chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: little pain in my arm; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a 58-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In October 2022, the patient received Shingles vaccine. On an unknown date, less than a month after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   The reporter considered the pain in arm to be possibly related to Shingles vaccine.     Additional Information: GSK Receipt Date: 30-NOV-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient received a dose of Shingles vaccine last month and reported just had a little pain in arm for a couple of days. Additional Supportive Information: Partial vaccination date captured as per narrative, conservatively. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: sore arm; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     Additional Information: GSK Receipt Date: 30-NOV-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient just finished the 2nd set of Shingrix. The patient experienced sore arm for couple of days. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash 15 days after shingle vac; This case was reported by a consumer via call center representative and described the occurrence of rash in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 15 days after receiving Shingles vaccine, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 30-Nov-2022. Reporter's Comment:  The reporter stated that it was 3rd attempt to ask about a rash development 15 days after shingles vaccine. The follow up would not possible as no contact details were available.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Pain, Tremor
Clinical narrative: tremors; chills; body aches; fatigue; This case was reported by a nurse via sales rep and described the occurrence of tremor in a 55-year-old female patient who received Herpes zoster (Shingrix) (batch number j9b25, expiry date unknown) for prophylaxis.   On 9th August 2022, the patient received the 1st dose of Shingrix. On an unknown date, several days after receiving Shingrix, the patient experienced tremor, chills, general body pain and fatigue. On an unknown date, the outcome of the tremor, chills, general body pain and fatigue were unknown.   It was unknown if the reporter considered the tremor, chills, general body pain and fatigue to be related to Shingrix.     Additional Information: GSK receipt date: 30-NOV-2022 Reporters comment: The nurse reported that the patient was given first dose of shingrix and within a few days reported tremors chills, body aches fatigue. The reporter consent to follow-up from GlaxoSmithKline.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: redness at injection site; itching at injection site; This case was reported by a consumer and described the occurrence of injection site erythema in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th November 2022, the patient received the 1st dose of Shingrix. On 30th November 2022, less than a day after receiving Shingrix, the patient experienced injection site erythema and injection site itching. On an unknown date, the outcome of the injection site erythema and injection site itching were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema and injection site itching to be related to Shingrix.     Additional Information: GSK receipt date: 30-NOV-2022 Reporters comment: The reporter was the patient and first Shingles Vaccine shot today at local internal medicine doctors' clinic. The patient was having redness and itching at the injection site, on upper left arm. Itching was not one of the symptoms listed, so thought that would share that information.
Sex: M
Vaccine: VARZOS
Symptoms: Musculoskeletal disorder
Clinical narrative: unable to use left arm; This case was reported by a consumer and described the occurrence of upper extremity dysfunction in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced upper extremity dysfunction. On an unknown date, the outcome of the upper extremity dysfunction was not recovered/not resolved.   It was unknown if the reporter considered the upper extremity dysfunction to be related to Shingrix.     Additional Information: GSK Receipt Date: 01-DEC-2022 Reporter's Comment: The reporters husband had a Shingrix shot 3 months prior to the reporting that had left him unable to use his left arm. The reporter wanted to know did you offered support in this situation.
