chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; DIZZINESS; This spontaneous report received from a patient concerned a 30-year-old. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient experienced drug allergy when treated with ibuprofen. The patient was not pregnant at the time of reporting or not breastfeeding. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: 21-JUN-2021) dose was not reported, 1 in total administered at left arm on 03-APR-2021 for prophylactic vaccination. The patient was taking iron supplements. On 07-MAY-2021, the patient went to an (indoor) family dinner (total of 6 adult guests, all vaccinated). On 10-MAY-2021, one of the participants tested positive to SARS-CoV2. Over that week, 4 of the 6 participants ended up testing positive. On 11-MAY-2021, the patient started feeling symptoms and described as fever, loss of taste and smell, nasal congestion, headache, body aches, chills, diarrhea, dizziness and fatigue. Patient tested positive for SARS-CoV2 on 12-MAY-2021. Most symptoms lasted for about 5 days and patient reported that the only symptoms left were a tiny bit of nasal congestion and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness on 15-MAY-2021, had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210554428-Covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Circadian rhythm sleep disorder, Dyspepsia, Fatigue, Feeling drunk, Injection site warmth
Clinical narrative: COMPRESSION RIGHT AT THE SOLAR PLEXUS; WOKEN UP FROM SLEEP; MAJOR HEART BURN; LEFT LEG SWELLING; FELT LIKE DRUNK; SEASICKNESS; FELT NAUSEOUS; FELT TIRED; FELT JET LAGGED; HOT OIL BEING INJECTED INTO ARM; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's past medical history included alcohol user, and concurrent conditions included non smoker, penicillin allergy, and sulfa allergy, and other pre-existing medical conditions included the patient did not have any drug abuse/illicit drug use. the patient was not relevant medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included cyanocobalamin for drug used for unknown indication, ergocalciferol for drug used for unknown indication, and for drug used for unknown indication.  On 09-APR-2021, the subject experienced hot oil being injected into arm. On 10-APR-2021, the subject experienced felt jet lagged. On 10-APR-2021, the subject experienced felt tired. On 11-APR-2021, the subject experienced seasickness. On 11-APR-2021, the subject experienced felt nauseous. On 12-APR-2021, the subject experienced felt like drunk. On 15-APR-2021, the subject experienced left leg swelling. On 01-MAY-2021, the subject experienced major heart burn. On an unspecified date, the subject experienced compression right at the solar plexus, and woken up from sleep. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt like drunk, felt jet lagged, seasickness, left leg swelling, hot oil being injected into arm, felt tired, and felt nauseous, had not recovered from major heart burn, and the outcome of compression right at the solar plexus and woken up from sleep was not reported. This report was non-serious.; Sender's Comments: V0. Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Motion sickness, Nausea, Nerve compression, Peripheral swelling, Sleep disorder
Clinical narrative: COMPRESSION RIGHT AT THE SOLAR PLEXUS; WOKEN UP FROM SLEEP; MAJOR HEART BURN; LEFT LEG SWELLING; FELT LIKE DRUNK; SEASICKNESS; FELT NAUSEOUS; FELT TIRED; FELT JET LAGGED; HOT OIL BEING INJECTED INTO ARM; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's past medical history included alcohol user, and concurrent conditions included non smoker, penicillin allergy, and sulfa allergy, and other pre-existing medical conditions included the patient did not have any drug abuse/illicit drug use. the patient was not relevant medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included cyanocobalamin for drug used for unknown indication, ergocalciferol for drug used for unknown indication, and for drug used for unknown indication.  On 09-APR-2021, the subject experienced hot oil being injected into arm. On 10-APR-2021, the subject experienced felt jet lagged. On 10-APR-2021, the subject experienced felt tired. On 11-APR-2021, the subject experienced seasickness. On 11-APR-2021, the subject experienced felt nauseous. On 12-APR-2021, the subject experienced felt like drunk. On 15-APR-2021, the subject experienced left leg swelling. On 01-MAY-2021, the subject experienced major heart burn. On an unspecified date, the subject experienced compression right at the solar plexus, and woken up from sleep. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt like drunk, felt jet lagged, seasickness, left leg swelling, hot oil being injected into arm, felt tired, and felt nauseous, had not recovered from major heart burn, and the outcome of compression right at the solar plexus and woken up from sleep was not reported. This report was non-serious.; Sender's Comments: V0. Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination error
