chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Decreased appetite, Hypophagia, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: SUSPECTED CLINICAL VACCINE FAILURE; SUSPECTED COVID-19 INFECTION; NO APPETITE; NOT ABLE TO EAT; This spontaneous report received from a health care professional concerned a 48 year old male of white race and unknown ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: 1 or 2 coronary stents, non-alcohol user, non-smoker and the patient had no known allergies. The patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 13-AUG-2021, the patient began having symptoms of aching, congestion, generalized malaise, temperature ranging from 100-102 Fahrenheit, no appetite and not able to eat and also experienced the event of suspected clinical vaccine failure. Laboratory data included: Body temperature (NR: not provided) 100-102 Fahrenheit. On 17-AUG-2021, after receiving vaccine about 2-3 months ago, the patient was found positive to covid-19 infection (suspected covid-19 infection), however reporter was not certain on the type of test performed (nasal or throat swab, or PCR vs rapid). The reporter stated that the patient's health care professional was aware of the symptoms and positive test result. The patient's symptoms abated when the patient was given a steroid injection and anti-emetic, and that the patient commented that nausea he was experiencing (date of onset unknown) had improved and was able to eat solid food and drink soup and green tea.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from no appetite, and not able to eat, and had not recovered from suspected covid-19 infection, and suspected clinical vaccine failure. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000190135.; Sender's Comments: V0: 20210837634-Covid-19 vaccine ad26.cov2.s-suspected clinical vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: M
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINE FAILURE; SUSPECTED COVID-19 INFECTION; NO APPETITE; NOT ABLE TO EAT; This spontaneous report received from a health care professional concerned a 48 year old male of white race and unknown ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: 1 or 2 coronary stents, non-alcohol user, non-smoker and the patient had no known allergies. The patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 13-AUG-2021, the patient began having symptoms of aching, congestion, generalized malaise, temperature ranging from 100-102 Fahrenheit, no appetite and not able to eat and also experienced the event of suspected clinical vaccine failure. Laboratory data included: Body temperature (NR: not provided) 100-102 Fahrenheit. On 17-AUG-2021, after receiving vaccine about 2-3 months ago, the patient was found positive to covid-19 infection (suspected covid-19 infection), however reporter was not certain on the type of test performed (nasal or throat swab, or PCR vs rapid). The reporter stated that the patient's health care professional was aware of the symptoms and positive test result. The patient's symptoms abated when the patient was given a steroid injection and anti-emetic, and that the patient commented that nausea he was experiencing (date of onset unknown) had improved and was able to eat solid food and drink soup and green tea.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from no appetite, and not able to eat, and had not recovered from suspected covid-19 infection, and suspected clinical vaccine failure. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000190135.; Sender's Comments: V0: 20210837634-Covid-19 vaccine ad26.cov2.s-suspected clinical vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Blood immunoglobulin A, Fatigue, Peripheral swelling, SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; SWOLLEN LEFT LEG AND SWOLLEN LEFT ARM; FATIGUE; This spontaneous report received from a patient concerned a 64 year old male of other race, and unknown 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: 1805029, and expiry: 23-AUG-2021) dose was not reported, 1 total, administered on 08-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the patient experienced fatigue, swollen left arm and swollen left leg, which lasted for a week. On 17-AUG-2021, the patient underwent ABIGGIGM (SARS-COV-2 IGM ANTIBODY TEST), IGG (SARS-COV-2 IGG ANTIBODY TEST) and IA test (immunoglobulin a), and the IA test was negative (confirmed immunological vaccine failure). On 18-AUG-2021, the results were given and those were negative.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swollen left leg and swollen left arm, and fatigue on 15-MAR-2021, and the outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with Product Complaint Number: 90000190130; Sender's Comments: V0: 20210837674-Covid-19 vaccine ad26.cov2.s-Confirmed immunological vaccine failure . This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chest pain, Fatigue, SARS-CoV-2 test, Scan
