chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Prostatic specific antigen increased
Clinical narrative: Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A, 010M20A and 038B21A) for COVID-19 vaccination.     The patient's past medical history included Renal insufficiency, Diverticulosis, Otitis media, Sinusitis, Viral infection, Headache, Tension, Lung cancer, Skin cancer, Chest wall pain, Prostate cancer, Ankle sprain, Colon cancer, Thrombocytopenia, Vitamin B12 deficiency, Neck pain, Back pain, Osteoporosis, Allergic rhinitis and Bundle branch block right. Previously administered products included for Product used for unknown indication: Influenza Vaccine (series 1) on 02-Oct-2019, Influenza vaccine (series 3) on 15-Oct-2021, Influenza Vaccine (series 2) on 15-Oct-2021, Influenza vaccine and Influenza vaccine. Past adverse reactions to the above products included No adverse reaction with Influenza Vaccine, Influenza Vaccine, Influenza vaccine, Influenza vaccine and Influenza vaccine. Family history included Heart disease, unspecified. Concurrent medical conditions included Spinal stenosis in cervical region and Hyperlipidemia. Concomitant products included DICLOFENAC SODIUM (VOLTAREN [DICLOFENAC SODIUM]) for Headache tension, SIMVASTATIN, CUCURBITA PEPO OIL, SERENOA REPENS, ZINC GLUCONATE (SAW PALMETTO [CUCURBITA PEPO OIL;SERENOA REPENS;ZINC GLUCONATE]) and CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]) for an unknown indication.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 28-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Prostatic specific antigen increased: increased (High) increased.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient has to check for HEMOCCULT or sigmoid  Patient had to take Flu Vax, Pneumovax,TD Booster vaccines.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrospinal fluid leakage
Clinical narrative: A brain leak; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROSPINAL FLUID LEAKAGE (A brain leak) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic and Hypertension.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CEREBROSPINAL FLUID LEAKAGE (A brain leak) (seriousness criterion medically significant). At the time of the report, CEREBROSPINAL FLUID LEAKAGE (A brain leak) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication provided.  Patient  was schedule for surgery and wanted to know the waiting period she had to wait before having surgery or taking the second dose No treatment information mentioned.  This case concerning a 68-year-old female patient with relevant medical history of Diabetes mellitus and Hypertension, who experienced the serious unexpected event of Cerebrospinal fluid leakage. The event occurred on unknown date after the first dose of mRNA-1273 vaccine administration. The event was conservatively considered as related to the product administration; however, the temporal association cannot be determined due to the limited information. The rechallenge was not applicable since no information available on the second dose. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerning a 68-year-old female patient with relevant medical history of Diabetes mellitus and Hypertension, who experienced the serious unexpected event of Cerebrospinal fluid leakage. The event occurred on unknown date after the first dose of mRNA-1273 vaccine administration. The event was conservatively considered as related to the product administration; however, the temporal association cannot be determined due to the limited information. The rechallenge was not applicable since no information available on the second dose. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Dizziness, Fall, Hypokinesia, Hypotension
Clinical narrative: She was very confused and light headed that she slid down the side of her bed. She mentioned that her mother said she was "paralyzed; low blood pressure; very confused; she slid down the side of of her bed; light headed; This spontaneous case was reported by a consumer and describes the occurrence of HYPOKINESIA (She was very confused and light headed that she slid down the side of her bed. She mentioned that her mother said she was "paralyzed), HYPOTENSION (low blood pressure), CONFUSIONAL STATE (very confused), FALL (she slid down the side of of her bed) and DIZZINESS (light headed) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 012M20A) for COVID-19 vaccination.     The patient's past medical history included Stroke in January 2021.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced HYPOKINESIA (She was very confused and light headed that she slid down the side of her bed. She mentioned that her mother said she was "paralyzed), HYPOTENSION (low blood pressure), CONFUSIONAL STATE (very confused), FALL (she slid down the side of of her bed) and DIZZINESS (light headed). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, HYPOKINESIA (She was very confused and light headed that she slid down the side of her bed. She mentioned that her mother said she was "paralyzed), HYPOTENSION (low blood pressure), CONFUSIONAL STATE (very confused), FALL (she slid down the side of of her bed) and DIZZINESS (light headed) outcome was unknown.            No Concomitant medication was reported.    Treatment information included patient treated with fluids   This case was linked to MOD-2021-403658 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Fatigue, Feeling abnormal, Pain in extremity
