chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling hot, Flushing, Thirst
Clinical narrative: FLUSH; LIGHT HEADED, DIZZINESS; VERY THIRSTY; FEELING OVERHEATED; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's past medical history included carpel tunnel surgery, right ankle surgery, weight loss surgery and chest reduction surgery, pneumonia, tonsillectomy, and liposuction, and concurrent conditions included hypertension, chronic rhinitis, chronic migraine, and allergy to pollens. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and  expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 08:30 for prophylactic vaccination. Concomitant medications included cannabis sativa for drug used for unknown indication, lisinopril for hypertension, zolpidem tartrate for sleep, amoxicillin/clavulanic acid, botulinum toxin type a, and montelukast non-company. On 12-APR-2021, the subject experienced flush. On 12-APR-2021, the subject experienced light headed, dizziness. On 12-APR-2021, the subject experienced very thirsty. On 12-APR-2021, the subject experienced feeling overheated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from flush, light headed, dizziness, very thirsty, and feeling overheated. This report was non-serious.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: VERTIGO EXPERIENCED AT DAY 3 AND DAY 4; LIGHTHEADEDNESS; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's past medical history included breast cancer, right knee replacement, and skin cancers, and concurrent conditions included lymphedema, type 2 diabetes mellitus, asthma, worse pollen allergy, severe allergies, meniere's disease, mold mildew allergy, naproxen dust allergy, non alcoholic, non smoker, and migraine, and other pre-existing medical conditions included the patient had no history of drug abuse/ illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808982, expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. Concomitant medications included fremanezumab for migraine.  On 06-APR-2021, the subject experienced lightheadedness. On 10-APR-2021 02:30, the subject experienced vertigo experienced at day 3 and day 4. Treatment medications (dates unspecified) included: dimenhydrinate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lightheadedness on 06-APR-2021, and was recovering from vertigo experienced at day 3 and day 4. This report was non-serious.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: FEVER; SORE ARM; This spontaneous report received from a patient concerned a 37 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: 041A21A 16609 expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 06-APR-2021, the subject experienced sore arm. On 07-APR-2021, the subject experienced fever. Treatment medications (dates unspecified) included: ibuprofen (Motrin). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 07-APR-2021, and had not recovered from sore arm. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Heart rate, Heart rate decreased
Clinical narrative: HIGHER BLOOD PRESSURE THAN NORMAL; LOWER HEART RATE THAN NORMAL; 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, start therapy date were not reported for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced higher blood pressure than normal, and lower heart rate than normal. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) 140s/90, and Heart rate (NR: not provided) 50s bpm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from higher blood pressure than normal, and lower heart rate than normal. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: TERRIBLE HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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 not reported, batch number: Unknown) dose was not reported, administered on 09-APR-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 09-APR-2021, the subject experienced terrible headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of terrible headache was not reported. This report was non-serious.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Pain
Clinical narrative: BODY ACHES; SORE ARM AT INJECTION SITE; This spontaneous report received from a parent concerned a 21 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and other pre-existing medical conditions included the patient had no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 11:30 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced body aches. On 12-APR-2021, the subject experienced sore arm at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sore arm at injection site, and body aches. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chest pain, Chills, Headache, Hypoaesthesia
Clinical narrative: BODY ACHES; NUMB FINGERS; HEART RACING; SHAKINESS; CHEST PAIN; CHILLS; SORE ARM; WEAKNESS; FEVER; HEADACHE; This spontaneous report received from a parent concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included smokes weed, alcoholic, and non smoker, and other pre-existing medical conditions included no known allergies drug abuse/illicit drug use. 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 10-APR-2021, the subject experienced body aches. On 10-APR-2021, the subject experienced numb fingers. On 10-APR-2021, the subject experienced heart racing. On 10-APR-2021, the subject experienced shakiness. On 10-APR-2021, the subject experienced chest pain. On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced sore arm. On 10-APR-2021, the subject experienced weakness. On 10-APR-2021, the subject experienced fever. On 10-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from numb fingers, heart racing, and shakiness on APR-2021, was recovering from sore arm, weakness, headache, fever, and chills, and had not recovered from body aches, and chest pain. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Palpitations, Pyrexia, Tremor
Clinical narrative: BODY ACHES; NUMB FINGERS; HEART RACING; SHAKINESS; CHEST PAIN; CHILLS; SORE ARM; WEAKNESS; FEVER; HEADACHE; This spontaneous report received from a parent concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included smokes weed, alcoholic, and non smoker, and other pre-existing medical conditions included no known allergies drug abuse/illicit drug use. 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 10-APR-2021, the subject experienced body aches. On 10-APR-2021, the subject experienced numb fingers. On 10-APR-2021, the subject experienced heart racing. On 10-APR-2021, the subject experienced shakiness. On 10-APR-2021, the subject experienced chest pain. On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced sore arm. On 10-APR-2021, the subject experienced weakness. On 10-APR-2021, the subject experienced fever. On 10-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from numb fingers, heart racing, and shakiness on APR-2021, was recovering from sore arm, weakness, headache, fever, and chills, and had not recovered from body aches, and chest pain. This report was non-serious.
