chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: child injected with Shingrix accidentally instead of with the Varicella vaccine; child injected with Shingrix; This case was reported by a consumer via call center representative and described the occurrence of wrong vaccine administered in a child 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 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.   Additional Information: GSK Receipt Date: 17-JUN-2022 Reporter's Comments: The patient was injected with Shingrix accidentally instead of with varicella (chickenpox) vaccine which led to inappropriate age at vaccine administration and wrong vaccine administered. The reporter wanted to know if there were any concerns as Shingrix was not tested in children.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got shingles after the shingles vaccine/suspected Vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 16-JUN-2022 Reporter's Comments: This case was reported by a parent via interactive digital media. The reporter's daughter got shingles after the shingles vaccine.  Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Blood pressure decreased, Dizziness, Laboratory test
Clinical narrative: Blood pressure has dropped drastically; I also have bouts of dizziness; This case was reported by a consumer via interactive digital media and described the occurrence of blood pressure decreased in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced blood pressure decreased and dizziness. On an unknown date, the outcome of the blood pressure decreased and dizziness were unknown.   It was unknown if the reporter considered the blood pressure decreased and dizziness to be related to Shingrix.     Additional Information: GSK receipt date: 18-June-2022 Reporter's comment: The patient self-reported the case via interactive digital media. The patient recently had a shot and his/her blood pressure dropped drastically. The patient also had bouts of dizziness. The patient inquired if it was normal. Additional supportive information: Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Been a year since my 1st shot, can I get my 2nd?; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received a year before the date of reporting).   On an unknown date, the patient did not receive 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 Information: GSK Receipt Date: 18-Jun-2022 Reporter's comments: This case was reported by the patient via interactive digital media. The patient reported that it had been a year since first Shingrix shot and asked if he or she could get the 2nd dose now. Additional Supportive Information: Till the time of reporting the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster, Vaccination failure, Vaccine breakthrough infection
Clinical narrative: I have Shingles, It is on my head and in my eye/ suspected Vaccination failure; I have Shingles, It is on my head and in my eye; Shingles on my head and in my eye/I have a breakthrough case; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), ophthalmic herpes zoster (serious criteria GSK medically significant) and shingles. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the ophthalmic herpes zoster and shingles were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 18-JUN-2022 Reporter's Comments: This case reported by the patient via interactive digital media. The patient was vaccinated a few years before the date of reporting. The patient was having bad breakthrough case of shingles on head and in eye. The patient found it to be creepy and invasive. Additional supportive information: 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: Therapeutic response unexpected
Clinical narrative: eczema gone, unexpected benefit; This case was reported by a consumer and described the occurrence of unexpected therapeutic effect in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date), Steroids, Lotion and cream. Concurrent medical conditions included eczema.   On 3rd March 2022, the patient received the 2nd dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced unexpected therapeutic effect. On an unknown date, the outcome of the unexpected therapeutic effect was unknown.   It was unknown if the reporter considered the unexpected therapeutic effect to be related to Shingrix.     Additional Information: GSK Receipt Date: 17-Jun-2022 Reporter's comments: This case was reported by the patient. The patient would like to report a possible good side effect of the vaccine. The patient had been living with a moderate case of eczema for many years now. The patient used every cream, steroids and lotions the doctors given and some the patient bought over the counter, and nothing had worked for any length of time. The patient gave up and just resigned to a life of long sleeves and long pants. Then one day the patient was at doctor's office and asked about a follow-up Shingles shot at which time was given Shingrix. The patient did not give it another thought until a couple of days later he or she was talking to his or her daughter about this really expensive medication that son in law was given for Psoriasis and the patient looked down at legs to see eczema and it was gone. The patient looked at arms and not a spot there either. The patient started thinking about what, if anything, was different that he or she had done or taken and the only thing was that Shingles shot. Now, nearly 4 full months later and not a single mark of eczema was anywhere. The patient hope it was gone forever but, for now, could only attribute it to vaccination. The patient believed this was something that company should explore, if have not done so already. The patient stated that other might already be aware of this unexpected benefit of the shingles vaccination.
