chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of HERPES ZOSTER (he got shingles 4 weeks ago) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In June 2022, the patient experienced HERPES ZOSTER (he got shingles 4 weeks ago). At the time of the report, HERPES ZOSTER (he got shingles 4 weeks ago) outcome was unknown. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. Patient wanted to get the booster dose of Moderna COVID-19 Vaccine but patient was not sure to get it due to recent shingles that patient experienced. Unknown if any treatment was given, or if patient was under any concomitant or regular medication. It was also unknown if previous doses of COVID-19 Vaccine were from Moderna. Reporter did not allow further contact.
Sex: M
Vaccine: PPV
Symptoms: Expired product administered, Feeling abnormal, Malaise
Clinical narrative: The patient has a blood disorder; the patient felt "strange" after an expired PNEUMOVAX 23 vaccine was given on 6/10/2022.   The medical assistant did not elaborate what the patient meant by "strange"; he received the wrong vaccine; The medical assistant stated that the patient felt "strange" after an expired PNEUMOVAX 23 vaccine was given on/he received a three-month-old vaccine on his previous visit; he reported he hasn't been feeling well; has been very fatigued; This spontaneous report has been received from a medical assistant, referring to a patient of unknown age and gender.  Information regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies was not provided.  On 10-JUN-2022, the patient was vaccinated with one expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23), as prophylaxis, (strength, exact dose, route of administration, anatomical injection site, and frequency were not provided; lot number t033663 has been verified to be a valid lot number with an expiration date on 21-MAR-2022 (expired product administered).  On the same date, after the vaccine was administered, the patient felt strange (feeling abnormal). At the reporting time, the outcome of the event was unknown. The causal relationship between the event feeling abnormal and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) was not provided.  This is a non-valid case due to the lack of patient identifiers.  Follow-up information has been received from a nurse via telephone call on 25-JUL-2022.  On 01-JUL-2022, the patient reported that he wasn't feeling well (malaise) and that he had been very fatigued (fatigue), on the same day, he was informed that he received the wrong vaccine (wrong product administered), and then he was asked to speak with the director of the office on 07-JUL-2022 for a follow-up appointment, when he received a call where he was informed that he received a three-month-old vaccine on his previous visit.    The reporter also mentioned that the patient has a blood disorder, and provided information about the administration of the vaccine.  This case, before considered as non-valid, is now considered as valid since information about patient demographics was received
Age: 1.08
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional Adverse event; PNEUMOVAX 23 administered to 13-month old patient.; This spontaneous report has been received from a nurse and refers to a 13 months-old patient.  The patient's medical history, current conditions, concomitant therapies, and previous drugs reactions or allergies were not reported.  On 07-JUL-2022, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23)at a dose of 0.5 ml/once, as prophylaxis (lot number, expiry date, and route of administration were not provided) (Inappropriate age at vaccine administration), It was stated that the patient had no adverse reactions (no adverse event), it was also stated that there was no previous temperature excursion or expiration of the vaccine lot number.
Age: 16.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional adverse event reported; Customer called and reported that a dose of PROQUAD was administered to a 16 year old consumer.; This spontaneous report was received from a medical assistant and refers to a 16-year-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 07-JUL-2022, the 16-year-old patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) (product administered to patient of inappropriate age) 0.5 milliliter (route of administration and anatomical location were not provided; lot #W010528, expiration date: 25-SEP-2023) for prophylaxis. No additional adverse event (AE) was reported. No additional information provided.
