chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
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 a 37 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808986, expiry: 02-OCT-2021) dose was not reported, administered on 24-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 24-MAY-2021, the patient experienced administration of vaccine from affected vials due to temperature excursion. On 24-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 20210915661, 20210916910, 20210915719, 20210916300, 20210916697, 20210916959, 20210917160, 20210916965, 20210915646, 20210916808, 20210915623, 20210917163, 20210916907, 20210916553, 20210913164, 20210916520, 20210915731, 20210915748, 20210915852, 20210916129, 20210916228, 20210916312, 20210916401, 20210916415, 20210916455, 20210916465, 20210916498, 20210916584, 20210916658, 20210916715, 20210916811, 20210916849, 20210917074, 20210917226, 20210917500, 20210917515, 20210917603 and 20210918425.
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: VACCINE PROVIDED MAJOR CHANGES IN BODY WHICH WERE POSITIVE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (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 vaccine provided major changes in body which were positive. The action taken with covid-19 vaccine was not applicable. The outcome of vaccine provided major changes in body which were positive was not reported. This report was non-serious.
Age: 22.0
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 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 07-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 07-JUN-2021, the patient experienced administration of vaccine from affected vials due to temperature excursion. On 07-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 excursion and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20210915719, 20210916300, 20210916959, 20210916965, 20210917160, 20210915661, 20210915646, 20210915623, 20210916808, 20210916715, 20210917163, 20210916520, 20210915731, 20210915748, 20210915852, 20210916129, 20210916228, 20210916312, 20210916401, 20210916415, 20210916455, 20210916465, 20210916498, 20210916553, 20210916584, 20210916658, 20210916697, 20210916768, 20210916808, 20210916811, 20210916849, 20210916910, 20210917074, 20210917226, 20210917500, 20210917515 and 20210917603.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: This spontaneous report received from a pharmacist concerned a 73 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: 1808986, 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 expired vaccine administered from the vial affected from temperature excursion. On 07-JUN-2021, the patient experienced out of specification product use. The action taken with covid-19 vaccine 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 20210915731, 20210915748, 20210916312, 20210915852, 20210916129, 20210916228, 20210916300, 20210916415, 20210916455, 20210916498, 20210916584, 20210916658, 20210916715, 20210916768, 20210916811, 20210916697, 20210916553, 20210916520, 20210916465, 20210916401, 20210913164, 20210915719, 20210916965, 20210915646, 20210917160, 20210915623, 20210916808, 20210917163, 20210916907, 20210917515, 20210917226, 20210915661, 20210916849, 20210916959, 20210917074, 20210917500 and 20210917603.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Laboratory test, Malaise, Multiple sclerosis, Pyrexia
Clinical narrative: MULTIPLE SCLEROSIS(BLURRY VISION IN EYES); CHILLS; NOT FEELING GOOD; FEVER; This spontaneous report received from a parent concerned a 27 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol user, non smoker, and patient had no known drug allergies and is healthy. Patient did not had a family history of multiple sclerosis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, expiry: 21-SEP-2021) dose was not reported, frequency 1 total, administered on 30-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 01-MAY-2021, the patient experienced chills. not feeling good, fever and then he felt better after couple of days. On 16-JUN-2021, developed blurred vision in his eyes. Patient went to different doctors had different tests done and was diagnosed with multiple sclerosis in July. Patient was perfectly health before getting the vaccine and reporter stated that it might had been a poison or something wrong with the vaccine that patient received.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, not feeling good, and fever on MAY-2021, and had not recovered from multiple sclerosis(blurry vision in eyes). This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210916940-Covid-19 vaccine ad26.cov2.s-Multiple sclerosis. 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: Chest discomfort, Headache, Nervousness, Overweight, Weight
