chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Loss of consciousness, Palpitations, Sensory disturbance
Clinical narrative: PASSED OUT; HEART PALPITATION; SENSATION ON HEAD LIKE FLASH OF LIGHT; This spontaneous report received from a patient concerned a 40 year old female. The patient's height, weight and medical history were not reported. The patient was not pregnant at the time of reporting. The patient does not have diabetes. 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, 1 total, administered on 19-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date in JUN-2021, the patient experienced heart palpitation and passed out. It was reported that the patient heard her heart beat very fast. The patient went to emergency room (ER) and they sent her home. The patient had couple more episodes. The patient also reported that while sleeping she felt the sensation on head like flash of light. The patient's palpitation comes and goes, she feels palpitation then sensation of passing out. The patient went to ER again and she mentioned that they said nothing was wrong. In JUN-2021, electrocardiogram (EKG) performed was not normal. ER recommended the patient to go to heart doctor once she has insurance. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from passed out, and heart palpitation, and the outcome of sensation on head like flash of light was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210666494-covid-19 vaccine ad26.cov2.s-passed out. 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, COVID19
Symptoms: Fatigue
Clinical narrative: TIRED AND FATIGUE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 23-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced tired and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tired and fatigue. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue
Clinical narrative: EXTREME FATIGUE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 23-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On JUN-2021, the subject experienced extreme fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from extreme fatigue. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: VACCINE GIVEN FROM PUNCTURED VIAL THAT HAD BEEN IN THE REFRIGERATOR FOR OVER 6 HOURS; VACCINE HAD BEEN IN THE REFRIGERATOR OVER 6 HOURS; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, and expiry: 07-AUG-2021) dose was not reported, administered on 29-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 29-JUN-2021, the subject experienced vaccine given from punctured vial that had been in the refrigerator for over 6 hours. On 29-JUN-2021, the subject experienced vaccine had been in the refrigerator over 6 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine given from punctured vial that had been in the refrigerator for over 6 hours and vaccine had been in the refrigerator over 6 hours was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: CHILLS; MUSCLE ACHES; HEADACHE; FEVER; EXTREME FATIGUE; 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 subject experienced chills, muscle aches, headache, fever, and extreme fatigue. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, muscle aches, headache, fever, and extreme fatigue. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Fatigue, Headache, Vomiting
Clinical narrative: SHORTNESS OF BREATH; THROWING UP; CHILLS; FATIGUE; HEADACHE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 28-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. On 28-JUN-2021, the subject experienced shortness of breath. On 28-JUN-2021, the subject experienced throwing up. On 28-JUN-2021, the subject experienced chills. On 28-JUN-2021, the subject experienced fatigue. On 28-JUN-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shortness of breath, chills, fatigue, headache, and throwing up. 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: U
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product administration error
Clinical narrative: ADMINISTRATION ERROR / DEVIATION; INAPPROPRIATE DOSE OF VACCINE ADMINISTERED; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: 07-AUG-2021) dose was not reported, administered on 29-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-JUN-2021, the subject experienced administration error / deviation. On 29-JUN-2021, the subject experienced inappropriate dose of vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration error / deviation and inappropriate dose of vaccine administered was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; This solicited report received from a physician via JS2020-26741: a regulatory authority concerned a female of unspecified age and Unknown race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced suspected clinical vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected clinical vaccination failure was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and suspected clinical vaccination failure as possible.  This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210666881-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: U
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a patient of unspecified age, sex, race and ethnicity . The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had never got covid in the past. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown; expiry: unknown) dose was not reported, 1 total administered on 04-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested.No concomitant medications were reported. On 28-JUN-2021,after 24 days after vaccination, the patient had antibody test done and the result found to be negative screen.Patient did not have antibodies in blood against covid-19(suspected immunological vaccine failure).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210666886-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: U
Vaccine: COVID19, COVID19
Symptoms: Antibody test
