chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: Coughs more/no mucus in the cough; This is a spontaneous report from a contactable consumer (patient). This female patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on 06Mar2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient called to inquire if she had to go to the same pharmacy to get both doses of BNT162B2. She reported she got her first dose of BNT162B2 on 06Mar2021 and last week she noticed that she coughed more. She stated there was no mucus in the cough and she planned to take guaifenesin (MUCINEX) for her cough. The clinical outcome of coughs more/no mucus in the cough was unknown.   Information about batch/lot number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Bone development abnormal, Immune system disorder
Clinical narrative: Immune system went into hyperdrive; She started growing bones where they shouldn't be; This is a spontaneous report from a contactable consumer. A female patient of unspecified age received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The reporter stated his friend's wife received the vaccine and had a reaction where her immune system went into "hyperdrive" and she started growing bones where they shouldn't be. The clinical outcomes of immune system went into "hyperdrive" and she started growing bones where they shouldn't be were unknown.   Information about batch/lot number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal distension, Blood test, Chills, Cognitive disorder, Diarrhoea
Clinical narrative: Severe diarrhea, extreme abdominal gas and bloating, this caused a pause in radiation treatments, nausea, chills, insomnia, cognitive impairment
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Loss of personal independence in daily activities, Nausea, Urine analysis
Clinical narrative: Severe diarrhea, extreme abdominal gas and bloating, this caused a pause in radiation treatments, nausea, chills, insomnia, cognitive impairment
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Hyperhidrosis
Clinical narrative: Severe abdominal cramping and excessive sweating for 15-20 min followed by bowel movements. Same symptoms again in 2 hours.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, SARS-CoV-2 test positive
Clinical narrative: Patient recieved covid vaccine #2 4/7/2021. Of note first dose was Moderna, second dose was Pfizer. Tested +Covid 4/15/2021, admitted to hospital with weakness.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Action tremor, Aphasia, C-reactive protein, Chills, Confusional state
Clinical narrative: he received Moderna vaccine on 03/15/2021 and on 04/13/2021.    On the day following his second dose of vaccine, he awoke fever up to 103, chills, and confusion, so wife called 911.             Per neurology consult 4/15 -  "... he got his COVID vaccine Tuesday (one day before admission), and since then he's felt warm and shaking. Jaw has had abnormal movements and clenching, upper extremities have had random, non-rhythmic, jerks. Not rhythmic shaking. Not tremor. Just jerks. Worse when he goes to grab something.  He's also having some altered mentation, mild confusion, though he can talk, he sounds confused and cannot find all of his words."              Tm 103.4.   On exam  4/15 one day after admission, He had upper motor neuron irritability signs, 3+ reflexes, myotonic jerks, new action tremor, jaw pain from constant jaw movements.   + headache.  Keppra and / or mirapex, then ativan later, seemed to help.  Symptoms had completely resolved by 4/16/21.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Dyskinesia, Feeling hot, Headache, Hyperreflexia, Magnetic resonance imaging head
Clinical narrative: he received Moderna vaccine on 03/15/2021 and on 04/13/2021.    On the day following his second dose of vaccine, he awoke fever up to 103, chills, and confusion, so wife called 911.             Per neurology consult 4/15 -  "... he got his COVID vaccine Tuesday (one day before admission), and since then he's felt warm and shaking. Jaw has had abnormal movements and clenching, upper extremities have had random, non-rhythmic, jerks. Not rhythmic shaking. Not tremor. Just jerks. Worse when he goes to grab something.  He's also having some altered mentation, mild confusion, though he can talk, he sounds confused and cannot find all of his words."              Tm 103.4.   On exam  4/15 one day after admission, He had upper motor neuron irritability signs, 3+ reflexes, myotonic jerks, new action tremor, jaw pain from constant jaw movements.   + headache.  Keppra and / or mirapex, then ativan later, seemed to help.  Symptoms had completely resolved by 4/16/21.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Mental status changes, Myotonia, Pain in jaw, Pyrexia, Scan with contrast
