chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional AEs; A 17 year old  female was administered a 4th dose of GARDASIL 9; This spontaneous report was received form an office manager and refers to a 17 years old female patient. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications.  On 13-MAY-2021, the patient was vaccinated with a fourth dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) for prophylaxis, lot # 1691180 with expiration date on 15-NOV-2022 (strength, dose number, anatomical location and route of administration were not reported). No adverse event occurred. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1691180; expirationdate: 15-NOV-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Sex: F
Vaccine: VARZOS
Symptoms: Meningoencephalitis herpetic
Clinical narrative: herpes encephalitis; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unspecified age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In or around July 2014, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot number, dosage and route of administration not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered herpes encephalitis. As a direct and proximate result of defective zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was considered not recovered/not resolved. The event was related to zoster vaccine live (ZOSTAVAX).   Upon internal review, herpes encephalitis was considered to be medically significant. The lawyer considered herpes encephalitis to be disability.
Sex: U
Vaccine: DTAPIPVHIB, HEP
Symptoms: Death
Clinical narrative: Death; This spontaneous report was received from a consumer, via Sanofi, and refers to an infant patient of unknown age and gender who was a participant in one of the reported "2 studies". No information was provided regarding the patient's pertinent medical history, concomitant medications, past drug reactions or allergies.  On an unknown date, the patient was vaccinated with diphtheria vaccine toxoid, hib vaccine conj (TET TOX), pertussis vaccine acellular 5-component, polio vaccine inact 3v (MRC 5), tetanus vaccine toxoid (PENTACEL) and hepatitis b vaccine (Recombinant) (RECOMBIVAX HB) (strengths, number of dose, vaccination scheme frequency, route of administration, anatomical location of vaccination, lot number and expiration date were not provided).  On an unspecified day, the infant patient was reported death. The cause of death was not provided. It was unknown if an autopsy was performed.  The causality assessment between the suspect vaccines and the patient's death was reported as not related. Company Causality Assessment: Based on the limited information currently available for this case, a reasonable possibility to suggest a relationship between the RECOMBIVAX vaccine and the reported event of "Death" cannot be established. Missing information includes: subject´s demographic information, complete medical history, concurrent conditions, dates of RECOMBIVAX administration and other concomitant vaccines, detailed clinical course, diagnostic workup results (if any performed), treatment details (if any provided), and primary cause of death (as per death certificate).   Company Comment- No changes to the RECOMBIVAX vaccine product safety information are warranted at this time.  Merck and Co., Inc. also known as MSD, continues to monitor the safety profile of the product.
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Autism spectrum disorder, Behaviour disorder, Eye disorder
Clinical narrative: autism spectrum disorder  (looked at her all he saw were black eyes, like something was living inside her body, other than his daughter / she had behavioral issues); This spontaneous report was received from a consumer via other pharmaceutical company, referring to a 26 month old female patient.  No information was provided regarding the patient's medical history, concurrent conditions, past drug history or concomitant medications.    On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) for prophylaxis (dose, route and site of administration, lot number and expiration date were not reported).          On an unknown date, the reporter stated when he looked at her all he saw were black eyes, like something was living inside her body other than his daughter.  She had behavioral issues and was diagnosed autism spectrum disorder.   The reporter said "the lights were out for almost 2 years" and that MMR (manufacturer unknown) vaccine changed the patient's life.  The reporter stated his daughter was a smart lady now and he was concerned over the covid 19 vaccine.    The outcome of the event and the causal relationship between the event and therapy with MMR vaccine (manufacturer unknown) were not reported.  Upon internal review autism spectrum disorder was determined medically significant.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs; Inadvertenly administered expired vaccine to a patient; This spontaneous report was received from a nurse, concerning a patient of unknown age and gender. The patient's concurrent conditions, concomitant medications, historical conditions and drug allergies or reactions were not reported.   On 01-JUL-2021, the patient was inadvertently vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live rHA (M-M-R II), at the dose of 0.5 milliliter (ml), for prophylaxis (schedule, anatomical site of injection and route of administration were not reported), lot number S020161 has been verified to be a valid lot number, expiration date reported and validated as 30-JUN-2021 (expired product administered). No adverse event nor product quality complain involved.
