chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Skin discolouration, Swelling face
Clinical narrative: FEET DISCOLORATION (PURPLE/BLUE) WHEN SITTING DOWN; CALVES FELT LIKE GOING TO SLEEP; TINGLING IN FEET; YUCKY AND TOXIC FEELING; NERVOUSNESS; HIGH BLOOD PRESSURE; SHORTNESS OF BREATH; FACIAL PUFFINESS; BAD FEELING (FELT LIKE HIT BY TRUCK); LIGHT HEADEDNESS AND DIZZINESS; PUFFY AND SWOLLEN FEET; HAND PUFFINESS; SORENESS OF ARM; FLU-LIKE SYMPTOMS; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included codeine allergy, alcohol use, and non smoker, and other pre-existing medical conditions included the patient did not had drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: UNKNOWN) dose was not reported, administered on 29-MAR-2021 for prophylactic vaccination. Concomitant medications included lisinopril for high blood pressure.  On MAR-2021, the subject experienced soreness of arm. On MAR-2021, the subject experienced flu-like symptoms. On APR-2021, the subject experienced hand puffiness. On 09-APR-2021, the subject experienced puffy and swollen feet. On 13-APR-2021, the subject experienced facial puffiness. On 13-APR-2021, the subject experienced bad feeling (felt like hit by truck). On 13-APR-2021, the subject experienced light headedness and dizziness. On 28-APR-2021, the subject experienced high blood pressure. On 28-APR-2021, the subject experienced shortness of breath. On MAY-2021, the subject experienced calves felt like going to sleep. On MAY-2021, the subject experienced tingling in feet. On MAY-2021, the subject experienced yucky and toxic feeling. On MAY-2021, the subject experienced nervousness. On 25-MAY-2021, the subject experienced feet discoloration (purple/blue) when sitting down. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from puffy and swollen feet, and feet discoloration (purple/blue) when sitting down, and the outcome of high blood pressure, shortness of breath, flu-like symptoms, soreness of arm, facial puffiness, bad feeling (felt like hit by truck), light headedness and dizziness, hand puffiness, calves felt like going to sleep, tingling in feet, yucky and toxic feeling and nervousness was not reported. This report was non-serious.; Sender's Comments: V0:  Medical Assessment Comment not required as per standard procedure as the case assessed as non-serious.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Anaplastic thyroid cancer, Computerised tomogram, Influenza like illness, Ultrasound scan
Clinical narrative: ANAPLASTIC THYROID CANCER; FLU LIKE SYMPTOMS; This spontaneous report received from a patient concerned a 60 year old or unspecified ethnic origin male. 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: 1805031 and expiry: UNKNOWN) dose was not reported, 1 total, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 21-MAR-2021, the patient experienced sore throat and flu like symptoms which were not severe and was not associated with temperature, however the patient had difficulty in drinking water which lasted for 2 to 3 weeks. The patient visited his primary care physician for the same and was prescribe antibiotics. The patient's physician noticed a small spot near the collar bone and planned for further investigation. On 30-APR-2021, the patient underwent a sonogram for the same which was negative. The patient then visited an Ear, Nose and Throat (ENT) physician who performed an examination and advised that nothing was wrong with patient neck and also prescribed second course of antibiotics for a period of 10 days. The bulge in the patient neck grew bigger with in period of 4 to 5 days. The patient visited a hospital and got CT-scan done along with the consultation with an oncologist. On 21-MAY-2021, the patient was diagnosed with anaplastic thyroid cancer with 20% chance in one year. The biopsy was planned but was not conducted due to the position of the bulge. On MAY-2021, Laboratory data included: CAT scan (NR: not provided) Cancer was not presence anywhere else in body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from anaplastic thyroid cancer, and the outcome of flu like symptoms was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210556602-COVID-19 VACCINE AD26.COV2.S-Anaplastic thyroid cancer. 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: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: INCORRECT PRODUCT STORAGE; VACCINATED WITH JANSSEN COVID-19 VACCINE WHICH WAS LEFT OUTSIDE IN ROOM TEMPERATURE MORE THAN 2 HOURS; This spontaneous report received from a pharmacist concerned a 62 year old male. 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: 1821281, and expiry: 23-JUL-2021) dose was not reported, administered on 27-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-MAY-2021, the subject experienced vaccinated with janssen covid-19 vaccine which was left outside in room temperature more than 2 hours. On an unspecified date, the subject experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccinated with janssen covid-19 vaccine which was left outside in room temperature more than 2 hours and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20210556518 and 20210556814.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a pharmacist concerned a 51 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: 201A21A expiry: 28-MAY-2021) dose was not reported, administered on 28-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-MAY-2021, the subject experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: DIZZINESS; This spontaneous report received from a patient concerned  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: 042A21A, and batch number: 042A21A) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 27-MAY-2021, the subject experienced dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of dizziness was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Drug specific antibody absent, SARS-CoV-2 antibody test
