chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Tachycardia, Urine analysis
Clinical narrative: CONFUSED FEELING; ELEVATED BLOOD PRESSURE 150/100; TACHYCARDIA/RACING HEART; DIARRHEA; WHOLE BODY ACHES; DIZZINESS/LIGHT HEADEDNESS/FELT FAINT; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 38 year old not Hispanic or Latino, White female. The patient's weight was 135 pounds, and height was 60 inches. The patient's concurrent conditions included thalassemia, no alcohol use, and non smoker, and other pre-existing medical conditions included patient had no known drug allergies. patient had no drug abuse or illicit drug usage. Patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: 09-JUN-2021) dose was not reported, frequency once total administered on 05-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 05-APR-2021, the patient experienced dizziness/light headedness/felt faint,  whole body aches, fever, headache. On 07-APR-2021, the patient then experienced tachycardia/racing heart and diarrhea, called 911 and had elevated blood pressure 150/100 and referred to cardiologist. On 08-APR-2021, the patient experienced confused feeling. Laboratory data included: Blood pressure (NR: not provided) 150/100 mmHg, complete blood count (NR: not provided) autolymphocytes numer 0.91, WBC 4.59, red cell distribution width 17.4 me, Chest X-ray (NR: not provided) unknown, Creatinine (NR: not provided) 0.6, Electrocardiogram (NR: not provided) unknown, Echocardiogram (NR: not provided) unknown, Glucose (NR: not provided) 105, Hematocrit (NR: not provided) 34.9, Lymphocytes (NR: not provided) 19.8, Monocyte count (NR: not provided) 11.8, and Urinalysis (NR: not provided) negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from whole body aches, and fever on 06-APR-2021, was recovering from headache, and elevated blood pressure 150/100 , had not recovered from dizziness/light headedness/felt faint, diarrhea, and tachycardia/racing heart, and the outcome of  confused feeling was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210420710- Covid-19 vaccine ad26.cov2.s-Elevated blood pressure 150/100. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Injection site pain, Nail discolouration, Pyrexia
Clinical narrative: BLUE NAILS; CHILLS; FEVER; HEADACHE; SORENESS ON INJECTION SITE; This spontaneous report received from a patient via a company representative concerned a 26 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, batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced blue nails. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced fever. On 08-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced soreness on injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blue nails on 09-APR-2021, and had not recovered from fever, chills, headache, and soreness on injection site. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Sensory disturbance
Clinical narrative: 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: 042a21a, and expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 14:00 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced right leg feel weird. On 10-APR-2021 23:48, the subject experienced right leg pain. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from right leg pain, and right leg feel weird. This report was non-serious.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Headache, Nausea, Pain, SARS-CoV-2 test
Clinical narrative: SHORTNESS OF BREATH; HEADACHE; NAUSEA; BODY ACHES; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's past medical history included anxiety, and covid-19, and concurrent conditions included penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On FEB-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Positive.  On 09-APR-2021, the subject experienced body aches. On 09-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced nausea. On 10-APR-2021, the subject experienced shortness of breath. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, body aches, nausea, and shortness of breath. This report was non-serious.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Dizziness, Headache, Muscular weakness
Clinical narrative: DIZZINESS; FEELS LIKE GOING TO PASS OUT; LEG WEAKNESS; QUEASINESS; HEADACHE; NAUSEA; FEVER; CHILLS; LOSS OF APPETITE; This spontaneous report received from a parent concerned a 19 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid 19 positive test in November 2020. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 15:15 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced loss of appetite. On 07-APR-2021, the subject experienced chills. On 07-APR-2021, the subject experienced nausea. On 07-APR-2021, the subject experienced fever. On 07-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced dizziness. On 09-APR-2021, the subject experienced feels like going to pass out. On 09-APR-2021, the subject experienced leg weakness. On 09-APR-2021, the subject experienced queasiness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from loss of appetite, chills, nausea, fever, and headache on 08-APR-2021, and had not recovered from dizziness, leg weakness, queasiness, and feels like going to pass out. This report was non-serious.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: DIZZINESS; FEELS LIKE GOING TO PASS OUT; LEG WEAKNESS; QUEASINESS; HEADACHE; NAUSEA; FEVER; CHILLS; LOSS OF APPETITE; This spontaneous report received from a parent concerned a 19 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid 19 positive test in November 2020. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 15:15 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced loss of appetite. On 07-APR-2021, the subject experienced chills. On 07-APR-2021, the subject experienced nausea. On 07-APR-2021, the subject experienced fever. On 07-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced dizziness. On 09-APR-2021, the subject experienced feels like going to pass out. On 09-APR-2021, the subject experienced leg weakness. On 09-APR-2021, the subject experienced queasiness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from loss of appetite, chills, nausea, fever, and headache on 08-APR-2021, and had not recovered from dizziness, leg weakness, queasiness, and feels like going to pass out. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Respiratory rate increased, Syncope
