chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, 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 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, and batch number were not reported, expiry date: unknown) dose was not reported, 1 total administered on 21-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, patient experienced really bad cold. On 04-JAN-2022, the patient tested positive for covid (confirmed clinical vaccination failure, and confirmed covid-19 infection). Laboratory data included: COVID-19 virus test (NR: not provided) Positive.  Patients antibodies were also tested. Laboratory data (dates unspecified) included: Antibody test (NR: not provided) 489. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed clinical vaccination failure and confirmed covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked. This report was associated with a product quality complaint.; Sender's Comments: V0: 20220228007-COVID-19 VACCINE AD26.COV2.S-confirmed clinical vaccination failure. 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. Therefore, this event(s) is considered not related.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Arthritis, Fatigue, Rash
Clinical narrative: ARTHRITIS WORSENED; WIPED OUT ME OUT; RASH ON BOTH ARMS; This spontaneous report received from a patient concerned a 58 year old white not Hispanic or Latino male. The patient's weight, height, and medical history were not reported. The patient was previously treated with covid-19 vaccine ad26. cov2. s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on 17-MAR-2021 for prophylactic vaccination. The patient did not experienced any issues with the primary vaccination doses of covid-19 vaccine ad26. cov2. s (dose number in series 1). The patient received booster covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 213D21A, and expiry: 11-APR-2022) dose was not reported, 1 total, administered at left arm on 10-DEC-2021 for prophylactic vaccination. No concomitant medications were reported.  It was reported that after about two weeks of booster dose (in Dec-2021), the patient had developed a rash (up both arms, especially on the left arm where the shot was administered). The patient went to PCP (primary care provider) for treatment and was prescribed on 08-FEB-2022 tacrolimus Ointment 1% apply topically twice daily, Doxepin 25mg 1 Capsule three times daily. The patient stated that rash was not resolved. The patient stated that dermatologist prescribed these medications. On an unspecified date, the patient experienced arthritis worsened, rash and wiped out me out (all events with dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash on both arms, arthritis worsened, and wiped out me out. This report was non-serious.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Pain
Clinical narrative: PAIN AFTER VACCINATION; This spontaneous report received from a patient via other company concerned a 6 decade old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: psoriatic arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on NOV-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.   Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for psoriatic arthritis. No concomitant medications were reported. On an unspecified date, the patient experienced pain after vaccination. The action taken with covid-19 vaccine ad26.cov2.s, and adalimumab was not applicable. The outcome of pain after vaccination was not reported. This report was non-serious.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Psoriatic arthropathy
Clinical narrative: PAIN AFTER VACCINATION; This spontaneous report received from a patient via other company concerned a 6 decade old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: psoriatic arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on NOV-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.   Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for psoriatic arthritis. No concomitant medications were reported. On an unspecified date, the patient experienced pain after vaccination. The action taken with covid-19 vaccine ad26.cov2.s, and adalimumab was not applicable. The outcome of pain after vaccination was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOT; This spontaneous report received from a consumer via a company representative via social media  concerned a patient of unspecified age, sex, race and ethnic origin. 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, and batch number were not reported) dose, start therapy date were not reported, 1 total was 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, after two months of vaccination, the patient died from blood clot. The reporter reported that, "A precious friend of mine died from a blood clot 2 months after and injection of your 'product'. There is no reason to take this fake vaxx". 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: V0-20220229023-covid-19 vaccine ad26.cov2.s-Blood clot. 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). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: BLOOD CLOT
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Headache, Heart rate, Malaise
Clinical narrative: HIGH BLOOD PRESSURE 180/115 MMHG; BLURRY VISION; NOT FEELING GOOD; HEADACHE; This spontaneous report received from a patient concerned a 44 year old male of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: penicillin allergy, non-smoker, and non alcohol user. The patient had no health conditions. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855190, expiry: 27-APR-2022) dose was not reported, 1 total administered on 11-FEB-2022 at about 10:00 to right arm for prophylactic vaccination. No concomitant medications were reported. On 11-FEB-2022, about 30 minutes after the vaccination, the patient's blood pressure had gone up to 180/115 mmHg and pulse rate was 125 {beats}/min. The patient also experienced blurry vision, headache, and was not feeling good. The patient wanted to know what he needed to do to lower his blood pressure. The patient was asked to contact his physician for medical advice. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blurry vision, and headache, and had not recovered from high blood pressure 180/115 mmHg, and not feeling good. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220229973-Covid-19 vaccine ad26.cov2.s-High blood pressure 180/115 mmHg. 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). Therefore, this event(s) is considered unassessable.