Age: 55.0
Sex: M
Vaccine: PPV
Symptoms: Condition aggravated, Multiple sclerosis relapse
Clinical narrative: flare up of MS Symptoms; This spontaneous report was received from a currently 57-year-old male patient, via Sanofi, who was reporting on himself. The patient's concurrent conditions included multiple sclerosis. The patient's past medical history, concomitant therapies and previous drug reactions or allergies was not provided.  On 05-NOV-2019, the patient started therapy with teriflunomide (AUBAGIO) 14 milligrams (mg) coated tablet, at a dose of 14 mg daily (QD), orally for multiple sclerosis (MS) (lot number reported as 1802217 and expiration date reported as 30-MAY-2023).   On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) as prophylactic vaccination (formulation, strength, dose, route of administration, vaccination scheme frequency, anatomical site of vaccination, lot number, and expiration date were not reported).  On an unknown date, the patient was hospitalized three days after pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) as it caused a flare up of MS symptoms (multiple sclerosis relapse). It was not reported if the patient received a corrective treatment for the event.  Therapy with teriflunomide (AUBAGIO) was continued. The outcome of the event multiple sclerosis relapse was not reported. The reporter considered the event multiple sclerosis relapse to be related to Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23). The causal relationship between the event multiple sclerosis relapse and therapy with teriflunomide (AUBAGIO) was not provided.  Upon internal review, the event multiple sclerosis relapse was considered to be medically significant.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no other AEs reported; improperly stored dose of VARlVAX was administered; This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.   On 19-JUN-2021, the patient was vaccinated with improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) 1 injection, lot # T032322, expiration date 22-SEP-2022 (exact dose, route of administration and anatomical location were not reported) for prophylaxis. Administered dose of vaccine experienced temperature excursion of 28 degrees Fahrenheit for 4 hours. There was no previous excursion reported. Digital data logger was involved. There was no additional adverse event reported.
Age: 62.0
Sex: M
Vaccine: PPV
Symptoms: Extra dose administered
Clinical narrative: Pneumovax 23 administered on 13-FEB-2009, and 23-SEP-2013; This spontaneous report was received from a health care professional and refers to a 67-year-old male patient. On 13-FEB-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (site and route of administration, lot# and expiration date were not provided) for prophylaxis. On 23-SEP-2013, the patient received another dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23).  This is one of two reports regarding the same patient.; Sender's Comments:  US-009507513-2105USA003308:
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Dizziness, Electrocardiogram, Face injury
Clinical narrative: Loss of consciousness; Dizziness; Face injury; Fall; Feeling abnormal; Headache; Nausea; This case was received via FDA VAERS (Reference number: 1243359) on 22-Jun-2021 and was forwarded to Moderna on 22-Jun-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of LOSS OF CONSCIOUSNESS (Loss of consciousness) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to antibiotic (patient has allergy to erythromycin.), Seasonal allergy (patient feels sick to stomach certain latex bandages.), Blood pressure high and High cholesterol. Concomitant products included ATENOLOL, SIMVASTATIN (SIMVASTATIN +PHARMA) and UBIDECARENONE (CO Q 10 [UBIDECARENONE]) for an unknown indication.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (Loss of consciousness) (seriousness criterion medically significant), DIZZINESS (Dizziness), FACE INJURY (Face injury), FALL (Fall), FEELING ABNORMAL (Feeling abnormal), HEADACHE (Headache) and NAUSEA (Nausea). At the time of the report, LOSS OF CONSCIOUSNESS (Loss of consciousness), DIZZINESS (Dizziness), FACE INJURY (Face injury), FALL (Fall), FEELING ABNORMAL (Feeling abnormal), HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Mar-2021, Blood test: inconclusive (Inconclusive) Inconclusive. On 31-Mar-2021, Computerised tomogram: inconclusive (Inconclusive) Inconclusive. On 31-Mar-2021, Electrocardiogram: inconclusive (Inconclusive) Inconclusive. On 31-Mar-2021, X-ray: inconclusive (Inconclusive) Inconclusive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   patient had taken unknown vaccine for Flu-ended up in emergency room within 5 hours of shot patient had taken Vitamin Apple cider vinegar capsules (2400 mg) as concomitant drug. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Feeling abnormal, Headache, Loss of consciousness, Nausea
