chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Sensitive skin
Clinical narrative: NAUSEA; MUSCLE SORENESS  (NECK, SHOULDERS AND BACK); FEVER; HEADACHE TURNED INTO A MIGRAINE; DIZZY; SENSITIVE SKIN; FEEL TIRED/FATIGUE; This spontaneous report received from a patient concerned a 43 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: non smoker, and non alcohol user, and other pre-existing medical conditions included: Patient had no known drug allergies and did not had any 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: 1808982, and expiry: 21-SEP-2021) dose was not reported, administered on 13-SEP-2021 09:30 for prophylactic vaccination. No concomitant medications were reported.  On 13-SEP-2021, the patient experienced headache turned into a migraine. On 13-SEP-2021, the patient experienced dizzy. On 13-SEP-2021, the patient experienced sensitive skin. On 13-SEP-2021, the patient experienced feel tired/fatigue. On 14-SEP-2021, the patient experienced nausea. On 14-SEP-2021, the patient experienced muscle soreness (neck, shoulders and back). On 14-SEP-2021, the patient experienced fever. Laboratory data included: Body temperature (NR: not provided) 99.32 F, 99.8 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from feel tired/fatigue, dizzy, headache turned into a migraine, sensitive skin, nausea, muscle soreness (neck, shoulders and back), and fever. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Dizziness, Headache, Hyperhidrosis, Nausea
Clinical narrative: DIZZINESS; SWEATING BULLETS IN A COOL ROOM, LIKE HAD JUST CLIMBED OUT OF A POOL; BEEFY BODY ACHES; SORE ARM AS THE TECH POKED HUMERUS WITH THE NEEDLE; HEADACHES JUST SHY OF MIGRAINE-STRENGTH; LOW GRADE FEVER; VERY LOW GRADE NAUSEA; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced dizziness, sweating bullets in a cool room, like had just climbed out of a pool, beefy body aches, sore arm as the tech poked humerus with the needle, headaches just shy of migraine-strength, low grade fever, and very low grade nausea. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) Low grade fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, sweating bullets in a cool room, like had just climbed out of a pool, beefy body aches, sore arm as the tech poked humerus with the needle, low grade fever, and very low grade nausea, and the outcome of headaches just shy of migraine-strength was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: DIZZINESS; SWEATING BULLETS IN A COOL ROOM, LIKE HAD JUST CLIMBED OUT OF A POOL; BEEFY BODY ACHES; SORE ARM AS THE TECH POKED HUMERUS WITH THE NEEDLE; HEADACHES JUST SHY OF MIGRAINE-STRENGTH; LOW GRADE FEVER; VERY LOW GRADE NAUSEA; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced dizziness, sweating bullets in a cool room, like had just climbed out of a pool, beefy body aches, sore arm as the tech poked humerus with the needle, headaches just shy of migraine-strength, low grade fever, and very low grade nausea. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) Low grade fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, sweating bullets in a cool room, like had just climbed out of a pool, beefy body aches, sore arm as the tech poked humerus with the needle, low grade fever, and very low grade nausea, and the outcome of headaches just shy of migraine-strength was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: MUSCLE ACHES SIX WEEKS AFTER GETTING VACCINE; This spontaneous report received from a parent concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin 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 muscle aches six weeks after getting vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of muscle aches six weeks after getting vaccine was not reported. This report was non-serious.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: LITTLE HEADACHE; This spontaneous report received from a patient concerned a 72 year old male. The patient's height, and weight were not reported. The patient's past medical history included: stroke, and heart attack, and concurrent conditions included: open heart surgery, non smoker, and non alcohol user, and other pre-existing medical conditions included: Patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 02-APR-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 little headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of little headache was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea, Suspected COVID-19
Clinical narrative: POSSIBLE COVID-19 REINFECTION; DIARRHEA; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included: covid-19 infection. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced possible covid-19 reinfection, and diarrhea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the diarrhea and possible covid-19 reinfection was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: THREE DEATHS; This spontaneous report received from a consumer via a company representative via social media concerned 3 multiple patients. The patient's weight, height, and medical histories were not reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: not reported) dose was not reported, 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 dates, the 3 multiple patients experienced deaths. As per the reporter, "Well, investigations happened and so far, three deaths in total have been confirmed, connected to the J and J vaccine. On an unspecified dates, the 3 multiple patients died from unknown cause of death. It was unknown whether autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0:20210925983-CDOVID-19 VACCINE AD26.COV2.S-Three deaths. 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
