chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Informnation has been received from a lawyer refers to a patient of unknown age and gender concerning a case in litigation. The patient's concurrent conditions, historical conditiona and concomitant therapy were not reported. In or around November 2011, patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot # and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), patient suffered shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, patient's symptoms have resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). Patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), patient sustained severe and permanent personal injuries. Further, as a tragic consequence of company's wrongful conduct, patient 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. As a direct and proximate result of company's conduct, patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of shingles was unknown.  The reporter considered shingles to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional adverse events reported; PROQUAD that was administered after improperly stored; This spontaneous report was received from a certified medical assistant (CMA) and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 05-OCT-2021, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) 0.5 ml, lot # U002534, expiration date 24-JUL-2022 (dose number, route of administration and vaccination site were not provided) for prophylaxis.  Administered dose of vaccine was exposed to the temperature excursion of 8.5 degrees Fahrenheit for 18 minutes and 11.9 degrees Fahrenheit for 1 hour. There was no previous temperature excursion. No additional adverse events were reported.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional adverse events reported; PROQUAD that was administered after improperly stored; This spontaneous report was received from a certified medical assistant (CMA) and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 11-OCT-2021, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) 0.5 ml, lot # U002534, expiration date 24-JUL-2022 (dose number, route of administration and vaccination site were not provided) for prophylaxis.  Administered dose of vaccine was exposed to the temperature excursion of 8.5 degrees Fahrenheit for 18 minutes and 11.9 degrees Fahrenheit for 1 hour. There was no previous temperature excursion. No additional adverse events were reported.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional adverse events reported; PROQUAD that was administered after improperly stored; This spontaneous report was received from a certified medical assistant (CMA) and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 14-OCT-2021, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) 0.5 ml, lot # T027115, expiration date 07-FEB-2022 (dose number, route of administration and vaccination site were not provided) for prophylaxis.  Administered dose of vaccine was exposed to the temperature excursion of 8.5 degrees Fahrenheit for 18 minutes and 11.9 degrees Fahrenheit for 1 hour. There was no previous temperature excursion. No additional adverse events were reported.
Sex: F
Vaccine: MENB
Symptoms: Product administered to patient of inappropriate age, Product use in unapproved indication
Clinical narrative: 88 year old / needed before Soliris; 88 year old received Bexsero; This case was reported by a consumer via interactive digital media and described the occurrence of drug use for unapproved indication in a 88-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concurrent medical conditions included myasthenia gravis.   On an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced drug use for unapproved indication and inappropriate age at vaccine administration. On an unknown date, the outcome of the drug use for unapproved indication and inappropriate age at vaccine administration 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 provided as follows: The reporter was the patient. The patient asked does meningococcal B vaccine affect an 88 year old woman with myasthenia graves, which led to drug use for unapproved indication and inappropriate age at vaccine administration. It was needed before taking Soliris.
Age: 12.0
Sex: M
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 12 yo received Shingrix; This case was reported by a pharmacist via sales rep and described the occurrence of inappropriate age at vaccine administration in a 12-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th October 2021, the patient received the 1st dose of Shingrix. On 14th October 2021, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.  Additional details were provided as follows: The 12 years old patient received dose of Shingrix, which led to inappropriate age at vaccine administration. The patient had not experienced any adverse events.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: tired; 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.   Previously administered products included Pneumonia vaccine with an associated reaction of pain in extremity (received dose on an unknown date).   On 21st October 2021, the patient received the 1st dose of Shingles vaccine. On 22nd October 2021, 1 days 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 details were provided as follows: The patient self-reported this case. The patient had the first shot last night, only felt tired a little bit today. The patient did not have arm pain like the pneumonia shot.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: took first shot of Shingrix in March, totally forgot to take it; This case was reported by a consumer via (Shingrix GSK Chatbot) interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in March 2021).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The patient totally forgot to took 2nd dose of Shingrix.
