations, potential vaccine contribution cannot be excluded.  Additional information has been requested for further assessment.
Age: 59.0
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: THROMBOSIS ARM; SHORTNESS OF BREATHE; ARM BURNING; ARM DISCOMFORT; SWOLLEN ARM; This spontaneous report received from a patient concerned a 59 year old of unspecified sex. The patient's height, and weight were not reported. The patient's past medical history included blood clots treated with Eliquis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and expiry: UNKNOWN) dose was not reported,1 total administered on 08-MAR-2021, left arm for prophylactic vaccination. No concomitant medications were reported.  On 22-MAR-2021, two weeks after vaccination the patient experienced swollen arm and arm discomfort. On 29-MAR-2021, the patient experienced shortness of breathe and arm burning. On 30-MAR-2021, the patient experienced thrombosis arm. Laboratory data (dates unspecified) included: Scan (NR: not provided) Right Arm Occluded. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from swollen arm, and shortness of breathe, and had not recovered from thrombosis arm, arm discomfort, and arm burning. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:  This 59-year-old of unspecified gender, currently on Eliquis for history of blood clots noted swelling of arm with discomfort and burning (described as "like from a match") as well as shortness of breath 14 days after receiving COVID-19 VACCINE AD26.COV2.S on left arm.  Scan showed right arm was occluded.  Treatment for the events was not reported; the patient is recovering from swelling of arm and shortness of breath; the patient have not recovered from thrombosis of arm and arm discomfort/burning.  The event is confounded by the underlying history of blood clots that is being treated medically.  However, the events are assessed as indeterminate with a causal association to immunization, per the causality classification for adverse events following immunization based on a lack of a definitive plausible biological mechanism.  Considering temporal relationship and recently evolving theories in the literature about COVID infections and vaccinations, potential vaccine contribution cannot be excluded.  Additional information has been requested for further assessment.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis
Clinical narrative: FEMORAL DEEP VEIN THROMBOSIS; This spontaneous report received from a physician concerned a 30-40 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions were unknown.  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 25-MAR-2021 for prophylactic vaccination. The batch number was not reported. the company is unable to perform follow-up to request batch/lot numbers.  No concomitant medications were reported.  On 14-APR-2021, approximately 20 days after the patient received vaccination, he experienced femoral deep vein thrombosis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from femoral deep vein thrombosis. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: A 30-40 year-old man experienced femoral deep vein thrombosis approximately 20 days after vaccination. No past medical history or concomitant medications were reported. There were no details provided, including diagnostic workup. There is insufficient information to make a meaningful medical assessment.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Dyspnoea, Epistaxis, Feeling of body temperature change
Clinical narrative: GAGGING; SHORTNESS OF BREATH; BACK HURTING; NOSEBLEED; GETTING HOT AND COLD; LEG PAIN / SORE ARM; CHILLS; HEADACHE; This spontaneous report received from a patient concerned a 56 year old female patient. 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: 1805025, expiry: not reported) dose was not reported, administered on 01-APR-2021 to the left arm as prophylactic vaccination. No concomitant medications were reported.  On 02-APR-2021, the day after vaccination, the patient experienced chills, hurting back, feeling hot and cold, headache and sore arms. The patient administered TYLENOL (acetaminophen) for headache. She stated the lower part of back was hurting so that she increased her water intake but the pain did not go away. On 03-APR-2021, third day after vaccination, the patient experienced blood clot came out of nose and nose started bleeding, described as dark red (subsumed under nosebleed).  At the same time on 03-APR-2021, patient experienced gagging, pain in legs, and shortness of breath. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, nosebleed, leg pain / sore arm, and shortness of breath, and the outcome of chills, back hurting, gagging and getting hot and cold was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Retching
Clinical narrative: GAGGING; SHORTNESS OF BREATH; BACK HURTING; NOSEBLEED; GETTING HOT AND COLD; LEG PAIN / SORE ARM; CHILLS; HEADACHE; This spontaneous report received from a patient concerned a 56 year old female patient. 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: 1805025, expiry: not reported) dose was not reported, administered on 01-APR-2021 to the left arm as prophylactic vaccination. No concomitant medications were reported.  On 02-APR-2021, the day after vaccination, the patient experienced chills, hurting back, feeling hot and cold, headache and sore arms. The patient administered TYLENOL (acetaminophen) for headache. She stated the lower part of back was hurting so that she increased her water intake but the pain did not go away. On 03-APR-2021, third day after vaccination, the patient experienced blood clot came out of nose and nose started bleeding, described as dark red (subsumed under nosebleed).  At the same time on 03-APR-2021, patient experienced gagging, pain in legs, and shortness of breath. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, nosebleed, leg pain / sore arm, and shortness of breath, and the outcome of chills, back hurting, gagging and getting hot and cold was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Fall, Heart rate, Heart rate decreased, Inflammation