Clinical narrative: CHEST PAIN; FATIGUE; FEELS WEAK; POST NASAL DRIP; This spontaneous report received from a consumer concerned a 75 year old female. The patient's height, and weight were not reported.  The patient's concurrent conditions included: exercise induced asthma, gout, blood pressure, anxiety, alcohol user, asthma, alcohol user, and non-smoker, and other pre-existing medical conditions included: The patient was not a drug abuse or illicit drug user. The patient experienced drug allergy when treated with acetylsalicylic acid. 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 09-AUG-2021 for prophylactic vaccination. Concomitant medications included lorazepam for anxiety, mometasone furoate for asthma, salmeterol xinafoate for asthma, verapamil for blood pressure, and allopurinol for gout.  On 15-AUG-2021, after receiving the vaccine, the patient started having post nasal drip from the nose. It was clear, but it was very heavy and everywhere then there was mucus.  On 16-AUG-2021, the patient experienced chest pain and the patient thought it was because of anxiety and took lorazepam which did not work, and was hospitalized and had to stay in emergency room for observation. The patient stated that lots of scans were done, received IV and then was released on 17-Aug-2021. The laboratory result for lots of scan was unknown. The Consumer stated that they tested him for Covid-19 and it came back negative. . On an unspecified date, the patient experienced fatigue, and feels weak, the patient was asked if the symptoms were gone the patient stated that the patient was feeling weak. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest pain and post nasal drip on 17-AUG-2021, the patient  had not recovered from feels weak, and the outcome of fatigue was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210837701-covid-19 vaccine ad26.cov2.s -Chest pain. 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: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Upper-airway cough syndrome
Clinical narrative: CHEST PAIN; FATIGUE; FEELS WEAK; POST NASAL DRIP; This spontaneous report received from a consumer concerned a 75 year old female. The patient's height, and weight were not reported.  The patient's concurrent conditions included: exercise induced asthma, gout, blood pressure, anxiety, alcohol user, asthma, alcohol user, and non-smoker, and other pre-existing medical conditions included: The patient was not a drug abuse or illicit drug user. The patient experienced drug allergy when treated with acetylsalicylic acid. 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 09-AUG-2021 for prophylactic vaccination. Concomitant medications included lorazepam for anxiety, mometasone furoate for asthma, salmeterol xinafoate for asthma, verapamil for blood pressure, and allopurinol for gout.  On 15-AUG-2021, after receiving the vaccine, the patient started having post nasal drip from the nose. It was clear, but it was very heavy and everywhere then there was mucus.  On 16-AUG-2021, the patient experienced chest pain and the patient thought it was because of anxiety and took lorazepam which did not work, and was hospitalized and had to stay in emergency room for observation. The patient stated that lots of scans were done, received IV and then was released on 17-Aug-2021. The laboratory result for lots of scan was unknown. The Consumer stated that they tested him for Covid-19 and it came back negative. . On an unspecified date, the patient experienced fatigue, and feels weak, the patient was asked if the symptoms were gone the patient stated that the patient was feeling weak. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest pain and post nasal drip on 17-AUG-2021, the patient  had not recovered from feels weak, and the outcome of fatigue was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210837701-covid-19 vaccine ad26.cov2.s -Chest pain. 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: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Blood test, Fall, Fatigue, Headache
Clinical narrative: FAINTING; SHE FELL AND HIT HER HEAD ON WALL; LAID DOWN FOR A FEW  HOURS AND WAS SCARED TO MOVE; HEADACHE; FELT TIRED; This spontaneous report received from a consumer concerned a 34 year old female of unknown ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. Patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A and expiry: unknown) dose was not reported, 1 total, administered to left arm on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021 (reported as following morning), patient experienced a fainting. She woke up to go to the restroom and when she came out of the bathroom, she fell. She hit her head on the side of the wall as she fell, and immediately went to the emergency room. Patient received X-ray (result not reported), heartbeat, and lungs were evaluated as well as blood tests (result not reported). They determined that she would not faint again and discharged her. After she returned home, she experienced headache and felt tired. She laid down for a few hours and was scared to move. On the day of reporting, she was no longer having any side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fainting, she fell and hit her head on wall, headache, laid down for a few hours and was scared to move and felt tired. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210837758- Covid-19 vaccine ad26.cov2.s- Fainting. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Syncope, X-ray
