chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Eye pain, Fatigue, Feeling abnormal, Gastroenteritis viral
Clinical narrative: STOMACH PAIN; LEFT LEG CRAMP; KNEE ACHE; TIRED; FEVER; FELT FOGGY AND DAZE; LOSS OF APPETITE; EYE PAIN; DIARRHEA; STOMACH FLU; VOMITING; HOT FLASHES ON BACK; HEADACHE; BODY TREMBLING; ARM BURNING; LYMPH NODE PAIN; UNDER ARM PAIN; INJECTION SITE WARM; ARM SORE; This spontaneous report received from a patient concerned a 54 year old female. The patient's height, and weight were not reported. The patient's past medical history included sore arm, injection site redness, and hand numbness, and concurrent conditions included asthma. The patient was previously treated with tetanus vaccine for tetanus.  The patient received 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 07-APR-2021 15:00 for prophylactic vaccination. Concomitant medications included salbutamol for asthma, and salbutamol sulfate for asthma.  On 07-APR-2021, the subject experienced body trembling. On 07-APR-2021, the subject experienced arm burning. On 07-APR-2021, the subject experienced lymph node pain. On 07-APR-2021, the subject experienced under arm pain. On 07-APR-2021, the subject experienced injection site warm. On 07-APR-2021, the subject experienced arm sore. Treatment medications included: paracetamol. On 08-APR-2021, the subject experienced eye pain. On 08-APR-2021, the subject experienced diarrhea. On 08-APR-2021, the subject experienced stomach flu. On 08-APR-2021, the subject experienced vomiting. On 08-APR-2021, the subject experienced hot flashes on back. On 08-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced felt foggy and daze. On 09-APR-2021, the subject experienced loss of appetite. On 09-APR-2021, the subject experienced tired. On 09-APR-2021, the subject experienced fever. Laboratory data included: Fever (NR: not provided) 100.1 T. On 10-APR-2021, the subject experienced stomach pain. On 10-APR-2021, the subject experienced left leg cramp. On 10-APR-2021, the subject experienced knee ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea, and vomiting on 08-APR-2021, and hot flashes on back on 11-APR-2021, had not recovered from headache, and stomach pain, and the outcome of body trembling, arm burning, arm sore, lymph node pain, under arm pain, injection site warm, eye pain, stomach flu, fever, left leg cramp, knee ache, felt foggy and daze, loss of appetite and tired was not reported. This report was non-serious.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hot flush, Injection site warmth, Lymph node pain, Muscle spasms
Clinical narrative: STOMACH PAIN; LEFT LEG CRAMP; KNEE ACHE; TIRED; FEVER; FELT FOGGY AND DAZE; LOSS OF APPETITE; EYE PAIN; DIARRHEA; STOMACH FLU; VOMITING; HOT FLASHES ON BACK; HEADACHE; BODY TREMBLING; ARM BURNING; LYMPH NODE PAIN; UNDER ARM PAIN; INJECTION SITE WARM; ARM SORE; This spontaneous report received from a patient concerned a 54 year old female. The patient's height, and weight were not reported. The patient's past medical history included sore arm, injection site redness, and hand numbness, and concurrent conditions included asthma. The patient was previously treated with tetanus vaccine for tetanus.  The patient received 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 07-APR-2021 15:00 for prophylactic vaccination. Concomitant medications included salbutamol for asthma, and salbutamol sulfate for asthma.  On 07-APR-2021, the subject experienced body trembling. On 07-APR-2021, the subject experienced arm burning. On 07-APR-2021, the subject experienced lymph node pain. On 07-APR-2021, the subject experienced under arm pain. On 07-APR-2021, the subject experienced injection site warm. On 07-APR-2021, the subject experienced arm sore. Treatment medications included: paracetamol. On 08-APR-2021, the subject experienced eye pain. On 08-APR-2021, the subject experienced diarrhea. On 08-APR-2021, the subject experienced stomach flu. On 08-APR-2021, the subject experienced vomiting. On 08-APR-2021, the subject experienced hot flashes on back. On 08-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced felt foggy and daze. On 09-APR-2021, the subject experienced loss of appetite. On 09-APR-2021, the subject experienced tired. On 09-APR-2021, the subject experienced fever. Laboratory data included: Fever (NR: not provided) 100.1 T. On 10-APR-2021, the subject experienced stomach pain. On 10-APR-2021, the subject experienced left leg cramp. On 10-APR-2021, the subject experienced knee ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea, and vomiting on 08-APR-2021, and hot flashes on back on 11-APR-2021, had not recovered from headache, and stomach pain, and the outcome of body trembling, arm burning, arm sore, lymph node pain, under arm pain, injection site warm, eye pain, stomach flu, fever, left leg cramp, knee ache, felt foggy and daze, loss of appetite and tired was not reported. This report was non-serious.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Tremor, Vomiting