Clinical narrative: he received Moderna vaccine on 03/15/2021 and on 04/13/2021.    On the day following his second dose of vaccine, he awoke fever up to 103, chills, and confusion, so wife called 911.             Per neurology consult 4/15 -  "... he got his COVID vaccine Tuesday (one day before admission), and since then he's felt warm and shaking. Jaw has had abnormal movements and clenching, upper extremities have had random, non-rhythmic, jerks. Not rhythmic shaking. Not tremor. Just jerks. Worse when he goes to grab something.  He's also having some altered mentation, mild confusion, though he can talk, he sounds confused and cannot find all of his words."              Tm 103.4.   On exam  4/15 one day after admission, He had upper motor neuron irritability signs, 3+ reflexes, myotonic jerks, new action tremor, jaw pain from constant jaw movements.   + headache.  Keppra and / or mirapex, then ativan later, seemed to help.  Symptoms had completely resolved by 4/16/21.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor, Trismus
Clinical narrative: he received Moderna vaccine on 03/15/2021 and on 04/13/2021.    On the day following his second dose of vaccine, he awoke fever up to 103, chills, and confusion, so wife called 911.             Per neurology consult 4/15 -  "... he got his COVID vaccine Tuesday (one day before admission), and since then he's felt warm and shaking. Jaw has had abnormal movements and clenching, upper extremities have had random, non-rhythmic, jerks. Not rhythmic shaking. Not tremor. Just jerks. Worse when he goes to grab something.  He's also having some altered mentation, mild confusion, though he can talk, he sounds confused and cannot find all of his words."              Tm 103.4.   On exam  4/15 one day after admission, He had upper motor neuron irritability signs, 3+ reflexes, myotonic jerks, new action tremor, jaw pain from constant jaw movements.   + headache.  Keppra and / or mirapex, then ativan later, seemed to help.  Symptoms had completely resolved by 4/16/21.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus - no known cure
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: High fever, 102+ Aches, chills  Tylenol treatment 500mg
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Injection Site: Light pain, tenderness, swelling and redness from 20:00h for roughly 24 hours.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Soreness specifically at injection site (right arm muscle) 10 days after vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure abnormal, Dizziness, Malaise, Nausea, Presyncope
Clinical narrative: got really sick; felt like passing out; got dizzy; nauseated feeling; blood pressure went down or up; This is a spontaneous report from a contactable consumer (patient). This 80-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on 23Feb2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient called to inquire about what time she would be picked up for her second vaccination and reported that after her first dose she ate a pork chop and got really sick; further stating she felt like passing out and got dizzy. She reported that two weeks after she still had a nauseated feeling like she was going to throw up and was unsure if her blood pressure went down or up because she couldn't find her blood pressure cuff. She inquired if the second dose of the vaccine would be worse. The clinical outcomes of got really sick, felt like passing out, got dizzy, nauseated feeing and blood pressure went down or up were unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Erythema of eyelid, Eyelid oedema, Eyelid pain
Clinical narrative: eyelids are all puffy, red and sore; eyelids are all puffy, red and sore; eyelids are all puffy, red and sore; This is a spontaneous report received from a non-contactable consumer, the patient. This female patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 12Mar2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On the morning of 15Mar2021, the patient experienced her eyelids are all puffy, red and sore. The clinical outcome of the "eyelids are all puffy, red and sore" was unknown.   The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: No additional AE's; ROTATEQ that underwent a temperature excrusion was administered to one patient; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not provided.  On 07-APR-2021, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # 1660995, expiration date 01-MAY-2021) orally for prophylaxis (strength, dose and vaccination schedule were not provided); The reporter stated that the vaccines had a temperature excursion of 10 degree Celsius for 1 hour, which was detected by a data logger and the vaccines had no previous temperature excrusions. No additional adverse event was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Balance disorder, Deafness, Herpes zoster, Post herpetic neuralgia