Sex: F
Vaccine: RV5
Symptoms: Accidental underdose
Clinical narrative: immediately started to vomit after the oral dose of ROTATE was administered; immediately started to vomit after the oral dose of ROTATE was administered; This spontaneous report was received from a nurse practitioner, referring to a 4-month-old female patient. Her concomitant medications included diphtheria vaccine toxoid, hepatitis b vaccine rhbsag (yeast), hib vaccine conj (menigococcal protein), pertussis vaccine acellular 5-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (VAXELIS) and pneumococcal vaccine conj 13v (CRM197) (PREVENAR 13). No information about medical history and concurrent conditions was reported.  On 05-JUL-2022, the patient was administered dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), 2 ml orally, lot # W004504 established to be valid with expiration date 16-JUN-2023, for routine immunisation.  On 05-JUL-2022, right after the dose administration, the patient started to vomit (accidental underdose). The outcome of the event was recovered. Action taken with the suspect vaccine was not reported.  The causality assessment between the events and Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) was not provided.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Vomiting projectile
Clinical narrative: Patient had immediately experienced projectile vomiting; This spontaneous report has been received from a Health Professional and refers to a 2-months-old female patient.  The patient's medical history, current conditions, concomitant therapies, and previous drugs reactions or allergies were not reported.  On 18-JUL-2022, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot number 1742415, expiration date: 12-OCT-2022, administered orally as part of routine vaccination (dose description was not provided).  On 18-JUL-2022, the patient immediately experienced projectile vomiting. The outcome of the event was not provided.  The causal relationship between the event and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was not provided.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; MMRII with a labeled expiry of 5/29/2022 was administered; This spontaneous report was received from an office manager via a Company representative referring to a patient of unspecified age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies was not provided.  On 27-JUN-2022, the patient was administered an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) 0.5 milliliters as prophylaxis (route of administration and anatomical site of vaccination were not provided; lot number T018669 has been verified to be valid, expiration date reported and established as 29-MAY-2022) (expired product administered). No additional adverse event reported (no adverse event).   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2207USA007052: US-009507513-2207USA006816: US-009507513-2207USA007188: US-009507513-2207USA007049: US-009507513-2207USA007041:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Herpes Zoster; Information has been received from a lawyer regarding a case in litigation which referred to a patient (pt) of unknown gender and age. Information regarding concomitant medications, concurrent conditions or medical history was not provided. On an unknown date, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) for its intended purpose: the prevention of shingles (herpes zoster) and for routine health maintenance (exact dose, dose number, route of administration, anatomical site of vaccination, lot number and expiration date were not provided). Afterwards, on an unknown date (reported as after receiving zoster vaccine live (ZOSTAVAX) vaccine), the pt suffered herpes zoster. As a result of this symptom, the pt was seen and treated by medical providers and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the pt's symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of pt's condition. In addition, the pt sustained severe and permanent personal injuries. Further, the pt had suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. Finally, as direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was considered as not recovered. The causal relationship between the event and zoster vaccine live (ZOSTAVAX) was assessed as related.  Herpes zoster was considered as a disabling event by the reporter.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported.; the PEDVAXHIB has been administered to the patient after the excursion occurred; This spontaneous report has been received from a nurse practitioner via customer, referring to a patient of unknown age and gender. The patient's historical condition, current condition and concomitant drug  were not reported.  On 12-MAY-2022, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot # U024090 with expiration date: 28-OCT-2023, 0.5 milliliter, strength and route were not reported) for prophylaxis after the excursion occurred (product storage error).   A temperature excursion evaluation was not performed at the time of the call. The complete cumulative time and temperature details were unknown until the customer returned the multiple excursion form that was submitted to the reporter. The previous temperature was unknown by reporter. No additional information provided. No additional adverse event reported.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No other AE; Caller is an office manager who reports vaccine was administered following multiple temperature excursions.; This spontaneous report has been received from an office manager referring a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications, previous drug reactions, or allergies were not provided.  