chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Blood glucose abnormal, CSF test abnormal, Cerebrospinal fluid drainage, Magnetic resonance imaging spinal abnormal
Clinical narrative: After taking the 1st vaccine in March 2021, His skin peeled over his entire body, with minimal itching. He was only given skin cream and tried different lotions. In april, he took the 2nd vaccine he had the normal side effects for a little over a week, and then he started getting weaker, eventually he was rushed to the hosptial on May 7. He had spiked fevers and sugar levels from him being so ill. He is now paralyzed from the waist down and still in the hospital fighting it.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Paralysis, Paraplegia, Pyrexia, Spinal operation
Clinical narrative: After taking the 1st vaccine in March 2021, His skin peeled over his entire body, with minimal itching. He was only given skin cream and tried different lotions. In april, he took the 2nd vaccine he had the normal side effects for a little over a week, and then he started getting weaker, eventually he was rushed to the hosptial on May 7. He had spiked fevers and sugar levels from him being so ill. He is now paralyzed from the waist down and still in the hospital fighting it.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Chlamydia test, Cold sweat, Diarrhoea, Dizziness, Gonorrhoea
Clinical narrative: I had no symptoms after receiving the first dose, but after receiving the second dose I developed a high fever of 103 degrees as well as body aches, hypersensitivity, dizziness, migraines, and diarrhea. I eventually began taking ibuprofen to manage the symptoms, starting on night one. I then usually took ibuprofen twice a day after that. My symptoms were completely treated by ibuprofen and nearly all of them disappeared when I took it, besides the diarrhea. Oddly I also developed cold sweats when taking ibuprofen, which would dissipate after the ibuprofen stopped working. The symptoms kept coming back, as far as a week later, however, I didn?t have to take as much ibuprofen as before because they were becoming intermittent. Today, I almost got through the whole day without a return of any of my symptoms, until about 11:00 PM, after which all symptoms came back, the difference being that my fever is now low grade. This has been the case for two days now, no symptoms until night, when they all return promptly.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity, Migraine, Pain, Pharyngeal swelling, Pyrexia
Clinical narrative: I had no symptoms after receiving the first dose, but after receiving the second dose I developed a high fever of 103 degrees as well as body aches, hypersensitivity, dizziness, migraines, and diarrhea. I eventually began taking ibuprofen to manage the symptoms, starting on night one. I then usually took ibuprofen twice a day after that. My symptoms were completely treated by ibuprofen and nearly all of them disappeared when I took it, besides the diarrhea. Oddly I also developed cold sweats when taking ibuprofen, which would dissipate after the ibuprofen stopped working. The symptoms kept coming back, as far as a week later, however, I didn?t have to take as much ibuprofen as before because they were becoming intermittent. Today, I almost got through the whole day without a return of any of my symptoms, until about 11:00 PM, after which all symptoms came back, the difference being that my fever is now low grade. This has been the case for two days now, no symptoms until night, when they all return promptly.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Streptococcus test
Clinical narrative: I had no symptoms after receiving the first dose, but after receiving the second dose I developed a high fever of 103 degrees as well as body aches, hypersensitivity, dizziness, migraines, and diarrhea. I eventually began taking ibuprofen to manage the symptoms, starting on night one. I then usually took ibuprofen twice a day after that. My symptoms were completely treated by ibuprofen and nearly all of them disappeared when I took it, besides the diarrhea. Oddly I also developed cold sweats when taking ibuprofen, which would dissipate after the ibuprofen stopped working. The symptoms kept coming back, as far as a week later, however, I didn?t have to take as much ibuprofen as before because they were becoming intermittent. Today, I almost got through the whole day without a return of any of my symptoms, until about 11:00 PM, after which all symptoms came back, the difference being that my fever is now low grade. This has been the case for two days now, no symptoms until night, when they all return promptly.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Insomnia
Clinical narrative: 1st night numbness in right arm (not the vaccinated arm) spreading to the entire right side of the body with the next 2 hours. Numbness similar to the numb feeling from Novacaine. By next morning, entire body was numb from toes to scalp. Full body numbness for 3-4 days, then both arms started to feel more normal, then in the next 2-3 days remaining body parts started to come back to normal, except for the scalp. After another week, the numbness faded and felt normal again. After the numbness subsided, started having difficulty falling asleep, taking up to 3-4 hours to fall asleep. Still having difficulty now falling asleep. Not sure if the sleep issues are vaccine related.