Age: 1.67
Sex: F
Vaccine: HEPA
Symptoms: Incorrect route of product administration
Clinical narrative: Havrix dose administered subcutaneously instead of intramuscularly; This case was reported by a nurse via call center representative and described the occurrence of intramuscular formulation administered by other route in a 20-month-old female patient who received HAV (Havrix) (batch number 2K57N, expiry date 11th December 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 10th June 2022, the patient received Havrix (subcutaneous) and Havrix Pre-Filled Syringe Device. On 10th June 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, 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.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 15-JUN-2022 Reporter's Comments: The patient received Havrix dose subcutaneously instead of intramuscularly.  The reporter consented to follow up.  The Vaccine Administration Facility was the same as Primary Reporter. Additional supportive Information: The patient received havrix subcutaneously instead of intramuscularly which led to intramuscular formulation administered by other route.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Product storage error
Clinical narrative: Administered havrix and infanrix after temperature excursion; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a female patient who received HAV (Havrix) (batch number 2K57N, expiry date 11th December 2022) for prophylaxis.   Co-suspect products included DTPa (Infanrix) (batch number 7EC55, expiry date 29th April 2023) for prophylaxis and dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 21st February 2022, the patient received the 1st dose of Havrix, the 1st dose of Infanrix and Infanrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix, Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Linked case(s) involving the same patient:  US2022093643   Additional Information: GSK Receipt Date: 15-JUN-2022 Reporter's Comment: Medical assistant reported that the patient was administered the doses of Havrix and infanrix vaccines after a temperature excursion in the right arm. The reporter consented to follow-up. Additional supportive information: The patient was administered the doses of Havrix and infanrix vaccines after a temperature excursion, which led to Incorrect storage of drug. This is one of 11 cases, reported by the same reporter. The case US2022093643 was identified as duplicate of this case. The case US2022093643 was deleted and all future correspondence would be added in the present case which stands as case of record for this patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022093643:Same reporter US-GLAXOSMITHKLINE-US2022093600:Same reporter. US-GLAXOSMITHKLINE-US2022093602:Same reporter. US-GLAXOSMITHKLINE-US2022093637:Same reporter. US-GLAXOSMITHKLINE-US2022093638:Same reporter. US-GLAXOSMITHKLINE-US2022093640:Same reporter. US-GLAXOSMITHKLINE-US2022093642:Same reporter. US-GLAXOSMITHKLINE-US2022093644:Same reporter. US-GLAXOSMITHKLINE-US2022093645:Same reporter. US-GLAXOSMITHKLINE-US2022093646:Same reporter. US-GLAXOSMITHKLINE-US2022093647:Same reporter. US-GLAXOSMITHKLINE-US2022093648:Same reporter.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Rash papular
Clinical narrative: Patient experienced a rash described as located on right flank; Rash as little red bumps; Rash as little red bumps; This case was reported by a nurse via call center representative and described the occurrence of rash in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th June 2022, the patient received Shingrix. In June 2022, less than a week after receiving Shingrix, the patient experienced rash, red rash and papular rash. On an unknown date, the outcome of the rash, red rash and papular rash were unknown.   It was unknown if the reporter considered the rash, red rash and papular rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 16-JUN-2022 Reporter's Comments: The nurse reported that the patient experienced a rash after a dose of Shingrix. HCP was also the patient.  The rash was described as located on right flank and as little red bumps. No lot number or expiration date provided.  The reporter was Consented to follow up.
Age: 4.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Administration of expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 4-year-old male patient who received HBV (Engerix B) (batch number d423n, expiry date 1st June 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th June 2022, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On 15th June 2022, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 16-JUN-2022 Reporter's Comments: The office manager reported that male patient received a dose of Engerix B on 15th June 2022 and the dose had expired on 1st June 2022.  The reporter was consented to follow up.  The Vaccine Administration Facility was the same as Primary Reporter.
Age: 31.0
Sex: M
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Engerix-B pediatric dose given to an adult; Engerix-B pediatric dose given to an adult; This case was reported by a nurse via call center representative and described the occurrence of underdose in a 31-year-old male patient who received HBV (Engerix B pediatric) (batch number L9Y4G, expiry date 5th April 2024) for prophylaxis.   On 15th June 2022, the patient received Engerix B pediatric. On 15th June 2022, unknown after receiving Engerix B pediatric, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 16-June-2022 Reporter's Comments:  The nurse reported that on 15th June 2022, an 22 years old male adult received an Engerix-B pediatrix dose, which led to underdose and adult use of a child product. The reporter consented to follow up. Additional supportive information: The age of the patient was captured as per the date of birth reported.