Clinical narrative: kidney infection; back was still hurting; heart rate at the second ER visit was 42 bpm; fell about 4 feet off a ladder onto his back; inflamed back; This spontaneous case was reported by a non-health professional and describes the occurrence of KIDNEY INFECTION (kidney infection) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No relevant medical history reported).    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced FALL (fell about 4 feet off a ladder onto his back) and INFLAMMATION (inflamed back). On 03-Apr-2021, the patient experienced BACK PAIN (back was still hurting) and HEART RATE DECREASED (heart rate at the second ER visit was 42 bpm). On an unknown date, the patient experienced KIDNEY INFECTION (kidney infection) (seriousness criterion medically significant). On 19-Mar-2021, FALL (fell about 4 feet off a ladder onto his back) had resolved. At the time of the report, KIDNEY INFECTION (kidney infection), INFLAMMATION (inflamed back) and HEART RATE DECREASED (heart rate at the second ER visit was 42 bpm) outcome was unknown and BACK PAIN (back was still hurting) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Apr-2021, Heart rate: 42 (Inconclusive) Inconclusive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  On 03 Apr 2021, he was prescribed ciprofloxacin and hydrocodone/acetaminophen which he has completed.  Based on the current available information and temporal association between the use of the product and the start date of the events fall, kidney infection and heart rate decreased, a causal relationship cannot be excluded. The event: inflamed back is unlikely related.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events fall, kidney infection and heart rate decreased, a causal relationship cannot be excluded. The event: inflamed back is unlikely related.
Sex: M
Vaccine: COVID19
Symptoms: Kidney infection
Clinical narrative: kidney infection; back was still hurting; heart rate at the second ER visit was 42 bpm; fell about 4 feet off a ladder onto his back; inflamed back; This spontaneous case was reported by a non-health professional and describes the occurrence of KIDNEY INFECTION (kidney infection) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No relevant medical history reported).    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced FALL (fell about 4 feet off a ladder onto his back) and INFLAMMATION (inflamed back). On 03-Apr-2021, the patient experienced BACK PAIN (back was still hurting) and HEART RATE DECREASED (heart rate at the second ER visit was 42 bpm). On an unknown date, the patient experienced KIDNEY INFECTION (kidney infection) (seriousness criterion medically significant). On 19-Mar-2021, FALL (fell about 4 feet off a ladder onto his back) had resolved. At the time of the report, KIDNEY INFECTION (kidney infection), INFLAMMATION (inflamed back) and HEART RATE DECREASED (heart rate at the second ER visit was 42 bpm) outcome was unknown and BACK PAIN (back was still hurting) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Apr-2021, Heart rate: 42 (Inconclusive) Inconclusive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  On 03 Apr 2021, he was prescribed ciprofloxacin and hydrocodone/acetaminophen which he has completed.  Based on the current available information and temporal association between the use of the product and the start date of the events fall, kidney infection and heart rate decreased, a causal relationship cannot be excluded. The event: inflamed back is unlikely related.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events fall, kidney infection and heart rate decreased, a causal relationship cannot be excluded. The event: inflamed back is unlikely related.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Stevens-Johnson syndrome
Clinical narrative: Stevens johnson syndrome/Small blisters first appeared in the nose and around the eyes a couple days; This is a spontaneous report from a contactable consumer (patient). A 71-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 28Jan2021 19:00 (Batch/Lot Number: el3247) as a single dose, and her second dose via an unspecified route of administration in left arm on 17Feb2021 11:30 (Batch/Lot Number: en7201) as a single dose for COVID-19 immunization. Medical history included allergies to sulfa and mycin drugs. Concomitant medications included Tamsulosin, atorvastatin, prasugrel, and acetylsalicylic acid (BABY ASPIRIN). The patient was not diagnosed with COVID-19 prior to vaccination. On 02Feb2021, the patient experienced Stevens Johnson Syndrome - small blisters first appeared in the nose and around the eyes a couple days after shot #1. It exploded with blisters all over face, neck and body a couple of days after the second shot. Patient had large blisters and open sores today and still getting new blisters 6 weeks after shot #2. Patient initially assumed that this was shingles in spite of the fact that he had the new shingles shot. He went to the doctor this morning and he diagnosed it as Stevens Johnson Syndrome. Biopsy was taken and sent to a lab. There was no other change in medication history, food, or exposure to potential allergens. Therapeutic measure included gabapentin to lessen pain. Events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Outcome of events was not recovered. The patient had not been tested for COVID-19 since the vaccination.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Blood potassium, Blood sodium, Dizziness, Dry mouth, Headache