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site erythema, Injection site induration, Injection site mass, Injection site swelling
Clinical narrative: INJECTION SITE LUMP VERY SORE; INJECTION SITE LUMP (HARD LUMP ABOUT THE SIZE OF A QUARTER); INJECTION SITE HARD; SWOLLEN VEINS (BLUE JAGGED LINE EXTENDING FROM THE INJECTION SITE ACROSS HER CHEST TO THE OTHER ARM, LOCATED ON HER FRONT, BELOW THE COLLARBONE ON THE LEFT SIDE); INJECTION SITE WARM TO TOUCH/WARM AT BUMP; FEELS LIKE THERE SOMETHING UNDER HER SKIN THAT SHE RUBBING; MILD HEADACHE (DESCRIBED IT AT THE FRONT OF HER FOREHEAD, AND DESCRIBES FEELING A BIT WARM); INJECTION SITE SWOLLEN; INJECTION SITE RED; This spontaneous report received from a patient concerned a 51 year old female. The patient's weight was 190 pounds, and height was 66 inches. The patient's past medical history included: tore her other arm, and concurrent conditions included: thin skin, non smoker, and non alcohol user, and other pre-existing medical conditions included: The patient had no known allergies. The patient have no history of drug abuse or illicit drug usage. The patient had no medical history. The patient past drug history included vitamins. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816207, expiry: UNKNOWN) dose was not reported, administered on 08-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On SEP-2021, the patient experienced injection site lump (hard lump about the size of a quarter). On SEP-2021, the patient experienced injection site hard. On SEP-2021, the patient experienced swollen veins (blue jagged line extending from the injection site across her chest to the other arm, located on her front, below the collarbone on the left side). On SEP-2021, the patient experienced injection site warm to touch/warm at bump. On SEP-2021, the patient experienced feels like there something under her skin that she rubbing. On SEP-2021, the patient experienced mild headache (described it at the front of her forehead, and describes feeling a bit warm). On SEP-2021, the patient experienced injection site swollen. On SEP-2021, the patient experienced injection site red. Treatment medications included: paracetamol, and trolamine salicylate. On 14-SEP-2021, the patient experienced injection site lump very sore. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from injection site lump very sore, mild headache (described it at the front of her forehead, and describes feeling a bit warm), swollen veins (blue jagged line extending from the injection site across her chest to the other arm, located on her front, below the collarbone on the left side), and injection site lump (hard lump about the size of a quarter), and the outcome of injection site swollen, injection site red, injection site warm to touch/warm at bump, feels like there something under her skin that she rubbing and injection site hard was not reported. This report was non-serious. This case, from the same reporter is linked to 20210925766.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth, Nodule, Sensory disturbance, Vasodilatation
Clinical narrative: INJECTION SITE LUMP VERY SORE; INJECTION SITE LUMP (HARD LUMP ABOUT THE SIZE OF A QUARTER); INJECTION SITE HARD; SWOLLEN VEINS (BLUE JAGGED LINE EXTENDING FROM THE INJECTION SITE ACROSS HER CHEST TO THE OTHER ARM, LOCATED ON HER FRONT, BELOW THE COLLARBONE ON THE LEFT SIDE); INJECTION SITE WARM TO TOUCH/WARM AT BUMP; FEELS LIKE THERE SOMETHING UNDER HER SKIN THAT SHE RUBBING; MILD HEADACHE (DESCRIBED IT AT THE FRONT OF HER FOREHEAD, AND DESCRIBES FEELING A BIT WARM); INJECTION SITE SWOLLEN; INJECTION SITE RED; This spontaneous report received from a patient concerned a 51 year old female. The patient's weight was 190 pounds, and height was 66 inches. The patient's past medical history included: tore her other arm, and concurrent conditions included: thin skin, non smoker, and non alcohol user, and other pre-existing medical conditions included: The patient had no known allergies. The patient have no history of drug abuse or illicit drug usage. The patient had no medical history. The patient past drug history included vitamins. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816207, expiry: UNKNOWN) dose was not reported, administered on 08-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On SEP-2021, the patient experienced injection site lump (hard lump about the size of a quarter). On SEP-2021, the patient experienced injection site hard. On SEP-2021, the patient experienced swollen veins (blue jagged line extending from the injection site across her chest to the other arm, located on her front, below the collarbone on the left side). On SEP-2021, the patient experienced injection site warm to touch/warm at bump. On SEP-2021, the patient experienced feels like there something under her skin that she rubbing. On SEP-2021, the patient experienced mild headache (described it at the front of her forehead, and describes feeling a bit warm). On SEP-2021, the patient experienced injection site swollen. On SEP-2021, the patient experienced injection site red. Treatment medications included: paracetamol, and trolamine salicylate. On 14-SEP-2021, the patient experienced injection site lump very sore. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from injection site lump very sore, mild headache (described it at the front of her forehead, and describes feeling a bit warm), swollen veins (blue jagged line extending from the injection site across her chest to the other arm, located on her front, below the collarbone on the left side), and injection site lump (hard lump about the size of a quarter), and the outcome of injection site swollen, injection site red, injection site warm to touch/warm at bump, feels like there something under her skin that she rubbing and injection site hard was not reported. This report was non-serious. This case, from the same reporter is linked to 20210925766.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac disorder, Hypoaesthesia
Clinical narrative: WENT TO THE EMERGENCY ROOM THEY SAID IT WAS HEART; RIGHT ARM WAS 100 PERCENT NUMB FROM THE ELBOW TO FINGER TIPS AND NO FEELING IN PINKY; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAR-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 APR-2021, the patient experienced went to the emergency room they said it was heart. On APR-2021, the patient experienced right arm was 100 percent numb from the elbow to finger tips and no feeling in pinky. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from right arm was 100 percent numb from the elbow to finger tips and no feeling in pinky, and the outcome of went to the emergency room they said it was heart was not reported. This report was non-serious.
Age: 35.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: COVID-19 TEST POSITIVE; This spontaneous report received from a patient concerned a 36 year old of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: human immunodeficiency virus. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A expiry: UNKNOWN) dose was not reported, administered on 07-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-AUG-2021, the patient experienced covid-19 test positive. Laboratory data included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 test positive was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: ADMINISTRATION OF EXPIRED VACCINE WHOSE VIAL WAS PUNCTURED AT 8:30 AM STORED IN THE REFRIGERATOR AND THEN ADMINISTERED APPROXIMATELY AT 3:20 PM (7 HOURS AFTER PUNCTURE, 50 MINUTES PAST EXPIRATION); This spontaneous report received from a health care professional concerned multiple patients. 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: 203A21A expiry: 21-SEP-2021) dose was not reported, administered on 14-SEP-2021 15:20 for prophylactic vaccination. No concomitant medications were reported. On 14-SEP-2021, the patient experienced administration of expired vaccine whose vial was punctured at 8:30 am stored in the refrigerator and then administered approximately at 3:20 pm (7 hours after puncture, 50 minutes past expiration). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine whose vial was punctured at 8:30 am stored in the refrigerator and then administered approximately at 3:20 pm (7 hours after puncture, 50 minutes past expiration) was not reported. This report was non-serious.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza, Magnetic resonance imaging head, Magnetic resonance imaging neck, Paraesthesia, Vertigo
Clinical narrative: SEVERE DEBILITATING VERTIGO; PERIPHERAL PARESTHESIA IN LOWER LEG AND HANDS; FLU SYMPTOMS; This spontaneous report received from a patient concerned a 32 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no known allergies and no medical history. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 043821A, batch number: 0438219, expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-APR-2021, the patient experienced flu symptoms. On 17-APR-2021, the patient experienced peripheral paresthesia in lower leg and hands. On 17-APR-2021, the patient experienced severe debilitating vertigo. Laboratory data (dates unspecified) included: Magnetic resonance imaging head (NR: not provided) Normal, and Magnetic resonance imaging neck (NR: not provided) Normal. The action taken with covid-19 vaccine was not applicable. The patient recovered from flu symptoms, had not recovered from peripheral paresthesia in lower leg and hands, and the outcome of severe debilitating vertigo was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: STROKE; 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, 01 total, administered for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced stroke within12 hours of the jab. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of stroke was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210926436- COVID-19 VACCINE AD26.COV2.S-stroke. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Hypokinesia, Impaired quality of life, Laboratory test, Lymphadenopathy, Swelling