Age: 57.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Erythema, Induration, Injection site bruising, Injection site erythema, Injection site induration
Clinical narrative: Injection site itches; Has a bruise at the injection site; Injection site burns; Very painful; Redness spreading, getting larger/Injection site is red; Arm swelling is hard; Arm swelled up, getting bigger going around arm/Swollen beyond inj site; This case was reported by a consumer and described the occurrence of injection site itching in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included INFLUENZA VACCINE INACT (FLUZONE QUAD) for prophylaxis.   Previously administered products included COVID-19 VACCINE with an associated reaction of injection site inflammation (on an unknown date received vaccine).   On 28th November 2022, the patient received the 1st dose of Shingrix (intramuscular) and FLUZONE QUAD (intramuscular). On 29th November 2022, 1 days after receiving Shingrix, the patient experienced swelling arm. On an unknown date, the patient experienced injection site itching, injection site bruising, injection site burning, pain, erythema of extremities and induration. The patient was treated with lidocain and calamine. On an unknown date, the outcome of the injection site itching, injection site bruising, injection site burning, pain, swelling arm, erythema of extremities and induration were not recovered/not resolved.   It was unknown if the reporter considered the injection site itching, injection site bruising, injection site burning, pain, swelling arm, erythema of extremities and induration to be related to Shingrix.     Additional Information: GSK Receipt Date: 01-DEC-2022 Reporter's Comment: The reporter reported that the patient received Shingrix and Fluzone quad 2022-2023 in the same arm on the same day. Both vaccines were administered intramuscularly in right arm deltoid in same pharmacy. The reporter did not have lot number. On Tuesday patients arm began to swell up. It keeps getting bigger and it was hard. It was going around her arm. The redness was getting larger and spreading out more. It was not in one concentrated area. It was going underneath the armpit and down to her elbow under her arm. The injection site was red, swollen, hard, burns and itches. The patient also had a bruise at the injection site. The patient was treated lidocaine topical cream, calamine lotion and has iced the area for an hour. These events had not resolved, and they did not seem to be letting up and seems to be getting worse. Today it was swelled up, bigger and hard. It was unknown if the reporter considered the injection site itching, injection site bruising, injection site burning, pain, swelling arm, erythema of extremities and induration to be related to Fluzone quad 2022-2023 vaccine
Age: 57.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Injection site inflammation, Injection site pain, Injection site pruritus, Injection site swelling, Pain
Clinical narrative: Injection site itches; Has a bruise at the injection site; Injection site burns; Very painful; Redness spreading, getting larger/Injection site is red; Arm swelling is hard; Arm swelled up, getting bigger going around arm/Swollen beyond inj site; This case was reported by a consumer and described the occurrence of injection site itching in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included INFLUENZA VACCINE INACT (FLUZONE QUAD) for prophylaxis.   Previously administered products included COVID-19 VACCINE with an associated reaction of injection site inflammation (on an unknown date received vaccine).   On 28th November 2022, the patient received the 1st dose of Shingrix (intramuscular) and FLUZONE QUAD (intramuscular). On 29th November 2022, 1 days after receiving Shingrix, the patient experienced swelling arm. On an unknown date, the patient experienced injection site itching, injection site bruising, injection site burning, pain, erythema of extremities and induration. The patient was treated with lidocain and calamine. On an unknown date, the outcome of the injection site itching, injection site bruising, injection site burning, pain, swelling arm, erythema of extremities and induration were not recovered/not resolved.   It was unknown if the reporter considered the injection site itching, injection site bruising, injection site burning, pain, swelling arm, erythema of extremities and induration to be related to Shingrix.     Additional Information: GSK Receipt Date: 01-DEC-2022 Reporter's Comment: The reporter reported that the patient received Shingrix and Fluzone quad 2022-2023 in the same arm on the same day. Both vaccines were administered intramuscularly in right arm deltoid in same pharmacy. The reporter did not have lot number. On Tuesday patients arm began to swell up. It keeps getting bigger and it was hard. It was going around her arm. The redness was getting larger and spreading out more. It was not in one concentrated area. It was going underneath the armpit and down to her elbow under her arm. The injection site was red, swollen, hard, burns and itches. The patient also had a bruise at the injection site. The patient was treated lidocaine topical cream, calamine lotion and has iced the area for an hour. These events had not resolved, and they did not seem to be letting up and seems to be getting worse. Today it was swelled up, bigger and hard. It was unknown if the reporter considered the injection site itching, injection site bruising, injection site burning, pain, swelling arm, erythema of extremities and induration to be related to Fluzone quad 2022-2023 vaccine
Age: 57.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Peripheral swelling
