chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: MMR
Symptoms: Rash
Clinical narrative: The caller reported an AE for MMRII. The caller said the patient received a dose of MMRII on 12/20/2017 and developed a rash. The caller said they were unsure if the rash was related to MMRII or Amoxicillin, because the patient received both products; This spontaneous report was received from Other Health Professional and refers to a 15-month-old female.  The patient's medical history was not reported. The patient's concurrent conditions included  prophylaxis. Concomitant therapies were not reported.  On 20-DEC-2017, the patient started therapy with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided); and  amoxicillin (AMOXICILLIN), unk, administered for prophylaxis (strength, formulation, lot #, expiry date, and route of administration were not provided).  On an unknown date, the patient developed a rash. The caller said they were unsure if the rash was related to measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) or Amoxicillin, because the patient received both products. The caller was unable to confirm a date for when the rash developed. The caller said that she did not have any further information about the patient, but the caller provided consent for follow up. AE letter sent to caller. No other AE. No PQC. At the time of reporting, the outcome of the event rash was not known. The action taken with M-M-R II regarding rash was reported as Not Applicable.   The causal relationship between rash and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was unknown.
Sex: F
Vaccine: HPV9
Symptoms: Smear cervix abnormal
Clinical narrative: a friend had suspicious cells in a pap smear and unsure if was HPV related; a friend had suspicious cells in a pap smear and unsure if was HPV related; This spontaneous report has been received from a physician or consumer (reported as unsure whether the podcast host or doctor), via a company representative) on a podcast, regarding a female patient of unknown age. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On an unspecified date, the patient was vaccinated with a dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, as prophylaxis (strength, dose, frequency, route and anatomical location of administration, lot number and expiration date were not reported).   On an unreported date, the patient's pap smear presented suspicious cells (Smear cervix abnormal), it was also stated it was unsure if it was related to human papilloma virus (HPV) (Papilloma viral infection). The outcome of the events was not reported.  The causal relationship between the aforementioned events and HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was not reported.
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Acoustic stimulation tests, Asthma, Deafness, Tinnitus
Clinical narrative: loss of hearing; Tinnitus\has roaring in her ears; bad asthma; This serious case was reported by a other health professional via other manufacturer and described the occurrence of hearing loss in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included TOZINAMERAN (PFIZER COVID VACCINE) for prophylaxis.   Concurrent medical conditions included allergy (allergic to Chinese hamster).   On an unknown date, the patient received Shingrix and PFIZER COVID VACCINE. On an unknown date, an unknown time after receiving Shingrix, the patient experienced hearing loss (Verbatim: loss of hearing) (serious criteria GSK medically significant), tinnitus (Verbatim: Tinnitus\has roaring in her ears) and asthma (Verbatim: bad asthma). The outcome of the hearing loss and tinnitus were not resolved and the outcome of the asthma was not reported.   It was unknown if the reporter considered the hearing loss, tinnitus and asthma to be related to Shingrix.     It was unknown if the company considered the hearing loss, tinnitus and asthma to be related to Shingrix.   Additional Information: GSK Receipt Date: 01-JUN-2023. It was reported the patient try to figure out if it was the cause or the Covid vaccine. It was reported a lot of people were getting the same thing.  It could be caused by Shingrix vaccine because it was around the same time.  The patient had roaring in her ears, basically tinnitus and has seen 2 ENT's and they had the same answer, loss of hearing. Two years ago the patient hearing test and then this time to see what was going on with the noise in her ear and loss of hearing. The recent hearing test was identical to the other one.  It was not like she all of a sudden lost hearing and was having tinnitus. It was bothersome and it was getting louder.  The patient trying to figure out how to get rid of it and what could have caused it. The patient's friend's nephew took the Covid shot and he has the same problem, tinnitus.  A lot of people were talking about it online and are demanded testing.  The patient didn't have the problems two years ago and had regular hearing test.  At the time of reporting with tinnitus they said had a hearing test. They compared the two hearing test and they were identical.  It couldn't have been identical.  It couldn't take 2 years to get tinnitus with no change in hearing test.  It could have happened because of the Shingrix.  The patient clarified the Covid vaccine was the Pfizer Covid vaccine.  After the Shingrix she got bad asthma and couldn't shake it and she went to allergist and apparently there was chinese hamster in that vaccine and that was what she was allergic to. It was unknown if the reporter considered the hearing loss, tinnitus and asthma to be related to covid vaccine.