Clinical narrative: NEGATIVE ANTIBODY TEST POST VACCINATION 3 WEEKS LATER; This spontaneous report received from a health care professional 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: Unknown) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 27-APR-2021, the subject experienced negative antibody test post vaccination 3 weeks later. Laboratory data included: SARS-CoV-2 IgG antibody test (NR: not provided) negative, and SARS-CoV-2 IgM antibody test (NR: not provided) negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of negative antibody test post vaccination 3 weeks later was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bone pain, Fatigue, Injection site pain, Lymph node pain
Clinical narrative: LYMPH NODES WERE HURTING; INJECTION SITE BURNING; FATIGUE; COLLAR BONE PAIN; This spontaneous report received from a patient concerned a 72 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 12:30 for prophylactic vaccination. Concomitant medications included etanercept, and methotrexate.  On APR-2021, the subject experienced collar bone pain. On 04-APR-2021, the subject experienced fatigue. On 11-APR-2021, the subject experienced lymph nodes were hurting. On 11-APR-2021, the subject experienced injection site burning. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from collar bone pain on 17-APR-2021, lymph nodes were hurting, and injection site burning on 18-APR-2021, and fatigue on 09-APR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Blood test normal, Fatigue, Lymphadenopathy, Pain in extremity
Clinical narrative: LYMPH NODES WERE HURTING; INJECTION SITE BURNING; FATIGUE; COLLAR BONE PAIN; This spontaneous report received from a patient concerned a 72 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 12:30 for prophylactic vaccination. Concomitant medications included etanercept, and methotrexate.  On APR-2021, the subject experienced collar bone pain. On 04-APR-2021, the subject experienced fatigue. On 11-APR-2021, the subject experienced lymph nodes were hurting. On 11-APR-2021, the subject experienced injection site burning. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from collar bone pain on 17-APR-2021, lymph nodes were hurting, and injection site burning on 18-APR-2021, and fatigue on 09-APR-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pulmonary thrombosis, Thrombosis
Clinical narrative: BLOOD CLOTS OF LUNGS; BLOOD CLOTS OF LEGS; This spontaneous report received from a patient via a company representative 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, Expiry: Unknown ) dose, start therapy date were not reported, 1 total for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient ended up getting blood clots of lungs and legs and was wanting to know more information. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clots of lungs and blood clots of legs was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210556674-COVID-19 VACCINE AD26.COV2.S-Blood clots of lungs, blood clots of legs. 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: Chills, Hypoaesthesia, Menstruation irregular, Paraesthesia
Clinical narrative: NUMBNESS IN LEGS; FEELS LIKE EXTREMITIES FALLING ASLEEP; MILD CHILLS; IRREGULAR MENSTRAL CYCLE; 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 thyroid problems, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination.. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced irregular menstral cycle. On 05-APR-2021, the subject experienced mild chills. On an unspecified date, the subject experienced numbness in legs, and feels like extremities falling asleep. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the mild chills, irregular menstral cycle, numbness in legs and feels like extremities falling asleep was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Hypersensitivity, Rash
Clinical narrative: FEEL BAD; RASH ALL OVER BODY; ALLERGY; 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: Unknown) dose was not reported, administered on 20-MAY-2021 11:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 20-MAY-2021, the subject experienced rash all over body. On 20-MAY-2021, the subject experienced allergy. On 21-MAY-2021, the subject experienced feel bad. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash all over body, and feel bad, and the outcome of allergy was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Injection site mass, Pain in extremity