Clinical narrative: postherpetic neuralgia; hearing loss; balance problems; herpes zoster; Information has been received from a lawyer regarding a case in litigation which referred to a patient (pt) of unknown gender and age. Information regarding concomitant medications, concurrent conditions or medical history was not provided. On an unknown date, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for its intended purpose: the prevention of shingles (herpes zoster) and for routine health maintenance (exact dose, dose number, route of administration, anatomical site of vaccination, lot number and expiration date were not provided). Afterwards, on an unknown date (reported as after receiving zoster vaccine live (ZOSTAVAX) vaccine), the patient suffered herpes zoster, postherpetic neuralgia, hearing loss (deafness) and balance problems. As a result of these symptoms, the patient was seen and treated by medical providers and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX vaccine, the pt's symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of pt's condition. In addition, the pt sustained severe and permanent personal injuries. Further, the pt had suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. Finally, as direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered as not recovered The causal relationship between the events and zoster vaccine live (ZOSTAVAX) was assessed as related.  Herpes zoster, postherpetic neuralgia, hearing loss and balance problems were considered as disabling events by the reporter.   Upon internal review, the event of hearing loss was determined to be medically significant.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Mobility decreased, Nasal congestion, Pain in extremity, Vaccination site urticaria
Clinical narrative: not able to rise arm up more than 90 degrees; hives are going down the arm; Chills; soreness/tenderness in the arm; Nasal congestion; A spontaneous report was received from a Healthcare Professional concerning a 45-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events of not able to rise arm up more than 90 degrees (Disabling/Incapacitating), more tenderness in the arm, soreness, nasal congestion, body aches, chills, and hives are going down the arm.  The patient's medical history was not provided. Concomitant medications reported were Multivitamins.  On unknown date, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot : 025L20A) intramuscularly in the right deltoid for prophylaxis of COVID-19 infection.   On 26 Jan 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot: 032O20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 27 Jan 2021, the patient experienced the events tenderness, soreness, nasal congestion, body aches, chills.   On 28 Jan 2021, the patient experienced the events more tenderness in the arm, hives are going down the arm and not able to rise it up more than 90 degrees.  Treatment included Benadryl and Pepsid.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome was not reported for all events.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Loss of consciousness
Clinical narrative: Stroke; Unconscious; This spontaneous case was reported by a patient family member or friend and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) and LOSS OF CONSCIOUSNESS (Unconscious) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criteria hospitalization and medically significant) and LOSS OF CONSCIOUSNESS (Unconscious) (seriousness criteria hospitalization and medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke) and LOSS OF CONSCIOUSNESS (Unconscious) outcome was unknown.            Concomitant medications were not reported.  Treatment information was not provided.; 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, a causal relationship cannot be excluded.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Blood potassium, Blood test, Fatigue, Hunger, Malaise
Clinical narrative: She was throwing up; She felt really sick; Stomach feels empty; She feels tired; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MALAISE (She felt really sick) and VOMITING (She was throwing up) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 015M20A) 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 reported medical history). Concomitant products included ANASTROZOLE and MULTI VIT for an unknown indication.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced MALAISE (She felt really sick) (seriousness criterion hospitalization). On 28-Mar-2021, the patient experienced VOMITING (She was throwing up) (seriousness criterion hospitalization). On 10-Apr-2021, the patient experienced HUNGER (Stomach feels empty) and FATIGUE (She feels tired). The patient was hospitalized from 28-Mar-2021 to 10-Apr-2021 due to MALAISE and VOMITING. At the time of the report, MALAISE (She felt really sick) and VOMITING (She was throwing up) outcome was unknown and HUNGER (Stomach feels empty) and FATIGUE (She feels tired) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Mar-2021, Blood test: normal (normal) Normal. On 28-Mar-2021, Blood potassium: decreased (Low) Decreased. On 28-Mar-2021, White blood cell count: decreased (Low) Decreased.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication included intravenous (IV) potassium for 24 hours, unspecified antibiotics, and unspecified medication for vomiting. Description: On 26 Mar 2021, the patient felt really sick, went to hospital, and was sent back to home. The patient's blood test was fine. On 28 Mar 2021, she felt really sick, and was throwing up. The patient went back to hospital, more blood work was done which showed white blood cells and potassium had dropped. The patient was in intensive care unit (ICU) for two and half days to three days in other part of the hospital for taking her blood levels to normal. On 10 Apr 2021, she was discharged from the hospital. The patient feels tired, and stomach feels like empty sometimes, puts crackers on it and it feels better.  Company comment: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting, White blood cell count