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: localized swelling; localized swelling and redness; This non-serious case was reported by a nurse via sales rep and described the occurrence of local swelling in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced local swelling (Verbatim: localized swelling) and localized erythema (Verbatim: localized swelling and redness). The outcome of the local swelling and localized erythema were not reported.   It was unknown if the reporter considered the local swelling and localized erythema to be related to Shingrix.     It was unknown if the company considered the local swelling and localized erythema to be related to Shingrix.   Additional Information: GSK receipt date: 6-JUN-2023 The reporter was a field staff employee. The nurse reported that the patient had dose of Shingrix, did not receive 2nd dose. The patient had localized reaction to first dose of Shingrix immunization that was localized swelling and redness. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain
Clinical narrative: Pain at injection site; experienced pain; This non-serious case was reported by a nurse via sales rep and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In FEB-2023, the patient received the 1st dose of Shingrix. In FEB-2023, an unknown time after receiving Shingrix, the patient experienced pain (Verbatim: experienced pain). On 07-JUN-2023, the patient experienced injection site pain (Verbatim: Pain at injection site). The outcome of the injection site pain and pain were not reported.   It was unknown if the reporter considered the injection site pain and pain to be related to Shingrix.     It was unknown if the company considered the injection site pain and pain to be related to Shingrix.   Additional Information: GSK Receipt Date:07-JUN-2023 The case was reported by patient who was nurse. The reporter stated that after self injecting shingrix in February experienced pain and reported pain at injection site on the day of reporting. The reporter did not consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Muscle spasms, Musculoskeletal pain, Rash
Clinical narrative: This non-serious case was reported by a consumer via call center representative and described the occurrence of buttock pain in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced buttock pain (Verbatim: Pain in right buttock area), rash (Verbatim: Skin rash that looked like infected cuts in right buttock/Infected cuts in skin her right buttock area), muscle spasm (Verbatim: Muscle Spasm) and shingles (Verbatim: Shingles outbreak). The outcome of the buttock pain, rash, muscle spasm and shingles were resolved (duration 3 weeks). It was unknown if the reporter considered the buttock pain, rash, muscle spasm and shingles to be related to SHINGRIX. It was unknown if the company considered the buttock pain, rash, muscle spasm and shingles to be related to SHINGRIX. Additional Information: GSK receipt date: 31-May-2023. This case was self reported by the patient. The patient received first dose of SHINGRIX vaccine about a month ago, date not provided) it was a Wednesday. Then the following week on Monday the patient developed pain in her right buttock area, muscle spasm and a skin rash that looked like infected cuts in her right buttock area. The patient stated that she was diagnosed with Shingles and it took 3 weeks to get rid of the symptoms. The adverse event was filed. No other information provided. The reporter consented to follow up.
Sex: M
Vaccine: MENB, MENB
Symptoms: Myasthenia gravis, Product administered to patient of inappropriate age
Clinical narrative: Myasthenia Gravis; in his 60's, received a complete series of Bexsero in 2020; This serious case was reported by a other health professional via call center representative and described the occurrence of myasthenia gravis in a adult male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero and Bexsero. On an unknown date, an unknown time after receiving Bexsero and not applicable after receiving Bexsero, the patient experienced myasthenia gravis (Verbatim: Myasthenia Gravis) (serious criteria GSK medically significant) and inappropriate age at vaccine administration (Verbatim: in his 60's, received a complete series of Bexsero in 2020). The outcome of the myasthenia gravis was not reported and the outcome of the inappropriate age at vaccine administration was unknown.   It was unknown if the reporter considered the myasthenia gravis to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     It was unknown if the company considered the myasthenia gravis to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   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: 01-JUN-2023 A study coordinator called in stating a patient, in his 60's, received a complete series of Bexsero in 2020 and one dose of a series of Bexsero in 2016.  The patient was now enrolled in a Myasthenia Gravis study, since 2018, that may or may not be requiring the patient receive a Bexsero booster.  Study coordinator was asking if the patient needs to get another booster dose or full series of Bexsero.  If so, will the dosing need to be adjusted due to the fact that the patient is enrolled in the Myasthenia Gravis study? The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.  The patient received complete series of Bexsero at an inappropriate age (in his 60's), which led to inappropriate age at vaccine administration.
