chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 21.0
Sex: F
Vaccine: HEP, COVID19, HEP
Symptoms: Hypoaesthesia, Injection site bruising, Injection site pain, Product administered at inappropriate site, Rotator cuff syndrome
Clinical narrative: ANAPHALATIC shock; Caller reports she developed right arm numbness after receiving RECOMBIVAX HB that lasted approximately one month.; Caller states she could not lift or move her arm or hold a pencil; she also experienced pain at the injection site and the area still "feels like a bruise" currently; she also experienced pain at the injection site and the area still "feels like a bruise" currently; This spontaneous report was received from a consumer, concerning to herself, an approximately 21-years-old female patient.  The patient's medical history was not reported. Her concurrent conditions included allergy to messenger RNA (MRNA) vaccines and egg protein allergy. The concomitant therapies were not reported.  On an unknown date in 2001, the patient received the first dose of hepatitis B vaccine (recombinant) (RECOMBIVAX HB) intramuscularly (IM) (dose, lot #, and expiry date not provided) as immunization from hepatitis B.  On an unknown date in 2001, the patient developed right arm numbness after the administration of the vaccine  (Hypoaesthesia), that lasted approximately one month. She stated that after she could not lift or move her arm or hold a pencil  (Injected limb mobility decreased). The patient was in the college at the time and had to have someone take class notes for her. She also experienced pain at the injection site and the area still "felt like a bruise" at that time. These symptoms happened after the administration of the vaccine. Furthermore, the patient reported that on an unknown date in 2021 (also reported as recently), she found out she was allergic to egg protein and had experienced anaphylactic (also reported as anaphalatic) shock by being close to people who had received Coronavirus disease (Covid) vaccine, and she was allergic to all MRNA vaccines. It was reported that at the moment of the administration of hepatitis B vaccine (RECOMBIVAX HB) (manufacturer unknown) she was not pregnant, but currently she was 4-month pregnant (Vaccine exposure before pregnancy, captured on report # 2204USA009974).  The action taken with hepatitis B vaccine (recombinant) (RECOMBIVAX HB) was reported as discontinued, since after the administration of the first dose of the vaccine the patient did not finish the vaccination series.  The causal assessment between the events and hepatitis B vaccine (RECOMBIVAX HB) (manufacturer unknown) was not provided.   Upon internal review, the event anaphylactic (also reported as anaphalatic) shock was determined to be medically significant.; Sender's Comments:  US-009507513-2204USA009974:
Age: 21.0
Sex: F
Vaccine: HEP, COVID19, HEP
Symptoms: Anaphylactic shock, Hypoaesthesia, Injected limb mobility decreased, Vaccination site bruising, Vaccination site pain
Clinical narrative: ANAPHALATIC shock; Caller reports she developed right arm numbness after receiving RECOMBIVAX HB that lasted approximately one month.; Caller states she could not lift or move her arm or hold a pencil; she also experienced pain at the injection site and the area still "feels like a bruise" currently; she also experienced pain at the injection site and the area still "feels like a bruise" currently; This spontaneous report was received from a consumer, concerning to herself, an approximately 21-years-old female patient.  The patient's medical history was not reported. Her concurrent conditions included allergy to messenger RNA (MRNA) vaccines and egg protein allergy. The concomitant therapies were not reported.  On an unknown date in 2001, the patient received the first dose of hepatitis B vaccine (recombinant) (RECOMBIVAX HB) intramuscularly (IM) (dose, lot #, and expiry date not provided) as immunization from hepatitis B.  