chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Gait disturbance, Immediate post-injection reaction, Injection site erythema, Injection site joint inflammation
Clinical narrative: Pain at the injection site / injection site is still sensitive when touched; Redness / at injection site; Arm soreness; unable to do daily walk due to fatigue; Right shoulder was big and puffy; Fatigue; severe itching /injection site; swelling/ injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th July 2021, the patient received the 1st dose of Shingrix. In July 2021, 1 day after receiving Shingrix, the patient experienced injection site itching, injection site swelling, injection site joint inflammation, fatigue and walking difficulty. On 27th July 2021, the patient experienced injection site pain, injection site erythema and pain in arm. On an unknown date, the outcome of the injection site pain and pain in arm were recovering/resolving and the outcome of the injection site erythema, injection site itching, injection site swelling and fatigue were recovered/resolved and the outcome of the injection site joint inflammation and walking difficulty were unknown.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site itching, injection site swelling, injection site joint inflammation, fatigue, pain in arm and walking difficulty to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient herself. The patient received Shingrix and experienced pain, swelling, severe itching and redness at the injection site.  The patient experienced fatigue and arm soreness. The pain at injection site and arm soreness began immediately and had greatly subsided. However, the right arm at injection site was still sensitive when touched or massaged.  The swelling began on the second day after receiving dose and was at its worst by day 2 to day 4 after receiving vaccine and resolved after a week. Right shoulder was big and puffy. The itching began on the second day after receiving vaccine and lasted for 3 weeks.  The redness at injection site began immediately and was resolved.  The patient was unsure how and when the redness had resolved.  Fatigue began the day after receiving vaccine and lasted between 5 and 7 days. The patient was unable to do her usual, daily walk due to fatigue. The patient stated that she received the dose at a special station set up at the main office, due to COVID restrictions. The reporter consented to follow up.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: Pain at the injection site / injection site is still sensitive when touched; Redness / at injection site; Arm soreness; unable to do daily walk due to fatigue; Right shoulder was big and puffy; Fatigue; severe itching /injection site; swelling/ injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th July 2021, the patient received the 1st dose of Shingrix. In July 2021, 1 day after receiving Shingrix, the patient experienced injection site itching, injection site swelling, injection site joint inflammation, fatigue and walking difficulty. On 27th July 2021, the patient experienced injection site pain, injection site erythema and pain in arm. On an unknown date, the outcome of the injection site pain and pain in arm were recovering/resolving and the outcome of the injection site erythema, injection site itching, injection site swelling and fatigue were recovered/resolved and the outcome of the injection site joint inflammation and walking difficulty were unknown.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site itching, injection site swelling, injection site joint inflammation, fatigue, pain in arm and walking difficulty to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient herself. The patient received Shingrix and experienced pain, swelling, severe itching and redness at the injection site.  The patient experienced fatigue and arm soreness. The pain at injection site and arm soreness began immediately and had greatly subsided. However, the right arm at injection site was still sensitive when touched or massaged.  The swelling began on the second day after receiving dose and was at its worst by day 2 to day 4 after receiving vaccine and resolved after a week. Right shoulder was big and puffy. The itching began on the second day after receiving vaccine and lasted for 3 weeks.  The redness at injection site began immediately and was resolved.  The patient was unsure how and when the redness had resolved.  Fatigue began the day after receiving vaccine and lasted between 5 and 7 days. The patient was unable to do her usual, daily walk due to fatigue. The patient stated that she received the dose at a special station set up at the main office, due to COVID restrictions. The reporter consented to follow up.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin swelling
Clinical narrative: Pain at the injection site / injection site is still sensitive when touched; Redness / at injection site; Arm soreness; unable to do daily walk due to fatigue; Right shoulder was big and puffy; Fatigue; severe itching /injection site; swelling/ injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th July 2021, the patient received the 1st dose of Shingrix. In July 2021, 1 day after receiving Shingrix, the patient experienced injection site itching, injection site swelling, injection site joint inflammation, fatigue and walking difficulty. On 27th July 2021, the patient experienced injection site pain, injection site erythema and pain in arm. On an unknown date, the outcome of the injection site pain and pain in arm were recovering/resolving and the outcome of the injection site erythema, injection site itching, injection site swelling and fatigue were recovered/resolved and the outcome of the injection site joint inflammation and walking difficulty were unknown.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site itching, injection site swelling, injection site joint inflammation, fatigue, pain in arm and walking difficulty to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient herself. The patient received Shingrix and experienced pain, swelling, severe itching and redness at the injection site.  The patient experienced fatigue and arm soreness. The pain at injection site and arm soreness began immediately and had greatly subsided. However, the right arm at injection site was still sensitive when touched or massaged.  The swelling began on the second day after receiving dose and was at its worst by day 2 to day 4 after receiving vaccine and resolved after a week. Right shoulder was big and puffy. The itching began on the second day after receiving vaccine and lasted for 3 weeks.  The redness at injection site began immediately and was resolved.  The patient was unsure how and when the redness had resolved.  Fatigue began the day after receiving vaccine and lasted between 5 and 7 days. The patient was unable to do her usual, daily walk due to fatigue. The patient stated that she received the dose at a special station set up at the main office, due to COVID restrictions. The reporter consented to follow up.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect product formulation administered
Clinical narrative: patient had been given only the adjuvant portion; patient had been given only the adjuvant portion; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number 7C4B3, expiry date 14th November 2022) for prophylaxis.   On 20th August 2021, the patient received Shingrix. On 20th August 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 had been given only the adjuvant portion of the Shingrix vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up.