Clinical narrative: SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a patient of unspecified age, sex, race and ethnicity . The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had never got covid in the past. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown; expiry: unknown) dose was not reported, 1 total administered on 04-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested.No concomitant medications were reported. On 28-JUN-2021,after 24 days after vaccination, the patient had antibody test done and the result found to be negative screen.Patient did not have antibodies in blood against covid-19(suspected immunological vaccine failure).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210666886-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: F
Vaccine: COVID19
Symptoms: 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 via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported, frequency 1 total 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 clinical vaccination failure, and experienced suspected covid-19 infection (loss of senses of taste, and loss of senses of smell). Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure and confirmed covid-19 infection was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20210666990-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: Death
Clinical narrative: DEATH; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age, race and ethnicity. 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, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient died from the vaccine due to unknown cause of death and could never got the second shot. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20210667006- JANSSEN COVID-19 VACCINE Ad26.COV2.S- Death. This event is considered unassessable. The event 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.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Neurological symptom, Pain in extremity
Clinical narrative: A LOT OF NEUROLOGICAL SYMPTOMS; ARM PAIN; DIZZINESS; FOGGINESS AND FELT REALLY BAD; This spontaneous report received from a patient concerned a 74 year old female. The patient's height, and weight were not reported.  The patient's past medical history included covid symptoms, and concurrent conditions included fibromyalgia, and various genetic based immune diseases. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: 01-MAY-2021) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-APR-2021, the subject experienced dizziness. On 08-APR-2021, the subject experienced fogginess and felt really bad. On 08-APR-2021, the subject experienced arm pain. On an unspecified date, the subject experienced a lot of neurological symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from arm pain, dizziness, fogginess and felt really bad, and a lot of neurological symptoms. This report was non-serious.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pyrexia, Tinnitus
Clinical narrative: TINNITUS; CHILLS; HEADACHE; FEVER; FATIGUE; This spontaneous report received from a patient concerned a 39 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid-19, and concurrent conditions included hypertension, and other pre-existing medical conditions included no known allergies. 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 13-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAY-2021, the subject experienced fever. On 13-MAY-2021, the subject experienced fatigue. On 14-MAY-2021, the subject experienced chills. On 14-MAY-2021, the subject experienced headache. On 19-MAY-2021, the subject experienced tinnitus. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, headache, and fever on 18-MAY-2021, and fatigue on 21-JUN-2021, and had not recovered from tinnitus. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is assessed non serious.
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: A DOSE WAS ADMINISTERED FROM THE VIAL WHICH IS OUTSIDE OF ACCEPTABLE REFRIGERATED TIME LIMITS; This spontaneous report received from a pharmacist concerned an adult male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: 07-AUG-2021) dose was not reported, administered on 29-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-JUN-2021, the subject experienced a dose was administered from the vial which is outside of acceptable refrigerated time limits. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of a dose was administered from the vial which is outside of acceptable refrigerated time limits was not reported. This report was non-serious.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Dreamy state, Fear, Hyperhidrosis, Loss of consciousness
Clinical narrative: SEIZURE; PASSED OUT; POSTURE CONTRACTED; DIAPHORETIC/ SUPER SWEATY; CONFUSED; AFRAID; IT WAS LIKE A DREAM; This spontaneous report received from a pharmacist concerned a 27 year old male. The patient's height, and weight were not reported. The patient's past medical history included chest burning, and concurrent conditions included seasonal allergy and non-alcoholic user and other pre-existing medical conditions included no previous medical history or conditions, no family history of seizures/epilepsy, no illness at the time of vaccination, no past history of similar event, no history of allergy to vaccine, drug, or food, no family history of any disease (relevant to vaccination) or allergy, no other suspected causes including co-administered vaccine(s)/risk factors. The patient had no drug abuse or brain surgery. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular and batch number: 1808609 expiry: unknown) dose was not reported, 1 total administered on JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On unspecified date in JUN-2021, Reporter stated that the patient had his head backwards, the patient posture contracted, passed out in the observe area, which was tight and small area. Reported did not see that patient fall to ground. Reporter assumes that patient must have had a fall to get from the chair to the ground when she was able to see. Reporter stated that the seizure was about 15 seconds, eyes rolled back, blank stare, eyeballs twitching, full blown seizure. Reporter stated that when patient came back, he was super sweaty, diaphoretic, and only remembers that his chest was burning prior to vaccine. Reporter mentioned that patient did not know that he passed out. Reporter stated that patient said it was like a dream and do not know how long he was out and stated that he just said his chest was burning. Reporter mentioned that the guy was afraid and did not know what happened. Patient was confused upon waking up. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from seizure, passed out and it was like a dream and the outcome of posture contracted, diaphoretic/super sweaty, confused and afraid was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20210667371-Covid 19 vaccine-Seizure, Passed out. 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: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Posture abnormal, Seizure
Clinical narrative: SEIZURE; PASSED OUT; POSTURE CONTRACTED; DIAPHORETIC/ SUPER SWEATY; CONFUSED; AFRAID; IT WAS LIKE A DREAM; This spontaneous report received from a pharmacist concerned a 27 year old male. The patient's height, and weight were not reported. The patient's past medical history included chest burning, and concurrent conditions included seasonal allergy and non-alcoholic user and other pre-existing medical conditions included no previous medical history or conditions, no family history of seizures/epilepsy, no illness at the time of vaccination, no past history of similar event, no history of allergy to vaccine, drug, or food, no family history of any disease (relevant to vaccination) or allergy, no other suspected causes including co-administered vaccine(s)/risk factors. The patient had no drug abuse or brain surgery. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular and batch number: 1808609 expiry: unknown) dose was not reported, 1 total administered on JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On unspecified date in JUN-2021, Reporter stated that the patient had his head backwards, the patient posture contracted, passed out in the observe area, which was tight and small area. Reported did not see that patient fall to ground. Reporter assumes that patient must have had a fall to get from the chair to the ground when she was able to see. Reporter stated that the seizure was about 15 seconds, eyes rolled back, blank stare, eyeballs twitching, full blown seizure. Reporter stated that when patient came back, he was super sweaty, diaphoretic, and only remembers that his chest was burning prior to vaccine. Reporter mentioned that patient did not know that he passed out. Reporter stated that patient said it was like a dream and do not know how long he was out and stated that he just said his chest was burning. Reporter mentioned that the guy was afraid and did not know what happened. Patient was confused upon waking up. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from seizure, passed out and it was like a dream and the outcome of posture contracted, diaphoretic/super sweaty, confused and afraid was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20210667371-Covid 19 vaccine-Seizure, Passed out. 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: Feeling abnormal, Headache, Nausea
Clinical narrative: FEELING AWFUL; EXTREME HEADACHE; NAUSEA; This spontaneous report received from a parent concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 22-JUN-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 JUN-2021, the subject experienced feeling awful. On JUN-2021, the subject experienced extreme headache. On JUN-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the extreme headache, nausea and feeling awful was not reported. This report was non-serious.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: REDNESS ON LEFT ARM; SWELLING ON LEFT ARM; LEFT ARM PAIN; ITCHING ON LEFT ARM SIMILAR TO ALLERGY; This spontaneous report received from a patient concerned a 54 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: Unknown) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 23-JUN-2021, the subject experienced itching on left arm similar to allergy. On 23-JUN-2021, the subject experienced left arm pain. On 29-JUN-2021, the subject experienced redness on left arm. On 29-JUN-2021, the subject experienced swelling on left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from itching on left arm, redness on left arm, swelling on left arm, and left arm pain. This report was non-serious.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal distension, Abdominal pain upper, Chills, Colonoscopy, Injection site pain
Clinical narrative: STOMACH PAINS; CHILLS WITH FREEZING SHIVERS; PAIN WHERE VACCINE WAS INJECTED; ENTIRE STOMACH FEELS BLOATED AND GASSY; This spontaneous report received from a patient concerned a 55 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included low testosterone, alcohol use, and non smoker, and other 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: 203A21A, and expiry: 07-AUG-2021) dose was not reported, administered on 23-JUN-2021 for prophylactic vaccination. Concomitant medications included testosterone for low testosterone.  On JUN-2021, the subject experienced entire stomach feels bloated and gassy. On 23-JUN-2021, the subject experienced pain where vaccine was injected. On 25-JUN-2021, the subject experienced stomach pains. On 25-JUN-2021, the subject experienced chills with freezing shivers. Laboratory data (dates unspecified) included: Colonoscopy (NR: not provided) colon twisted. Treatment medications (dates unspecified) included: simeticone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills with freezing shivers, and had not recovered from stomach pains, pain where vaccine was injected, and entire stomach feels bloated and gassy. This report was non-serious.