Clinical narrative: SOMEDAYS CHEST FEELS TIGHT; NERVOUS; OVERWEIGHT; HEADACHE ALMOST EVERY DAY; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight was 30 pounds, and height was not reported. The patient's past medical history included: headache, and concurrent conditions included: autoimmune disease, overweight, and smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced somedays chest feels tight, nervous, overweight, and headache almost every day. Laboratory data (dates unspecified) included: Weight (NR: not provided) 30 lbs. overweight. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the somedays chest feels tight, headache almost every day, nervous and overweight was not reported. This report was non-serious.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: ADMINISTRATION OF EXPIRED VACCINE FROM THE AFFECTED VIALS DUE TO TEMPERATURE EXCURSION; OUT OF SPECIFICATION PRODUCT USE; 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: 1808986, 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 from the affected vials due to temperature excursion. On 07-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 expired vaccine from the 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 20210916808, 20210916401, 20210916553, 20210915719, 20210915731, 20210915852, 20210916228, 20210915623, 20210915646, 20210915661, 20210915748, 20210916300, 20210916312, 20210916415, 20210916455, 20210916520, 20210916584, 20210916658, 20210916715, 20210916768, 20210916811, 20210916849, 20210916910, 20210916959, 20210916129, 20210916907, 20210917163, 20210917515, 20210917226, 20210913164, 20210916465, 20210916498, 20210916697, 20210917074, 20210917160, 20210917603 and 20210917500.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: ADMINISTRATION OF JANSSEN COVID 19 VACCINE TEMPERATURE EXCURSION; ADMINISTRATION OF JANSSEN COVID 19 VACCINE TEMPERATURE EXCURSION; This spontaneous report received from a pharmacist concerned a 70 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 12-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-JUL-2021, the patient experienced administration of janssen covid 19 vaccine temperature excursion. On 12-JUL-2021, the patient experienced administration of janssen covid 19 vaccine temperature excursion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of janssen covid 19 vaccine temperature excursion and administration of janssen covid 19 vaccine temperature excursion was not reported. This report was non-serious. This case, from the same reporter is linked to 20210915719, 20210915646, 20210916808, 20210915661, 20210915748, 20210915623, 20210916715, 20210917163, 20210916907, 20210916553, 20210916768, 20210917515, 20210917226, 20210916697, 20210916910, 20210915852, 20210916965 and 20210916959.
Sex: M
Vaccine: COVID19
Symptoms: Rhinorrhoea, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19 INFECTION; Runny nose; This spontaneous report received from a patient via a company representative concerned a 30 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe adult crohn's disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch and lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose was not reported, 1 time every 2 weeks, from 12-APR-2021 for moderate to severe adult crohn's disease. No concomitant medications were reported.  On 27-AUG-2021, the patient experienced runny nose. On 30-AUG-2021, the patient experienced suspected covid-19 infection. Laboratory data included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from runny nose, and the outcome of suspected covid-19 infection was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Bedridden, Chills, Gait inability, Insomnia, Pain
Clinical narrative: ACHES ALL OVER/PAIN; COULD NOT SLEEP; COULD NOT WALK; BEDRIDDEN THE WHOLE NEXT DAY; CHILLS PULSING THROUGHOUT BODY; 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, 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 aches all over/pain, could not sleep, could not walk, bedridden the whole next day, and chills pulsing throughout body. The action taken with covid-19 vaccine was not applicable. The patient was recovering from chills pulsing throughout body, aches all over/pain, could not sleep, could not walk, and bedridden the whole next day. This report was non-serious.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: ADMINISTRATION OF VACCINE FROM AFFECTED VIALS DUE TO TEMPERATURE EXCURSION; INCORRECT PRODUCT STORAGE; This spontaneous report received from a pharmacist concerned a 23 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: 21-SEP-2021) dose was not reported, administered on 23-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 23-JUN-2021, the patient experienced administration of vaccine from affected vials due to temperature excursion. On 23-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 excursion and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20210915731, 20210915852, 20210916228, 20210916312, 20210916455, 20210916553, 20210915623, 20210915661, 20210915748, 20210916312, 20210916401, 20210916455, 20210916553, 20210916715, 20210916768, 20210916808, 20210916811, 20210916849, 20210916849, 20210913164, 20210916520, 20210916129, 20210916415, 20210916520, 20210916584, 20210916658, 20210916959, 20210916907 and 20210916910.
