chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acute kidney injury, Anti-neutrophil cytoplasmic antibody positive vasculitis, Antineutrophil cytoplasmic antibody positive, Blood creatinine increased, Blood phosphorus
Clinical narrative: ANCA vasculitis; dose received 3; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 75 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 13Nov2021 (Lot number: FF8841) at the age of 75 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Known allergies: sulfa" (unspecified if ongoing), notes: known allergies: sulfa, morphine; "Pneumonia" (unspecified if ongoing), notes: other medications in two weeks: IV antibiotics for pneumonia during, hospital stay. The patient took concomitant medications. Past drug history included: Morphine, reaction(s): "Known allergies morphine". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6203), administration date: 02Mar2021, when the patient was 74 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6201), administration date: 09Feb2021, when the patient was 74 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (hospitalization) with onset 13Nov2021, outcome "unknown", described as "dose received 3"; VASCULITIS (hospitalization) with onset 06Dec2021, outcome "recovering", described as "ANCA vasculitis". The event "anca vasculitis" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (06Dec2021) negative. Therapeutic measures were taken as a result of vasculitis and included treatment with IV steriod, riuximab.  No follow-up attempts are possible. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Metabolic function test
Clinical narrative: ANCA vasculitis; dose received 3; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 75 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 13Nov2021 (Lot number: FF8841) at the age of 75 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Known allergies: sulfa" (unspecified if ongoing), notes: known allergies: sulfa, morphine; "Pneumonia" (unspecified if ongoing), notes: other medications in two weeks: IV antibiotics for pneumonia during, hospital stay. The patient took concomitant medications. Past drug history included: Morphine, reaction(s): "Known allergies morphine". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6203), administration date: 02Mar2021, when the patient was 74 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6201), administration date: 09Feb2021, when the patient was 74 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (hospitalization) with onset 13Nov2021, outcome "unknown", described as "dose received 3"; VASCULITIS (hospitalization) with onset 06Dec2021, outcome "recovering", described as "ANCA vasculitis". The event "anca vasculitis" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (06Dec2021) negative. Therapeutic measures were taken as a result of vasculitis and included treatment with IV steriod, riuximab.  No follow-up attempts are possible. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immunisation, SARS-CoV-2 test, Vasculitis
Clinical narrative: ANCA vasculitis; dose received 3; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 75 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 13Nov2021 (Lot number: FF8841) at the age of 75 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Known allergies: sulfa" (unspecified if ongoing), notes: known allergies: sulfa, morphine; "Pneumonia" (unspecified if ongoing), notes: other medications in two weeks: IV antibiotics for pneumonia during, hospital stay. The patient took concomitant medications. Past drug history included: Morphine, reaction(s): "Known allergies morphine". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6203), administration date: 02Mar2021, when the patient was 74 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6201), administration date: 09Feb2021, when the patient was 74 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (hospitalization) with onset 13Nov2021, outcome "unknown", described as "dose received 3"; VASCULITIS (hospitalization) with onset 06Dec2021, outcome "recovering", described as "ANCA vasculitis". The event "anca vasculitis" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (06Dec2021) negative. Therapeutic measures were taken as a result of vasculitis and included treatment with IV steriod, riuximab.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test normal, Electromyogram abnormal, Neuropathy peripheral, Pain, Pain in extremity
Clinical narrative: right big toe pain.  Then it moved to all toes; This is a spontaneous report received from contactable reporter (Other HCP, nurse). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01Apr2021 (Lot number: EW0170) at the age of 50 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Fibromyalgia" (unspecified if ongoing); "migraines" (unspecified if ongoing); "Hypothyroid" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; LEXAPRO; PROBIOTICS NOS; KLONOPIN; VISTARIL [HYDROXYZINE HYDROCHLORIDE]. Past drug history included: Macrobid, reaction: "Drug allergy"; Erythromycin, reaction: "Drug allergy"; Keflex, reaction: "Drug allergy"; Bactrim, reaction: "Drug allergy". The following information was reported: PAIN IN EXTREMITY (medically significant) with onset 2021, outcome "not recovered", described as "right big toe pain.  Then it moved to all toes". The event "right big toe pain.  then it moved to all toes" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative. Therapeutic measures were taken as a result of pain in extremity and included treatment with Toe injection, medications.; Sender's Comments: A causal association between BNT162B2 and the reported pain in toes cannot be excluded based on temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: X-ray