Clinical narrative: STOMACH PAIN; LEFT LEG CRAMP; KNEE ACHE; TIRED; FEVER; FELT FOGGY AND DAZE; LOSS OF APPETITE; EYE PAIN; DIARRHEA; STOMACH FLU; VOMITING; HOT FLASHES ON BACK; HEADACHE; BODY TREMBLING; ARM BURNING; LYMPH NODE PAIN; UNDER ARM PAIN; INJECTION SITE WARM; ARM SORE; This spontaneous report received from a patient concerned a 54 year old female. The patient's height, and weight were not reported. The patient's past medical history included sore arm, injection site redness, and hand numbness, and concurrent conditions included asthma. The patient was previously treated with tetanus vaccine for tetanus.  The patient received 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 07-APR-2021 15:00 for prophylactic vaccination. Concomitant medications included salbutamol for asthma, and salbutamol sulfate for asthma.  On 07-APR-2021, the subject experienced body trembling. On 07-APR-2021, the subject experienced arm burning. On 07-APR-2021, the subject experienced lymph node pain. On 07-APR-2021, the subject experienced under arm pain. On 07-APR-2021, the subject experienced injection site warm. On 07-APR-2021, the subject experienced arm sore. Treatment medications included: paracetamol. On 08-APR-2021, the subject experienced eye pain. On 08-APR-2021, the subject experienced diarrhea. On 08-APR-2021, the subject experienced stomach flu. On 08-APR-2021, the subject experienced vomiting. On 08-APR-2021, the subject experienced hot flashes on back. On 08-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced felt foggy and daze. On 09-APR-2021, the subject experienced loss of appetite. On 09-APR-2021, the subject experienced tired. On 09-APR-2021, the subject experienced fever. Laboratory data included: Fever (NR: not provided) 100.1 T. On 10-APR-2021, the subject experienced stomach pain. On 10-APR-2021, the subject experienced left leg cramp. On 10-APR-2021, the subject experienced knee ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea, and vomiting on 08-APR-2021, and hot flashes on back on 11-APR-2021, had not recovered from headache, and stomach pain, and the outcome of body trembling, arm burning, arm sore, lymph node pain, under arm pain, injection site warm, eye pain, stomach flu, fever, left leg cramp, knee ache, felt foggy and daze, loss of appetite and tired was not reported. This report was non-serious.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal behaviour, Confusional state, Dizziness, Fatigue, Feeling abnormal
Clinical narrative: MILD CONFUSION; CAN NOT GET A THOUGHT TO GO OUT; SEVERE HEADACHE; NAUSEA; FATIGUE; DIZZINESS; VOMITING; BRAIN FOG; This spontaneous report received from a patient concerned a 65 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, expiry: UNKNOWN) dose was not reported, administered on 27-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, the subject experienced brain fog. On 27-MAR-2021, the subject experienced dizziness. On 27-MAR-2021, the subject experienced vomiting. On 27-MAR-2021, the subject experienced severe headache. On 27-MAR-2021, the subject experienced nausea. On 27-MAR-2021, the subject experienced fatigue. On 28-MAR-2021, the subject experienced mild confusion. On 28-MAR-2021, the subject experienced can not get a thought to go out. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, vomiting, brain fog, mild confusion, can not get a thought to go out, severe headache, nausea, and fatigue on 2021. This report was non-serious.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Vomiting