Sex: U
Vaccine: COVID19
Symptoms: Systemic lupus erythematosus
Clinical narrative: I read on an app that DR. has 2 patients who have developed Lupus and after the Pfizer vaccine. He is still studying the cases closely to report them; This is a spontaneous report from a contactable consumer. This consumer reported for patient 2 of 2 patients. A patient of unspecified age and gender received bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as unknown, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The consumer stated that, read on the app that doctor has 2 patients who had developed lupus after the Pfizer vaccine. He was still studying the cases closely to report them. Treatment received for the event was unknown. The seriousness of the reported event was medically significant. The clinical outcome of the event was unknown.  Information about lot/batch number cannot be obtained. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: HEPA, MMR, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AEs, no PQCs; MMR II, VARIVAX, and Hep A vaccines were administered on 26FEB2021 to a patient that was 12 months old at the time, then MMR II, VARIVAX and Hep A vaccines were administered again on 03MAY2021; This spontaneous report was received from a medical assistant referring to a 15-month-old patient of unknown gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 26-FEB-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, route, lot number and expiration date were not provided),  hepatitis  A (manufacture unknown) (1 dosage form (reported as 1 time dose), strength, route, lot number and expiration date were not provided) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (1 dosage form (reported as 1 time dose), lot number reported as CE74N, conflicting information: the reporter did not know the date this LOT was administered; strength, route and expiration were not provided) as prophylaxis.      On 03-MAY-2021, the patient was vaccinated again with varicella virus vaccine live (oka/merck) (VARIVAX) (lot # T027303, expiration date was not provided, but upon internal validation established as 12-AUG-2022, 1 dosage form (1 time dose)),  hepatitis  A (manufacture unknown) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) as prophylaxis (inappropriate schedule of product administration). No additional adverse events (AEs), no product quality complaints (PQCs) (no adverse event).
Sex: U
Vaccine: HPV9
Symptoms: Incomplete course of vaccination
Clinical narrative: The customer on the line to inquire if GARDASIL 9 dosing schedule needs to be restarted/The patient received the first dose of GARDASIL 9 in August 2020/1 time dose.; This spontaneous report was received from a patient of unknown age and gender referring to him\her self. pertinent medical history, previous drug reactions or allergies and concomitant medications were not provided.  In August 2020, the patient was vaccinated at doctor's office, with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, route of administration, anatomical location, lot# and expiration date were not provided) 1 time dose as prophylaxis.         The patient inquired if hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) dosing schedule was needed to be restarted (inappropriate schedule of product administration).  This is one of several reports received from the same reporter.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional AE reported; scheduled to receive one dose of PROQUAD and one dose of QUADRACEL, but was accidently administered two doses of PROQUAD; scheduled to receive one dose of PROQUAD and one dose of QUADRACEL, but was accidently administered two doses of PROQUAD; This spontaneous report was received from a licensed practical nurse concerning a 5-year-old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.      On an unspecified date (reported as at the age of 12 to 15 months), the patient was vaccinated with her first dose of  measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (dose, route, lot # and expiry date were unknown).  On 09-JUN-2021, the patient  was scheduled to receive one dose of  measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) and one dose of diphtheria vaccine toxoid, pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid(QUADRACEL); but was accidentaly administered two doses (1 millilter) of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(rHA)(PROQUAD) (route not reported) lot # U002529, expiration date 24-JUL-2022, for prophylaxis. No additional adverse event reported.
