chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Insomnia, Nausea, Pain, Pyrexia
Clinical narrative: APPETITE ABSENT; WEAKNESS; FEVER 102.3; NAUSEA; LOOSE GREENISH STOOL; HEART RATE INCREASED; BODY ACHES; CHILLS; SLEEPING DIFFICULTY; FEELS AWFUL; HEADACHE; FLATULENCE; TIREDNESS; DIARRHEA; This spontaneous report received from a patient concerned a 73 year old female. The patient's height, and weight were not reported. The patient's past medical history included anaphylaxis to penicillin, accident, vomiting, hives, low blood pressure, hospitalised, on iv fluids, redness of arm, swelling of arm, fever, anaphylaxis to tetanus vaccine, reaction to pneumovax vaccine, whipple surgery, adenocarcinoma in situ in pancreas, urinary tract infection, and yeast infection. The patient was previously treated with benzylpenicillin for accident, tetanus vaccine for accident, pneumococcal vaccine, pancrelipase for pancreas adenocarcinoma, and for urinary tract infection.  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 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 09-APR-2021, the subject experienced flatulence. On 09-APR-2021, the subject experienced tiredness. On 10-APR-2021, the subject experienced sleeping difficulty. On 10-APR-2021, the subject experienced feels awful. On 10-APR-2021, the subject experienced headache. On 10-APR-2021 03:00, the subject experienced body aches. On 10-APR-2021 03:00, the subject experienced chills. On 11-APR-2021, the subject experienced loose greenish stool. On 11-APR-2021, the subject experienced heart rate increased. On 11-APR-2021, the subject experienced fever 102.3. On 11-APR-2021, the subject experienced nausea. Laboratory data included: Body temperature (NR: not provided) 102.3 F. On 12-APR-2021, the subject experienced appetite absent. On 12-APR-2021, the subject experienced weakness. On APR-2021, the subject experienced diarrhea. Treatment medications (dates unspecified) included: acetylsalicylic acid, and oxycodone/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tiredness, flatulence, chills, body aches, sleeping difficulty, feels awful, headache, fever 102.3, nausea, loose greenish stool, heart rate increased, weakness, appetite absent and diarrhea was not reported. This report was non-serious.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Dental discomfort, Headache, Pain in jaw
Clinical narrative: DISCOMFORT OF THE JAW; DISCOMFORT OF THE TEETH; ABDOMINAL PAIN; MODERATE HEADACHE; This spontaneous report received from a consumer concerned a 67 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and non alcoholic, and other pre-existing medical conditions included the patient had no any medical history and 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 batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-MAR-2021, the subject experienced moderate headache. On 31-MAR-2021, the subject experienced abdominal pain. On 12-APR-2021, the subject experienced discomfort of the jaw. On 12-APR-2021, the subject experienced discomfort of the teeth. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from abdominal pain, was recovering from moderate headache, and the outcome of discomfort of the jaw and discomfort of the teeth was not reported. This report was non-serious. This case, from the same reporter is linked to 20210445480.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Tinnitus, Vertigo
Clinical narrative: RINGING IN HEAD; RINGING IN EARS; VERTIGO; DIZZINESS; This spontaneous report received from a consumer concerned multiple patients 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced ringing in head, ringing in ears, vertigo, and dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the ringing in head, ringing in ears, vertigo and dizziness was not reported. This report was non-serious. This case, from the same reporter is linked to 20210407556.