On 18-JUL-2022, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-Merck) virus vaccine live (PROQUAD) 0.5ml once (lot number W006583 has been verified to be a valid lot number, expiration date 23-AUG-2023) (strength, route of administration, and anatomical location were not provided) for prophylaxis, the vial was reconstituted with sterile diluent (MERCK STERILE DILUENT) (strength, dose, lot number, and expiry date were not reported) (product storage error).  The measles, mumps, rubella and varicella (oka-Merck) virus vaccine live (PROQUAD) vaccine experienced multiple temperature excursions: on 11-MAY-2022 was stored at a temperature of 5.7 Fahrenheit (F) for 7 minutes, 27-MAY-2022 5.7 F for 5 minutes, 06-JUN-2022 5.9 F for 6 minutes, 09-JUN-2022 5.4 F for 4 minutes, 14-JUN-2022 5.7 F for 7 minutes, 17-JUN-2022 29.1 F for 39 minutes, 20-JUN-2022 7.2F for 10 minutes, 22-JUN-2022 8.4F for 15 minutes, and on 28-JUN-2022 5.2F for 3 minutes. No temperature excursion occurred prior to the aforementioned date.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2207USA007832: US-009507513-2207USA007847: US-009507513-2207USA007985: US-009507513-2207USA007729: US-009507513-2207USA007826: US-009507513-2207USA008018: US-009507513-2207USA007975: US-009507513-2207USA008097: US-009507513-2207USA007867:
Sex: F
Vaccine: HEP
Symptoms: Herpes zoster, Inappropriate schedule of product administration
Clinical narrative: Hepatitis B vaccine received on 12/28/09, 1/29/10 and 8/11/10; This spontaneous report was received from a nurse and refers to a female patient of unknown age. Patient's concurrent conditions, medical history and concomitant medications were not provided.  On 28-DEC-2009, the patient was vaccinated with the first dose of hepatitis b vaccine (recombinant)(manufacturer unknown), on 29-JAN-2010, she received the second dose of the vaccine and on 11-AUG-2010, she received  the third dose of hepatitis b vaccine (recombinant)(manufacturer unknown) (lot #, expiration date, route of administration, anatomical location not provided) all as prophylaxis (inappropriate schedule of product administration). The patient also experienced shingles (herpes zoster) (captured in MARRS# 1806USA004086) and had an allergy to lisinopril (manufacturer unknown) with a reaction of cough (captured in MARRS# 1911USA009757).; Sender's Comments:  US-009507513-1806USA004086: US-009507513-1911USA009757:
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Impaired work ability, Rheumatoid arthritis
Clinical narrative: RA flare up, had to call off work; This case was reported by a other health professional via call center representative and described the occurrence of rheumatoid arthritis flare up in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received in Feb 2022, reference case US2022AMR109363). Concurrent medical conditions included rheumatoid arthritis (diagnosed about 4 years prior to the reporting). Concomitant products included etanercept (Enbrel) and methotrexate.   On 20th July 2022, the patient received the 2nd dose of Shingrix. In July 2022, less than a week after receiving Shingrix, the patient experienced rheumatoid arthritis flare up (serious criteria GSK medically significant). On an unknown date, the outcome of the rheumatoid arthritis flare up was not recovered/not resolved.   It was unknown if the reporter considered the rheumatoid arthritis flare up to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR109363   Additional Information: GSK Receipt Date: 21-JUL-2022. Reporter's Comments: The reporter was also a patient and she was paramedic, work in a hospital. The reporter stated, she was wondered about the Shingrix caused an rheumatoid arthritis flare up, it seems that was what happened with her. The reporter stated that, it was a pretty bad flare up so she became curious if others have reported this. The reporter still would have chosen to get the vaccine. The patient had to call off work after second dose. The reporter stated, she never missed work for an unscheduled event in years.  The patient was diagnosed with rheumatoid arthritis about 4 years before from the reporting date, but really started more aggressive treatment before about 1.5 years. The patient guessed that she had the worst symptoms on the day of reporting (she hoped that anyway). The reporter mentioned, she like research so she would love to read anything related and asked if anyone reported a flare up from their rheumatoid arthritis after a vaccine. The reporter consented to follow up. Additional supportive information: This case has been linked to the case US2022AMR109366 and US2022AMR109365 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR109363:Same reporter US-GSK-US2022AMR109365:Same reporter US-GSK-US2022AMR109366:Same reporter
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Feeling abnormal, Herpes zoster, Vaccination failure
Clinical narrative: had the shots and still got shingles/Suspected vaccination failure; still got shingles; miserable and was bad; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a elderly patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine  (received one shot about 10 years ago ).   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 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and feeling bad. On an unknown date, the outcome of the vaccination failure, shingles and feeling bad were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and feeling bad to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 21-Jul-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had one shot about 10 years ago and the 2 new ones a year before and still got shingles.  The patient was miserable for more than 2 months. The patient had shingles on the right side of my face, in my ear and scalp 3 days before his/her 91st birthday, miserable and was bad for a couple of months. 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. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Pain, Vaccination failure
