chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Adverse reaction
Clinical narrative: REACTIONS; This spontaneous report received from a consumer via a company representative concerned multiple patients. 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 reactions. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of reactions was not reported. This report was non-serious. This case, from the same reporter is linked to 20220104572 and 20220105368.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain
Clinical narrative: LITTLE TIRED; PAIN WITH THE INJECTION; 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, and batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 02-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On JUL-2021, the patient experienced little tired, and pain with the injection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the little tired and pain with the injection was not reported. This report was non-serious.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Burning mouth syndrome
Clinical narrative: BURN MOUTH SYNDROME; This spontaneous report received from a patient concerned a 57 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 (suspension for injection, route of admin not reported, batch number: 1808609 expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the patient experienced burn mouth syndrome. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from burn mouth syndrome. This report was non-serious. This case, from the same reporter is linked to 20220105063.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID 19 INFECTION; This spontaneous report received from a patient concerned a 60-year-old male. The patient's height and weight were not reported. The patient's concurrent conditions included: seasonal allergies. 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, 1 total administered at left arm in MAY-2021 for prophylactic vaccination (Dose number in series 1). No concomitant medications were reported. The patient had cut grass the day before on 02-JAN-2022. On 03-JAN-2022, patient had symptoms of runny nose, severe headache, temperature of 101 Fahrenheit helped by meds and sleep, runny nose, throat was scratchy/sore, sneezing, congestion behind the eyes. The patient thought symptoms may be due to seasonal allergies. The patient had not received the booster yet. On 03-JAN-2022, Laboratory data included: Body temperature (NR: not provided) 101 F, and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) rapid diagnostic test (NR: not provided) Positive. The patient tested covid positive (suspected covid 19 infection and suspected clinical vaccination failure) yesterday (03-JAN-2022) with supplied home rapid antigen test. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid 19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000210187.; Sender's Comments: V0: 20220104721 -Covid-19 vaccine ad26.cov2.s- Suspected clinical vaccination 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.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Laboratory test, Pain in extremity
Clinical narrative: PAIN ON LOWER BACK; PAIN HIPS; PAIN ON LEGS; This spontaneous report received from a patient concerned a 49 year old male. The patient's height, and weight were not reported. The patient's past medical history included: covid-19 infection in APR-2020 and AUG-2020, and concurrent conditions included: non-alcoholic and non-smoker, and other pre-existing medical conditions included: The patient had no known allergies and had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: UNKNOWN) 1 total, administered on 30-AUG-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 31-AUG-2021, patient stated that, he had a reaction to the vaccine. He got pain on 31-Aug-2021 on his lower back, hips and legs and could not stand the pain. He had to go the emergency room and was told it was a syndrome caused by the vaccine. The patient went to the hospital on 01-Jan-2022 and left on 02-Jan-2022. The patient never went with healthcare professional because the patient went to get lab test done and healthcare professional never gave them so patient got upset and never went back. The patient was hospitalized for 1 day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pain on lower back, pain hips and pain on legs was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0- 20220104725-Covid-19 vaccine ad26.CoV-2.s-Pain in lower back . 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). 20220104725-Covid-19 vaccine ad26.CoV-2.s- Pain in hips, Pain on legs. This event(s) is labeled per a regulatory authority and is therefore considered potentially related.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: RAPID ONSET DIZZINESS (DIZZY); SOMETIMES NAUSEA (NAUSEOUS); 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 was not reported, administered on MAR-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 MAR-2021, the patient experienced rapid onset dizziness (dizzy), and sometimes nausea (nauseous). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rapid onset dizziness (dizzy), and sometimes nausea (nauseous). This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Illness, Peripheral swelling
Clinical narrative: ARM SWELLED UP TILL HIS BACK; GOT REALLY SICK; This spontaneous report received from a consumer concerned a male of unspecified age, race and ethnicity. 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) 1 total, dose, start therapy date were not reported for prophylactic vaccination (Dose number in series: 1). The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient got really sick after getting covid 19 vaccine but the reporter was not sure if the patient received JNJ covid 19 vaccine or not. The patient's arm swelled up till his back and had cut his arm open to relieve the pressure and was hospitalized. The number of days of hospitalization was unspecified. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the arm swelled up till his back and got really sick was not reported. This report was serious (Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20220105183 and 20220105260.; Sender's Comments: V0: 20220105023-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Arm swelled up till his back. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: GOT COVID; 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, 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 number. No concomitant medications were reported.  On DEC-2021, the patient experienced got covid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of got covid was not reported. This report was non-serious. This report was associated with product quality complaint: 90000210015.