Clinical narrative: VACCINATION WITH JANSSEN COVID19 VACCINE WHO HAD ALREADY RECEIVED FIRST DOSE OF MODERNA COVID19 VACCINE; This spontaneous report received from a pharmacist concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with mrna 1273 for prophylactic vaccination. 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 27-MAY-2021 15:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 27-MAY-2021, the subject experienced vaccination with janssen covid19 vaccine who had already received first dose of moderna covid19 vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccination with janssen covid19 vaccine who had already received first dose of moderna covid19 vaccine was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Nausea
Clinical narrative: FEELING UNWELL; NAUSEA; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, the subject experienced feeling unwell. On 2021, the subject experienced nausea. On 2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nausea, headache and feeling unwell was not reported. This report was non-serious.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Balance disorder, Dyspepsia, Nausea
Clinical narrative: OFF BALANCE; STOMACH PAINS; BOILING STOMACH (FELT LIKE HEARTBURN); NAUSEA; This spontaneous report received from a patient concerned a 26 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 allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: Unknown) dose was not reported, administered on 26-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 27-MAY-2021, the subject experienced off balance. On 27-MAY-2021, the subject experienced stomach pains. On 27-MAY-2021, the subject experienced boiling stomach (felt like heartburn). On 27-MAY-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nausea, off balance, stomach pains, and boiling stomach (felt like heartburn). This report was non-serious.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Ligamentitis, Paraesthesia, Peripheral swelling, Skin discolouration
Clinical narrative: INFLAMMATION OF THE BALL OF RIGHT FOOT; BRUISING OF THE RIGHT FOOT AND TOE; TINGLING IN THE BALL OF FOOT; SWOLLEN BALL OF FOOT; THE BALL OF FOOT WAS DISCOLORED/ DISCOLORATION (DEEP RED AND PURPLE) HAD SPREAD TO THE WHOLE BOTTOM OF FOOT AND BIG TOE; This spontaneous report received from a patient concerned a 78 year old female. The patient's height, and weight were not reported. The patient's past medical history included fractured vertebra, and concurrent conditions included no alcohol use, non-smoker, mast cell activation syndrome, seasonal allergies, and drug allergy, and other pre-existing medical conditions included the patient had seasonal and atypical (gastric and dermatologic) sensitivities to medications. 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: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 24-MAY-2021 16:30 for prophylactic vaccination. No concomitant medications were reported. On 25-MAY-2021, the subject experienced inflammation of the ball of right foot. On 25-MAY-2021, the subject experienced bruising of the right foot and toe. On 25-MAY-2021, the subject experienced tingling in the ball of foot. On 25-MAY-2021, the subject experienced swollen ball of foot. On 25-MAY-2021, the subject experienced the ball of foot was discolored/ discoloration (deep red and purple) had spread to the whole bottom of foot and big toe. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from inflammation of the ball of right foot, had not recovered from bruising of the right foot and toe, and the outcome of tingling in the ball of foot, swollen ball of foot and the ball of foot was discolored/ discoloration (deep red and purple) had spread to the whole bottom of foot and big toe was not reported. This report was non-serious.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Adverse event, Joint swelling, Peripheral coldness
Clinical narrative: SWOLLEN ANKLES; ICE COLD FEET; TYPICAL SIGNS AND SYMPTOM; This spontaneous report received from a parent concerned a 30 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid-19, and concurrent conditions included postural orthostatic tachycardia syndrome (POTS). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, expiry: UNKNOWN) dose was not reported, administered on 25-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAY-2021, the subject experienced typical signs and symptom. On 27-MAY-2021, the subject experienced swollen ankles. On 27-MAY-2021, the subject experienced ice cold feet. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the swollen ankles, ice cold feet and typical signs and symptom was not reported. This report was non-serious.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Body temperature, Headache, Hypoaesthesia, Insomnia
