chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Back pain, Depression, Dizziness
Clinical narrative: REQUIRING NAPS ALMOST DAILY; WOOZY FEELING/BROWN OUT; DEPRESSION; DOES NOT FEEL LIKE HERSELF; LACK OF ENERGY; HEADACHE; LETHARGY; HARD TO TAKE A DEEP BREATH; WEIGHT GAIN; METALLIC/NUMB TASTE IN MOUTH; SWELLING; LOWER BACK PAIN; STOMACH CRAMPING; BODY SORENESS; ALMOST PASSING OUT; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included menopause. The patient experienced anaphylaxis when treated with acetylsalicylic acid for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 005A21A expiry: UNKNOWN) dose was not reported, administered on 15-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-MAY-2021, the subject experienced lethargy. On 15-MAY-2021, the subject experienced hard to take a deep breath. On 15-MAY-2021, the subject experienced weight gain. On 15-MAY-2021, the subject experienced metallic/numb taste in mouth. On 15-MAY-2021, the subject experienced swelling. On 15-MAY-2021, the subject experienced lower back pain. On 15-MAY-2021, the subject experienced stomach cramping. On 15-MAY-2021, the subject experienced body soreness. On 15-MAY-2021, the subject experienced almost passing out. On 15-MAY-2021, the subject experienced woozy feeling/brown out. On 15-MAY-2021, the subject experienced depression. On 15-MAY-2021, the subject experienced does not feel like herself. On 15-MAY-2021, the subject experienced lack of energy. On 15-MAY-2021, the subject experienced headache. On an unspecified date, the subject experienced requiring naps almost daily. Laboratory data (dates unspecified) included: Weight (NR: not provided) 16 pounds gained. Treatment medications (dates unspecified) included: caffeine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from woozy feeling/brown out, headache, lower back pain, stomach cramping, body soreness, depression, and hard to take a deep breath, had not recovered from lethargy, weight gain, metallic/numb taste in mouth, swelling, lack of energy, does not feel like herself, and requiring naps almost daily, and the outcome of almost passing out was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Dyspnoea, Feeling abnormal, Headache, Lethargy
Clinical narrative: REQUIRING NAPS ALMOST DAILY; WOOZY FEELING/BROWN OUT; DEPRESSION; DOES NOT FEEL LIKE HERSELF; LACK OF ENERGY; HEADACHE; LETHARGY; HARD TO TAKE A DEEP BREATH; WEIGHT GAIN; METALLIC/NUMB TASTE IN MOUTH; SWELLING; LOWER BACK PAIN; STOMACH CRAMPING; BODY SORENESS; ALMOST PASSING OUT; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included menopause. The patient experienced anaphylaxis when treated with acetylsalicylic acid for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 005A21A expiry: UNKNOWN) dose was not reported, administered on 15-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-MAY-2021, the subject experienced lethargy. On 15-MAY-2021, the subject experienced hard to take a deep breath. On 15-MAY-2021, the subject experienced weight gain. On 15-MAY-2021, the subject experienced metallic/numb taste in mouth. On 15-MAY-2021, the subject experienced swelling. On 15-MAY-2021, the subject experienced lower back pain. On 15-MAY-2021, the subject experienced stomach cramping. On 15-MAY-2021, the subject experienced body soreness. On 15-MAY-2021, the subject experienced almost passing out. On 15-MAY-2021, the subject experienced woozy feeling/brown out. On 15-MAY-2021, the subject experienced depression. On 15-MAY-2021, the subject experienced does not feel like herself. On 15-MAY-2021, the subject experienced lack of energy. On 15-MAY-2021, the subject experienced headache. On an unspecified date, the subject experienced requiring naps almost daily. Laboratory data (dates unspecified) included: Weight (NR: not provided) 16 pounds gained. Treatment medications (dates unspecified) included: caffeine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from woozy feeling/brown out, headache, lower back pain, stomach cramping, body soreness, depression, and hard to take a deep breath, had not recovered from lethargy, weight gain, metallic/numb taste in mouth, swelling, lack of energy, does not feel like herself, and requiring naps almost daily, and the outcome of almost passing out was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Presyncope, Somnolence, Swelling, Weight