Clinical narrative: FAINTING; INCREASED BREATHING; LIGHTHEADEDNESS/DIZZINESS; NAUSEA; This spontaneous report received from a consumer concerned multiple patients (18). The reporter saw this information on the news.  The patients' weight, height, and medical history were not reported.  The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, 18 patients experienced fainting, increased breathing, dizziness/lightheadedness, and nausea. 4 out of the 18 patients went to the hospital.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nausea, lightheadedness/dizziness, fainting and increased breathing was not reported.. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210420362.; Sender's Comments: V0-20210420809-covid-19 vaccine ad26.cov2.s -Fainting. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dizziness, Headache, Injection site pain
Clinical narrative: CHILLS; BODY ACHE; DIZZINESS/LIGHTHEADEDNESS; INJECTION SITE PAIN; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 31 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had topical soaps allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, Laboratory data included: Body temperature (NR: not provided) 95.5 Unit not reported, 93.4 Unit not reported. On 08-APR-2021, the subject experienced dizziness/lightheadedness. On 08-APR-2021, the subject experienced injection site pain. On 08-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced fever. On 08-APR-2021 17:30, the subject experienced body ache. On 08-APR-2021 17:30, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, chills, injection site pain, headache, and fever on 09-APR-2021, and had not recovered from dizziness/lightheadedness. This report was non-serious.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: CHILLS; BODY ACHE; DIZZINESS/LIGHTHEADEDNESS; INJECTION SITE PAIN; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 31 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had topical soaps allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, Laboratory data included: Body temperature (NR: not provided) 95.5 Unit not reported, 93.4 Unit not reported. On 08-APR-2021, the subject experienced dizziness/lightheadedness. On 08-APR-2021, the subject experienced injection site pain. On 08-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced fever. On 08-APR-2021 17:30, the subject experienced body ache. On 08-APR-2021 17:30, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, chills, injection site pain, headache, and fever on 09-APR-2021, and had not recovered from dizziness/lightheadedness. This report was non-serious.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Body temperature, Body temperature decreased, Chills, Nausea
Clinical narrative: LOWER BACK/KIDNEY PAIN; CHILLS (SEVERE, UNCONTROLLABLE SHAKING, COLD HANDS AND FEET); SORE ARM; NAUSEA; FEVER; This spontaneous report received from a consumer concerned a 52 year old male. The patient's height, and weight were not reported. The patient's past medical history included panic attacks. The patient was previously treated with alprazolam for panic attacks.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 09-APR-2021 10:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 09-APR-2021, the subject experienced lower back/kidney pain. On 09-APR-2021, the subject experienced chills (severe, uncontrollable shaking, cold hands and feet). On 09-APR-2021, the subject experienced sore arm. On 09-APR-2021, the subject experienced nausea. On 09-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 109 F, and Body temperature decreased (NR: not provided) 102.8 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills (severe, uncontrollable shaking, cold hands and feet), nausea, lower back/kidney pain, sore arm, and fever. This report was non-serious.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: LOWER BACK/KIDNEY PAIN; CHILLS (SEVERE, UNCONTROLLABLE SHAKING, COLD HANDS AND FEET); SORE ARM; NAUSEA; FEVER; This spontaneous report received from a consumer concerned a 52 year old male. The patient's height, and weight were not reported. The patient's past medical history included panic attacks. The patient was previously treated with alprazolam for panic attacks.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 09-APR-2021 10:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 09-APR-2021, the subject experienced lower back/kidney pain. On 09-APR-2021, the subject experienced chills (severe, uncontrollable shaking, cold hands and feet). On 09-APR-2021, the subject experienced sore arm. On 09-APR-2021, the subject experienced nausea. On 09-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 109 F, and Body temperature decreased (NR: not provided) 102.8 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills (severe, uncontrollable shaking, cold hands and feet), nausea, lower back/kidney pain, sore arm, and fever. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia, Vomiting
