chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; temperature excursion / temperature: 11.1 C; This spontaneous report was received from a nurse and refers to a 13-year-old patient of unknown gender. There was no information regarding their medical history, concurrent conditions nor concomitant therapies provided.  On 30-JUL-2021, the patient was vaccinated with an improperly stored dose of hepatitis A vaccine, inactivated (VAQTA) 0.5 mL, lot # T023913, expiration date 31-MAR-2022 (route of administration and anatomical location were not provided) for prophylaxis. The administered vaccine was stored in a temperature of 11.1 degree Celsius (C) for 1 hour and 17 minutes. No previous temperature excursion was reported. Digital data logger was involved. No adverse effect was reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: T023913; expirationdate: 31-MAR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability; Sender's Comments:  US-009507513-2108USA000581: US-009507513-2108USA000580:
Age: 15.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No further information provided, no additional adverse effect reported; temperature excursion for VAQTA that was administered to three different patients; This spontaneous report was received from a nurse and refers to a 15-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 30-JUL-2021, the patient was vaccinated with improperly stored dose of hepatitis A vaccine, inactivated (VAQTA) 0.5 mL, lot # T023913, expiration date 31-MAR-2022 (route of administration and anatomical location were not provided) for prophylaxis. Administered dose of vaccine experienced excursion of 11.1 degrees Celsius for 1 hour and 17 minutes. There was no previous excursion reported. Digital data logger was involved. There was no additional adverse event reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T023913; expirationdate: 31-MAR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability; Sender's Comments:  US-009507513-2108USA000554: US-009507513-2108USA000581:
Age: 19.0
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: No further information provided, no additional adverse effect reported; temperature excursion for VAQTA that was administered to three different patients; This spontaneous report was received from a nurse and refers to a 19-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 30-JUL-2021, the patient was vaccinated with improperly stored dose of hepatitis A vaccine, inactivated (VAQTA) 0.5 mL, lot # T023913, expiration date 31-MAR-2022 (route of administration and anatomical location were not provided) for prophylaxis. Administered dose of vaccine experienced excursion of 11.1 degrees Celsius for 1 hour and 17 minutes. There was no previous excursion reported. Digital data logger was involved. There was no additional adverse event reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T023913; expirationdate: 31-MAR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability; Sender's Comments:  US-009507513-2108USA000554: US-009507513-2108USA000580:
Age: 10.0
Sex: U
Vaccine: TDAP
Symptoms: Fatigue, Feeling jittery, Gastrointestinal disorder, Headache, Laryngitis
Clinical narrative: my arm felt sore; sudden intestinal attacks; headache; sore throat; laryngitis; body very jittery; tired; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a 10-year-old patient who received DTPa (Reduced antigen) (dTpa vaccine) for prophylaxis.   Previously administered products included Tetanus vaccine (Received tetnus vaccine on unknown date).   In June 2021, the patient received dTpa vaccine. On an unknown date, 1 day after receiving dTpa vaccine, the patient experienced pain in arm, gastrointestinal disorder, headache, sore throat, laryngitis, feeling jittery and tiredness. On an unknown date, the outcome of the pain in arm, gastrointestinal disorder, headache, sore throat, laryngitis, feeling jittery and tiredness were recovered/resolved.   It was unknown if the reporter considered the pain in arm, gastrointestinal disorder, headache, sore throat, laryngitis, feeling jittery and tiredness to be related to dTpa vaccine.  Additional details were provided as follows: The case was reported by the patient himself/herself. The patient received the dose of Tetanus vaccine in past and patient did not remember side effects. The patient received the booster dose for Tetanus, Diphtheria and Pertussis last month of reporting date and 2nd day the patient experienced sore arm and the 3rd day patient did not have fever but had sudden intestinal attacks,headache,sore throat,laryngitis,body was very jittery and tired for two weeks The reporter stated that the side effects were horrible for two weeks and he/she was glad that was over.
