chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOT; This spontaneous report received from a consumer via news 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 administration was not reported, batch number: unknown) dose, start therapy date were not reported, 1 total, 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 developed a blood clot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clot was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: -Blood clot. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: POSSIBLE ADVERSE REACTION TO COVID-19 VACCINE; This spontaneous report received from a health care professional concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 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 nurse provided information regarding a patient who was admitted to the hospital with a possible adverse reaction to her COVID 19 vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of possible adverse reaction to vaccine was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0 20210450525-Covid-19 vaccine ad26.cov2.s-Possible adverse reaction to COVID 19 vaccine.. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pyrexia, Restless legs syndrome, Somnolence
Clinical narrative: RESTLESS LEG SYNDROME ON THE RIGHT LEG; SLEEPY; TIRED; BODY ACHES; FEVER; This spontaneous report received from a patient concerned a 35 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient denies having a history of restless leg syndrome. patient had 1 to 2 brief instances years ago. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: 25-MAY-2021) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 16-MAR-2021, the subject experienced body aches. On 16-MAR-2021, the subject experienced fever. On 18-MAR-2021, the subject experienced restless leg syndrome on the right leg. On 18-MAR-2021, the subject experienced sleepy. On 18-MAR-2021, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from restless leg syndrome on the right leg on 18-MAR-2021, and body aches, and fever on 16-MAR-2021, and had not recovered from sleepy, and tired. This report was non-serious.; Sender's Comments: Medical assessment comment not required as per standard operating procedure, as the case is assessed as Non-serious.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Myelitis transverse
Clinical narrative: TRANSVERSE MYELITIS; This spontaneous report received from a patient concerned a 72 year old female. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown) frequency one total, 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 transverse myelitis, a post-infectious or post-vaccine autoimmune phenomenon, in which the body's immune system mistakenly attacks the body's own tissue while responding to the infection. The patient was hospitalized (date unspecified) and the duration of hospitalization was not reported. She was still in need of medical treatment. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from transverse myelitis. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20210450559-COVID-19 VACCINE AD26.COV2.S-transverse myelitis. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: M
Vaccine: COVID19
Symptoms: Hepatic failure
Clinical narrative: LIVER IS FAILING; This spontaneous report received from a consumer via a company representative through social media 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, expiry: unknown) dose, start therapy date were not reported, 1 total administered 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. It was reported that, on an unspecified date, the patient was hospitalized and was kept in the intensive care unit (ICU), after receiving covid-19 vaccine ad26.cov2.s. His liver was failing, according to the doctors. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of liver is failing was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210450603-covid-19 vaccine ad26.cov2.s-Liver is failing. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Heart rate, Lymphadenopathy, Muscle twitching
Clinical narrative: LYMPH NODE SWELLING; MUSCLE TWITCHING; TACHYCARDIA; CHILLS; FEVER; HEADACHE; This spontaneous report received from a consumer concerned a 49 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609 and expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, Laboratory data included: Heart rate (NR: not provided) 120-130 heart rate when resting. On 01-APR-2021, the subject experienced chills. On 01-APR-2021, the subject experienced fever. On 01-APR-2021, the subject experienced headache. On 07-APR-2021, the subject experienced tachycardia. On 18-APR-2021, the subject experienced lymph node swelling. On 18-APR-2021, the subject experienced muscle twitching. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 03-APR-2021, and fever, and headache on 06-APR-2021, and was recovering from tachycardia, lymph node swelling, and muscle twitching. This report was non-serious.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tachycardia
Clinical narrative: LYMPH NODE SWELLING; MUSCLE TWITCHING; TACHYCARDIA; CHILLS; FEVER; HEADACHE; This spontaneous report received from a consumer concerned a 49 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609 and expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, Laboratory data included: Heart rate (NR: not provided) 120-130 heart rate when resting. On 01-APR-2021, the subject experienced chills. On 01-APR-2021, the subject experienced fever. On 01-APR-2021, the subject experienced headache. On 07-APR-2021, the subject experienced tachycardia. On 18-APR-2021, the subject experienced lymph node swelling. On 18-APR-2021, the subject experienced muscle twitching. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 03-APR-2021, and fever, and headache on 06-APR-2021, and was recovering from tachycardia, lymph node swelling, and muscle twitching. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal distension, Chills, Headache, Migraine, Musculoskeletal stiffness