Age: 30.0
Sex: U
Vaccine: COVID19
Symptoms: Chills, Disturbance in attention, Fatigue, Feeling hot, Headache
Clinical narrative: REALLY SICK; TROUBLE FOCUSING; TROUBLE SLEEPING; BURNING UP; FLU-LIKE SYMPTOMS; BAD DREAMS; BODY SORENESS; CHILLS; TIREDNESS; FEVERISH; SPLITTING HEADACHE; MUSCLE PAIN; This spontaneous report received from a patient concerned a 30 year old of unspecified sex. The patient's weight was 125 pounds, and height was 67 inches. The patient's concurrent conditions included non-alcohol user, non-smoker, takes medication for transgender care - estradial/estrogen, and seasonal allergies, 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: 205A21A expiry: 07-AUG-2021) dose was not reported, administered on 29-JUN-2021 for prophylactic vaccination. Concomitant medications included estradiol. On 29-JUN-2021, the subject experienced really sick. On 29-JUN-2021, the subject experienced trouble focusing. On 29-JUN-2021, the subject experienced trouble sleeping. On 29-JUN-2021, the subject experienced burning up. On 29-JUN-2021, the subject experienced flu-like symptoms. On 29-JUN-2021, the subject experienced bad dreams. On 29-JUN-2021, the subject experienced body soreness. On 29-JUN-2021, the subject experienced chills. On 29-JUN-2021, the subject experienced tiredness. On 29-JUN-2021, the subject experienced feverish. On 29-JUN-2021, the subject experienced splitting headache. On 29-JUN-2021, the subject experienced muscle pain. Laboratory data included: Fever (NR: not provided) 101.5 - 102F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the really sick, trouble focusing, trouble sleeping, burning up, flu-like symptoms, bad dreams, body soreness, tiredness, chills, feverish, splitting headache and muscle pain was not reported. This report was non-serious.
Age: 30.0
Sex: U
Vaccine: COVID19
Symptoms: Illness, Influenza like illness, Insomnia, Myalgia, Nightmare
Clinical narrative: REALLY SICK; TROUBLE FOCUSING; TROUBLE SLEEPING; BURNING UP; FLU-LIKE SYMPTOMS; BAD DREAMS; BODY SORENESS; CHILLS; TIREDNESS; FEVERISH; SPLITTING HEADACHE; MUSCLE PAIN; This spontaneous report received from a patient concerned a 30 year old of unspecified sex. The patient's weight was 125 pounds, and height was 67 inches. The patient's concurrent conditions included non-alcohol user, non-smoker, takes medication for transgender care - estradial/estrogen, and seasonal allergies, 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: 205A21A expiry: 07-AUG-2021) dose was not reported, administered on 29-JUN-2021 for prophylactic vaccination. Concomitant medications included estradiol. On 29-JUN-2021, the subject experienced really sick. On 29-JUN-2021, the subject experienced trouble focusing. On 29-JUN-2021, the subject experienced trouble sleeping. On 29-JUN-2021, the subject experienced burning up. On 29-JUN-2021, the subject experienced flu-like symptoms. On 29-JUN-2021, the subject experienced bad dreams. On 29-JUN-2021, the subject experienced body soreness. On 29-JUN-2021, the subject experienced chills. On 29-JUN-2021, the subject experienced tiredness. On 29-JUN-2021, the subject experienced feverish. On 29-JUN-2021, the subject experienced splitting headache. On 29-JUN-2021, the subject experienced muscle pain. Laboratory data included: Fever (NR: not provided) 101.5 - 102F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the really sick, trouble focusing, trouble sleeping, burning up, flu-like symptoms, bad dreams, body soreness, tiredness, chills, feverish, splitting headache and muscle pain was not reported. This report was non-serious.
