chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; FEELING COLD; FEELING SICK; NO ENERGY; FEELING TIRED; This spontaneous report received from a patient concerned a 92 year old female. The patient's height, and weight were not reported. The patient's past medical history included dropped bladder, and concurrent conditions included non-alcohol user, non-smoker, penicillin allergy, hard time hearing, and hard time understanding. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and expiry: 28-JUL-2021) 1 total, dose was not reported, administered on left arm on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  After vaccination, the patient had no side effects. On unspecified date in MAY-2021, the patient was sick and had cold (put a sweater while was 90 F). She felt tired and had no energy. The patient had stated that she was usually energetic. The patient had blood work done on 03-JUN-2021 and chest X-ray on 07-JUN-2021 for which results were not reported. The patient's physician informed that her test results showed that she did not get the COVID-19 vaccine. It was reported that, the patient had covid-19 antibody test which came back negative (suspected immunological vaccine failure).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected immunological vaccine failure, feeling cold, feeling tired, feeling sick and no energy was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210630052-COVID-19 VACCINE AD26.COV2.S-Suspected Immunological Vaccine Failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Chills, Dyspnoea, Haematemesis, Headache
Clinical narrative: FAINTING; VOMITING BLOOD; SHORTNESS OF BREATH; RACING HEARTBEAT; CHEST PAIN; VOMITING; COLD CHILLS; NAUSEA; FEVER; HEADACHE; This spontaneous report received from a consumer concerned a 31-year-old male patient of unspecified race and ethnic origin.  The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: unknown, expiry date: unknown) dose, start therapy date were not reported, 1 total, administered 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 shortness of breath, racing heartbeat, chest pain, vomiting blood, vomiting, cold chills, nausea, fainting, fever, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, fever, cold chills, shortness of breath, racing heartbeat, chest pain, fainting, nausea, vomiting and vomiting blood was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210633054.; Sender's Comments: V0: 20210630836- covid-19 vaccine ad26.cov2.s -Fainting, vomiting blood. 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: M
Vaccine: COVID19
Symptoms: Heart rate increased, Nausea, Pyrexia, Syncope, Vomiting
Clinical narrative: FAINTING; VOMITING BLOOD; SHORTNESS OF BREATH; RACING HEARTBEAT; CHEST PAIN; VOMITING; COLD CHILLS; NAUSEA; FEVER; HEADACHE; This spontaneous report received from a consumer concerned a 31-year-old male patient of unspecified race and ethnic origin.  The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: unknown, expiry date: unknown) dose, start therapy date were not reported, 1 total, administered 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 shortness of breath, racing heartbeat, chest pain, vomiting blood, vomiting, cold chills, nausea, fainting, fever, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, fever, cold chills, shortness of breath, racing heartbeat, chest pain, fainting, nausea, vomiting and vomiting blood was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210633054.; Sender's Comments: V0: 20210630836- covid-19 vaccine ad26.cov2.s -Fainting, vomiting blood. 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).
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: SICK FOR TWO OR THREE DAYS; This spontaneous report received from a patient via a company representative concerned a 22 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included levofloxacin, lorazepam, and omalizumab.  On an unspecified date, the subject experienced sick for two or three days. The action taken with covid-19 vaccine was not applicable. The outcome of sick for two or three days was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Limb mass, Pain in extremity
Clinical narrative: LUMP UNDER THE FOREARM; PAIN IN THE ARM ALL THE WAY TO THE TIP OF FINGERS; HEADACHE LIKE MIGRAINE; 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 diabetes, and chronic obstructive pulmonary disease. 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 27-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the subject experienced lump under the forearm, pain in the arm all the way to the tip of fingers, and headache like migraine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache like migraine, and had not recovered from pain in the arm all the way to the tip of fingers, and lump under the forearm. This report was non-serious.
