chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: INCORRECT PRODUCT STORAGE; ADMINISTRATION OF TEMPERATURE EXCURSION AFFECTED VACCINE; This spontaneous report received from a pharmacist concerned a 20 year old male. Initial information was processed along with the additional information received on 10-SEP-2021. 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 07-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-JUL-2021, the patient experienced administration of temperature excursion affected vaccine. 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 temperature excursion affected vaccine and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20210913164, 20210915731, 20210916129, 20210916520, 20210915852, 20210916228, 20210916498, 20210916415, 20210916455, 20210916401, 20210916811, 20210916768, 20210916849, 20210917226, 20210916312, 20210916465, 20210916584, 20210915661, 20210916910, 20210916300, 20210915719, 20210916959, 20210916808, 20210917160, 20210916965, 20210916697, 20210915646, 20210915623, 20210915748, 20210917074, 20210917500, 20210917515, 20210916907, 20210917163, 20210916553, 20210916658 and 20210918425.; Sender's Comments: V0: Medical assessment comment not required as per standard operating procedure as the case is assessed as Non-serious
Age: 22.0
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 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, and batch number: 207A21A 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 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 20210916910, 20210915646, 20210915719, 20210916697, 20210916959, 20210917160, 20210916965, 20210916808, 20210915661, 20210915623, 20210915748, 20210916715, 20210917163, 20210916907, 20210916553, 20210916768, 20210917515, 20210917226, 20210915852, 20210916658, 20210917500, 20210916584, 20210915731, 20210916228, 20210916312, 20210916300, 20210916455, 20210916520, 20210916129, 20210916415, 20210916498, 20210916465, 20210913164, 20210916849, 20210916965, 20210917074, 20210916401 and 20210917603.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Poor quality product administered
Clinical narrative: EXPIRED VACCINE USED; POOR QUALITY DRUG ADMINISTERED; This spontaneous report received from a pharmacist concerned a 21 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: UNKNOWN) dose was not reported, administered on 09-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-JUL-2021, the patient experienced expired vaccine used. On 09-JUL-2021, the patient experienced poor quality drug administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the expired vaccine used and poor quality drug administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20210915646, 20210915719, 20210916300, 20210916697, 20210916959, 20210917160, 20210916965, 20210915661, 20210915623, 20210916808, 20210915748, 20210916715, 20210917163, 20210916907, 20210916553, 20210916768, 20210917515, 20210917226, 20210916910, 20210915852, 20210916658, 20210917500, 20210916584, 20210916811 and 20210918425.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: ADMINISTRATION OF VACCINE FROM AFFECTED VIALS DUE TO TEMPERATURE EXCURSION; INCORRECT PRODUCT STORAGE; This spontaneous report received from a pharmacist concerned an 18 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 26-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 26-MAY-2021, the patient experienced administration of vaccine from affected vials due to temperature excursion. On 26-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 administration of vaccine from affected vials 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 20210916658, 20210916455, 20210916312, 20210916228, 20210915731, 20210916300, 20210916697, 20210916553, 20210916401, 20210916415, 20210916520, 20210916584, 20210916658, 20210916715, 20210916768, 20210916811, 20210916849, 20210916907, 20210915719, 20210916965, 20210917160, 20210915661, 20210915646, 20210915623, 20210915852, 20210916808, 20210915748, 20210917515, 20210917226, 20210916910, 20210916498, 20210916465, 20210916129, 20210917074 and 20210917163.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19 pneumonia, Oxygen saturation, Pulmonary thrombosis, SARS-CoV-2 test
Clinical narrative: BLOOD CLOT IN BOTH LUNGS; BLOOD CLOT IN THE LEFT CALF; COVID-19 PNEUMONIA; This spontaneous report received from a patient concerned a 71 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, intramuscular, batch number: 1805022, expiry: unknown) dose was not reported, 1 total, administered on 06-MAR-2021 to left deltoid for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, patient developed a high fever with body temperature approximately 104 degree fahrenheit. He decided to go to urgent care and he was tested positive for covid-19 and was given monoclonal antibody treatment and was sent home. Since he had a pulse oximeter at home, when he checked oxygen saturation, it was dipping to 80 and he did not felt well. He decided to go to the hospital and was hospitalized on 20-MAR-2021, where he was diagnosed with covid-19 pneumonia. His computed tomography scan with contrast and doppler ultrasound showed blood clot on each lung (left & right) and one on the left calf (lower end of the left leg). He was hospitalized for 8 days and was discharged on 27-MAR-2021 with oxygen and prescribed with xarelto (rivaroxaban, 20 mg tablet). On 04-APR-2021, he reported that he finally removed the oxygen and felt better. His pulmonologist had also informed that he was cleared of any blood clots. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from covid-19 pneumonia, blood clot in both lungs, and blood clot in the left calf on 04-APR-2021. This report was serious (Hospitalization Caused / Prolonged). This report was associated with a product quality complaint: 90000192893. The suspected product quality complaint has been confirmed to be voided (tested positive for covid-19 2 days post vaccination does not meet the definition of a product quality complaint for loss of effect) based on the PQC evaluation/investigation performed.; Sender's Comments: V0:20210918314-Covid-19 vaccine ad26.cov2.s -covid-19 pneumonia, blood clot in both lungs, blood clot in the left calf. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: M
