chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HEP
Symptoms: No adverse event, Product storage error, Vaccination failure
Clinical narrative: improperly stored vaccine was administered to an unspecified patient; The birth dose seemed not effective and the series to be restarted; This non-valid, spontaneous report was received from a Licensed Practical Nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.   On 12-FEB-2022, the patient was vaccinated with an improperly stored dose of hepatitis b vaccine, thimerosal-free (recombinant)(RECOMBIVAX HB) lot # T028933, expiration date 03-NOV-2022 (dose and route of administration were not reported) for prophylaxis (incorrect product storage). There was no adverse event or product quality complaint reported. Administered dose of vaccine experienced the temperature excursion of 17.6 degrees Fahrenheit (F) for 7 hours. It was also reported that the vaccine was not monitored for 7 hours and it is actually unknown what the temperature of the vaccine reached during that time. There were no previous excursions reported.  Lot Number T028933 has been verified to be valid lot number for Recombivax HB formulation vial.  This is a non-valid report due to lack of patient's identifiers.  Follow-up information was received from Licensed Practical Nurse on 28-MAR-2022. The patients identifiers were provided. The patient had no other vaccines withing 4 weeks prior, no illness at time of the vaccination and no preexisting physician-diagnosed allergies, birth defects or medical conditions.  The dose of hepatitis b vaccine, thimerosal-free (recombinant)(RECOMBIVAX HB) was administrated to the patient intramuscularly in the left thigh by trained healthcare professional in accordance with the instruction leaflet and it was the first one she received.  On 11-FEB-2022, the primary data logger was replaced and normalizing, vaccine were kept in a backup refrigerator.  On 12-FEB-2022, the data logger at the back up refrigerator indicated an excursion of 17.6 degrees Fahrenheit (F). It appeared that the data logger was malfunctioning for 1 hour. Actual conditions and observation showed that none of the fluid in the fridge or vaccines were frozen. Due to malfunctioning data logger, the vaccine was not monitored before administration. Immediately after noticing, vaccines were put aside to avoid usage (the vaccines would not to be used due to no data supporting the excursion). Medical director of the clinic, pediatrician and public health department were notified about the incident.  Per agreement with medical director and pediatrician the birth dose hepatitis b vaccine, thimerosal-free (recombinant)(RECOMBIVAX HB) seemed not effective  (Vaccination failure) and the series to be restarted. The patient vital signs and assessment did not show any adverse reaction to the vaccine. The patient's parents were aware of care plan.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; vaccines were administered after the excursion; This spontaneous report as received from an office manager refers to a patient of unknown age and gender.  On 12-NOV-2021, the patient was vaccinated with a 0.5 mL dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # U017140 exp date 28-NOV-2012) rHA after the excursion. Concomitant therapy included sterile diluent. The temperature of excursion was 6 °F up to 14 °F for 4 hours and 14°F up to 46°F for 4 hours 45 minutes. There was no previous temperature excursion.  The office manager also stated that she did not have any patient information and that 10 patients received the vaccine after the excursion. The excursion was identified right away and there were no reported adverse events.  This is one of several cases received from the same source.; Sender's Comments:  US-009507513-2203USA001850: US-009507513-2203USA001841: US-009507513-2203USA001716: US-009507513-2203USA001578: US-009507513-2203USA001612: US-009507513-2203USA001688: US-009507513-2203USA001728: US-009507513-2203USA001890:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Patient was administered improperly stored VAQTA; This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent condition, drug reactions/allergies and concomitant medication was not provided.  On 14-FEB-2022, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) (lot # U024504, expiration date 15-OCT-2022, doses, strengths and route were not provided) for prophylaxis (product storage error). The vaccines administered experienced temperature excursions of 0.8 Degree Celsius for 35 minutes on 05-FEB-2022. There was no previous temperature excursion. No additional adverse event reported.  This is one of multiple cases received from the same reporter. ; Sender's Comments:  US-009507513-2203USA003820: US-009507513-2203USA003814: US-009507513-2203USA003938: US-009507513-2203USA003853: US-009507513-2203USA003841: US-009507513-2203USA003951:
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; an expired PROQUAD was inadvertently administered to a patient; This spontaneous report was received from a licensed practical nurse and nurse supervisor and refers to a 4-year-old male patient. The patient's concurrent conditions, concomitant medication and medical history were not provided.  On 08-MAR-2022, the patient was inadvertently vaccinated with an expired measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin (rHA)) (PROQUAD) first dose, 0.5 ml, administered subcutaneously (SQ) into left arm, lot # 030481, expiration date 07-MAR-2022 for prophylaxis (Expired product administered). It was reported that nurse received order for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) from provider, pulled vaccine from box, checked lot number, expiration date, obtained consent from patient, and administered vaccine. Upon returning to chart vaccine registered nurse realized that the date was 08-MAR-2022 and not 07-MAR-2022. 07-MAR was the expiration date on the bottle and she thought that was the date for the day. Upon noticing her mistake she called the nursing supervisor. The nursing supervisor contacted manufacturer and provider, per manufacturer potency still viable one day after expiration. The nursing supervisor contacted the patient's mother and made her aware of the situation, and the patient's mother agreed no revaccination needed. No additional adverse event was reported (No adverse event).
Sex: U
Vaccine: MMRV
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No additional AE or PQC reported.; a patient only received half a dose of PROQUAD due to moving around when the vaccine was injected; This spontaneous report was received from an administrator and refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported.  On 16-MAR-2022, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) subcutaneous injection, 0.5 milliliter, lot #U029321, expiration date: 19-MAR-2023, administered for prophylaxis (strength, side and route of administration were not provided). Administered vaccine was diluted in a 0.5 ml sterile diluent (lot# U002746, expiration date: 25-JUN-2023). The patient received only half a dose of the vaccine due to moving around when the vaccine was being injected (accidental underdose). No additional adverse event was reported.
Sex: M
Vaccine: MMR
Symptoms: COVID-19, Tic
Clinical narrative: neurological/small tics; COVID-19; This unsolicited report was received from the patient's mother via pfizer regarding a 8-year-old male patient. The patient's concurrent conditions and concomitant therapies were not reported. The patient had 4 previous adverse reactions to vaccines.  On an unknown date, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown) as prophylaxis (dose, route, lot # and expiration date not reported). Following the vaccine, the patient developed neurological tics (also reported as small tics). On an unspecified date in December 2021, the patient had coronavirus disease (COVID-19) with minor symptoms. Outcome for both events were not reported at the time of this report. The reporter stated that the tics were not related to the vaccine and she believed it was related to an immune disease; whereas causal relationship regarding COVID-19 was not provided.    This is one of several reports received from the same reporter.
Sex: M
Vaccine: MMR
Symptoms: COVID-19, Tic
Clinical narrative: neurological/small tics; covid-19; This unsolicited report was received from the patient's mother via pfizer regarding a 16-year-old male patient. The patient's concurrent conditions and concomitant therapies were not reported. The patient had 4 previous adverse reactions to vaccines.  On an unknown date, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown) as prophylaxis (dose, route, lot # and expiration date not reported). Following the vaccine, the patient developed neurological tics (also reported as small tics). On an unspecified date in December 2021, the patient had coronavirus disease (COVID-19) with minor symptoms. Outcome for both events were not reported at the time of this report. The reporter stated that the tics were not related to the vaccine and she believed it was related to an immune disease; whereas causal relationship regarding COVID-19 was not provided.    This is one of several reports received from the same reporter.
Age: 0.08
Sex: M
Vaccine: HPV9
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: No known inmediate side effects; a 1 month old male was administered GARDASIL 9; This spontaneous report was received from a nurse referring to a 1-month-old male patient. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.     On 23-MAR-2022, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (formulation, strength, dose, frequency, route of administration, lot number and expiration date were not reported) (product administered to patient of inappropriate age).
