chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain, Sensory disturbance
Clinical narrative: COULDN'T BREATHE WHEN WENT UPSTAIRS; SEVERE BODY ACHES; FELT DRUNK; FELT LIKE GOT HIT/GOT HIT EVERYWHERE ON THE BODY/COULD FEEL IT IN BONES; FELT COMPLETELY OUT OF IT AND FELT LIKE NOT THERE; CHILLS/ CHILLS THAT SHE COULD NOT SHAKE OFF; FELT LIKE COMPLETE CRAP; HEADACHE/REALLY BAD HEADACHE AT FRONT OF THE HEAD; This spontaneous report received from a patient concerned a 25 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1808980, expiry: 20-JUN-2021) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced couldn't breathe when went upstairs. On APR-2021, the subject experienced severe body aches. On APR-2021, the subject experienced felt drunk. On APR-2021, the subject experienced felt like got hit/got hit everywhere on the body/could feel it in bones. On APR-2021, the subject experienced felt completely out of it and felt like not there. On APR-2021, the subject experienced chills/ chills that she could not shake off. On APR-2021, the subject experienced felt like complete crap. On APR-2021, the subject experienced headache/really bad headache at front of the head. The action taken with covid-19 vaccine  was not applicable. The outcome of the headache/really bad headache at front of the head, chills/ chills that she could not shake off, couldn't breathe when went upstairs, severe body aches, felt drunk, felt like got hit/got hit everywhere on the body/could feel it in bones, felt like complete crap and felt completely out of it and felt like not there was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Coagulation test, Erythema, Full blood count, Rash
Clinical narrative: RED SPOTS ON PUBIC AREA; TINY RED SPOTS UNDER RIGHT BREAST AND TWO ON RIGHT ABDOMEN WHICH ARE GETTING MORE REDDER AND PROTRUDING MORE; RED SPOTS ON BACK AND RIGHT FOREARM; TWITCH OF PAIN TO LEFT BREAST OR HEART AREA; This spontaneous report received from a patient concerned a 55 year old female. The patient's weight was 134 pounds, and height was 54 inches. The patient's concurrent conditions included non smoker, and non-alcoholic, and other pre-existing medical conditions included patient had no drug abuse/illicit drug usage and no known allergies. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: 21-JUN-2021) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-APR-2021, the subject experienced twitch of pain to left breast or heart area. On 16-MAY-2021, the subject experienced red spots on pubic area. On 16-MAY-2021, the subject experienced tiny red spots under right breast and two on right abdomen which are getting more redder and protruding more. On 16-MAY-2021, the subject experienced red spots on back and right forearm. Laboratory data included: Coagulation test (NR: not provided) Refer result unstructured data, and Complete blood count (NR: not provided) Refer result unstructured data. The action taken with covid-19 vaccine  was not applicable. The patient recovered from twitch of pain to left breast or heart area on 27-APR-2021, and had not recovered from tiny red spots under right breast and two on right abdomen which are getting more redder and protruding more, red spots on back and right forearm, and red spots on pubic area. This report was non-serious.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous
Clinical narrative: RED SPOTS ON PUBIC AREA; TINY RED SPOTS UNDER RIGHT BREAST AND TWO ON RIGHT ABDOMEN WHICH ARE GETTING MORE REDDER AND PROTRUDING MORE; RED SPOTS ON BACK AND RIGHT FOREARM; TWITCH OF PAIN TO LEFT BREAST OR HEART AREA; This spontaneous report received from a patient concerned a 55 year old female. The patient's weight was 134 pounds, and height was 54 inches. The patient's concurrent conditions included non smoker, and non-alcoholic, and other pre-existing medical conditions included patient had no drug abuse/illicit drug usage and no known allergies. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: 21-JUN-2021) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-APR-2021, the subject experienced twitch of pain to left breast or heart area. On 16-MAY-2021, the subject experienced red spots on pubic area. On 16-MAY-2021, the subject experienced tiny red spots under right breast and two on right abdomen which are getting more redder and protruding more. On 16-MAY-2021, the subject experienced red spots on back and right forearm. Laboratory data included: Coagulation test (NR: not provided) Refer result unstructured data, and Complete blood count (NR: not provided) Refer result unstructured data. The action taken with covid-19 vaccine  was not applicable. The patient recovered from twitch of pain to left breast or heart area on 27-APR-2021, and had not recovered from tiny red spots under right breast and two on right abdomen which are getting more redder and protruding more, red spots on back and right forearm, and red spots on pubic area. This report was non-serious.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: DIARRHEA; This spontaneous report received from a patient concerned a 49 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included vegan. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 210A21A, and expiry: 27/JUN/2021) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced diarrhea. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from diarrhea. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Age: 25.0