Vaccine: COVID19
Symptoms: Scan with contrast, Thrombosis, Ultrasound Doppler
Clinical narrative: BLOOD CLOT IN BOTH LUNGS; BLOOD CLOT IN THE LEFT CALF; COVID-19 PNEUMONIA; This spontaneous report received from a patient concerned a 71 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, intramuscular, batch number: 1805022, expiry: unknown) dose was not reported, 1 total, administered on 06-MAR-2021 to left deltoid for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, patient developed a high fever with body temperature approximately 104 degree fahrenheit. He decided to go to urgent care and he was tested positive for covid-19 and was given monoclonal antibody treatment and was sent home. Since he had a pulse oximeter at home, when he checked oxygen saturation, it was dipping to 80 and he did not felt well. He decided to go to the hospital and was hospitalized on 20-MAR-2021, where he was diagnosed with covid-19 pneumonia. His computed tomography scan with contrast and doppler ultrasound showed blood clot on each lung (left & right) and one on the left calf (lower end of the left leg). He was hospitalized for 8 days and was discharged on 27-MAR-2021 with oxygen and prescribed with xarelto (rivaroxaban, 20 mg tablet). On 04-APR-2021, he reported that he finally removed the oxygen and felt better. His pulmonologist had also informed that he was cleared of any blood clots. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from covid-19 pneumonia, blood clot in both lungs, and blood clot in the left calf on 04-APR-2021. This report was serious (Hospitalization Caused / Prolonged). This report was associated with a product quality complaint: 90000192893. The suspected product quality complaint has been confirmed to be voided (tested positive for covid-19 2 days post vaccination does not meet the definition of a product quality complaint for loss of effect) based on the PQC evaluation/investigation performed.; Sender's Comments: V0:20210918314-Covid-19 vaccine ad26.cov2.s -covid-19 pneumonia, blood clot in both lungs, blood clot in the left calf. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer via a company representative concerned a 24 year old male of unspecified race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown, expiry: unknown) dose was not reported, 1 total administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 07-SEP-2021, the patient underwent rapid test for Covid-19 and it was tested positive (Suspected clinical vaccination failure and Suspected covid-19 infection). At the time of this report the patient felt very ill and closed to be hospitalized. On 08-SEP-2021, the patient reported that he was feeling much better. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000192895.; Sender's Comments: V0:20210918333-Covid-19 vaccine ad26.cov2.s- Suspected clinical 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: F
Vaccine: COVID19
Symptoms: Chest pain, Paraesthesia, Vaccination site pain
Clinical narrative: PAIN IN THE CHEST; PAIN IN LEFT ARM; TINGLING IN THE ARM; This spontaneous report received from a consumer concerned a 28 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: Unknown) dose was not reported, administered on 02-SEP-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 SEP-2021, the patient experienced pain in the chest. On SEP-2021, the patient experienced pain in left arm. On SEP-2021, the patient experienced tingling in the arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in left arm, and pain in the chest, and the outcome of tingling in the arm was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Angiogram, Blood test, Chest discomfort, Coronary artery occlusion, Physical examination
Clinical narrative: POSSIBLE CLOGGING; CHEST TIGHTNESS; This spontaneous report received from a patient concerned a 7 decade 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: 204A21A and expiry: UNKNOWN) dose was not reported, 1 total, administered on 14-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  After receiving the vaccine, patient had nothing out of the normal. The patient went to get annual physical done (gets physical done routinely). The physician heard something that might indicate some clogging so wanted to make sure that everything was okay with circulation of the patient. The physician listened to heart then ordered a CTA (computerized tomogram angiography) for patient. On an unspecified date, the patient felt a little bit of chest tightness after seeing the physician. The patient was generally healthy (not diabetic). On an unspecified date, the patient got blood work (blood counts were normal and nothing stood out), CT and physical examination were done and reports not reported. It was not sure whether something was wrong with patient and wanted to wait until the CTA scan result came out. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chest tightness and possible clogging was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210918545- COVID-19 VACCINE AD26.COV2.S- possible clogging. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pyrexia, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; FEVER; HEADACHE; NAUSEA; This spontaneous report received from a parent concerned a 27 year old white female. The patient's height, and weight were not reported. The patient had no known allergies and was not on any medications. 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 12-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 12-MAR-2021, 10 hours after vaccination the patient experienced fever, headache, and nausea which lasted about 8 hours. On 06-AUG-2021, the patient started experiencing symptoms of COVID-19 (stuffed nose, fever, suspected clinical vaccination failure and suspected covid-19 infection). On 08-AUG-2021, the patient went to doctor care (urgent care center) where she had nasal swab rapid test. Laboratory data: COVID-19 antigen test (NR: not provided) positive. The reporter stated that the patient had not notified her Health Care Professional (HCP) that she had tested positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from suspected covid-19 infection, and fever, headache, and nausea on 13-MAR-2021, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000192839. The suspected product quality complaint has been confirmed to be the reported allegation could not be confirmed. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed. This case, from the same reporter is linked to 20210851625.; Sender's Comments: V0: 20210918762-Covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; FEVER; HEADACHE; NAUSEA; This spontaneous report received from a parent concerned a 27 year old white female. The patient's height, and weight were not reported. The patient had no known allergies and was not on any medications. 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 12-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 12-MAR-2021, 10 hours after vaccination the patient experienced fever, headache, and nausea which lasted about 8 hours. On 06-AUG-2021, the patient started experiencing symptoms of COVID-19 (stuffed nose, fever, suspected clinical vaccination failure and suspected covid-19 infection). On 08-AUG-2021, the patient went to doctor care (urgent care center) where she had nasal swab rapid test. Laboratory data: COVID-19 antigen test (NR: not provided) positive. The reporter stated that the patient had not notified her Health Care Professional (HCP) that she had tested positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from suspected covid-19 infection, and fever, headache, and nausea on 13-MAR-2021, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000192839. The suspected product quality complaint has been confirmed to be the reported allegation could not be confirmed. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed. This case, from the same reporter is linked to 20210851625.; Sender's Comments: V0: 20210918762-Covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: F
Vaccine: COVID19
Symptoms: Infection, SARS-CoV-2 test, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SARS-COV-2 BREAKTHROUGH INFECTIONS; This spontaneous report was received from literature. This report concerned an 81 year old female of unknown race and ethnic origin. Initial information was processed along with the additional information received on 14-SEP-2021. The patient's height, and weight were not reported. The patient's past medical history included: CVA (cerebrovascular accident) and concurrent conditions included: heart disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) frequency 1 total, 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 suspected clinical vaccination failure and SARS-COV-2 breakthrough infections (shortness of breath, cough), and was hospitalized (date unspecified). Laboratory data (date unspecified) included: RT-PCR test was positive and viral load was 18.8 Ct (cycle threshold). Viral load was evaluated and RNA was isolated from the nasopharyngeal swabs and evaluated for the presence of SARS-CoV-2 RNA using RT-PCR. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure and SARS-COV-2 breakthrough infections was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with a product quality complaint: 90000193362; Sender's Comments: V0: 20210918885-COVID-19 VACCINE AD26.COV2.S-suspected clinical vaccination failure . This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS 20210918885-COVID-19 VACCINE AD26.COV2.S-sars-cov-2 breakthrough infection. 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: F
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: CLASSIC SYMPTOMS OF GUILLAIN-BARRÉ SYNDROME; This spontaneous report received from a consumer via a company representative concerned a 66 year old female of unspecified race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown) dose was not reported, one total administered on 11-AUG-2021 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 started experiencing classic symptoms of guillain-barré syndrome which began from lower extremity paralysis and went up to bladder dystonia and bowel dysfunction. It was reported that patient would literally poop on the bed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the classic symptoms of guillain-barré syndrome was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210918928-covid-19 vaccine ad26.cov2.s -classic symptoms of Guillain-Barré Syndrome. This event(s) is labeled per RSI and is therefore considered potentially related.