Clinical narrative: Loss of consciousness; Dizziness; Face injury; Fall; Feeling abnormal; Headache; Nausea; This case was received via FDA VAERS (Reference number: 1243359) on 22-Jun-2021 and was forwarded to Moderna on 22-Jun-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of LOSS OF CONSCIOUSNESS (Loss of consciousness) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to antibiotic (patient has allergy to erythromycin.), Seasonal allergy (patient feels sick to stomach certain latex bandages.), Blood pressure high and High cholesterol. Concomitant products included ATENOLOL, SIMVASTATIN (SIMVASTATIN +PHARMA) and UBIDECARENONE (CO Q 10 [UBIDECARENONE]) for an unknown indication.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (Loss of consciousness) (seriousness criterion medically significant), DIZZINESS (Dizziness), FACE INJURY (Face injury), FALL (Fall), FEELING ABNORMAL (Feeling abnormal), HEADACHE (Headache) and NAUSEA (Nausea). At the time of the report, LOSS OF CONSCIOUSNESS (Loss of consciousness), DIZZINESS (Dizziness), FACE INJURY (Face injury), FALL (Fall), FEELING ABNORMAL (Feeling abnormal), HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Mar-2021, Blood test: inconclusive (Inconclusive) Inconclusive. On 31-Mar-2021, Computerised tomogram: inconclusive (Inconclusive) Inconclusive. On 31-Mar-2021, Electrocardiogram: inconclusive (Inconclusive) Inconclusive. On 31-Mar-2021, X-ray: inconclusive (Inconclusive) Inconclusive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   patient had taken unknown vaccine for Flu-ended up in emergency room within 5 hours of shot patient had taken Vitamin Apple cider vinegar capsules (2400 mg) as concomitant drug. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: Loss of consciousness; Dizziness; Face injury; Fall; Feeling abnormal; Headache; Nausea; This case was received via FDA VAERS (Reference number: 1243359) on 22-Jun-2021 and was forwarded to Moderna on 22-Jun-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of LOSS OF CONSCIOUSNESS (Loss of consciousness) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to antibiotic (patient has allergy to erythromycin.), Seasonal allergy (patient feels sick to stomach certain latex bandages.), Blood pressure high and High cholesterol. Concomitant products included ATENOLOL, SIMVASTATIN (SIMVASTATIN +PHARMA) and UBIDECARENONE (CO Q 10 [UBIDECARENONE]) for an unknown indication.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (Loss of consciousness) (seriousness criterion medically significant), DIZZINESS (Dizziness), FACE INJURY (Face injury), FALL (Fall), FEELING ABNORMAL (Feeling abnormal), HEADACHE (Headache) and NAUSEA (Nausea). At the time of the report, LOSS OF CONSCIOUSNESS (Loss of consciousness), DIZZINESS (Dizziness), FACE INJURY (Face injury), FALL (Fall), FEELING ABNORMAL (Feeling abnormal), HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Mar-2021, Blood test: inconclusive (Inconclusive) Inconclusive. On 31-Mar-2021, Computerised tomogram: inconclusive (Inconclusive) Inconclusive. On 31-Mar-2021, Electrocardiogram: inconclusive (Inconclusive) Inconclusive. On 31-Mar-2021, X-ray: inconclusive (Inconclusive) Inconclusive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   patient had taken unknown vaccine for Flu-ended up in emergency room within 5 hours of shot patient had taken Vitamin Apple cider vinegar capsules (2400 mg) as concomitant drug. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: Seizure; This case was received via FDA VAERS (Reference number: 1284289) on 29-Jun-2021 and was forwarded to Moderna on 29-Jun-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of SEIZURE (Seizure) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Apr-2021, the patient experienced SEIZURE (Seizure) (seriousness criterion medically significant). At the time of the report, SEIZURE (Seizure) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication provided. No treatment information mentioned.  Action taken with respect to mRNA-1273 was not applicable.  Very limited information regarding the event have been provided at this time. No further information is expected.; Sender's Comments: Very limited information regarding the event have been provided at this time. No further information is expected.
