chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No other AE or PQC reported; a temperature excursion happened/unsure if ROT ATEQ and VAQTA had been administered since the excursion occurred; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.      On 05-NOV-2021, rotavirus vaccine, live, oral, pentavalent (ROTATEQ) experienced temperature excursion. On 09-NOV-2021, the patient was vaccinated with the improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (1 time dose, lot # 1742078, expiration date 06-JUL-2022; strength and dose were not reported) orally for prophylaxis (product storage error). Current temperature excursion was 47.1 Fahrenheit degrees for 36 minutes. There was no previous temperature excursion. No other adverse event (AE) or product quality complaint (PQC) was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2112USA000877: US-009507513-2112USA000883: US-009507513-2111USA005243: US-009507513-2112USA000879:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No other AE or PQC reported; a temperature excursion happened/unsure if ROT ATEQ and VAQTA had been administered since the excursion occurred; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.      On 05-NOV-2021, rotavirus vaccine, live, oral, pentavalent (ROTATEQ) experienced temperature excursion. On 10-NOV-2021, the patient was vaccinated with the improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (1 time dose, lot # 1742078, expiration date 06-JUL-2022; strength was not reported) orally for prophylaxis (product storage error). Current temperature excursion was 47.1 Fahrenheit degrees for 36 minutes. There was no previous temperature excursion. No other adverse event (AE) or product quality complaint (PQC) was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2112USA000877: US-009507513-2112USA000882: US-009507513-2111USA005243: US-009507513-2112USA000879:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Product was administered to patient after an excursion; This spontaneous report was received from an office manager referring to a patient of unknown age and gender. Patient's concurrent conditions, medical history and concomitant medications were not provided.       On 29-NOV-2021 the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine Live recombinant human albumin (rHA)(PROQUAD) (lot # U015479 expiration date reported 13-NOV-2022) after an excursion for prophylaxis (product storage error).   The temperature of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was stored had been between 14F to 46F (31.8F) for 5 hours 30 minutes for lot U015479. There was previous temperature excursion. No additional adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2112USA001242:
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/PQC information; a dose of ROTATEQ was administered to a patient after undergoing a temperature excursion; This spontaneous report was received from a medical assistant and refers to a 4-months-old patient of unknown gender. There was no information about the patient's pertinent medical history, drug reactions, allergies and concomitant medications.   On 01-DEC-2021, the patient was vaccinated with an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 1 time dose, 0.5 ml, route defaulted to oral, lot # 1742428, has been confirmed to be a valid lot #, expiration date 01-SEP-2022) (route of administration and anatomical location were not provided), for prophylaxis. Administered dose of vaccine experienced temperature excursion of 50 degrees Fahrenheit for 5 minutes. There was no adverse event reported. There were no previous excursions reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2112USA001112:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received regarding a case in litigation from a lawyer and referred to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In or around 2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route, lot# and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms had resulted in physical limitations not present prior to using the product. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacturer, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event shingles was considered as not recovered. The causality assessment between the event and zoster vaccine live (ZOSTAVAX) was considered as related by the lawyer.    The lawyer considered the event shingles to be disability.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Contusion, Erythema, Injection site pain, Injection site swelling
Clinical narrative: cellulitis; injection site swelling; injection site pain; redness down to their elbow; arme swelling; bruise; arm pain; Information has been received from a 65 year old female patient, referring on herself. The patient's medical history and  concurrent conditions included drug reactions/ allergies to tetanus vaccine, penicillin, tramadol and codeine. As  concomitant therapies were reported unspecified medications.  On 28-NOV-2021 at 2:00 pm, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (dose, anatomical location, administration route, lot number and expiration ate were not reported) for prophylaxis.       On the same date, shortly after the vaccination, the patient experienced a "huge" swelling in the injection site with pain. The night of the 28-NOV-2021, the patient noticed redness down to their elbow that began to spread to their fingertips. She said that it looked similar to cellulitis. The patient reported swelling increased 3 times the size from prior to injection and the redness subsided last night on 01-DEC-2021. The color was now "rust with some gray/green , similar to a bruise". She stated there was still a lot of pain from their shoulder to forearm, but swelling has improved 80%.  The outcome of cellulitis, pain in extremity, contusion, peripheral swelling, erythema, injection site pain and injection site swelling was reported as recovering.        The casuality assessment between the vaccination with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) and cellulitis, pain in extremity, contusion, peripheral swelling, erythema, injection site pain and injection site swelling were not provided.  Upon internal review, the cellulitis was considered as a medically significant event.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Skin discolouration
