chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Disturbance in attention, Fatigue, Malaise, Pain
Clinical narrative: BODY ACHES; DIFFICULTY FOCUSING / CONCENTRATING; GENERAL MALAISE; EXTREME FATIGUE; 101.5 FEVER; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 2021 for prophylactic vaccination. The batch number was not reported has been requested. No concomitant medications were reported.  On 2021, the subject experienced body aches. On 2021, the subject experienced difficulty focusing / concentrating. On 2021, the subject experienced general malaise. On 2021, the subject experienced extreme fatigue. On 2021, the subject experienced 101.5 fever.  Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 101.5. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the 101.5 fever, body aches, general malaise, extreme fatigue and difficulty focusing / concentrating was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: BODY ACHES; DIFFICULTY FOCUSING / CONCENTRATING; GENERAL MALAISE; EXTREME FATIGUE; 101.5 FEVER; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 2021 for prophylactic vaccination. The batch number was not reported has been requested. No concomitant medications were reported.  On 2021, the subject experienced body aches. On 2021, the subject experienced difficulty focusing / concentrating. On 2021, the subject experienced general malaise. On 2021, the subject experienced extreme fatigue. On 2021, the subject experienced 101.5 fever.  Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 101.5. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the 101.5 fever, body aches, general malaise, extreme fatigue and difficulty focusing / concentrating was not reported. This report was non-serious.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dizziness, Heart rate, Heart rate increased, Paraesthesia
Clinical narrative: ARMS FEEL SLEEPY/FACE SENSATION; DIZZY; DROWSINESS; HEARS A BEEP IN BRAIN; HEART BEATING FASTER THAN NORMAL; TONGUE SENSATION; FEVER; This spontaneous report received from a patient 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, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 13:30 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, Laboratory data included: Body temperature (NR: not provided) 99.8 F, and Heart rate (NR: not provided) heart beating faster than normal. On 10-APR-2021 19:00, the subject experienced arms feel sleepy/face sensation. On 10-APR-2021 19:00, the subject experienced dizzy. On 10-APR-2021 19:00, the subject experienced drowsiness. On 10-APR-2021 19:00, the subject experienced hears a beep in brain. On 10-APR-2021 19:00, the subject experienced heart beating faster than normal. On 10-APR-2021 19:00, the subject experienced tongue sensation. On 10-APR-2021 19:00, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from arms feel sleepy/face sensation, dizzy, fever, drowsiness, hears a beep in brain, heart beating faster than normal, and tongue sensation. This report was non-serious.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Pyrexia, Somnolence, Tinnitus
Clinical narrative: ARMS FEEL SLEEPY/FACE SENSATION; DIZZY; DROWSINESS; HEARS A BEEP IN BRAIN; HEART BEATING FASTER THAN NORMAL; TONGUE SENSATION; FEVER; This spontaneous report received from a patient 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, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 13:30 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, Laboratory data included: Body temperature (NR: not provided) 99.8 F, and Heart rate (NR: not provided) heart beating faster than normal. On 10-APR-2021 19:00, the subject experienced arms feel sleepy/face sensation. On 10-APR-2021 19:00, the subject experienced dizzy. On 10-APR-2021 19:00, the subject experienced drowsiness. On 10-APR-2021 19:00, the subject experienced hears a beep in brain. On 10-APR-2021 19:00, the subject experienced heart beating faster than normal. On 10-APR-2021 19:00, the subject experienced tongue sensation. On 10-APR-2021 19:00, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from arms feel sleepy/face sensation, dizzy, fever, drowsiness, hears a beep in brain, heart beating faster than normal, and tongue sensation. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Genital discomfort, Gingival discomfort, Malaise, Oral discomfort
Clinical narrative: BURNING LIPS; IRRITATION GUM; GENITAL IRRITATION; LIGHT-HEADED; BURNING TONGUE; SKIN RASH; FEELING UNWELL; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 12-APR-2021, the subject experienced burning lips. On 12-APR-2021, the subject experienced irritation gum. On 12-APR-2021, the subject experienced genital irritation. On 12-APR-2021, the subject experienced light-headed. On 12-APR-2021, the subject experienced burning tongue. On 12-APR-2021, the subject experienced skin rash. On 12-APR-2021, the subject experienced feeling unwell. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from skin rash, burning lips, irritation gum, genital irritation, light-headed, feeling unwell, and burning tongue. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Tongue discomfort