Clinical narrative: SEVERE SWELLING; AFFECTING DAILY LIFE; LYMPH NODE SWOLLEN LEFT SIDE OF BODY; CAN NOT BEND LEGS; REACTION FROM VACCINE; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient don't have blood clots. The patient had ruling out orthopedic issues. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820095, and expiry: 22-FEB-2022) dose was not reported, administered on 25-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 25-AUG-2021, the patient experienced reaction from vaccine. On 25-AUG-2021, the patient experienced can not bend legs. On SEP-2021, the patient experienced lymph node swollen left side of body. On an unspecified date, the patient experienced severe swelling, and affecting daily life. Laboratory data (dates unspecified) included: Lab test (NR: not provided) not a blood clot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from reaction from vaccine, can not bend legs, severe swelling, lymph node swollen left side of body, and affecting daily life. This report was non-serious.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: SEVERE SWELLING; AFFECTING DAILY LIFE; LYMPH NODE SWOLLEN LEFT SIDE OF BODY; CAN NOT BEND LEGS; REACTION FROM VACCINE; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient don't have blood clots. The patient had ruling out orthopedic issues. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820095, and expiry: 22-FEB-2022) dose was not reported, administered on 25-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 25-AUG-2021, the patient experienced reaction from vaccine. On 25-AUG-2021, the patient experienced can not bend legs. On SEP-2021, the patient experienced lymph node swollen left side of body. On an unspecified date, the patient experienced severe swelling, and affecting daily life. Laboratory data (dates unspecified) included: Lab test (NR: not provided) not a blood clot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from reaction from vaccine, can not bend legs, severe swelling, lymph node swollen left side of body, and affecting daily life. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Vomiting
Clinical narrative: DOES NOT SEEM LIKE HIMSELF; VOMITING; 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 (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 10-SEP-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 SEP-2021, the patient experienced does not seem like himself. On SEP-2021, the patient experienced vomiting. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from vomiting, and does not seem like himself. This report was non-serious.
Age: 63.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Condition aggravated, Diarrhoea, Muscle spasms, Pain
Clinical narrative: Condition aggravated; Pain; Cramps; Stools watery; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe adult Crohn's disease, and moderate to severe ulcerative colitis. 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 01-APR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot number.  Non-company suspect drugs included: adalimumab (form of admin unknown, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported, and dose, frequency, and therapy dates were not reported for moderate to severe adult crohn's disease, and moderate to severe ulcerative colitis. No concomitant medications were reported.  On 07-SEP-2021, the patient experienced condition aggravated. On 07-SEP-2021, the patient experienced pain. On 07-SEP-2021, the patient experienced cramps. On 07-SEP-2021, the patient experienced stools watery. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the condition aggravated, pain, stools watery and cramps was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Bone pain, Cold sweat, Headache, Pain, Pyrexia
Clinical narrative: COLD SWEATS; PAIN ALL OVER THE BODY; COULD FEEL EACH ONE OF BONES BECAUSE THEY WERE HURTING SO BAD; FEVER THAT WOULD NOT GO DOWN; EXTREME HEADACHE (SWOLLEN 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced cold sweats, pain all over the body, could feel each one of bones because they were hurting so bad, fever that would not go down, and extreme headache (swollen brain). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the cold sweats, pain all over the body, could feel each one of bones because they were hurting so bad, fever that would not go down and extreme headache (swollen brain) was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: SEVERE SHIVERING FOR 3 DAYS; This spontaneous report received from a consumer concerned a 25 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced severe shivering for 3 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe shivering for 3 days. This report was non-serious. This case, from the same reporter is linked to 20210926966.