Age: 60.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia, Visual impairment
Clinical narrative: shingles; postherpetic neuralgia; vision issues; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently might be 67 years old patient of unknown gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 08-AUG-2014, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot number, dosage and route of administration not provided) for the long-term prevention of shingles and zoster-related conditions. Subsequently, the patient was treated by providers for the following injuries resulting from the patient's zoster vaccine live (ZOSTAVAX) use: herpes zoster, postherpetic neuralgia and vision issues. The outcome of the events were not reported. The events were considered related to zoster vaccine live (ZOSTAVAX).
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Product storage error
Clinical narrative: No other AEs reported.; administration of improperly stored MMR II and VARlVAX; This spontaneous report was received from a physician who refers to a 12-month-old male patient. Information regarding the patient's drug reactions or allergies, concomitant therapies and his pertinent medical history was not provided. On 11-JUN-2021, the patient was vaccinated with improperly stored: varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 ml one time, lot # T025944, expiry date 30-JUL-2022, and measles (+) mumps (+) rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) 0.5 ml one time, lot # S039311, expiry date 04-DEC-2021; both for prophylaxis (formulation, concentration, dose number, route of administration for both vaccines were not reported). Digital data logger was involved. The vaccines underwent the temperature excursion in the range from 14 degrees of Fahrenheit (F) to 46 F for 2 hours and from 6 F to 14 F for 40 minutes (temperature excursion was also reported as 19.7 F "max"). There was no previous temperature excursion. No additional adverse effects were reported. No product quality complaint (PQC) was involved.
Sex: F
Vaccine: HPV4
Symptoms: Cervical dysplasia, Chlamydial infection, Colposcopy abnormal, Papilloma viral infection, Precancerous condition
Clinical narrative: precancerous dysplasia; HPV positive/HPV; Chlamydia; This spontaneous report was received from a nurse practitioner concerning her step daughter, a 25 years old female patient. The patient's concurrent conditions included gastrooesophageal reflux disease (GERD), hiatus hernia and haematuria. The patient's medical history included tonsillectomy. Concomitant therapies included unspecified birth control medication, folic acid and dicycloverine hydrochloride (BENTYL).  On an unknown date (reported as when the patient was younger), the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (the dose, lot# were not reported; at the route of intramuscular) as prophylaxis.         In 2017, the patient was diagnosed with chlamydial (preferred term: chlamydial infection). In 2019, the patient was diagnosed with chlamydial and Human papillomavirus (HPV) (preferred term: papilloma viral infection). She completed a colposcopy. However, the reporter did not have the records available. The reporter did not know which HPV type which the patient had. However, the reporter was told it was the low risk HPV type. In 2020, the patient had another pap smear and was told she needed another colposcopy. In 2021, the patient was diagnosed with precancerous dysplasia (preferred term: cervical dysplasia) and was advised she would need another colposcopy and possibly a loop electrosurgical excision procedure (LEEP) procedure. No medical attention was sought. The patient had not recovered from all the events. Action taken with quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) was not applicable.   The causality between the quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) and all the events was not reported.   Upon internal review, the event of chlamydial infection was considered to be medically significant.
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix abnormal
Clinical narrative: precancerous dysplasia; HPV positive/HPV; Chlamydia; This spontaneous report was received from a nurse practitioner concerning her step daughter, a 25 years old female patient. The patient's concurrent conditions included gastrooesophageal reflux disease (GERD), hiatus hernia and haematuria. The patient's medical history included tonsillectomy. Concomitant therapies included unspecified birth control medication, folic acid and dicycloverine hydrochloride (BENTYL).  On an unknown date (reported as when the patient was younger), the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (the dose, lot# were not reported; at the route of intramuscular) as prophylaxis.         In 2017, the patient was diagnosed with chlamydial (preferred term: chlamydial infection). In 2019, the patient was diagnosed with chlamydial and Human papillomavirus (HPV) (preferred term: papilloma viral infection). She completed a colposcopy. However, the reporter did not have the records available. The reporter did not know which HPV type which the patient had. However, the reporter was told it was the low risk HPV type. In 2020, the patient had another pap smear and was told she needed another colposcopy. In 2021, the patient was diagnosed with precancerous dysplasia (preferred term: cervical dysplasia) and was advised she would need another colposcopy and possibly a loop electrosurgical excision procedure (LEEP) procedure. No medical attention was sought. The patient had not recovered from all the events. Action taken with quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) was not applicable.   The causality between the quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) and all the events was not reported.   Upon internal review, the event of chlamydial infection was considered to be medically significant.
