chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site swelling, Pain
Clinical narrative: injetion site itching; Pain; injection site swelling/almost glof-ball sized; This non-serious case was reported by a other health professional via sales rep and described the occurrence of injection site swelling in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 02-DEC-2023, the patient received the 1st dose of Shingrix. On 04-DEC-2023, 2 days after receiving Shingrix, the patient experienced injection site itching (Verbatim: injetion site itching). In DEC-2023, the patient experienced injection site swelling (Verbatim: injection site swelling/almost glof-ball sized) and pain (Verbatim: Pain). The outcome of the injection site swelling and pain were not reported and the outcome of the injection site itching was not resolved.   It was unknown if the reporter considered the injection site swelling, injection site itching and pain to be related to Shingrix.     It was unknown if the company considered the injection site swelling, injection site itching and pain to be related to Shingrix.   Additional Information: RA Receipt Date: 04-DEC-2023 The reporter reported that the patient received Shingrix vaccine and experienced site of administration was swelling, almost golf-ball size and itchy on the day of reporting. The patient declined the presence of a new diffuse rash, declines difficulty breathing or numbness/tingling. The patient decided to place a cold compress on her arm and will follow up in 2 days if the pain worsens, if symptoms persist past Monday or if she develops numbness, tingling or difficulty breathing. The reporter consented to follow up denied.
Sex: M
Vaccine: DTAPIPV
Symptoms: Incorrect dose administered
Clinical narrative: patient received less than a full dose of the Kinrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete dose administered in a male patient who received DTPa-IPV (Kinrix) for prophylaxis.   On an unknown date, the patient received Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced incomplete dose administered (Verbatim: patient received less than a full dose of the Kinrix). The outcome of the incomplete dose administered was unknown.   This report is made by RA without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: RA Receipt date: 06-DEC-2023 Healthcare professional reported that patient received less than a full dose of the Kinrix to being squirmy which led to incomplete dose administered. No reactions reported.
Sex: M
Vaccine: RVX
Symptoms: Arthralgia
Clinical narrative: RSV vaccine causing joint pain; This non-serious case was reported by a physician via sales rep and described the occurrence of joint pain in a adult male patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced joint pain (Verbatim: RSV vaccine causing joint pain). The outcome of the joint pain was not reported.   The reporter considered the joint pain to be related to RSV vaccine.     The company considered the joint pain to be related to RSV vaccine.   Additional Information: RA receipt date: 05-DEC-2023 The physician was reporter. The reporter stated not necessarily with GSK product, physician just mentioned RSV vaccine caused joint pain. The reporter consented to follow up.
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, No adverse event, Product use issue, Wrong product administered
Clinical narrative: 32 to 36 weeks gestation, unintentionally received Arexvy off label; This non-serious prospective pregnancy case was reported by a pharmacist via sales rep and described the occurrence of vaccine exposure during pregnancy in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy .5 ml. On an unknown date, an unknown time after receiving Arexvy, the patient experienced vaccine exposure during pregnancy (Verbatim: 32 to 36 weeks gestation, unintentionally received Arexvy off label). The outcome of the vaccine exposure during pregnancy was unknown.   Pregnancy exposure: Gestation time at first exposure (Arexvy): 36 Weeks Pregnancy Exposure (Arexvy): To mother in third trimester Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt date: 04-DEC-2023 The supervisor reported an incident where a maternal patient, 32 to 36 weeks gestation, unintentionally received Arexvy off label which led to vaccine exposure during pregnancy. No specific adverse events have been reported. Vaccine is approved for non pregnant, older adults (60 years and older). No specific patient information was able to be obtained. Supervisor reported that VAERS report has already been filed.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: patient without properly reconstituting with the lyophilized powder; patient without properly reconstituting with the lyophilized powder; This non-serious case was reported by a pharmacist via sales rep 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: patient without properly reconstituting with the lyophilized powder) and inappropriate dose of vaccine administered (Verbatim: patient without properly reconstituting with the lyophilized powder). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 06-DEC-2023 The reporter administered Shingrix liquid component to a patient without properly reconstituting with the lyophilized powder a couple of months ago, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This did not occur within the pharmacy department, so the healthcare professional did not have any other details. The reporter agree to follow up from GlaxoSmithKline.