Sex: F
Vaccine: COVID19
Symptoms: Anger, Malaise
Clinical narrative: VERY ANGRY; NOT FEELING WELL; 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 patient experienced very angry, and not feeling well. The outcome of the not feeling well and very angry was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: SHIVERING  FOR 3 DAYS; This spontaneous report received from a consumer concerned a 25 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: 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 patient experienced shivering for 3 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shivering for 3 days. This report was non-serious. This case, from the same reporter is linked to 20210926785.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: LEG PAIN; This spontaneous report received from a consumer 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 and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced leg pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of leg pain was not reported. This report was non-serious. This case, from the same reporter is linked to 20210925773.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Medication error
Clinical narrative: SEQUENTIAL USE OF JANSSEN COVID-19 VACCINE AFTER USE OF PFIZER COVID-19 VACCINES; This spontaneous report received from a patient concerned a 73 year old male. The patient's height, and weight were not reported. The patient's past medical history included: covid-19, and concurrent conditions included: stroke, dementia, high blood pressure, and high cholesterol, and other pre-existing medical conditions included: The patient had no known medication allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown ,expiry: unknown ) dose was not reported, administered on 13-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included bnt 162.  On 13-SEP-2021, the patient experienced sequential use of janssen covid-19 vaccine after use of pfizer covid-19 vaccines. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sequential use of janssen covid-19 vaccine after use of pfizer covid-19 vaccines was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: TINGLING IN HIS LEGS; 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, and batch number were not reported) dose was not reported, administered on 27-APR-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 tingling in his legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tingling in his legs was not reported. This report was non-serious. This case, from the same reporter is linked to 20210920710.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Musculoskeletal stiffness
Clinical narrative: STIFF NECK; HEADACHES; NUMBNESS IN ARM; This spontaneous report received from a patient concerned a 29 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: penicillin allergy, and other pre-existing medical conditions included: The patient had no current medical conditions, and was taking no medications besides allergy medications. The patient experienced drug allergy 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: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 15-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-SEP-2021, the patient experienced stiff neck. On 15-SEP-2021, the patient experienced headaches. On 15-SEP-2021, the patient experienced numbness in arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headaches, numbness in arm, and stiff neck. This report was non-serious.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dizziness, Dyskinesia, Dyspnoea, Gait disturbance
Clinical narrative: SWOLLEN FACE; RAPID HEARTBEAT; DIFFICULTY WALKING; EYES ARE BLURRY; RIGHT EYE TWITCHING/LIPS SHAKE WHEN SMILE; FEELS LIKE AN ANXIETY ATTACK IN COMING; WEAK MUSCLES; SORE MUSCLES; NAUSEA; HEADACHE; FACE FEEL TIGHT; DIZZY; SHORT OF BREATH; TEETH FEEL FUNNY; JAW FEEL TIGHT; FACE IS DOING WEIRD MOVEMENT; This spontaneous report received from a patient 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 14-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-SEP-2021, the patient experienced dizzy. On 14-SEP-2021, the patient experienced short of breath. On 14-SEP-2021, the patient experienced face is doing weird movement. On 14-SEP-2021, the patient experienced teeth feel funny. On 14-SEP-2021, the patient experienced jaw feel tight. On 14-SEP-2021, the patient experienced face feel tight. On 14-SEP-2021, the patient