On an unknown date in 2001, the patient developed right arm numbness after the administration of the vaccine  (Hypoaesthesia), that lasted approximately one month. She stated that after she could not lift or move her arm or hold a pencil  (Injected limb mobility decreased). The patient was in the college at the time and had to have someone take class notes for her. She also experienced pain at the injection site and the area still "felt like a bruise" at that time. These symptoms happened after the administration of the vaccine. Furthermore, the patient reported that on an unknown date in 2021 (also reported as recently), she found out she was allergic to egg protein and had experienced anaphylactic (also reported as anaphalatic) shock by being close to people who had received Coronavirus disease (Covid) vaccine, and she was allergic to all MRNA vaccines. It was reported that at the moment of the administration of hepatitis B vaccine (RECOMBIVAX HB) (manufacturer unknown) she was not pregnant, but currently she was 4-month pregnant (Vaccine exposure before pregnancy, captured on report # 2204USA009974).  The action taken with hepatitis B vaccine (recombinant) (RECOMBIVAX HB) was reported as discontinued, since after the administration of the first dose of the vaccine the patient did not finish the vaccination series.  The causal assessment between the events and hepatitis B vaccine (RECOMBIVAX HB) (manufacturer unknown) was not provided.   Upon internal review, the event anaphylactic (also reported as anaphalatic) shock was determined to be medically significant.; Sender's Comments:  US-009507513-2204USA009974:
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (the patient); program ID: (005570). A patient (no qualifiers provided) received the 1st, 2nd, 3rd and 4th dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown); all single dose, for COVID-19 immunization. Medical history and concomitant medications not reported. The patient experienced increased blood pressure, with outcome of unknown. Patient described, "I am experiencing an unusually high blood pressure since receiving my 2nd booster shot. I noticed increased blood pressure after the first dose and the 2nd dose and my 1 booster." Relevant laboratory tests and procedures available in the appropriate section. The information on the batch/lot number for BNT162B2 requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Blood pressure measurement
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (the patient); program ID: (005570). A patient (no qualifiers provided) received the 1st, 2nd, 3rd and 4th dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown); all single dose, for COVID-19 immunization. Medical history and concomitant medications not reported. The patient experienced increased blood pressure, with outcome of unknown. Patient described, "I am experiencing an unusually high blood pressure since receiving my 2nd booster shot. I noticed increased blood pressure after the first dose and the 2nd dose and my 1 booster." Relevant laboratory tests and procedures available in the appropriate section. The information on the batch/lot number for BNT162B2 requested and will be submitted if and when received.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Syncope, Urticaria, Vomiting
Clinical narrative: Broke out in a rash; fainted twice; threw up; face, hands, and feet swelled; blood pressure dropped; and developed fever of 100.4.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure decreased, Peripheral swelling, Pyrexia, Rash, Swelling face
Clinical narrative: Broke out in a rash; fainted twice; threw up; face, hands, and feet swelled; blood pressure dropped; and developed fever of 100.4.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Syncope, Vomiting
Clinical narrative: Broke out in a rash; fainted twice; threw up; face, hands, and feet swelled; blood pressure dropped; and developed fever of 100.4.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Immunisation reaction
Clinical narrative: Rash; Temperature of 98-99; Very fatigued; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash), PYREXIA (Temperature of 98-99) and FATIGUE (Very fatigued) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     Concurrent medical conditions included Migraine, Immunocompromised and CLL (Immunocompromised with CLL, a type of leukemia). Concomitant products included BUSPIRONE HYDROCHLORIDE (BUSPAR) for Migraine, ESTRADIOL for an unknown indication.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Rash), PYREXIA (Temperature of 98-99) and FATIGUE (Very fatigued). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, RASH (Rash), PYREXIA (Temperature of 98-99) and FATIGUE (Very fatigued) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 98-99 98-99.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       It was reported that the adverse events lasted for a week and a half.   This case was linked to MOD-2022-550746, MOD-2022-550747, MOD-2022-550751 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Body temperature, Fatigue, Pyrexia, Rash
