chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood test, Colonoscopy, Decreased appetite, Diverticulitis
Clinical narrative: DIVERTICULITIS; ULCER; LOST APPETITE; FELT BAD; LOST WEIGHT; BODY  NUMBNESS; BODY WEAKNESS/NO ENERGY; TERRIBLE FATIGUE; This spontaneous report received from a patient concerned an 80 year old female. The patient's weight was 100 pounds, and height was 60 inches. The patient's past medical history included: gastric bypass(has been on vitamins for it unspecified) could not raise arm in 1960 after giving birth was unable raise her arm until a doctor suggested vitamins and patient felt better within 2 weeks, and concurrent conditions included: non-smoker, non-alcoholic, tree allergy, atrial fibrillation, asthma, thyroid deficiency(on thyroid medications), cholesterol issue, and patient had one arm only, lost one arm due to bone cancer. Patient experienced sensitivity to oven cleaner,(which had difficulty breathing and ended up in the hospital and her asthma symptoms started from that point). Patient had no known drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: 18-SEP-2021) dose was not reported,1 in total, administered on 01-APR-2021 for prophylactic vaccination on right arm. Concomitant medications included metoprolol and rivaroxaban for atrial fibrillation. On 22-APR-2021, 3 weeks after receiving the vaccine, the patient felt bad with no energy, terrible fatigue and body weakness and numbness and patient also lost appetite, lost weight and contacted doctor because patient thought that was cancer. Patient primary care physician did blood work and checked everything and it were okay. Primary care physician sent patient for colonoscopy in which it was detected patient had diverticulitis and ulcer that physician addressed. The patient indicated that patient was feeling better(at least 50% better).  Laboratory data included: Weight (NR: not provided) decreased, Blood work (NR: not provided) was okay, and Colonoscopy (NR: not provided) diverticulitis and ulcer. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lost appetite, and lost weight, and was recovering from felt bad, terrible fatigue, body weakness/no energy, diverticulitis, ulcer, and body numbness. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211045982-Covid-19 vaccine ad26.cov2.s-Diverticulitis. 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: Fatigue, Feeling abnormal, Hypoaesthesia, Ulcer, Weight
Clinical narrative: DIVERTICULITIS; ULCER; LOST APPETITE; FELT BAD; LOST WEIGHT; BODY  NUMBNESS; BODY WEAKNESS/NO ENERGY; TERRIBLE FATIGUE; This spontaneous report received from a patient concerned an 80 year old female. The patient's weight was 100 pounds, and height was 60 inches. The patient's past medical history included: gastric bypass(has been on vitamins for it unspecified) could not raise arm in 1960 after giving birth was unable raise her arm until a doctor suggested vitamins and patient felt better within 2 weeks, and concurrent conditions included: non-smoker, non-alcoholic, tree allergy, atrial fibrillation, asthma, thyroid deficiency(on thyroid medications), cholesterol issue, and patient had one arm only, lost one arm due to bone cancer. Patient experienced sensitivity to oven cleaner,(which had difficulty breathing and ended up in the hospital and her asthma symptoms started from that point). Patient had no known drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: 18-SEP-2021) dose was not reported,1 in total, administered on 01-APR-2021 for prophylactic vaccination on right arm. Concomitant medications included metoprolol and rivaroxaban for atrial fibrillation. On 22-APR-2021, 3 weeks after receiving the vaccine, the patient felt bad with no energy, terrible fatigue and body weakness and numbness and patient also lost appetite, lost weight and contacted doctor because patient thought that was cancer. Patient primary care physician did blood work and checked everything and it were okay. Primary care physician sent patient for colonoscopy in which it was detected patient had diverticulitis and ulcer that physician addressed. The patient indicated that patient was feeling better(at least 50% better).  Laboratory data included: Weight (NR: not provided) decreased, Blood work (NR: not provided) was okay, and Colonoscopy (NR: not provided) diverticulitis and ulcer. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lost appetite, and lost weight, and was recovering from felt bad, terrible fatigue, body weakness/no energy, diverticulitis, ulcer, and body numbness. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211045982-Covid-19 vaccine ad26.cov2.s-Diverticulitis. 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: Weight decreased
