chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure; Still got shingles; Suffering the pain even after 17 months of the blisters disappeared; Suffering the pain even after 17 months of the blisters disappeared; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain and blister. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown and the outcome of the blister was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain and blister to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the son or daughter of the patient. The age at vaccination as not reported. The reporter stated that, his or her mother had the Shingles vaccine, still got shingles and was suffering from the pain even after 17 months of the blisters was disappeared.  The reporter said that, it was very heart breaking that there was nothing for the pain. This case was considered as suspected vaccination failure, since the details regarding the time to onset for event and laboratory confirmation for shingles were not provided.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives / on their feet / arms, legs, and stomach/ hives were accompanied by a terrible itch; hives were accompanied by a terrible itch; This case was reported by a consumer via call center representative and described the occurrence of hives in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st May 2021, the patient received the 1st dose of Shingrix. On 23rd May 2021, 2 days after receiving Shingrix, the patient experienced hives and pruritus. On an unknown date, the outcome of the hives and pruritus were recovered/resolved.   It was unknown if the reporter considered the hives and pruritus to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient herself. The patient had received first dose of Shingrix and experienced hives. The patient reported that the hives had began on her feet, then spread to arms, legs, and stomach and the hives was accompanied by a terrible itch. The reporter was unsure of how long it took hives to resolve, after first dose, but reported that they did eventually resolve. The reporter did not consent to follow-up. For tolerance with second dose, refer case US2021AMR162087.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR162087:same patient/reporter (2nd dose)
Sex: F
Vaccine: VARZOS
Symptoms: Product complaint, Skin laceration
Clinical narrative: the adjuvant vial broke / it was empty and had no powder in the vial; cut her finger / broken vial caused the AE of cut finger; This case was reported by a other health professional and described the occurrence of laceration of finger in a female patient who received Herpes zoster (Shingrix) for prophylaxis. This case was associated with a product complaint.   On 27th July 2021, the patient received Shingrix. On 27th July 2021, immediately after receiving Shingrix, the patient experienced laceration of finger. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the laceration of finger and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the laceration of finger to be related to Shingrix.  Additional details were provided as follows: The reporter was the account manager for the health care practice with the device in question.  The age at the vaccination was not applicable. The reporter stated that a Medical Assistant was preparing the Shingrix vaccine, when the Medical Assistant attempted to remove the cap of the adjuvant vial, the adjuvant vial broke and cut her finger.  The product quality complaint of broken vial caused the adverse event of cut finger.  The Medical Assistant indicated to the reporter that when the adjuvant vial broke she realized it was empty and had no powder in the vial.  The reporter did not know the following information, unknown if the health care professional office took pictures, unknown if they would return the defective device, unknown if the Medical Assistant  was an experienced user, does not know any of the answers to product quality complaint empty vial questions or broken vial questions, lot number and expiration date were unknown as well as the NDC was unknown.  The reporter would call back with additional information.  Related product quality complaint/ adverse event reports completed. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: rash on both sides of body and chest and crotch area./buttocks/ slightly itchy/externalized rash that was slightly itchy; Rash erythematous; This case was reported by a physician via call center representative and described the occurrence of itchy rash in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, 24 hrs after receiving Shingrix, the patient experienced itchy rash and red rash. On an unknown date, the outcome of the itchy rash and red rash were recovered/resolved.   It was unknown if the reporter considered the itchy rash and red rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient developed an externalized rash on both sides of body, on mid axillary line sides of chest, crotch and buttocks that was slightly itchy. Not hive like, but slightly raised erythematous rash that resolved over 48 hours. The reporter (Allergist) saw rash and said it was not hives like, not chickenpox-like.  There were no pustules and no fluid lesions. It resolved in 72 hours. The reporter consented to follow up.
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Only the liquid portion/ was given; Only the liquid portion/ was given; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 35-year-old female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 27th July 2021, the patient received Menveo. On 27th July 2021, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The other health care professional reported that, the patient was administered partial dose of Menveo.  Only the liquid portion of the vaccine was administered, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.  Lot number was not available to the reporter. Only lot number for powder portion.  The reporter consented to follow up via email.
