chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Immediate post-injection reaction
Clinical narrative: Shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, immediately after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Shingles). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     It was unknown if the company considered the shingles to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2023AMR084559   Additional Information: GSK Receipt Date: 15-JUN-2023 This case was reported by a patient via interactive digital media. It was reported that a patient who got the Shingles vaccine shot immediately got shingles. The follow-up could not be possible as no contact details were available. This case is linked with US2023AMR084559 and US2023AMR084563, same reporter.; Sender's Comments:  US-GSK-US2023AMR084563:Same Reporter US-GSK-US2023AMR084559:Same Reporter
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Menveo had been reconstituted with the incorrect diluent; Menveo had been reconstituted with the incorrect diluent; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong diluent used in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced wrong diluent used (Verbatim: Menveo had been reconstituted with the incorrect diluent) and inappropriate dose of vaccine administered (Verbatim: Menveo had been reconstituted with the incorrect diluent). The outcome of the wrong diluent used and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 14-JUN-2023 The reporter called in to report that a nurse accidentally gave a dose of Menveo that had been reconstituted with the incorrect diluent and wished to know how to proceed. The patient received Menveo with wrong diluent, which led to wrong diluent used and inappropriate dose of vaccine administered.
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Pain
Clinical narrative: pain in my body; pain in head; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of general body pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included chickenpox (patient had chicken pox in childhood). Family history included shingles (patient mother suffered from shingles disease).   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced general body pain (Verbatim: pain in my body ) and headache (Verbatim: pain in head). The outcome of the general body pain and headache were resolved (duration 2 days).   It was unknown if the reporter considered the general body pain and headache to be related to Shingles vaccine.     It was unknown if the company considered the general body pain and headache to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 14-JUN-2023. This case was reported by a patient via interactive digital media. This vaccine hurts, patient felt pain in the whole body and head for almost 2 days.  The patient had chicken pox in childhood and patient mother suffered from shingles disease, so it was better to prevent it.  The patient saw a TV ad that on shingles disease, a pain of 2 days was better than feeling worse for two weeks. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Pain
Clinical narrative: hurt me; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received old vaccine on an unknown date). Family history included shingles.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced pain (Verbatim: hurt me). The outcome of the pain was resolved (duration 4 days).   It was unknown if the reporter considered the pain to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the pain to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 15-JUN-2023 The case was received from the consumer interactive digital media. The patient stated that take the vaccine, it hurt him/her a little for 4 days, but it was better to than having Shingles disease.  When there was no vaccine yet, people topped to check that the shingles was not following it, heating a silver spoon and applying it on the skin, the spoon had to be of silver, it was a strong cure, but it stopped it.  The patient stated that physician cured his/her mother like this, it started in the middle of the chest and it reached till the middle of the back, but it did not progress any further.  As soon as the first vaccine was launched a few years ago, patient got vaccine and now he/she had got the new one, which was two vaccines.  The patient requested to get vaccinated. The follow-up could not be possible as no contact details were available.