Clinical narrative: right big toe pain.  Then it moved to all toes; This is a spontaneous report received from contactable reporter (Other HCP, nurse). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01Apr2021 (Lot number: EW0170) at the age of 50 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Fibromyalgia" (unspecified if ongoing); "migraines" (unspecified if ongoing); "Hypothyroid" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; LEXAPRO; PROBIOTICS NOS; KLONOPIN; VISTARIL [HYDROXYZINE HYDROCHLORIDE]. Past drug history included: Macrobid, reaction: "Drug allergy"; Erythromycin, reaction: "Drug allergy"; Keflex, reaction: "Drug allergy"; Bactrim, reaction: "Drug allergy". The following information was reported: PAIN IN EXTREMITY (medically significant) with onset 2021, outcome "not recovered", described as "right big toe pain.  Then it moved to all toes". The event "right big toe pain.  then it moved to all toes" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative. Therapeutic measures were taken as a result of pain in extremity and included treatment with Toe injection, medications.; Sender's Comments: A causal association between BNT162B2 and the reported pain in toes cannot be excluded based on temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain in extremity, SARS-CoV-2 test
Clinical narrative: right big toe pain.  Then it moved to all toes; This is a spontaneous report received from contactable reporter (Other HCP, nurse). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01Apr2021 (Lot number: EW0170) at the age of 50 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Fibromyalgia" (unspecified if ongoing); "migraines" (unspecified if ongoing); "Hypothyroid" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; LEXAPRO; PROBIOTICS NOS; KLONOPIN; VISTARIL [HYDROXYZINE HYDROCHLORIDE]. Past drug history included: Macrobid, reaction: "Drug allergy"; Erythromycin, reaction: "Drug allergy"; Keflex, reaction: "Drug allergy"; Bactrim, reaction: "Drug allergy". The following information was reported: PAIN IN EXTREMITY (medically significant) with onset 2021, outcome "not recovered", described as "right big toe pain.  Then it moved to all toes". The event "right big toe pain.  then it moved to all toes" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative. Therapeutic measures were taken as a result of pain in extremity and included treatment with Toe injection, medications.; Sender's Comments: A causal association between BNT162B2 and the reported pain in toes cannot be excluded based on temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Trigeminal neuralgia
Clinical narrative: This is a spontaneous report from a contactable reporter (other healthcare professional). The reporter is the patient. A 39-year-old male patient received the 1st dose of BNT162B2 (Comirnaty, batch/lot# FL3197), at the age of 39, left arm, on Dec 20, 2021, at 16:00, single dose, for COVID-19 immunisation. Medical history included obesity (unspecified if ongoing). There were no concomitant medications. Past drug history included Sudafed (reaction/drug allergy/known allergies: Sudafed). The patient reported trigeminal neuralgia/trigeminal neuralgia on left jaw, onset Dec 20, 2021, at 16:45, with outcome of not recovered. Trigeminal neuralgia on left jaw was evaluated at the emergency room visit. Therapeutic measures were taken as a result of trigeminal neuralgia. Additional information: Prior to vaccination, patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Treatment included prednisone for trigeminal neuralgia. Since the vaccination, patient has not tested for COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during breast feeding
Clinical narrative: Breastfeeding mother; This spontaneous case was reported by an other health care professional and describes the occurrence of MATERNAL EXPOSURE DURING BREAST FEEDING (Breastfeeding mother) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (Breastfeeding mother). At the time of the report, MATERNAL EXPOSURE DURING BREAST FEEDING (Breastfeeding mother) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatment information was reported.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, SARS-CoV-2 test
Clinical narrative: pregnant and got 3 shots of moderna; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (pregnant and got 3 shots of moderna) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A, 007C21A and 067H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 26-Dec-2021. On 13-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (pregnant and got 3 shots of moderna). On 13-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (pregnant and got 3 shots of moderna) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Dec-2021, SARS-CoV-2 test: negative (Negative) Negative.         Concomitant medication list was not provided. Treatment information was not provided.   This case was linked to MOD-2021-422830 (Patient Link).