Clinical narrative: TROUBLE SLEEPING; NUMB PINKY AND RING FINGER; TINGLING IN THE LEFT PINKY/RING FINGER; JOINT PAIN; LOW GRADE FEVER; NAUSEA; MUSCLE ACHES; HEADACHE; LEFT ARM PAIN; LEFT SHOULDER PAIN; This spontaneous report received from a patient concerned a 49 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 1808982 expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced left shoulder pain. On 10-APR-2021, the subject experienced left arm pain. On 11-APR-2021, the subject experienced joint pain. On 11-APR-2021, the subject experienced low grade fever. On 11-APR-2021, the subject experienced nausea. On 11-APR-2021, the subject experienced muscle aches. On 11-APR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 99.5 degrees. On 15-MAY-2021, the subject experienced numb pinky and ring finger. On 15-MAY-2021, the subject experienced tingling in the left pinky/ring finger. On an unspecified date, the subject experienced trouble sleeping. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from joint pain, nausea, and muscle aches on 17-APR-2021, low grade fever on 12-APR-2021, and headache on 13-APR-2021, had not recovered from left arm pain, left shoulder pain, numb pinky and ring finger, and trouble sleeping, and the outcome of tingling in the left pinky/ring finger was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Nausea, Pain in extremity, Paraesthesia, Pyrexia
Clinical narrative: TROUBLE SLEEPING; NUMB PINKY AND RING FINGER; TINGLING IN THE LEFT PINKY/RING FINGER; JOINT PAIN; LOW GRADE FEVER; NAUSEA; MUSCLE ACHES; HEADACHE; LEFT ARM PAIN; LEFT SHOULDER PAIN; This spontaneous report received from a patient concerned a 49 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 1808982 expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced left shoulder pain. On 10-APR-2021, the subject experienced left arm pain. On 11-APR-2021, the subject experienced joint pain. On 11-APR-2021, the subject experienced low grade fever. On 11-APR-2021, the subject experienced nausea. On 11-APR-2021, the subject experienced muscle aches. On 11-APR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 99.5 degrees. On 15-MAY-2021, the subject experienced numb pinky and ring finger. On 15-MAY-2021, the subject experienced tingling in the left pinky/ring finger. On an unspecified date, the subject experienced trouble sleeping. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from joint pain, nausea, and muscle aches on 17-APR-2021, low grade fever on 12-APR-2021, and headache on 13-APR-2021, had not recovered from left arm pain, left shoulder pain, numb pinky and ring finger, and trouble sleeping, and the outcome of tingling in the left pinky/ring finger was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Hypoaesthesia, Joint range of motion decreased, Pain, Product administered at inappropriate site
Clinical narrative: TROUBLE SLEEPING; NUMB PINKY AND RING FINGER; TINGLING IN THE LEFT PINKY/RING FINGER; JOINT PAIN; LOW GRADE FEVER; NAUSEA; MUSCLE ACHES; HEADACHE; LEFT ARM PAIN; LEFT SHOULDER PAIN; This spontaneous report received from a patient concerned a 49 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 1808982 expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced left shoulder pain. On 10-APR-2021, the subject experienced left arm pain. On 11-APR-2021, the subject experienced joint pain. On 11-APR-2021, the subject experienced low grade fever. On 11-APR-2021, the subject experienced nausea. On 11-APR-2021, the subject experienced muscle aches. On 11-APR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 99.5 degrees. On 15-MAY-2021, the subject experienced numb pinky and ring finger. On 15-MAY-2021, the subject experienced tingling in the left pinky/ring finger. On an unspecified date, the subject experienced trouble sleeping. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from joint pain, nausea, and muscle aches on 17-APR-2021, low grade fever on 12-APR-2021, and headache on 13-APR-2021, had not recovered from left arm pain, left shoulder pain, numb pinky and ring finger, and trouble sleeping, and the outcome of tingling in the left pinky/ring finger was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTERED EXPIRED VACCINE; This spontaneous report received from a pharmacist concerned a 23 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 expiry: 25-MAY-2021) dose was not reported, administered on 26-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 26-MAY-2021, the subject experienced administered expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administered expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210554908 and 20210554625.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness
