chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pain, Pain in extremity, Pyrexia
Clinical narrative: BODY ACHES; CHILLS; SORE ARM; MILD FEVER; 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, batch number: Unknown) dose was not reported, administered on MAR-2021 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 MAR-2021, the subject experienced body aches. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced sore arm. On MAR-2021, the subject experienced mild fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, chills, sore arm, and mild fever on MAR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pyrexia
Clinical narrative: CHILLS WITHIN 7 HOURS; FEVER 101.5 WITHIN 7 HOURS; HEADACHE LASTED FOR 48 HOURS; 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. The batch number was not reported and was unable to perform follow up to request batch/lot number.  No concomitant medications were reported. On MAR-2021, the subject experienced chills within 7 hours. On MAR-2021, the subject experienced fever 101.5 within 7 hours. On MAR-2021, the subject experienced headache lasted for 48 hours. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 101.5 degrees F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache lasted for 48 hours on MAR-2021, and the outcome of chills within 7 hours and fever 101.5 within 7 hours was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: NAUSEA; 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, and batch number: 1808609) dose was not reported, administered on 22-MAR-2021 at 10:40 for prophylactic vaccination. No concomitant medications were reported. On 22-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nausea. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Coccydynia, Myalgia, Nausea
Clinical narrative: PAIN BY TAIL BONE (SHARP); MUSCLE PAIN; NAUSEA; 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, and batch number: 1805025 expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 12-MAR-2021, the subject experienced nausea. On 13-MAR-2021, the subject experienced pain by tail bone (sharp). On 13-MAR-2021, the subject experienced muscle pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea on 14-MAR-2021, and muscle pain on 15-MAR-2021, and had not recovered from pain by tail bone (sharp). This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Product administration error
Clinical narrative: FELT THE NEEDLE ONLY; WORRY; This spontaneous report received from a patient concerned a 72 year old female. The patient's weight, height, and medical history were not reported. The patient was previously treated with pneumococcal vaccine for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, 1 total, administered on 14-MAR-2021 13:10 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced worry. On 14-MAR-2021, the subject experienced felt the needle only. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the felt the needle only and worry was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Decreased appetite, Diarrhoea, Fatigue, Feeling abnormal
Clinical narrative: LOW APPETITE; MIND FOGY; DIARRHEA/ IRRITATED STOOL; AT NIGHT WAS FEELING DRAINED/ TIRED; NAUSEA; STOMACH ACHE/ STOMACH DISCOMFORT; FLU LIKE SYMPTOMS; 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: 1805022, expiry: UNKNOWN) dose was not reported, administered on 17-MAR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On 18-MAR-2021, the subject experienced flu like symptoms. On 19-MAR-2021, the subject experienced stomach ache/ stomach discomfort. On 19-MAR-2021, the subject experienced nausea. On 20-MAR-2021, the subject experienced diarrhea/ irritated stool. On 20-MAR-2021, the subject experienced at night was feeling drained/ tired. On 21-MAR-2021, the subject experienced low appetite. On 21-MAR-2021, the subject experienced mind fogy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the flu like symptoms, nausea, stomach ache/ stomach discomfort, at night was feeling drained/ tired, diarrhea/ irritated stool, low appetite and mind fogy was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Nausea
Clinical narrative: LOW APPETITE; MIND FOGY; DIARRHEA/ IRRITATED STOOL; AT NIGHT WAS FEELING DRAINED/ TIRED; NAUSEA; STOMACH ACHE/ STOMACH DISCOMFORT; FLU LIKE SYMPTOMS; 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: 1805022, expiry: UNKNOWN) dose was not reported, administered on 17-MAR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On 18-MAR-2021, the subject experienced flu like symptoms. On 19-MAR-2021, the subject experienced stomach ache/ stomach discomfort. On 19-MAR-2021, the subject experienced nausea. On 20-MAR-2021, the subject experienced diarrhea/ irritated stool. On 20-MAR-2021, the subject experienced at night was feeling drained/ tired. On 21-MAR-2021, the subject experienced low appetite. On 21-MAR-2021, the subject experienced mind fogy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the flu like symptoms, nausea, stomach ache/ stomach discomfort, at night was feeling drained/ tired, diarrhea/ irritated stool, low appetite and mind fogy was not reported. This report was non-serious.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Diarrhoea, Herpes zoster, Neck pain