Age: 20.0
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 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 04-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-AUG-2021, the patient experienced expired vaccine administered from the vial affected from 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 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 20210915719, 20210916697, 20210915646, 20210916808, 20210915661, 20210915623, 20210915748, 20210916228, 20210916300, 20210916312, 20210916401, 20210916415, 20210916455, 20210916465, 20210916498, 20210916520, 20210916553, 20210916584, 20210916658, 20210916768, 20210916811, 20210916849, 20210916907, 20210916910, 20210916959, 20210916965, 20210917074, 20210917160, 20210917226, 20210917500, 20210917515, 20210913164, 20210916715, 20210915731, 20210916129, 20210915852 and 20210917603.
Age: 19.0
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 19 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 24-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-MAY-2021, the patient experienced administration of expired vaccine. On 24-MAY-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 20210913164, 20210916129, 20210916498, 20210916465, 20210916415, 20210916401, 20210916697, 20210915646, 20210915719, 20210916715, 20210915661, 20210917163, 20210916907, 20210916553, 20210916768, 20210917515, 20210915623, 20210915731, 20210915748, 20210915852, 20210916228, 20210916300, 20210916312, 20210916455, 20210916520, 20210916584, 20210916658, 20210916808, 20210916811, 20210916849, 20210916910, 20210916959, 20210916965, 20210917074, 20210917160, 20210917500 and 20210917603.
Age: 71.0
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; INCORRECT PRODUCT STORAGE; This spontaneous report received from a pharmacist 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, route of admin not reported, batch number: 1808986, expiry: 02-OCT-2021) dose was not reported, administered on 21-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 21-JUN-2021, the patient experienced expired vaccine administered from the vial affected due to temperature excursion. On 21-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 expired vaccine administered from the vial affected 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 20210915719, 20210915661, 20210916715, 20210917163, 20210916907, 20210916553, 20210916768, 20210917515, 20210917226, 20210916697, 20210916910, 20210915852, 20210915646, 20210916965, 20210915623, 20210915731, 20210916228, 20210916312, 20210916697, 20210915748, 20210916415, 20210916455, 20210916520, 20210916584, 20210916658, 20210916808, 20210916811, 20210916849, 20210916959, 20210916465 and 20210916300.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: ADMINISTRATION OF VACCINE FROM AFFECTED VIALS DUE TO TEMPERATURE EXCURSION; INCORRECT PRODUCT STORAGE; This spontaneous report received from a pharmacist concerned a 64 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: 02-OCT-2021) dose was not reported, administered on 21-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 21-JUN-2021, the patient experienced administration of vaccine from affected vials due to temperature excursion. On 21-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 excursion and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20210915719, 20210915661, 20210916715, 20210917163, 20210916907, 20210916553, 20210916768, 20210913164, 20210915623, 20210916520, 20210915646, 20210915731, 20210915748, 20210915852, 20210916129, 20210916228, 20210916300, 20210916312, 20210916401, 20210916415, 20210916455, 20210916465, 20210916498, 20210916584, 20210916658, 20210916697, 20210916808, 20210916811, 20210916849, 20210916910, 20210916959, 20210916965, 20210917074, 20210917160, 20210917226, 20210917500 and 20210917603.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE WAS GIVEN; This spontaneous report received from a health care professional concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: 07-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 expired vaccine was given. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine was given was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Ear infection, Ear swelling, Erythema, Pain in jaw