Clinical narrative: REQUIRING NAPS ALMOST DAILY; WOOZY FEELING/BROWN OUT; DEPRESSION; DOES NOT FEEL LIKE HERSELF; LACK OF ENERGY; HEADACHE; LETHARGY; HARD TO TAKE A DEEP BREATH; WEIGHT GAIN; METALLIC/NUMB TASTE IN MOUTH; SWELLING; LOWER BACK PAIN; STOMACH CRAMPING; BODY SORENESS; ALMOST PASSING OUT; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included menopause. The patient experienced anaphylaxis when treated with acetylsalicylic acid for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 005A21A expiry: UNKNOWN) dose was not reported, administered on 15-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-MAY-2021, the subject experienced lethargy. On 15-MAY-2021, the subject experienced hard to take a deep breath. On 15-MAY-2021, the subject experienced weight gain. On 15-MAY-2021, the subject experienced metallic/numb taste in mouth. On 15-MAY-2021, the subject experienced swelling. On 15-MAY-2021, the subject experienced lower back pain. On 15-MAY-2021, the subject experienced stomach cramping. On 15-MAY-2021, the subject experienced body soreness. On 15-MAY-2021, the subject experienced almost passing out. On 15-MAY-2021, the subject experienced woozy feeling/brown out. On 15-MAY-2021, the subject experienced depression. On 15-MAY-2021, the subject experienced does not feel like herself. On 15-MAY-2021, the subject experienced lack of energy. On 15-MAY-2021, the subject experienced headache. On an unspecified date, the subject experienced requiring naps almost daily. Laboratory data (dates unspecified) included: Weight (NR: not provided) 16 pounds gained. Treatment medications (dates unspecified) included: caffeine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from woozy feeling/brown out, headache, lower back pain, stomach cramping, body soreness, depression, and hard to take a deep breath, had not recovered from lethargy, weight gain, metallic/numb taste in mouth, swelling, lack of energy, does not feel like herself, and requiring naps almost daily, and the outcome of almost passing out was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Weight increased
Clinical narrative: REQUIRING NAPS ALMOST DAILY; WOOZY FEELING/BROWN OUT; DEPRESSION; DOES NOT FEEL LIKE HERSELF; LACK OF ENERGY; HEADACHE; LETHARGY; HARD TO TAKE A DEEP BREATH; WEIGHT GAIN; METALLIC/NUMB TASTE IN MOUTH; SWELLING; LOWER BACK PAIN; STOMACH CRAMPING; BODY SORENESS; ALMOST PASSING OUT; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included menopause. The patient experienced anaphylaxis when treated with acetylsalicylic acid for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 005A21A expiry: UNKNOWN) dose was not reported, administered on 15-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-MAY-2021, the subject experienced lethargy. On 15-MAY-2021, the subject experienced hard to take a deep breath. On 15-MAY-2021, the subject experienced weight gain. On 15-MAY-2021, the subject experienced metallic/numb taste in mouth. On 15-MAY-2021, the subject experienced swelling. On 15-MAY-2021, the subject experienced lower back pain. On 15-MAY-2021, the subject experienced stomach cramping. On 15-MAY-2021, the subject experienced body soreness. On 15-MAY-2021, the subject experienced almost passing out. On 15-MAY-2021, the subject experienced woozy feeling/brown out. On 15-MAY-2021, the subject experienced depression. On 15-MAY-2021, the subject experienced does not feel like herself. On 15-MAY-2021, the subject experienced lack of energy. On 15-MAY-2021, the subject experienced headache. On an unspecified date, the subject experienced requiring naps almost daily. Laboratory data (dates unspecified) included: Weight (NR: not provided) 16 pounds gained. Treatment medications (dates unspecified) included: caffeine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from woozy feeling/brown out, headache, lower back pain, stomach cramping, body soreness, depression, and hard to take a deep breath, had not recovered from lethargy, weight gain, metallic/numb taste in mouth, swelling, lack of energy, does not feel like herself, and requiring naps almost daily, and the outcome of almost passing out was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pyrexia, Seizure
Clinical narrative: CONVULSION; FEVER; INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; This spontaneous report received from a consumer via social media by 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 not reported, batch number: 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 14-JUN-2021, the patient received second dose of covid-19 vaccine ad26.cov2.s vaccine (inappropriate schedule of vaccine administered), On 14-JUN-2021, the patient experienced convulsion after a couple of hours of getting the vaccine and was hospitalized.  On JUN-2021, the patient experienced fever, and was hospitalized (date unspecified).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, and the outcome of convulsion and inappropriate schedule of vaccine administered was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210634102-covid-19 vaccine ad26.cov2.s-convulsion. 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). 20210634102-covid-19 vaccine ad26.cov2.s-fever. This event(s) is labeled per RSI and is therefore considered potentially related.
