chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: This regulatory authority case was reported by an other health care professional and describes the occurrence of BACK PAIN (Back pain) in a 27-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) for COVID-19 prophylaxis. No Medical History information was reported. On 29-Dec-2021, the patient received dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 05-Aug-2022, the patient experienced BACK PAIN (Back pain) (seriousness criterion hospitalization). At the time of the report, BACK PAIN (Back pain) outcome was unknown. The action taken with mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) was unknown. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication details were reported. The worldwide unique id was reported as PH-PHFDA-300153509. No treatment medication details were reported. Company Comment: This is a regulatory case concerning a 27-year-old female patient with no reported medical history, who experienced the unexpected serious (Caused / prolonged hospitalization) event of Back pain which occurred approximately 7 months after receiving a dose of mRNA-1273 Vaccine, dose number unknown. There is no available information regarding clinical course, diagnostic tests/procedures, and treatment medication. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Sender's Comments: This is a regulatory case concerning a 27-year-old female patient with no reported medical history, who experienced the unexpected serious (Caused / prolonged hospitalization) event of Back pain which occurred approximately 7 months after receiving a dose of mRNA-1273 Vaccine, dose number unknown. There is no available information regarding clinical course, diagnostic tests/procedures, and treatment medication. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event, Product storage error
Clinical narrative: No additional AE; Two doses of MMR II administered after a prior temperature excursion; route: IM; Information has been received from a nurse, referring to a 4 years old male patient.  Information about concurrent condition, concomitant medication and medical history was not provided.    On 31-MAR-2022, the patient was vaccinated with the first dose of temperature excursion measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot # T039671 (therapy type rHA), expiration date on 24-NOV-2022) intramuscularly for prophylaxis (incorrect route of product administration and product storage error). No adverse effects were reported.   The measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was entered with freezer temperature/time instead of the refrigerated temperature/time. The vaccines had a temperature prior of 10.4 Celsius degree for 3 hours and 30 minutes; current of 8.6 Celsius degree of 1 hour 1 minute.  This is one of two reports received from the same reporter.
Sex: M
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; an expired dose of ROTATEQ was administered to a patient; the vaccine was also potentially part of a temperature excursion; This spontaneous report was received from the other health professional referring to a male patient of unknown age. No information about the patient's pertinent medical history, concurrent conditions, concomitant medications, or drug reactions or allergies was provided.  On an unknown date, the patient was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, administered orally for prophylaxis (strength, vaccination scheme frequency, dose, lot number and expiration date were not reported).  On 21-JUL-2022, the patient was vaccinated with the second dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #1742080, expiration date: 14-JUL-2022, administered orally for prophylaxis (strength, vaccination scheme frequency and dose were not reported) (expired product administered) after a temperature excursion (temperature: 67 Fahrenheit (F); time frame: 4 hours and 15 minutes, date of excursion: 06-MAR-2022) (product storage error). No additional adverse event was reported (no adverse event).
Age: 6.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE reported; a six year old patient was accidently administered GARDASIL 9 on Jul 25, 2022; This spontaneous report was received from a medical assistant referring to a 6-year-old patient of an unknown gender. The patient's pertinent medical history, concurrent conditions, drugs reactions or allergies and concomitant therapies were not provided.  On 25-JUL-2022, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) once (lot #1780876, expiration date: 09-NOV-2023; strength, dose, anatomical injection site and route of administration were not provided) administered for prophylaxis (product administered to patient of inappropriate age). No additional adverse event (AE) reported (no adverse event).  This is one of two reports from the same reporter. ; Sender's Comments:  US-009507513-2207USA007948:MSD
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event, Product storage error
Clinical narrative: No additional AE; Two doses of MMR II administered after a prior temperature excursion; route: IM; Information has been received from a nurse, referring to a 12 month old male patient. Information about concurrent condition, concomitant medication and medical history was not provided.    On 15-JUN-2022, the patient was vaccinated with the first dose of temperature excursion measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot # T039671 (therapy type rHA), expiration date on 24-NOV-2022) intramuscularly for prophylaxis (incorrect route of product administration and product storage error). No adverse effects were reported.   The measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was entered with freezer temperature/time instead of the refrigerated temperature/time on 12-APR-2022. The vaccines had a temperature prior of 10.4 Celsius degree for 3 hours and 30 minutes; current of 8.6 Celsius degree of 1 hour 1 minute.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2207USA006637:
Age: 1.0
Sex: F
Vaccine: DTAPHEPBIP, HEPA, MMR, PNC13, VARCEL
Symptoms: Hypersensitivity, Rash
Clinical narrative: Systemic trunk reaction and extremity rash; extremity rash; This spontaneous report has been received from a nurse practitioner referring to a 1-year-old female patient. Information regarding the patient's pertinent medical history, concomitant therapies and previous drug reactions or allergies was not provided. On an unknown date in 2022 (also reported as 8 days prior to having the vaccines administered), the child tested positive for COVID.  On an unknown date in 2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX), measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), pneumococcal vaccine conj 13v (crm197) (PREVENAR 13), hepatitis a vaccine inact (HAVRIX), and diphtheria vaccine toxoid hepatitis b vaccine rhbsag (yeast), pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (PEDIARIX) administered for prophylaxis (also reported as 12 month shots) (strength, dose, frequency, route of administration lot number and expiration date were unknown by the reporter).  On an unknown date in 2022, the patient experienced systemic trunk reaction and extremity rash (hypersensitivity/rash). At the time of reporting, the patient was recovering from the events.  The causal relationship between the vaccines and the aforementioned events was not provided.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No AE/PQC.; Inbound call from HCP reporting a patient was administered and expired dose of ROTATEQ. No AE/PQC.; This spontaneous report has been received from a certified medical assistant concerning an infant of 4 months and 5 days of unknown gender. The patient's concomitant medications, pertinent medical history, and drug reactions/allergies were not reported.  On 01-AUG-2022, the patient was administered with expired rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # 1821795, expiration date 27-JUL-2022; strength and dose were not reported) orally for prophylaxis (expired product administered). There was no adverse event (AE).
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antibody
Clinical narrative: Caller is pharmacist that reports nursing student states she had a hepatitis B titer drawn and it was "too low (3.2)" after receiving a three dose series of hepatitis B vaccine as a child. Unknown manufacturer of hepatitis B vaccine. Unknown dates of; This spontaneous report was received from a pharmacist referring to a female patient of an unknown age. The patient's medical history, concurrent conditions, concomitant medications and previous drugs allergies or reactions were not reported.  On an unspecified date (reported as "as a child"), the patient was vaccinated with three dose series of hepatitis B vaccine (recombinant) (manufacturer unknown).  On an unspecified date (reported as "after receiving three dose series of hepatitis B vaccine"), the patient underwent the following laboratory test: hepatitis B titer drawn (hepatitis B surface antibody) that showed too low (3.2) (units not provided) (hepatitis B surface antibody negative). At the time of reporting, the outcome of the event was not reported.  The causal relationship between hepatitis B vaccine (recombinant) and the event was not reported.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE information reported.; HCP called to report that ROTATEQ vaccine that expired on 7/14/2022 was inadvertently administered to two patients.; This spontaneous report was received from a medical assistant regarding a patient of an unknown age and gender. The patient's medical history, concurrent conditions, and concomitant medications were not reported.   On 20-JUL-2022, the patient was inadvertently vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 ml, lot #1742080, expiration date: 14-JUL-2022, (strength was not provided) as prophylaxis (Expired product administered). The reporter confirmed that the product did not have any temperature excursions prior to administration. No additional adverse event (AE) information reported.  This is one of two cases from the same reporter.; Sender's Comments:  US-009507513-2208USA002381:
Sex: U
Vaccine: VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Pharmacist reports that patient received first dose of VARIVAX as a child but did not complete series as recommended. Pharmacist reports that patient received the second dose as an adult. No additional details available. Call was disconnected before; No additional adverse events.; This spontaneous report was received from pharmacist and refers to a adult patient (exact age not reported) of unknown gender. The patient's medical, concurrent conditions and concomitant therapies were not reported.  On an unknown date, as child, the patient was vaccinated with first dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection (exact dose, lot #, expiry date, route of administration, and anatomic location were not provided) for prophylaxis. The patient did not complete series as recommended and on an unknown date, second dose was administered to adult patient (inappropriate schedule of product administration). No additional adverse events was reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Medical assistant reported PROQUAD was administered after a temperature excursion to multiple patients. This case is for patient three of four.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and therapies were not reported.  On 04-AUG-2022, the patient was vaccinated with improperly stored (product storage error) dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin) (PROQUAD) once, lot #: W010061, expiration date: 20-SEP-2023 (exact dose, strength, formulation, site and route of administration were not provided) for prophylaxis. Temperature excursion information: 5.56 degree Fahrenheit for 3 hours and 30 minutes. No previous temperature excursion. There was no additional adverse event reported.
