chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Pain in extremity
Clinical narrative: FINGERS ARE VERY STIFF AND SORE; THE ARM IN WHICH THE VACCINE WAS INJECTED WAS SORE; 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 10-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 23-MAR-2021, the subject experienced the arm in which the vaccine was injected was sore. On 24-MAR-2021, the subject experienced fingers are very stiff and sore. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the the arm in which the vaccine was injected was sore and fingers are very stiff and sore was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Influenza like illness, Pain, Pyrexia
Clinical narrative: FLU LIKE SIDE EFFECTS; SEVERE BODY ACHES; SEVERE CHILLS; MODERATE FEVER; SEVERE TENSION IN MY HEAD; SEVERE FATIGUE; This spontaneous report received from a patient concerned a 31 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, the batch number were not reported and has been requested) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On Mar-2021, the subject experienced flu like side effects, severe body aches, severe chills, moderate fever, severe tension in my head, and severe fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the flu like side effects, severe chills, moderate fever, severe body aches, severe tension in my head and severe fatigue was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Tension headache
Clinical narrative: FLU LIKE SIDE EFFECTS; SEVERE BODY ACHES; SEVERE CHILLS; MODERATE FEVER; SEVERE TENSION IN MY HEAD; SEVERE FATIGUE; This spontaneous report received from a patient concerned a 31 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, the batch number were not reported and has been requested) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On Mar-2021, the subject experienced flu like side effects, severe body aches, severe chills, moderate fever, severe tension in my head, and severe fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the flu like side effects, severe chills, moderate fever, severe body aches, severe tension in my head and severe fatigue was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Abnormal dreams
Clinical narrative: WEIRD DREAMS; 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 20-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 20-MAR-2021, the subject experienced weird dreams. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of weird dreams was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Sinusitis, Therapeutic response unexpected
Clinical narrative: CLEARED SINUSES; UNEXPECTED THERAPEUTIC BENEFIT; 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 concurrent conditions included seasonal allergy of sinuses problem. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, one total, administered on 21-MAR-2021 in left arm for prophylactic vaccination. No concomitant medications were reported. On 21-MAR-2021, the subject experienced cleared sinuses. On 21-MAR-2021, the subject experienced unexpected therapeutic benefit. Treatment medications (dates unspecified) included: loratadine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the cleared sinuses and unexpected therapeutic benefit was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nausea, Neck pain
Clinical narrative: NECK PAIN; HEADACHE; NAUSEA; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered on 13-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 18-MAR-2021, the subject experienced neck pain. On 18-MAR-2021, the subject experienced headache. On 18-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, nausea, and neck pain. This report was non-serious.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Skin irritation, Skin lesion
Clinical narrative: RAISED LESION ON CALF; NON RAISED LESION ON CALF; FATIGUE; This spontaneous report received from a patient concerned an 82 year old female. The patient's height, and weight were not reported. The patient's past medical history included hypothyroid, and hx of hyperthyroid, and concurrent conditions included seasonal tobacco allergy, does not consume alcohol, and does not smoke. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: 25-MAY-2021) dose was not reported, administered on 19-MAR-2021 for prophylactic vaccination on left arm. No concomitant medications were reported.  On 19-MAR-2021, the subject experienced fatigue. On 23-MAR-2021, the subject experienced raised lesion on calf. On 23-MAR-2021, the subject experienced non raised lesion on calf. Treatment medications (dates unspecified) included: bacitracin zinc/polymyxin b sulfate, povidone-iodine, and hydrogen peroxide. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from raised lesion on calf, non raised lesion on calf, and fatigue. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea, Pain