Clinical narrative: Injection site itches; Has a bruise at the injection site; Injection site burns; Very painful; Redness spreading, getting larger/Injection site is red; Arm swelling is hard; Arm swelled up, getting bigger going around arm/Swollen beyond inj site; This case was reported by a consumer and described the occurrence of injection site itching in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included INFLUENZA VACCINE INACT (FLUZONE QUAD) for prophylaxis.   Previously administered products included COVID-19 VACCINE with an associated reaction of injection site inflammation (on an unknown date received vaccine).   On 28th November 2022, the patient received the 1st dose of Shingrix (intramuscular) and FLUZONE QUAD (intramuscular). On 29th November 2022, 1 days after receiving Shingrix, the patient experienced swelling arm. On an unknown date, the patient experienced injection site itching, injection site bruising, injection site burning, pain, erythema of extremities and induration. The patient was treated with lidocain and calamine. On an unknown date, the outcome of the injection site itching, injection site bruising, injection site burning, pain, swelling arm, erythema of extremities and induration were not recovered/not resolved.   It was unknown if the reporter considered the injection site itching, injection site bruising, injection site burning, pain, swelling arm, erythema of extremities and induration to be related to Shingrix.     Additional Information: GSK Receipt Date: 01-DEC-2022 Reporter's Comment: The reporter reported that the patient received Shingrix and Fluzone quad 2022-2023 in the same arm on the same day. Both vaccines were administered intramuscularly in right arm deltoid in same pharmacy. The reporter did not have lot number. On Tuesday patients arm began to swell up. It keeps getting bigger and it was hard. It was going around her arm. The redness was getting larger and spreading out more. It was not in one concentrated area. It was going underneath the armpit and down to her elbow under her arm. The injection site was red, swollen, hard, burns and itches. The patient also had a bruise at the injection site. The patient was treated lidocaine topical cream, calamine lotion and has iced the area for an hour. These events had not resolved, and they did not seem to be letting up and seems to be getting worse. Today it was swelled up, bigger and hard. It was unknown if the reporter considered the injection site itching, injection site bruising, injection site burning, pain, swelling arm, erythema of extremities and induration to be related to Fluzone quad 2022-2023 vaccine
Sex: U
Vaccine: VARZOS
Symptoms: Feeling hot, Headache, Injection site rash, Injection site swelling, Rash
Clinical narrative: warm to the touch; headache; swelling at and around injection site; rash at and around injection site; This case was reported by a consumer via interactive digital media and described the occurrence of injection site swelling in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2022, the patient received Shingrix. In November 2022, less than a week after receiving Shingrix, the patient experienced injection site swelling, injection site rash and headache. On 1st December 2022, the patient experienced feeling of warmth. On an unknown date, the outcome of the injection site swelling and injection site rash were recovered/resolved and the outcome of the headache and feeling of warmth were not recovered/not resolved.   It was unknown if the reporter considered the injection site swelling, injection site rash, headache and feeling of warmth to be related to Shingrix.     Additional Information: GSK receipt date: 01-DEC-2022 Reporters comment:  The patient received Shingrix vaccine a week prior to the reporting.  The patient experienced swelling and rash at and around the sight of injection and headache. After several days it went away.  Then on the day of reporting I woke, and the rash had returned and feels warm to the touch.  The patient had headache again.
Sex: U
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: warm to the touch; headache; swelling at and around injection site; rash at and around injection site; This case was reported by a consumer via interactive digital media and described the occurrence of injection site swelling in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2022, the patient received Shingrix. In November 2022, less than a week after receiving Shingrix, the patient experienced injection site swelling, injection site rash and headache. On 1st December 2022, the patient experienced feeling of warmth. On an unknown date, the outcome of the injection site swelling and injection site rash were recovered/resolved and the outcome of the headache and feeling of warmth were not recovered/not resolved.   It was unknown if the reporter considered the injection site swelling, injection site rash, headache and feeling of warmth to be related to Shingrix.     Additional Information: GSK receipt date: 01-DEC-2022 Reporters comment:  The patient received Shingrix vaccine a week prior to the reporting.  The patient experienced swelling and rash at and around the sight of injection and headache. After several days it went away.  Then on the day of reporting I woke, and the rash had returned and feels warm to the touch.  The patient had headache again.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 59-year-old male patient who received Herpes zoster (Shingrix) (batch number F9TG5, expiry date 18th September 2023) for prophylaxis.   On 2nd September 2022, the patient received the 1st dose of Shingrix. In September 2022, 2 weeks after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     Additional Information: GSK receipt date: 30-NOV-2022 Reporters comment: The pharmacist reported that the patient developed a shingles approximately two weeks after the 1st dose of shingrix.  The reporter consented to follow-up. Additional supportive information: This case is linked to the case US2022179394, reported by the same reporter.; Sender's Comments:  US-GSK-US2022179394:Same reporter