Clinical narrative: VOMITING; 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, and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 12:00 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced vomiting. On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 103 F, 104 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills and vomiting was not reported. This report was non-serious.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Disorientation, Hypertension, Restlessness
Clinical narrative: HIGH BLOOD PRESSURE; SLIGHTLY DISORIENTED FROM THE SHOT; FELT ANTSY TO GO FOR WALK; This spontaneous report received from a patient concerned a 51 year old white, Not Hispanic or Latino male. The patient's height, and weight were not reported. The patient's concurrent conditions included blood pressure monitoring, overweight, non-smoker, and no alcohol use.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1808980 expiry: UNKNOWN) dose was not reported, 1 total administered on 09-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021 in morning, the patient reported his blood pressure was 170/100 which he felt high for him. It was stated that, usually patient's blood pressure was 125-138 systolic blood pressure. On 10-APR-2021, when he first woke up in the morning patient measured his blood pressure as 109/75 and was therefore concerned about the increase. Patient visited physician office for high blood pressure. Patient felt slightly disoriented since he received vaccination and felt antsy to go for a walk. It was stated that patient did not have any fever and felt okay. Laboratory data included: Blood pressure (NR: not provided) 170/100, 109/75. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) 125-138 systolic blood pressure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from high blood pressure, slightly disoriented from the shot, and felt antsy to go for walk. This report was serious (Other Medically Important Condition).; Sender's Comments: V0;20210421042-covid-19 vaccine ad26.cov2. s-High blood pressure. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Electroencephalogram, Intracranial aneurysm
Clinical narrative: BRAIN ANEURYSM; CHEST PAIN; This spontaneous report received from consumer (company representative) and concerned a female patient of unspecified age received via social media. 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 administered 1 total for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, one day after vaccination, the patient started with chest pain and paralysis on her left side. She rushed to the hospital where numerus tests were performed. She had about 8 seizures in previous 2 days. She never had seizures before. Patient was continuously monitoring via EEG (electroencephalogram). Doctor found 3 millimeter brain aneurysm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of brain aneurysm and chest pain was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0-20210421076- Covid-19 vaccine ad26.cov2.s- Brain aneurysm and chest pain. These event are considered unassessable. The event have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: 102 FEVER; 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 09-APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On 09-APR-2021, the subject experienced 102 fever. 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 102 fever on 10-APR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Neck mass
Clinical narrative: SWOLLEN LUMP ABOVE THE COLLARBONE; This spontaneous report received from a patient concerned a 49 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: 042A21A, and batch number: 042A21A expiry: 06-JUN-2021) dose was not reported, 1 total, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the subject experienced swollen lump above the collarbone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swollen lump above the collarbone. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Alopecia, Chills, Influenza like illness, Pain, Pyrexia
Clinical narrative: FLU-LIKE SYMPTOMS; LOSING BODY HAIR ( ARMS AND LEGS); ACHES; CHILLS; FEVER; This spontaneous report received from a patient via a company representative 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, dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On 08-APR-2021, the subject experienced flu-like symptoms. On 08-APR-2021, the subject experienced losing body hair ( arms and legs). On 08-APR-2021, the subject experienced aches. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the flu-like symptoms, fever, aches, chills and losing body hair ( arms and legs) was not reported. This report was non-serious.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Body temperature, Chills, Contusion
Clinical narrative: OPTIC NERVE DAMAGE; DIARRHEA; BRUISED ARM; TINGLY FACE; STOMACH CRAMPS; SHIVERING/CHILLS/FELT COLD; SORE ARM; WEAKNESS; NAUSEOUS RIGHT ON THE SPOT.; TIREDNESS; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included minor low pressure glaucoma, blood pressure, mild asthma, augmentin allergy, non alcoholic, non-smoker, and pre-diabetic.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered on 17-MAR-2021 10:00 on left arm for prophylactic vaccination. No concomitant medications were reported.  