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Thrombosis
Clinical narrative: BLOOD CLOTS; NUMBNESS IN BOTH OF THE KNEES; This spontaneous report received from a patient concerned a male of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced blood clots, and numbness in both of the knees. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the numbness in both of the knees and blood clots was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210919371 -covid-19 vaccine ad26.cov2.s- blood clots. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Lymphadenopathy
Clinical narrative: INJECTION SITE PAIN; SWOLLEN LYMPH NODES; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 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 JUL-2021, the patient experienced swollen lymph nodes. On SEP-2021, the patient experienced injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the injection site pain and swollen lymph nodes was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Hepatic enzyme, Hepatic enzyme increased, Liver disorder
Clinical narrative: ELEVATED LIVER ENZYMES; DIAGNOSED WITH LIVER ISSUE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 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 AUG-2021, the patient experienced elevated liver enzymes. On AUG-2021, the patient experienced diagnosed with liver issue. Laboratory data included: Hepatic enzyme (NR: not provided) Elevated. Laboratory data (dates unspecified) included: Biopsy (NR: not provided) No cancer and hepatic issue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the elevated liver enzymes and diagnosed with liver issue was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINE FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via social media concerned a patient of unspecified age and sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported, 1 total administered 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 06-SEP-2021, the patient was diagnosed with suspected covid-19 infection (it had not been too bad) and suspected clinical vaccination failure.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0. 20210920261-COVID-19 VACCINE AD26.COV2.S- Suspected clinical vaccine failure. This event is considered not related. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the events than the drug. Specifically: SPECIAL SITUATIONS
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Bone pain, Cough, Decreased appetite, Fatigue
Clinical narrative: COUGH; PAIN IN BONES; TREMBLING; WHEN STOOD UP FELT LIKE SHE MIGHT LOSE BALANCE (GOES AND COMES); WHEN SHE STOOD FELT LIKE FAINT AND GO AWAY; PAIN IN MUSCLES; FEVER (GOING AND COMING LIKE CHILLS); PAINFUL BODY; FEELING DRUNK; CANNOT ORGANIZE SELF/FUNNY FEELING/OUTERSPACE FEELING; TIREDNESS; DECREASED APPETITE; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: high blood pressure. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 01-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On SEP-2021, the patient experienced decreased appetite. On SEP-2021, the patient experienced feeling drunk. On SEP-2021, the patient experienced cannot organize self/funny feeling/outerspace feeling. On SEP-2021, the patient experienced tiredness. On 01-SEP-2021, the patient experienced painful body. On 01-SEP-2021, the patient experienced fever (going and coming like chills). Treatment medications included: ibuprofen, and paracetamol. On 02-SEP-2021, the patient experienced pain in bones. On 02-SEP-2021, the patient experienced trembling. On 02-SEP-2021, the patient experienced when stood up felt like she might lose balance (goes and comes). On 02-SEP-2021, the patient experienced when she stood felt like faint and go away. On 02-SEP-2021, the patient experienced pain in muscles. On 07-SEP-2021, the patient experienced cough. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from pain in bones, fever (going and coming like chills), trembling, painful body, and pain in muscles, had not recovered from when she stood felt like faint and go away, when stood up felt like she might lose balance (goes and comes), tiredness, decreased appetite, and cough, and the outcome of feeling drunk and cannot organize self/funny feeling/outerspace feeling was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Feeling drunk, Myalgia, Pain, Presyncope
