chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia, Sleep disorder
Clinical narrative: TRAVELLED TO CHEST/CHEST SYMPTOMS/DIFFICULTY BREATHING (COULDN'T GET A DEEP BREATH); SEVERE HEADACHE (RESIDUAL HEADACHE STILL ONGOING); FEVER; OVERWHELMING BODY ACHES; COULD NOT WALK DUE TO EXCRUCIATING PAIN; WOKE UP EVERY 2 HOURS; CRAMPING IN LEFT FOOT(FELT LIKE A CHARLIE HORSE IN THE ARCH OF THE FOOT); PAIN IN LEFT FOOT(FELT LIKE A CHARLIE HORSE IN THE ARCH OF THE FOOT); This spontaneous report received from a patient concerned a 50 year old female. The patient's weight was 129 pounds, and height was 62 inches. The patient's concurrent conditions included: alcohol user, non-smoker, and antibiotic induced colitis, and other pre-existing medical conditions included: The patient did not have any history of drug abuse or illicit drug use. The patient was previously treated with ergocalciferol for drug used for unknown indication; and experienced bad reaction to vaccine (gets the flu) when treated with influenza vaccine for prophylactic vaccination, and joints hurt/upper shoulder hurt when treated with tetanus vaccine for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, Z06AZ1A, expiry: UNKNOWN) dose was not reported, administered on 31-AUG-2021 12:30 for prophylactic vaccination. No concomitant medications were reported. On 31-AUG-2021, the patient experienced overwhelming body aches. On 31-AUG-2021, the patient experienced could not walk due to excruciating pain. On 31-AUG-2021, the patient experienced woke up every 2 hours. On 31-AUG-2021, the patient experienced cramping in left foot (felt like a charlie horse in the arch of the foot). On 31-AUG-2021, the patient experienced pain in left foot (felt like a charlie horse in the arch of the foot). On SEP-2021, treatment medications included: paracetamol. On 01-SEP-2021, the patient experienced severe headache (residual headache still ongoing). On 01-SEP-2021, the patient experienced fever. Laboratory data included: Body temperature (NR: not provided) 100 F. On 02-SEP-2021, the patient experienced travelled to chest/chest symptoms/difficulty breathing (couldn't get a deep breath). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from overwhelming body aches, and could not walk due to excruciating pain, travelled to chest/chest symptoms/difficulty breathing (couldn't get a deep breath) on 07-SEP-2021, and fever on 03-SEP-2021, was recovering from pain in left foot(felt like a charlie horse in the arch of the foot), severe headache (residual headache still ongoing), and cramping in left foot(felt like a charlie horse in the arch of the foot), and the outcome of woke up every 2 hours was not reported. This report was non-serious.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Poor quality product administered, Product storage error
Clinical narrative: INCORRECT PRODUCT STORAGE; ADMINISTRATION OF EXPIRED VACCINE; ADMINISTRATION OF VACCINE EXPIRED DUE TO TEMPERATURE EXCURSION; This spontaneous report received from a pharmacist concerned a 25 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1808986, and expiry: UNKNOWN) dose was not reported, administered on 14-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-JUN-2021, the patient experienced administration of vaccine expired due to temperature excursion. On 14-JUN-2021, the patient experienced administration of expired vaccine. On an unspecified date, the patient experienced incorrect product storage. The action taken with covid-19 vaccine was not applicable. The outcome of the administration of vaccine expired due to temperature excursion, incorrect product storage and administration of expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210915852, 20210915731, 20210916228, 20210916312, 20210916300, 20210916455, 20210916553, 20210916520, 20210916129, 20210916415, 20210916498, 20210916584, 20210916715, 20210916768, 20210916697, 20210916658, 20210915719, 20210916465, 20210916910, 20210913164, 20210915623, 20210915646, 20210916965, 20210917160, 20210916849, 20210916907, 20210916959, 20210916808, 20210916811, 20210916965, 20210917074, 20210917163, 20210916401, 20210915748, 20210917500, 20210917515, 20210917603 and 20210917226.
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: 7 BLOOD CLOTS; This spontaneous report received from a consumer through social media concerned a 5 decade old male of unspecified race and ethic origin. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient ended up with 7 blood clots after the vaccination and It was reported that luckily the clots were identified before it leads to stroke, or death. The patient's friend mentioned that the patient's life was changed as the patient had to take the blood thinning shots daily. The patient's friend commented that this seemed to be a big secret on the deaths & injuries caused by the shot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of 7 blood clots was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210915668- Covid-19 vaccine ad26.cov2.s- 7 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).