Clinical narrative: BURNING LIPS; IRRITATION GUM; GENITAL IRRITATION; LIGHT-HEADED; BURNING TONGUE; SKIN RASH; FEELING UNWELL; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 12-APR-2021, the subject experienced burning lips. On 12-APR-2021, the subject experienced irritation gum. On 12-APR-2021, the subject experienced genital irritation. On 12-APR-2021, the subject experienced light-headed. On 12-APR-2021, the subject experienced burning tongue. On 12-APR-2021, the subject experienced skin rash. On 12-APR-2021, the subject experienced feeling unwell. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from skin rash, burning lips, irritation gum, genital irritation, light-headed, feeling unwell, and burning tongue. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: SWOLLEN LYMPH NODES IN ARMPIT AND NECK; This spontaneous report received from a patient via a company representative concerned a 48 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergy. 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 swollen lymph nodes in armpit and neck. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swollen lymph nodes in armpit and neck. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: HAVE PAIN ON  SHOULDER DOWN TO ARM; CAN NOT MOVE ARM; 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. No concomitant medications were reported. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. On an unspecified date, the subject experienced have pain on shoulder down to arm, and can not move arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the have pain on shoulder down to arm and can not move arm was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Cyanosis, Feeling abnormal, Oxygen saturation, Oxygen saturation decreased, Skin discolouration
Clinical narrative: LIPS TURNED BLUE; OXYGEN DROPPED TO 80; HANDS AND FEET TURNED BLUE; NIGHT OF MISERY; 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: 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 lips turned blue, oxygen dropped to 80, hands and feet turned blue, and night of misery. Laboratory data (dates unspecified) included: Oxygen saturation (NR: not provided) dropped to 80. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the lips turned blue, oxygen dropped to 80, hands and feet turned blue and night of misery was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: SHORTNESS OF BREATH AND LABOURED BREATHING; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 15-APR-2021, the subject experienced shortness of breath and laboured breathing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of shortness of breath and laboured breathing was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dizziness, Fatigue, Nervousness, Pain in extremity
Clinical narrative: TENSION; ANXIETY; NERVOUS; LIGHT-HEADED/DIZZY; SORE ARM; FATIGUE; This spontaneous report received from a patient concerned a 26 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included anxiety.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, 1 total, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced nervous. On 02-APR-2021, the subject experienced light-headed/dizzy. On 02-APR-2021, the subject experienced sore arm. On 02-APR-2021, the subject experienced fatigue. On 06-APR-2021, the subject experienced tension. On 06-APR-2021, the subject experienced anxiety. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from light-headed/dizzy on 13-APR-2021, and sore arm, and fatigue on 09-APR-2021, was recovering from nervous, and had not recovered from anxiety, and tension. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Tension
Clinical narrative: TENSION; ANXIETY; NERVOUS; LIGHT-HEADED/DIZZY; SORE ARM; FATIGUE; This spontaneous report received from a patient concerned a 26 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included anxiety.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, 1 total, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced nervous. On 02-APR-2021, the subject experienced light-headed/dizzy. On 02-APR-2021, the subject experienced sore arm. On 02-APR-2021, the subject experienced fatigue. On 06-APR-2021, the subject experienced tension. On 06-APR-2021, the subject experienced anxiety. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from light-headed/dizzy on 13-APR-2021, and sore arm, and fatigue on 09-APR-2021, was recovering from nervous, and had not recovered from anxiety, and tension. This report was non-serious.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: PURPLISH BRUISE ON FOREARM; This spontaneous report received from a patient concerned a 53 year old male. The patient's height, and weight were not reported. The patient's past medical history included heart surgery, and concurrent conditions included alcoholic, and non-smoker, and other pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, and batch number: 1805025 expiry: 25-MAY-2021) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid. On 08-MAR-2021, the subject experienced purplish bruise on forearm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from purplish bruise on forearm on MAR-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: RASH; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure no follow up will be requested for the case. No concomitant medications were reported. On an unspecified date, the subject experienced rash. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of rash was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Oropharyngeal pain
