chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEP
Symptoms: Product dispensing error, Recalled product administered
Clinical narrative: Recalled Lot  Product was administered; Recalled Lot  Product administered; This case was reported by a other health professional via call center representative and described the occurrence of recalled drug administered in a patient who received HBV (Engerix B pediatric) (batch number CP23D, expiry date unknown) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced recalled drug administered and drug dispensing error. On an unknown date, the outcome of the recalled drug administered and drug dispensing error were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 26-May-2022 Reporter's Comments: The vaccine coordinator reported a dose of Engerix-B from recalled Lot Product was administered to patients. The patients were administered this lot number but no adverse event reported. The reporter inquired what information should they send to patient regarding Engerix recall from back in October 2021. The reporter did not consent to follow-up. Additional Supportive Information: The patient received engerix B from recalled Lot which led to recalled drug administered and drug dispensing error. This is one of 10 cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR085025:Same Reporter US-GLAXOSMITHKLINE-US2022084603:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085027:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085028:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085029:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085030:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085031:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085032:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085033:Same Reporter
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product dispensing error, Recalled product administered
Clinical narrative: Recalled Lot  Product was administered; Recalled Lot  Product administered; This case was reported by a other health professional via call center representative and described the occurrence of recalled drug administered in a patient who received HBV (Engerix B pediatric) (batch number CP23D, expiry date unknown) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced recalled drug administered and drug dispensing error. On an unknown date, the outcome of the recalled drug administered and drug dispensing error were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 26-May-2022 Reporter's Comments: The vaccine coordinator reported a dose of Engerix-B from recalled Lot Product was administered to patients. The patients were administered this lot number but no adverse event reported. The reporter inquired what information should they send to patient regarding Engerix recall from back in October 2021. The reporter did not consent to follow-up. Additional Supportive Information: The patient received engerix B from recalled Lot which led to recalled drug administered and drug dispensing error. This is one of 10 cases reported by same reporter; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR085025:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085026:Same Reporter US-GLAXOSMITHKLINE-US2022084603:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085028:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085029:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085030:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085031:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085032:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085033:Same Reporter
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product dispensing error, Recalled product administered
Clinical narrative: Recalled Lot  Product was administered; Recalled Lot  Product administered; This case was reported by a other health professional via call center representative and described the occurrence of recalled drug administered in a patient who received HBV (Engerix B pediatric) (batch number CP23D, expiry date unknown) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced recalled drug administered and drug dispensing error. On an unknown date, the outcome of the recalled drug administered and drug dispensing error were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 26-May-2022 Reporter's Comments: The vaccine coordinator reported a dose of Engerix-B from recalled Lot Product was administered to patients. The patients were administered this lot number but no adverse event reported. The reporter inquired what information should they send to patient regarding Engerix recall from back in October 2021. The reporter did not consent to follow-up. Additional Supportive Information: The patient received engerix B from recalled Lot which led to recalled drug administered and drug dispensing error. This is one of 10 cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022084603:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085025:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085026:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085027:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085029:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085030:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085031:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085032:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085033:Same Reporter
Sex: U
Vaccine: HEP
Symptoms: Product dispensing error, Recalled product administered
Clinical narrative: Recalled Lot  Product was administered; Recalled Lot  Product administered; This case was reported by a other health professional via call center representative and described the occurrence of recalled drug administered in a patient who received HBV (Engerix B pediatric) (batch number CP23D, expiry date unknown) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced recalled drug administered and drug dispensing error. On an unknown date, the outcome of the recalled drug administered and drug dispensing error were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 26-May-2022 Reporter's Comments: The vaccine coordinator reported a dose of Engerix-B from recalled Lot Product was administered to patients. The patients were administered this lot number but no adverse event reported. The reporter inquired what information should they send to patient regarding Engerix recall from back in October 2021. The reporter did not consent to follow-up. Additional Supportive Information: The patient received engerix B from recalled Lot which led to recalled drug administered and drug dispensing error. This is one of 10 cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR085028:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085026:Same Reporter US-GLAXOSMITHKLINE-US2022084603:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085025:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085027:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085030:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085031:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085032:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085033:Same Reporter