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Pain in extremity
Clinical narrative: Side effects of / her arm hurting; Side effects of how it didn't feel great; This case was reported by a nurse via call center representative and described the occurrence of pain in arm in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm and feeling bad. On an unknown date, the outcome of the pain in arm and feeling bad were unknown.   It was unknown if the reporter considered the pain in arm and feeling bad to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Nurse reported that the patient received 1st dose of Shingrix and experienced pain in arm and feeling bad. The nurse enquired if it would be harmful for the patient to redo vaccine series. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR163645:Same reporter
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Pyrexia, Vaccination failure
Clinical narrative: Suspected vaccination failure; Got shingles 2-3 times; Fever; Felt achy; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 84-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In March 2021, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix and unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, fever and pain. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the fever and pain were recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. It was unknown if the reporter considered the fever and pain to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient's wife. The age at vaccination was not reported. The patient received second dose of Shingrix vaccine 4 months ago and got shingles 2 to 3 times. He also had fever and felt achy which resolved in 2 to 3 days. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Anxiety, Underdose
Clinical narrative: some liquid leaked from the syringe; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete dose administered. On an unknown date, the outcome of the incomplete dose administered was unknown.  Additional details were provided as follows:  The age at vaccination was not reported. The pharmacist reported that a patient who was anxious prior to the receipt of a dose of Shingrix moved and some liquid leaked from the syringe during administration, which led to incomplete dose administered. Pharmacist did not clarify if this was dose 1 or 2 dose of Shingrix.  No more information was provided.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Arrhythmia, Dyspnoea, Dyspnoea exertional, Exercise tolerance decreased
Clinical narrative: Heart arrhythmia, shortness of breath during and after exercise, more easily winded, trouble exercising, nearly fainted, heightened sense of anxiety and noticeably increased resting heart rate, issues ongoing.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased, Presyncope
Clinical narrative: Heart arrhythmia, shortness of breath during and after exercise, more easily winded, trouble exercising, nearly fainted, heightened sense of anxiety and noticeably increased resting heart rate, issues ongoing.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Peripheral swelling, Ultrasound Doppler
Clinical narrative: Swelling of right right leg from below the knee to my toes caused me to go to the doctor which concluded that I had a DVT in my right leg
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 concerned a 26 year old male of unspecified race & ethnicity. Initial information was processed along with additional information received on 30-JUL-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) 1 total, dose was administered on MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 14-JUL-2021, the patient experienced sore throat, cough, loss of taste and possibly a fever. On the same day, he was tested positive for covid-19 infection (suspected covid-19 infection 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 vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated: 90000187910. The suspected product has been confirmed to be not voided (meet criteria) in investigation result. based on the evaluation/investigation performed.; Sender's Comments: V0:20210800428-JANSSEN 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: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Multiple sclerosis
Clinical narrative: WORSENING MULTIPLE SCLEROSIS; MIGRAINE; This spontaneous report received from a patient concerned a 42 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included multiple sclerosis, interstitial cystitis, and prior migraines. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: UNKNOWN) dose was not reported, 1 total administered on 15-JUN-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 15-JUN-2021, the patient started to experience migraine every day except for two days since the day of vaccination. It was reported that the patient used to have migraines before vaccination but the ones after vaccination were different and they would hurt a lot more than before and the patient had experienced vision going funny with migraines and had sickness to stomach from migraine. The patient was treated with steroids (unspecified) by the neurologist which did not help. On 16-JUN-2021, the patient experienced worsening multiple sclerosis and loss of strength in arms. The patient had planned to have MRI on 05-AUG-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from migraine, and worsening multiple sclerosis. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 - 20210800516-covid-19 vaccine ad26.cov2.s-Worsening of multiple sclerosis. 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: MEDICAL HISTORY, UNDERLYING DISEASE