Sex: F
Vaccine: PPV
Symptoms: Allergy to vaccine
Clinical narrative: My wife is allergic to pnuemovax; This spontaneous report was received from a consumer and refers to a female patient of unknown age. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, route of administration, lot # and expiration date were unknown) )for prophylaxis. On an unknown date, the patient experienced allergy to vaccine. The outcome of allergy to vaccine was unknown. The reporter considered allergy to vaccine to be related to Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23).
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: the administration of an expired RECOMBIV AX HB; the nurse administered a fourth dose today since the last dose the patient received "did not count".; he patient was given the third dose too early/The nurse states that the third dose should have been administered after 24 months; he patient was given the third dose too early/The nurse states that the third dose should have been administered after 24 months; This spontaneous report was received from a nurse referring to a 10 years old patient of unknown gender. The patient's pertinent medical history, drug reactions/ allergies and concomitant medication were not reported.  On 30-MAR-2011, at 1 day old, the patient was vaccinated with the first dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) (dose, strength, frequency, route, lot# and expiration date unknown) for prophylaxis. On 05-MAY-2011, at 5 weeks old, the patient was vaccinated with the second dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) (dose, strength, frequency, route, lot# and expiration date unknown) for prophylaxis. On 08-SEP-2011, the patient was vaccinated with the third dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) (dose, strength, frequency, route, lot# and expiration date unknown) for prophylaxis. The reporter stated that the third dose should have been administered after 24 months (inappropriate schedule of product administration and circumstance or information capable of leading to medication error). Then on 15-JUN-2021 (also reported today), the patient was vaccinated with the fourth dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) (0.5 ml, once, lot# R028384, expiration date 08-JUN-2021; route unknow) for prophylaxis (Extra dose administered). The administrated Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) was expired (Expired product administered).
Age: 0.08
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 1 month old patient was administered VAQTA; there was "not a clinical reason" for the administration; no AE reported; This spontaneous report was received from a registered pharmacist and refers to a 1-month-old patient of unknown gender. There was no information regarding their medical history, concurrent conditions nor concomitant therapies provided.  On an unspecified date, the patient was vaccinated at a hospital with hepatitis A vaccine, inactivated (VAQTA) (dose, route of administration, anatomical location, lot # and expiration date were not provided) for prophylaxis (inappropriate age at vaccine administration). The pharmacist stated that there was "not a clinical reason" for the administration of the vaccine to the patient. No adverse event (AE) was reported.  The pharmacist was inquiring if there was data regarding hepatitis A vaccine, inactivated (VAQTA) administration to patients younger than 6 months of age. He said he was aware of reports of administering the vaccine to patients below 6 months old who may be at risk for infection due to travel.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: the patient did not report experiencing symptoms after the improperly stored ROTATEQ; temperature excursion / temperature 8.6 C; This spontaneous report was received from a clinical coordinator and refers to a patient of unknown age and gender. There was no information regarding their medical history, concurrent conditions nor concomitant therapies provided.  On 18-MAY-2021, a dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally, lot # T026932, expiration date 28-DEC-2021 (exact dose was not provided) was stored improperly in a temperature of 8.6 degree Celsius (C) for 16 minutes. There was previous temperature excursion reported: 9.3 C for 45 minutes. Digital data logger was involved.  On 04-JUN-2021, the improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was administered to the patient for prophylaxis. They did not report experiencing symptoms after the vaccination.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Unevaluable event; This case was received via FDA VAERS on 08-Jun-2021 and was forwarded to Moderna on 08-Jun-2021.    This regulatory authority case was reported by a health care professional and describes the occurrence of UNEVALUABLE EVENT (Unevaluable event) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced UNEVALUABLE EVENT (Unevaluable event) (seriousness criterion hospitalization). At the time of the report, UNEVALUABLE EVENT (Unevaluable event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant product use was not provided. It was reported that the patient had an ED visit and/or hospitalization within 6 weeks of receiving COVID vaccine. Treatment information was unknown.  Very limited information regarding this event has been provided at this time.  No further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time.  No further information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Had vaccine a couple years ago now has shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, several years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient's wife. The age at vaccination was not reported.  The reporter stated that the patient had received the vaccine couple of years ago and presently had shingles. The reporter was asking if the shingles would be milder with the shot. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule and lab test confirmation were unknown at the time of reporting.