Age: 11.0
Sex: M
Vaccine: DTAP
Symptoms: Extra dose administered, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 11 years child received Infanrix; Patient got Infanrix instead of Boostrix; Patient received 6th Dtap dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 11-year-old male patient who received DTPa (Infanrix) (batch number 9HP9Z) for prophylaxis.   On 02-JUN-2023, the patient received the 6th dose of Infanrix. On 02-JUN-2023, an unknown time after receiving Infanrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 11 years child received Infanrix), wrong vaccine administered (Verbatim: Patient got Infanrix instead of Boostrix) and extra dose administered (Verbatim: Patient received 6th Dtap dose). The outcome of the inappropriate age at vaccine administration, wrong vaccine administered and extra dose administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 06-JUN-2023 The reporter reported that the 11 years old patient received Infanrix vaccine instead of Boostrix vaccine which was the patient 6th Dtap dose, which led to age at vaccine administration, wrong vaccine administered, and extra dose administered. The reporter did consent to follow up via email.
Sex: F
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: administration of expired Twinrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 55-year-old female patient who received HAB (Twinrix) (batch number J477Y, expiry date 20-MAY-2023) for prophylaxis.   On 03-JUN-2023, the patient received Twinrix. On 03-JUN-2023, an unknown time after receiving Twinrix, the patient experienced expired vaccine used (Verbatim: administration of expired Twinrix). 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: 05-JUN-2023 Pharmacist reported administration of expired Twinrix to a patient. Patient received a dose of Twinrix on June 03, 2023 which was expired on May 20 2023, which led to expired vaccine used. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: developed rashes on both of her calves; This non-serious case was reported by a consumer via call center representative and described the occurrence of rash in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   In MAR-2023, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced rash (Verbatim: developed rashes on both of her calves). The patient was treated with medication unknown (Topical Cream). The outcome of the rash was not resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.     It was unknown if the company considered the rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 05-JUN-2023 The patient self-reported this case. The patient received her first dose of Shingrix and she developed rashes on both of her calves.  The rash on the left calf had resolved but the one on the right calf was still present.  The doctor gave a topical cream to treat the rash but it had not gone away. The reporter did not consent to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Blister
Clinical narrative: Blisters on his upper shoulder, around the waistline, (both sides), buttocks, arm and back; This non-serious case was reported by a consumer via call center representative and described the occurrence of blister in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23-MAY-2023, the patient received the 1st dose of Shingrix (intramuscular). On 25-MAY-2023, 2 days after receiving Shingrix, the patient experienced blister (Verbatim: Blisters on his upper shoulder, around the waistline, (both sides), buttocks, arm and back). The patient was treated with cortisone cream. The outcome of the blister was not resolved.   It was unknown if the reporter considered the blister to be related to Shingrix.     It was unknown if the company considered the blister to be related to Shingrix.   Additional Information: GSK Receipt Date: 05-JUN-2023 The reporter was a patient. The reporter stated that after 2 days of vaccination with Shingrix he developed blisters on his upper shoulder, around the waistline both sides, buttocks, arm and back. The patient described as reddened blisters that the pharmacy told him to put Cortisone cream on to help it feel better. The patient reported that the blisters were ongoing. The patient asked if this was normal as a side effect, gave medical disclaimer. Referred to HCP. Spoke per PI and content. The reporter requested to consent the follow up.
Age: 3.0
Sex: U
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Boostrix was administered to 3 year old; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 3-year-old patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 05-JUN-2023, the patient received Boostrix. On 05-JUN-2023, an unknown time after receiving Boostrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Boostrix was administered to 3 year old). 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 Information: GSK receipt date: 05-June-2023 The pharmacist informed the representative that the 3 years old patient received the Boostrix which led to inappropriate age at vaccine administration. The reporter did not consent to follow up.