Age: 73.0
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: LITTLE SORENESS OF THE ARM/ LITTLE TENDERNESS; This spontaneous report received from a patient concerned a 73 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: 0432A21A, expiry: UNKNOWN) dose was not reported, administered on 07-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 07-JUN-2021, the subject experienced little soreness of the arm/ little tenderness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from little soreness of the arm/ little tenderness on 07-JUN-2021. This report was non-serious.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Nausea, Vomiting
Clinical narrative: CHEST PAIN; VOMITING; NAUSEOUS; This spontaneous report received from a patient concerned a 28 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 14-JUN-2021 11:28 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 14-JUN-2021, the subject experienced chest pain. On 14-JUN-2021, the subject experienced vomiting. On 14-JUN-2021, the subject experienced nauseous. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from vomiting, nauseous, and chest pain. This report was non-serious.; Sender's Comments: MAC not required as per standard procedure for Non Serious cases.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Illness, Migraine with aura
Clinical narrative: SICKNESS; SEVERE MIGRAINE THAT FLARED UP WITH CONSTANT PAIN AND EXTREME LIGHT SENSITIVITY THAT AFFECTED THE VISION AND ABILITY TO TEACH, WRITE OR LOOKING AT THE SCREEN; ENERGY AFFECTED; This spontaneous report received from a patient concerned a 71 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. 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 MAY-2021 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 sickness, severe migraine that flared up with constant pain and extreme light sensitivity that affected the vision and ability to teach, write or looking at the screen, and energy affected. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe migraine that flared up with constant pain and extreme light sensitivity that affected the vision and ability to teach, write or looking at the screen, and energy affected, and the outcome of sickness was not reported. This report was non-serious. This parent/child case is linked to 20210632026.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Oropharyngeal pain, Pain, Somatotropin stimulation test
Clinical narrative: BODY ACHES; SORE THROAT; NAUSEA; This spontaneous report received from a patient concerned a 66 year old female. The patient's weight was 161 pounds, and height was not reported. The patient's past medical history included mood change, not sleeping, chest pain, frequent bowel movement, faeces discoloured more orange in color, pain between shoulder blades, faeces soft or sluggish, itching on front leg, unspecified sleep issues, and sweating, and concurrent conditions included acromegaly. The patient was previously treated with acetylsalicylic acid for chest pain; and experienced vulvovaginal swelling when treated with octreotide for acromegaly.  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 01-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included octreotide acetate for acromegaly, cyclobenzaprine hydrochloride, fenofibrate, ibuprofen, macrogol 3350, and tramadol.  On JUN-2021, the subject experienced generalised aching. On JUN-2021, the subject experienced sore throat. On JUN-2021, the subject experienced nausea. Laboratory data (dates unspecified) included: Growth hormone stimulation test (NR: not provided) Unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from generalised aching, nausea, and sore throat. This report was non-serious.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Diplopia, Dizziness, Headache
Clinical narrative: DIARRHEA; VOMITING; DIZZINESS; WEIRD SMELL; SEEING DOUBLE; PAIN FROM EYEBALLS ALL THE WAY DOWN TO TOES ON LEFT SIDE OF BODY; SWEATING; CHILLS; SORE ARM; FEVER; NAUSEA; HEADACHE; This spontaneous report received from a patient concerned a 53 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, intramuscular, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 12-JUN-2021 17:45 for prophylactic vaccination. Concomitant medications included diphenhydramine hydrochloride, and famotidine. On 13-JUN-2021, the subject experienced dizziness. On 13-JUN-2021, the subject experienced weird smell. On 13-JUN-2021, the subject experienced seeing double. On 13-JUN-2021, the subject experienced pain from eyeballs all the way down to toes on left side of body. On 13-JUN-2021, the subject experienced sweating. On 13-JUN-2021, the subject experienced chills. On 13-JUN-2021, the subject experienced sore arm. On 13-JUN-2021, the subject experienced fever. On 13-JUN-2021, the subject experienced nausea. On 13-JUN-2021, the subject experienced headache. On 14-JUN-2021, the subject experienced diarrhea. On 14-JUN-2021, the subject experienced vomiting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, and sore arm on 14-JUN-2021, was recovering from nausea, and diarrhea, and had not recovered from fever, dizziness, weird smell, seeing double, pain from eyeballs all the way down to toes on left side of body, sweating, chills, and headache. This report was non-serious.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Nausea, Pain, Pain in extremity, Parosmia