Sex: U
Vaccine: MENB
Symptoms: Product storage error
Clinical narrative: 12 hrs at 66.92 °F and  42 hrs 24 minutes at 65.6 °F; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received Men B NVS (Bexsero) (batch number 59M3M, expiry date 28th February 2023) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 9th November 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 30-NOV-2022 Reporters comment: The office manager reported that the bexsero vaccines had a temperature excursion lasting 12 hours with a maximum temperature of 66.92 Fahrenheit, and then a second excursion lasting 42 hours 24 minutes, with a maximum temperature of 65.6 Fahrenheit.  She reported that the 1st dose of the vaccine were administered to patients after the second excursion occurred. At the time of reporting, the Office Manager did not have patient specific identifiers. Vaccine administration facility was the same as primary reporter. The reporter consent to follow-up. Additional Supportive information: The bexsero vaccines had a temperature excursion lasting 12 hours with a maximum temperature of 66.92 Fahrenheit, which led to incorrect storage of drug. This case is linked to the case US2022AMR179995 and US2022AMR179996, reported by the same reporter.; Sender's Comments:  US-GSK-US2022AMR179995:Same reporter US-GSK-US2022AMR179996:Same reporter
Age: 79.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Diarrhoea, Fatigue, Nausea, Vomiting
Clinical narrative: Vomiting; Diarrhea; Fatigue; Nausea; This case was reported by a consumer via call center representative and described the occurrence of vomiting in a 79-year-old male patient who received Flu unspecified (Flu vaccine) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE) for prophylaxis.   On 23rd November 2022, the patient received the 1st dose of Flu vaccine (intramuscular) and the 1st dose of PNEUMONIA VACCINE (intramuscular). On 23rd November 2022, less than a day after receiving Flu vaccine, the patient experienced vomiting, diarrhea, fatigue and nausea. On 24th November 2022, the outcome of the vomiting, diarrhea and fatigue were recovered/resolved. On an unknown date, the outcome of the nausea was not recovered/not resolved.   It was unknown if the reporter considered the vomiting, diarrhea, fatigue and nausea to be related to Flu vaccine.     Additional Information: GSK receipt date:30-NOV-2022 Reporters comment: The reporter was the patient and he stated that he had a flu shot unknown manufacturer had a pneumonia shot which was unknown manufacturer and experienced vomiting, diarrhea, fatigue, and nausea. The patient planned to follow-up with his physician on an unknown date. The reporter given consent to follow-up. Additional Supportive information: It was unknown if the reporter considered the vomiting, diarrhea, fatigue and nausea to be related to pneumonia vaccine.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Accidental overdose, Product administered to patient of inappropriate age
Clinical narrative: 19 year old patient received Engerix B adult; 19 year old received Engerix B adult; This case was reported by a other health professional via call center representative and described the occurrence of accidental overdose in a 19-year-old female patient who received HBV (Engerix B adult) (batch number NT9X3, expiry date 9th September 2024) for prophylaxis.   On an unknown date, the patient received Engerix B adult. On an unknown date, unknown after receiving Engerix B adult, the patient experienced accidental overdose and inappropriate age at vaccine administration. On an unknown date, the outcome of the accidental overdose and inappropriate age at vaccine administration were unknown.      Additional Information: GSK Receipt Date: 30-NOV-2022 Reporter's Comment: The medical assistant reported that a 19 year old patient was inadvertently administered an adult dose of Engerix-B. The vaccine administration facility was the same as primary reporter. The reporter consent to follow up via email. Additional supportive information: The patient was inadvertently administered an adult dose of Engerix-B, which led to overdose and inappropriate age at vaccine administration.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Axillary mass, Pruritus
Clinical narrative: Raised skin under arm; Itchiness in upper torso/thigh; This case was reported by a consumer via call center representative and described the occurrence of axillary lump in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included COVID-19 VACCINE (COVID-19 BOOSTER).   On 24th November 2022, the patient received the 1st dose of Shingrix. In November 2022, less than a week after receiving Shingrix, the patient experienced axillary lump and pruritus. On an unknown date, the outcome of the axillary lump and pruritus were unknown.   It was unknown if the reporter considered the axillary lump and pruritus to be related to Shingrix.     Additional Information: GSK Receipt Date: 01-DEC-2022 Reporter's Comment: The case was self reported by the patient. The patient received first dose of Shingrix into left arm and reported that for the past few days he had experienced raised skin under his left arm and itchiness in his upper torso and thigh. The patient also reported that he received a COVID-19 booster a week before receiving the Shingrix dose. The reporter did not consent to follow up.