Sex: U
Vaccine: COVID19
Symptoms: Ill-defined disorder, Pyrexia
Clinical narrative: GAINED THE ABILITY TO SET THINGS ON FIRE WITH MIND; SLIGHT FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced gained the ability to set things on fire with mind, and slight fever. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slight fever, and the outcome of gained the ability to set things on fire with mind was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: This spontaneous report received from parent via social media via a company representative concerned a female of unspecified age. Initial information was processed along with additional information received from central complaint vigilance on 17-JUN-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 not reported) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient contracted COVID-19 infection (coded as suspected COVID-19 infection and suspected clinical vaccination failure). The action taken with COVID-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case was associated with product quality complaint 90000183041.; Sender's Comments: V0: 20210634766-COVID-19 VACCINE AD26.COV2.S- suspected covid-19 infection and suspected clinical vaccination failure. These events are considered not related. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Sex: U
Vaccine: COVID19
Symptoms: Death, Suspected COVID-19, Vaccination failure
Clinical narrative: PASSED AWAY; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer via a company representative via social media concerned a patient of unspecified age, sex, 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: not reported, expiry: unknown) dose was not reported, 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, patient had suspected Covid-19, suspected clinical vaccination failure and patient passed away from unknown cause. It was unknown if the autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was passed away on an unspecified date. The outcome of suspected covid-19 infection and suspected clinical vaccination failure was not reported.  This report was serious (Death, and Other Medically Important Condition). This case, from the same reporter is linked to 20210629346.; Sender's Comments: V0: 20210635272-Covid-19 vaccine ad26.cov2.s-Passed away 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). 20210635272-Covid-19 vaccine ad26.cov2.-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.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOTS IN HER BRAIN, WHICH SPREAD THROUGH OUT HER BODY; This spontaneous report received from a consumer via social media (Twitter) and concerned a female patient of 29 year old. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered on APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On APR-2021, the patient experienced blood clots in her brain, which spread through out her body, and was hospitalized (date unspecified).The patient was hospitalized for four weeks. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clots in her brain, which spread through out her body was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210637099-Covid-19 vaccine ad26.cov2.s-Blood clots in her brain, which spread through out her body. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Hypersomnia, Pain in extremity
Clinical narrative: SLEPT A LOT THE NEXT 2 DAYS; ARM WASN'T EVEN SORE FOR MORE THAN AN HOUR; TIRED; This spontaneous report received from a patient via a company representative concerned an adult of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included lupus autoimmune illness, and celiac autoimmune illness. The patient was previously treated with influenza vaccine for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 17-MAR-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 17-MAR-2021, the subject experienced arm wasn't even sore for more than an hour. On 17-MAR-2021, the subject experienced tired. On 18-MAR-2021, the subject experienced slept a lot the next 2 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm wasn't even sore for more than an hour on 17-MAR-2021, and the outcome of tired and slept a lot the next 2 days was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Blindness
Clinical narrative: BLINDNESS; This spontaneous report received from a contact concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced blindness. No other information was provided. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blindness was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210637236-covid-19 vaccine ad26.cov2.s-blindness. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Heart rate, Heart rate increased, Hot flush, Hypertension
Clinical narrative: HIGH HEART RATE; HIGH BLOOD PRESSURE; HOT FLASHES; HARDLY ABLE TO SLEEP; 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 concurrent conditions included sleep disorder. 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 10-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included propranolol for for sleep, and quetiapine fumarate. On an unspecified date, the subject experienced high heart rate, high blood pressure, hot flashes, and hardly able to sleep. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) High, and Heart rate (NR: not provided) High. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the high heart rate, high blood pressure, hot flashes and hardly able to sleep was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Insomnia