Clinical narrative: DIARRHEA; VOMITING; DIZZINESS; WEIRD SMELL; SEEING DOUBLE; PAIN FROM EYEBALLS ALL THE WAY DOWN TO TOES ON LEFT SIDE OF BODY; SWEATING; CHILLS; SORE ARM; FEVER; NAUSEA; HEADACHE; This spontaneous report received from a patient concerned a 53 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, intramuscular, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 12-JUN-2021 17:45 for prophylactic vaccination. Concomitant medications included diphenhydramine hydrochloride, and famotidine. On 13-JUN-2021, the subject experienced dizziness. On 13-JUN-2021, the subject experienced weird smell. On 13-JUN-2021, the subject experienced seeing double. On 13-JUN-2021, the subject experienced pain from eyeballs all the way down to toes on left side of body. On 13-JUN-2021, the subject experienced sweating. On 13-JUN-2021, the subject experienced chills. On 13-JUN-2021, the subject experienced sore arm. On 13-JUN-2021, the subject experienced fever. On 13-JUN-2021, the subject experienced nausea. On 13-JUN-2021, the subject experienced headache. On 14-JUN-2021, the subject experienced diarrhea. On 14-JUN-2021, the subject experienced vomiting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, and sore arm on 14-JUN-2021, was recovering from nausea, and diarrhea, and had not recovered from fever, dizziness, weird smell, seeing double, pain from eyeballs all the way down to toes on left side of body, sweating, chills, and headache. This report was non-serious.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: DIARRHEA; VOMITING; DIZZINESS; WEIRD SMELL; SEEING DOUBLE; PAIN FROM EYEBALLS ALL THE WAY DOWN TO TOES ON LEFT SIDE OF BODY; SWEATING; CHILLS; SORE ARM; FEVER; NAUSEA; HEADACHE; This spontaneous report received from a patient concerned a 53 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, intramuscular, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 12-JUN-2021 17:45 for prophylactic vaccination. Concomitant medications included diphenhydramine hydrochloride, and famotidine. On 13-JUN-2021, the subject experienced dizziness. On 13-JUN-2021, the subject experienced weird smell. On 13-JUN-2021, the subject experienced seeing double. On 13-JUN-2021, the subject experienced pain from eyeballs all the way down to toes on left side of body. On 13-JUN-2021, the subject experienced sweating. On 13-JUN-2021, the subject experienced chills. On 13-JUN-2021, the subject experienced sore arm. On 13-JUN-2021, the subject experienced fever. On 13-JUN-2021, the subject experienced nausea. On 13-JUN-2021, the subject experienced headache. On 14-JUN-2021, the subject experienced diarrhea. On 14-JUN-2021, the subject experienced vomiting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, and sore arm on 14-JUN-2021, was recovering from nausea, and diarrhea, and had not recovered from fever, dizziness, weird smell, seeing double, pain from eyeballs all the way down to toes on left side of body, sweating, chills, and headache. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: SHIVERS; HIGH FEVER; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 12-JUN-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 12-JUN-2021, the subject experienced shivers. On 12-JUN-2021, the subject experienced high fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shivers, and high fever on 13-JUN-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure, Vomiting
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; VOMITING; This spontaneous report received from a health care professional concerned a female of unspecified age, ethnic origin and race. The patient's height, and weight were not reported. The patient's past medical history included flu virus, and concurrent conditions included disabilities and compromised immune system. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered on an unspecified date in 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 suspected covid-19 infection, suspected clinical vaccination failure, vomiting and not being able to hold down water or food. ER (Emergency Room) balanced her system, just like they had to when her crones like symptoms' had caused many times, for many years, without any viral infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection, suspected clinical vaccination failure and not being able to hold down water or food was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210632001-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.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nausea, Syncope
