chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: INCORRECT PRODUCT STORAGE; OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a health care professional concerned a 94 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: chronic kidney disease, anemia, high cholesterol, hypertension, latex allergy, and penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 212A21A, and expiry: 21-DEC-2021) dose was not reported, administered on 07-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-OCT-2021, the patient experienced incorrect product storage. On 07-OCT-2021, the patient experienced out of specification product use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the incorrect product storage and out of specification product use was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Cerebrospinal fluid leakage, Magnetic resonance imaging spinal
Clinical narrative: SPONTANEOUS CEREBROSPINAL FLUID LEAKAGE; This spontaneous report received from a patient via other company (Pfizer) concerned a 33 year old female of unspecified race and ethic origin. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was not ill at the time of vaccination and had no known medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Z03AZIA, expiry: UNKNOWN) dose was not reported, 1 total administered on 12-APR-2021 to right arm for prophylactic vaccination. Concomitant medications included ethinylestradiol/norgestimate for birth control.  On 28-JUN-2021, the patient diagnosed with a spontaneous cerebrospinal fluid leakage (CSF leak), and was hospitalized (date unspecified). Duration of hospitalization was not reported. On 05-JUL-2021, Laboratory data included: Magnetic resonance imaging spinal (NR: not provided) abnormal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from spontaneous cerebrospinal fluid leakage. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20211029187-Covid-19 vaccine ad26.cov2.s - spontaneous cerebrospinal fluid leakage. 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: Antibody test, Arthralgia, Body temperature, Chills, Fatigue
Clinical narrative: TINGLING IN RIGHT HAND; TIREDNESS AND FATIGUE; TWO VACCINE DOSES GIVEN IN ERROR; ACHES AND PAINS ESPECIALLY IN KNEES; COLD CHILLS; LOW GRADE FEVER; MILD HEADACHE; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: alcohol user, non-smoker, high hemoglobin, and ragweed allergy, and other pre-existing medical conditions included: Patient did not have any history of drug abuse or illicit drug use. The patient never had the covid-19 virus. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A expiry: UNKNOWN, and batch number: 211A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021, and dose was not reported, administered on 24-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the patient experienced aches and pains especially in knees. On 08-APR-2021, the patient experienced cold chills. On 08-APR-2021, the patient experienced low grade fever. On 08-APR-2021, the patient experienced mild headache. Laboratory data included: Body temperature (NR: not provided) Low grade. On 24-SEP-2021, the patient experienced two vaccine doses given in error. On 13-OCT-2021, Laboratory data included: Antibody test (NR: not provided) levels were greater than 2500. On an unspecified date, the patient experienced tingling in right hand, and tiredness and fatigue. Treatment medications (dates unspecified) included: ibuprofen, mecobalamin, and magnesium. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from aches and pains especially in knees, cold chills, low grade fever, and mild headache on 08-APR-2021, and tiredness and fatigue, had not recovered from tingling in right hand, and the outcome of two vaccine doses given in error was not reported. This report was non-serious. This case, from the same reporter is linked to 20211031574.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Medication error, Paraesthesia, Pyrexia
Clinical narrative: TINGLING IN RIGHT HAND; TIREDNESS AND FATIGUE; TWO VACCINE DOSES GIVEN IN ERROR; ACHES AND PAINS ESPECIALLY IN KNEES; COLD CHILLS; LOW GRADE FEVER; MILD HEADACHE; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: alcohol user, non-smoker, high hemoglobin, and ragweed allergy, and other pre-existing medical conditions included: Patient did not have any history of drug abuse or illicit drug use. The patient never had the covid-19 virus. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A expiry: UNKNOWN, and batch number: 211A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021, and dose was not reported, administered on 24-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the patient experienced aches and pains especially in knees. On 08-APR-2021, the patient experienced cold chills. On 08-APR-2021, the patient experienced low grade fever. On 08-APR-2021, the patient experienced mild headache. Laboratory data included: Body temperature (NR: not provided) Low grade. On 24-SEP-2021, the patient experienced two vaccine doses given in error. On 13-OCT-2021, Laboratory data included: Antibody test (NR: not provided) levels were greater than 2500. On an unspecified date, the patient experienced tingling in right hand, and tiredness and fatigue. Treatment medications (dates unspecified) included: ibuprofen, mecobalamin, and magnesium. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from aches and pains especially in knees, cold chills, low grade fever, and mild headache on 08-APR-2021, and tiredness and fatigue, had not recovered from tingling in right hand, and the outcome of two vaccine doses given in error was not reported. This report was non-serious. This case, from the same reporter is linked to 20211031574.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event, Off label use, Product administered to patient of inappropriate age
Clinical narrative: HORRIBLE SIDE EFFECTS; OFF LABEL USE; VACCINE ADMINISTERED TO CHILD; This spontaneous report received from a consumer via a company representative concerned a child of unspecified age, sex, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total, 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 horrible side effects that had to be corrected by surgery, off label use, and vaccine administered to child. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the horrible side effects, off label use and vaccine administered to child was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0;20211031658-covid-19 vaccine ad26.cov2.s- Horrible side effects that had to be corrected by surgery. This event is considered unassessable. The event 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.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 37 year old female. The patient's weight was 130 pounds, and height was 67 inches. The patient's pre-existing medical conditions included: The patient was not pregnant at the time of vaccination, had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 202A21A expiry: 21-SEP-2021), 1 total, dose was not reported, administered on 17-AUG-2021 for prophylactic vaccination on left arm. No concomitant medications were reported. On SEP-2021 about a month after vaccination, the patient started experiencing achy, exhausted (flu-like symptoms) for about 2 days along with fever of 101 F. On 22-SEP-2021, the patient was tested positive for covid (confirmed clinical vaccination failure) along with loss of taste and smell (confirmed covid-19 infection). The patient did not seek medical treatment and stayed home. Laboratory data included: COVID-19 virus test (NR: not provided) Positive and Body temperature (NR: not provided) 101 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from confirmed clinical vaccination failure, and confirmed covid-19 infection. This report was serious (Other Medically Important Condition). This case was associated with regulatory authority 90000197714.; Sender's Comments: V0: 20211031819-covid-19 vaccine ad26.cov2.s-Confirmed clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Burning sensation, Fatigue, Hypoaesthesia, Increased tendency to bruise
Clinical narrative: MENSES; RASH ALL OVER BODY; PASSED OUT; VOMITING; ASTHMA ATTACK; MIGRAINE HEADACHE; FATIGUE; NUMBNESS AND TINGLING IN LOWER EXTREMITIES AND HANDS; PETEHIAE ALL OVER BODY; WAKE UP I ALL HOURS OF NIGHT; BRUISE EASILY; BURNING SENSATION IN LOWER  EXTREMITIES & HANDS; MUSCLE SPASMS IN LOWER EXTREMITIES; This spontaneous report received from a patient concerned a patient of unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient have not had menses in plus 2 years and was fine until received vaccine. 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 14-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 14-AUG-2021, 15-20 minutes after receiving the vaccination, had an asthma attack with a migraine headache, on 15-AUG-2021, had vomiting and passed out. On 17-AUG-2021, had rash all over body & menses, Haven't had menses in 2 plus years and had seen gynecologist and all tests came negative. Petechiae all over the body. Numbness and tingling in lower extremities and hands with burning sensation and Wake up all hours of night with muscle spasms in lower extremities and bruise easily, Fatigue easily. This all occurred within days of receiving the vaccine. And patient was fine until getting the vaccine. The patient reported that, ultimately have untoward life long side effects from the product that is horrific. Laboratory data (dates unspecified) included: Investigation (NR: not provided) negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the asthma attack, migraine headache, vomiting, passed out, rash all over body, menses, petechiae all over body, numbness and tingling in lower extremities and hands, muscle spasms in lower extremities, bruise easily, fatigue and burning sensation in lower extremities & hands was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211031961-Covid-19 vaccine ad26.cov2.s 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: F