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: HIGH BLOOD PRESSURE 180/115 MMHG; BLURRY VISION; NOT FEELING GOOD; HEADACHE; This spontaneous report received from a patient concerned a 44 year old male of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: penicillin allergy, non-smoker, and non alcohol user. The patient had no health conditions. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855190, expiry: 27-APR-2022) dose was not reported, 1 total administered on 11-FEB-2022 at about 10:00 to right arm for prophylactic vaccination. No concomitant medications were reported. On 11-FEB-2022, about 30 minutes after the vaccination, the patient's blood pressure had gone up to 180/115 mmHg and pulse rate was 125 {beats}/min. The patient also experienced blurry vision, headache, and was not feeling good. The patient wanted to know what he needed to do to lower his blood pressure. The patient was asked to contact his physician for medical advice. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blurry vision, and headache, and had not recovered from high blood pressure 180/115 mmHg, and not feeling good. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220229973-Covid-19 vaccine ad26.cov2.s-High blood pressure 180/115 mmHg. 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). Therefore, this event(s) is considered unassessable.
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: REACTIONS; This spontaneous report received from a consumer via a company representative from social media concerned multiple patients.  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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced reactions. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of reactions was not reported. This report was non-serious. This case, from the same reporter is linked to 20220230451.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: GOT SO SICK NEXT DAY AND COULDN'T MAKE IT TO WORK; This spontaneous report received from a parent 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced got so sick next day and couldn't make it to work. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of got so sick next day and couldn't make it to work was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEATH; This spontaneous report received from a consumer via social media via company representative 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 admin, and batch number were not reported) 1 total, 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.  The reporter stated that "I lost a sister to it after the vaccine". On an unspecified date, the patient died from unknown cause of death. It was unknown if autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20220230560.; Sender's Comments: V0:20220230385-Covid-19 vaccine ad26.cov2.s-Death.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). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: ADMINISTRATION OF VACCINE POST 6 HOURS AFTER FIRST PUNCTURE (OUT OF SPECIFICATION PRODUCT USE); INCORRECT PRODUCT STORAGE; This spontaneous report received from a health care professional 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: 1822811, expiry: 20-MAR-2022) dose was not reported, administered on 11-FEB-2022 for prophylactic vaccination. No concomitant medications were reported. On FEB-2022, the patient experienced incorrect product storage. On 11-FEB-2022, the patient experienced administration of vaccine post 6 hours after first puncture (out of specification product use). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of vaccine post 6 hours after first puncture (out of specification product use) and incorrect product storage was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEATH; This spontaneous report received from a consumer via a company representative from social media 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 was not reported, and batch number: unknown, expiry: unknown ) dose, 1 total, 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 death. It was unknown if autopsy was performed. On an unspecified date, the patient died from unknown cause of death. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20220230560.; Sender's Comments: V0 20220230564-COVID-19 VACCINE AD26.COV2.S-Death. 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). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEATH; This spontaneous report received from a consumer via a company representative via social media ( JnJ Corporate social media) concerned a patient of unspecified age, sex, 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, and batch number were not reported) dose was not reported, 1 total, start therapy date was 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.  After vaccination, on an unspecified date, the patient died from unknown cause of death. As per the reporter, "Lost 2 friends to covid and 1 to the vaxxing." 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). This case, from the same reporter is linked to 20220230301.; Sender's Comments: V0:20220230585-Covid-19 vaccine ad26.cov2.s-Death.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). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Bone pain, Cough, Fatigue, Joint noise
Clinical narrative: HEARING A NOISE FROM THE BONES WHEN MOVING HER LEGS WHILE GETTING UP FROM A LYING DOWN OR SEATED POSITION FOR A PERIOD OF TIME; COUGH; PAIN IN THE BONES; PAIN ALL OVER THE BODY; FEVER; PAIN IN THE MUSCLES; FEELING REALLY TIRED; NO ENERGY TO DO ANYTHING; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included: covid-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855191, expiry: UNKNOWN) dose was not reported, administered on 04-FEB-2022 10:00 for prophylactic vaccination. No concomitant medications were reported. On JUL-2020, Laboratory data included: COVID-19 virus test (NR: not provided) positive. On 14-JAN-2022, Laboratory data included: Physical examination (NR: not provided) doing very well. On 04-FEB-2022, the patient experienced pain in the bones, pain all over the body, fever, pain in the muscles, feeling really tired, and no energy to do anything. On 10-FEB-2022, the patient experienced cough. On an unspecified date, the patient experienced hearing a noise from the bones when moving her legs while getting up from a lying down or seated position for a period of time. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 06-FEB-2022, and had not recovered from cough, hearing a noise from the bones when moving her legs while getting up from a lying down or seated position for a period of time, pain in the muscles, feeling really tired, pain in the bones, pain all over the body, and no energy to do anything. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain, Physical examination, Pyrexia, SARS-CoV-2 test