Clinical narrative: FAINTING; SHE FELL AND HIT HER HEAD ON WALL; LAID DOWN FOR A FEW  HOURS AND WAS SCARED TO MOVE; HEADACHE; FELT TIRED; This spontaneous report received from a consumer concerned a 34 year old female of unknown ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. Patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A and expiry: unknown) dose was not reported, 1 total, administered to left arm on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021 (reported as following morning), patient experienced a fainting. She woke up to go to the restroom and when she came out of the bathroom, she fell. She hit her head on the side of the wall as she fell, and immediately went to the emergency room. Patient received X-ray (result not reported), heartbeat, and lungs were evaluated as well as blood tests (result not reported). They determined that she would not faint again and discharged her. After she returned home, she experienced headache and felt tired. She laid down for a few hours and was scared to move. On the day of reporting, she was no longer having any side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fainting, she fell and hit her head on wall, headache, laid down for a few hours and was scared to move and felt tired. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210837758- Covid-19 vaccine ad26.cov2.s- Fainting. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: 48 HOURS PUNCTURED VIAL; This spontaneous report received from a health care professional concerned a 58 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient did not have any 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: 21-SEP-2021) dose was not reported, administered on 17-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-AUG-2021, the patient experienced 48 hours punctured vial. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of 48 hours punctured vial was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: ITCHING ALL OVER; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced itching all over. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of itching all over was not reported. This report was non-serious.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: INADVERTENT ADMINISTRATION OF JANSSEN COVID-19 VACCINE THAT WAS BEYOND THE BEYOND USE DATE; This spontaneous report received from a pharmacist concerned a 27 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: type 2 diabetes, gastroparesis, and hepatosteatosis, and other pre-existing medical conditions included: No known drug allergies. Patient was on medications (not listed). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 17-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 17-AUG-2021, the patient experienced inadvertent administration of janssen covid-19 vaccine that was beyond the beyond use date. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of inadvertent administration of janssen covid-19 vaccine that was beyond the beyond use date was not reported. This report was non-serious.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cough, Gait inability, Loss of personal independence in daily activities, Muscular weakness
Clinical narrative: COUGHING; CONGESTION; CANNOT WALK DUE TO WEAKNESS; ACHING; VERTIGO; DIFFICULTY GETTING UP AND NEED ASSISTANCE TO GET UP / CANNOT SUPPORT HERSELF; EXTREME WEAKNESS IN LEGS; WEAKNESS; HIGH FEVER; This spontaneous report received from a consumer concerned a 75 year old female. The patient's height, and weight were not reported. The patient's past medical history included: covid-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: 19-SEP-2021) dose was not reported, administered on 17-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 18-AUG-2021, the patient experienced coughing. On 18-AUG-2021, the patient experienced congestion. On 18-AUG-2021, the patient experienced cannot walk due to weakness. On 18-AUG-2021, the patient experienced aching. On 18-AUG-2021, the patient experienced vertigo. On 18-AUG-2021, the patient experienced difficulty getting up and need assistance to get up / cannot support herself. On 18-AUG-2021, the patient experienced extreme weakness in legs. On 18-AUG-2021, the patient experienced weakness. On 18-AUG-2021, the patient experienced high fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from coughing, congestion, high fever, weakness, cannot walk due to weakness, aching, vertigo, extreme weakness in legs, and difficulty getting up and need assistance to get up / cannot support herself. This report was non-serious.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Sinus congestion, Vertigo
Clinical narrative: COUGHING; CONGESTION; CANNOT WALK DUE TO WEAKNESS; ACHING; VERTIGO; DIFFICULTY GETTING UP AND NEED ASSISTANCE TO GET UP / CANNOT SUPPORT HERSELF; EXTREME WEAKNESS IN LEGS; WEAKNESS; HIGH FEVER; This spontaneous report received from a consumer concerned a 75 year old female. The patient's height, and weight were not reported. The patient's past medical history included: covid-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: 19-SEP-2021) dose was not reported, administered on 17-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 18-AUG-2021, the patient experienced coughing. On 18-AUG-2021, the patient experienced congestion. On 18-AUG-2021, the patient experienced cannot walk due to weakness. On 18-AUG-2021, the patient experienced aching. On 18-AUG-2021, the patient experienced vertigo. On 18-AUG-2021, the patient experienced difficulty getting up and need assistance to get up / cannot support herself. On 18-AUG-2021, the patient experienced extreme weakness in legs. On 18-AUG-2021, the patient experienced weakness. On 18-AUG-2021, the patient experienced high fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from coughing, congestion, high fever, weakness, cannot walk due to weakness, aching, vertigo, extreme weakness in legs, and difficulty getting up and need assistance to get up / cannot support herself. This report was non-serious.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Myalgia