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Pain in extremity, Pyrexia
Clinical narrative: SORE ARM FOR THE NIGHT AFTER A COUPLE HOURS; LOW TEMPERATURE FEVER; 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) 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 for the night after a couple hours, and low temperature fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) Low temperature fever. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore arm for the night after a couple hours and low temperature fever was not reported. This report was non-serious.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: ADMINISTRATION OF EXPIRED JANSSEN COVID-19 VACCINE DUE TO TEMPERATURE EXCURSION; INCORRECT PRODUCT STORAGE; This spontaneous report received from a pharmacist concerned a 60 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: 1808986, and expiry: UNKNOWN) dose was not reported, administered on 28-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-MAY-2021, the patient experienced administration of expired janssen covid-19 vaccine due to temperature excursion. On 28-MAY-2021, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the incorrect product storage and administration of expired janssen covid-19 vaccine due to temperature excursion was not reported. This report was non-serious. This case, from the same reporter is linked to 20210915661, 20210913164, 20210915623, 20210915731, 20210916129, 20210916228, 20210916300, 20210916312, 20210916455, 20210916498, 20210916520, 20210916584, 20210916658, 20210916697, 20210916768, 20210916808, 20210916965, 20210916907, 20210916849, 20210916811, 20210916415, 20210916465, 20210916553, 20210916715, 20210916910, 20210916959, 20210917074, 20210917163, 20210915646, 20210915852, 20210916401, 20210917226, 20210917500, 20210917515, 20210917160, 20210917603 and 20210916465.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: EXPIRED VACCINE ADMINISTERED FROM THE VIAL AFFECTED FROM TEMPERATURE EXCURSION; OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a pharmacist concerned a 56 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, and batch number: 1808986 expiry: 02-OCT-2021) dose was not reported, administered on 04-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-JUN-2021, the patient experienced expired vaccine administered from the vial affected from temperature excursion. On 04-JUN-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 expired vaccine administered from the vial affected from temperature excursion and out of specification product use was not reported. This report was non-serious. This case, from the same reporter is linked to 20210913164, 20210915623, 20210915646, 20210915661, 20210915719, 20210915748, 20210915852, 20210916228, 20210916312, 20210916300, 20210916455, 20210916553 and 20210916520.
Sex: U
Vaccine: COVID19
Symptoms: Alopecia, Blood test
Clinical narrative: EXCESSIVE AND PROGRESSIVE UNNATURAL HAIR LOSS; 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  (suspension for injection, route of admin not reported, batch number: UNKNOWN) 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 JUN-2021, the patient experienced excessive and progressive unnatural hair loss. Laboratory data (dates unspecified) included: Blood test (NR: not provided) showed no reasonable indication for the hair loss. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from excessive and progressive unnatural hair loss. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Therapy partial responder
Clinical narrative: HE DID NOT MOUNT AN ADEQUATE RESPONSE AND MANUFACTURE ANTIBODIES; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: immunocompromised. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered on an unspecified date in MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included abatacept and methotrexate.  On an unspecified date, the patient did not mount an adequate response and manufacture antibodies because had reason to believe. Consumer was very concerned that patient needs additional protection against covid and would like him to receive additional doses. The action taken with covid-19 vaccine was not applicable. The outcome of he did not mount an adequate response and manufacture antibodies was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000192651; Sender's Comments: V0: 20210915814 -COVID-19 VACCINE- "He did not mount an adequate response and manufacture antibodies". 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: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a pharmacist concerned a 45 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: 1808986, expiry: UNKNOWN) dose was not reported, administered on 26-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-MAY-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210915623, 20210915646, 20210915661, 20210915719, 20210913164, 20210915731 and 20210915748.
