chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: General physical health deterioration, Guillain-Barre syndrome, Intensive care, Laboratory test, Lumbar puncture
Clinical narrative: On April 4, I received the J&J vaccine  On April 18, I was admitted to the local Hospital ER with near-death swelling of my brain shutting down my body's ability to function After weeks of being in the hospital, I was diagnosed with autoimmune encephalitis Bickerstaff syndrome by the ICU neuro doctors at the HCF.  The week of May 16, an aggressive steroid plan was introduced, and my ability to physically function returned to an acceptable level for independence.  On May 21, I was transferred for the third time to (rehab hospital) On May 29, I was discharged from the Rehab hospital with no restrictions. On Jun 15, my neurologist (Dr.) indicated she thought my condition was related to the J&J vaccine. This was around the same time J&J and the CDC announced the connection to Guillain-Barré syndrome   On July 13, my neurologist refined my diagnosis to ADEM (Acute Disseminated Encephalomyelitis)/AIDP (Inflammatory DemyselinatingPolyradiculopathy aka Gillian-Barre Syndrome) On Nov 19, my neurologist indicated she thought my symptoms would have been gone On Dec 20, I reported that I had 10 noticeable symptomatic events since our last meeting on Nov 19. I inquired about how I compare to my cohort of 278 individuals.
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Magnetic resonance imaging, Near death experience
Clinical narrative: On April 4, I received the J&J vaccine  On April 18, I was admitted to the local Hospital ER with near-death swelling of my brain shutting down my body's ability to function After weeks of being in the hospital, I was diagnosed with autoimmune encephalitis Bickerstaff syndrome by the ICU neuro doctors at the HCF.  The week of May 16, an aggressive steroid plan was introduced, and my ability to physically function returned to an acceptable level for independence.  On May 21, I was transferred for the third time to (rehab hospital) On May 29, I was discharged from the Rehab hospital with no restrictions. On Jun 15, my neurologist (Dr.) indicated she thought my condition was related to the J&J vaccine. This was around the same time J&J and the CDC announced the connection to Guillain-Barré syndrome   On July 13, my neurologist refined my diagnosis to ADEM (Acute Disseminated Encephalomyelitis)/AIDP (Inflammatory DemyselinatingPolyradiculopathy aka Gillian-Barre Syndrome) On Nov 19, my neurologist indicated she thought my symptoms would have been gone On Dec 20, I reported that I had 10 noticeable symptomatic events since our last meeting on Nov 19. I inquired about how I compare to my cohort of 278 individuals.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death
Clinical narrative: died in sleep; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 58 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Apr2021 15:30 (Lot number: EW0176) at the age of 58 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose, Lot Number: ER8737, vaccine Location: left arm), administration date: 05Apr2021, when the patient was 58 years old, for COVID-19 immunization. The following information was reported: DEATH (death) with onset 28Apr2021, outcome "fatal", described as "died in sleep ". Therapeutic measures were not taken as a result of death. The patient date of death was 28Apr2021. The reported cause of death was "died in sleep ". No autopsy was performed.; Reported Cause(s) of Death: died in sleep
Age: 29.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Chills, Headache, Heart rate increased, Injection site pain
Clinical narrative: the pain he felt in that arm was a cramping across palm and thumb; Chills; Fever of 101 degrees Fahrenheit; Mild Nausea; Headache; Soreness in left arm; Feeling weak and shaky; Feeling weak and shaky; Light pressure in chest/chest tightness; a resting pulse of 120 beats/min/increased pulse; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 29 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06May2021 (Batch/Lot number: unknown) at the age of 29 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "genetic/chromosomal abnormalities" (unspecified if ongoing); "respiratory illness" (unspecified if ongoing); "endocrine abnormalities" (unspecified if ongoing); "diabetes" (unspecified if ongoing); "obesity" (unspecified if ongoing), notes: She thinks he may be considered Obese but not morbidly obese. He has a belly.; "allergic to raw apples" (unspecified if ongoing); "Seasonal allergy" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (1st dose), for Covid-19 immunization. The following information was reported: HEART RATE INCREASED (non-serious) with onset 06May2021, outcome "recovered", described as "a resting pulse of 120 beats/min/increased pulse"; CHILLS (non-serious) with onset 07May2021, outcome "recovering", described as "Chills"; PYREXIA (non-serious) with onset 07May2021, outcome "recovering", described as "Fever of 101 degrees Fahrenheit"; NAUSEA (non-serious) with onset 07May2021, outcome "recovering", described as "Mild Nausea"; HEADACHE (non-serious) with onset 07May2021, outcome "recovering", described as "Headache"; PAIN IN EXTREMITY (non-serious) with onset 07May2021, outcome "recovering", described as "Soreness in left arm"; ASTHENIA (non-serious), NERVOUSNESS (non-serious) all with onset 06May2021, outcome "recovering" and all described as "Feeling weak and shaky"; MUSCLE SPASMS (non-serious), outcome "unknown", described as "the pain he felt in that arm was a cramping across palm and thumb"; CHEST DISCOMFORT (non-serious) with onset 06May2021, outcome "recovering", described as "Light pressure in chest/chest tightness". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Patient did not any AE(s) require a visit to: Emergency Room/ Physician Office. he was on an antibiotic when he got second dose.  No follow-up attempts are possible. No further information is expected; Batch/lot number is not available..