Clinical narrative: She was throwing up; She felt really sick; Stomach feels empty; She feels tired; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MALAISE (She felt really sick) and VOMITING (She was throwing up) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 015M20A) 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 reported medical history). Concomitant products included ANASTROZOLE and MULTI VIT for an unknown indication.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced MALAISE (She felt really sick) (seriousness criterion hospitalization). On 28-Mar-2021, the patient experienced VOMITING (She was throwing up) (seriousness criterion hospitalization). On 10-Apr-2021, the patient experienced HUNGER (Stomach feels empty) and FATIGUE (She feels tired). The patient was hospitalized from 28-Mar-2021 to 10-Apr-2021 due to MALAISE and VOMITING. At the time of the report, MALAISE (She felt really sick) and VOMITING (She was throwing up) outcome was unknown and HUNGER (Stomach feels empty) and FATIGUE (She feels tired) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Mar-2021, Blood test: normal (normal) Normal. On 28-Mar-2021, Blood potassium: decreased (Low) Decreased. On 28-Mar-2021, White blood cell count: decreased (Low) Decreased.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication included intravenous (IV) potassium for 24 hours, unspecified antibiotics, and unspecified medication for vomiting. Description: On 26 Mar 2021, the patient felt really sick, went to hospital, and was sent back to home. The patient's blood test was fine. On 28 Mar 2021, she felt really sick, and was throwing up. The patient went back to hospital, more blood work was done which showed white blood cells and potassium had dropped. The patient was in intensive care unit (ICU) for two and half days to three days in other part of the hospital for taking her blood levels to normal. On 10 Apr 2021, she was discharged from the hospital. The patient feels tired, and stomach feels like empty sometimes, puts crackers on it and it feels better.  Company comment: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebral haemorrhage, Cerebrovascular accident, Coma, Confusional state, Fall
Clinical narrative: Acute  intertribal hemorrhage; Stroke; Starting getting confused; Had a fall; Brain bleeding, brain hemorrhage; Induced coma; This spontaneous case was reported by a consumer and describes the occurrence of CEREBRAL HAEMORRHAGE (Acute  intertribal hemorrhage), CEREBROVASCULAR ACCIDENT (Stroke), CONFUSIONAL STATE (Starting getting confused), FALL (Had a fall), HAEMORRHAGE (Brain bleeding, brain hemorrhage) and COMA (Induced coma) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) Dosage form. On 24-Mar-2021, the patient experienced COMA (Induced coma) (seriousness criterion medically significant). On an unknown date, the patient experienced CEREBRAL HAEMORRHAGE (Acute  intertribal hemorrhage) (seriousness criterion death), CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criterion medically significant), CONFUSIONAL STATE (Starting getting confused) (seriousness criterion medically significant), FALL (Had a fall) (seriousness criterion medically significant) and HAEMORRHAGE (Brain bleeding, brain hemorrhage) (seriousness criterion medically significant). The patient died on an unknown date. The reported cause of death was intra cerebral hemorrhage. At the time of death, CEREBROVASCULAR ACCIDENT (Stroke), CONFUSIONAL STATE (Starting getting confused), FALL (Had a fall), HAEMORRHAGE (Brain bleeding, brain hemorrhage) and COMA (Induced coma) outcome was unknown. Not Provided          Concomitant medication not provided. No treatment information/hospitalization information provided.  This case concerns death of a 79-year-old male patient who expired from acute intertribal hemorrhage after receiving mRNA-1273 vaccine.  three days after vaccine administration, the patient developed confusion and fell with subsequent events ensuing.  Based on the available information causal association between the event if confusion leading to fall and product use cannot be excluded.  The other events are assessed as directly related to the fall and unlikely due to product use.; Sender's Comments: This case concerns death of a 79-year-old male patient who expired from acute intertribal hemorrhage after receiving mRNA-1273 vaccine.  three days after vaccine administration, the patient developed confusion and fell with subsequent events ensuing.  Based on the available information causal association between the event if confusion leading to fall and product use cannot be excluded.  The other events are assessed as directly related to the fall and unlikely due to product use.; Reported Cause(s) of Death: intra cerebral hemorrhage