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: 5 year old female child received a Fluarix Vaccination on 02-NOV-2023 and today, 04-DEC-2023 received a second Fluarix; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 5-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2023-2024 season) (batch number C2PH4, expiry date 30-JUN-2024) for prophylaxis.   Concomitant products included Influenza vaccine inact split 4v (Fluarix quadrivalent).   On 04-DEC-2023, the patient received the 2nd dose of Fluarix Quadrivalent 2023-2024 season (intramuscular, right deltoid) .5 ml. On 04-DEC-2023, an unknown time after receiving Fluarix Quadrivalent 2023-2024 season, the patient experienced extra dose administered (Verbatim: 5 year old female child received a Fluarix Vaccination on 02-NOV-2023 and today, 04-DEC-2023 received a second Fluarix). The outcome of the extra dose 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: 04-Dec-2023 The reporter reported that the patient received 1st dose of Fluarix vaccine on 2nd November 2023 and 2nd dose on 4th December 2023. The reporter stated that there was no symptoms had been reported. The vaccine administration facility was the same as primary reporter. The patient received 2nd dose of Fluarix vaccine, which led to extra dose administrated. The reporter consented to follow up.
Sex: F
Vaccine: RSV
Symptoms: Exposure via eye contact, Exposure via skin contact, Occupational exposure to product
Clinical narrative: while mixing the diluent into the syringe she punctured the powder vial it blew up everywhere on her face and eyes; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of occupational exposure while preparing product for administration in a female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 929PN, expiry date 29-MAR-2025) for prophylaxis. This case was associated with a product complaint.   On 21-NOV-2023, the patient received Arexvy. On 21-NOV-2023, an unknown time after receiving Arexvy, the patient experienced occupational exposure while preparing product for administration (Verbatim: while mixing the diluent into the syringe she punctured the powder vial it blew up everywhere on her face and eyes). The outcome of the occupational exposure while preparing product for administration was unknown.   Additional Information: GSK receipt date:04-DEC-2023 The reporter reported that at the time of mixing the diluent into syringe the syringe was punctured the powder vial it blew up everywhere on the face and eyes, which led to occupational exposure while preparing product for administration. The reporter stated that it seems like a pressure issue or could be a faulty syringe. She was rinsed her eyes and she was fine after incident. The reporter consented to follow up.
Age: 23.0
Sex: M
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: administration of Havrix peds dose to an adult in April 2023.; Havrix peds dose to an adult; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 23-year-old male patient who received HAV (Havrix 720 Junior) for prophylaxis.   In APR-2023, the patient received Havrix 720 Junior. In APR-2023, an unknown time after receiving Havrix 720 Junior, the patient experienced underdose (Verbatim: administration of Havrix peds dose to an adult in April 2023.) and adult use of a child product (Verbatim: Havrix peds dose to an adult). The outcome of the underdose and adult use of a child product were unknown.   Additional Information: RA Receipt Date: 04-DEC-2023 The pharmacist requested data on the administration of Havrix peds dose to an adult patient, which led to underdose and adult use of a child product. The reporter consented to follow-up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cochlea implant, Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: Cochlear implant; 3rd dose was administered in July 2023; the 2nd dose was administered in April 2023,; This serious case was reported by a other health professional via call center representative and described the occurrence of cochlear implant in a 73-year-old female patient who received Herpes zoster (Shingrix) (batch number 2A54M) and (batch number 5954H) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on October 2021).   In JUL-2023, the patient received the 3rd dose of Shingrix. In APR-2023, the patient received the 2nd dose of Shingrix. In APR-2023, not applicable after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: the 2nd dose was administered in April 2023,). In JUL-2023, the patient experienced extra dose administered (Verbatim: 3rd dose was administered in July 2023). On an unknown date, the patient experienced cochlear implant (Verbatim: Cochlear implant) (serious criteria clinically significant/intervention required). The outcome of the cochlear implant, extra dose administered and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the cochlear implant to be related to Shingrix and Shingrix.     It was unknown if the company considered the cochlear implant to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date-04-DEC-2023 The patient received 3 doses of Shingrix and from which received second dose of Shingrix later than the recommended interval, which led to lengthening of vaccine schedule and extra dose administered. The reporter also stated that the patient had gotten a cochlear implant during 2023. The reporter consented to follow up.