Clinical narrative: SEVERE MUSCLE DEEP TISSUE PAIN THAT STRETCHED TO POSTERIOR TRAPEZOID, DELTOID AND A LITTLE TO THE QUAD AND GENERALLY TO THE WHOLE BODY; EXTREME DISCOMFORT BUT THERE WAS NO CONTRACTION OR CRAMPING AND NO SWELLING; This spontaneous report received from a patient concerned a 63 year old female. The patient's weight was 120 pounds, and height was 68 inches. The patient's past medical history included: suspected covid-19, bronchitis, and pneumonia, and concurrent conditions included: non alcohol user, smoker, and penicillin allergy, and other pre-existing medical conditions included: The patient had no history of drug abuse or illicit drug usage. The patient was previously treated with azithromycin; and experienced drug allergy when treated with erythromycin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820096, and expiry: 21-OCT-2021) dose was not reported, administered on 15-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On AUG-2021, the patient experienced extreme discomfort but there was no contraction or cramping and no swelling. On 15-AUG-2021, the patient experienced severe muscle deep tissue pain that stretched to posterior trapezoid, deltoid and a little to the quad and generally to the whole body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from extreme discomfort but there was no contraction or cramping and no swelling, and severe muscle deep tissue pain that stretched to posterior trapezoid, deltoid and a little to the quad and generally to the whole body on 18-AUG-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Ultrasound Doppler, Vascular pain
Clinical narrative: PAIN ALONG SOME OF THE VEINS IN LEGS; HEAVY FEELING IN LEGS; This spontaneous report received from a physician concerned a 67 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: varicose vein. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 01-JUN-2021, the patient experienced pain along some of the veins in legs. On 01-JUN-2021, the patient experienced heavy feeling in legs. Laboratory data (dates unspecified) included: Venous Doppler (NR: not provided) No blood clot or no DVT (deep vein thrombosis). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain along some of the veins in legs, and heavy feeling in legs on AUG-2021. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Sinusitis
Clinical narrative: SYMPTOMS OF SINUSITIS HEADACHE SINUS PRESSURE; FATIGUE; MUSCLE ACHES; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. 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 14-AUG-2021, the subject experienced symptoms of sinusitis headache sinus pressure. On 14-AUG-2021, the subject experienced fatigue. On 14-AUG-2021, the subject experienced muscle aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from symptoms of sinusitis headache sinus pressure, fatigue, and muscle aches. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: WORSENED TINNITUS IN BOTH EARS (RINGING WORSENED IN BOTH EARS BUT LEFT EAR MORE AFFECTED); This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: low level tinnitus, and allergies, and other pre-existing medical conditions included: The patient was not taking any other medications at the time the vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk.) dose was not reported, administered on MAY-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced worsened tinnitus in both ears (ringing worsened in both ears but left ear more affected). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of worsened tinnitus in both ears (ringing worsened in both ears but left ear more affected) was not reported. This report was non-serious.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: VACCINE ADMINISTERED AFTER VIAL PUNCTURED X48 HOURS; OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a health care professional concerned a 19 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 drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 17-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-AUG-2021, the patient experienced vaccine administered after vial punctured x 48 hours. On 17-AUG-2021, the patient experienced out of specification product use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine administered after vial punctured x48 hours and out of specification product use was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Blood immunoglobulin G, SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 78 year old male. The patient's height, and weight were not reported. The patient's past medical history included: Covid-19 in Mar-2020. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206H21A, expiry: not reported) dose was not reported, 1 total, administered on 22-MAY-2021 to left deltoid for prophylactic vaccination. No concomitant medications were reported.  On 10-AUG-2021, the patient had bloodwork or antibody test. Patient IgG was 0.36. Patient reported that, antibodies were not present (confirmed immunological vaccine failure).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210838354-COVID-19 VACCINE AD26.COV2.S-Confirmed Immunological vaccine 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.
Sex: U
Vaccine: COVID19
Symptoms: Exposure via breast milk
Clinical narrative: DRUG EXPOSURE VIA BREAST MILK; This spontaneous report received from a consumer concerned an infant of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient's parent received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unk) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced drug exposure via breast milk. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of drug exposure via breast milk was not reported. This report was non-serious. This parent/child case is linked to 20210818073.