Age: 26.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE reported; a patient received her first dose of GARDASIL 9 in 2019 when she was 23 years old, received her second dose in 2020 and came in today (23MAR2022) to complete the series; This spontaneous report was received from an office manager and refers to a 26-year-old female patient. The patient's concurrent conditions, concomitant medications, medical history and drug allergies were not reported.  On an unknown date in 2019, the patient was was vaccinated with first dose of HPV rl1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) for prophylaxis. On an unknown date in 2020, she received her second dose of the same vaccine, and on 23-MAR-2022, she was vaccinated with third dose (inappropriate schedule of product administration). For all vaccines dose, formulation, route of administration and injection site were not reported. No adverse events were reported.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/PQC reported.; vaccine stored out of recommended storage range was administered to patient; This spontaneous report as received from another health professional (Nurse prescriber) referring to a patient of unknown age and gender. The patient's concurrent condition, pertinent medical history and drug allergies and reactions were not reported.      On 14-DEC-2020, the patient was vaccinated was vaccinated with the temperate excursion vaccine (also reported as vaccine stored out of recommended storage range) of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, dose, frequency, and route of administration were not provided) (Lot # was T027937 and expiration date was 08-AUG-2022) for prophylaxis. The patient did not experience any adverse event.
Age: 13.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE reported; 13 Year Old' Patient was administered PROQUAD; This spontaneous report was received from an advanced practice nurse (APN) and refers to a 13-years-old patient of an unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 22-MAR-2022 at 15:00, the patient was vaccinated with the first dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (recombinant Human Albumin (rHA)) (PROQUAD) vial, lot number: U030588, expiration date 29-MAR-2023 (dose, dosage schedule and route of administration were not reported) for prophylaxis, due to having no prior immunization with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (product administered to patient of inappropriate age). No additional adverse event were reported.
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Anaphylactic reaction
Clinical narrative: patient had an anaphylactic reaction after receiving KINRIX and PROQUAD; This spontaneous report was received from  a physician (epidemiologist) via GlaxiSmithKline and refers to a 4 year old female patient. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) along with diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (KINRIX) (strength, lot #, expiration dates, doses, routes, and frequencies were not reported) for prophylaxis.  On an unknown date the patient experienced anaphylactic reaction. The patient went to the emergency room and sought medical attention; and received an unsp3ecified treatment. At the reporting time, the outcome of anaphylactic reaction was reported as recovered. The reporter did not provide a causal relationship between the event and Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) or diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (KINRIX).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no other symptoms or other AE reported; doses of VARIVAX were given following temperature excursion; This spontaneous report as received from a office manager refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, or concomitant therapies were not provided.   A temperature excursion of varicella virus vaccine live (oka/merck)(VARIVAX)  was registered as 7.4 °F for 10 minutes on 01-MAR-2022. On 23-MAR-2022, the patient was vaccinated with the improperly storage dose of varicella virus vaccine live (oka/merck)(VARIVAX) (strength, dose, route were not provided) with lot # U022732 and expiration date of 20-JUL-2023 for prophylaxis. There was no previous temperature excursion. No adverse events were reported.   This is one of several cases received from  the same reporter.      ?; Sender's Comments:  US-009507513-2203USA010197:
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: shot is painful; 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 Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient stated that the shingles shot was painful but nothing compared to the alternative, one was wise if they got it. The follow-up would not be possible as no contact details were available.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Amnesia, Dysgeusia, Fatigue, Gait inability, Hypersomnia
