chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: COULD NOT SEE; MATERNAL EXPOSURE DURING PREGNANCY; COULD NOT BREATHE; DIZZINESS; FEELING UNWELL; MUSCLE PAIN; This solicited pregnancy report received from a consumer concerned a 38 year old female of unknown race and ethnicity. The patient was enrolled in a non-company sponsored study.  The patient's height, and weight were not reported. The patient's past medical history included: miscarriage (one), and concurrent conditions included: multigravida (four previous pregnancies, three resulting in a live baby).  The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A expiry: UNKNOWN) dose was not reported, 1 total was administered on 12-OCT-2021 for covid-19 immunisation. No concomitant medications were reported. The first day of the last menstrual period (LMP) was calculated to be 06-Mar-2021. The estimated delivery date (EDD) was reported to be 11-Dec-2021. Type of pregnancy was not reported. On 12-Oct-2021 (at the time of vaccination), patient was at gestational age of 31 weeks and three days. On 12-OCT-2021, the patient experienced maternal exposure during pregnancy, muscle pain, dizziness, was feeling unwell and could not see or breathe. All reported events led to emergency room and subsequently hospital admission. The patient received intravenous infusion and medical attention. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from could not see, could not breathe, dizziness, feeling unwell, and muscle pain on 13-OCT-2021, and the outcome of maternal exposure during pregnancy was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and maternal exposure during pregnancy was not related, and between covid-19 vaccine ad26.cov2.s, and could not see, could not breathe, dizziness, feeling unwell, and muscle pain was related.  This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20211118554-COVID-19 VACCINE AD26.COV2.S- Could not see, Could not breathe, Dizziness. This event(s) is considered related. 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). 20211118554-COVID-19 VACCINE AD26.COV2.S-Maternal exposure during pregnancy. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS 20211118554-COVID-19 VACCINE AD26.COV2.S- Feeling unwell, Muscle pain. This event(s) is labeled per RSI and is therefore considered potentially related.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Breech presentation, Exposure during pregnancy, Myalgia
Clinical narrative: BREECH PRESENTATION; MATERNAL EXPOSURE DURING PREGNANCY; MUSCLE PAIN; This solicited pregnancy report received from a patient concerned a 29 year old female. The patient was enrolled in a study. COVID 19 Registry number: C01768). The patient's weight was 58.96 kilograms, and height was not reported. The patient's pre-existing medical conditions included the patient was pregnant at the time of vaccination.  The patient initiated treatment with Covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 1802072 and expiry: Unknown) dose was not reported, 1 total administered on 09-MAR-2021 for prophylactic vaccination. The patient's concomitant medications included prenatal vitamins (minerals NOS; vitamins NOS). The patient was gravida 1, para 1. The date of the patient's last menstrual period was 22-SEP-2020. On 09-MAR-2021, the patient had maternal exposure during pregnancy. On the same date, the patient had experienced muscle pain. At gestational age of 39 weeks and 3 days, the mother delivered live male neonate by caesarean method of delivery. On an unspecified date, the patient's was in breech presentation and was hospitalized for two days. The patient gave birth to a male baby. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from breech presentation, and the outcome of muscle pain and maternal exposure during pregnancy was not reported. The reporter provided no causality assessment. Company causality between Covid-19 vaccine ad26.cov2.s, and breech presentation, and muscle pain was related, and between covid-19 vaccine ad26.cov2.s, and maternal exposure during pregnancy was not related.  This report was serious (Hospitalization Caused / Prolonged). This parent/child case is linked to 20211106549.  This case was reassessed as serious based on additional information received from patient on 29-JUL-2021, the following information was updated and incorporated into case narrative: Event added (Breech presentation); Seriousness criteria (hospitalization); Pregnancy outcome updated (C-section); Pregnancy details updated; Narrative updated.; Sender's Comments: V1-  Version created for addition of serious event (Breech presentation); Seriousness criteria (hospitalization); Pregnancy outcome updated (C-section); Pregnancy details and narrative.   20210763277 - covid-19 vaccine ad26.cov2.s- maternal exposure during pregnancy. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS   20210763277 - covid-19 vaccine ad26.cov2.s  Breech presentation. This event(s) is considered related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: M