Sex: M
Vaccine: COVID19
Symptoms: Death, Internal haemorrhage, Myocardial infarction, Pulmonary thrombosis, Thrombosis
Clinical narrative: BLOOD CLOTS IN LUNGS; BLOOD CLOTS IN LIVER; INTERNAL BLEEDING; HEART ATTACK; DEATH; This spontaneous report received from a consumer via a company representative concerned a 52 year old male of unknown race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, and expiry: Unknown) dose was not reported, 1 total, administered on 03-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 06-JUN-2021, 3 days after vaccination the patient had heart attack on the golf course. On an unspecified date, the patient had internal bleeding and blood clots in his liver and lungs. The patient was in intensive care for 13 weeks and was put on liver transplant list but they could not stop the internal bleeding. The patient hospitalized for unspecified date and days. The patient died from unknown cause of death. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of heart attack, internal bleeding, blood clots in lungs and blood clots in liver was not reported. This report was serious (Death, and Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210916075-COVID-19 VACCINE AD26.COV2.S-Death, Heart attack,  Blood clots in lungs, Blood clots in liver, Internal bleeding. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID INFECTION; 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 (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 08-SEP-2021, the patient experienced covid infection. Laboratory data included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from covid infection. This report was non-serious.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: INCORRECT PRODUCT STORAGE; ADMINISTRATION OF VACCINE FROM THE VIAL AFFECTED FROM TEMPERATURE EXCURSION; This spontaneous report received from a pharmacist concerned a 41 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: 1808986, and expiry: 02-OCT-2021) dose was not reported, administered on 17-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-MAY-2021, the patient experienced administration of vaccine from the vial affected from temperature excursion. On an unspecified date, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of vaccine from the vial affected from temperature excursion and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20210916312, 20210916455, 20210916228, 20210916498, 20210916553, 20210915661, 20210916658, 20210916910, 20210915719 and 20210916697.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Epistaxis, Headache, Pain
Clinical narrative: NOSEBLEEDS; DIZZY SPELLS; BODY ACHE; HEADACHE; This spontaneous report received from a consumer concerned an adult male. The patient's weight was 190 pounds, and height was 74 inches. The patient's past medical history included: smoker, and concurrent conditions included: high blood pressure, and non alcoholic, and other pre-existing medical conditions included: The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 22-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On MAY-2021, the patient experienced nosebleeds. On MAY-2021, the patient experienced dizzy spells. On MAY-2021, the patient experienced body ache. On MAY-2021, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, nosebleeds, dizzy spells, and body ache. This report was non-serious.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: EXPIRED VACCINE ADMINISTERED FROM THE VIAL AFFECTED FROM TEMPERATURE EXCURSION; OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a pharmacist concerned a 31 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: 1808986, and expiry: 02-OCT-2021) dose was not reported, administered on 15-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-JUN-2021, the patient experienced expired vaccine administered from the vial affected from temperature excursion. On 15-JUN-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 expired vaccine administered from the vial affected from temperature excursion and out of specification product use was not reported. This report was non-serious. This case, from the same reporter is linked to 20210915623, 20210915646, 20210915661, 20210915719, 20210915731, 20210915748, 20210915852, 20210913164, 20210916401, 20210916415, 20210916520, 20210916300, 20210916520, 20210916129, 20210916312, 20210916553, 20210916697, 20210916658, 20210916910 and 20210916959.
Age: 98.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: EXPIRED VACCINE ADMINISTERED FROM THE VIAL AFFECTED FROM TEMPERATURE EXCURSION; OUT OF SPECIFICATION PRODUCT; This spontaneous report received from a pharmacist concerned a 98 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: 207A21A and expiry: 21-SEP-2021) dose was not reported, administered on 25-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 25-JUN-2021, the patient experienced expired vaccine administered from the vial affected from temperature excursion. On 25-JUN-2021, the patient experienced out of specification product. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the expired vaccine administered from the vial affected from temperature excursion and out of specification product was not reported. This report was non-serious. This case, from the same reporter is linked to 20210915623, 20210915646, 20210915661, 20210915719, 20210915731, 20210915748, 20210915852, 20210916455, 20210916520, 20210916228, 20210916401, 20210916553, 20210916312, 20210916658, 20210916697, 20210916959, 20210916907, 20210916849, 20210916910, 20210916808, 20210916768, 20210916715, 20210916584, 20210916415, 20210916129 and 20210916811, 20210916965, 20210917163, 20210917515, 20210917226, 20210913164, 20210916498, 20210917074, 20210917160, 20210916465, 20210917603 and 20210917500.