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product dispensing error, Recalled product administered
Clinical narrative: Recalled Lot  Product was administered; Recalled Lot  Product administered; This case was reported by a other health professional via call center representative and described the occurrence of recalled drug administered in a patient who received HBV (Engerix B pediatric) (batch number CP23D, expiry date unknown) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced recalled drug administered and drug dispensing error. On an unknown date, the outcome of the recalled drug administered and drug dispensing error were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 26-May-2022 Reporter's Comments: The vaccine coordinator reported a dose of Engerix-B from recalled Lot Product was administered to patients. The patients were administered this lot number but no adverse event reported. The reporter inquired what information should they send to patient regarding Engerix recall from back in October 2021. The reporter did not consent to follow-up. Additional Supportive Information: The patient received engerix B from recalled Lot which led to recalled drug administered and drug dispensing error. This is one of 10 cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR085028:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085026:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085029:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085025:Same Reporter US-GLAXOSMITHKLINE-US2022084603:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085027:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085031:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085032:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085033:Same Reporter
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product dispensing error, Recalled product administered
Clinical narrative: Recalled Lot  Product was administered; Recalled Lot  Product administered; This case was reported by a other health professional via call center representative and described the occurrence of recalled drug administered in a patient who received HBV (Engerix B pediatric) (batch number CP23D, expiry date unknown) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced recalled drug administered and drug dispensing error. On an unknown date, the outcome of the recalled drug administered and drug dispensing error were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 26-May-2022 Reporter's Comments: The vaccine coordinator reported a dose of Engerix-B from recalled Lot Product was administered to patients. The patients were administered this lot number but no adverse event reported. The reporter inquired what information should they send to patient regarding Engerix recall from back in October 2021. The reporter did not consent to follow-up. Additional Supportive Information: The patient received engerix B from recalled Lot which led to recalled drug administered and drug dispensing error. This is one of 10 cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR085028:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085026:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085029:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085030:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085025:Same Reporter US-GLAXOSMITHKLINE-US2022084603:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085027:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085032:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085033:Same Reporter
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product dispensing error, Recalled product administered
Clinical narrative: Recalled Lot  Product was administered; Recalled Lot  Product administered; This case was reported by a other health professional via call center representative and described the occurrence of recalled drug administered in a patient who received HBV (Engerix B pediatric) (batch number CP23D, expiry date unknown) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced recalled drug administered and drug dispensing error. On an unknown date, the outcome of the recalled drug administered and drug dispensing error were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 26-May-2022 Reporter's Comments: The vaccine coordinator reported a dose of Engerix-B from recalled Lot Product was administered to patients. The patients were administered this lot number but no adverse event reported. The reporter inquired what information should they send to patient regarding Engerix recall from back in October 2021. The reporter did not consent to follow-up. Additional Supportive Information: The patient received engerix B from recalled Lot which led to recalled drug administered and drug dispensing error. This is one of 10 cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022084603:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085025:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085031:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085030:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085029:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085026:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085027:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085028:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085033:Same Reporter
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product dispensing error, Recalled product administered