Clinical narrative: HEARING A NOISE FROM THE BONES WHEN MOVING HER LEGS WHILE GETTING UP FROM A LYING DOWN OR SEATED POSITION FOR A PERIOD OF TIME; COUGH; PAIN IN THE BONES; PAIN ALL OVER THE BODY; FEVER; PAIN IN THE MUSCLES; FEELING REALLY TIRED; NO ENERGY TO DO ANYTHING; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included: covid-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855191, expiry: UNKNOWN) dose was not reported, administered on 04-FEB-2022 10:00 for prophylactic vaccination. No concomitant medications were reported. On JUL-2020, Laboratory data included: COVID-19 virus test (NR: not provided) positive. On 14-JAN-2022, Laboratory data included: Physical examination (NR: not provided) doing very well. On 04-FEB-2022, the patient experienced pain in the bones, pain all over the body, fever, pain in the muscles, feeling really tired, and no energy to do anything. On 10-FEB-2022, the patient experienced cough. On an unspecified date, the patient experienced hearing a noise from the bones when moving her legs while getting up from a lying down or seated position for a period of time. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 06-FEB-2022, and had not recovered from cough, hearing a noise from the bones when moving her legs while getting up from a lying down or seated position for a period of time, pain in the muscles, feeling really tired, pain in the bones, pain all over the body, and no energy to do anything. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse reaction
Clinical narrative: ADVERSE REACTION; 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, 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 adverse reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of adverse reaction was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Muscle twitching
Clinical narrative: REGULAR TWITCHING UNDER LEFT EYE; This spontaneous report received from a patient via a company representative via social media concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had not been sick nor had covid-19 symptoms after vaccination. 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 JUL-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On JUL-2021, the patient experienced regular twitching under left eye. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of regular twitching under left eye was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: SUFFERING AFTER EFFECTS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on JUL-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On JUL-2021, the patient experienced suffering after effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suffering after effects. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: SHINGLES BREAKOUT AFTER THE SHOT; This spontaneous report received from a consumer via social media via a company representative concerned multiple patients. 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced shingles breakout after the shot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of shingles breakout after the shot was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: MESSED UP SINCE TOOK VACCINE; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 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 messed up since took vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of messed up since took vaccine was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEATH; This spontaneous report received from a consumer via a company representative via social media concerned a patient of unspecified age, sex, 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, and batch number were not reported) dose was not reported, start therapy date was 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, as per reporter "That is was they want. These people are killing us. Lost my sister in law who was fully vaxed, lost a friend also vaxed, and an uncle who is critical fully vaxed. These people are playing you very badly. I am sorry you live in fear. I am not vaxed had covid it sucked but dr. Prescribed hydroxychlorquin and I took zinc and vitamin d3 felt great in 30 hrs".  On an unspecified date, the patient died from unknown cause of death. 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). This case, from the same reporter is linked to 20220231819 and 20220232101.; Sender's Comments: V0: 20220231552-covid-19 vaccine ad26.cov2.s-Death. 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). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Rash macular, Rash pruritic, Swelling
Clinical narrative: RED BLOTCHY RASH; ITCHY RASH ON RIGHT LEG; PROGRESSIVELY GOTTEN MORE; MOST AGGRESSIVE ITCHY RASH HAD AND IT WAS SCALDED; ITCHING; SWELLING FOR A COUPLE OF DAYS; This spontaneous report received from a patient concerned a 66 year old female. The patient's weight was 155 pounds, and height was 65 inches. The patient's concurrent conditions included: high blood pressure, angiotensin converting enzyme inhibitors allergy, and alcohol use, and other pre-existing medical conditions included: The patient had no drug abuse or illicit drug usage and patient was non-smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286 expiry: UNKNOWN) dose was not reported, administered on JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On JUN-2021, the patient experienced swelling for a couple of days.  On NOV-2021, the patient experienced itching, red blotchy rash, itchy rash on right leg, progressively gotten more, and most aggressive itchy rash had and it was scalded. Treatment medications (dates unspecified) included: prednisone, and diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swelling for a couple of days, and had not recovered from itching, red blotchy rash, itchy rash on right leg, progressively gotten more, and most aggressive itchy rash had and it was scalded. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Nervous system disorder