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOTS; This spontaneous report received from a consumer 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: Unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced blood clots, and was hospitalized (date unspecified). It was unknown if patient was discharged from hospital. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clots was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20210800582-covid-19 vaccine ad26.cov2-blood clots. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: F
Vaccine: COVID19
Symptoms: Emotional distress, Vision blurred
Clinical narrative: BLURRY RIGHT EYE; DISTRESSED MOOD; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 30-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 31-JUL-2021, the subject experienced blurry right eye. On 31-JUL-2021, the subject experienced distressed mood. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blurry right eye, and the outcome of distressed mood was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as case assessed as non-serious.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Blood pressure measurement, Body temperature, Diarrhoea, Dyspnoea
Clinical narrative: OUT OF BREATH; HIGH BLOOD PRESSURE; BACK SORENESS; SLEEPLESSNESS; TIREDNESS; SLIGHT HEADACHE; INJECTION SITE SORENESS; LOOSE STOOL; This spontaneous report received from a patient concerned a 74 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, amoxicillin allergy, shellfish allergy, back soreness, and non-smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 55, and expiry: UNKNOWN) dose was not reported, administered on 28-JUL-2021 10:00 for prophylactic vaccination. No concomitant medications were reported.  On JUL-2021, the subject experienced loose stool. On 28-JUL-2021, the subject experienced injection site soreness. On 29-JUL-2021, the subject experienced back soreness. On 29-JUL-2021, the subject experienced sleeplessness. On 29-JUL-2021, the subject experienced tiredness. On 29-JUL-2021, the subject experienced slight headache. On 30-JUL-2021, the subject experienced out of breath. On 30-JUL-2021, the subject experienced high blood pressure. Laboratory data included: Body temperature (NR: not provided) 97.2 F. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) High. Treatment medications (dates unspecified) included: zolpidem. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tiredness, injection site soreness, and out of breath, and the outcome of slight headache, back soreness, sleeplessness, high blood pressure and loose stool was not reported. This report was non-serious.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hypertension, Injection site pain, Insomnia
Clinical narrative: OUT OF BREATH; HIGH BLOOD PRESSURE; BACK SORENESS; SLEEPLESSNESS; TIREDNESS; SLIGHT HEADACHE; INJECTION SITE SORENESS; LOOSE STOOL; This spontaneous report received from a patient concerned a 74 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, amoxicillin allergy, shellfish allergy, back soreness, and non-smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 55, and expiry: UNKNOWN) dose was not reported, administered on 28-JUL-2021 10:00 for prophylactic vaccination. No concomitant medications were reported.  On JUL-2021, the subject experienced loose stool. On 28-JUL-2021, the subject experienced injection site soreness. On 29-JUL-2021, the subject experienced back soreness. On 29-JUL-2021, the subject experienced sleeplessness. On 29-JUL-2021, the subject experienced tiredness. On 29-JUL-2021, the subject experienced slight headache. On 30-JUL-2021, the subject experienced out of breath. On 30-JUL-2021, the subject experienced high blood pressure. Laboratory data included: Body temperature (NR: not provided) 97.2 F. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) High. Treatment medications (dates unspecified) included: zolpidem. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tiredness, injection site soreness, and out of breath, and the outcome of slight headache, back soreness, sleeplessness, high blood pressure and loose stool was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: ADMINISTRATION OF VACCINE THAT WAS NOT PROPERLY STORED; OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a pharmacist concerned an adult 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: 1820096, and expiry: 03-SEP-2021) dose was not reported, administered on 27-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-JUL-2021, the subject experienced administration of vaccine that was not properly stored. On 27-JUL-2021, the subject experienced out of specification product use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of vaccine that was not properly stored and out of specification product use was not reported. This report was non-serious. This case, from the same reporter is linked to 20210800873 and 20210800576.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Hypoaesthesia, Hypokinesia, Pain, Pain assessment
