chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Papilloma viral infection, Smear cervix abnormal
Clinical narrative: This spontaneous report was received from a company representative who was reporting on her daughter, a female patient of unknown age. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. On an unknown date, the patient started series of human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot#, expiration date, dose, route of administration and anatomical location were not reported). The reporter was not sure which vaccine the patient received. It was reported that the patient finished her series late in 2020 (reported as late last year). On an unknown date in 2021, the patient was diagnosed with an abnormal pap smear, high risk non 16/18 human papillomavirus (HPV). The outcome of the events was reported as not recovered/not resolved. Causality assessment was not provided.
Age: 0.5
Sex: M
Vaccine: HIBV
Symptoms: Crying, Extra dose administered, Inappropriate schedule of product administration, Injection site pain, Irritability
Clinical narrative: This spontaneous report was received from a consumer regarding his son, a 6-months-old male patient. Information regarding the patient's concomitant therapies, current conditions, medical history and historical drug was not provided. In July of 2021, the patient received the first dose of Haemophilus B Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB), on 11-OCT-2021, the patient received the second dose a little late because he was sick so it was held off (inappropriate schedule of vaccine administered) and, on 17-NOV-2021, the patient went to the doctors, however, the doctors did not have in their system that the patient had already received the second dose of the vaccine so it was administered again at 6 months old (Extra dose administered) (dosage, route of administration, lot number and expiration date were not provided) vaccine was administered to prevent HIB. At the time of the report, the patient was irritable, crying and wouldn't put pressure on the leg that had the shot, had leg soreness. No treatment or laboratory test had been performed. At the time of the report the patient had not recovered from irritability, crying and pain in extremity. The causal relationship between Haemophilus B Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) and the events was not reported.
Age: 0.33
Sex: M
Vaccine: PPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE reported; patient inadvertently received a dose of PNEUMOVAX 23; This spontaneous report was received from a medical assistant concerning a 4-month-old male patient. Information regarding the patient's concomitant therapies, current conditions, medical history and historical drug was not provided.   On 24-NOV-2021, the patient was inadvertently vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) (Drug administered to patient of inappropriate age) (dosage regimen, route of administration, lot number and expiration date were not provided) as prophylaxis. No additional adverse events were reported.
Age: 27.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional concerning a 27-year-old female patient. Information regarding the patient's concomitant therapies, current conditions, medical history and historical drug was not provided.   In August of 2013, the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), In October of 2013, the patient received the second dose of the vaccine and on 26-NOV-2021, the third dose was administered (Inappropriate schedule of vaccine administered) 0.5 milliliter (route of administration, lot number and expiration date were not provided) all vaccines administered as prophylaxis.  No additional adverse events were reported.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: No AE/PQC; An expired VAQTA was administered to a patient; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. Information regarding the patient's concomitant therapies, current conditions, medical history and historical drug was not provided.   On 30-NOV-2021, the patient was vaccinated with Hepatitis A Vaccine, Inactivated (VAQTA) 1 milliliter lot number T014589 expiration date 25-OCT-2021 (Expired product administered) (route of administration was not provided) as prophylaxis.
Age: 21.0
Sex: F
Vaccine: COVID19, HPV9
Symptoms: Arthralgia, Henoch-Schonlein purpura, Incomplete course of vaccination
Clinical narrative: will not be completing the Gardasil 9 series; henoch-schonlein purpura (HSP) rash in both of her lower legs, including blisters behind her knees; joint pain; This spontaneous report was received from a physician via a company representative referring to a 21 year old female patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  The patient also completed 3 doses of the COVID vaccine prior to receiving hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9).  On 08-NOV-2021, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # U006800, expiry date: 28-APR-2023, for prophylaxis (dose and route were not reported). This was the patient's first dose in the series and it was reported that she will not be completing the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) series.  On 09-NOV-2021, the patient developed a henoch-schonlein purpura (HSP) rash and has some joint pain. The physician reported there was no renal involvement. The rash was on both of her lower legs, including blisters behind her knees. The patient had been seeing a rheumatologist for a couple of months for unspecified reasons. The physician reported to the employee that the patient had taking 2 unspecified medications from the Rheumatologist, however she was off of them prior to taking hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9). The patient had been to the emergency room twice and had seen a dermatologist. She was given steroids for the rash. The patient was not back at work yet. No additional information was reported. No additional adverse events presented and no product quality complaint present. The outcome of henoch-schonlein purpura and arthralgia was reported as not recovered. Therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was discontinued.    The causal assessment between the events and the suspect therapies were not reported.