Sex: U
Vaccine: TDAP, VARZOS
Symptoms: Blood immunoglobulin G increased, Herpes zoster, Pruritus, Rash, Urticaria
Clinical narrative: IGG was greater than 4000, other one positive, greater than 160; Hives; rash; I believe it to be Shingles.; night itching; This case was reported by a consumer and described the occurrence of hives in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   On 13th August 2021, the patient received Shingrix and Tdap Vaccine. On 18th August 2021, 5 days after receiving Shingrix and Tdap Vaccine, the patient experienced hives, rash, shingles and pruritus. On 7th October 2021, the patient experienced immunoglobulin g increased. The patient was treated with allergy medication {nos} (Claritin (Allergy Medication Nos)), famotidine (Pepcid Ac), fexofenadine hydrochloride (Allegra), hydroxyzine, mometasone (Mometasone Cream), methylprednisolone (Medrol Dose Pack), benadryl (nos) (Benadryl) and prednisone burst packs. On an unknown date, the outcome of the hives, rash, shingles and pruritus were recovering/resolving and the outcome of the immunoglobulin g increased was unknown.   It was unknown if the reporter considered the hives, rash, shingles, pruritus and immunoglobulin g increased to be related to Shingrix and Tdap Vaccine.  Additional details were provided as follows: The reporter was the patient. The patient required urgent care for hives, rash, shingles after vaccination with Shingrix and Tdap Vaccine. The patient prescribed with Prednisone Burst, Medrol dose pack and was instructed to take Claritin. The patient instructed to continue taking Claritin and Pepcid AC in the morning and Benadryl in the evening. The patient belived it to be shingles. On 16th September 2021, the dermatologist prescribed 15 days of Prednisone, and continued with Claritin and Pepcid AC. She also prescribed Hyrdroxyzine for the night itching and mometasone cream. This regimen seemed to have calmed it down tremendously. On 7th October 2021, the patient was off Prednisone and felt the hives or rash beginning again. The Allergest instructed to take Allegra & Pepcid AC in the morning, Clartin and Hydroxyzine in the evening, which helped. The patient had some blood tests and according to the results, immunoglobulin g was greater than 4,000, other one positive, greater than 160. The Allergist recommended not to take the 2nd shot unless they could do a patch test with the 2nd shot. The patient asked was there a way to have a sample sent to Allergist so that he could perform a patch test or did recommend not to take the 2nd shot.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: only diluent was injected; only diluent was injected; This case was reported by a consumer via interactive digital media and described the occurrence of inappropriate preparation of medication 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 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 details were provided as follows: The reporter was the patient. The patient received only Shingrix diluent, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: U
Vaccine: VARZOS
Symptoms: Musculoskeletal stiffness, Skin warm
Clinical narrative: arm was a little stiff; warm; This case was reported by a consumer and described the occurrence of stiffness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st dose on an unknown date).   On 22nd October 2021, the patient received the 2nd dose of Shingles vaccine. In October 2021, less than a week after receiving Shingles vaccine, the patient experienced stiffness and skin warm. On an unknown date, the outcome of the stiffness and skin warm were unknown.   It was unknown if the reporter considered the stiffness and skin warm to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient stated that, after vaccination arm was a little stiff and warm to the touch.
Sex: U
Vaccine: VARZOS
Symptoms: Therapeutic response unexpected
Clinical narrative: no longer have mouth sores; This case was reported by a consumer via interactive digital media and described the occurrence of unexpected beneficial therapeutic response in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included sores mouth.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced unexpected beneficial therapeutic response. On an unknown date, the outcome of the unexpected beneficial therapeutic response was unknown.   Additional details were provided as follows: The age at vaccination was not reported. The patient had the shot, no longer had mouth sores, the patient did not know the connection.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Vaccination failure
Clinical narrative: had all the shingles vaccines, and still had them/ suspected vaccination failure; had them six times/ had them 4 times; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (2 times before vaccination).   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 details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had got all the shingles vaccines, and still had them 4 times after vaccination. The patient stated that it was no fun. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: sick; This case was reported by a consumer via (Facebook) interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 20th October 2021, the patient received the 1st dose of Shingles vaccine. In October 2021, less than a week after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient received first shot Wednesday.  The patient was very, very sick.  The patient would not get the second shot.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had the shot and had them/ suspected vaccination failure; had them; This case was reported by a consumer via interactive digital 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, 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 details were provided as follows: The age at vaccination was not reported. The reporter mentioned that, the patient had the shot and had his 3rd bout with shingles after the shot. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation for shingles were unknown at the time of reporting.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got both shots. Then a few months later got shingles/suspected vaccination failure; got shingles in his right arm.; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male 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, several months 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 details were provided as follows: This case was reported by patient's wife. The age at vaccination was not reported. The patient got both shingles shots and then a few months later got shingles in his right arm. This case was considered as suspected vaccination failure since the details regarding laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Ophthalmic herpes zoster, Vaccination failure