Clinical narrative: COVID-19; I felt congested; restless; I was real tired/tired; chills; My arm was sore; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (My arm was sore), FEELING ABNORMAL (I felt congested), COVID-19 (COVID-19), RESTLESSNESS (restless) and FATIGUE (I was real tired/tired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 077C21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Smoker.    On 26-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Nov-2021, the patient experienced PAIN IN EXTREMITY (My arm was sore). On 28-Nov-2021, the patient experienced RESTLESSNESS (restless), FATIGUE (I was real tired/tired) and CHILLS (chills). On 29-Nov-2021, the patient experienced FEELING ABNORMAL (I felt congested). On 30-Nov-2021, the patient experienced COVID-19 (COVID-19). At the time of the report, PAIN IN EXTREMITY (My arm was sore), FEELING ABNORMAL (I felt congested), COVID-19 (COVID-19), RESTLESSNESS (restless), FATIGUE (I was real tired/tired) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Nov-2021, SARS-CoV-2 test: positive (Positive) positive. On 01-Dec-2021, SARS-CoV-2 test: positive (Positive) positive.     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.   Concomitant product use was not provided by the reporter.  No treatment information was provided.  Company comment: This case concerns a female patient with medical history of smoking, who experienced the unexpected non serious event of COVID 19 along with other non serious events. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination. The event occurred approximately 4 days after the first dose of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a female patient with medical history of smoking, who experienced the unexpected non serious event of COVID 19 along with other non serious events. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination. The event occurred approximately 4 days after the first dose of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Restlessness, SARS-CoV-2 test
Clinical narrative: COVID-19; I felt congested; restless; I was real tired/tired; chills; My arm was sore; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (My arm was sore), FEELING ABNORMAL (I felt congested), COVID-19 (COVID-19), RESTLESSNESS (restless) and FATIGUE (I was real tired/tired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 077C21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Smoker.    On 26-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Nov-2021, the patient experienced PAIN IN EXTREMITY (My arm was sore). On 28-Nov-2021, the patient experienced RESTLESSNESS (restless), FATIGUE (I was real tired/tired) and CHILLS (chills). On 29-Nov-2021, the patient experienced FEELING ABNORMAL (I felt congested). On 30-Nov-2021, the patient experienced COVID-19 (COVID-19). At the time of the report, PAIN IN EXTREMITY (My arm was sore), FEELING ABNORMAL (I felt congested), COVID-19 (COVID-19), RESTLESSNESS (restless), FATIGUE (I was real tired/tired) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Nov-2021, SARS-CoV-2 test: positive (Positive) positive. On 01-Dec-2021, SARS-CoV-2 test: positive (Positive) positive.     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.   Concomitant product use was not provided by the reporter.  No treatment information was provided.  Company comment: This case concerns a female patient with medical history of smoking, who experienced the unexpected non serious event of COVID 19 along with other non serious events. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination. The event occurred approximately 4 days after the first dose of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a female patient with medical history of smoking, who experienced the unexpected non serious event of COVID 19 along with other non serious events. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination. The event occurred approximately 4 days after the first dose of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Hot flush, Lymphadenopathy, Nausea, Pyrexia, Vaccination complication
Clinical narrative: egg sized lump in his left armpit/lump is very noticeable/believes this is a swollen lymph node; normal side effects; hot flashes; fever; nausea; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (normal side effects), HOT FLUSH (hot flashes), PYREXIA (fever), NAUSEA (nausea) and LYMPHADENOPATHY (egg sized lump in his left armpit/lump is very noticeable/believes this is a swollen lymph node) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041J21A, 006C21A and 007B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Dec-2021, the patient experienced VACCINATION COMPLICATION (normal side effects), HOT FLUSH (hot flashes), PYREXIA (fever) and NAUSEA (nausea). On an unknown date, the patient experienced LYMPHADENOPATHY (egg sized lump in his left armpit/lump is very noticeable/believes this is a swollen lymph node). At the time of the report, VACCINATION COMPLICATION (normal side effects), HOT FLUSH (hot flashes), PYREXIA (fever), NAUSEA (nausea) and LYMPHADENOPATHY (egg sized lump in his left armpit/lump is very noticeable/believes this is a swollen lymph node) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment medication use was not provided by the reporter.   This case was linked to MOD-2021-424596, MOD-2021-424570 (Patient Link).
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2021, the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.   This case was linked to MOD-2021-426305 (Patient Link).