Clinical narrative: Rash; Temperature of 98-99; Very fatigued; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash), PYREXIA (Temperature of 98-99) and FATIGUE (Very fatigued) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     Concurrent medical conditions included Migraine, Immunocompromised and CLL (Immunocompromised with CLL, a type of leukemia). Concomitant products included BUSPIRONE HYDROCHLORIDE (BUSPAR) for Migraine, ESTRADIOL for an unknown indication.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Rash), PYREXIA (Temperature of 98-99) and FATIGUE (Very fatigued). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, RASH (Rash), PYREXIA (Temperature of 98-99) and FATIGUE (Very fatigued) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 98-99 98-99.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       It was reported that the adverse events lasted for a week and a half.   This case was linked to MOD-2022-550746, MOD-2022-550747, MOD-2022-550751 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Chills, Erythema, Fatigue, Headache, Insomnia
Clinical narrative: Rash; Temperature of 98-99; Very fatigued; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash), PYREXIA (Temperature of 98-99) and FATIGUE (Very fatigued) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     Concurrent medical conditions included Migraine, Immunocompromised and CLL (Immunocompromised with CLL, a type of leukemia). Concomitant products included BUSPIRONE HYDROCHLORIDE (BUSPAR) for Migraine, ESTRADIOL for an unknown indication.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Rash), PYREXIA (Temperature of 98-99) and FATIGUE (Very fatigued). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, RASH (Rash), PYREXIA (Temperature of 98-99) and FATIGUE (Very fatigued) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 98-99 98-99.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       It was reported that the adverse events lasted for a week and a half.   This case was linked to MOD-2022-550746, MOD-2022-550747, MOD-2022-550751 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Pruritus, Sensitive skin, Skin reaction, Somnolence
Clinical narrative: Rash; Temperature of 98-99; Very fatigued; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash), PYREXIA (Temperature of 98-99) and FATIGUE (Very fatigued) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     Concurrent medical conditions included Migraine, Immunocompromised and CLL (Immunocompromised with CLL, a type of leukemia). Concomitant products included BUSPIRONE HYDROCHLORIDE (BUSPAR) for Migraine, ESTRADIOL for an unknown indication.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Rash), PYREXIA (Temperature of 98-99) and FATIGUE (Very fatigued). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, RASH (Rash), PYREXIA (Temperature of 98-99) and FATIGUE (Very fatigued) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 98-99 98-99.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       It was reported that the adverse events lasted for a week and a half.   This case was linked to MOD-2022-550746, MOD-2022-550747, MOD-2022-550751 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Accidental underdose, Somnolence
Clinical narrative: Rash; Temperature of 98-99; Very fatigued; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash), PYREXIA (Temperature of 98-99) and FATIGUE (Very fatigued) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     Concurrent medical conditions included Migraine, Immunocompromised and CLL (Immunocompromised with CLL, a type of leukemia). Concomitant products included BUSPIRONE HYDROCHLORIDE (BUSPAR) for Migraine, ESTRADIOL for an unknown indication.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Rash), PYREXIA (Temperature of 98-99) and FATIGUE (Very fatigued). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, RASH (Rash), PYREXIA (Temperature of 98-99) and FATIGUE (Very fatigued) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 98-99 98-99.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       It was reported that the adverse events lasted for a week and a half.   This case was linked to MOD-2022-550746, MOD-2022-550747, MOD-2022-550751 (Patient Link).