Sex: M
Vaccine: MENB
Symptoms: Ligament disorder, Product administered to patient of inappropriate age, Tendon disorder
Clinical narrative: severe tendon/ligament issue in his knee; severe tendon/ligament issue in his knee; patient is over 25 years old; This non-serious case was reported by a physician via sales rep and described the occurrence of tendon disorder in a adult male patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero. On an unknown date, 3 weeks after receiving Bexsero, the patient experienced tendon disorder (Verbatim: severe tendon/ligament issue in his knee), ligament disorder (Verbatim: severe tendon/ligament issue in his knee) and inappropriate age at vaccine administration (Verbatim: patient is over 25 years old). The outcome of the tendon disorder, ligament disorder and inappropriate age at vaccine administration were unknown.   The reporter considered the tendon disorder and ligament disorder to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     The company considered the tendon disorder and ligament disorder 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.   Linked case(s) involving the same patient:  US2023AMR084621   Additional Information: GSK Receipt Date: 13-JUN-2023 The patient self-reported this case. The patient was over 25 years old. The patient received the Bexsero in preparation for a trip. Three weeks after the administration of first dose of Bexsero he experienced a severe tendon/ligament issue in his knee because he runs every day. Initially, the patient attributed it to being older (age and DOB unknown). The patient believed it was related to Bexsero. The reporter consented to follow up. No further information was reported. For tolerance of 2nd dose refer case US2023AMR084621, reported by same reporter.; Sender's Comments:  US-GSK-US2023AMR084621:Same patient, different dose
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Did not get the second dose of Shingrix; This non-serious case was reported by a other health professional via sales rep and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles outbreak before 1st dose of Shingrix). Previously administered products included Shingrix (1st dose received on unknown date).   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: Did not get the second dose of Shingrix). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 13-JUN-2023 The reporter wanted to know how to proceed if the patient got the first dose of Shingrix vaccine and had an outbreak (he believed outbreak started before the first dose).  The reporter wanted to know how to proceed if the patient got the first dose of Shingrix vaccine in the past and did not get the second dose of Shingrix. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Pain
Clinical narrative: today he is experiencing pain at the injection site; body aches; This non-serious case was reported by a physician via call center representative and described the occurrence of injection site pain in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included arthritis.   On 12-JUN-2023, the patient received the 1st dose of Shingrix. On 13-JUN-2023, 1 days after receiving Shingrix, the patient experienced injection site pain (Verbatim: today he is experiencing pain at the injection site) and general body pain (Verbatim: body aches). The outcome of the injection site pain and general body pain were not resolved.   It was unknown if the reporter considered the injection site pain and general body pain to be related to Shingrix.     It was unknown if the company considered the injection site pain and general body pain to be related to Shingrix.   Additional Information: GSK receipt date: 13-Jun-2023 The patient was Doctor of Medicine. Today (on the day of reporting), the patient experienced pain at the injection site and the body aches. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Received the most recent dose of the shingrix vaccine on March 29, 2022; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st dose about 10 or 6 years ago (unspecified).), Shingles vaccine (received 2nd dose about 10 or 6 years ago (unspecified).) and Shingrix (received the most recent dose of the Shingrix vaccine on March 29, 2022.).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Received the most recent dose of the shingrix vaccine on March 29, 2022). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 13-Jun-2023 The patient reported that she received 3 doses of Shingrix vaccine. The patient received first 2 doses about 10 years ago (although the patient stated that it may have been 6 years ago). The patient received the most recent Shingrix vaccine from doctors' office on March 29, 2022. Till the date of reporting the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up with the health care professional (HCP).
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Burning sensation, Herpes zoster, Pain, Pain in extremity
Clinical narrative: Sore arm; Rash on back, armpit and chest; Blister on back, armpit and chest; Fever; Achy; Burning sensation in my armpit and arm; Shingles; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a 52-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Additional patient notes included never had shingles in the past.   On 31-MAY-2023, the patient received the 1st dose of Shingrix (left deltoid). On 07-JUN-2023, 7 days after receiving Shingrix, the patient experienced shingles (Verbatim: Shingles) and burning sensation (Verbatim: Burning sensation in my armpit and arm). On 10-JUN-2023, the patient experienced pain (Verbatim: Achy). On 11-JUN-2023, the patient experienced fever (Verbatim: Fever). On 12-JUN-2023, the patient experienced rash (Verbatim: Rash on back, armpit and chest) and blister (Verbatim: Blister on back, armpit and chest). On an unknown date, the patient experienced pain in arm (Verbatim: Sore arm). The patient was treated with valaciclovir (Valacyclovir). The outcome of the shingles was not resolved and the outcome of the fever, pain, burning sensation, pain in arm, rash and blister were unknown.   