chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: ADVERSE REACTION; This spontaneous report received from a parent via a company representative 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, 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 adverse reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from adverse reaction. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: RARE SEVERE BLOOD CLOTS; This spontaneous report received from a consumer via a company representative concerned 12 adult female patients of unspecified age, race and ethnic origin. No past medical history or concurrent conditions were reported. The patients received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown and expiry: Unknown) dose, start therapy date were not reported, 1 total, administered 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 patients had rare severe blood clots. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of rare severe blood clots was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20211010045 and 20211009808.; Sender's Comments: V0: 20211023372-Covid-19 vaccine ad26.cov2.s -Rare severe blood clots. 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: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dizziness, Dyspnoea, Dysstasia
Clinical narrative: FELT EXTREMELY LETHARGIC; SLIGHT AND MILD SHORTNESS OF BREATH; MUSCLE WEAKNESS AND WOBBLY LEG WHENEVER PATIENT TRIED TO GET UP CANNOT STAY UP FOR LONG (ALMOST FELL GETTING OFF THE TRUCK); CHILLS; EXTREME TENDERNESS IN THE ARM (INJECTION SITE); VOMITING; 101 DEGREE FAHRENHEIT BODY TEMPERATURE; DIZZINESS; CANNOT STAND UP; This spontaneous report received from a patient concerned a 61 year old male. The patient's height, and weight were not reported. The patient's past medical history included: asthma, and concurrent conditions included: non-smoker, and non-alcohol user, and other pre-existing medical conditions included: The patient had no known allergies. The patient did not have any drug abuse or illicit drug use. Patient had never been hospitalized, never broke a bone and never had an operation. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and 211A21A expiry: UNKNOWN) dose was not reported, administered on 30-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-SEP-2021, the patient experienced dizziness. On 30-SEP-2021, the patient experienced cannot stand up. On 30-SEP-2021, the patient experienced slight and mild shortness of breath. On 30-SEP-2021, the patient experienced muscle weakness and wobbly leg whenever patient tried to get up cannot stay up for long (almost fell getting off the truck). On 30-SEP-2021, the patient experienced chills. On 30-SEP-2021, the patient experienced extreme tenderness in the arm (injection site). On 30-SEP-2021, the patient experienced vomiting. On 30-SEP-2021, the patient experienced 101 degree fahrenheit body temperature. Laboratory data included: Body temperature (NR: not provided) 101 F. On 07-OCT-2021, the patient experienced felt extremely lethargic. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from 101 degree fahrenheit body temperature, dizziness, vomiting, chills, muscle weakness and wobbly leg whenever patient tried to get up cannot stay up for long (almost fell getting off the truck), cannot stand up, extreme tenderness in the arm (injection site), felt extremely lethargic, and slight and mild shortness of breath. This report was non-serious.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Lethargy, Muscular weakness, Pyrexia, SARS-CoV-2 test
Clinical narrative: FELT EXTREMELY LETHARGIC; SLIGHT AND MILD SHORTNESS OF BREATH; MUSCLE WEAKNESS AND WOBBLY LEG WHENEVER PATIENT TRIED TO GET UP CANNOT STAY UP FOR LONG (ALMOST FELL GETTING OFF THE TRUCK); CHILLS; EXTREME TENDERNESS IN THE ARM (INJECTION SITE); VOMITING; 101 DEGREE FAHRENHEIT BODY TEMPERATURE; DIZZINESS; CANNOT STAND UP; This spontaneous report received from a patient concerned a 61 year old male. The patient's height, and weight were not reported. The patient's past medical history included: asthma, and concurrent conditions included: non-smoker, and non-alcohol user, and other pre-existing medical conditions included: The patient had no known allergies. The patient did not have any drug abuse or illicit drug use. Patient had never been hospitalized, never broke a bone and never had an operation. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and 211A21A expiry: UNKNOWN) dose was not reported, administered on 30-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-SEP-2021, the patient experienced dizziness. On 30-SEP-2021, the patient experienced cannot stand up. On 30-SEP-2021, the patient experienced slight and mild shortness of breath. On 30-SEP-2021, the patient experienced muscle weakness and wobbly leg whenever patient tried to get up cannot stay up for long (almost fell getting off the truck). On 30-SEP-2021, the patient experienced chills. On 30-SEP-2021, the patient experienced extreme tenderness in the arm (injection site). On 30-SEP-2021, the patient experienced vomiting. On 30-SEP-2021, the patient experienced 101 degree fahrenheit body temperature. Laboratory data included: Body temperature (NR: not provided) 101 F. On 07-OCT-2021, the patient experienced felt extremely lethargic. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from 101 degree fahrenheit body temperature, dizziness, vomiting, chills, muscle weakness and wobbly leg whenever patient tried to get up cannot stay up for long (almost fell getting off the truck), cannot stand up, extreme tenderness in the arm (injection site), felt extremely lethargic, and slight and mild shortness of breath. This report was non-serious.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: FELT EXTREMELY LETHARGIC; SLIGHT AND MILD SHORTNESS OF BREATH; MUSCLE WEAKNESS AND WOBBLY LEG WHENEVER PATIENT TRIED TO GET UP CANNOT STAY UP FOR LONG (ALMOST FELL GETTING OFF THE TRUCK); CHILLS; EXTREME TENDERNESS IN THE ARM (INJECTION SITE); VOMITING; 101 DEGREE FAHRENHEIT BODY TEMPERATURE; DIZZINESS; CANNOT STAND UP; This spontaneous report received from a patient concerned a 61 year old male. The patient's height, and weight were not reported. The patient's past medical history included: asthma, and concurrent conditions included: non-smoker, and non-alcohol user, and other pre-existing medical conditions included: The patient had no known allergies. The patient did not have any drug abuse or illicit drug use. Patient had never been hospitalized, never broke a bone and never had an operation. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and 211A21A expiry: UNKNOWN) dose was not reported, administered on 30-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-SEP-2021, the patient experienced dizziness. On 30-SEP-2021, the patient experienced cannot stand up. On 30-SEP-2021, the patient experienced slight and mild shortness of breath. On 30-SEP-2021, the patient experienced muscle weakness and wobbly leg whenever patient tried to get up cannot stay up for long (almost fell getting off the truck). On 30-SEP-2021, the patient experienced chills. On 30-SEP-2021, the patient experienced extreme tenderness in the arm (injection site). On 30-SEP-2021, the patient experienced vomiting. On 30-SEP-2021, the patient experienced 101 degree fahrenheit body temperature. Laboratory data included: Body temperature (NR: not provided) 101 F. On 07-OCT-2021, the patient experienced felt extremely lethargic. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from 101 degree fahrenheit body temperature, dizziness, vomiting, chills, muscle weakness and wobbly leg whenever patient tried to get up cannot stay up for long (almost fell getting off the truck), cannot stand up, extreme tenderness in the arm (injection site), felt extremely lethargic, and slight and mild shortness of breath. This report was non-serious.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Gait disturbance, Headache, Joint swelling
Clinical narrative: SWOLLEN ANKLES; SWOLLEN FEET; CHILLS; LEFT ARM PAIN THAT FEELS LIKE IT IS IN THE BONE (FROM THE SHOULDER ALL THE WAY TO THE FINGER TIPS); BODY PAIN (HIPS ALL THE WAY DOWN TO BOTH FEET); TOO PAINFUL TO WALK; FEVER; HEADACHE; FATIGUE; This spontaneous report received from a patient concerned a 42 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, intramuscular, and batch number: 211A21A expiry: UNKNOWN) dose was not reported, administered on 08-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-OCT-2021, the patient experienced fatigue. On 09-OCT-2021, the patient experienced body pain (hips all the way down to both feet). On 09-OCT-2021, the patient experienced too painful to walk. On 09-OCT-2021, the patient experienced chills. On 09-OCT-2021, the patient experienced left arm pain that feels like it is in the bone (from the shoulder all the way to the finger tips). On 09-OCT-2021, the patient experienced fever. On 09-OCT-2021, the patient experienced headache. On 10-OCT-2021, the patient experienced swollen ankles. On 10-OCT-2021, the patient experienced swollen feet. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body pain (hips all the way down to both feet), too painful to walk, chills, fever, and headache on 10-OCT-2021, and swollen ankles, and swollen feet on 11-OCT-2021, and had not recovered from fatigue, and left arm pain that feels like it is in the bone (from the shoulder all the way to the finger tips). This report was non-serious.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: SWOLLEN ANKLES; SWOLLEN FEET; CHILLS; LEFT ARM PAIN THAT FEELS LIKE IT IS IN THE BONE (FROM THE SHOULDER ALL THE WAY TO THE FINGER TIPS); BODY PAIN (HIPS ALL THE WAY DOWN TO BOTH FEET); TOO PAINFUL TO WALK; FEVER; HEADACHE; FATIGUE; This spontaneous report received from a patient concerned a 42 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, intramuscular, and batch number: 211A21A expiry: UNKNOWN) dose was not reported, administered on 08-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-OCT-2021, the patient experienced fatigue. On 09-OCT-2021, the patient experienced body pain (hips all the way down to both feet). On 09-OCT-2021, the patient experienced too painful to walk. On 09-OCT-2021, the patient experienced chills. On 09-OCT-2021, the patient experienced left arm pain that feels like it is in the bone (from the shoulder all the way to the finger tips). On 09-OCT-2021, the patient experienced fever. On 09-OCT-2021, the patient experienced headache. On 10-OCT-2021, the patient experienced swollen ankles. On 10-OCT-2021, the patient experienced swollen feet. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body pain (hips all the way down to both feet), too painful to walk, chills, fever, and headache on 10-OCT-2021, and swollen ankles, and swollen feet on 11-OCT-2021, and had not recovered from fatigue, and left arm pain that feels like it is in the bone (from the shoulder all the way to the finger tips). This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: MORE BLOOD CLOT; This spontaneous report received from a patient via a company representative concerned a male of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: blood clot. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) dose, start therapy date were not reported, 01 total, administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  The patient reported he suffered from blood clots and believed he suffered from more blood clots (aggravated condition) after receiving the Johnson and Johnson Covid shot on unspecified date. The action taken with covid-19 vaccine was not applicable. The outcome of more blood clot was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20211023460- covid-19 vaccine -more blood clot. 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: MEDICAL HISTORY
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: POUNDING HEADACHE; 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) 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 pounding headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pounding headache. This report was non-serious.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Medication error, Psoriatic arthropathy, SARS-CoV-2 antibody test, SARS-CoV-2 antibody test positive
Clinical narrative: LOW ANTIBODIES IN BLOOD WORK TESTED; MEDICATION ERROR; PSORIATIC ARTHRITIS FLARE UP; This spontaneous report received from a patient concerned a 58 year old male of an unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent condition included: psoriatic arthritis. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number, and expiry date: unknown) dose was not reported, with frequency time 1 total administered on 08-MAR-2021 for Covid-19 vaccination. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number, and expiry date: unknown) dose and frequency were not reported from an unspecified date to 08-MAR-2021 for psoriatic arthritis. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. Concomitant medications included MRNA 1273 for Covid-19 vaccination (medication error).  On an unspecified date in 2021, the patient had low antibodies in blood work tested. Laboratory data included: Covid-19 antibody test (NR: not provided) Positive (low). On an unspecified date in OCT-2021, the patient experienced psoriatic arthritis flare up. It was reported that it was unknown if the patient was enrolled in Covid-19 vaccine trial.  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 low antibodies in blood work tested, and psoriatic arthritis flare up, and the outcome of medication error was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000197405.; Sender's Comments: V0: 20211023652-COVID-19 VACCINE AD26.COV2.S-psoriatic arthritis flare up. 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: MEDICAL HISTORY
Sex: M
Vaccine: COVID19, UNK
Symptoms: Fatigue, Feeling cold, Influenza like illness, Pain
Clinical narrative: FLU-LIKE SYMPTOMS; GENERALIZED ACHING; COLDNESS; FATIGUE; This spontaneous report received from a patient concerned an adult male. The patient's height, and weight were not reported. The patient's concurrent conditions included: immense pain/dull ache in bones and joint, bad time walking, psoriatic arthritis, and breathing was hurting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for covid-19 vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled syringe, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for psoriatic arthritis. No concomitant medications were reported.  On an unspecified date, the patient experienced flu-like symptoms, generalized aching, coldness, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient recovered from flu-like symptoms, generalized aching, coldness, and fatigue. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: VACCINE ADMINISTRATION ERROR DOSE ADMINISTERED AFTER VIAL WAS PUNCTURED FOR 7.25 HOURS; This spontaneous report received from a health care professional concerned a female of unspecified age. 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: Unknown) dose was not reported, administered on 12-OCT-2021 15:30 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported.  On 12-OCT-2021, the patient experienced vaccine administration error dose administered after vial was punctured for 7.25 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine administration error dose administered after vial was punctured for 7.25 hours was not reported. This report was non-serious.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood test, Body temperature, C-reactive protein, Hepatic enzyme
