chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINE FAILURE; SUSPECTED COVID-19 SYMPTOMS; This spontaneous report received from a patient concerned a 60 year old male. The patient's weight was 189 pounds, and height was 68 inches. The patient's concurrent conditions included non-alcohol user, and non-smoker, and other pre-existing medical conditions included no known drug allergies and no drug abuse or illicit drug usage. 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 with frequency 1 total, dose administered at right arm on 11-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 11-JUL-2021, the patient only felt like he had Covid coded to (suspected covid-19 symptoms) all over again but it resolved in 24 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from suspected covid-19 symptoms on 12-JUL-2021, and the outcome of suspected clinical vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210728143-COVID-19 VACCINE AD26.COV2.S- suspected clinical 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: Hypoaesthesia, Pain in extremity
Clinical narrative: LEFT ARM NUMBNESS; SHOCKING PAIN IN LEFT ARM; 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 10-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 10-APR-2021, the subject experienced left arm numbness. On 10-APR-2021, the subject experienced shocking pain in left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from left arm numbness, and shocking pain in left arm. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Disturbance in attention, Tinnitus
Clinical narrative: RINGING IN EAR; HARD TO CONCENTRATE; 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 and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced ringing in ear, and hard to concentrate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the ringing in ear and hard to concentrate was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Dysgeusia, Gastric disorder, Headache
Clinical narrative: LOSS OF SMELL; BODY ACHES; STOMACH ISSUES; NOT TASTING AT ALL; TASTE IS METALLIC LIKE PENNY/ THINGS STARTED TASTING WEIRD; STRANGE METALLIC SMELL; BODY ODOR CHANGED; BAD HEADACHE; FEVER; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced loss of smell, body aches, stomach issues, not tasting at all, taste is metallic like penny/ things started tasting weird, strange metallic smell, body odor changed, bad headache, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, stomach issues, bad headache, and fever, had not recovered from not tasting at all, taste is metallic like penny/ things started tasting weird, loss of smell, and strange metallic smell, and the outcome of body odor changed was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pain, Parosmia, Pyrexia, Skin odour abnormal
Clinical narrative: LOSS OF SMELL; BODY ACHES; STOMACH ISSUES; NOT TASTING AT ALL; TASTE IS METALLIC LIKE PENNY/ THINGS STARTED TASTING WEIRD; STRANGE METALLIC SMELL; BODY ODOR CHANGED; BAD HEADACHE; FEVER; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced loss of smell, body aches, stomach issues, not tasting at all, taste is metallic like penny/ things started tasting weird, strange metallic smell, body odor changed, bad headache, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, stomach issues, bad headache, and fever, had not recovered from not tasting at all, taste is metallic like penny/ things started tasting weird, loss of smell, and strange metallic smell, and the outcome of body odor changed was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Headache, Injection site pain, Myalgia, Pain in extremity
Clinical narrative: SHORTNESS OF BREATHE WHILE DOING STRENUOUS WALKING; RUNNY NOSE; SLIGHT SORENESS IN LEFT ARM; SLIGHT SORENESS IN LEFT ARM DELTOID AND TRAPEZOID MUSCLE; INJECTION SITE SORENESS; EPISODES OF BOWEL MOVEMENT ACCOMPANIED BY BLOODY DISCHARGE FROM RECTUM; SLIGHT/MILD/DULL HEADACHE; This spontaneous report received from a patient 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 expiry: unknown) dose was not reported,1 total administered on 07-JUL-2021 16:45 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 07-JUL-2021 16:45 after 30 minutes to one hour after the injection patient experienced slight headache, after fifteen hours of injection on 08-JUL-2021 patient experienced slight soreness in left arm, deltoid and trapezoid muscle and runny nose. Patient also experienced first bowel movement accompanied by bloody discharge from rectum after fifteen hours of injection followed by second bowel movement accompanied by bloody discharge from rectum after eighteen hours of injection on 08-JUL-2021 and third bowel movement accompanied by bloody discharge from rectum after twenty hours of injection on 08-JUL-2021. After forty two hours of injection on 09-JUL-2021 bowel movement was normal and no bloody discharge from rectum was there, his left arm was still slightly sore and had occasional