Age: 17.0
Sex: M
Vaccine: COVID19-2
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Minor is not having any adverse reaction at this point. Minor received 2 doses of Covid bivalent in a period of 2 days difference.
Age: 16.0
Sex: F
Vaccine: UNK
Symptoms: Expired product administered
Clinical narrative: Vaccine administered and had expired 2 days prior
Age: 17.0
Sex: F
Vaccine: COVID19-2
Symptoms: Wrong product administered
Clinical narrative: Patient was supposed to receive a meningococcal vaccine and received the covid vaccine instead
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient experience local reaction; redness, swelling, itching , following injection below injection site.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Loss of personal independence in daily activities, Urinary incontinence
Clinical narrative: Urinary incontinence. Pt wears a panty liner and cannot leave the house.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Overdose
Clinical narrative: two doses of Bexsero were given to a patient the same day; This non-serious case was reported by a physician via call center representative and described the occurrence of overdose in a 16-year-old female patient who received Men B NVS (Bexsero) (batch number 5AR2D, expiry date 31-DEC-2025) for prophylaxis.   Concomitant products included MENINGOCOCCAL B VACCINE (BEXSERO).   On 05-JUN-2023, the patient received Bexsero. On 05-JUN-2023, an unknown time after receiving Bexsero, the patient experienced overdose (Verbatim: two doses of Bexsero were given to a patient the same day). The outcome of the overdose 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: 05-JUN-2023 The physician called to report that two doses of Bexsero were given to a patient the same day which led to overdose. The reporter consented to follow up via email. The Vaccine Administration Facility is the same as Primary Reporter.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administered only the adjuvant component in the syringe to the patient; administered only the adjuvant component in the syringe to the patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 51-year-old male patient who received Herpes zoster (Shingrix) (batch number LG374, expiry date 28-MAY-2024) for prophylaxis.   On 02-JUN-2023, the patient received the 2nd dose of Shingrix. On 02-JUN-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: administered only the adjuvant component in the syringe to the patient) and inappropriate dose of vaccine administered (Verbatim: administered only the adjuvant component in the syringe to the patient). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 6-Jun-2023 A medical assistant calling from a physician's office to report that a physician's assistant (PA) in the office administered the 2nd dose of Shingrix to a patient in the office. The adjuvant component had been drawn into a syringe, but had not been added to the antigen component and the physician's assistant did not realized and administered only the adjuvant component in the syringe to the patient. The reporter had no further information about this event. The reporter consent to follow up with health care professional. The patient received a dose of Shingrix without reconstituting the vaccine, which led inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Inappropriate schedule of vaccine/ never received the second dose; This non-serious 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 (received first dose about 2 to 3 years ago over the age of 50).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Inappropriate schedule of vaccine/ never received the second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 6-Jun-2023 The pharmacist had limited details. The reporter did not consent to follow-up. Till the time of reporting, the patient did not receive the second dose of Shingrix, which led to incomplete course of vaccination.