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOTS; This spontaneous report received from a consumer concerned multiple female patients of child bearing age and unspecified race and ethnic origin. 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 and expiry were not reported) 1 total, dose, start therapy date were not reported for prophylactic vaccination (dose number in series is 1). The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the reporter stated that she heard people talking about blood clots with JNJ covid 19 vaccine and that the ones who got blood clots are women with child bearing age that are on birth control pills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clots was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20220105023 and 20220105260.; Sender's Comments: V0-20220105183-Covid-19 vaccine ad26.CoV-2.s- Blood clot. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: GOT REALLY SICK; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, 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 got really sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of got really sick was not reported. This report was non-serious. This case, from the same reporter is linked to 20220105023 and 20220105183.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19 infection; This spontaneous report received from a consumer via a company representative 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced covid-19 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 infection was not reported. This report was non-serious. This report was associated with product quality complaint (PQC) 90000210009. This case, from the same reporter is linked to 20220104644.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 63 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(dose number in series 1) (suspension for injection, route of admin not reported, batch number: 042AZ1A, expiry: unknown) dose was not reported, 1 total, administered on 10-APR-2021 for prophylactic vaccination on left arm. No concomitant medications were reported.  On 31-DEC-2021,the patient had scratchy throat, coughing, headache and body aches (suspected covid-19 infection) and suspected clinical vaccination failure. On 01-JAN-2022, the patient tested positive for COVID-19. Laboratory data included: COVID-19 virus test (home kit test) (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition).  This report was associated with product quality complaint.; Sender's Comments: V0: 20220105390-Covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination 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
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Head discomfort, SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: LOTS OF HEAD PRESSURE; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 30 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: alcohol user, and non smoker, and other pre-existing medical conditions included: The patient had no known drug allergies. The patient had no relevant medical history. 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, 1 total, administered on 05-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 01-JAN-2022, the patient experienced cough, chest congestion, trouble breathing (suspected covid-19 infection and suspected clinical vaccination failure) and tested positive for covid-19. On 02-JAN-2022, the patient experienced lots of head pressure and tested positive for covid-19 at the doctor. It was a rapid test because patient got the results in 15 minutes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from suspected covid-19 infection, lots of head pressure and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). The case was associated with Product quality complaint 90000210218.; Sender's Comments: V0: 20220105438-Covid-19 vaccine ad26.cov2.s-Suspected clinical Vaccination 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: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: GOT COVID; This spontaneous report received from a consumer via a company representative 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, 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 got covid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of got covid was not reported. This report was non-serious. This case, from the same reporter is linked to 20220105113 and 20220105064.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Burning mouth syndrome
Clinical narrative: DEVELOPED BURNING MOUTH SYNDROME AROUND THE BOTTOM LIP AND INSIDE AND FEELS LIKE IT IS BURNING ALL THE TIME LIKE IT IS ON FIRE; This spontaneous report received from a consumer concerned a 74 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: breast cancer. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609 expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced developed burning mouth syndrome around the bottom lip and inside and feels like it is burning all the time like it is on fire. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from developed burning mouth syndrome around the bottom lip and inside and feels like it is burning all the time like it is on fire. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Myalgia, Nasopharyngitis
Clinical narrative: HEAD CONGESTION; JOINT ACHE; MUSCLE ACHE; HEADACHE; FATIGUE; 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. Per procedure, no follow up will be requested for the case. No concomitant medications were reported. On an unspecified date, the patient experienced head congestion, joint ache, muscle ache, headache, and fatigue. Treatment medications (dates unspecified) included: guaifenesin, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the head congestion, headache, fatigue, joint ache and muscle ache was not reported. This report was non-serious. This case, involving the same patient is linked to 20220102781.