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: ADMINISTERED VACCINE AFTER IT WAS AT ROOM TEMPERATURE FOR MORE THAN 2 HOURS BUT LESS THAN 6 HOURS; This spontaneous report received from a pharmacist concerned a 25 year old of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported and batch number: 023A21A expiry: 23-JUN-2021) dose was not reported, administered on 17-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-MAY-2021, the subject experienced administered vaccine after it was at room temperature for more than 2 hours but less than 6 hours. The action taken with covid-19 vaccine  was not applicable. The outcome of administered vaccine after it was at room temperature for more than 2 hours but less than 6 hours was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site mass, Injection site pruritus, Pain in extremity
Clinical narrative: RED LACERATION ON ARM WITH SLIGHT BRUISING; MASS IN THE ARM AND HARD TO TOUCH; PAIN IN THE ARM THAT PREVENTED HER FROM SLEEPING; EXTREME TIREDNESS; PERSISTENT HEADACHES IN MIDDLE OF HEAD; ITCHINESS IN INJECTION SITE; This spontaneous report received from a patient concerned a 39 year old female. The patient's height, and weight were not reported. The patient had no known allergies and no medical issues.  The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 26-APR-2021 10:00 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced itchiness in injection site. On 26-APR-2021, the subject experienced mass in the arm and hard to touch. On 26-APR-2021, the subject experienced pain in the arm that prevented her from sleeping. On 26-APR-2021, the subject experienced extreme tiredness. On 26-APR-2021, the subject experienced persistent headaches in middle of head. On 27-APR-2021, the subject experienced red laceration on arm with slight bruising. The action taken with covid-19 vaccine  was not applicable. The patient recovered from red laceration on arm with slight bruising on 02-MAY-2021, mass in the arm and hard to touch on 01-MAY-2021, pain in the arm that prevented her from sleeping on 07-MAY-2021, and extreme tiredness on 29-APR-2021, was recovering from itchiness in injection site, and had not recovered from persistent headaches in middle of head. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Skin laceration
Clinical narrative: RED LACERATION ON ARM WITH SLIGHT BRUISING; MASS IN THE ARM AND HARD TO TOUCH; PAIN IN THE ARM THAT PREVENTED HER FROM SLEEPING; EXTREME TIREDNESS; PERSISTENT HEADACHES IN MIDDLE OF HEAD; ITCHINESS IN INJECTION SITE; This spontaneous report received from a patient concerned a 39 year old female. The patient's height, and weight were not reported. The patient had no known allergies and no medical issues.  The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 26-APR-2021 10:00 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced itchiness in injection site. On 26-APR-2021, the subject experienced mass in the arm and hard to touch. On 26-APR-2021, the subject experienced pain in the arm that prevented her from sleeping. On 26-APR-2021, the subject experienced extreme tiredness. On 26-APR-2021, the subject experienced persistent headaches in middle of head. On 27-APR-2021, the subject experienced red laceration on arm with slight bruising. The action taken with covid-19 vaccine  was not applicable. The patient recovered from red laceration on arm with slight bruising on 02-MAY-2021, mass in the arm and hard to touch on 01-MAY-2021, pain in the arm that prevented her from sleeping on 07-MAY-2021, and extreme tiredness on 29-APR-2021, was recovering from itchiness in injection site, and had not recovered from persistent headaches in middle of head. This report was non-serious.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS FROZEN BEFORE GIVEN TO PATIENT; This spontaneous report received from a pharmacist concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported and batch number: 1820095 expiry: 04-JUL-2021) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the subject experienced vaccine was frozen before given to subject. The action taken with covid-19 vaccine  was not applicable. The outcome of vaccine was frozen before given to patient was not reported. This report was non-serious.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Blood thyroid stimulating hormone, Blood thyroid stimulating hormone abnormal, Eye infection, Influenza