Age: 72.0
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: F1st dose of Havrix on 12Oct2022 and an early 2nd dose on 12Nov2022.; This 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 72-year-old female patient who received HAV (Havrix) (batch number NZ7GR, expiry date 17th June 2023) for prophylaxis.   Concomitant products included HEPATITIS A VACCINE (HAVRIX), HEPATITIS B VACCINE (ENGERIX B) and HEPATITIS B VACCINE (ENGERIX B).   On 12th November 2022, the patient received the 2nd dose of Havrix. On 12th November 2022, unknown after receiving Havrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.    Additional Information: GSK receipt date: 01-DEC-2022 Reporters comment: The patient also received the 1st and 2nd dose of Engerix on the same dates of Havrix on 12th October 2022 and 12th November 2022. The reporter reported that patient received the 1st dose of Havrix and an early 2nd dose. The reporter consent to follow-up. Additional Supportive information: The patient received the 2nd dose earlier than the recommended interval, which led to shortening of vaccinations schedule. ; Sender's Comments:  US-GSK-US2022180225:Same reporter
Age: 60.0
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose on 12Oct2022, 2nd on 12Nov2022; This 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 60-year-old female patient who received HAV (Havrix) (batch number NZ7GR, expiry date 17th June 2023) for prophylaxis.   Concomitant products included HEPATITIS A VACCINE (HAVRIX), HEPATITIS B VACCINE (ENGERIX B) and HEPATITIS B VACCINE (ENGERIX B).   On 12th November 2022, the patient received the 2nd dose of Havrix. On 12th November 2022, unknown after receiving Havrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.       Additional Information: GSK receipt date: 01-DEC-2022 Reporters comment:  The reporter reported that patient received the 1st dose of Havrix and an early 2nd dose of Havrix. The patient also received the 1st and 2nd dose of Engerix on the same dates. The reporter consent to follow up. Additional Supportive information: The patient received 2nd dose of havrix, earlier than the recommended interval, which led to shortening of vaccinations schedule. This case had been linked with US2022180223 same reporter. Note-As per source document Engerix B coded as concomitant vaccine.; Sender's Comments:  US-GSK-US2022180223:Same reporter
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose 02Oct2019, 2nd 18Nov2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number HE4P7, expiry date 25th January 2024) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 2 October 2019).   On 18th November 2022, the patient received the 2nd dose of Shingrix. On 18th November 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 01-DEC-2022 Reporter's comment: This case was reported by pharmacist. The pharmacist reported that patient received first dose of Shingrix on 2 October 2022 and then did not get the second dose until 18th November 2022. The first dose was administered at a different facility so the reporter did not have the lot number, expiration date. The second dose was administered from lot number HE4P7 expiration date 25th January 2024. Additional supportive information: As patient received first dose of Shingrix on did not get the second dose until 18th November 2022 which led to drug dose administration interval too long. Reporter consented to follow.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose 04Dec2019, 2nd 1Dec2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 53-year-old male patient who received Herpes zoster (Shingrix) (batch number 43Y5R, expiry date 8th February 2024) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (first dose was received on 04 December 2019).   On 1st December 2022, the patient received the 2nd dose of Shingrix. On 1st December 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.      Additional Information: GSK Receipt Date: 01-DEC-2022 Reporter's comments: The pharmacist had reported that a patient did not receive the second dose until 01 December 2022. The pharmacist did not had the lot number information from the first dose and had provided the lot number information from the second dose administered to the patient. The reporter had consented to follow-up. Additional supportive information: The patient had received the second dose later than the recommended interval, which led to lengthening of vaccination schedule.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 2018, 2nd not yet; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2018).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 01-DEC-2022 Reporter's comment: The reporter stated that the patient received first dose of Shingrix in 2018 and has not yet received her second dose. Additional supportive information: Till the time of reporting the patient did not receive the second dose of Shingrix which led to incomplete course of vaccination. Reporter did not consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd shot 2 years after the 1st; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (on an unknown date received 1st dose in July 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.      Additional Information: GSK Receipt Date: 01-DEC-2022 Reporter's Comment: The inquiry came in via chat and pharmacist reported only partial data. The reporter wanted to know was it considered a completed series if the second Shingrix shot was 2 years after the 1st shot. The Hcp (health care professional) provided date July 2019 but it was unclear if its 1st or 2nd dose. The chat ended by user no consent was obtained for follow up. Additional Supportive Information: The patient received 2nd dose of Shingrix later than the recommended interval, which led to lengthening of the vaccine schedule.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Product storage error