Clinical narrative: LIGHTHEADED; DIZZY; FELT LIKE LOSS OF BALANCE WHEN STANDING UP; This spontaneous report received from a consumer concerned a 62 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included squamous cell cancer on right arm. 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 26-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 27-MAY-2021, the subject experienced lightheaded. On 27-MAY-2021, the subject experienced dizzy. On 27-MAY-2021, the subject experienced felt like loss of balance when standing up. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lightheaded, dizzy, and felt like loss of balance when standing up. This report was non-serious.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: RASHES ALL OVER THE ARMS, NECK, FACE, CHEST AND HEAD/ IT ITCHES EVERYWHERE; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included copd, and other pre-existing medical conditions included 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: 1805031, expiry: UNKNOWN) dose was not reported, administered on 24-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, treatment medications included: diphenhydramine hydrochloride. On 24-MAY-2021, the subject experienced rashes all over the arms, neck, face, chest and head/ it itches everywhere. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rashes all over the arms, neck, face, chest and head/ it itches everywhere. This report was non-serious.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Cold sweat, Dizziness, Nausea
Clinical narrative: FEELING DIZZY; CLAMMY; TIGHNESS ON CHEST; NAUSEA WITHOUT VOMITING; This spontaneous report received from a parent concerned a 23 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included alcoholic, and non smoker, and other pre-existing medical conditions included patient has no allergies, no drug abuse or illicit drug usage. patient was non smoker and consume alcohol sometimes.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 207A21A, and batch number: 207A21A) dose was not reported, administered on 27-MAY-2021 11:30 for prophylactic vaccination. No concomitant medications were reported. On 27-MAY-2021, the subject experienced feeling dizzy. On 27-MAY-2021, the subject experienced clammy. On 27-MAY-2021, the subject experienced tighness on chest. On 27-MAY-2021, the subject experienced nausea without vomiting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feeling dizzy, clammy, nausea without vomiting, and tighness on chest. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Product administration error, Syringe issue
Clinical narrative: LOOSE SYRINGE CAUSING VACCINE CONTENT LEAKAGE; MEDICATION ERROR; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 27-MAY-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 loose syringe causing vaccine content leakage, and medication error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the loose syringe causing vaccine content leakage and medication error was not reported. This report was non-serious The report was associated with product quality complaint:90000181024.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: LOT OF EXTRA PAIN; This spontaneous report received from a patient concerned a 62-year-old Other race (Not Hispanic/Latino) female. The patient's height, and weight were not reported. The patient's concurrent conditions included multiple sclerosis, and glaucoma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 207A21A expiry: UNKNOWN) dose was not reported, administered on 20-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-MAY-2021, the subject experienced lot of extra pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lot of extra pain. This report was non-serious.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Dysphagia, Dyspnoea, Feeling abnormal, Obstructive airways disorder
Clinical narrative: BREATHING DIFFICULTIES; CONSTANT COUGH; LUMP IN THE THROAT; FEEL LIKE HE IS DYING; SWALLOWING DIFFICULTY; AIRWAY BLOCKAGE; This spontaneous report received from a patient concerned a 54 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018 expiry: 25-MAY-2021) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced breathing difficulties. On 01-APR-2021, the subject experienced constant cough. On 01-APR-2021, the subject experienced lump in the throat. On 01-APR-2021, the subject experienced feel like he is dying. On 01-APR-2021, the subject experienced swallowing difficulty. On 01-APR-2021, the subject experienced airway blockage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the breathing difficulties, constant cough, lump in the throat, feel like he is dying, swallowing difficulty and airway blockage was not reported. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as case assessed as non serious.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Sensation of foreign body