Age: 29.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy, Nausea, Pyrexia
Clinical narrative: the pain he felt in that arm was a cramping across palm and thumb; Chills; Fever of 101 degrees Fahrenheit; Mild Nausea; Headache; Soreness in left arm; Feeling weak and shaky; Feeling weak and shaky; Light pressure in chest/chest tightness; a resting pulse of 120 beats/min/increased pulse; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 29 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06May2021 (Batch/Lot number: unknown) at the age of 29 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "genetic/chromosomal abnormalities" (unspecified if ongoing); "respiratory illness" (unspecified if ongoing); "endocrine abnormalities" (unspecified if ongoing); "diabetes" (unspecified if ongoing); "obesity" (unspecified if ongoing), notes: She thinks he may be considered Obese but not morbidly obese. He has a belly.; "allergic to raw apples" (unspecified if ongoing); "Seasonal allergy" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (1st dose), for Covid-19 immunization. The following information was reported: HEART RATE INCREASED (non-serious) with onset 06May2021, outcome "recovered", described as "a resting pulse of 120 beats/min/increased pulse"; CHILLS (non-serious) with onset 07May2021, outcome "recovering", described as "Chills"; PYREXIA (non-serious) with onset 07May2021, outcome "recovering", described as "Fever of 101 degrees Fahrenheit"; NAUSEA (non-serious) with onset 07May2021, outcome "recovering", described as "Mild Nausea"; HEADACHE (non-serious) with onset 07May2021, outcome "recovering", described as "Headache"; PAIN IN EXTREMITY (non-serious) with onset 07May2021, outcome "recovering", described as "Soreness in left arm"; ASTHENIA (non-serious), NERVOUSNESS (non-serious) all with onset 06May2021, outcome "recovering" and all described as "Feeling weak and shaky"; MUSCLE SPASMS (non-serious), outcome "unknown", described as "the pain he felt in that arm was a cramping across palm and thumb"; CHEST DISCOMFORT (non-serious) with onset 06May2021, outcome "recovering", described as "Light pressure in chest/chest tightness". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Patient did not any AE(s) require a visit to: Emergency Room/ Physician Office. he was on an antibiotic when he got second dose.  No follow-up attempts are possible. No further information is expected; Batch/lot number is not available..
Age: 29.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Body temperature, Chest discomfort, Chills, Headache
Clinical narrative: the pain he felt in that arm was a cramping across palm and thumb; Chills; Fever of 101 degrees Fahrenheit; Mild Nausea; Headache; Soreness in left arm; Feeling weak and shaky; Feeling weak and shaky; Light pressure in chest/chest tightness; a resting pulse of 120 beats/min/increased pulse; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 29 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06May2021 (Batch/Lot number: unknown) at the age of 29 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "genetic/chromosomal abnormalities" (unspecified if ongoing); "respiratory illness" (unspecified if ongoing); "endocrine abnormalities" (unspecified if ongoing); "diabetes" (unspecified if ongoing); "obesity" (unspecified if ongoing), notes: She thinks he may be considered Obese but not morbidly obese. He has a belly.; "allergic to raw apples" (unspecified if ongoing); "Seasonal allergy" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (1st dose), for Covid-19 immunization. The following information was reported: HEART RATE INCREASED (non-serious) with onset 06May2021, outcome "recovered", described as "a resting pulse of 120 beats/min/increased pulse"; CHILLS (non-serious) with onset 07May2021, outcome "recovering", described as "Chills"; PYREXIA (non-serious) with onset 07May2021, outcome "recovering", described as "Fever of 101 degrees Fahrenheit"; NAUSEA (non-serious) with onset 07May2021, outcome "recovering", described as "Mild Nausea"; HEADACHE (non-serious) with onset 07May2021, outcome "recovering", described as "Headache"; PAIN IN EXTREMITY (non-serious) with onset 07May2021, outcome "recovering", described as "Soreness in left arm"; ASTHENIA (non-serious), NERVOUSNESS (non-serious) all with onset 06May2021, outcome "recovering" and all described as "Feeling weak and shaky"; MUSCLE SPASMS (non-serious), outcome "unknown", described as "the pain he felt in that arm was a cramping across palm and thumb"; CHEST DISCOMFORT (non-serious) with onset 06May2021, outcome "recovering", described as "Light pressure in chest/chest tightness". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Patient did not any AE(s) require a visit to: Emergency Room/ Physician Office. he was on an antibiotic when he got second dose.  No follow-up attempts are possible. No further information is expected; Batch/lot number is not available..