Clinical narrative: LEFT COLLAR BONE PAIN; NECK PAIN; SHINGLES (RIGHT EYE SCRATCHY LIKE SAND IN IT VERY SOON POST VACCINATION, SWOLLEN LEFT FACIAL LYMPH NODES AT LEFT JAW, RIGHT EYE PAIN AND PAIN PRESSURE BEHIND RIGHT EYE, LIPS AND EYE DEVELOPED BLISTERS AROUND THEM , LEFT FACIAL SWELLING); DIARRHEA; This spontaneous report received from a patient concerned a 54 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, diabetes, acid reflux, and other pre-existing medical conditions included patient had no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072, expiry: 25/MAR/2021) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced shingles (right eye scratchy like sand in it very soon post vaccination, swollen left facial lymph nodes at left jaw, right eye pain and pain pressure behind right eye, lips and eye developed blisters around them, left facial swelling). On 09-MAR-2021, the subject experienced diarrhea. On 10-MAR-2021, the subject experienced left collar bone pain. On 10-MAR-2021, the subject experienced neck pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea on 10-MAR-2021, was recovering from left collar bone pain, and had not recovered from neck pain, and shingles (right eye scratchy like sand in it very soon post vaccination, swollen left facial lymph nodes at left jaw, right eye pain and pain pressure behind right eye, lips and eye developed blisters around them , left facial swelling). This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per the standard procedure as the case is assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: SMALL FEVER; .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: Unk) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced small fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of small fever was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Insomnia
Clinical narrative: UNABLE TO SLEEP AT NIGHT; EXTREME TIREDNESS; 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, 1 total, administered on 18-MAR-2021 for prophylactic vaccination. Batch number was not reported. The company is unable to perform follow up to request batch/lot number. No concomitant medications were reported. On an unspecified date, the subject experienced unable to sleep at night, extreme tiredness, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the extreme tiredness, headache and unable to sleep at night was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: FELT TIRED; 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: Unk) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. The batch number was not reported. We are unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 19-MAR-2021, the subject experienced felt tired. On 19-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt tired on 22-MAR-2021, and headache on MAR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Nail discolouration, Pyrexia, Renal pain, Thirst
Clinical narrative: RINGING IN EARS; FINGERS TURN BLUE; PAIN IN KIDNEYS; FEVER; THIRSTY; 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 past medical history included penicillin allergy, and concurrent conditions included non alcoholic, and non smoker, and other pre-existing medical conditions included the patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and expiry: UNKNOWN) dose was not reported, administered on 21-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, Laboratory data included: Body temperature (NR: not provided) 97.3, 101.5. On 21-MAR-2021, the subject experienced thirsty. On 22-MAR-2021, the subject experienced ringing in ears. On 22-MAR-2021, the subject experienced fingers turn blue. On 22-MAR-2021, the subject experienced pain in kidneys. On 22-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from ringing in ears, fever, fingers turn blue, thirsty, and pain in kidneys. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: RINGING IN EARS; FINGERS TURN BLUE; PAIN IN KIDNEYS; FEVER; THIRSTY; 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 past medical history included penicillin allergy, and concurrent conditions included non alcoholic, and non smoker, and other pre-existing medical conditions included the patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and expiry: UNKNOWN) dose was not reported, administered on 21-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, Laboratory data included: Body temperature (NR: not provided) 97.3, 101.5. On 21-MAR-2021, the subject experienced thirsty. On 22-MAR-2021, the subject experienced ringing in ears. On 22-MAR-2021, the subject experienced fingers turn blue. On 22-MAR-2021, the subject experienced pain in kidneys. On 22-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from ringing in ears, fever, fingers turn blue, thirsty, and pain in kidneys. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SORE ARM; 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 ad26.cov2.s (suspension for injection, intramuscular) dose, start therapy date were not reported for prophylactic vaccination. The batch no was not known and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The outcome of sore arm was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Headache, Hypoaesthesia oral, Joint swelling
Clinical narrative: SWOLLEN ELBOW WITH REDNESS (LEFT ARM); REDNESS (LEFT ARM); HEADACHE; LIPS NUMB; 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: 1805022 expiry: 26-MAY-2021) dose was not reported, administered on right arm on 18-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-MAR-2021, the subject experienced lips numb. On 18-MAR-2021, the subject experienced headache. On 22-MAR-2021, the subject experienced swollen elbow with redness (left arm). On 22-MAR-2021, the subject experienced redness (left arm). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, had not recovered from lips numb, and the outcome of swollen elbow with redness (left arm) and redness (left arm) was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: This spontaneous report received from a consumer 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, vaccination site not given, batch number: Unknown) dose was not reported, administered on 19-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested No concomitant medications were reported. On MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on MAR-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Insomnia, Middle insomnia, Nausea, Pain in extremity
Clinical narrative: DIFFICULTY SLEEPING; NIGHT TIME AWAKENINGS; SORENESS IN LEFT ARM; NAUSEA; This spontaneous report received from a consumer 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, 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 difficulty sleeping, night time awakenings, soreness in left arm, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the difficulty sleeping, soreness in left arm, nausea and night time awakenings was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Diarrhoea, Dizziness, Dyschromatopsia
Clinical narrative: SHARP PAIN IN LOWER LEFT GROIN; JAGGED RAINBOW COLORS IN RIGHT EYE IN RIGHT LATERAL VISION; BRAIN SPEECH WASN'T FIRING CORRECTLY; HEADACHE IN LEFT TEMPORAL LOBE; FATIGUE; NAUSEA; RING IN EARS; CHILLS; PRESSURE IN HEAD; DIZZINESS; DIARRHEA; FLUSHED FACE; RED FACE; FEELING HOT; JOINT PAIN; MUSCLE PAIN; SHAKING; 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: 1805029, and batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered to left arm on 11-MAR-2021 17:26 for prophylactic vaccination. No concomitant medications were reported. On 15-MAR-2021, the subject experienced feeling hot. On 15-MAR-2021, the subject experienced shaking. On 15-MAR-2021, the subject experienced joint pain. On 15-MAR-2021, the subject experienced muscle pain. On 15-MAR-2021 06:00, the subject experienced pressure in head. On 15-MAR-2021 06:00, the subject experienced dizziness. On 15-MAR-2021 06:00, the subject experienced diarrhea. On 15-MAR-2021 06:00, the subject experienced flushed face. On 15-MAR-2021 06:00, the subject experienced red face. On 15-MAR-2021 06:00, the subject experienced ring in ears. On 15-MAR-2021 06:00, the subject experienced chills. On 15-MAR-2021 06:00, the subject experienced headache in left temporal lobe. On 15-MAR-2021 06:00, the subject experienced fatigue. On 15-MAR-2021 06:00, the subject experienced nausea. On 17-MAR-2021, the subject experienced brain speech wasn't firing correctly. On 20-MAR-2021, the subject experienced jagged rainbow colors in right eye in right lateral vision. On 21-MAR-2021, the subject experienced sharp pain in lower left groin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea on 19-MAR-2021, and had not recovered from ring in ears, pressure in head, headache in left temporal lobe, fatigue, chills, dizziness, nausea, flushed face, red face, feeling hot, muscle pain, joint pain, jagged rainbow colors in right eye in right lateral vision, brain speech wasn't firing correctly, shaking, and sharp pain in lower left groin. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Feeling hot, Flushing, Groin pain