Clinical narrative: ACHY; CLOGGED SINUSES; SHIVERING AND COULD NOT GET WARM; TIRED; NAUSEOUS; FEVER; HEADACHE; This spontaneous report received from a patient via an unspecified 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: 1805028, expiry: UNKNOWN) dose was not reported, administered on MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced achy. On MAR-2021, the subject experienced clogged sinuses. On MAR-2021, the subject experienced shivering and could not get warm. On MAR-2021, the subject experienced tired. On MAR-2021, the subject experienced nauseous. On MAR-2021, the subject experienced fever. On MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from achy, clogged sinuses, shivering and could not get warm, tired, nauseous, fever, and headache on MAR-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia, Sinus congestion
Clinical narrative: ACHY; CLOGGED SINUSES; SHIVERING AND COULD NOT GET WARM; TIRED; NAUSEOUS; FEVER; HEADACHE; This spontaneous report received from a patient via an unspecified 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: 1805028, expiry: UNKNOWN) dose was not reported, administered on MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced achy. On MAR-2021, the subject experienced clogged sinuses. On MAR-2021, the subject experienced shivering and could not get warm. On MAR-2021, the subject experienced tired. On MAR-2021, the subject experienced nauseous. On MAR-2021, the subject experienced fever. On MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from achy, clogged sinuses, shivering and could not get warm, tired, nauseous, fever, and headache on MAR-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: REACTION TO VACCINE; 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 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 reaction to vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The outcome of reaction to vaccine was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Hypersomnia, Injection site pain
Clinical narrative: SLEPT FOR TWO DAYS; PINCH-LIKE PAIN AT INJECTION SITE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 20-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. No concomitant medications were reported. On MAR-2021, the subject experienced slept for two days. On MAR-2021, the subject experienced pinch-like pain at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pinch-like pain at injection site and slept for two days was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia, Somnolence
Clinical narrative: BODY SORENESS; FEELING BAD WHOLE SECOND DAY; FEVER; HEADACHE; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 09-MAR-2021 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 body soreness, feeling bad whole second day, fever, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body soreness, feeling bad whole second day, fever, and headache on 12-MAR-2021. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Lip blister
Clinical narrative: FEVER BLISTER ON LIP; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 22-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced fever blister on lip. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fever blister on lip was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Feeling abnormal, Pain
Clinical narrative: FELT LIKE HIT BY A TRUCK; COULDN'T GET OUT OF BED; EVERYTHING HURT; 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. 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 felt like hit by a truck, couldn't get out of bed, and everything hurt. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the felt like hit by a truck, couldn't get out of bed and everything hurt was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: HAS A SORE ARM AFTER THE INJECTION FROM A FEW WEEKS AGO; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the subject experienced has a sore arm after the injection from a few weeks ago. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from has a sore arm after the injection from a few weeks ago. This report was non-serious.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Headache, Pain, Pyrexia
Clinical narrative: CHILLS; FEVER; MILD HEADACHE; BODY ACHES AND PAINS; DIARRHEA; This spontaneous report received from a patient concerned a 47 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included familial tremors, non alcohol user, and smoker, and other pre-existing medical conditions included the patient had no known allergies and did not had drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805025, and expiry: UNKNOWN) dose was not reported, administered on 22-MAR-2021 for prophylactic vaccination on left arm. Concomitant medications included propranolol, and venlafaxine hydrochloride. On 22-MAR-2021, the subject experienced diarrhea. On 23-MAR-2021, the subject experienced body aches and pains. On 23-MAR-2021, the subject experienced fever. On 23-MAR-2021, the subject experienced mild headache. On an unspecified date, the subject experienced chills. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea on 22-MAR-2021, and body aches and pains, fever, and mild headache on 23-MAR-2021, and the outcome of chills was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: CHILLS; LINGERING HEADACHE; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced chills, and lingering headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills and lingering headache was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: FEVER; This spontaneous report received from a patient 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) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch or lot number. No concomitant medications were reported. On 22-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fever was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Heart rate increased, Illness
