chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Back pain, Body temperature, Chills, Feeling hot, Flushing
Clinical narrative: INCREASED SORENESS; FLUSHED SKIN; LOWER BACK IN EXTREME PAIN; LEGS IN EXTREME PAIN; HEADACHE/ SKULL WAS IN A LOT OF PAIN/ PAIN AROUND TEMPLES; CHILLS IN MY EXTREMITIES; FEEL WARMER; FEVER; VOMITING; PAIN AROUND EYES; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included multiple sclerosis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 10-MAR-2021, the subject experienced increased soreness. On 10-MAR-2021, the subject experienced flushed skin. On 10-MAR-2021, the subject experienced lower back in extreme pain. On 10-MAR-2021, the subject experienced legs in extreme pain. On 10-MAR-2021, the subject experienced headache/ skull was in a lot of pain/ pain around temples. On 10-MAR-2021, the subject experienced chills in my extremities. On 10-MAR-2021, the subject experienced feel warmer. On 10-MAR-2021, the subject experienced fever. On 10-MAR-2021, the subject experienced vomiting. On 10-MAR-2021, the subject experienced pain around eyes. Laboratory data included: Body temperature (NR: not provided) 100, 104.5, 102.5. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from increased soreness, flushed skin, legs in extreme pain, chills in my extremities, feel warmer, fever, vomiting, and pain around eyes on 11-MAR-2021, and was recovering from lower back in extreme pain, and headache/ skull was in a lot of pain/ pain around temples. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pain, Pain in extremity, Periorbital pain, Pyrexia
Clinical narrative: INCREASED SORENESS; FLUSHED SKIN; LOWER BACK IN EXTREME PAIN; LEGS IN EXTREME PAIN; HEADACHE/ SKULL WAS IN A LOT OF PAIN/ PAIN AROUND TEMPLES; CHILLS IN MY EXTREMITIES; FEEL WARMER; FEVER; VOMITING; PAIN AROUND EYES; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included multiple sclerosis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 10-MAR-2021, the subject experienced increased soreness. On 10-MAR-2021, the subject experienced flushed skin. On 10-MAR-2021, the subject experienced lower back in extreme pain. On 10-MAR-2021, the subject experienced legs in extreme pain. On 10-MAR-2021, the subject experienced headache/ skull was in a lot of pain/ pain around temples. On 10-MAR-2021, the subject experienced chills in my extremities. On 10-MAR-2021, the subject experienced feel warmer. On 10-MAR-2021, the subject experienced fever. On 10-MAR-2021, the subject experienced vomiting. On 10-MAR-2021, the subject experienced pain around eyes. Laboratory data included: Body temperature (NR: not provided) 100, 104.5, 102.5. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from increased soreness, flushed skin, legs in extreme pain, chills in my extremities, feel warmer, fever, vomiting, and pain around eyes on 11-MAR-2021, and was recovering from lower back in extreme pain, and headache/ skull was in a lot of pain/ pain around temples. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: INCREASED SORENESS; FLUSHED SKIN; LOWER BACK IN EXTREME PAIN; LEGS IN EXTREME PAIN; HEADACHE/ SKULL WAS IN A LOT OF PAIN/ PAIN AROUND TEMPLES; CHILLS IN MY EXTREMITIES; FEEL WARMER; FEVER; VOMITING; PAIN AROUND EYES; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included multiple sclerosis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 10-MAR-2021, the subject experienced increased soreness. On 10-MAR-2021, the subject experienced flushed skin. On 10-MAR-2021, the subject experienced lower back in extreme pain. On 10-MAR-2021, the subject experienced legs in extreme pain. On 10-MAR-2021, the subject experienced headache/ skull was in a lot of pain/ pain around temples. On 10-MAR-2021, the subject experienced chills in my extremities. On 10-MAR-2021, the subject experienced feel warmer. On 10-MAR-2021, the subject experienced fever. On 10-MAR-2021, the subject experienced vomiting. On 10-MAR-2021, the subject experienced pain around eyes. Laboratory data included: Body temperature (NR: not provided) 100, 104.5, 102.5. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from increased soreness, flushed skin, legs in extreme pain, chills in my extremities, feel warmer, fever, vomiting, and pain around eyes on 11-MAR-2021, and was recovering from lower back in extreme pain, and headache/ skull was in a lot of pain/ pain around temples. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Influenza like illness, Pyrexia