Clinical narrative: MILD CONFUSION; CAN NOT GET A THOUGHT TO GO OUT; SEVERE HEADACHE; NAUSEA; FATIGUE; DIZZINESS; VOMITING; BRAIN FOG; This spontaneous report received from a patient concerned a 65 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, expiry: UNKNOWN) dose was not reported, administered on 27-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, the subject experienced brain fog. On 27-MAR-2021, the subject experienced dizziness. On 27-MAR-2021, the subject experienced vomiting. On 27-MAR-2021, the subject experienced severe headache. On 27-MAR-2021, the subject experienced nausea. On 27-MAR-2021, the subject experienced fatigue. On 28-MAR-2021, the subject experienced mild confusion. On 28-MAR-2021, the subject experienced can not get a thought to go out. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, vomiting, brain fog, mild confusion, can not get a thought to go out, severe headache, nausea, and fatigue on 2021. This report was non-serious.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: PAIN IN BOTH LEGS; This spontaneous report received from a patient concerned a 61 year old male. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 25-MAR-2021, the subject experienced pain in both legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in both legs. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: Vertigo; Dizziness; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced vertigo. On APR-2021, the subject experienced dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from vertigo, and dizziness. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Discomfort, Dizziness, Headache, Myalgia
Clinical narrative: SEVERE BODY ACHES; DIZZINESS; UNABLE TO GET COMFORTABLE; PAIN IN ARM; MYALGIA; FEVER; SEVERE HEADACHE; NAUSEA; WEAKNESS; This spontaneous report received from a patient concerned a 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, and 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 severe body aches, dizziness, unable to get comfortable, pain in arm, myalgia, fever, headache, nausea, and weakness. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from severe body aches, myalgia, fever, headache, nausea, weakness, dizziness, pain in arm, and unable to get comfortable. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Nausea, Pain, Pain in extremity, Pyrexia
Clinical narrative: SEVERE BODY ACHES; DIZZINESS; UNABLE TO GET COMFORTABLE; PAIN IN ARM; MYALGIA; FEVER; SEVERE HEADACHE; NAUSEA; WEAKNESS; This spontaneous report received from a patient concerned a 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, and 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 severe body aches, dizziness, unable to get comfortable, pain in arm, myalgia, fever, headache, nausea, and weakness. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from severe body aches, myalgia, fever, headache, nausea, weakness, dizziness, pain in arm, and unable to get comfortable. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hot flush, Hypoaesthesia oral, Neck pain, Paraesthesia oral
Clinical narrative: HOT FLASHES; NUMBNESS MOUTH; NUMBNESS OF TONGUE; SORENESS IN THE BASE OF NECK; TINGLY TONGUE; RASH ON TORSO; HEADACHES; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included breast cancer, sulfa allergy, neuropathy in the face, and chemotherapy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 11:20 for prophylactic vaccination. No concomitant medications were reported.  On 12-APR-2021, the subject experienced hot flashes. On 12-APR-2021, the subject experienced numbness mouth. On 12-APR-2021, the subject experienced numbness of tongue. On 12-APR-2021, the subject experienced soreness in the base of neck. On 12-APR-2021, the subject experienced tingly tongue. On 12-APR-2021, the subject experienced rash on torso. On 12-APR-2021, the subject experienced headaches. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hot flashes, numbness of tongue, tingly tongue, and rash on torso on 12-APR-2021, was recovering from numbness mouth, and had not recovered from headaches, and soreness in the base of neck. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: HOT FLASHES; NUMBNESS MOUTH; NUMBNESS OF TONGUE; SORENESS IN THE BASE OF NECK; TINGLY TONGUE; RASH ON TORSO; HEADACHES; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included breast cancer, sulfa allergy, neuropathy in the face, and chemotherapy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 11:20 for prophylactic vaccination. No concomitant medications were reported.  On 12-APR-2021, the subject experienced hot flashes. On 12-APR-2021, the subject experienced numbness mouth. On 12-APR-2021, the subject experienced numbness of tongue. On 12-APR-2021, the subject experienced soreness in the base of neck. On 12-APR-2021, the subject experienced tingly tongue. On 12-APR-2021, the subject experienced rash on torso. On 12-APR-2021, the subject experienced headaches. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hot flashes, numbness of tongue, tingly tongue, and rash on torso on 12-APR-2021, was recovering from numbness mouth, and had not recovered from headaches, and soreness in the base of neck. This report was non-serious.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Headache, Influenza like illness