Clinical narrative: nightmare; needed help walking; slight loss of short-term memory; food tasted bitter; tired; stayed in bed asleep for 3 days; This case was reported by a consumer via call center representative and described the occurrence of taste bitter in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pyrexia (1st dose received on 1st October 2020, refer case US2022053011).   On 1st March 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 1st March 2021, 6 hrs after receiving Shingrix, the patient experienced taste bitter and tiredness. On 4th March 2021, the patient experienced nightmare, unable to walk and short-term memory loss. In March 2021, the patient experienced hypersomnia. On 4th March 2021, the outcome of the nightmare was recovered/resolved. On 4th April 2021, the outcome of the unable to walk was recovered/resolved. On an unknown date, the outcome of the taste bitter and hypersomnia were recovered/resolved and the outcome of the tiredness was unknown and the outcome of the short-term memory loss was not recovered/not resolved.   It was unknown if the reporter considered the taste bitter, tiredness, hypersomnia, nightmare, unable to walk and short-term memory loss to be related to Shingrix.     Additional details were provided as follows: The patient self-reported this case. The patient received her second Shingrix vaccine on left arm.  The patient reported about 6 hours after the injection she ate dinner and the food tasted bitter.  After dinner less than a day after vaccination patient was so tired, she dragged herself up the stairs and 12 hours after vaccination she stayed in bed asleep for 3 days.  On the third day, she had a nightmare that woke her from the 3-day sleep.  After she awoke, she needed help walking for about 1 month.  The patient also reports she had a slight loss of short-term memory.  On 4th March 2021, 3 days after vaccination the patient experienced nightmare, unable to walk and short-term memory loss. The reporter did not give permission to contact HCP.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022053011:Same patient
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Nightmare, Pyrexia
Clinical narrative: nightmare; needed help walking; slight loss of short-term memory; food tasted bitter; tired; stayed in bed asleep for 3 days; This case was reported by a consumer via call center representative and described the occurrence of taste bitter in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pyrexia (1st dose received on 1st October 2020, refer case US2022053011).   On 1st March 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 1st March 2021, 6 hrs after receiving Shingrix, the patient experienced taste bitter and tiredness. On 4th March 2021, the patient experienced nightmare, unable to walk and short-term memory loss. In March 2021, the patient experienced hypersomnia. On 4th March 2021, the outcome of the nightmare was recovered/resolved. On 4th April 2021, the outcome of the unable to walk was recovered/resolved. On an unknown date, the outcome of the taste bitter and hypersomnia were recovered/resolved and the outcome of the tiredness was unknown and the outcome of the short-term memory loss was not recovered/not resolved.   It was unknown if the reporter considered the taste bitter, tiredness, hypersomnia, nightmare, unable to walk and short-term memory loss to be related to Shingrix.     Additional details were provided as follows: The patient self-reported this case. The patient received her second Shingrix vaccine on left arm.  The patient reported about 6 hours after the injection she ate dinner and the food tasted bitter.  After dinner less than a day after vaccination patient was so tired, she dragged herself up the stairs and 12 hours after vaccination she stayed in bed asleep for 3 days.  On the third day, she had a nightmare that woke her from the 3-day sleep.  After she awoke, she needed help walking for about 1 month.  The patient also reports she had a slight loss of short-term memory.  On 4th March 2021, 3 days after vaccination the patient experienced nightmare, unable to walk and short-term memory loss. The reporter did not give permission to contact HCP.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022053011:Same patient
Sex: F
Vaccine: VARZOS
Symptoms: Influenza
Clinical narrative: worst case of flu; This case was reported by a consumer via other manufacturer and described the occurrence of influenza in a 67-year-old 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 influenza. On an unknown date, the outcome of the influenza was unknown.   It was unknown if the reporter considered the influenza to be related to Shingles vaccine.     Linked case(s) involving the same patient: US2022AMR053663   Additional Information: GSK Receipt Date: 24-Mar-2022 Reporter's comment: The case was self reported by the patient. The patient experienced worst case of flu after taking Shingles vaccine. The reporter consented to follow up. Additional Supportive Information: This case is linked with case US2022AMR053663 reported by same reporter for same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR053663:
Sex: U
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: adult given pediatric dose; adult given pediatric dose; This case was reported by a pharmacist via call center representative and described the occurrence of underdose in a adult patient who received HBV (Engerix B pediatric) for an unknown indication.   On 21st March 2022, the patient received Engerix B pediatric. On 21st March 2022, unknown after receiving Engerix B pediatric, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 24-MAR-2022 Reporter's Comments: Consented to follow up. Additional Supportive Information: The patient was administered pediatric dose of Engerix B, which led to underdose and adult use of a child product. This case has been linked to US2022AMR054853 and US2022053923, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR054853:Same reporter US-GLAXOSMITHKLINE-US2022053923:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Pruritus, Rash