Sex: U
Vaccine: TYP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient took 1 dose of expired Vivotif; On 22JUN2021 a non-serious spontaneous report was received from a pharmacist:  A pharmacist reported that a 66 year old male had taken one dose of Vivotif (typhoid vaccine live oral Ty21A) that was expired (PT: Expired product administered). The patient did not report any adverse events after consuming the expired Vivotif (lot unknown).   No medical history, concomitant medications, or further information is available.; Sender's Comments: A spontaneous case of administration of expired capsule of Vivotif (unknown lot number and expiration date), in a 66-year-old male consumer with no associated AEs. No further information is expected as there is no consent for follow-up. Per medical assessment with limited information, this case is non-serious.
Sex: U
Vaccine: VARZOS
Symptoms: Axillary pain, Back pain, Chest pain, Herpes zoster, Pain in extremity
Clinical narrative: suspected vaccination failure; I'm seven weeks into shingles I was told I had a bad dice of them/whole back on my chest and right arm; whole back on my chest and right arm and armpit it's extremely painful; whole back on my chest and right arm and armpit it's extremely painful; whole back on my chest and right arm and armpit it's extremely painful; whole back on my chest and right arm and armpit it's extremely painful; 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, chest pain, pain in arm, axillary pain and back pain. On an unknown date, the outcome of the vaccination failure, shingles, chest pain, pain in arm, axillary pain and back pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, chest pain, pain in arm, axillary pain and back pain 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 was seven weeks into shingles The patient had a shingles shot but could not escape them, whole back, on chest and right arm and armpit it was extremely painful. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Vaccination failure
Clinical narrative: suspected vaccination failure; I'm seven weeks into shingles I was told I had a bad dice of them/whole back on my chest and right arm; whole back on my chest and right arm and armpit it's extremely painful; whole back on my chest and right arm and armpit it's extremely painful; whole back on my chest and right arm and armpit it's extremely painful; whole back on my chest and right arm and armpit it's extremely painful; 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, chest pain, pain in arm, axillary pain and back pain. On an unknown date, the outcome of the vaccination failure, shingles, chest pain, pain in arm, axillary pain and back pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, chest pain, pain in arm, axillary pain and back pain 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 was seven weeks into shingles The patient had a shingles shot but could not escape them, whole back, on chest and right arm and armpit it was extremely painful. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Induration, Skin discolouration
Clinical narrative: Never had shingles EVER until I got the shingles vaccine within a day; Within a day I had a hard spot from my shoulder to my elbow; not turned bright red purple; Began to blister; This case was reported by a consumer via media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than a day after receiving Shingles vaccine, the patient experienced shingles, induration, skin discoloration and blister. On an unknown date, the outcome of the shingles, induration, skin discoloration and blister were unknown.   It was unknown if the reporter considered the shingles, induration, skin discoloration and blister to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient. The patient reported that he/she never had shingles ever until got the shingles vaccine. The patient reported that within a day after vaccination he/she had a hard spot from shoulder to elbow which was not turned bright red purple and began to blister. The follow up was not possible for this report as no contact details were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain, Paraesthesia
Clinical narrative: Having pings and needles feeling my legs and hands; This case was reported by a consumer via interactive digital media and described the occurrence of puncture site pain 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 puncture site pain. On an unknown date, the outcome of the puncture site pain was unknown.   It was unknown if the reporter considered the puncture site pain to be related to Shingles vaccine.  Additional details were provided as follows: Age at vaccination was not reported. The patient received Shingles vaccine and experienced pins and needles feeling in legs and hands. The patient asked was that common.