Sex: U
Vaccine: COVID19
Symptoms: Hyperhidrosis
Clinical narrative: SWEATY; 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 (Dose number in series 1). The batch number was not reported. The company is unable to perform follow up to request batch/lot number. No concomitant medications were reported. On an unspecified date, the patient experienced sweaty. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sweaty. This report was non-serious.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: COVID-19 TEST POSITIVE; This spontaneous report received from a consumer concerned a 43 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, and batch number were not reported) dose was not reported, administered on JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 05-JAN-2022, the patient experienced covid-19 test positive. Laboratory data included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 test positive was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain, SARS-CoV-2 test
Clinical narrative: SORE THROAT; This spontaneous report received from a consumer concerned a 72 year old male. The patient's height, and weight were not reported. The patient's past medical history included: covid-19 infections. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 26-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-JAN-2021, Laboratory data included: COVID-19 PCR test (NR: not provided) Positive. On 05-JAN-2022, the patient experienced sore throat. Laboratory data included: COVID-19 rapid POC test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sore throat. This report was non-serious. This case, from the same reporter was linked to 20220107982.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Back pain, Coordination abnormal, Feeling abnormal, Pelvic pain
Clinical narrative: ABDOMINAL PAIN (A FEELING OF NEEDLES IN STOMACH AND ABDOMEN); FEELING OF BRAIN FOG (DOES NOT FEEL THE SAME); FEELS UNCOORDINATION (FEELS HE WAS NOT AS CONNECTED AS HE WAS BEFORE); BACK PAIN; PAIN IN THE PELVIC REGION; This spontaneous report received from a patient concerned a 66 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: high blood pressure, and other pre-existing medical conditions included: Patient did not have known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, and expiry: UNKNOWN) dose was not reported, administered on 19-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced abdominal pain (a feeling of needles in stomach and abdomen), feeling of brain fog (does not feel the same), feels uncoordination (feels he was not as connected as he was before), back pain, and pain in the pelvic region. Laboratory data (dates unspecified) included: PSA (NR: not provided) doubled from 1.3. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the abdominal pain (a feeling of needles in stomach and abdomen), feeling of brain fog (does not feel the same), feels uncoordination (feels he was not as connected as he was before), back pain and pain in the pelvic region was not reported. This report was non-serious. This case was associated with product quality complaint number 90000210359.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Prostatic specific antigen
Clinical narrative: ABDOMINAL PAIN (A FEELING OF NEEDLES IN STOMACH AND ABDOMEN); FEELING OF BRAIN FOG (DOES NOT FEEL THE SAME); FEELS UNCOORDINATION (FEELS HE WAS NOT AS CONNECTED AS HE WAS BEFORE); BACK PAIN; PAIN IN THE PELVIC REGION; This spontaneous report received from a patient concerned a 66 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: high blood pressure, and other pre-existing medical conditions included: Patient did not have known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, and expiry: UNKNOWN) dose was not reported, administered on 19-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced abdominal pain (a feeling of needles in stomach and abdomen), feeling of brain fog (does not feel the same), feels uncoordination (feels he was not as connected as he was before), back pain, and pain in the pelvic region. Laboratory data (dates unspecified) included: PSA (NR: not provided) doubled from 1.3. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the abdominal pain (a feeling of needles in stomach and abdomen), feeling of brain fog (does not feel the same), feels uncoordination (feels he was not as connected as he was before), back pain and pain in the pelvic region was not reported. This report was non-serious. This case was associated with product quality complaint number 90000210359.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID AFTER RECEIVING THE JANSSEN COVID 19 VACCINE; This spontaneous report received from a patient concerned a 40 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: 204521A expiry: UNKNOWN) dose was not reported, administered on 10-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-JAN-2022, the patient experienced covid after receiving the Janssen Covid 19 vaccine. Laboratory data included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid after receiving the Janssen Covid 19 vaccine was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Bone pain, Decreased appetite, Epicondylitis, Gait inability, Injection site pain
Clinical narrative: ACHES; SORE BONES; LOSS OF APPETITE; INABILITY TO WALK; MUSCLE SPASMS RADIATING FROM INJECTION SITE; TENNIS ELBOW WITH GROWTH ON ELBOW; FEVER; SORENESS AT INJECTION SITE; 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 not reported, batch number: Unknown) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced aches, sore bones, loss of appetite, inability to walk, muscle spasms radiating from injection site, tennis elbow with growth on elbow, fever, and soreness at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, aches, sore bones, loss of appetite, inability to walk, soreness at injection site, muscle spasms radiating from injection site and tennis elbow with growth on elbow was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Muscle spasms, Pain, Pyrexia