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Axillary pain, Immunisation, Vaccination site inflammation, Vaccination site pain
Clinical narrative: Plain and inflammation of left arm in vaccine administration area; Plain and inflammation of left arm in vaccine administration area; Pain in both armpits; Weakness after 7 hours of administration; Dose received: 3/ dose number= 3; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.   A 40-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 18Dec2021 at 15:00 (Lot number: S3025BD) at the age of 40 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: MONTELUKAST; CETRIZINE and BREO ELLIPTA. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE, Lot Number: EP6955, Anatomical Location: Right arm, Administration time: 14:00), administration date: 11Apr2021, when the patient was 40 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 1, SINGLE, Lot Number: EP7534, Anatomical Location: Left arm, Administration time: 14:00), administration date: 21Mar2021, when the patient was 40 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 18Dec2021 at 15:00, outcome "unknown", described as "Dose received: 3/ dose number= 3"; VACCINATION SITE PAIN (non-serious), VACCINATION SITE INFLAMMATION (non-serious) both with onset 18Dec2021 at 22:00, outcome "not recovered" and both described as "Pain and inflammation of left arm in vaccine administration area"; AXILLARY PAIN (non-serious) with onset 18Dec2021 at 22:00, outcome "not recovered", described as "Pain in both armpits"; ASTHENIA (non-serious) with onset 18Dec2021 at 22:00, outcome "not recovered", described as "Weakness after 7 hours of administration". Therapeutic measures were not taken as a result of vaccination site pain, vaccination site inflammation, axillary pain and asthenia.  Additional information: The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.
Age: 61.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Ill-defined disorder
Clinical narrative: Shingles in the occipital nerve; Other zoster-related conditions; Information has been received from a lawyer regarding a case in litigation and refers to a patient (pt) of unspecified age and gender. The pt's concurrent conditions, concomitant medications and medical history were unknown. On or about November 2011 (at approximately 61 years old), the pt was administered the zoster vaccine live(ZOSTAVAX) vaccine (strength, dose, rout of administration, lot# and expire date were not reported) by a doctor in a clinic for the long-term prevention of shingles and zoster-related conditions. Subsequently (unspecified date), the pt was treated by healthcare providers (HCP) at urgent care for the following injuries resulting from the zoster vaccine live(ZOSTAVAX) use: shingles in the occipital nerve and other zoster-related conditions (ill-defined disorder). The outcome of the events was not provided. The events were assessed as related to zoster vaccine live(ZOSTAVAX) by the lawyer.  Upon internal review, shingles in the occipital nerve was considered to be medically significant.
Sex: U
Vaccine: MMR
Symptoms: No adverse event
Clinical narrative: No Additional AE; Two month old recieved the MMR II vaccine; This spontaneous report was received from a pharmacist via regulatory authority referring to a 2-month-old infant patient of unknown gender. Patient's concurrent conditions, medical history and concomitant medications were not provided.    On 22-DEC-2021, the 2-month-old patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live rha (recombinant human albumin) M-M-R II) (dose, frequency, route of administration lot#, expiration date were not provided) vaccine for prophylaxis. The Pharmacist did not have any additional information but provided permission to reach out the physician. No additional Adverse event nor PQC.