Clinical narrative: NASAL CONGESTION; SORE THROAT; This spontaneous report received from a patient concerned a 22 year old female. The patient's weight was 180 pounds, and height was 69 inches. The patient's concurrent conditions included seasonal allergies, celiac disease, non alcohol user, and mri dye allergy, and other pre-existing medical conditions included no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 07-APR-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 nasal congestion, and sore throat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nasal congestion and sore throat was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOT IN LEFT CALF; This spontaneous report received from a patient and concerned a female of unspecified age. The patient was called to obtain additional information on 21-APR-2021 and message was left on a voicemail. The patient's height, and weight were not reported. The patient has no family history of thrombosis. The patient does not have any underlying conditions. 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 14-APR-2021, the subject experienced blood clot in left calf. The patient noted that she did not have any underlying conditions or family history that may have made her more predisposed to this diagnosis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clot in left calf. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: This spontaneous report concerns a female patient of unspecified age who experienced a blood clot one day after Janssen COVID-19 vaccine was administered for prevention of symptomatic SARS-CoV-2 virus infection. The patient's height, and weight were not reported. The patient has no family history of thrombosis and has not reported any underlying conditions. No concomitant medications were reported. The patient did not provide details related to the blood clot, except it was not resolved at the time of the report. Given lack of alternative explanation and temporal plausibility the event is considered possibly related to Janssen COVID-19 vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Injection site pain, Pain in extremity
Clinical narrative: LEG PAIN; STOMACH PAIN; PAIN DURING THE 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: 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 08-APR-2021, the subject experienced pain during the injection. On 09-APR-2021, the subject experienced stomach pain. On 13-APR-2021, the subject experienced leg pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from leg pain, and the outcome of pain during the injection and stomach pain was not reported. This report was non-serious.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: HIV test, Lymphocyte count, Meningitis viral, Varicella zoster virus infection
Clinical narrative: VARICELLA-ZOSTER VIRUS MENINGITIS (VESICULAR SKIN LESIONS ON RIGHT LEG, HEADACHE, ACHES AND FEVER); VARICELLA-ZOSTER VIRUS MENINGITIS (VESICULAR SKIN LESIONS ON RIGHT LEG, HEADACHE, ACHES AND FEVER); This spontaneous report received from a patient concerned a 34 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no past medical history.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin was not reported, and batch number unknown, Expiry Date: UNKNOWN) dose was not reported, once total, administered on unspecified date in 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 in 2021, the patient experienced vesicular skin lesions on right leg and headache with eventual diagnosis of varicella-zoster virus meningitis and it was stated that patient administered vaccine two weeks before and had significant immunological response (fever, aches). On an unspecified date in 2021, the patient had done HIV test and was Ag/Ab Negative and absolute lymphocyte count of the patient was normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the varicella-zoster virus meningitis (vesicular skin lesions on right leg, headache, aches and fever) and varicella-zoster virus meningitis (vesicular skin lesions on right leg, headache, aches and fever) was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210431759-covid-19 vaccine ad26.cov2.s -varicella-zoster virus meningitis (vesicular skin lesions on right leg, headache, aches and fever) . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Decreased appetite, Oropharyngeal pain, Productive cough, Pyrexia
Clinical narrative: SORE THROAT; TERRIBLE COUGH; NO APPETITE; RUNNY NOSE; DARK GREEN MUCOUS; AFFECTING VOCAL CHORDS; FEVER; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's past medical history included stroke. The patient was previously treated with apixaban for stroke. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 180502) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 24-MAR-2021, the subject experienced fever. On APR-2021, the subject experienced sore throat. On APR-2021, the subject experienced cough. On APR-2021, the subject experienced no appetite. On APR-2021, the subject experienced runny nose. On APR-2021, the subject experienced dark green mucous. On APR-2021, the subject experienced affecting vocal chords. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, and had not recovered from sore throat, cough, no appetite, runny nose, dark green mucous, and affecting vocal chords. This report was non-serious.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, Vocal cord disorder
Clinical narrative: SORE THROAT; TERRIBLE COUGH; NO APPETITE; RUNNY NOSE; DARK GREEN MUCOUS; AFFECTING VOCAL CHORDS; FEVER; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's past medical history included stroke. The patient was previously treated with apixaban for stroke. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 180502) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 24-MAR-2021, the subject experienced fever. On APR-2021, the subject experienced sore throat. On APR-2021, the subject experienced cough. On APR-2021, the subject experienced no appetite. On APR-2021, the subject experienced runny nose. On APR-2021, the subject experienced dark green mucous. On APR-2021, the subject experienced affecting vocal chords. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, and had not recovered from sore throat, cough, no appetite, runny nose, dark green mucous, and affecting vocal chords. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Hypoaesthesia, Pain in extremity