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune hepatitis, Hepatitis acute, Laboratory test, Stent placement
Clinical narrative: Acute hepatits which led to a four day stint in the hospital and an eventual diagnosis of autoimmune hepatitis.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Endometriosis, Hysterectomy, Pain, Uterine leiomyoma
Clinical narrative: I was hospitalized for a week in severe pain. My existing diseases worsened and I had to get a hysterectomy
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: BUD was 01-Nov-2021 but the vaccine was administered on 25-01-2022; Stored Moderna vaccine in their refrigerator and administered past the BUD date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (BUD was 01-Nov-2021 but the vaccine was administered on 25-01-2022) and PRODUCT STORAGE ERROR (Stored Moderna vaccine in their refrigerator and administered past the BUD date) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (BUD was 01-Nov-2021 but the vaccine was administered on 25-01-2022) and PRODUCT STORAGE ERROR (Stored Moderna vaccine in their refrigerator and administered past the BUD date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (BUD was 01-Nov-2021 but the vaccine was administered on 25-01-2022) and PRODUCT STORAGE ERROR (Stored Moderna vaccine in their refrigerator and administered past the BUD date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment medication reported.  CDC Expiration date was reported as 19 Mar 2022. It was reported that One of the providers was storing their Moderna vaccine in their refrigerator and administering past the BUD date. The administrations have been summarized by date, lot and BUD date was reported as 01 Nov 2021.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Physician). A 40-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 40 years for Covid-19 immunisation; CoviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history included: "Systemic lupus erythematosus" (unspecified if ongoing). Concomitant medication(s) included: RINVOQ oral; PLAQUENIL [HYDROXYCHLOROQUINE SULFATE] oral. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2022, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of Covid-19. Clinical Course: Treatment start date, on 26Apr2022 and stop date 26Apr2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the drug ineffective (LOE) cannot be ruled out.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event, Product preparation error
Clinical narrative: No additional AE information/ What was the patient's response? Well tolerated; Clinical supervisor calling to inquire about safety of dose of VARIVAX that expired 24MAR2022 that was administered to patient; Indicate at which point in the process the medication error occurred: Preparation for Administration; This spontaneous report was received from a physician and the clinical supervisor referring to a 1-year-old male patient. The patient's pertinent medical history, drug reactions, allergies, and concomitant medications were not reported.   On 28-MAR-2022, a medication error occurred in preparation for administration of varicella virus vaccine live (oka/merck) (VARIVAX) (product preparation error). Therefore, the first 0.5 milliliters (ml) dose (valid lot number T010313, expiration date 24-MAR-2022) was administered subcutaneously (once) for prophylaxis to the patient (expired product administered) by a healthcare professional. The product did not undergo any temperature excursions.   No additional adverse events (AE); the patient well-tolerated varicella virus vaccine live (oka/merck) (VARIVAX).
Age: 40.0
Sex: F
Vaccine: COVID19, HEPA, UNK
Symptoms: No adverse event, Product use issue, Underdose
Clinical narrative: No additional AEs were reported; patient received less than the recommended dose of VAQTA.  An adult received a pediatric dose of VAQTA on 3/1/2022.   No additional AEs were reported, no further information provided.; An adult received a pediatric dose of VAQTA on 3/1/2022.; This spontaneous report, received from an HCP, refers to a 40-year-old female patient. The patient's concurrent conditions included neck pain, migraine, fibromyalgia, and general symptoms. Concomitant therapies and medical history were not reported.  On 01-MAR-2022, a medication error occurred in the dispensing process; the patient was vaccinated, by a trained healthcare professional, with a pediatric dose of hepatitis a vaccine, inactivated (VAQTA) 0.5 milliliters/one time, lot #U003450, expiration date: 02-MAY-2022, administered intramuscularly in the left arm for prophylaxis, with hepatitis b vaccine (HEPATITIS-B), lot #4345R, expiration date: 11-AUG-2023, administered intramuscularly (strenght, formulation, and indication were not provided); and coronavirus disease vaccine 2019 (COVID-19), lot #FK9894, expiration date: 30-Apr-2022 (strenght, formulation, route of administration, and indication were not provided). It was stated that the vaccine was not used in accordance with the instruction leaflet. The vaccine was not available for return or evaluation as it had been administered. The vaccination error was reported to the physician and manufacturer. No other adverse events were reported.
Sex: F
Vaccine: RV5
Symptoms: Frequent bowel movements, Intentional dose omission
Clinical narrative: they had a Baptism to go to this weekend and she wanted to wait to give the patient the dose she was supposed to receive today; after the patient received her first dose of ROTATEQ,  she had more frequent bowel movements; This spontaneous report was received from a registered nurse referring to a 4-month-old female patient. The patient's pertinent medical history, drug reactions, allergies, and concomitant medications were not reported.  On 28-JAN-2022, the patient received the first (1st) dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) to prevent rotavirus (dose, vaccination scheme, lot number, and expiration date were not reported).  On an unspecified subsequent date in 2022, after receiving her 1st dose, the patient had more frequent bowel movements.   According to the nurse, the patient's mother stated they had a baptism to go to over the weekend; therefore, she wanted to wait to give the patient the second dose that was supposed to be received on 01-APR-2022 (intentional dose omission).   The patient's outcome from frequent bowel movements was not reported.   The registered nurse causal relationship assessment between frequent bowel movements and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was not reported.
