chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Back injury, Burning sensation, C-reactive protein, Colonoscopy, Dyskinesia
Clinical narrative: BACK INJURY; SHOULDER INJURY; BULGED DISCS; BURNING SENSATIONS IN HER NECK, SHOULDER, SPINE THAT TRAVELS TO LEGS AND ARMS, HEAD AND WORST AT NIGHT WHEN LYING DOWN; JERKY MOVEMENTS; CANNOT HOLD ANYTHING AND EVERYTHING IS HEAVY; FEELING SICK; MUSCLES ARE FALLING APART INSIDE OF ME/THE PAIN THE PATIENT IS EXPERIENCING; BAD HEADACHE; This spontaneous report received from a patient concerned a 46 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: 1808980 expiry: 18-SEP-2021) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, the patient experienced burning sensations in her neck, shoulder, spine that travels to legs and arms, head and worst at night when lying down. On JUN-2021, the patient experienced jerky movements. On JUN-2021, the patient experienced cannot hold anything and everything is heavy. On JUN-2021, the patient experienced feeling sick. On JUN-2021, the patient experienced muscles are falling apart inside of me/the pain the patient is experiencing. On JUN-2021, the patient experienced bad headache. Treatment medications included: gabapentin. On 04-JUN-2021, the patient experienced bulged discs. On 23-JUN-2021, the patient experienced back injury. On 23-JUN-2021, the patient experienced shoulder injury. On 12-AUG-2021, Laboratory data included: C-reactive protein (NR: not provided) not reported, Colonoscopy (NR: not provided) not reported, Comprehensive metabolic panel (NR: not provided) not reported, Endoscopy (NR: not provided) not reported, Ferritin (NR: not provided) not reported, HIV infection (NR: not provided) not reported, Hemoglobin (NR: not provided) not reported, and Vitamin B12 (NR: not provided) not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from burning sensations in her neck, shoulder, spine that travels to legs and arms, head and worst at night when lying down, feeling sick, muscles are falling apart inside of me/the pain the patient is experiencing, and cannot hold anything and everything is heavy, and the outcome of bad headache, jerky movements, bulged discs, shoulder injury and back injury was not reported. This report was non-serious.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Endoscopy, HIV infection, Haemoglobin, Headache, Impaired work ability
Clinical narrative: BACK INJURY; SHOULDER INJURY; BULGED DISCS; BURNING SENSATIONS IN HER NECK, SHOULDER, SPINE THAT TRAVELS TO LEGS AND ARMS, HEAD AND WORST AT NIGHT WHEN LYING DOWN; JERKY MOVEMENTS; CANNOT HOLD ANYTHING AND EVERYTHING IS HEAVY; FEELING SICK; MUSCLES ARE FALLING APART INSIDE OF ME/THE PAIN THE PATIENT IS EXPERIENCING; BAD HEADACHE; This spontaneous report received from a patient concerned a 46 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: 1808980 expiry: 18-SEP-2021) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, the patient experienced burning sensations in her neck, shoulder, spine that travels to legs and arms, head and worst at night when lying down. On JUN-2021, the patient experienced jerky movements. On JUN-2021, the patient experienced cannot hold anything and everything is heavy. On JUN-2021, the patient experienced feeling sick. On JUN-2021, the patient experienced muscles are falling apart inside of me/the pain the patient is experiencing. On JUN-2021, the patient experienced bad headache. Treatment medications included: gabapentin. On 04-JUN-2021, the patient experienced bulged discs. On 23-JUN-2021, the patient experienced back injury. On 23-JUN-2021, the patient experienced shoulder injury. On 12-AUG-2021, Laboratory data included: C-reactive protein (NR: not provided) not reported, Colonoscopy (NR: not provided) not reported, Comprehensive metabolic panel (NR: not provided) not reported, Endoscopy (NR: not provided) not reported, Ferritin (NR: not provided) not reported, HIV infection (NR: not provided) not reported, Hemoglobin (NR: not provided) not reported, and Vitamin B12 (NR: not provided) not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from burning sensations in her neck, shoulder, spine that travels to legs and arms, head and worst at night when lying down, feeling sick, muscles are falling apart inside of me/the pain the patient is experiencing, and cannot hold anything and everything is heavy, and the outcome of bad headache, jerky movements, bulged discs, shoulder injury and back injury was not reported. This report was non-serious.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Intervertebral disc protrusion, Limb injury, Malaise, Metabolic function test, Myalgia