It was unknown if the reporter considered the shingles, fever, pain, burning sensation, pain in arm, rash and blister to be related to Shingrix.     It was unknown if the company considered the shingles, fever, pain, burning sensation, pain in arm, rash and blister to be related to Shingrix.   Additional Information: GSK Receipt Date: 14-JUN-2023 The patient self-reported this case. The reporter reported that he received the Shingrix vaccine and just had a sore arm for the first few days. Then had a burning sensation in his armpit and arm of the vaccinated arm. The patient woke up on 11th June 2023 with a fever. The patient started getting blisters and rash on his back, armpit and a chest. The rash on the back, armpit, and chest are located on the left side.   The patient started Valacyclovir medicine from the day of reporting. The reporter asked question that why he got this, he took the vaccine to avoid getting it, could not be the only person that had experiencing this. This agent made an outbound call to gather further information. The vaccine in question was Shingrix. The patient was diagnosed with shingles and was started on Valacyclovir from the day of reporting. The reporter did consent to follow up with health care professional.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Rash
Clinical narrative: Sore arm; Rash on back, armpit and chest; Blister on back, armpit and chest; Fever; Achy; Burning sensation in my armpit and arm; Shingles; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a 52-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Additional patient notes included never had shingles in the past.   On 31-MAY-2023, the patient received the 1st dose of Shingrix (left deltoid). On 07-JUN-2023, 7 days after receiving Shingrix, the patient experienced shingles (Verbatim: Shingles) and burning sensation (Verbatim: Burning sensation in my armpit and arm). On 10-JUN-2023, the patient experienced pain (Verbatim: Achy). On 11-JUN-2023, the patient experienced fever (Verbatim: Fever). On 12-JUN-2023, the patient experienced rash (Verbatim: Rash on back, armpit and chest) and blister (Verbatim: Blister on back, armpit and chest). On an unknown date, the patient experienced pain in arm (Verbatim: Sore arm). The patient was treated with valaciclovir (Valacyclovir). The outcome of the shingles was not resolved and the outcome of the fever, pain, burning sensation, pain in arm, rash and blister were unknown.   It was unknown if the reporter considered the shingles, fever, pain, burning sensation, pain in arm, rash and blister to be related to Shingrix.     It was unknown if the company considered the shingles, fever, pain, burning sensation, pain in arm, rash and blister to be related to Shingrix.   Additional Information: GSK Receipt Date: 14-JUN-2023 The patient self-reported this case. The reporter reported that he received the Shingrix vaccine and just had a sore arm for the first few days. Then had a burning sensation in his armpit and arm of the vaccinated arm. The patient woke up on 11th June 2023 with a fever. The patient started getting blisters and rash on his back, armpit and a chest. The rash on the back, armpit, and chest are located on the left side.   The patient started Valacyclovir medicine from the day of reporting. The reporter asked question that why he got this, he took the vaccine to avoid getting it, could not be the only person that had experiencing this. This agent made an outbound call to gather further information. The vaccine in question was Shingrix. The patient was diagnosed with shingles and was started on Valacyclovir from the day of reporting. The reporter did consent to follow up with health care professional.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood lactic acid, Confusional state, Influenza like illness, Sepsis, White blood cell count increased
Clinical narrative: WBC 12.5; Lactic Acid 3.2; woke up confused (only knew names); septicemia; Flu-like symptoms; Fever (100 degrees); This serious case was reported by a consumer via call center representative and described the occurrence of septicemia in a 68-year-old male patient who received Herpes zoster (Shingrix) (batch number DJ455, expiry date 26-JAN-2024) for prophylaxis.   On 18-MAY-2023, the patient received the 1st dose of Shingrix (intramuscular, left arm). On 19-MAY-2023, 1 days after receiving Shingrix, the patient experienced septicemia (Verbatim: septicemia) (serious criteria hospitalization and GSK medically significant), influenza-like symptoms (Verbatim: Flu-like symptoms) (serious criteria hospitalization) and fever (Verbatim: Fever (100 degrees)) (serious criteria hospitalization). On 26-MAY-2023, the patient experienced confusion (Verbatim: woke up confused (only knew names)) (serious criteria hospitalization). On an unknown date, the patient experienced white blood cell count abnormal (Verbatim: WBC 12.5) (serious criteria hospitalization) and blood lactic acid abnormal (Verbatim: Lactic Acid 3.2) (serious criteria hospitalization). The outcome of the septicemia, influenza-like symptoms, fever, confusion, white blood cell count abnormal and blood lactic acid abnormal were resolved.   It was unknown if the reporter considered the septicemia, influenza-like symptoms, fever, confusion, white blood cell count abnormal and blood lactic acid abnormal to be related to Shingrix.     It was unknown if the company considered the septicemia, influenza-like symptoms, fever, confusion, white blood cell count abnormal and blood lactic acid abnormal to be related to Shingrix.   Additional Information: GSK Receipt Date: 14-JUN-2023 The patient was reporter's husband. A day later of vaccination, the patient had flu-like symptoms and a fever (100 degrees).  Reporter called EMS and the patient was hospitalized for a few days. The patient was diagnosed with septicemia. The reporter did not consent to follow-up.