Clinical narrative: SEVERE FLU; THYROID NUMBERS OFF; EYE INFECTION; This spontaneous report received from a patient concerned a 52 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergic to genetically modified organism (gmo), no corn, no soy, and thyroid autoimmune disease. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 202A21A, and batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 2021, the subject experienced thyroid numbers off. On 2021, the subject experienced eye infection. Laboratory data included: TSH (NR: not provided) 34. On 09-APR-2021, the subject experienced severe flu. Treatment medications (dates unspecified) included: ciprofloxacin. The action taken with covid-19 vaccine  was not applicable. The patient recovered from severe flu on 10-APR-2021, had not recovered from thyroid numbers off, and the outcome of eye infection was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Eye irritation, Fatigue, Feeling hot, Myalgia, Nausea
Clinical narrative: RASHES THAT BURN; RED ITCHY RASH; BURNING EYES; BUMPY RASH ON WHOLE BODY EXCEPT FOR FACE AND VACCINATION SITE; FELT VERY HOT ( LIKE HAD A FEVER); FELT TIRED; FELT A BIT QUEASY; MUSCLE ACHES; ACHES AND PAINS; This spontaneous report received from a patient concerned a 45 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non-alcoholic, non-smoker, fibromyalgia, and allergic reactions to antidepressants, and other pre-existing medical conditions included patient had allergic reactions to antidepressants. the patient had no drug abuse or illicit drug usage. The patient experienced swelling of throat due to allergy when treated with erythromycin, and paroxetine hydrochloride.  The patient received covid-19 vaccine  (suspension for injection, route of admin not reported and batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 15-MAY-2021 for prophylactic vaccination. Concomitant medications included pregabalin for fibromyalgia, hydrochlorothiazide, and naproxen. On 16-MAY-2021, the subject experienced aches and pains. On 16-MAY-2021, the subject experienced felt tired. On 16-MAY-2021, the subject experienced felt a bit queasy. On 16-MAY-2021, the subject experienced muscle aches. On 18-MAY-2021, the subject experienced felt very hot ( like had a fever). On 19-MAY-2021, the subject experienced rashes that burn. On 19-MAY-2021, the subject experienced red itchy rash. On 19-MAY-2021, the subject experienced burning eyes. On 19-MAY-2021, the subject experienced bumpy rash on whole body except for face and vaccination site. The action taken with covid-19 vaccine  was not applicable. The patient recovered from aches and pains, felt tired, felt a bit queasy, and muscle aches on 16-MAY-2021, had not recovered from bumpy rash on whole body except for face and vaccination site, red itchy rash, rashes that burn, and burning eyes, and the outcome of felt very hot ( like had a fever) was not reported. This report was non-serious.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Rash, Rash erythematous, Rash pruritic
Clinical narrative: RASHES THAT BURN; RED ITCHY RASH; BURNING EYES; BUMPY RASH ON WHOLE BODY EXCEPT FOR FACE AND VACCINATION SITE; FELT VERY HOT ( LIKE HAD A FEVER); FELT TIRED; FELT A BIT QUEASY; MUSCLE ACHES; ACHES AND PAINS; This spontaneous report received from a patient concerned a 45 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non-alcoholic, non-smoker, fibromyalgia, and allergic reactions to antidepressants, and other pre-existing medical conditions included patient had allergic reactions to antidepressants. the patient had no drug abuse or illicit drug usage. The patient experienced swelling of throat due to allergy when treated with erythromycin, and paroxetine hydrochloride.  The patient received covid-19 vaccine  (suspension for injection, route of admin not reported and batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 15-MAY-2021 for prophylactic vaccination. Concomitant medications included pregabalin for fibromyalgia, hydrochlorothiazide, and naproxen. On 16-MAY-2021, the subject experienced aches and pains. On 16-MAY-2021, the subject experienced felt tired. On 16-MAY-2021, the subject experienced felt a bit queasy. On 16-MAY-2021, the subject experienced muscle aches. On 18-MAY-2021, the subject experienced felt very hot ( like had a fever). On 19-MAY-2021, the subject experienced rashes that burn. On 19-MAY-2021, the subject experienced red itchy rash. On 19-MAY-2021, the subject experienced burning eyes. On 19-MAY-2021, the subject experienced bumpy rash on whole body except for face and vaccination site. The action taken with covid-19 vaccine  was not applicable. The patient recovered from aches and pains, felt tired, felt a bit queasy, and muscle aches on 16-MAY-2021, had not recovered from bumpy rash on whole body except for face and vaccination site, red itchy rash, rashes that burn, and burning eyes, and the outcome of felt very hot ( like had a fever) was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEATH; This spontaneous report received from a consumer concerned four female patients. The patient's weight, height, and medical history were not reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total dose was administered, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On unspecified date in 2021, the patients died from unknown cause of death after vaccination. The autopsy details were not provided.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20210320422.; Sender's Comments: V0- 20210536600- Covid-19 vaccine ad26.cov2.s-death.This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea exertional, Lethargy, Menstruation delayed