Clinical narrative: got the vaccine after I had it/suspected vaccination failure; shingles behind my eye; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (shingles behind my eye).   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 ophthalmic herpes zoster (serious criteria GSK medically significant). The patient was treated with ophthalmologicals (nos) (Eye Drop (Nos)). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the ophthalmic herpes zoster was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and ophthalmic herpes zoster to be related to Shingles vaccine.   Additional details were reported as follows: This case was reported by the patient for herself/himself. The age at vaccination was not reported. The patient got vaccine after he/she had it, but not bad though, now he/she had small amount of shingles behind his/her eye.  The patient further stated that medications and eye drops were not fun. This case was considered as suspected vaccination failure, since the details regarding the completion of primary vaccination schedule and laboratory confirmation for shingles were not provided. The follow up would not possible as no contact information was available.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Administration of only the diluent portion; Administration of only the diluent portion; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication 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 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 details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient was administered only the diluent portion of the shingrix vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter did not have info regarding the date of the administration nor gender or age of the patients. Agreed to be contacted for follow-up and claimed they would try to find more details about the event.  No further events were reported.  The reporter consented to follow up. This case was linked with US2021221646, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021221646:Same reporter. Patient 1.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Vaccine positive rechallenge
Clinical narrative: Both injections, feeling absolute crap; This case was reported by a other health professional via interactive digital media and described the occurrence of feels awful in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of feeling abnormal (received 1st dose on an unknown date, refer case: US2021AMR222515).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced feels awful. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the feels awful was recovered/resolved.   It was unknown if the reporter considered the feels awful to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient. The age at vaccination was not reported. The patient got the shingles vaccine. The shingles vaccine injections made the patient feeling absolute crap for a few days. The patient stated that it was much better than getting shingles.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR222515:Same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Death, Herpes zoster, Nerve injury, Pain, Vaccination failure
Clinical narrative: Had vaccine and had shingles/Suspected vaccination failure; shingles; hospitalized with excrutiating pain, never came out of hospital; hospitalized with nerve damage, never came out of hospital; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria death, hospitalization and GSK medically significant), shingles (serious criteria death and hospitalization), pain (serious criteria death and hospitalization) and nerve damage (serious criteria death and hospitalization). On an unknown date, the outcome of the vaccination failure, shingles, pain and nerve damage were fatal. The reported cause of death was vaccination failure, shingles, pain and nerve damage.   It was unknown if the reporter considered the vaccination failure, shingles, pain and nerve damage to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient's friend. The age at vaccination was not reported. The reporter said you could not prevent shingles with a vaccine.  The patient had that Shingles vaccine and had the worst case of shingles ever.  The patient landed up in the hospital in excruciating pain and nerve damage.  The reporter stated that the patient never came out of the hospital, the reporter said god rest her soul. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation for shingles were unknown at the time of reporting.; Reported Cause(s) of Death: hospitalized with nerve damage, never came out of hospital; Had vaccine and had shingles/Suspected vaccination failure; Had vaccine and had shingles/Suspected vaccination failure; hospitalized with excrutiating pain, never came out of hospital
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: shot is painful; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was unknown. The reporter stated that, the shot was painful. The doctor had told the reporter that, he/she can still get shingles but not as bad. The case is linked with US2021AMR222588, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR222588:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Muscle ache; This case was reported by a consumer via (Shingrix GSK Chatbot) interactive digital media and described the occurrence of muscle pain 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 muscle pain. On an unknown date, the outcome of the muscle pain was unknown.   It was unknown if the reporter considered the muscle pain to be related to Shingrix.  Additional details were reported as follows: The patient self-reported this case. The age at vaccination was not reported. The patient inquired that it was okay to take Tylenol for muscle ache after the Shingrix vaccination. The follow up would not possible as contact information was not available.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: miss second shingles shot; This case was reported by a consumer via (Shingrix GSK Chatbot) interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 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 provided as follows: The case was self-reported. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix as per the vaccination schedule, which led to incomplete course of vaccination. The reporter was asking if he/she needs to start over the series, for missing the 2nd shot.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Product preparation error, Product preparation issue