Sex: U
Vaccine: DTAP, DTAPHEPBIP, DTAPIPV, FLU4, HEPA
Symptoms: Product storage error
Clinical narrative: Flulaval, Havrix, Kinrix, Pediarix, Infanrix that was stored at 49.8F x 185.5 hours; 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 an unspecified number of patients who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) (batch number 2YB4G, expiry date 30-JUN-2023) for prophylaxis.   Co-suspect products included HAV (Havrix) (batch number 9R5LC, expiry date 02-NOV-2024) for prophylaxis, DTPa-IPV (Kinrix) (batch number 5AY2J, expiry date 10-JUN-2024) for prophylaxis, DTPa-HBV-IPV (Pediarix) (batch number 4N2PM, expiry date 28-MAR-2025) and (batch number 25L32, expiry date 28-MAR-2025) for prophylaxis and DTPa (Infanrix) (batch number 7HM5J, expiry date 18-SEP-2024) and (batch number 7C9NJ, expiry date 10-NOV-2024) for prophylaxis.   On an unknown date, the patient received FluLaval Quadrivalent 2022-2023 season, Havrix, Kinrix and Pediarix. On an unknown date, the patient received Infanrix. On 23-MAR-2023, an unknown time after receiving FluLaval Quadrivalent 2022-2023 season, Havrix, Kinrix, Pediarix and Infanrix, the patient experienced incorrect storage of drug (Verbatim: Flulaval, Havrix, Kinrix, Pediarix, Infanrix that was stored at 49.8F x 185.5 hours). 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:14-JUN-2023 The health care professional (HCP) reported administration of Flulaval, Havrix, Kinrix, Pediarix, Infanrix that was stored at 49.8F x 185.5 hours (per audit, multiple excursions from March 23, 2023 - May 18, 2023).  It was unknown how many patients and which vaccines were administered during this period or up until the current date. The reporter did not consent to follow up. The vaccines were stored wrongly which led to Incorrect storage of drug.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: pain is generalized all over his body; This non-serious case was reported by a consumer via call center representative and described the occurrence of general body pain in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included rheumatoid arthritis. Concomitant products included methotrexate and ibuprofen.   On 05-JUN-2023, the patient received the 2nd dose of Shingrix (left deltoid) .5 ml. On 06-JUN-2023, 1 days after receiving Shingrix, the patient experienced general body pain (Verbatim: pain is generalized all over his body). The patient was treated with non-drug therapy (Cold Pack). The outcome of the general body pain was not resolved.   It was unknown if the reporter considered the general body pain to be related to Shingrix.     It was unknown if the company considered the general body pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 15-JUN-2023. The reporter was the consumer who received his second dose of Shingrix (left deltoid) on 5 June 2023.   The consumer gave himself an injection of Methotrexate in his right leg on 4 June 2023 the day before getting the Shingrix vaccine.  The consumer stated that he had been taking Methotrexate for 4 years to treat Rheumatoid Arthritis.  Consumer reported pain the day 6 June 2023 after getting the Shingrix vaccine.  The reporter stated the pain was generalized all over his body and stated the pain gets worsen at night.  The consumer was currently taking Ibuprofen 3 times a day and applying cold packs to painful areas. The reporter consented to follow up. Consent to follow up with healthcare professional was obtained.