Sex: U
Vaccine: VARZOS
Symptoms: Blindness, Optic neuropathy, Retinal infarction
Clinical narrative: retinal infarct; optic neuropathy of the right eye; loss of vision; Information has been received from a lawyer regarding a case in litigation which referred to a patient (pt) of unknown gender and age. Information regarding concomitant medications, concurrent conditions or medical history was not provided. On an unknown date, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) for its intended purpose: the prevention of shingles (herpes zoster) and for routine health maintenance (exact dose, dose number, route of administration, anatomical site of vaccination, lot number and expiration date were not provided). Afterwards, on an unknown date (reported as after receiving zoster vaccine live (ZOSTAVAX) vaccine), the pt suffered retinal infarct (retinal infarction), optic neuropathy of the right eye, and loss of vision (blindness). As a result of those symptoms, the pt was seen and treated by medical providers and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the pt's symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of pt's condition. In addition, the pt sustained severe and permanent personal injuries. Further, the pt had 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. Finally, as direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered as not recovered. The causal relationship between the events and zoster vaccine live (ZOSTAVAX) was assessed as related. All the events were considered as disabling by the reporter.   Upon internal review, the events retinal infarction, optic neuropathy, and blindness were determined to be medically significant.
Age: 66.0
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: This spontaneous report has been received from a physician, via immunization record from a case in litigation for zoster vaccine live (ZOSTAVAX) (MARRS # 1804USA006650), concerning a 68-year-old male patient.  On 30-DEC-2016 (at 66 years old) and on 08-MAR-2019, the patient was vaccinated by health care providers with Hepatitis B Vaccine (Recombinant) (reported as Hep B (adult, 3-dose) or (adol. 11-15, 2-dose) (CVX=43)) (manufacturer unknown) 1 milliliter administered Intramuscularly in left and right deltoid; respectively (strengths, lot numbers, and expiration dates were not reported) as prophylaxis (inappropriate schedule of product administration).; Sender's Comments:  US-009507513-1804USA006650: US-009507513-2112USA001568:
Age: 54.0
Sex: M
Vaccine: PNC13, PPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: This spontaneous report has been received from a physician, via immunization record from a case in litigation for zoster vaccine live (ZOSTAVAX) (MARRS # 1804USA006650), concerning a 68-year-old male patient. On 13-APR-2005, the patient was vaccinated by a licensed practical nurse (LPN) with pneumococcal vaccine, polyvalent (23-valent) (reported as pneumococcal polysaccharide 23-valent (PPSV23) (CVX=33)) (manufacturer unknown) 0.5 milliliter administered Intramuscularly in left deltoid, as prophylaxis; on 09-DEC-2015, the patient was vaccinated by a registered nurse (RN) with pneumococcal vaccine, polyvalent (23-valent) (reported as pneumococcal polysaccharide 13 valent (PCV13) (CVX=133)) (manufacturer unknown) 0.5 milliliter administered Intramuscularly in left deltoid; and on 05-DEC-2016, the patient was vaccinated by a RN with pneumococcal 13 valent vaccine (reported as pneumococcal polysaccharide 23-valent (PPSV23) (CVX=33)) (manufacturer unknown) 0.5 milliliter administered Intramuscularly in right deltoid, as prophylaxis (strengths, lot numbers, and expiration dates for all 3 doses were not reported) (inappropriate schedule of product administration).; Sender's Comments:  US-009507513-1804USA006650: US-009507513-2112USA001567.
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product use issue, Wrong product administered
Clinical narrative: Inadvertently administered Proquad instead of MMR II; No additional adverse event; A 45 Years-old patient received Proquad; This spontaneous report was received from a nurse referring to a 45 years old male patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On an unknown date the 45-year-old patient was inadvertently vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD), 0.5 milliliter (strength, vaccination scheme, route of administration, anatomical location, lot number and expiration date were not reported) for prophylaxis, instead of Measles, mumps, and rubella virus vaccine live (M-M-R II) (wrong vaccine administered and product use issue). No additional side effects or product quality complaints were reported (no adverse event).