Age: 50.0
Sex: M
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: just received the 2nd dose; 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 50-year-old male patient who received HAB (Twinrix) (batch number 7X224) for prophylaxis.   Previously administered products included Twinrix (On 30th July 2023, received first dose).   On 05-DEC-2023, the patient received the 2nd dose of Twinrix. On 05-DEC-2023, an unknown time after receiving Twinrix and 365 days after starting Twinrix, the patient experienced drug dose administration interval too long (Verbatim: just received the 2nd dose). The outcome of the drug dose administration interval too long was unknown.   This report is made by RA without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: RA Receipt Date: 5-DEC-2023 A pharmacist called to inform that a patient who received the 1st dose of Twinrix on 30th July 2023 had just received the 2nd dose on 5th December 2023, which led to lengthening of vaccine schedule. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Sex: M
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Administration of Twinrix at times longer than the 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 56-year-old male patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received first dose of Twinrix on 01-JUL-2023).   On 05-DEC-2023, the patient received the 2nd dose of Twinrix. On 05-DEC-2023, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: Administration of Twinrix at times longer than the recommended interval). The outcome of the drug dose administration interval too long was unknown.   This report is made by RA without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: RA Receipt Date: 05-DEC-2023 The pharmacist contacted GlaxoSmithKline via phone for available Twinrix information and about the recommendation available for the administration of Twinrix at times longer than the recommended interval. The reporter gave partial information about vaccine, patient and event. The vaccine administration facility was the same as primary reporter. The patient received 2nd dose of Twinrix, later than the recommended interval, which led to lengthening of vaccination schedule. The reporter accepted and consented the follow up.
Age: 1.58
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: an adult dose of Havrix administered to a 19 month old patient.; an adult dose of Havrix administered to a 19 month old patient.; This non-serious case was reported by a physician via call center representative and described the occurrence of overdose in a 19-month-old male patient who received HAV (Havrix 1440 adult) (batch number T9TL9, expiry date 05-DEC-2025) for prophylaxis.   On 05-DEC-2023, the patient received the 2nd dose of Havrix 1440 adult. On 05-DEC-2023, an unknown time after receiving Havrix 1440 adult, the patient experienced overdose (Verbatim: an adult dose of Havrix administered to a 19 month old patient.) and adult product administered to child (Verbatim: an adult dose of Havrix administered to a 19 month old patient.). The outcome of the overdose and adult product administered to child were unknown.   This report is made by RA without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: RA Receipt Date: 05-Dec-2023 The reporter reported that the 19 month old patient received adult dose of Havrix vaccine, which led to overdose and adult product administered to child. The vaccine administration facility was the same as primary reporter. The reporter did consent to follow up via postal.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: going to receive second dose today; This non-serious case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in November 2018).   On 05-DEC-2023, 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: going to receive second dose today). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date:05-DEC-2023 The reporter reported that a patient received 1st dose in November 2018, and is going to receive second dose on the day of reporting. The reporter declined to provide any further details. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow up.
Age: 79.0
Sex: F
Vaccine: RSV
Symptoms: Injection site rash, Sneezing
Clinical narrative: Rash around injection site; Sneezing; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 79-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 59K92, expiry date 26-MAR-2025) for prophylaxis.   On 30-NOV-2023, the patient received Arexvy (intramuscular, unknown deltoid). In DEC-2023, 1 week after receiving Arexvy, the patient experienced injection site rash (Verbatim: Rash around injection site) and sneezing (Verbatim: Sneezing). The outcome of the injection site rash was unknown and the outcome of the sneezing was resolved.   It was unknown if the reporter considered the injection site rash and sneezing to be related to Arexvy.     It was unknown if the company considered the injection site rash and sneezing to be related to Arexvy.   Additional Information: GSK Receipt Date: 05-DEC-2023 and 6th DEC 2023 The reporter was pharmacist. The reporter reported that the patient received arexvy vaccine on 30th November 2023 and about a week later developed a rash around the injection site. The pharmacist believed the dose was administered in the left deltoid muscle, but she was not certain. Pharmacist thought the rash began 04Dec2023 or 05Dec2023. The reporter stated that about a week later or a couple days after vaccination with the patient began sneezing. It resolved within a couple days. The reporter said there were alot of allergies in their area. The reporter consented to follow up granted.