Clinical narrative: adjuvant portion administered / did not reconstitute; adjuvant portion administered / only gave the adjuvant; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 51-year-old female patient who received Herpes zoster (Shingrix) (batch number L4LH5, expiry date 25th January 2023) and (batch number AP545, expiry date 25th January 2023) for prophylaxis.   On 9th April 2021, the patient received the 1st dose of Shingrix. On an unknown date, the dose was an unknown dose. On 9th April 2021, unknown after receiving Shingrix, 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 details were provided as follows: The patient received adjuvant portion of Shingrix vaccination, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up. This case was linked with case US2021216655, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021216655:same reporter US-GLAXOSMITHKLINE-US2021216677:same reporter, FU#1 Original case, deleted for being created in error
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Muscle pain; Temperature of 99.3F/Fever; Arm pain; Headache; Feeling really tired / fatigue; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th October 2021, the patient received the 1st dose of Shingrix. On 19th October 2021, less than a day after receiving Shingrix, the patient experienced pain in arm, headache and tiredness. On 20th October 2021, the patient experienced muscle pain and fever. On an unknown date, the outcome of the pain in arm, headache, tiredness, muscle pain and fever were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, headache, tiredness, muscle pain and fever to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. The patient received the Shingrix vaccine at the doctor's office and reported that he had arm pain, headache and was feeling really tired on the same day as he received the vaccine. At the reporting date, he had muscle pain, fatigue and a temperature of 99.3F.  The reporter wanted to knowhow long after receiving Shingrix should he might experience side effects.   The reporter did not consent to follow-up and was not willing to provide contact details of the physician
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Vomiting
Clinical narrative: High fever; Vomiting; This case was reported by a consumer via call center representative and described the occurrence of fever in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th October 2021, the patient received the 1st dose of Shingrix (intramuscular). In October 2021, 12 hrs after receiving Shingrix, the patient experienced fever and vomiting. On an unknown date, the outcome of the fever and vomiting were unknown.   It was unknown if the reporter considered the fever and vomiting to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. The patient received Shingrix into his left deltoid.  Twelve hours after his dose, the patient started vomiting and reported having a high fever. The patient could not provide lot or expiration date of vaccine. The reporter was not asked about consent via email or consent to contact his doctor.
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Arthralgia, Back pain, Breast pain, Herpes zoster
Clinical narrative: Rash down her right arm; Shingles was diagnosed; Nerve pain in mid right upper shoulder and back/shoulder and back pain; Still has a lot of pain on her right side upper quadrant; Still has a lot of pain going down her arm; Pain into into her right breast; This case was reported by a nurse via call center representative and described the occurrence of neuralgia in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included acyclovir tablet for rash and shingles and prednisone for neuralgia.   On 8th October 2021, the patient received the 1st dose of Shingrix. In October 2021, the patient started acyclovir 800 mg at an unknown frequency and prednisone 60 mg at an unknown frequency. On 12th October 2021, 4 days after receiving Shingrix and not applicable after starting acyclovir, the patient experienced neuralgia. In October 2021, the patient experienced upper abdominal pain, pain in arm and breast pain. On 17th October 2021, the patient experienced rash and shingles. The action taken with acyclovir was unknown. The dose of prednisone was decreased. On an unknown date, the outcome of the neuralgia, rash and shingles were unknown and the outcome of the upper abdominal pain, pain in arm and breast pain were not recovered/not resolved.   It was unknown if the reporter considered the neuralgia, rash, shingles, upper abdominal pain, pain in arm and breast pain to be related to Shingrix. It was unknown if the reporter considered the upper abdominal pain, pain in arm and breast pain to be related to acyclovir.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient received the vaccine on her right arm. Four days after the vaccination, she developed nerve pain in her mid right upper shoulder and back.  On 15th October 2021, the patient needed to be started on Prednisone (60mg for 3 days) and then was titrated down daily.  Nine days after vaccination, she developed a rash down her right arm and shingles was diagnosed. The patient was started on Acyclovir (800mg 5 times a day for 7 days).  The patient still had a lot of pain on her right side upper quadrant, going down her arm and into her right breast. The reporter consented to follow -up. The reporter was upset during the call so details like date of birth or lot and expiration date of Shingrix were not asked during the call.  The reporter did agree to follow-up via phone or email.