Clinical narrative: NEUROLOGICAL PROBLEM AFTER YOUR COVID VACCINE; 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, and batch number were not reported) 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 neurological problem after your covid vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of neurological problem after your covid vaccine was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Libido increased
Clinical narrative: HORNEY AS HELL; 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, and batch number were not reported) 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 horney as hell. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of horney as hell was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SORE ARM; This spontaneous report received from a patient via a company representative via social media concerned a 75 year old of unspecified sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received with covid-19 vaccine ad26. cov2.s (dose number in series 1) (suspension for injection, route of admin and batch number were not reported) 1 total, dose, start therapy date were not reported for prophylactic vaccination.  It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, and batch number were not reported) 1 total, 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 sore arm (dose number in series 2). It was reported that, "I got the J&J vaccine and booster. I had a sore arm but other than that no side effects. Still wear my mask and the only gathering I have is my family whom all of us got vaccinated at the same time. I am almost 75 years old and believe in being vaccinated. This virus is the worst I have seen". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sore arm was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: SHINGLES; This spontaneous report received from a consumer 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, 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 shingles. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of shingles was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: TREMORS; This spontaneous report received from a patient via a company representative from social media concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced tremors. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tremors was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: HARDER ERECTIONS/SEX LIFE HAS IMPROVED  DRAMATICALLY/SEX LIFE HAS IMPROVED  DRAMATICALLY; This spontaneous report received from a patient via a company representative from social media 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, and batch number were not reported) 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 harder erections/sex life has improved dramatically/sex life has improved dramatically. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of harder erections/sex life has improved dramatically/sex life has improved dramatically was not reported. This report was non-serious.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Nasopharyngitis
Clinical narrative: DRY COUGH; COLD; This spontaneous report received from a patient concerned a 49 year old White, Not Hispanic/Latino male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26. cov2. s (dose number in series 1) (suspension for injection, route of admin not reported and batch number: 1808609 and expiry: unknown) dose was not reported, 1 total, administered at right arm on 27-MAY-2021 for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s (dose number in series 1). The patient received booster covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 211A21a and expiry: unknown) dose was not reported, 1 total, administered at right arm on 16-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date in FEB-2022, the patient experienced dry cough and cold (all events with dose number in series 2). It was reported that patient had not been tested for covid, and suffering from cold for last week and thought dry cough was due to cold remnants but agent reporting any symptoms out of an abundance of caution. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the dry cough and cold was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Renal impairment
Clinical narrative: AFFECTED KIDNEY FUNCTION; CAUSED MY BLOOD PRESSURE TO GET REALLY HIGH; This spontaneous report received from a patient via social media via a company representative concerned a patient of unspecified age, sex, 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, and batch number were not reported) dose was not reported, 1 total, start therapy date was 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 it was reported that "Don't take it caused my blood pressure to get really high and affected my kidney function." Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) High. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the caused blood pressure to get really high and affected kidney function was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20220233866 -COVID-19 VACCINE AD26.COV2.S- Affected kidney function. 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). Therefore, this event(s) is considered unassessable.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: REAL SICK; This spontaneous report received from a consumer via a company representative via social media concerned multiple patients of unspecified age, sex, race and ethnicity. No past medical history or concurrent conditions were reported. The patients were previously received covid-19 vaccine ad26. cov2. s (unspecified manufacturer) (dose number in series 1) (suspension for injection, route of admin and batch number were not reported, expiry: unknown) dose was not reported, 1 total, administered on an unspecified date for prophylactic vaccination. It was unspecified whether patients had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s (dose number in series 1). The patients received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin and batch number were not reported, expiry: unknown) dose was not reported, 1 total, start therapy date were not reported for prophylactic vaccination. The batch numbers were not reported. Per procedure no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patients got real sick (dose number in series 2). It was reported that "every one I know that have got the booster have also got real sick after getting it". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of real sick was not reported. This report was non-serious. This case, from the same reporter is linked to 20220234001.