Sex: M
Vaccine: COVID19
Symptoms: Dental discomfort, Headache, Injection site pain, Pain in jaw
Clinical narrative: MILD HEADACHE; DISCOMFORT OF THE JAW; DISCOMFORT OF TEETH; INJECTION SITE/ ARM SORENESS; This spontaneous report received from a patient concerned a 69 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included glaucoma, alcohol user, and non smoker, and other pre-existing medical conditions included no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination. Concomitant medications included latanoprost for glaucoma. On 30-MAR-2021, the subject experienced injection site/ arm soreness. On 02-APR-2021, the subject experienced discomfort of the jaw. On 02-APR-2021, the subject experienced discomfort of teeth. On an unspecified date, the subject experienced mild headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site/ arm soreness, and mild headache, and the outcome of discomfort of the jaw and discomfort of teeth was not reported. This report was non-serious. This case, from the same reporter is linked.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SORE ARM; 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 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 2021, the subject experienced sore arm. Treatment medications (dates unspecified) included: isopropanol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sore arm was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Cardiac discomfort, Chest discomfort, Chest pain, Pain in extremity, Painful respiration
Clinical narrative: CHEST TIGHTNESS ON LEFT SIDE (5 TIMES WITHIN THE LAST 72 HOURS); PAIN ON THE LEFT SIDE OF CHEST (5 TIMES WITHIN THE LAST 72 HOURS); PAINFUL TO BREATHE; HEART WAS TIGHT; SORE ARM A LITTLE; This spontaneous report received from a patient concerned a 61 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid for high blood pressure. On 07-APR-2021, the subject experienced sore arm a little. On 19-APR-2021, the subject experienced chest tightness on left side (5 times within the last 72 hours). On 19-APR-2021, the subject experienced pain on the left side of chest (5 times within the last 72 hours). On 19-APR-2021, the subject experienced painful to breathe. On 19-APR-2021, the subject experienced heart was tight. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm a little on 09-APR-2021, had not recovered from chest tightness on left side (5 times within the last 72 hours), and pain on the left side of chest (5 times within the last 72 hours), and the outcome of painful to breathe and heart was tight was not reported. This report was non-serious.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: SORE ARM AT INJECTION SITE; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no known allergies and did not have any drug abuse/illicit drug use. 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 18-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-MAR-2021, the subject experienced sore arm at injection site. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm at injection site on 25-MAR-2021. This report was non-serious.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pain of skin
Clinical narrative: TENDER TO TOUCH; MILD SORENESS IN INJECTED ARM; BOTH LEG PAIN; 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 past medical history included stromal tumor, right thyroid removed, and total knee replacement, and concurrent conditions included brain aneurysm, reflux thickening of uterine wall, asthma, seasonal allergies, non alcohol user, non smoker, and brain tumor, 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: 1802068, expiry: UNKNOWN) dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced both leg pain. On 05-MAR-2021, the subject experienced mild soreness in injected arm. On APR-2021, the subject experienced tender to touch. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from both leg pain on 2021, had not recovered from mild soreness in injected arm, and the outcome of tender to touch was not reported. This report was non-serious.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: BODY PAIN / BODY ACHE; HEADACHE; FEVER; This spontaneous report received from a pharmacist concerned a 64 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, and other pre-existing medical conditions included the patient did not have known allergies .The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid. On 06-APR-2021, the subject experienced body pain / body ache. On 06-APR-2021, the subject experienced headache. On 06-APR-2021, the subject experienced fever. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, body pain / body ache, and fever. This report was non-serious.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: HEADACHE; This spontaneous report received from a patient concerned a 32 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 07-APR-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 07-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 08-APR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypersomnia, Rash
Clinical narrative: MOSQUITO LIKE BITES / BUMP; SLEPT A LOT; TIRED; This spontaneous report received from a patient concerned a 55 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 12-APR-2021 for prophylactic vaccination.  No concomitant medications were reported.  On 12-APR-2021, the subject experienced slept a lot. On 12-APR-2021, the subject experienced tired. On 15-APR-2021, the subject experienced mosquito like bites / bump.  Treatment medications (dates unspecified) included: cortisone, and ethanol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the mosquito like bites / bump, tired and slept a lot was not reported. This report was non-serious.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth
Clinical narrative: DRY MOUTH; This spontaneous report received from a patient concerned an 86 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, and batch number were 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 06-APR-2021, the subject experienced dry mouth. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of dry mouth was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Pain, Pain in extremity, Vomiting
Clinical narrative: THROBBING PAIN; THROWING UP; DIARRHEA; SORE ARM / SEVERE ARM PAIN; This spontaneous report received from a patient concerned a 55 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: 1805031, and expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination.  No concomitant medications were reported.  On an unspecified date, the subject experienced sore arm / severe arm pain, throbbing pain, throwing up, and diarrhea.  Treatment medications (dates unspecified) included: naproxen sodium, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore arm / severe arm pain, throbbing pain, throwing up and diarrhea was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Asthenopia, Dehydration, Headache, Lethargy
Clinical narrative: EYE STRAIN; DEHYDRATION; FELT LETHARGIC A LITTLE BIT; DULL HEADACHE; This spontaneous report received from a patient concerned a 35 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: 21/JUN/2021) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced eye strain. On 05-APR-2021, the subject experienced dehydration. On 05-APR-2021, the subject experienced felt lethargic a little bit. On 05-APR-2021, the subject experienced dull headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from eye strain, dehydration, felt lethargic a little bit, and dull headache on APR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Dizziness, Fatigue, Headache, Vertigo
Clinical narrative: UNUSUAL  FATIGUE; HEADACHE; SEVERE VERTIGO; DIZZINESS; This spontaneous report received from a patient concerned a 60 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: 1808978, expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced severe vertigo. On 06-APR-2021, the subject experienced dizziness. On 10-APR-2021, treatment medications included: cortisone. On an unspecified date, the subject experienced unusual fatigue, and headache. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from severe vertigo, and had not recovered from unusual fatigue, headache, and dizziness. This report was non-serious.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: FEVER; MUSCLE ACHES RIGHT SIDE OF THE  BODY/MUSCLE SORENESS; This spontaneous report received from a patient concerned a 30 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant and not breastfeeding at the time of reporting.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced muscle aches right side of the body/muscle soreness. On 06-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 07-APR-2021, and had not recovered from muscle aches right side of the body/muscle soreness. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Coordination abnormal, Dizziness, Headache, Platelet count
Clinical narrative: LIGHT HEADEDNESS; LACK OF COORDINATION; SEVERE HEADACHE; 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 connective disease, and anticardiolipin antibody.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 180898 expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced light headedness. On APR-2021, the subject experienced lack of coordination. On APR-2021, the subject experienced severe headache. Laboratory data included: CT scan (NR: not provided) non revealing, and Platelet count (NR: not provided) normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from light headedness, and lack of coordination on APR-2021, and the outcome of severe headache was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Hypersomnia, Laziness, Pain in extremity, Peripheral swelling
Clinical narrative: NON-STOP SLEEPING; LAZINESS; SWOLLEN LEFT ARM; SORENESS IN LEFT ARM; This spontaneous report received from a patient concerned a 53 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: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced non-stop sleeping. On APR-2021, the subject experienced laziness. On APR-2021, the subject experienced swollen left arm. On APR-2021, the subject experienced soreness in left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from non-stop sleeping, soreness in left arm, laziness, and swollen left arm. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Computerised tomogram, Ear infection, Headache, Urinary tract infection
Clinical narrative: SEVERE EAR INFECTION; URINARY TRACT INFECTION; STOMACH CRAMPS; SEVERE/WORSENING HEADACHE; 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, 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 severe ear infection, urinary tract infection, stomach cramps, and severe/worsening headache. Laboratory data (dates unspecified) included: CAT scan (NR: not provided) No blood clots. Treatment medications (dates unspecified) included: cefalexin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe/worsening headache, stomach cramps, severe ear infection and urinary tract infection was not reported. 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: Arthralgia, Fatigue, Headache, Injection site erythema, Injection site rash