Clinical narrative: DIARRHEA; VOMITING; BODY ACHES; CHILLS; TIREDNESS; HEADACHE; FLU LIKE SYMPTOMS; This spontaneous report received from a consumer concerned multiple patients. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, and non-smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced flu like symptoms. On 09-APR-2021, the subject experienced vomiting. On 09-APR-2021, the subject experienced body aches. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced tiredness. On 09-APR-2021, the subject experienced headache. On 13-APR-2021, the subject experienced diarrhea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, chills, tiredness, and headache on 10-APR-2021, was recovering from vomiting, and diarrhea, and the outcome of flu like symptoms was not reported. This report was non-serious. This case, from the same reporter is linked to 20210424370.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vomiting
Clinical narrative: DIARRHEA; VOMITING; BODY ACHES; CHILLS; TIREDNESS; HEADACHE; FLU LIKE SYMPTOMS; This spontaneous report received from a consumer concerned multiple patients. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, and non-smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced flu like symptoms. On 09-APR-2021, the subject experienced vomiting. On 09-APR-2021, the subject experienced body aches. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced tiredness. On 09-APR-2021, the subject experienced headache. On 13-APR-2021, the subject experienced diarrhea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, chills, tiredness, and headache on 10-APR-2021, was recovering from vomiting, and diarrhea, and the outcome of flu like symptoms was not reported. This report was non-serious. This case, from the same reporter is linked to 20210424370.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Parosmia, Taste disorder
Clinical narrative: SMELL ALTERATION; TASTE ABNORMALITY; headache; This spontaneous report received from a patient concerned a 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: 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 smell alteration, taste abnormality, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from smell alteration, taste abnormality, and headache. This report was non-serious.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Anosmia, Fatigue, Ocular discomfort, Ocular hyperaemia
Clinical narrative: LEFT EYE DISCOMFORT; RED VEIN ON EYES; TIREDNESS; SENSE OF SMELL WENT AWAY; This spontaneous report received from a patient concerned a 50 year old male. The patient's height, and weight were not reported.  The patient's past medical history included cocaine use, marijuana use, abstains from alcohol, and smoker, and concurrent conditions included sleep disorder, high blood pressure, fast heartbeat, problem with urination, and allergy, and other pre-existing medical conditions included unspecified allergy medication a little white pill. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on 29-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 2021, the subject experienced sense of smell went away. On 29-MAR-2021, the subject experienced tiredness. On 31-MAR-2021, the subject experienced left eye discomfort. On 31-MAR-2021, the subject experienced red vein on eyes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sense of smell went away, left eye discomfort, tiredness and red vein on eyes was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, Headache
Clinical narrative: HEADACHE; UNSPECIFIED ADVERSE EVENT; This spontaneous report received from a parent concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced headache, and unspecified adverse event. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache and unspecified adverse event was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: BAD ACHES; CHILLS; FEVER; HEADACHE; FELT WIPED OUT; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On APR-2021, the subject experienced bad aches. On APR-2021, the subject experienced chills. On APR-2021, the subject experienced fever. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced felt wiped out. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bad aches, chills, fever, headache, and felt wiped out on APR-2021. This report was non-serious. This case, from the same reporter is linked to 20210429180.