Clinical narrative: FLU LIKE SYMPTOMS; CHILLS; FEVER; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 10-MAR-2021, the subject experienced flu like symptoms. On 10-MAR-2021, the subject experienced chills. On 10-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from flu like symptoms, fever, and chills. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: MILD HEADACHE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. Concomitant medications included ibuprofen for pain in back (sciatica). On 06-MAR-2021, the subject experienced mild headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mild headache on 07-MAR-2021. This report was non-serious.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: SORE IN  ARM AT THE INJECTION SITE; This spontaneous report received from a patient concerned a 64 year old female. 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 had no drug or non-drug allergies. the patient did not have any history of drug abuse or illicit drug use. the patient previously had vitamins. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072, and batch number: 1802072/1402072 expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. Concomitant medications included paracetamol.  On 09-MAR-2021, the subject experienced sore in arm at the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore in arm at the injection site on 09-MAR-2021. This report was non-serious. This case, from the same reporter is linked to 20210319996.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Injection site pain, Myalgia
Clinical narrative: PAIN AT INJECTION SITE; SEVERE MUSCLE ACHES; Chills; Headache; Fatigue; FEVER; This spontaneous report received from a pharmacist concerned a African American, Not Hispanic/Latino patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination.  .Batch number was not reported has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced fever. On 06-MAR-2021, the subject experienced pain at injection site. On 06-MAR-2021, the subject experienced severe muscle aches. On 06-MAR-2021, the subject experienced chills. On 06-MAR-2021, the subject experienced headache. On 06-MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe muscle aches, chills, headache, and fatigue on 07-MAR-2021, was recovering from pain at injection site, and the outcome of fever was not reported. This report was non-serious. This case, from the same reporter is linked.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: PAIN AT INJECTION SITE; SEVERE MUSCLE ACHES; Chills; Headache; Fatigue; FEVER; This spontaneous report received from a pharmacist concerned a African American, Not Hispanic/Latino patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination.  .Batch number was not reported has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced fever. On 06-MAR-2021, the subject experienced pain at injection site. On 06-MAR-2021, the subject experienced severe muscle aches. On 06-MAR-2021, the subject experienced chills. On 06-MAR-2021, the subject experienced headache. On 06-MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe muscle aches, chills, headache, and fatigue on 07-MAR-2021, was recovering from pain at injection site, and the outcome of fever was not reported. This report was non-serious. This case, from the same reporter is linked.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Insomnia, Migraine
Clinical narrative: TIRED; ALMOST PASSED OUT; MIGRAINE HEADACHE; NAUSEA; SHIVERS/CHILLS; SHAKING; WAS UP ALL NIGHT; SORE ARM; FEVER; 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 strong reaction to vaccine such as the flu vaccine., and other pre-existing medical conditions included unknown. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 08:00 for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, the subject experienced was up all night. On 06-MAR-2021, the subject experienced sore arm. On 06-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 104 F. On 06-MAR-2021 15:00, the subject experienced shaking. On 06-MAR-2021 15:00, the subject experienced shivers/chills. On 06-MAR-2021 23:00, the subject experienced migraine headache. On 06-MAR-2021 23:00, the subject experienced nausea. On 07-MAR-2021 05:00, the subject experienced almost passed out. On 08-MAR-2021, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from migraine headache, shaking, almost passed out, shivers/chills, fever, and nausea on 07-MAR-2021, and tired on MAR-2021, was recovering from sore arm, and the outcome of was up all night was not reported. This report was non-serious.  Version created to amend previously reported information on 17-Mar-2021. Upon review the following information was amended: reporter causality (WAS UP ALL NIGHT).; Sender's Comments: V0. medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Presyncope, Pyrexia, Tremor