Clinical narrative: MUSCLE ACHES; EXCESSIVE SWEATING (JUST ON HEAD); CANNOT SLEEP ON THE SIDES, AND WAKES UP IF ROLLS OVER; JOINT PAIN IN SHOULDERS AND HIPS / UNABLE TO PUT ARMS BEHIND THE BACK; LOW GRADE FEVER; INFLAMMATION; This spontaneous report received from a patient concerned a 74 year old female. The patient's weight was 145 pounds, and height was 64 inches. The patient's concurrent conditions included: alcohol user, and non smoker, and other pre-existing medical conditions included: The patient was in good health and very active before she received the vaccine. The patient did 100 push-ups a day. 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: 201A21A, and expiry: UNKNOWN) dose was not reported, administered on 10-SEP-2021 for prophylactic vaccination. Concomitant medications included amlodipine. On SEP-2021, the patient experienced inflammation. Laboratory data included: Blood test (NR: not provided) elevated CRP, Liver enzymes, C-reactive protein (NR: not provided) elevated, and Hepatic enzyme (NR: not provided) higher. Treatment medications included: naproxen sodium, and paracetamol. On 13-SEP-2021, the patient experienced cannot sleep on the sides, and wakes up if rolls over. On 13-SEP-2021, the patient experienced joint pain in shoulders and hips / unable to put arms behind the back. On 13-SEP-2021, the patient experienced low grade fever. On 15-SEP-2021, the patient experienced excessive sweating (just on head). On 12-OCT-2021, Laboratory data included: Body temperature (NR: not provided) around 100F. On an unspecified date, the patient experienced muscle aches. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 99.5F to 100.5 F, and X-ray (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from excessive sweating (just on head), had not recovered from joint pain in shoulders and hips / unable to put arms behind the back, and low grade fever, and the outcome of muscle aches, cannot sleep on the sides, and wakes up if rolls over and inflammation was not reported. This report was non-serious.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Inflammation, Insomnia, Myalgia, Pyrexia
Clinical narrative: MUSCLE ACHES; EXCESSIVE SWEATING (JUST ON HEAD); CANNOT SLEEP ON THE SIDES, AND WAKES UP IF ROLLS OVER; JOINT PAIN IN SHOULDERS AND HIPS / UNABLE TO PUT ARMS BEHIND THE BACK; LOW GRADE FEVER; INFLAMMATION; This spontaneous report received from a patient concerned a 74 year old female. The patient's weight was 145 pounds, and height was 64 inches. The patient's concurrent conditions included: alcohol user, and non smoker, and other pre-existing medical conditions included: The patient was in good health and very active before she received the vaccine. The patient did 100 push-ups a day. 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: 201A21A, and expiry: UNKNOWN) dose was not reported, administered on 10-SEP-2021 for prophylactic vaccination. Concomitant medications included amlodipine. On SEP-2021, the patient experienced inflammation. Laboratory data included: Blood test (NR: not provided) elevated CRP, Liver enzymes, C-reactive protein (NR: not provided) elevated, and Hepatic enzyme (NR: not provided) higher. Treatment medications included: naproxen sodium, and paracetamol. On 13-SEP-2021, the patient experienced cannot sleep on the sides, and wakes up if rolls over. On 13-SEP-2021, the patient experienced joint pain in shoulders and hips / unable to put arms behind the back. On 13-SEP-2021, the patient experienced low grade fever. On 15-SEP-2021, the patient experienced excessive sweating (just on head). On 12-OCT-2021, Laboratory data included: Body temperature (NR: not provided) around 100F. On an unspecified date, the patient experienced muscle aches. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 99.5F to 100.5 F, and X-ray (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from excessive sweating (just on head), had not recovered from joint pain in shoulders and hips / unable to put arms behind the back, and low grade fever, and the outcome of muscle aches, cannot sleep on the sides, and wakes up if rolls over and inflammation was not reported. This report was non-serious.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: MUSCLE ACHES; EXCESSIVE SWEATING (JUST ON HEAD); CANNOT SLEEP ON THE SIDES, AND WAKES UP IF ROLLS OVER; JOINT PAIN IN SHOULDERS AND HIPS / UNABLE TO PUT ARMS BEHIND THE BACK; LOW GRADE FEVER; INFLAMMATION; This spontaneous report received from a patient concerned a 74 year old female. The patient's weight was 145 pounds, and height was 64 inches. The patient's concurrent conditions included: alcohol user, and non smoker, and other pre-existing medical conditions included: The patient was in good health and very active before she received the vaccine. The patient did 100 push-ups a day. 