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: DIARRHEA; This spontaneous report received from a patient via a company representative via social media concerned a 78 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, 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 diarrhea. Treatment medications (dates unspecified) included: silver. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Injection site rash, Injection site reaction
Clinical narrative: ROUGH PATCH, RED DOTS, ITCHY AND SCRATCHING AT INJECTION SITE; RASH AT INJECTION SITE; This spontaneous report received from a patient concerned a 33 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: 211D21A, expiry: 11-APR-2022) dose was not reported, administered on 07-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-NOV-2021, the patient experienced rough patch, red dots, itchy and scratching at injection site, and rash at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash at injection site, and rough patch, red dots, itchy and scratching at injection site. This report was non-serious.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: ADMINISTRATION OF VACCINE TO AN ELEVEN YEAR OLD PATIENT; OFF LABEL USE; This spontaneous report received from a health care professional concerned an 11 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included food allergies, and asthma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855835, expiry: 27-APR-2022) dose was not reported, administered on 14-FEB-2022 for prophylactic vaccination. Concomitant medications included montelukast sodium for asthma, and procaterol hydrochloride for asthma. On 14-FEB-2022, the patient experienced administration of vaccine to an eleven year old patient, and off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of vaccine to an eleven year old patient and off label use was not reported. This report was non-serious.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore left arm) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 011A21A) for COVID-19 vaccination.     Concurrent medical conditions included Vertigo since 2018 and Blood pressure high (under control with medications Benazepril 20mg, Amlodipine 5Mg. Spironolactone 25mg). Concomitant products included BENAZEPRIL, AMLODIPINE and SPIRONOLACTONE for Blood pressure high.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced VACCINATION SITE PAIN (Sore left arm). On 11-Apr-2021, VACCINATION SITE PAIN (Sore left arm) had resolved.            No treatment medication was provided.   This case was linked to MOD-2022-480662, MOD-2022-480677 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Administration of expired dose >30 days in frigde; Product storage error; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of expired dose >30 days in frigde) and PRODUCT STORAGE ERROR (Product storage error) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045J21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of expired dose >30 days in frigde) and PRODUCT STORAGE ERROR (Product storage error). On 17-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Administration of expired dose >30 days in frigde) and PRODUCT STORAGE ERROR (Product storage error) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 02-FEB-2022, case MOD-2022-467027 became invalid as there are no identifiable patient who received the Moderna vaccine. Therefore this case will be logically deleted from the safety database.  No concomitant medication and treatment information was reported. Reporter stated that the vials were put in the refrigerator and it was only good for 30 days but it had been 60 day and were administered to patients. 30 doses were administered from 6 vials. On 29-Nov-2021 the vial was initially stored in the refrigerator. The vial did not go any temperature excursions. Date of administration of vaccine was given as: 17-DEC-2021 - 1 vial 28-DEC-2021 - 1 vial 14-JAN-2022 - 2 vial 28-JAN-2022 - 2 vial  Reporter stated that Per Moderna CMC Lot analysis, regarding dose(s) administered on 3Feb2022 at 12:45pm: Moderna cannot guarantee patients received full protection against the COVID-19 Virus.   This case was linked to MOD-2022-467053, MOD-2022-467081, MOD-2022-467090, MOD-2022-473378 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-Feb-2022: Follow-up received with added reporter's information and narrative was updated. On 04-Feb-2022: Follow up received on 08-FEB-2022 which contains no new information.