Age: 1.25
Sex: U
Vaccine: HEPA, HEPA
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient had no symptoms or adverse effects from administration of vaccine.; patient received two doses of VAQTA at less than minimum interval; This spontaneous report was received from a nurse and refers to a 15-month-old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On 14-MAR-2022, the patient was vaccinated with a dose of hepatitis a vaccine, inactivated (VAQTA) first dose (strength, dose, lot #, expiration date, and route of administration were not provided) for prophylaxis. On 11-APR-2022, the patient was vaccinated with a dose of hepatitis a vaccine, inactivated (VAQTA) second dose, 0.5 milliliter, lot #U012007, expiration date: 18-JAN-2023 (strength, and route of administration were not provided) for prophylaxis (Inappropriate schedule of product administration). No adverse events were reported (No adverse event).
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Dizziness, Erythema, Incomplete course of vaccination, Nausea
Clinical narrative: nausea; dizziness; Would the second shot now do any good?; red arm; This case was reported by a consumer via interactive digital media and described the occurrence of erythema of extremities in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 16th September 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced erythema of extremities, nausea, dizziness and incomplete course of vaccination. On an unknown date, the outcome of the erythema of extremities was recovered/resolved and the outcome of the nausea, dizziness and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the erythema of extremities, nausea and dizziness to be related to Shingrix.     Additional Information: GSK Receipt Date: 20-APR-2022  Reporter's Comments: This case was received from the patient via interactive digital media. The patient had the first Shingrix shot and had a red arm for a week, nausea and dizziness.  The patient asked would the second shot now do any good. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Burning sensation, Immediate post-injection reaction, Rash, Rash vesicular
Clinical narrative: severe burning, on face from eye to jawbone, over chest to groin; severe rash, on face from eye to jawbone, over chest to groin/painful, over chest to groin; had what looked like chicken pox, on side that was injected; This case was reported by a consumer via interactive digital media and described the occurrence of burning sensation in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included chickenpox (Family History) (patient's kids had it).   On an unknown date, the patient received Shingles vaccine. On an unknown date, immediately after receiving Shingles vaccine, the patient experienced burning sensation, painful rash and vesicular rash. On an unknown date, the outcome of the burning sensation, painful rash and vesicular rash were unknown.   It was unknown if the reporter considered the burning sensation, painful rash and vesicular rash to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 20-APR-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient received dose of Shingles vaccine and immediately after the shot he/she got a severe burning rash on his/her face from his/her eye to his/her jawbone.  The patient had other burning painful rashes over his/her chest to his/her groin area. The patient also had what looked like chicken pox spots interspersed. These were only on the side that he/she was injected on. The nurse that injected he/she told him/her the same thing. Since his/her kids had it he/she had been exposed & needed the shot. The patient thought most people who take the shot had no problems. However, this was what happened to him/her. Additional supportive information: The follow-up would not possible, as no contact, details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Rash, Skin exfoliation
Clinical narrative: Hand skin rash; Hand skin peeling; This case was reported by a consumer via interactive digital media and described the occurrence of hand rash in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th March 2022, the patient received Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced hand rash and skin peeling. On an unknown date, the outcome of the hand rash and skin peeling were unknown.   It was unknown if the reporter considered the hand rash and skin peeling to be related to Shingrix.     Additional Information: GSK Receipt Date: 21-Apr-2022 Reporter's comments: This case was received from Shingrix. This case was reported by the patient. The patient received Shingrix and since developed hand skin rash with peeling. The patient asked if this could be related to Shingrix or not.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: bouts of shooting pain in my thing; This case was reported by a consumer via interactive digital media and described the occurrence of shooting pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shooting pain. On an unknown date, the outcome of the shooting pain was unknown.   It was unknown if the reporter considered the shooting pain to be related to Shingles vaccine.     Additional Information: GSK receipt date: 21-Apr-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient self reported this case. The patient had not broken out but had terrible bouts of shooting pain in his/her thing, mainly early morning. The patient had all the shots but could not image what else it could be. Additional Supportive Information: The follow-up could not be possible as no contact details were available.