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Vertigo
Clinical narrative: vertigo was reactivated; This case was reported by a physician via sales rep and described the occurrence of vertigo in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included vertigo.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vertigo. On an unknown date, the outcome of the vertigo was unknown.   It was unknown if the reporter considered the vertigo to be related to Shingrix.     Additional Information: GSK Receipt Date: 16-JUN-2022 Reporter's Comment: The case was reported by patient himself who was MD. The reporter stated that during a luncheon for a clinical team one of the MD present stated they had an adverse event occur after his own Shingrix.   The reporter stated that, he felt as if after receiving the dose his vertigo was reactivated.  The reporter consented to follow up.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Engerix-b expired dose administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a adult patient who received HBV (Engerix B) (batch number H2T35, expiry date 29th May 2022) for prophylaxis.   On 16th June 2022, the patient received Engerix B. On 16th June 2022, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 16-Jun-2022 Reporter's Comments: The reporter stated that a nurse gave by error an Engerix-B expired vaccine to a patient. The reporter had no information about the patient at the time of reporting. The reporter consented to follow up via email. Additional Supportive Information: The patient received Engerix B, which was already expired in 29th May 2022, which led to expired vaccine administered.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Headache, Onychalgia, Pain in extremity
Clinical narrative: Pain of the arm; Redness of the arm; Toenail pain; Headache; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included shingles. Concomitant products included acetylsalicylic acid (Aspirin).   On 14th June 2022, the patient received the 1st dose of Shingrix. On 14th June 2022, less than a day after receiving Shingrix, the patient experienced pain in arm, erythema of extremities, nail pain and headache. On an unknown date, the outcome of the pain in arm, erythema of extremities, nail pain and headache were unknown.   It was unknown if the reporter considered the pain in arm, erythema of extremities, nail pain and headache to be related to Shingrix.     Additional Information: GSK Receipt Date: 16-JUN-2022 Reporter's Comments: The reporter called and stated that she had her first dose of Shingrix and then experienced pain and redness of the arm, toenail pain and headache. The patient was referred to health care professional.  The reporter consented to follow up.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain, Pyrexia
Clinical narrative: Pain at injection site; Fever; Tiredness; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (On an unknown date received 1st dose of 0.5 mg/ml.).   On 15th June 2022, the patient received the 2nd dose of Shingrix .5 mg/ml. On 15th June 2022, immediately after receiving Shingrix, the patient experienced injection site pain, fever and tiredness. On an unknown date, the outcome of the injection site pain, fever and tiredness were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, fever and tiredness to be related to Shingrix.     Additional Information: GSK Receipt Date: 16-JUN-2022 Reporter's Comments: The caller was the husband of the patient. The reporter stated that the patient got her second Shingrix vaccine on left arm and was experiencing pain at the injection site, fever, and tiredness. The reporter stated that the pain started almost immediately, and the fever and tiredness started about 8 hours later. The patient was still experiencing these symptoms at the time of reporting. The reporter was unsure when patient got her first vaccine, but that it was in the appropriate time frame. The reporter did not have any further information about the vaccines such as lot or expiration. The reporter did not consent to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose of shingrix on AUG 2020,  2nd dose was given June 16th 2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) (batch number 34L52, expiry date 6th July 2023) for prophylaxis.   Previously administered products included Shingrix (patient got 1st dose of Shingrix in August 2020).   On 16th June 2022, the patient received the 2nd dose of Shingrix. On 16th June 2022, 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 Information: GSK Receipt Date: 16-JUN-2022 Reporter's Comment: The patient details were not available. The reporter consented to follow up. No email provided. Additional Supportive Information: The patient received the 2nd dose of Shingrix later than the recommended interval, which led to lengthening of vaccination schedule.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: possibly not receiving both components of Shingrix; possibly not receiving both components of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a female patient who received Herpes zoster (Shingrix) (batch number Z4J77, expiry date unknown) for prophylaxis.   On 11th March 2022, the patient received the 1st dose of Shingrix. On 11th March 2022, 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 Information: GSK Receipt Date: 16-JUN-2022  Reporter's comments: The pharmacist reported that, the patient received dose of Shingrix and they were researching a patient's vaccine history due to them possibly not receiving both components of Shingrix.   The reported lot number was Z4J77 (confirmed twice). However, this was not bringing up any matches. The reporter consented to follow up by email but the reporter declined to provide date of birth. Additional Supportive Information: The pharmacist reported that, the patient received dose of Shingrix and they were researching a patient's vaccine history due to them possibly not receiving both components of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 1.0
Sex: M
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaccine administered to a 21month baby boy; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 1-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 2G3PH, expiry date 27th October 2023) for prophylaxis.   On 17th June 2022, the patient received Boostrix. On 17th June 2022, unknown after receiving Boostrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 17-Jun-2022 Reporter's comments: Medical Assistant administered a Boostrix to 21 months old patient. The consent to follow up was given by mail. Additional Supportive Information: Twenty one months old patient received Boostrix, which led to inappropriate age at vaccine administration.