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose abnormal, Blood pressure measurement, Electrocardiogram, Hypotension, Syncope
Clinical narrative: FAINTED; BLOOD PRESSURE WAS LOW; This spontaneous report received from a consumer concerned a 31-year-old female patient. Initial information was received on 13-APR-2021 and processed with additional information received on 20-APR-2021 via telephone log.  The patient's height, and weight were not reported. The patient's medical history included flu shot in OCT-2020 without any side effects, gestational diabetes during pregnancy 6 years ago, and gave normal birth. The patient is a non-smoker and does not consumer alcohol. No surgery or injuries were reported. The patient did not have any prior clotting disorder or family history of clotting disorders. The patient did not have vericose veins. No allergies were reported.  The patient received vaccination with JANSSEN COVID-19 VACCINE (covid-19 vaccine ad26.cov2.s) (suspension for injection, route of admin not reported, batch number: 206A217, expiry: UNKNOWN) dose was not reported, 1 total, administered on right deltoid muscle on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported as it was reported that patient did not take any medications.  On 11-APR-2021, the patient received the vaccine and within 3 minutes, she felt dizzy and fainted and was taken by Emergency Medical Services to a hospital. Her vital signs were taken (pulse rate, blood pressure, and oxygen saturation) and patient was found to be hypotensive (the husband did not recall blood pressure level). When blood sugar was being tested using a needle for a prick, the blood was not coming out. Her blood sugar was normal at 129 and electrocardiogram was normal. The patient was given intravenous fluids and released home after 6 hours without any other treatment. The patient has been doing well since the release from the hospital ED and no further complaints were reported.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fainted and blood pressure was low on 11-APR-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: The case concerns a 31-year -old female who experienced low blood pressure 3-4 minutes after Janssen Covid-19 vaccine was administered intramuscularly for prevention of symptomatic SARS-CoV-2 virus infection. Patient's height and weight were not reported. Medical history included resolved gestational diabetes. The patient had no history of allergic reactions or reactions to a flu vaccine (last one received OCT-2020). No concomitant medications. Post vaccination the patient felt dizzy, could not sit on the chair and fainted and was taken to Emergency Room.  Her blood pressure was low and she experienced hot flashes and watery eyes. Her blood sugar was 129 and electrocardiogram was normal. The subject was given IV infusion and was released from the ED without any medication. Symptoms of low blood pressure and fainting are known anxiety related reactions to immunization and given temporal relationship are considered likely related  to Janssen vaccine administration.