Clinical narrative: COUGH; PAIN IN BONES; TREMBLING; WHEN STOOD UP FELT LIKE SHE MIGHT LOSE BALANCE (GOES AND COMES); WHEN SHE STOOD FELT LIKE FAINT AND GO AWAY; PAIN IN MUSCLES; FEVER (GOING AND COMING LIKE CHILLS); PAINFUL BODY; FEELING DRUNK; CANNOT ORGANIZE SELF/FUNNY FEELING/OUTERSPACE FEELING; TIREDNESS; DECREASED APPETITE; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: high blood pressure. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 01-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On SEP-2021, the patient experienced decreased appetite. On SEP-2021, the patient experienced feeling drunk. On SEP-2021, the patient experienced cannot organize self/funny feeling/outerspace feeling. On SEP-2021, the patient experienced tiredness. On 01-SEP-2021, the patient experienced painful body. On 01-SEP-2021, the patient experienced fever (going and coming like chills). Treatment medications included: ibuprofen, and paracetamol. On 02-SEP-2021, the patient experienced pain in bones. On 02-SEP-2021, the patient experienced trembling. On 02-SEP-2021, the patient experienced when stood up felt like she might lose balance (goes and comes). On 02-SEP-2021, the patient experienced when she stood felt like faint and go away. On 02-SEP-2021, the patient experienced pain in muscles. On 07-SEP-2021, the patient experienced cough. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from pain in bones, fever (going and coming like chills), trembling, painful body, and pain in muscles, had not recovered from when she stood felt like faint and go away, when stood up felt like she might lose balance (goes and comes), tiredness, decreased appetite, and cough, and the outcome of feeling drunk and cannot organize self/funny feeling/outerspace feeling was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tremor
Clinical narrative: COUGH; PAIN IN BONES; TREMBLING; WHEN STOOD UP FELT LIKE SHE MIGHT LOSE BALANCE (GOES AND COMES); WHEN SHE STOOD FELT LIKE FAINT AND GO AWAY; PAIN IN MUSCLES; FEVER (GOING AND COMING LIKE CHILLS); PAINFUL BODY; FEELING DRUNK; CANNOT ORGANIZE SELF/FUNNY FEELING/OUTERSPACE FEELING; TIREDNESS; DECREASED APPETITE; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: high blood pressure. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 01-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On SEP-2021, the patient experienced decreased appetite. On SEP-2021, the patient experienced feeling drunk. On SEP-2021, the patient experienced cannot organize self/funny feeling/outerspace feeling. On SEP-2021, the patient experienced tiredness. On 01-SEP-2021, the patient experienced painful body. On 01-SEP-2021, the patient experienced fever (going and coming like chills). Treatment medications included: ibuprofen, and paracetamol. On 02-SEP-2021, the patient experienced pain in bones. On 02-SEP-2021, the patient experienced trembling. On 02-SEP-2021, the patient experienced when stood up felt like she might lose balance (goes and comes). On 02-SEP-2021, the patient experienced when she stood felt like faint and go away. On 02-SEP-2021, the patient experienced pain in muscles. On 07-SEP-2021, the patient experienced cough. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from pain in bones, fever (going and coming like chills), trembling, painful body, and pain in muscles, had not recovered from when she stood felt like faint and go away, when stood up felt like she might lose balance (goes and comes), tiredness, decreased appetite, and cough, and the outcome of feeling drunk and cannot organize self/funny feeling/outerspace feeling was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Hypoacusis
Clinical narrative: RIGHT EAR HAD SLIGHT LOSS OF HEARING/ ALMOST LIKE WATER IN THE EAR; CHILLS; BAD HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included ascorbic acid, and zinc.  On an unspecified date, the patient experienced right ear had slight loss of hearing/ almost like water in the ear, chills, and bad headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from right ear had slight loss of hearing/ almost like water in the ear, chills, and bad headache. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Amnesia, Fatigue, Senile dementia, Swelling
Clinical narrative: FELT LIKE GOING SENILE; SHORT TERM MEMORY LOSS; SWELLING; FATIGUE; This spontaneous report received from a consumer concerned a patient of unspecified age and sex and unknown race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin 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 short term memory loss, swelling, felt like going senile, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the short term memory loss, fatigue, swelling and felt like going senile was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210754945.; Sender's Comments: V0.20210920395-covid-19 vaccine ad26.cov2.s -Senile dementia. 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: Poor quality product administered, Product storage error