Sex: F
Vaccine: MMR
Symptoms: Rubella antibody negative
Clinical narrative: Has a low rubella titer and unknown MMR II vaccination status; This spontaneous report has been received from a nurse, and refers to a 41 year old female patient. The information about patient's concurrent condition, medical history, drug history and concomitant medications was unknown.  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) as prophylaxis (exact dose, strength,frequency, route of administration and anatomical site of vaccination, lot number and expiration date were not reported). On an unknown date, the patient had a low rubella titer (Rubella antibody negative) and unknown measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) vaccination status (Rubella antibody negative). It was reported that, the patients measles and mumps titer was within normal limits. The patient did not receive a dose of measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) at the current time. No treatment was given for the adverse event.  At the time of reporting, the outcome of the rubella antibody negative was unknown. The reporter did not provide the causality assessment between the event and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live(M-M-R II).
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender.   The patient's concurrent conditions, medical history, and concomitant therapies were not provided.  On 03-DEC-2021, the patient was vaccinated with an expired varicella virus vaccine live (VARIVAX) 0.5 ml (lot number S038700, expiration date 01-DEC-2021) for prophylaxis. There were no temperature excursion and there was no adverse event reported.
Age: 46.0
Sex: U
Vaccine: PPV
Symptoms: Rheumatoid arthritis
Clinical narrative: The patient asked "does rheumatoid arthritis count to make me higher risk"; A 46 year old patient received PNEUMOVAX23; This spontaneous report was received from a 46-year-old patient of unknown gender reporter on him ot herself. The patient's concurrent conditions, drug reactions or allergies, pertinent medical history and concomitant therapy were not reported.      On an unknown date, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, lot #, expiration date and route were not reported) for prophylaxis (product administered to patient of inappropriate age).         On an unknown date, the patient asked, "does rheumatoid arthritis count to make me higher risk"(rheumatoid arthritis). There was no product quality complain.  At the time of the report, the outcome of rheumatoid arthritis was not reported.    The reporter considered rheumatoid arthritis to be related to Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23).     Upon internal review, rheumatoid arthritis was determined to be medically significant.
Age: 60.0
Sex: U
Vaccine: VARZOS
Symptoms: Post herpetic neuralgia
Clinical narrative: Information has been received regarding a case in litigation from a lawyer referring to a currently 66 years old patient of unknown gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 02-NOV-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) in a Family Care for the long-term prevention of shingles and zoster-related conditions. Subsequently, the patient was treated by a provider for the following injury resulting from the patient's zoster vaccine live (ZOSTAVAX) use: postherpetic neuralgia. The outcome of the event postherpetic neuralgia was unknown.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error, Wrong technique in product usage process
Clinical narrative: This spontaneous report was received from a physician and referred 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 11-NOV-2021, rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # 1742428, expiration date: 01-SEP-2022, 2 milliliter), orally was administered for prophylaxis and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) cap was twisted and punctured but not administered. It was placed back in the refrigerator and administered to a patient on 29-NOV-2021consumercap was twisted and punctured but not administered (Wrong technique in product usage process). It was placed back in the on 29-NOV-2021 (wrong technique in product usage process and incorrect product storage). No additional adverse event was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Paraesthesia
Clinical narrative: This case was reported by a consumer interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 3 weeks after receiving Shingles vaccine, the patient experienced shingles and pins and needles. On an unknown date, the outcome of the shingles and pins and needles were unknown.   It was unknown if the reporter considered the shingles and pins and needles 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 shingles about 3 weeks after booster and felt like pins poking to him/her.