Age: 1.42
Sex: F
Vaccine: HIBV
Symptoms: Product preparation issue
Clinical narrative: Hiberix / reconstituted with an sterile diluent; Hiberix / reconstituted with an sterile diluent; This case was reported by a nurse via a representative and described the occurrence of wrong solution used in drug reconstitution in a 12-month-old female patient who received Hib (Hiberix) (batch number PJ7ER, expiry date 13th November 2022) for prophylaxis.   On 20th August 2021, the patient received the 3rd dose of Hiberix. On 20th August 2021, unknown after receiving Hiberix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as the reporter stated that, Hiberix was reconstituted with an sterile diluent and administered to a female patient.  Nurse states a patient was given a dose of Hiberix that was reconstituted using the saline for MMR vaccine instead of the diluent that comes with the Hiberix, which led to wrong solution used in drug reconstitution, and inappropriate dose of vaccine administered. The Nurse was not at the primary office location where vaccine administration error occurred and does not have any further details available at the time of this call. The reporter consented to follow up. This case was linked with case US2021176206, reported by same reporter for different patient.
Sex: F
Vaccine: VARZOS
Symptoms: Foot fracture, Orthopaedic procedure, Walking aid user, Weight bearing difficulty
Clinical narrative: Calcaneus fracture fracture that required a surgery; being on crutches with no weight bearing; This case was reported by a nurse via call center representative and described the occurrence of calcaneus fracture in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included osteoporosis.   On 13th April 2021, the patient received the 1st dose of Shingrix. In July 2021, between 1 and 2 months after receiving Shingrix, the patient experienced calcaneus fracture and crutch user. On an unknown date, the outcome of the calcaneus fracture was unknown and the outcome of the crutch user was not recovered/not resolved.   The reporter considered the calcaneus fracture and crutch user to be unrelated to Shingrix.  Additional details were provided as follows: This case was reported by the nurse who was also the patient. The age at vaccination was not reported. The patient had received Shingrix and had a calcaneous fracture that required surgery with "placement of hardware" (the surgery was 36 days before this report).  The patient was on crutches with no weight bearing and that would be a major ordeal to retrieve her vaccination card.  The reporter had assessed the causality as not related to the administration of Shingrix. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Condition aggravated, Ophthalmic herpes zoster, Vaccination failure
Clinical narrative: After series shingles around eye\Suspected vaccination failure; Shingles around eye; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included ophthalmic herpes zoster. Concomitant products included valaciclovir hydrochloride (Valtrex).   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and ophthalmic herpes zoster (serious criteria GSK medically significant). 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 Shingrix and Shingrix.  Additional details were provided as follows: This case was reported by patient himself. The age at vaccination was not reported. The patient reported that he had shingles around his eye. The patient was advised by his health care professional to get the Shingrix vaccine series.  The patient received the Shingrix vaccine series as per package inserts.  After getting the Shingrix vaccinations, he developed shingles again around his eye.  The patient was considering getting another Shingrix vaccine. Referred to health care professional and spoke per package inserts or content.  The patient did not pay any other additional information.  The reporter did not consent to follow-up. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: experienced shingles after vaccination/ suspected vaccination failure; shingles; This case was reported by a physician via call center representative and described the occurrence of suspected vaccination failure in an unspecified number of patients 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 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 Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The physician mentioned that, he knew that more than one patient experienced shingles after vaccination with Shingrix but did not want to share the exact number of patients.  This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting. The reporter consented to follow up. No more information was provided. This case has been linked to the case US2021177362 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021177362:reporter´s case