Age: 10.0
Sex: U
Vaccine: TDAP
Symptoms: Oropharyngeal pain, Pain in extremity
Clinical narrative: my arm felt sore; sudden intestinal attacks; headache; sore throat; laryngitis; body very jittery; tired; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a 10-year-old patient who received DTPa (Reduced antigen) (dTpa vaccine) for prophylaxis.   Previously administered products included Tetanus vaccine (Received tetnus vaccine on unknown date).   In June 2021, the patient received dTpa vaccine. On an unknown date, 1 day after receiving dTpa vaccine, the patient experienced pain in arm, gastrointestinal disorder, headache, sore throat, laryngitis, feeling jittery and tiredness. On an unknown date, the outcome of the pain in arm, gastrointestinal disorder, headache, sore throat, laryngitis, feeling jittery and tiredness were recovered/resolved.   It was unknown if the reporter considered the pain in arm, gastrointestinal disorder, headache, sore throat, laryngitis, feeling jittery and tiredness to be related to dTpa vaccine.  Additional details were provided as follows: The case was reported by the patient himself/herself. The patient received the dose of Tetanus vaccine in past and patient did not remember side effects. The patient received the booster dose for Tetanus, Diphtheria and Pertussis last month of reporting date and 2nd day the patient experienced sore arm and the 3rd day patient did not have fever but had sudden intestinal attacks,headache,sore throat,laryngitis,body was very jittery and tired for two weeks The reporter stated that the side effects were horrible for two weeks and he/she was glad that was over.
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Pain, Peripheral swelling, Pyrexia
Clinical narrative: Experienced and allergic reaction; Fever; Arm swelling; Body aches; This case was reported by a consumer via other manufacturer and described the occurrence of allergic reaction in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced allergic reaction, fever, swelling arm and general body pain. On an unknown date, the outcome of the allergic reaction, fever, swelling arm and general body pain were recovered/resolved.   It was unknown if the reporter considered the allergic reaction, fever, swelling arm and general body pain to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient herself. The age at vaccination was not reported. The patient received the dose of Shingrix two years before reporting date and less than 2 years after the vaccination the patient had allergic reactions with fever, arm swelling, and body aches. The patient wanted to know if she would have the same reaction from taking the COVID-19 vaccine. The patient state that she had not taken the vaccine yet but her doctor told her to check the list of ingredients in the vaccine to make sure they did not line up with the Shingrix vaccine. The reporter was provided the attached list of ingredients to compare to the Shingrix ingredients with her provider.
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Feeling abnormal, Myalgia
Clinical narrative: myalgia; extreme fatigue; felt so bad, didn't want to get the second dose; This case was reported by a physician via sales rep and described the occurrence of myalgia in a male 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 myalgia, fatigue and feeling bad. On an unknown date, the outcome of the myalgia, fatigue and feeling bad were recovered/resolved.   It was unknown if the reporter considered the myalgia, fatigue and feeling bad to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient himself, who was also the physician.  The age at vaccination was not reported. Patient received 1st dose of Shingrix and experienced myalgia, extreme fatigue and felt so bad symptoms persisted for about 3 to 4 days. Patient didn't want to get the second dose.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: have a red circle around the injection site; This case was reported by a consumer via interactive digital media and described the occurrence of injection site erythema in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In July 2021, the patient received Shingles vaccine. On an unknown date, less than a week after receiving Shingles vaccine, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema to be related to Shingles vaccine.  Additional details were provide are as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. The patient received the vaccine for shingles (roughly 3 days ago) and had red circle around injection site. The follow-up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure; Got the shingles / very mild case; They still hurt; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a 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 and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the consumer for himself or herself. The age at vaccination was not reported. The patient reporter that, he or she got the shingles a few years after receiving the Shingles shot very mild case but they still hurt. 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.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination faailure/ had my / shots in January / have had five outbreaks since then / last outbreak being severe; have had five outbreaks since then / last outbreak being severe; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine).   In January 2021, the patient received Shingles vaccine. On an unknown date, less than 9 months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient received shingles shots and had five outbreaks since then. The patient stated that the last outbreak was severe. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: was vaccinated but still got them/suspected vaccination failure; was vaccinated but still got them; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a 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) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by the patient. The age at vaccination was not reported. The patient was vaccinated but still got them (shingles). This case was considered as suspected vaccination failure as details regarding primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. The follow up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Sore arm; fatigue; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles in mouth at the age of 16, lasted one month).