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: RECENTLY GOT THE BOOSTER DOSE OF JANSSEN VACCINE AND HE FELT SO MUCH BETTER AFTER THAN WHEN HE RECEIVED  HIS FIRST DOSE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient recently got the booster dose of Janssen vaccine and he felt so much better after than when he received his first dose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of recently got the booster dose of Janssen vaccine and he felt so much better after than when he received his first dose was not reported. This report was non-serious.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Colitis, Diarrhoea, Haematochezia, Hypersomnia
Clinical narrative: BLOODY MUCOUS IN STOOL; HIGH BLOOD PRESSURE; COLITIS; SLEPT MOST OF THE DAY; ABDOMINAL CRAMPS; VOMITING; DIARRHEA; FATIGUE; This spontaneous report received from a patient concerned a 43-year-old white female of not Hispanic or Latino. The patient's weight was not reported and height was 66 inches. The patient's concurrent conditions included: no alcohol use, and non-smoker, and the patient had no drug abuse or illicit drug usage. The patient was not pregnant. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown and expiry: unknown) dose was not reported, 01 total dose administered on 30-OCT-2021;12:30 to left deltoid for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included Zofran (ondansetron).  On the subsequent day of vaccine administration in addition to Flu shot, on 31-OCT-2021 the patient was extremely fatigued and slept most of the day (Sleep excessive). At around 7:40 abdominal cramps began and she had vomiting with diarrhea. She returned to bed until 7:00 AM on 01-NOV-2021, and had multiple events of bloody mucous in stool. She went to emergency room (ER) at 15:00 PM and checked her blood pressure which was over 200/140. (high) and also performed Computerised tomogram (CAT) scan which showed colitis and was discharged with prescriptions and instructions to follow-up with primary care provider (PCP). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, and diarrhea on 31-OCT-2021, was recovering from high blood pressure, and fatigue, and the outcome of colitis, bloody mucous in stool, slept most of the day and abdominal cramps was not reported. This report was serious (Other Medically Important Condition); Sender's Comments: V0: 20211109951-Covid-19 vaccine ad26.cov2.s-Bloody mucous in stool, High blood pressure. 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: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Vomiting
Clinical narrative: BLOODY MUCOUS IN STOOL; HIGH BLOOD PRESSURE; COLITIS; SLEPT MOST OF THE DAY; ABDOMINAL CRAMPS; VOMITING; DIARRHEA; FATIGUE; This spontaneous report received from a patient concerned a 43-year-old white female of not Hispanic or Latino. The patient's weight was not reported and height was 66 inches. The patient's concurrent conditions included: no alcohol use, and non-smoker, and the patient had no drug abuse or illicit drug usage. The patient was not pregnant. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown and expiry: unknown) dose was not reported, 01 total dose administered on 30-OCT-2021;12:30 to left deltoid for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included Zofran (ondansetron).  On the subsequent day of vaccine administration in addition to Flu shot, on 31-OCT-2021 the patient was extremely fatigued and slept most of the day (Sleep excessive). At around 7:40 abdominal cramps began and she had vomiting with diarrhea. She returned to bed until 7:00 AM on 01-NOV-2021, and had multiple events of bloody mucous in stool. She went to emergency room (ER) at 15:00 PM and checked her blood pressure which was over 200/140. (high) and also performed Computerised tomogram (CAT) scan which showed colitis and was discharged with prescriptions and instructions to follow-up with primary care provider (PCP). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, and diarrhea on 31-OCT-2021, was recovering from high blood pressure, and fatigue, and the outcome of colitis, bloody mucous in stool, slept most of the day and abdominal cramps was not reported. This report was serious (Other Medically Important Condition); Sender's Comments: V0: 20211109951-Covid-19 vaccine ad26.cov2.s-Bloody mucous in stool, High blood pressure. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Injection site pain
Clinical narrative: LARGE WATERY LUMP UNDERNEATH ARMPIT; PAIN DURING VACCINE ADMINISTRATION (FELT A LOT OF PAIN WHEN PUTTING NEEDLE INSIDE ARM); This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with covid-19 vaccine for prophylactic vaccination. 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 30-OCT-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 30-OCT-2021, the patient experienced pain during vaccine administration (felt a lot of pain when putting needle inside arm). On 31-OCT-2021, the patient experienced large watery lump underneath armpit. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain during vaccine administration (felt a lot of pain when putting needle inside arm) on 04-NOV-2021, and was recovering from large watery lump underneath armpit. This report was non-serious.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram, Echocardiogram, Malaise, Myocardial infarction, Stress cardiomyopathy