Vaccine: COVID19
Symptoms: Insomnia, Investigation, Loss of consciousness, Menstrual disorder, Migraine
Clinical narrative: MENSES; RASH ALL OVER BODY; PASSED OUT; VOMITING; ASTHMA ATTACK; MIGRAINE HEADACHE; FATIGUE; NUMBNESS AND TINGLING IN LOWER EXTREMITIES AND HANDS; PETEHIAE ALL OVER BODY; WAKE UP I ALL HOURS OF NIGHT; BRUISE EASILY; BURNING SENSATION IN LOWER  EXTREMITIES & HANDS; MUSCLE SPASMS IN LOWER EXTREMITIES; This spontaneous report received from a patient concerned a patient of unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient have not had menses in plus 2 years and was fine until received vaccine. 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 14-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 14-AUG-2021, 15-20 minutes after receiving the vaccination, had an asthma attack with a migraine headache, on 15-AUG-2021, had vomiting and passed out. On 17-AUG-2021, had rash all over body & menses, Haven't had menses in 2 plus years and had seen gynecologist and all tests came negative. Petechiae all over the body. Numbness and tingling in lower extremities and hands with burning sensation and Wake up all hours of night with muscle spasms in lower extremities and bruise easily, Fatigue easily. This all occurred within days of receiving the vaccine. And patient was fine until getting the vaccine. The patient reported that, ultimately have untoward life long side effects from the product that is horrific. Laboratory data (dates unspecified) included: Investigation (NR: not provided) negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the asthma attack, migraine headache, vomiting, passed out, rash all over body, menses, petechiae all over body, numbness and tingling in lower extremities and hands, muscle spasms in lower extremities, bruise easily, fatigue and burning sensation in lower extremities & hands was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211031961-Covid-19 vaccine ad26.cov2.s 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: F
Vaccine: COVID19
Symptoms: Muscle spasms, Petechiae, Rash, Vomiting
Clinical narrative: MENSES; RASH ALL OVER BODY; PASSED OUT; VOMITING; ASTHMA ATTACK; MIGRAINE HEADACHE; FATIGUE; NUMBNESS AND TINGLING IN LOWER EXTREMITIES AND HANDS; PETEHIAE ALL OVER BODY; WAKE UP I ALL HOURS OF NIGHT; BRUISE EASILY; BURNING SENSATION IN LOWER  EXTREMITIES & HANDS; MUSCLE SPASMS IN LOWER EXTREMITIES; This spontaneous report received from a patient concerned a patient of unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient have not had menses in plus 2 years and was fine until received vaccine. 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 14-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 14-AUG-2021, 15-20 minutes after receiving the vaccination, had an asthma attack with a migraine headache, on 15-AUG-2021, had vomiting and passed out. On 17-AUG-2021, had rash all over body & menses, Haven't had menses in 2 plus years and had seen gynecologist and all tests came negative. Petechiae all over the body. Numbness and tingling in lower extremities and hands with burning sensation and Wake up all hours of night with muscle spasms in lower extremities and bruise easily, Fatigue easily. This all occurred within days of receiving the vaccine. And patient was fine until getting the vaccine. The patient reported that, ultimately have untoward life long side effects from the product that is horrific. Laboratory data (dates unspecified) included: Investigation (NR: not provided) negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the asthma attack, migraine headache, vomiting, passed out, rash all over body, menses, petechiae all over body, numbness and tingling in lower extremities and hands, muscle spasms in lower extremities, bruise easily, fatigue and burning sensation in lower extremities & hands was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211031961-Covid-19 vaccine ad26.cov2.s 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: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Asthenia, Fatigue, Feeling abnormal, Insomnia