Clinical narrative: Arm is red; Arm is painful; Arm is itchy; Rash on neck; This case was reported by a consumer via interactive digital media and described the occurrence of erythema of extremities in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 20th March 2022, the patient received the 1st dose of Shingles vaccine. In March 2022, less than a week after receiving Shingles vaccine, the patient experienced erythema of extremities, pain in arm, itchy upper limbs and rash. On an unknown date, the outcome of the erythema of extremities, pain in arm, itchy upper limbs and rash were not recovered/not resolved.   It was unknown if the reporter considered the erythema of extremities, pain in arm, itchy upper limbs and rash to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 26-Mar-2022 Reporter's comment: The case was self reported by the patient. The patient received first dose of Shingles vaccine on last Sunday and The patient's arm was red, painful, itchy, and had rash on neck area. Additional Supportive Information: This case was reported via interactive digital media. Follow-up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: dose received, compromised due to improper storage; This case was reported by a pharmacist and described the occurrence of incorrect storage of drug in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date, (batch number 7D73A)).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   Linked case(s) involving the same patient:  US2022055941   Additional Information: Additional Information: GSK Receipt Date: 28-MAR-2022 Reporter's Comment: The patient received dose of Shingrix which had been compromised due to improper storage at her local pharmacy, which led to Incorrect storage of drug. The reporter asked did GlaxoSmithKline recommend that she repeat the second dose. The reporter consented to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: arm hurt for three 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.   In February 2022, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than 2 months 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.     Linked case(s) involving the same patient:  US2022AMR056428   Additional Information: GSK Receipt Date: 25-MAR-2022 Reporter's Comment: The patient received dose of Shingles vaccine last month and experienced arm hurt for three days. The patient stated that the Shingles shot was not too much worse than a flu shot. The patient also stated that he/she was not interested in finding out how shingles felt. Getting on face or eye could be very serious. Additional supportive information: The patient self-reported this case via interactive digital media. The follow-up would not possible, as no contact details were available. This case has been linked to the case US2022AMR056428 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR056428:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: i still get shingles/Suspected vaccination failure; had the vaccine and i still get shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 26-Mar-2022 Reporter's Comments: The patient self-reported this report. The patient had Shingle vaccine and still got shingles. Additional Supportive Information: This case was received from consumer via interactive digital media. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: made me sicker and worse side effects than shingles; 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.   The patient's past medical history included shingles.   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 Information: GSK Receipt Date: 25-Mar-2022 Reporter's Comments:  The patient had shingles and stated that he/she had to get the Shingle vaccine anyway. The patient reported that vaccine made him/her sicker and had worse side effects than shingles. The patient still got vaccine as his/her physician had ordered. Additional Supportive Information:  The patient self-reported this report. This case was received from consumer via interactive digital media. The follow-up would not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity, Tenderness
Clinical narrative: arm hurt pretty good, now it´s just little tender; 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 22nd March 2022, the patient received the 1st dose of Shingles vaccine. In March 2022, 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 recovering/resolving.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 27-Mar-2022 Reporter's Comments:  The patient got the Shingle shot on Tuesday and his/her arm hurt pretty good for 3 days. On the day of reporting, it was just a little tender.  The patient reported that there was second shot due in a couple months and he/she imagined results would be similar.  The patient stated that it was still a small price to pay for not having to deal with it. Additional Supportive Information: The patient self-reported this report. This case was received from consumer via interactive digital media. The follow-up would not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Illness, Vaccination failure