Age: 28.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient had no reported side effects; was accidently administered to a patient intramuscularly instead of subcutaneously today.; vaccine administered to a 28-years-old patient; This spontaneous report was received from certified medical assistant and refers to a 28-year-old patient of unknown gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 05-AUG-2022, the patient was administered a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, recombinant human albumin (rHA), 0.5 ml, lot # U006487, expiration date: 26-FEB-2023, administered intramuscularly for prophylaxis (strength, and route of administration were not provided) (incorrect route of product administration, product administered to patient of inappropriate age). Patient had no reported side effects (no adverse event).
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: No additional adverse events; Caller is medical assistant requesting four doses administered of improperly stored MMR II.; This spontaneous report has been received from a medical assistant, referring to a 12-month-old patient. The patient's concurrent conditions, medical history, concomitant medications, previous drug reactions, or allergies were not provided.  On 27-JUL-2022, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (recombinant human albumin rHA) (Wistar RA 27-3) virus vaccine, live (M-M-R II) (lot number U023829 has been verified to be a valid lot number, expiry date 30-JUL-2023) (strength, dose, frequency, and route of administration were not provided) as prophylaxis.  The measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) wsa stored at a temperature of 10.1 degree Celsius (C) for a time frame of 15 minutes. There was no previous temperature excursion.  No additional adverse event were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2208USA003406:
Sex: M
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: HCP called for temperature stability evaluation of vaccines and reported that 10 pediatric patients received PROQUAD vaccine since excursion date on 7/14/2022. See additional AEs filed under interaction 02221034.  No PQCs reported at this time.; This spontaneous report was received from a medical assistant referring to a 5-year-old male. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date in 2022, the patient was vaccinated with an improperly stored first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, 0.5ml, lot number W002781 with expiration date: 24-JUL-2023, administered for prophylaxis (strength, and route of administration were not provided).; Sender's Comments:  US-009507513-2208USA004135:
Age: 13.0
Sex: M
Vaccine: MMR, MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no adverse event; PROQUAD was administered to a 16 year old patient; the patient received a dose of MMR in 2019; This spontaneous report was received from a nurse and refers to a 16-year-old male patient.  The patient's medical history and concurrent conditions were not reported. Hisconcomitant therapies included varicella virus vaccine live (oka/merck) (VARIVAX).  On an unknown date in 2019, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, dosage regimen, lot #, expiry date, anatomical location, and route of administration were not provided), as prophylaxis (Inappropriate age at vaccine administration).  On 03-AUG-2022, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumina (rHA) (PROQUAD) 1 time dose, lot #W012729, expiration date: 16-OCT-2023, (strength, dosage regimen, anatomical location, and route of administration were not provided) as prophylaxis(Inappropriate age at vaccine administration). No adverse event was reported.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: HCP states 18 year old patient received 1st dose of GARDASIL 9 at 13 years and is in clinic today 8/15/22 to receive 2nd dose.; No additional AEs; This spontaneous report was received from a physician and refers to an 18-year-old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On an unknown date, at the age of 13 years old, the patient was vaccinated with her first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5ml, for prophylaxis (lot #, expiry date, anatomical location and route of administration were not provided). The vaccine was planned to be administered according to 3-dose schedule at 0, 2, and 6 months. It was not administered according to the recommended immunization schedule and at the reporting time, at the age of 18 years old, the patient was at a clinic to receive her second dose (inappropriate schedule of product administered).  There were no adverse events reported (no adverse event).