Age: 29.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Heart rate, Heart rate increased, Muscle spasms, Nausea, Nervousness
Clinical narrative: the pain he felt in that arm was a cramping across palm and thumb; Chills; Fever of 101 degrees Fahrenheit; Mild Nausea; Headache; Soreness in left arm; Feeling weak and shaky; Feeling weak and shaky; Light pressure in chest/chest tightness; a resting pulse of 120 beats/min/increased pulse; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 29 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06May2021 (Batch/Lot number: unknown) at the age of 29 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "genetic/chromosomal abnormalities" (unspecified if ongoing); "respiratory illness" (unspecified if ongoing); "endocrine abnormalities" (unspecified if ongoing); "diabetes" (unspecified if ongoing); "obesity" (unspecified if ongoing), notes: She thinks he may be considered Obese but not morbidly obese. He has a belly.; "allergic to raw apples" (unspecified if ongoing); "Seasonal allergy" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (1st dose), for Covid-19 immunization. The following information was reported: HEART RATE INCREASED (non-serious) with onset 06May2021, outcome "recovered", described as "a resting pulse of 120 beats/min/increased pulse"; CHILLS (non-serious) with onset 07May2021, outcome "recovering", described as "Chills"; PYREXIA (non-serious) with onset 07May2021, outcome "recovering", described as "Fever of 101 degrees Fahrenheit"; NAUSEA (non-serious) with onset 07May2021, outcome "recovering", described as "Mild Nausea"; HEADACHE (non-serious) with onset 07May2021, outcome "recovering", described as "Headache"; PAIN IN EXTREMITY (non-serious) with onset 07May2021, outcome "recovering", described as "Soreness in left arm"; ASTHENIA (non-serious), NERVOUSNESS (non-serious) all with onset 06May2021, outcome "recovering" and all described as "Feeling weak and shaky"; MUSCLE SPASMS (non-serious), outcome "unknown", described as "the pain he felt in that arm was a cramping across palm and thumb"; CHEST DISCOMFORT (non-serious) with onset 06May2021, outcome "recovering", described as "Light pressure in chest/chest tightness". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Patient did not any AE(s) require a visit to: Emergency Room/ Physician Office. he was on an antibiotic when he got second dose.  No follow-up attempts are possible. No further information is expected; Batch/lot number is not available..
Age: 29.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: the pain he felt in that arm was a cramping across palm and thumb; Chills; Fever of 101 degrees Fahrenheit; Mild Nausea; Headache; Soreness in left arm; Feeling weak and shaky; Feeling weak and shaky; Light pressure in chest/chest tightness; a resting pulse of 120 beats/min/increased pulse; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 29 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06May2021 (Batch/Lot number: unknown) at the age of 29 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "genetic/chromosomal abnormalities" (unspecified if ongoing); "respiratory illness" (unspecified if ongoing); "endocrine abnormalities" (unspecified if ongoing); "diabetes" (unspecified if ongoing); "obesity" (unspecified if ongoing), notes: She thinks he may be considered Obese but not morbidly obese. He has a belly.; "allergic to raw apples" (unspecified if ongoing); "Seasonal allergy" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (1st dose), for Covid-19 immunization. The following information was reported: HEART RATE INCREASED (non-serious) with onset 06May2021, outcome "recovered", described as "a resting pulse of 120 beats/min/increased pulse"; CHILLS (non-serious) with onset 07May2021, outcome "recovering", described as "Chills"; PYREXIA (non-serious) with onset 07May2021, outcome "recovering", described as "Fever of 101 degrees Fahrenheit"; NAUSEA (non-serious) with onset 07May2021, outcome "recovering", described as "Mild Nausea"; HEADACHE (non-serious) with onset 07May2021, outcome "recovering", described as "Headache"; PAIN IN EXTREMITY (non-serious) with onset 07May2021, outcome "recovering", described as "Soreness in left arm"; ASTHENIA (non-serious), NERVOUSNESS (non-serious) all with onset 06May2021, outcome "recovering" and all described as "Feeling weak and shaky"; MUSCLE SPASMS (non-serious), outcome "unknown", described as "the pain he felt in that arm was a cramping across palm and thumb"; CHEST DISCOMFORT (non-serious) with onset 06May2021, outcome "recovering", described as "Light pressure in chest/chest tightness". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Patient did not any AE(s) require a visit to: Emergency Room/ Physician Office. he was on an antibiotic when he got second dose.  No follow-up attempts are possible. No further information is expected; Batch/lot number is not available..
