chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Headache, Illness, Nausea, Pain, Paraesthesia
Clinical narrative: SICK; BODY ACHES; TINGLING; NAUSEA; HEADACHES; FEVER; 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced sick, body aches, tingling, nausea, headaches, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sick, body aches, tingling, nausea, headaches and fever was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: SICK; BODY ACHES; TINGLING; NAUSEA; HEADACHES; FEVER; 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced sick, body aches, tingling, nausea, headaches, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sick, body aches, tingling, nausea, headaches and fever was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Lethargy, Nightmare, Pain
Clinical narrative: SEVERE BODY ACHES; NIGHTMARES; LETHARGY; ARM SWELLING; HEADACHE; FEVER; SEVERE FATIGUE; This spontaneous report received from a patient via a company representative concerned an 18 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: 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 an unspecified date, the subject experienced severe body aches, nightmares, lethargy, arm swelling, headache, fever, and severe fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, fever, severe body aches, nightmares, lethargy, severe fatigue and arm swelling was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: SEVERE BODY ACHES; NIGHTMARES; LETHARGY; ARM SWELLING; HEADACHE; FEVER; SEVERE FATIGUE; This spontaneous report received from a patient via a company representative concerned an 18 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: 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 an unspecified date, the subject experienced severe body aches, nightmares, lethargy, arm swelling, headache, fever, and severe fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, fever, severe body aches, nightmares, lethargy, severe fatigue and arm swelling was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: POSITIVE SIDE EFFECT (TREMORS GONE); This spontaneous report received from a patient concerned a 60 year old male. The patient's height, and weight were not reported. The patient's past medical history included tremors, and concurrent conditions included parkinsons.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced positive side effect (tremors gone). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of positive side effect (tremors gone) was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity, Pyrexia
Clinical narrative: SORE ARM; LOW GRADE FEVER; EXHAUSTION; PERSISTENT INTERMITTENT HEADACHE; This spontaneous report received from a patient via a company representative concerned a 63 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, 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 sore arm, low grade fever, exhaustion, and persistent intermittent headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from low grade fever, and the outcome of exhaustion, persistent intermittent headache and sore arm was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Irritability, Rash
Clinical narrative: FEELING CRANKY; RASH/HIVES ON THE BODY; EXTRA TIREDNESS; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's past medical history included chicken pox, and concurrent conditions included sulpha drug allergy, and other pre-existing medical conditions included on hormone replacement therapy for a long time progesterone and estradiol on some longstanding otc's, sulpha drug allergy.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and batch number: 1808609 expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. Concomitant medications included estradiol for hormone replacement therapy, and progesterone for hormone replacement therapy. On an unspecified date, the subject experienced feeling cranky, rash/hives on the body, and extra tiredness. Treatment medications (dates unspecified) included: camphor, menthol, loratadine, and pramocaine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the rash/hives on the body, extra tiredness and feeling cranky was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Feeling cold, Headache, Nausea, Pain in extremity
Clinical narrative: COLD SENSATION ON NOSE, FINGERS AND TOES; SORE ARM; HEADACHE; nausea; This spontaneous report received from a patient concerned a 61 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and  expiry: UNKNOWN) dose was not reported, administered on 07-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-MAR-2021, the subject experienced cold sensation on nose, fingers and toes. On 07-MAR-2021, the subject experienced sore arm. On 07-MAR-2021, the subject experienced headache. On 07-MAR-2021, the subject experienced nausea. On 08-APR-2021, Laboratory data included: Blood test (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm, headache, and nausea on 08-MAR-2021, and had not recovered from cold sensation on nose, fingers and toes. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Sinusitis
Clinical narrative: SINUS INFECTION A WEEK AFTER SHOT; 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 12-APR-2021 for prophylactic vaccination. The batch number was not reported. As per procedure no follow-up will be requested for this case. No concomitant medications were reported. On 19-APR-2021, the patient experienced sinus infection a week after shot. Laboratory data included: Blood test (NR: not provided) results came out clear, and CAT scan (NR: not provided) results came out clear. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sinus infection a week after shot was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Nasopharyngitis