Clinical narrative: SWELLING ABDOMEN; BODY ACHES; TIGHTNESS IN THE CALF; MIGRAINE HEADACHE; CHILLS; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported.  The patient's concurrent conditions included caller usually suffer migraine headache for about 2 days a month.  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, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021, the subject experienced swelling abdomen, body aches tightness in the calf, migraine headache, chills and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the swelling abdomen, chills, body aches, tightness in the calf, headache and migraine headache was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: SWELLING ABDOMEN; BODY ACHES; TIGHTNESS IN THE CALF; MIGRAINE HEADACHE; CHILLS; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported.  The patient's concurrent conditions included caller usually suffer migraine headache for about 2 days a month.  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, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021, the subject experienced swelling abdomen, body aches tightness in the calf, migraine headache, chills and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the swelling abdomen, chills, body aches, tightness in the calf, headache and migraine headache was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Joint stiffness, Rash
Clinical narrative: RASH ON LEGS, BACK, CHEST AND STOMACH; ACHY JOINTS; STIFF JOINTS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced stiff joints. On APR-2021, the subject experienced achy joints. On 15-APR-2021, the subject experienced rash on legs, back, chest and stomach. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the rash on legs, back, chest and stomach, achy joints and stiff joints was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Computerised tomogram, Injection site reaction, Magnetic resonance imaging, Pain in extremity
Clinical narrative: STROKE/HEADACHE; BLOOD CLOT; INJECTION SITE REACTION; PAIN IN ARM; This spontaneous report received from a patient concerned a 79 year old male.  The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: UNKNOWN) dose was not reported, administered to left arm on 11-MAR-2021 for prophylactic vaccination.  No concomitant medications were reported.  On 25-MAR-2021, 2 weeks after receiving the vaccination, the patient stated his injection site on his left arm "felt horrible" "like someone was stabbing him in that joint" (both events captured as injection site reaction). The patient reported his doctors did not know what was causing this and he could not get rid of it. On an unspecified date the patient experienced headaches with one being described as going from the back of his head to his left temple, he reported not usually having headaches. The patient also experienced severe pain when moving left arm with pain worsening at night when not moving. The patient was unable to reach up to grab things.  On 24-APR-2021, the patient was taken to the hospital and was diagnosed as had a stroke. On an unspecified date results of Magnetic Resonance Imaging (MRI) were 'blood clots in the artery that goes up middle of spine and back of neck. The patient stated the results also had "right side numbness, vertigo, slurred speech". Results of Computerised Tomogram (CT) (date unspecified) were per the patient "internal carotid arteries demonstrated calcified plaque, stenosis, arteries demonstrate localized  three-four segment of left local artery". The patient was discharged on an unspecified date and had not seen his regular physician yet. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the stroke, blood clot, injection site reaction, pain in arm and headache was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0 -covid-19 vaccine ad26.cov2.s-Stroke/Blood clot. This case concerns a patient of 79 year old male. 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).
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: STROKE/HEADACHE; BLOOD CLOT; INJECTION SITE REACTION; PAIN IN ARM; This spontaneous report received from a patient concerned a 79 year old male.  The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: UNKNOWN) dose was not reported, administered to left arm on 11-MAR-2021 for prophylactic vaccination.  No concomitant medications were reported.  On 25-MAR-2021, 2 weeks after receiving the vaccination, the patient stated his injection site on his left arm "felt horrible" "like someone was stabbing him in that joint" (both events captured as injection site reaction). The patient reported his doctors did not know what was causing this and he could not get rid of it. On an unspecified date the patient experienced headaches with one being described as going from the back of his head to his left temple, he reported not usually having headaches. The patient also experienced severe pain when moving left arm with pain worsening at night when not moving. The patient was unable to reach up to grab things.  On 24-APR-2021, the patient was taken to the hospital and was diagnosed as had a stroke. On an unspecified date results of Magnetic Resonance Imaging (MRI) were 'blood clots in the artery that goes up middle of spine and back of neck. The patient stated the results also had "right side numbness, vertigo, slurred speech". Results of Computerised Tomogram (CT) (date unspecified) were per the patient "internal carotid arteries demonstrated calcified plaque, stenosis, arteries demonstrate localized  three-four segment of left local artery". The patient was discharged on an unspecified date and had not seen his regular physician yet. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the stroke, blood clot, injection site reaction, pain in arm and headache was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0 -covid-19 vaccine ad26.cov2.s-Stroke/Blood clot. This case concerns a patient of 79 year old male. 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).