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was not recovered/not resolved.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were reported as follows: Age at vaccination was not reported. The reporter wanted to know how long does a fever last after the Shingrix Vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd shingle shot 8 months later; This case was reported by a consumer via interactive digital 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 (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced 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 patient self-reported this case. The age at vaccination was not reported. The patient received 2nd shingles shot 8 months later, which led to drug dose administration interval too long.  The patient asked that was it going to make his/her vaccine ineffective. The follow-up would not possible as no contact details were available.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of extra dose administered in a 18-year-old female patient who received Men B NVS (Bexsero) (batch number ABXB39AA, expiry date 31st July 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Bexsero (1st dose received on 23rd March 2021 at a local pharmacy) and Bexsero (2nd dose received on 30th June 2021 at a local pharmacy).   On 2nd December 2021, the patient received the 3rd dose of Bexsero .5 ml and Bexsero Pre-Filled Syringe Device. On 2nd December 2021, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient inadvertently received 3 doses of Bexsero, which led to extra dose administered. The patient was unaware that she had received menB vaccine previously and the nurse office didn't have documentation of previous vaccination. The patient's mom was aware and called nurse office when she learned of the additional dose. Nurse stated that while in the office the patient did not report any adverse events. The patient's mom also stated that the patient did not currently had any adverse events following vaccination. The patient's mom was advised to call the office if any adverse events developed. The reporter stated that the GlaxoSmithKline could follow up on the maladministration.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site pain
Clinical narrative: This case was reported by a consumer via (Shingrix GSK Chatbot) interactive digital media and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix with an associated reaction of no adverse event (received 1st dose on an unknown date).   On 1st December 2021, the patient received the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced injection site pain, headache and tiredness. On an unknown date, the outcome of the injection site pain, headache and tiredness were unknown.   It was unknown if the reporter considered the injection site pain, headache and tiredness to be related to Shingrix.  Additional details provided were as follows: The case was reported by patient himself/herself. Age at vaccination was not reported. The patient did not had problems with the 1st dose but felt side effects from the second dose received last night and experienced Injection site pain, headache and tired. The patient enquired how long should a person feel side effects from the Shingrix vaccine. Follow-up would not be possible as no contact details available.
Sex: U
Vaccine: VARZOS
Symptoms: COVID-19, Herpes zoster, Vaccination failure
Clinical narrative: This case was reported by a consumer  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 (caught the shingles last year). Previously administered products included Shingles vaccine (had 2 doses around 10 years ago).   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and covid-19. On an unknown date, the outcome of the vaccination failure, shingles and covid-19 were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and covid-19 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 2 shingle vaccine around 10 years ago, then caught the shingles last year. The patient repeated the vaccines again and had a mild though miserable case. The patient reported that the immune system was fine because the patient caught Covid. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Insomnia, Nausea
Clinical narrative: trouble sleeping; very bad headache; nauseous; This case was reported by a consumer via interactive digital media and described the occurrence of difficulty sleeping in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st December 2021, the patient received the 1st dose of Shingrix. In December 2021, less than a week after receiving Shingrix, the patient experienced difficulty sleeping, headache and nausea. On an unknown date, the outcome of the difficulty sleeping, headache and nausea were not recovered/not resolved.   It was unknown if the reporter considered the difficulty sleeping, headache and nausea to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received first dose of Shingrix vaccine one day before reporting and had trouble sleeping, very bad headache and was nauseous.
Sex: F
Vaccine: VARZOS
Symptoms: Myocardial infarction
Clinical narrative: in the emergency for a heart attack; This case was reported by a consumer via interactive digital media and described the occurrence of heart attack in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced heart attack (serious criteria GSK medically significant). On an unknown date, the outcome of the heart attack was unknown.   It was unknown if the reporter considered the heart attack to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient's friend. The age at vaccination was not reported. After receiving Shingrix, the patient was in the emergency for a heart attack. The patient's physician said that the patient was the 6th case of post Shingrix heart attack that week. This case is one of 6 linked cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR249784:Same reporter US-GLAXOSMITHKLINE-US2021AMR249783:Same reporter US-GLAXOSMITHKLINE-US2021AMR249782:Same reporter US-GLAXOSMITHKLINE-US2021AMR249785:Same reporter US-GLAXOSMITHKLINE-US2021AMR249781:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: very painful / got bad; 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.   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 pain. On an unknown date, the outcome of the pain was unknown.   The reporter considered the pain to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient for himself/herself. The age at vaccination was not reported. The patient stated he/she received shingles vaccine and it was very painful . The patient got bad with the vaccine. The follow up would not possible as no contact details was available. For tolerance of second dose refer linked case US2021AMR249896, reported by the same reporter, for second dose.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR249896:Same reporter, 2nd dose
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Pain, Vaccine positive rechallenge
Clinical narrative: 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. Previously administered products included Shingles vaccine with an associated reaction of pain (received 1st dose on an unknown date and experienced pain, refer case- US2021AMR249864). On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the pain was unknown. It was unknown if the reporter considered the pain to be related to Shingles vaccine. Additional details were provided as follows: The case was self reported by the patient. The age at vaccination was not reported. The reporter stated that, he/she got bad with the vaccine and it was very painful. The follow-up would not possible as no contact details were available. Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR249864:Same reporter, 1st dose.