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; A patient was administered PEDVAXHIB after a temperature excursion. Caller stated the patient was administered PEDVAXHIB on 8NOV2021; This spontaneous report has been received from other reporter (reported as: "HBP") and referred to patient of unknown gender an age. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not provided.   On 08-NOV-2021, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) at a dose of 0.5 milliliter (strength, vaccine scheme and route of administration were not provided; lot number T037650 has been verified to be a valid lot number, expiration date reported and established as 21-JUL-2023), as prophylaxis, after a temperature excursion (product storage error).  The vaccine was expose to a temperature of 47.29 Fahrenheit degree, for a time frame of 3 hours and 22 minutes. It was not reported if there was a previous temperature excursion. No additional adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2112USA003366: US-009507513-2112USA003663: US-009507513-2112USA003742:
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE or PQC reported; expired on 14 NOV 2021 and was administered 09 DEC 2021.; This spontaneous report was received from a medical assistant and refers to a 22-year-old female patient. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 09-DEC-2021, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) 0.5 mL, subcutaneously, lot # S036663, expiration date 14-NOV-2021 (dose number and vaccination site were not provided) for prophylaxis. No prescription drug treatment was required. The patient was doing well with no issues. The vaccine did not have any previous temperature excursions, no additional adverse event (AE) was reported.
Sex: F
Vaccine: VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: 9 year old patient received a second dose of VARlVAX 16 days after the first dose; no additional AE reported; This spontaneous report has been received from a pharmacist referring to a 9-year-old female patient. Concomitant medication, pertinent medical history, and drug reactions/allergies were not reported.  On an unknown date, the patient was vaccinated with the second dose of varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis 16 days after the first dose (strength, dose, route, lot#, and expiration date were not reported) (inappropriate schedule of product administration). The reporter did not know the exact dates of administration. No additional adverse event (AE) or further information was reported.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Death, Herpes zoster, Ill-defined disorder
Clinical narrative: Information has been received from a lawyer and a consumer, regarding a case in litigation concerning an 75-year-old female patient. No information was received regarding the pt's past medical history, concurrent conditions, or concomitant medication. On 07-JUL-2009 (at 73 years old), the pt was inoculated with zoster vaccine live (ZOSTAVAX) at a clinic, as prophylaxis (strength, dose, route of administration, lot number, and expiry date were not provided). On an unspecified date in June 2011, as a result of her receipt of zoster vaccine live (ZOSTAVAX), she was caused to suffer shingles (herpes zoster), including any and all of its sequelae (ill-defined disorder). As a result of her receipt of zoster vaccine live (ZOSTAVAX) vaccine, she had been caused to suffer severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages. On 30-MAR-2017 (at 81 years old), the pt passed away (no cause of death was reported) and it was unknown whether an autopsy was performed. At the time of reporting, the outcome of the herpes zoster and ill-defined disorder was not known. The reporter considered herpes zoster and ill-defined disorder to be related to zoster vaccine live (ZOSTAVAX). The causal relationship between the pt's death and zoster vaccine live (ZOSTAVAX) was unknown.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; Expired product administered; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Patient's concurrent conditions, medical history and concomitant medications were not provided.  On 22-NOV-2021 the patient was vaccinated with expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) (lot # S035355 and expiration date provided as 05-NOV-2021),0.5 milliliter for prophylaxis (expired product administered). No additional AE and PQC reported.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: the patient did not experience any other AE; the patient received PEDVAX HIB after it experienced a temperature excursion; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent condition, drug reactions/allergies and concomitant medication was not provided.  On 23-NOV-2021, the patient was vaccinated with haemophilus B conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) 1 dose (lot #T037648, expiration date: 20-JUL-2023; strength and route of administration were not provided) for prophylaxis after a temperature excursion of 8.5 degrees Celsius (C) for 30 minutes (product storage error). No previous temperature excursion. The patient did not experience any other adverse event (AE).   This is one of three reports received from the same reporter.; Sender's Comments:  US-009507513-2112USA008367: US-009507513-2112USA008430:
Sex: U
Vaccine: VARZOS
Symptoms: Hypersensitivity
Clinical narrative: allergic reaction; This case was reported by a consumer via interactive digital media and described the occurrence of allergic reaction in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In September 2021, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown.   It was unknown if the reporter considered the allergic reaction to be related to Shingles vaccine.  Additional details were reported as follows: Age at vaccination was not reported. The patient received Shingles and experienced horrible side effects and allergic reaction. The patient could not receive second dose. Consent to follow up was not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: vaccine did hurt some; This case was reported by a consumer via interactive digital media and described the occurrence of pain 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 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain 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 stated the worst case of shingles in past. The patient stated that the vaccine did hurt some, but he/she would take the 2 shots any day over having shingles again. The follow-up would not be possible as no contact details were available. This case has been linked to US2021AMR259929, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR259929:Samepatient differentdose
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: flu like symptoms for 2 days; This case was reported by a consumer via interactive digital media and described the occurrence of influenza-like symptoms in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   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 influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved.   The reporter considered the influenza-like symptoms 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 had flu like symptoms for 2 days from the second Shingles shot. The patient stated that definitely did not want to get the shingles. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: after having the simplex shots (2) I got shingles/suspected vaccination failure; I got shingles; This case was reported by a other health professional 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 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was treated with gabapentin. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got the 2 doses of Shingrix shots in 2019 and still got shingles. The patient took gabapentin for 11 months.  The patient asked being under physician's care and 1 being a nerve specialist, how advertisement says the shots would keep us from getting the virus. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, 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. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not recovered/ not 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 patient self-reported this case. The age at vaccination was not reported. The patient received all the shots and still had shingles and they were very painful. This case was considered as suspected vaccination failure as details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got both shots and had 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 prophylaxi.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was treated with acetic acid (Apple Cider Vinegar). On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got both shots and had shingles twice, the patient was on remedy. The patient stated that to use apple cider vinegar with the mother in it. Fab it on with cotton ball. Might sting a little but dries them (shingles) up and stops spreading. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as time to onset and laboratory confirmation for shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: incorrectly mixed SHINGRIX which was administered; incorrectly mixed SHINGRIX which was administered; This case was reported by a other health professional via other manufacturer and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that the medical assistant incorrectly mixed Shingrix which was administered to a patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter wanted to know if it needed to be re-administered. No additional information reported. This case has been linked to US2021261507, reported by the same reporter. The reporter denied consent to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021261507:same reporter
Age: 17.0
Sex: U
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Gave a 17 year-old Kinrix instead of boostrix; Gave a 17 year-old Kinrix instead of boostrix; This case was reported by a nurse and described the occurrence of wrong vaccine administered in a 17-year-old patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, 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.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter informed that one of the employees in clinic gave a 17-year-old patient a dose of Kinrix instead of boostrix, which led to wrong vaccine administered and inappropriate age at vaccine administration. The case has been linked to US2021AMR262202, reported by the same reporter, for a different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR262202:Same reporter. Pt 1 - 16y/o
Sex: U
Vaccine: VARZOS
Symptoms: Deafness unilateral
Clinical narrative: went deaf in right ear; This case was reported by a consumer via interactive digital media and described the occurrence of deafness unilateral 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 deafness unilateral (serious criteria GSK medically significant). On an unknown date, the outcome of the deafness unilateral was unknown.   It was unknown if the reporter considered the deafness unilateral to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient. The age at vaccination was not reported. The patient got the Shingles vaccine and went deaf in right ear. The patient stated that he/she would rather get shingles than go deaf in one of ears. The follow-up would not possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Ear pain, Headache, Herpes zoster, Neck pain, Pain
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. In November 2021, several years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain, headache, ear pain and neck pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, pain, headache, ear pain and neck pain were not recovered/not resolved. It was unknown if the reporter considered the vaccination failure, shingles, pain, headache, ear pain and neck pain to be related to Shingles vaccine. Additional details were provided as follows: The patient was the reporter's brother-in-law. The age at vaccination was not reported. The reporter stated that, the patient had the shingles shot several years ago but still got shingles anyway. The patient got the shingles 3 and a half weeks ago from the day of reporting. The patient had terrible pain on his head, ear and neck and had miserable sharp stabbing pain. The reporter hoped that the shingles get better soon. 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. The follow-up would not possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: 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 male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. In November 2021, several years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain, headache, ear pain and neck pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, pain, headache, ear pain and neck pain were not recovered/not resolved. It was unknown if the reporter considered the vaccination failure, shingles, pain, headache, ear pain and neck pain to be related to Shingles vaccine. Additional details were provided as follows: The patient was the reporter's brother-in-law. The age at vaccination was not reported. The reporter stated that, the patient had the shingles shot several years ago but still got shingles anyway. The patient got the shingles 3 and a half weeks ago from the day of reporting. The patient had terrible pain on his head, ear and neck and had miserable sharp stabbing pain. The reporter hoped that the shingles get better soon. 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. The follow-up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Ophthalmic herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure/Having both shots you can still get the shingles; Got it in her left eye; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and ophthalmic herpes zoster (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the ophthalmic herpes zoster was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and ophthalmic herpes zoster to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The case was reported by patient's friend. The age at vaccination was not reported. The reporter reported that even after having both shots anyone can still get the shingles. The reporter's friend was living proof and got shingles in her left eye and still not over them. This case was considered as suspected vaccination failure as details regarding the time to onset and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Had the shot years ago, have shingles now/ Suspected vaccination failure; Have shingles now; These are 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, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not recovered/not 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 had the shot years ago but had shingles now. The reporter advised to get the shot as these shingles were so painful. 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. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got shingles shot then got a mild case 3 mos later/Suspected vaccination failure; Got a mild case, it was horrible; 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 months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   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 Shingle shot then got a mild case of shingles 3 months later. The patient reported that it was mild and had been still horrible. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had them after I had 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 provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had them (shingles) after received the Shingles shot. The patient stated they just was not as bad. The follow-up could not be possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation regarding shingles were unknown at the time of reporting.