Clinical narrative: BACK INJURY; SHOULDER INJURY; BULGED DISCS; BURNING SENSATIONS IN HER NECK, SHOULDER, SPINE THAT TRAVELS TO LEGS AND ARMS, HEAD AND WORST AT NIGHT WHEN LYING DOWN; JERKY MOVEMENTS; CANNOT HOLD ANYTHING AND EVERYTHING IS HEAVY; FEELING SICK; MUSCLES ARE FALLING APART INSIDE OF ME/THE PAIN THE PATIENT IS EXPERIENCING; BAD HEADACHE; This spontaneous report received from a patient concerned a 46 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: 1808980 expiry: 18-SEP-2021) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, the patient experienced burning sensations in her neck, shoulder, spine that travels to legs and arms, head and worst at night when lying down. On JUN-2021, the patient experienced jerky movements. On JUN-2021, the patient experienced cannot hold anything and everything is heavy. On JUN-2021, the patient experienced feeling sick. On JUN-2021, the patient experienced muscles are falling apart inside of me/the pain the patient is experiencing. On JUN-2021, the patient experienced bad headache. Treatment medications included: gabapentin. On 04-JUN-2021, the patient experienced bulged discs. On 23-JUN-2021, the patient experienced back injury. On 23-JUN-2021, the patient experienced shoulder injury. On 12-AUG-2021, Laboratory data included: C-reactive protein (NR: not provided) not reported, Colonoscopy (NR: not provided) not reported, Comprehensive metabolic panel (NR: not provided) not reported, Endoscopy (NR: not provided) not reported, Ferritin (NR: not provided) not reported, HIV infection (NR: not provided) not reported, Hemoglobin (NR: not provided) not reported, and Vitamin B12 (NR: not provided) not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from burning sensations in her neck, shoulder, spine that travels to legs and arms, head and worst at night when lying down, feeling sick, muscles are falling apart inside of me/the pain the patient is experiencing, and cannot hold anything and everything is heavy, and the outcome of bad headache, jerky movements, bulged discs, shoulder injury and back injury was not reported. This report was non-serious.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Serum ferritin, Vitamin B12
Clinical narrative: BACK INJURY; SHOULDER INJURY; BULGED DISCS; BURNING SENSATIONS IN HER NECK, SHOULDER, SPINE THAT TRAVELS TO LEGS AND ARMS, HEAD AND WORST AT NIGHT WHEN LYING DOWN; JERKY MOVEMENTS; CANNOT HOLD ANYTHING AND EVERYTHING IS HEAVY; FEELING SICK; MUSCLES ARE FALLING APART INSIDE OF ME/THE PAIN THE PATIENT IS EXPERIENCING; BAD HEADACHE; This spontaneous report received from a patient concerned a 46 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: 1808980 expiry: 18-SEP-2021) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, the patient experienced burning sensations in her neck, shoulder, spine that travels to legs and arms, head and worst at night when lying down. On JUN-2021, the patient experienced jerky movements. On JUN-2021, the patient experienced cannot hold anything and everything is heavy. On JUN-2021, the patient experienced feeling sick. On JUN-2021, the patient experienced muscles are falling apart inside of me/the pain the patient is experiencing. On JUN-2021, the patient experienced bad headache. Treatment medications included: gabapentin. On 04-JUN-2021, the patient experienced bulged discs. On 23-JUN-2021, the patient experienced back injury. On 23-JUN-2021, the patient experienced shoulder injury. On 12-AUG-2021, Laboratory data included: C-reactive protein (NR: not provided) not reported, Colonoscopy (NR: not provided) not reported, Comprehensive metabolic panel (NR: not provided) not reported, Endoscopy (NR: not provided) not reported, Ferritin (NR: not provided) not reported, HIV infection (NR: not provided) not reported, Hemoglobin (NR: not provided) not reported, and Vitamin B12 (NR: not provided) not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from burning sensations in her neck, shoulder, spine that travels to legs and arms, head and worst at night when lying down, feeling sick, muscles are falling apart inside of me/the pain the patient is experiencing, and cannot hold anything and everything is heavy, and the outcome of bad headache, jerky movements, bulged discs, shoulder injury and back injury was not reported. This report was non-serious.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: CONFIRMED COVID-19 INFECTION; CONFIRMED CLINICAL VACCINATION FAILURE; This spontaneous report received from a health care professional concerned a 56 year old male of an unspecified race and ethnic origin. The patient's height and weight were not reported. The patient's past medical history included thymoma (removed 5 years ago followed by radiation treatment) and concurrent conditions included he had recurrent pneumonia (not related to covid but related to the thymoma), non-alcohol user, non-smoker, left lung disfunction, nerve damage on the left side (related to the thymoma) and other pre-existing medical conditions included he had no known allergies.  