Clinical narrative: LOW GRADE FEVER; EARLOBE AND EAR RED ON LEFT SIDE (RIGHT WHERE THE JAWBONE ENDS); EARLOBE AND EAR SWOLLEN ON LEFT SIDE (RIGHT WHERE THE JAWBONE ENDS); PAIN FROM EAR TO JAWBONE/EAR TO JAWBONE SORE/PAIN IN JAWBONE BELOW EAR/TIP OF THE JAW HAD LITTLE PAIN; HAD SOMETHING ON EAR AND SCRATCHED IT AND MAYBE THAT IS WHAT STARTED THE INFECTION; RASH ON LEG NEAR KNEE-ITCHY, A LITTLE REDNESS; This spontaneous report received from a patient concerned a 76 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: lymphedema, diverticulitis, osteoarthritis knee, and allergy to penicillin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: UNKNOWN) dose was not reported, administered on 26-AUG-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid. On SEP-2021, the patient experienced had something on ear and scratched it and maybe that is what started the infection. On SEP-2021, the patient experienced rash on leg near knee-itchy, a little redness. On 08-SEP-2021, the patient experienced pain from ear to jawbone/ear to jawbone sore/pain in jawbone below ear/tip of the jaw had little pain. On 08-SEP-2021, the patient experienced earlobe and ear red on left side (right where the jawbone ends). On 08-SEP-2021, the patient experienced earlobe and ear swollen on left side (right where the jawbone ends). On 09-SEP-2021, the patient experienced low grade fever. Laboratory data included: Body temperature (NR: not provided) Low grade fever 99.2 was the highest. Treatment medications (dates unspecified) included: sulfamethoxazole/trimethoprim. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rash on leg near knee-itchy, a little redness, was recovering from low grade fever, and pain from ear to jawbone/ear to jawbone sore/pain in jawbone below ear/tip of the jaw had little pain, had not recovered from earlobe and ear red on left side (right where the jawbone ends), and earlobe and ear swollen on left side (right where the jawbone ends), and the outcome of had something on ear and scratched it and maybe that is what started the infection was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Rash pruritic
Clinical narrative: LOW GRADE FEVER; EARLOBE AND EAR RED ON LEFT SIDE (RIGHT WHERE THE JAWBONE ENDS); EARLOBE AND EAR SWOLLEN ON LEFT SIDE (RIGHT WHERE THE JAWBONE ENDS); PAIN FROM EAR TO JAWBONE/EAR TO JAWBONE SORE/PAIN IN JAWBONE BELOW EAR/TIP OF THE JAW HAD LITTLE PAIN; HAD SOMETHING ON EAR AND SCRATCHED IT AND MAYBE THAT IS WHAT STARTED THE INFECTION; RASH ON LEG NEAR KNEE-ITCHY, A LITTLE REDNESS; This spontaneous report received from a patient concerned a 76 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: lymphedema, diverticulitis, osteoarthritis knee, and allergy to penicillin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: UNKNOWN) dose was not reported, administered on 26-AUG-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid. On SEP-2021, the patient experienced had something on ear and scratched it and maybe that is what started the infection. On SEP-2021, the patient experienced rash on leg near knee-itchy, a little redness. On 08-SEP-2021, the patient experienced pain from ear to jawbone/ear to jawbone sore/pain in jawbone below ear/tip of the jaw had little pain. On 08-SEP-2021, the patient experienced earlobe and ear red on left side (right where the jawbone ends). On 08-SEP-2021, the patient experienced earlobe and ear swollen on left side (right where the jawbone ends). On 09-SEP-2021, the patient experienced low grade fever. Laboratory data included: Body temperature (NR: not provided) Low grade fever 99.2 was the highest. Treatment medications (dates unspecified) included: sulfamethoxazole/trimethoprim. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rash on leg near knee-itchy, a little redness, was recovering from low grade fever, and pain from ear to jawbone/ear to jawbone sore/pain in jawbone below ear/tip of the jaw had little pain, had not recovered from earlobe and ear red on left side (right where the jawbone ends), and earlobe and ear swollen on left side (right where the jawbone ends), and the outcome of had something on ear and scratched it and maybe that is what started the infection was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Head discomfort, Hypoaesthesia, Memory impairment, Nervousness, Paraesthesia