Clinical narrative: DIVERTICULITIS; ULCER; LOST APPETITE; FELT BAD; LOST WEIGHT; BODY  NUMBNESS; BODY WEAKNESS/NO ENERGY; TERRIBLE FATIGUE; This spontaneous report received from a patient concerned an 80 year old female. The patient's weight was 100 pounds, and height was 60 inches. The patient's past medical history included: gastric bypass(has been on vitamins for it unspecified) could not raise arm in 1960 after giving birth was unable raise her arm until a doctor suggested vitamins and patient felt better within 2 weeks, and concurrent conditions included: non-smoker, non-alcoholic, tree allergy, atrial fibrillation, asthma, thyroid deficiency(on thyroid medications), cholesterol issue, and patient had one arm only, lost one arm due to bone cancer. Patient experienced sensitivity to oven cleaner,(which had difficulty breathing and ended up in the hospital and her asthma symptoms started from that point). Patient had no known drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: 18-SEP-2021) dose was not reported,1 in total, administered on 01-APR-2021 for prophylactic vaccination on right arm. Concomitant medications included metoprolol and rivaroxaban for atrial fibrillation. On 22-APR-2021, 3 weeks after receiving the vaccine, the patient felt bad with no energy, terrible fatigue and body weakness and numbness and patient also lost appetite, lost weight and contacted doctor because patient thought that was cancer. Patient primary care physician did blood work and checked everything and it were okay. Primary care physician sent patient for colonoscopy in which it was detected patient had diverticulitis and ulcer that physician addressed. The patient indicated that patient was feeling better(at least 50% better).  Laboratory data included: Weight (NR: not provided) decreased, Blood work (NR: not provided) was okay, and Colonoscopy (NR: not provided) diverticulitis and ulcer. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lost appetite, and lost weight, and was recovering from felt bad, terrible fatigue, body weakness/no energy, diverticulitis, ulcer, and body numbness. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211045982-Covid-19 vaccine ad26.cov2.s-Diverticulitis. 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: COVID-19, SARS-CoV-2 test positive
Clinical narrative: CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 52 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: the patient was not pregnant at the time of report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 04-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 23-MAR-2021, the patient experienced confirmed covid-19 infection. On 26-MAR-2021, Laboratory data included: COVID-19 virus test positive (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed covid-19 infection was not reported. This report was non-serious. This report was associated with product quality complaint number: 90000198938 The suspected product quality complaint has been confirmed to be voided (this record indicates a medical adverse event for the patient. while a positive covid test result was received after vaccination, insufficient time had elapsed for immunity to develop) based on the PQC evaluation/investigation performed.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious
Sex: U
Vaccine: COVID19
Symptoms: Epilepsy
Clinical narrative: EPILEPSY HAS INCREASED/EPILEPTIC SEIZURE; This spontaneous report received from a patient 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. The patient's concurrent conditions included: epilepsy. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose and start therapy date were not reported, 1 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.  On an unspecified date, the patient reported that her epilepsy had increased and had an epileptic seizure recently that had caused compression fractures. It was also reported that the patient could not get the booster shot. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of epilepsy has increased/epileptic seizure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211046186-COVID-19 VACCINE AD26.COV2.S-Epilepsy has increased/ epileptic seizure. 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: U
Vaccine: COVID19
Symptoms: Incorrect dose administered, Syringe issue
Clinical narrative: PART OF THE VACCINE CONTENT SPILLED OUT BECAUSE THE SYRINGE WAS NOT FIRM; THE AMOUNT OF VACCINE ADMINISTERED WAS UNKNOWN; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 23-OCT-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 23-OCT-2021, the patient experienced part of the vaccine content spilled out because the syringe was not firm. On 23-OCT-2021, the patient experienced and the amount of vaccine administered was unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the and the amount of vaccine administered was unknown and part of the vaccine content spilled out because the syringe was not firm was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Liver disorder, Pancreatic disorder, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; CONTRACTED COVID-19; PROBLEMS WITH LIVER AFTER TAKING JANSSEN COVID 19 VACCINE; PROBLEMS WITH PANCREAS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, sex, race and ethnicity. Initial information was processed along with the additional information received on 25-OCT-2021 and 26-OCT-2021. 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, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient had problems with liver after taking the Janssen Covid-19 vaccine and problems with pancreas. The patient also claimed that the vaccine was not effective as patient contracted Covid-19 (suspected clinical vaccination failure, suspected Covid-19). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the problems with liver after taking Janssen Covid-19 vaccine, problems with pancreas, contracted covid-19 and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000198940.; Sender's Comments: V0: 20211047596-Covid-19 vaccine ad26.cov2.s- Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DIED DAYS AFTER THE SHOT; This spontaneous report received from a consumer via a company representative concerned a 35 year old male with unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was healthy and an Olympian. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported,1 total, start therapy date was not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient died days after the shot and 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: 20211048841-Covid-19 vaccine ad26.cov2.s-Died days after the shot. 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).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: F