Clinical narrative: BROKEN HEART SYNDROME TACHYCARDIA; HEART ATTACK; FEELING UNWELL; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's past medical history included: sick, and covid-19 (was prescribed steroids and oxygen at home, cough medicine) and concurrent conditions included: diabetes, thyroid, fibromyalgia, chronic migraine, chronic sinusitis (was prescribed antibiotics), allergy to antibiotics, allergy to sulpha, food allergy, allergy to weed grass, allergy to dust, allergy to mould, and allergy to animal, severe anxiety, and panic attack. The patient experienced drug allergy when treated with codeine, and prednisone.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025 and expiry: 25-MAY-2021) 1 total administered on 20-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 20-MAR-2021, the patient experienced heart attack around 11-12 pm, patient was screaming and hollering following a family incident, her son gave her some water hoping the chest pain would go away, patient's son took her to hospital and in emergency room was informed that having a heart attack. They took her for check up in an emergency room and was checked for clogged arteries [by opening up leg arteries and checking] and none was found. The doctor informed the patient that she had broken heart syndrome tachycardia. The patient was hospitalized for 1 day and was advised for complete bed rest for minimum 5 days. The patient was feeling crazy as never had anything like this before, suffered from severe anxiety and panic attack. The patient returned to emergency room on an unspecified date, as patient was feeling unwell. The doctor informed the patient, it would take months/weeks to recover from her heart attack. On JUL-2021, Laboratory data included: Echocardiogram (NR: not provided) Not reported. Laboratory data (dates unspecified) included: Angiography (NR: not provided). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from heart attack, and the outcome of feeling unwell and broken heart syndrome tachycardia was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20211115420 -covid-19 vaccine ad26.cov2.s- heart attack, broken heart syndrome tachycardia. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: F
Vaccine: COVID19
Symptoms: Ear swelling, Erythema, Eye movement disorder, Fear, Feeling abnormal
Clinical narrative: WEIRD FEELING IN LEFT LEG MUSCLE; REDNESS BETWEEN ONE EYEBROW  TO THE OTHER; NUMBNESS IN THE LEFT LEG; FEEL DIFFERENT WHEN EYE MOVES, ONE EYE  WORSE THAN THE OTHER; SWELLING AROUND RIGHT EYE; POSSIBLE MILD SWELLING OF RIGHT EAR/EAR FELT A LITTLE DIFFERENT; GOT SCARED; SWELLING INCREASED FROM EYEBROW TO THE CORNER OF NOSE; MILDLY BLURRY EYE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 08-NOV-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On NOV-2021, the patient experienced swelling around right eye. On NOV-2021, the patient experienced possible mild swelling of right ear/ear felt a little different. On NOV-2021, the patient experienced got scared. On NOV-2021, the patient experienced swelling increased from eyebrow to the corner of nose. On NOV-2021, the patient experienced mildly blurry eye. On NOV-2021, the patient experienced feel different when eye moves, one eye worse than the other. On 08-NOV-2021, the patient experienced weird feeling in left leg muscle. On 08-NOV-2021, the patient experienced redness between one eyebrow to the other. On 08-NOV-2021, the patient experienced numbness in the left leg. On 09-NOV-2021, treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from numbness in the left leg, weird feeling in left leg muscle, swelling around right eye, possible mild swelling of right ear/ear felt a little different, got scared, swelling increased from eyebrow to the corner of nose, mildly blurry eye, redness between one eyebrow to the other, and feel different when eye moves, one eye worse than the other. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Periorbital swelling, Swelling face, Vision blurred
Clinical narrative: WEIRD FEELING IN LEFT LEG MUSCLE; REDNESS BETWEEN ONE EYEBROW  TO THE OTHER; NUMBNESS IN THE LEFT LEG; FEEL DIFFERENT WHEN EYE MOVES, ONE EYE  WORSE THAN THE OTHER; SWELLING AROUND RIGHT EYE; POSSIBLE MILD SWELLING OF RIGHT EAR/EAR FELT A LITTLE DIFFERENT; GOT SCARED; SWELLING INCREASED FROM EYEBROW TO THE CORNER OF NOSE; MILDLY BLURRY EYE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 08-NOV-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On NOV-2021, the patient experienced swelling around right eye. On NOV-2021, the patient experienced possible mild swelling of right ear/ear felt a little different. On NOV-2021, the patient experienced got scared. On NOV-2021, the patient experienced swelling increased from eyebrow to the corner of nose. On NOV-2021, the patient experienced mildly blurry eye. On NOV-2021, the patient experienced feel different when eye moves, one eye worse than the other. On 08-NOV-2021, the patient experienced weird feeling in left leg muscle. On 08-NOV-2021, the patient experienced redness between one eyebrow to the other. On 08-NOV-2021, the patient experienced numbness in the left leg. On 09-NOV-2021, treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from numbness in the left leg, weird feeling in left leg muscle, swelling around right eye, possible mild swelling of right ear/ear felt a little different, got scared, swelling increased from eyebrow to the corner of nose, mildly blurry eye, redness between one eyebrow to the other, and feel different when eye moves, one eye worse than the other. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; COVID-19 INFECTION; This spontaneous report received from a patient via a company representative concerned a male of unspecified age.  The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: no further information. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: unknown and expiry: unknown) 1 total, start therapy date was not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  It was reported that, he experienced flu like symptoms and not feeling any better, he did not know what type of Covid test taken. He, stated vaccine did not work for him. On 06-NOV-2021, He was started feeling bad and sick on Saturday and not much better since. On 08-NOV-2021, he made coffee in morning and could not taste it. He stated his wife bought a couple of home test Covid kits she tested negative while he was positive, then he made appointment at pharmacy and got positive results. On same day, he experienced suspected clinical vaccination failure. Laboratory data included: COVID-19 virus test positive (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure and covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This case is associated with product quality complaint: 90000201208.; Sender's Comments: V0: 20211119231-covid-19 vaccine ad26.cov2.s-suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Product administered to patient of inappropriate age, Seizure
Clinical narrative: SEIZURE; INAPPROPRIATE AGE AT VACCINE ADMINISTRATION; OFF LABEL USE; This spontaneous report received from a parent via a company representative via social media concerned a 16 year old male of unspecified race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported.  A week or so after vaccination on an unknown date the patient experienced seizure, inappropriate age at vaccine administration and off label use. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the seizure, inappropriate age at vaccine administration and off label use was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211119833]-COVID-19 VACCINE AD26.COV2.S-seizure. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: M
Vaccine: COVID19
Symptoms: Pneumonia, Weight decreased
Clinical narrative: PNEUMONIA; BODY ACHE; WEIGHT LOSS 20 LBS; This spontaneous report received from a patient concerned a 6 decade old white male of an unspecified ethnic origin. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient was not sedentary and has not been impacted by any major health issues prior to vaccination. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: unknown, expiry: unknown) dose, start therapy date were not reported. Frequency time of 01 total was administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced symptoms of pneumonia for 10 days. The patient was hospitalized for 3 days and discharge information (date unspecified) was not reported and received the treatment with anticoagulant and antibiotic therapy. The patient also experienced headache, body ache, inability to eat and weight loss of 20 pound (lbs). Laboratory data (dates unspecified) included: Corona Virus Disease-19 (COVID-19) virus test (NR: not provided) resulted as Negative and Weight (NR: not provided) 20 lbs was lost. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pneumonia, body ache, and weight loss 20 lbs. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:  20211119868-Covid-19 vaccine ad26.cov2.s-Pneumonia. 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: 58.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Flatulence, Pain
Clinical narrative: PAIN AGGRAVATED; EXCESSIVE FLATULENCE; This spontaneous report received from a patient concerned a 58 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe adult crohn's disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on JUN-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot number. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe adult crohn's disease. No concomitant medications were reported. On an unspecified date, the patient experienced pain aggravated, and excessive flatulence. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient had not recovered from pain aggravated, and the outcome of excessive flatulence was not reported. This report was non-serious.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: FELT TIRED; ACHINESS; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: non smoker, non alcoholic, allergic reaction, anaphylaxis, sulfa allergy, and asthma, and other pre-existing medical conditions included: The Patient did not have history of drug abuse/illicit drug use. The patient experienced drug allergy when treated with erythromycin, sulfamethoxazole/trimethoprim, and tetracycline.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072 expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for an unspecified indication. No concomitant medications were reported.  On 11-MAR-2021, the patient experienced achiness. On 12-MAR-2021, the patient experienced felt tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from achiness, and felt tired. This report was non-serious. This case, involving the same patient is linked to 20211106318.