Age: 57.0
Sex: U
Vaccine: COVID19
Symptoms: Chills, Injection site pain, Pain, Pyrexia
Clinical narrative: BODY ACHING; CHILLS; PAIN DURING INJECTION; FEVER 100.9; This spontaneous report received from a patient concerned a 57 year old of unspecified sex. The patient's weight, height, and medical history were not reported.  The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 12:20 for prophylactic vaccination. No concomitant medications were reported.  On 08-APR-2021, the subject experienced body aching. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced pain during injection. On 08-APR-2021, the subject experienced fever 100.9. Treatment medications included: paracetamol. The action taken with COVID-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aching, chills, and fever 100.9 on 09-APR-2021, and pain during injection on 08-APR-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dizziness, Muscular weakness, Nausea
Clinical narrative: SEVERE ACHES; SORE THROAT; DIZZINESS; MUSCLE WEAKNESS; CHILLS; NAUSEA; FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. Batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On 11-APR-2021, the subject experienced severe aches. On 11-APR-2021, the subject experienced sore throat. On 11-APR-2021, the subject experienced dizziness. On 11-APR-2021, the subject experienced muscle weakness. On 11-APR-2021, the subject experienced chills. On 11-APR-2021, the subject experienced nausea. On 11-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 102 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe aches, muscle weakness, nausea, dizziness, chills, sore throat and fever was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: SEVERE ACHES; SORE THROAT; DIZZINESS; MUSCLE WEAKNESS; CHILLS; NAUSEA; FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. Batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On 11-APR-2021, the subject experienced severe aches. On 11-APR-2021, the subject experienced sore throat. On 11-APR-2021, the subject experienced dizziness. On 11-APR-2021, the subject experienced muscle weakness. On 11-APR-2021, the subject experienced chills. On 11-APR-2021, the subject experienced nausea. On 11-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 102 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe aches, muscle weakness, nausea, dizziness, chills, sore throat and fever was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Hypogeusia
Clinical narrative: APPETITE LOST; DIMINISHED SENSE OF TASTE; 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 21-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch number. No concomitant medications were reported.  On 21-MAR-2021, the subject experienced appetite lost. On 21-MAR-2021, the subject experienced diminished sense of taste. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from appetite lost and diminished sense of taste. This report was non-serious.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Nasal congestion, Pain, Respiratory tract congestion
Clinical narrative: RESTLESSNESS; RIGHT ARM INJECTION SITE PAIN; HEADACHE; NASAL CONGESTION; CHEST CONGESTION; BODY ACHES; RUNNY NOSE; This spontaneous report received from a patient concerned a 52 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non-alcoholic, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies. The patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and batch number: 203A21A expiry: not reported) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced nasal congestion. On APR-2021, the subject experienced chest congestion. On APR-2021, the subject experienced body aches. On APR-2021, the subject experienced runny nose. On APR-2021, the subject experienced headache. On 11-APR-2021, the subject experienced restlessness. On 11-APR-2021, the subject experienced right arm injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the right arm injection site pain, nasal congestion, chest congestion, headache, body aches, runny nose and restlessness was not reported. This report was non-serious.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Restlessness, Rhinorrhoea
Clinical narrative: RESTLESSNESS; RIGHT ARM INJECTION SITE PAIN; HEADACHE; NASAL CONGESTION; CHEST CONGESTION; BODY ACHES; RUNNY NOSE; This spontaneous report received from a patient concerned a 52 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non-alcoholic, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies. The patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and batch number: 203A21A expiry: not reported) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced nasal congestion. On APR-2021, the subject experienced chest congestion. On APR-2021, the subject experienced body aches. On APR-2021, the subject experienced runny nose. On APR-2021, the subject experienced headache. On 11-APR-2021, the subject experienced restlessness. On 11-APR-2021, the subject experienced right arm injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the right arm injection site pain, nasal congestion, chest congestion, headache, body aches, runny nose and restlessness was not reported. This report was non-serious.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain, Nausea, Pain