Clinical narrative: 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) dose not reported, 1 total, start therapy date was 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 fainted after getting the Janssen COVID-19 vaccine. She felt nauseated and sick after.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fainting, nauseated and feeling sick was not reported. This report was serious (Other Medically Important Condition). 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: Headache
Clinical narrative: HEADACHE; 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: Unknown) dose was not reported, administered on 14-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 15-JUN-2021, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: VACCINATION SITE ERYTHEMA (SCRATCHED IT MADE RED INFLAMED MARK); This spontaneous report received from a consumer via a company representative concerned a 55 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included moderate to severe chronic plaque psoriasis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot number. Non-company suspect drugs included: risankizumab (form of admin unknown, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe chronic plaque psoriasis. No concomitant medications were reported.  On an unspecified date, the subject experienced vaccination site erythema (scratched it made red inflamed mark). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from vaccination site erythema (scratched it made red inflamed mark). This report was non-serious.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: HEADACHE PERSISTING AND UNABLE  TO CONTINUE WITH REGULAR DAILY TASKS; TIREDNESS; This spontaneous report received from a consumer concerned a 31 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included seizures, high blood pressure, and bad stomach. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: 07-AUG-2021) dose was not reported, administered on 14-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 14-JUN-2021, the subject experienced headache persisting and unable to continue with regular daily tasks. On 14-JUN-2021, the subject experienced tiredness.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache persisting and unable to continue with regular daily tasks, and the outcome of tiredness was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: Bruising over arms and legs; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number: Unknown) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On APR-2021, the subject experienced bruising over arms and legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bruising over arms and legs. This report was non-serious. This case, from the same reporter is linked to 20210630100.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash erythematous
Clinical narrative: ITCHING UNDER BREAST; SUNBURN LOOKING RASH UNDER BREAST; 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 was not reported, administered on 04-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 14-JUN-2021, the subject experienced itching under breast. On 14-JUN-2021, the subject experienced sunburn looking rash under breast. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sunburn looking rash under breast, and itching under breast. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Seizure like phenomena
Clinical narrative: SEIZURE LIKE EVENT; This spontaneous report received from a health care professional concerned 3 male patients of unspecified age.   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) 1 total, 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.  It was reported that, on an unspecified date, three patients experienced seizure like event after vaccination (within 21 days prior to this report). It was also reported that, the seizures happened without any type of warning and were dangerous. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of seizure like event was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210627629.; Sender's Comments: V0: 20210632989-covid-19 vaccine ad26.cov2.s-seizure like event. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Poor quality product administered
Clinical narrative: THE DOSES WERE ADMINISTERED 2 HOURS PAST RECOMMENDED EXPIRY DATE FOR ROOM TEMPERATURE STORAGE; OUT OF SPECIFICATIONS PRODUCT USE; This spontaneous report received from a health care professional concerned a 63 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 14-JUN-2021 13:26 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 14-JUN-2021, the subject experienced the doses were administered 2 hours past recommended expiry date for room temperature storage. On 14-JUN-2021, the subject experienced out of specifications product use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the the doses were administered 2 hours past recommended expiry date for room temperature storage and out of specifications product use was not reported. This report was non-serious. This case, from the same reporter is linked to 20210632891.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Blood urea, Dizziness, Dyspnoea