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Audiogram, Deafness unilateral, Magnetic resonance imaging normal
Clinical narrative: lost all hearing in my left ear; This is a spontaneous report received from contactable reporter(s) (Physician and Consumer or other non HCP).  A 72 year-old female patient received bnt162b2 (BNT162B2), administration date 16Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), for COVID-19 Immunization. The following information was reported: DEAFNESS (medically significant) with onset Apr2021, outcome "recovering", described as "lost all hearing in my left ear". Therapeutic measures were taken as a result of deafness.   Additional information: It was reported that, approximately 2.5 weeks later she lost all hearing in left ear. After a few days, the patient was on oral steroids that was offering no improvement, she sought treatment from another doctor who administered trans-tympanic steroids approximately every other day for 3 weeks. She was more than pleased, in fact ecstatic, to report that most of her hearing had been restored, although with a few residual issues though none that interfere once she made her condition known to with the quality of her life. The patient had heard that steroid treatment might lessen immunity. But while it was currently highly recommended that everyone to receive a booster. The patient was extremely reluctant (to the point of fear) to receive this additional dose. The patient also reported that when she asked the doctor if he would recommend the booster shot, his frank answer was, "I don't know".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Deafness
Clinical narrative: lost all hearing in my left ear; This is a spontaneous report received from contactable reporter(s) (Physician and Consumer or other non HCP).  A 72 year-old female patient received bnt162b2 (BNT162B2), administration date 16Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), for COVID-19 Immunization. The following information was reported: DEAFNESS (medically significant) with onset Apr2021, outcome "recovering", described as "lost all hearing in my left ear". Therapeutic measures were taken as a result of deafness.   Additional information: It was reported that, approximately 2.5 weeks later she lost all hearing in left ear. After a few days, the patient was on oral steroids that was offering no improvement, she sought treatment from another doctor who administered trans-tympanic steroids approximately every other day for 3 weeks. She was more than pleased, in fact ecstatic, to report that most of her hearing had been restored, although with a few residual issues though none that interfere once she made her condition known to with the quality of her life. The patient had heard that steroid treatment might lessen immunity. But while it was currently highly recommended that everyone to receive a booster. The patient was extremely reluctant (to the point of fear) to receive this additional dose. The patient also reported that when she asked the doctor if he would recommend the booster shot, his frank answer was, "I don't know".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Injection site pain, Limb injury, Pain in extremity, Paraesthesia
Clinical narrative: BAD CRAMPING WITH MENSTRUAL CYCLE BEFORE, DURING AND AFTER/ POST MENSTRUAL  CRAMPING; ANXIETY FROM FEAR; TENDONITIS IN ARM; HIGH BLOOD PRESSURE; MIGRAINE; PARESTHESIA; ARM PAIN LIKE MUSCLE WAS GOING TO EXPLODE/ ARM HURTS/ ARM DULL ACHE; ARM FELT BRUISED BEYOND BELIEF; HORRIBLE MENSTRUAL CYCLE FOR FIRST 2 DAYS; This spontaneous report received from a patient concerned a 39 year old female. The patient's height, and weight were not reported. The patient's past medical history included: migraines, and covid-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, and expiry: UNKNOWN) dose was not reported, administered on 19-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the patient experienced horrible menstrual cycle for first 2 days. On 19-MAY-2021, the patient experienced arm felt bruised beyond belief, and arm pain like muscle was going to explode/ arm hurts/ arm dull ache. On 01-SEP-2021, Laboratory data included: Blood test (NR: not provided) Everything was normal. On 25-SEP-2021, the patient experienced migraine, and paresthesia. On 11-OCT-2021, the patient experienced high blood pressure. Laboratory data included: CAT scan (NR: not provided) paraesthesia. On an unspecified date, the patient experienced bad cramping with menstrual cycle before, during and after/ post menstrual cramping, anxiety from fear, and tendonitis in arm. Laboratory data (dates unspecified) included: Blood pressure increased (NR: not provided) 148/xx. Treatment medications (dates unspecified) included: riboflavin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from migraine, and paresthesia on 16-OCT-2021, was recovering from arm pain like muscle was going to explode/ arm hurts/ arm dull ache, arm felt bruised beyond belief, and tendonitis in arm, and had not recovered from horrible menstrual cycle for first 2 days, bad cramping with menstrual cycle before, during and after/ post menstrual cramping, high blood pressure, and anxiety from fear. This report was non-serious. This case, from the same reporter is linked to 20211261549.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Injection site pain, Loss of personal independence in daily activities, Mobility decreased