Clinical narrative: TIRED; ALMOST PASSED OUT; MIGRAINE HEADACHE; NAUSEA; SHIVERS/CHILLS; SHAKING; WAS UP ALL NIGHT; SORE ARM; FEVER; 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 strong reaction to vaccine such as the flu vaccine., and other pre-existing medical conditions included unknown. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 08:00 for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, the subject experienced was up all night. On 06-MAR-2021, the subject experienced sore arm. On 06-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 104 F. On 06-MAR-2021 15:00, the subject experienced shaking. On 06-MAR-2021 15:00, the subject experienced shivers/chills. On 06-MAR-2021 23:00, the subject experienced migraine headache. On 06-MAR-2021 23:00, the subject experienced nausea. On 07-MAR-2021 05:00, the subject experienced almost passed out. On 08-MAR-2021, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from migraine headache, shaking, almost passed out, shivers/chills, fever, and nausea on 07-MAR-2021, and tired on MAR-2021, was recovering from sore arm, and the outcome of was up all night was not reported. This report was non-serious.  Version created to amend previously reported information on 17-Mar-2021. Upon review the following information was amended: reporter causality (WAS UP ALL NIGHT).; Sender's Comments: V0. medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pain, Pyrexia
Clinical narrative: BODY ACHES; CHILLS; 102.3 FEVER; HEADACHE; This spontaneous report received from a consumer concerned a 38 year old White (Not Hispanic/Latino)male. The patient's height, and weight were not reported. The patient's past medical history included stroke, dialysis, and drug abuse or illicit drug, and concurrent conditions included smoker, and non-alcoholic, and other pre-existing medical conditions included the patient had no known drug or non drug allergy.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031 expiry: 26-MAY-2021) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the subject experienced body aches. On 10-MAR-2021, the subject experienced chills. On 10-MAR-2021, the subject experienced 102.3 fever. On 10-MAR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 102.3 (not reported). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from 102.3 fever, body aches, headache, and chills. This report was non-serious.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Diarrhoea, Frequent bowel movements, Insomnia
Clinical narrative: BOWEL MOVEMENT; NOT ABLE TO SLEEP; DIARRHEA; NO APPETITE; This spontaneous report received from a patient concerned an 88 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, and batch number: 1805025 expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 at around 12:00 noon for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced diarrhea. On 09-MAR-2021, the subject experienced no appetite. On 10-MAR-2021, the subject experienced not able to sleep. On 11-MAR-2021, the subject experienced bowel movement. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from diarrhea, and no appetite, and the outcome of not able to sleep and bowel movement was not reported. This report was non-serious.; Sender's Comments: MAC Comment: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Exposure during pregnancy, Fatigue, Feeling abnormal
Clinical narrative: DID NOT SLEEP WELL; WOKE UP SWEATY; GETTING HOT; FEELING CHILLED/CHILLED; FEELING A LITTLE FOGGY/FELT OFF; MORE THIRSTY THAN USUAL; HOT FLASHY; FEELING LITTLE ACHY AND SORE; ACTIVE SHIVER; LOW GRADE FEVER; SORE ARM; LITTLE ENERGY; FATIGUE/TIRED; VACCINATION AT 8TH MONTH OF PREGNANCY; INJECTION SITE SORENESS/STUNG A LITTLE; This spontaneous pregnancy report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown. It was not reported whether the patient had been pregnant before. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry date: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 13-MAR-2021, the subject experienced 8th month of pregnancy. On 13-MAR-2021, the subject experienced injection site soreness/stung a little. The date of the subject's last menstrual period and expected delivery date were not reported. On 14-MAR-2021, the subject experienced did not sleep well. On 14-MAR-2021, the subject experienced woke up sweaty. On 14-MAR-2021, the subject experienced getting hot. On 14-MAR-2021, the subject experienced feeling chilled/chilled. On 14-MAR-2021, the subject experienced feeling a little foggy/felt off. On 14-MAR-2021, the subject experienced more thirsty than usual. On 14-MAR-2021, the subject experienced hot flashy. On 14-MAR-2021, the subject experienced feeling little achy and sore. On 14-MAR-2021, the subject experienced active shiver. On 14-MAR-2021, the subject experienced low grade fever. On 14-MAR-2021, the subject experienced sore arm. On 14-MAR-2021, the subject experienced little energy. On 14-MAR-2021, the subject experienced fatigue/tired. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The outcome of the 8th month of pregnancy, injection site soreness/stung a little, feeling chilled/chilled, active shiver, did not sleep well, woke up sweaty, low grade fever, feeling a little foggy/felt off, fatigue/tired, more thirsty than usual, getting hot, hot flashy, sore arm, feeling little achy and sore and little energy was not reported. This report was non-serious. This case, involving the same patient is linked to 20210330993.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious.