Clinical narrative: HIGH HEART RATE; HIGH BLOOD PRESSURE; HOT FLASHES; HARDLY ABLE TO SLEEP; 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 concurrent conditions included sleep disorder. 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 10-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included propranolol for for sleep, and quetiapine fumarate. On an unspecified date, the subject experienced high heart rate, high blood pressure, hot flashes, and hardly able to sleep. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) High, and Heart rate (NR: not provided) High. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the high heart rate, high blood pressure, hot flashes and hardly able to sleep was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: SERIOUS REACTION; This spontaneous report received from a consumer (husband of the patient) via social media (Twitter) via a company representative concerned a female of an 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, 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 had a serious reaction (unspecified). On an unspecified date, the patient was hospitalized for 75 days and counting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of serious reaction was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210638913-COVID-19 VACCINE AD26.COV2.S-Serious Reaction. 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: Pruritus
Clinical narrative: ITCHING ALL OVER BODY; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced itching all over body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of itching all over body was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Ageusia, Anosmia, Diarrhoea haemorrhagic, Dyspepsia
Clinical narrative: UNABLE TO BREATHE; STOMACH ON FIRE; NAUSEOUS; UNABLE TO EAT; LOSS OF TASTE UNRELATED TO COVID-19; BLOATING; THROAT PAIN; LOSS OF SMELL UNRELATED TO COVID-19; MOUTH PAIN; THROAT SWELLING; BLOODY DIARRHEA; NOT FEELING GOOD; SEVERE HEADACHES; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: UNKNOWN) 1 total, dose was not reported, administered on left arm on 27-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 27-APR-2021, the patient had severe headaches that were not resolved with narcotic and migraine medication. On 05-MAY-2021 (8 days after vaccination), the patient had bloody diarrhea which lasted 3 days. On 16-JUN-2021, the patient was hospitalized for the stomach being on fire and would be getting an endoscopy to rule out an ulcer. The patient also had throat and mouth pain as well as bloating. It was reported that, the patient was unable to breathe because of throat swelling. The patient had visited emergency room on 17-JUN-2021 and 18-JUN-2021. The patient was discharged on 18-JUN-2021. It was reported that, the patient had not felt good since vaccination. On an unspecified date, the patient was being nauseous, unable to eat, loss of taste/smell unrelated to COVID-19.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bloody diarrhea on 08-MAY-2021, had not recovered from severe headaches, and not feeling good, and the outcome of nauseous, unable to eat, loss of taste unrelated to covid-19, bloating, throat pain, loss of smell unrelated to covid-19, mouth pain, throat swelling, stomach on fire and unable to breathe was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition). This case, from the same reporter is linked to 20210643383.; Sender's Comments: V0: 20210642487-covid-19 vaccine ad26.cov2.s-bloody diarrhea, stomach on fire, unable to breathe. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Endoscopy, Feeding disorder, Headache, Malaise
Clinical narrative: UNABLE TO BREATHE; STOMACH ON FIRE; NAUSEOUS; UNABLE TO EAT; LOSS OF TASTE UNRELATED TO COVID-19; BLOATING; THROAT PAIN; LOSS OF SMELL UNRELATED TO COVID-19; MOUTH PAIN; THROAT SWELLING; BLOODY DIARRHEA; NOT FEELING GOOD; SEVERE HEADACHES; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: UNKNOWN) 1 total, dose was not reported, administered on left arm on 27-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 27-APR-2021, the patient had severe headaches that were not resolved with narcotic and migraine medication. On 05-MAY-2021 (8 days after vaccination), the patient had bloody diarrhea which lasted 3 days. On 16-JUN-2021, the patient was hospitalized for the stomach being on fire and would be getting an endoscopy to rule out an ulcer. The patient also had throat and mouth pain as well as bloating. It was reported that, the patient was unable to breathe because of throat swelling. The patient had visited emergency room on 17-JUN-2021 and 18-JUN-2021. The patient was discharged on 18-JUN-2021. It was reported that, the patient had not felt good since vaccination. On an unspecified date, the patient was being nauseous, unable to eat, loss of taste/smell unrelated to COVID-19.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bloody diarrhea on 08-MAY-2021, had not recovered from severe headaches, and not feeling good, and the outcome of nauseous, unable to eat, loss of taste unrelated to covid-19, bloating, throat pain, loss of smell unrelated to covid-19, mouth pain, throat swelling, stomach on fire and unable to breathe was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition). This case, from the same reporter is linked to 20210643383.; Sender's Comments: V0: 20210642487-covid-19 vaccine ad26.cov2.s-bloody diarrhea, stomach on fire, unable to breathe. 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: Nausea, Oral pain, Oropharyngeal pain, Pharyngeal swelling