Vaccine: COVID19
Symptoms: Arthropathy, Neuropathy peripheral
Clinical narrative: NEUROPATHY; SHOULDER WAS NOT NORMAL; This spontaneous report received from a patient 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. The patient's pre-existing medical conditions included: Patient was a power lifter before the 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, 1 total, administered on an unspecified date in AUG-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced neuropathy. Patient stated that as per neurologist, neuropathy was not listed under the side effects of vaccination. Patient reported that no one was knowing that if her shoulder would get back to normal or not.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shoulder was not normal, and the outcome of neuropathy was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000199077.; Sender's Comments: V0:20211048891-covid-19 vaccine ad26.cov2.s-Neuropathy- 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: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTERED EXPIRED VACCINE; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286, expiry: 21-OCT-2021) dose was not reported, administered on 25-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-OCT-2021, the patient experienced administered expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administered expired vaccine was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Periorbital swelling, Rash pruritic, Skin discolouration
Clinical narrative: SKIN RASHES THAT BRUISED UP; BIG DARK RED CIRCLES SPOTS ALL OVER BODY (ITCHY, PAINFUL AND BURNING SPOTS ON HANDS, LEGS, ARMS AND PRIVATE PARTS AND THE SPOTS APPEAR FLAT (NOT RAISED)/RED SPOTS ON HANDS AND FINGERS/SKIN RASH; SWELLING AROUND EYES; ITCHY, PAINFUL, AND BURNING DARK PURPLE SPOTS UNDER THE SKIN ALL OVER THE BODY; This spontaneous report received from a consumer via a company representative concerned a 38 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no prior medical history and no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286, and expiry: 21-OCT-2021) dose was not reported, administered on 07-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 20-JUN-2021, the patient experienced swelling around eyes. On 20-JUN-2021, the patient experienced itchy, painful, and burning dark purple spots under the skin all over the body. On 20-JUN-2021, the patient experienced big dark red circles spots all over body (itchy, painful and burning spots on hands, legs, arms and private parts and the spots appear flat (not raised) /red spots on hands and fingers/skin rash. On an unspecified date, the patient experienced skin rashes that bruised up. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swelling around eyes, big dark red circles spots all over body (itchy, painful and burning spots on hands, legs, arms and private parts and the spots appear flat (not raised)/red spots on hands and fingers/skin rash, and itchy, painful, and burning dark purple spots under the skin all over the body, and the outcome of skin rashes that bruised up was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF AN EXPIRED VACCINE; This spontaneous report received from a health care professional 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 not reported, batch number: 201A21A expiry: 21-SEP-2021) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced administration of an expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of an expired vaccine was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Poor quality product administered, Product storage error
Clinical narrative: INCORRECT PRODUCT STORAGE; OUT OF SPECIFICATION PRODUCT USE; ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional 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 not reported, batch number: 1816027, and expiry: 29-SEP-2021) dose was not reported, administered on 04-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-OCT-2021, the patient experienced administration of expired vaccine. On 04-OCT-2021, the patient experienced out of specification product use. On an unspecified date, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of expired vaccine, incorrect product storage and out of specification product use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211049577, 20211049738 and 20211049203.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Limb discomfort
Clinical narrative: SORE ARM, ARM NOT PAINFUL, FEELS DISCOMFORT AND AWARENESS, EXPERIENCES SORENESS; This spontaneous report received from a patient concerned a 70 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: 1808609, expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the patient experienced sore arm, arm not painful, feels discomfort and awareness, experiences soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sore arm, arm not painful, feels discomfort and awareness, experiences soreness. This report was non-serious. This case, from the same reporter is linked to 20211049491  .