Age: 79.0
Sex: F
Vaccine: RSV
Symptoms: Eye pruritus, Injection site reaction, Rash erythematous, Rhinorrhoea
Clinical narrative: feels bumpy at injection site; red rash at the injection site; runny nose; itchy eyes; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 79-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 30-NOV-2023, the patient received Arexvy (intramuscular). On an unknown date, an unknown time after receiving Arexvy, the patient experienced injection site swelling (Verbatim: feels bumpy at injection site), injection site rash (Verbatim: red rash at the injection site), runny nose (Verbatim: runny nose) and eye pruritus (Verbatim: itchy eyes). The outcome of the injection site swelling was not reported and the outcome of the injection site rash was unknown and the outcome of the runny nose and eye pruritus were resolved (duration 24 hrs).   It was unknown if the reporter considered the injection site swelling, injection site rash, runny nose and eye pruritus to be related to Arexvy.     It was unknown if the company considered the injection site swelling, injection site rash, runny nose and eye pruritus to be related to Arexvy.   Additional Information: GSK Receipt Date - 05-DEC-2023 The patient reported that she got the arexvy vaccine and after the vaccine she started developing runny nose, itchy eyes, and a red rash at the injection site.  The reported that runny nose and itchy eyes lasted for 24 hours. The she had red rash was the size of her hand palm and feels bumpy. The reporter did not consent to follow-up.
Age: 51.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Herpes zoster, Injection site rash, Pain in extremity, Tenderness
Clinical narrative: she noticed a rash which was 7 cm; Shingles; tenderness with pain in arm; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site rash in a 51-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number c5m4m, expiry date 30-SEP-2025) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 02-DEC-2023, the patient received Boostrix (left arm) and the 1st dose of Shingrix (right arm). On 04-DEC-2023, 2 days after receiving Boostrix and Shingrix, the patient experienced injection site rash (Verbatim: she noticed a rash which was 7 cm) and shingles (Verbatim: Shingles). In DEC-2023, the patient experienced pain in arm (Verbatim: tenderness with pain in arm). The outcome of the injection site rash, pain in arm and shingles were unknown.   It was unknown if the reporter considered the injection site rash, pain in arm and shingles to be related to Boostrix and Shingrix.     It was unknown if the company considered the injection site rash, pain in arm and shingles to be related to Boostrix and Shingrix.   Additional Information: RA receipt date: 05-DEC-2023 The reporter was the patient. The reporter was a physician. The physician received 1st dose of Shingrix in right arm, and Boostrix in the left arm. The physician stated that intense in right arm after 1st dose, 2 days later patient noticed a rash which was 7 cm distal to the injection site on her right arm which was tender and painful. The rash measured about 5 x 5 cm and seems consistent with shingles. Did not consent to follow up.