Clinical narrative: tachycardia (avg. 125 bpm); dry mouth; low sodium; low potassium; excruciating headache with light and sound sensitivity/head pounding; light and sound sensitivity; light and sound sensitivity; nausea; lightheadedness; My arm was sore; Felt absolutely terrible; This is a spontaneous report from a contactable consumer (patient). A 61-year-old non-pregnant female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8734), via an unspecified route of administration, administered in left arm on 01Apr2021 13:30 (1:30 pm) as single dose for COVID-19 immunization in a clinic. Medical history included autoimmune hypothyroidism, gastrooesophageal reflux disease and don't tolerate NSAIDs but not allergic all from an unknown date. Concomitant medications included levothyroxine; esomeprazole magnesium (NEXIUM); cetirizine hydrochloride (ZYRTEC ALLERGY); gabapentin; and estradiol (ESTROGEL) all taken for an unspecified indication, start and stop date were not reported. The patient previously took erythromicin and experienced drug intolerance but not allergic on an unspecified date. The patient previously received the first dose of bnt162b2 (lot number: EN6204) on 11Mar2021 1:30 pm administered in left arm for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested since the vaccination. On 01Apr2021, it was reported that the patient experienced tachycardia (avg. 125 bpm), dry mouth, low sodium, low potassium, excruciating headache/head pounding, light and sound sensitivity, nausea, lightheadedness, arm was sore, and felt absolutely terrible. The patient was hospitalized for tachycardia (avg. 125 bpm) for 1 day. The events required physician office and emergency room visit. the patient was treated with IV saline, IV anti-nausea, and IV morphine. The patient underwent lab tests and procedures which included blood potassium: low, blood sodium: low, and heart rate: 125 bpm - tachycardia all on 01Apr2021. The outcome of the events was recovered.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Hyperacusis, Hypokalaemic syndrome, Hyponatraemic syndrome, Malaise
Clinical narrative: tachycardia (avg. 125 bpm); dry mouth; low sodium; low potassium; excruciating headache with light and sound sensitivity/head pounding; light and sound sensitivity; light and sound sensitivity; nausea; lightheadedness; My arm was sore; Felt absolutely terrible; This is a spontaneous report from a contactable consumer (patient). A 61-year-old non-pregnant female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8734), via an unspecified route of administration, administered in left arm on 01Apr2021 13:30 (1:30 pm) as single dose for COVID-19 immunization in a clinic. Medical history included autoimmune hypothyroidism, gastrooesophageal reflux disease and don't tolerate NSAIDs but not allergic all from an unknown date. Concomitant medications included levothyroxine; esomeprazole magnesium (NEXIUM); cetirizine hydrochloride (ZYRTEC ALLERGY); gabapentin; and estradiol (ESTROGEL) all taken for an unspecified indication, start and stop date were not reported. The patient previously took erythromicin and experienced drug intolerance but not allergic on an unspecified date. The patient previously received the first dose of bnt162b2 (lot number: EN6204) on 11Mar2021 1:30 pm administered in left arm for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested since the vaccination. On 01Apr2021, it was reported that the patient experienced tachycardia (avg. 125 bpm), dry mouth, low sodium, low potassium, excruciating headache/head pounding, light and sound sensitivity, nausea, lightheadedness, arm was sore, and felt absolutely terrible. The patient was hospitalized for tachycardia (avg. 125 bpm) for 1 day. The events required physician office and emergency room visit. the patient was treated with IV saline, IV anti-nausea, and IV morphine. The patient underwent lab tests and procedures which included blood potassium: low, blood sodium: low, and heart rate: 125 bpm - tachycardia all on 01Apr2021. The outcome of the events was recovered.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Photosensitivity reaction, Tachycardia
Clinical narrative: tachycardia (avg. 125 bpm); dry mouth; low sodium; low potassium; excruciating headache with light and sound sensitivity/head pounding; light and sound sensitivity; light and sound sensitivity; nausea; lightheadedness; My arm was sore; Felt absolutely terrible; This is a spontaneous report from a contactable consumer (patient). A 61-year-old non-pregnant female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8734), via an unspecified route of administration, administered in left arm on 01Apr2021 13:30 (1:30 pm) as single dose for COVID-19 immunization in a clinic. Medical history included autoimmune hypothyroidism, gastrooesophageal reflux disease and don't tolerate NSAIDs but not allergic all from an unknown date. Concomitant medications included levothyroxine; esomeprazole magnesium (NEXIUM); cetirizine hydrochloride (ZYRTEC ALLERGY); gabapentin; and estradiol (ESTROGEL) all taken for an unspecified indication, start and stop date were not reported. The patient previously took erythromicin and experienced drug intolerance but not allergic on an