Clinical narrative: SHARP PAIN IN LOWER LEFT GROIN; JAGGED RAINBOW COLORS IN RIGHT EYE IN RIGHT LATERAL VISION; BRAIN SPEECH WASN'T FIRING CORRECTLY; HEADACHE IN LEFT TEMPORAL LOBE; FATIGUE; NAUSEA; RING IN EARS; CHILLS; PRESSURE IN HEAD; DIZZINESS; DIARRHEA; FLUSHED FACE; RED FACE; FEELING HOT; JOINT PAIN; MUSCLE PAIN; SHAKING; 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: 1805029, and batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered to left arm on 11-MAR-2021 17:26 for prophylactic vaccination. No concomitant medications were reported. On 15-MAR-2021, the subject experienced feeling hot. On 15-MAR-2021, the subject experienced shaking. On 15-MAR-2021, the subject experienced joint pain. On 15-MAR-2021, the subject experienced muscle pain. On 15-MAR-2021 06:00, the subject experienced pressure in head. On 15-MAR-2021 06:00, the subject experienced dizziness. On 15-MAR-2021 06:00, the subject experienced diarrhea. On 15-MAR-2021 06:00, the subject experienced flushed face. On 15-MAR-2021 06:00, the subject experienced red face. On 15-MAR-2021 06:00, the subject experienced ring in ears. On 15-MAR-2021 06:00, the subject experienced chills. On 15-MAR-2021 06:00, the subject experienced headache in left temporal lobe. On 15-MAR-2021 06:00, the subject experienced fatigue. On 15-MAR-2021 06:00, the subject experienced nausea. On 17-MAR-2021, the subject experienced brain speech wasn't firing correctly. On 20-MAR-2021, the subject experienced jagged rainbow colors in right eye in right lateral vision. On 21-MAR-2021, the subject experienced sharp pain in lower left groin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea on 19-MAR-2021, and had not recovered from ring in ears, pressure in head, headache in left temporal lobe, fatigue, chills, dizziness, nausea, flushed face, red face, feeling hot, muscle pain, joint pain, jagged rainbow colors in right eye in right lateral vision, brain speech wasn't firing correctly, shaking, and sharp pain in lower left groin. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Head discomfort, Headache, Myalgia, Nausea, Speech disorder
Clinical narrative: SHARP PAIN IN LOWER LEFT GROIN; JAGGED RAINBOW COLORS IN RIGHT EYE IN RIGHT LATERAL VISION; BRAIN SPEECH WASN'T FIRING CORRECTLY; HEADACHE IN LEFT TEMPORAL LOBE; FATIGUE; NAUSEA; RING IN EARS; CHILLS; PRESSURE IN HEAD; DIZZINESS; DIARRHEA; FLUSHED FACE; RED FACE; FEELING HOT; JOINT PAIN; MUSCLE PAIN; SHAKING; 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: 1805029, and batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered to left arm on 11-MAR-2021 17:26 for prophylactic vaccination. No concomitant medications were reported. On 15-MAR-2021, the subject experienced feeling hot. On 15-MAR-2021, the subject experienced shaking. On 15-MAR-2021, the subject experienced joint pain. On 15-MAR-2021, the subject experienced muscle pain. On 15-MAR-2021 06:00, the subject experienced pressure in head. On 15-MAR-2021 06:00, the subject experienced dizziness. On 15-MAR-2021 06:00, the subject experienced diarrhea. On 15-MAR-2021 06:00, the subject experienced flushed face. On 15-MAR-2021 06:00, the subject experienced red face. On 15-MAR-2021 06:00, the subject experienced ring in ears. On 15-MAR-2021 06:00, the subject experienced chills. On 15-MAR-2021 06:00, the subject experienced headache in left temporal lobe. On 15-MAR-2021 06:00, the subject experienced fatigue. On 15-MAR-2021 06:00, the subject experienced nausea. On 17-MAR-2021, the subject experienced brain speech wasn't firing correctly. On 20-MAR-2021, the subject experienced jagged rainbow colors in right eye in right lateral vision. On 21-MAR-2021, the subject experienced sharp pain in lower left groin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea on 19-MAR-2021, and had not recovered from ring in ears, pressure in head, headache in left temporal lobe, fatigue, chills, dizziness, nausea, flushed face, red face, feeling hot, muscle pain, joint pain, jagged rainbow colors in right eye in right lateral vision, brain speech wasn't firing correctly, shaking, and sharp pain in lower left groin. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus, Tremor