Age: 63.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Inappropriate schedule of product administration, Rash pruritic, Vaccination failure, Vaccine positive rechallenge
Clinical narrative: Approx 15 outbreaks since 1st and second doses\ suspected Vaccination failure; Approximately 15 outbreaks; Rash is itchy\ rash along upper buttocks/lower back\ rash on left side; 1st dose August 2019  2nd on July 26 2020; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 26th July 2020, the patient received the 2nd dose of Shingrix. In August 2019, the patient received the 1st dose of Shingrix. On 26th July 2020, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and itchy rash. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the vaccination failure and drug dose administration interval too long were unknown and the outcome of the shingles and itchy rash were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and itchy rash to be related to Shingrix and Shingrix.  Additional details were provided as follows: This case was reported by patient himself. The patient experienced approximately 15 outbreaks of Shingles since receiving first and second dose of Shingrix. For tolerance of 1st dose of Shingrix, refer case US2021AMR178368. The patient reported outbreak always occurs on the left side, on the upper buttocks or lower back where the waistband of the underwear lies.  The patient reported rash was itchy and has the appearance on mosquito or spider bites.  Less than 1 years after 1st dose of Shingrix, the patient experienced suspected vaccination failure, shingles and itchy rash. Less than 2 years after 2nd dose of Shingrix, the patient experienced vaccination failure, shingles and itchy rash. The patient reported not having an outbreak for the past 4 weeks. This case was considered as suspected vaccination failure as details time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting. The reporter consented to follow up.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles two days after 1st dose; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had a history of shingles for several years).   On 18th August 2021, the patient received the 1st dose of Shingrix .5 ml. In August 2021, 2 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The case was reported by the consumer for herself. The patient stated that, got her first vaccine of Shingrix on Wednesday at the time of reporting. The patient said that, two days later she had an outbreak of shingles. The reporter did not consent to follow up.
Age: 15.0
Sex: F
Vaccine: HEPAB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: had been given Twinrix patient is currently 15 years old; This case was reported by a other health professional via representative and described the occurrence of inappropriate age at vaccine administration in a 15-year-old female patient who received HAB (Twinrix) (batch number 75C72, expiry date 13th June 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 23rd August 2021, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 23rd August 2021, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. The action taken with Twinrix Pre-Filled Syringe Device was unknown. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as the reporter informed that, the patient had been given Twinrix and the patient was currently 15 years old at the time of reporting, which led to inappropriate age at vaccine administration.  The health care professional  mentioned they could help follow up with patient.  The reporter agreed to follow up, preferably by email.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: rash where she received her injection; This case was reported by a consumer via call center representative and described the occurrence of injection site rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd August 2021, the patient received the 1st dose of Shingrix. On 24th August 2021, 1 days after receiving Shingrix, the patient experienced injection site rash. On an unknown date, the outcome of the injection site rash was unknown.   It was unknown if the reporter considered the injection site rash to be related to Shingrix.  Additional details were provided as follows: The case was reported by the consumer for herself. The age at vaccination was not reported. The patient stated that, she got her first Shingrix vaccine yesterday and woke up this morning on day of reporting with a rash on her arm where she received her injection.  The patient declined to provide any additional information regarding this report.  The reporter did not consent to follow up. The patient declined to provide any additional adverse event details.