Age: 0.08
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: A new born received the 2nd dose of Engerix-B PED at the 3rd week instead of the 4th week; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 4-week-old male patient who received HBV (Engerix B pediatric) (batch number 9K74F, expiry date 27-OCT-2025) for prophylaxis.   Concomitant products included HEPATITIS B VACCINE RHBSAG (YEAST) (ENGERIX B).   On 31-OCT-2023, the patient received the 2nd dose of Engerix B pediatric. On 31-OCT-2023, an unknown time after receiving Engerix B pediatric and 22 days after receiving ENGERIX B, the patient experienced drug dose administration interval too short (Verbatim: A new born received the 2nd dose of Engerix-B PED at the 3rd week instead of the 4th week). The outcome of the drug dose administration interval too short was unknown.   This report is made by RA without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: RA receipt date: 06-DEC-2023 The medical assistant reported that the patient was received 2nd dose of Engerix-B pediatrics at the 3rd week instead of the 4th week, which led to drug dose administration interval too short. Consent to follow up.; Sender's Comments:  US-GSK-US2023171099:SAME PATIENT
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: The pain is now also in his right arm and states that it is difficult to raise his left arm; The pain is now also in his right arm and states that it is difficult to raise his left arm; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) (batch number 3zx3e, expiry date 02-JUL-2025) for prophylaxis.   On 22-AUG-2023, the patient received the 1st dose of Shingrix (right arm). In AUG-2023, 1 week after receiving Shingrix, the patient experienced pain in arm (Verbatim: The pain is now also in his right arm and states that it is difficult to raise his left arm). On an unknown date, the patient experienced mobility decreased (Verbatim: The pain is now also in his right arm and states that it is difficult to raise his left arm). The outcome of the pain in arm was not resolved and the outcome of the mobility decreased was not reported.   It was unknown if the reporter considered the pain in arm and mobility decreased to be related to Shingrix.     It was unknown if the company considered the pain in arm and mobility decreased to be related to Shingrix.   Additional Information: GSK Receipt Date: 06-DEC-2023 The patient reported that he received his first dose of Shingrix and a week after the vaccination he experienced pain in left arm. The pain was now also in his right arm. He stated that it was difficult to raise his left arm. The reporter consented to follow up.
Age: 1.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: 18 month old patient on 16-Nov-2023; 18 month old patient on 16-Nov-2023. This was his 3rd of each (DTaP and IPV); 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 18-month-old male patient who received DTPa-IPV (Kinrix) (batch number 7d2y4, expiry date 22-AUG-2025) for prophylaxis.   Previously administered products included Pediarix (2nd dose of DTaP and IPV received on 16th November 2022).   On 16-NOV-2023, the patient received the 3rd dose of Kinrix. On 16-NOV-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 18 month old patient on 16-Nov-2023) and inappropriate schedule of vaccine administered (Verbatim: 18 month old patient on 16-Nov-2023. This was his 3rd of each (DTaP and IPV)). The outcome of the inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were unknown.   This report is made by RA without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: RA Receipt Date: 06-Dec-2023 The reporter was a medical assistant. The reporter reported that the Kinrix vaccine was administered to an 18 month old patient which was his 3rd dose of DTaP and IPV. The reporter stated that the patient was so far behind and he got a bunch of vaccines together.  They were trying to reduce the number of vaccines by giving Kinrix.  The reporter stated that aside from Pediarix, none of the vaccines he was behind in were RA vaccines. The patient received Kinirix as 3rd dose of DTaP and IPV and who was younger than the indicated age which led to inappropriate schedule of vaccine administered and inappropriate age at vaccine administration. The reporter did consent to follow up.
Age: 0.33
Sex: U
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: a 4 months baby received Havrix pediatric dose vaccine; 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 pediatric) for prophylaxis.   On 05-DEC-2023, the patient received Havrix pediatric. On 05-DEC-2023, an unknown time after receiving Havrix pediatric, the patient experienced inappropriate age at vaccine administration (Verbatim: a 4 months baby received Havrix pediatric dose vaccine). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: RA Receipt Date: 06-DEC-2023 Healthcare professional reported that a 4 months baby received Havrix pediatric dose vaccine, which led to inappropriate age at vaccine administration. The reporter did not consent to follow-up. Permission to storage personal information within Medical Information database declined. No further information was possible to get form the call due healthcare professional disconnected.