Clinical narrative: had the shots, now shingles/Suspected vaccination failure; shingles; felt like sitting on a BBQ or being branded; awful pain; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, burning sensation and pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, burning sensation and pain were recovering/resolving.   It was unknown if the reporter considered the vaccination failure, shingles, burning sensation and pain to be related to Shingles vaccine.     Additional Information: GSK receipt date: 22-Jul-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had the shots years ago and just now getting over three months of shingles suffering.  The patient stated that just like most vaccines, not reliable, just in his /her opinion, probably should listen to the physician. The patient stated that he/she felt like he/she was sitting on a BBQ grill or being branded like a cow and the awful pain that you could not escape, started in March and just now getting back to normal. The patient mentioned that prayers for all who suffer.  Evidently the shingles shots the patient had years ago did not help one bit. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, 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: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I have them now; I have them now; 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: 22-Jul-2022 Reporter's Comments: The patient self-reported the case via interactive digital media The patient had the Vax and he/ she had them now (at the time of reporting). All over right side of his/ her face, on chin in her/ his mouth and in ear.  The reporter stated that it was miserable. The reporter stated that thank goodness not in his/ her eye. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Herpes zoster, Pain, Vaccination failure
Clinical narrative: Got vaccinate steel got it in my face; got it just in my face; got bad; 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.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, feeling bad and pain. On an unknown date, the outcome of the vaccination failure, shingles, feeling bad and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, feeling bad and pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 23-Jul-2022 Reporter's Comments: The patient self-reported the case via interactive digital media The patient got vaccinate still got it just in his/ her face thinking was mosquito bites, got bad very painful. The doctor said was mild because got the vaccine. The reporter said please over 50 years do it. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Had vaccine years ago, still got shingles; shingles on face; pain; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 25-Jul-2022 Reporter's Comments: The patient self-reported the case via interactive digital media The patient had vaccine years ago and still got shingles on his/ her face was the worse pain he/ she ever experienced. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: I've had it for at least 2 months now; I've had it for at least 2 months now; still hurting; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 69-year-old 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, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 23-Jul-2022 Reporter's Comments: The patient self-reported the case via interactive digital media The patient had it for at least 2 months at the time of reporting (on her butt) and still hurting. The would be 70 in about 10 days and they Still hurt. She had the new shot for shingles which was a 2-time shot. The patient stated that thank goodness she had the shot because it would had been worse. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation 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: Suspected vaccination failure/Had shingles vaccinated, also have has shingles; Had shingles vaccinated, also have has 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 chickenpox (had chick pox as child ).   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 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 Shingles vaccine.     Additional Information: GSK receipt date: 24-Jul-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had shingles vaccinated and also have had shingles. The patient stated that although it was a difficult experience. It could have been worst. The patient also mentioned that age was not necessarily a factor, check with the medical profession. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, 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: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: horrible pain; had the vaccine, have them again/suspected vaccination failure; had the vaccine, have them again; 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 them 9 years ago for 6 weeks horrible pain) and pain (had horrible pain ).   On an unknown date, the patient received Shingles vaccine. In July 2022, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     Additional Information: GSK receipt date: 25-Jul-2022 Reporter's comment: Reporter's comment: The case was received from the consumer via interactive digital media. The patient had them 9 years ago for 6 week and horrible pain.  The patient had the vaccine after that and had them again now going into his/her 3rd week. The patient also experienced horrible pain again. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, 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