Age: 0.25
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: inadvertently administered Kinrix to a 3 month old patient yesterday; 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-month-old female patient who received DTPa-IPV (Kinrix) (batch number 2TP74, expiry date 10-JUN-2024) for prophylaxis.   On 14-JUN-2023, the patient received Kinrix (right thigh). On 14-JUN-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: inadvertently administered Kinrix to a 3 month old patient yesterday). 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: 15-June-2023 The pharmacist called to inquire on how to proceed and what to look for in the patient. The reporter stated that Kinrix was inadvertently administered to a 3 month old patient.  The reporter confirmed vaccine was administered at their facility. The reporter did not consent to follow-up. A 3 months old patient received a dose of Kinrix, which led to inappropriate age at vaccine administration.
Age: 0.33
Sex: U
Vaccine: HEPA, MMR
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 4-month-old patient received a dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old patient who received HAV (Havrix) for prophylaxis.   Co-suspect products included MMR (Priorix) for prophylaxis.   Concomitant products included AMBIGUOUS MEDICATION NOS (VARIVAX).   On 14-JUN-2023, the patient received Havrix and Priorix. On 14-JUN-2023, an unknown time after receiving Havrix and Priorix, the patient experienced inappropriate age at vaccine administration (Verbatim: 4-month-old patient received a dose). 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: 15-JUN-2023 A sales representative called on behalf of a healthcare professional to inform that, a 4-month-old patient received a dose of Havrix and Priorix. The vaccine administration facility is the same as primary reporter. Call was done originally by a sales representative who did not provide many details for the adverse event (AE). Also sales representative stated that on that same visit Varivax was also administered to the patient. The reporter consented to follow up.  A 4 month old patient received a dose of Havrix and Priorix, which led to inappropriate age at vaccine administration.
Sex: F
Vaccine: HEP, HEP, HEP
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age, Underdose
Clinical narrative: second dose on 31Jan2023 and third dose 10Mar2023; second dose on 31Jan2023 and pediatric dose of Engerix-B on 09Dec2022; Underdose; Adult use of a child product; This non-serious case was reported by a other health professional via call center representative and described the occurrence of underdose in a 55-year-old female patient who received HBV (Engerix B adult) (batch number AX2D5, expiry date 07-DEC-2024) for prophylaxis.   Co-suspect products included HBV (Engerix B adult) (batch number 337TC, expiry date 29-MAR-2024) for prophylaxis and HBV (Engerix B pediatric) (batch number N73FA, expiry date 31-MAY-2024) for prophylaxis.   On 10-MAR-2023, the patient received the 3rd dose of Engerix B adult. On 31-JAN-2023, the patient received the 2nd dose of Engerix B adult. On 09-DEC-2022, the patient received the 1st dose of Engerix B pediatric. On 09-DEC-2022, not applicable after receiving Engerix B adult and Engerix B adult and an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: Underdose) and adult use of a child product (Verbatim: Adult use of a child product). On 31-JAN-2023, the patient experienced drug dose administration interval too long (Verbatim: second dose on 31Jan2023 and pediatric dose of Engerix-B on 09Dec2022). On 10-MAR-2023, the patient experienced drug dose administration interval too short (Verbatim: second dose on 31Jan2023 and third dose 10Mar2023). The outcome of the underdose, adult use of a child product, drug dose administration interval too long and drug dose administration interval too short were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 15-JUN-2023 The reporter was medical assistant. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.  The reporter reported that it was discovered that an employee that was no longer with the clinic administered a pediatric dose of Engerix-B to a 55 year old patient, which led to underdose and adult use of a child product. The patient received 2nd dose of Engerix-B adult later than the recommended schedule, which led to lengthening of vaccination schedule. The patient received 3rd dose of Engerix-B adult earlier than the recommended schedule , which led to shortening of vaccination schedule.
Age: 1.33
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: Infanrix expired dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 16-month-old female patient who received DTPa (Infanrix) (batch number 7KM94, expiry date 10-JUN-2023) for prophylaxis.   On 16-JUN-2023, the patient received Infanrix. On 16-JUN-2023, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: Infanrix expired dose). 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-2023 Medical assistant called to report an expired dose of Infanrix was administered to a patient. The vaccine Administration facility was the same as primary reporter. Consent to follow up via email agreed.