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Feeling hot, Hot flush, Hyperhidrosis, Injection site pain
Clinical narrative: DID NOT SLEEP WELL; WOKE UP SWEATY; GETTING HOT; FEELING CHILLED/CHILLED; FEELING A LITTLE FOGGY/FELT OFF; MORE THIRSTY THAN USUAL; HOT FLASHY; FEELING LITTLE ACHY AND SORE; ACTIVE SHIVER; LOW GRADE FEVER; SORE ARM; LITTLE ENERGY; FATIGUE/TIRED; VACCINATION AT 8TH MONTH OF PREGNANCY; INJECTION SITE SORENESS/STUNG A LITTLE; This spontaneous pregnancy report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown. It was not reported whether the patient had been pregnant before. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry date: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 13-MAR-2021, the subject experienced 8th month of pregnancy. On 13-MAR-2021, the subject experienced injection site soreness/stung a little. The date of the subject's last menstrual period and expected delivery date were not reported. On 14-MAR-2021, the subject experienced did not sleep well. On 14-MAR-2021, the subject experienced woke up sweaty. On 14-MAR-2021, the subject experienced getting hot. On 14-MAR-2021, the subject experienced feeling chilled/chilled. On 14-MAR-2021, the subject experienced feeling a little foggy/felt off. On 14-MAR-2021, the subject experienced more thirsty than usual. On 14-MAR-2021, the subject experienced hot flashy. On 14-MAR-2021, the subject experienced feeling little achy and sore. On 14-MAR-2021, the subject experienced active shiver. On 14-MAR-2021, the subject experienced low grade fever. On 14-MAR-2021, the subject experienced sore arm. On 14-MAR-2021, the subject experienced little energy. On 14-MAR-2021, the subject experienced fatigue/tired. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The outcome of the 8th month of pregnancy, injection site soreness/stung a little, feeling chilled/chilled, active shiver, did not sleep well, woke up sweaty, low grade fever, feeling a little foggy/felt off, fatigue/tired, more thirsty than usual, getting hot, hot flashy, sore arm, feeling little achy and sore and little energy was not reported. This report was non-serious. This case, involving the same patient is linked to 20210330993.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious.
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Pain, Pain in extremity, Pyrexia, Thirst
Clinical narrative: DID NOT SLEEP WELL; WOKE UP SWEATY; GETTING HOT; FEELING CHILLED/CHILLED; FEELING A LITTLE FOGGY/FELT OFF; MORE THIRSTY THAN USUAL; HOT FLASHY; FEELING LITTLE ACHY AND SORE; ACTIVE SHIVER; LOW GRADE FEVER; SORE ARM; LITTLE ENERGY; FATIGUE/TIRED; VACCINATION AT 8TH MONTH OF PREGNANCY; INJECTION SITE SORENESS/STUNG A LITTLE; This spontaneous pregnancy report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown. It was not reported whether the patient had been pregnant before. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry date: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 13-MAR-2021, the subject experienced 8th month of pregnancy. On 13-MAR-2021, the subject experienced injection site soreness/stung a little. The date of the subject's last menstrual period and expected delivery date were not reported. On 14-MAR-2021, the subject experienced did not sleep well. On 14-MAR-2021, the subject experienced woke up sweaty. On 14-MAR-2021, the subject experienced getting hot. On 14-MAR-2021, the subject experienced feeling chilled/chilled. On 14-MAR-2021, the subject experienced feeling a little foggy/felt off. On 14-MAR-2021, the subject experienced more thirsty than usual. On 14-MAR-2021, the subject experienced hot flashy. On 14-MAR-2021, the subject experienced feeling little achy and sore. On 14-MAR-2021, the subject experienced active shiver. On 14-MAR-2021, the subject experienced low grade fever. On 14-MAR-2021, the subject experienced sore arm. On 14-MAR-2021, the subject experienced little energy. On 14-MAR-2021, the subject experienced fatigue/tired. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The outcome of the 8th month of pregnancy, injection site soreness/stung a little, feeling chilled/chilled, active shiver, did not sleep well, woke up sweaty, low grade fever, feeling a little foggy/felt off, fatigue/tired, more thirsty than usual, getting hot, hot flashy, sore arm, feeling little achy and sore and little energy was not reported. This report was non-serious. This case, involving the same patient is linked to 20210330993.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious.