Clinical narrative: Recalled Lot  Product was administered; Recalled Lot  Product administered; This case was reported by a other health professional via call center representative and described the occurrence of recalled drug administered in a patient who received HBV (Engerix B pediatric) (batch number CP23D, expiry date unknown) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced recalled drug administered and drug dispensing error. On an unknown date, the outcome of the recalled drug administered and drug dispensing error were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 26-May-2022 Reporter's Comments: The vaccine coordinator reported a dose of Engerix-B from recalled Lot Product was administered to patients. The patients were administered this lot number but no adverse event reported. The reporter inquired what information should they send to patient regarding Engerix recall from back in October 2021. The reporter did not consent to follow-up. Additional Supportive Information: The patient received engerix B from recalled Lot which led to recalled drug administered and drug dispensing error. This is one of 10 cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR085031:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085025:Same Reporter US-GLAXOSMITHKLINE-US2022084603:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085030:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085029:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085026:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085027:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085028:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085032:Same Reporter
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests abnormal, Deafness unilateral, Fatigue, Feeling abnormal, Headache
Clinical narrative: Loud sustained Tinnitus, fatigue, brain fog, numbness, headache started on April 18th following 2nd booster of Moderna. Previous 3 shots were Pfizer and was told it was ok to take Moderna for 2nd booster.   14 day course of prednisone was given with no sustained relief. Sumatriptan prescribed but no relief.  Required increase in anxiety medication which helps to cope with disability the symptoms have caused.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Impaired quality of life, Impaired work ability, Tinnitus
Clinical narrative: Loud sustained Tinnitus, fatigue, brain fog, numbness, headache started on April 18th following 2nd booster of Moderna. Previous 3 shots were Pfizer and was told it was ok to take Moderna for 2nd booster.   14 day course of prednisone was given with no sustained relief. Sumatriptan prescribed but no relief.  Required increase in anxiety medication which helps to cope with disability the symptoms have caused.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Blood creatinine increased, Haemoglobin decreased, Haemolytic anaemia, Hepatic enzyme increased, Multiple organ dysfunction syndrome
Clinical narrative: Out of nowhere he had a hemolytic anemia crisis which led to multiple organ failure. He has never had anything like this before so we are not sure if it's possibly a reaction to the vaccine
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Myocardial necrosis marker increased
Clinical narrative: Out of nowhere he had a hemolytic anemia crisis which led to multiple organ failure. He has never had anything like this before so we are not sure if it's possibly a reaction to the vaccine
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Erythema, Loss of personal independence in daily activities, Pruritus, Skin discolouration, Skin disorder
Clinical narrative: hey, i had my covid vaccine at pharmacy and a few hours later all my body turned red and itchy I have no idea what is happening to me . the next day i went to see my doctor and he gives me a steroid shot thinking it will help me but it doesn't. a week later a went to see a dermatologist but he just gives me some cream that I bought at the pharmacy .righ now I can't even take a shower and there are all black spots over my body including my face. The last time I went to get a job and my employer don't want to hire me because they can't figure out what going on with my skin. they just told me i will be working with chemicals so they don't want to put my life in danger.i had ever have any skin problem in my my life .all these problems began a few hours after the shot.
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Erythema, Pigmentation disorder, Pruritus
Clinical narrative: hey, i had my covid vaccine at pharmacy and a few hours later all my body turned red and itchy I have no idea what is happening to me . the next day i went to see my doctor and he gives me a steroid shot thinking it will help me but it doesn't. a week later a went to see a dermatologist but he just gives me some cream that I bought at the pharmacy .righ now I can't even take a shower and there are all black spots over my body including my face. The last time I went to get a job and my employer don't want to hire me because they can't figure out what going on with my skin. they just told me i will be working with chemicals so they don't want to put my life in danger.i had ever have any skin problem in my my life .all these problems began a few hours after the shot.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Tenderness
Clinical narrative: Adverse event: tenderness and swelling at site of dermal filler (both cheeks of the face).   Treatment: none.  Time course: symptoms started approximately 48 hours after vaccination and lasted for approximately 36 hours.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hyporeflexia, Laboratory test abnormal, Pain in extremity, Paraesthesia
Clinical narrative: Lower extremity pain followed by paresthesia and hyporeflexia. Workup concerning for Guillain Barre Syndrome
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Alanine aminotransferase increased, Arthralgia, Blood albumin increased, Blood chloride decreased, Blood immunoglobulin G
Clinical narrative: Lower extremity pain followed by paresthesia and hyporeflexia. Workup concerning for Guillain Barre Syndrome
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood sodium decreased, CSF protein increased, Full blood count normal, Hypoaesthesia, Magnetic resonance imaging head normal
Clinical narrative: Lower extremity pain followed by paresthesia and hyporeflexia. Workup concerning for Guillain Barre Syndrome
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging spinal abnormal, Metabolic function test, Myalgia, Nucleated red cells, Osteoarthritis
Clinical narrative: Lower extremity pain followed by paresthesia and hyporeflexia. Workup concerning for Guillain Barre Syndrome