Clinical narrative: SHARP PAIN IN LOWER LEFT GROIN; JAGGED RAINBOW COLORS IN RIGHT EYE IN RIGHT LATERAL VISION; BRAIN SPEECH WASN'T FIRING CORRECTLY; HEADACHE IN LEFT TEMPORAL LOBE; FATIGUE; NAUSEA; RING IN EARS; CHILLS; PRESSURE IN HEAD; DIZZINESS; DIARRHEA; FLUSHED FACE; RED FACE; FEELING HOT; JOINT PAIN; MUSCLE PAIN; SHAKING; 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: 1805029, and batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered to left arm on 11-MAR-2021 17:26 for prophylactic vaccination. No concomitant medications were reported. On 15-MAR-2021, the subject experienced feeling hot. On 15-MAR-2021, the subject experienced shaking. On 15-MAR-2021, the subject experienced joint pain. On 15-MAR-2021, the subject experienced muscle pain. On 15-MAR-2021 06:00, the subject experienced pressure in head. On 15-MAR-2021 06:00, the subject experienced dizziness. On 15-MAR-2021 06:00, the subject experienced diarrhea. On 15-MAR-2021 06:00, the subject experienced flushed face. On 15-MAR-2021 06:00, the subject experienced red face. On 15-MAR-2021 06:00, the subject experienced ring in ears. On 15-MAR-2021 06:00, the subject experienced chills. On 15-MAR-2021 06:00, the subject experienced headache in left temporal lobe. On 15-MAR-2021 06:00, the subject experienced fatigue. On 15-MAR-2021 06:00, the subject experienced nausea. On 17-MAR-2021, the subject experienced brain speech wasn't firing correctly. On 20-MAR-2021, the subject experienced jagged rainbow colors in right eye in right lateral vision. On 21-MAR-2021, the subject experienced sharp pain in lower left groin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea on 19-MAR-2021, and had not recovered from ring in ears, pressure in head, headache in left temporal lobe, fatigue, chills, dizziness, nausea, flushed face, red face, feeling hot, muscle pain, joint pain, jagged rainbow colors in right eye in right lateral vision, brain speech wasn't firing correctly, shaking, and sharp pain in lower left groin. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Tremor
Clinical narrative: FELT LIGHT HEADED; SHAKING; HAD A BUNCH OF CHILLS; This spontaneous report received from a consumer 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, expiry: UNKNOWN) dose was not reported, administered on 2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, the subject experienced felt light headed. On 2021, the subject experienced shaking. On 2021, the subject experienced had a bunch of chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt light headed on 2021, and the outcome of had a bunch of chills and shaking was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal discomfort, Headache, Pain in extremity
Clinical narrative: SORE ARM; UPSET STOMACH FOR 48 HOURS; HEADACHE; This spontaneous report received from a consumer 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: Unk) dose was not reported, administered on 2021 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 2021, the subject experienced sore arm. On 2021, the subject experienced upset stomach for 48 hours. On 2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore arm, headache and upset stomach for 48 hours was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: HEADACHE; This spontaneous report received from a parent concerned a 53 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, and other pre-existing medical conditions included penicillin allergy and breaks out in welts all over. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805029, and expiry: UNKNOWN) dose was not reported, administered to right deltoid on 22-MAR-2021 14:40 for prophylactic vaccination. No concomitant medications were reported. On 23-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction, Incoherent, Somnolence
Clinical narrative: AWFUL SIDE EFFECTS; SLEEPY; INCOHERENT; This spontaneous report received from a consumer 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, intramuscular, batch number: Unknown, expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced awful side effects, sleepy, and incoherent. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sleepy, incoherent and awful side effects was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lip swelling, Rash, Swelling face, Throat tightness
Clinical narrative: RASH STARTING ON LEFT ARM UPTO NECK; FEELING TIRED; SWELLING OF FACE; FEELING OF THROAT CLOSING UP; SWELLING OF LIPS; 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 past medical history included hives. The patient was previously treated with diphenhydramine hydrochloride, fexofenadine, and prednisone. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 19-MAR-2021, the subject experienced swelling of face. On 19-MAR-2021, the subject experienced feeling of throat closing up. On 19-MAR-2021, the subject experienced swelling of lips. On 19-MAR-2021 23:30, the subject experienced feeling tired. On 20-MAR-2021, the subject experienced rash starting on left arm upto neck. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride, fexofenadine, and prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swelling of face, feeling of throat closing up, and swelling of lips on 20-MAR-2021, had not recovered from rash starting on left arm upto neck, and the outcome of feeling tired was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: FLU LIKE SIDE EFFECTS; This spontaneous report received from a consumer 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: Unk) dose was not reported, administered on 2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, the subject experienced flu like side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of flu like side effects was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: HEAD ACHE; 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 19-MAR-2021 for prophylactic vaccination. The batch number was not provided and has been requested. No concomitant medications were reported. On MAR-2021, treatment medications included: ibuprofen, and paracetamol. On 19-MAR-2021, the subject experienced head ache. On 19-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, and the outcome of head ache was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Pain, Pain in extremity
Clinical narrative: CHILLS AT NIGHT; FEVER OF 101.6 DEGREES FAHRENHEIT; TIRED; BODY ACHES; SORE ARM; This spontaneous report received from a consumer 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 20-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 20-MAR-2021, the subject experienced sore arm. On 21-MAR-2021, the subject experienced body aches. On 21-MAR-2021, the subject experienced tired. On an unspecified date, the subject experienced chills at night, and fever of 101.6 degrees fahrenheit. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 101.6 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore arm, chills at night, fever of 101.6 degrees fahrenheit, body aches and tired was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: CHILLS AT NIGHT; FEVER OF 101.6 DEGREES FAHRENHEIT; TIRED; BODY ACHES; SORE ARM; This spontaneous report received from a consumer 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 20-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 20-MAR-2021, the subject experienced sore arm. On 21-MAR-2021, the subject experienced body aches. On 21-MAR-2021, the subject experienced tired. On an unspecified date, the subject experienced chills at night, and fever of 101.6 degrees fahrenheit. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 101.6 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore arm, chills at night, fever of 101.6 degrees fahrenheit, body aches and tired was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Muscle tightness, Musculoskeletal discomfort, Pyrexia
Clinical narrative: MUSCLE TIGHTNESS; JOINT DISCOMFORT; FEVER; 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 was not reported, administered on 08-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 21-MAR-2021, the subject experienced muscle tightness. On 21-MAR-2021, the subject experienced joint discomfort. On 21-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 99.1 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, muscle tightness, and joint discomfort. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Body temperature, Chills, Influenza virus test, Pain
Clinical narrative: BODY ACHES; SHIVERING; LOW GRADE FEVER; VOMITED ONCE; STAYED IN BED 2 DAYS; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's past medical history included nerve block, and concurrent conditions included asthma, get sick a lot, fibromyalgia, temperature normally runs 97.1 to 97.2 degrees f, non-smoker, and non-alcoholic user, and other pre-existing medical conditions included the patient did not have any history of drug abuse or illicit drug use. The patient experienced thrush allergy when treated with sulfamethoxazole/trimethoprim, and clarithromycin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and batch number: 1805022 expiry: 25-MAY-2021) dose was not reported, 1 total, administered on 07-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On OCT-2020, Laboratory data included: Influenza virus test (NR: not provided) NO INFECTIONS. On 29-JAN-2021, Laboratory data included: COVID-19 virus test (NR: not provided) NEGATIVE. On 08-MAR-2021, the subject experienced vomited once. On 08-MAR-2021, the subject experienced stayed in bed 2 days. On 08-MAR-2021 07:00, the subject experienced body aches. On 08-MAR-2021 07:00, the subject experienced shivering. On 08-MAR-2021 07:00, the subject experienced low grade fever. Laboratory data included: Body temperature (NR: not provided) 100.8 degrees F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomited once, stayed in bed 2 days on MAR-2021, and body aches, shivering, and low grade fever on 22-MAR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Vomiting