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Therapy non-responder
Clinical narrative: SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included Crohn's disease.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022) dose was not reported, frequency 1 total, administered on 06-MAR-2021 at left arm for prophylactic vaccination. Concomitant medications included azathioprine for Crohn's disease, and ustekinumab for Crohn's disease.  It was reported that the patient took covid-19 vaccine ad26.cov2.s on 06-MAR-2021. On 30-MAR-2021, the patient experienced suspected immunological vaccine failure and took antibody test on 30-MAR-2021 and test results on 31-MAR-2021, stated that the patient did not had any detectable antibodies in the test. Laboratory data included: Antibody test (NR: not provided) No detectable antibodies. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210407542-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Suspected Immunological Vaccine Failure. This event is considered not related. The event 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 than the drug. Specifically: SPECIAL SITUATIONS
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Syncope
Clinical narrative: Pt received first dose of Moderna.  While in waiting area she became lightheaded and had a syncopal episode.  911 was called and pt transported to hospital.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Cough, Decreased appetite, Dizziness, Dyspnoea
Clinical narrative: Light headedness, wooziness, nausea and vomiting, shortness of breath, migraine, neck pain, bone aches, cough, hypoxia, loss of appetite, exhaustion
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypoxia, Migraine, Nausea, Neck pain
Clinical narrative: Light headedness, wooziness, nausea and vomiting, shortness of breath, migraine, neck pain, bone aches, cough, hypoxia, loss of appetite, exhaustion
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Light headedness, wooziness, nausea and vomiting, shortness of breath, migraine, neck pain, bone aches, cough, hypoxia, loss of appetite, exhaustion
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cold sweat, Dizziness, Electrocardiogram normal, Fatigue, Heart rate abnormal
Clinical narrative: Dizziness, light headedness, nausea, cold sweat, fatigue, sleepiness accompanied by low blood pressure of 90/59 and a low pulse rate of 50 bpm 10 minutes following injection.  Symptoms alleviated within 30 minutes of onset except fatigue without further intervention.
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Heart rate decreased, Hypotension, Nausea, Somnolence
Clinical narrative: Dizziness, light headedness, nausea, cold sweat, fatigue, sleepiness accompanied by low blood pressure of 90/59 and a low pulse rate of 50 bpm 10 minutes following injection.  Symptoms alleviated within 30 minutes of onset except fatigue without further intervention.
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood pressure measurement, Dizziness, Hypotension
Clinical narrative: Dizziness, light headedness, nausea, cold sweat, fatigue, sleepiness accompanied by low blood pressure of 90/59 and a low pulse rate of 50 bpm 10 minutes following injection.  Symptoms alleviated within 30 minutes of onset except fatigue without further intervention.
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cold sweat, Dizziness, Electrocardiogram normal, Fatigue, Heart rate abnormal
Clinical narrative: Patient received 1st Pfizer dose of Covid-19 vaccine at approximately 9:55am.  Patient reported feeling lightheaded and dizzy and "not right" at approximately 10:00am.  Pharmacist took blood pressure reading (90/59 with pulse of 50) and initiated emergency response system (911).  Paramedics arrived at approximately 10:05am and assessed the patient.  After approximately 5 minutes under paramedic observation, the patient stated he was feeling better and the paramedics assessed the patient's blood pressure was normalizing.  After another 5 minutes, the paramedics left when they thought the patient was fine.  We kept the patient under observation for another 15 minutes and the patient, who was back to normal, left.
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Heart rate decreased, Hypotension, Nausea, Somnolence
Clinical narrative: Patient received 1st Pfizer dose of Covid-19 vaccine at approximately 9:55am.  Patient reported feeling lightheaded and dizzy and "not right" at approximately 10:00am.  Pharmacist took blood pressure reading (90/59 with pulse of 50) and initiated emergency response system (911).  Paramedics arrived at approximately 10:05am and assessed the patient.  After approximately 5 minutes under paramedic observation, the patient stated he was feeling better and the paramedics assessed the patient's blood pressure was normalizing.  After another 5 minutes, the paramedics left when they thought the patient was fine.  We kept the patient under observation for another 15 minutes and the patient, who was back to normal, left.