Clinical narrative: BREATHING DIFFICULTIES; CONSTANT COUGH; LUMP IN THE THROAT; FEEL LIKE HE IS DYING; SWALLOWING DIFFICULTY; AIRWAY BLOCKAGE; This spontaneous report received from a patient concerned a 54 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018 expiry: 25-MAY-2021) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced breathing difficulties. On 01-APR-2021, the subject experienced constant cough. On 01-APR-2021, the subject experienced lump in the throat. On 01-APR-2021, the subject experienced feel like he is dying. On 01-APR-2021, the subject experienced swallowing difficulty. On 01-APR-2021, the subject experienced airway blockage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the breathing difficulties, constant cough, lump in the throat, feel like he is dying, swallowing difficulty and airway blockage was not reported. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as case assessed as non serious.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Electrocardiogram, Palpitations, Peripheral swelling, Skin discolouration
Clinical narrative: LEFT THUMB SWOLLEN; LEFT THUMB BRUISED; LEFT THUMB CHANGED TO BLACK COLOR; HEART RACING; This spontaneous report received from a patient concerned a 43 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergies, and other pre-existing medical conditions included 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: 207A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced left thumb swollen. On 07-APR-2021, the subject experienced left thumb bruised. On 07-APR-2021, the subject experienced left thumb changed to black color. On 07-APR-2021, the subject experienced heart racing. Laboratory data included: Diagnostic ultrasound (NR: not provided) Could not find anything, EKG (NR: not provided) Unknown, and Vital signs measurement (NR: not provided) Unknown. Treatment medications included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from left thumb swollen, left thumb bruised, and left thumb changed to black color on 10-APR-2021, and the outcome of heart racing was not reported. This report was non-serious.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound scan, Vital signs measurement
Clinical narrative: LEFT THUMB SWOLLEN; LEFT THUMB BRUISED; LEFT THUMB CHANGED TO BLACK COLOR; HEART RACING; This spontaneous report received from a patient concerned a 43 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergies, and other pre-existing medical conditions included 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: 207A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced left thumb swollen. On 07-APR-2021, the subject experienced left thumb bruised. On 07-APR-2021, the subject experienced left thumb changed to black color. On 07-APR-2021, the subject experienced heart racing. Laboratory data included: Diagnostic ultrasound (NR: not provided) Could not find anything, EKG (NR: not provided) Unknown, and Vital signs measurement (NR: not provided) Unknown. Treatment medications included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from left thumb swollen, left thumb bruised, and left thumb changed to black color on 10-APR-2021, and the outcome of heart racing was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Contusion, Pruritus
Clinical narrative: SEVERE ITCHING/SCRATCHING  ALL OVER; BRUISING; This spontaneous report received from a health care professional concerned a 22 year old of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included autistic, non verbal, seizures, and obesity. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A expiry: 23/JUN/2021) dose was not reported, administered on 10-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-MAY-2021, the subject experienced severe itching/scratching all over. On 12-MAY-2021, the subject experienced bruising. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe itching/scratching all over, and bruising. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: SPOT ON MY FOREARM POP UP; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 01-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 01-MAY-2021, the subject experienced spot on my forearm pop up. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from spot on my forearm pop up. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19 INFECTION (SYMPTOMS INCLUDED RUNNY NOSE, CONGESTION AND BODY ACHES); This spontaneous report received from a consumer concerned a 3 decade old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 30-APR-2021, the subject experienced suspected covid-19 infection (symptoms included runny nose, congestion and body aches). On 02-MAY-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from suspected covid-19 infection (symptoms included runny nose, congestion and body aches) on MAY-2021. This report was non-serious. This report was associated with product quality complaint: 90000180984. This case, from the same reporter is linked to 20210554340.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is assessed as non serious