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816027 and expiry: 29-SEP-2021) dose was not reported, administered on 06-OCT-2021 for prophylactic vaccination. No concomitant medications were reported.  On 06-OCT-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20211049577, 20211049738 and 20211049134.
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: AN UNEVALUABLE EVENT; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose, start therapy date were not reported, 1 total was administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported.  On an unspecified date, the patient experienced an unevaluable event, and had to be hospitalized. It was got so bad that patient had been relocated an hour and a half away to a bigger, more adequate hospital. Number of days hospitalized and discharge information was not reported. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of an unevaluable event was not reported. This report was serious (Hospitalization Caused / Prolonged). This case, from the same reporter was linked to 20211045102.; Sender's Comments: V0:20211049317-COVID-19 VACCINE AD26.COV2.S-An unevaluable event. 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: Laboratory test, Peripheral swelling
Clinical narrative: SWELLING IN LOWER LEGS; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported 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 swelling in lower legs. Laboratory data (dates unspecified) included: Lab test (NR: not provided) no blood clot in legs and lungs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swelling in lower legs. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: HAIR FALLING OUT; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. 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: Pyrexia
Clinical narrative: FEVER; This spontaneous report received from a health care professional 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 (suspension for injection, route of admin not reported, batch number: 1808609 expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced fever. Treatment medications (dates unspecified) included: naproxen sodium. The action taken with covid-19 vaccine was not applicable. The patient recovered from fever. This report was non-serious. This case, from the same reporter is linked to 20211049191.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional 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  (suspension for injection, route of admin not reported, batch number: 1816027, and expiry: 29-SEP-2021) dose was not reported, administered on 30-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 30-SEP-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine  was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20211049203, 20211049134 and 20211049738.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: 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 (suspension for injection, route of admin not reported, batch number: 1822811, expiry: 20-MAR-2022) dose was not reported, administered on 21-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On OCT-2021, the patient experienced incorrect product storage. On 21-OCT-2021, the patient experienced out of specification product use. The action taken with covid-19 vaccine  was not applicable. The outcome of the out of specification product use and incorrect product storage was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Hypokinesia
Clinical narrative: CAN NOT MOVE LEFT ARM; This spontaneous report received from a patient 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 was not reported, administered on JUN-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced can not move left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from can not move left arm. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Secretion discharge
Clinical narrative: SEVERE REACTION OF MUCUS BUILD ON BRAIN; 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  (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. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced severe reaction of mucus build on brain. Laboratory data (dates unspecified) included: MRI (NR: not provided) Unknown. The action taken with covid-19 vaccine  was not applicable. The outcome of severe reaction of mucus build on brain was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional 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: 1816027, expiry: 29-SEP-2021) dose was not reported, administered on 06-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-OCT-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20211049134, 20211049203 and 20211049577.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Injection site haematoma, Pain