Clinical narrative: FAST HEARTBEAT; DIARRHEA; TIRED; SICKNESS; 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 15-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAR-2021, the subject experienced sickness. On 19-MAR-2021, the subject experienced fast heartbeat. On 19-MAR-2021, the subject experienced diarrhea. On 19-MAR-2021, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tired, fast heartbeat, diarrhea and sickness was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Headache, Insomnia, Pyrexia
Clinical narrative: FEVER; LOW ENERGY; EXTREME FATIGUE; SLEEPLESS; SEVERE HEADACHE; 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: 1805031 )expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-MAR-2021, the subject experienced severe headache. On 15-MAR-2021, the subject experienced sleepless. On 16-MAR-2021, the subject experienced extreme fatigue. On 21-MAR-2021, the subject experienced low energy. On 23-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered with sequelae from sleepless on 16-MAR-2021, was recovering from severe headache, and fever, and had not recovered from extreme fatigue, and low energy. The reporter considered related  causality between covid-19 vaccine ad26.cov2.s and sleepless ,severe headache, fever ,extreme fatigue, and low energy and company causality between covid-19 vaccine ad26.cov2.s and sleepless ,severe headache, fever ,extreme fatigue, and low energy was possible. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Injection site pain
Clinical narrative: FELT SOMETHING DRIPPING DOWN HER ARM; NEEDLE GO IN A LITTLE BURN; 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: 1805031, and expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 20-MAR-2021, the subject experienced felt something dripping down her arm. On 20-MAR-2021, the subject experienced needle go in a little burn. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the felt something dripping down her arm and needle go in a little burn was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: VACCINE AFFECTED HORRIBLY; 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, expiry: UNKNOWN) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On MAR-2021, the subject experienced vaccine affected horribly. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine affected horribly was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Headache, Hypoaesthesia, Joint swelling
Clinical narrative: BACK ACHE; TINGLING ON BOTH HANDS / TINGLING SENSATION; NUMBNESS IN THE JOINTS; LEFT KNEE SWELLING; LEFT LEG MUSCLE ACHE; LEFT KNEE ACHE; HEADACHE; 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: Unk) dose was not reported, administered on 06-MAR-2021 08:30 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-MAR-2021, the subject experienced back ache. On 06-MAR-2021, the subject experienced tingling on both hands / tingling sensation. On 06-MAR-2021, the subject experienced numbness in the joints. On 06-MAR-2021, the subject experienced left knee swelling. On 06-MAR-2021, the subject experienced left leg muscle ache. On 06-MAR-2021, the subject experienced left knee ache. On 06-MAR-2021, the subject experienced headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 06-MAR-2021, and had not recovered from left knee ache, back ache, numbness in the joints, left knee swelling, left leg muscle ache, and tingling on both hands / tingling sensation. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: BACK ACHE; TINGLING ON BOTH HANDS / TINGLING SENSATION; NUMBNESS IN THE JOINTS; LEFT KNEE SWELLING; LEFT LEG MUSCLE ACHE; LEFT KNEE ACHE; HEADACHE; 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: Unk) dose was not reported, administered on 06-MAR-2021 08:30 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-MAR-2021, the subject experienced back ache. On 06-MAR-2021, the subject experienced tingling on both hands / tingling sensation. On 06-MAR-2021, the subject experienced numbness in the joints. On 06-MAR-2021, the subject experienced left knee swelling. On 06-MAR-2021, the subject experienced left leg muscle ache. On 06-MAR-2021, the subject experienced left knee ache. On 06-MAR-2021, the subject experienced headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 06-MAR-2021, and had not recovered from left knee ache, back ache, numbness in the joints, left knee swelling, left leg muscle ache, and tingling on both hands / tingling sensation. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: ITCHINESS ALL OVER BODY AND FOREHEAD; 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 13-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced itchiness all over body and forehead. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from itchiness all over body and forehead. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Injection site pain