Age: 73.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Metabolic function test, Neutrophil count, Neutrophil count decreased, Scan
Clinical narrative: my chem panel was off; my neutrophils went to 0.7; This case was reported by a consumer via patient support programs and described the occurrence of comprehensive metabolic panel in a 73-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   Co-suspect products included COVID-19 VACCINE for prophylaxis and niraparib (Zejula) unknown (batch number 2054130, expiry date 31st March 2024) for malignant neoplasm of ovary.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season and the 2nd dose of COVID-19 VACCINE. On 2nd September 2021, the patient started Zejula (oral) 100 mg once daily (100 mg daily). On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season and less than 4 months after starting Zejula, the patient experienced comprehensive metabolic panel and neutrophil count decreased. Zejula was continued with no change. On an unknown date, the outcome of the comprehensive metabolic panel and neutrophil count decreased were unknown.   It was unknown if the reporter considered the comprehensive metabolic panel to be related to Influenza vaccine Quadrivalent unspecified season and Zejula. It was unknown if the reporter considered the neutrophil count decreased to be related to Zejula.  Additional details were provided as follows: The case was self reported by the patient. The age at vaccination was unknown. The reporter stated that, after the flu shot her chem panel was off. On an unknown date, unknown after receiving Covid vaccine, the patient experienced neutrophil count decreased (neutrophil went ot 0.7). The patient was taking Zejula from 2nd September 2021 for malignan neoplasm of unspecified ovary. The reporter stated that, her scan in November 2021 was clear. The reporter stated that she had seen the provider every two weeks and had blood work done monthly. The patient would have a scan in May 2022. It was unknown if the reporter considered the neutrophil count decreased to be related to Covid vaccine. The consent to follow up was granted.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Erythema, Skin discolouration
Clinical narrative: large red mark on my breast; skin discoloration on left breast; underarm pain; This case was reported by a consumer via Shingrix GSK call center representative and described the occurrence of axillary pain in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th December 2021, the patient received the 1st dose of Shingrix. In December 2021, less than a week after receiving Shingrix, the patient experienced axillary pain, localized erythema and skin discoloration. On an unknown date, the outcome of the axillary pain was recovered/resolved and the outcome of the localized erythema and skin discoloration were unknown.   It was unknown if the reporter considered the axillary pain, localized erythema and skin discoloration to be related to Shingrix.  Additional details were reported as follows: The patient received first dose of Shingrix and experienced underarm pain for two days. At the end of second day, the patient had a large red mark on the left side of breast, about the size of palm of hand. The patient said it was large red skin discoloration of left breast. Consent to follow up had been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included autoimmune disorder and post herpetic neuralgia.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were reported as follows: Age at vaccination was not reported. The patient received first dose of Shingles and still experienced shingles. The patient also has historic autoimmune condition, after effects of which were experienced even after 5 years called post hepatic syndrome. The patient received second dose of Shingles and had no recurrence. The reporter consent to follow up was not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR258508:Same reporter, same product, same patient - case for another dose
Sex: U
Vaccine: VARZOS
Symptoms: Induration
Clinical narrative: hard lump in my arm; This case was reported by a consumer via interactive digital media and described the occurrence of induration in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th December 2021, the patient received Shingrix. In December 2021, less than a week after receiving Shingrix, the patient experienced induration. On an unknown date, the outcome of the induration was unknown.   It was unknown if the reporter considered the induration to be related to Shingrix.  Additional details were reported as follows: Age at vaccination was not reported. The patient received a dose of Shingrix and experienced a hard lump in arm. Consent to follow up was not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain, Vaccine positive rechallenge
Clinical narrative: the vaccine did hurt; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received Shingles vaccine for prophylaxis.   The patient's past medical history included shingles (had them and they were the worst). Previously administered products included Shingles vaccine with an associated reaction of injection site pain (1st dose received on an unknown date refer case US2021AMR259665).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced injection site pain. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient said that the vaccine did hurt some, but he/she would take the 2 shots any day over having shingles again. No contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR259665:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had vaccine, diagnosed with shingles/ suspected vaccination failure; 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.   Previously administered products included Pneumonia vaccine with an associated reaction of pneumonia (Pneumonia vaccine twice and was diagnosed with pneumonia 2 years ago).   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 patient self-reported this case. The age at vaccination was not reported. The patient got the shingles vaccine few years ago, even paid for it and still had been diagnosed with shingles. The patient was being treated for it now. The patient had the Pneumonia vaccine twice and was diagnosed with pneumonia 2 years ago. The patient also had Covid-19 vaccines. So far the patient had been healthy, but knew of others that were getting sick after having the vaccines. The patient stated that the vaccines did not work. 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: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Local anaesthesia, Nerve block, Pain, Vaccination failure