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Pathology test, Protein total increased, Pyrexia, Red blood cell count increased
Clinical narrative: Lower extremity pain followed by paresthesia and hyporeflexia. Workup concerning for Guillain Barre Syndrome
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test negative
Clinical narrative: Lower extremity pain followed by paresthesia and hyporeflexia. Workup concerning for Guillain Barre Syndrome
Sex: U
Vaccine: VARZOS
Symptoms: Ear pain, Facial pain, Injection site pain, Rash, Rash vesicular
Clinical narrative: Soreness at the injection site; Pain on right side of face; Ear ache; blistery rash along my jaw line; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 12th May 2022, the patient received the 1st dose of Shingles vaccine. In May 2022, between 1 and 3 weeks after receiving Shingles vaccine, the patient experienced facial pain, ear pain and blistery rash. On 23rd May 2022, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the facial pain, ear pain and blistery rash were unknown.   It was unknown if the reporter considered the injection site pain, facial pain, ear pain and blistery rash to be related to Shingles vaccine.     Additional Information: GSK receipt date: 26-MAR-2022 Reporter's comment: This case was reported by a consumer via interactive digital media. The patient received his/her Shingles vaccine and had soreness at injection site. This week the patient started with pain on the right side of the face, ear ache and a blistery rash along jaw line. Eleven days after receiving shingles vaccine the patient experienced injection site pain. Additional supportive information: The follow up would not possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error, Product preparation issue
Clinical narrative: Shingrix dilution with sterile distilled water; Shingrix dilution with sterile distilled water; This case was reported by a consumer via call center representative and described the occurrence of wrong solution used in drug reconstitution in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced wrong 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: 26-MAY-2022 Reporter's Comment: The reporter said one person had not properly diluted the patients Shingrix vaccine. The reporter did the dilution with sterile distilled water (water for injection), one normal diluent.  The reporter wanted to know if he could have any reaction, if the vaccine will work, if the patient run any risk. Therefore, the patient would like to talk to those responsible to know the possible adverse effects. Additional supportive information: The reporter did the dilution with sterile distilled water (water for injection), one normal diluent which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Received 1st dose 1 yr ago but no second dose; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 1 year ago from reporting date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 26-MAY-2022 Reporter's Comments: The reporter was a healthcare professional from Doctor office. The reporter enquired if the patient received Shingrix 1st dose 1 year ago but never got 2nd dose, could patient still get the 2nd dose. The reporter stated that he/she was in the corrections system and hippa rules did not allow for this type (contact details) of information sharing. He/she just need a general information. Additional Supportive Information: The patient did not receive the 2nd dose of Shingrix till the time of reporting, which led to incomplete course of vaccination.
Sex: U
Vaccine: TDAP
Symptoms: Incorrect route of product administration
Clinical narrative: Nurse in the ER administered by error intravenously; This case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Boostrix (intravenous). On an unknown date, unknown after receiving Boostrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.   Additional Information: Additional Information: GSK Receipt Date: 24-May-2022 Reporter's Comments: Pharmacist called to report that a nurse in the emergency room administered by error Boostrix intravenously.  No other information available at the time of reporting. The reporter consented to follow-up by email. Additional Supportive Information: The patient received Boostrix intravenously, which led to intramuscular formulation administered by other route.
Age: 47.0
Sex: M
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 47 year old patient was administered shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 47-year-old male patient who received Herpes zoster (Shingrix) (batch number 7m785, expiry date unknown) for prophylaxis.   On 24th May 2022, the patient received Shingrix. On 24th May 2022, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 24-May-2022 Reporter's Comments: Health care professional (HCP) reported a 47-year-old patient was administered Shingrix.  She believes he was not immunocompromised. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.  Additional Supportive Information: The 47-year-old patient was administered Shingrix, which led to inappropriate age at vaccine administration.
Age: 74.0
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Injection site pruritus
Clinical narrative: itching at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site itching in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included COVID-19 VACCINE (COVID 19 BOOSTER) for prophylaxis.   On 9th May 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml and the 2nd dose of COVID 19 BOOSTER. In May 2022, several days after receiving Shingrix, the patient experienced injection site itching. On an unknown date, the outcome of the injection site itching was recovered/resolved.   It was unknown if the reporter considered the injection site itching to be related to Shingrix.     Linked case(s) involving the same patient: Additional Information: Receipt Date: 24-May-2022 Reporter's Comments: The patient got her first Shingrix vaccine in the left deltoid and 2nd COVID booster (on unknown arm) at the same time. A few days after her first vaccine, she had itching at the injection site that lasted a few days. In May 2022, outcome for injection site itching was recovered.  The reporter consented to follow up. Additional Supportive Information: For tolerance of 2nd dose of Shingrix vaccine, refer linked case reported by same reporter. Sender's Comments: same reporter.