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: 201A21A, and expiry: UNKNOWN) dose was not reported, administered on 10-SEP-2021 for prophylactic vaccination. Concomitant medications included amlodipine. On SEP-2021, the patient experienced inflammation. Laboratory data included: Blood test (NR: not provided) elevated CRP, Liver enzymes, C-reactive protein (NR: not provided) elevated, and Hepatic enzyme (NR: not provided) higher. Treatment medications included: naproxen sodium, and paracetamol. On 13-SEP-2021, the patient experienced cannot sleep on the sides, and wakes up if rolls over. On 13-SEP-2021, the patient experienced joint pain in shoulders and hips / unable to put arms behind the back. On 13-SEP-2021, the patient experienced low grade fever. On 15-SEP-2021, the patient experienced excessive sweating (just on head). On 12-OCT-2021, Laboratory data included: Body temperature (NR: not provided) around 100F. On an unspecified date, the patient experienced muscle aches. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 99.5F to 100.5 F, and X-ray (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from excessive sweating (just on head), had not recovered from joint pain in shoulders and hips / unable to put arms behind the back, and low grade fever, and the outcome of muscle aches, cannot sleep on the sides, and wakes up if rolls over and inflammation was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: HEADACHE; 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 18-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 18-AUG-2021, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Gastrooesophageal reflux disease, Rash
Clinical narrative: ACID REFLUX; RASH; 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, Expiry: 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 acid reflux, and rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the rash and acid reflux was not reported. This report was non-serious.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Fibrin D dimer, Illness, Pain, Pulmonary embolism, Pulmonary thrombosis
Clinical narrative: PULMONARY EMBOLISM; SEVERAL BLOOD CLOTS IN LUNGS; SEVERELY ILL; PAIN IN SIDES; This spontaneous report received from a consumer concerned a 52 year old male. The patient's weight was 180 pounds, and height was 69 inches. The patient's concurrent conditions included: non smoker, and non alcohol user. The patient had no known allergies. The patient did not have any history of drug abuse or illicit drug use. The patient had health with no prior medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 043A21A expiry: 19-SEP-2021) dose was not reported, 1 total, administered on 10-APR-2021 on left arm for prophylactic vaccination. Concomitant medications included Multivitamins, ergocalciferol, and fish oil.  On 10-OCT-2021, the patient experienced pain in side and was severely ill. On 11-OCT-2O21, the patient was transported by ambulance to emergency room and admitted to hospital. The patient was initially diagnosed incorrectly with pneumonia, but was later found to have pulmonary embolism and several blood clots in lungs after further tests were performed. On 11-OCT-2021, Laboratory data included: CAT scan twice (NR: not provided) Blood clots and pulmonary embolism, Fibrin D dimer (NR: not provided) Positive for blood clots and pulmonary embolism, and X-ray (NR: not provided) Blood clots and pulmonary embolism. On 12-OCT-2021, Laboratory data included: Ultrasound Doppler (NR: not provided) Negative. The patient was discharged on 12-OCT-2021. The patient was hospitalized for 2 days. The patient was treated with heparin, an antibiotic and pain medication in hospital and was sent home on Eliquis (apixaban) 10 mg oral twice daily (dose was being titrated). The patient would be required to take Eliquis for at least 3 months and possibly for the rest of life. The patient was being followed by a pulmonologist and would be seen for follow up in the next 2 weeks on 28-OCT-2021.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pulmonary embolism, several blood clots in lungs, severely ill and pain in sides was not reported. This report was serious (Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20211025566.; Sender's Comments: V0: 20211025143- covid-19 vaccine ad26.cov2.s-pulmonary embolism, several blood clots in lungs. 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: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: STROKE; This spontaneous report received from a patient concerned an 80 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had always good cholesterol and was physically active. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered on 30-MAR-2021 to left deltoid for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 24-JUN-2021, the patient experienced stroke and had weakness on the left side of body (left arm and left leg). The patient was recovering from the symptoms but it was slow and was still doing physical therapy and occupational therapy for the stroke. The patient attributed the stroke to the Janssen Covid-19 vaccine. The patient was in therapy at the hospital for 29 days. On 24-JUN-2021, the patient was admitted and discharged on 22-JUL-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from stroke. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20211025160- COVID-19 VACCINE AD26.COV2.S- Stroke. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Headache, Hyperhidrosis, Loss of personal independence in daily activities
Clinical narrative: BODY IS FIGHTING SO BADLY; SWEATING; CAN NOT FUNCTION; CHILLS; HEADACHE; FEVER; NAUSEA; MUSCLE PAIN; 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, 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 body is fighting so badly, sweating, can not function, chills, headache, fever, nausea, and muscle pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body is fighting so badly, headache, fever, chills, nausea, sweating, muscle pain, and can not function. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: BODY IS FIGHTING SO BADLY; SWEATING; CAN NOT FUNCTION; CHILLS; HEADACHE; FEVER; NAUSEA; MUSCLE PAIN; 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, 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 body is fighting so badly, sweating, can not function, chills, headache, fever, nausea, and muscle pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body is fighting so badly, headache, fever, chills, nausea, sweating, muscle pain, and can not function. This report was non-serious.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia, Sensory loss
Clinical narrative: LOSS OF FEELING; FEELING NUMBNESS IN LEFT ARM; TINGLING IN LEFT ARM; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was not pregnant at the time of reporting. 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: 204B21A, and expiry: 11-DEC-2021) dose was not reported, administered on 05-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-OCT-2021, the patient experienced loss of feeling. On 12-OCT-2021, the patient experienced feeling numbness in left arm. On 12-OCT-2021, the patient experienced tingling in left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feeling numbness in left arm, and tingling in left arm, and the outcome of loss of feeling was not reported. This report was non-serious.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Fatigue, Injection site erythema
Clinical narrative: UNCOMFORTABLE; RED, FLAT, AND ROUND SPOT WHICH WAS ABOUT 6 INCHES AT INJECTION SITE; LITTLE TIRED; This spontaneous report received from a patient concerned a 91 year old female. The patient's weight was 160 pounds, and height was 62 inches. The patient's concurrent conditions included: diabetes, non-alcohol user, non-smoker, arrhythmia, osteoarthritis (bad), and low kidney function, and other pre-existing medical conditions included: The patient had no history of drug abuse or illicit drug use. The patient experienced large red spot at the injection site when treated with influenza vaccine.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811, expiry: UNKNOWN) dose was not reported, administered on 06-OCT-2021 for prophylactic vaccination. Concomitant medications included tramadol for drug used for unknown indication.  On OCT-2021, the patient experienced little tired. On 12-OCT-2021, the patient experienced uncomfortable. On 12-OCT-2021, the patient experienced red, flat, and round spot which was about 6 inches at injection site. Treatment medications included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from red, flat, and round spot which was about 6 inches at injection site, and the outcome of little tired and uncomfortable was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Death, Headache
Clinical narrative: DEATH; HEADACHE; This spontaneous report received from a health care professional via a company representative concerned a male of unspecified age, 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, start therapy date were not reported, frequency time 1 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, after receiving the covid-19 vaccine patient complained of a headache that day. The next day he died due to unknown cause of death. It was reported that the patient did not have anything else going on with him. Reporter did not know whether it was related to the covid-19 vaccine and was going to talk about it to his cousin. It was unknown if an autopsy was performed. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient died from an unknown cause on an unspecified date, and the outcome of headache was not reported. This report was serious (Death).; Sender's Comments: V0: 20211025751-COVID-19 VACCINE AD26.COV2.S-Death. 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: UNKNOWN CAUSE OF DEATH