Clinical narrative: NUMBNESS IN RIGHT LEG ABOUT AN INCH OR 2 AWAY FROM THE KNEE CAP; TINGLING IN THE RIGHT LEG; RADIATING PAIN UP THE LEG TO THE HIP AND AROUND LOWER PART OF BACK; BACK PAIN (WITH RADIATION); CAN HARDLY MOVE; PAIN IN THE RIGHT LEG; This spontaneous report received from a patient concerned a 69 year old female. The patient's weight was 165 pounds, and height was 60 inches. The patient's concurrent conditions included non-smoker, non-alcoholic, peptic ulcer disease, high blood pressure, and spice allergy, and other pre-existing medical conditions included patient have numerous allergies to medication, food and additives. the patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: 25-MAY-2021) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. Concomitant medications included cimetidine for peptic ulcer disease, and levothyroxine sodium. On APR-2021, the subject experienced numbness in right leg about an inch or 2 away from the knee cap. On APR-2021, the subject experienced tingling in the right leg. On APR-2021, the subject experienced radiating pain up the leg to the hip and around lower part of back. On APR-2021, the subject experienced back pain (with radiation). On APR-2021, the subject experienced can hardly move. On APR-2021, the subject experienced pain in the right leg. Laboratory data (dates unspecified) included: Pain scale (NR: not provided) Pain 1/10, Raised to 5/10, 10/10, It went up to a 15/10. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from numbness in right leg about an inch or 2 away from the knee cap, tingling in the right leg, radiating pain up the leg to the hip and around lower part of back, back pain (with radiation), can hardly move, and pain in the right leg. This report was non-serious.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: NUMBNESS IN RIGHT LEG ABOUT AN INCH OR 2 AWAY FROM THE KNEE CAP; TINGLING IN THE RIGHT LEG; RADIATING PAIN UP THE LEG TO THE HIP AND AROUND LOWER PART OF BACK; BACK PAIN (WITH RADIATION); CAN HARDLY MOVE; PAIN IN THE RIGHT LEG; This spontaneous report received from a patient concerned a 69 year old female. The patient's weight was 165 pounds, and height was 60 inches. The patient's concurrent conditions included non-smoker, non-alcoholic, peptic ulcer disease, high blood pressure, and spice allergy, and other pre-existing medical conditions included patient have numerous allergies to medication, food and additives. the patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: 25-MAY-2021) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. Concomitant medications included cimetidine for peptic ulcer disease, and levothyroxine sodium. On APR-2021, the subject experienced numbness in right leg about an inch or 2 away from the knee cap. On APR-2021, the subject experienced tingling in the right leg. On APR-2021, the subject experienced radiating pain up the leg to the hip and around lower part of back. On APR-2021, the subject experienced back pain (with radiation). On APR-2021, the subject experienced can hardly move. On APR-2021, the subject experienced pain in the right leg. Laboratory data (dates unspecified) included: Pain scale (NR: not provided) Pain 1/10, Raised to 5/10, 10/10, It went up to a 15/10. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from numbness in right leg about an inch or 2 away from the knee cap, tingling in the right leg, radiating pain up the leg to the hip and around lower part of back, back pain (with radiation), can hardly move, and pain in the right leg. This report was non-serious.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: VACCINE ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 16 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known allergies and no significant past medical history.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: 20-AUG-2021) dose was not reported, administered on 30-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-JUL-2021, the subject experienced vaccine administered to subject of inappropriate age. On 30-JUL-2021, the subject experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine administered to patient of inappropriate age and off label use was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Blood immunoglobulin G, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 57 year old. The patient's height, and weight were not reported. The patient's concurrent conditions included gout. 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 on 11-MAR-2021 10:03 vaccinated at left arm as prophylactic vaccination. Concomitant medications included prednisone 20 mg a day for gout.   On 29-JUL-2021, the patient had confirmed immunological vaccine failure.  Laboratory data included: IgG (NR: not provided) test that showed no antibodies. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210800851-covid-19 vaccine ad26.cov2.s-Confirmed immunological vaccine failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: ADMINISTRATION OF VACCINE LEFT AT ROOM TEMPERATURE FOR UNKNOWN AMOUNT OF TIME; INCORRECT PRODUCT STORAGE; This spontaneous report received from a pharmacist concerned a 2 decade 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: 1820096 expiry: 03-SEP-2021) dose was not reported, administered on 29-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-JUL-2021, the subject experienced administration of vaccine left at room temperature for unknown amount of time. On 29-JUL-2021, the subject experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of vaccine left at room temperature for unknown amount of time and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20210800576 and 20210800634.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: COVID-19 TEST POSITIVE; This spontaneous report received from a patient concerned a 50 year old male. The patient's height, and weight were not reported. The patient's past medical history included high blood pressure, and concurrent conditions included pollen allergy, non-alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: 23-AUG-2021) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-JUL-2021, the subject experienced covid-19 test positive. Laboratory data included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from covid-19 test positive. This report was non-serious.; Sender's Comments: V0 :  Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: VACCINE NOT EFFECTIVE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer concerned a male of unspecified age. Initial information was processed along with the additional information received from central complaint vigilance on 30-JUL-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) 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 was at very high risk and got COVID-19 infection. It was also reported that, the vaccine was not effective. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and vaccine not effective was not reported. This report was serious (Other Medically Important Condition). This report was associated with RA: 90000187891. The suspected RA has been confirmed to be not voided (meet criteria) in investigation result. based on the evaluation/investigation performed.; Sender's Comments: V0-20210801047-Covid-19 vaccine ad26.cov2.s -VACCINE NOT EFFECTIVE .This event(s) is considered not related. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Paraesthesia, Swelling