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Received diluent without reconstitution; Received diluent without reconstitution; This case was reported by a other health professional via a representative and described the occurrence of inappropriate preparation of medication in a 19-year-old female patient who received ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, 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 the age at vaccination was not reported. The patient had received the Menveo diluent without reconstitution with the lyophilized powder, which led to inappropriate preparation of medication, and inappropriate dose of vaccine administered. The reporter consented to follow up. This case was linked with US2021178412, reported by the same reporter. Sender's Comments:  US-GLAXOSMITHKLINE-US2021178412, Same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: More than six months since first dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 16th July 2019 by Intramuscular route, which was more than six months from the date of reporting).   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 case details were reported as follows: The case was reported by patient. The age at vaccination was not applicable for this report. The patient did not received 2nd dose till the time of reporting which led to incomplete course of vaccination. The patient asked to find out if she needs to restart the Shingrix series since it's been more than six months since her first dose. The patient stated she plans on getting the 2nd dose in the near future after speaking to her health care professional.  The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: First dose given 2 years ago. Second dose not yet given.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on an unknown date  2 years ago).   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 age at vaccination was not applicable for this report. Pharmacist reported Shingrix second dose than 6 months. Till the time of reporting, the patient did not receive the second dose, which led to, incomplete course of vaccination.  The healthcare professional could not provide date of first dose, lot number, or expiration date.  The reporter consented to follow up.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Pain in extremity, Pyrexia, Rash, Rash erythematous
Clinical narrative: red rash (over the face, neck, chest, and the backside (halfway down the waist); Fever (99.9F); Sore Arm; Tredness; This case was reported by a consumer via call center representative and described the occurrence of red rash in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax with an associated reaction of herpes zoster (received years ago and then developed shingles).   On 3rd June 2021, the patient received the 1st dose of Shingrix (intramuscular) 50 ug. In June 2021, less than a week after receiving Shingrix, the patient experienced red rash, fever, pain in arm and tiredness. In June 2021, the outcome of the red rash, fever, pain in arm and tiredness were recovered/resolved.   It was unknown if the reporter considered the red rash, fever, pain in arm and tiredness to be related to Shingrix.  Additional details were reported follows: The patient reported this case for herself. The reporter mentioned that she received Zostavax years ago and then developed shingles. Later, she was advised to take Shingrix by her health care professional. The patient received shingrix in the left deltoid. The patient experienced tiredness, sore arm, fever 99.9 degree F , red rash all over the face, neck, chest, and the backside, halfway down the waist. The side effects were resolved on the 4th day post vaccination. The reporter did not consent to follow-up.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, Fatigue, Headache, Malaise
Clinical narrative: headache; fatigue; feels lowsy; received a third dose by accident; This case was reported by a consumer via call center representative and described the occurrence of headache in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 3rd January 2020) and Shingrix (2nd dose received in 24th June 2020).   On 23rd August 2021, the patient received the 3rd dose of Shingrix. On 23rd August 2021, less than a day after receiving Shingrix, the patient experienced headache, fatigue, feeling unwell and extra dose administered. On an unknown date, the outcome of the headache, fatigue and feeling unwell were recovering/resolving and the outcome of the extra dose administered was unknown.   It was unknown if the reporter considered the headache, fatigue and feeling unwell to be related to Shingrix.  Additional case details were reported as follows: The case was reported by patient. The patient received a 3rd dose of Shingrix by accident on the day of reporting still after received 2 dose of Shingrix which led to extra dose administered. The patient had a headache, fatigue, and feels lowsy but was starting to feel better. The patient did not know the lot number and expiration date of the product. The reporter did not consent to follow-up. The patient declined to provide health care professional details.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Fatigue, Headache, Immediate post-injection reaction
Clinical narrative: nausea; stomach pain; fatigue; headache; shivering; sore arm where she received the injection; This case was reported by a consumer and described the occurrence of injection site pain in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included chronic obstructive pulmonary disease (included difficulty breathing with other symptoms) and difficulty breathing. Concomitant products included VIRAL VACCINES (COVID VACCINE (NOS)) and VIRAL VACCINES (COVID VACCINE (NOS)).   