Clinical narrative: cellulitis; injection site swelling; injection site pain; redness down to their elbow; arme swelling; bruise; arm pain; Information has been received from a 65 year old female patient, referring on herself. The patient's medical history and  concurrent conditions included drug reactions/ allergies to tetanus vaccine, penicillin, tramadol and codeine. As  concomitant therapies were reported unspecified medications.  On 28-NOV-2021 at 2:00 pm, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (dose, anatomical location, administration route, lot number and expiration ate were not reported) for prophylaxis.       On the same date, shortly after the vaccination, the patient experienced a "huge" swelling in the injection site with pain. The night of the 28-NOV-2021, the patient noticed redness down to their elbow that began to spread to their fingertips. She said that it looked similar to cellulitis. The patient reported swelling increased 3 times the size from prior to injection and the redness subsided last night on 01-DEC-2021. The color was now "rust with some gray/green , similar to a bruise". She stated there was still a lot of pain from their shoulder to forearm, but swelling has improved 80%.  The outcome of cellulitis, pain in extremity, contusion, peripheral swelling, erythema, injection site pain and injection site swelling was reported as recovering.        The casuality assessment between the vaccination with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) and cellulitis, pain in extremity, contusion, peripheral swelling, erythema, injection site pain and injection site swelling were not provided.  Upon internal review, the cellulitis was considered as a medically significant event.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No other AE; ROTATEQ was administered to patients after the excursion occurred; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 08-NOV-2021, the patient was vaccinated with dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 1 time dose, lot # 1742081, expiration date 18-JUL-2022 (exact dose, route of administration, anatomical location were not reported) for prophylaxis.  Administered dose of vaccine has been stored in the temperature of 35.0 degrees Fahrenheit (°F), 35.1 F, 35.3 F, 35.2 F, 34.9 F for 53 minutes (cumulative). There were no previous temperature excursions reported. No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2112USA001754: US-009507513-2112USA001755: US-009507513-2111USA004488:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No other AE; ROTATEQ was administered to patients after the excursion occurred; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 02-NOV-2021 , the patient was vaccinated with dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 1 time dose, lot # 1742081, expiration date 18-JUL-2022 (exact dose, route of administration, anatomical location were not reported) for prophylaxis.  Administered dose of vaccine has been stored in the temperature of 35.0 degrees Fahrenheit (°F), 35.1 F, 35.3 F, 35.2 F, 34.9 F for 53 minutes (cumulative). There were no previous temperature excursions reported. No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2112USA001753: US-009507513-2111USA004488: US-009507513-2112USA001755:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No other AE; ROTATEQ was administered to patients after the excursion occurred; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 01-NOV-2021, the patient was vaccinated with dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 1 time dose, lot # 1742081, expiration date 18-JUL-2022 (exact dose, route of administration, anatomical location were not reported) for prophylaxis.  Administered dose of vaccine has been stored in the temperature of 35.0 degrees Fahrenheit (°F), 35.1 F, 35.3 F, 35.2 F, 34.9 F for 53 minutes (cumulative). There were no previous temperature excursions reported. No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2112USA001753: US-009507513-2111USA004488: US-009507513-2112USA001754:
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary thrombosis