Sex: U
Vaccine: COVID19
Symptoms: Intracardiac thrombus, Pulmonary thrombosis
Clinical narrative: LOST TWO FAMILY MEMBERS FROM BLOOD CLOTS IN LUNGS; LOST TWO FAMILY MEMBERS FROM BLOOD CLOTS IN HEART; This spontaneous report received from a consumer concerned multiple patients of unspecified race and ethnicity. The patient's weight, height, and medical history were not reported. The patient's received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported,1 total for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the consumer lost two family members from blood clots in lungs and heart. The reporter stated I lost two family members from blood clots after this shot in the heart and lungs. It was unknown 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: 20211122792-COVID-19 VACCINE AD26.COV2.S- lost two family members from blood clots in lungs , lost two family members from blood clots in heart.. 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).; Reported Cause(s) of Death: LOST TWO FAMILY MEMBERS FROM BLOOD CLOTS IN LUNGS; LOST TWO FAMILY MEMBERS FROM BLOOD CLOTS IN HEART
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Peripheral coldness
Clinical narrative: LEFT ARM BECAME COLD; LEFT ARM BECAME NUMB; This spontaneous report received from a patient concerned a 25 year old female. The patient's weight, height, and medical history were not reported. The patient experienced drug allergy when treated with cefalexin, and azithromycin for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811 and expiry: UNKNOWN) dose was not reported, administered on 10-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-NOV-2021, the patient experienced left arm became cold. On 10-NOV-2021, the patient experienced left arm became numb. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the left arm became cold and left arm became numb was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: HEADACHES; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of headaches was not reported. This report was non-serious.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Fatigue, Feeling abnormal, Joint stiffness, Lethargy
Clinical narrative: STIFF JOINTS; ACHINESS/SORENESS; LETHARGY; FEVER; NAUSEA; TIRED; FELT MESSED UP/BONES GOING TO GET MESSED UP; WORRIED; This spontaneous report received from a consumer concerned a 51 year old female. The patient's weight was 150 pounds, and height was 65 inches. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A, and expiry: UNKNOWN) dose was not reported, administered on 08-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On NOV-2021, the patient experienced felt messed up/bones going to get messed up. On NOV-2021, the patient experienced worried. On 09-NOV-2021, the patient experienced stiff joints. On 09-NOV-2021, the patient experienced achiness/soreness. On 09-NOV-2021, the patient experienced lethargy. On 09-NOV-2021, the patient experienced fever. On 09-NOV-2021, the patient experienced nausea. On 09-NOV-2021, the patient experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, nausea, achiness/soreness, stiff joints, tired, lethargy, felt messed up/bones going to get messed up and worried was not reported. This report was non-serious. This case, from the same reporter is linked to 20211125901.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: STIFF JOINTS; ACHINESS/SORENESS; LETHARGY; FEVER; NAUSEA; TIRED; FELT MESSED UP/BONES GOING TO GET MESSED UP; WORRIED; This spontaneous report received from a consumer concerned a 51 year old female. The patient's weight was 150 pounds, and height was 65 inches. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A, and expiry: UNKNOWN) dose was not reported, administered on 08-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On NOV-2021, the patient experienced felt messed up/bones going to get messed up. On NOV-2021, the patient experienced worried. On 09-NOV-2021, the patient experienced stiff joints. On 09-NOV-2021, the patient experienced achiness/soreness. On 09-NOV-2021, the patient experienced lethargy. On 09-NOV-2021, the patient experienced fever. On 09-NOV-2021, the patient experienced nausea. On 09-NOV-2021, the patient experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, nausea, achiness/soreness, stiff joints, tired, lethargy, felt messed up/bones going to get messed up and worried was not reported. This report was non-serious. This case, from the same reporter is linked to 20211125901.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: HIVES; 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: hives. 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-MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Concomitant medications included ciclosporin, omalizumab, and prednisone.  On 20-JUL-2021, the patient experienced hives. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hives. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain, Pain in extremity
Clinical narrative: RADIATING PAIN IN THE GROIN AREA TO HIS HIP AND UPWARDS.; CHILLS; SORE ARM OF INJECTION; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the patient experienced chills. On MAR-2021, the patient experienced sore arm of injection. On 25-APR-2021, the patient experienced radiating pain in the groin area to his hip and upwards. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from radiating pain in the groin area to his hip and upwards. On 09-MAY-2021, and chills, and sore arm of injection. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Panic attack
Clinical narrative: HEART PALPITATION; PANIC ATTACKS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A expiry: UNKNOWN) dose was not reported, administered on 05-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On NOV-2021, the patient experienced panic attacks. On 05-NOV-2021, the patient experienced heart palpitation. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from heart palpitation, and panic attacks. This report was non-serious.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 52 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: 21-SEP-2021) dose was not reported, administered on 10-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-NOV-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious.
Age: 38.0
Sex: U
Vaccine: COVID19
Symptoms: Abdominal discomfort, Dyspnoea, Fatigue, Injection site erythema, Injection site pruritus
Clinical narrative: DIFFICULTY BREATHING; ITCHY AT INJECTION SITE; BODY ACHES; UPSET STOMACH; REDNESS AT INJECTION SITE; SWELLING AT INJECTION SITE; FATIGUE; FEVER; This spontaneous report received from a patient concerned a 38 year old of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: seasonal allergies, latex allergy, formaldehyde allergy, non smoker, non-alcoholic, medication allergy, and black rubber allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1822811 expiry: UNKNOWN) dose was not reported, administered on 08-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-NOV-2021, the patient experienced difficulty breathing. On 08-NOV-2021, the patient experienced itchy at injection site. On 08-NOV-2021, the patient experienced body aches. On 08-NOV-2021, the patient experienced upset stomach. On 08-NOV-2021, the patient experienced redness at injection site. On 08-NOV-2021, the patient experienced swelling at injection site. On 08-NOV-2021, the patient experienced fatigue. On 08-NOV-2021, the patient experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from difficulty breathing, upset stomach, and body aches, and had not recovered from itchy at injection site, swelling at injection site, fatigue, fever, and redness at injection site. This report was non-serious.