mild headache and experienced shortness of breath later that day on 09-JUL-2021  when doing strenuous walking. Patient reported that approximately after seventy two hours of the injection there was slight soreness at injection site and dull headache at times. Patient stated not to experience all of these symptoms before the injection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from episodes of bowel movement accompanied by bloody discharge from rectum on 09-JUL-2021, was recovering from slight/mild/dull headache, slight soreness in left arm deltoid and trapezoid muscle, slight soreness in left arm, and injection site soreness, and had not recovered from shortness of breathe while doing strenuous walking, and the outcome of runny nose was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210728244-Covid-19 vaccine ad26.cov2.s-Episodes of bowel movement accompanied by bloody discharge from rectum. 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: Rectal haemorrhage, Rhinorrhoea
Clinical narrative: SHORTNESS OF BREATHE WHILE DOING STRENUOUS WALKING; RUNNY NOSE; SLIGHT SORENESS IN LEFT ARM; SLIGHT SORENESS IN LEFT ARM DELTOID AND TRAPEZOID MUSCLE; INJECTION SITE SORENESS; EPISODES OF BOWEL MOVEMENT ACCOMPANIED BY BLOODY DISCHARGE FROM RECTUM; SLIGHT/MILD/DULL HEADACHE; This spontaneous report received from a patient 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 expiry: unknown) dose was not reported,1 total administered on 07-JUL-2021 16:45 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 07-JUL-2021 16:45 after 30 minutes to one hour after the injection patient experienced slight headache, after fifteen hours of injection on 08-JUL-2021 patient experienced slight soreness in left arm, deltoid and trapezoid muscle and runny nose. Patient also experienced first bowel movement accompanied by bloody discharge from rectum after fifteen hours of injection followed by second bowel movement accompanied by bloody discharge from rectum after eighteen hours of injection on 08-JUL-2021 and third bowel movement accompanied by bloody discharge from rectum after twenty hours of injection on 08-JUL-2021. After forty two hours of injection on 09-JUL-2021 bowel movement was normal and no bloody discharge from rectum was there, his left arm was still slightly sore and had occasional mild headache and experienced shortness of breath later that day on 09-JUL-2021  when doing strenuous walking. Patient reported that approximately after seventy two hours of the injection there was slight soreness at injection site and dull headache at times. Patient stated not to experience all of these symptoms before the injection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from episodes of bowel movement accompanied by bloody discharge from rectum on 09-JUL-2021, was recovering from slight/mild/dull headache, slight soreness in left arm deltoid and trapezoid muscle, slight soreness in left arm, and injection site soreness, and had not recovered from shortness of breathe while doing strenuous walking, and the outcome of runny nose was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210728244-Covid-19 vaccine ad26.cov2.s-Episodes of bowel movement accompanied by bloody discharge from rectum. 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: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Muscular weakness, Pyrexia
Clinical narrative: WEAKNESS OF THE RIGHT ARM; OCCASIONAL PAIN OF  THE SHOULDER DURING THE DAY WORSE AT NIGHT; FEVERISH; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hyperthyroidism. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: 23-AUG-2021) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. Concomitant medications included levothyroxine for hyperthyroidism.  On 11-APR-2021, the subject experienced feverish. Treatment medications included: paracetamol. On 25-APR-2021, the subject experienced occasional pain of the shoulder during the day worse at night. On 25-MAY-2021, the subject experienced weakness of the right arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feverish on 11-APR-2021, and had not recovered from occasional pain of the shoulder during the day worse at night, and weakness of the right arm. This report was non-serious.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Blood cholesterol, Dizziness, Hypoaesthesia, Myalgia, Pain in extremity