Clinical narrative: BAD CRAMPING WITH MENSTRUAL CYCLE BEFORE, DURING AND AFTER/ POST MENSTRUAL  CRAMPING; ANXIETY FROM FEAR; TENDONITIS IN ARM; HIGH BLOOD PRESSURE; MIGRAINE; PARESTHESIA; ARM PAIN LIKE MUSCLE WAS GOING TO EXPLODE/ ARM HURTS/ ARM DULL ACHE; ARM FELT BRUISED BEYOND BELIEF; HORRIBLE MENSTRUAL CYCLE FOR FIRST 2 DAYS; This spontaneous report received from a patient concerned a 39 year old female. The patient's height, and weight were not reported. The patient's past medical history included: migraines, and covid-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, and expiry: UNKNOWN) dose was not reported, administered on 19-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the patient experienced horrible menstrual cycle for first 2 days. On 19-MAY-2021, the patient experienced arm felt bruised beyond belief, and arm pain like muscle was going to explode/ arm hurts/ arm dull ache. On 01-SEP-2021, Laboratory data included: Blood test (NR: not provided) Everything was normal. On 25-SEP-2021, the patient experienced migraine, and paresthesia. On 11-OCT-2021, the patient experienced high blood pressure. Laboratory data included: CAT scan (NR: not provided) paraesthesia. On an unspecified date, the patient experienced bad cramping with menstrual cycle before, during and after/ post menstrual cramping, anxiety from fear, and tendonitis in arm. Laboratory data (dates unspecified) included: Blood pressure increased (NR: not provided) 148/xx. Treatment medications (dates unspecified) included: riboflavin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from migraine, and paresthesia on 16-OCT-2021, was recovering from arm pain like muscle was going to explode/ arm hurts/ arm dull ache, arm felt bruised beyond belief, and tendonitis in arm, and had not recovered from horrible menstrual cycle for first 2 days, bad cramping with menstrual cycle before, during and after/ post menstrual cramping, high blood pressure, and anxiety from fear. This report was non-serious. This case, from the same reporter is linked to 20211261549.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anxiety, Blood pressure increased, Blood test, Computerised tomogram, Contusion
Clinical narrative: BAD CRAMPING WITH MENSTRUAL CYCLE BEFORE, DURING AND AFTER/ POST MENSTRUAL  CRAMPING; ANXIETY FROM FEAR; TENDONITIS IN ARM; HIGH BLOOD PRESSURE; MIGRAINE; PARESTHESIA; ARM PAIN LIKE MUSCLE WAS GOING TO EXPLODE/ ARM HURTS/ ARM DULL ACHE; ARM FELT BRUISED BEYOND BELIEF; HORRIBLE MENSTRUAL CYCLE FOR FIRST 2 DAYS; This spontaneous report received from a patient concerned a 39 year old female. The patient's height, and weight were not reported. The patient's past medical history included: migraines, and covid-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, and expiry: UNKNOWN) dose was not reported, administered on 19-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the patient experienced horrible menstrual cycle for first 2 days. On 19-MAY-2021, the patient experienced arm felt bruised beyond belief, and arm pain like muscle was going to explode/ arm hurts/ arm dull ache. On 01-SEP-2021, Laboratory data included: Blood test (NR: not provided) Everything was normal. On 25-SEP-2021, the patient experienced migraine, and paresthesia. On 11-OCT-2021, the patient experienced high blood pressure. Laboratory data included: CAT scan (NR: not provided) paraesthesia. On an unspecified date, the patient experienced bad cramping with menstrual cycle before, during and after/ post menstrual cramping, anxiety from fear, and tendonitis in arm. Laboratory data (dates unspecified) included: Blood pressure increased (NR: not provided) 148/xx. Treatment medications (dates unspecified) included: riboflavin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from migraine, and paresthesia on 16-OCT-2021, was recovering from arm pain like muscle was going to explode/ arm hurts/ arm dull ache, arm felt bruised beyond belief, and tendonitis in arm, and had not recovered from horrible menstrual cycle for first 2 days, bad cramping with menstrual cycle before, during and after/ post menstrual cramping, high blood pressure, and anxiety from fear. This report was non-serious. This case, from the same reporter is linked to 20211261549.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Hypertension, Migraine, Pain in extremity