Clinical narrative: SWOLLEN LUMP AT THE  INJECTION SITE THAT IS WARM TO THE TOUCH; SORE ARM; This spontaneous report received from a patient concerned a 44 year old female. The patient's weight was 165 pounds, and height was 60 inches. The patient's past medical history included tubal ligation, and concurrent conditions included non-alcoholic, and smoker, and other pre-existing medical conditions included patient had no drug abuse or illicit drug usage, patient had no past medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A and expiry: unknown) dose was not reported, administered on 24-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-MAY-2021, the subject experienced warm, swollen lump at the injection site. On 26-MAY-2021, the subject experienced sore arm. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sore arm, and had not recovered from warm, swollen lump at the injection site. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: FEELING UNWELL; 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 27-MAY-2021 for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 27-MAY-2021, the subject experienced feeling unwell. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feeling unwell. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Heart rate, Pain, Palpitations, Pyrexia
Clinical narrative: HEART POUNDING  (RESTING HEART RATE SHOT UP FROM MY AVERAGE 48 TO 95 AND POUNDING); MASSIVE ACHES; CHILLS; FEVER; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 23-MAY-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 MAY-2021, the subject experienced heart pounding (resting heart rate shot up from my average 48 to 95 and pounding). On MAY-2021, the subject experienced massive aches. On MAY-2021, the subject experienced chills. On MAY-2021, the subject experienced fever. Laboratory data included: Heart rate (NR: not provided) AVERAGE 48 TO 95 AND POUNDING. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the heart pounding (resting heart rate shot up from my average 48 to 95 and pounding), fever, massive aches and chills was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: PRODUCT TEMPERATURE EXCURSION ISSUE; POOR QUALITY PRODUCT ADMINISTERED; This spontaneous report received from a pharmacist concerned multiple patients. 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 17-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 17-MAY-2021, the subject experienced product temperature excursion issue. On 17-MAY-2021, the subject experienced poor quality product administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the product temperature excursion issue and poor quality product administered was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram abdomen, Gastric disorder
Clinical narrative: STOMACH ISSUES; This spontaneous report received from a consumer concerned a 57 year old male. The patient's height, and weight were not reported. The patient's 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: 1805025, and expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced stomach issues. Laboratory data (dates unspecified) included: Abdomen CT (NR: not provided) Unspecified. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from stomach issues. This report was non-serious. This case, from the same reporter is linked to 20210556510.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Dysphagia, Hypophagia, Increased upper airway secretion, Myalgia
Clinical narrative: LOST SENSE OF TASTE; DRAINING IN BACK OF THROAT; DIFFICULTY SWALLOWING; POSSIBLE WEIGHT LOSS; HAD NOT EATEN MUCH; SLIGHT RUNNY NOSE; SORE HIP MUSCLE; This spontaneous report received from a patient concerned an 87 year old female. The patient's weight was 130 pounds, and height was 61 inches. The patient's past medical history included lost sense of taste, and concurrent conditions included alcohol use, non-smoker, and detergent allergy, and other pre-existing medical conditions included the patient did not have any past medical history. the patient had no history of drug abuse or illicit drug use. the patient takes blood pressure pills. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 202A21A expiry: 23-JUN-2021) dose was not reported, administered on 02-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAY-2021, the subject experienced lost sense of taste. On MAY-2021, the subject experienced draining in back of throat. On MAY-2021, the subject experienced difficulty swallowing. On MAY-2021, the subject experienced possible weight loss. On MAY-2021, the subject experienced had not eaten much. On MAY-2021, the subject experienced slight runny nose. On MAY-2021, the subject experienced sore hip muscle. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the lost sense of taste, slight runny nose, sore hip muscle, draining in back of throat, difficulty swallowing, possible weight loss and had not eaten much was not reported. This report was non-serious.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, Weight decreased