Clinical narrative: COLD LIKE SYMPTOM; FELT SICK/NOT FEEL WELL; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. 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 cold like symptom, and felt sick/not feel well. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cold like symptom, and felt sick/not feel well. This report was non-serious. This case, from the same reporter is linked to 20210442783.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Headache, Hypoaesthesia, Muscle spasms
Clinical narrative: NAUSEA; DIARRHEA; LEG CRAMPS; TINGLING TO THE HANDS, FEET AND THROUGHOUT THE WHOLE BODY; NUMBNESS TO THE FINGERS AND TOES; BLURRED VISION; INTERMITTENT HEADACHE; PAIN INSIDE THE RIGHT THIGH; FATIGUE; SORE RIGHT ARM; This spontaneous report received from a patient concerned a 74 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included chronic obstructive pulmonary disease, hypothyroidism, milk allergy, tomato allergy, wheat allergy, allergic to weeds, allergic to cat and dog dander, sulfonamide allergy, and tetracycline allergy. The patient experienced drug allergy when treated with epinephrine, and erythromycin. 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 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced sore right arm. On 06-APR-2021, the subject experienced fatigue. On 12-APR-2021, the subject experienced tingling to the hands, feet and throughout the whole body. On 12-APR-2021, the subject experienced numbness to the fingers and toes. On 12-APR-2021, the subject experienced blurred vision. On 12-APR-2021, the subject experienced leg cramps. On 12-APR-2021, the subject experienced pain inside the right thigh. On 12-APR-2021, the subject experienced intermittent headache. On 14-APR-2021, the subject experienced diarrhea. On 18-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore right arm, and fatigue on 09-APR-2021, and had not recovered from tingling to the hands, feet and throughout the whole body, numbness to the fingers and toes, intermittent headache, blurred vision, diarrhea, nausea, leg cramps, and pain inside the right thigh. This report was non-serious.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Paraesthesia, Vision blurred
Clinical narrative: NAUSEA; DIARRHEA; LEG CRAMPS; TINGLING TO THE HANDS, FEET AND THROUGHOUT THE WHOLE BODY; NUMBNESS TO THE FINGERS AND TOES; BLURRED VISION; INTERMITTENT HEADACHE; PAIN INSIDE THE RIGHT THIGH; FATIGUE; SORE RIGHT ARM; This spontaneous report received from a patient concerned a 74 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included chronic obstructive pulmonary disease, hypothyroidism, milk allergy, tomato allergy, wheat allergy, allergic to weeds, allergic to cat and dog dander, sulfonamide allergy, and tetracycline allergy. The patient experienced drug allergy when treated with epinephrine, and erythromycin. 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 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced sore right arm. On 06-APR-2021, the subject experienced fatigue. On 12-APR-2021, the subject experienced tingling to the hands, feet and throughout the whole body. On 12-APR-2021, the subject experienced numbness to the fingers and toes. On 12-APR-2021, the subject experienced blurred vision. On 12-APR-2021, the subject experienced leg cramps. On 12-APR-2021, the subject experienced pain inside the right thigh. On 12-APR-2021, the subject experienced intermittent headache. On 14-APR-2021, the subject experienced diarrhea. On 18-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore right arm, and fatigue on 09-APR-2021, and had not recovered from tingling to the hands, feet and throughout the whole body, numbness to the fingers and toes, intermittent headache, blurred vision, diarrhea, nausea, leg cramps, and pain inside the right thigh. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Lethargy, Myalgia, Pyrexia
Clinical narrative: LETHARGY; CHILLS; FEVER; MUSCLE ACHE; 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 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 an unspecified date, the subject experienced lethargy, chills, fever, and muscle ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, fever, lethargy and muscle ache was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue
Clinical narrative: DIARRHEA; EXTREME TIREDNESS; This spontaneous report received from a patient concerned a 57 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) dose was not reported, administered on 28-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported. On 29-MAR-2021, the patient experienced diarrhea. On 29-MAR-2021, the patient experienced extreme tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from extreme tiredness, and diarrhea. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Lip swelling, Paraesthesia, Paraesthesia oral, Pruritus, Rash macular