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Too shot, developed shingles/suspected vaccination failure; shingles/ developed shingles a year later; 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.   On an unknown date, the patient received Shingles vaccine at an unknown dose. On an unknown date, 1 year 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: 25-Jul-2022 Reporter's comment: The case was received from the consumer via interactive digital media. The reporter reported that the patient (lady from their church) also too had the shot and developed shingles a year later. The reporter stated that the vaccine was expensive and did not work. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule 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. The case is 1 of 5 linked cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR105917:Same reporter US-GLAXOSMITHKLINE-US2022AMR105921:Same reporter US-GSK-US2022AMR111697:Same reporter US-GSK-US2022AMR111698:Same reporter US-GSK-US2022AMR111699:Same reporter US-GSK-US2022AMR111700:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Took vaccine, still got shingles/suspected vaccination failure; shingles/Took vaccine, still 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: 25-Jul-2022 Reporter's comment: The case was received from the consumer via interactive digital media. The reporter reported that she personally knew 4 other people who took vaccine and still got shingles. The reporter stated that the vaccine was expensive and did not work. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, 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. The case is 1 of 5 linked cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR105917:Same reporter US-GLAXOSMITHKLINE-US2022AMR105921:Same reporter US-GSK-US2022AMR111696:Same reporter US-GSK-US2022AMR111698:Same reporter US-GSK-US2022AMR111699:Same reporter US-GSK-US2022AMR111700:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Took vaccine, still got shingles/suspected vaccination failure; shingles/Took vaccine, still 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: 25-Jul-2022 Reporter's comment: The case was received from the consumer via interactive digital media. The reporter reported that she personally knew 4 other people who took vaccine and still got shingles. The reporter stated that the vaccine was expensive and did not work. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, 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. The case is 1 of 5 linked cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR105917:Same reporter US-GLAXOSMITHKLINE-US2022AMR105921:Same reporter US-GSK-US2022AMR111697:Same reporter US-GSK-US2022AMR111696:Same reporter US-GSK-US2022AMR111699:Same reporter US-GSK-US2022AMR111700:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Took vaccine, still got shingles/suspected vaccination failure; shingles/Took vaccine, still 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: 25-Jul-2022 Reporter's comment: The case was received from the consumer via interactive digital media. The reporter reported that she personally knew 4 other people who took vaccine and still got shingles. The reporter stated that the vaccine was expensive and did not work. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, 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. The case is 1 of 5 linked cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR105917:Same reporter US-GLAXOSMITHKLINE-US2022AMR105921:Same reporter US-GSK-US2022AMR111697:Same reporter US-GSK-US2022AMR111696:Same reporter US-GSK-US2022AMR111698:Same reporter US-GSK-US2022AMR111700:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Took vaccine, still got shingles/suspected vaccination failure; shingles/Took vaccine, still 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: 25-Jul-2022 Reporter's comment: The case was received from the consumer via interactive digital media. The reporter reported that she personally knew 4 other people who took vaccine and still got shingles. The reporter stated that the vaccine was expensive and did not work. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, 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. The case is 1 of 5 linked cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR105917:Same reporter US-GLAXOSMITHKLINE-US2022AMR105921:Same reporter US-GSK-US2022AMR111698:Same reporter US-GSK-US2022AMR111697:Same reporter US-GSK-US2022AMR111696:Same reporter US-GSK-US2022AMR111699:Same reporter
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got both shots,I have them again/suspected vaccination failure; got both shots, have them again; 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.   The patient's past medical history included shingles.   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) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 24-Jul-2022 Reporter's Comments: This case was received from consumer via interactive digital media The reporter stated that the patient  got both shots and he/she thought have them again. The follow-up would not possible as no contact details were available. Additional supportive information: The case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation was not given.