Clinical narrative: LOST SENSE OF TASTE; DRAINING IN BACK OF THROAT; DIFFICULTY SWALLOWING; POSSIBLE WEIGHT LOSS; HAD NOT EATEN MUCH; SLIGHT RUNNY NOSE; SORE HIP MUSCLE; This spontaneous report received from a patient concerned an 87 year old female. The patient's weight was 130 pounds, and height was 61 inches. The patient's past medical history included lost sense of taste, and concurrent conditions included alcohol use, non-smoker, and detergent allergy, and other pre-existing medical conditions included the patient did not have any past medical history. the patient had no history of drug abuse or illicit drug use. the patient takes blood pressure pills. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 202A21A expiry: 23-JUN-2021) dose was not reported, administered on 02-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAY-2021, the subject experienced lost sense of taste. On MAY-2021, the subject experienced draining in back of throat. On MAY-2021, the subject experienced difficulty swallowing. On MAY-2021, the subject experienced possible weight loss. On MAY-2021, the subject experienced had not eaten much. On MAY-2021, the subject experienced slight runny nose. On MAY-2021, the subject experienced sore hip muscle. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the lost sense of taste, slight runny nose, sore hip muscle, draining in back of throat, difficulty swallowing, possible weight loss and had not eaten much was not reported. This report was non-serious.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: VACCINE STORE MORE THAN 2 HOURS AT ROOM TEMPERATURE WAS ADMINISTERED; VACCINE STORE MORE THAN 2 HOURS AT ROOM TEMPERATURE; This spontaneous report received from a pharmacist concerned a 29 year old male. 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: 1821281 expiry: 23/JUL/2021) dose was not reported, administered on 27-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 27-MAY-2021, the subject experienced vaccine store more than 2 hours at room temperature was administered. On 27-MAY-2021, the subject experienced vaccine store more than 2 hours at room temperature. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine store more than 2 hours at room temperature was administered and vaccine store more than 2 hours at room temperature was not reported. This report was non-serious. This case, from the same reporter is linked
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: THE EFFECTS THAT THEY HAD, WHICH DISAPPEARED; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not provided and it has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced the effects that they had, which disappeared. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from the effects that they had, which disappeared. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: MILD PAIN IN THE SITE OF INJECTION; This spontaneous report received from a patient concerned a 35 year old of unspecified 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: 204A21A expiry: UNKNOWN) dose was not reported, administered on 26-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 26-MAY-2021, the subject experienced mild pain in the site of injection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of mild pain in the site of injection was not reported. This report was non-serious. This case, from the same reporter is linked to 20210556420, 20210556156 and 20210556038.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: LEFT ARM MUSCLE PAIN; 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 pre-existing medical conditions included patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-MAY-2021, the subject experienced left arm muscle pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from left arm muscle pain. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: MILD PAIN IN THE AREA OF APPLICATION; This spontaneous report received from a patient concerned a 35 year old of unspecified 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, and batch number: 204A21A expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced mild pain in the area of application. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of mild pain in the area of application was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a pharmacist concerned a 45 year old male. 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: 201A21A expiry: UNKNOWN) dose was not reported, administered on 28-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-MAY-2021, the subject experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 73 year old  female. The patient's weight was 150 pounds, and height was not reported. The patient's concurrent conditions included breast cancer, pollen allergy, non-alcoholic, and non-smoker. The patient had no history of drug abuse or illicit drug usage. The patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 203A21A, expiry: 23-JUN-2021) dose was not reported, 1 total administered on 12-APR-2021 to left deltoid for prophylactic vaccination. No concomitant medications were reported.  On 19-MAY-2021 and a week after, on 26-MAY-2021, the patient did antibody testing both of which came negative (confirmed immunological vaccine failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:  20210556839-COVID-19 VACCINE AD26.COV2.S- Confirmed immunological vaccine failure . This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal distension, Asthenia, Feeding disorder, Headache
Clinical narrative: SORENESS ALL OVER; UPSET STOMACH; THROWING UP; UNABLE TO EAT; STOMACH TIGHT; WEAKNESS; FEVER; BAD HEADACHE; This spontaneous report received from a patient concerned a 21 year old male. 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, and batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 18-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-MAY-2021, the subject experienced soreness all over. On 25-MAY-2021, the subject experienced upset stomach. On 25-MAY-2021, the subject experienced throwing up. On 25-MAY-2021, the subject experienced unable to eat. On 25-MAY-2021, the subject experienced stomach tight. On 25-MAY-2021, the subject experienced weakness. On 25-MAY-2021, the subject experienced fever. On 25-MAY-2021, the subject experienced bad headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from soreness all over, weakness, fever, bad headache, upset stomach, throwing up, unable to eat, and stomach tight. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Vomiting