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Diarrhoea, Headache, Lethargy
Clinical narrative: SORE THROAT; DIARRHEA; CHILLS; HEADACHE; FEVER OF 101.7; STILL FEELS VERY LETHARGIC; BODY ACHE; 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: 203A21A, and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, Laboratory data included: Body temperature (NR: not provided) 101.7 F. On 12-APR-2021, the subject experienced body ache. On 12-APR-2021, the subject experienced still feels very lethargic. On 12-APR-2021, the subject experienced headache. On 12-APR-2021, the subject experienced fever of 101.7. On 13-APR-2021, the subject experienced chills. On 14-APR-2021, the subject experienced sore throat. On 14-APR-2021, the subject experienced diarrhea. Treatment medications (dates unspecified) included: acetylsalicylic acid, and hydrogen peroxide. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, chills, and fever of 101.7 on 14-APR-2021, and diarrhea, was recovering from sore throat, and headache, and had not recovered from still feels very lethargic. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: SORE THROAT; DIARRHEA; CHILLS; HEADACHE; FEVER OF 101.7; STILL FEELS VERY LETHARGIC; BODY ACHE; 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: 203A21A, and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, Laboratory data included: Body temperature (NR: not provided) 101.7 F. On 12-APR-2021, the subject experienced body ache. On 12-APR-2021, the subject experienced still feels very lethargic. On 12-APR-2021, the subject experienced headache. On 12-APR-2021, the subject experienced fever of 101.7. On 13-APR-2021, the subject experienced chills. On 14-APR-2021, the subject experienced sore throat. On 14-APR-2021, the subject experienced diarrhea. Treatment medications (dates unspecified) included: acetylsalicylic acid, and hydrogen peroxide. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, chills, and fever of 101.7 on 14-APR-2021, and diarrhea, was recovering from sore throat, and headache, and had not recovered from still feels very lethargic. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Lymphadenopathy, Myalgia, Pleural effusion, Tendon pain
Clinical narrative: SWOLLEN LYMPH NODES (FOUND IT HARD TO SWALLOW); SORE TENDONS; JOINT SWELLING IN KNEES, ANKLES, AND KNUCKLES IN HANDS; PLEURAL EFFUSION (HAD A HARD TIME BREATHING AND TAKING SHALLOW BREATHS); HIVES; SORE MUSCLES; This spontaneous report received from a health care professional (parent) concerned a 34 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no history of allergies or autoimmune disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206AZ14, expiry: UNKNOWN) frequency 1 total, dose was not reported, administered on 10-APR-2021 to Left arm for prophylactic vaccination.  No concomitant medications were reported.  Patient started experiencing significant side effects about 6 days after receiving the vaccine. On 16-APR-2021 patient developed hives, swollen lymph nodes (found it hard to swallow), sore muscles, sore tendons, and joint swelling in her knees, ankles, and knuckles in her hands. All of these symptoms appeared within 1 day of each other.She went to the Emergency Department, and was subsequently hospitalized (date unspecified) for 3 days.There, she was diagnosed with pleural effusion, where she had fluid on the outside of her lungs, had a hard time breathing and was taking shallow breaths.Patient was treated with prednisone for hives in the hospital, which improved her hives. All other symptoms were still ongoing at the time of reporting. Caller also reported that the patient had  an appointment with the allergist on 29-APR-2021 (this Thursday). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from hives, had not recovered from swollen lymph nodes (found it hard to swallow), sore muscles, sore tendons, and joint swelling in knees, ankles, and knuckles in hands, and the outcome of pleural effusion (had a hard time breathing and taking shallow breaths) was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: 20210451762-covid-19 vaccine ad26.cov2.s- pleural effusion. This event(s) is considered not related. The event(s) is deemed to be scientifically implausible, i.e., there is scientific evidence against a drug/event relationship; AND there is no known class effect.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: SWOLLEN LYMPH NODES (FOUND IT HARD TO SWALLOW); SORE TENDONS; JOINT SWELLING IN KNEES, ANKLES, AND KNUCKLES IN HANDS; PLEURAL EFFUSION (HAD A HARD TIME BREATHING AND TAKING SHALLOW BREATHS); HIVES; SORE MUSCLES; This spontaneous report received from a health care professional (parent) concerned a 34 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no history of allergies or autoimmune disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206AZ14, expiry: UNKNOWN) frequency 1 total, dose was not reported, administered on 10-APR-2021 to Left arm for prophylactic vaccination.  No concomitant medications were reported.  Patient started experiencing significant side effects about 6 days after receiving the vaccine. On 16-APR-2021 patient developed hives, swollen lymph nodes (found it hard to swallow), sore muscles, sore tendons, and joint swelling in her knees, ankles, and knuckles in her hands. All of these symptoms appeared within 1 day of each other.She went to the Emergency Department, and was subsequently hospitalized (date unspecified) for 3 days.There, she was diagnosed with pleural effusion, where she had fluid on the outside of her lungs, had a hard time breathing and was taking shallow breaths.Patient was treated with prednisone for hives in the hospital, which improved her hives. All other symptoms were still ongoing at the time of reporting. Caller also reported that the patient had  an appointment with the allergist on 29-APR-2021 (this Thursday). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from hives, had not recovered from swollen lymph nodes (found it hard to swallow), sore muscles, sore tendons, and joint swelling in knees, ankles, and knuckles in hands, and the outcome of pleural effusion (had a hard time breathing and taking shallow breaths) was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: 20210451762-covid-19 vaccine ad26.cov2.s- pleural effusion. This event(s) is considered not related. The event(s) is deemed to be scientifically implausible, i.e., there is scientific evidence against a drug/event relationship; AND there is no known class effect.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID 19 INFECTION; This spontaneous report received from a patient concerned a 57 year old  male. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, codeine, demerol, NSAIDS allergy, and bananas, strawberries, carrots allergy.  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 in total administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-APR-2021, the patient had a dry cough. On 22-APR-2021, the patient started to feel sore all over. On 23-APR-2021 (Friday) night, patient had chills and fever of 101F and took Tylenol to relieve the fever. On 24-APR-2021, patient got a COVID test and it came back positive for COVID (coded suspected covid 19 infection and suspected clinical vaccination failure). On 26-APR-2021, the patient saw infectious disease specialist and received the monoclonal antibody treatment for COVID. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient 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). This case, from the same reporter is linked to 20210452164. This case is associated with product quality complaint (PQC) number 90000177846.; Sender's Comments: V0: 20210451939-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
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: BELL'S PALSY; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, 1 in total, administered on MAR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date 2021, the patients head started to hurt on one side of her face and she was in hospital because she was having a stroke but it turns out she got Bell's Palsy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of Bell's palsy was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210451954- COVID-19 VACCINE AD26.COV2.S-BELL'S PALSY. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Malaise, Nausea, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: RAPID COVID-19 TEST POSITIVE; SLIGHTLY UNDER THE WEATHER; WEAK; NAUSEOUS; This spontaneous report received from a parent concerned a 23 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 16:45 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced slightly under the weather. On 06-APR-2021, the subject experienced weak. On 06-APR-2021, the subject experienced nauseous. On 26-APR-2021, the subject experienced rapid covid-19 test positive. Laboratory data included: COVID-19 antigen test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slightly under the weather, weak, and nauseous on 07-APR-2021, and the outcome of rapid covid-19 test positive was not reported. This report was non-serious. This report was associated with product quality complaint:  The suspected product quality complaint has been confirmed to be voided (no PQC was identified within the reported complaint reported) based on the PQC evaluation/investigation performed.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Fibromyalgia, Lymph node pain, Nausea, Pain in extremity
Clinical narrative: FIBROMYALGIA EXACERBATION; SORE GLANDS AT JAW LINE; FEELING LIKE CENTRAL NERVOUS SYSTEM ON FIRE; SPINAL CORD PAIN; VERTIGO; SORE ARM; NAUSEOUS; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included fibromyalgia, atrial fibrillation, and anxiety. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: (6 or 0)43A(2or Z)(Ior1)A) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced fibromyalgia exacerbation. On APR-2021, the subject experienced sore glands at jaw line. On APR-2021, the subject experienced feeling like central nervous system on fire. On APR-2021, the subject experienced spinal cord pain. On APR-2021, the subject experienced vertigo. On APR-2021, the subject experienced sore arm. On APR-2021, the subject experienced nauseous. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vertigo, sore arm, sore glands at jaw line, feeling like central nervous system on fire, spinal cord pain, fibromyalgia exacerbation and nauseous was not reported. This report was non-serious. The Product Complaint Number was 90000177550 The suspected product quality complaint has been confirmed to be confirmed no PQC was identified within the reported complaint reported. complaint is approved for void. based on the PQC evaluation/investigation performed.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Spinal pain, Vertigo
Clinical narrative: FIBROMYALGIA EXACERBATION; SORE GLANDS AT JAW LINE; FEELING LIKE CENTRAL NERVOUS SYSTEM ON FIRE; SPINAL CORD PAIN; VERTIGO; SORE ARM; NAUSEOUS; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included fibromyalgia, atrial fibrillation, and anxiety. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: (6 or 0)43A(2or Z)(Ior1)A) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced fibromyalgia exacerbation. On APR-2021, the subject experienced sore glands at jaw line. On APR-2021, the subject experienced feeling like central nervous system on fire. On APR-2021, the subject experienced spinal cord pain. On APR-2021, the subject experienced vertigo. On APR-2021, the subject experienced sore arm. On APR-2021, the subject experienced nauseous. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vertigo, sore arm, sore glands at jaw line, feeling like central nervous system on fire, spinal cord pain, fibromyalgia exacerbation and nauseous was not reported. This report was non-serious. The Product Complaint Number was 90000177550 The suspected product quality complaint has been confirmed to be confirmed no PQC was identified within the reported complaint reported. complaint is approved for void. based on the PQC evaluation/investigation performed.