Clinical narrative: DIZZINESS; PALPITATIONS; DIFFICULTY BREATHING; JOINT PAIN IN BILATERAL SHOLDERS; MUSCLE ACHES; WEAKNESS; TIREDNESS; HEADACHE; This spontaneous report received from a patient concerned a 75 year old female. The patient's weight was 123 pounds, and height was 67 inches. The patient's past medical history included laminectomy of l4 & l5, urinary mesh insertion, and removal of urinary mesh, and concurrent conditions included chronic obstructive pulmonary disease, thyroid problems, urinary incontinence, mold allergy, alcohol, and occasional smoking, and other pre-existing medical conditions included the patient has allergy of different plants and prilosec (difficulty breathing & swallowing). The patient had correction of urinary mesh in 2009 and 2010 and did not have history of drug abuse or illicit drug. The patient experienced difficulty breathing and swallowing when treated with omeprazole.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 27-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 13-MAR-2020, Laboratory data included: BUN (NR: not provided) UNKNOWN, CBC (NR: not provided) UNKNOWN, Thyroid function test (NR: not provided) UNKNOWN, and WBC (NR: not provided) Elevated. On 29-APR-2021, the subject experienced dizziness. On 29-APR-2021, the subject experienced palpitations. On 29-APR-2021, the subject experienced difficulty breathing. On 29-APR-2021, the subject experienced joint pain in bilateral sholders. On 29-APR-2021, the subject experienced muscle aches. On 29-APR-2021, the subject experienced weakness. On 29-APR-2021, the subject experienced tiredness. On 29-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the dizziness, palpitations, muscle aches, weakness, tiredness, headache, difficulty breathing and joint pain in bilateral sholders was not reported. This report was non-serious.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Full blood count, Headache, Myalgia, Palpitations
Clinical narrative: DIZZINESS; PALPITATIONS; DIFFICULTY BREATHING; JOINT PAIN IN BILATERAL SHOLDERS; MUSCLE ACHES; WEAKNESS; TIREDNESS; HEADACHE; This spontaneous report received from a patient concerned a 75 year old female. The patient's weight was 123 pounds, and height was 67 inches. The patient's past medical history included laminectomy of l4 & l5, urinary mesh insertion, and removal of urinary mesh, and concurrent conditions included chronic obstructive pulmonary disease, thyroid problems, urinary incontinence, mold allergy, alcohol, and occasional smoking, and other pre-existing medical conditions included the patient has allergy of different plants and prilosec (difficulty breathing & swallowing). The patient had correction of urinary mesh in 2009 and 2010 and did not have history of drug abuse or illicit drug. The patient experienced difficulty breathing and swallowing when treated with omeprazole.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 27-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 13-MAR-2020, Laboratory data included: BUN (NR: not provided) UNKNOWN, CBC (NR: not provided) UNKNOWN, Thyroid function test (NR: not provided) UNKNOWN, and WBC (NR: not provided) Elevated. On 29-APR-2021, the subject experienced dizziness. On 29-APR-2021, the subject experienced palpitations. On 29-APR-2021, the subject experienced difficulty breathing. On 29-APR-2021, the subject experienced joint pain in bilateral sholders. On 29-APR-2021, the subject experienced muscle aches. On 29-APR-2021, the subject experienced weakness. On 29-APR-2021, the subject experienced tiredness. On 29-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the dizziness, palpitations, muscle aches, weakness, tiredness, headache, difficulty breathing and joint pain in bilateral sholders was not reported. This report was non-serious.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Thyroid function test, White blood cell count