Clinical narrative: LETHARGIC (FATIGUED,VERY TIRED,UNABLE TO GET OUT OF BED); WINDED  FROM WALKING AND RUNNING; PERIOD DELAYED BY TWO WEEKS; This spontaneous report received from a consumer concerned a 42 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, the subject experienced period delayed by two weeks. On 26-APR-2021, the subject experienced lethargic (fatigued/ very tired/ unable to get out of bed). On 26-APR-2021, the subject experienced winded from walking and running. The action taken with covid-19 vaccine  was not applicable. The patient recovered from period delayed by two weeks on MAY-2021, had not recovered from lethargic (fatigued/ very tired/ unable to get out of bed), and the outcome of winded from walking and running was not reported. This report was non-serious. This case, from the same reporter is linked to 20210537297.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: SHOULDER HURTING SO BAD; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown ) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced shoulder hurting so bad. The action taken with covid-19 vaccine  was not applicable. The outcome of shoulder hurting so bad was not reported. This report was non-serious.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Lethargy, Somnolence, Suspected COVID-19
Clinical narrative: FELT LIKE COVID-19 SYMPTOMS; SLEEPINESS; EXTREMELY LETHARGIC; EXTREMELY FATIGUED; This spontaneous report received from a patient concerned a 53 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid-19. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 18-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-MAY-2021, the subject experienced sleepiness. On 18-MAY-2021, the subject experienced extremely lethargic. On 18-MAY-2021, the subject experienced extremely fatigued. On 19-MAY-2021, the subject experienced felt like covid-19 symptoms. Laboratory data included: Body temperature (NR: not provided) 103.1 F. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from sleepiness, and extremely lethargic, and the outcome of felt like covid-19 symptoms and extremely fatigued was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Body temperature, Chills, Pyrexia
Clinical narrative: BACK ACHE; CHILLS; FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 19-MAY-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 19-MAY-2021, the subject experienced back ache. On 19-MAY-2021, the subject experienced chills. On 19-MAY-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 103 F. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from fever, back ache, and chills. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: BAD CHILLS; MAJOR HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced bad chills, and major headache. The action taken with covid-19 vaccine  was not applicable. The patient recovered from bad chills, and major headache. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Hypokinesia, Limb discomfort, Pain in extremity
Clinical narrative: ARM PAIN; UNABLE TO RAISE ARM; DISCOMFORT IN UPPER LEFT ARM; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: UNKNOWN) dose was not reported, administered on 12-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAY-2021, the subject experienced unable to raise arm. On MAY-2021, the subject experienced discomfort in upper left arm. On 14-MAY-2021, the subject experienced arm pain. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from arm pain, unable to raise arm, and discomfort in upper left arm. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Paraesthesia
Clinical narrative: INJECTION SITE PAIN; PINS AND NEEDLES BOTH LEGS; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 201A21A expiry: UNKNOWN) dose was not reported, administered on 14-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced pins and needles both legs. On 14-MAY-2021, the subject experienced injection site pain. The action taken with covid-19 vaccine was not applicable. The patient recovered from injection site pain on MAY-2021, and had not recovered from pins and needles both legs. This report was non-serious.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dizziness, Feeling cold, Pyrexia