Clinical narrative: BODY ACHES; SHIVERING; LOW GRADE FEVER; VOMITED ONCE; STAYED IN BED 2 DAYS; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's past medical history included nerve block, and concurrent conditions included asthma, get sick a lot, fibromyalgia, temperature normally runs 97.1 to 97.2 degrees f, non-smoker, and non-alcoholic user, and other pre-existing medical conditions included the patient did not have any history of drug abuse or illicit drug use. The patient experienced thrush allergy when treated with sulfamethoxazole/trimethoprim, and clarithromycin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and batch number: 1805022 expiry: 25-MAY-2021) dose was not reported, 1 total, administered on 07-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On OCT-2020, Laboratory data included: Influenza virus test (NR: not provided) NO INFECTIONS. On 29-JAN-2021, Laboratory data included: COVID-19 virus test (NR: not provided) NEGATIVE. On 08-MAR-2021, the subject experienced vomited once. On 08-MAR-2021, the subject experienced stayed in bed 2 days. On 08-MAR-2021 07:00, the subject experienced body aches. On 08-MAR-2021 07:00, the subject experienced shivering. On 08-MAR-2021 07:00, the subject experienced low grade fever. Laboratory data included: Body temperature (NR: not provided) 100.8 degrees F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomited once, stayed in bed 2 days on MAR-2021, and body aches, shivering, and low grade fever on 22-MAR-2021. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: 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) dose was not reported, administered on 18-MAR-2021 15:00 to left deltoid for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported. On 19-MAR-2021, the subject experienced feeling faint. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of feeling faint was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case was assessed as non serious.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, SARS-CoV-2 test
Clinical narrative: FEVER; MUSCLE ACHE; 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 covid-19.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, expiry: UNKNOWN) dose was not reported, administered on 21-MAR-2021 around 13 for prophylactic vaccination. No concomitant medications were reported. On JUL-2020, Laboratory data included: COVID-19 virus test (NR: not provided) positive. On 22-MAR-2021, the subject experienced fever. On 22-MAR-2021, the subject experienced muscle ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and muscle ache was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Pain, Pyrexia
Clinical narrative: FELT VERY ACHY; FEVER; This spontaneous report received from a consumer 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 expiry: 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 felt very achy, and fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 100 plus Fahrenheit. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and felt very achy was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: BODY ACHES; CHILLS; 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAR-2021, the subject experienced body aches. On MAR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, and body aches. This report was non-serious. This case, from the same reporter is linked to 20210333265.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Hyperhidrosis, Injection site swelling, Injection site warmth
Clinical narrative: SWEATING; INJECTION SITE WARMTH; CHILLS; INJECTION SITE SWELLING; FATIGUE; 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, 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 number No concomitant medications were reported. On an unspecified date, the subject experienced sweating, injection site warmth, chills, injection site swelling, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fatigue, sweating, chills, injection site swelling and injection site warmth was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: FEVER; This spontaneous report received from a consumer 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 22-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fever was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: SORE ARM; FEVER AT NIGHT; This spontaneous report received from a consumer 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 and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced sore arm, and fever at night. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore arm and fever at night was not reported. This report was non-serious.