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Pain in extremity
Clinical narrative: DIARRHOEA; PAINFUL ARM; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 19-MAY-2021 for prophylactic vaccination. The batch number was not provided and it has been requested. No concomitant medications were reported.  On 19-MAY-2021, the subject experienced painful arm. On 19-MAY-2021, the subject experienced headache. On 25-MAY-2021, the subject experienced diarrhoea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from diarrhoea, and the outcome of painful arm and headache was not reported. This report was non-serious.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTERED EXPIRED VACCINE; This spontaneous report received from a pharmacist concerned a 28 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 expiry: 25-MAY-2021) dose was not reported, administered on 26-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-MAY-2021, the subject experienced administered expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administered expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210554908, 20210554431, 20210551574, 20210554478 and 20210554296.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Product use issue
Clinical narrative: VACCINE WAS GIVEN TO THE 17.5 YEARS OLD PATIENT; OFF LABEL USE; This spontaneous report received from a pharmacist concerned a 17 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 203A21A expiry: 23-JUN-2021) dose was not reported, administered on 26-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-MAY-2021, the subject experienced vaccine was given to the 17.5 years old subject. On 26-MAY-2021, the subject experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine was given to the 17.5 years old patient and off label use was not reported. This report was non-serious.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Dizziness, Tremor, Vision blurred
Clinical narrative: DIZZINESS; BLURRED VISION; BODY SHAKES; ABDOMINAL PAIN; This spontaneous report received from a patient concerned a 53 year old female. The patient's weight was 261 pounds, and height was 67 inches. The patient's past medical history included ablations of heart, atl knee surgery, foot surgery, jaw surgery, 2 cesarean section, and cholecystectomy, and concurrent conditions included brain tumor right temporal lobe, thyroid tumor 4 cm benign, non alcohol user, and cigarette smoker, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug usage. The patient experienced rash (drug allergy) when treated with erythromycin.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 26-MAY-2021 14:00 for prophylactic vaccination. No concomitant medications were reported.  On 26-MAY-2021, the subject experienced dizziness. On 26-MAY-2021, the subject experienced blurred vision. On 26-MAY-2021, the subject experienced body shakes. On 26-MAY-2021, the subject experienced abdominal pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from abdominal pain, and had not recovered from dizziness, blurred vision, and body shakes. This report was non-serious.; Sender's Comments: V0:  Medical Assessment Comment not required as per standard procedure as the case assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Multiple allergies, SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; ALLERGIES; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown expiry: unknown) dose was not reported, 1 total administered on 05-APR-2021 for prophylactic vaccination. The batch number was not reported. the company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date in 2021, the patient developed symptoms that the patient put down as allergies. There was an overlap between the symptoms of COVID and seasonal allergies including cough, sore throat, but when the patient experienced temperature, and body aches his partner suggested to do laboratory test. On an unspecified date in 2021, the patient's COVID-19 virus test for which result was positive and patient was diagnosed with suspected covid-19 infection and suspected clinical vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection, suspected clinical vaccination failure and allergies was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210554707-Covid-19 vaccine ad26.cov2.s-suspected clinical vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.