experienced headache. On 15-SEP-2021, the patient experienced swollen face. On 15-SEP-2021, the patient experienced rapid heartbeat. On 15-SEP-2021, the patient experienced difficulty walking. On 15-SEP-2021, the patient experienced eyes are blurry. On 15-SEP-2021, the patient experienced right eye twitching/lips shake when smile. On 15-SEP-2021, the patient experienced feels like an anxiety attack in coming. On 15-SEP-2021, the patient experienced weak muscles. On 15-SEP-2021, the patient experienced sore muscles. On 15-SEP-2021, the patient experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dizzy, and short of breath, and the outcome of swollen face, rapid heartbeat, nausea, sore muscles, difficulty walking, face is doing weird movement, eyes are blurry, right eye twitching/lips shake when smile, teeth feel funny, jaw feel tight, headache, feels like an anxiety attack in coming, weak muscles and face feel tight was not reported. This report was non-serious.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate increased, Muscle tightness, Muscle twitching, Muscular weakness
Clinical narrative: SWOLLEN FACE; RAPID HEARTBEAT; DIFFICULTY WALKING; EYES ARE BLURRY; RIGHT EYE TWITCHING/LIPS SHAKE WHEN SMILE; FEELS LIKE AN ANXIETY ATTACK IN COMING; WEAK MUSCLES; SORE MUSCLES; NAUSEA; HEADACHE; FACE FEEL TIGHT; DIZZY; SHORT OF BREATH; TEETH FEEL FUNNY; JAW FEEL TIGHT; FACE IS DOING WEIRD MOVEMENT; This spontaneous report received from a patient 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 14-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-SEP-2021, the patient experienced dizzy. On 14-SEP-2021, the patient experienced short of breath. On 14-SEP-2021, the patient experienced face is doing weird movement. On 14-SEP-2021, the patient experienced teeth feel funny. On 14-SEP-2021, the patient experienced jaw feel tight. On 14-SEP-2021, the patient experienced face feel tight. On 14-SEP-2021, the patient experienced headache. On 15-SEP-2021, the patient experienced swollen face. On 15-SEP-2021, the patient experienced rapid heartbeat. On 15-SEP-2021, the patient experienced difficulty walking. On 15-SEP-2021, the patient experienced eyes are blurry. On 15-SEP-2021, the patient experienced right eye twitching/lips shake when smile. On 15-SEP-2021, the patient experienced feels like an anxiety attack in coming. On 15-SEP-2021, the patient experienced weak muscles. On 15-SEP-2021, the patient experienced sore muscles. On 15-SEP-2021, the patient experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dizzy, and short of breath, and the outcome of swollen face, rapid heartbeat, nausea, sore muscles, difficulty walking, face is doing weird movement, eyes are blurry, right eye twitching/lips shake when smile, teeth feel funny, jaw feel tight, headache, feels like an anxiety attack in coming, weak muscles and face feel tight was not reported. This report was non-serious.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Skin tightness, Swelling face, Tooth disorder
Clinical narrative: SWOLLEN FACE; RAPID HEARTBEAT; DIFFICULTY WALKING; EYES ARE BLURRY; RIGHT EYE TWITCHING/LIPS SHAKE WHEN SMILE; FEELS LIKE AN ANXIETY ATTACK IN COMING; WEAK MUSCLES; SORE MUSCLES; NAUSEA; HEADACHE; FACE FEEL TIGHT; DIZZY; SHORT OF BREATH; TEETH FEEL FUNNY; JAW FEEL TIGHT; FACE IS DOING WEIRD MOVEMENT; This spontaneous report received from a patient 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 14-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-SEP-2021, the patient experienced dizzy. On 14-SEP-2021, the patient experienced short of breath. On 14-SEP-2021, the patient experienced face is doing weird movement. On 14-SEP-2021, the patient experienced teeth feel funny. On 14-SEP-2021, the patient experienced jaw feel tight. On 14-SEP-2021, the patient experienced face feel tight. On 14-SEP-2021, the patient experienced headache. On 15-SEP-2021, the patient experienced swollen face. On 15-SEP-2021, the patient experienced rapid heartbeat. On 15-SEP-2021, the patient experienced difficulty walking. On 15-SEP-2021, the patient experienced eyes are blurry. On 15-SEP-2021, the patient experienced right eye twitching/lips shake when smile. On 15-SEP-2021, the patient experienced feels like an anxiety attack in coming. On 15-SEP-2021, the patient experienced weak muscles. On 15-SEP-2021, the patient experienced sore muscles. On 15-SEP-2021, the patient experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dizzy, and short of breath, and the outcome of swollen face, rapid heartbeat, nausea, sore muscles, difficulty walking, face is doing weird movement, eyes are blurry, right eye twitching/lips shake when smile, teeth feel funny, jaw feel tight, headache, feels like an anxiety attack in coming, weak muscles and face feel tight was not reported. This report was non-serious.