Age: 30.0
Sex: U
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: REALLY SICK; TROUBLE FOCUSING; TROUBLE SLEEPING; BURNING UP; FLU-LIKE SYMPTOMS; BAD DREAMS; BODY SORENESS; CHILLS; TIREDNESS; FEVERISH; SPLITTING HEADACHE; MUSCLE PAIN; This spontaneous report received from a patient concerned a 30 year old of unspecified sex. The patient's weight was 125 pounds, and height was 67 inches. The patient's concurrent conditions included non-alcohol user, non-smoker, takes medication for transgender care - estradial/estrogen, and seasonal allergies, 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: 205A21A expiry: 07-AUG-2021) dose was not reported, administered on 29-JUN-2021 for prophylactic vaccination. Concomitant medications included estradiol. On 29-JUN-2021, the subject experienced really sick. On 29-JUN-2021, the subject experienced trouble focusing. On 29-JUN-2021, the subject experienced trouble sleeping. On 29-JUN-2021, the subject experienced burning up. On 29-JUN-2021, the subject experienced flu-like symptoms. On 29-JUN-2021, the subject experienced bad dreams. On 29-JUN-2021, the subject experienced body soreness. On 29-JUN-2021, the subject experienced chills. On 29-JUN-2021, the subject experienced tiredness. On 29-JUN-2021, the subject experienced feverish. On 29-JUN-2021, the subject experienced splitting headache. On 29-JUN-2021, the subject experienced muscle pain. Laboratory data included: Fever (NR: not provided) 101.5 - 102F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the really sick, trouble focusing, trouble sleeping, burning up, flu-like symptoms, bad dreams, body soreness, tiredness, chills, feverish, splitting headache and muscle pain was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; 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 was not reported, 1 total administered on APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced suspected clinical vaccination failure, and suspected covid-19 infection. In an article, Patient stated to have experienced first hand what it was like to be a breakthrough case. Patient believed to be exposed at a family gathering on a holiday weekend. In patient's immediate family, patient was the only one sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210668131-covid-19 vaccine ad26.cov2.s-suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Headache, Pyrexia
Clinical narrative: COVID-19 INFECTION; COUGH; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 27 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user, and non-smoker, and other pre-existing medical conditions included no relevant medical history and no known drug allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 041A21A and expiry: UNKNOWN) dose was not reported, administered on 07-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-JUN-2021, the subject experienced cough. On 07-JUN-2021, the subject experienced fever. On 07-JUN-2021, the subject experienced headache. On 11-JUN-2021, Laboratory data included: COVID-19 (NR: not provided) Positive. On 12-JUN-2021, the subject experienced covid-19 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from covid-19 infection on 28-JUN-2021, cough on JUN-2021, fever on 10-JUN-2021, and headache on 12-JUN-2021. This report was non-serious.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Decreased appetite, Injection site pain, Pain, Pyrexia
Clinical narrative: RECTAL BLEEDING; LOSS OF APPETITE; ABDOMINAL PAIN; BODY ACHES; FEVER; INJECTION SITE SORENESS; This spontaneous report received from a consumer concerned an 18 year old female. The patient's height, and weight were not reported. The patient was not pregnant at the time of reporting and had no medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, 1 total administered on 28-JUN-2021 early afternoon to left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 28-JUN-2021, the patient experienced injection site soreness. On 29-JUN-2021, the patient experienced loss of appetite (good 12 hours without eating), abdominal pain, body aches, and fever. The patient also experienced rectal bleeding which started in the afternoon and described as bleeding every time she went; it was like having period but it was not. The patient bled pretty good amount. The patient recovered from loss of appetite and was able to eat dinner. The reporter stated that the patient was feeling pretty good except for the bleeding and that the patient had not had any treatment and had not notified the health care provider. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from loss of appetite on 29-JUN-2021, and abdominal pain, and fever on JUN-2021, was recovering from body aches, and had not recovered from injection site soreness, and rectal bleeding. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210668208-Covid-19 vaccine ad26.cov2.s - RECTAL BLEEDING . 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: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Rectal haemorrhage