On 17th August 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 17th August 2021, immediately after receiving Shingrix, the patient experienced injection site pain. On 20th August 2021, the patient experienced nausea, stomach pain, fatigue, headache and shivering. The patient was treated with maalox (nos) (Maalox) and acetylsalicylic acid (Aspirin). On 17th August 2021, the outcome of the injection site pain was recovered/resolved. On an unknown date, the outcome of the nausea, stomach pain, fatigue, headache and shivering were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, nausea, stomach pain, fatigue, headache and shivering to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient received her first dose of Shingrix and right away she had a sore arm where she had received the injection, soreness went away on the same day. As patient had COPD (chronic obstructive pulmonary disease) and included difficulty breathing with other symptoms, but her level of difficulty breathing was unchanged by the Shingrix vaccine. 3 days after receiving Shingrix, the patient experienced nausea, stomach pain, fatigue, headache and shivering.  The doctor recommended an aspirin, prescribed a compound called Maalox Cocktail and recommended a heat pad for abdominal pain.  That did help but nausea, stomach pain, fatigue, headache, and shivering are all unresolved, she had all of those symptoms till the time of reporting. The reporter consented to follow up.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Nausea
Clinical narrative: nausea; stomach pain; fatigue; headache; shivering; sore arm where she received the injection; This case was reported by a consumer and described the occurrence of injection site pain in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included chronic obstructive pulmonary disease (included difficulty breathing with other symptoms) and difficulty breathing. Concomitant products included VIRAL VACCINES (COVID VACCINE (NOS)) and VIRAL VACCINES (COVID VACCINE (NOS)).   On 17th August 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 17th August 2021, immediately after receiving Shingrix, the patient experienced injection site pain. On 20th August 2021, the patient experienced nausea, stomach pain, fatigue, headache and shivering. The patient was treated with maalox (nos) (Maalox) and acetylsalicylic acid (Aspirin). On 17th August 2021, the outcome of the injection site pain was recovered/resolved. On an unknown date, the outcome of the nausea, stomach pain, fatigue, headache and shivering were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, nausea, stomach pain, fatigue, headache and shivering to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient received her first dose of Shingrix and right away she had a sore arm where she had received the injection, soreness went away on the same day. As patient had COPD (chronic obstructive pulmonary disease) and included difficulty breathing with other symptoms, but her level of difficulty breathing was unchanged by the Shingrix vaccine. 3 days after receiving Shingrix, the patient experienced nausea, stomach pain, fatigue, headache and shivering.  The doctor recommended an aspirin, prescribed a compound called Maalox Cocktail and recommended a heat pad for abdominal pain.  That did help but nausea, stomach pain, fatigue, headache, and shivering are all unresolved, she had all of those symptoms till the time of reporting. The reporter consented to follow up.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: third dose administered; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 27th November 2018) and Shingrix (2nd dose received on 8th February 2019).   On 24th August 2021, the patient received the 3rd dose of Shingrix. On 24th August 2021, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional case details were reported as follows: Pharmacist reported that they inadvertently administered a 3rd dose of Shingrix to a patient which led to extra dose administered. Pharmacist thought the patient never received the 2nd dose of Shingrix but then after administration of 3rd dose, they found out the patient received the full series of the 2 doses. The reporter also stated they spoke with patient and no adverse reactions reported The reporter did not consent to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: received only the diluent component; received only the diluent component; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th August 2021, the patient received Shingrix. On 25th August 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 age at vaccination was not reported. The patient received only diluent component of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter did not consent to follow up.
Sex: F
Vaccine: MNQ
Symptoms: Incorrect route of product administration
Clinical narrative: subcutaneous administration instead of IM; This case was reported by a other health professional via representative and described the occurrence of intramuscular formulation administered by other route in a 11-year-old female patient who received ACWY-CRM NVS (Menveo) (batch number AMVA468A, expiry date 31st March 2022) for prophylaxis.   On 23rd August 2021, the patient received Menveo (subcutaneous). On 23rd August 2021, unknown after receiving Menveo, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.  Additional details were provided as the patient received Menveo dose subcutaneously instead of intramuscular, which led to intramuscular formulation administered by other route. The reporter consented to follow up via mail.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Social problem
Clinical narrative: due to Covid-19 situation / not vaccinated with the 2nd dose yet; This case was reported by a physician via call center representative and described the occurrence of social problem in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose a year ago, batch number 4N2AB, expiry date 10th February 2023).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The age vaccination was not applicable for this report. The patient did not receive 2nd dose due to Covid-19 situation. The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose 3 years ago / never got the second dose; This case was reported by a pharmacist via call center representative 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 3 year ago).   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 age at vaccination was not applicable to this report.  The patient received the first dose of the Shingrix vaccine 3 years ago but never got the second dose.  The pharmacy did not have any patient information, lot number or expiration date.  The reporter did not consent to follow-up.  No additional information provided.