Clinical narrative: was administered after the excursion; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA724Z, expiry date 30th September 2023) for prophylaxis.   On 5th October 2022, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.      Additional Information: GSK Receipt Date: 01-DEC-2022 Reporter's Comment: The reporter reported a clinic site recorded maximum temperature of 35 degree C for Menveo vaccines and that one dose of the Menveo was administered after the excursion. At the time of reporting, the patient had not been redosed. The reporter consented to follow up. Additional Supportive Information: The reporter stated that, one dose of the Menveo was administered after the excursion, which led to incorrect storage of drug. The case had been linked to US2022AMR180586,reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2022AMR180586:same reporter
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Expired product administered
Clinical narrative: an expired Pediarix was given; This case was reported by a nurse via sales rep and described the occurrence of expired vaccine used in a 3-month-old patient who received DTPa-HBV-IPV (Pediarix) (batch number unknown, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st December 2022, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 1st December 2022, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 01-DEC-2022 and 02-DEC-2022 Reporter's Comment: The reporter called to report that, an expired dose of Pediarix had been administered to a patient. The Vaccine Administration Facility was the same as Primary Reporter. The reporter did not had any information on the patient (only the age) or the vaccine (dose, lot number, etc.) since the information was at the clinic. However, consent for follow-up by safety team was granted. The reporter had no information on the patient or any other details.  The reporter said that, follow-up via e-mail would be better than via phone number. Additional Supportive Information: The reporter reported that, an expired Pediarix was given to a patient (expired drug used),which led to expired vaccine used.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Expired dose was given; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMV8638A, expiry date 30th November 2022) for prophylaxis.   On 1st December 2022, the patient received Menveo. On 1st December 2022, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 02-DEC-2022 Reporter's Comment: The reporter reported that the patient received a dose of Menveo and it was already expired.  The reporter consented to follow up by email. Additional Supportive Information: The use of Menveo dose, which was already expired on 30th November 2022, which led to expired vaccine used.
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Expired Menveo administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA690A, expiry date 31st October 2022) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 02-DEC-2022 Reporter's Comment: The nurse reported that the patient received a dose of Menveo and it was already expired.  The reporter consented to follow up. Additional Supportive Information: The use of Menveo dose, which was already expired on 31st October 2022, which led to expired vaccine used.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: got the flu was after the shot; Initial information received on 05-Dec-2022 regarding an unsolicited valid social media non-serious case received via consumer/non-hcp.  This case involves a 35-year-old and unknown gender patient who experienced got the flu was after the shot while receiving vaccine Influenza Vaccine (Flu shot).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received suspect INFLUENZA VACCINE produced by unknown manufacturer at (unknown: formulation, strength, dose, lot number, route in unknown administration site) for prophylactic vaccination. Information regarding batch and expiry date requested.  On an unknown date, the patient developed flu (influenza) at unknown latency after the shot of INFLUENZA VACCINE.  It was reported that "how about natural prevention like good eating habits! FYI the only time in the last 35 years i got the flu was after the shot. Find out more about natural prevention not chemical crap."  Action taken: Not applicable.  Corrective treatment: not reported.  At time of reporting, the outcome was Unknown for the event influenza.