Clinical narrative: shingle vaccine, before getting shingles/ suspected vaccination failure; severe shingles; pain; 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, 3 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. The patient was treated with local anesthetic nos (Nerve Block (Nos)). On an unknown date, the outcome of the vaccination failure and pain were unknown and the outcome of the shingles was recovered/resolved.   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 self-reported by the patient. The age at vaccination was not reported. The reporter stated that, he/she got the Shingle vaccine 3 years before getting the shingles. His/her outbreak was severe and lasted all of 2020.  The patient was still taking the nerve blocker.  The patient also stated that, it was described perfectly, and nothing could be compared to that kind of pain. 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 confirmation regarding shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got hte shingles from the shot/suspected vaccination failure; 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.   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 reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient actually got the shingles from the shot. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. No contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Social problem
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of social problem in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not applicable for this report. The patient had the first dose and need the 2nd one but he/she could not had it because he/she was not able to find an appointment due to the fact they were working with Covid vaccine.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Burning sensation, Herpes zoster, Pruritus, Vaccination failure
Clinical narrative: 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 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), shingles, burning sensation and pruritus. The patient was treated with antivirals nos (Antiviral (Drug Name Unknown)). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovering/resolving and the outcome of the burning sensation and pruritus were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, burning sensation and pruritus to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got the Shingles shots and got shingles now. The patient had a light case, but still burned and itched.  The patient took the antiviral five pills a day for a week.  The patient stated that they (shingles) did not spread and were going away.  The patient stated that it would had been awful if he/she not had the shots. The follow-up would not possible as no contact details were available. 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: Condition aggravated, Herpes zoster, Vaccination failure
Clinical narrative: I got the shot but still have break-outs/ suspected vaccination failure; still have break-outs.; 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.   The patient's past medical history included shingles (had shingles atleast 5 times).   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 self-reported by the patient. The age at vaccination was not reported. The reporter stated that, he/she got the Shingles shot but still had breakouts. 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, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: 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 (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), shingles, shingles and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved and the outcome of the shingles and shingles were not recovered/not resolved. It was unknown if the reporter considered the vaccination failure, shingles and shingles to be related to Shingrix. Additional details were provided as follows: The patient was self-reported this case. The age at vaccination was not reported. The patient got shingles within a week after 1st and 2nd shot. The patient discussed with pharmacist and he ok'd 2nd shot. The patient continued to get shingles about every 6 weeks. The patient asked that it would help to get another round of Shingrix. The follow-up could not be possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding the laboratory test confirming shingles were unknown at the time of reporting. Note: As the follow up was not possible for the case, the shingles experienced within a week after 1st and 2nd dose was considered as recovered and case was conservatively considered as SVF for shingles occurred after every 6 weeks.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of feels awful in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced feels awful. On an unknown date, the outcome of the feels awful was unknown.   It was unknown if the reporter considered the feels awful to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient felt awful after first dose of Shingles vaccine. The patient gets his/her second vaccine after 2nd January 2021. The patient stated that he/she would not like to get shingles again as that was a living hell. The follow-up could not be possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Computerised tomogram normal, Hypoaesthesia, Magnetic resonance imaging normal, Pain in extremity
Clinical narrative: numbness with two of his toes and in both legs; pain in both legs; This case was reported by a consumer via other manufacturer and described the occurrence of numbness in toes in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2020, an year ago from the day of reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced numbness in toes and leg pain. On an unknown date, the outcome of the numbness in toes and leg pain were unknown.   It was unknown if the reporter considered the numbness in toes and leg pain to be related to Shingrix.  Additional details were provided as follows: The case was self reported by the patient. The age at vaccination was not reported. Within 60 days of having the 2nd dose of Shingrix, the patient started to have numbness with two of his toes. Then within 6 months of the symptoms starting and less than 9 months after receiving 2nd dose of Shingrix, the patient started to experiencing pain and numbness in both legs from his toes to right above his knees. The reporter stated that, he visited many different specialists (i.e. neurologist, podiatrist, etc) and had several tests done (i.e. Magnetic resonance imaging, computed tomography (CAT) scan, etc) and no one had been able to figured out the main cause. The reporter was asking information related to Shingrix. No other information was provided. No Product complaint was reported. The follow-up would not possible as no contact details were available.