Clinical narrative: VERTIGO; RACING HEART; ANXIETY; NOT FEELING QUITE LIKE SELF; TROUBLE SLEEPING AT NIGHT; NAUSEA; FELT TIRED; TINNITUS; NO ENERGY; 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: glaucoma, and other pre-existing medical conditions included: Patient had no pertinent medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025 expiry: 23-AUG-2021) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-APR-2021, the patient experienced vertigo. On 28-APR-2021, the patient experienced racing heart. On 28-APR-2021, the patient experienced anxiety. On 28-APR-2021, the patient experienced not feeling quite like self. On 28-APR-2021, the patient experienced trouble sleeping at night. On 28-APR-2021, the patient experienced nausea. On 28-APR-2021, the patient experienced felt tired. On 28-APR-2021, the patient experienced tinnitus. On 28-APR-2021, the patient experienced no energy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vertigo, racing heart, anxiety, not feeling quite like self, nausea, felt tired, and no energy on 23-JUN-2021, and trouble sleeping at night on 11-OCT-2021, and had not recovered from tinnitus. This report was non-serious.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Palpitations, Tinnitus, Vertigo
Clinical narrative: VERTIGO; RACING HEART; ANXIETY; NOT FEELING QUITE LIKE SELF; TROUBLE SLEEPING AT NIGHT; NAUSEA; FELT TIRED; TINNITUS; NO ENERGY; 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: glaucoma, and other pre-existing medical conditions included: Patient had no pertinent medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025 expiry: 23-AUG-2021) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-APR-2021, the patient experienced vertigo. On 28-APR-2021, the patient experienced racing heart. On 28-APR-2021, the patient experienced anxiety. On 28-APR-2021, the patient experienced not feeling quite like self. On 28-APR-2021, the patient experienced trouble sleeping at night. On 28-APR-2021, the patient experienced nausea. On 28-APR-2021, the patient experienced felt tired. On 28-APR-2021, the patient experienced tinnitus. On 28-APR-2021, the patient experienced no energy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vertigo, racing heart, anxiety, not feeling quite like self, nausea, felt tired, and no energy on 23-JUN-2021, and trouble sleeping at night on 11-OCT-2021, and had not recovered from tinnitus. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Antibody test, Illness
Clinical narrative: EXTREMELY SICK; This spontaneous report received from a consumer via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included: covid-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, 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 extremely sick. Laboratory data (dates unspecified) included: Antibody test (NR: not provided) Antibodies increase. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of extremely sick was not reported. This report was non-serious. This case, from the same reporter is linked to 20211032028.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Illness, Pyrexia
Clinical narrative: VERY SICK FOR 12 HOURS STRAIGHT; FEVER WAS AT 102 FOR A FEW HOURS; 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: Unk) dose, 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 very sick for 12 hours straight, and fever was at 102 for a few hours. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from very sick for 12 hours straight, and fever was at 102 for a few hours. This report was non-serious. This case, from the same reporter is linked to 20211031768.
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Antibody test abnormal, Drug ineffective
Clinical narrative: LACK OF EFFECT/VACCINE DID NOT WORK; LOW ANTIBODIES WHEN TESTED; This spontaneous report received from a patient concerned a male of unspecified age, race and ethnicity. Initial information was processed along with the additional information received on 15-OCT-2021. The patient's height, and weight were not reported. The patient's past medical history included: cancer, and the patient is not being treated for cancer and the patient is not using immunosuppressive therapy at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 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. On an unspecified date, the patient had performed antibody test and the results came back as low (low antibody count). The patient reports that the Janssen Covid-19 vaccine did not work (lack of effect) and the patient also states that he cannot travel due to antibody testing requirements in other countries due to his low antibodies. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the lack of effect/vaccine did not work and low antibodies when tested was not reported. This report was serious (Other Medically Important Condition). This case was associated with Product quality complaint number: 90000197727.; Sender's Comments: V0; 20211032610-COVID-19 VACCINE AD26.COV2.S-Lack of effect. This event 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 than the drug. Specifically: SPECIAL SITUATIONS.