Clinical narrative: ACHINESS; HEMATOMA AT INJECTION SITE; JOINT PAIN; CHILLS; FATIGUE; LOW GRADE FEVER; This spontaneous report received from a patient concerned an 82 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: 23-AUG-2021) dose was not reported, administered on 04-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 04-MAR-2021, the patient experienced achiness. On 04-MAR-2021, the patient experienced hematoma at injection site. On 04-MAR-2021, the patient experienced joint pain. On 04-MAR-2021, the patient experienced chills. On 04-MAR-2021, the patient experienced fatigue. On 04-MAR-2021, the patient experienced low grade fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from achiness, joint pain, chills, fatigue, and low grade fever on 06-MAR-2021, and hematoma at injection site on 25-MAR-2021. This report was non-serious.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: ACHINESS; HEMATOMA AT INJECTION SITE; JOINT PAIN; CHILLS; FATIGUE; LOW GRADE FEVER; This spontaneous report received from a patient concerned an 82 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: 23-AUG-2021) dose was not reported, administered on 04-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 04-MAR-2021, the patient experienced achiness. On 04-MAR-2021, the patient experienced hematoma at injection site. On 04-MAR-2021, the patient experienced joint pain. On 04-MAR-2021, the patient experienced chills. On 04-MAR-2021, the patient experienced fatigue. On 04-MAR-2021, the patient experienced low grade fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from achiness, joint pain, chills, fatigue, and low grade fever on 06-MAR-2021, and hematoma at injection site on 25-MAR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: SOME REACTIONS FROM VACCINE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced some reactions from vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of some reactions from vaccine was not reported. This report was non-serious.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: VIAL WAS PUNCTURED AND LEFT OVERNIGHT (OVER 6 HOURS); This spontaneous report received from a pharmacist concerned a 57 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 211A21A, and expiry: 14-DEC-2021) dose was not reported, administered on 25-OCT-2021 11:40 for prophylactic vaccination. No concomitant medications were reported. On 25-OCT-2021, the patient experienced vial was punctured and left overnight (over 6 hours). The action taken with covid-19 vaccine  was not applicable. The outcome of vial was punctured and left overnight (over 6 hours) was not reported. This report was non-serious. This case, from the same reporter is linked to 20211050252.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dehydration, Headache, Lethargy
Clinical narrative: BODY ACHES; SEVERE FATIGUE OR LETHARGY; FELT DEHYDRATED; SEVERE CHILLS OR SHAKING; HEADACHE; FEVER; 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 pre-existing medical conditions included: The patient did not really had a medical history. The patient received covid-19 vaccine  (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-APR-2021, the patient experienced body aches. On 12-APR-2021, the patient experienced severe fatigue or lethargy. On 12-APR-2021, the patient experienced felt dehydrated. On 12-APR-2021, the patient experienced severe chills or shaking. On 12-APR-2021, the patient experienced headache. On 12-APR-2021, the patient experienced fever. Laboratory data included: Body temperature (NR: not provided) Under 102. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine  was not applicable. The patient recovered from body aches, severe chills or shaking, and fever on 13-APR-2021, severe fatigue or lethargy, and headache on 14-APR-2021, and felt dehydrated. This report was non-serious.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: BODY ACHES; SEVERE FATIGUE OR LETHARGY; FELT DEHYDRATED; SEVERE CHILLS OR SHAKING; HEADACHE; FEVER; 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 pre-existing medical conditions included: The patient did not really had a medical history. The patient received covid-19 vaccine  (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-APR-2021, the patient experienced body aches. On 12-APR-2021, the patient experienced severe fatigue or lethargy. On 12-APR-2021, the patient experienced felt dehydrated. On 12-APR-2021, the patient experienced severe chills or shaking. On 12-APR-2021, the patient experienced headache. On 12-APR-2021, the patient experienced fever. Laboratory data included: Body temperature (NR: not provided) Under 102. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine  was not applicable. The patient recovered from body aches, severe chills or shaking, and fever on 13-APR-2021, severe fatigue or lethargy, and headache on 14-APR-2021, and felt dehydrated. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea, Pain, Pyrexia
Clinical narrative: BODY ACHES; FEVER; DIARRHEA; 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 (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. 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 body aches, fever, and diarrhea. The action taken with covid-19 vaccine  was not applicable. The patient recovered from body aches, fever, and diarrhea. This report was non-serious.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: INCORRECT PRODUCT STORAGE; ADMINISTRATION OF VACCINE FROM PUNCTURED VIAL LEFT OVERNIGHT (OVER 6 HOURS); This spontaneous report received from a pharmacist concerned a 61 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A, and expiry: 14-DEC-2021) dose was not reported, administered on 25-OCT-2021 11:14 for prophylactic vaccination. No concomitant medications were reported.  On 25-OCT-2021, the patient experienced administration of vaccine from punctured vial left overnight (over 6 hours). On an unspecified date, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of vaccine from punctured vial left overnight (over 6 hours) and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20211049878.