Clinical narrative: LIGHT HEADED; FELT COLD; FEVER; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's past medical history included full hysterectomy, and concurrent conditions included no alcohol use, and cigarette smoker, and other pre-existing medical conditions included the patient had no known allergies. the patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 19-MAY-2021 11:00 for prophylactic vaccination. No concomitant medications were reported. On 19-MAY-2021, the subject experienced light headed. On 19-MAY-2021, the subject experienced felt cold. On 19-MAY-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101.1 F, 100.9 F, 101.5 F. The action taken with covid-19 vaccine  was not applicable. The patient was recovering from fever, light headed, and felt cold. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: VACCINE NOT SWIRLED BEFORE ADMINISTRATION; This spontaneous report received from a pharmacist concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 13-MAY-2021, the subject experienced vaccine not swirled before administration. The action taken with covid-19 vaccine  was not applicable. The outcome of vaccine not swirled before administration was not reported. This report was non-serious.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dizziness, Headache, Hypoaesthesia
Clinical narrative: NUMBING IN THE FACE; DIZZINESS; CHILLS; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 32 year old male. The patient's height, and weight were not reported. The patient's past medical history included ulcerative colitis, and concurrent conditions included no alcohol use, and non smoker, and other pre-existing medical conditions included the patient did not have no known drug allergies. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 203A21A, and batch number: 203A21A expiry: 23-JUN-2021) dose was not reported, administered on 17-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-MAY-2021, the subject experienced chills. On 18-MAY-2021, the subject experienced headache. On 18-MAY-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101 F. On 19-MAY-2021, the subject experienced numbing in the face. On 19-MAY-2021, the subject experienced dizziness. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine  was not applicable. The patient was recovering from chills, headache, and fever, and had not recovered from dizziness, and numbing in the face. This report was non-serious.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: NUMBING IN THE FACE; DIZZINESS; CHILLS; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 32 year old male. The patient's height, and weight were not reported. The patient's past medical history included ulcerative colitis, and concurrent conditions included no alcohol use, and non smoker, and other pre-existing medical conditions included the patient did not have no known drug allergies. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 203A21A, and batch number: 203A21A expiry: 23-JUN-2021) dose was not reported, administered on 17-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-MAY-2021, the subject experienced chills. On 18-MAY-2021, the subject experienced headache. On 18-MAY-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101 F. On 19-MAY-2021, the subject experienced numbing in the face. On 19-MAY-2021, the subject experienced dizziness. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine  was not applicable. The patient was recovering from chills, headache, and fever, and had not recovered from dizziness, and numbing in the face. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hyperhidrosis, Myalgia, Pain in extremity
Clinical narrative: SWEATS; SORE ARM; FATIGUE; MUSCLE ACHES; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced sweats, sore arm, fatigue, and muscle aches. The action taken with covid-19 vaccine  was not applicable. The outcome of the fatigue, sweats, muscle aches and sore arm was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Malaise, Pain in extremity
Clinical narrative: MODERATELY UNDER THE WEATHER; SOME CHILLS; FELT A LITTLE PAIN IN ARM AFTER IT WENT IN; TIRED; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced moderately under the weather, chills, pain in arm, and tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from moderately under the weather, chills, pain in arm, and tired. This report was non-serious.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: BODY ACHES; CHILLS; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 41 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: UNKNOWN) dose was not reported, administered on 19-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced body aches, chills, headache, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, body aches, chills and fever was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: BAD HEADACHE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced bad headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from bad headache. This report was non-serious.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Tingling feeling all along left side of face...over underside of left eye...sinus area Felt like when novacaine was almost alk done wearing off...I could still feel... it was not a totally numb feeling