Sex: F
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: MYOCARDITIS; This spontaneous report received from a consumer via social media 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, expiry: 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, as per reporter "Your shot gave my wife myocarditis" The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of myocarditis was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211033613-covid-19 vaccine ad26.cov2.s-myocarditis. 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: Death
Clinical narrative: DEATH; This spontaneous report received from a consumer via a company representative concerned a 35 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: Unknown and expiry: 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 consumer's lawyer's husband got the johnson and johnson shot and died days later. On 2021, the patient died from unknown cause of death. It was unknown 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: 20211033764- 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
Sex: M
Vaccine: COVID19
Symptoms: Dry skin, Pruritus, Rash
Clinical narrative: VERY DRY HANDS WITH OPEN AREAS; BODY RASH; ITCHING BODY; 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: 1805022, and expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-MAR-2021, the patient experienced itching body. On 25-MAR-2021, the patient experienced body rash. On 01-SEP-2021, the patient experienced very dry hands with open areas. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from itching body, and body rash on 29-APR-2021, and had not recovered from very dry hands with open areas. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: HAIR FALLING OUT; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, Expiry: Unknown) dose, 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 hair falling out. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of hair falling out was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: EXHAUSTION; This spontaneous report received from a consumer 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, and batch number were not reported) 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 exhaustion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of exhaustion was not reported. This report was non-serious. This case, from the same reporter is linked to 20211016208.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Blood test, Fatigue, Feeling abnormal, Physical examination
Clinical narrative: BRAIN FOG; MAJOR FATIGUE; ENERGY LEVEL NOT AT THE SAME LEVEL IT USED TO BE; This spontaneous report received from a patient concerned a 63 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: penicillin allergy, alcohol user, and non smoker, and other pre-existing medical conditions included: The patient did not have any history of drug abuse or illicit drug use. The patient experienced severe chills and shakes when treated with influenza vaccine for prophylactic vaccination.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 17-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 18-APR-2021, the patient experienced brain fog. On 18-APR-2021, the patient experienced major fatigue. On 18-APR-2021, the patient experienced energy level not at the same level it used to be. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Everything good, and Physical examination (NR: not provided) Not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from brain fog on JUN-2021, was recovering from major fatigue, and had not recovered from energy level not at the same level it used to be. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Illness
Clinical narrative: SOMETHING POPPED IN HEAD; SICK AS DOG; 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: Unk) dose, 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 17-OCT-2021, the patient experienced something popped in head. On 17-OCT-2021, the patient experienced sick as dog. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the something popped in head and sick as dog was not reported. This report was non-serious.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: RIGHT AND LEFT THIGH AND CALF PAIN, THE DISCOMFORT SUBSIDES AFTER MOVING AND WALKING A BIT, PAIN WAS TOWARDS THE FRONT AND WORSE ON THE LEFT; This spontaneous report received from a patient concerned a 70 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: non-alcohol user, and non-smoker, and other pre-existing medical conditions included: The patient had no known allergies. The patient did not have any drug abuse/illicit drug use. Patient has no medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1822809 expiry: 07-MAR-2022) dose was not reported, administered on 22-SEP-2021 for prophylactic vaccination. Concomitant medications included influenza vaccine for prophylactic vaccination. On 06-OCT-2021, the patient experienced right and left thigh and calf pain, the discomfort subsides after moving and walking a bit, pain was towards the front and worse on the left. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from right and left thigh and calf pain, the discomfort subsides after moving and walking a bit, pain was towards the front and worse on the left. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: SIDE EFFECTS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of side effects was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Polymenorrhoea
Clinical narrative: STARTED PERIOD A WEEK EARLY; 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, and batch number were not reported) dose was not reported, administered on 08-OCT-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On OCT-2021, the patient experienced started period a week early. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of started period a week early was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: BELLS PALSY; This spontaneous report received from a consumer via a company representative through social media concerned a patient of unspecified age, sex, race and ethnic origin.  The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown expiry: Unknown) dose, start therapy date were not reported, 01 total administered 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.  It was reported that, "the patient got bells palsy exactly 1 month after the J and J jab." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bells palsy was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211034768-COVID-19 VACCINE AD26.COV2.S-Bells palsy. 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.