Clinical narrative: TIRED; HEADACHE; MILD FEVER; ARM SWOLLEN AT SITE OF INJECTION; BODY ACHE; CHILLS; SORE ARM AT SITE OF INJECTION; 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: 1802070, and expiry: UNKNOWN) dose was not reported, administered on 23-MAR-2021 at left arm for prophylactic vaccination.  No concomitant medications were reported. On 23-MAR-2021, the subject experienced sore arm at site of injection. On 24-MAR-2021, the subject experienced body ache. On 24-MAR-2021, the subject experienced chills. On 24-MAR-2021, the subject experienced headache. On 24-MAR-2021, the subject experienced mild fever. On 24-MAR-2021, the subject experienced arm swollen at site of injection. On 24-MAR-2021, the subject experienced tired. Laboratory data included: Body temperature (NR: not provided) 97.6 degrees F. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, mild fever, chills, body ache, arm swollen at site of injection, tired and sore arm at site of injection was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Pain, Pyrexia
Clinical narrative: TIRED; HEADACHE; MILD FEVER; ARM SWOLLEN AT SITE OF INJECTION; BODY ACHE; CHILLS; SORE ARM AT SITE OF INJECTION; 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: 1802070, and expiry: UNKNOWN) dose was not reported, administered on 23-MAR-2021 at left arm for prophylactic vaccination.  No concomitant medications were reported. On 23-MAR-2021, the subject experienced sore arm at site of injection. On 24-MAR-2021, the subject experienced body ache. On 24-MAR-2021, the subject experienced chills. On 24-MAR-2021, the subject experienced headache. On 24-MAR-2021, the subject experienced mild fever. On 24-MAR-2021, the subject experienced arm swollen at site of injection. On 24-MAR-2021, the subject experienced tired. Laboratory data included: Body temperature (NR: not provided) 97.6 degrees F. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, mild fever, chills, body ache, arm swollen at site of injection, tired and sore arm at site of injection was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Exposure via breast milk
Clinical narrative: VACCINE EXPOSURE VIA BREAST MILK; This spontaneous report received from a parent concerned a 13 month old female. The patient's weight, height, and medical history were not reported.The patient's parent 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 24-MAR-2021 for an unspecified indication. No concomitant medications were reported. On 24-MAR-2021, the subject experienced vaccine exposure via breast milk. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine exposure via breast milk was not reported. This report was non-serious.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: BODY ACHE; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 59 year old male. The patient's weight, height, and medical history were not reported. The patient experienced drug allergy when treated with amoxicillin. 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 24-MAR-2021at left arm for prophylactic vaccination. Batch number was not reported and has been requested No concomitant medications were reported. On 24-MAR-2021, the subject experienced body ache. On 24-MAR-2021, the subject experienced headache. On 24-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, and had not recovered from headache, and body ache. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Blood pressure measurement, Ear pain, Eye pain
Clinical narrative: PAIN IN EAR; PAIN BEHIND EYES; CAN NOT FALL ASLEEP; LOW BACK PAIN; PAIN BEHIND EAR; PAIN AND BODY ACHES; EXHAUSTED; SEVER HEADACHE; JOINT PAIN; COLD HANDS AND FEET; This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid 19 infection, and concurrent conditions included chronic pain, kidney problems, on physiotherapy, non alcoholic, and non smoker, and other pre-existing medical conditions included she had more 3 drug allergy but not remember. The patient experienced drug allergy when treated with levofloxacin, and sulfacetamide sodium/sulfadiazine/sulfadimidine/sulfamerazine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 23-MAR-2021 on left arm for prophylactic vaccination. Concomitant medications included gabapentin for pain, and oxycodone hydrochloride/paracetamol for pain. On MAR-2021, the subject experienced cold hands and feet. On MAR-2021, the subject experienced joint pain. Laboratory data included: Blood pressure (NR: not provided) FINE, and Renal function test (NR: not provided) BETTER. On 24-MAR-2021, the subject experienced pain in ear. On 24-MAR-2021, the subject experienced pain behind eyes. On 24-MAR-2021, the subject experienced can not fall asleep. On 24-MAR-2021, the subject experienced low back pain. On 24-MAR-2021, the subject experienced pain behind ear. On 24-MAR-2021, the subject experienced pain and body aches. On 24-MAR-2021, the subject experienced exhausted. On 24-MAR-2021, the subject experienced sever headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cold hands and feet on 24-MAR-2021, and low back pain on MAR-2021, had not recovered from sever headache, pain in ear, pain behind eyes, can not fall asleep, exhausted, pain and body aches, and joint pain, and the outcome of pain behind ear was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Initial insomnia, Pain, Peripheral coldness