Sex: U
Vaccine: MNQ
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Menveo administered to patients greater than 55 years 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 patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced inappropriate age at vaccine administration (Verbatim: Menveo administered to patients greater than 55 years old). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 16-JUN-2023 The pharmacist reported that she saw Menveo administered to patients greater than 55 years old but not at this current facility. Pharmacist declined safety team follow-up as the administration of Menveo in patients over the age of 55 years did not occur at the current facility.  No patient involvement at current facility. The reporter did not consented to follow up. The 55 years old patients received Menveo, which led to inappropriate age at vaccine administration.
Sex: U
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: received an expired dose of Infanrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received DTPa (Infanrix) (batch number 7KM94, expiry date 10-JUN-2023) for prophylaxis.   On 14-JUN-2023, the patient received Infanrix. On 14-JUN-2023, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: received an expired dose of Infanrix). 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-2023 The reporter was a clinical supervisor. The health care professional (HCP) unaware of the patient details at that moment.  Patient received a dose of Infanrix, which was expired on 10th June 2023, which led to expired vaccine used. The reporter consented to follow up via email.
Sex: M
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: Incomplete vaccines schedule; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 55-year-old male patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (on September received 1st dose.).   On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: Incomplete vaccines schedule). The outcome of the incomplete course of vaccination 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-2023 A pharmacist reported about a patient who initiated their series of Twinrix in September but did not return to finish the series and wished to know how to proceed.  Reporter states that partial information about the event, patient and incomplete information about the vaccine was given. The vaccine administration facility is the same as primary reporter for 1st dose.   The reporter was consented to follow up. Till the time of reporting the patient had not received the second dose of Twinrix, which led to incomplete course of vaccination.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Expired product administered, Inappropriate schedule of product administration
Clinical narrative: Patient received the 2nd dose of Shingrix; Expiry date 05 august 2021; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 67-year-old male patient who received Herpes zoster (Shingrix) (batch number B4999, expiry date 05-AUG-2021) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On 16-JUN-2023, the patient received the 2nd dose of Shingrix. On 16-JUN-2023, an unknown time after receiving Shingrix and an unknown time after receiving SHINGRIX, the patient experienced drug dose administration interval too short (Verbatim: Patient received the 2nd dose of Shingrix) and expired vaccine used (Verbatim: Expiry date 05 august 2021). The outcome of the drug dose administration interval too short and expired vaccine used were unknown.   Additional Information: GSK Receipt Date: 16-JUN-2023 The reporter reported that the patient received 2nd dose earlier than the recommended schedule. The vaccine administration facility was the same as primary. The reporter did consent to follow up. The patient received 2nd dose of Shingrix vaccine, earlier than the recommended interval, which led to shortening of vaccinations schedule. The patient administered vaccine beyond its expiry date, which lead to expired vaccine used.
Sex: U
Vaccine: COVID19
Symptoms: Oesophageal achalasia
Clinical narrative: Achalasia; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was previously in perfect health. Patient not had any other vaccines in over 30 years. 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 and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced achalasia. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of achalasia was not reported. This report was non-serious. This case, from the same reporter is linked to 20230636250 and 20230636293.