Clinical narrative: FORGETFULNESS; MILD PRESSURE ON THE RIGHT SIDE OF SKULL; NERVOUSNESS; TINGLING SENSATION ON RIGHT SIDE OF SKULL AT CROWN TO NECK NEAR LYMPH NODES; NUMBNESS ON RIGHT SIDE OF SKULL AT CROWN TO NECK NEAR LYMPH NODES; This spontaneous report received from a patient concerned a 69 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN, Expiry: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced forgetfulness, mild pressure on the right side of skull, nervousness, tingling sensation on right side of skull at crown to neck near lymph nodes, and numbness on right side of skull at crown to neck near lymph nodes. Laboratory data (dates unspecified) included: Brain scan NOS (NR: not provided) no problem detected. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from forgetfulness, mild pressure on the right side of skull, and nervousness, and the outcome of numbness on right side of skull at crown to neck near lymph nodes and tingling sensation on right side of skull at crown to neck near lymph nodes was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Scan brain
Clinical narrative: FORGETFULNESS; MILD PRESSURE ON THE RIGHT SIDE OF SKULL; NERVOUSNESS; TINGLING SENSATION ON RIGHT SIDE OF SKULL AT CROWN TO NECK NEAR LYMPH NODES; NUMBNESS ON RIGHT SIDE OF SKULL AT CROWN TO NECK NEAR LYMPH NODES; This spontaneous report received from a patient concerned a 69 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN, Expiry: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced forgetfulness, mild pressure on the right side of skull, nervousness, tingling sensation on right side of skull at crown to neck near lymph nodes, and numbness on right side of skull at crown to neck near lymph nodes. Laboratory data (dates unspecified) included: Brain scan NOS (NR: not provided) no problem detected. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from forgetfulness, mild pressure on the right side of skull, and nervousness, and the outcome of numbness on right side of skull at crown to neck near lymph nodes and tingling sensation on right side of skull at crown to neck near lymph nodes was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event, Illness, Influenza, Pyrexia
Clinical narrative: SICKNESS WITHIN 4 HOUR; OTHER SYMPTOMS; FLU; FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced sickness within 4 hour, other symptoms, flu, and fever. Treatment medications (dates unspecified) included: ascorbic acid/calcium carbonate/calcium pantothenate/calcium phosphate/chromium/cyanocobalamin/folic acid/magnesium carbonate/magnesium hydroxide/manganese gluconate/nicotinic acid/potassium bicarbonate/potassium carbonate/potassium phosphate dibasic/pyridoxine hydrochloride/quercetin/riboflavin sodium phosphate/sodium bicarbonate/sodium phosphate/thiamine hydrochloride/thioctic acid/zinc ascorbate, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sickness within 4 hour, fever, other symptoms and flu was not reported. This report was non-serious.
Age: 22.0
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 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 17-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-MAY-2021, the patient experienced administration of vaccine from affected vials due to temperature excursion. On 17-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 20210913164, 20210915623, 20210915646, 20210915661, 20210915731, 20210915748, 20210915852, 20210916129, 20210916129, 20210916228, 20210916300, 20210916312, 20210916401, 20210916415, 20210916455, 20210916465, 20210916498, 20210916520, 20210916553, 20210916584, 20210916650, 20210916697, 20210916715, 20210916768, 20210916808, 20210916811, 20210916849, 20210916907, 20210916910, 20210916959, 20210916965, 20210917074, 20210917160, 20210917163, 20210917226, 20210917500, 20210917515, 20210917603 and 20210917603.