Clinical narrative: BUMP IN THE LEFT WRIST; TINGLING AND NUMBNESS IN THE LEFT ARM; PAIN AT THE INJECTION SITE; This spontaneous report received from a patient concerned a 49 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient does not want to disclose anything about his medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 30-APR-2021 for prophylactic vaccination.  No concomitant medications were reported.  On an unspecified date, the subject experienced bump in the left wrist, tingling and numbness in the left arm, and pain at the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain at the injection site, and tingling and numbness in the left arm, and the outcome of bump in the left wrist was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as case assessed as non-serious.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Body temperature, Menstruation irregular, Muscle spasms, Pyrexia
Clinical narrative: CRAMPS IN BODY; PERIODS STARTED ONE WEEK EARLY THAN USUAL; CRAMPS IN STOMACH; FEVER; This spontaneous report received from a parent concerned a 19 year old female. The patient's weight was 60 kilograms, and height was 164 centimeters. The patient's pre-existing medical conditions included patient had no known medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported,  batch number: 202A21A and expiry: UNKNOWN) dose was not reported, administered on 30-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-JUL-2021, the subject experienced cramps in body. On 31-JUL-2021, the subject experienced periods started one week early than usual. On 31-JUL-2021, the subject experienced cramps in stomach. On 31-JUL-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 99 F. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, and the outcome of cramps in body, periods started one week early than usual and cramps in stomach was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: HAVE NOT HAD A MIGRAINE AGAIN; 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. The patient's past medical history included migraine. 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 subject experienced have not had a migraine again. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of have not had a migraine again was not reported. This report was non-serious.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Electromyogram, Magnetic resonance imaging head, Magnetic resonance imaging neck, Neuralgic amyotrophy
Clinical narrative: BRACHIAL PLEXITIS (RIGHT ARM); This spontaneous report received from a patient via a company representative concerned a 40 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: UNKNOWN) dose was not reported, administered on 27-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-JUL-2021, the subject experienced brachial plexitis (right arm). Laboratory data (dates unspecified) included: Blood test (NR: not provided) Excluded Lyme Disease, Electromyogram (NR: not provided) Confirmed Brachial Plexitis, most like due to vaccination, Magnetic resonance imaging head (NR: not provided) Negative for signs of stroke or other issues, and Magnetic resonance imaging neck (NR: not provided) Negative for signs of stroke or other issues. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of brachial plexitis (right arm) was not reported. This report was non-serious.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Heart rate, Heart rate increased, Hypertension, Insomnia
Clinical narrative: COULD NOT SLEEP WELL; ELEVATED PULSE; FELT LIKE HEARTBEAT WAS TOO FAST; ELEVATED BLOOD PRESSURE; FELT LIKE A FEVER; SORE BODY; This spontaneous report received from a patient concerned a 64 year old female. The patient's weight was 120 pounds, and height was 62 inches. The patient's concurrent conditions included diabetes type 2, osteoporosis, allergy to statins, and abnormal cholesterol, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 206A21A expiry: 21-SEP-2021) dose was not reported, administered on 28-JUL-2021 for prophylactic vaccination. Concomitant medications included sitagliptin for diabetes type 2, and cinacalcet for osteoporosis.  On 29-JUL-2021, the subject experienced sore body. On 29-JUL-2021, the subject experienced felt like a fever. Treatment medications included: paracetamol. On 31-JUL-2021, the subject experienced could not sleep well. On 31-JUL-2021, the subject experienced elevated pulse. On 31-JUL-2021, the subject experienced felt like heartbeat was too fast. On 31-JUL-2021, the subject experienced elevated blood pressure. Laboratory data included: Blood pressure (NR: not provided) 185/97 (unit not reported), and Pulse rate (NR: not provided) 114 (unit not reported). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore body, and felt like a fever on 29-JUL-2021, and the outcome of could not sleep well, elevated pulse, felt like heartbeat was too fast and elevated blood pressure was not reported. This report was non-serious.