Clinical narrative: NUMBNESS IN LEG; PAIN IN ARM; HANDS FREEZING COLD; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included hypothyroid, and concurrent conditions included seasonal allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-APR-2021, the subject experienced numbness in leg. On 14-APR-2021, the subject experienced pain in arm. On 14-APR-2021, the subject experienced hands freezing cold. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from numbness in leg, pain in arm, and hands freezing cold on APR-2021. This report was non-serious.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Feeling abnormal
Clinical narrative: ZOMBIE LIKE; NO ENERGY; This spontaneous report received from a patient via a company representative concerned a 68 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included dykinesia with parkinson's disease, covid-19, diverticulosis of intestine, opioid dependence, repeated fall, ventricular tachycardia, continuous positive airway pressure, and flopping like a fish. 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-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included amantadine hydrochloride for dykinesia with parkinson's disease, carbidopa/entacapone/levodopa for dykinesia with parkinson's disease, carbidopa/levodopa for dykinesia with parkinson's disease, rotigotine for dykinesia with parkinson's disease, levodopa for dykinesia with parkinson's disease, and flopping like a fish, calcium, carvedilol, celecoxib, colecalciferol, entacapone, estradiol, ezetimibe, fluoxetine, gabapentin, hydrocodone, loratadine, mirabegron, nortriptyline, ramipril, tapentadol hydrochloride, and vitamin e nos.  On 16-MAR-2021, the subject experienced zombie like. On 16-MAR-2021, the subject experienced no energy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from zombie like, and no energy on 20-MAR-2021. This report was non-serious.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Eczema, Headache, Ocular discomfort, Pain in extremity
Clinical narrative: ECZEMA ON HAIRLINE AT THE BACK OF NECK AND BEHIND EARS, ON ELBOWS AND ON FRONT OF THE OF ANKLE/RASH/ITCHINESS/BUMPS/REDNESS; SLIGHT SORE ARM; MILD HEADACHE; KIND OF PRESSURE BEHIND ONE EYE; This spontaneous report received from a patient concerned a 62 year old female. The patient's weight was 150 pounds, and height was 62 inches. The patient's concurrent conditions included non-smoker, non-alcohol user, and overweight, and other pre-existing medical conditions included the patient does not have any medical conditions and not taking any medication, the patient had no known allergies, the patient had no history of drug abuse or illicit drug use, the patient was not pregnant at the time of reporting. 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, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced kind of pressure behind one eye. On 06-APR-2021, the subject experienced slight sore arm. On 06-APR-2021, the subject experienced mild headache. On 09-APR-2021, the subject experienced eczema on hairline at the back of neck and behind ears, on elbows and on front of the of ankle/rash/itchiness/bumps/redness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slight sore arm on 08-APR-2021, and mild headache on 06-APR-2021, had not recovered from eczema on hairline at the back of neck and behind ears, on elbows and on front of the of ankle/rash/itchiness/bumps/redness, and the outcome of kind of pressure behind one eye was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Intraocular pressure test, Ocular discomfort, Ocular hyperaemia
Clinical narrative: EYE PRESSURE; BLOODSHOT EYE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight was 179 pounds, and height was not reported. The patient's pre-existing medical conditions included patient's race. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-APR-2021 21:00, the subject experienced bloodshot eye. On 15-APR-2021, Laboratory data included: Intraocular pressure test (NR: not provided) 2-3/10 pressure, 1/10 pressure. On 15-APR-2021 07:00, the subject experienced eye pressure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from bloodshot eye, and eye pressure. This report was non-serious.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Rash, Rash pruritic
Clinical narrative: EXHAUSTION; PAIN IN ARM; SCABBY RASH/RASH ON BACK/UPPER AND LOWER ARM/LEG; ITCHY RED RASH ON BACK/UPPER AND LOWER ARM/LEG; This spontaneous report received from a consumer concerned a 43 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, and tiny clot in lung. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 042A21A 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 itchy red rash on back/upper and lower arm/leg. On APR-2021, the subject experienced scabby rash/rash on back/upper and lower arm/leg. On 09-APR-2021, the subject experienced pain in arm. On 10-APR-2021, the subject experienced exhaustion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from exhaustion on APR-2021, was recovering from scabby rash/rash on back/upper and lower arm/leg, and the outcome of pain in arm and itchy red rash on back/upper and lower arm/leg was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: MILD TINGLING TO LEGS; 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, intramuscular, batch number: Unknown) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 13-APR-2021, the subject experienced mild tingling to legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from mild tingling to legs. This report was non-serious.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Anxiety, Feeding disorder, Headache