Clinical narrative: PAIN IN EAR; PAIN BEHIND EYES; CAN NOT FALL ASLEEP; LOW BACK PAIN; PAIN BEHIND EAR; PAIN AND BODY ACHES; EXHAUSTED; SEVER HEADACHE; JOINT PAIN; COLD HANDS AND FEET; This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid 19 infection, and concurrent conditions included chronic pain, kidney problems, on physiotherapy, non alcoholic, and non smoker, and other pre-existing medical conditions included she had more 3 drug allergy but not remember. The patient experienced drug allergy when treated with levofloxacin, and sulfacetamide sodium/sulfadiazine/sulfadimidine/sulfamerazine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 23-MAR-2021 on left arm for prophylactic vaccination. Concomitant medications included gabapentin for pain, and oxycodone hydrochloride/paracetamol for pain. On MAR-2021, the subject experienced cold hands and feet. On MAR-2021, the subject experienced joint pain. Laboratory data included: Blood pressure (NR: not provided) FINE, and Renal function test (NR: not provided) BETTER. On 24-MAR-2021, the subject experienced pain in ear. On 24-MAR-2021, the subject experienced pain behind eyes. On 24-MAR-2021, the subject experienced can not fall asleep. On 24-MAR-2021, the subject experienced low back pain. On 24-MAR-2021, the subject experienced pain behind ear. On 24-MAR-2021, the subject experienced pain and body aches. On 24-MAR-2021, the subject experienced exhausted. On 24-MAR-2021, the subject experienced sever headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cold hands and feet on 24-MAR-2021, and low back pain on MAR-2021, had not recovered from sever headache, pain in ear, pain behind eyes, can not fall asleep, exhausted, pain and body aches, and joint pain, and the outcome of pain behind ear was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Renal function test
Clinical narrative: PAIN IN EAR; PAIN BEHIND EYES; CAN NOT FALL ASLEEP; LOW BACK PAIN; PAIN BEHIND EAR; PAIN AND BODY ACHES; EXHAUSTED; SEVER HEADACHE; JOINT PAIN; COLD HANDS AND FEET; This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid 19 infection, and concurrent conditions included chronic pain, kidney problems, on physiotherapy, non alcoholic, and non smoker, and other pre-existing medical conditions included she had more 3 drug allergy but not remember. The patient experienced drug allergy when treated with levofloxacin, and sulfacetamide sodium/sulfadiazine/sulfadimidine/sulfamerazine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 23-MAR-2021 on left arm for prophylactic vaccination. Concomitant medications included gabapentin for pain, and oxycodone hydrochloride/paracetamol for pain. On MAR-2021, the subject experienced cold hands and feet. On MAR-2021, the subject experienced joint pain. Laboratory data included: Blood pressure (NR: not provided) FINE, and Renal function test (NR: not provided) BETTER. On 24-MAR-2021, the subject experienced pain in ear. On 24-MAR-2021, the subject experienced pain behind eyes. On 24-MAR-2021, the subject experienced can not fall asleep. On 24-MAR-2021, the subject experienced low back pain. On 24-MAR-2021, the subject experienced pain behind ear. On 24-MAR-2021, the subject experienced pain and body aches. On 24-MAR-2021, the subject experienced exhausted. On 24-MAR-2021, the subject experienced sever headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cold hands and feet on 24-MAR-2021, and low back pain on MAR-2021, had not recovered from sever headache, pain in ear, pain behind eyes, can not fall asleep, exhausted, pain and body aches, and joint pain, and the outcome of pain behind ear was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperhidrosis, Pain, Pyrexia
Clinical narrative: BODY ACHE; SWEATING; SHIVERING; FEVER; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, the batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers) dose was not reported, administered on 23-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-MAR-2021, the subject experienced body ache. On 23-MAR-2021, the subject experienced sweating. On 23-MAR-2021, the subject experienced shivering. On 23-MAR-2021, the subject experienced fever. On 23-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, shivering, sweating, headache and body ache was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Cough, Pain, Pyrexia