Clinical narrative: PERSISTENT NUMBNESS IN LEFT LEG, BOTH ARMS AND RIGHT LEG HALFWAY FROM SIDE OF LEG TO HALFWAY AROUND THE CALF, BETWEEN ANKLE, KNEE AND HIP; LIGHTHEADEDNESS; SORE ARM; MUSCLE ACHES; This spontaneous report received from a patient concerned a 56 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol user, and non smoker, and other pre-existing medical conditions included the patient takes no prescription or over the counter medications and has no medical conditions and describes self as healthy. the patient had no known allergies and was not a drug abuse or illicit drug user.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805031, expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the subject experienced sore arm. On 10-MAR-2021, the subject experienced muscle aches. On APR-2021, the subject experienced persistent numbness in left leg, both arms and right leg halfway from side of leg to halfway around the calf, between ankle, knee and hip. On APR-2021, the subject experienced lightheadedness. Laboratory data (dates unspecified) included: Cholesterol (NR: not provided) within range. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lightheadedness, and sore arm, and muscle aches on 12-MAR-2021, and had not recovered from persistent numbness in left leg, both arms and right leg halfway from side of leg to halfway around the calf, between ankle, knee and hip. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Malaise
Clinical narrative: MATERNAL EXPOSURE DURING PREGNANCY; FEELING UNWELL; CHILLS; MUSCLE PAIN; HEADACHE; FEVER 100 FAHRENHEIT (°F); FATIGUE; .This solicited pregnancy report received from a consumer concerned a 30 year old female.  The patient was enrolled in a study. The patient's weight was 56.59 kilograms, and height was not reported. The patient's concurrent conditions included alcohol use. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. Concomitant medications included loratadine, and minerals nos/vitamins nos. On 06-APR-2021, the patient experienced maternal exposure during pregnancy. On 06-APR-2021, the patient experienced feeling unwell. On 06-APR-2021, the patient experienced chills. On 06-APR-2021, the patient experienced muscle pain. On 06-APR-2021, the patient experienced headache. On 06-APR-2021, the patient experienced fever 100 fahrenheit (°f). On 06-APR-2021, the patient experienced fatigue. Laboratory data included: Body temperature (NR: not provided) 100 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the muscle pain, headache, fever 100 fahrenheit (°f), feeling unwell, chills, maternal exposure during pregnancy and fatigue was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and maternal exposure during pregnancy was not related, and between covid-19 vaccine ad26.cov2.s, and feeling unwell, chills, muscle pain, headache, fever 100 fahrenheit (°f), and fatigue was related.  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: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Myalgia, Pyrexia
Clinical narrative: MATERNAL EXPOSURE DURING PREGNANCY; FEELING UNWELL; CHILLS; MUSCLE PAIN; HEADACHE; FEVER 100 FAHRENHEIT (°F); FATIGUE; .This solicited pregnancy report received from a consumer concerned a 30 year old female.  The patient was enrolled in a study. The patient's weight was 56.59 kilograms, and height was not reported. The patient's concurrent conditions included alcohol use. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. Concomitant medications included loratadine, and minerals nos/vitamins nos. On 06-APR-2021, the patient experienced maternal exposure during pregnancy. On 06-APR-2021, the patient experienced feeling unwell. On 06-APR-2021, the patient experienced chills. On 06-APR-2021, the patient experienced muscle pain. On 06-APR-2021, the patient experienced headache. On 06-APR-2021, the patient experienced fever 100 fahrenheit (°f). On 06-APR-2021, the patient experienced fatigue. Laboratory data included: Body temperature (NR: not provided) 100 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the muscle pain, headache, fever 100 fahrenheit (°f), feeling unwell, chills, maternal exposure during pregnancy and fatigue was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and maternal exposure during pregnancy was not related, and between covid-19 vaccine ad26.cov2.s, and feeling unwell, chills, muscle pain, headache, fever 100 fahrenheit (°f), and fatigue was related.  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: M
Vaccine: COVID19
Symptoms: Illness, Influenza, Pyrexia
Clinical narrative: WORST FLU SYMPTOMS; REALLY SICK; FEVER; 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced worst flu symptoms, really sick, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from worst flu symptoms, really sick, and fever. This report was non-serious. This case, from the same reporter is linked to 20210727891, 20210728165 and 20210661128.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Dysarthria, Mouth swelling