Sex: M
Vaccine: VARZOS
Symptoms: Ear pain, Headache, Herpes zoster, Pain, Pain in jaw
Clinical narrative: Suspected vaccination failure; Got his single shot four years ago / had the shingles for over a month now; Lot of pain head; Lot of pain ear; Lot of pain jaw; He's in pain all the time so much for the shot Doctor said it could last up to a year; This case was reported by a consumer via media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, more than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, headache, ear pain, jaw pain and pain. On an unknown date, the outcome of the vaccination failure, shingles, headache, ear pain, jaw pain and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, headache, ear pain, jaw pain and pain to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient's sibling.  The age at vaccination was not reported. The patient had got his single shot four years ago and he had been having the shingles for over a month then and he was in a lot of pain of head ,ear and jaw. The patient was very much in pain all the time. The patient's doctor stated that it could last up to a year. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule and lab test confirmation was unknown at the time of reporting.  Note: This case was conservatively kept valid considering that four years could be exactly four years or approximately 4 years from the time of reporting until further clarification on follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Vaccination failure
Clinical narrative: Suspected vaccination failure; Got his single shot four years ago / had the shingles for over a month now; Lot of pain head; Lot of pain ear; Lot of pain jaw; He's in pain all the time so much for the shot Doctor said it could last up to a year; This case was reported by a consumer via media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, more than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, headache, ear pain, jaw pain and pain. On an unknown date, the outcome of the vaccination failure, shingles, headache, ear pain, jaw pain and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, headache, ear pain, jaw pain and pain to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient's sibling.  The age at vaccination was not reported. The patient had got his single shot four years ago and he had been having the shingles for over a month then and he was in a lot of pain of head ,ear and jaw. The patient was very much in pain all the time. The patient's doctor stated that it could last up to a year. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule and lab test confirmation was unknown at the time of reporting.  Note: This case was conservatively kept valid considering that four years could be exactly four years or approximately 4 years from the time of reporting until further clarification on follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Peripheral swelling
Clinical narrative: Arm  swelled some but that was it; This case was reported by a consumer via interactive digital media and described the occurrence of swelling arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than 4 months after receiving Shingles vaccine, the patient experienced swelling arm. On an unknown date, the outcome of the swelling arm was unknown.   It was unknown if the reporter considered the swelling arm to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The reporter told the patient to come back 3 months after 1st shot of Shingrix. The patient received Shingrix and arm swelled some but that was it The patient heard from too many people that did have the shingles the horrible pain they were in and that made the patient mind up to get it.
Age: 33.0
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age, Underdose
Clinical narrative: Engerix-B was given in the 3 dose/second dose administered on 20210102; Pediatric (0.5 ml)dose / to a 33 year old / patient / All doses / in / series was pediatric dose; Pediatric (0.5 ml)dose / to a 33 year old / patient; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 33-year-old female patient who received HBV (Engerix B pediatric) (batch number 4CL44, expiry date 24th January 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Engerix B pediatric with an associated reaction of product administered to patient of inappropriate age (received 1st dose on 22nd December 2020, batch number-4CL44, expiry date-24th January 2022, refer case US2021AMR132394).   On 2nd January 2021, the patient received the 2nd dose of Engerix B pediatric .5 ml and Engerix B Pre-Filled Syringe Device. On 2nd January 2021, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the underdose, adult use of a child product and drug dose administration interval too short were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were received as follows: The 33 year old patient received 0.5ml pediatric dose of Engerix B in the 3 dose series, which led to underdose and adult use of a child product. This case was for the 2nd dose of Engerix B pediatric. The patient received second dose of Engerix B in less than 1 month which led to drug dose administration interval too short. All doses given in the series was pediatric dose. The reporter enquired to draw a titer or revaccination. The reporter consented to follow up. As per sales data sheet reported batch number was changed from 4co44 to 4CL44. For tolerance to 3rd dose, refer case US2021131430.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021131430:Same reporter. US-GLAXOSMITHKLINE-US2021AMR132394:Same reporter.