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Heart rate increased
Clinical narrative: Dizziness, weakness, rapid heart rate suddenly set in at about 9:45pm. By 10 I was unable to remain standing and laid down to go to sleep. At 4am I woke up with no symptoms.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Pyrexia, Tinnitus
Clinical narrative: Fever 102.2 lasting about 18 hours; Severe headache lasting about 24 hours; Nausea with vomiting lasting about 10 hours; Ringing in ears still occurring; Tiredness lasting 24 hours
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Fever 102.2 lasting about 18 hours; Severe headache lasting about 24 hours; Nausea with vomiting lasting about 10 hours; Ringing in ears still occurring; Tiredness lasting 24 hours
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Erythema, Injection site urticaria, Lip swelling, Pruritus
Clinical narrative: 2 inch diameter hive at injection site appearing 9 days after injection, swelling of top lip, swelling, rash, itching, burning and redness on palms of hands which then spread to wrists and started moving down forearms. Most symptoms are being relieved by 2 days of prednisone except for the palms of my hands.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous
Clinical narrative: 2 inch diameter hive at injection site appearing 9 days after injection, swelling of top lip, swelling, rash, itching, burning and redness on palms of hands which then spread to wrists and started moving down forearms. Most symptoms are being relieved by 2 days of prednisone except for the palms of my hands.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: SEVERE HEADACHE/ SPLITTING HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 19-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 20-MAY-2021, the subject experienced severe headache/ splitting headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of severe headache/ splitting headache was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On MAY-2021, the subject experienced expired vaccine administered.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Muscle tightness
Clinical narrative: PRESENCE IN LEFT LEG; BACK TENSION; FATIGUE; This spontaneous report received from a patient concerned a 61 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A expiry: 23-JUN-2021) dose was not reported, administered on 04-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-MAY-2021, the subject experienced fatigue. On 12-MAY-2021, the subject experienced back tension. On 18-MAY-2021, the subject experienced presence in left leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from back tension, and fatigue, and had not recovered from presence in left leg. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: RAPID HEARTBEAT SYMPTOMS; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included rapid heartbeat symptoms, and covid-19.  The patient received covid-19 vaccine  (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 20-MAY-2021 15:00 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. On MAY-2021, the subject experienced rapid heartbeat symptoms. The action taken with covid-19 vaccine  was not applicable. The outcome of rapid heartbeat symptoms was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: SEVERE HEADACHES; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested .No concomitant medications were reported. On an unspecified date, the subject experienced severe headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of severe headaches was not reported. This report was non-serious.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Vomiting
Clinical narrative: VOMITING; HEADACHE; This spontaneous report received from a patient concerned a 59 year old male. The patient's height, and weight were not reported. The patient's past medical history included smoker, and concurrent conditions included non-alcoholic, and penicillin allergy.  The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 201A21A expiry: 23-JUN-2021) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination.  No concomitant medications were reported.  On 12-MAY-2021, the subject experienced vomiting. On 12-MAY-2021, the subject experienced headache. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine  was not applicable. The patient recovered from vomiting on 13-MAY-2021, and headache on 20-MAY-2021. This report was non-serious.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Discomfort, Dizziness, Fatigue