Clinical narrative: SWOLLEN LIPS AND TONGUE; SLURRED SPEECH; This spontaneous report received from a patient concerned a 67 year old female. The patient's weight was 140 pounds, and height was 67 inches. The patient's concurrent conditions included non-smoker, and non-alcohol user, and other pre-existing medical conditions included no abuse or illicit drug usage. The patient experienced anaphylactic reaction to morphine and drug allergy when treated with morphine, drug allergy when treated with codeine, lisinopril, hydrocodone bitartrate/paracetamol, and tramadol. 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 12-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On JUL-2021, the subject experienced slurred speech. On 12-JUL-2021, the subject experienced swollen lips and tongue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slurred speech on JUL-2021, and was recovering from swollen lips and tongue. This report was non-serious.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Malaise
Clinical narrative: MATERNAL EXPOSURE DURING PREGNANCY; CHILLS; FEELING UNWELL; SORE ARM; FATIGUE; FEVER; HEADACHE; MUSCLE PAIN; This solicited pregnancy report received from a patient concerned a 29 year old female. The patient was enrolled in a non-company sponsored study. The patient's weight was 61.22 kilograms, and height was not reported. The patient's concurrent conditions included multigravida. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and expiry: UNKNOWN) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. Concomitant medications included docosahexaenoic acid. On MAR-2021, the patient experienced chills. On MAR-2021, the patient experienced feeling unwell. On MAR-2021, the patient experienced sore arm. On MAR-2021, the patient experienced fatigue. On MAR-2021, the patient experienced fever. On MAR-2021, the patient experienced headache. On MAR-2021, the patient experienced muscle pain. Laboratory data included: Body temperature (NR: not provided) 100.6. On 16-MAR-2021, the patient experienced maternal exposure during pregnancy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, fatigue, feeling unwell, headache, muscle pain, sore arm, maternal exposure during pregnancy and fever was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and maternal exposure during pregnancy was not related, and between covid-19 vaccine ad26.cov2.s, and chills, feeling unwell, sore arm, fatigue, fever, headache, and muscle pain was related.  This report was non-serious.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: MATERNAL EXPOSURE DURING PREGNANCY; CHILLS; FEELING UNWELL; SORE ARM; FATIGUE; FEVER; HEADACHE; MUSCLE PAIN; This solicited pregnancy report received from a patient concerned a 29 year old female. The patient was enrolled in a non-company sponsored study. The patient's weight was 61.22 kilograms, and height was not reported. The patient's concurrent conditions included multigravida. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and expiry: UNKNOWN) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. Concomitant medications included docosahexaenoic acid. On MAR-2021, the patient experienced chills. On MAR-2021, the patient experienced feeling unwell. On MAR-2021, the patient experienced sore arm. On MAR-2021, the patient experienced fatigue. On MAR-2021, the patient experienced fever. On MAR-2021, the patient experienced headache. On MAR-2021, the patient experienced muscle pain. Laboratory data included: Body temperature (NR: not provided) 100.6. On 16-MAR-2021, the patient experienced maternal exposure during pregnancy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, fatigue, feeling unwell, headache, muscle pain, sore arm, maternal exposure during pregnancy and fever was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and maternal exposure during pregnancy was not related, and between covid-19 vaccine ad26.cov2.s, and chills, feeling unwell, sore arm, fatigue, fever, headache, and muscle pain was related.  This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Asthenia, Cold-stimulus headache, Fatigue, Headache
Clinical narrative: BRAIN FREEZE SENSATIONS; TINGLING; NUMBNESS; UPSET STOMACH; SLOWER THAN HIS NORMAL LIFE; WEAKNESS IN HANDS AND BODY; NAUSEA; HEADACHE; TIREDNESS; SORE ARM; BODY ACHES; This spontaneous report received from a consumer concerned an 18 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no 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 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-APR-2021, the subject experienced body aches. On 08-APR-2021, the subject experienced sore arm. On 08-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced tiredness. On 05-JUL-2021, the subject experienced brain freeze sensations. On 05-JUL-2021, the subject experienced tingling. On 05-JUL-2021, the subject experienced numbness. On 05-JUL-2021, the subject experienced weakness in hands and body. On 05-JUL-2021, the subject experienced upset stomach. On 05-JUL-2021, the subject experienced slower than his normal life. On 05-JUL-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, sore arm, headache, and tiredness on 11-APR-2021, and upset stomach, slower than his normal life, and nausea, and had not recovered from brain freeze sensations, weakness in hands and body, tingling, and numbness. This report was non-serious. This case, from the same reporter is linked to 20210728775.