Sex: U
Vaccine: VARZOS
Symptoms: Rash, Scratch
Clinical narrative: Have this rash / on my leg; Have this / scratch on my leg; This case was reported by a consumer via media and described the occurrence of rash on leg in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than a week after receiving Shingles vaccine, the patient experienced rash on leg and scratch. On an unknown date, the outcome of the rash on leg and scratch were unknown.   It was unknown if the reporter considered the rash on leg and scratch to be related to Shingles vaccine.  Additional details were provided as follows: Age at vaccination was not reported. The patient received Shingles vaccine and experienced rash or a scratch on leg. The patient did not known what it was from and patient took the shingles shot maybe a week ago of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: vomiting after each dose; This case was reported by a pharmacist via sales rep and described the occurrence of vomiting in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix .5 ml. On an unknown date, unknown after receiving Shingrix, the patient experienced vomiting. On an unknown date, the outcome of the vomiting was unknown.   It was unknown if the reporter considered the vomiting to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received shingrix and experienced vomiting. No further information was reported. The reporter consented to follow up. For tolerance of 2nd dose, refer link case US2021AMR141814.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR141814:same patient
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I had shot and still got them / Suspected Vaccination failure; 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 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 patient had reported the case for himself/herself. The age at vaccination was not reported. The patient had shot and still got shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster, Pain, Vaccination failure
Clinical narrative: got the / vaccine and two months later shingles / on the cornea of left eye / Suspected Vaccination failure; two months later shingles / on the cornea of left eye / returned two other times; so painful; 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, 2 months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), ophthalmic herpes zoster (serious criteria GSK medically significant) and pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the ophthalmic herpes zoster and pain were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster and pain to be related to Shingles vaccine.  Additional details were provided as follows:  The patient had reported the case for himself/herself. The age at vaccination was not reported. The patient got the Shingles vaccine and two months later shingles appeared on the cornea of left eye which was so painful. The reporter mentioned that, it returned two other times and now at the time of reporting it had been gone. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule and laboratory test confirming shingles were unknown at the time of reporting. Follow-up would not be possible, as no contact details were available.
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: received a dose / where the diluent was correctly administered, but the powder was expirated since July 2020; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a adult male patient who received Men ACWY-CRM NVS (Menveo) (batch number amva1738, expiry date 31st July 2020) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: Age at vaccination was not reported. Nurse reported that the patient received a dose of Menveo where the diluent was correctly administered, but the powder was expirated since July 2020, which led to  expired vaccine used. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: First / vaccine in 2019 / wondering if it is okay to get the second vaccine; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2019).   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 provided as follows: The reporter was the patient. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia, Therapeutic response unexpected
Clinical narrative: had a sore arm; since getting the vaccine/ has had no cold sores, but previously had them.; after the second / had a fever of 100 degrees; This case was reported by a other health professional via sales rep and described the occurrence of pain in arm in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included cold sores. Previously administered products included Shingrix with an associated reaction of pain in extremity (also experienced unexpected therapeutic drug effect after receiving 1st dose on an unknown date, refer case US2021AMR141632).   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm, fever and unexpected therapeutic drug effect. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm and fever were recovered/resolved and the outcome of the unexpected therapeutic drug effect was unknown.   It was unknown if the reporter considered the pain in arm, fever and unexpected therapeutic drug effect to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Three years ago, from the reporting date, the patient received 2nd dose of Shingrix in an unknown arm and experienced sore arm and had fever of 100 degree F for 24 hours. In the 3 years since getting the vaccine the patient has had no cold sores, but previously had them. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR141632:same reporter and same patient
Sex: F
Vaccine: TDAP
Symptoms: Syringe issue, Underdose
Clinical narrative: patient was administered boostrix on 6/26 and syringe leaked; patient was administered boostrix on 6/26 and syringe leaked; This case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a 33-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 575hc, expiry date 28th February 2023) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 26th June 2021, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On 26th June 2021, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced accidental underdose and syringe leak. On an unknown date, the outcome of the accidental underdose and syringe leak were 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 are as follows: The age at vaccination was not reported. The registered pharmacist reported that the patient was administered with Boostrix and syringe leaked which led to accidental underdose and syringe leak. The reporter asked for the dose re administration. No product quality complaint was reported. The reporter consented to follow up.