Clinical narrative: ABDOMINAL PAIN; UNABLE TO EAT; ANXIETY; SEVERE HEADACHES; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's past medical history included heart problems, and diastolic heart failure, and concurrent conditions included non-alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies. the patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: 21-JUN-2021) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced unable to eat. On 02-APR-2021, the subject experienced anxiety. On 02-APR-2021, the subject experienced severe headaches. On 09-APR-2021, the subject experienced abdominal pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe headaches, abdominal pain, unable to eat, and anxiety. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Feeling of body temperature change, Hyperhidrosis, Pain in extremity
Clinical narrative: SORE ARM; TIRED; FEVER; SLEEP EARLY; HOT AND COLD FLASHES; SWEATING; SLIGHTLY DIZZY; 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 11-APR-2021 for prophylactic vaccination. Batch number was not reported. The company is unable to perform follow up to request batch/lot numbers. No concomitant medications were reported. On 11-APR-2021, the subject experienced sleep early. On 11-APR-2021, the subject experienced hot and cold flashes. On 11-APR-2021, the subject experienced sweating. On 11-APR-2021, the subject experienced slightly dizzy. On 11-APR-2021, the subject experienced tired. On 11-APR-2021, the subject experienced fever. On 12-APR-2021, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tired, slightly dizzy, sleep early, hot and cold flashes, sweating, fever and sore arm was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Somnolence
Clinical narrative: SORE ARM; TIRED; FEVER; SLEEP EARLY; HOT AND COLD FLASHES; SWEATING; SLIGHTLY DIZZY; 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 11-APR-2021 for prophylactic vaccination. Batch number was not reported. The company is unable to perform follow up to request batch/lot numbers. No concomitant medications were reported. On 11-APR-2021, the subject experienced sleep early. On 11-APR-2021, the subject experienced hot and cold flashes. On 11-APR-2021, the subject experienced sweating. On 11-APR-2021, the subject experienced slightly dizzy. On 11-APR-2021, the subject experienced tired. On 11-APR-2021, the subject experienced fever. On 12-APR-2021, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tired, slightly dizzy, sleep early, hot and cold flashes, sweating, fever and sore arm was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: POTENTIAL ADVERSE EVENT (AE); 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 date: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced possible adverse event (ae). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of possible adverse event (ae) was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: FELT SLEEPY; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had unknown drug abuse and drug illicit use.  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 felt sleepy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of felt sleepy was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: 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: Unknown) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 14-APR-2021, the subject experienced headache. Treatment medications (dates unspecified) included: camphor/eucalyptus spp. oil/menthol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache. This report was non-serious.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Heart rate increased, Pain in extremity
Clinical narrative: DIZZINESS; RACING HEARTBEAT; SORENESS IN THE ARM; HEADACHE (PAIN : 7/10); FATIGUE; This spontaneous report received from a patient concerned a 49 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was on no medication and was a healthy individual. 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 12-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-APR-2021, the subject experienced soreness in the arm. On 12-APR-2021, the subject experienced headache (pain : 7/10). On 12-APR-2021, the subject experienced fatigue. On 15-APR-2021, the subject experienced dizziness. On 15-APR-2021, the subject experienced racing heartbeat. Treatment medications included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from soreness in the arm, and fatigue on 14-APR-2021, and had not recovered from headache (pain : 7/10), dizziness, and racing heartbeat. This report was non-serious.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Therapeutic response unexpected
Clinical narrative: POSSIBLE UNEXPECTED BENEFIT (RELIEF FROM CHRONIC PAIN OF 20 YEARS); ITCHING; This spontaneous report received from a patient concerned a 79 year old female. The patient's height, and weight were not reported. The patient's past medical history included multiple abdominal surgeries, and concurrent conditions included breast cancer, chronic pain, chemotherapy, abdominal aneurysm, allergy to egg whites, and penicillin allergy and macrodantin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 31-MAR-2021, the subject experienced itching. On an unspecified date, the subject experienced possible unexpected benefit (relief from chronic pain of 20 years). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from itching on 02-APR-2021, and the outcome of possible unexpected benefit (relief from chronic pain of 20 years) was not reported. This report was non-serious.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Abdominal pain upper, Chills, Diarrhoea, Headache