Sex: M
Vaccine: RSV
Symptoms: Computerised tomogram normal, Fatigue, Headache, Salivary gland enlargement
Clinical narrative: swollen submandibular gland; fatigue; headache; This non-serious case was reported by a consumer via call center representative and described the occurrence of salivary gland enlargement in a 70-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 18-OCT-2023, the patient received Arexvy. On 20-OCT-2023, 2 days after receiving Arexvy, the patient experienced salivary gland enlargement (Verbatim: swollen submandibular gland), fatigue (Verbatim: fatigue) and headache (Verbatim: headache). On 23-OCT-2023, the outcome of the fatigue and headache were resolved (duration 3 days). The outcome of the salivary gland enlargement was not resolved.   It was unknown if the reporter considered the salivary gland enlargement, fatigue and headache to be related to Arexvy.     It was unknown if the company considered the salivary gland enlargement, fatigue and headache to be related to Arexvy.   Additional Information: GSK Receipt Date: 06-DEC-2023 This case was self-reported by the patient. The headache and fatigue were subsided, but the submandibular swelling remained.  He stated that it had been decreased but was definitely still there.  He reported that he was following up with his physician. Patient stated that the doctor did not had much information. The reporter consented to follow up.
Age: 0.25
Sex: F
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: she inadvertently administered a dose of FluLaval QIV to a 3 month old female on 06Dec2023; 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 3-month-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2023-2024 season) (batch number 5EK43, expiry date 30-JUN-2024) for prophylaxis.   On 06-DEC-2023, the patient received FluLaval Quadrivalent 2023-2024 season. On 06-DEC-2023, an unknown time after receiving FluLaval Quadrivalent 2023-2024 season, the patient experienced inappropriate age at vaccine administration (Verbatim: she inadvertently administered a dose of FluLaval QIV to a 3 month old female on 06Dec2023). 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: 06-DEC-2023 The reporter was medical assistant. The reporter reported that she inadvertently administered a dose of FluLaval QIV. The Vaccine Administration Facility was the same as Primary Reporter. The patient received FluLaval QIV earlier than the recommended age schedule, which led to inappropriate age at vaccine administration. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: inadvertently administered the appeared frozen Shingrix to a patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 50-year-old patient who received Herpes zoster (Shingrix) (batch number 4NG3F, expiry date 06-DEC-2025) for prophylaxis.   On 30-NOV-2023, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incorrect storage of drug (Verbatim: inadvertently administered the appeared frozen Shingrix to a patient). The outcome of the incorrect storage of drug was unknown.   Additional Information: RA receipt date: 06-DEC-2023 The registered nurse (RN) inquired that was Shingrix still viable? The reporter reported that they received a Shingrix delivery and upon receipt looked frozen based on temperature indicator. The healthcare professional (HCP) instructed staff to place in fridge for quarantine until further notice. The reporter reported that one of the staff member inadvertently administered the appeared frozen Shingrix to a patient. The HCP confirmed this was an attempt as a first Shingrix dose. The reporter unable to provide any patient details. The reporter did not consent to follow up.
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Product complaint, Syringe issue, Underdose
Clinical narrative: Leakage coming from the PFS and the patient may have only received half the dose; Pharmaceutical product complaint; Leakage coming from the PFS; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a 2-month-old patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis. This case was associated with a product complaint.   On 06-DEC-2023, the patient received the 1st dose of Pediarix. On 06-DEC-2023, an unknown time after receiving Pediarix, the patient experienced syringe leak (Verbatim: Leakage coming from the PFS). On an unknown date, the patient experienced accidental underdose (Verbatim: Leakage coming from the PFS and the patient may have only received half the dose) and pharmaceutical product complaint (Verbatim: Pharmaceutical product complaint). The outcome of the accidental underdose, syringe leak and pharmaceutical product complaint were unknown.   This report is made by RA without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: RA Receipt Date: 06-Dec-2023 The reporter reported that the nurse was attaching a needle to the Pediarix PFS and discovered that it must had cracked when the needle was being attached as there was leakage coming from the PFS and the patient may had only received half of the dose, which led to accidental underdose and syringe leak. The reporter reported that a nurse complained of a leaky syringe.  The reporter was not present when the issue occurred so he had no further knowledge of the event and was not able to specify or answer any of the questions from content.  The reporter stated that the suspect product was not available, HCP was unable to provide the lot number. The defect was classified as cracked syringe. The vaccine administration facility was the same as primary reporter. The reporter did consent to follow up via postal.