The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, expiry: unknown) dose was not reported, 1 total administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On AUG-2021, the patient had confirmed covid-19 infection and confirmed clinical vaccination failure. On 12-AUG-2021 he was hospitalized for Covid. The number of days hospitalized was not reported. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed clinical vaccination failure and confirmed covid-19 infection was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0-20210829316-COVID-19 Vaccine AD26.COV2.S-Confirmed Covid-19 Infection, Confirmed 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
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: ADMINISTRATION FROM PUNCTURED VIAL HELD LONGER THAN RECOMMENDED STORAGE TIME; PRODUCT STORAGE ERROR; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. 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, 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 patient experienced administration from punctured vial held longer than recommended storage time, and product storage error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration from punctured vial held longer than recommended storage time and product storage error was not reported. This report was non-serious.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dizziness, Headache, Myalgia
Clinical narrative: FEELING DIZZY; CHILLS; MUSCLE ACHES; NAUSEA; FEVER OF 103.5; SEVERE HEADACHE; This spontaneous report received from a consumer concerned a 23 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 13-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-AUG-2021, the patient experienced feeling dizzy. On 13-AUG-2021, the patient experienced chills. On 13-AUG-2021, the patient experienced muscle aches. On 13-AUG-2021, the patient experienced nausea. On 13-AUG-2021, the patient experienced fever of 103.5. On 13-AUG-2021, the patient experienced severe headache. Laboratory data included: Body temperature (NR: not provided) 103.5. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from muscle aches, nausea, fever of 103.5, chills, feeling dizzy, and severe headache. This report was non-serious.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: FEELING DIZZY; CHILLS; MUSCLE ACHES; NAUSEA; FEVER OF 103.5; SEVERE HEADACHE; This spontaneous report received from a consumer concerned a 23 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 13-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-AUG-2021, the patient experienced feeling dizzy. On 13-AUG-2021, the patient experienced chills. On 13-AUG-2021, the patient experienced muscle aches. On 13-AUG-2021, the patient experienced nausea. On 13-AUG-2021, the patient experienced fever of 103.5. On 13-AUG-2021, the patient experienced severe headache. Laboratory data included: Body temperature (NR: not provided) 103.5. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from muscle aches, nausea, fever of 103.5, chills, feeling dizzy, and severe headache. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, SARS-CoV-2 test, Therapy non-responder
Clinical narrative: SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a consumer concerned a male of an unspecified age, race and ethnic origin. 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, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient had suspected immunological vaccine failure (exposed to someone with Covid). Laboratory data included: antibody and COVID-19 virus test was negative.  The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210830362-covid-19 vaccine ad26.cov2.s-suspected immunological 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: Pyrexia, SARS-CoV-2 test, Suspected COVID-19, Vital signs measurement
Clinical narrative: TESTED POSITIVE FOR COVID-19; This spontaneous report received from a physician concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: feeling ill, felt weak, and tired. 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 10-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On AUG-2021, Laboratory data included: Fever (NR: not provided) 100.5 degree Fahrenheit, and Vital signs measurement (NR: not provided) stable. On 10-AUG-2021, the patient experienced tested positive for covid-19. On 14-AUG-2021, Laboratory data included: SARS-CoV-2 rapid diagnostic test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tested positive for covid-19 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.