Clinical narrative: BAD CRAMPING WITH MENSTRUAL CYCLE BEFORE, DURING AND AFTER/ POST MENSTRUAL  CRAMPING; ANXIETY FROM FEAR; TENDONITIS IN ARM; HIGH BLOOD PRESSURE; MIGRAINE; PARESTHESIA; ARM PAIN LIKE MUSCLE WAS GOING TO EXPLODE/ ARM HURTS/ ARM DULL ACHE; ARM FELT BRUISED BEYOND BELIEF; HORRIBLE MENSTRUAL CYCLE FOR FIRST 2 DAYS; This spontaneous report received from a patient concerned a 39 year old female. The patient's height, and weight were not reported. The patient's past medical history included: migraines, and covid-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, and expiry: UNKNOWN) dose was not reported, administered on 19-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the patient experienced horrible menstrual cycle for first 2 days. On 19-MAY-2021, the patient experienced arm felt bruised beyond belief, and arm pain like muscle was going to explode/ arm hurts/ arm dull ache. On 01-SEP-2021, Laboratory data included: Blood test (NR: not provided) Everything was normal. On 25-SEP-2021, the patient experienced migraine, and paresthesia. On 11-OCT-2021, the patient experienced high blood pressure. Laboratory data included: CAT scan (NR: not provided) paraesthesia. On an unspecified date, the patient experienced bad cramping with menstrual cycle before, during and after/ post menstrual cramping, anxiety from fear, and tendonitis in arm. Laboratory data (dates unspecified) included: Blood pressure increased (NR: not provided) 148/xx. Treatment medications (dates unspecified) included: riboflavin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from migraine, and paresthesia on 16-OCT-2021, was recovering from arm pain like muscle was going to explode/ arm hurts/ arm dull ache, arm felt bruised beyond belief, and tendonitis in arm, and had not recovered from horrible menstrual cycle for first 2 days, bad cramping with menstrual cycle before, during and after/ post menstrual cramping, high blood pressure, and anxiety from fear. This report was non-serious. This case, from the same reporter is linked to 20211261549.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Paraesthesia, Tendonitis
Clinical narrative: BAD CRAMPING WITH MENSTRUAL CYCLE BEFORE, DURING AND AFTER/ POST MENSTRUAL  CRAMPING; ANXIETY FROM FEAR; TENDONITIS IN ARM; HIGH BLOOD PRESSURE; MIGRAINE; PARESTHESIA; ARM PAIN LIKE MUSCLE WAS GOING TO EXPLODE/ ARM HURTS/ ARM DULL ACHE; ARM FELT BRUISED BEYOND BELIEF; HORRIBLE MENSTRUAL CYCLE FOR FIRST 2 DAYS; This spontaneous report received from a patient concerned a 39 year old female. The patient's height, and weight were not reported. The patient's past medical history included: migraines, and covid-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, and expiry: UNKNOWN) dose was not reported, administered on 19-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the patient experienced horrible menstrual cycle for first 2 days. On 19-MAY-2021, the patient experienced arm felt bruised beyond belief, and arm pain like muscle was going to explode/ arm hurts/ arm dull ache. On 01-SEP-2021, Laboratory data included: Blood test (NR: not provided) Everything was normal. On 25-SEP-2021, the patient experienced migraine, and paresthesia. On 11-OCT-2021, the patient experienced high blood pressure. Laboratory data included: CAT scan (NR: not provided) paraesthesia. On an unspecified date, the patient experienced bad cramping with menstrual cycle before, during and after/ post menstrual cramping, anxiety from fear, and tendonitis in arm. Laboratory data (dates unspecified) included: Blood pressure increased (NR: not provided) 148/xx. Treatment medications (dates unspecified) included: riboflavin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from migraine, and paresthesia on 16-OCT-2021, was recovering from arm pain like muscle was going to explode/ arm hurts/ arm dull ache, arm felt bruised beyond belief, and tendonitis in arm, and had not recovered from horrible menstrual cycle for first 2 days, bad cramping with menstrual cycle before, during and after/ post menstrual cramping, high blood pressure, and anxiety from fear. This report was non-serious. This case, from the same reporter is linked to 20211261549.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angiogram, Blindness, Dural arteriovenous fistula, Magnetic resonance imaging abnormal, Optic nerve compression
Clinical narrative: Pulsatile tinnitus; This is a spontaneous report received from a contactable reporter (consumer). The reporter is the patient.  A 60 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), administered in arm right, administration date 23Feb2021 (Lot number: EP7534) at the age of 60 years as dose 1, single for covid-19 immunisation. Vaccination facility type was Public Health Clinic/facility. The patient had no relevant medical history. The patient has no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other unspecified medications within 2 weeks of vaccination. The patient took concomitant medications. The following information was reported: TINNITUS (disability) with onset Feb2021, outcome "not recovered", described as "Pulsatile tinnitus". Clinical course: Pulsatile tinnitus started right after the vaccine first dose. Adverse event start date was on Feb2021. The event resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. The patient has not recovered and received no treatment. Seriousness criteria was reported as disabling/incapacitating.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: Pulsatile tinnitus; This is a spontaneous report received from a contactable reporter (consumer). The reporter is the patient.  