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Malaise
Clinical narrative: had the flu 2 weeks ago and I was very sick; Initial information received on 05-Dec-2022 regarding an unsolicited valid social media non-serious case received via consumer/non-hcp.  This case involves patient of unknown demographics who experienced had the flu 2 weeks ago and i was very sick while receiving vaccine Influenza Vaccine (Flu shot).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received suspect INFLUENZA VACCINE produced by unknown manufacturer at (unknown: formulation, strength, lot number, route in unknown administration site) for Influenza vaccination. Information regarding batch number requested.  On an unknown date, the patient developed a non-serious had the flu 2 weeks ago and i was very sick (influenza) at unknown latency following the administration of INFLUENZA VACCINE.  Action taken: Not applicable.  Corrective treatment: not reported.  At time of reporting, the outcome was Unknown for the event Influenza.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lip swelling, Peripheral coldness, Peripheral swelling, Pyrexia
Clinical narrative: The day after the shot, my left hand fingertips swole up for a few days straight. I had a fever for about 12 hours, and a bit of a headache, but the swelling in my hand persisted for days after. Ever since then, I'll experience swelling in my hands and feet if they're exposed to cold temperatures for more than a few minutes, and sometimes the swelling will last for hours.  I've had my 4th dose, and I'm getting more random swelling (a weird spot on my butt, occasionally my lip). The internet says this is what chilblains are? I've never experienced anything like this in my life, and until I experienced it, I didn't know you could experience allergic reactions to cold temperatures.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative, Swelling, Temperature intolerance
Clinical narrative: The day after the shot, my left hand fingertips swole up for a few days straight. I had a fever for about 12 hours, and a bit of a headache, but the swelling in my hand persisted for days after. Ever since then, I'll experience swelling in my hands and feet if they're exposed to cold temperatures for more than a few minutes, and sometimes the swelling will last for hours.  I've had my 4th dose, and I'm getting more random swelling (a weird spot on my butt, occasionally my lip). The internet says this is what chilblains are? I've never experienced anything like this in my life, and until I experienced it, I didn't know you could experience allergic reactions to cold temperatures.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hallucination, auditory, Involuntary commitment, Paranoia
Clinical narrative: Extreme auditory hallucinations, paranoia
Age: 52.0
Sex: F
Vaccine: COVID19-2
Symptoms: Postmenopausal haemorrhage
Clinical narrative: Post-menopausal breakthrough bleeding
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Then he broke into a rash in the chest.; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Then he broke into a rash in the chest.) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 28-Nov-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced RASH (Then he broke into a rash in the chest.). At the time of the report, RASH (Then he broke into a rash in the chest.) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medicine were reported. No treatment medicine were reported.   Reporter did not allow further contact
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: FLU; Initial information received on 04-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves Adult and unknown gender patient who experienced flu after receiving vaccine Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect Influenza Vaccine produced by unknown manufacturer lot number not reported (formulation, expiry date, strength was unknown) via unknown route in unknown administration site for Flu vaccination.  On an unknown date the patient developed flu (influenza) (unknown latency).  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (FLU).  At time of reporting, the outcome was Unknown for the event flu.
Sex: F
Vaccine: UNK
Symptoms: Extra dose administered
Clinical narrative: 1st dose 21 Oct 2022, 2nd 01 dec 2022; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 53-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) (batch number 9249L, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included INFLUENZA VACCINE INACT (FLULAVAL QUADRIVALENT).   On 1st December 2022, the patient received the 2nd dose of FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device. On 1st December 2022, unknown after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced extra dose administered. On an unknown date, 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: 02-DEC-2022 Reporter's Comment: The reporter was a medical assistant. The reporter reported that the patient received 1st dose Flulaval vaccine on 21st October 2022. The patient stated to the staff that she did not received her Flu vaccine this season, so another dose of Flulaval vaccine was received. The reporter reported that afterwards, it was discovered that the patient already received a dose of this season. The reporter did consent to follow up. Additional supportive information: The patient received extra dose of FluLaval Quadrivalent, which led to extra dose administered.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: received Menveo reconstituted with a different diluent; received Menveo reconstituted with a different diluent; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA714A, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 02-DEC-2022 Reporter's comment: The practice manager reported that while doing inventory a vial of Menveo diluent was found and the patient just received a dose of Menveo powder portion of Menveo reconstituted with a different diluent. It was assumed that one of three possible patients had received just the powder portion of Menveo reconstituted with a different diluent.  There was no data on the administration date, patient's identifiers or confirmation that the above situation had occurred. The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow up. Additional supportive information: The patient received dose of Menveo powder reconstituted with different diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Age: 58.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect route of product administration
Clinical narrative: Administered via subcutaneous route; Menveo administered to a 58 year-old; This case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a 58-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA748A, expiry date 20th November 2023) for prophylaxis.   On 1st December 2022, the patient received Menveo (subcutaneous). On 1st December 2022, unknown after receiving Menveo, the patient experienced intramuscular formulation administered by other route and inappropriate age at vaccine administration. On an unknown date, the outcome of the intramuscular formulation administered by other route and inappropriate age at vaccine administration were unknown.   Additional Information: GSK Receipt Date: 02-DEC-2022 Reporter's comment: The pharmacist reported that the patient received a dose of Menveo via subcutaneous route instead of intramuscular.  The reporter consented to follow up. Additional Supportive Information: The fifty-eight-year-old patient received a dose Menveo subcutaneously instead of intramuscularly, which led to inappropriate age at vaccine administration and intramuscular formulation administered by other route.