Clinical narrative: ACHES; SORE BONES; LOSS OF APPETITE; INABILITY TO WALK; MUSCLE SPASMS RADIATING FROM INJECTION SITE; TENNIS ELBOW WITH GROWTH ON ELBOW; FEVER; SORENESS AT INJECTION SITE; 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 not reported, batch number: Unknown) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced aches, sore bones, loss of appetite, inability to walk, muscle spasms radiating from injection site, tennis elbow with growth on elbow, fever, and soreness at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, aches, sore bones, loss of appetite, inability to walk, soreness at injection site, muscle spasms radiating from injection site and tennis elbow with growth on elbow was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: STARTED SHAKING WHEN USED HANDS FOR ANYTHING LIKE HAD PARKINSON'S; 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 started shaking when used hands for anything like parkinson's. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of started shaking when used hands for anything like had parkinson's was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Acute kidney injury
Clinical narrative: KIDNEYS SHUT DOWN; This spontaneous report received from a consumer through social media 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 administration not reported, batch number: Unknown, expiry: Unknown) dose, start therapy date were not reported, dose number in series was 1, 01 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.  It was reported that, 10 days later after JnJ shot, his kidneys were shut down. Reportedly, he was on dialysis 3 days a week and was looking for kidney transplant (dose number in series was 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from kidneys shut down. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220107450-COVID-19 VACCINE AD26.COV2.S-kidneys shut down. 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: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy bone marrow, Blood test, Chills, Colonoscopy, Pain in extremity
Clinical narrative: GAINED 30 POUNDS; CHILLS; LEG PAIN FROM BACK ALL THE WAY DOWN THE LEG FEELING LIKE SCIATICA AND CURRENTLY THE PAIN WAS FROM CALF TO ANKLE; LOST 40 POUNDS; This spontaneous report received from a consumer concerned a 67 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, and expiry: 19-SEP-2021) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the patient experienced lost 40 pounds. On 21-APR-2021, the patient experienced leg pain from back all the way down the leg feeling like sciatica and currently the pain was from calf to ankle. On 28-JUL-2021, Laboratory data included: Weight loss (not provided) lost 40 pounds. On an unspecified date, the patient experienced gained 30 pounds, and chills. Laboratory data (dates unspecified) included: Blood test (not provided) Negative, Bone marrow biopsy (not provided) Unknown, Colonoscopy (not provided) Unknown, Weight gain (not provided) Gained 30 pounds, and White blood cell count (not provided) 15. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lost 40 pounds on 28-JUL-2021, and chills, had not recovered from leg pain from back all the way down the leg feeling like sciatica and currently the pain was from calf to ankle, and the outcome of gained 30 pounds was not reported. This report was non-serious.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Weight decreased, Weight increased, White blood cell count
Clinical narrative: GAINED 30 POUNDS; CHILLS; LEG PAIN FROM BACK ALL THE WAY DOWN THE LEG FEELING LIKE SCIATICA AND CURRENTLY THE PAIN WAS FROM CALF TO ANKLE; LOST 40 POUNDS; This spontaneous report received from a consumer concerned a 67 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, and expiry: 19-SEP-2021) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the patient experienced lost 40 pounds. On 21-APR-2021, the patient experienced leg pain from back all the way down the leg feeling like sciatica and currently the pain was from calf to ankle. On 28-JUL-2021, Laboratory data included: Weight loss (not provided) lost 40 pounds. On an unspecified date, the patient experienced gained 30 pounds, and chills. Laboratory data (dates unspecified) included: Blood test (not provided) Negative, Bone marrow biopsy (not provided) Unknown, Colonoscopy (not provided) Unknown, Weight gain (not provided) Gained 30 pounds, and White blood cell count (not provided) 15. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lost 40 pounds on 28-JUL-2021, and chills, had not recovered from leg pain from back all the way down the leg feeling like sciatica and currently the pain was from calf to ankle, and the outcome of gained 30 pounds was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 29 year old female of unspecified 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: 203A21A and expiry: 21-SEP-2021) 1 total, dose was not reported, administered to left arm on 04-MAY-2021 for prophylactic vaccination (dose number in series 1). No concomitant medications were reported. On 29-DEC-2021, the patient experienced confirmed clinical vaccination failure. The patient reported that she has covid (confirmed covid-19 infection) after receiving the Janssen covid 19 vaccine (dose number in series 1). On 29-DEC-2021, laboratory data included: COVID-19 PCR test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed covid-19 infection and confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with Product quality compliant: 90000210291.; Sender's Comments: V0-20220107534-Covid-19 vaccine ad26.cov2.s- Confirmed Clinical Vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, SARS-CoV-2 test