Sex: F
Vaccine: COVID19
Symptoms: Sensory disturbance
Clinical narrative: MAGNET STICKING TO INJECTION SITE; This spontaneous report received from a consumer concerned a 30 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, 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 patient experienced magnet sticking to injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of magnet sticking to injection site was not reported. This report was non-serious. This case, from the same reporter is linked to 20210830342 and 20210830364.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Pain, Pyrexia, Vertigo
Clinical narrative: VERTIGO; BODY ACHES AND PAINS; FEVER; FATIGUE; MUSCLE PAIN; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included: covid-19. 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 30-JUL-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 an unspecified date, the patient experienced vertigo, body aches and pains, fever, fatigue, and muscle pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, body aches and pains, fatigue, muscle pain, and vertigo. This report was non-serious.
Age: 67.0
Sex: U
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Fall, Respiratory arrest
Clinical narrative: FELL FOR NO REASON; CHEST IS SO TIGHT ALL THE TIME; RESPIRATORY ARREST; DIFFICULTY TAKING DEEP BREATHS; This spontaneous report received from a patient concerned a 67 year old of unspecified sex, unknown race, and ethnic origin. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had severe immune IgG (Immunoglobulin G). 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, 1 total, administered on 13-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 13-MAR-2021, the patient experienced a reaction within 1 hour of receiving the vaccination. Within 40 minutes, the patient went into respiratory arrest. The patient was finally able to breathe but with a lot of difficulty. The patient had an appointment with her Physician the next day (14-MAR-2021) and since then she had been on 3 Liter oxygen 24/7. When the patient did not  realize what was going on, a couple of times the patient fell for no reason and that was because was not getting enough oxygen in her system. The patient still had difficulty taking deep breaths on the day of reporting, and her chest felt so tight all the time. The patient knew she needed the booster but did not know which one and where. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from respiratory arrest, chest is so tight all the time, and difficulty taking deep breaths, and the outcome of fell for no reason was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210830722-Covid-19 vaccine ad26.cov2.s -Respiratory arrest , Difficulty taking deep breaths. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Pyrexia
Clinical narrative: CHILLS; LOW GRADE TEMPERATURE (99.5F AND 100.8F); HEADACHE; FATIGUE; This spontaneous report received from a patient concerned a 21 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: 202A21A expiry: UNKNOWN) dose was not reported, administered on 13-AUG-2021 18:00 for prophylactic vaccination. No concomitant medications were reported.  On 14-AUG-2021, the patient experienced chills. On 14-AUG-2021, the patient experienced low grade temperature (99.5f and 100.8f). On 14-AUG-2021, the patient experienced headache. On 14-AUG-2021, the patient experienced fatigue. Laboratory data included: Body temperature (NR: not provided) 99.5 F, 100.8 F. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, low grade temperature, headache, and fatigue on 15-AUG-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Nausea, Pain, Pyrexia
Clinical narrative: FELT LIKE ABSOLUTE SHIT THE DAY AFTER VACCINATION, LIKE DEADASS. BUT DEADASS IT FELT LIKE GETTING THE FLU SHOT; BODY ACHES; HEADACHE; NAUSEA; MILD FEVERS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. 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, 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 patient experienced felt like absolute the day after vaccination, like. but it felt like getting the flu shot, body aches, headache, nausea, and mild fevers. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body aches, mild fevers, nausea, and headache, and the outcome of felt like absolute  the day after vaccination, like deadass. but  it felt like getting the flu shot was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: DIAGNOSED BLOOD CLOT; This spontaneous report received from a patient via a company representative concerned a 51year 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, batch number: Unknown, Expiry: Unknown) dose not reported, 1 total administered, 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 (within 30 days of vaccination), the patient was diagnosed with blood clot and was hospitalized (date unspecified). Duration of hospitalization was unspecified. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The outcome of diagnosed blood clot was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:  20210832291-Covid-19 vaccine ad26.cov2.s-Diagnosed Blood clot. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Hot flush, Rhinorrhoea
Clinical narrative: HOT FLASHES; RUNNY NOSE; TINNITUS; JOINT PAIN; LIGHT HEADACHES; MORE TIRED; This spontaneous report received from a consumer concerned a 69 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: 1820096 expiry: UNKNOWN) dose was not reported, administered on 06-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-AUG-2021, the patient experienced hot flashes. On 15-AUG-2021, the patient experienced runny nose. On 15-AUG-2021, the patient experienced tinnitus. On 15-AUG-2021, the patient experienced joint pain. On 15-AUG-2021, the patient experienced light headaches. On 15-AUG-2021, the patient experienced more tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the light headaches, more tired, joint pain, tinnitus, runny nose and hot flashes was not reported. This report was non-serious. This case, from the same reporter is linked to 20210832500.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: HOT FLASHES; RUNNY NOSE; TINNITUS; JOINT PAIN; LIGHT HEADACHES; MORE TIRED; This spontaneous report received from a consumer concerned a 69 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: 1820096 expiry: UNKNOWN) dose was not reported, administered on 06-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-AUG-2021, the patient experienced hot flashes. On 15-AUG-2021, the patient experienced runny nose. On 15-AUG-2021, the patient experienced tinnitus. On 15-AUG-2021, the patient experienced joint pain. On 15-AUG-2021, the patient experienced light headaches. On 15-AUG-2021, the patient experienced more tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the light headaches, more tired, joint pain, tinnitus, runny nose and hot flashes was not reported. This report was non-serious. This case, from the same reporter is linked to 20210832500.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenopia, Hernia, Impaired driving ability, Pain in extremity
Clinical narrative: HERNIA; PAIN IN THE LEFT ARM; DEBILITATING PAIN IN JOINTS PRIMARILY, THE LOWER TORSO LIKE HIPS AND BUTTOCKS; BLURRED VISION; UNCOMFORTABLE DRIVING; HEAVY FEELING IN THE EYEBALL; This spontaneous report received from a patient concerned a 72 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate sleep apnea, alcohol use, non smoker, mild hypertension, elevated cholesterol, hernia, and gastrooesophageal reflux disease, and other pre-existing medical conditions included: The patient had no known allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on 22-MAR-2021 for prophylactic vaccination. Concomitant medications included rosuvastatin for elevated cholesterol, pantoprazole for gastrooesophageal reflux disease, hydrochlorothiazide/losartan potassium for mild hypertension, and metoprolol for mild hypertension. On MAR-2021, the patient experienced blurred vision. On MAR-2021, the patient experienced uncomfortable driving. On MAR-2021, the patient experienced heavy feeling in the eyeball. On MAR-2021, the patient experienced pain in the left arm. On MAR-2021, the patient experienced debilitating pain in joints primarily, the lower torso like hips and buttocks. On an unspecified date, the patient experienced hernia. Laboratory data (dates unspecified) included: Visual acuity tests (NR: not provided) 20/20 (normal). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from debilitating pain in joints primarily, the lower torso like hips and buttocks, blurred vision, heavy feeling in the eyeball, pain in the left arm, and uncomfortable driving, and the outcome of hernia was not reported. This report was non-serious.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Vision blurred, Visual acuity tests