Sex: M
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: UNSPECIFIED ADVERSE EVENTS; 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. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced unspecified adverse events. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unspecified adverse events was not reported. This report was non-serious.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Chills, Dysgeusia, Fatigue, Headache
Clinical narrative: BURNING  ( AROUND EYEBALLS,NECK AND BODY); HOT FLASHES; SLEEPINESS; CHILLS; SUPER FATIGUE; HEADACHE; WEIRD TASTE IN MOUTH; This spontaneous report received from a patient concerned a 49 year old male. The patient's weight was 279 pounds, and height was 67 inches. The patient's past medical history included asthma younger, and concurrent conditions included non smoker. The patient experienced drug allergy when treated with methylprednisolone sodium succinate. 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: 23-JUN-2021) dose was not reported, administered on 24-MAY-2021 14:45 for prophylactic vaccination. No concomitant medications were reported. On 24-MAY-2021, the subject experienced weird taste in mouth. On 24-MAY-2021, the subject experienced headache. On 25-MAY-2021, the subject experienced sleepiness. On 25-MAY-2021, the subject experienced chills. On 25-MAY-2021, the subject experienced super fatigue. On 26-MAY-2021, the subject experienced hot flashes. On 26-MAY-2021, the subject experienced burning ( around eyeballs, neck and body). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, weird taste in mouth, super fatigue, hot flashes, chills, sleepiness, and burning ( around eyeballs,neck and body). This report was non-serious.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Hot flush, Somnolence
Clinical narrative: BURNING  ( AROUND EYEBALLS,NECK AND BODY); HOT FLASHES; SLEEPINESS; CHILLS; SUPER FATIGUE; HEADACHE; WEIRD TASTE IN MOUTH; This spontaneous report received from a patient concerned a 49 year old male. The patient's weight was 279 pounds, and height was 67 inches. The patient's past medical history included asthma younger, and concurrent conditions included non smoker. The patient experienced drug allergy when treated with methylprednisolone sodium succinate. 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: 23-JUN-2021) dose was not reported, administered on 24-MAY-2021 14:45 for prophylactic vaccination. No concomitant medications were reported. On 24-MAY-2021, the subject experienced weird taste in mouth. On 24-MAY-2021, the subject experienced headache. On 25-MAY-2021, the subject experienced sleepiness. On 25-MAY-2021, the subject experienced chills. On 25-MAY-2021, the subject experienced super fatigue. On 26-MAY-2021, the subject experienced hot flashes. On 26-MAY-2021, the subject experienced burning ( around eyeballs, neck and body). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, weird taste in mouth, super fatigue, hot flashes, chills, sleepiness, and burning ( around eyeballs,neck and body). This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: SMALL RED BUMPS BELLY AND SPREAD UP CHEST/ RANDOM RED DOTS/IF DO NOT THINK ABOUT THEM, IT DOES NOT ITCH, WHEN DO THINK ABOUT THE DOTS, THEY DO ITCH; This spontaneous report received from a patient concerned a 56 year old of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included latex allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 24-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included acetylsalicylic acid. On 26-MAY-2021, the subject experienced small red bumps belly and spread up chest/ random red dots/if do not think about them, it does not itch, when do think about the dots, they do itch. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of small red bumps belly and spread up chest/ random red dots/if do not think about them, it does not itch, when do think about the dots, they do itch was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: SORENESS OF LEFT SHOULDER; This spontaneous report received from a patient concerned an 80 year old male. 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 has no allergies,no drug abuse or illicit drug usage. patient was non alcohol consumer, non smoker.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 26-MAY-2021 to Left Deltoid for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 27-MAY-2021, the subject experienced soreness of left shoulder. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from soreness of left shoulder. This report was non-serious.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Thrombosis
Clinical narrative: BLOOD CLOT; STROKE; This spontaneous report received from a patient concerned a 46 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 202A21A expiry: 23-JUN-2021) dose was not reported, 1 total administered on 07-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 19-May-2021, the patient begun to experiencing confusion and could not think straight. On 23-MAY-2021, the symptoms progressed when the patient went to the hospital. The patient was diagnosed with blood clot and had stroke. The patient was hospitalized on 23-MAY-2021 and was discharged on 26-MAY-2021. The patient was hospitalized for 3 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clot and stroke was not reported. This report was serious (Hospitalization Caused/Prolonged).; Sender's Comments: V0: 20210554839-covid-19 vaccine ad26.cov2.s-blood clot and stroke. 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).