Sex: F
Vaccine: VARZOS
Symptoms: Recalled product administered
Clinical narrative: received the recall batch of Shingrix that GSK issued on 02/10/2021; received the recall batch of Shingrix that GSK issued on 02/10/2021; This case was reported by a other health professional via call center representative and described the occurrence of recalled drug administered in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number TT2JF, expiry date 28th October 2022) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced recalled drug administered and drug dispensing error. On an unknown date, the outcome of the recalled drug administered and drug dispensing error were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient received the recall batch of Shingrix that Glaxosmithkline issued on 10th February 2021. The reporter stated that, the lot number was not 9LH3Y and was not sure if this the lot number from one of the vials. The reporter stated that, the vaccine was administered to the patient before the recall of drug. This case was 1 of 8 linked cases, reported by same reporter for different patients. The reporter consented to follow up via email.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR180389:Original Case : US2021179651 US-GLAXOSMITHKLINE-US2021AMR180391:Original Case : US2021179651 US-GLAXOSMITHKLINE-US2021AMR180388:Original Case : US2021179651 US-GLAXOSMITHKLINE-US2021AMR180387:Original Case : US2021179651 US-GLAXOSMITHKLINE-US2021AMR180386:Original Case : US2021179651 US-GLAXOSMITHKLINE-US2021AMR180385:Original Case : US2021179651 US-GLAXOSMITHKLINE-US2021AMR180390:Original Case : US2021179651
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination
Clinical narrative: first Shingrix vaccine in October of 2020/ has not received second dose; Shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In October 2020, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. In July 2021, between 8 and 10 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the shingles and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received his first dose of shingrix vaccine and got shingles in early July 2021. Till nowpatient had not received his second dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to followup.
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered
Clinical narrative: received 2 doses of Shignrix in 24 hours; This case was reported by a nurse via call center representative and described the occurrence of overdose in a 95-year-old male patient who received Herpes zoster (Shingrix) (batch number FZ7Z4, expiry date 27th January 2023) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 25th August 2021, the patient received the 2nd dose of Shingrix. In August 2021, unknown after receiving Shingrix and Shingrix, the patient experienced overdose. On an unknown date, the outcome of the overdose was unknown.  Additional details were reported as follows: This case was reported by the Nurse. The age at vaccination was not reported. The nurse reported that, the patient received two doses of shingrix withing 24 hours, which led to overdose  The reporter did not consent to followup.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose of the Shingrix vaccine 8/22/2019 has not received the second dose.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 22nd August 2019).   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 age at vaccination was not applicable to this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow up. This case had been linked with case US2021179653, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021179653:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose of Shingrix vaccine 10/25/18 and the second dose today.; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 25th October 2018).   On 25th August 2021, the patient received the 2nd dose of Shingrix. On 25th August 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 2nd dose of Shingrix later than the recommended interval, which led to lengthening of vaccine schedule. The reporter did not consent to follow up. This case has been linked with case US2021179654, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021179654:Same reporter
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Immediate post-injection reaction, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: injection site started itching; pain at the injection site; swelling at the injection site; fever; sleepiness; pain in the right arm / used my arm for 4 hours and after it was hurting / arm is still sore; joint pain in my right shoulder; knot on her armpit, like a swollen gland; knot on her armpit very painful; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included type ii diabetes mellitus. Concomitant products included drug used in diabetes (Diabetes Medication (Nos)).   On 21st August 2021 16:30, the patient received the 1st dose of Shingrix. In August 2021, less than a week after receiving Shingrix, the patient experienced injection site swelling, fever, sleepiness, pain in arm, pain in joint involving shoulder region, axillary lymph nodes enlarged and pain. On 21st August 2021, the patient experienced injection site pain. On 25th August 2021, the patient experienced injection site itching. On an unknown date, the outcome of the injection site pain, injection site swelling, fever, sleepiness, pain in joint involving shoulder region, axillary lymph nodes enlarged and pain were unknown and the outcome of the injection site itching and pain in arm were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site swelling, injection site itching, fever, sleepiness, pain in arm, pain in joint involving shoulder region, axillary lymph nodes enlarged and pain to be related to Shingrix.  Additional details were reported as follows: The patient self-reported this case. Patient reported that she had diabetes mellitus type 2 and was on medications (unspecified) for this condition.  The patient received first dose of Shingrix vaccine in right arm at a local pharmacy and immediately experienced pain at the injection site. The patient experienced swelling at the injection site, fever, sleepiness, pain in the right arm and joint pain in right shoulder. The patient reported that she had a knot on her armpit, like a swollen gland and it was very painful. The patient reported that she ate right and exercises daily.  On the day of reporting, 4 days after receiving vaccination, the injection site started itching and arm was still sore.  The patient reported that at her part time job she used her arm for 4 hours and after it was hurting.  The patient provided consent to follow up with healthcare professional. The reporter consented to follow up.