Age: 89.0
Sex: F
Vaccine: RSV
Symptoms: Chest pain, Injection site mass, Lethargy, Pain in extremity, Productive cough
Clinical narrative: small lump inside her arm at the injection site; patient reported soreness in the arm; moderate pain in her lower chest area; feeling very lethargic; a bit of phlegm in the lungs; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site lump in a female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 2X7NA, expiry date 23-MAR-2025) for prophylaxis.   Concurrent medical conditions included artificial cardiac pacemaker user (6 months ago).   On 01-DEC-2023, the patient received Arexvy (intramuscular, left arm). In DEC-2023, an unknown time after receiving Arexvy, the patient experienced injection site lump (Verbatim: small lump inside her arm at the injection site), pain in arm (Verbatim: patient reported soreness in the arm), chest pain (Verbatim: moderate pain in her lower chest area), lethargy (Verbatim: feeling very lethargic) and phlegm (Verbatim: a bit of phlegm in the lungs). The outcome of the injection site lump, pain in arm, chest pain, lethargy and phlegm were not resolved.   It was unknown if the reporter considered the injection site lump, pain in arm, chest pain, lethargy and phlegm to be related to Arexvy.  It was unknown if the company considered the injection site lump, pain in arm, chest pain, lethargy and phlegm to be related to Arexvy.   Additional Information: GSK Receipt Date: 06-DEC-2023 The reporter was the spouse of the patient.  The reporter stated that his spouse got the RSV vaccine (Arexvy) at a local retail pharmacy.  The reporter stated that the next day the patient reported soreness in the arm, small lump inside her arm at the injection site, a bit of phlegm in the lungs and feeling very lethargic. The reporter stated that the patient had a moderate pain in her lower chest area. It was a dull pain, not acute, in her lower chest; like in her lungs, like inflammation or something.  The reporter wanted to inform that she had a pacemaker put in her chest 6 months ago.  He did not know if it was related. Not all information was available.  The consent for follow up was not obtained and customer would follow up with additional information.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Hyperhidrosis, Malaise, Pyrexia
Clinical narrative: she felt really sick for a day and a half approximately; strong headache; super tired; fever; sweating all day.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of feeling unwell in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Covid with an associated reaction of illness (received on an unknown date) and Zostavax with an associated reaction of illness (received on an unknown date).   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 feeling unwell (Verbatim: she felt really sick for a day and a half approximately), headache (Verbatim: strong headache), tiredness (Verbatim: super tired), fever (Verbatim: fever) and sweating (Verbatim: sweating all day.). The outcome of the feeling unwell was resolved and the outcome of the headache, tiredness, fever and sweating were not reported.   It was unknown if the reporter considered the feeling unwell, headache, tiredness, fever and sweating to be related to Shingrix.     It was unknown if the company considered the feeling unwell, headache, tiredness, fever and sweating to be related to Shingrix.   Additional Information: GSK  receipt date: 06-DEC-2023 The patient self-reported this case (nurse with an active license). The patient had received 1st dose of Shingrix (no data about injection date) and felt really sick for a day and a half approximately. The patient had symptoms such as strong headache, super tired, fever, and sweating all day. On 12th May 2023, patient got Shingrix 2nd dose believed that nurse who prepared the vaccine had gotten confused and had injected her with Covid vaccine (NDC number: 58160-823-11) and  was now surprised about feeling so well. Both Shingrix injections were administered at the same place. The patient also mentioned that she got other vaccine and Zostavax, but she had never felt as sick as she did after receiving the Shingrix vaccine. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: did not confirm if 2nd dose had been given; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 76-year-old female patient who received Herpes zoster (Shingrix) (batch number 4JP7M, expiry date 21-NOV-2025) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2020).   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 confirm if 2nd dose had been given). The outcome of the incomplete course of vaccination was unknown.   Additional Information: RA Receipt Date: 06-DEC-2023 The pharmacist called inquiring how to proceed if patient received her first dose of Shingrix and came for another Shingrix and he was asking how they should proceed. At the time of reporting, it was not confirm if 2nd dose had been given or not but registered pharmacist provided lot for a second dose. Till the time of reporting the patient had not received the second dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Sex: F
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Administration of 0.5 ml of Boostrix to a new born; patient received Boostrix instead of a Hepatitis B vaccine; This non-serious case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 1-day-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 324b2, expiry date 30-JAN-2026) for prophylaxis.   On 07-DEC-2023, the patient received Boostrix .5 ml. On 07-DEC-2023, an unknown time after receiving Boostrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Administration of 0.5 ml of Boostrix to a new born) and wrong vaccine administered (Verbatim: patient received Boostrix instead of a Hepatitis B vaccine). The outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by RA without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: RA Receipt Date: 07-Dec-2023 The reporter reported that the new born baby patient received Boostrix vaccine, which led to inappropriate age at vaccine administration. The reporter stated that the patient received Boostrix vaccine instead of Hepatitis B vaccine, which led wrong vaccine administered. The patient was born on 2:26 am in the morning and Boostrix was administered at 5 am. The reporter did not consent to follow up.