Age: 69.0
Sex: M
Vaccine: HEPAB, HEPAB
Symptoms: Inappropriate schedule of product administration, Incomplete course of vaccination, No adverse event
Clinical narrative: 1st dose of Twinrix in 11Oct2021, late for 3rd; 1st dose of Twinrix in 11Oct2021, 2nd dose in 07Jan2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 69-year-old male patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, HAB (Twinrix) for prophylaxis and hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (1st dose received on 11th Oct 2021).   On 7th January 2022, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, the patient did not receive the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 7th January 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device and not applicable after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the drug dose administration interval too long and incomplete course of vaccination were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date:24-May-2022 Reporter's Comments: A pharmacist reported that a patient received 1st dose of Twinrix on 11th October 2021, was late for 2nd dose given on 7th Jan 2022, and was late for the 3rd dose at the time of reporting.  No symptoms reported. The reporter consented to follow up via mail. Additional Supportive Information: The patient received 1st dose of Twinrix on 11th October 2021 and received 2nd dose on 7th Jan 2022, later than the recommended standard schedule, which led to lengthening of the vaccination schedule. Till the time of reporting, the patient did not receive 3rd dose of Twinrix, which led to incomplete course of vaccination
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood test abnormal, Mobility decreased, Musculoskeletal stiffness, Tendinous contracture
Clinical narrative: muscle stiffness that affected his mobility; muscle stiffness that affected his mobility; hamstrings were tight; This case was reported by a consumer via call center representative and described the occurrence of muscle stiffness in a 55-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th November 2021, the patient received the 1st dose of Shingrix. In November 2021, less than a week after receiving Shingrix, the patient experienced muscle stiffness, mobility decreased and tendinous contracture. On an unknown date, the outcome of the muscle stiffness and tendinous contracture were unknown and the outcome of the mobility decreased was not recovered/not resolved.   It was unknown if the reporter considered the muscle stiffness, mobility decreased and tendinous contracture to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR084332   Additional Information: GSK Receipt Date: 25-MAY-2022 Reporter's Comment: The patient self-reported this case. the patient received dose of Shingrix and within a week or so after, he started experiencing muscle stiffness that affected his mobility. The patient went to his primary doctor who referred him to an orthopedic doctor.  Around January 2022, the patient saw the orthopedic doctor and was told that his hamstrings were tight which was why bending and moving was difficult for him. The orthopedic doctor recommended either physical therapy (PT) or yoga. The patient stared doing yoga and his muscles were starting to loosen up. Beginning of April 2022, he went on a trip and he wasn't able to do yoga during that time. The patient received  his second Shingrix shot on 18-April-2022 and around that time the muscle stiffness was getting worse and even with doing the yoga it was not improving, refer case US2022AMR084332. The patient also reported that he had abnormal blood work. He did not remember what specific lab value was abnormal or if that value was high or low. The reporter did not have the lot number for the Shingrix vaccines but he did provide his doctor's contact information as he received the shots at his doctor's office and they should have the lot numbers on file.  The reporter consented to follow up; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR084332:same reporter
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Fever; Chills; Headache; Myalgia; This case was reported by a consumer via call center representative and described the occurrence of fever in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On 24th May 2022, the patient received the 2nd dose of Shingrix. On 24th May 2022, less than a day after receiving Shingrix, the patient experienced fever, chills, headache and myalgia. On an unknown date, the outcome of the fever, chills, headache and myalgia were not recovered/not resolved.   It was unknown if the reporter considered the fever, chills, headache and myalgia to be related to Shingrix.     Additional Information: GSK Receipt Date: 25-MAY-2022 Reporter's comment: The case was self reported by the patient. The patient reported that he received the second dose of Shingrix vaccine and that evening after receiving his second dose patient developed side effects such as fever, chills, headache, and myalgia. Till the time of reporting, symptoms were not resolved.  Offered medical advise disclaimer. The reporter did not consent to follow-up.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Reconstituted with sterile water for injection and not the diluent provided; Reconstituted with sterile water for injection and not the diluent provided; 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) 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: 25-MAY-2022 Reporter's Comment: The reporter reported that the patient was administered Menveo which was reconstituted with sterile water for injection and not the diluent provided. The reporter did not have any information about patient or vaccines. The reporter consented to follow up. Additional Supportive Information: The patient was administered Menveo which was reconstituted with sterile water for injection and not the diluent provided, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product dispensing error, Recalled product administered