Clinical narrative: CONGESTED COUGH; LOW GRADE FEVER/HIGH FEVER; BODY ACHES; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, , and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 in the left arm for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the patient experienced body aches. On 13-MAR-2021, the patient experienced low grade fever Laboratory data included: Body temperature (NR: not provided) 99.6-99.7. Laboratory data included: Body temperature (NR: not provided) 100.7-101. On 21-MAR-2021, the patient experienced congested cough. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body aches, low grade fever, congested cough, and high fever. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: CHILLS; FEVER; This spontaneous report received from a patient via a company representative concerned a 28 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol use. 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. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, a couple hours after taking the vaccine, the subject experienced chills, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and chills was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Back pain, Chills, Fatigue, Headache, Pain in extremity
Clinical narrative: ACHY LOWER BACK 6 HOURS AFTER VACCINATION; ARM SORENESS 3 HOURS AFTER VACCINATION; FULL BODY CHILLS 7 HOURS AFTER VACCINATION; SLIGHT HEADACHE 3 HOURS AFTER VACCINATION; TIREDNESS 6 HOURS AFTER VACCINATION; 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 expiry: UNKNOWN) dose was not reported, administered on 23-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 23-MAR-2021, the subject experienced achy lower back 6 hours after vaccination. On 23-MAR-2021, the subject experienced arm soreness 3 hours after vaccination. On 23-MAR-2021, the subject experienced full body chills 7 hours after vaccination. On 23-MAR-2021, the subject experienced slight headache 3 hours after vaccination. On 23-MAR-2021, the subject experienced tiredness 6 hours after vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the arm soreness 3 hours after vaccination, slight headache 3 hours after vaccination, tiredness 6 hours after vaccination, achy lower back 6 hours after vaccination and full body chills 7 hours after vaccination was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: HEADACHE; FATIGUE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 22-MAR-2021 for prophylactic vaccination. The batch number was not reported. We are unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 24-MAR-2021, the subject experienced headache. On 24-MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache and fatigue was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Influenza like illness, Pyrexia
Clinical narrative: FLU LIKE SYMPTOMS; HEADACHE; FEVER; FATIGUE; 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 was not reported, administered on 23-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 an unspecified date, the patient experienced flu like symptoms, headache, fever, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, flu like symptoms, fever and fatigue was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: FEVER; FATIGUE; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 23-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAR-2021, the subject experienced fatigue. On 23-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on MAR-2021, and had not recovered from fatigue. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: BODYACHE; CHILL; HEADACHE; FEVER; This spontaneous report received from a health care professional 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: 59676D58015 expiry: UNKNOWN) dose was not reported, administered on 24-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 24-MAR-2021, the subject experienced bodyache. On 24-MAR-2021, the subject experienced chill. On 24-MAR-2021, the subject experienced headache. On 24-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, bodyache, fever and chill was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: VACCINE ARM SORE, TENDER AND SENSITIVE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAR-2021, the subject experienced vaccine arm sore, tender and sensitive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from vaccine arm sore, tender and sensitive. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Insomnia, Pain, Tremor
Clinical narrative: NOT ABLE TO SLEEP/INSOMNIA; SHAKES; SORE ALL OVER BODY/SORENESS; SEVERE HEADACHE; This spontaneous report received from a consumer concerned a 48 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 and batch number: 1808609 expiry: UNKNOWN) dose was not reported, administered on 24-MAR-2021 01:00 pm for prophylactic vaccination on left deltoid. No concomitant medications were reported.  On 24-MAR-2021, the subject experienced not able to sleep/insomnia. On 24-MAR-2021, the subject experienced shakes. On 24-MAR-2021, the subject experienced sore all over body/soreness. On 24-MAR-2021, the subject experienced severe headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe headache, not able to sleep/insomnia, and sore all over body/soreness, and the outcome of shakes was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Decreased appetite, Illness
Clinical narrative: LOST APPETITE; SICK; 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, expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up would be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced lost appetite, and sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sick and lost appetite was not reported. This report was non-serious.