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: COULD NOT SLEEP WELL; ELEVATED PULSE; FELT LIKE HEARTBEAT WAS TOO FAST; ELEVATED BLOOD PRESSURE; FELT LIKE A FEVER; SORE BODY; This spontaneous report received from a patient concerned a 64 year old female. The patient's weight was 120 pounds, and height was 62 inches. The patient's concurrent conditions included diabetes type 2, osteoporosis, allergy to statins, and abnormal cholesterol, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 206A21A expiry: 21-SEP-2021) dose was not reported, administered on 28-JUL-2021 for prophylactic vaccination. Concomitant medications included sitagliptin for diabetes type 2, and cinacalcet for osteoporosis.  On 29-JUL-2021, the subject experienced sore body. On 29-JUL-2021, the subject experienced felt like a fever. Treatment medications included: paracetamol. On 31-JUL-2021, the subject experienced could not sleep well. On 31-JUL-2021, the subject experienced elevated pulse. On 31-JUL-2021, the subject experienced felt like heartbeat was too fast. On 31-JUL-2021, the subject experienced elevated blood pressure. Laboratory data included: Blood pressure (NR: not provided) 185/97 (unit not reported), and Pulse rate (NR: not provided) 114 (unit not reported). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore body, and felt like a fever on 29-JUL-2021, and the outcome of could not sleep well, elevated pulse, felt like heartbeat was too fast and elevated blood pressure was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia, Vision blurred
Clinical narrative: LOT OF BODY PAIN (LEGS, BACK, ARMS, NECK); BLURRY SPOTS IN VISION; NAUSEA; FEVER; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 30-JUL-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch number. No concomitant medications were reported.  On 31-JUL-2021, the subject experienced lot of body pain (legs, back, arms, neck). On 31-JUL-2021, the subject experienced blurry spots in vision. On 31-JUL-2021, the subject experienced nausea. On 31-JUL-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blurry spots in vision, and had not recovered from lot of body pain (legs, back, arms, neck), nausea, and fever. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: RASH TO UNDERARM AND STILL PAINFUL TO THE SITE; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's past medical history included gastric bypass, and hysterectomy, and concurrent conditions included osteoporosis, shellfish allergy, and coconut allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207a21a,and expiry: 21-SEP-2021) dose was not reported, administered on 20-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On 31-JUL-2021, the subject experienced rash to underarm and still painful to the site. Treatment medications (dates unspecified) included: cortisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash to underarm and still painful to the site. This report was non-serious.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Blood bilirubin, Blood creatine phosphokinase normal, Brain natriuretic peptide, Chest X-ray
Clinical narrative: TIREDNESS/GENERAL FATIGUE; BACK PAIN; CHEST PAIN; INABILITY TO TAKE DEEP BREATHS/BREATHING DIFFICULTIES; FEVER; WEIRD SENSATION; TINGLING IN  FEET AND HANDS; CHILLS; This spontaneous report received from a consumer concerned a 22 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included exercise induced asthma, non smoker, and non alcoholic, and other pre-existing medical conditions included the patient had no known allergies and no history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 13-JUL-2021 for prophylactic vaccination. Concomitant medications included salbutamol for exercise induced asthma. On JUL-2021, the subject experienced chills. On 13-JUL-2021, the subject experienced weird sensation. On 13-JUL-2021, the subject experienced tingling in feet and hands. On 13-JUL-2021, the subject experienced fever. On 26-JUL-2021, the subject experienced inability to take deep breaths/breathing difficulties. On 29-JUL-2021, the subject experienced back pain. On 29-JUL-2021, the subject experienced chest pain. Laboratory data included: B-type natriuretic peptide (NR: not provided) no significant findings. Results were considered normal, Bilirubin (NR: not provided) significant results and results were normal, Chest X-ray (NR: not provided) significant results and results were normal, Complete blood count (NR: not provided) no significant findings. Results were considered normal, Comprehensive metabolic panel (NR: not provided) no significant findings. Results were considered normal, Creatine kinase total normal (NR: not provided) no significant findings. Results were considered normal, EKG (NR: not provided) significant results and results were normal, Fibrin D dimer (NR: not provided) no significant findings. Results were considered normal, Respiratory viral panel (NR: not provided) Unknown, SARS-CoV-2 RT-PCR test (NR: not provided) negative, Troponin (NR: not provided) no significant findings. Results were considered normal., and Urinalysis (NR: not provided) no significant findings. Results were considered normal. On an unspecified date, the subject experienced tiredness/general fatigue. Treatment medications (dates unspecified) included: methylprednisolone, and salbutamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from back pain on JUL-2021, and chills, and fever on 19-JUL-2021, had not recovered from inability to take deep breaths/breathing difficulties, and chest pain, and the outcome of tiredness/general fatigue, tingling in feet and hands and weird sensation was not reported. This report was non-serious.