Clinical narrative: I got the shots for shingles, still had shingles/suspected vaccination failure; had shingles; sick and meds they made me sick; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and sickness. On an unknown date, the outcome of the vaccination failure, shingles and sickness were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and sickness to be related to Shingles vaccine.   Additional Information: GSK receipt date: 27-MAR-2022 Reporter's comment: This case was reported via interactive digital media. The patient got the shots for shingles but still had shingles and was so sick.  The physician gave him/her medicine and they made him/her sick so the patient let shingles run its purse.  Additional supportive information: The case was reported by the patient. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Post herpetic neuralgia, Vaccination failure
Clinical narrative: Got vaccine and came down with Shingles/Suspected vaccination failure; Wicked case of Shingles; Extremely painful; Deep nerve pain; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain and post herpetic neuralgia. On an unknown date, the outcome of the vaccination failure, shingles, pain and post herpetic neuralgia were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, pain and post herpetic neuralgia to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 26-Mar-2022 Reporter's Comments:  This case was received from consumer via interactive digital media. The patient self-reported this report. The stated that he/she got Shingle vaccine and came down with a wicked case of the Shingles and it was extremely painful and still deal with deep nerve pain, so he/she advised to be careful. Additional Supportive Information: This case described the occurrence of suspected vaccination failure This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash, Vaccination failure
Clinical narrative: has them now, had the Shingrix/suspected vaccination failure; has them now; rash; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and rash. The patient was treated with dermatologicals nos (Cream (Nos)) and medication unknown. On an unknown date, the outcome of the vaccination failure and rash were unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and rash to be related to Shingrix and Shingrix.     Additional Information: GSK receipt date: 26-MAR-2022 Reporter's comment: This case was reported via interactive digital media. The case was reported by the patient's wife. The patient had shingles now but had the 2 shot of Shingrix vaccine when it came out. The patient had the rash but never blistered. The patient was on medicine and creams. Additional supportive information: The case describe the occurrence of suspected vaccination failure. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR056675(invalid):Same reporter
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Asthenia, Chills, Fatigue, Feeling cold
Clinical narrative: Pain in arm; Headache; Tired; Muscle Aches; Shivering; coldness; Upset Stomach; Hives; Weakness; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th March 2022, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 19th March 2022, 1 days after receiving Shingrix, the patient experienced injection site pain, headache, tiredness, muscle pain, shivering, coldness, upset stomach, hives and weakness. On an unknown date, the outcome of the injection site pain, headache, tiredness, muscle pain, shivering, coldness, upset stomach, hives and weakness were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, headache, tiredness, muscle pain, shivering, coldness, upset stomach, hives and weakness to be related to Shingrix.     Additional Information: GSK Receipt Date: 22-MAR-2022 Reporter's Comments:  The patient self-reported this case. The patient received Shingrix on left deltoid and on next day after, the patient began experiencing headache, tiredness, pain in arm, muscle aches, shivering, coldness, upset stomach, hives and weakness. Till the time of reporting, the patient was still experiencing these symptoms as they had not resolved.   The reporter asked how long side effects last. The reporter consented to follow up.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Myalgia, Pain in extremity, Urticaria
Clinical narrative: Pain in arm; Headache; Tired; Muscle Aches; Shivering; coldness; Upset Stomach; Hives; Weakness; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th March 2022, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 19th March 2022, 1 days after receiving Shingrix, the patient experienced injection site pain, headache, tiredness, muscle pain, shivering, coldness, upset stomach, hives and weakness. On an unknown date, the outcome of the injection site pain, headache, tiredness, muscle pain, shivering, coldness, upset stomach, hives and weakness were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, headache, tiredness, muscle pain, shivering, coldness, upset stomach, hives and weakness to be related to Shingrix.     Additional Information: GSK Receipt Date: 22-MAR-2022 Reporter's Comments:  The patient self-reported this case. The patient received Shingrix on left deltoid and on next day after, the patient began experiencing headache, tiredness, pain in arm, muscle aches, shivering, coldness, upset stomach, hives and weakness. Till the time of reporting, the patient was still experiencing these symptoms as they had not resolved.   The reporter asked how long side effects last. The reporter consented to follow up.