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood pressure measurement, Dizziness, Hypotension
Clinical narrative: Patient received 1st Pfizer dose of Covid-19 vaccine at approximately 9:55am.  Patient reported feeling lightheaded and dizzy and "not right" at approximately 10:00am.  Pharmacist took blood pressure reading (90/59 with pulse of 50) and initiated emergency response system (911).  Paramedics arrived at approximately 10:05am and assessed the patient.  After approximately 5 minutes under paramedic observation, the patient stated he was feeling better and the paramedics assessed the patient's blood pressure was normalizing.  After another 5 minutes, the paramedics left when they thought the patient was fine.  We kept the patient under observation for another 15 minutes and the patient, who was back to normal, left.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Musculoskeletal discomfort, Pain, Pityriasis rosea
Clinical narrative: Received vaccine 3/31 and experienced fatigue and body aches, but back began burning and itching on 4/6. This was qualified as pityriasis rosea on 4/10. Patient stated that headache began 4/12 and still persists with body aches and rash on back.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Received vaccine 3/31 and experienced fatigue and body aches, but back began burning and itching on 4/6. This was qualified as pityriasis rosea on 4/10. Patient stated that headache began 4/12 and still persists with body aches and rash on back.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Head injury, Loss of consciousness
Clinical narrative: Patient received COVID-19 vaccine at approximately 6:30pm 4/23/21. After waiting 15 minutes in the observation area, patient tried to stand up and lost consciousness. Patient hit his head on the floor. EMS was called, but patient refused treatment or transportation to the hospital. EMS advised patient he may have a mild concussion and he should follow up with a medical professional.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral
Clinical narrative: Patient described perioral numbness 15 minutes after administration of the vaccine. No sign of edema on exam. She was given 25mg of diphenhydramine PO. She was observed for 40 mintues total, then discharged home as she reported resolution of sx.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Menopause, Menstrual disorder
Clinical narrative: recurrence of menstrual bleeding  post menopause
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Blood test, Computerised tomogram abnormal, Diarrhoea, Fatigue
Clinical narrative: Fevers fatigue painful muscles joint inflammation. Diarrhea for 1 month. Headaches
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pyrexia, Stool analysis
Clinical narrative: Fevers fatigue painful muscles joint inflammation. Diarrhea for 1 month. Headaches
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Hyperhidrosis, Injection site erythema
Clinical narrative: Fever/chills/sweats Extremely soar and painful muscles Exhaustion Headache Red patch on injection site appeared 36 hrs after shot (I got this with the first shot which was in my other arm)  Tender lymph nodes in right armpit
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Myalgia, Pyrexia
Clinical narrative: Fever/chills/sweats Extremely soar and painful muscles Exhaustion Headache Red patch on injection site appeared 36 hrs after shot (I got this with the first shot which was in my other arm)  Tender lymph nodes in right armpit
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Injection site pain, Injection site swelling, Pruritus
Clinical narrative: Patient stated she started feeling poorly the night of her vaccination. Symptoms included fever of 100.8F and chills. She also noticed her left arm (arm of vaccination) became very itchy. After the itchiness subsided hours later, she noticed a tight, swollen feeling at the site of injection that was painful. She stated that today 4-23-2021, 8pm, that she is feeling better and her fever and chills have subsided. She still feels tightness and her deltoid area is swollen. We talked about how these symptoms can happen with vaccination and she will continue to use otc pain reliever to help manage painful symptoms. She asked me to submit reaction to VAERS as reaction worried her and she wanted her experience to help with the research and information that we are obtaining about this vaccine to help other people.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Skin tightness
Clinical narrative: Patient stated she started feeling poorly the night of her vaccination. Symptoms included fever of 100.8F and chills. She also noticed her left arm (arm of vaccination) became very itchy. After the itchiness subsided hours later, she noticed a tight, swollen feeling at the site of injection that was painful. She stated that today 4-23-2021, 8pm, that she is feeling better and her fever and chills have subsided. She still feels tightness and her deltoid area is swollen. We talked about how these symptoms can happen with vaccination and she will continue to use otc pain reliever to help manage painful symptoms. She asked me to submit reaction to VAERS as reaction worried her and she wanted her experience to help with the research and information that we are obtaining about this vaccine to help other people.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Injection site warmth, Nausea, Peripheral swelling