Clinical narrative: blood clots in lungs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from License Party. The reporter is the patient. Other Case identifier(s): US-BRISTOL-MYERS SQUIBB COMPANY-BMS-2021-125941 (Bristol-Myers Squibb Company).  This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY THROMBOSIS (blood clots in lungs) in female patient of an unknown age who received apixaban (Eliquis) for Cerebrovascular accident prophylaxis. CO-SUSPECT PRODUCTS included Covid-19 Vaccine for COVID-19. On an unknown date, the patient started Eliquis (unknown route) and Covid-19 Vaccine (unknown route). On an unknown date, the patient experienced PULMONARY THROMBOSIS (seriousness criteria hospitalization and medically significant). The patient was treated with Heparin for Pulmonary thrombosis. The action taken with Eliquis(Unknown) was unknown. At the time of the report, PULMONARY THROMBOSIS outcome was unknown. The patient received apixaban for prophylaxis stroke (atrial fibrillation). The patient inquired that if it was safe to take the Covid 19 vaccine with Eliquis. She reported that she had been on Eliquis for at least 2 years or may be 3 because she did not want to deal with the lab work which she later stated was associated with warfarin. She had received both Covid 19 injections and after that within a month she had blood clots in his lungs. The patient stated that she was sick for 4 days in bed and that she could not get enough oxygen. She was taking Eliquis for afib, that she began to get worse all the sudden and her daughter had to call an ambulance for her and was hospitalized for 6 days, placed on a Heparin drip. The patient stated that she never had any problems before with Eliquis that she began this medication because with warfarin there was a time issue and she was frequently having to get stuck. She said that she had to wonder because the blood clots in the lungs came on so suddenly after 2 years of successful use with Eliquis if there was any correlation or association with the use of Eliquis with the Covid 19 vaccine. She mentioned that Eliquis has a 99.9% success rate in doing what is needed for patients, and that she wanted to know why this happened all of the sudden when she had experienced no problems before. For Eliquis(Unknown), the reporter did not provide any causality assessments.  Causality Assessments: Drug = ELIQUIS Event = Thrombosis pulmonary Per Reporter = No Information Per Company (Bristol-Myers Squibb) = Not Related.  Apixaban (ELIQUIS) is under agreement with Bristol-Myers Squibb.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: This patient had pulmonary thrombosis after receiving apixaban therapy and COVID-19 vaccine. Based on the limited information available regarding event details with relevant medical history and therapy details, it cannot be ascertained with reasonable possibility that apixaban contributed to the reported event.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B
Clinical narrative: A primary care physician reported that a patient (age, gender, race and ethnicity not provided) who "was just not responding to Engerix" a year ago received HEPLISAV-B (Hepatitis B vaccine) for Hepatitis B immunization and the patient responded after just one dose of HEPLISAV-B. Medical history was reported as immunocompromised. The patient was reported to have tried different vaccines previously 3 times without success; it was not very clear whether it was 3 doses or 3 series, but with different vaccines, likely 3 series. No relevant concomitant medications were reported. On an unspecified date, the patient received the first dose of HEPLISAV-B (Lot #, expiration date and NDC # not reported) through an unknown route and site. On an unspecified date, after having been vaccinated with HEPLISAV-B, the patient was reported to have responded after just one dose of HEPLISAV-B. No additional information was reported. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: M
Vaccine: COVID19, UNK, VARZOS
Symptoms: Body temperature, Chills, Cough, Dysgeusia, Headache
Clinical narrative: Got sick, Flu like symptoms; Fever 101.4 F; Chills; General body pain; Sore throat; Headache; Metalic taste in mouth; Cough; Runny nose; This case was reported by a consumer via other manufacturer and described the occurrence of influenza-like symptoms in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included INFLUENZA VIRUS VACCINE INACTIVATED (FLUZONE HIGH-DOSE QUADRIVALENT INFLUENZA VACCINE) for prophylaxis and COVID-19 VACCINE MRNA (MRNA 1273) (COVID-19 VACCINE MODERNA) for prophylaxis.   On an unknown date, the patient received Shingrix. On 1st September 2021, the patient received FLUZONE HIGH-DOSE QUADRIVALENT INFLUENZA VACCINE .7 ml. In September 2021, the patient received COVID-19 VACCINE MODERNA. On an unknown date, unknown after receiving Shingrix and an unknown time after receiving COVID-19 VACCINE MODERNA, the patient experienced influenza-like symptoms, fever, chills, general body pain, sore throat, headache, taste metallic, cough and runny nose. On an unknown date, the outcome of the influenza-like symptoms, sore throat and headache were unknown and the outcome of the fever, chills, general body pain, taste metallic, cough and runny nose were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, fever, chills, general body pain, sore throat, headache, taste metallic, cough and runny nose to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient's medical history, past medical treatment, vaccination, concomitant medications and family history were not provided. On 1st September 2021, the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE. On an unknown date, patient received Shingrix. The patient got sick with flu like symptoms, metallic taste in his mouth,  body aches, chills, 101.4 degrees fever, cough, runny nose, sore throat and headache three weeks after getting the shot on 1st  September 2021, less than 36 hours after giving my Covid-19 booster. Other relevant laboratory test not reported. It was not reported if the patient received any corrective treatment for the events.