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than 2 months after receiving Shingles vaccine, the patient experienced pain in arm and fatigue. On an unknown date, the outcome of the pain in arm and fatigue were recovered/resolved.   It was unknown if the reporter considered the pain in arm and fatigue to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the consumer for herself or himself. The age at vaccination was not reported. The patient had shingles in his or her mouth at the age of 16, which lasted one month. The patient decided to request, and received Shingles vaccine shots at 60 days intervals. The patient reported that, after receiving vaccine he or she experienced sore arm and fatigue symptoms each time, which only lasted one day.  The patient said glad he or she did, peace of mind. No further information was reported. For the tolerance of the 2nd dose, refer case US2021AMR165332.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR165332:same patient/reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had both shots / since have gotten shingles 3 times / got both Shingrix doses / has had shingles 3 times/suspected vaccination failure; since have gotten shingles 3 times / has had shingles 3 times; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 71-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: This case was reported by the patient. The age at vaccination was not reported. The patient had both the doses of Shingrix within the required time frame (within 6 months) and had shingles 3 times since. The reporter asked are there any other ways to protect against shingles. This case was considered as suspected vaccination failure as details time to onset and laboratory confirmation were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles. I still get them; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a 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) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the consumer for herself or himself. The age at vaccination was not reported. The patient reported that, he or she was received the Shingles vaccine for shingles and still get them all of the time. 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. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; still got the shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient reported that he/she got the shots and still got shingles for 4 months and it was harable worst thing in life. 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.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Still had a moderate to severe case; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a 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) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that the patient had the shot and still had a moderate to severe case of shingles. This case was considered as suspected vaccination failure, since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles was not reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Got shingles; 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) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by the patient's sister. The age at vaccination was not reported. The patient had received the shot but still got shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: Developed a headache; This case was reported by a consumer via call center representative and described the occurrence of headache in a 68-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 headache. On an unknown date, the outcome of the headache was not recovered/not resolved.   It was unknown if the reporter considered the headache to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient herself. The age at vaccination was not reported. The patient received the first dose of Shingrix and developed a headache. She did not want to provide any other details or information and did not want to be contacted following call. No further information was available. The reporter did not consent to follow up.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received the second dose / on the 29th July, 2021 / first dose / back in May 2018; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of shingrix in May 2018).   On 29th July 2021, the patient received the 2nd dose of Shingrix. On 29th July 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details provided were as follows: The case was reported by the reporter for herself. Health care professional called to report that the patient received 2nd dose later than the recommended interval, which led to lengthening of vaccination schedule. The patient was not sure at the time of call that she received the 1st dose from Shingrix or Zostavax. No further events were reported at the time of call. Health care professional consented to follow-up by email.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: administered Kinrix / was the patient's 3rd DTaP and 3rd IPV dose; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate schedule of vaccine administered in a 4-year-old male patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 28th July 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 28th July 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate schedule of vaccine administered. On an unknown date, the outcome of the inappropriate schedule of vaccine administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional information was provided as follows: The nurse practioner reported that a 4 year old patient was administered kinrix last wednesday. It was the patient's 3rd DTaP and 3rd IPV dose, which led to inappropriate schedule of vaccine administered. The reporter consented to follow up.
Age: 0.5
Sex: U
Vaccine: DTAP
Symptoms: Incorrect dose administered