On 17-MAR-2021, Patient stated that the shot hurt so bad not like any other shot she had before, she felt nauseous right on the spot. When she went home, she felt tired, weak and had headache, stomach cramps and her face was tingly but not red. At around 9 or 10 PM, She felt cold, had shiver, diarrhea, chills, and a fever of 100.8 F max. Her arm felt sore and looked bruised so she took Tylenol. By 21-MAR-2021, she had minor symptoms but fever went away, her arm was sore and she had diarrhea. Her symptoms completely resolved by 25-MAR-2021. On 08-APR-2021, patient went to see her Ophthalmologist to follow up on her minor low pressure Glaucoma and Dr. told her she had an Optic Nerve Damage. Dr. told her that her eye pressure is 10 or 11 and it did not make sense that her pressure was low but she had an optic nerve damage. Ophthalmologist suggested that this could be because her oxygen level was low or she had sleep apnea but patient regularly checked her oxygen (always around 98) and did not had sleep apnea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea, bruised arm, tingly face, stomach cramps, shivering/chills/felt cold, sore arm, weakness, nauseous right on the spot, tiredness, headache, and fever on 25-MAR-2021, and the outcome of optic nerve damage was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210421255-Covid-19 vaccine ad26.cov2.s-Optic Nerve Damage. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: UNDERLYING DISEASE
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Headache, Intraocular pressure test, Nausea
Clinical narrative: OPTIC NERVE DAMAGE; DIARRHEA; BRUISED ARM; TINGLY FACE; STOMACH CRAMPS; SHIVERING/CHILLS/FELT COLD; SORE ARM; WEAKNESS; NAUSEOUS RIGHT ON THE SPOT.; TIREDNESS; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included minor low pressure glaucoma, blood pressure, mild asthma, augmentin allergy, non alcoholic, non-smoker, and pre-diabetic.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered on 17-MAR-2021 10:00 on left arm for prophylactic vaccination. No concomitant medications were reported.  On 17-MAR-2021, Patient stated that the shot hurt so bad not like any other shot she had before, she felt nauseous right on the spot. When she went home, she felt tired, weak and had headache, stomach cramps and her face was tingly but not red. At around 9 or 10 PM, She felt cold, had shiver, diarrhea, chills, and a fever of 100.8 F max. Her arm felt sore and looked bruised so she took Tylenol. By 21-MAR-2021, she had minor symptoms but fever went away, her arm was sore and she had diarrhea. Her symptoms completely resolved by 25-MAR-2021. On 08-APR-2021, patient went to see her Ophthalmologist to follow up on her minor low pressure Glaucoma and Dr. told her she had an Optic Nerve Damage. Dr. told her that her eye pressure is 10 or 11 and it did not make sense that her pressure was low but she had an optic nerve damage. Ophthalmologist suggested that this could be because her oxygen level was low or she had sleep apnea but patient regularly checked her oxygen (always around 98) and did not had sleep apnea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea, bruised arm, tingly face, stomach cramps, shivering/chills/felt cold, sore arm, weakness, nauseous right on the spot, tiredness, headache, and fever on 25-MAR-2021, and the outcome of optic nerve damage was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210421255-Covid-19 vaccine ad26.cov2.s-Optic Nerve Damage. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: UNDERLYING DISEASE
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Optic nerve injury, Oxygen saturation, Pain in extremity, Paraesthesia, Pyrexia
Clinical narrative: OPTIC NERVE DAMAGE; DIARRHEA; BRUISED ARM; TINGLY FACE; STOMACH CRAMPS; SHIVERING/CHILLS/FELT COLD; SORE ARM; WEAKNESS; NAUSEOUS RIGHT ON THE SPOT.; TIREDNESS; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included minor low pressure glaucoma, blood pressure, mild asthma, augmentin allergy, non alcoholic, non-smoker, and pre-diabetic.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered on 17-MAR-2021 10:00 on left arm for prophylactic vaccination. No concomitant medications were reported.  On 17-MAR-2021, Patient stated that the shot hurt so bad not like any other shot she had before, she felt nauseous right on the spot. When she went home, she felt tired, weak and had headache, stomach cramps and her face was tingly but not red. At around 9 or 10 PM, She felt cold, had shiver, diarrhea, chills, and a fever of 100.8 F max. Her arm felt sore and looked bruised so she took Tylenol. By 21-MAR-2021, she had minor symptoms but fever went away, her arm was sore and she had diarrhea. Her symptoms completely resolved by 25-MAR-2021. On 08-APR-2021, patient went to see her Ophthalmologist to follow up on her minor low pressure Glaucoma and Dr. told her she had an Optic Nerve Damage. Dr. told her that her eye pressure is 10 or 11 and it did not make sense that her pressure was low but she had an optic nerve damage. Ophthalmologist suggested that this could be because her oxygen level was low or she had sleep apnea but patient regularly checked her oxygen (always around 98) and did not had sleep apnea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea, bruised arm, tingly face, stomach cramps, shivering/chills/felt cold, sore arm, weakness, nauseous right on the spot, tiredness, headache, and fever on 25-MAR-2021, and the outcome of optic nerve damage was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210421255-Covid-19 vaccine ad26.cov2.s-Optic Nerve Damage. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: UNDERLYING DISEASE
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Feeling abnormal, Feeling of body temperature change, Headache, Pain