Sex: F
Vaccine: MENB
Symptoms: Extra dose administered
Clinical narrative: received a third Bexsero; This case was reported by a other health professional via sales rep and described the occurrence of extra dose administered in a female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Bexsero (received 2nd dose at pharmacy this past summer and there was no record of it in database).   On 2nd December 2021, the patient received the 3rd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 2nd December 2021, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided are as follows: The age at vaccination was not reported. The patient did not told that she had received her 2nd dose at pharmacy this past summer (in 2021) and there was no record of it in the database. The patient received 3rd dose of Bexsero, which led to extra dose administered. The reporter consented to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Arm sore two days; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than a week after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The patient stated that he/she received dose of Shingles vaccine this week and experienced  arm sore two days, but better then shingles. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Infection
Clinical narrative: symptoms of an infection on my right thigh; This case was reported by a consumer via interactive digital media and described the occurrence of infection in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced infection. On an unknown date, the outcome of the infection was unknown.   It was unknown if the reporter considered the infection to be related to Shingrix.  Narrative suggestion : Additional details provided were as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received a dose of Shingrix 2 months ago and experienced potential symptoms of infection on right thigh. The patient enquired would the first shot reduce his/her potential outbreak or should he/she get the 2nd shot now. Follow-up would not be possible as no contact details available.
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: This case was reported by a consumer interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of illness (1st dose received on an unknown date and also had flu-like symptoms, refer case US2021AMR241152).   On 29th November 2021, the patient received the 2nd dose of Shingles vaccine. On an unknown date, less than a week after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   The reporter considered the sickness 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 2nd dose of Shingles vaccine on Monday before reporting date and that made him/her very sick. The patient stated that he/she did not know what would be worse. The follow-up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR241152:Same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Asthenia, Mass, Pain
Clinical narrative: weak; painfully sore; very lumpy; This case was reported by a consumer via interactive digital media and described the occurrence of weakness in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had internal shingles and it was so bad and painful) and covid-19. Previously administered products included Shingles vaccine (1st dose received when hit 51 years). Concurrent medical conditions included nerve damage (it was a year and ten months in and it was getting better).   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 weakness, pain localized and mass. On an unknown date, the outcome of the weakness, pain localized and mass were recovered/resolved.   It was unknown if the reporter considered the weakness, pain localized and mass 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 waited 6 months after 1st dose and then received 2nd dose of Shingles vaccine and felt weak and painfully sore that was very lumpy. It went away in seven days. The patient waited another month and received the pneumonia vaccine, waited another month and received the flu vax too. The patient had all three vaccines with covid. He/she rather had 300 percent than Covid vaccine at 47 percent. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Injection site pain, Vaccine positive rechallenge
Clinical narrative: hurt; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of injection site reaction (1st dose received on an unknown date, refer case US2021AMR250998).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced injection site pain. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received Shingles shots and that hurt. Follow up would not be possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR250998:same patient/ different dose
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer  interactive digital media and described the occurrence of pain in arm in a adult 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 pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.  Additional details provided were as follows: The patient self-reported this case. The age at vaccination was not reported but the patient was over 60 years old. The patient received a dose of Shingles vaccine and was only suffered with a sore arm for a few days. Follow-up would not be processed as no contact details available.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included chickenpox (had chickenpox at 3 years of age) and shingles (had shingles at 50 years of age). Concurrent medical conditions included reaction to drug preservatives. In September 2021, the patient received the 1st dose of Shingrix. In September 2021, less than a day after receiving Shingrix, the patient experienced pain in arm and general body pain. On an unknown date, the outcome of the pain in arm and general body pain were recovered/ resolved. It was unknown if the reporter considered the pain in arm and general body pain to be related to Shingrix. Additional details were provided are as follows: The patient received a dose of Shingrix in left arm in September 2021 (unknown date) and she felt pain after the injection was administered and then in 3 to 4 hours, she experienced the pain spread throughout her body and had body pain and lasted for 3 to 4 days. The reporter called to inquired how long was Shingrix effective in patients 50 years and older, regarding approval date of Shingrix, placement of Shingrix in arm and ingredients of Shingrix. The reporter reported that she has many allergies including allergy to preservatives and would like to know the ingredients in the vaccine. The reporter was given medical disclaimer and was referred to health care professional. The reporter consented to follow-up. For tolerance of 2nd dose, refer case US2021AMR249057.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR249057: Same reporter.