Clinical narrative: About 8 hours after injection (around 1:20 am), I experienced body chills and extreme nausea.  I went to bed swaddled in 8 blankets and teeth chattering.  I woke up about 9 am and vomited.    I still had the body chills as well so I stayed in bed and slept.  I woke up around 7 pm and I felt normal except for feeling fatigued.  My arm was swollen and warm to the touch at the injection site but it did not hurt.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: About 8 hours after injection (around 1:20 am), I experienced body chills and extreme nausea.  I went to bed swaddled in 8 blankets and teeth chattering.  I woke up about 9 am and vomited.    I still had the body chills as well so I stayed in bed and slept.  I woke up around 7 pm and I felt normal except for feeling fatigued.  My arm was swollen and warm to the touch at the injection site but it did not hurt.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Decreased appetite, Headache
Clinical narrative: 8th day- 5? circle of itchy rash arm Headache & severe pain in bad left ankle ( broken in Nov 2020) No energy Chills No appetite  Blurry vision still to today
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic, Vision blurred
Clinical narrative: 8th day- 5? circle of itchy rash arm Headache & severe pain in bad left ankle ( broken in Nov 2020) No energy Chills No appetite  Blurry vision still to today
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Hypersomnia, Somnolence
Clinical narrative: Ice cold sensation on upper left arm, gradually extended across upper back.  Also extremely drowsy, taking multiple naps during day, 4/23. Can't find any information regarding this symptom with the vaccine.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Peripheral swelling
Clinical narrative: About 8 days after the vaccine pt developed slight swelling of her upper left arm and then developed redness around the site.  After a few days the redness extended from the top of your left arm down to the elbow.  The redness and swelling slowly subsided and then cleared after about another 4 to 5 days.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Dizziness, Drowning, Erythema, Hyperhidrosis
Clinical narrative: Patient complained of dizziness, nausea, felt like she was "drowning," BP 181/110 elevated, redness, diaphoretic. Patient refused to lay down. Given juice, water, snack, Continued to monitor vital signs. Contacted EMS.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Patient complained of dizziness, nausea, felt like she was "drowning," BP 181/110 elevated, redness, diaphoretic. Patient refused to lay down. Given juice, water, snack, Continued to monitor vital signs. Contacted EMS.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash
Clinical narrative: Rash developed today at injection site. Not bad enough to seek treatment.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Echocardiogram, Electrocardiogram, Electrocardiogram ST segment elevation
Clinical narrative: Chest pain began ~8 hours after receiving vaccine. Pain increased over next week, present in waves with no noticeable cause.  Aggravated by deep breaths.  Diagnosed as likely pericarditis, supported by symptoms and EKG with elevated STs. Began treatment of 800mg Ibuprofen daily.  Currently 15 days after vaccine,  still showing symptoms after 3 days of treatment.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Pericarditis, Red blood cell sedimentation rate increased, Troponin, X-ray
Clinical narrative: Chest pain began ~8 hours after receiving vaccine. Pain increased over next week, present in waves with no noticeable cause.  Aggravated by deep breaths.  Diagnosed as likely pericarditis, supported by symptoms and EKG with elevated STs. Began treatment of 800mg Ibuprofen daily.  Currently 15 days after vaccine,  still showing symptoms after 3 days of treatment.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Injection site pain, Lymph node pain, Lymphadenopathy, Sleep disorder
Clinical narrative: Had pain in injection area and in armpit/lymph node area for 36 hours after shot and then was fine. One week after shot couldn?t sleep night of 4/23/21 due to pain in my armpit.  Got up in the morning on 4/23/21 with very swollen and painful armpit/lymph node area. Contacted doctor.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: AT OFFSITE MASS VACCINATION CLINIC, PATIENT WAS GIVEN PFIZER COVID VACCINE WHEN HE WAS NOT YET 16 YEARS OLD (JUST 4 DAYS SHY OF BIRTHDAY). DISCOVERED THE WEEK AFTER WHEN PHARMACY WAS PROCESSING THE CLINIC PAPERWORK.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Stroke
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Paraesthesia
Clinical narrative: Patient came to second dose vaccine appointment. Patient screened by nurse and stated she had facial tingling and increased heart rate after first dose received for 45  min. Patient did not report symptoms to staff while under observation.  Patient advised to receive second dose vaccine at hospital due to reaction. Patient verbalized understanding.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray abnormal, Deep vein thrombosis, Dyspnoea, Peripheral swelling, Pneumonia
Clinical narrative: First DVT in an 85-year-old ambulatory female on daily ASA.  Also found to have pneumonia at the same time.  Presented afebrile with gradually progressive dyspnea over days and acute onset right lower extremity swelling and pain over hours.  Normal O2 sat.  Pt was evaluated and seen in memory care where she currently lives.  Treatment:  ASA discontinued, Eliquis and Levaquin started.  Pt remained in memory care and is doing well with almost complete recovery 10 weeks later.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound Doppler