Clinical narrative: COUGH; COULD NOT SLEEP; BODY HURTS; FEELS TERRIBLE; HEADACHE; TEMPERATURE KEEPS  GOING UP AND DOWN; This spontaneous report received from a patient concerned a 52 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included recently diagnosed with metastatic breast cancer which has spread to the lymph nodes, and smoker.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced temperature keeps going up and down. On 09-APR-2021, the subject experienced headache. On 10-APR-2021, the subject experienced cough. On 10-APR-2021, the subject experienced could not sleep. On 10-APR-2021, the subject experienced body hurts. On 10-APR-2021, the subject experienced feels terrible. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 09-APR-2021, had not recovered from cough, could not sleep, and body hurts, and the outcome of temperature keeps going up and down and feels terrible was not reported. This report was non-serious.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder
Clinical narrative: COUGH; COULD NOT SLEEP; BODY HURTS; FEELS TERRIBLE; HEADACHE; TEMPERATURE KEEPS  GOING UP AND DOWN; This spontaneous report received from a patient concerned a 52 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included recently diagnosed with metastatic breast cancer which has spread to the lymph nodes, and smoker.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced temperature keeps going up and down. On 09-APR-2021, the subject experienced headache. On 10-APR-2021, the subject experienced cough. On 10-APR-2021, the subject experienced could not sleep. On 10-APR-2021, the subject experienced body hurts. On 10-APR-2021, the subject experienced feels terrible. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 09-APR-2021, had not recovered from cough, could not sleep, and body hurts, and the outcome of temperature keeps going up and down and feels terrible was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Hallucination
Clinical narrative: HALLUCINATIONS; This spontaneous report received from a patient concerned 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: 1805020, and expiry: UNKNOWN) dose was not reported, administered in right arm on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  The patient reported that she was concerned because she was seeing things she knew wasn't there (out of the peripheral of her eye). It was reported that she was hallucinating from afternoon of 09-Apr-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hallucinations. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210421275-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Hallucination. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Heart rate increased, Panic attack
Clinical narrative: FAST HEART RATE/ FAST PULSE RATE; LIGHTHEADEDNESS; PANIC ATTACK; This spontaneous report received from a patient concerned a 43 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included sulfa allergy, and cigarette smoker. 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 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included alprazolam, amfetamine aspartate/amfetamine sulfate/dexamfetamine saccharate/dexamfetamine sulfate, bupropion hydrochloride, and fluoxetine hydrochloride. On 09-APR-2021, the subject experienced fast heart rate/ fast pulse rate. On 09-APR-2021, the subject experienced lightheadedness. On 09-APR-2021, the subject experienced panic attack. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fast heart rate/ fast pulse rate, lightheadedness, and panic attack on 09-APR-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Burning sensation, Pruritus
Clinical narrative: GENERALIZED ITCHING; SKIN FEELS FUNNY; This spontaneous report received from a physician 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 was not reported, administered on 03-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced generalized itching, and skin feels funny. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from generalized itching, and skin feels funny. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: FEELING SICK; This spontaneous report received from a patient concerned an adult female. The patient's height, and weight were not reported. The patient's past medical history included tested positive for covid-19 infection. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch number. No concomitant medications were reported.  On 10-APR-2021, the subject experienced feeling sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling sick. This report was non-serious.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: FEELING VERY TIRED; HEADACHE; This spontaneous report received from a patient concerned a 44 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: 041A21A, and batch number: 041A21A expiry: UNKNOWN) dose was not reported, 1 total, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced feeling very tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling very tired on 09-APR-2021, and had not recovered from headache. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Nausea, Pain
Clinical narrative: NAUSEA; BODY PAIN; CHILLS; LEGS HURT; FEVER 102 DEGREE F; BAD HEADACHE; This spontaneous report received from a consumer 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: 201A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced body pain. On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced legs hurt. On 10-APR-2021, the subject experienced fever 102 degree F. On 10-APR-2021, the subject experienced bad headache. On 10-APR-2021, the subject experienced nausea. Laboratory data included: Body temperature (NR: not provided) 102 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever 102 degree F, chills, bad headache, nausea, body pain and legs hurt was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: NAUSEA; BODY PAIN; CHILLS; LEGS HURT; FEVER 102 DEGREE F; BAD HEADACHE; This spontaneous report received from a consumer 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: 201A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced body pain. On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced legs hurt. On 10-APR-2021, the subject experienced fever 102 degree F. On 10-APR-2021, the subject experienced bad headache. On 10-APR-2021, the subject experienced nausea. Laboratory data included: Body temperature (NR: not provided) 102 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever 102 degree F, chills, bad headache, nausea, body pain and legs hurt was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Hunger, Pyrexia