Sex: U
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: Patient received an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received HAB (Twinrix) (batch number gg3s5, expiry date 28th February 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 21st March 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 21st March 2022, unknown after receiving Twinrix and Twinrix 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 Information: GSK receipt date:23-Mar-2022 Reporter's comment: The reporter was medical assistant. The patient's demographics were not reported since reporter did not have any information. Number of dose was not specified. The reporter consented to follow up via fax number.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: only liquid CYW-135 component was administered; only liquid CYW-135 component was administered; This case was reported by a physician via call center representative and described the occurrence of inappropriate preparation of medication in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMAA687A, expiry date 31st October 2022) for prophylaxis.   On 14th March 2022, the patient received Menveo. On 14th March 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 24-MAR-2022, 24-MAR-2022 Reporter's Comment:  The patient received a partial dose of Menveo as the nurse only administered the liquid CYW-135 component. The reporter consented to follow. Additional supportive information:  The patient received only liquid component, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The case US2022053914 is identified as duplicate of case US2022053915. All future correspondence would be added in case US2022053914, which stands as case of record for this patient and the case US2022053915 would be deleted. This case has been linked to the case US2022053912 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022053912:same reporter US-GLAXOSMITHKLINE-US2022053915:same patient, same reporter - FU1 - Deleted
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Muscle soreness in her arms and legs; This case was reported by a consumer via call center representative and described the occurrence of muscle soreness in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th March 2022, the patient received the 2nd dose of Shingrix. On 25th March 2022, 1 days after receiving Shingrix, the patient experienced muscle soreness. On an unknown date, the outcome of the muscle soreness was not recovered/not resolved.   It was unknown if the reporter considered the muscle soreness to be related to Shingrix.     Additional Information: GSK Receipt Date: 25-MAR-2022 Reporter's Comment: At the time of reporting, the patient was experiencing muscle soreness in her arms and legs. The reporter did not consent to follow-up. Additional supportive information: The patient self-reported this case. This case has been linked to the case US2022054959 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022054959:Same Reporter
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Inflammation, Injection site pain, Injection site swelling, Lip swelling, Pain in extremity
Clinical narrative: upper lip is swollen; prickly feeling; inflammation to the pre-existing areas of eczema on her arms and neck; arm pain at the injection site; swelling at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included hypertension, eczema, hypothyroidism, anxiety and anaphylaxis (after beta blocker). Concomitant products included clonazepam and levothyroxine sodium (Synthroid).   On 21st March 2022, the patient received the 1st dose of Shingrix (intramuscular). On 21st March 2022, less than a day after receiving Shingrix, the patient experienced injection site pain and injection site swelling. On 24th March 2022, the patient experienced pricking skin sensation and inflammation localized. On 25th March 2022, the patient experienced lip swelling. The patient was treated with benadryl (nos) (Benadryl Oral). On an unknown date, the outcome of the injection site pain was recovering/resolving and the outcome of the injection site swelling was recovered/resolved and the outcome of the pricking skin sensation and lip swelling were not recovered/not resolved and the outcome of the inflammation localized was unknown.   It was unknown if the reporter considered the injection site pain, injection site swelling, pricking skin sensation, inflammation localized and lip swelling to be related to Shingrix.     Additional Information: GSK Receipt Date: 25-Mar-2022 Reporter's comment: The patient self reported the case. On the day of Shingrix dose, the patient had arm pain and swelling at the injection site. On 24th March 2022 at 8pm, 3 days after Shingrix dose,the patient developed a prickly feeling and further described this feeling as inflammation to the pre-existing areas of eczema on arms and neck. On the day of reporting, 4 days after Shingrix administration, half of her upper lip was swollen. The injection site pain had decreased over the past four days and was mild now. She treated the prickly feeling and lip swelling with oral Benadryl. On the day of reporting patient was having appointment with her doctor.  The reporter consented to follow up with physician but declined to provide doctor's name or contact information at this time as she wanted to speak with him first. The reporter consented to follow up by email but declined to provide email.