Clinical narrative: HERNIA; PAIN IN THE LEFT ARM; DEBILITATING PAIN IN JOINTS PRIMARILY, THE LOWER TORSO LIKE HIPS AND BUTTOCKS; BLURRED VISION; UNCOMFORTABLE DRIVING; HEAVY FEELING IN THE EYEBALL; This spontaneous report received from a patient concerned a 72 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate sleep apnea, alcohol use, non smoker, mild hypertension, elevated cholesterol, hernia, and gastrooesophageal reflux disease, and other pre-existing medical conditions included: The patient had no known allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on 22-MAR-2021 for prophylactic vaccination. Concomitant medications included rosuvastatin for elevated cholesterol, pantoprazole for gastrooesophageal reflux disease, hydrochlorothiazide/losartan potassium for mild hypertension, and metoprolol for mild hypertension. On MAR-2021, the patient experienced blurred vision. On MAR-2021, the patient experienced uncomfortable driving. On MAR-2021, the patient experienced heavy feeling in the eyeball. On MAR-2021, the patient experienced pain in the left arm. On MAR-2021, the patient experienced debilitating pain in joints primarily, the lower torso like hips and buttocks. On an unspecified date, the patient experienced hernia. Laboratory data (dates unspecified) included: Visual acuity tests (NR: not provided) 20/20 (normal). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from debilitating pain in joints primarily, the lower torso like hips and buttocks, blurred vision, heavy feeling in the eyeball, pain in the left arm, and uncomfortable driving, and the outcome of hernia was not reported. This report was non-serious.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Diarrhoea, Feeling abnormal, Gastrointestinal disorder, Headache
Clinical narrative: LOWER BACK PAIN; GASTROINTESTINAL ISSUES; DIARRHEA; PAIN AT INJECTION SITE; NAUSEA; HEADACHE; FELT YUCKY; 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 concurrent conditions included: narcolepsy, heart issues, penicillin allergy, non alcohol user, non-smoker, and sulfonamide allergy, and other pre-existing medical conditions included: The patient had no history of 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: 1820095, expiry: UNKNOWN) dose was not reported, administered on 12-AUG-2021 for prophylactic vaccination. Concomitant medications included hydrochlorothiazide for heart issues, lisinopril for heart issues, and pneumococcal vaccine polysacch 23v. On AUG-2021, treatment medications included: naproxen sodium. On 12-AUG-2021, the patient experienced felt yucky. On 12-AUG-2021, the patient experienced pain at injection site. On 12-AUG-2021, the patient experienced nausea. On 12-AUG-2021, the patient experienced headache. On 14-AUG-2021, the patient experienced gastrointestinal issues. On 14-AUG-2021, the patient experienced diarrhea. On 15-AUG-2021, the patient experienced lower back pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from gastrointestinal issues, diarrhea, pain at injection site, nausea, and headache on 15-AUG-2021, was recovering from felt yucky, and had not recovered from lower back pain. This report was non-serious.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Nausea
Clinical narrative: LOWER BACK PAIN; GASTROINTESTINAL ISSUES; DIARRHEA; PAIN AT INJECTION SITE; NAUSEA; HEADACHE; FELT YUCKY; 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 concurrent conditions included: narcolepsy, heart issues, penicillin allergy, non alcohol user, non-smoker, and sulfonamide allergy, and other pre-existing medical conditions included: The patient had no history of 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: 1820095, expiry: UNKNOWN) dose was not reported, administered on 12-AUG-2021 for prophylactic vaccination. Concomitant medications included hydrochlorothiazide for heart issues, lisinopril for heart issues, and pneumococcal vaccine polysacch 23v. On AUG-2021, treatment medications included: naproxen sodium. On 12-AUG-2021, the patient experienced felt yucky. On 12-AUG-2021, the patient experienced pain at injection site. On 12-AUG-2021, the patient experienced nausea. On 12-AUG-2021, the patient experienced headache. On 14-AUG-2021, the patient experienced gastrointestinal issues. On 14-AUG-2021, the patient experienced diarrhea. On 15-AUG-2021, the patient experienced lower back pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from gastrointestinal issues, diarrhea, pain at injection site, nausea, and headache on 15-AUG-2021, was recovering from felt yucky, and had not recovered from lower back pain. This report was non-serious.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dizziness, Fatigue, Headache