Clinical narrative: First DVT in an 85-year-old ambulatory female on daily ASA.  Also found to have pneumonia at the same time.  Presented afebrile with gradually progressive dyspnea over days and acute onset right lower extremity swelling and pain over hours.  Normal O2 sat.  Pt was evaluated and seen in memory care where she currently lives.  Treatment:  ASA discontinued, Eliquis and Levaquin started.  Pt remained in memory care and is doing well with almost complete recovery 10 weeks later.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Headache, Oversensing
Clinical narrative: Daily headache and left ear noise sensitivity and pain. Onset March 28, 2021. Not yet resolved.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic, Skin burning sensation
Clinical narrative: 12-36 hours after, hands were burning. 11 days after injection - small rash on middle, right finger. Blister has not gone away - itches and stings.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Vaccination site reaction
Clinical narrative: Red circle rash on vaccine site arm
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: Large rash near injection site-- probably 4 inches in diameter, feels similar to a mosquito bite (slightly painful and itchy)
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Injection site pruritus, Vaccination site mass, Vaccination site pain, Vaccination site swelling
Clinical narrative: At first the vaccination site was a little sore and I had a small pea sized bump. It went away within a few days, however I woke up this morning with a burning sensation in my upper arm. The area is warm to the touch, itchy and there is a large egg sized lump.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: At first the vaccination site was a little sore and I had a small pea sized bump. It went away within a few days, however I woke up this morning with a burning sensation in my upper arm. The area is warm to the touch, itchy and there is a large egg sized lump.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Coronary arterial stent insertion, Myocardial infarction, Type 2 diabetes mellitus
Clinical narrative: Heart Attack, two stents placed
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: PATIENT STARTED FEELING FAINT AND NAUSEA AFTER RECEIVING PFIZER COVID -19 VACCINE. DID NOT RESOLVE AFTER ABOUT 7 MINUTES. WAS GETTING WORSE PER PATIENT. I CALLED PARAMEDICS. PATIENT WAS TAKEN OUT OF THE BUILDING BY PARAMEDICS TO BE ATTENDED TO. FOLLOWED UP WITH MOTHER SINCE PATIENT WAS A MINOR. PER MOM, PATIENT DOING OK NOW. AT HOME. WAS NOT TAKEN TO E.R.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Ear pain, Fatigue, Injection site pain
Clinical narrative: At 9:00 PM on the day of vaccination (8 hours after vaccination) I felt achy and tired and needed to lay down. I also had chills and soreness & swelling at the injection site. I went to bed at 10:30pm. At 1:45 AM (13 hours after vaccination) I woke up with low grade fever, chills, muscle/body aches, fatigue, headache, earache, and sore throat. I could not go back to sleep all night and by 3:00 AM (14 hours after vaccination) I also had nausea and light, dry cough. I had sharp headache and earache pangs. These symptoms persisted. At 11:00 AM the following day (22 hours after vaccination) I took Nyquil containing acetominophen. At around 4:00 AM the next night (39 hours after vaccination) my fever was gone and the other symptoms started to slowly get better the following day.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Myalgia, Nausea, Oropharyngeal pain, Pain
Clinical narrative: At 9:00 PM on the day of vaccination (8 hours after vaccination) I felt achy and tired and needed to lay down. I also had chills and soreness & swelling at the injection site. I went to bed at 10:30pm. At 1:45 AM (13 hours after vaccination) I woke up with low grade fever, chills, muscle/body aches, fatigue, headache, earache, and sore throat. I could not go back to sleep all night and by 3:00 AM (14 hours after vaccination) I also had nausea and light, dry cough. I had sharp headache and earache pangs. These symptoms persisted. At 11:00 AM the following day (22 hours after vaccination) I took Nyquil containing acetominophen. At around 4:00 AM the next night (39 hours after vaccination) my fever was gone and the other symptoms started to slowly get better the following day.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Sleep disorder
Clinical narrative: At 9:00 PM on the day of vaccination (8 hours after vaccination) I felt achy and tired and needed to lay down. I also had chills and soreness & swelling at the injection site. I went to bed at 10:30pm. At 1:45 AM (13 hours after vaccination) I woke up with low grade fever, chills, muscle/body aches, fatigue, headache, earache, and sore throat. I could not go back to sleep all night and by 3:00 AM (14 hours after vaccination) I also had nausea and light, dry cough. I had sharp headache and earache pangs. These symptoms persisted. At 11:00 AM the following day (22 hours after vaccination) I took Nyquil containing acetominophen. At around 4:00 AM the next night (39 hours after vaccination) my fever was gone and the other symptoms started to slowly get better the following day.