unspecified date. The patient previously received the first dose of bnt162b2 (lot number: EN6204) on 11Mar2021 1:30 pm administered in left arm for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested since the vaccination. On 01Apr2021, it was reported that the patient experienced tachycardia (avg. 125 bpm), dry mouth, low sodium, low potassium, excruciating headache/head pounding, light and sound sensitivity, nausea, lightheadedness, arm was sore, and felt absolutely terrible. The patient was hospitalized for tachycardia (avg. 125 bpm) for 1 day. The events required physician office and emergency room visit. the patient was treated with IV saline, IV anti-nausea, and IV morphine. The patient underwent lab tests and procedures which included blood potassium: low, blood sodium: low, and heart rate: 125 bpm - tachycardia all on 01Apr2021. The outcome of the events was recovered.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Pericarditis, SARS-CoV-2 test
Clinical narrative: pericarditis; Chest pain; This is a spontaneous report from a non-contactable physician. A 20-year-old female patient received second dose of BNT162B2 (Batch/Lot number and expiry date was not reported), via an unspecified route of administration on 31Mar2021 as a single dose for COVID-19 immunization. Medical history included generalised anxiety from an unknown date. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 on 10Mar2021 for COVID-19 immunization. On 01Apr2021, the patient experienced pericarditis and chest pain. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included Nasal swab and PCR: both negative on an unknown date. The adverse events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were taken as a result of pericarditis and chest pain which included High Dose NSAIDs. The outcome of the events was unknown. The events were assessed as serious which caused hospitalization.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: The events pericarditis and chest pain are most likely intercurrent conditions and unrelated to suspect vaccine BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Postmenopausal haemorrhage
Clinical narrative: Vaginal bleeding--got what appears to be my period although I stopped menstruating a year ago.; This is a spontaneous report from a Pfizer-sponsored program Corporate (Pfizer) Social Media Platforms from a contactable consumer, the patient. A 52-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in the left arm on 21Mar2021 at 14:00 (Lot Number: ER8732) as single dose for COVID-19 immunisation. Medical history included psoriasis of scalp from an unknown date and unknown if ongoing. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medications included adalimumab (HUMIRA), loratadine, and omeprazole (OMEPRAZOL); all from unknown dates, for unspecified indications.  The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in the left arm on 27Feb2021 at 14:00 (Lot Number: EN6198), (at the age of 52 years old), as single dose for COVID-19 immunisation.  On 29Mar2021 at 15:00 the patient experienced vaginal bleeding, the patient got what appears to be her period although she stopped menstruating a year ago.  The patient stated they had both doses and no negative reaction, but the patient inquired if it's just coincidence or if there is a connection with getting your period suddenly start again after its stopped (patient had not had a period in about a year), since the patient did about a week after the second dose. The patient did not receive any treatment for the event. The clinical outcome of the postmenopausal bleeding was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Hyperpyrexia
Clinical narrative: 101F fever; chills; headache; fatigue; swollen lymph nodes in armpit and right clavicle; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female non-pregnant patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in right arm on 01Apr2021, at 15:00 (at the age of 46-year-old) as a single dose for COVID-19 immunisation. The patient medical history included Obesity, Hypothyroidism and High blood pressure. Allergies to medications, food, or other products was reported as none. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient concomitant medication included levothyroxine, amlodipine and rosuvastatin. The patient had not received any other vaccine within 4 weeks prior to the vaccine. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) in right arm, on 11Mar2021 at 15:00 for COVID-19 immunization. On 01Apr2021, at 21:00 the patient experienced 101F fever, chills, headache, fatigue, swollen lymph nodes in armpit and right clavicle. The therapeutic measures were taken as a result of events include extra sleep, extra fluids and acetaminophen. The patient underwent laboratory tests and procedure included body temperature resulted in 101 Fahrenheit on 01Apr2021. The outcome of the events was recovering.  Information about batch/Lot number has been requested.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: 101F fever; chills; headache; fatigue; swollen lymph nodes in armpit and right clavicle; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female non-pregnant patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in right arm on 01Apr2021, at 15:00 (at the age of 46-year-old) as a single dose for COVID-19 immunisation. The patient medical history included Obesity, Hypothyroidism and High blood pressure. Allergies to medications, food, or other products was reported as none. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient concomitant medication included levothyroxine, amlodipine and rosuvastatin. The patient had not received any other vaccine within 4 weeks prior to the vaccine. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) in right arm, on 11Mar2021 at 15:00 for COVID-19 immunization. On 01Apr2021, at 21:00 the patient experienced 101F fever, chills, headache, fatigue, swollen lymph nodes in armpit and right clavicle. The therapeutic measures were taken as a result of events include extra sleep, extra fluids and acetaminophen. The patient underwent laboratory tests and procedure included body temperature resulted in 101 Fahrenheit on 01Apr2021. The outcome of the events was recovering.  Information about batch/Lot number has been requested.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Decreased appetite, Dizziness, Fatigue, Headache