Clinical narrative: FEVER WITH TEMPERATURE OF 100.4 DEGREE FAHRENHEIT; SLIGHT DIZZINESS; CHILLS; HEADACHE; MUSCLE ACHES; FATIGUE; This spontaneous report received from a patient concerned a 19 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: 202A21A, and batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 13-AUG-2021 10:15 for prophylactic vaccination. No concomitant medications were reported. On 13-AUG-2021, the patient experienced slight dizziness. On 13-AUG-2021, the patient experienced chills. On 13-AUG-2021, the patient experienced headache. On 13-AUG-2021, the patient experienced muscle aches. On 13-AUG-2021, the patient experienced fatigue. Treatment medications included: ibuprofen, and paracetamol. On 14-AUG-2021, the patient experienced fever with temperature of 100.4 degree fahrenheit. Laboratory data included: Body temperature (NR: not provided) 100.4 F, 99.5 F, and Pain scale (NR: not provided) 4/10. Treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever with temperature of 100.4 degree fahrenheit on 15-AUG-2021, and was recovering from headache, chills, muscle aches, slight dizziness, and fatigue. This report was non-serious.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pain assessment, Pyrexia
Clinical narrative: FEVER WITH TEMPERATURE OF 100.4 DEGREE FAHRENHEIT; SLIGHT DIZZINESS; CHILLS; HEADACHE; MUSCLE ACHES; FATIGUE; This spontaneous report received from a patient concerned a 19 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: 202A21A, and batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 13-AUG-2021 10:15 for prophylactic vaccination. No concomitant medications were reported. On 13-AUG-2021, the patient experienced slight dizziness. On 13-AUG-2021, the patient experienced chills. On 13-AUG-2021, the patient experienced headache. On 13-AUG-2021, the patient experienced muscle aches. On 13-AUG-2021, the patient experienced fatigue. Treatment medications included: ibuprofen, and paracetamol. On 14-AUG-2021, the patient experienced fever with temperature of 100.4 degree fahrenheit. Laboratory data included: Body temperature (NR: not provided) 100.4 F, 99.5 F, and Pain scale (NR: not provided) 4/10. Treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever with temperature of 100.4 degree fahrenheit on 15-AUG-2021, and was recovering from headache, chills, muscle aches, slight dizziness, and fatigue. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a male patient 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: 1802072 expiry: UNKNOWN) dose was not reported, 1 total administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. In AUG-2021, the patient used the (IgG antibody test) to assess his IgG and the result was negative (confirmed immunological vaccine failure). He stated that other patients who received an mRNA vaccine get a positive test for IgG when this test was used. Laboratory data included: SARS-CoV-2 rapid antibody test (NR: not provided) Negative for IgM IgG. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210832350-COVID-19 VACCINE AD26.COV2.S-confirmed immunological 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: F
Vaccine: COVID19
Symptoms: Axillary pain, Back pain, Blood test, Chest X-ray, Mammogram
Clinical narrative: PAIN MOVED FROM CENTER OF BACK AND MOVED BACK AGAIN TO CENTER OF CHEST; PAIN GOT WORSE EVERY TIME WHILE BREATHING AND FEELS LIKE IT IS BETWEEN TOP LAYER OF SKIN AND RIBS; PAIN UNDER LEFT ARM; This spontaneous report received from a patient concerned a 73 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: disabled, and other pre-existing medical conditions included: Patient took the product as directed. Patient had no marks or lesions on skin. Patient reports that she did not fall and there is no other reason for any pain being caused. Patient did not left her apartment in 5 or 6 years. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on 23-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced pain moved from center of back and moved back again to center of chest, pain got worse every time while breathing and feels like it is between top layer of skin and ribs, and pain under left arm. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Normal, Chest X-ray (NR: not provided) Normal, Mammogram (NR: not provided) Normal, and Sonogram (NR: not provided) Normal. Treatment medications (dates unspecified) included: paracetamol/tramadol hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain under left arm, pain moved from center of back and moved back again to center of chest, and pain got worse every time while breathing and feels like it is between top layer of skin and ribs. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Painful respiration, Ultrasound scan