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Hepatic enzyme, Hepatic enzyme increased
Clinical narrative: ELEVATED LIVER FUNCTIONS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included auto immune hepatitis. 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 elevated liver functions. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Results not provided, and Hepatic enzyme (NR: not provided) over 1300. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of elevated liver functions was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Diarrhoea, Dizziness, Fatigue, Headache
Clinical narrative: LOSS OF APPETITE; DIARRHEA; HEADACHE; DIZZY; BODY ACHE; NAUSEA; TIRED; URINARY TRACT INFECTION; This spontaneous report received from a patient concerned an 84 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included atrial fibrillation, hypothyroidism, high cholesterol, and allergy to codeine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21, and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced urinary tract infection. On 18-APR-2021, the subject experienced body ache. On 18-APR-2021, the subject experienced tired. On 18-APR-2021, the subject experienced nausea. On 25-APR-2021, the subject experienced dizzy. On 26-APR-2021, the subject experienced diarrhea. On 26-APR-2021, the subject experienced headache. On an unspecified date, the subject experienced loss of appetite. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nausea, headache, tired, and diarrhea, and the outcome of body ache, dizzy, loss of appetite and urinary tract infection was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Urinary tract infection
Clinical narrative: LOSS OF APPETITE; DIARRHEA; HEADACHE; DIZZY; BODY ACHE; NAUSEA; TIRED; URINARY TRACT INFECTION; This spontaneous report received from a patient concerned an 84 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included atrial fibrillation, hypothyroidism, high cholesterol, and allergy to codeine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21, and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced urinary tract infection. On 18-APR-2021, the subject experienced body ache. On 18-APR-2021, the subject experienced tired. On 18-APR-2021, the subject experienced nausea. On 25-APR-2021, the subject experienced dizzy. On 26-APR-2021, the subject experienced diarrhea. On 26-APR-2021, the subject experienced headache. On an unspecified date, the subject experienced loss of appetite. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nausea, headache, tired, and diarrhea, and the outcome of body ache, dizzy, loss of appetite and urinary tract infection was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Nausea, Platelet count, Platelet count decreased, Rash
Clinical narrative: LOW PLATELET COUNT; RASH ON LEGS AND FEET WHICH SPREAD TO GROIN AND ABDOMEN; NAUSEA; This spontaneous report received from a consumer (company representative) 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, Expiry Date: UNKNOWN) dose was not reported, 1 total, administered on 10-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 19-APR-2021, the patient developed rash on legs and feet. On 20-APR-2021, the rash spread to groin and abdomen. The patient visited the Emergency Room. The patient's platelet counts were low. There was no thrombosis reported. Patient was admitted to ICU on 20-APR-2021 to investigate about the low platelet counts. On an unspecified date in APR-2021, the patient undergone an antibody test which was found to be negative. IVIG treatment was administered in ICU. The patient got discharged on the 23-APR-2021. The patient was fine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from low platelet count, rash on legs and feet which spread to groin and abdomen, and nausea on APR-2021. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210452143-Covid-19 vaccine ad26.cov2.s-Low platelet count. 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: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Fatigue, Headache, Nausea, Positron emission tomogram
Clinical narrative: UNBEARABLE HEAD POUNDING; NAUSEA; VOMITING; LOW FEVER; FATIGUE; This spontaneous report received from a patient concerned a 61 year old  adult female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805022 expiry: unknown) dose was not reported, administered on 23-MAR-2021 14:37:00 for prophylactic vaccination. No concomitant medications were reported.  On 25-MAR-2021, the subject experienced fatigue. On 27-MAR-2021, the subject experienced low fever. 100 F. On 02-APR-2021, the patient woke up at 3am with unbearable head pounding for which the patient took 2 acetaminophen even after 15 min there was no relief so she took small amount of codeine around (1/3 of a 15mg tab) after 5-10 min the patient threw both meds and experienced nausea for which she took anti-nausea tab under her tongue but that did not released her nausea. The Patient could not take her medication due to nausea and vomiting.  