Age: 80.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; In 2020 he developed shingles; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 82-year-old male 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 2nd dose of Shingrix and the 1st 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 was unknown and the outcome of the shingles was recovered/resolved.   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: The reporter was the patient. The reporter stated that, the patient received Shingrix series in 2018 and in 2020 developed shingles. The patient inquiring about getting shingrix vaccine series for a second time for shingles prevention. The reporter did not consent to follow up. This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation for shingles was unknown.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: ate for the second dose / First dose / adinistrated on November 16 2020 / second dose was not administered; This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (first dose of shingrix received on 16th November 2020).   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. The patient received 1st dose of Shingrix at primary reporter's facility. The patient was late for the 2nd dose. Till the time of reporting, the patient did not receive second dose of Shingrix, which led to incomplete course of vaccination. No adverse event was reported. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: got first dose / on 09/08/2020 never got the 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (as 1st dose received on 9th August 2020 X3P72 and expiry date 7th November 2022').   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. The patient received first dose of Shingrix at primary reporter's facility. Till the time of reporting, the patient never received 2nd dose of Shingrix,which led to incomplete course of vaccination. The pharmacist inquired for revaccination. The reporter consented to follow up.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Wrong product administered
Clinical narrative: administration /  of a dose of Menveo to a / patient who was meant to receive the second dose of Bexsero; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number amva55da, expiry date 28th February 2022) for prophylaxis.   On 1st July 2021, the patient received Menveo. On 1st July 2021, unknown after receiving Menveo, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown.  Additional details were reported as follows: The patient was meant to receive the second dose of Bexsero but received a dose of Menveo, which led to wrong vaccine administered. No further events were reported. The healthcare professional gave consent to follow up.
Sex: U
Vaccine: COVID19
Symptoms: Asthma, Body temperature, Feeling abnormal, Magnetic resonance imaging, Pyrexia
Clinical narrative: WORSENING ASTHMA SYMPTOMS; FELT LITTLE WEIRD; FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma. 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 worsening asthma symptoms, felt little weird, and fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 101, and MRI (NR: not provided) Unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, worsening asthma symptoms and felt little weird was not reported. This report was non-serious.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache
Clinical narrative: DIZZINESS; HEADACHE; This spontaneous report received from a consumer concerned a 68 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 29-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced dizziness, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, and the outcome of dizziness was not reported. This report was non-serious. This case, from the same reporter is linked to 20210701429 and 20210701921.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Headache, Myalgia, Pain
Clinical narrative: PAIN EVERYWHERE; SHORTNESS OF BREATH; HEADACHE; MUSCLE ACHES ALL OVER BODY; This spontaneous report received from a patient concerned a 56 year old female. The patient's weight was 120 pounds, and height was 64 inches. The patient's past medical history included back surgery, and hysterectomy, and concurrent conditions included spinal stenosis, asthma, pain, gastrointestinal disorders, and uterine cancer, and other pre-existing medical conditions included the patient was not pregnant at the time of vaccination.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: UNKNOWN) dose was not reported, administered on 01-JUL-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid/caffeine/paracetamol for pain everywhere, shortness of breath, headache, and muscle aches all over body. On 01-JUL-2021, the subject experienced pain everywhere. On 01-JUL-2021, the subject experienced shortness of breath. On 01-JUL-2021, the subject experienced headache. On 01-JUL-2021, the subject experienced muscle aches all over body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, muscle aches all over body, shortness of breath, and pain everywhere. This report was non-serious.