Clinical narrative: UNABLE TO BREATHE; STOMACH ON FIRE; NAUSEOUS; UNABLE TO EAT; LOSS OF TASTE UNRELATED TO COVID-19; BLOATING; THROAT PAIN; LOSS OF SMELL UNRELATED TO COVID-19; MOUTH PAIN; THROAT SWELLING; BLOODY DIARRHEA; NOT FEELING GOOD; SEVERE HEADACHES; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: UNKNOWN) 1 total, dose was not reported, administered on left arm on 27-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 27-APR-2021, the patient had severe headaches that were not resolved with narcotic and migraine medication. On 05-MAY-2021 (8 days after vaccination), the patient had bloody diarrhea which lasted 3 days. On 16-JUN-2021, the patient was hospitalized for the stomach being on fire and would be getting an endoscopy to rule out an ulcer. The patient also had throat and mouth pain as well as bloating. It was reported that, the patient was unable to breathe because of throat swelling. The patient had visited emergency room on 17-JUN-2021 and 18-JUN-2021. The patient was discharged on 18-JUN-2021. It was reported that, the patient had not felt good since vaccination. On an unspecified date, the patient was being nauseous, unable to eat, loss of taste/smell unrelated to COVID-19.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bloody diarrhea on 08-MAY-2021, had not recovered from severe headaches, and not feeling good, and the outcome of nauseous, unable to eat, loss of taste unrelated to covid-19, bloating, throat pain, loss of smell unrelated to covid-19, mouth pain, throat swelling, stomach on fire and unable to breathe was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition). This case, from the same reporter is linked to 20210643383.; Sender's Comments: V0: 20210642487-covid-19 vaccine ad26.cov2.s-bloody diarrhea, stomach on fire, unable to breathe. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Pyrexia, SARS-CoV-2 test
Clinical narrative: CONFIRMED COVID-19 INFECTION; FEVER; This spontaneous report received from a patient concerned a 49 year old male. The patient's height, and weight were not reported.  The patient's concurrent conditions included alcohol use, and cigarette smoker, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug use.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A and expiry: UNKNOWN) dose was not reported, administered on 13-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 11-JUN-2021, Laboratory data included: COVID-19 virus test (NR: not provided) negative. On 16-JUN-2021, the subject experienced fever. On 17-JUN-2021, the subject experienced confirmed covid-19 infection. Laboratory data included: COVID-19 virus test (NR: not provided) positive. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, and the outcome of confirmed covid-19 infection was not reported. This report was non-serious. The product quality complaint number was assigned to this case as 90000183353.
Age: 58.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: DOSE WITHDRAWAL AT 1.5 HOURS OUTSIDE OF THE 6 HOUR WINDOW PERIOD; EXPIRED VACCINE WAS GIVEN TO A PATIENT; This spontaneous report received from a health care professional concerned a 58 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 not reported, batch number: 043A21A expiry: 05-AUG-2021) dose was not reported, administered on 16-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced dose withdrawal at 1.5 hours outside of the 6 hour window period, and expired vaccine was given to a subject. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the expired vaccine was given to a patient and dose withdrawal at 1.5 hours outside of the 6 hour window period was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Cough, Ear discomfort, Headache
Clinical narrative: 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: Unk) dose was not reported, administered on 15-MAY-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 MAY-2021, Laboratory data included: Body temperature (NR: not provided) 98.8. On 25-MAY-2021, the subject experienced possible sinuses acting up. On 25-MAY-2021, the subject experienced sneezing. On 25-MAY-2021, the subject experienced coughing. On 25-MAY-2021, the subject experienced pressure on ears. On 25-MAY-2021, the subject experienced blowing nose. On 25-MAY-2021, the subject experienced sore throat. On 25-MAY-2021, the subject experienced cramps. On 25-MAY-2021, the subject experienced chills. On 25-MAY-2021, the subject experienced headaches. On 25-MAY-2021, the subject experienced temperature/fever. On 25-MAY-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sneezing, coughing, headaches, pressure on ears, sore throat, chills, temperature/fever, cramps, nausea, possible sinuses acting up and blowing nose was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Nausea, Oropharyngeal pain, Pyrexia, Rhinorrhoea