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Expired dose administered to newborn; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a neonate female patient who received HBV (Engerix B pediatric) for prophylaxis.   On 17th June 2022, the patient received Engerix B pediatric. On 17th June 2022, unknown after receiving Engerix B pediatric, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: SK Receipt Date: 17-Jun-2022 Reporter's comments: An expired dose of Engerix-B administered to newborn patient. The consent to follow up was given. Expiration date, lot number, and initials were unavailable at the time of reporting.  Additional Supportive Information: An expired dose of Engerix-B administered to newborn patient, which led to expired vaccine used.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose at the end of OCT 2021 has not received his 2nd dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received at the end of October 2021, exact date was not known).   On an unknown date, the patient did not receive 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 Information: GSK Receipt Date: 17-Jun-2022 Reporter's comments: This case was reported by the patient. The patient had not received his second dose of Shingrix to the date. The patient was provided medical advice disclaimer and referred to healthcare professional. The patient was provided Centers for disease control guidance per content on alternative dosing schedules. The reporter did not consent to follow-up. Additional Supportive Information: Till the time of reporting the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: MENB
Symptoms: Intercepted product prescribing error
Clinical narrative: prescribed Bexsero to 70 year old, never started series; This case was reported by a pharmacist via call center representative and described the occurrence of intercepted drug prescribing error in a 69-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 splenectomy.   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 intercepted drug prescribing error. On an unknown date, the outcome of the intercepted drug prescribing error was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 17-Jun-2022 Reporter's comments: Pharmacy manager called in to inquire that was any information available for the healthcare professional to make informed decision and how to proceed with Bexsero. The registered pharmacist reported that a provider prescribed Bexsero and Menactra to a 69 year old patient without a spleen. The patient never started Bexsero series. No vaccine administered. The registered pharmacist gathering information to make informed decision. The reporter did not consent to follow-up. Additional Supportive Information: The 69 year old patient received prescription for Bexsero that was identified and intercepted by the pharmacist, which led to intercepted drug prescribing error.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Has never received second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 14th June 2021 from batch number 4Y2P4, expiry date 23rd January 2023).   On an unknown date, the patient did not 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 Information: GSK Receipt Date: 17-JUN-2022 Reporter's Comments: The patient had never received second dose. The reporter did not give consent to follow-up. Additional supportive Information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Device leakage, Exposure via skin contact, Occupational exposure to product, Product complaint
Clinical narrative: Nurse preparing the dose got adjuvant on her bare skin; Got adjuvant on her bare skin; Leak came from the stopper at the neck of the vial; Leak came from the stopper at the neck of the vial; This case was reported by a other health professional via call center representative and described the occurrence of occupational exposure to product in a 38-year-old female patient who was preparing Herpes zoster (Shingrix) (batch number dc434, expiry date 3rd June 2023) and (batch number 75pez, expiry date 3rd June 2023) to administer in another the patient for prophylaxis. This case was associated with a product complaint.   On an unknown date, the patient received Shingrix. On an unknown date, the dose was an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced occupational exposure to product, exposure via skin contact, vial adapter leak and pharmaceutical product complaint. On an unknown date, the outcome of the occupational exposure to product, exposure via skin contact, vial adapter leak and pharmaceutical product complaint were unknown.   Additional Information: GSK Receipt Date: 17-Jun-2022 Reporter's comments: The reporter stated that as contents of Shingrix adjuvant in the syringe were being transferred into the antigen vial, the nurse preparing the dose heard a pop and saw leakage from the antigen vial. The patient did not inject air from the syringe into the vial during preparation. Leak came from the stopper at the neck of the vial. The vial rubber stopper or metallic skirt did not detach or become loose during handling or without any manipulation. The patient removed only the plastic flip-off before handling. There was no evidence of leakage in package or carton. The nurse preparing the dose got Shingrix adjuvant on her bare skin due to the leakage. The reporter did not consent to follow-up. Additional Supportive Information: The nurse preparing the dose got Shingrix adjuvant on her bare skin due to the leakage, which led to occupational exposure to product, exposure via skin contact, vial adapter leak and product complaint.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR094958:Same reporter.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Impaired driving ability, Loss of personal independence in daily activities