Age: 1.25
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Wrong product administered
Clinical narrative: received pediarix instead of infanrix inadvertently; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 15-month-old patient who received DTPa-HBV-IPV (Pediarix) (batch number 4N2PM, expiry date 28-MAR-2025) for prophylaxis.   On an unknown date, the patient received Pediarix (right thigh). On an unknown date, an unknown time after receiving Pediarix, the patient experienced wrong vaccine administered (Verbatim: received pediarix instead of infanrix inadvertently). The outcome of the wrong vaccine administered 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: 6-Jun-2023 The reporter consented to follow-up. The patient received a dose of Pediarix instead of Infanrix inadvertently, which led to wrong vaccine administered.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: probably a vial of diluent was administered without the powder component; probably a vial of diluent was administered without the powder component; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: probably a vial of diluent was administered without the powder component) and inappropriate dose of vaccine administered (Verbatim: probably a vial of diluent was administered without the powder component). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 6-Jun-2023 A pharmacist called to inform that there was a vial of lyophilized powder component left without the correspondent diluent vial.  This indicates that probably a vial of diluent was administered without the powder component. The reporter had no information on this matter.  The reporter stated that they had recently arrived to that new facility. Did not consent to follow-up. The patient probably received a vial of diluent without the powder component of Shingrix vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: F
Vaccine: MNQ, VARZOS
Symptoms: Incorrect dose administered, Product preparation error, Product preparation issue
Clinical narrative: menveo lyophilized part with reconstituted with the diluent of shingrix; menveo lyophilized part with reconstituted with the diluent of shingrix; menveo lyophilized part with reconstituted with the diluent of shingrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 58-year-old female patient who received Herpes zoster (Shingrix) (batch number AMVA751A, expiry date 30-NOV-2023) and (batch number NF442, expiry date 05-OCT-2023) for prophylaxis.   Co-suspect products included Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Shingrix and not applicable after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: menveo lyophilized part with reconstituted with the diluent of shingrix), wrong solution used in drug reconstitution (Verbatim: menveo lyophilized part with reconstituted with the diluent of shingrix) and inappropriate dose of vaccine administered (Verbatim: menveo lyophilized part with reconstituted with the diluent of shingrix). The outcome of the inappropriate preparation of medication, wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 6-Jun-2023 The reporter consented to follow-up. The patient received a dose of a menveo lyophilized part with reconstituted with the diluent of shingrix, which led to inappropriate preparation of medication, wrong solution in drug reconstitution and inappropriate dose of vaccine administered.
Sex: F
Vaccine: DTAP
Symptoms: Wrong product administered
Clinical narrative: infanrix instead of boostrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 12-year-old female patient who received DTPa (Infanrix) (batch number AK443, expiry date 16-SEP-2023) for prophylaxis.   On an unknown date, the patient received Infanrix. On an unknown date, an unknown time after receiving Infanrix, the patient experienced wrong vaccine administered (Verbatim: infanrix instead of boostrix). The outcome of the wrong vaccine administered 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: 6-Jun-2023 The reporter consented to follow-up. The patient received an infanrix dose but the patient was supposed to receive a boostrix dose, which led to wrong vaccine administered.
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Product storage error
Clinical narrative: Improper Storage (wet outer box); This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   On an unknown date, the patient received Pediarix. On an unknown date, an unknown time after receiving Pediarix, the patient experienced incorrect storage of drug (Verbatim: Improper Storage (wet outer box)). 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.   Additional Information: GSK receipt date: 6-Jun-2023 No patient involvement. Adverse event reported after the caller disconnected, did not ask permission for safety follow-up. The pediarix outer box was exposed to condensation in the refrigerator and wet the outer box of the vaccines, which led to incorrect storage of drug.
Sex: F
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: never came back for the second dose within the recommended dosing schedul; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 48-year-old female patient who received HBV (Engerix B adult) for prophylaxis.   Previously administered products included Engerix B adult (received first dose on 5th December 2022 of batch number NT9X3 and expiry date 9th September 2024).   On an unknown date, the patient did not receive the 2nd dose of Engerix B adult. On an unknown date, an unknown time after receiving Engerix B adult, the patient experienced incomplete course of vaccination (Verbatim: never came back for the second dose within the recommended dosing schedul). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 6-Jun-2023 The pharmacist called to inquired that how to proceed. The patient never came back for the second dose within the recommended dosing schedule. The reporter asked that any guidance. The reporter did not consent to follow-up. Till the time of reporting, the patient did not receive the second dose of Engerix-B adult, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Intercepted product prescribing error, Stem cell transplant