Clinical narrative: ITCHY HEAD AND FACE; LIPS SLIGHTLY SWOLLEN; BLOTCHY LOOKING RASH ABOVE AND BELOW THE INJECTION SITE SPREAD TO NECK AND CHEST; HIVES; INJECTION ARM TINGLING; TONGUE TINGLING; 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, 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 it has been requested. No concomitant medications were reported. On 09-APR-2021, the subject experienced injection arm tingling. On 09-APR-2021, the subject experienced tongue tingling. Treatment medications included: diphenhydramine hydrochloride. On 10-APR-2021, the subject experienced blotchy looking rash above and below the injection site spread to neck and chest. On 10-APR-2021, the subject experienced hives. Treatment medications included: calamine/glycerol/zinc oxide, and cetirizine hydrochloride/pseudoephedrine hydrochloride. On 12-APR-2021, the subject experienced itchy head and face. On 12-APR-2021, the subject experienced lips slightly swollen. On 13-APR-2021, treatment medications included: cetirizine hydrochloride, and famotidine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection arm tingling, tongue tingling, itchy head and face, lips slightly swollen, blotchy looking rash above and below the injection site spread to neck and chest, and hives on APR-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: ITCHY HEAD AND FACE; LIPS SLIGHTLY SWOLLEN; BLOTCHY LOOKING RASH ABOVE AND BELOW THE INJECTION SITE SPREAD TO NECK AND CHEST; HIVES; INJECTION ARM TINGLING; TONGUE TINGLING; 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, 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 it has been requested. No concomitant medications were reported. On 09-APR-2021, the subject experienced injection arm tingling. On 09-APR-2021, the subject experienced tongue tingling. Treatment medications included: diphenhydramine hydrochloride. On 10-APR-2021, the subject experienced blotchy looking rash above and below the injection site spread to neck and chest. On 10-APR-2021, the subject experienced hives. Treatment medications included: calamine/glycerol/zinc oxide, and cetirizine hydrochloride/pseudoephedrine hydrochloride. On 12-APR-2021, the subject experienced itchy head and face. On 12-APR-2021, the subject experienced lips slightly swollen. On 13-APR-2021, treatment medications included: cetirizine hydrochloride, and famotidine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection arm tingling, tongue tingling, itchy head and face, lips slightly swollen, blotchy looking rash above and below the injection site spread to neck and chest, and hives on APR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Bone pain, Bronchitis, Chest X-ray, Influenza like illness
Clinical narrative: BRONCHITIS; WEAKNESS THROUGHOUT ENTIRE BODY; RIGHT NOSE SWELLED; BONES BEGAN TO ACHE; FLU LIKE SYMPTOMS; This spontaneous report received from a patient concerned a 38 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 09-APR-2021 for prophylactic vaccination. Concomitant medications included leuprorelin acetate. On 10-APR-2021, the subject experienced flu like symptoms. On 12-APR-2021, the subject experienced bones began to ache. On 13-APR-2021, the subject experienced right nose swelled. On 14-APR-2021, the subject experienced bronchitis. On 14-APR-2021, the subject experienced weakness throughout entire body. On 15-APR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) negative, and Chest X-ray (NR: not provided) bronchitis. Treatment medications (dates unspecified) included: salbutamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bronchitis, and the outcome of bones began to ache, right nose swelled, weakness throughout entire body and flu like symptoms was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Nasal oedema, SARS-CoV-2 test
Clinical narrative: BRONCHITIS; WEAKNESS THROUGHOUT ENTIRE BODY; RIGHT NOSE SWELLED; BONES BEGAN TO ACHE; FLU LIKE SYMPTOMS; This spontaneous report received from a patient concerned a 38 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 09-APR-2021 for prophylactic vaccination. Concomitant medications included leuprorelin acetate. On 10-APR-2021, the subject experienced flu like symptoms. On 12-APR-2021, the subject experienced bones began to ache. On 13-APR-2021, the subject experienced right nose swelled. On 14-APR-2021, the subject experienced bronchitis. On 14-APR-2021, the subject experienced weakness throughout entire body. On 15-APR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) negative, and Chest X-ray (NR: not provided) bronchitis. Treatment medications (dates unspecified) included: salbutamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bronchitis, and the outcome of bones began to ache, right nose swelled, weakness throughout entire body and flu like symptoms was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Balance disorder, Dyspnoea, Hypoaesthesia, Muscular weakness, Palpitations
Clinical narrative: PALPITATIONS; LESS STRENGTH IN ARM AND HAND; FINGERS ARE COLD; NUMBNESS IN HAND AND FINGERS; SHORT WINDED; LITTLE OFF BALANCED; This spontaneous report received from a patient concerned a 65 year old of unspecified sex. The patient's height, and weight were not reported.  The patient's concurrent conditions included abstains from alcohol, and abstains from drugs. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and expiry: UNKNOWN) dose was not reported, administered on 22-MAR-2021 for prophylactic vaccination.  No concomitant medications were reported.  On 01-APR-2021, the subject experienced short winded. On 01-APR-2021, the subject experienced little off balanced. On 10-APR-2021, the subject experienced numbness in hand and fingers. On 10-APR-2021, the subject experienced fingers are cold. On 16-APR-2021, the subject experienced less strength in arm and hand. On an unspecified date, the subject experienced palpitations. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from short winded, little off balanced, numbness in hand and fingers, and fingers are cold, and had not recovered from palpitations, and less strength in arm and hand. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Peripheral coldness