A 60 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), administered in arm right, administration date 23Feb2021 (Lot number: EP7534) at the age of 60 years as dose 1, single for covid-19 immunisation. Vaccination facility type was Public Health Clinic/facility. The patient had no relevant medical history. The patient has no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other unspecified medications within 2 weeks of vaccination. The patient took concomitant medications. The following information was reported: TINNITUS (disability) with onset Feb2021, outcome "not recovered", described as "Pulsatile tinnitus". Clinical course: Pulsatile tinnitus started right after the vaccine first dose. Adverse event start date was on Feb2021. The event resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. The patient has not recovered and received no treatment. Seriousness criteria was reported as disabling/incapacitating.  Follow-up attempts are completed. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Can't get up, all joints hurt States he is in extreme pain
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Blood test, Mobility decreased, Pain
Clinical narrative: Can't get up, all joints hurt States he is in extreme pain
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Antinuclear antibody positive, Blood sodium, Blood test, Dizziness, Hypersensitivity
Clinical narrative: First vaccine went into my muscle and it was sore for a few days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 61 year-old male patient received bnt162b2 (COMIRNATY), intramuscular (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYALGIA (non-serious), outcome "unknown", described as "First vaccine went into my muscle and it was sore for a few days".  ADDITIONAL INFORMATION: There is no product quality complaint and there is an adverse event. Please notice that cross reference case AER #(withheld) has the reporter slider #1 mailing information, no need to perform a phone call as the information for the reporter is currently available.  Duplicate AE as caller has previously filed a report but this could be additional information Both doses received- noticed side effects after the second that was received on 31May2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Influenza like illness, Lyme disease, Malaise, Presyncope, Pyrexia
Clinical narrative: First vaccine went into my muscle and it was sore for a few days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 61 year-old male patient received bnt162b2 (COMIRNATY), intramuscular (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYALGIA (non-serious), outcome "unknown", described as "First vaccine went into my muscle and it was sore for a few days".  ADDITIONAL INFORMATION: There is no product quality complaint and there is an adverse event. Please notice that cross reference case AER #(withheld) has the reporter slider #1 mailing information, no need to perform a phone call as the information for the reporter is currently available.  Duplicate AE as caller has previously filed a report but this could be additional information Both doses received- noticed side effects after the second that was received on 31May2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, Sinusitis, Weight, Weight decreased
Clinical narrative: First vaccine went into my muscle and it was sore for a few days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 61 year-old male patient received bnt162b2 (COMIRNATY), intramuscular (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYALGIA (non-serious), outcome "unknown", described as "First vaccine went into my muscle and it was sore for a few days".  ADDITIONAL INFORMATION: There is no product quality complaint and there is an adverse event. Please notice that cross reference case AER #(withheld) has the reporter slider #1 mailing information, no need to perform a phone call as the information for the reporter is currently available.  Duplicate AE as caller has previously filed a report but this could be additional information Both doses received- noticed side effects after the second that was received on 31May2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myalgia
Clinical narrative: First vaccine went into my muscle and it was sore for a few days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 61 year-old male patient received bnt162b2 (COMIRNATY), intramuscular (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYALGIA (non-serious), outcome "unknown", described as "First vaccine went into my muscle and it was sore for a few days".  ADDITIONAL INFORMATION: There is no product quality complaint and there is an adverse event. Please notice that cross reference case AER #(withheld) has the reporter slider #1 mailing information, no need to perform a phone call as the information for the reporter is currently available.  Duplicate AE as caller has previously filed a report but this could be additional information Both doses received- noticed side effects after the second that was received on 31May2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: HEP, HEP