Age: 1.25
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: received an expired 4th dose of Infanrix; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 15-month-old male patient who received DTPa (Infanrix) (batch number D2KX9, expiry date 26th November 2021) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 2nd December 2021, the patient received the 4th dose of Infanrix and Infanrix Pre-Filled Syringe Device. On 2nd December 2021, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient's date of birth was not provided. The reporter reported that patient received an expired dose of Infanrix, which led to expired vaccine used. The reporter did not consent to follow-up.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: 2nd dose of Fluarix to adult patient; This case was reported by a pharmacist via Regulatory Authority and described the occurrence of extra dose administered in a 62-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number H32SG, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Fluarix Quadrivalent 2021-2022 season with an associated reaction of no adverse event (the patient received the first dose of the Fluarix vaccine on 22-September 2021).   On 2nd December 2021, the patient received the 2nd dose of Fluarix Quadrivalent 2021-2022 season. On an unknown date, the patient started Fluarix Tetra Pre-Filled Syringe Device. On 2nd December 2021, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The reporter was a Pharmacist. The reporter reported that the patient received first dose of Fluarix on 22nd September 2021 and second dose on 2nd December 2021, which led to extra dose of Fluarix vaccine. The Fluarix vaccine was for 2021-2022 season and mentioned batch number and expiry date was for second dose. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Shingrix reconstituted with sterile water; Shingrix reconstituted with sterile water; This case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were reported as follows: The reporter was Pharmacist. Age at vaccination was not reported. The reporter did not have available information related to the patient neither lot number and expiration date. Pharmacist called to report that a patient received a dose of Shingrix that was reconstituted with sterile water, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The vaccine administration facility was same as primary reporter. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose in 2018,  has not yet received second; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable to this report. The pharmacist reported that the patient did not receive 2nd dose till the time of reporting, which led to incomplete course of vaccination. The pharmacist was inquiring if his patient should restart the Shingrix vaccine series because she received her 1st dose in 2018. No further information was reported. The reporter consented to follow up.
Age: 0.17
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 2-month-old female patient who received Hib (Hiberix) (batch number A5449, expiry date 13th November 2022) and (batch number 7JG74, expiry date 13th November 2022) for prophylaxis.   On 3rd December 2021, the patient received the 1st dose of Hiberix. On an unknown date, the dose was an unknown dose. On 3rd December 2021, unknown after receiving Hiberix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The patient received expired dose of Hiberix, which led to expired vaccine used. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Disorientation, Incomplete course of vaccination, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced fever, disorientation and incomplete course of vaccination. On an unknown date, the outcome of the fever, disorientation and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the fever and disorientation to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received 1st dose of Shingrix vaccine about a year ago and experienced fever and felt disoriented. Till the time of call the patient did not receive the 2nd dose, which led to incomplete course of vaccination. The patient was inquiring about the recommendation for timing of the second dose and the severity of the side effects associated with the second dose.  The patient spoke from Shingrix FAQs content. Provided medical advice disclaimer and referred to HCP. No additional details were provided. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: second dose administered after 6 months; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 16th May 2018).   On 18th October 2019, the patient received the 2nd dose of Shingrix. On 18th October 2019, 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 age at vaccination was not reported. Pharmacist called to ask regarding the vaccination schedule of Shingrix. The pharmacist reported that the patient was vaccinated with the 2 dose of Shingrix but the second dose was administered after the 6 month series, which led to drug dose administration interval too long. The vaccine administration facility was the same as primary reporter. No other information reported. The reporter consented to follow up.