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Haemorrhage
Clinical narrative: Acute  intertribal hemorrhage; Stroke; Starting getting confused; Had a fall; Brain bleeding, brain hemorrhage; Induced coma; This spontaneous case was reported by a consumer and describes the occurrence of CEREBRAL HAEMORRHAGE (Acute  intertribal hemorrhage), CEREBROVASCULAR ACCIDENT (Stroke), CONFUSIONAL STATE (Starting getting confused), FALL (Had a fall), HAEMORRHAGE (Brain bleeding, brain hemorrhage) and COMA (Induced coma) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) Dosage form. On 24-Mar-2021, the patient experienced COMA (Induced coma) (seriousness criterion medically significant). On an unknown date, the patient experienced CEREBRAL HAEMORRHAGE (Acute  intertribal hemorrhage) (seriousness criterion death), CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criterion medically significant), CONFUSIONAL STATE (Starting getting confused) (seriousness criterion medically significant), FALL (Had a fall) (seriousness criterion medically significant) and HAEMORRHAGE (Brain bleeding, brain hemorrhage) (seriousness criterion medically significant). The patient died on an unknown date. The reported cause of death was intra cerebral hemorrhage. At the time of death, CEREBROVASCULAR ACCIDENT (Stroke), CONFUSIONAL STATE (Starting getting confused), FALL (Had a fall), HAEMORRHAGE (Brain bleeding, brain hemorrhage) and COMA (Induced coma) outcome was unknown. Not Provided          Concomitant medication not provided. No treatment information/hospitalization information provided.  This case concerns death of a 79-year-old male patient who expired from acute intertribal hemorrhage after receiving mRNA-1273 vaccine.  three days after vaccine administration, the patient developed confusion and fell with subsequent events ensuing.  Based on the available information causal association between the event if confusion leading to fall and product use cannot be excluded.  The other events are assessed as directly related to the fall and unlikely due to product use.; Sender's Comments: This case concerns death of a 79-year-old male patient who expired from acute intertribal hemorrhage after receiving mRNA-1273 vaccine.  three days after vaccine administration, the patient developed confusion and fell with subsequent events ensuing.  Based on the available information causal association between the event if confusion leading to fall and product use cannot be excluded.  The other events are assessed as directly related to the fall and unlikely due to product use.; Reported Cause(s) of Death: intra cerebral hemorrhage
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Brain death, Cerebral thrombosis, Loss of consciousness, X-ray
Clinical narrative: blood clot in his brain; Patient collapsed on the floor at night 2 days after receiving 2nd dose; brain was dead; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BRAIN DEATH (brain was dead), CEREBRAL THROMBOSIS (blood clot in his brain) and LOSS OF CONSCIOUSNESS (Patient collapsed on the floor at night 2 days after receiving 2nd dose) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0021B21A and 001821A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history reported).   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (Patient collapsed on the floor at night 2 days after receiving 2nd dose) (seriousness criterion hospitalization prolonged). On 30-Mar-2021, the patient experienced CEREBRAL THROMBOSIS (blood clot in his brain) (seriousness criteria death and hospitalization prolonged). The patient died on 08-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, LOSS OF CONSCIOUSNESS (Patient collapsed on the floor at night 2 days after receiving 2nd dose) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Mar-2021, X-ray: blood clot (Positive) x-rays revealed blood clot in his brain.         No concomitant medications were reported.  After the 2nd dose, On 29Mar2021, at night, he collapsed on the floor and was taken at the hospital on same night by ambulance. So he was hospitalized on 30Mar2021 and upon doing tests and x-rays, they found blood clot in his brain. He stayed in hospital through out and transferred to hospice center on 06Apr2021 where he passed away on 08Apr2021. His brain was dead and never recovered from the clot.  Unknown treatment medications were given at the hospital.  Very limited information regarding these events have been provided at this time. No further information is expected.; Sender's Comments: Very limited information regarding these events have been provided at this time. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Epididymitis, Testicular pain