Clinical narrative: DIZZINESS; PALPITATIONS; DIFFICULTY BREATHING; JOINT PAIN IN BILATERAL SHOLDERS; MUSCLE ACHES; WEAKNESS; TIREDNESS; HEADACHE; This spontaneous report received from a patient concerned a 75 year old female. The patient's weight was 123 pounds, and height was 67 inches. The patient's past medical history included laminectomy of l4 & l5, urinary mesh insertion, and removal of urinary mesh, and concurrent conditions included chronic obstructive pulmonary disease, thyroid problems, urinary incontinence, mold allergy, alcohol, and occasional smoking, and other pre-existing medical conditions included the patient has allergy of different plants and prilosec (difficulty breathing & swallowing). The patient had correction of urinary mesh in 2009 and 2010 and did not have history of drug abuse or illicit drug. The patient experienced difficulty breathing and swallowing when treated with omeprazole.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 27-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 13-MAR-2020, Laboratory data included: BUN (NR: not provided) UNKNOWN, CBC (NR: not provided) UNKNOWN, Thyroid function test (NR: not provided) UNKNOWN, and WBC (NR: not provided) Elevated. On 29-APR-2021, the subject experienced dizziness. On 29-APR-2021, the subject experienced palpitations. On 29-APR-2021, the subject experienced difficulty breathing. On 29-APR-2021, the subject experienced joint pain in bilateral sholders. On 29-APR-2021, the subject experienced muscle aches. On 29-APR-2021, the subject experienced weakness. On 29-APR-2021, the subject experienced tiredness. On 29-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the dizziness, palpitations, muscle aches, weakness, tiredness, headache, difficulty breathing and joint pain in bilateral sholders was not reported. This report was non-serious.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site nodule, Injection site pain, Injection site pruritus
Clinical narrative: LEFT ARM ITCHING AT INJECTION SITE; LEFT ARM PAIN AT INJECTION SITE; HARD KNOT AT INJECTION SITE UNDER THE SKIN; This spontaneous report received from a patient concerned a 60 year old female. The patient's weight was 260 pounds, and height was 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, and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 10-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-JUN-2021, the subject experienced hard knot at injection site under the skin. On 11-JUN-2021, the subject experienced left arm pain at injection site. On 13-JUN-2021, the subject experienced left arm itching at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hard knot at injection site under the skin, left arm pain at injection site, and left arm itching at injection site. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction, Pain in extremity
Clinical narrative: UNPLEASANT SIDE EFFECTS; MAJOR CALF PAIN IN BOTH LEGS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced unpleasant side effects, and major calf pain in both legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the unpleasant side effects and major calf pain in both legs was not reported. This report was non-serious.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Muscle spasms, Pain assessment, Pain in extremity, Paraesthesia
Clinical narrative: TINGLING IN TOES / TINGLING IN FOOT; NUMBNESS IN FOOT; CRAMPS IN LEGS / CRAMPS IN BOTH FEET/ MUSCLE SPASM IN THIGHS; PAIN THE FOOT AND THIGHS; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient was previously treated with ibuprofen for pain, and acetylsalicylic acid for pain. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, Laboratory data included: Pain scale (NR: not provided) 11/10 intensity. On 07-MAY-2021, the subject experienced tingling in toes / tingling in foot. On 07-MAY-2021, the subject experienced numbness in foot. On 07-MAY-2021, the subject experienced cramps in legs / cramps in both feet/ muscle spasm in thighs. On 07-MAY-2021, the subject experienced pain the foot and thighs. Treatment medications (dates unspecified) included: ergocalciferol, and magnesium. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tingling in toes / tingling in foot, numbness in foot, and pain the foot and thighs, and the outcome of cramps in legs / cramps in both feet/ muscle spasm in thighs was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Joint swelling, Peripheral swelling
Clinical narrative: ARM SWOLLEN; ELBOW SWOLLEN; 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, Expiry: Unknown) dose was not reported, administered on MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAY-2021, the patient's experienced arm swollen and elbow swollen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from arm swollen, and elbow swollen. This report was non-serious.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: This spontaneous report received from a patient concerned a 26 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non-smoker, and non-alcoholic, and other pre-existing medical conditions included the patient had no known allergies and 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: 1808986, and expiry: 15-JUNE-2021) dose was not reported, administered on 15-JUNE-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-JUNE-2021, the subject experienced tired/feeling drained. The action taken with COVID-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tired/feeling drained. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: OUT OF RANGE FOR 3 DAYS; 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: 206A21A expiry: 07-AUG-2021) dose was not reported, administered on 11-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-JUN-2021, the subject experienced out of range for 3 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of out of range for 3 days was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site swelling, Nausea, Pyrexia, Somnolence