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: FELT LIKE HAVING THE FLU; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no new changes in lifestyle within the last two weeks. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811, and expiry: 20-MAR-2022) dose was not reported, administered on 17-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-OCT-2021, the patient experienced felt like having the flu. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from felt like having the flu. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Swelling face
Clinical narrative: Cheek Redness; Cheek Swelling; A spontaneous report was received from a consumer concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events cheek swelling, cheek redness and redness. ?  The patient's medical history included dermatological fillers on an unknown date in 2014. No relevant concomitant medications were reported.???  ?  On an unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 042L20A ) intramuscularly in the right arm for prophylaxis of COVID-19 infection.?  ?  On  an unknown date,?the?patient experienced the swelling on both cheeks but predominantly on the left side (cheek) immediately following the vaccination on her right arm.?    Laboratory details was not provided.?  ?  No treatment information was provided.??  ?  Action taken with mRNA-1273 in response to the events was not reported.??  ?  The outcome of the events were resolved.; Reporter's Comments: This case concerns a patient of unknown age and gender, with a medical history of dermatological fillers, who had NS unexpected events of erythema, swelling face, and circumoral swelling.  Event onset with unknown latency after first dose of mRNA-1273. Treatment known. The "reaction went away about 30 minutes."  Events resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Insomnia, Myalgia, Neck pain
Clinical narrative: Didn't sleep hardly any; Neck hurt; Chills in the night; Arm was sore; Fever of 101.7; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Didn't sleep hardly any), NECK PAIN (Neck hurt), CHILLS (Chills in the night), MYALGIA (Arm was sore) and PYREXIA (Fever of 101.7) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Aug-2021, the patient experienced INSOMNIA (Didn't sleep hardly any), NECK PAIN (Neck hurt), CHILLS (Chills in the night), MYALGIA (Arm was sore) and PYREXIA (Fever of 101.7). At the time of the report, INSOMNIA (Didn't sleep hardly any), NECK PAIN (Neck hurt), CHILLS (Chills in the night), MYALGIA (Arm was sore) and PYREXIA (Fever of 101.7) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.7 (High) 101.7.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by the reporter.  No treatment information was provided by the reporter.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Didn't sleep hardly any; Neck hurt; Chills in the night; Arm was sore; Fever of 101.7; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Didn't sleep hardly any), NECK PAIN (Neck hurt), CHILLS (Chills in the night), MYALGIA (Arm was sore) and PYREXIA (Fever of 101.7) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Aug-2021, the patient experienced INSOMNIA (Didn't sleep hardly any), NECK PAIN (Neck hurt), CHILLS (Chills in the night), MYALGIA (Arm was sore) and PYREXIA (Fever of 101.7). At the time of the report, INSOMNIA (Didn't sleep hardly any), NECK PAIN (Neck hurt), CHILLS (Chills in the night), MYALGIA (Arm was sore) and PYREXIA (Fever of 101.7) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.7 (High) 101.7.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by the reporter.  No treatment information was provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Received 3rd dose being not eligible; This spontaneous case was reported by a physician and describes the occurrence of INCORRECT DOSE ADMINISTERED (Received 3rd dose being not eligible) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INCORRECT DOSE ADMINISTERED (Received 3rd dose being not eligible). At the time of the report, INCORRECT DOSE ADMINISTERED (Received 3rd dose being not eligible) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Lab test data included Patient did antibody test PCR test but results are not provided.  No Concomitant medication was reported. No treatment medication use was reported.  Pharmacist used 100 ul instead of the 50 original two part series.   This case was linked to MOD-2021-329821 (Patient Link).
Age: 58.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received expired second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired second dose) in a 58-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037f21a and 014F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired second dose). On 03-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received expired second dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.   This case was linked to MOD-2021-347607, MOD-2021-347368 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Oct-2021: Non-Significant follow up appended-Email ID updated
Age: 74.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received expired second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired second dose) in a 74-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037f21a and 014F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired second dose). On 01-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received expired second dose) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications was reported. Treatment information was not provided.  This case was linked to MOD-2021-347607, MOD-2021-347368 (Patient Link).
Age: 55.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received expired second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired second dose) in a 55-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014F21A and 037f21a) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired second dose). On 01-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received expired second dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported. No treatment information was provided.  The patient received expired second dose.   This case was linked to MOD-2021-347607, MOD-2021-346406, MOD-2021-346347, MOD-2021-346608, MOD-2021-346268, MOD-2021-347607, MOD-2021-346421, MOD-2021-347067, MOD-2021-347112, MOD-2021-346981 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Oct-2021: Follow-up information includes reporter email id.