Age: 33.0
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Pediatric (0.5 ml)dose / to a 33 year old / patient / All doses / in / series was pediatric dose; Pediatric (0.5 ml)dose / to a 33 year old / patient; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 33-year-old female patient who received HBV (Engerix B pediatric) (batch number 4CL44, expiry date 24th January 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 22nd December 2020, the patient received the 1st dose of Engerix B pediatric .5 ml and Engerix B Pre-Filled Syringe Device. On 22nd December 2020, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, 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.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were received as follows: The 33 year old patient had received 0.5ml pediatric dose of Engerix B in the 3 dose series, which led to underdose and adult use of a child product. This case was for the 1st dose of Engerix B pediatric. All doses given in the series was pediatric dose. The reporter enquired to draw a titer or revaccination. The reporter consented to follow up. For tolerance to 2nd dose refer case US2021AMR132393 and for 3rd dose, refer case US2021131430.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021131430:Same reporter. US-GLAXOSMITHKLINE-US2021AMR132393:Same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Shingrix vaccine fever, how long does it last; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was not recovered/not resolved.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix vaccine and experience fever. The reporter wanted to know how long do it lasts.
Sex: U
Vaccine: VARZOS
Symptoms: Discomfort
Clinical narrative: What is best for the minor discomfort from a shingrix; This case was reported by a consumer via interactive digital media and described the occurrence of discomfort in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced discomfort. On an unknown date, the outcome of the discomfort was unknown.   It was unknown if the reporter considered the discomfort to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient for himself/herself. The age at vaccination was not reported. The patient asked what was best for the minor discomfort from Shingrix.
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Back pain, Fatigue, Herpes zoster, Myalgia, Rash
Clinical narrative: Suspected vaccination failure; was diagnosed with Shingles by her HCP; had a rash throughout her back, shoulder, hairline and stomach; experienced "terrible back pain".; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 17th December 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, the patient received the 1st dose of Shingrix. In February 2021, between 1 and 3 months after receiving Shingrix and less than 2 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, rash and low back pain. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and rash were not recovered/not resolved and the outcome of the low back pain was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, rash and low back pain to be related to Shingrix and Shingrix.  Additional details were provided as follows: The case was reported by patient herself. The patient received 1st dose of Shingrix in right arm and experienced fatigue and muscle aches, refer linked case. After receiving 2nd dose, in February 2021, she experienced "terrible back pain". Then she discovered she had a rash throughout her back, shoulder, hairline and stomach. She was diagnosed with Shingles by her healthcare professional. She had been taking Valtrex and felt better. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were not provided. The reporter did not consent to follow up.