Clinical narrative: Stem cell transplant; had been prescribed to repeat the Shingrix series; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of stem cell transplant in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix and Shingrix. On an unknown date, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced stem cell transplant (Verbatim: Stem cell transplant) and intercepted drug prescribing error (Verbatim: had been prescribed to repeat the Shingrix series). The outcome of the stem cell transplant and intercepted drug prescribing error were unknown.   It was unknown if the reporter considered the stem cell transplant to be related to Shingrix.   It was unknown if the company considered the stem cell transplant to be related to Shingrix.   Additional Information: GSK Receipt Date: 06-JUN-2023 The reporter did not consent to follow-up. The reporter informed that a patient that had a stem cell transplant and that had already completed the Shingrix scheme before that stem cell transplant had been prescribed to repeat the Shingrix series, which led to intercepted drug prescribing error.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: 2 patients received a dose of Boostrix that expired on June 3rd 2023; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 12-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 4N2EZ, expiry date 03-JUN-2023) for prophylaxis.   On 06-JUN-2023, the patient received Boostrix. On 06-JUN-2023, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: 2 patients received a dose of Boostrix that expired on June 3rd 2023). 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: 07-JUN-2023 The reporter wanted to know if the dose was valid. The Vaccine Administration Facility is the same as Primary Reporter. The reporter did not consent to follow-up. The patient received a dose of Boostrix that expired, which led to expired vaccine used. This was 1 of 2 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023080435:same reporter, different patient
Age: 1.5
Sex: M
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Boostrix administered instead of Infanrix; Inappropriate age at vaccine administration; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 18-month-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number TR292, expiry date 03-NOV-2024) for prophylaxis.   On 07-JUN-2023, the patient received Boostrix. On 07-JUN-2023, an unknown time after receiving Boostrix, the patient experienced wrong vaccine administered (Verbatim: Boostrix administered instead of Infanrix) and inappropriate age at vaccine administration (Verbatim: Inappropriate age at vaccine administration). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   Additional Information: GSK Receipt Date: 07-JUN-2023 This would had been the 4th dose of DTap but was administered Boostrix instead . The reporter consented to follow up via email. The reporter reported that an 18 month old child was administered Boostrix Instead of Infanrix, which led to wrong vaccine administered and inappropriate age at vaccine administration.
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Longer than recommended interval; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 38-year-old male patient who received HAV (Havrix) (batch number 3J9G4, expiry date 30-AUG-2025) for prophylaxis.   Previously administered products included Havrix (received 1st dose in 2017).   On 16-JAN-2023, the patient received the 2nd dose of Havrix. On 16-JAN-2023, an unknown time after receiving Havrix, the patient experienced drug dose administration interval too long (Verbatim: Longer than recommended interval). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 07-JUN-2023 The reporter reported that a patient received their second dose of Havrix 6 years apart and wanted to know if they had to restart the series. Information about the patient, vaccine and vaccination was collected. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.  The patient received 2nd dose of Havrix later than the recommended schedule, which led to lengthening of vaccination schedule.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: patient was accidentally given the liquid portion of Menveo; patient was accidentally given the liquid portion of Menveo; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA758A, expiry date 30-NOV-2023) for prophylaxis.   On 07-JUN-2023, the patient received the 2nd dose of Menveo. On 07-JUN-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: patient was accidentally given the liquid portion of Menveo) and inappropriate dose of vaccine administered (Verbatim: patient was accidentally given the liquid portion of Menveo). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 07-JUN-2023 The reporter was a. medical assistant. The reporter called to report that a patient was accidentally given the liquid portion of Menveo and wished to know how to proceed.  The partial information about event, vaccine and patient was collected.  The reporter gave only partial information and ended call on own accord. The Vaccine Administration Facility was the same as Primary Reporter. The reporter called to report that a patient was accidentally given the liquid portion of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: Administered expired dose of Shingrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number K3YC7, expiry date 07-NOV-2022) for prophylaxis.   On 20-JAN-2023, the patient received Shingrix. On 20-JAN-2023, an unknown time after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: Administered expired dose of Shingrix). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 07-JUN-2023 At the time of reporting, the dose had not been repeated. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up. The patient was administered an expired dose of Shingrix, which led to expired vaccine used. This was 1 of 3 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023080477:Same reporter US-GSK-US2023080475:Same reporter
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: PASSED AWAY; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin was not reported, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total, therapy start date was not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date earlier this week, the patient unexpectedly passed away. On an unspecified date, the patient died from an unknown cause of death. It was unknown if an autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20230572578.; Sender's Comments: V0:20230560836 - Passed away. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: SHIVERING COLD WITH BODY; FELT FEVERISH; HEADACHES; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced shivering cold with body, felt feverish, and headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the felt feverish, shivering cold with body and headaches was not reported. This report was non-serious. This case, from the same reporter is linked to 20230560836.