Clinical narrative: Recalled Lot  Product was administered; Recalled Lot  Product administered; This case was reported by a other health professional via call center representative and described the occurrence of recalled drug administered in a patient who received HBV (Engerix B pediatric) (batch number CP23D, expiry date unknown) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced recalled drug administered and drug dispensing error. On an unknown date, the outcome of the recalled drug administered and drug dispensing error were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 26-May-2022 Reporter's Comments: The vaccine coordinator reported a dose of Engerix-B from recalled lot product was administered to patient.  The patient was administered this lot number, but no adverse event reported.  The reporter inquired what information should they send to patient regarding Engerix recall from back in October 2021. The reporter did not consent to follow-up. Additional Supportive Information: The patient received Engerix B from recalled lot which led to recalled drug administered and drug dispensing error. This was one of 10 cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR085025:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085026:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085027:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085028:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085029:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085030:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085031:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085032:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085033:Same Reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: late for 2nd dose. 1st dose on 8/16/2021; This 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 (1st dose received on 16th August 2021).   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: 26-May-2022 Reporter's Comments: The nurse reported patient was late for 2nd dose.  The reporter consented to follow up via email. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 4.0
Sex: M
Vaccine: HIBV
Symptoms: Extra dose administered
Clinical narrative: Patient completed the 4 dose series of Hiberix but received a 5th dose on 16May2022; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 4-year-old male patient who received Hib (Hiberix) (batch number 2977H, expiry date 16th May 2023) for prophylaxis.   Previously administered products included Hiberix (the patient completed the 4 doses series).   On 16th May 2022, the patient received the 5th dose of Hiberix. On 16th May 2022, unknown after receiving Hiberix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: Reporter's Comments: The nurse reported that the patient received a 5th dose of Hiberix. The reporter consented to follow up. Additional Supportive Information: The patient received 5th dose of Hiberix, which led to extra dose administered.
Age: 14.0
Sex: M
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 14-year-old patient received Infanrix on 26May2022; Intending to administered a Tdap and Infanrix was given in error to this patient.; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 14-year-old male patient who received DTPa (Infanrix) (batch number 7EC55, expiry date 29th April 2023) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 24th May 2022, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 24th May 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 26-MAY-2022 Reporter's Comments: The reporter was a medical assistant. The reporter reported that a 14-year-old patient received Infanrix. They were intending to administer a Tdap and Infanrix was given in error to this patient. The reporter consented to follow up. Additional Supportive Information: A 14-year-old patient received Infanrix vaccine instead of Tdap, which led to inappropriate age at vaccine administration and wrong vaccine administered.
Age: 55.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Patient received a dose on 05-apr-2022 the vaccine was expired on 07-feb-2022; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 55-year-old male patient who received HBV (Engerix B) (batch number 9p9b5, expiry date 7th February 2022) for prophylaxis.   On 5th April 2022, the patient received Engerix B. On 5th April 2022, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 26-May-2022 Reporter's comments: The patient received Engerix-B which was already expired. The consent to follow up was given. Additional Supportive Information: The patient received Engerix-B that was already expired, which led to expired vaccine used.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Patient was administered 1st dose on March 2018; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 90-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in March 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: 26-May-2022 Reporter's comments: The patient wanted to get 2nd dose of Shingrix. The consent to follow up was given. Lot number and expiration date information of 1st dose was asked but was not available. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: at least 10 patients who were 1-2 years past their due date for dose three; This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in an unspecified number of patients who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (1st dose received on an unknown date) and Twinrix (2nd dose received 1-2 years before the date of reporting).   On an unknown date, the patients did not receive the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 26-May-2022 Reporter's comments: The nurse reported that she had been seen at least 10 patients who were 1-2 years past their due date for dose three of Twinrix. The consent to follow up was given. Additional Supportive Information: Till the time of reporting, the patients did not receive 3rd dose of Twinrix, which led to incomplete course of vaccination.