Sex: F
Vaccine: VARZOS
Symptoms: Neuralgia, Pain in extremity, Rash
Clinical narrative: Rash down her right arm; Shingles was diagnosed; Nerve pain in mid right upper shoulder and back/shoulder and back pain; Still has a lot of pain on her right side upper quadrant; Still has a lot of pain going down her arm; Pain into into her right breast; This case was reported by a nurse via call center representative and described the occurrence of neuralgia in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included acyclovir tablet for rash and shingles and prednisone for neuralgia.   On 8th October 2021, the patient received the 1st dose of Shingrix. In October 2021, the patient started acyclovir 800 mg at an unknown frequency and prednisone 60 mg at an unknown frequency. On 12th October 2021, 4 days after receiving Shingrix and not applicable after starting acyclovir, the patient experienced neuralgia. In October 2021, the patient experienced upper abdominal pain, pain in arm and breast pain. On 17th October 2021, the patient experienced rash and shingles. The action taken with acyclovir was unknown. The dose of prednisone was decreased. On an unknown date, the outcome of the neuralgia, rash and shingles were unknown and the outcome of the upper abdominal pain, pain in arm and breast pain were not recovered/not resolved.   It was unknown if the reporter considered the neuralgia, rash, shingles, upper abdominal pain, pain in arm and breast pain to be related to Shingrix. It was unknown if the reporter considered the upper abdominal pain, pain in arm and breast pain to be related to acyclovir.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient received the vaccine on her right arm. Four days after the vaccination, she developed nerve pain in her mid right upper shoulder and back.  On 15th October 2021, the patient needed to be started on Prednisone (60mg for 3 days) and then was titrated down daily.  Nine days after vaccination, she developed a rash down her right arm and shingles was diagnosed. The patient was started on Acyclovir (800mg 5 times a day for 7 days).  The patient still had a lot of pain on her right side upper quadrant, going down her arm and into her right breast. The reporter consented to follow -up. The reporter was upset during the call so details like date of birth or lot and expiration date of Shingrix were not asked during the call.  The reporter did agree to follow-up via phone or email.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Oropharyngeal pain, Pyrexia, Rash vesicular
Clinical narrative: Rash that looks like chickenpox; Slight sore throat; Fever; Fatigue; This case was reported by a other health professional via call center representative and described the occurrence of fatigue in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th October 2021, the patient received the 1st dose of Shingrix. On 16th October 2021, 4 days after receiving Shingrix, the patient experienced fatigue. On 17th October 2021, the patient experienced fever and sore throat. On 18th October 2021, the patient experienced varicella-like rash. On 20th October 2021, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the fatigue, varicella-like rash and sore throat were not recovered/not resolved.   It was unknown if the reporter considered the fatigue, fever, varicella-like rash and sore throat to be related to Shingrix.  Additional details were provided as follows: The reporter was a physician assistant who reported on behalf of patient. The patient received the Shingrix vaccine and developed fatigue. Five days after vaccination, the patient developed fever and slight sore throat. Six days after vaccination, the patient developed rash that looked like chickenpox. Fever had resolved at the time of reporting.  Fatigue, slight sore throat, and rash were ongoing at the time of reporting. The reporter consented to follow up.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: liquid portion administered alone; liquid portion administered alone; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 10-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA636A, expiry date 31st May 2023) for prophylaxis.   On 15th October 2021, the patient received Menveo. On 15th October 2021, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The patient administered with Menveo liquid portion alone, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up.