Age: 64.0
Sex: M
Vaccine: COVID19, VARZOS
Symptoms: Body temperature, COVID-19, Pyrexia, Vaccination site pain
Clinical narrative: Patient also had COVID after COVID Vaccine; 102 degree temperature; Patient had the vaccine he experienced achiness and soreness for 3 day; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Patient also had COVID after COVID Vaccine), PYREXIA (102 degree temperature) and VACCINATION SITE PAIN (Patient had the vaccine he experienced achiness and soreness for 3 day) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for Immunisation.    Co-suspect products included non-company products DUPILUMAB (DUPIXENT) solution for injection for Atopic dermatitis and VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) for Immunisation.    Concurrent medical conditions included Atopic dermatitis.   On 17-May-2017, the patient DUPILUMAB (DUPIXENT) (Subcutaneous) dosage was changed to 600 milligram. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form., DUPILUMAB (DUPIXENT) (Subcutaneous) 300 milligram and dose of VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Patient also had COVID after COVID Vaccine), PYREXIA (102 degree temperature) and VACCINATION SITE PAIN (Patient had the vaccine he experienced achiness and soreness for 3 day). At the time of the report, COVID-19 (Patient also had COVID after COVID Vaccine) and PYREXIA (102 degree temperature) outcome was unknown and VACCINATION SITE PAIN (Patient had the vaccine he experienced achiness and soreness for 3 day) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 degree.         No concomitant medications were provided.  Patient had been on Dupixent for 6 or 7 years and never had a reaction. It was reported that the last time the patient had the vaccine he experienced achiness and soreness for 3 days and had a slight temperature. He reported he had 3 Moderna COVID vaccines and for each injection he was in bed all weekend with a 102-degree temperature. He reported additional potential for COVID vaccines. He also had COVID after the COVID vaccine. It was reported that at the time of the report, the Dupixent was ongoing.  Treatment medications were not provided.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Skin disorder
Clinical narrative: Problem with my skin started just few days after i had my second covid vaccination; This spontaneous case was reported by a patient and describes the occurrence of SKIN DISORDER (Problem with my skin started just few days after i had my second covid vaccination) in a 71-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 immunisation.    Co-suspect product included non-company product DUPILUMAB (DUPIXENT) for Atopic dermatitis.    Concurrent medical conditions included Atopic dermatitis.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form and DUPILUMAB (DUPIXENT) (Subcutaneous) 300 mg strength at an unknown loading dose. On an unknown date, DUPILUMAB (DUPIXENT) (Subcutaneous) dosage was changed to 300 milligram. On an unknown date, the patient experienced SKIN DISORDER (Problem with my skin started just few days after i had my second covid vaccination). At the time of the report, SKIN DISORDER (Problem with my skin started just few days after i had my second covid vaccination) had resolved.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported.  Patient started treatment with DUPIXENT for about 4 months. Patient thought that Dupixent was knocked out of system. Patient had skin issue started just a few days after second covid vaccination. His hands were extremely bad for a year and a half. Tried everything in the world, every cream, had steroids, nothing working. At the time patient thought Dupixent was knocked out of system. After a few weeks of Dupixent, they have cleared up and have been cleared up for some time now. Patient's last dose of Dupixent was on 01-Feb-2023. At the time of the report, Dupixent was discontinued.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore right arm injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore right arm injection site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A, 007B21A, 091D21A and 025L21B) for COVID-19 prophylaxis.     The patient's past medical history included Cardiac disorder. Previously administered products included for Product used for unknown indication: Flu shot. Past adverse reactions to the above products included No adverse event with Flu shot. Concurrent medical conditions included Blood pressure high.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Jan-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (sore right arm injection site). At the time of the report, VACCINATION SITE PAIN (sore right arm injection site) outcome was unknown.            Patient received other vaccines 4 weeks prior to COVID-19 vaccine.  Concomitant product use was not provided by the reporter.  Patient experienced sore right arm injection site after the first two doses of 19-Mar-2021 and 23-Apr-2021 and did not had any adverse reaction after later two doses of 15-Aug-2021 and 22-Jan-2022.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-727708 (E2B Linked Report). This case was linked to MOD-2023-727708 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-727708:Bivalent Dose