Clinical narrative: SWOLLEN RIGHT PINKY  FINGER; PAIN IN RIGHT ARM; SHIVERS; LOW GRADE HEADACHES; DARK DIARRHEA; SEVERE STOMACH PAIN; DIFFICULTY SLEEPING; SWOLLEN STOMACH OR BLOATEDEDNESS; LETHARGIC; This spontaneous report received from a patient concerned a 68 year old female. The patient's weight was not reported and height was 59 inches. The patient's concurrent conditions included irritable bowel syndrome, and migraine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A2A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. Concomitant medications included linaclotide for irritable bowel syndrome, macrogol 3350 for irritable bowel syndrome, senna alexandrina for irritable bowel syndrome, simeticone for irritable bowel syndrome, sodium phosphate dibasic/sodium phosphate monobasic for irritable bowel syndrome, and acetylsalicylic acid/caffeine/paracetamol/salicylamide for migraine. On 09-APR-2021, the subject experienced dark diarrhea. On 09-APR-2021, the subject experienced severe stomach pain. On 09-APR-2021, the subject experienced difficulty sleeping. On 09-APR-2021, the subject experienced swollen stomach or bloatededness. On 09-APR-2021, the subject experienced lethargic. On 09-APR-2021, the subject experienced shivers. On 09-APR-2021, the subject experienced low grade headaches. On 12-APR-2021, the subject experienced swollen right pinky finger. On 12-APR-2021, the subject experienced pain in right arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain in right arm on 14-APR-2021, was recovering from dark diarrhea, and swollen stomach or bloatededness, had not recovered from swollen right pinky finger, severe stomach pain, and low grade headaches, and the outcome of difficulty sleeping, shivers and lethargic was not reported. This report was non-serious.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Lethargy, Pain in extremity, Peripheral swelling
Clinical narrative: SWOLLEN RIGHT PINKY  FINGER; PAIN IN RIGHT ARM; SHIVERS; LOW GRADE HEADACHES; DARK DIARRHEA; SEVERE STOMACH PAIN; DIFFICULTY SLEEPING; SWOLLEN STOMACH OR BLOATEDEDNESS; LETHARGIC; This spontaneous report received from a patient concerned a 68 year old female. The patient's weight was not reported and height was 59 inches. The patient's concurrent conditions included irritable bowel syndrome, and migraine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A2A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. Concomitant medications included linaclotide for irritable bowel syndrome, macrogol 3350 for irritable bowel syndrome, senna alexandrina for irritable bowel syndrome, simeticone for irritable bowel syndrome, sodium phosphate dibasic/sodium phosphate monobasic for irritable bowel syndrome, and acetylsalicylic acid/caffeine/paracetamol/salicylamide for migraine. On 09-APR-2021, the subject experienced dark diarrhea. On 09-APR-2021, the subject experienced severe stomach pain. On 09-APR-2021, the subject experienced difficulty sleeping. On 09-APR-2021, the subject experienced swollen stomach or bloatededness. On 09-APR-2021, the subject experienced lethargic. On 09-APR-2021, the subject experienced shivers. On 09-APR-2021, the subject experienced low grade headaches. On 12-APR-2021, the subject experienced swollen right pinky finger. On 12-APR-2021, the subject experienced pain in right arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain in right arm on 14-APR-2021, was recovering from dark diarrhea, and swollen stomach or bloatededness, had not recovered from swollen right pinky finger, severe stomach pain, and low grade headaches, and the outcome of difficulty sleeping, shivers and lethargic was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Eye swelling, Pain, Peripheral swelling, Pruritus
Clinical narrative: ITCHY SCALP; EYES SWELL; FEET SWELL; RASH; GENERAL ACHE; CHILLS; 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 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 general ache. On APR-2021, the subject experienced chills. On 13-APR-2021, the subject experienced itchy scalp. On 13-APR-2021, the subject experienced eyes swell. On 13-APR-2021, the subject experienced feet swell. On 13-APR-2021, the subject experienced rash. Treatment medications (dates unspecified) included: prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the itchy scalp, rash, eyes swell, feet swell, chills and general ache was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: ITCHY SCALP; EYES SWELL; FEET SWELL; RASH; GENERAL ACHE; CHILLS; 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 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 general ache. On APR-2021, the subject experienced chills. On 13-APR-2021, the subject experienced itchy scalp. On 13-APR-2021, the subject experienced eyes swell. On 13-APR-2021, the subject experienced feet swell. On 13-APR-2021, the subject experienced rash. Treatment medications (dates unspecified) included: prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the itchy scalp, rash, eyes swell, feet swell, chills and general ache was not reported. This report was non-serious.