Clinical narrative: COULD NOT FOCUS; SKIN HARD AT INJECTION SITE; POSSIBLE SEASONAL ALLERGIES; LITTLE BIT OF STIFF NECK; NECK PAIN; LITTLE RASH AROUND INJECTION SITE; TOP SHOULDER SORE; SORE ARM; RAISED RED SPOT AT INJECTION SITE; FATIGUE; HEADACHE; NAUSEA; LIGHT SENSITIVITY; 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 thrombocytopenia, and concurrent conditions included allergies. 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 APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced light sensitivity. On APR-2021, the subject experienced skin hard at injection site. On APR-2021, the subject experienced possible seasonal allergies. On APR-2021, the subject experienced little bit of stiff neck. On APR-2021, the subject experienced neck pain. On APR-2021, the subject experienced little rash around injection site. On APR-2021, the subject experienced top shoulder sore. On APR-2021, the subject experienced sore arm. On APR-2021, the subject experienced raised red spot at injection site. On APR-2021, the subject experienced fatigue. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced nausea. Treatment medications included: cetirizine hydrochloride, paracetamol, and rizatriptan benzoate. On 21-APR-2021, the subject experienced could not focus. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, top shoulder sore, nausea, and neck pain, had not recovered from sore arm, fatigue, and light sensitivity, and the outcome of little rash around injection site, could not focus, raised red spot at injection site, skin hard at injection site, little bit of stiff neck and possible seasonal allergies was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Injection site reaction, Musculoskeletal stiffness, Nausea, Neck pain, Pain in extremity
Clinical narrative: COULD NOT FOCUS; SKIN HARD AT INJECTION SITE; POSSIBLE SEASONAL ALLERGIES; LITTLE BIT OF STIFF NECK; NECK PAIN; LITTLE RASH AROUND INJECTION SITE; TOP SHOULDER SORE; SORE ARM; RAISED RED SPOT AT INJECTION SITE; FATIGUE; HEADACHE; NAUSEA; LIGHT SENSITIVITY; 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 thrombocytopenia, and concurrent conditions included allergies. 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 APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced light sensitivity. On APR-2021, the subject experienced skin hard at injection site. On APR-2021, the subject experienced possible seasonal allergies. On APR-2021, the subject experienced little bit of stiff neck. On APR-2021, the subject experienced neck pain. On APR-2021, the subject experienced little rash around injection site. On APR-2021, the subject experienced top shoulder sore. On APR-2021, the subject experienced sore arm. On APR-2021, the subject experienced raised red spot at injection site. On APR-2021, the subject experienced fatigue. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced nausea. Treatment medications included: cetirizine hydrochloride, paracetamol, and rizatriptan benzoate. On 21-APR-2021, the subject experienced could not focus. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, top shoulder sore, nausea, and neck pain, had not recovered from sore arm, fatigue, and light sensitivity, and the outcome of little rash around injection site, could not focus, raised red spot at injection site, skin hard at injection site, little bit of stiff neck and possible seasonal allergies was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Photosensitivity reaction, Seasonal allergy, Vision blurred
Clinical narrative: COULD NOT FOCUS; SKIN HARD AT INJECTION SITE; POSSIBLE SEASONAL ALLERGIES; LITTLE BIT OF STIFF NECK; NECK PAIN; LITTLE RASH AROUND INJECTION SITE; TOP SHOULDER SORE; SORE ARM; RAISED RED SPOT AT INJECTION SITE; FATIGUE; HEADACHE; NAUSEA; LIGHT SENSITIVITY; 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 thrombocytopenia, and concurrent conditions included allergies. 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 APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced light sensitivity. On APR-2021, the subject experienced skin hard at injection site. On APR-2021, the subject experienced possible seasonal allergies. On APR-2021, the subject experienced little bit of stiff neck. On APR-2021, the subject experienced neck pain. On APR-2021, the subject experienced little rash around injection site. On APR-2021, the subject experienced top shoulder sore. On APR-2021, the subject experienced sore arm. On APR-2021, the subject experienced raised red spot at injection site. On APR-2021, the subject experienced fatigue. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced nausea. Treatment medications included: cetirizine hydrochloride, paracetamol, and rizatriptan benzoate. On 21-APR-2021, the subject experienced could not focus. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, top shoulder sore, nausea, and neck pain, had not recovered from sore arm, fatigue, and light sensitivity, and the outcome of little rash around injection site, could not focus, raised red spot at injection site, skin hard at injection site, little bit of stiff neck and possible seasonal allergies was not reported. This report was non-serious.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Sensory disturbance, Tinnitus
Clinical narrative: PRONOUNCE THUMPING AND RINGING IN THE EAR; SQUEEZING IN THE RIGHT LOWER LEG; RIGHT EAR ACHE; This spontaneous report received from a patient via a  representative concerned a 71 year old female. The patient's weight was 153 pounds, and height was 66.5 inches. The patient's concurrent conditions included mild case of high blood pressure, mild case of cholesterol, alcohol use 1 beer can a day, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: 25-MAY-2021) dose was not reported, administered on 20-MAR-2021 13:30 for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, the subject experienced right ear ache. On 21-MAR-2021, the subject experienced squeezing in the right lower leg. On 30-MAR-2021, the subject experienced pronounce thumping and ringing in the ear. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from squeezing in the right lower leg, and had not recovered from pronounce thumping and ringing in the ear, and right ear ache. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: CHILLS; FEVER; MUSCLE ACHE; This spontaneous report received from a consumer concerned an adult male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 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 chills, fever, and muscle ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, fever, and muscle ache. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: CHILLS; FEVER; MUSCLE ACHES; This spontaneous report received from a consumer concerned an adult 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: Unk) 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 chills, fever, and muscle aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, fever, and muscle aches. This report was non-serious. This case, from the same reporter.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue
Clinical narrative: DIZZINESS; FATIGUE/TIREDNESS; This spontaneous report received from a patient concerned a 73 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included hypothyroidism, sulfa allergy, azithromycin allergy, and non-smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. Concomitant medications included levothyroxine sodium for hypothyroidism.  On 03-APR-2021, the subject experienced fatigue/tiredness. On 17-APR-2021, the subject experienced dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness on 18-APR-2021, and fatigue/tiredness on 04-APR-2021. This report was non-serious.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Bradyphrenia, Eating disorder, Exercise tolerance decreased, Headache
Clinical narrative: FEELING INTENSE DEBILITATING PAIN AROUND LOWER STOMACH AND GROIN AREA ON RIGHT SIDE; NEW TREMOR IN HANDS; THOUGHTS JUMBLING; INTERRUPT SLEEP; UNABLE TO EXERCISE; TERRIBLE HEADACHE; TERRIBLE VOMITING; COULD TAKE NO FOOD OR MEDICATION AT ALL; INTENSE VOMITING IT CAUSED TO LOSE CONTROL OF BLADDER; This spontaneous report received from a patient via a company representative concerned a 68 year old female. The patient's height, and weight were not reported. The patient's past medical history included dental implants, and concurrent conditions included malignant neoplasm of right kidney except renal pelvis. 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. Concomitant medications included axitinib, and ondansetron. On MAR-2021, the subject experienced intense vomiting it caused to lose control of bladder. On 10-MAR-2021, the subject experienced terrible vomiting. On 10-MAR-2021, the subject experienced could take no food or medication at all. On an unspecified date, the subject experienced feeling intense debilitating pain around lower stomach and groin area on right side, new tremor in hands, thoughts jumbling, interrupt sleep, unable to exercise, and terrible headache. Treatment medications (dates unspecified) included: naproxen, and codeine phosphate/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from terrible vomiting, could take no food or medication at all, and intense vomiting it caused to lose control of bladder on 2021, and the outcome of feeling intense debilitating pain around lower stomach and groin area on right side, new tremor in hands, terrible headache, thoughts jumbling, interrupt sleep and unable to exercise was not reported. This report was non-serious.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder, Tremor, Urinary incontinence, Vomiting
Clinical narrative: FEELING INTENSE DEBILITATING PAIN AROUND LOWER STOMACH AND GROIN AREA ON RIGHT SIDE; NEW TREMOR IN HANDS; THOUGHTS JUMBLING; INTERRUPT SLEEP; UNABLE TO EXERCISE; TERRIBLE HEADACHE; TERRIBLE VOMITING; COULD TAKE NO FOOD OR MEDICATION AT ALL; INTENSE VOMITING IT CAUSED TO LOSE CONTROL OF BLADDER; This spontaneous report received from a patient via a company representative concerned a 68 year old female. The patient's height, and weight were not reported. The patient's past medical history included dental implants, and concurrent conditions included malignant neoplasm of right kidney except renal pelvis. 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. Concomitant medications included axitinib, and ondansetron. On MAR-2021, the subject experienced intense vomiting it caused to lose control of bladder. On 10-MAR-2021, the subject experienced terrible vomiting. On 10-MAR-2021, the subject experienced could take no food or medication at all. On an unspecified date, the subject experienced feeling intense debilitating pain around lower stomach and groin area on right side, new tremor in hands, thoughts jumbling, interrupt sleep, unable to exercise, and terrible headache. Treatment medications (dates unspecified) included: naproxen, and codeine phosphate/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from terrible vomiting, could take no food or medication at all, and intense vomiting it caused to lose control of bladder on 2021, and the outcome of feeling intense debilitating pain around lower stomach and groin area on right side, new tremor in hands, terrible headache, thoughts jumbling, interrupt sleep and unable to exercise was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: TINNITUS; This spontaneous report received from a patient 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, 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 tinnitus. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tinnitus was not reported. 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: U
Vaccine: COVID19
Symptoms: Paraesthesia oral, Rash
Clinical narrative: TINGLING IN MOUTH; 2 BODY RASHES; 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, 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 tingling in mouth, and 2 body rashes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the 2 body rashes and tingling in mouth was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Hypokinesia, Pain, Pyrexia