Age: 55.0
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: Got the first dose the injection made me so sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a 57-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had in 30s).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     Additional Information: GSK receipt date: 22-APR-2022 Reporter's comments: This case was reported by a consumer via interactive digital media. The patient got the first shot, the injection made him/her so sick that the patient never got the 2nd one. It was horrible. Additional Supportive Information: Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Nasopharyngitis, Pain, Pyrexia
Clinical narrative: Gave me flu like symptoms; Achy all over; Fever; Cold chills; Cold chills; 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 20th April 2022, the patient received the 1st dose of Shingles vaccine. In April 2022, less than a week after receiving Shingles vaccine, the patient experienced influenza-like symptoms, general body pain, fever, chills and cold. On an unknown date, the outcome of the influenza-like symptoms, general body pain, fever, chills and cold were unknown.   It was unknown if the reporter considered the influenza-like symptoms, general body pain, fever, chills and cold to be related to Shingles vaccine.     Additional Information: GSK receipt date: 22-APR-2022 Reporter's comments: This case was reported by a patient via interactive digital media. The patient got the first shingles vaccine 2 days prior to the reporting. The patient experienced flu like symptoms, achy all over, cold chills and fever Additional Supportive Information: Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Burning sensation, Discomfort, Herpes zoster, Pain
Clinical narrative: Getting over second bout of Shingles in 3 yrs/ Suspected vaccination failure; Getting over second bout of Shingles in 3 yrs; Burning; Itching; Pain; Discomfort; Rash starts to blister; Rash starts to blister; This case was reported by a consumer via interactive digital media and described the occurrence of 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, burning sensation, pruritus, pain, discomfort, rash and blister. On an unknown date, the outcome of the vaccination failure, shingles, burning sensation, pruritus, pain and discomfort were unknown and the outcome of the rash and blister were recovering/resolving.   It was unknown if the reporter considered the vaccination failure, shingles, burning sensation, pruritus, pain, discomfort, rash and blister to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 23-APR-2022 Reporter's comment: This case was reported by the patient via interactive digital media. The patient had the Shingles vaccine and was just getting over second bout of Shingles in 3 years. Burning and itching and pain were the pain discomforts. Once the rash starts to blister it starts getting better. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Vaccination failure
Clinical narrative: Getting over second bout of Shingles in 3 yrs/ Suspected vaccination failure; Getting over second bout of Shingles in 3 yrs; Burning; Itching; Pain; Discomfort; Rash starts to blister; Rash starts to blister; This case was reported by a consumer via interactive digital media and described the occurrence of 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, burning sensation, pruritus, pain, discomfort, rash and blister. On an unknown date, the outcome of the vaccination failure, shingles, burning sensation, pruritus, pain and discomfort were unknown and the outcome of the rash and blister were recovering/resolving.   It was unknown if the reporter considered the vaccination failure, shingles, burning sensation, pruritus, pain, discomfort, rash and blister to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 23-APR-2022 Reporter's comment: This case was reported by the patient via interactive digital media. The patient had the Shingles vaccine and was just getting over second bout of Shingles in 3 years. Burning and itching and pain were the pain discomforts. Once the rash starts to blister it starts getting better. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Got the shot, then got it three more times/Suspected vaccination failure; got it three more times; So painful; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (The patient got the shot after his/her first bout with shingles).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 24-APR-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient got the shot after his/her first bout with shingles.  Then got it three more times shingles.  The patient stated that anyone could get it inside and it was so painful. The patient further stated that it was life changing and it never seemed to go away. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure.; I got the shot and got the shingles.; This case was reported by a consumer via interactive digital media and described the occurrence of 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 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 Information: GSK Receipt Date: 24-APR-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient got the shot and got the shingles. It had been 2 years and patient was fighting them. Additional supportive information: 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. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had two reoccurrences since the vaccines/Suspected vaccination failure; Had two reocurrences; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (the patient had shingles off and on for about 12 years).   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional Information: GSK Receipt Date: 24-APR-2022 Reporter's Comment: This case was reported by the patient via interactive digital media. The patient took both Shingrix shots and had two reoccurrences since the vaccines. Additional supportive information: This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming 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 a shingle vaccine years ago. It didn't work/suspected vaccination failure; got a shingle vaccine years ago. It didn't work; This case was reported by a consumer via interactive digital media and described the occurrence of 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. The patient was treated with acyclovir. 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.     Linked case(s) involving the same patient:  US2022AMR070612   Additional Information: GSK receipt date: 25-Apr-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient got a shingle vaccine years ago from reporting and it did not work. The patient's friend told him/her about acyclovir and that worked. The patient stated that when you felt shingles coming on took an acyclovir 2 times a day for a couple of days and you would not break out with the shingles. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up could not be possible as no contact details were available. The case was linked with case US2022AMR070612, reported by same reporter for different product.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR070612:same patient
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I had shingles injection years back and now have shingles/Suspected vaccination failure; I had shingles injection years back and now have shingles; This case was reported by a consumer via interactive digital media and described the occurrence of 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, several years 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 Information: GSK Receipt Date: 25-APR-2022  Reporter's Comments: This case was received from the patient via interactive digital media. The patient had Shingles injection years back from reporting and now had shingles. The patient asked that why he/she was not protected. Additional Supportive Information: This case described the occurrence of suspected vaccination failure. 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. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: three patients were administered with only the adjuvant part of Shingrix; three patients were administered with only the adjuvant part of Shingrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) (batch number M397F, expiry date 23rd April 2023) 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 Information: GSK Receipt Date: 20-APR-2022 Reporter's Comments: A medical assistant reported that the patient was administered with only the adjuvant part of Shingrix. The medical assistant discovered the error but she could not provide any details about the patient administered with a partial dose because that information was still not available. There were 3 patients who received only adjuvant part out of total 10 patients. This last situation made that all the patient would be revaccinated, and considering this, 7 patients would receive a third dose of Shingrix. The reporter consented to follow up. Additional Supportive Information: The patient was administered with only the adjuvant part of Shingrix, which led to Inappropriate preparation of medication and inappropriate dose of vaccine administered. The case is one of 4 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR067807:same reporter US-GLAXOSMITHKLINE-US2022AMR071124:same reporter US-GLAXOSMITHKLINE-US2022067585:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: three patients were administered with only the adjuvant part of Shingrix; three patients were administered with only the adjuvant part of Shingrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) (batch number M397F, expiry date 23rd April 2023) 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 Information: GSK Receipt Date: 20-APR-2022 Reporter's Comments: A medical assistant reported that the patient was administered with only the adjuvant part of Shingrix. The medical assistant discovered the error but she could not provide any details about the patient administered with a partial dose because that information was still not available. There were 3 patients who received only adjuvant part out of total 10 patients. This last situation made that all the patient would be revaccinated, and considering this, 7 patients would receive a third dose of Shingrix. The reporter consented to follow up. Additional Supportive Information: The patient was administered with only the adjuvant part of Shingrix, which led to Inappropriate preparation of medication and inappropriate dose of vaccine administered. The case is one of 4 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR067807:same reporter US-GLAXOSMITHKLINE-US2022AMR071123:same reporter US-GLAXOSMITHKLINE-US2022067585:same reporter