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: EXPIRED VACCINE ADMINISTERED FROM THE VIAL AFFECTED FROM TEMPERATURE EXCURSION; OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a pharmacist concerned a 22 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808986, expiry: 02-OCT-2021) dose was not reported, administered on 20-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-MAY-2021, the patient experienced expired vaccine administered from the vial affected from temperature excursion. On 20-MAY-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 expired vaccine administered from the vial affected from temperature excursion and out of specification product use was not reported. This report was non-serious. This case, from the same reporter is linked to 20210915623, 20210915646, 20210915661, 20210915719, 20210915731, 20210915748, 20210915852, 20210916129, 20210913164, 20210916455, 20210916520, 20210916228, 20210916553, 20210916300, 20210916228, 20210916465, 20210916553, 20210916228, 20210916300, 20210916401 and 20210916415.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: SHOULDER PAIN; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's past medical history included: diarrhea. 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 29-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included adalimumab for moderate to severe adult crohn's disease.  On MAR-2021, the patient experienced shoulder pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shoulder pain. The reporter considered the causality between covid-19 vaccine ad26.cov2.s and shoulder pain as not related. This report was non-serious.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: ADMINISTRATION OF VACCINE FROM AFFECTED VIALS DUE TO TEMPERATURE EXCURSTION; INCORRECT PRODUCT STORAGE; This spontaneous report received from a pharmacist concerned a 20 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: 207A21A, expiry: 21-SEP-2021) dose was not reported, administered on 09-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-JUL-2021, the patient experienced administration of vaccine from affected vials due to temperature excurstion. On 09-JUL-2021, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of vaccine from affected vials due to temperature excurstion and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20210916228, 20210916300, 20210916312, 20210916553, 20210916697, 20210915646, 20210915748, 20210915852, 20210916312, 20210916300, 20210916455, 20210916553, 20210916910, 20210917226, 20210916959, 20210917160, 20210915719, 20210916808, 20210915661, 20210915623, 20210916715, 20210917163, 20210916907, 20210916768, 20210917515 and 20210916658.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: ADMINISTRATION OF VACCINE FROM AFFECTED VIALS DUE TO TEMPERATURE EXCURSION; OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a pharmacist concerned a 22 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: 207A21A, expiry: 21-SEP-2021) dose was not reported, administered on 04-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 04-AUG-2021, the patient experienced administration of vaccine from affected vials due to temperature excursion. On 04-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 administration of vaccine from affected vials due to temperature excursion and out of specification product use was not reported. This report was non-serious. This case, from the same reporter is linked to 20210916228, 20210916455, 20210916312, 20210916553, 20210916697, 20210915661, 20210916658, 20210915748, 20210916300, 20210915719, 20210917226, 20210916965, 20210916959, 20210915646, 20210917160, 20210916808, 20210915623, 20210916715, 20210917163, 20210916907, 20210916768, 20210917515 and 20210915852.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Hidradenitis
Clinical narrative: MANY HIDRADENITIS SUPPURATIVA FLARE UPS; This spontaneous report received from a patient concerned a 54 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe hidradenitis suppurativa. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on JUN-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number: UNKNOWN expiry: UNKNOWN) dose, frequency, and therapy dates were not reported for moderate to severe hidradenitis suppurativa. No concomitant medications were reported. On an unspecified date, the patient experienced many hidradenitis suppurativa flare ups. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient was recovering from many hidradenitis suppurativa flare ups. This report was non-serious.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: ADMINISTRATION OF VACCINE FROM AFFECTED VIALS DUE TO TEMPERATURE EXCURSION; OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a pharmacist concerned a 23 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: 1808986, expiry: 02-OCT-2021) dose was not reported, administered on 04-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 04-JUN-2021, the patient experienced administration of vaccine from affected vials due to temperature excursion. On 04-JUN-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 administration of vaccine from affected vials due to temperature excursion and out of specification product use was not reported. This report was non-serious. This case, from the same reporter is linked to 20210915731, 20210915623, 20210915646, 20210915661, 20210915719, 20210915748, 20210915852, 20210916465, 20210916129, 20210916300, 20210916312, 20210913164, 20210913164, 20210916415, 20210913164, 20210916415, 20210916498, 20210913164, 20210916401, 20210916910, 20210916959, 20210916697, 20210916808 and 20210917160.