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Burning sensation, Herpes zoster, Lacrimation increased, Pain, Phantom limb syndrome
Clinical narrative: I had both shots and still got shingles/suspected vaccination failure; I had both shots and still got shingles/down my back n around my breast/Going on 9 weeks with shingles; still have phantom pain; rash disappearing; still have burning n pain; still have pain/worst pain in my life; Brought me to tears; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, phantom pain, rash, burning sensation, pain and lacrimation. On an unknown date, the outcome of the vaccination failure and lacrimation were unknown and the outcome of the shingles, phantom pain, burning sensation and pain were not recovered/not resolved and the outcome of the rash was recovering/resolving.   It was unknown if the reporter considered the vaccination failure, shingles, phantom pain, rash, burning sensation, pain and lacrimation to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 30-Aug-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had both the shots 3 years ago and still got shingles down in his/her back and around his/her breast on right side, going on his/her 9th week. The patient still have had phantom pain, rash disappearing but still have had burning and pain. The patient stated that he/she had worst pain in his/her life, brought him/her to tears when he/she had to lay down. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available. In worst approach, Lacrimation event was coded based upon the verbatim brought me to tears.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Vaccination failure
Clinical narrative: I had both shots and still got shingles/suspected vaccination failure; I had both shots and still got shingles/down my back n around my breast/Going on 9 weeks with shingles; still have phantom pain; rash disappearing; still have burning n pain; still have pain/worst pain in my life; Brought me to tears; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, phantom pain, rash, burning sensation, pain and lacrimation. On an unknown date, the outcome of the vaccination failure and lacrimation were unknown and the outcome of the shingles, phantom pain, burning sensation and pain were not recovered/not resolved and the outcome of the rash was recovering/resolving.   It was unknown if the reporter considered the vaccination failure, shingles, phantom pain, rash, burning sensation, pain and lacrimation to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 30-Aug-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had both the shots 3 years ago and still got shingles down in his/her back and around his/her breast on right side, going on his/her 9th week. The patient still have had phantom pain, rash disappearing but still have had burning and pain. The patient stated that he/she had worst pain in his/her life, brought him/her to tears when he/she had to lay down. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available. In worst approach, Lacrimation event was coded based upon the verbatim brought me to tears.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: I received 2 shots and I still got it/ Suspected Vaccination Failure; I received 2 shots and I still got it; still got it, very painful; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. The patient was treated with lidocaine. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 10-Aug-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient reported that it does not matter, he/she received 2 shots and still got them. The patient stated that it was very very painful. The patient did not had blisters and they gave lidocaine to him/her it really helped. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Rash, Sciatica, Vaccination failure
Clinical narrative: HAD SHINGLES/Suspected vaccination failure; Shingles; Sciatica; rash; pain; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, less than a year after receiving Shingles vaccine and unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, sciatica, rash and pain. On an unknown date, the outcome of the vaccination failure, shingles and rash were unknown and the outcome of the sciatica was recovered/resolved and the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, rash and pain to be related to Shingles vaccine and Shingles vaccine. It was unknown if the reporter considered the sciatica to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 31-JUL-2022 Reporter's Comments: This case was reported by the patient via interactive digital media. Last year the patient had a four-month battle with sciatica and had gone to pharmacy to get second dose of Shingrix.  The patient was broken out with rash on same side as sciatica and the pharmacist said patient did not had shingles. The patient's husband took a picture of the rash when it started and when patient went to doctor patient had shingles. The patient still had a pain a year later. The patient was doing PT (unspecified) right now till the patient got into back to doctor. The patient reported that shingles were not nearly as bad as they could had been without vaccine. The patient stated glad she got vaccine. Additional Supportive Information: This case was considered as suspected vaccination failure as detail regarding laboratory test confirming shingles was unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had the shot and got Shingles/Suspected vaccination failure; Had the shot and got 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: 03-AUG-2022 Reporter's Comments: The case was received from the patient via interactive digital media. The patient had the Shingles shot and got shingles. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination, time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had shingles, just took a shingle shot/Suspected vaccination failure; 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.   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 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: 01-AUG-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient stated that he/she could write a book on shingles, he/she had them twice and the 2nd time, he/she had just taken a Shingle shot. The patient also stated that it must had caused him/her to get them the 2nd time around. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: took shingles shot, still got them again/ Suspected Vaccination failure; 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.   The patient's past medical history included shingles (had shingles twice).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was treated with amitriptyline. 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: 3-AUG-2022 Reporter's Comments: The patient self-reported the case via  interactive digital media. The patient had the Shingles shot and still got shingles again. The patient took Amitriptyline every day to hold them back to that day. The patient still felt like the shot had helped. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. Follow up was not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain, Vaccine positive rechallenge