Clinical narrative: BODY ACHE FELT MOSTLY ON KNEES, PELVIS AND HIPS; NAUSEA; INJECTION SITE PAIN; FEELING VERY TIRED; This spontaneous report received from a patient concerned a female. The patient's height, and weight were not reported. The patient's past medical history included anxiety, and concurrent conditions included bactrim allergy, alcohol use, and non-smoker, and other pre-existing medical conditions included patient had no drug abuse or illicit drug usage.  The patient was previously treated with lorazepam for anxiety. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043a21A or batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021, the subject experienced body ache felt mostly on knees, pelvis and hips. On 10-APR-2021, the subject experienced nausea. On 10-APR-2021, the subject experienced injection site pain. On 10-APR-2021, the subject experienced feeling very tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea, and feeling very tired on APR-2021, and was recovering from body ache felt mostly on knees, pelvis and hips, and injection site pain. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Dizziness
Clinical narrative: WEAKNESS; DIZZY; This spontaneous report received from a patient concerned an 80 year old female. The patient's height and weight were not reported. The patient's past medical history included endometriosis surgery, mild hydro nephrosis, gastric ulcer, thyroid removed and tonsil removed and concurrent conditions included atrial fibrillation and other pre-existing medical conditions included no history of drug abuse. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. Concomitant medications included warfarin sodium. On 08-APR-2021, the subject experienced dizzy. On 09-APR-2021, the subject experienced weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizzy and weakness on 12-APR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Atrial fibrillation
Clinical narrative: WEAKNESS; DIZZY; This spontaneous report received from a patient concerned an 80 year old female. The patient's height and weight were not reported. The patient's past medical history included endometriosis surgery, mild hydro nephrosis, gastric ulcer, thyroid removed and tonsil removed and concurrent conditions included atrial fibrillation and other pre-existing medical conditions included no history of drug abuse. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. Concomitant medications included warfarin sodium. On 08-APR-2021, the subject experienced dizzy. On 09-APR-2021, the subject experienced weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizzy and weakness on 12-APR-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia
Clinical narrative: SEVERE HEADACHE; MUSCLE ACHE; CHILLS; 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: 041A21A,  expiry: 27-JUN-2021) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 07-APR-2021, the subject experienced chills. On 07-APR-2021, the subject experienced muscle ache. On 08-APR-2021, the subject experienced severe headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, severe headache, and muscle ache on 08-APR-2021. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Fatigue
Clinical narrative: SEVERE FATIGUE; ANXIETY; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 12-APR-2021, the subject experienced severe fatigue. On 12-APR-2021, the subject experienced anxiety. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the anxiety and severe fatigue was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Decreased appetite, Fatigue, Headache
Clinical narrative: Appetite lost; GENERAL SORENESS; CHILLS; JOINT PAIN, HIP PAIN; LEG PAIN; 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, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced appetite lost, general soreness, chills, joint pain, hip pain, leg pain, headache, fever, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, chills, fever, joint pain, hip pain, leg pain, fatigue, appetite lost, and general soreness. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: Appetite lost; GENERAL SORENESS; CHILLS; JOINT PAIN, HIP PAIN; LEG PAIN; 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, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced appetite lost, general soreness, chills, joint pain, hip pain, leg pain, headache, fever, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, chills, fever, joint pain, hip pain, leg pain, fatigue, appetite lost, and general soreness. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SORE ARM; 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, start therapy date were not reported for prophylactic vaccination.   The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sore arm was not reported. This report was non-serious.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: OFF LABEL USE; PRODUCT USED IN UNAPPROVED AGE; This spontaneous report received from a health care professional concerned a 17 year old male. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. Batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On 10-APR-2021, the subject experienced off label use. On 10-APR-2021, the subject experienced product used in unapproved age. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and product used in unapproved age was not reported. This report was non-serious.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dizziness, Headache, Hot flush, Hypertension