Clinical narrative: VACCINE ADMINISTERED OUTSIDE OF THE RECOMMENDED HOLD TIME; INCORRECT STORAGE OF DRUG; This spontaneous report received from a pharmacist concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 09-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-SEP-2021, the patient experienced vaccine administered outside of the recommended hold time. On 09-SEP-2021, the patient experienced incorrect storage of drug. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine administered outside of the recommended hold time and incorrect storage of drug was not reported. This report was non-serious. This case, from the same reporter is linked to 20210924112.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache
Clinical narrative: SEVERE HEADACHE/HURTING; NOT REALLY LOOSE STOOL BUT ALMOST GETTING THERE; 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: allergy to wheat, and celiac. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A expiry: UNKNOWN) dose was not reported, administered on 09-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-SEP-2021, the patient experienced severe headache/hurting. On 09-SEP-2021, the patient experienced not really loose stool but almost getting there. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe headache/hurting, and not really loose stool but almost getting there. This report was non-serious.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthropod bite, Lymph node pain, Pain, Pruritus
Clinical narrative: LYMPH NODES ON BOTH ARMS; SORT OF TWO MOSQUITO BITES ON HER LEFT UPPER THIGH; MOSQUITO BITES ARE ITCHY, ROUND AND SIZE OF A DIME; GENERAL ACHINESS; This spontaneous report received from a patient concerned a 52 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1821286, and expiry: UNKNOWN) dose was not reported, administered on 07-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-SEP-2021, the patient experienced general achiness. On 10-SEP-2021, the patient experienced lymph nodes on both arms. On 10-SEP-2021, the patient experienced sort of two mosquito bites on her left upper thigh. On 10-SEP-2021, the patient experienced mosquito bites are itchy, round and size of a dime. The action taken with covid-19 vaccine  was not applicable. The patient was recovering from general achiness, had not recovered from lymph nodes on both arms, and sort of two mosquito bites on her left upper thigh, and the outcome of mosquito bites are itchy, round and size of a dime was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative concerned a 32 year old male. The patient's weight was 180 pounds, and height was 74 inches. The patient's pre-existing medical conditions included: Patient had no known drug allergies. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number:1802070 expiry: 23-AUG-2021) dose was not reported, 1 total administered at right arm on 05-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-SEP-2021, the patient experienced suspected clinical vaccination failure and suspected Covid-19 infection. Laboratory data included: COVID-19 virus test positive (NR: not provided) positive. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected Covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210920642-COVID-19 VACCINE AD26.COV2.S - Suspected clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site discomfort
Clinical narrative: D-DIMER HIGH; HEADACHE; SENSATION OF THE VACCINE RUNNING DOWN ARM INTERNALLY; This spontaneous report received from a patient concerned a 76 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no medical history. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1808978 and expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 25-MAY-2021, the patient experienced sensation of the vaccine running down arm internally. On JUL-2021, Laboratory data included: Fibrin D dimer (NR: not provided) High. On an unspecified date, the patient experienced d-dimer high, and headache. Laboratory data (dates unspecified) included: Fibrin D dimer (NR: not provided) High. The action taken with covid-19 vaccine  was not applicable. The patient recovered from headache, was recovering from d-dimer high, and the outcome of sensation of the vaccine running down arm internally was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: VACCINE WAS ADMINISTERED AFTER THE EXPIRY TIME, ADMINISTERED APPROXIMATELY 24 HOURS  AFTER VIAL PUNCTURE; INCORRECT PRODUCT STORAGE; This spontaneous report received from a physician 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, and batch number were not reported) dose was not reported, administered on 09-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On SEP-2021, the patient experienced incorrect product storage. On 09-SEP-2021, the patient experienced vaccine was administered after the expiry time, administered approximately 24 hours after vial puncture. The action taken with covid-19 vaccine  was not applicable. The outcome of the vaccine was administered after the expiry time, administered approximately 24 hours after vial puncture and incorrect product storage was not reported. This report was non-serious.