Clinical narrative: PAIN MOVED FROM CENTER OF BACK AND MOVED BACK AGAIN TO CENTER OF CHEST; PAIN GOT WORSE EVERY TIME WHILE BREATHING AND FEELS LIKE IT IS BETWEEN TOP LAYER OF SKIN AND RIBS; PAIN UNDER LEFT ARM; This spontaneous report received from a patient concerned a 73 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: disabled, and other pre-existing medical conditions included: Patient took the product as directed. Patient had no marks or lesions on skin. Patient reports that she did not fall and there is no other reason for any pain being caused. Patient did not left her apartment in 5 or 6 years. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on 23-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced pain moved from center of back and moved back again to center of chest, pain got worse every time while breathing and feels like it is between top layer of skin and ribs, and pain under left arm. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Normal, Chest X-ray (NR: not provided) Normal, Mammogram (NR: not provided) Normal, and Sonogram (NR: not provided) Normal. Treatment medications (dates unspecified) included: paracetamol/tramadol hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain under left arm, pain moved from center of back and moved back again to center of chest, and pain got worse every time while breathing and feels like it is between top layer of skin and ribs. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Dysstasia, Feeling abnormal, Pain in extremity, Pyrexia
Clinical narrative: COULD NOT STAND; FEEL CRAZY; CHILLS; LEG PAIN SO BAD; FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. 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, 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 patient experienced could not stand, feel crazy, chills, leg pain so bad, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from could not stand, and leg pain so bad, and the outcome of chills, fever and feel crazy was not reported. This report was non-serious.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Chills, Fatigue, Musculoskeletal pain, Nausea
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; SEVERE CHILLS; BONE AND JOINT PAIN; FEVER; NAUSEA; FATIGUE; This spontaneous report received from a patient concerned a 50 year old white female of unknown ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: high blood pressure, alcohol use once every 3 months, and non-smoker, and other pre-existing medical conditions included: the patient had no drug abuse or illicit drug usage. The patient experienced drug allergy (mild hives) when treated with omeprazole, and azithromycin.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 205A21A, and expiry: UNKNOWN) dose was not reported, frequency one total administered on right arm on 10-APR-2021 at about 10:30 for prophylactic vaccination. No concomitant medications were reported.  On the day of vaccination after 6 to 8 hours of taking vaccine, the patient experienced severe chills, fever for 12 hours, nausea and fatigue for 4 days, bone and joint pain relieved after 24 hours. On 13-AUG-2021, the patient experienced confirmed immunological vaccine failure. Laboratory data included: IgG (Immunoglobulin G), Spike protein, semi-quantitative Antibody test (NR: not provided) Negative. On an unspecified date the patient took Tylenol and Advil for fever.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe chills, bone and joint pain, and fever on 11-APR-2021, and nausea, and fatigue on 14-APR-2021, and the outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000189749.; Sender's Comments: V0:20210832418- covid-19 vaccine ad26.cov2.s -CONFIRMED IMMUNOLOGICAL 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