Clinical narrative: SORENESS ALL OVER; UPSET STOMACH; THROWING UP; UNABLE TO EAT; STOMACH TIGHT; WEAKNESS; FEVER; BAD HEADACHE; This spontaneous report received from a patient concerned a 21 year old male. 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, and batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 18-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-MAY-2021, the subject experienced soreness all over. On 25-MAY-2021, the subject experienced upset stomach. On 25-MAY-2021, the subject experienced throwing up. On 25-MAY-2021, the subject experienced unable to eat. On 25-MAY-2021, the subject experienced stomach tight. On 25-MAY-2021, the subject experienced weakness. On 25-MAY-2021, the subject experienced fever. On 25-MAY-2021, the subject experienced bad headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from soreness all over, weakness, fever, bad headache, upset stomach, throwing up, unable to eat, and stomach tight. This report was non-serious.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Deep vein thrombosis, Pain in extremity
Clinical narrative: DVT IN LEFT LEG; SORE ARM; This spontaneous report received from a consumer (wife) concerned a 54 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on 25-APR-2021 to right arm for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported. On 25-APR-2021, the patient had sore arm. On 17-MAY-2021, the patient noticed that his left leg got bigger and ignored it, he measured his calf which was 2 inch wider and elevated his feet. On 24-MAY-2021, it was really big and then the doctor sent him to urgent care and it was confirmed a case of deep vein thrombosis (DVT) and he was treated with blood thinner. Still his calf, ankle and foot looks bigger. The patient's wife did not have the lot number. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm on 28-APR-2021, and had not recovered from DVT in left leg. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210556854 -Covid-19 vaccine ad26.cov2.s - DVT IN LEFT LEG . 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: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Peripheral swelling, Temperature difference of extremities, Ultrasound scan
Clinical narrative: DVT IN LEFT LEG; SORE ARM; This spontaneous report received from a consumer (wife) concerned a 54 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on 25-APR-2021 to right arm for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported. On 25-APR-2021, the patient had sore arm. On 17-MAY-2021, the patient noticed that his left leg got bigger and ignored it, he measured his calf which was 2 inch wider and elevated his feet. On 24-MAY-2021, it was really big and then the doctor sent him to urgent care and it was confirmed a case of deep vein thrombosis (DVT) and he was treated with blood thinner. Still his calf, ankle and foot looks bigger. The patient's wife did not have the lot number. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm on 28-APR-2021, and had not recovered from DVT in left leg. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210556854 -Covid-19 vaccine ad26.cov2.s - DVT IN LEFT LEG . 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: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a health care professional 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: 1805018, and expiry: 25-MAY-2021) dose was not reported, administered on 27-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-MAY-2021, the subject experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Confusional state, Disorientation, Dizziness, Dyspnoea
Clinical narrative: FEELING HAZY; RAISED BUMP AT INJECTION SITE; HEADACHE; WATER BLISTERS UNDER NOSE AND TURNED INTO SORES ON UPPER LIP AND UNDER LEFT NOSTRIL AND COMING DOWN TO LIP; FELT HORRIBLE; DISORIENTATED; DIZZINESS; SHORTNESS OF BREATH; TIREDNESS; This spontaneous report received from a patient concerned a 40 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: 042A21A, and expiry: 21/06/2021) dose was not reported, administered on 25-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-MAY-2021, the subject experienced tiredness. On 26-MAY-2021, the subject experienced water blisters under nose and turned into sores on upper lip and under left nostril and coming down to lip. On 26-MAY-2021, the subject experienced felt horrible. On 26-MAY-2021, the subject experienced disorientated. On 26-MAY-2021, the subject experienced dizziness. On 26-MAY-2021, the subject experienced shortness of breath. On 26-MAY-2021, the subject experienced raised bump at injection site. On 26-MAY-2021, the subject experienced headache. On 28-MAY-2021, the subject experienced feeling hazy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from felt horrible, disorientated, dizziness, tiredness, and headache, had not recovered from water blisters under nose and turned into sores on upper lip and under left nostril and coming down to lip, raised bump at injection site, and shortness of breath, and the outcome of feeling hazy was not reported. This report was non-serious.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Injection site nodule