Clinical narrative: RECTAL BLEEDING; LOSS OF APPETITE; ABDOMINAL PAIN; BODY ACHES; FEVER; INJECTION SITE SORENESS; This spontaneous report received from a consumer concerned an 18 year old female. The patient's height, and weight were not reported. The patient was not pregnant at the time of reporting and had no medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, 1 total administered on 28-JUN-2021 early afternoon to left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 28-JUN-2021, the patient experienced injection site soreness. On 29-JUN-2021, the patient experienced loss of appetite (good 12 hours without eating), abdominal pain, body aches, and fever. The patient also experienced rectal bleeding which started in the afternoon and described as bleeding every time she went; it was like having period but it was not. The patient bled pretty good amount. The patient recovered from loss of appetite and was able to eat dinner. The reporter stated that the patient was feeling pretty good except for the bleeding and that the patient had not had any treatment and had not notified the health care provider. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from loss of appetite on 29-JUN-2021, and abdominal pain, and fever on JUN-2021, was recovering from body aches, and had not recovered from injection site soreness, and rectal bleeding. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210668208-Covid-19 vaccine ad26.cov2.s - RECTAL BLEEDING . 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: Arthralgia, Influenza, Pain, Pain in extremity
Clinical narrative: FLU; BODY ACHE; SORE ARM; RADIATING PAIN FROM SHOULDERS AND JOINT PAIN; 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 pre-existing medical conditions included it was unknown if patient consume alcohol, smokes or had any drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced flu, body ache, sore arm, and radiating pain from shoulders and joint pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from flu, body ache, sore arm, and radiating pain from shoulders and joint pain. This report was non-serious.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, X-ray
Clinical narrative: INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 76 year old female. The patient's weight was 200 pounds, and height was 70 inches. The patient's past medical history included peripheral neuropathy, and myasthenia gravis, and concurrent conditions included non-alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug use. The patient experienced drug allergy when treated with sulfamethoxazole/trimethoprim, nitrofurantoin, and benzylpenicillin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 043A21AB, expiry: 21-JUN-2021) dose was not reported, administered on 08-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-MAY-2021, the subject experienced injection site pain. Laboratory data (dates unspecified) included: X-ray (NR: not provided) Negative X-Ray. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from injection site pain. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Cerebrovascular accident, Laboratory test
Clinical narrative: POSSIBLE STROKE; BELL'S PALSY; This spontaneous report received from a patient concerned a 46 year old female. The patient's concurrent conditions included cigarette smoker, no alcohol use, penicillin allergy, high blood pressure, and lower back pain from bone loss after menopause, and patient had no drug abuse or illicit drug usage. The patient was previously treated with ibuprofen for drug allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21a and expiry: 07-AUG-2021) dose was not reported, 1 total, administered on 01-JUN-2021 to left arm for prophylactic vaccination.  Concomitant medications included lisinopril, and oxycodone.  On 27-JUN-2021, The patient had a stroke and patient states that, mouth felt different and went to take a drink and it ran down the mouth, patient's whole right side of face was paralyzed, patient drove to the hospital and patient was scans performed in the emergency room (ER), was given a diagnosis of Bell's Palsy and a referral to a neurologist. The patient was told that a stroke could not be ruled out, and patient was not admitted to hospital and was discharged from emergency room (ER) around 1:30 am on 28-JUN-2021. The patient was contacted primary doctor and a referral for a neurologist was sent and patient was awaiting a call back with appointment information and reports symptoms have not improved including feeling the right side of face being paralyzed and being unable to close right eye. Laboratory data included: Lab test (NR: not provided) Patient willing to provide reports if requested. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from stroke and bell's palsy. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210700241-covid-19 vaccine ad26.cov2.s-possible stroke, bell's palsy. 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: Aphonia, Cough, Decreased appetite, Diarrhoea, Rhinorrhoea
Clinical narrative: DIARRHEA; COUGH; LOSS OF VOICE; LOSS OF APPETITE; RUNNY NOSE; SNEEZING; 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, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 15-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced diarrhea. On MAY-2021, the subject experienced cough. On MAY-2021, the subject experienced loss of voice. On MAY-2021, the subject experienced loss of appetite. On MAY-2021, the subject experienced runny nose. On MAY-2021, the subject experienced sneezing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea, cough, loss of voice, loss of appetite, runny nose, and sneezing. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Sneezing
Clinical narrative: DIARRHEA; COUGH; LOSS OF VOICE; LOSS OF APPETITE; RUNNY NOSE; SNEEZING; 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, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 15-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced diarrhea. On MAY-2021, the subject experienced cough. On MAY-2021, the subject experienced loss of voice. On MAY-2021, the subject experienced loss of appetite. On MAY-2021, the subject experienced runny nose. On MAY-2021, the subject experienced sneezing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea, cough, loss of voice, loss of appetite, runny nose, and sneezing. This report was non-serious.