Age: 38.0
Sex: U
Vaccine: COVID19
Symptoms: Injection site swelling, Pain, Pyrexia
Clinical narrative: DIFFICULTY BREATHING; ITCHY AT INJECTION SITE; BODY ACHES; UPSET STOMACH; REDNESS AT INJECTION SITE; SWELLING AT INJECTION SITE; FATIGUE; FEVER; This spontaneous report received from a patient concerned a 38 year old of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: seasonal allergies, latex allergy, formaldehyde allergy, non smoker, non-alcoholic, medication allergy, and black rubber allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1822811 expiry: UNKNOWN) dose was not reported, administered on 08-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-NOV-2021, the patient experienced difficulty breathing. On 08-NOV-2021, the patient experienced itchy at injection site. On 08-NOV-2021, the patient experienced body aches. On 08-NOV-2021, the patient experienced upset stomach. On 08-NOV-2021, the patient experienced redness at injection site. On 08-NOV-2021, the patient experienced swelling at injection site. On 08-NOV-2021, the patient experienced fatigue. On 08-NOV-2021, the patient experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from difficulty breathing, upset stomach, and body aches, and had not recovered from itchy at injection site, swelling at injection site, fatigue, fever, and redness at injection site. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Hot flush, Influenza like illness, Malaise, Migraine
Clinical narrative: HOT FLASHES; FELT LIKE 'CRAP'; NAUSEA; HEADACHES OR MIGRAINES; FLU LIKE SYMPTOMS; 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 pre-existing medical conditions included: Patient had severe allergies to many substances so had to have the vaccine administered by allergy specialist. 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 22-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On JUN-2021, Laboratory data included: Body temperature (NR: not provided) slightly elevated but no fever. On 22-JUN-2021, the patient experienced flu like symptoms. On 23-JUN-2021, the patient experienced headaches or migraines. On 23-JUN-2021, the patient experienced felt like 'crap'. On 23-JUN-2021, the patient experienced nausea. On 24-JUN-2021, the patient experienced hot flashes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea, was recovering from hot flashes, flu like symptoms, and felt like 'crap', and had not recovered from headaches or migraines. This report was non-serious. This case, from the same reporter is linked to 20211124550.
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: HOT FLASHES; FELT LIKE 'CRAP'; NAUSEA; HEADACHES OR MIGRAINES; FLU LIKE SYMPTOMS; 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 pre-existing medical conditions included: Patient had severe allergies to many substances so had to have the vaccine administered by allergy specialist. 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 22-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On JUN-2021, Laboratory data included: Body temperature (NR: not provided) slightly elevated but no fever. On 22-JUN-2021, the patient experienced flu like symptoms. On 23-JUN-2021, the patient experienced headaches or migraines. On 23-JUN-2021, the patient experienced felt like 'crap'. On 23-JUN-2021, the patient experienced nausea. On 24-JUN-2021, the patient experienced hot flashes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea, was recovering from hot flashes, flu like symptoms, and felt like 'crap', and had not recovered from headaches or migraines. This report was non-serious. This case, from the same reporter is linked to 20211124550.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Illness, Pyrexia
Clinical narrative: VERY SICK; CHILLS; FEVER; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced very sick, chills, and fever. The action taken with covid-19 vaccine  was not applicable. The outcome of the fever, chills and very sick was not reported. This report was non-serious. This case, from the same reporter is linked to 20211125279.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Body temperature increased, Chest pain, Chills
Clinical narrative: BLURRED VISION; CHEST PAIN/ FELT LIKE A TRUCK SITTING ON STERNUM; JOINT PAIN; CHILLS; MUSCLE PAIN; TEMPERATURE 99.7; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 09-NOV-2021 15:30 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 09-NOV-2021, the patient experienced chest pain/ felt like a truck sitting on sternum. On 09-NOV-2021, the patient experienced joint pain. On 09-NOV-2021, the patient experienced chills. On 09-NOV-2021, the patient experienced muscle pain. On 09-NOV-2021, the patient experienced temperature 99.7. Laboratory data included: Body temperature (NR: not provided) 99.7 F. On 10-NOV-2021, the patient experienced blurred vision. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from temperature 99.7, chills, chest pain/ felt like a truck sitting on sternum, blurred vision, muscle pain, and joint pain. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Vision blurred
Clinical narrative: BLURRED VISION; CHEST PAIN/ FELT LIKE A TRUCK SITTING ON STERNUM; JOINT PAIN; CHILLS; MUSCLE PAIN; TEMPERATURE 99.7; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 09-NOV-2021 15:30 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 09-NOV-2021, the patient experienced chest pain/ felt like a truck sitting on sternum. On 09-NOV-2021, the patient experienced joint pain. On 09-NOV-2021, the patient experienced chills. On 09-NOV-2021, the patient experienced muscle pain. On 09-NOV-2021, the patient experienced temperature 99.7. Laboratory data included: Body temperature (NR: not provided) 99.7 F. On 10-NOV-2021, the patient experienced blurred vision. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from temperature 99.7, chills, chest pain/ felt like a truck sitting on sternum, blurred vision, muscle pain, and joint pain. This report was non-serious.