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: TEMPERATURE EXCURSION OF VACCINE; ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a pharmacist concerned a 49 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: 1808986, expiry: 02-OCT-2021) dose was not reported, administered on 26-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 26-MAY-2021, the patient experienced temperature excursion of vaccine. On 26-MAY-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the temperature excursion of vaccine and administration of expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210916455, 20210916553, 20210916312, 20210916910, 20210915661, 20210916697, 20210915719, 20210917226, 20210916808, 20210915646, 20210913164, 20210916715, 20210917163, 20210916907, 20210916768, 20210917515, 20210915852, 20210916965, 20210916959, 20210916658, 20210915623, 20210917500, 20210916300, 20210916584 and 20210916811.; Sender's Comments: V0; Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Inflammation
Clinical narrative: INFLAMMATION OF BODY WENT DOWN FOR ONE MONTH AND WENT BACK; This spontaneous report received from a patient via a company representative concerned a 6 decade old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: ankylosing spondylitis, and moderate to severe rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, 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. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for ankylosing spondylitis, and moderate to severe rheumatoid arthritis. No concomitant medications were reported. On an unspecified date, the patient experienced inflammation of body went down for one month and went back. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of inflammation of body went down for one month and went back was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Hemiplegia
Clinical narrative: TEMPORARY LEFT SIDE PARALYSIS; This spontaneous report received from a physician concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) 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 an unspecified date, the patient experienced temporary left side paralysis after the vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of temporary left side paralysis was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210916478-COVID-19 VACCINE AD26.COV2.S.- Temporary left side paralysis. This event is considered unassessable. The event 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.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Influenza
Clinical narrative: FULL ON FLU SIX HOURS LATER (FULL ON FEVER, LIKE 100 SIX HOURS LATER AND IT WAS HORRIFIC NIGHT INVOLVING "SHEETS ON, SHEETS OFF" (DUE TO BEING FEBRILE); This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 07-APR-2021, the patient experienced full on flu six hours later (full on fever, like 100 six hours later and it was horrific night involving "sheets on, sheets off" (due to being febrile). Laboratory data included: Body temperature (NR: not provided) full on fever like 100. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from full on flu six hours later (full on fever, like 100 six hours later and it was horrific night involving "sheets on, sheets off" (due to being febrile) on 08-APR-2021. This report was non-serious. This case, from the same reporter is linked to 20210905634.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: ADMINISTRATION OF VACCINE FROM AFFECTED VIALS DUE TO TEMPERATURE EXCURSTION; INCORRECT PRODUCT STORAGE; This spontaneous report received from a pharmacist concerned a 21 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: 21-SEP-2021) dose was not reported, administered on 30-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 30-JUN-2021, the patient experienced administration of vaccine from affected vials due to temperature excurstion. On 30-JUN-2021, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of vaccine from affected vials due to temperature excurstion and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20210916553, 20210916455, 20210916129, 20210915661, 20210916910 and 20210915719.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: EXPIRED VACCINE ADMINISTERED FROM THE VIAL AFFECTED FROM TEMPERATURE EXCURSION; OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a pharmacist concerned a 31 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: 1808986 and expiry: 02-OCT-2021) dose was not reported, administered on 17-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-MAY-2021, the patient experienced expired vaccine administered from the vial affected from temperature excursion. On 17-MAY-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 out of specification product use and expired vaccine administered from the vial affected from temperature excursion was not reported. This report was non-serious. This case, from the same reporter is linked to 20210916300, 20210916228, 20210915661, 20210915731, 20210915852, 20210916312, 20210915623, 20210916553, 20210916658, 20210916697, 20210916910 and 20210915719.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Psoriasis, Therapeutic product effect incomplete
Clinical narrative: PSORIASIS FLARE UP/ PSORIASIS CAME BACK EVERYWHERE; DRUG EFFECT INCOMPLETE; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: rheumatoid arthritis, and psoriatic arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 10-AUG-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included adalimumab for rheumatoid arthritis, and psoriatic arthritis. On an unspecified date, the patient experienced psoriasis flare up/ psoriasis came back everywhere, and drug effect incomplete. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from psoriasis flare up/ psoriasis came back everywhere, and drug effect incomplete. This report was non-serious.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Arthralgia, Red blood cell sedimentation rate