Clinical narrative: NAUSEA; FEVER; MUSCLE PAIN AT INJECTION SITE (LEFT ARM)/AT INJECTION SITE FEELS VERY HOT; SWELLING AT INJECTION SITE (LEFT ARM); DROWSINESS; 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 hypothyroid, high blood pressure, and restless legs.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821288, expiry: UNKNOWN) dose was not reported, administered on 12-JUN-2021 12:30 for prophylactic vaccination. No concomitant medications were reported. On 12-JUN-2021, the subject experienced drowsiness. On 15-JUN-2021, the subject experienced muscle pain at injection site (left arm) /at injection site feels very hot. On 15-JUN-2021, the subject experienced swelling at injection site (left arm). On 16-JUN-2021, the subject experienced nausea. On 16-JUN-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from drowsiness on 14-JUN-2021, and had not recovered from nausea, fever, muscle pain at injection site (left arm)/at injection site feels very hot, and swelling at injection site (left arm). This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: MASSIVE INSANE CHILLS; MASSIVE INSANE 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced massive insane chills, and massive insane fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from massive insane chills, and massive insane fever. This report was non-serious.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dehydration, Diarrhoea, Disturbance in attention, Feeling abnormal
Clinical narrative: DIARRHEA; FOGGY FEELING; BEING UNABLE  TO FOCUS; COLD AND HOT SWEATS; FINGER NUMBNESS WHICH COMES AND GOES; FEELING DEHYDRATED; BODY WEAK/CAN ONLY LAY IN BED; HEADACHE; SORE IN RIGHT ARM AT INJECTION SITE; This spontaneous report received from a patient concerned a 28 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no change in lifestyle. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: 07-AUG-2021) dose was not reported, administered on 15-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, treatment medications included: paracetamol. On 15-JUN-2021, the subject experienced diarrhea. On 15-JUN-2021, the subject experienced foggy feeling. On 15-JUN-2021, the subject experienced being unable to focus. On 15-JUN-2021, the subject experienced cold and hot sweats. On 15-JUN-2021, the subject experienced finger numbness which comes and goes. On 15-JUN-2021, the subject experienced feeling dehydrated. On 15-JUN-2021, the subject experienced body weak/can only lay in bed. On 15-JUN-2021, the subject experienced headache. On 15-JUN-2021, the subject experienced sore in right arm at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body weak/can only lay in bed, headache, diarrhea, foggy feeling, cold and hot sweats, sore in right arm at injection site, finger numbness which comes and goes, feeling dehydrated, and being unable to focus. This report was non-serious.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Hypoaesthesia, Injection site pain
Clinical narrative: DIARRHEA; FOGGY FEELING; BEING UNABLE  TO FOCUS; COLD AND HOT SWEATS; FINGER NUMBNESS WHICH COMES AND GOES; FEELING DEHYDRATED; BODY WEAK/CAN ONLY LAY IN BED; HEADACHE; SORE IN RIGHT ARM AT INJECTION SITE; This spontaneous report received from a patient concerned a 28 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no change in lifestyle. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: 07-AUG-2021) dose was not reported, administered on 15-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, treatment medications included: paracetamol. On 15-JUN-2021, the subject experienced diarrhea. On 15-JUN-2021, the subject experienced foggy feeling. On 15-JUN-2021, the subject experienced being unable to focus. On 15-JUN-2021, the subject experienced cold and hot sweats. On 15-JUN-2021, the subject experienced finger numbness which comes and goes. On 15-JUN-2021, the subject experienced feeling dehydrated. On 15-JUN-2021, the subject experienced body weak/can only lay in bed. On 15-JUN-2021, the subject experienced headache. On 15-JUN-2021, the subject experienced sore in right arm at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body weak/can only lay in bed, headache, diarrhea, foggy feeling, cold and hot sweats, sore in right arm at injection site, finger numbness which comes and goes, feeling dehydrated, and being unable to focus. This report was non-serious.