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; 5 patients were administered an expired vaccine on 12 JUNE 2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 patients were administered an expired vaccine on 12 JUNE 2023) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 041H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 12-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (5 patients were administered an expired vaccine on 12 JUNE 2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (5 patients were administered an expired vaccine on 12 JUNE 2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (5 patients were administered an expired vaccine on 12 JUNE 2023).    This case contain information of 4th patient out of 5th reported by reporter. Concomitant Medication use information was not provided by reporter. A day ago, checking on the viability of a vaccine that was expired. Treatment Medication use information was not provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-728837 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-728837:Master case patient no. 01
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Expired vaccine vial was stored in the refrigerator; No adverse event; They gave some Moderna vaccine on 12Jun2023 Monday, and they actually expired the end of May; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They gave some Moderna vaccine on 12Jun2023 Monday, and they actually expired the end of May), PRODUCT STORAGE ERROR (Expired vaccine vial was stored in the refrigerator) and NO ADVERSE EVENT (No adverse event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 12-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (They gave some Moderna vaccine on 12Jun2023 Monday, and they actually expired the end of May). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expired vaccine vial was stored in the refrigerator) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They gave some Moderna vaccine on 12Jun2023 Monday, and they actually expired the end of May), PRODUCT STORAGE ERROR (Expired vaccine vial was stored in the refrigerator) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (They gave some Moderna vaccine on 12Jun2023 Monday, and they actually expired the end of May) and PRODUCT STORAGE ERROR (Expired vaccine vial was stored in the refrigerator).    The case was for Patient 4 out 12 patients.  No concomitant medications were reported.   It was reported that the vial size was 2.5 ml. On 12-Jun-2023, the vial was initially stored in the refrigerator. The vial did not undergo any temperature excursions. The reporter asked to escalate the case to Tier-2 for a lot analysis.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-729389 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2023: Live follow-up received, updated patient gender and suspect drug information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-729389:Master case
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Expiry date was 17-May-2023 and on 12-Jun-2023 the vial was initially stored in the refrigerator; No adverse event; They gave some Moderna vaccine on 12Jun2023 Monday, and they actually expired the end of May; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They gave some Moderna vaccine on 12Jun2023 Monday, and they actually expired the end of May), PRODUCT STORAGE ERROR (Expiry date was 17-May-2023 and on 12-Jun-2023 the vial was initially stored in the refrigerator) and NO ADVERSE EVENT (No adverse event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 12-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (They gave some Moderna vaccine on 12Jun2023 Monday, and they actually expired the end of May). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expiry date was 17-May-2023 and on 12-Jun-2023 the vial was initially stored in the refrigerator) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They gave some Moderna vaccine on 12Jun2023 Monday, and they actually expired the end of May), PRODUCT STORAGE ERROR (Expiry date was 17-May-2023 and on 12-Jun-2023 the vial was initially stored in the refrigerator) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (They gave some Moderna vaccine on 12Jun2023 Monday, and they actually expired the end of May) and PRODUCT STORAGE ERROR (Expiry date was 17-May-2023 and on 12-Jun-2023 the vial was initially stored in the refrigerator).    Concomitant medications were not reported.  The vial size was of 2.5 mL.  On 12-Jun-2023, the vial was initially stored in the refrigerator and was administered on same date.  12 adult patients received expired Bivalent Moderna COVID-19 vaccine on 12JUN2023 beyond MFG expiration date.  The vial did not undergo any temperature excursions.  Treatment information was not reported.  This case contains information for the 10th of 12 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-729389 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2023: Live follow up received is Significant. Reporter, Patient details, Batch number, Expiry date, Event and Narrative was updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-729389:Patient 1
Age: 24.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; patient received expired vaccine dose; This spontaneous case was reported by an other health professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received expired vaccine dose) and NO ADVERSE EVENT (no adverse event) in a 24-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 074B22A) for COVID-19 prophylaxis.     No Medical History information was reported.  On 14-Mar-2023, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 14-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received expired vaccine dose). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). On 14-Mar-2023, EXPIRED PRODUCT ADMINISTERED (patient received expired vaccine dose) and NO ADVERSE EVENT (no adverse event) had resolved.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (patient received expired vaccine dose).    Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered
Clinical narrative: Client was inadvertantly given a 3rd dose of HPV9 vaccine. Client had received their initial vaccination for the HPV series at 11 years old. Client did not need a third dose to complete the series. Upon reviewing Client chart the medication error was noticed. Client's list of vaccinations due indicated that HPV9 3rd dose was due along with  influenza, COVID-19 first dose, and MCV4. The vaccination forecast was incorrect and therefore client given a 3rd dose in the series. No other vaccinations given at time of visit. Client stated feeling fine and had no side effects. upon leaving the clinic.
Age: 33.0
Sex: M
Vaccine: TDAP
Symptoms: Wrong product administered
Clinical narrative: Doctor ordered PCV 20 and by error Tdap was administered, no reaction to vaccine. Patient was contacted and notified of error, he scheduled for 06/22 at 9:45am to administer the correct vaccine (PCV 20).