Clinical narrative: HOT FLASHES; SHAKY LEGS; NUMBNESS FROM HEAD TO TOE; DIZZINESS; HIGH BLOOD PRESSURE ( 140/90); FEVER; LETHARGY; SLEEPINESS; BODY PAIN; HEADACHE; MUSCLE PAIN IN ARM; This spontaneous report received from a patient concerned a 37 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcoholic, and non smoker, and other pre-existing medical conditions included patient had no known drug allergies. patient had no history of 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: 1805031 and expiry: unknown) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021, the subject experienced muscle pain in arm. On 11-APR-2021, the subject experienced lethargy. On 11-APR-2021, the subject experienced sleepiness. On 11-APR-2021, the subject experienced body pain. On 11-APR-2021, the subject experienced fever. On 11-APR-2021, the subject experienced headache. On 12-APR-2021, the subject experienced hot flashes. On 12-APR-2021, the subject experienced shaky legs. On 12-APR-2021, the subject experienced numbness from head to toe. On 12-APR-2021, the subject experienced dizziness. On 12-APR-2021, the subject experienced high blood pressure (140/90). Laboratory data included: Blood pressure (NR: not provided) 140/90. Treatment medications (dates unspecified) included: Paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the muscle pain in arm, fever, lethargy, sleepiness, hot flashes, shaky legs, numbness from head to toe, dizziness, high blood pressure (140/90), headache and body pain was not reported. This report was non-serious.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Lethargy, Myalgia, Pain, Pyrexia
Clinical narrative: HOT FLASHES; SHAKY LEGS; NUMBNESS FROM HEAD TO TOE; DIZZINESS; HIGH BLOOD PRESSURE ( 140/90); FEVER; LETHARGY; SLEEPINESS; BODY PAIN; HEADACHE; MUSCLE PAIN IN ARM; This spontaneous report received from a patient concerned a 37 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcoholic, and non smoker, and other pre-existing medical conditions included patient had no known drug allergies. patient had no history of 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: 1805031 and expiry: unknown) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021, the subject experienced muscle pain in arm. On 11-APR-2021, the subject experienced lethargy. On 11-APR-2021, the subject experienced sleepiness. On 11-APR-2021, the subject experienced body pain. On 11-APR-2021, the subject experienced fever. On 11-APR-2021, the subject experienced headache. On 12-APR-2021, the subject experienced hot flashes. On 12-APR-2021, the subject experienced shaky legs. On 12-APR-2021, the subject experienced numbness from head to toe. On 12-APR-2021, the subject experienced dizziness. On 12-APR-2021, the subject experienced high blood pressure (140/90). Laboratory data included: Blood pressure (NR: not provided) 140/90. Treatment medications (dates unspecified) included: Paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the muscle pain in arm, fever, lethargy, sleepiness, hot flashes, shaky legs, numbness from head to toe, dizziness, high blood pressure (140/90), headache and body pain was not reported. This report was non-serious.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence, Tremor
Clinical narrative: HOT FLASHES; SHAKY LEGS; NUMBNESS FROM HEAD TO TOE; DIZZINESS; HIGH BLOOD PRESSURE ( 140/90); FEVER; LETHARGY; SLEEPINESS; BODY PAIN; HEADACHE; MUSCLE PAIN IN ARM; This spontaneous report received from a patient concerned a 37 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcoholic, and non smoker, and other pre-existing medical conditions included patient had no known drug allergies. patient had no history of 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: 1805031 and expiry: unknown) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021, the subject experienced muscle pain in arm. On 11-APR-2021, the subject experienced lethargy. On 11-APR-2021, the subject experienced sleepiness. On 11-APR-2021, the subject experienced body pain. On 11-APR-2021, the subject experienced fever. On 11-APR-2021, the subject experienced headache. On 12-APR-2021, the subject experienced hot flashes. On 12-APR-2021, the subject experienced shaky legs. On 12-APR-2021, the subject experienced numbness from head to toe. On 12-APR-2021, the subject experienced dizziness. On 12-APR-2021, the subject experienced high blood pressure (140/90). Laboratory data included: Blood pressure (NR: not provided) 140/90. Treatment medications (dates unspecified) included: Paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the muscle pain in arm, fever, lethargy, sleepiness, hot flashes, shaky legs, numbness from head to toe, dizziness, high blood pressure (140/90), headache and body pain was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Defaecation urgency