Clinical narrative: Just 3/4 of the vaccine was injected; This case was reported by a nurse via call center representative and described the occurrence of incomplete dose administered in a 6-month-old patient who received DTPa (Infanrix) (batch number 4L9e4, expiry date 28th February 2023) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 28th July 2021, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 28th July 2021, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced incomplete dose administered. On an unknown date, the outcome of the incomplete dose administered was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: No complete patient's identifiers were provided. The nurse reported that the when administering the dose of Infanrix the patient started moving and wiggling so just three fourth of the vaccine was injected and the other part leaked, which led to incomplete dose administered. The reporter did not consent to follow up.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration
Clinical narrative: Was administered the first dose / subcutaneously; This case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a 50-year-old female patient who received Herpes zoster (Shingrix) (batch number 74359, expiry date 15th November 2022) for prophylaxis.   On 31st July 2021, the patient received the 1st dose of Shingrix (subcutaneous). On 31st July 2021, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.  Additional details were provided as follows: The pharmacist reported that the patient was administered with the 1st dose Shingrix vaccine in left arm subcutaneously, which led to intramuscular formulation administered by other route. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first, and only, dose / on 14Nov2017.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 14th November 2017, batch number N025570).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The age at vaccination was not applicable for this report. Till the time of reporting patient did not receive 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination. The reporter consented to follow up by email.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: TESTED POSITIVE FOR COVID-19; This spontaneous report received from a consumer concerned a 43 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included 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 tested positive for covid-19. 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 tested positive for covid-19. This report was non-serious. This report was associated with product quality complaint: 90000187968.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is considered non serious.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; GOT (COVID-19); This spontaneous report received from a patient via social media via company representative concerned a male of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total, was administered on unspecified date 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 JUL-2021, the patient got CV (covid-19), and suspected clinical vaccination failure. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the got CV (covid-19) and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000187876.; Sender's Comments: V0: 20210800676-Covid-19 vaccine ad26.cov2.s -Suspected Clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dysgeusia, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; GOT (COVID-19); This spontaneous report received from a patient via social media via company representative concerned a male of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total, was administered on unspecified date 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 JUL-2021, the patient got CV (covid-19), and suspected clinical vaccination failure. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the got CV (covid-19) and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000187876.; Sender's Comments: V0: 20210800676-Covid-19 vaccine ad26.cov2.s -Suspected Clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 69 year old male. Initial information was processed along with the additional information received on 03-AUG-2021. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020 expiry: UNKNOWN) dose was not reported, 1 total administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 30-JUL-2021, the patient underwent antibody test which came negative (confirmed immunological vaccine failure). Laboratory data included (on 30-JUL-2021), severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibody test (NR, not provided) Negative. 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: 20210800862 -Covid-19 vaccine ad26.cov2.s-Confirmed immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Hypoaesthesia oral, Oedema peripheral, Pain in extremity
Clinical narrative: SWOLLEN LEFT ANKLE; NUMBNESS AROUND HER MOUTH; MILD LEG PAIN; TINGLING SENSATION ALL OVER THE BODY; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 51 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high-blood pressure, asthma, and seizure disorder. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: UNKNOWN) dose was not reported, administered on 30-JUL-2021 for prophylactic vaccination. Concomitant medications included carbamazepine for anti-convulsant, and levetiracetam for anti-convulsant.  On 30-JUL-2021, the subject experienced swollen left ankle. On 30-JUL-2021, the subject experienced numbness around her mouth. On 30-JUL-2021, the subject experienced mild leg pain. On 30-JUL-2021, the subject experienced tingling sensation all over the body. On 30-JUL-2021, the subject experienced fever. On 30-JUL-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 99.5 F. On 31-JUL-2021, Laboratory data included: Body temperature (NR: not provided) 99.4 degree Fahrenheit. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from numbness around her mouth, fever, swollen left ankle, mild leg pain, tingling sensation all over the body, and headache. This report was non-serious.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Pyrexia