Age: 38.0
Sex: U
Vaccine: COVID19
Symptoms: Immunisation
Clinical narrative: RECEIVED THE JANSSEN VACCINE TODAY AFTER HAVING THE MODERNA (POTENTIAL MEDICATION ERROR); This spontaneous report received from a health care professional concerned a 38 year old of unspecified sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had everything normal after getting vaccine. The patient was previously treated with mrna 1273 for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, 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 received the janssen vaccine today after having the moderna (potential medication error). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of received the janssen vaccine today after having the moderna (potential medication error) was not reported. This report was non-serious.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Hypokinesia, Insomnia, Muscle fatigue, Muscular weakness
Clinical narrative: FEELS HORRIBLE; CANNOT USE ARM; UNABLE TO SLEEP; MUSCLE FATIGUE; SHOOTING NERVE PAIN IN THE INJECTION SITE, INTO THE BACK, UP TO THE NECK AND DOWN THE ARM; MUSCLE WEAKNESS; This spontaneous report received from a patient concerned a 63 year old female. The patient's weight was 120 pounds, and height was 68 inches. The patient's concurrent conditions included: cholesterol, cigarette smoker 10 cigarettes/day, and non alcohol user, and other pre-existing medical conditions included: The patient had no drug abuse or illicit drug usage. The patient experienced did not wear off for 2 weeks after receiving it at the dentist's office when treated with articaine hydrochloride/epinephrine bitartrate.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 26-AUG-2021 13:15 for prophylactic vaccination. Concomitant medications included rosuvastatin for cholesterol. On 05-SEP-2021, the patient experienced shooting nerve pain in the injection site, into the back, up to the neck and down the arm. On 05-SEP-2021, the patient experienced muscle fatigue. On 05-SEP-2021, the patient experienced muscle weakness. On 06-SEP-2021, the patient experienced unable to sleep. On 09-SEP-2021, the patient experienced cannot use arm. On an unspecified date, the patient experienced feels horrible. Treatment medications (dates unspecified) included: ibuprofen, diphenhydramine hydrochloride, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shooting nerve pain in the injection site, into the back, up to the neck and down the arm, muscle weakness, unable to sleep, muscle fatigue, and cannot use arm, and the outcome of feels horrible was not reported. This report was non-serious.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Neuralgia
Clinical narrative: FEELS HORRIBLE; CANNOT USE ARM; UNABLE TO SLEEP; MUSCLE FATIGUE; SHOOTING NERVE PAIN IN THE INJECTION SITE, INTO THE BACK, UP TO THE NECK AND DOWN THE ARM; MUSCLE WEAKNESS; This spontaneous report received from a patient concerned a 63 year old female. The patient's weight was 120 pounds, and height was 68 inches. The patient's concurrent conditions included: cholesterol, cigarette smoker 10 cigarettes/day, and non alcohol user, and other pre-existing medical conditions included: The patient had no drug abuse or illicit drug usage. The patient experienced did not wear off for 2 weeks after receiving it at the dentist's office when treated with articaine hydrochloride/epinephrine bitartrate.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 26-AUG-2021 13:15 for prophylactic vaccination. Concomitant medications included rosuvastatin for cholesterol. On 05-SEP-2021, the patient experienced shooting nerve pain in the injection site, into the back, up to the neck and down the arm. On 05-SEP-2021, the patient experienced muscle fatigue. On 05-SEP-2021, the patient experienced muscle weakness. On 06-SEP-2021, the patient experienced unable to sleep. On 09-SEP-2021, the patient experienced cannot use arm. On an unspecified date, the patient experienced feels horrible. Treatment medications (dates unspecified) included: ibuprofen, diphenhydramine hydrochloride, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shooting nerve pain in the injection site, into the back, up to the neck and down the arm, muscle weakness, unable to sleep, muscle fatigue, and cannot use arm, and the outcome of feels horrible was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pyrexia, Tinnitus
Clinical narrative: AT 4 AM PATIENT WAS AWOKEN WITH AN AMBULANCE IN HEAD. 27,500HZ. HIGHEST "C" ON THE GRAND PIANO VERY LOUD SCREAMING SOUND IN HEAD AFTER THE SHOT,; FEVER NEXT DAY; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, 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 at 4 am patient was awoken with an ambulance in head. 27, 500hz. highest "c" on the grand piano very loud screaming sound in head after the shot, fever next day, and headache. Treatment medications (dates unspecified) included: prednisone, and ascorbic acid/bioflavonoids nos/choline bitartrate/dl-methionine/hydroxocobalamin/inositol/nicotinamide/panthenol/pyridoxine/riboflavin/thiamine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever next day, and headache, and the outcome of at 4 am patient was awoken with an ambulance in head. 27,500hz. highest "c" on the grand piano very loud screaming sound in head after the shot, was not reported. This report was non-serious.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate irregular