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia, Inflammation, Pain, Paraesthesia
Clinical narrative: PAIN; INFLAMMATION; TINGLING; NUMBNESS; 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) 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 pain, inflammation, tingling, and numbness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain, and the outcome of tingling, numbness and inflammation was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED TO PATIENTS; 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: 206A21A and expiry: 21-SEP-2021) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced expired vaccine administered to subjects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered to patients was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: SIDE EFFECTS FROM THE VACCINE; 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 11-OCT-2021 for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch number. No concomitant medications were reported.  On OCT-2021, the patient experienced side effects from the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of side effects from the vaccine was not reported. This report was non-serious.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Death, Deep vein thrombosis, Pulmonary embolism
Clinical narrative: DEATH; PULMONARY EMBOLISM; DEEP VEIN THROMBOSIS; This spontaneous report received from a health care professional via a Regulatory Authority Vaccine Adverse Event Reporting System (VAERS) (VAERS ID 1731745) concerned a 88 year old female 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 administration not reported, batch number: unknown and expiry: unknown) dose was not reported, 1 total, administered on 19-JUN-2021 for an unknown indication. 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 16-JUL-2021, the patient had deep vein thrombosis (blood clot in leg) and pulmonary embolism (bilateral blood clots in the lungs). On an unspecified date, the patient was hospitalized for events. Number of days hospitalized and discharge information was not reported. On 31-JUL-2021, the patient died from deep vein thrombosis and pulmonary embolism (thromboembolism). It was unknown if an autopsy was performed. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient died from deep vein thrombosis and pulmonary embolism (thromboembolism) on 31-JUL-2021. This report was serious (Death, and Hospitalization Caused / Prolonged). This case, involving the same patient is linked to 20211016947.  Additional information was received from health care professional on 08-Oct-2021. Following receipt of additional information, it was determined that nullification and deletion was required for Manufacturer Report Number 20211016947. The information indicated that Manufacturer Report Number 20211016947 had E2B submission failure, due to incorrect format of VAERS ID. Therefore, this case was created to correct VAERS ID format. All relevant information will be submitted under Manufacturer Report Number 20211027314.; Sender's Comments: V0: Additional information was received from health care professional on 08-Oct-2021. The information indicated that Manufacturer Report Number 20211016947 had E2B submission failure, due to incorrect format of VAERS ID. Therefore, this case was created to correct VAERS ID format. 20211027314- Covid-19 vaccine ad26.cov2.s- Death, deep vein thrombosis and pulmonary embolism. 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: DEEP VEIN THROMBOSIS; PULMONARY EMBOLISM
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: LEARNING TO WALK AGAIN FOLLOWING RARE VACCINE-RELATED REACTION; 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced learning to walk again following rare vaccine-related reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from learning to walk again following rare vaccine-related reaction. This report was non-serious.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Injection site pain, Paraesthesia
Clinical narrative: PAIN AT INJECTION SITE; FEELS NUMBNESS FROM INJECTION SITE TO HAND/WRIST; FEELS TINGLING FROM INJECTION SITE TO HAND/WRIST AND WHEN RUN FINGER ACROSS SKIN; This spontaneous report received from a patient concerned a 37 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 (suspension for injection, route of admin not reported, batch number: 212A21A, and expiry: 21-DEC-2021) dose was not reported, administered on 12-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-OCT-2021, the patient experienced pain at injection site. On 12-OCT-2021, the patient experienced feels numbness from injection site to hand/wrist. On 12-OCT-2021, the patient experienced feels tingling from injection site to hand/wrist and when run finger across skin. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from pain at injection site, feels numbness from injection site to hand/wrist, and feels tingling from injection site to hand/wrist and when run finger across skin. This report was non-serious.