Clinical narrative: CAN NOT DRIVE; NOT ABLE TO OPERATE HEAVY EQUIPMENT AND TOOLS; STROKE; This spontaneous report received from a consumer concerned a 56 year old adult male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no underlying medical condition or concomitant use of medications. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total was administered in left arm on 29-OCT-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Age at time of vaccination 56 years old. No concomitant medications were reported.  On 02-NOV-2021, in morning, the patient was unable to wake up from the bed, had slurred speech, symptoms of facial palsy, and numbness in his left side limbs. The patient also had stroke and as derived consequences the patient can not drive nor can operate heavy equipment and tools (that are precisely tasks associated to the patient's work activities). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered with sequelae from stroke and the outcome of can not drive and not able to operate heavy equipment and tools was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220638528- covid-19 vaccine ad26.cov2.s-stroke. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: FEVER FOR 8 TO 9 HOURS; This spontaneous report received from a patient concerned a 5 decade old male. The patient's weight was 163 pounds, and height was 175.26 centimeters. The patient's past medical history included: multiple surgeries (to remove benign nerve sheath tumors (schwannomas)) and mosaic schwannomatosis (also known as nerve fibromatosis type 3, presents only on the left side of the body, a condition of benign nerve sheath tumors called schwannomas that had nothing to do with respiratory), and other pre-existing medical conditions included: No family history of immune disorders. No concomitant medications or vaccine, any immunomodulatory drugs, steroids prior or after vaccination. No illness at the time of vaccination. No past history of similar event. No adverse event after any previous vaccination. No history of allergy to vaccine, drug or food. No pre-existing acute illness 30 days prior to vaccination. No history of hospitalization in the last 30 days prior to vaccination, with cause. Family history of hay fever. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. Age at time of vaccination 45 years old. No concomitant medications were reported. On 2021, the patient experienced fever for 8 to 9 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever for 8 to 9 hours on 2021. This report was non-serious. This case, involving the same patient is linked to 20220627527.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Stress, Suspected COVID-19, Thrombosis, Vaccination failure
Clinical narrative: This spontaneous report received from a patient concerned a 62 year old female of an unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: ankylosing spondylitis (Non-infectious intermediate, posterior and Panuveitis). The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown and expiry: Unknown) dose was not reported, 1 total, first dose (1 in 1 once) administered on 05-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Age at time of vaccination 62 years old. No concomitant medications were reported. The patient received non-company suspect drugs adalimumab (Humira) (solution for injection in pre-filled pen, subcutaneous, batch number and expiry were not reported) dose, frequency, and therapy dates were not reported, Citrate free, administered for ankylosing spondylitis non-infectious intermediate, posterior and Panuveitis. On an unspecified date, the patient experienced seven blood clots in leg (thrombosis leg), flare up from stress, swelling in knee joints, condition aggravated, sensitivity after injection in stomach (Injection site hypersensitivity), knee pain, and injection site burns/stings and had an area of pain (Injection site pain). On JAN-2022 (date unspecified), the patient experienced Covid-19 which was coded as suspected Covid-19 infection and suspected clinical vaccination failure. On 09-JUN-2022, Laboratory data included: Magnetic resonance imaging result was unknown. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient recovered from suspected Covid-19 infection on 2022 (date unspecified), was recovering from seven blood clots in leg, condition aggravated, and sensitivity after injection in stomach, had not recovered from injection site burns/stings and had an area of pain, and knee pain, and the outcome of flare up from stress, swelling in knee joints and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint and reference number requested. Sender's Comments: V0: 20220639689- COVID-19 VACCINE AD26.COV2.S- SEVEN BLOOD CLOTS IN LEG. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable. 20220639689-COVID-19 VACCINE AD26.COV2.S-SUSPECTED CLINICAL VACCINATION FAILURE. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Age: 45.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Anxiety, Depression, Hypoaesthesia, Immunisation reaction, Inflammation
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Felt sick after second moderna COVID vaccine), SKIN DISCOMFORT (Bumps in both the index fingers), ANXIETY (Anxiety), DEPRESSION (Depression) and INFLAMMATION (Inflammation increased just prior to next Humira dose) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis and Panuveitis.    No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced IMMUNISATION REACTION (Felt sick after second moderna COVID vaccine). On 17-Aug-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). On an unknown date, the patient experienced SKIN DISCOMFORT (Bumps in both the index fingers), ANXIETY (Anxiety), DEPRESSION (Depression), INFLAMMATION (Inflammation increased just prior to next Humira dose), NASOPHARYNGITIS (Trouble getting over cold), HYPOAESTHESIA (Hands got numb) and PAIN IN EXTREMITY (Pain in both index fingers / Pain in Hands). At the time of the report, IMMUNISATION REACTION (Felt sick after second moderna COVID vaccine), ANXIETY (Anxiety), DEPRESSION (Depression), INFLAMMATION (Inflammation increased just prior to next Humira dose), NASOPHARYNGITIS (Trouble getting over cold), HYPOAESTHESIA (Hands got numb), PAIN IN EXTREMITY (Pain in both index fingers / Pain in Hands) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) outcome was unknown and SKIN DISCOMFORT (Bumps in both the index fingers) had not resolved.            No concomitant medication were reported.  It was unknown if patient was enrolled in a COVID-19 trial.  Causality for the co-suspect Humira was provided as Not reported.   The patient experienced wearing off effect. On 17-Aug-2021 Patient received 1st booster dose of Pfizer Biontech COVID-19 Vaccine through intramuscular route. indication was provided as COVID-19 Vaccination.   No treatment medication information provided.