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness, Pain
Clinical narrative: flue like symptoms; body aches; headaches; This case was reported by a consumer via interactive digital media and described the occurrence of influenza-like symptoms in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th July 2022 17:00, the patient received Shingrix. On 17th July 2022 22:00, 5 hrs after receiving Shingrix, the patient experienced influenza-like symptoms, general body pain and headache. On an unknown date, the outcome of the influenza-like symptoms, general body pain and headache were unknown.   It was unknown if the reporter considered the influenza-like symptoms, general body pain and headache to be related to Shingrix.     Additional Information: GSK Receipt Date: 18-JUL-2022 Reporter's comment: This case was reported by consumer via interactive digital media. The case was reported by the consumer for himself/herself. The patient received the vaccine yesterday (at the time of reporting) at 5pm. The reporter stated that by 10pm he/she was having flue like symptoms with body aches and headaches. The reporter asked was this normal. Additional Supportive Information: The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: Tired after vaccine; This case was reported by a consumer via interactive digital media and described the occurrence of tiredness 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 tiredness. On an unknown date, the outcome of the tiredness was unknown.   It was unknown if the reporter considered the tiredness to be related to Shingles vaccine.     Additional Information: Reporter's comment: This case was reported by a patient via interactive digital media. The patient was tired after taking vaccine.  Additional Supportive Information: Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: giving the entire diluent, 0.85 mL; giving the entire diluent, 0.85 mL; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in unspecified number of patients who received Hib (Hiberix) for prophylaxis.   On an unknown date, the patient received Hiberix. On an unknown date, unknown after receiving Hiberix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 20-JUL-2022 Reporter's Comments: Registered Nurse called in to inquire about if any information was available.  The reporter reported that they reconstituted the Hiberix lyophilized vial with 0.85 mL of diluent instead the 0.6 mL diluent recommended and administered to around 700 patients.  The reporter stated that patients were administered the 0.5 mL dose after the reconstitution of the 0.85 mL.  The reporter mentioned that these was how they have reconstituted the vaccine since obtaining the Hiberix.  The reporter unable to provide any additional details.  The reporter consented to follow up. Additional Supportive Information: Reconstituted the Hiberix lyophilized vial with 0.85 mL of diluent instead the 0.6 mL diluent recommended and administered to around 700 patients which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.; Sender's Comments:  US-GSK-US2022108804:FU1 - Deleted
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Eye swelling, Pain in extremity
Clinical narrative: Left eye was swollen; Arm was red; Sore arm; This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (first dose received on unknown date without any issues).   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 erythema of extremities, pain in arm and eye swelling. On an unknown date, the outcome of the erythema of extremities and pain in arm were recovered/resolved and the outcome of the eye swelling was not recovered/not resolved.   It was unknown if the reporter considered the erythema of extremities, pain in arm and eye swelling to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 21-Jul-2022 Reporter's comment: The patient arm was red and sore for 3 days afterwards, when patient had received the second dose. Then, on day 5 patient left eye was swollen. Till day 8, patient had not got better. The patient saw the doctor yesterday (from the date of reporting), and they disagreed it was from the vaccine. The patient requested consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: barely had a sore arm; This case was reported by a other health professional via call center representative and described the occurrence of pain in arm in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included rheumatoid arthritis (The patient was diagnosed with RA 4 years ago). Concomitant products included etanercept (Enbrel) and methotrexate.   In February 2022, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     Additional Information: GSK Receipt Date: 21-JUL-2022 Reporter's Comments: This case was reported by the patient. The patient received first dose of Shingrix in February and barely had a sore arm. The reporter gave consent to follow up. For second dose refer case US2022AMR109364; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR109364:Same reporter US-GLAXOSMITHKLINE-US2022AMR109365:Same reporter US-GLAXOSMITHKLINE-US2022AMR109366:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Musculoskeletal stiffness
Clinical narrative: stiff arm; This case was reported by a consumer via interactive digital media and described the occurrence of limbs stiffness 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 limbs stiffness. On an unknown date, the outcome of the limbs stiffness was recovered/resolved.   It was unknown if the reporter considered the limbs stiffness to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 20th July 2022 Reporter's Comments: This case was reported by the patient via interactive digital media. Patient reported that no problem but experienced stiff arm for half day. Additional Supportive Information: The follow-up could not be possible as no contact details were available.