Clinical narrative: epididymitis; testicle pain; This spontaneous case was reported by a consumer and describes the occurrence of EPIDIDYMITIS (epididymitis) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 26-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Dec-2020, the patient experienced TESTICULAR PAIN (testicle pain). On an unknown date, the patient experienced EPIDIDYMITIS (epididymitis) (seriousness criterion medically significant). At the time of the report, EPIDIDYMITIS (epididymitis) and TESTICULAR PAIN (testicle pain) outcome was unknown. Not Provided          Event occurred after patient received the fist dose of mRNA-1273  vaccine.  No concomitant product was reported.  Treatment drug include Antibiotics , pain killers, Gabapentin, Tramadol, Hydrocodone, Celebrex.  Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.   This case was linked to MODERNATX, INC.-MOD-2021-076180 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded. MODERNATX, INC.-MOD-2021-076180:CROSSLINKED WITH DOSE 2
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Death, Heart rate
Clinical narrative: Died; The initial case was missing the following minimum criteria: Reporter with no first-hand knowledge. Upon receipt of follow-up information on 13Apr2021, this case now contains all required information to be considered valid. This is a spontaneous report from a Pfizer-sponsored program. A non-contactable consumer reported that a 66-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 11Jan2021 (at the age of 66-year-old) (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 21Dec2020 for COVID-19 immunisation. The patient died on 11Jan2021; the cause of death was unknown. On 11Jan2021, the patient experienced cardiac arrest and breathless with outcome unknown. The patient was found pulseless and breathless 20 minutes following the vaccine administration. MD found no signs of anaphylaxis. It was not reported if an autopsy was performed.  No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Died
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal discomfort, Pain in extremity, Vaccination site discolouration, Vaccination site erythema, Vaccination site warmth
Clinical narrative: warm and has some red color; warm and has some red color; My arm hurt; my arm is where I got my shot because it was discolored.; discomfort in my neck in my lymph nodes; This is a spontaneous report from a contactable consumer. A 77-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), second dose, via an unspecified route of administration on 10Mar2021 (Batch/Lot number unknown) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications were not reported. On 10Mar2021, the patient received the second dose of BNT162B2. The patient stated she haven't really had any real repercussions at all. On 10Mar2021, her arm hurt for the first two days.  In Mar2021, her arm was discolored and she has some discomfort in her neck and lymph nodes. On 15Mar2021, it was warm and has some red color. It's almost a week later after getting the shot. The outcome of events arm hurt, discolored, warm, red color and discomfort in neck and lymph nodes was unknown.      Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: swollen lymph nodes under her left arm; This is a spontaneous report from a contactable consumer, the patient. This 67-year-old female patient reported that she received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration on 13Mar2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, the patient experienced swollen lymph nodes under her left arm. The clinical outcome of swollen lymph nodes under her left arm was unknown.     No follow-up attempts are possible; information about lot number cannot be obtained.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: Short of breath; This is a spontaneous report from a contactable consumer, the patient. A 67-years-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration in the left arm on 13Mar2021 13:45 (Batch/Lot Number: EN6208) (at the age of 67 years old) as a single dose for COVID-19 immunisation. Medical history included diabetes from an unknown date and unknown if ongoing. The patient was taking concomitant medications. The patient previously took amoxicillin and had allergy to amoxicillin. 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 had not been tested for COVID-19. At about an hour after the vaccine on 13Mar2021 14:45, the patient started to be short of breath. It only lasted for about 20 minutes and then it went away. The patient went to the emergency room (ER) but by the time the patient was checked in, it went away. No treatment was received for the event. The outcome of event, short of breath, was recovered on 13Mar2021 15:05.