Clinical narrative: UNCOMFORTABLE; FATIGUE; TOTAL BODY ACHES; CAN'T SLEEP; DIZZY; UNWELL; CHILLS; LEFT ARM IS SORE AT INJECTION SITE; WEAK; FELT NAUSEOUS; This spontaneous report received from a patient concerned a 41 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included pineapple allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 19-MAY-2021 for an unspecified indication. No concomitant medications were reported. On 19-MAY-2021, the subject experienced total body aches. On 19-MAY-2021, the subject experienced can't sleep. On 19-MAY-2021, the subject experienced dizzy. On 19-MAY-2021, the subject experienced unwell. On 19-MAY-2021, the subject experienced chills. On 19-MAY-2021, the subject experienced left arm is sore at injection site. On 19-MAY-2021, the subject experienced weak. On 19-MAY-2021, the subject experienced nausea. On 20-MAY-2021, the subject experienced uncomfortable. On 20-MAY-2021, the subject experienced fatigue. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from unwell, dizzy, nausea, can't sleep, chills, uncomfortable, left arm is sore at injection site, total body aches, weak, and fatigue. This report was non-serious.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Malaise, Nausea, Pain, Pain in extremity
Clinical narrative: UNCOMFORTABLE; FATIGUE; TOTAL BODY ACHES; CAN'T SLEEP; DIZZY; UNWELL; CHILLS; LEFT ARM IS SORE AT INJECTION SITE; WEAK; FELT NAUSEOUS; This spontaneous report received from a patient concerned a 41 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included pineapple allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 19-MAY-2021 for an unspecified indication. No concomitant medications were reported. On 19-MAY-2021, the subject experienced total body aches. On 19-MAY-2021, the subject experienced can't sleep. On 19-MAY-2021, the subject experienced dizzy. On 19-MAY-2021, the subject experienced unwell. On 19-MAY-2021, the subject experienced chills. On 19-MAY-2021, the subject experienced left arm is sore at injection site. On 19-MAY-2021, the subject experienced weak. On 19-MAY-2021, the subject experienced nausea. On 20-MAY-2021, the subject experienced uncomfortable. On 20-MAY-2021, the subject experienced fatigue. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from unwell, dizzy, nausea, can't sleep, chills, uncomfortable, left arm is sore at injection site, total body aches, weak, and fatigue. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: RASH; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 17-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On MAY-2021, the subject experienced rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: POTENTIAL ADMINISTRATION ERROR; VACCINE VIALS WERE TRANSPORTED IN A STYROFOAM BOX WITH ICE WITH NO TEMPERATURE READINGS FOR 30MIN; This spontaneous report received from a health care professional concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 20-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAY-2021, the subject experienced vaccine vials were transported in a styrofoam box with ice with no temperature readings for 30min. On 20-MAY-2021, the subject experienced potential administration error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the potential administration error and vaccine vials were transported in a styrofoam box with ice with no temperature readings for 30min was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Headache, Nausea, Pain
Clinical narrative: DIZZY/LIGHT HEADED; STRANGE FEELING; OUT OF SORTS/DID NOT FEEL CONNECTED TO THE OUTSIDE WORLD; INCREASED PAIN; EXTREME HEADACHE; NAUSEOUS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included rheumatoid arthritis, fibromyalgia, superventricular tachycardia, low thyroid, and autoimmune disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 15-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 15-MAY-2021, the subject experienced dizzy/light headed. On 15-MAY-2021, the subject experienced nauseous. On 15-MAY-2021, the subject experienced out of sorts/did not feel connected to the outside world. On 15-MAY-2021, the subject experienced increased pain. On 15-MAY-2021, the subject experienced extreme headache. On 15-MAY-2021, the subject experienced strange feeling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the dizzy/light headed, nauseous, out of sorts/did not feel connected to the outside world, increased pain, extreme headache and strange feeling was not reported. This report was non-serious.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Chills, Hypoaesthesia
Clinical narrative: BACK PAIN; NUMBNESS IN BACK AND ARMS; CHILLS FEELING HOT AND THEN COLD; This spontaneous report received from a patient concerned a 33 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included post traumatic stress disorder, chest pain (heart and lungs problems), and body pain. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A) dose was not reported, administered on 20-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-MAY-2021, the subject experienced back pain. On 20-MAY-2021, the subject experienced numbness in back and arms. On 20-MAY-2021, the subject experienced chills feeling hot and then cold. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills feeling hot and then cold, back pain, and numbness in back and arms. This report was non-serious.