Clinical narrative: 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: Unk) dose was not reported, administered on 15-MAY-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 MAY-2021, Laboratory data included: Body temperature (NR: not provided) 98.8. On 25-MAY-2021, the subject experienced possible sinuses acting up. On 25-MAY-2021, the subject experienced sneezing. On 25-MAY-2021, the subject experienced coughing. On 25-MAY-2021, the subject experienced pressure on ears. On 25-MAY-2021, the subject experienced blowing nose. On 25-MAY-2021, the subject experienced sore throat. On 25-MAY-2021, the subject experienced cramps. On 25-MAY-2021, the subject experienced chills. On 25-MAY-2021, the subject experienced headaches. On 25-MAY-2021, the subject experienced temperature/fever. On 25-MAY-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sneezing, coughing, headaches, pressure on ears, sore throat, chills, temperature/fever, cramps, nausea, possible sinuses acting up and blowing nose was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Sinus pain, Sneezing
Clinical narrative: 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: Unk) dose was not reported, administered on 15-MAY-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 MAY-2021, Laboratory data included: Body temperature (NR: not provided) 98.8. On 25-MAY-2021, the subject experienced possible sinuses acting up. On 25-MAY-2021, the subject experienced sneezing. On 25-MAY-2021, the subject experienced coughing. On 25-MAY-2021, the subject experienced pressure on ears. On 25-MAY-2021, the subject experienced blowing nose. On 25-MAY-2021, the subject experienced sore throat. On 25-MAY-2021, the subject experienced cramps. On 25-MAY-2021, the subject experienced chills. On 25-MAY-2021, the subject experienced headaches. On 25-MAY-2021, the subject experienced temperature/fever. On 25-MAY-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sneezing, coughing, headaches, pressure on ears, sore throat, chills, temperature/fever, cramps, nausea, possible sinuses acting up and blowing nose was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Headache
Clinical narrative: PERSISTENT HEADACHE TOP OF SKULL AND FOREHEAD; 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 10-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On JUN-2021, the subject experienced persistent headache top of skull and forehead. Laboratory data included: Blood test (NR: not provided) Seems fine, and CAT scan (NR: not provided) Seems fine. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from persistent headache top of skull and forehead. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: DULL ACHES AND PAINS IN LEGS; TIREDNESS; This spontaneous report received from a consumer concerned a 46 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: 1821286, and batch number: 1821286 expiry: UNKNOWN) dose was not reported, administered on 18-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-JUN-2021, the subject experienced dull aches and pains in legs. On 19-JUN-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tiredness and dull aches and pains in legs was not reported. This report was non-serious. This case, from the same reporter is linked to 20210642462.
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: UNSPECIFIED SIDE EFFECTS; This spontaneous report received from a patient 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, for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, after receiving the vaccine, the patient experienced side effects (unspecified), and was hospitalized (date unspecified). The patient was discharged from the hospital on 18-JUN-2021. The patient reported that she had read up on the vaccine online and was being afraid to die. No additional information about the side effects was reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unspecified side effects was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210643142- covid-19 vaccine ad26.cov2.s- unspecified side effects. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Malaise
Clinical narrative: FEELS GENERALLY UNWELL; FATIGUE; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: UNKNOWN) dose was not reported, administered on 27-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced feels generally unwell, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fatigue, and feels generally unwell. This report was non-serious. This case, from the same reporter is linked to 20210644172 and 20210642487.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: NOT FEELING WELL; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced not feeling well. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of not feeling well was not reported. This report was non-serious.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: BLURRED VISION; This spontaneous report received from a consumer concerned a 67 year old female. The patient's height, and weight were not reported. The patient's past medical history included blurred vision. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808986, expiry: UNKNOWN) dose was not reported, administered on 18-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-JUN-2021, the subject experienced blurred vision. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from blurred vision. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: PEDIATRIC ADMINISTRATION; OFF LABEL USE; 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced pediatric administration, and off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pediatric administration and off label use was not reported. This report was non-serious.