Symptoms: Dyspnoea, Seizure, Urticaria
Clinical narrative: 30 Second Seizure; Shortness of Breath; Hives; Initial Report Received on 17-Nov-2021  Follow-up Report Received on 16-Dec-2021 included an upgrade in the event of seizure by the Medical Reviewer to serious as seizure is on the list.  This report was retrieved from FDA VAERS (Centers for Disease Control and Prevention) (VAERS ID # 1753263-1) and was noted as being reported to VAERS on 01-Oct-2021.   A 21-year-old male (age, race, and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.   The patient had no medical history or allergies.  No concomitant medications were taken.  On 24-Aug-2021, the patient received a dose #1 of a hepatitis B vaccine [HEPLISAV-B (Lot # 934600, expiration date, NDC # not reported)] intramuscularly in the left arm.  On the same day, the patient experienced hives, shortness of breath, and a 30-second seizure. He went to the emergency room and was given diphenhydramine (Benadryl) and prednisone. No further information was provided.  The outcome of the events was reported as recovered and as non-serious.   Company Comment: Upon further review, the event of seizure was considered an important medical event and upgraded to serious. Based on the temporal relationship, the seizure occurred on the same day after initiating the first dose of HEPLISAV-B, a causal association between the event and HEPLISAV-B is possible. The patient also experienced hives and shortness of breath. The prevalence of epilepsy is associated with allergic diseases in children; it is possible that inflammation occurring in allergic disease might also contribute toward the development of seizures. The company assessed the events of dyspnea and urticaria as non-serious. The events of seizure, dyspnea are unlisted per HEPLISAV-B IB. The event of urticaria is listed per HEPLISAV-B IB and unlisted per HEPLISAV-B.; Sender's Comments: Upon further review, the event of seizure was considered an important medical event and upgraded to serious. Based on the temporal relationship, the seizure occurred on the same day after initiating the first dose of HEPLISAV-B, a causal association between the event and HEPLISAV-B is possible. The patient also experienced hives and shortness of breath. The prevalence of epilepsy is associated with allergic diseases in children; it is possible that inflammation occurring in allergic disease might also contribute toward the development of seizures. The company assessed the events of dyspnea and urticaria as non-serious. The events of seizure, dyspnea are unlisted per HEPLISAV-B. The event of urticaria is listed per HEPLISAV-B and unlisted per HEPLISAV-B.
Age: 12.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Alopecia
Clinical narrative: Losing lots of hair; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 12 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Oct2021 12:00 (Lot number: 20021) at the age of 12 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: ALOPECIA (non-serious) with onset 30Oct2021 12:00, outcome "recovering", described as "Losing lots of hair". It was unknown if therapeutic measures were taken as a result of alopecia.  Additional information: other vaccine same date lot number=32030BD, other vaccine same date vaccine date=29Oct2021, other vaccine same date dose number= 30.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Headache, Influenza, Malaise, Pyrexia
Clinical narrative: have interaction with the vaccine; I am not well like at all; I have been having terrible headaches; Fever; Flu; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 09Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: RSV VACCINE taken for immunisation, administration date 03Nov2021. The following information was reported: DRUG INTERACTION (non-serious), outcome "unknown", described as "have interaction with the vaccine"; MALAISE (non-serious), outcome "unknown", described as "I am not well like at all"; HEADACHE (non-serious), outcome "unknown", described as "I have been having terrible headaches"; PYREXIA (non-serious), outcome "unknown", described as "Fever"; INFLUENZA (non-serious), outcome "unknown", described as "Flu". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Suspected COVID-19
Clinical narrative: have interaction with the vaccine; I am not well like at all; I have been having terrible headaches; Fever; Flu; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 09Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: RSV VACCINE taken for immunisation, administration date 03Nov2021. The following information was reported: DRUG INTERACTION (non-serious), outcome "unknown", described as "have interaction with the vaccine"; MALAISE (non-serious), outcome "unknown", described as "I am not well like at all"; HEADACHE (non-serious), outcome "unknown", described as "I have been having terrible headaches"; PYREXIA (non-serious), outcome "unknown", described as "Fever"; INFLUENZA (non-serious), outcome "unknown", described as "Flu". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.