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: SWOLLEN FACE; RAPID HEARTBEAT; DIFFICULTY WALKING; EYES ARE BLURRY; RIGHT EYE TWITCHING/LIPS SHAKE WHEN SMILE; FEELS LIKE AN ANXIETY ATTACK IN COMING; WEAK MUSCLES; SORE MUSCLES; NAUSEA; HEADACHE; FACE FEEL TIGHT; DIZZY; SHORT OF BREATH; TEETH FEEL FUNNY; JAW FEEL TIGHT; FACE IS DOING WEIRD MOVEMENT; This spontaneous report received from a patient 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 14-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-SEP-2021, the patient experienced dizzy. On 14-SEP-2021, the patient experienced short of breath. On 14-SEP-2021, the patient experienced face is doing weird movement. On 14-SEP-2021, the patient experienced teeth feel funny. On 14-SEP-2021, the patient experienced jaw feel tight. On 14-SEP-2021, the patient experienced face feel tight. On 14-SEP-2021, the patient experienced headache. On 15-SEP-2021, the patient experienced swollen face. On 15-SEP-2021, the patient experienced rapid heartbeat. On 15-SEP-2021, the patient experienced difficulty walking. On 15-SEP-2021, the patient experienced eyes are blurry. On 15-SEP-2021, the patient experienced right eye twitching/lips shake when smile. On 15-SEP-2021, the patient experienced feels like an anxiety attack in coming. On 15-SEP-2021, the patient experienced weak muscles. On 15-SEP-2021, the patient experienced sore muscles. On 15-SEP-2021, the patient experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dizzy, and short of breath, and the outcome of swollen face, rapid heartbeat, nausea, sore muscles, difficulty walking, face is doing weird movement, eyes are blurry, right eye twitching/lips shake when smile, teeth feel funny, jaw feel tight, headache, feels like an anxiety attack in coming, weak muscles and face feel tight was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Immune system disorder
Clinical narrative: FELT LIKE ATTACKING IMMUNE SYSTEM; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 14-SEP-2021 18:00 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 14-SEP-2021, the patient experienced felt like attacking immune system. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from felt like attacking immune system. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: JANSSEN COVID-19 VACCINE AS SECOND DOSE AFTER RECEIVING MODERNA; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. Concomitant medications included mrna 1273 for prophylactic vaccination. On 20-MAR-2021, the patient experienced janssen covid-19 vaccine as second dose after receiving moderna. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of janssen covid-19 vaccine as second dose after receiving moderna was not reported. This report was non-serious.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Poor quality product administered, Product administered to patient of inappropriate age, Underdose
Clinical narrative: OFF LABEL USE; VACCINE WAS WITHDRAWN ON THE PREVIOUS DAY OF VACCINATION AT NOON AND GIVEN ON THE DAY OF REPORT AT NOON; ADMINISTRATED 0.3 ML OF VACCINE; VACCINE ADMINISTRATED TO 12 YEARS PATIENT; This spontaneous report received from a health care professional concerned a 12 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: 201A21A, and expiry: UNKNOWN) dose was not reported, administered on 15-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-SEP-2021, the patient experienced off label use. On 15-SEP-2021, the patient experienced vaccine was withdrawn on the previous day of vaccination at noon and given on the day of report at noon. On 15-SEP-2021, the patient experienced administrated 0.3 ml of vaccine. On 15-SEP-2021, the patient experienced vaccine administrated to 12 years subject. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use, vaccine was withdrawn on the previous day of vaccination at noon and given on the day of report at noon, administrated 0.3 ml of vaccine and vaccine administrated to 12 years patient was not reported. This report was non-serious.