Sex: M
Vaccine: COVID19, UNK, VARZOS
Symptoms: Influenza like illness, Oropharyngeal pain, Pain, Pyrexia, Rhinorrhoea
Clinical narrative: Got sick, Flu like symptoms; Fever 101.4 F; Chills; General body pain; Sore throat; Headache; Metalic taste in mouth; Cough; Runny nose; This case was reported by a consumer via other manufacturer and described the occurrence of influenza-like symptoms in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included INFLUENZA VIRUS VACCINE INACTIVATED (FLUZONE HIGH-DOSE QUADRIVALENT INFLUENZA VACCINE) for prophylaxis and COVID-19 VACCINE MRNA (MRNA 1273) (COVID-19 VACCINE MODERNA) for prophylaxis.   On an unknown date, the patient received Shingrix. On 1st September 2021, the patient received FLUZONE HIGH-DOSE QUADRIVALENT INFLUENZA VACCINE .7 ml. In September 2021, the patient received COVID-19 VACCINE MODERNA. On an unknown date, unknown after receiving Shingrix and an unknown time after receiving COVID-19 VACCINE MODERNA, the patient experienced influenza-like symptoms, fever, chills, general body pain, sore throat, headache, taste metallic, cough and runny nose. On an unknown date, the outcome of the influenza-like symptoms, sore throat and headache were unknown and the outcome of the fever, chills, general body pain, taste metallic, cough and runny nose were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, fever, chills, general body pain, sore throat, headache, taste metallic, cough and runny nose to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient's medical history, past medical treatment, vaccination, concomitant medications and family history were not provided. On 1st September 2021, the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE. On an unknown date, patient received Shingrix. The patient got sick with flu like symptoms, metallic taste in his mouth,  body aches, chills, 101.4 degrees fever, cough, runny nose, sore throat and headache three weeks after getting the shot on 1st  September 2021, less than 36 hours after giving my Covid-19 booster. Other relevant laboratory test not reported. It was not reported if the patient received any corrective treatment for the events.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose a year after his first; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 1 year ago on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The reporter was the patient's wife. The age at vaccination was not reported. The reporter stated that, the patient received 2nd dose of Shingrix 1 year after received 1st dose of Shingrix, which led to lengthening of vaccination schedule. The reporter asked if the patient should get a 3rd dose 2 to 6 months after 2nd dose.