Clinical narrative: soreness at injection site; Fatigue; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (For tolerance of 1st dose refer case US2022116441).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain and fatigue. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain and fatigue were recovered/resolved.   It was unknown if the reporter considered the injection site pain and fatigue to be related to Shingrix.   Linked case(s) involving the same patient:US2022116441   Additional Information: GSK Receipt Date: 08-AUG-2022. Reporter's Comments: The case was reported by the patient. In 2018, the patient received Shingrix. The patient experienced soreness at injection site and fatigue after 2nd dose. The reporter did not consent to follow-up.; Sender's Comments:  US-GSK-US2022116441:Same reporter,same patient
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: First shot 12/27/21. It has been more than 6 months; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose of Shingles vaccine received on 27th December 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional Information: GSK Receipt Date: 11-Aug-2022. Reporter's Comments: This case was reported by the patient via interactive digital media. The patient received 1st dose more than 6 months ago. The patient asked he/she should get a 2nd dose. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingles vaccine, which led to incomplete course of vaccination. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Herpes zoster, Rash papular, Rash pruritic
Clinical narrative: I had shingles/Now I have shingles; I'm allergic to the vaccine; I feel horrible with the people who have shingles.; All bumpy on my chest; itchy on my chest; This case was reported by a consumer via interactive digital media and described the occurrence of shingles 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, less than a day after receiving Shingles vaccine, the patient experienced shingles, allergy to vaccine, feeling bad, papular rash and itchy rash. Shingles vaccine was discontinued. On an unknown date, the outcome of the shingles was not recovered/not resolved and the outcome of the allergy to vaccine, feeling bad, papular rash and itchy rash were unknown.   The reporter considered the shingles to be related to Shingles vaccine. It was unknown if the reporter considered the allergy to vaccine, feeling bad, papular rash and itchy rash to be related to Shingles vaccine.     Additional Information: GSK receipt date: 31-July-2022 Reporters comment: This case was reported by the patient via interactive digital media. The patient never had shingles in his/her life. As a precautionary measure he/she got the first dose of vaccine because he/she was over 60 years.  The patient thought he or she was allergic to the vaccine. Within 24 hours he/she got shingles. All bumpy and itchy on my chest. The patient stated that the vaccine gave him/her shingles. Not fun. It keeps spreading. The patient stated would not be getting the second dose. Obviously, he/she was allergic to whatever was in that vaccine, but how would he/she know what he/she was allergic to with words he/she could not even pronounce. The patient felt horrible with the people who had shingles. Now the patient had shingles. The patient stated do not get that vaccine unless you do your research. Additional Supportive Information: Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: lots of pain have it 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 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 not recovered/not resolved.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 01-AUG-2022 Reporter's Comments: This case was received from consumer via interactive digital media. The reporter reported that the worse thing he/she ever had going on seven weeks had the old vaccine. The patient had lots of bad pain. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Illness
Clinical narrative: got the shingles within days of the 2nd shot/Within days I got shingles; I was so sick; This case was reported by a consumer via 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 the 2nd dose of Shingles vaccine. On an unknown date, less than a week after receiving Shingles vaccine, the patient experienced shingles and sickness. On an unknown date, the outcome of the shingles and sickness were unknown.   It was unknown if the reporter considered the shingles and sickness to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 03-AUG-2022 Reporter's Comments: This case was reported by the patient via interactive digital media. The patient had no intention of getting the vaccine. One of his/her friends talked him/her into it. After the second dose the patient was so sick, he/she thought that they gave him/her the Covid vaccine by mistake. The patient reported that the Shingles shot did not prevent you from getting it.  The patient got the shingles within days of the second shot. Once the patient posted it so many others said, it happened to them as well. Same thing happened to the patient.  Additional supportive information: This case was linked with case US2022AMR119367 reported by same reporter.  The follow-up could not be possible as no contact details were available.; Sender's Comments:  US-GSK-US2022AMR119367: case/Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Sore arm; 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 2nd August 2022, the patient received Shingles vaccine. On 2nd August 2022, less than a day after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Additional Information: GSK receipt date: 2-AUG-2022 Reporter's comments: This case was reported by patient via interactive digital media. The patient went and had his/her vaccine today after a recommendation from doctor.  The patient had sore arm so far. The follow up would not be possible as contact details were not provided.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Product use in unapproved indication, Pruritus, Rash, Vaccination failure