Clinical narrative: PSORIASIS FLARE UP/ PSORIASIS CAME BACK EVERYWHERE; DRUG EFFECT INCOMPLETE; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: rheumatoid arthritis, and psoriatic arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 10-AUG-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included adalimumab for rheumatoid arthritis, and psoriatic arthritis. On an unspecified date, the patient experienced psoriasis flare up/ psoriasis came back everywhere, and drug effect incomplete. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from psoriasis flare up/ psoriasis came back everywhere, and drug effect incomplete. This report was non-serious.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: ADMINISTRATION OF EXPIRED VACCINE; TEMPERATURE EXCURSION; This spontaneous report received from a pharmacist concerned a 44 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: 1808986, and expiry: 02-OCT-2021) dose was not reported, administered on 07-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-JUN-2021, the patient experienced administration of expired vaccine. On 07-JUN-2021, the patient experienced temperature excursion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of expired vaccine and temperature excursion was not reported. This report was non-serious. This case, from the same reporter is linked to 20210915623, 20210915646, 20210915661, 20210915719, 20210915731, 20210915852, 20210916498, 20210916520, 20210916465, 20210916312, 20210916228, 20210916300, 20210916415, 20210916401, 20210913164, 20210916129, 20210915748, 20210916697, 20210916910, 20210916965, 20210916959, 20210917160, 20210917163, 20210916907, 20210916455, 20210916584, 20210916658, 20210916768, 20210916808, 20210916811, 20210916849, 20210917074, 20210917226, 20210917500, 20210917515, 20210917603 and 20210916715.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: INCORRECT PRODUCT STORAGE; ADMINISTRATION OF VACCINE EXPIRED DUE TO TEMPERATURE EXCURSION; This spontaneous report received from a pharmacist concerned a 50 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: 207A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 12-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-JUL-2021, the patient experienced administration of vaccine expired due to temperature excursion. On an unspecified date, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of vaccine expired due to temperature excursion and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20210915661, 20210916910, 20210915719, 20210916300, 20210916697, 20210916959, 20210916965, 20210917160, 20210916808, 20210915646, 20210915623, 20210916715, 20210917163, 20210916907, 20210916553, 20210916768, 20210917515, 20210917226, 20210915852, 20210916658, 20210917500, 20210915731, 20210916228, 20210916312, 20210916455, 20210916520, 20210916129, 20210916415, 20210916498, 20210916465, 20210916849, 20210916811, 20210915748, 20210917603, 20210913164, 20210915852, 20210917074 and 20210916401.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: EXPIRED VACCINE ADMINISTERED FROM THE VIAL AFFECTED DUE TO TEMPERATURE EXCURSION; OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a pharmacist concerned a 19 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: 207A21A, and  expiry: 21-SEP-2021) dose was not reported, administered on 28-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-JUL-2021, the patient experienced expired vaccine administered from the vial affected due to temperature excursion. On 28-JUL-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 expired vaccine administered from the vial affected due to temperature excursion and out of specification product use was not reported. This report was non-serious. This case, from the same reporter is linked to 20210916520, 20210916300, 20210916228, 20210913164, 20210916129, 20210916415, 20210915623, 20210915661, 20210913164, 20210915748, 20210915852, 20210916228, 20210916910, 20210916959, 20210915719, 20210916697, 20210917160, 20210915646, 20210917163, 20210916907, 20210916553, 20210916768, 20210917515, 20210917226, 20210916312, 20210916401, 20210916455, 20210916465, 20210916498, 20210916584, 20210916715, 20210916808, 20210916811, 20210917603, 20210916849, 20210916965 and 20210917074.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: EXPIRED VACCINE ADMINISTERED FROM THE VIAL AFFECTED FROM TEMPERATURE EXCURSION; OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a pharmacist concerned a 54 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, and batch number: 207A21A expiry: 21-SEP-2021) dose was not reported, administered on 07-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-JUL-2021, the patient experienced expired vaccine administered from the vial affected from temperature excursion. On 07-JUL-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 expired vaccine administered from the vial affected from temperature excursion and out of specification product use was not reported. This report was non-serious. This case, from the same reporter is linked to 20210916300, 20210916228, 20210916520, 20210915646, 20210915852, 20210916312, 20210916401, 20210916415, 20210915731, 20210916553, 20210915661, 20210915623, 20210916455, 20210916910, 20210915719, 20210916129, 20210916465, 20210915748, 20210916584, 20210916658, 20210916768, 20210916811, 20210916849, 20210916959, 20210916498, 20210913164, 20210916715, 20210916808, 20210917160, 20210917163, 20210916965, 20210917226, 20210916907, 20210917515, 20210917603, 20210917074 and 20210917500.