Clinical narrative: FEELING HAZY; RAISED BUMP AT INJECTION SITE; HEADACHE; WATER BLISTERS UNDER NOSE AND TURNED INTO SORES ON UPPER LIP AND UNDER LEFT NOSTRIL AND COMING DOWN TO LIP; FELT HORRIBLE; DISORIENTATED; DIZZINESS; SHORTNESS OF BREATH; TIREDNESS; This spontaneous report received from a patient concerned a 40 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: 042A21A, and expiry: 21/06/2021) dose was not reported, administered on 25-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-MAY-2021, the subject experienced tiredness. On 26-MAY-2021, the subject experienced water blisters under nose and turned into sores on upper lip and under left nostril and coming down to lip. On 26-MAY-2021, the subject experienced felt horrible. On 26-MAY-2021, the subject experienced disorientated. On 26-MAY-2021, the subject experienced dizziness. On 26-MAY-2021, the subject experienced shortness of breath. On 26-MAY-2021, the subject experienced raised bump at injection site. On 26-MAY-2021, the subject experienced headache. On 28-MAY-2021, the subject experienced feeling hazy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from felt horrible, disorientated, dizziness, tiredness, and headache, had not recovered from water blisters under nose and turned into sores on upper lip and under left nostril and coming down to lip, raised bump at injection site, and shortness of breath, and the outcome of feeling hazy was not reported. This report was non-serious.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: LEFT UPPER ARM HURTING; SLIGHT AND POUNDING HEADACHE; This spontaneous report received from a patient concerned a 22 year old male. 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: 17676, and batch number: 17676) dose was not reported, administered on 28-MAY-2021 15:50:00 for prophylactic vaccination. No concomitant medications were reported. On 28-MAY-2021, the subject experienced left upper arm hurting. On 28-MAY-2021, the subject experienced slight and pounding headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from slight and pounding headache, and left upper arm hurting. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Mucosal disorder
Clinical narrative: FLU-LIKE SYMPTOMS; MUCUS; This spontaneous report received from a consumer concerned a 21 year old male. 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 MAY-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 MAY-2021, the subject experienced flu-like symptoms. On MAY-2021, the subject experienced mucus. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu-like symptoms, and mucus on MAY-2021. This report was non-serious. This case, from the same reporter is linked to 20210556420.
Sex: F
Vaccine: COVID19
Symptoms: Injection site mass
Clinical narrative: LUMP ON ARM AT THE INJECTION SITE; 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) dose was not reported, administered on MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAY-2021, the subject experienced lump on arm at the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from lump on arm at the injection site. This report was non-serious.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Cold sweat, Limb discomfort, Migraine
Clinical narrative: COLD SWEAT; MIGRAINE HEADACHES; ARM SORE 5-6 HOURS; LEGS HURTING AFTER JANITORIAL WORK; CHILLS; BODY TEMPERATURE; This spontaneous report received from a patient concerned a 33 year old male. 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: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 26-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced cold sweat. On MAY-2021, the subject experienced migraine headaches. On MAY-2021, the subject experienced arm sore 5-6 hours. On MAY-2021, the subject experienced legs hurting after work. On MAY-2021, the subject experienced chills. On MAY-2021, the subject experienced body temperature. Treatment medications included: paracetamol. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) Not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cold sweat, migraine headaches, arm sore 5-6 hours, legs hurting after  work, chills, and body temperature on 29-MAY-2021. This report was non-serious.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: COLD SWEAT; MIGRAINE HEADACHES; ARM SORE 5-6 HOURS; LEGS HURTING AFTER JANITORIAL WORK; CHILLS; BODY TEMPERATURE; This spontaneous report received from a patient concerned a 33 year old male. 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: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 26-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced cold sweat. On MAY-2021, the subject experienced migraine headaches. On MAY-2021, the subject experienced arm sore 5-6 hours. On MAY-2021, the subject experienced legs hurting after work. On MAY-2021, the subject experienced chills. On MAY-2021, the subject experienced body temperature. Treatment medications included: paracetamol. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) Not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cold sweat, migraine headaches, arm sore 5-6 hours, legs hurting after  work, chills, and body temperature on 29-MAY-2021. This report was non-serious.