Clinical narrative: PALPITATIONS; LESS STRENGTH IN ARM AND HAND; FINGERS ARE COLD; NUMBNESS IN HAND AND FINGERS; SHORT WINDED; LITTLE OFF BALANCED; This spontaneous report received from a patient concerned a 65 year old of unspecified sex. The patient's height, and weight were not reported.  The patient's concurrent conditions included abstains from alcohol, and abstains from drugs. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and expiry: UNKNOWN) dose was not reported, administered on 22-MAR-2021 for prophylactic vaccination.  No concomitant medications were reported.  On 01-APR-2021, the subject experienced short winded. On 01-APR-2021, the subject experienced little off balanced. On 10-APR-2021, the subject experienced numbness in hand and fingers. On 10-APR-2021, the subject experienced fingers are cold. On 16-APR-2021, the subject experienced less strength in arm and hand. On an unspecified date, the subject experienced palpitations. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from short winded, little off balanced, numbness in hand and fingers, and fingers are cold, and had not recovered from palpitations, and less strength in arm and hand. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2, Hypokinesia, Insomnia, Muscle strain, Rib fracture
Clinical narrative: FELT LIKE CRACKED RIB; ABDOMINAL MUSCLE PULL; COULD NOT SLEEP ON AFFECTED SIDE; COULD NOT MOVE; EXPOSED TO COVID-19 INFECTED PERSON; 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-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 felt like cracked rib. On APR-2021, the subject experienced abdominal muscle pull. On APR-2021, the subject experienced could not sleep on affected side. On APR-2021, the subject experienced could not move. On APR-2021, the subject experienced exposed to covid-19 infected person. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the could not sleep on affected side, abdominal muscle pull, could not move, felt like cracked rib and exposed to covid-19 infected person was not reported. This report was non-serious.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Pain in extremity
Clinical narrative: THROBBING LEG PAIN/LEGS SORE TO TOUCH; STOMACH UPSET; This spontaneous report received from a patient concerned a 32 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, expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, treatment medications included: naproxen sodium. On 22-MAR-2021, the subject experienced stomach upset. On 10-APR-2021, the subject experienced throbbing leg pain/legs sore to touch. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stomach upset on 24-MAR-2021, and had not recovered from throbbing leg pain/legs sore to touch. This report was non-serious.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SORE ARM; This spontaneous report received from a patient concerned a 78 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, 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 and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 11-APR-2021, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sore arm. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: EXTREME TIREDNESS; This spontaneous report received from a consumer concerned a 59 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: Unk) dose was not reported, administered on 28-MAR-2021 12:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 29-MAR-2021, the subject experienced extreme tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from extreme tiredness. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Feeling jittery, Headache, Insomnia, Pain
Clinical narrative: SORENESS; JITTERINESS; UNABLE TO SLEEP; FATIGUE; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 71 year old of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergy, and codeine allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A 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 soreness. On 12-APR-2021, the subject experienced jitteriness. On 12-APR-2021, the subject experienced unable to sleep. On 12-APR-2021, the subject experienced fatigue. On 12-APR-2021, the subject experienced fever. On 12-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from jitteriness, unable to sleep, and fever on 13-APR-2021, fatigue on 14-APR-2021, and headache on 15-APR-2021, and was recovering from soreness. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: SORENESS; JITTERINESS; UNABLE TO SLEEP; FATIGUE; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 71 year old of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergy, and codeine allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A 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 soreness. On 12-APR-2021, the subject experienced jitteriness. On 12-APR-2021, the subject experienced unable to sleep. On 12-APR-2021, the subject experienced fatigue. On 12-APR-2021, the subject experienced fever. On 12-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from jitteriness, unable to sleep, and fever on 13-APR-2021, fatigue on 14-APR-2021, and headache on 15-APR-2021, and was recovering from soreness. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Productive cough