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: This is a spontaneous report received from a Pfizer from a contactable consumer, the patient. This 71-year-old female patient reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration on 02Mar2021 as a single dose for COVID-19 immunization. Medical history included degenerative disc disease, always have pain in lower back and down lower hip and legs, for which once in a while she gets a shot. She stated that she always has the pain, it just acts up sometimes. Concomitant medication was not specified (reported as medication for her disease). The patient reported that she was experiencing terrible pain right now (unspecified date) and asked if she can take pain reliever. The patient is scheduled for the second dose of the BNT162b2 vaccine on 23Mar2021. The clinical outcome of terrible pain was unknown. No follow-up attempts are possible; information about lot number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Heart rate, Heart rate increased, Palpitations
Clinical narrative: Heart was racing; even at rest my heart rate was over 100". Caller reports that the highest it went was around 130; This is a spontaneous report from Pfizer-sponsored program. A contactable consumer, the patient, reported a female of unspecified age received the first dose BNT162b2 (solution for injection; batch/lot and expiry information reported as not available) as a single dose via unspecified route on 10Mar2021 at around 3:30 - 4:00pm, for COVID-19 immunisation. There was no medical history, concomitant medications or past drug history reported. On 11Mar2021, the morning after receiving the vaccine, the patient experienced her heart was racing. The patient explained that morning after the vaccine she noticed that her heart was racing and even at rest her heart rate was over 100. The patient stated that at the highest it was around 130. The patient reported that on 15Mar2021, five days later, it is still happening; her heartrate is still around 110. The patient stated that she went to her doctor where an electrocardiogram (EKG) was performed which was normal. The outcome of the events heart racing, and even at rest my heart rate was over 100". Caller reports that the highest it went was around 130, was not recovered.   Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Severe vertigo; This is a spontaneous report from a contactable consumer, the patient. A 42-years-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 10Feb2021 at 12:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included migraine from an unknown date and unknown if ongoing, kidney stones from an unknown date and unknown if ongoing. The patient did not have allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included tizanidine hydrochloride (ZANAFLEX); amitriptilina [amitriptyline] (AMITRIPTILINA); and topiramate (TOPAMAX), all taken for an unspecified indication, start and stop date were not reported. Tizanidine, amitriptyline, and topiramate were taken within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination.  On 28Feb2021 at 08:00, two weeks after the first vaccination, the patient experienced severe vertigo requiring an emergency room (ER) visit. It went away after 4 days. Therapeutic measures were taken as a result of severe vertigo included anti-inflammatory steroid. Clinical outcome of the event severe vertigo was recovered.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021285977 same reporter/ patient, different drug dose/ AE.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Rash, Rash erythematous, Vaccination site pain
Clinical narrative: some soreness at injection site & behind her ears since receiving the vaccine; Caller noticed a rash under her left breast. Caller described it as deep red & painful; Caller noticed a rash under her left breast. Caller described it as deep red & painful/She had a previous rash that came back; she had some back pain; This is a spontaneous report from a contactable consumer (patient herself) from a Pfizer sponsored program.  A 76-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot/Batch number: unknown), via an unspecified route of administration on 10Mar2021 as a single dose for COVID-19 immunization. The patient's medical history included rash (rash was prior to vaccine). The patient's concomitant medications included Pravastatin as a blood thinner; Lisinopril for blood pressure, Levothyroxine 100mg and Metoprolol-ER Scciniate (100mg once per day after a meal). On 15Mar2021, the patient noticed a rash under her left breast and described it as deep red & painful. The patient reported her previous rash that came back. The patient also had some back pain. The patient was wondering if she could take the second dose. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: Broke out in a rash on the left side of her chest going up to the neck and on to her face; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 59-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered (at the age of 59-years-old) in Arm Left on 24Feb2021 14:30 (Batch/Lot Number: EL9266) as SINGLE DOSE for covid-19 immunisation. Patient stated that she had not yet had her 2nd dose but was scheduled on 17Mar2021. The patient medical history and concomitant medications were not reported. The patient had the vaccine administered in her left arm and experienced broke out in a rash on the left side of her chest going up to the neck and on to her face on 25Feb2021. It was an itchy rash that took a couple of days to subside and it started the next day after her 1st dose of the Pfizer COVID Vaccine and took a couple of days to go away but was completely gone now. She did not have treatment for the event. None additional vaccines administered on same date of the pfizer suspect. There was none prior vaccinations (within 4 weeks). The outcome of event was recovered on an unspecified date in 2021.   Follow-up attempts are needed. Information on the lot/batch number has been requested.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Headache, Nausea
Clinical narrative: headache; feeling sick in her stomach.; Nausea; This is a spontaneous report from a contactable female consumer reported for herself.  A 76-year-old female patient received her 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9261) at single dose on 13Feb2021 13:50 via an unknown route in left arm for Covid-19 immunization. Medical history and concomitant drug were not provided. Historical vaccine included 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot: EL0142) on 23Jan2021 at 13:30 injection to left arm for Covid-19 immunization and reported that she did not have any problems with the first dose of the Pfizer-BioNTech COVID-19 Vaccine except for her arm was really sore and heavy the next day (on 24Jan2021 13:50) which lasted about 2-3 days until she recovered completely from event, and flu shot around Sep2020 for immunization. She initially described event as arm was really sore and heavy with Pfizer-BioNTech COVID-19 Vaccine as being sore the next day like a flu shot where arm was really sore and heavy, but also reported that she had no history of adverse events or reactions to prior vaccinations. No vaccines administered on same date with the Pfizer vaccine considered as suspect. Family Medical History Relevant to events was none. No any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. Patient experienced headaches and nausea on 15Feb2021, approximately 2 days after second dose administered. She reported headache lasting more than 7 days.  The clinical course was reported as follows: Having headaches off and on, had not been a constant day and night thing. It kind of comes and goes. The past weekend (as of 15Mar2021), on 14Mar2021 it was really bothering her. She took a Tylenol on 14Mar2021 after she got back from church and last night took 2 Benadryl and that seemed to help. That was the first time she has taken Tylenol for events. She had just been letting headache wear itself out. Regarding nausea, it was further described as sick to her stomach. Outcome of Headaches was not resolved. Seriousness for headaches was unspecified. No visit to Emergency Room/Physician Office required, not hospitalized. Outcome of the events was not resolved.    Follow-up attempts are completed. No further information is expected.  Follow-Up (13Apr2021): Follow-up attempts are completed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: UNK, COVID19, COVID19
Symptoms: Arteriogram coronary abnormal, Atrial fibrillation, Chest X-ray abnormal, Computerised tomogram abdomen, Echocardiogram
Clinical narrative: pericarditis with pleural effusion and fib rvr. thoracenthesis, beta blocker and calcium channel blocker. NSAID, colchicine
Age: 69.0
Sex: F
Vaccine: UNK, COVID19, COVID19
Symptoms: Electrocardiogram, Pericarditis, Pleural effusion
Clinical narrative: pericarditis with pleural effusion and fib rvr. thoracenthesis, beta blocker and calcium channel blocker. NSAID, colchicine
Age: 69.0
Sex: F
Vaccine: UNK, COVID19, COVID19
Symptoms: Chest pain, Cold sweat, Cough, Hyperhidrosis, Nausea
Clinical narrative: pericarditis with pleural effusion and fib rvr. thoracenthesis, beta blocker and calcium channel blocker. NSAID, colchicine
Age: 69.0
Sex: F
Vaccine: UNK, COVID19, COVID19
Symptoms: Neck pain, Oropharyngeal pain, Pericarditis, Viral infection
Clinical narrative: pericarditis with pleural effusion and fib rvr. thoracenthesis, beta blocker and calcium channel blocker. NSAID, colchicine
Age: 69.0
Sex: F
Vaccine: UNK, COVID19, COVID19
Symptoms: Brain natriuretic peptide increased, C-reactive protein increased, Chest X-ray normal, Chest pain, Chills
Clinical narrative: pericarditis with pleural effusion and fib rvr. thoracenthesis, beta blocker and calcium channel blocker. NSAID, colchicine
Age: 69.0
Sex: F
Vaccine: UNK, COVID19, COVID19
Symptoms: Electrocardiogram, Hyperhidrosis, Infection, Pain, Pyrexia
Clinical narrative: pericarditis with pleural effusion and fib rvr. thoracenthesis, beta blocker and calcium channel blocker. NSAID, colchicine
Age: 69.0
Sex: F
Vaccine: UNK, COVID19, COVID19
Symptoms: Sleep disorder, Troponin increased
Clinical narrative: pericarditis with pleural effusion and fib rvr. thoracenthesis, beta blocker and calcium channel blocker. NSAID, colchicine