Age: 72.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: received an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 72-year-old male patient who received HAV (Havrix) (batch number F4EL2, expiry date 11th September 2021) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 9th December 2021, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 9th December 2021, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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 reported as follows: The patient received dose of Havrix that already got expired on 11th September 2021, which led to expired vaccine used. Health care professional gave consent for the safety team to follow up. The reporter consented to follow up.
Age: 19.0
Sex: M
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Shingrix instead of Meningitis vaccine; 19 yo received Shingrix; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 19-year-old male patient who received Herpes zoster (Shingrix) (batch number PG352, expiry date unknown) for prophylaxis.   On 21st December 2021, the patient received Shingrix. On 21st December 2021, unknown after receiving Shingrix, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.  Additional details were provided as follows: The reporter stated that a 19-year-old male patient received Shingrix by mistake instead of Meningitis vaccine, which led to wrong vaccine administered and inappropriate age at vaccine administration. The reporter confirmed patient had no particular condition. The reporter consented to follow up. The VAERS details were updated.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 79-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles in past and also had 2 other times in his lifetime).   On 22nd October 2021, the patient received the 1st dose of Shingrix. On 1st November 2021, 10 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient himself. The patient had shingles in the past.  The patient received his first dose of Shingrix and advised that he got Shingles. It lasted about 2 and a half weeks and was now resolved.  Provided info per content that the clinical trials for Shingrix excluded patients with a history of shingles therefore there was little information.  The reporter consented to follow up.
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: received an expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 37-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA433A, expiry date 31st October 2021) for prophylaxis.   On 1st December 2021, the patient received Menveo. On 1st December 2021, 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: The age at vaccination was not reported. The patient received an expired dose of Menveo, which led to expired vaccine used. The reporter consented to follow up. This case was 1 of 6 linked cases, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021261527:Same reporter US-GLAXOSMITHKLINE-US2021261528:Same reporter US-GLAXOSMITHKLINE-US2021261529:Same reporter US-GLAXOSMITHKLINE-US2021261531:Same reporter US-GLAXOSMITHKLINE-US2021261533:Same reporter
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 34-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA433A, expiry date 31st October 2021) for prophylaxis.   On 3rd December 2021, the patient received Menveo. On 3rd December 2021, 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: The age at vaccination was not reported. The patient received an expired dose of Menveo, which led to expired vaccine used. The reporter consented to follow up. This case was 1 of 6 linked cases, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021261523:Same reporter US-GLAXOSMITHKLINE-US2021261533:Same reporter US-GLAXOSMITHKLINE-US2021261528:Same reporter US-GLAXOSMITHKLINE-US2021261529:Same reporter US-GLAXOSMITHKLINE-US2021261531:Same reporter
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered, Product administered to patient of inappropriate age
Clinical narrative: received an expired dose; 61 years old received menveo; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 61-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA433A, expiry date 31st October 2021) for prophylaxis.   On 3rd December 2021, the patient received Menveo. On 3rd December 2021, unknown after receiving Menveo, the patient experienced expired vaccine used and inappropriate age at vaccine administration. On an unknown date, the outcome of the expired vaccine used and inappropriate age at vaccine administration were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received an expired dose of Menveo, which led to expired vaccine used and inappropriate age at vaccine administration.  The reporter consented to follow up. This case was 1 of 6 linked cases, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021261528:Same reporter US-GLAXOSMITHKLINE-US2021261523:Same reporter US-GLAXOSMITHKLINE-US2021261527:Same reporter US-GLAXOSMITHKLINE-US2021261531:Same reporter
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: received an expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 32-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA433A, expiry date 31st October 2021) for prophylaxis.   On 10th December 2021, the patient received Menveo. On 10th December 2021, 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: The age at vaccination was not reported. The patient received an expired dose of Menveo, which led to expired vaccine used. The reporter consented to follow up. This case was 1 of 6 linked cases, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021261523:Same reporter US-GLAXOSMITHKLINE-US2021261527:Same reporter US-GLAXOSMITHKLINE-US2021261531:Same reporter US-GLAXOSMITHKLINE-US2021261529:Same reporter US-GLAXOSMITHKLINE-US2021261533:Same reporter