Clinical narrative: COUGHING UP PHLEGM ALL THE TIME; EXTREMELY TIRED; This spontaneous report received from a consumer concerned a 74 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: Unknown) dose was not reported, administered on 28-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 29-MAR-2021, the subject experienced coughing up phlegm all the time. On 29-MAR-2021, the subject experienced extremely tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from extremely tired, and coughing up phlegm all the time. This report was non-serious.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Eye swelling, Fatigue, Headache, Injection site pain
Clinical narrative: SWOLLEN LEFT EYE; HEADACHE; INJECTION SITE SORENESS; TIREDNESS; This spontaneous report received from a patient concerned a 33 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: 1808982 expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced injection site soreness. On 09-APR-2021, the subject experienced tiredness. On 21-APR-2021, the subject experienced swollen left eye. On 21-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site soreness, and tiredness on APR-2021, and had not recovered from swollen left eye, and headache. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Decreased appetite, Fatigue, Malaise, Nausea
Clinical narrative: MALAISE; FATIGUE; LOW-GRADE FEVER; SLIGHT NAUSEA; LACK OF APPETITE; ACHINESS; 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, and batch number were not reported) dose was not reported, administered on 06-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 lack of appetite. On APR-2021, the subject experienced achiness. On APR-2021, the subject experienced malaise. On APR-2021, the subject experienced fatigue. On APR-2021, the subject experienced low-grade fever. On APR-2021, the subject experienced slight nausea. Laboratory data included: Body temperature (NR: not provided) 99-100 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from achiness, malaise, low-grade fever, and slight nausea on 18-APR-2021, was recovering from lack of appetite, and had not recovered from fatigue. This report was non-serious. This case, from the same reporter is linked to 20210440747.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: MALAISE; FATIGUE; LOW-GRADE FEVER; SLIGHT NAUSEA; LACK OF APPETITE; ACHINESS; 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, and batch number were not reported) dose was not reported, administered on 06-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 lack of appetite. On APR-2021, the subject experienced achiness. On APR-2021, the subject experienced malaise. On APR-2021, the subject experienced fatigue. On APR-2021, the subject experienced low-grade fever. On APR-2021, the subject experienced slight nausea. Laboratory data included: Body temperature (NR: not provided) 99-100 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from achiness, malaise, low-grade fever, and slight nausea on 18-APR-2021, was recovering from lack of appetite, and had not recovered from fatigue. This report was non-serious. This case, from the same reporter is linked to 20210440747.
Sex: M
Vaccine: COVID19
Symptoms: Dysstasia, Fatigue
Clinical narrative: DIFFICULTY IN STANDING; FATIGUE; 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 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 difficulty in standing. On APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fatigue and difficulty in standing was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Nasopharyngitis
Clinical narrative: FLU SYMPTOMS/FEVER/CHILLS/HEADACHE/ACHES AND PAINS; COLD SYMPTOMS; This spontaneous report received from a consumer concerned a 51 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: 041A21A expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced flu symptoms/fever/chills/headache/aches and pains. On 07-APR-2021, the subject experienced cold symptoms. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cold symptoms, and had not recovered from flu symptoms/fever/chills/headache/aches and pains. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Malaise, Nasopharyngitis
Clinical narrative: COLD; CHILLS; FELT RUNDOWN; HEADACHE; 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. 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 cold, chills, felt rundown, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chills, headache, felt rundown, and cold. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Movement disorder, Pain in extremity
Clinical narrative: PAIN IN ARMS; PAIN IN SHOULDERS; UNABLE TO LIFT ARMS; This spontaneous report received from a patient concerned a 21 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: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced unable to lift arms. On 14-APR-2021, the subject experienced pain in arms. On 14-APR-2021, the subject experienced pain in shoulders. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in arms, pain in shoulders, and unable to lift arms. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal discomfort, Anxiety, Chills, Dizziness, Fatigue