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Vaccination failure
Clinical narrative: Suspected vaccination failure; was diagnosed with Shingles by her HCP; had a rash throughout her back, shoulder, hairline and stomach; experienced "terrible back pain".; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 17th December 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, the patient received the 1st dose of Shingrix. In February 2021, between 1 and 3 months after receiving Shingrix and less than 2 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, rash and low back pain. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and rash were not recovered/not resolved and the outcome of the low back pain was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, rash and low back pain to be related to Shingrix and Shingrix.  Additional details were provided as follows: The case was reported by patient herself. The patient received 1st dose of Shingrix in right arm and experienced fatigue and muscle aches, refer linked case. After receiving 2nd dose, in February 2021, she experienced "terrible back pain". Then she discovered she had a rash throughout her back, shoulder, hairline and stomach. She was diagnosed with Shingles by her healthcare professional. She had been taking Valtrex and felt better. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were not provided. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: had her first dose / in 2018 / has not yet had second dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in September 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: This case was reported by patient herself. The age at vaccination was not applicable for this report. The patient did not know a 2nd dose was required and till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The patient consented to follow up with her doctor. The reporter consented to follow-up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; has now developed Shingles; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 99-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) and the 2nd dose of Shingrix (intramuscular). On an unknown date, between 1 and 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received 2 doses of shingrix vaccine one and half year ago and got shingles. The reporter did not consent to follow up. This case was considered as suspected vaccination failure as details regarding laboratory test confirming herpes zoster was unknown at the time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Not receiving the second dose of Shingrix within 6 months after dose one; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: This case was reported by patient herself. The age at vaccination was not applicable for this report. The patient reported that she had not received the 2nd dose of Shingrix within 6 months after dose one and till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow-up. No more information was available.
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age, Underdose
Clinical narrative: Pediatric (0.5 ml)dose / to a 33 year old / patient; Pediatric (0.5 ml)dose / to a 33 year old / patient / All doses / in / series was pediatric dose; Drug dose administration interval too short; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 33-year-old female patient who received HBV (Engerix B pediatric) (batch number 4CL44, expiry date 24th January 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Engerix B pediatric with an associated reaction of product administered to patient of inappropriate age (1st dose received on 22nd December 2020, batch number-4CL44, expiry date-24th January 2022, refer case US2021AMR132394) and Engerix B pediatric with an associated reaction of product administered to patient of inappropriate age (2nd dose received on 02nd January 2021, batch number-4CL44, expiry date-24th January 2022, refer case US2021AMR132393).   On 8th June 2021, the patient received the 3rd dose of Engerix B pediatric .5 ml and Engerix B Pre-Filled Syringe Device. On 8th June 2021, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced underdose, adult use of a child product and drug dose administration interval too short. On an unknown date, the outcome of the underdose, adult use of a child product and drug dose administration interval too short were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were received as follows: The age at vaccination was not reported.  The 33 year old patient had received 0.5ml pediatric dose of Engerix B in the 3 dose series, which led to underdose and adult use of a child product. The patient received 3rd dose earlier than the recommended schedule, which led to shortening of vaccination schedule. All doses given in the series was pediatric doses. The reporter enquired to draw a titer or revaccination. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR132393:Same reporter. US-GLAXOSMITHKLINE-US2021AMR132394:Same reporter.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Inappropriate schedule of product administration, Injection site erythema, Injection site pain, Nausea
Clinical narrative: First / vaccine in / November 2020 or November 2019 / second / on 6-14-2021; Pain / at injection site; Redness at injection site; Nausea; Chills; Slight fever; Noticed spots all over her tongue; 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.   Previously administered products included Shingrix (received 1st dose  in November 2020).   On 14th June 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 14th June 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. In June 2021, the patient experienced injection site pain, injection site erythema, nausea, chills, fever and tongue pigmentation. On 16th June 2021, the outcome of the nausea, chills and fever were recovered/resolved. On an unknown date, the outcome of the injection site pain, injection site erythema and tongue pigmentation were not recovered/not resolved and the outcome of the drug dose administration interval too long was unknown.   The reporter considered the injection site pain and injection site erythema to be related to Shingrix. It was unknown if the reporter considered the nausea, chills, fever and tongue pigmentation to be related to Shingrix.  Additional details were provided as follows: 12 hours after receiving 2nddose of Shingrix, patient experienced injection site pain, injection site redness, chills, fever, nausea and 21 hours after receiving Shingrix, patient experienced spots on tongue. The patient received 2nd dose of Shingrix, more than the recommended interval, which led to lengthening of vaccination schedule. The reporter mentioned that, fever, nausea, chills resolved after about 12 hours. The reporter also mentioned that, injection site pain, injection site redness and spots on tongue were not resolved. No other information was given on spots on tongue. The reporter did not consent to follow up  Note- As start date for 1st dose was not clearly specified, November 2020 was being captured conservatively