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Heavy menstrual bleeding, Menstrual disorder
Clinical narrative: MISSING MENSTRUAL PERIOD; HEAVY MENSTRUATION PERIOD; PASSING OUT MENSTRUAL BLOOD CLOTS A LOT; This spontaneous report received from a patient concerned a 48 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: sulfa allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 207A21A, expiry: UNKNOWN) dose was not reported, administered on 03-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On JUN-2021, the patient experienced heavy menstruation period. On JUN-2021, the patient experienced passing out menstrual blood clots a lot. On AUG-2021, the patient experienced missing menstrual period. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from passing out menstrual blood clots a lot on JUL-2021, had not recovered from heavy menstruation period, and the outcome of missing menstrual period was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: JANSSEN COVID-19 VACCINE GOT ADMINISTERED OUTSIDE OF THE 2 HOURS WINDOW; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) 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 janssen covid-19 vaccine got administered outside of the 2 hours window. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of janssen covid-19 vaccine got administered outside of the 2 hours window was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Malaise, SARS-CoV-2 test
Clinical narrative: SYMPTOMS GOT WORSE; NOT FEELING TOO GREAT; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported.  The patient's concurrent conditions included: immunocompromised, and other pre-existing medical conditions included: patient was on immunosuppressant medication. 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 and has been requested. No concomitant medications were reported. On AUG-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Not reported. On an unspecified date, the patient experienced symptoms got worse, and not feeling too great. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the not feeling too great and symptoms got worse was not reported. This report was non-serious.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED (VACCINE GIVEN 20 MINUTES AFTER THE 6 HOURS EXPIRATION MARK FOR A PUNCTURED VIAL STORED IN THE REFRIGERATOR); This spontaneous report received from a pharmacist concerned a 44 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: diabetes, non alcohol user, and non smoker, and other pre-existing medical conditions included: Patient not have any known allergies and 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: 205A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 17-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-AUG-2021, the patient experienced expired vaccine administered (vaccine given 20 minutes after the 6 hours expiration mark for a punctured vial stored in the refrigerator). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered (vaccine given 20 minutes after the 6 hours expiration mark for a punctured vial stored in the refrigerator) was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain in extremity, Pyrexia
Clinical narrative: SORE ARM; FEVER; HEADACHES; NAUSEA; 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 not reported, batch number: Unk) 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 this case. No concomitant medications were reported. On an unspecified date, the patient experienced sore arm, fever, headaches, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm, fever, headaches, and nausea. This report was non-serious. This case, from the same reporter is linked to 20210837630.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Cough, Headache, Nasal congestion
Clinical narrative: LOSS OF TASTE; COUGH TORE HER UP; CONGESTION; LOSS OF SMELL; SORE THROAT; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, and batch number: 204A21A expiry: UNKNOWN) dose was not reported, administered on 10-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-AUG-2021, the patient experienced loss of taste. On 10-AUG-2021, the patient experienced cough tore her up. On 10-AUG-2021, the patient experienced congestion. On 10-AUG-2021, the patient experienced loss of smell. On 10-AUG-2021, the patient experienced sore throat. On 10-AUG-2021, the patient experienced headache. On 10-AUG-2021, the patient experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from loss of taste, fever, sore throat, cough tore her up, congestion, headache, and loss of smell. This report was non-serious.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pyrexia
Clinical narrative: LOSS OF TASTE; COUGH TORE HER UP; CONGESTION; LOSS OF SMELL; SORE THROAT; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, and batch number: 204A21A expiry: UNKNOWN) dose was not reported, administered on 10-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-AUG-2021, the patient experienced loss of taste. On 10-AUG-2021, the patient experienced cough tore her up. On 10-AUG-2021, the patient experienced congestion. On 10-AUG-2021, the patient experienced loss of smell. On 10-AUG-2021, the patient experienced sore throat. On 10-AUG-2021, the patient experienced headache. On 10-AUG-2021, the patient experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from loss of taste, fever, sore throat, cough tore her up, congestion, headache, and loss of smell. This report was non-serious.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: PAIN IN BOTH ARMS, HANDS, LEGS AND FEET; SORENESS AT ADMINISTRATION SITE MOMENTARILY; This spontaneous report received from a patient concerned a 72 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: antibiotics allergy, latex allergy, alcohol user, non smoker, and type 2 diabetes, and other pre-existing medical conditions included: The patient had no history of 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) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. Concomitant medications included metformin for type 2 diabetes. On 07-APR-2021, the patient experienced soreness at administration site momentarily. On 15-APR-2021, the patient experienced pain in both arms, hands, legs and feet. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from soreness at administration site momentarily on 07-APR-2021, and had not recovered from pain in both arms, hands, legs and feet. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Tooth disorder