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Illness
Clinical narrative: sick as a dog; headache; This case was reported by a consumer via media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 26th November 2021, the patient received the 2nd dose of Shingles vaccine. In November 2021, less than a week after receiving Shingles vaccine, the patient experienced sickness and headache. On an unknown date, the outcome of the sickness was unknown and the outcome of the headache was not recovered/not resolved.   It was unknown if the reporter considered the sickness and headache to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had received the 2nd Shingles vaccine on Friday before reporting date. The patient was sick as a dog and still had a headache. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Stress, Vaccination failure
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received 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), shingles and stress. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and stress were not recovered/not resolved. It was unknown if the reporter considered the vaccination failure, shingles and stress to be related to Shingles vaccine and Shingles vaccine. Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had two Shingles shots, but thought that he/she a small patch on the left arm now. The patient stated it was not bad so maybe the shots helped. The patient had too much stress lately. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: M
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome
Clinical narrative: got gillian barre; This case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a male 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 guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was unknown.   The reporter considered the guillain barre syndrome to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient's wife. The age at vaccination was not reported. The reporter's husband got Guillain barre from shingle shot be careful. No contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Condition aggravated, Herpes zoster, Muscular weakness, Nephrolithiasis
Clinical narrative: suspected vaccination failure/had my third outbreak; diagnosed with kidney stones; had my third outbreak; my arm was pretty sore; had weakness in that arm; incredibly painful; blisters showed up; itch; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had them two times before receiving Shingles vaccines).   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 month after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), renal stone (serious criteria GSK medically significant), shingles, pain in arm, weakness of arms, pain, blister and pruritus. On an unknown date, the outcome of the vaccination failure, renal stone, shingles, pain, blister and pruritus were unknown and the outcome of the pain in arm and weakness of arms were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, renal stone, shingles, pain in arm, weakness of arms, pain, blister and pruritus 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 shingles three times. The patient was too young to get the Shingles vaccine and the finally received Shingles vaccine 2 years ago from the date of reporting. A month after receiving Shingles vaccine, the patient had third outbreak. The patient stated that they were incredibly painful.  The patient's arm was pretty sore for a couple of days, but he/she had weakness in that arm for a month or two. The patient also experienced itch. The patient was actually diagnosed with kidney stones until the blisters finally showed up. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Pruritus, Vaccination failure
Clinical narrative: suspected vaccination failure/had my third outbreak; diagnosed with kidney stones; had my third outbreak; my arm was pretty sore; had weakness in that arm; incredibly painful; blisters showed up; itch; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had them two times before receiving Shingles vaccines).   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 month after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), renal stone (serious criteria GSK medically significant), shingles, pain in arm, weakness of arms, pain, blister and pruritus. On an unknown date, the outcome of the vaccination failure, renal stone, shingles, pain, blister and pruritus were unknown and the outcome of the pain in arm and weakness of arms were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, renal stone, shingles, pain in arm, weakness of arms, pain, blister and pruritus 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 shingles three times. The patient was too young to get the Shingles vaccine and the finally received Shingles vaccine 2 years ago from the date of reporting. A month after receiving Shingles vaccine, the patient had third outbreak. The patient stated that they were incredibly painful.  The patient's arm was pretty sore for a couple of days, but he/she had weakness in that arm for a month or two. The patient also experienced itch. The patient was actually diagnosed with kidney stones until the blisters finally showed up. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient stated that worst thing the patient experienced was he/she had the shingles shot and still got it. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. No contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Illness, Pain in extremity
Clinical narrative: sick; sore arm; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In November 2021, the patient received the 2nd dose of Shingles vaccine. In November 2021, less than a week after receiving Shingles vaccine, the patient experienced sickness and pain in arm. On an unknown date, the outcome of the sickness was unknown and the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the sickness and pain in arm 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 sick with 2nd dose and was still having a very sore arm 2 days later. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Itching, still itches; Red blotchy large circle at site of injection; This case was reported by a consumer via interactive digital media and described the occurrence of injection site itching in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. In November 2021, 5 days after receiving Shingles vaccine, the patient experienced injection site itching and injection site erythema. The patient was treated with calamine + zinc oxide (Calamine Lotion). On an unknown date, the outcome of the injection site itching was not recovered/not resolved and the outcome of the injection site erythema was recovered/resolved.   It was unknown if the reporter considered the injection site itching and injection site erythema 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 a Shingles shot about a month ago from reporting date and 5 days after vaccination he/she started itching and red blotchy large circle at the site of injection and still had month later somewhat itches during the day just not blotchy red circle anymore, so the patient rubbed calamine lotion on it when he/she felt the itch. In May 2022, the patient supposed to went back for 2nd part of the shot but not sure if he/she would. The follow-up could not be possible as no contact details were available.