Age: 52.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Exposure via skin contact, Pain in extremity, Pyrexia, Syringe issue, Underdose
Clinical narrative: During administration the syringe leaked and part of the contents fell on his arm and sides; He was concerned that he did not receive a full dose; Inadvertent exposure to vaccine; fever; Soreness in arm; This non-serious case was reported by a consumer via call center representative and described the occurrence of exposure via skin contact in a 52-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 06-DEC-2023, the patient received the 2nd dose of Shingrix. In OCT-2023, the patient received the 1st dose of Shingrix. On 06-DEC-2023, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced exposure via skin contact (Verbatim: During administration the syringe leaked and part of the contents fell on his arm and sides), accidental underdose (Verbatim: He was concerned that he did not receive a full dose) and inadvertent exposure to vaccine (Verbatim: Inadvertent exposure to vaccine). On an unknown date, the patient experienced fever (Verbatim: fever) and pain in arm (Verbatim: Soreness in arm). The outcome of the exposure via skin contact, accidental underdose and inadvertent exposure to vaccine were unknown and the outcome of the fever and pain in arm were resolved (duration 1 day).   It was unknown if the reporter considered the fever and pain in arm to be related to Shingrix.     It was unknown if the company considered the fever and pain in arm to be related to Shingrix.   Additional Information: RA receipt date: 07-DEC-2023 The reporter was the patient and the patient receive the 1st dose of Shingrix vaccine after that patient experienced soreness, fever, and was down for a day. and receive 2nd dose of Shingrix but during administration the syringe leaked and part of the contents fell on his arm and sides, which led to exposure via skin contact. The patient concerned that did not receive a full dose. Did not consent to follow up.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Vaccine positive rechallenge
Clinical narrative: only the diluent component of Shingrix; only the diluent component of Shingrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 61-year-old male patient who received Herpes zoster (Shingrix) (batch number N425G, expiry date 07-DEC-2025) for prophylaxis.   On 05-DEC-2023, the patient received the 1st dose of Shingrix. On 05-DEC-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: only the diluent component of Shingrix) and inappropriate dose of vaccine administered (Verbatim: only the diluent component of Shingrix). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: RA Receipt Date: 07-DEC-2023. The reporter reported on 07-Dec-2023 that a male patient received on 5th December only the diluent component of Shingrix, as 1st dose which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: received the liquid only component of Menveo; received the liquid only component of Menveo; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 06-NOV-2023, the patient received Menveo. On 06-NOV-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: received the liquid only component of Menveo) and inappropriate dose of vaccine administered (Verbatim: received the liquid only component of Menveo). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 07-DEC-2023 The nurse reported that patient received the liquid only component of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. It was not known if the patient received only diluent. The reporter consented to follow up via email. This case was linked with US2023AMR172682 and US2023171742, reported by same reporter for different patient.; Sender's Comments:  US-GSK-US2023171742:Original Case : US2023171742 US-GSK-US2023AMR172682:Original Case : US2023171742