Clinical narrative: DIZZINESS; UPSET STOMACH; ANXIETY ATTACK; MALAISE; CHILLS; EXHAUSTED; 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, 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 number. No concomitant medications were reported. On an unspecified date, the subject experienced dizziness, upset stomach, anxiety attack, malaise, chills, and exhausted. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, upset stomach, anxiety attack, malaise, chills, and exhausted. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: DIZZINESS; UPSET STOMACH; ANXIETY ATTACK; MALAISE; CHILLS; EXHAUSTED; 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, 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 number. No concomitant medications were reported. On an unspecified date, the subject experienced dizziness, upset stomach, anxiety attack, malaise, chills, and exhausted. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, upset stomach, anxiety attack, malaise, chills, and exhausted. This report was non-serious.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Head discomfort, Headache, Impaired work ability, Suicidal ideation
Clinical narrative: felt suicidal; head pressure; head throbbing/ feels like head is being stabbed/ 3 months of chronic headache (daily head pressure and pain) since receiving the second dose; head burning; Lost two months of work; This spontaneous case was reported by an attorney (subsequently medically confirmed) and describes the occurrence of SUICIDAL IDEATION (felt suicidal) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported).   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced HEAD DISCOMFORT (head pressure), HEADACHE (head throbbing/ feels like head is being stabbed/ 3 months of chronic headache (daily head pressure and pain) since receiving the second dose), BURNING SENSATION (head burning) and IMPAIRED WORK ABILITY (Lost two months of work). On an unknown date, the patient experienced SUICIDAL IDEATION (felt suicidal) (seriousness criterion medically significant). At the time of the report, SUICIDAL IDEATION (felt suicidal), HEAD DISCOMFORT (head pressure), HEADACHE (head throbbing/ feels like head is being stabbed/ 3 months of chronic headache (daily head pressure and pain) since receiving the second dose), BURNING SENSATION (head burning) and IMPAIRED WORK ABILITY (Lost two months of work) outcome was unknown.            The Patient emphasized that lot number 042L20A was discontinued in the beginning stages of the Moderna vaccination distribution. The patient had been to multiple specialists, had CT scans, MRIs, multiple prescriptions, and nothing has worked. Treatment medications included Tylenol, Aleve, prednisone, Topemax, sumatriptan and multiple others.  Very limited information regarding these events has been provided at this time. No follow up is possible.   This case was linked to MOD-2021-080204 (E2B Linked Report). This case was linked to MOD-2021-080106 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Updated medically confirmed to yes, patient medical history, suspect product details, treatment medications and added new events.; Sender's Comments: Very limited information regarding these events has been provided at this time. No follow up is possible. MOD-2021-080204:MOD21-033662
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Cough, Decreased appetite, Hallucination
Clinical narrative: not feeling well; Cough; My lungs feel like fine ,I can hold my breath for a long time .It is a kind of irrritation there.; Could not drink or eat anything; Vomited; when I close my eyes I was seeing weird stuff (people, monsters), it felt like I was hallucinating; Fever; Headache; Little of nausea; dry cough; feeling washed out; Chills; This spontaneous case was reported by a consumer and describes the occurrence of HALLUCINATION (when I close my eyes I was seeing weird stuff (people, monsters), it felt like I was hallucinating) in a 54-year-old female patient who received mRNA-1273  for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported).    On 13-Mar-2021, the patient received first dose of mRNA-1273  (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced CHILLS (Chills). On 16-Mar-2021, the patient experienced HALLUCINATION (when I close my eyes I was seeing weird stuff (people, monsters), it felt like I was hallucinating) (seriousness criterion medically significant), COUGH (dry cough), ASTHENIA (feeling washed out), PYREXIA (Fever), HEADACHE (Headache) and NAUSEA (Little of nausea). On 17-Mar-2021, the patient experienced DECREASED APPETITE (Could not drink or eat anything) and VOMITING (Vomited). On 19-Mar-2021, the patient experienced COUGH (Cough) and RESPIRATORY TRACT IRRITATION (My lungs feel like fine ,I can hold my breath for a long time .It is a kind of irrritation there.). On an unknown date, the patient experienced MALAISE (not feeling well). On 18-Mar-2021, VOMITING (Vomited) had not resolved. On 23-Mar-2021, CHILLS (Chills), PYREXIA (Fever), HEADACHE (Headache) and NAUSEA (Little of nausea) had resolved. At the time of the report, HALLUCINATION (when I close my eyes I was seeing weird stuff (people, monsters), it felt like I was hallucinating), MALAISE (not feeling well), DECREASED APPETITE (Could not drink or eat anything) and ASTHENIA (feeling washed out) outcome was unknown and COUGH (Cough), RESPIRATORY TRACT IRRITATION (My lungs feel like fine ,I can hold my breath for a long time .It is a kind of irrritation there.) and COUGH (dry cough) had not resolved.        The action taken with mRNA-1273 (Intramuscular) was unknown.       Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 29-Mar-2021: Outcome of the events included nausea, headache, fever, chills were updated as recovered on 23-Mar-2021. Dry cough was added as new event.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.