Clinical narrative: ASYMPTOMATIC COVID-19; This spontaneous report received from a patient concerned a 52 year old female. The patient's height, and weight were not reported. The patient's past medical history included: covid-19, and other pre-existing medical conditions included: The patient was quarantine for five days after the second time of corona. The patient had has underlying health conditions. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 30-MAR-2021 14:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 24-DEC-2021, the patient experienced asymptomatic covid-19. Laboratory data included: COVID-19 PCR test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of asymptomatic covid-19 was not reported. This report was non-serious. This report was associated with product complaint number 90000210331
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOTS; This spontaneous report received from a consumer via a company representative via social media concerned a male of unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient was older but healthy men. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, start therapy date was 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, it was reported that "My father in law died from sudden blood clots after they got vaxxed. Older but healthy men." It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20220108012.; Sender's Comments: V0: 20220107619 - Covid-19 vaccine ad26.cov2.s- 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).; Reported Cause(s) of Death: BLOOD CLOTS
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 30 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: 1808980, expiry: UNKNOWN) dose was not reported, 1 total, administered on 20-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 05-JAN-2022, the patient experienced some minor sinus congestion since this afternoon and tested positive for Covid 19 today (binax home test) (suspected clinical vaccination failure, and suspected covid-19 infection). Laboratory data included: COVID-19 rapid POC (Point of care) test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). The report was associated with product quality complaint number: 90000210323.; Sender's Comments: V0 20220107754-COVID-19 VACCINE AD26.COV2.S-suspected clinical vaccination 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.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 41 year old female. The patient's height, and weight were not reported. The patient's past medical history included: anemia, and low b12, and other pre-existing medical conditions included: The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s(dose series 1) (suspension for injection, route of admin not reported, batch number: 264B21A expiry: unknown) dose was not reported, 1 total, administered on 13-SEP-2021 on right arm for prophylactic vaccination. No concomitant medications were reported.  On 28-DEC-2021, the patient experienced loss of taste and smell, sore throat, headache, cough, and stuff nose (confirmed covid-19 infection) and also had confirmed clinical vaccination failure for which patient tested Covid-19 positive . On 04-JAN-2022, Laboratory data included: COVID-19 PCR (polymerase case reaction) test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000210342.; Sender's Comments: V0-20220107787-Covid-19 vaccine ad26.cov2.s-Confirmed Clinical Vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 28 year old female. 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: 1808980 expiry: unknown) 1 total, administered on 20-AUG-2021 to right arm for prophylactic vaccination (Dose number in series 1). No concomitant medications were reported.  On 05-JAN-2022, the patient experienced suspected clinical vaccination failure, and suspected covid-19 infection. The patient was experiencing symptoms cough, sneezing, nasal congestion, body aches (symptoms started on 05-JAN-2021). Laboratory data included: COVID-19 rapid POC test (NR: not provided) and result found to be positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000210326.; Sender's Comments: V0: 20220108048-covid-19 vaccine ad26.cov2.s- Suspected clinical Vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: COVID-19 TEST POSITIVE; This spontaneous report received from a patient concerned a 47 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: 206A21A expiry: 21-SEP-2021) dose was not reported, administered on 07-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 27-DEC-2021, the patient experienced covid-19 test positive. Laboratory data included: COVID-19 virus test (not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 test positive was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: COVID-19 TEST POSITIVE; 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: 1808986, and expiry: 02-OCT-2021) dose was not reported, administered on 27-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On 30-DEC-2021, the patient experienced covid-19 test positive. Laboratory data included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 test positive was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Pain
Clinical narrative: ALL OVER BODY ACHES; JOINT PAIN; FATIGUE; 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 all over body aches, joint pain, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the all over body aches, joint pain and fatigue was not reported. This report was non-serious.