Clinical narrative: recurrent shingles rashes after second dose; recurrent shingles rashes after second dose; second dose may have been given while shingles; shingles rashes; Itching; second dose may have been given while shingles; This case was reported by a other health professional via call center representative and described the occurrence of vaccination failure in a adult female patient who received Herpes zoster (Shingrix) (batch number 9EY93, expiry date 15th April 2023) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 20th January 2022, the patient received the 1st dose of Shingrix. In 2022, the patient received the 2nd dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix and 3 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, shingles, rash, itching and drug use for unapproved indication. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the vaccination failure, shingles, shingles and drug use for unapproved indication were unknown and the outcome of the rash was recovered/resolved and the outcome of the itching was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and shingles to be related to Shingrix. It was unknown if the reporter considered the vaccination failure, shingles, rash and itching to be related to Shingrix.     Additional Information: GSK Receipt Date: 03-AUG-2022.  Reporter's Comments: Pharmacy intern stated female patient received first dose of Shingrix series. The patient did receive the second dose, but it was given at a different location so reporter was unsure of the date received.  Pharmacy intern stated it was believed the second dose might have been given while the patient had a case of shingles, but the patient did not know she had shingles at the time.  The patient reported she started having recurrent shingles rashes 3 months after the second dose.  She currently (at the time of reporting) did not have a rash but did still have itching.  The consent to follow up was granted. Additional Supportive Information: This case was considered as suspected vaccination failure since the details regarding laboratory confirmation of shingles were unknown at the time of reporting. As patient received second dose while patient having shingles, which led to drug use for unapproved indication.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Vaccine positive rechallenge
Clinical narrative: recurrent shingles rashes after second dose; recurrent shingles rashes after second dose; second dose may have been given while shingles; shingles rashes; Itching; second dose may have been given while shingles; This case was reported by a other health professional via call center representative and described the occurrence of vaccination failure in a adult female patient who received Herpes zoster (Shingrix) (batch number 9EY93, expiry date 15th April 2023) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 20th January 2022, the patient received the 1st dose of Shingrix. In 2022, the patient received the 2nd dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix and 3 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, shingles, rash, itching and drug use for unapproved indication. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the vaccination failure, shingles, shingles and drug use for unapproved indication were unknown and the outcome of the rash was recovered/resolved and the outcome of the itching was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and shingles to be related to Shingrix. It was unknown if the reporter considered the vaccination failure, shingles, rash and itching to be related to Shingrix.     Additional Information: GSK Receipt Date: 03-AUG-2022.  Reporter's Comments: Pharmacy intern stated female patient received first dose of Shingrix series. The patient did receive the second dose, but it was given at a different location so reporter was unsure of the date received.  Pharmacy intern stated it was believed the second dose might have been given while the patient had a case of shingles, but the patient did not know she had shingles at the time.  The patient reported she started having recurrent shingles rashes 3 months after the second dose.  She currently (at the time of reporting) did not have a rash but did still have itching.  The consent to follow up was granted. Additional Supportive Information: This case was considered as suspected vaccination failure since the details regarding laboratory confirmation of shingles were unknown at the time of reporting. As patient received second dose while patient having shingles, which led to drug use for unapproved indication.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: dose of boostrix to a patient on 8/9/2022, last dose of tdap was on OCT 2021.; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 11-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 3A745, expiry date 12th March 2024) for prophylaxis.   Previously administered products included Tdap vaccine (Last dose of Tdap vaccine received on October 2021).   On 9th August 2022, the patient received the 2nd dose of Boostrix. On 9th August 2022, unknown after receiving Boostrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.      Additional Information: GSK Receipt Date: 09-AUG-2022 Reporter's Comment: The reporter was a healthcare professional. The reporter stated that on the day of reporting healthcare professional administered Boostrix vaccine to the patient. The reporter wanted any data. The reporter consented to follow up. Additional supportive information: The patient received Boostrix vaccine early than recommended time frame, which led to shortening of vaccinations schedule.
Sex: U
Vaccine: RV1
Symptoms: Product preparation error
Clinical narrative: Using another diluent than recommended; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Rota (Rotarix lyophilized formulation) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On an unknown date, the patient received Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On an unknown date, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced wrong solution used in drug reconstitution. On an unknown date, the outcome of the wrong solution used in drug reconstitution 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: 09-Aug-2022 Reporter comment: A nurse reported that a box of Rotarix vaccines had an extra diluent. The nurse explained that the potential risk of a patient who may be administered with Rotarix using another diluent than recommended. The nurse was not sure if the vaccine was administered orally or using another route. The reporter consented to follow up. Additional Supportive Information: Rotarix reconstituted with another diluent than recommend, which led to wrong solution used in drug reconstitution.