Clinical narrative: TEETH STARTED CRACKING WHERE HAD FILLINGS AFTER THE SHOT IN 2 WEEKS; 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 and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced teeth started cracking where had fillings after the shot in 2 weeks. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of teeth started cracking where had fillings after the shot in 2 weeks was not reported. This report was non-serious.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Injection site pain, Tremor
Clinical narrative: SHAKING; CHILLS; INJECTION SITE SORENESS; This spontaneous report received from a consumer concerned a 65 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: high blood pressure, non smoker, and non alcohol user, and other pre-existing medical conditions included: The patient did not have any history of drug abuse or illicit drug use. The patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and expiry: 23-AUG-2021) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-MAR-2021, the patient experienced shaking. On 15-MAR-2021, the patient experienced chills. On 15-MAR-2021, the patient experienced injection site soreness. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shaking, chills, and injection site soreness on 16-MAR-2021. This report was non-serious. This case, from the same reporter is linked to 20210840442 and 20210840671.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Hypersomnia, Pyrexia
Clinical narrative: SLEEP MORE THAN USUAL; CHILLS; STABBING JOINT PAIN; FEVER; This spontaneous report received from a consumer concerned a 40 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: asthma. 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 16-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included salbutamol for asthma. On 16-AUG-2021, the patient experienced sleep more than usual. On 16-AUG-2021, the patient experienced chills. On 16-AUG-2021, the patient experienced stabbing joint pain. On 16-AUG-2021, the patient experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sleep more than usual, and stabbing joint pain, and the outcome of fever and chills was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache
Clinical narrative: ACHY JOINTS; HEADACHE; VERY TIRED; 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced achy joints, headache, and very tired. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, achy joints and very tired was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site swelling, Myalgia, Nausea
Clinical narrative: SWELL (PLACE OF INJECTION); TIREDNESS; HEADACHE; 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 not reported, batch number: Unknown) 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 this case. No concomitant medications were reported. On an unspecified date, the patient experienced swell (place of injection), tiredness, headache, nausea, and muscle pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tiredness, headache, nausea, swell (place of injection) and muscle pain was not reported. This report was non-serious.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling hot, Headache, Hyperhidrosis, Vision blurred
Clinical narrative: HEADACHE; VISION BECAME VERY BLURRY; GOT VERY HOT; STARTED TO SWEAT/SWEATING; FELT LIKE WAS GOING TO PASS OUT.; This spontaneous report received from a parent concerned a 26 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number:1816022, expiry: UNKNOWN) dose was not reported, administered on 18-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-AUG-2021, the patient experienced vision became very blurry. On 18-AUG-2021, the patient experienced got very hot. On 18-AUG-2021, the patient experienced started to sweat/sweating. On 18-AUG-2021, the patient experienced felt like was going to pass out. On 19-AUG-2021, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vision became very blurry, got very hot, and felt like was going to pass out. on 18-AUG-2021, had not recovered from started to sweat/sweating, and the outcome of headache was not reported. This report was non-serious.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Feeling of body temperature change, Injection site pain, Neck pain, Tension headache
Clinical narrative: TOP BACK ON NECK SORE; FELT LIKE A FEVER/WARM; TENSION HEADACHE; LITTLE ACHES AT INJECTION SITE; This spontaneous report received from a patient concerned a 35 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A and expiry: 21-SEP-2021) dose was not reported, administered on 18-AUG-2021 16:30 for prophylactic vaccination. No concomitant medications were reported.  On 18-AUG-2021, the patient experienced little aches at injection site. On 19-AUG-2021, the patient experienced top back on neck sore. On 19-AUG-2021, the patient experienced felt like a fever/warm. On 19-AUG-2021, the patient experienced tension headache. Laboratory data included: Body temperature (NR: not provided) 98.3 F. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from little aches at injection site, tension headache, top back on neck sore, and felt like a fever/warm. This report was non-serious.