Sex: M
Vaccine: DTAP, DTAP
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: Administration to a 76 year old patient; 1st dose on 7 july 2021 and 2nd dose on 21 sep 2021; Administration to a 76 year old patient; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 76-year-old male patient who received DTPa (Infanrix) (batch number 49tm3, expiry date 28th May 2022) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Infanrix) (batch number 49tm3, expiry date 28th May 2022) for prophylaxis and dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 21st September 2021, the patient received the 2nd dose of Infanrix and Infanrix Pre-Filled Syringe Device. On 7th July 2021, the patient received the 1st dose of Infanrix and Infanrix Pre-Filled Syringe Device. On 7th July 2021, not applicable after receiving Infanrix and Infanrix Pre-Filled Syringe Device and unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On 21st September 2021, the patient experienced inappropriate age at vaccine administration and drug dose administration interval too short. On an unknown date, the outcome of the inappropriate age at vaccine administration, inappropriate age at vaccine administration 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 provided as follows: The 76 year old male patient received 1st and 2nd dose of Infanrix, which led to inappropriate age at vaccine administration. The patient received 2nd dose later than the recommended time interval, which led to shortening of vaccination schedule. No further events were reported. The reporter consented to follow up.
Age: 3.0
Sex: F
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: was administered Boostrix instead of Infanrix; was administered Boostrix instead of Infanrix; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 3-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 3E52S, expiry date 21st June 2022) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 19th October 2021, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On 19th October 2021, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration 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 provided as follows: The patient administered with a Boostrix dose instead of an Infanrix dose, which led to wrong vaccine administered and inappropriate age at vaccine administration. The reporter consented to follow up.
Sex: F
Vaccine: FLU4
Symptoms: Throat tightness
Clinical narrative: throat tightening; This case was reported by a nurse via call center representative and described the occurrence of throat tightness in a 55-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   Concurrent medical conditions included food allergy (very allergic to corn, wheat and maize).   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season (intramuscular). On an unknown date, less than an hour after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced throat tightness. On an unknown date, the outcome of the throat tightness was recovered/resolved.   It was unknown if the reporter considered the throat tightness to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: This case was reported by the patient herself, who was also the nurse. Over the last several years she had experienced throat tightening after receiving a flu vaccine (unsure of brand).  It happened within the first 5 minutes of receiving the vaccine. They asked her to sit for 30 minutes following administration and then let her go since it didn't worsen.  She could not recall how long it lasted. The reporter consented to follow up.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Abdominal pain upper, Back pain, Blood sodium decreased, Blood test abnormal
Clinical narrative: sharp pain in stomach and back; sharp pain in stomach and back; faint; soreness at injection site; diarrhea; nausea/vomiting; nausea; dizziness; chemical feeling in her stomach; This case was reported by a consumer via call center representative and described the occurrence of faint in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th October 2021 10:00, the patient received the 1st dose of Shingrix (intramuscular). On 11th October 2021, 6 hrs after receiving Shingrix, the patient experienced faint (serious criteria GSK medically significant), injection site pain, diarrhea, vomiting, nausea and dizziness. On 14th October 2021, the patient experienced stomach pain and back pain. In October 2021, the patient experienced stomach discomfort. The patient was treated with hyoscine (Scopolamine Patch). On an unknown date, the outcome of the faint, injection site pain, diarrhea, vomiting, nausea, dizziness, stomach pain, back pain and stomach discomfort were not recovered/not resolved.   It was unknown if the reporter considered the faint, diarrhea, vomiting, nausea, dizziness, stomach pain, back pain and stomach discomfort to be related to Shingrix. The reporter considered the injection site pain to be related to Shingrix.  Additional details provided were as follows: The case was reported by patient herself. The patient received a dose of Shingrix in right arm and about 4 hours later she experienced diarrhea, nausea/vomiting, dizziness and a sore arm at the injection site. The patient reported that approximately 6 hours after the Shingrix injection she began to feel faint while laying by the pool. The patient reported that all the previous symptoms had continued in waves for the past 10 days and was not resolved. The patient reported that she called her health care professional, who gave her the vaccine, and she told her to use a scopolamine patch behind her ear and the patient reported which helped with the dizziness. The patient reported that 3 days after receiving the Shingrix vaccine she began to experience sharp pains in her stomach and back, they come and go in waves. On 15th November 2021, the health care professional took a blood sample and told her that her sodium was low and suggested to increase her salt intake. The patient reported that for the past 10 days she could only eat bland food because of the nausea and vomiting. Less than 2 weeks after vaccination, the patient reported that her stomach feels like there was chemicals floating in her stomach. The patient did not give permission to contact health care professional. The reporter did not consent to follow-up.