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Hypokinesia, Nausea, Pain, Pain in extremity
Clinical narrative: BRAIN FREEZE SENSATIONS; TINGLING; NUMBNESS; UPSET STOMACH; SLOWER THAN HIS NORMAL LIFE; WEAKNESS IN HANDS AND BODY; NAUSEA; HEADACHE; TIREDNESS; SORE ARM; BODY ACHES; This spontaneous report received from a consumer concerned an 18 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no 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 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-APR-2021, the subject experienced body aches. On 08-APR-2021, the subject experienced sore arm. On 08-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced tiredness. On 05-JUL-2021, the subject experienced brain freeze sensations. On 05-JUL-2021, the subject experienced tingling. On 05-JUL-2021, the subject experienced numbness. On 05-JUL-2021, the subject experienced weakness in hands and body. On 05-JUL-2021, the subject experienced upset stomach. On 05-JUL-2021, the subject experienced slower than his normal life. On 05-JUL-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, sore arm, headache, and tiredness on 11-APR-2021, and upset stomach, slower than his normal life, and nausea, and had not recovered from brain freeze sensations, weakness in hands and body, tingling, and numbness. This report was non-serious. This case, from the same reporter is linked to 20210728775.
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: BRAIN FREEZE SENSATIONS; TINGLING; NUMBNESS; UPSET STOMACH; SLOWER THAN HIS NORMAL LIFE; WEAKNESS IN HANDS AND BODY; NAUSEA; HEADACHE; TIREDNESS; SORE ARM; BODY ACHES; This spontaneous report received from a consumer concerned an 18 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no 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 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-APR-2021, the subject experienced body aches. On 08-APR-2021, the subject experienced sore arm. On 08-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced tiredness. On 05-JUL-2021, the subject experienced brain freeze sensations. On 05-JUL-2021, the subject experienced tingling. On 05-JUL-2021, the subject experienced numbness. On 05-JUL-2021, the subject experienced weakness in hands and body. On 05-JUL-2021, the subject experienced upset stomach. On 05-JUL-2021, the subject experienced slower than his normal life. On 05-JUL-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, sore arm, headache, and tiredness on 11-APR-2021, and upset stomach, slower than his normal life, and nausea, and had not recovered from brain freeze sensations, weakness in hands and body, tingling, and numbness. This report was non-serious. This case, from the same reporter is linked to 20210728775.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety
Clinical narrative: WORRY; This spontaneous report was received from a patient and concerned a female of unspecified age, race and ethnicity. The patient's height and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 14-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 patients "was so worry" because she heard on the news that people had Guillain Barre syndrome after they got their Janssen Covid 19 vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of worry was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Fatigue, Injection site haemorrhage, Injection site pain, Injection site pruritus
Clinical narrative: WORRY; This spontaneous report was received from a patient and concerned a female of unspecified age, race and ethnicity. The patient's height and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 14-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 patients "was so worry" because she heard on the news that people had Guillain Barre syndrome after they got their Janssen Covid 19 vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of worry was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscular weakness, Respiratory rate increased, Somnolence, Stress, Wrong technique in product usage process
Clinical narrative: WORRY; This spontaneous report was received from a patient and concerned a female of unspecified age, race and ethnicity. The patient's height and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 14-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 patients "was so worry" because she heard on the news that people had Guillain Barre syndrome after they got their Janssen Covid 19 vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of worry was not reported. This report was non-serious.