At 10:30 am one of her family member took her to  Hospital in  and performed CT (computerized tomography) scan and PET (positron emission tomography) scan which are normal The Patient was hospitalized for 5 hours and received IV of a steroid (unspecified), Benadryl, anti-nausea (unspecified) and (unspecified) pain medication as a treatment CT scan and PET scan was normal based on which Doctor concluded that the side effects are due to J and J vaccine. Treatment medications included: codeine, diphenhydramine hydrochloride, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from unbearable head pounding, nausea, and vomiting on 02-APR-2021, fatigue on 26-MAR-2021, and low fever on 27-MAR-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210452159-COVID-19 VACCINE AD26.COV2.S-headache. This event(s) is labeled per RSI and is therefore considered potentially related. 20210452159-COVID-19 VACCINE AD26.COV2.S-vomiting. This event(s) is considered not related. The event(s) has an unknown/unclear 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: CONMEDS-OTHER SUSPECT DRUGS
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: UNBEARABLE HEAD POUNDING; NAUSEA; VOMITING; LOW FEVER; FATIGUE; This spontaneous report received from a patient concerned a 61 year old  adult female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805022 expiry: unknown) dose was not reported, administered on 23-MAR-2021 14:37:00 for prophylactic vaccination. No concomitant medications were reported.  On 25-MAR-2021, the subject experienced fatigue. On 27-MAR-2021, the subject experienced low fever. 100 F. On 02-APR-2021, the patient woke up at 3am with unbearable head pounding for which the patient took 2 acetaminophen even after 15 min there was no relief so she took small amount of codeine around (1/3 of a 15mg tab) after 5-10 min the patient threw both meds and experienced nausea for which she took anti-nausea tab under her tongue but that did not released her nausea. The Patient could not take her medication due to nausea and vomiting.  At 10:30 am one of her family member took her to  Hospital in  and performed CT (computerized tomography) scan and PET (positron emission tomography) scan which are normal The Patient was hospitalized for 5 hours and received IV of a steroid (unspecified), Benadryl, anti-nausea (unspecified) and (unspecified) pain medication as a treatment CT scan and PET scan was normal based on which Doctor concluded that the side effects are due to J and J vaccine. Treatment medications included: codeine, diphenhydramine hydrochloride, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from unbearable head pounding, nausea, and vomiting on 02-APR-2021, fatigue on 26-MAR-2021, and low fever on 27-MAR-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210452159-COVID-19 VACCINE AD26.COV2.S-headache. This event(s) is labeled per RSI and is therefore considered potentially related. 20210452159-COVID-19 VACCINE AD26.COV2.S-vomiting. This event(s) is considered not related. The event(s) has an unknown/unclear 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: CONMEDS-OTHER SUSPECT DRUGS
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Migraine, SARS-CoV-2 test, SARS-CoV-2 test negative, Vaccination failure
Clinical narrative: CONFIRMED COVID-19 INFECTION; confirmed clinical vaccination failure; MIGRAINE; This spontaneous report received from a consumer concerned a 56 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had unknown drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072, and expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 11-MAR-2021, the subject experienced migraine. On 24-APR-2021, Laboratory data included: COVID-19 virus test negative (NR: not provided) negative. On 26-APR-2021, the subject experienced confirmed covid-19 infection. On 26-APR-2021, the subject experienced confirmed clinical vaccination failure. Laboratory data included: COVID-19 PCR test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from migraine on 13-MAR-2021, and the outcome of confirmed covid-19 infection and confirmed clinical vaccination failure was not reported. This report was non-serious. This case, from the same reporter is linked to 20210451939.; Sender's Comments: V0.20210452164-covid-19 vaccine ad26.cov2.s-confirmed clinical vaccination failure. 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).
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Headache, SARS-CoV-2 test
Clinical narrative: SHORTNESS OF BREATH; HEADACHE; This spontaneous report received from a health care professional concerned a 19 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 2U6A21A, expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination.  No concomitant medications were reported. On 19-APR-2021, the subject experienced shortness of breath. On 19-APR-2021, the subject experienced headache. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the shortness of breath and headache was not reported. 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.