Clinical narrative: 3 weeks after the vaccine I started to have an irregular heart beat. At first it was not constant but over a few more weeks it has gotten worse. Sometimes it settles but it is irregular most of the time
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Oral disorder, Oral soft tissue biopsy, Otitis media, Pharyngitis, SARS-CoV-2 test negative
Clinical narrative: Not sure if related or an adverse reaction to COVID-19 vaccine:  Taking Rinvoq - immunosuppressant for Rheumatoid Arthritis:   dentist found lesion under tongue on 8/28/21; saw oral surgeon on 8/31/21 - removed lesion and sent to lab for biopsy; 9/4/21 - Urgent care Visit - diagnosis throat infection and otitis media infection:  antibiotic prescribed for 10 days.  Covid test:  negative; strep test: negative. Biopsy of lesion under tongue - results received 9/10/21 at oral surgeon's office. Biopsy diagnosis - Submucosal Inclusion Cyst, Benign.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Streptococcus test negative, Tongue cyst
Clinical narrative: Not sure if related or an adverse reaction to COVID-19 vaccine:  Taking Rinvoq - immunosuppressant for Rheumatoid Arthritis:   dentist found lesion under tongue on 8/28/21; saw oral surgeon on 8/31/21 - removed lesion and sent to lab for biopsy; 9/4/21 - Urgent care Visit - diagnosis throat infection and otitis media infection:  antibiotic prescribed for 10 days.  Covid test:  negative; strep test: negative. Biopsy of lesion under tongue - results received 9/10/21 at oral surgeon's office. Biopsy diagnosis - Submucosal Inclusion Cyst, Benign.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose given 25June2021 (more than 36 days from the 1st dose); This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose given 25June2021 (more than 36 days from the 1st dose)) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939676 and 022C21A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis, Fibrositis, Heartburn and Dry eyes. Concomitant products included FISH OIL for Dry eye, OMEPRAZOLE for Heartburn, MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose given 25June2021 (more than 36 days from the 1st dose)). On 25-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose given 25June2021 (more than 36 days from the 1st dose)) had resolved.            No treatment medications were provided by the reporter.   This case was linked to MOD-2021-154239 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Non-significant follow-up appended On 31-Aug-2021: Patient details, Medical history and concomitant products updated
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Feeling abnormal, Headache, Lethargy, Pain
Clinical narrative: Small bruises on different part of body; There is pain and the experience of being remote from my surroundings-fog lke.; pain; lethargy; graying of vision; I also have had headaches unlike any experienced before.; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (Small bruises on different part of body), FEELING ABNORMAL (There is pain and the experience of being remote from my surroundings-fog lke.), PAIN (pain), LETHARGY (lethargy) and VISUAL IMPAIRMENT (graying of vision) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 047B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Iodine allergy, Environmental allergy (Numerous Environmental Allergies), Asthma since 15-Dec-1947 and Hypothyroidism. Concomitant products included CALCIUM CITRATE from 15-Jun-2019 to an unknown date for Bone disorder, THYROID (ARMOUR THYROID) for Hypothyroidism, DOCUSATE SODIUM (COLACE) from 30-Nov-2017 to an unknown date for Stools hard, MAGNESIUM CITRATE from 30-Nov-2017 to an unknown date and VITAMIN D NOS from 15-Jun-2019 to an unknown date for Supplementation therapy.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced HEADACHE (I also have had headaches unlike any experienced before.). On an unknown date, the patient experienced CONTUSION (Small bruises on different part of body), FEELING ABNORMAL (There is pain and the experience of being remote from my surroundings-fog lke.), PAIN (pain), LETHARGY (lethargy) and VISUAL IMPAIRMENT (graying of vision). At the time of the report, CONTUSION (Small bruises on different part of body), FEELING ABNORMAL (There is pain and the experience of being remote from my surroundings-fog lke.), PAIN (pain) and HEADACHE (I also have had headaches unlike any experienced before.) had not resolved and LETHARGY (lethargy) and VISUAL IMPAIRMENT (graying of vision) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2020, SARS-CoV-2 test: positive (Positive) Positive for Covid 19.         Patient says she has Headache behind eyes and nose, graying of vision, sensation of being remote from surroundings and lethargy. Treatment information was not provided   Most recent FOLLOW-UP information incorporated above includes: On 27-Aug-2021: Significant FU : Patient details, product details, concomitant medication , event outcome updated