Sex: F
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 female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the pain was recovered/resolved. It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine. Additional details were provided as follows: This case was reported for reporter's mother. The age at vaccination was not reported. The reporter stated the patient got the Shingles vaccine and got shingles. The patient was in pain for 3 months. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting. The follow-up would not possible as no contact details were available.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR249095:same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Pain, Pain in extremity, Tremor
Clinical narrative: Arm is really sore; It hurt; Chills so severe; I was shaking; 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.   Concomitant products included COVID-19 VACCINE.   On 1st December 2021, the patient received the 2nd dose of Shingles vaccine. On 1st December 2021, less than a day after receiving Shingles vaccine, the patient experienced pain, chills and tremor. On 2nd December 2021, the patient experienced pain in arm. On an unknown date, the outcome of the pain, chills and tremor were recovered/resolved and the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain, chills, tremor and pain in arm 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 Covid-19 booster vaccine exactly 2 weeks before second dose of Shingles vaccine. The patient received Shingles vaccine and it hurt and the pharmacist wanted the patient to stick around to see if he/she had after affects. About 40 minutes later the patient experienced severe chills and was shaking. The patient reported that arm was really sore next morning. The patient felt better. The follow-up would not possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Neuralgia, 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. On an unknown date, 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, nerve pain and burning sensation. On an unknown date, the outcome of the vaccination failure, shingles, nerve pain and burning sensation were unknown. It was unknown if the reporter considered the vaccination failure, shingles, nerve pain and burning sensation to be related to Shingles vaccine. Additional details were provided as follows: This case was reported for reporter's husband. The age at vaccination was not reported. The reported stated the patient got Shingles shot and at the time of reporting he has shingles. The reporter stated burning the nerve pain were horrible. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: Never been that sick in my life; This case was reported by a consumer via interactive digital media and described the occurrence of sickness 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 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 details were provided as follows: The age at vaccination was not reported. The patient had Shingles vaccine some years before the date of reporting and was so sick. The patient reported that he/she was never this sick in his/her life. Follow up would not be possible as no contact details were available.
Sex: U
Vaccine: FLU4
Symptoms: Illness
Clinical narrative: never sicker; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   The patient's past medical history included shingles (had shingles in his/her mid 20 years). Previously administered products included Chickenpox vaccine.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, 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 Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The case was self-reported by the patient. The age at vaccination was not reported. The patient received Flu shot and was sick after getting the shot.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Fatigue
Clinical narrative: mild reaction, chills; tiredness; This case was reported by a consumer via media and described the occurrence of chills in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced chills and tiredness. On an unknown date, the outcome of the chills and tiredness were unknown.   It was unknown if the reporter considered the chills and tiredness 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 Shingles vaccine and had mild reaction (chills and tiredness). This case was linked with he case US2021AMR249129, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR249129:same reporter
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got Shingles shots about a year ago. Today I have shingles/ suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine and Shingles vaccine. On 26th November 2021, less than 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she got Shingles shots about a year ago of reporting. At the time of reporting the patient had shingles. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Stress, Vaccination failure
Clinical narrative: HAD THE SHOT BUT I STILL GET SHINGLES/ Suspected vaccination failure; SHINGLES, STRESS CAN BRING IT ON; IT'S STILL PAINFUL; BEEN UNDER SOO MUCH STRESS; 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, pain and stress. The patient was treated with analgesic, nos (Pain Pill (Nos)). On an unknown date, the outcome of the vaccination failure, shingles, pain and stress were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, pain and stress to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she had Shingles shot but still get shingles.  The patient stated he/she had another outbreak over week ago of reporting date.  The patient stated he/she did not get the full-blown outbreak, never less it was still painful, stress could bring it. The patient stated he/she has been under so much stress. A pain pill helps reduce the pain, if they did like other times in a week, they should get better. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster 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, shingles and pain were unknown. It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine. Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she it was November 2021 and got shingles. Evidently the Shingles vaccine did not work. The pain was excruciating. The patient stated hopefully because he/she got the vaccine it would not last as long. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd shot 7 months after the 1st; This case was reported by a consumer via media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st dose 7 months ago on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details provided were as follows: Case was reported by patient himself/herself. Age at vaccination was not provided. The patient received the 2nd dose of shingles vaccine almost after 7 months, which led to lengthening of vaccination schedule. The patient enquired if it was ok if he/she received the 2nd dose after 7 months. Follow-up would not be possible as no contact details provided.