Sex: M
Vaccine: COVID19
Symptoms: Paralysis, Thrombosis
Clinical narrative: BLOOD CLOTS; PARALYZED FROM THE TAILBONE DOWN; This spontaneous report received from a consumer via social media concerned a male of unspecified age of unknown 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) 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date in JUL-2021, the patient was paralyzed from the tailbone down and soon after was treated for several blood clots during emergency surgery. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from paralyzed from the tailbone down, and the outcome of blood clots was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20211050258-covid-19 vaccine ad26.cov2.s -paralyzed from the tailbone down,blood clots . 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: U
Vaccine: COVID19
Symptoms: Contusion, Tissue injury
Clinical narrative: ARM TISSUES AND BONES STILL BRUISED; MUSCLE TISSUE WERE DAMAGED; This spontaneous report received from a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total administered on JUN-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced arm tissues and bones bruised and the doctor said that the patient's muscle tissues were damaged. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from arm tissues and bones still bruised, and muscle tissue were damaged. This report was non-serious.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Dyspepsia, Dyspnoea, Ear discomfort
Clinical narrative: disrupted her sleep; On and off; Chest pain subsided; Bubble popping; Extreme chest pain; shortness of breath; chest would "squeeze tight for a few minutes"; feeling like burping; possible bad heartburn; This spontaneous case was reported by a consumer and describes the occurrence of DYSPEPSIA (possible bad heartburn), CHEST PAIN (Extreme chest pain), DYSPNOEA (shortness of breath), CHEST DISCOMFORT (chest would "squeeze tight for a few minutes") and ERUCTATION (feeling like burping) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006021A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Systemic lupus erythematosis in 2005, Shellfish allergy, Drug allergy (Erythromycin), Cholesterol and Hypertension. Concomitant products included HYDROXYCHLOROQUINE SULFATE (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and BELIMUMAB (BENLYSTA) for an unknown indication.    On 25-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jul-2021, the patient experienced DYSPEPSIA (possible bad heartburn). On 02-Aug-2021, the patient experienced CHEST PAIN (Extreme chest pain), DYSPNOEA (shortness of breath), CHEST DISCOMFORT (chest would "squeeze tight for a few minutes"), ERUCTATION (feeling like burping) and EAR DISCOMFORT (Bubble popping). On an unknown date, the patient experienced SLEEP DISORDER (disrupted her sleep), ON AND OFF PHENOMENON (On and off) and NON-CARDIAC CHEST PAIN (Chest pain subsided). At the time of the report, DYSPEPSIA (possible bad heartburn), DYSPNOEA (shortness of breath), CHEST DISCOMFORT (chest would "squeeze tight for a few minutes"), ERUCTATION (feeling like burping), SLEEP DISORDER (disrupted her sleep), EAR DISCOMFORT (Bubble popping) and ON AND OFF PHENOMENON (On and off) outcome was unknown, CHEST PAIN (Extreme chest pain) had resolved and NON-CARDIAC CHEST PAIN (Chest pain subsided) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication provided by reporter.  Lab data included The caller stated that she had a echocardiogram procedure yesterday (10Aug2021) but the results have not come back yet.  On follow-up patient repprted that she is doing much better.   Most recent FOLLOW-UP information incorporated above includes: On 18-Oct-2021: Follow-up received, Chest pain event outcome updated from unknown to recovering and added information in inarrative.From initial  Source Document- Captured reporter contact number and mail id and medical history( which was missed out to capture in initial submitted version). On 21-Oct-2021: Follow-up information received on 21-Oct-2021 included about outcome of event chest pain updated.