Clinical narrative: BOWEL URGENCY; This solicited report received from a patient via RRA-18356: Nurse Navigators from Janssen program for STELARA Crohns concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included hand surgery. The patient received combination product ustekinumab (solution for injection in pre-filled syringe, route of admin, and batch number were not reported) dose and frequency were not reported from 15-MAR-2021 for an unspecified indication. Product constituent parts included ultrasafe passive (route of admin, lot, serial number, model number, UDI number, and expiration were not reported); and ultrasafe passive accessory (route of admin, lot, serial number, model number, UDI number, and expiration were not reported). The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number: Unknown and expiry: Unknown) dose was not reported, administered on 2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 2021, the patient experienced bowel urgency. The action taken with covid-19 vaccine ad26.cov2.s, and ustekinumab was not applicable. The outcome of bowel urgency was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and bowel urgency as possible; and between ustekinumab, and bowel urgency as possible.  This report was non-serious.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Nausea, Pain
Clinical narrative: BODY PAINS; SNEEZING; RUNNY NOSE; FEELING OUT; SORE ARM; EXTREME TIREDNESS; MILD NAUSEA; MILD FEVER; HEADACHE; This spontaneous report received from a patient concerned a 38 year old male. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, 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, treatment medications included: diphenhydramine hydrochloride, and pseudoephedrine hydrochloride. On 09-APR-2021, the subject experienced body pains. On 09-APR-2021, the subject experienced sneezing. On 09-APR-2021, the subject experienced runny nose. On 09-APR-2021, the subject experienced feeling out. On 09-APR-2021, the subject experienced sore arm. On 09-APR-2021, the subject experienced extreme tiredness. On 09-APR-2021, the subject experienced mild nausea. On 09-APR-2021, the subject experienced mild fever. On 09-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from extreme tiredness, and feeling out, and had not recovered from headache, body pains, mild fever, mild nausea, sneezing, runny nose, and sore arm. This report was non-serious.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Rhinorrhoea, Sneezing
Clinical narrative: BODY PAINS; SNEEZING; RUNNY NOSE; FEELING OUT; SORE ARM; EXTREME TIREDNESS; MILD NAUSEA; MILD FEVER; HEADACHE; This spontaneous report received from a patient concerned a 38 year old male. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, 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, treatment medications included: diphenhydramine hydrochloride, and pseudoephedrine hydrochloride. On 09-APR-2021, the subject experienced body pains. On 09-APR-2021, the subject experienced sneezing. On 09-APR-2021, the subject experienced runny nose. On 09-APR-2021, the subject experienced feeling out. On 09-APR-2021, the subject experienced sore arm. On 09-APR-2021, the subject experienced extreme tiredness. On 09-APR-2021, the subject experienced mild nausea. On 09-APR-2021, the subject experienced mild fever. On 09-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from extreme tiredness, and feeling out, and had not recovered from headache, body pains, mild fever, mild nausea, sneezing, runny nose, and sore arm. This report was non-serious.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Pyrexia, Vomiting
Clinical narrative: VOMITING; CHILLS; NAUSEA; 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 pre-existing medical conditions included patient's medical history was unknown and had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021 03:00, the subject experienced vomiting. On 09-APR-2021 03:00, the subject experienced chills. On 09-APR-2021 03:00, the subject experienced nausea. On 09-APR-2021 03:00, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, chills, nausea, and fever on 10-APR-2021. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: BODY ACHES; HIGH FEVER; HEADACHE; This spontaneous report received from a parent 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: 042A21A, expiry: not reported) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced body aches. On 08-APR-2021, the subject experienced high fever. On 08-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the high fever, headache and body aches was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Injection site nodule, Injection site pain