Age: 89.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety
Clinical narrative: VERY RAPID BREATHING; FEELING WEAK; EXHAUSTED; BLEEDING AT THE SITE OF INJECTION; WRONG INJECTION TECHNIQUE (INSTEAD OF TAKING THE SYRINGE IN AND PUSHING IT IN THEN INJECTING THE FLUID INTO ARM, ADMINISTRATOR JAMMED THE WHOLE SYRINGE, INJECTED THE FLUID AT THE SAME TIME); DIFFICULTY STAYING AWAKE FOR MORE THAN TWO HOURS; ITCHING AT THE SITE OF INJECTION; STRESS; VERY WEAK LEGS; PAIN AT THE SITE OF INJECTION; This spontaneous report received from a patient concerned an 89 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A and expiry: 07-AUG-2021) dose was not reported, administered on 14-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 14-MAY-2021, the subject experienced bleeding at the site of injection. On 14-MAY-2021, the subject experienced wrong injection technique (instead of taking the syringe in and pushing it in then injecting the fluid into arm, administrator jammed the whole syringe, injected the fluid at the same time). On 14-MAY-2021, the subject experienced difficulty staying awake for more than two hours. On 14-MAY-2021, the subject experienced itching at the site of injection. On 14-MAY-2021, the subject experienced stress. On 14-MAY-2021, the subject experienced very weak legs. On 14-MAY-2021, the subject experienced pain at the site of injection. On 13-JUL-2021, the subject experienced exhausted. On an unspecified date, the subject experienced very rapid breathing, and feeling weak. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from difficulty staying awake for more than two hours, and itching at the site of injection on JUN-2021, and very weak legs on 28-MAY-2021, was recovering from bleeding at the site of injection, and pain at the site of injection, had not recovered from very rapid breathing, and exhausted, and the outcome of stress, wrong injection technique (instead of taking the syringe in and pushing it in then injecting the fluid into arm, administrator jammed the whole syringe, injected the fluid at the same time) and feeling weak was not reported. This report was non-serious.
Age: 89.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Fatigue, Injection site haemorrhage, Injection site pain, Injection site pruritus
Clinical narrative: VERY RAPID BREATHING; FEELING WEAK; EXHAUSTED; BLEEDING AT THE SITE OF INJECTION; WRONG INJECTION TECHNIQUE (INSTEAD OF TAKING THE SYRINGE IN AND PUSHING IT IN THEN INJECTING THE FLUID INTO ARM, ADMINISTRATOR JAMMED THE WHOLE SYRINGE, INJECTED THE FLUID AT THE SAME TIME); DIFFICULTY STAYING AWAKE FOR MORE THAN TWO HOURS; ITCHING AT THE SITE OF INJECTION; STRESS; VERY WEAK LEGS; PAIN AT THE SITE OF INJECTION; This spontaneous report received from a patient concerned an 89 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A and expiry: 07-AUG-2021) dose was not reported, administered on 14-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 14-MAY-2021, the subject experienced bleeding at the site of injection. On 14-MAY-2021, the subject experienced wrong injection technique (instead of taking the syringe in and pushing it in then injecting the fluid into arm, administrator jammed the whole syringe, injected the fluid at the same time). On 14-MAY-2021, the subject experienced difficulty staying awake for more than two hours. On 14-MAY-2021, the subject experienced itching at the site of injection. On 14-MAY-2021, the subject experienced stress. On 14-MAY-2021, the subject experienced very weak legs. On 14-MAY-2021, the subject experienced pain at the site of injection. On 13-JUL-2021, the subject experienced exhausted. On an unspecified date, the subject experienced very rapid breathing, and feeling weak. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from difficulty staying awake for more than two hours, and itching at the site of injection on JUN-2021, and very weak legs on 28-MAY-2021, was recovering from bleeding at the site of injection, and pain at the site of injection, had not recovered from very rapid breathing, and exhausted, and the outcome of stress, wrong injection technique (instead of taking the syringe in and pushing it in then injecting the fluid into arm, administrator jammed the whole syringe, injected the fluid at the same time) and feeling weak was not reported. This report was non-serious.