Clinical narrative: BODY ACHES; FELT LIKE COULDN'T MOVE BODY; INTENSE CHILLS; 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. 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 fever. On 2021, the subject experienced intense chills. On 2021, the subject experienced body aches. On 2021, the subject experienced felt like couldn't move body. Laboratory data included: Body temperature (NR: not provided) 103 F. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The patient recovered from fever, intense chills, body aches, and felt like couldn't move body. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Hypoaesthesia, Musculoskeletal stiffness
Clinical narrative: ARM STIFFNESS; NUMBING PAIN; LIGHTHEADEDNESS; 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 was not reported, administered on MAR-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 MAR-2021, the subject experienced arm stiffness. On MAR-2021, the subject experienced numbing pain. On MAR-2021, the subject experienced lightheadedness. On MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the arm stiffness, numbing pain, lightheadedness and fatigue was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Hypokinesia, Neuralgia, Pain in extremity
Clinical narrative: NERVE PAIN; CANNOT MOVE ARM; ARM PAIN; 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, 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 nerve pain, cannot move arm, and arm pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the arm pain, nerve pain and cannot move arm was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Medication error, Product temperature excursion issue
Clinical narrative: POTENTIAL TEMPERATURE EXCURSION VIALS USED TO VACCINATE PATIENTS; MEDICATION ERROR; 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) 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 potential temperature excursion vials used to vaccinate subjects, and medication error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the potential temperature excursion vials used to vaccinate patients and medication error was not reported. This report was non-serious.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Fatigue, Nausea, Pain, Pain in extremity
Clinical narrative: PAIN AND BODY ACHES; ABDOMINAL DISCOMFORT; LITTLE SORE ARM; FATIGUE; NAUSEA; This spontaneous report received from a consumer concerned a 62 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced pain and body aches. On 13-MAR-2021, the subject experienced abdominal discomfort. On 13-MAR-2021, the subject experienced little sore arm. On 13-MAR-2021, the subject experienced fatigue. On 13-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from little sore arm on 15-MAR-2021, was recovering from pain and body aches, abdominal discomfort, and nausea, and had not recovered from fatigue. This report was non-serious.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Pain
Clinical narrative: BODY ACHES; SHOULDER PAIN/FELT SYMPTOMS OF SORE JOINTS; FELT FATIGUE/EXTREMELY TIRED; This spontaneous report received from a patient concerned a 46 year old male. The patient's height, and weight were not reported. The patient's past medical history included exercise induced asthma, and concurrent conditions included occasional alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no known drug allergies. The patient was previously treated with salbutamol for exercise induced asthma.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 01-APR-2021, the subject experienced body aches. On 01-APR-2021, the subject experienced shoulder pain/felt symptoms of sore joints. On 01-APR-2021, the subject experienced felt fatigue/extremely tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, shoulder pain/felt symptoms of sore joints, and felt fatigue/extremely tired on 03-APR-2021. This report was non-serious.
Age: 19.0
Sex: U
Vaccine: COVID19
Symptoms: Burning sensation, Muscle spasms
Clinical narrative: CRAMP IN UNDERARM OF RIGHT ARM; BURNING IN UNDERARM OF RIGHT ARM; This spontaneous report received from a patient concerned a 19 year old of unspecified 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: 1805031, expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 14:00 for prophylactic vaccination. No concomitant medications were reported. On 22-APR-2021, the subject experienced cramp in underarm of right arm. On 22-APR-2021, the subject experienced burning in underarm of right arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from cramp in underarm of right arm, and burning in underarm of right arm. This report was non-serious.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Polymerase chain reaction
Clinical narrative: CHILLS; This spontaneous report received from a patient concerned a 50 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and abstains from alcohol, and other pre-existing medical conditions included patient had no known drug allergies. Patient had no history of illness.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported.  On JAN-2021, Laboratory data included: PCR (NR: not provided) NEGETIVE. On 08-APR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 09-APR-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event, Headache
Clinical narrative: SOME OTHER SYMPTOMS; BRAIN HURTS; 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) 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 some other symptoms, and brain hurts. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the brain hurts and some other symptoms was not reported. This report was non-serious.