Clinical narrative: EXTREMELY HUNGRY; FEVER; 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 pre-existing medical conditions included whenever the patient gets sick or had a fever, experiences loss of appetite.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number: Unknown) dose was not reported, administered on 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 extremely hungry. On 10-APR-2021, the subject experienced fever. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 10-APR-2021, and the outcome of extremely hungry was not reported. This report was non-serious.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Pain in extremity, Sensory disturbance
Clinical narrative: ARM WAS VERY SORE; NO APPETITE; COULD FEEL MEDICINE GO IN; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included scleroderma, esophageal disorder, problems swallowing, raynaud in hands, allergy of dairy products, and alcohol consumer.  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. Concomitant medications included esomeprazole magnesium for esophageal disorder, and nifedipine for raynaud in hands.  On 09-APR-2021, the subject experienced no appetite. On 09-APR-2021, the subject experienced could feel medicine go in. On 10-APR-2021, the subject experienced arm was very sore. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from could feel medicine go in, had not recovered from arm was very sore, and the outcome of no appetite was not reported. This report was non-serious. This case, from the same reporter is linked to 20210420295.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Eye irritation, Fatigue, Injection site pain
Clinical narrative: SORE THROAT; BURNING EYES; BODY ACHES OR BODY WAS PAINFUL TO THE TOUCH; MIGRAINE; NIGHTMARES THROUGHOUT THE NIGHT; DIZZY; FEELING COLD; SHAKING; CHILLS; INJECTION SITE PAIN; FEVER OR BODY WAS BURNING UP LIKE A FURNACE; FELT FATIGUED; This spontaneous report received from a patient concerned a 22 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included smoker, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 15:50 for prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021, the subject experienced body aches or body was painful to the touch. On 09-APR-2021, the subject experienced migraine. On 09-APR-2021, the subject experienced nightmares throughout the night. On 09-APR-2021, the subject experienced dizzy. On 09-APR-2021, the subject experienced feeling cold. On 09-APR-2021, the subject experienced shaking. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced injection site pain. On 09-APR-2021, the subject experienced fever or body was burning up like a furnace. On 09-APR-2021, the subject experienced felt fatigued. On 09-APR-2021 19:00, the subject experienced burning eyes. On 10-APR-2021, the subject experienced sore throat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from burning eyes, nightmares throughout the night, dizzy, chills, fever or body was burning up like a furnace, and felt fatigued on 10-APR-2021, was recovering from injection site pain, body aches or body was painful to the touch, migraine, and sore throat, and the outcome of feeling cold and shaking was not reported. This report was non-serious.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Nasopharyngitis, Nightmare, Oropharyngeal pain, Pain
Clinical narrative: SORE THROAT; BURNING EYES; BODY ACHES OR BODY WAS PAINFUL TO THE TOUCH; MIGRAINE; NIGHTMARES THROUGHOUT THE NIGHT; DIZZY; FEELING COLD; SHAKING; CHILLS; INJECTION SITE PAIN; FEVER OR BODY WAS BURNING UP LIKE A FURNACE; FELT FATIGUED; This spontaneous report received from a patient concerned a 22 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included smoker, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 15:50 for prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021, the subject experienced body aches or body was painful to the touch. On 09-APR-2021, the subject experienced migraine. On 09-APR-2021, the subject experienced nightmares throughout the night. On 09-APR-2021, the subject experienced dizzy. On 09-APR-2021, the subject experienced feeling cold. On 09-APR-2021, the subject experienced shaking. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced injection site pain. On 09-APR-2021, the subject experienced fever or body was burning up like a furnace. On 09-APR-2021, the subject experienced felt fatigued. On 09-APR-2021 19:00, the subject experienced burning eyes. On 10-APR-2021, the subject experienced sore throat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from burning eyes, nightmares throughout the night, dizzy, chills, fever or body was burning up like a furnace, and felt fatigued on 10-APR-2021, was recovering from injection site pain, body aches or body was painful to the touch, migraine, and sore throat, and the outcome of feeling cold and shaking was not reported. This report was non-serious.