Age: 89.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscular weakness, Respiratory rate increased, Somnolence, Stress, Wrong technique in product usage process
Clinical narrative: VERY RAPID BREATHING; FEELING WEAK; EXHAUSTED; BLEEDING AT THE SITE OF INJECTION; WRONG INJECTION TECHNIQUE (INSTEAD OF TAKING THE SYRINGE IN AND PUSHING IT IN THEN INJECTING THE FLUID INTO ARM, ADMINISTRATOR JAMMED THE WHOLE SYRINGE, INJECTED THE FLUID AT THE SAME TIME); DIFFICULTY STAYING AWAKE FOR MORE THAN TWO HOURS; ITCHING AT THE SITE OF INJECTION; STRESS; VERY WEAK LEGS; PAIN AT THE SITE OF INJECTION; This spontaneous report received from a patient concerned an 89 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A and expiry: 07-AUG-2021) dose was not reported, administered on 14-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 14-MAY-2021, the subject experienced bleeding at the site of injection. On 14-MAY-2021, the subject experienced wrong injection technique (instead of taking the syringe in and pushing it in then injecting the fluid into arm, administrator jammed the whole syringe, injected the fluid at the same time). On 14-MAY-2021, the subject experienced difficulty staying awake for more than two hours. On 14-MAY-2021, the subject experienced itching at the site of injection. On 14-MAY-2021, the subject experienced stress. On 14-MAY-2021, the subject experienced very weak legs. On 14-MAY-2021, the subject experienced pain at the site of injection. On 13-JUL-2021, the subject experienced exhausted. On an unspecified date, the subject experienced very rapid breathing, and feeling weak. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from difficulty staying awake for more than two hours, and itching at the site of injection on JUN-2021, and very weak legs on 28-MAY-2021, was recovering from bleeding at the site of injection, and pain at the site of injection, had not recovered from very rapid breathing, and exhausted, and the outcome of stress, wrong injection technique (instead of taking the syringe in and pushing it in then injecting the fluid into arm, administrator jammed the whole syringe, injected the fluid at the same time) and feeling weak was not reported. This report was non-serious.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Alopecia, Arthralgia, Balance disorder, Dizziness, Limb discomfort
Clinical narrative: DIZZINESS; EQUILIBRIUM OFF WHENEVER STANDING FOR PROLONGED PERIOD; BACK OF LEG DISCOMFORT; SORENESS AND PAIN IN MUSCLES; SORENESS AND PAIN IN JOINTS; HAIR LOSS; SORE ARM; 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 concurrent conditions included penicillin allergy, non alcoholic, non smoker, bouts of irritable bowels syndrome, and fibromyalgia. The patient experienced drug allergy when treated with hydrocodone. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1821288 expiry: UNKNOWN) dose was not reported, administered on 24-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-JUN-2021, the subject experienced hair loss. On 24-JUN-2021, the subject experienced sore arm. On 25-JUN-2021, the subject experienced soreness and pain in joints. On 25-JUN-2021, the subject experienced soreness and pain in muscles. On 26-JUN-2021, the subject experienced dizziness. On 26-JUN-2021, the subject experienced equilibrium off whenever standing for prolonged period. On 26-JUN-2021, the subject experienced back of leg discomfort. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sore arm, soreness and pain in joints, dizziness, back of leg discomfort, hair loss, soreness and pain in muscles, and equilibrium off whenever standing for prolonged period. This report was non-serious.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Pain in extremity