Age: 13.0
Sex: F
Vaccine: FLU4
Symptoms: Accidental exposure to product, Exposure via skin contact, Incorrect dose administered, Injection site extravasation
Clinical narrative: didn't receive full dose; it leaked through the arm; it leaked through the arm; This case was reported by a nurse via call center representative and described the occurrence of incomplete dose administered in a 13-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number 93Z32, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 9th December 2021, the patient received Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. On 9th December 2021, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced incomplete dose administered, inadvertent exposure to vaccine and exposure via skin contact. On an unknown date, the outcome of the incomplete dose administered, inadvertent exposure to vaccine and exposure via skin contact 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 as follows: The patient did not receive full dose of Fluarix since it leaked through the arm while another nurse was administering it, which led to incomplete dose administered, inadvertent exposure to vaccine and exposure via skin contact. The reporter confirmed that, this was maladministration by the other nurse since she was new at given injections. The syringe was intact. The reporter consented to follow up.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Burning sensation, Chills, Erythema, Fatigue
Clinical narrative: redness in her chest area; Dry heaves; Felt weak; Nausea; Fatigue; Burning sensation; Sweats; Chills; 100 degree fever; Body aches /  stabbing pain in right rib area; Headache; pain around her eye; stabbing pain in right rib area that shot across her chest; stabbing pain in right rib area that shot across her chest; This case was reported by a consumer via call center representative and described the occurrence of localized erythema in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in August 2021). Concurrent medical conditions included hashimoto's disease. Concomitant products included levothyroxine.   In December 2021, the patient received the 2nd dose of Shingrix. In December 2021, less than 2 weeks after receiving Shingrix, the patient experienced localized erythema, dry heaves, feelings of weakness, nausea, fatigue, burning sensation, sweating, chills, fever, general body pain, headache, periorbital pain, chest pain and rib pain. On an unknown date, the outcome of the localized erythema, dry heaves, feelings of weakness, nausea, fatigue, burning sensation, sweating, chills, fever, general body pain, headache, periorbital pain, chest pain and rib pain were recovered/resolved.   It was unknown if the reporter considered the localized erythema, dry heaves, feelings of weakness, nausea, fatigue, burning sensation, sweating, chills, fever, general body pain, headache, periorbital pain, chest pain and rib pain to be related to Shingrix.  Additional details were provided as follows: The case was self reported by the patient. The reporter stated that, she received her second dose of the Shingrix vaccine one day last week from the day of reporting and experienced pain around her eye, a headache, body aches, a 100 degree fever, chills, sweats, burning sensation, fatigue, nausea, felt weak, stabbing pain in right rib area that shot across her chest, dry heaves, and redness in her chest area. The patient had a history of Hashimoto's disease and was taking Levothyroxine 125 mcg to treat it. The reporter's adverse reactions subsided after 2 to 3 days.  The reporter was inquiring if what she experienced was an adverse reaction and was also inquiring about the recommendation to receive the Shingrix series again in 4 to 5 years.  The reporter inquired if she should report her adverse reactions to the pharmacy who administered her vaccine and spoke from the Shingrix frequently asked questions. Provided the medical advice disclaimer. The reporter was referred to the Healthcare professional. The reporter did not consent to follow up and also declined the permission to contact her Healthcare professional.