Clinical narrative: I then felt very fatigued & came down with w/a fever that night.; the headache was improved; I felt a lot of fatigue; a lot of arm pain; I felt some mild dizziness later in the day; irritable bowels throughout the day as well as a loss of appetite./My appetite is very much diminished; irritable bowels throughout the day as well as a loss of appetite.; I also started experiencing an odd ribcage/breast pain on the side of the injection (left side).; This is a spontaneous report from a contactable consumer (patient).  A 56-year-old female patient (Patient was not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number: EW0150), via an unspecified route of administration in the left arm on 02Apr2021 (age at time of vaccination: 55-years-old) at a single dose for COVID-19 immunization. Medical history included asthma, allergies to medications, food, or other products as Tree Nuts and NSAIDS. Concomitant medication patient received within 2 weeks of vaccination included zyrtec, vitamins C, Vitamin D, Vitamin E, Probiotic and Tylenol. The patient previously took first dose of BNT162B2 for COVID-19 immunization. The patient experienced about 90 mins after 1 vaccine dose on 02Apr2021 at 04:00 PM, she developed a strong headache. The patient then felt very fatigued and came down with fever that night. The next day (yesterday), the headache was improved still present but she felt a lot of fatigue and a lot of arm pain. She felt some mild dizziness later in the day and irritable bowels throughout the day as well as a loss of appetite. On 02Apr2021, a day after 2 vaccine dose, she again felt fatigued with mild headache. her appetite was very much diminished with still irritable bowels. She also started experiencing an odd ribcage or breast pain on the side of the injection, it was felt like deep shooting pains. There was no pain or redness or swelling. she not breast issues to date (last mammography was clear-Fall 2018). Facility where the most recent COVID-19 vaccine was administered was Clinic. The event was considered as non-serious. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. No treatment was received for the events. The patient underwent lab tests and procedures which included Nasal swab was unknown on 02Apr2021. The outcome of the events was not recovered.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Irritable bowel syndrome, Pain in extremity, SARS-CoV-2 test, Syncope
Clinical narrative: I then felt very fatigued & came down with w/a fever that night.; the headache was improved; I felt a lot of fatigue; a lot of arm pain; I felt some mild dizziness later in the day; irritable bowels throughout the day as well as a loss of appetite./My appetite is very much diminished; irritable bowels throughout the day as well as a loss of appetite.; I also started experiencing an odd ribcage/breast pain on the side of the injection (left side).; This is a spontaneous report from a contactable consumer (patient).  A 56-year-old female patient (Patient was not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number: EW0150), via an unspecified route of administration in the left arm on 02Apr2021 (age at time of vaccination: 55-years-old) at a single dose for COVID-19 immunization. Medical history included asthma, allergies to medications, food, or other products as Tree Nuts and NSAIDS. Concomitant medication patient received within 2 weeks of vaccination included zyrtec, vitamins C, Vitamin D, Vitamin E, Probiotic and Tylenol. The patient previously took first dose of BNT162B2 for COVID-19 immunization. The patient experienced about 90 mins after 1 vaccine dose on 02Apr2021 at 04:00 PM, she developed a strong headache. The patient then felt very fatigued and came down with fever that night. The next day (yesterday), the headache was improved still present but she felt a lot of fatigue and a lot of arm pain. She felt some mild dizziness later in the day and irritable bowels throughout the day as well as a loss of appetite. On 02Apr2021, a day after 2 vaccine dose, she again felt fatigued with mild headache. her appetite was very much diminished with still irritable bowels. She also started experiencing an odd ribcage or breast pain on the side of the injection, it was felt like deep shooting pains. There was no pain or redness or swelling. she not breast issues to date (last mammography was clear-Fall 2018). Facility where the most recent COVID-19 vaccine was administered was Clinic. The event was considered as non-serious. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. No treatment was received for the events. The patient underwent lab tests and procedures which included Nasal swab was unknown on 02Apr2021. The outcome of the events was not recovered.  Information on Lot/Batch number was available. Additional information has been requested.