Age: 52.0
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: RASHES ON  LEFT ARM, BELLY, LEFT ARM PIT AND GROIN AREA; This spontaneous report received from a patient concerned a 52 year old of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (form of admin and route of admin were 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 rashes on left arm, belly, left arm pit and groin area. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from rashes on left arm, belly, left arm pit and groin area. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: GENERALIZED RASH; This spontaneous report received from a patient concerned a 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: 207AD1A expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced generalized rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from generalized rash. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Menstruation delayed, Pain in extremity, Pyrexia
Clinical narrative: CHILLS; LOW GRADE FEVER; EXTREMELY FATIGUED; SORE ARM; DELAYED OF MENSTRUAL CYCLE; This spontaneous report received from a patient concerned a 46 year old female. The patient's weight was 100 pounds, and height was 61 inches. The patient's concurrent conditions included hypothyroidism, seasonal allergies, alcohol user, and non smoker, and other pre-existing medical conditions included patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. Concomitant medications included cetirizine hydrochloride.  On 08-APR-2021, the subject experienced delayed of menstrual cycle. On 08-APR-2021, the subject experienced sore arm. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced low grade fever. On 09-APR-2021, the subject experienced extremely fatigued.  Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, sore arm, and low grade fever, and extremely fatigued on 10-APR-2021, and had not recovered from delayed of menstrual cycle. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Blood immunoglobulin G, Blood immunoglobulin M, Body temperature, Cough, Headache
Clinical narrative: NASAL CONGESTION; SPORADIC COUGH; SORE THROAT; HEADACHE; LOW GRADE 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: 1805031, and expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced nasal congestion.  On APR-2021, the subject experienced sporadic cough. On APR-2021, the subject experienced sore throat. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced low grade fever.  Laboratory data (dates unspecified) included: Blood immunoglobulin G (NR: not provided) POSITIVE, Blood immunoglobulin M (NR: not provided) NEGATIVE, and Body temperature (NR: not provided) 37.5 C. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nasal congestion, sore throat, headache, sporadic cough and low grade fever was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Nasal congestion, Oropharyngeal pain, Pyrexia
Clinical narrative: NASAL CONGESTION; SPORADIC COUGH; SORE THROAT; HEADACHE; LOW GRADE 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: 1805031, and expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced nasal congestion.  On APR-2021, the subject experienced sporadic cough. On APR-2021, the subject experienced sore throat. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced low grade fever.  Laboratory data (dates unspecified) included: Blood immunoglobulin G (NR: not provided) POSITIVE, Blood immunoglobulin M (NR: not provided) NEGATIVE, and Body temperature (NR: not provided) 37.5 C. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nasal congestion, sore throat, headache, sporadic cough and low grade fever was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOT; This spontaneous report received from a male patient of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, frequency 1 total administered on MAR-2021(2weeks ago from date of reporting) 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.  The patient wanted to know about the blood clots with the JNJ shot and was thinking that he had a blood clot on 13-APR-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clot was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: A consumer of unknown age or gender called company to inquire what is going on with blood clots after vaccine. The subject stated that he thinks he has a blood clot 2 weeks after vaccine, but did not provide details, did not see a doctor or have an any diagnosis, and refused to see a doctor despite encouragement. He did not share any contact information or other information stating he would "wait for our lies to come out about clots."  This case is confounded by a lack of meaningful history, a lack of diagnosis, a lack of workup, and a lack of contact information for any follow up. A meaningful medical assessment can not be made.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pyrexia
Clinical narrative: FEVER OF 102 F; HEADACHE; This spontaneous report received from a parent concerned a 48 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: Unknown) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination.  The batch number was not reported and has been requested. No concomitant medications were reported. On 06-APR-2021, the subject experienced fever of 102 f. On 06-APR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 102 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever of 102 f, and headache on APR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: MENSIS; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included break through menstruation, and other pre-existing medical conditions included patient had allergy to benedryl causes break-thru vaginal bleeding and prednisone-causes break-thru vaginal bleeding. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: 23/JUN/2021) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. Concomitant medications included progesterone.  On 11-APR-2021, the subject experienced mensis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from mensis. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: SORE ARM; HEADACHE; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 11-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 sore arm, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore arm and headache was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: HEADACHE; This spontaneous report received from a patient concerned a 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: 1805022, and expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination.  No concomitant medications were reported. On 09-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Limb mass