Age: 45.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Interchange of vaccine products, Nasopharyngitis, Pain in extremity, Skin discomfort
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Felt sick after second moderna COVID vaccine), SKIN DISCOMFORT (Bumps in both the index fingers), ANXIETY (Anxiety), DEPRESSION (Depression) and INFLAMMATION (Inflammation increased just prior to next Humira dose) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis and Panuveitis.    No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced IMMUNISATION REACTION (Felt sick after second moderna COVID vaccine). On 17-Aug-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). On an unknown date, the patient experienced SKIN DISCOMFORT (Bumps in both the index fingers), ANXIETY (Anxiety), DEPRESSION (Depression), INFLAMMATION (Inflammation increased just prior to next Humira dose), NASOPHARYNGITIS (Trouble getting over cold), HYPOAESTHESIA (Hands got numb) and PAIN IN EXTREMITY (Pain in both index fingers / Pain in Hands). At the time of the report, IMMUNISATION REACTION (Felt sick after second moderna COVID vaccine), ANXIETY (Anxiety), DEPRESSION (Depression), INFLAMMATION (Inflammation increased just prior to next Humira dose), NASOPHARYNGITIS (Trouble getting over cold), HYPOAESTHESIA (Hands got numb), PAIN IN EXTREMITY (Pain in both index fingers / Pain in Hands) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) outcome was unknown and SKIN DISCOMFORT (Bumps in both the index fingers) had not resolved.            No concomitant medication were reported.  It was unknown if patient was enrolled in a COVID-19 trial.  Causality for the co-suspect Humira was provided as Not reported.   The patient experienced wearing off effect. On 17-Aug-2021 Patient received 1st booster dose of Pfizer Biontech COVID-19 Vaccine through intramuscular route. indication was provided as COVID-19 Vaccination.   No treatment medication information provided.
Sex: U
Vaccine: COVID19
Symptoms: Hypoacusis, Illness
Clinical narrative: Violently ill; Losing hearing in the left ear; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (Violently ill) and HYPOACUSIS (Losing hearing in the left ear) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Violently ill) and HYPOACUSIS (Losing hearing in the left ear). At the time of the report, ILLNESS (Violently ill) and HYPOACUSIS (Losing hearing in the left ear) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were provided by the reporter.  No treatment information was provided by the reporter.   Reporter did not allow further contact
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Palpitations
Clinical narrative: Palpating feeling in the left neck part/ Pumping in the neck vein; This spontaneous case was reported by a patient and describes the occurrence of PALPITATIONS (Palpating feeling in the left neck part/ Pumping in the neck vein) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Patient has no known allergies to food, medications or any products. Patient did not receive any other vaccine 1 month prior to getting the Moderna COVID-19 Vaccine.  Concurrent medical conditions included Diabetes (Start date was about 10 years ago and vaccine has no effect on his medical condition.).   On 17-Jun-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Jun-2022, the patient experienced PALPITATIONS (Palpating feeling in the left neck part/ Pumping in the neck vein). At the time of the report, PALPITATIONS (Palpating feeling in the left neck part/ Pumping in the neck vein) had not resolved.            Concomitant drugs were not reported.  The patient had pumping in the neck vein after receiving vaccine on 17-Jun-2022 around 11pm. The patient had this events for the first time and that the events had worsened. Patient did not seek medical care.  Treatment medications were not provided.   This case was linked to MOD-2022-592313 (Patient Link).