Clinical narrative: DIZZINESS; EQUILIBRIUM OFF WHENEVER STANDING FOR PROLONGED PERIOD; BACK OF LEG DISCOMFORT; SORENESS AND PAIN IN MUSCLES; SORENESS AND PAIN IN JOINTS; HAIR LOSS; SORE ARM; 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 concurrent conditions included penicillin allergy, non alcoholic, non smoker, bouts of irritable bowels syndrome, and fibromyalgia. The patient experienced drug allergy when treated with hydrocodone. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1821288 expiry: UNKNOWN) dose was not reported, administered on 24-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-JUN-2021, the subject experienced hair loss. On 24-JUN-2021, the subject experienced sore arm. On 25-JUN-2021, the subject experienced soreness and pain in joints. On 25-JUN-2021, the subject experienced soreness and pain in muscles. On 26-JUN-2021, the subject experienced dizziness. On 26-JUN-2021, the subject experienced equilibrium off whenever standing for prolonged period. On 26-JUN-2021, the subject experienced back of leg discomfort. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sore arm, soreness and pain in joints, dizziness, back of leg discomfort, hair loss, soreness and pain in muscles, and equilibrium off whenever standing for prolonged period. This report was non-serious.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Antinuclear antibody, Arthralgia, Blood creatine phosphokinase normal, C-reactive protein, Metabolic function test
Clinical narrative: DIZZINESS; EQUILIBRIUM OFF WHENEVER STANDING FOR PROLONGED PERIOD; BACK OF LEG DISCOMFORT; SORENESS AND PAIN IN MUSCLES; SORENESS AND PAIN IN JOINTS; HAIR LOSS; SORE ARM; 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 concurrent conditions included penicillin allergy, non alcoholic, non smoker, bouts of irritable bowels syndrome, and fibromyalgia. The patient experienced drug allergy when treated with hydrocodone. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1821288 expiry: UNKNOWN) dose was not reported, administered on 24-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-JUN-2021, the subject experienced hair loss. On 24-JUN-2021, the subject experienced sore arm. On 25-JUN-2021, the subject experienced soreness and pain in joints. On 25-JUN-2021, the subject experienced soreness and pain in muscles. On 26-JUN-2021, the subject experienced dizziness. On 26-JUN-2021, the subject experienced equilibrium off whenever standing for prolonged period. On 26-JUN-2021, the subject experienced back of leg discomfort. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sore arm, soreness and pain in joints, dizziness, back of leg discomfort, hair loss, soreness and pain in muscles, and equilibrium off whenever standing for prolonged period. This report was non-serious.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscular weakness, Myalgia
Clinical narrative: DIZZINESS; EQUILIBRIUM OFF WHENEVER STANDING FOR PROLONGED PERIOD; BACK OF LEG DISCOMFORT; SORENESS AND PAIN IN MUSCLES; SORENESS AND PAIN IN JOINTS; HAIR LOSS; SORE ARM; 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 concurrent conditions included penicillin allergy, non alcoholic, non smoker, bouts of irritable bowels syndrome, and fibromyalgia. The patient experienced drug allergy when treated with hydrocodone. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1821288 expiry: UNKNOWN) dose was not reported, administered on 24-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-JUN-2021, the subject experienced hair loss. On 24-JUN-2021, the subject experienced sore arm. On 25-JUN-2021, the subject experienced soreness and pain in joints. On 25-JUN-2021, the subject experienced soreness and pain in muscles. On 26-JUN-2021, the subject experienced dizziness. On 26-JUN-2021, the subject experienced equilibrium off whenever standing for prolonged period. On 26-JUN-2021, the subject experienced back of leg discomfort. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sore arm, soreness and pain in joints, dizziness, back of leg discomfort, hair loss, soreness and pain in muscles, and equilibrium off whenever standing for prolonged period. This report was non-serious.