Clinical narrative: BUMP ON HAND; BURNING IN HAND; This spontaneous report received from a parent concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on APR-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-APR-2021, the subject experienced bump on hand. On 13-APR-2021, the subject experienced burning in hand. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bump on hand and burning in hand was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: SINCE GETTING THE SHOT, NO PAIN IN SHOULDER (HAD PAINFUL ARTHRITIS IN LEFT ARM); 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 arthritis in upper left arm.  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 APR-2021 for prophylactic vaccination. Batch number was not reported has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced since getting the shot, no pain in shoulder (had painful arthritis in left arm). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of since getting the shot, no pain in shoulder (had painful arthritis in left arm) was not reported. This report was non-serious.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Injection site pain, Pyrexia
Clinical narrative: HIGH FEVER; EXTREME FATIGUE; SORE ARM AT INJECTION SITE; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin and aspirin allergy, alcoholic, non smoker, and reye's syndrome. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 13:00 for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021 21:30, the subject experienced high fever. On 10-APR-2021 21:30, the subject experienced extreme fatigue. On 10-APR-2021 21:30, the subject experienced sore arm at injection site.  Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 101 F.  Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from high fever, and extreme fatigue on 12-APR-2021, and had not recovered from sore arm at injection site. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pyrexia
Clinical narrative: FELT TIRED; FEVER; This spontaneous report received from a parent concerned a 50 year old male. 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-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101 F. On 07-APR-2021, the subject experienced felt tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and felt tired was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEATH; This spontaneous report received from a consumer concerned a female of unspecified age and unknown race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 05-APR-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 08-APR-2021, after 3 days of vaccination the patient died due to unknown cause. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0:  This is a spontaneous report of a female of unspecified age who died 3 days following the administration of the Janssen COVID-19 vaccine.  Cause of death, details surrounding the death, the patient's medical history and concomitant medications were not reported. There are insufficient details to make a meaningful medical assessment at this time.; Reported Cause(s) of Death: UNKNOWN CASE OF DEATH
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Body temperature increased, Dizziness, Eating disorder, Feeling abnormal
Clinical narrative: SKIN HURTS; COULD NOT EAT; MISERABLE; LIGHTHEADEDNESS; SCREAMS; WEAKNESS; MUSCLE ACHE; TEMPERATURE 101.4; This spontaneous report received from a patient via a company representative concerned a 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. As per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced skin hurts, could not eat, miserable, lightheadedness, screams, weakness, muscle ache, and temperature 101.4. Laboratory data (dates unspecified) included: Body temperature increased (NR: not provided) 101.4 (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the temperature 101.4, skin hurts, muscle ache, weakness, could not eat, miserable, lightheadedness and screams was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Pain of skin, Screaming
Clinical narrative: SKIN HURTS; COULD NOT EAT; MISERABLE; LIGHTHEADEDNESS; SCREAMS; WEAKNESS; MUSCLE ACHE; TEMPERATURE 101.4; This spontaneous report received from a patient via a company representative concerned a 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. As per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced skin hurts, could not eat, miserable, lightheadedness, screams, weakness, muscle ache, and temperature 101.4. Laboratory data (dates unspecified) included: Body temperature increased (NR: not provided) 101.4 (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the temperature 101.4, skin hurts, muscle ache, weakness, could not eat, miserable, lightheadedness and screams was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: FEELS ITCHY ALL OVER THE CHEST AREA; RASH; 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 abstains from alcohol, and non-smoker, and other pre-existing medical conditions included patient had no known allergies and no drug abuse or illicit drug usage. The patient received 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 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, treatment medications included: diphenhydramine hydrochloride. On 12-APR-2021, the subject experienced feels itchy all over the chest area. On 12-APR-2021, the subject experienced rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from rash, and the outcome of feels itchy all over the chest area was not reported. This report was non-serious.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Peripheral swelling, Vomiting
Clinical narrative: SWELLING IN CALF; VOMITING; NAUSEA; This spontaneous report received from a patient concerned a 79 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypothyroid, joint pain, macrobid iv dye allergy, and bowel impacting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: UNKNOWN) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination. Concomitant medications included oxybutynin for bowel impacting.  On 30-MAR-2021, the subject experienced nausea. On 04-APR-2021, the subject experienced vomiting. On 08-APR-2021, the subject experienced swelling in calf. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting on 05-APR-2021, and had not recovered from swelling in calf, and nausea. This report was non-serious.