Clinical narrative: SWOLLEN LEFT ANKLE; NUMBNESS AROUND HER MOUTH; MILD LEG PAIN; TINGLING SENSATION ALL OVER THE BODY; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 51 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high-blood pressure, asthma, and seizure disorder. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: UNKNOWN) dose was not reported, administered on 30-JUL-2021 for prophylactic vaccination. Concomitant medications included carbamazepine for anti-convulsant, and levetiracetam for anti-convulsant.  On 30-JUL-2021, the subject experienced swollen left ankle. On 30-JUL-2021, the subject experienced numbness around her mouth. On 30-JUL-2021, the subject experienced mild leg pain. On 30-JUL-2021, the subject experienced tingling sensation all over the body. On 30-JUL-2021, the subject experienced fever. On 30-JUL-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 99.5 F. On 31-JUL-2021, Laboratory data included: Body temperature (NR: not provided) 99.4 degree Fahrenheit. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from numbness around her mouth, fever, swollen left ankle, mild leg pain, tingling sensation all over the body, and headache. This report was non-serious.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Gait disturbance, Hypokinesia, Impaired driving ability
Clinical narrative: FEELS DEAD; DIZZINESS; CAN'T MOVE ARM; SHAKINESS; CAN BARELY WALK UP THE STAIRS; UNABLE TO DRIVE; ARM PAIN; MUSCLE ACHES FROM HEAD TO TOE; FEVER; This spontaneous report received from a patient concerned a 35 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no known drug or non-drug allergies. 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, administered on 30-JUL-2021 15:00 for prophylactic vaccination. No concomitant medications were reported.  On 30-JUL-2021, the subject experienced feels dead. On 30-JUL-2021, the subject experienced dizziness. On 30-JUL-2021, the subject experienced can't move arm. On 30-JUL-2021, the subject experienced shakiness. On 30-JUL-2021, the subject experienced can barely walk up the stairs. On 30-JUL-2021, the subject experienced unable to drive. On 30-JUL-2021, the subject experienced arm pain. On 30-JUL-2021, the subject experienced muscle aches from head to toe. On 30-JUL-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feels dead, fever, muscle aches from head to toe, shakiness, arm pain, dizziness, can barely walk up the stairs, unable to drive, and can't move arm. This report was non-serious.; Sender's Comments: V0-Medical Assessment Comment is not required as per standard procedures, as the case was assessed as non-serious.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Pyrexia, Tremor
Clinical narrative: FEELS DEAD; DIZZINESS; CAN'T MOVE ARM; SHAKINESS; CAN BARELY WALK UP THE STAIRS; UNABLE TO DRIVE; ARM PAIN; MUSCLE ACHES FROM HEAD TO TOE; FEVER; This spontaneous report received from a patient concerned a 35 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no known drug or non-drug allergies. 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, administered on 30-JUL-2021 15:00 for prophylactic vaccination. No concomitant medications were reported.  On 30-JUL-2021, the subject experienced feels dead. On 30-JUL-2021, the subject experienced dizziness. On 30-JUL-2021, the subject experienced can't move arm. On 30-JUL-2021, the subject experienced shakiness. On 30-JUL-2021, the subject experienced can barely walk up the stairs. On 30-JUL-2021, the subject experienced unable to drive. On 30-JUL-2021, the subject experienced arm pain. On 30-JUL-2021, the subject experienced muscle aches from head to toe. On 30-JUL-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feels dead, fever, muscle aches from head to toe, shakiness, arm pain, dizziness, can barely walk up the stairs, unable to drive, and can't move arm. This report was non-serious.; Sender's Comments: V0-Medical Assessment Comment is not required as per standard procedures, as the case was assessed as non-serious.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Facial pain, Headache, Injection site pain
Clinical narrative: CHILLS; FEVER; LEFT SIDE HEADACHE; LEFT SIDE OF FACE HURTING (FACE THROBBING); TEETH SORE AND CHEWING HURT; SORE IN THE ARM (SAME SIDE THAT WAS INJECTED); This spontaneous report received from a patient concerned a 40 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol use, non-smoker, and codeine allergy, and other pre-existing medical conditions included the patient was a healthy guy and does not see his doctor regularly. the patient never contracted covid.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1821286 expiry: 21-OCT-2021) dose was not reported, administered on 23-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-JUL-2021, the subject experienced sore in the arm (same side that was injected). On 27-JUL-2021, the subject experienced left side of face hurting (face throbbing). On 27-JUL-2021, the subject experienced teeth sore and chewing hurt. On 27-JUL-2021, the subject experienced left side headache. On 01-AUG-2021, the subject experienced chills. On 01-AUG-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 103.5 F. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore in the arm (same side that was injected) on 26-JUL-2021, had not recovered from left side of face hurting (face throbbing), teeth sore and chewing hurt, and left side headache, and the outcome of fever and chills was not reported. This report was non-serious.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Toothache
Clinical narrative: CHILLS; FEVER; LEFT SIDE HEADACHE; LEFT SIDE OF FACE HURTING (FACE THROBBING); TEETH SORE AND CHEWING HURT; SORE IN THE ARM (SAME SIDE THAT WAS INJECTED); This spontaneous report received from a patient concerned a 40 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol use, non-smoker, and codeine allergy, and other pre-existing medical conditions included the patient was a healthy guy and does not see his doctor regularly. the patient never contracted covid.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1821286 expiry: 21-OCT-2021) dose was not reported, administered on 23-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-JUL-2021, the subject experienced sore in the arm (same side that was injected). On 27-JUL-2021, the subject experienced left side of face hurting (face throbbing). On 27-JUL-2021, the subject experienced teeth sore and chewing hurt. On 27-JUL-2021, the subject experienced left side headache. On 01-AUG-2021, the subject experienced chills. On 01-AUG-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 103.5 F. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore in the arm (same side that was injected) on 26-JUL-2021, had not recovered from left side of face hurting (face throbbing), teeth sore and chewing hurt, and left side headache, and the outcome of fever and chills was not reported. This report was non-serious.