Clinical narrative: SORE BUMP ON INJECTION SITE; CHILLS; PAIN AT INJECTION SITE; HEADACHE; FATIGUE; NAUSEA; This spontaneous report received from a consumer concerned a 36 year old male. The patient's height, and weight were not reported. The patient's 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: 201A21A expiry: 23-JUN-2021) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced sore bump on injection site. On 12-APR-2021, the subject experienced chills. On 12-APR-2021, the subject experienced pain at injection site. On 12-APR-2021, the subject experienced headache. On 12-APR-2021, the subject experienced fatigue. On 12-APR-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, chills, fatigue, pain at injection site, sore bump on injection site, and nausea. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: SORE BUMP ON INJECTION SITE; CHILLS; PAIN AT INJECTION SITE; HEADACHE; FATIGUE; NAUSEA; This spontaneous report received from a consumer concerned a 36 year old male. The patient's height, and weight were not reported. The patient's 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: 201A21A expiry: 23-JUN-2021) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced sore bump on injection site. On 12-APR-2021, the subject experienced chills. On 12-APR-2021, the subject experienced pain at injection site. On 12-APR-2021, the subject experienced headache. On 12-APR-2021, the subject experienced fatigue. On 12-APR-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, chills, fatigue, pain at injection site, sore bump on injection site, and nausea. This report was non-serious.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Nausea
Clinical narrative: DIZZINESS; HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known other medical condition and not on any medications.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: jj206a21a, and batch number: JJ206A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced dizziness. On 09-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on APR-2021, and had not recovered from dizziness, and nausea. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site nodule, Nausea
Clinical narrative: KNOTS IN THE SITE OF INJECTION; HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1a08609, expiry: UNKNOWN) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced knots in the site of injection, headache, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, and the outcome of nausea and knots in the site of injection was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: HEADACHES; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. Batch number was not reported. The company was unable to follow-up request for batch number. No concomitant medications were reported. On an unspecified date, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of headache was not reported. This report was non-serious.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: TIRED; This spontaneous report received from a consumer concerned a 51 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tired on 01-APR-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SEVERE FOOT PAIN; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included abstains from alcohol, and non smoker, and other pre-existing medical conditions included no known allergies and does not have drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1008609, and  expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination.  No concomitant medications were reported.  On 04-APR-2021, the subject experienced severe foot pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe foot pain on 05-APR-2021. This report was non-serious.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Headache, Injection site pain, Lacrimation increased, Muscle tightness
Clinical narrative: NECK TIGHT FEELING ON RIGHT SIDE IN GLAND AREA WHEN SWALLOWS; LEFT EYE WATERING CONSTANTLY WHILE AWAKE; NO APPETITE; PAIN AT INJECTION SITE; NAUSEA; MUSCLE ACHES; SHARP STABBING PAIN IN HEAD; HEADACHE; BODY ACHES; PAIN BACK OF LEFT LEG NEAR KNEE; FEVER; This spontaneous report received from a patient concerned a 57 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: EL043A21A,  expiry: not reported) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination.  No concomitant medications were reported. On 10-APR-2021 16:45, the subject experienced fever. On 11-APR-2021, the subject experienced pain back of left leg near knee. On 11-APR-2021 04:00, the subject experienced body aches. On 11-APR-2021 04:00, the subject experienced sharp stabbing pain in head. On 11-APR-2021 04:00, the subject experienced headache. On 12-APR-2021, the subject experienced neck tight feeling on right side in gland area when swallows. On 12-APR-2021, the subject experienced left eye watering constantly while awake. On 12-APR-2021, the subject experienced no appetite. On 12-APR-2021, the subject experienced pain at injection site. On 12-APR-2021, the subject experienced nausea. On 12-APR-2021, the subject experienced muscle aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sharp stabbing pain in head on 12-APR-2021, and had not recovered from pain at injection site, neck tight feeling on right side in gland area when swallows, fever, headache, body aches, nausea, left eye watering constantly while awake, pain back of left leg near knee, muscle aches, and no appetite. This report was non-serious.