chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pruritus
Clinical narrative: Injection pain at site; Itching; This non-serious case was reported by a nurse via sales rep and described the occurrence of injection site pain in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: Injection pain at site) and pruritus (Verbatim: Itching). The outcome of the injection site pain and pruritus were not reported.   It was unknown if the reporter considered the injection site pain and pruritus to be related to Shingrix.     It was unknown if the company considered the injection site pain and pruritus to be related to Shingrix.   Linked case(s) involving the same patient:  US2023AMR052438   Additional Information: GSK receipt date: 09-Apr-2023 The patient self-reported this case The patient had some itching and injection pain at site. The reporter consent to follow up. For tolerance of 2nd dose, refer case US2023AMR052438. This case was one of 3 cases, reported by same reporter.; Sender's Comments:  US-GSK-US2023AMR052438:Same reporter US-GSK-US2023052528:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Broke out with shingles after 1st dose; This non-serious case was reported by a consumer and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (above the gluteal fold ). Previously administered products included Acyclovir.   On 30-MAR-2023, the patient received the 1st dose of Shingrix. On 04-APR-2023, 5 days after receiving Shingrix, the patient experienced shingles (Verbatim: Broke out with shingles after 1st dose). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 10-APR-2023 The patient suffered from shingles at the hairline of head.  The patient previously had break out just above the gluteal fold and would take acyclovir as treatment. The patient was very surprised to had a breakout in hairline and asked was this normal for an outbreak to occur after getting the vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Facial discomfort, Hypoaesthesia, Paraesthesia, Pruritus, Rash
Clinical narrative: Still afflicted, face upper right quadrant; Started numb; rash; Piercing crusty scabs; Ugly tingly; Itching; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of facial discomfort in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced facial discomfort (Verbatim: Still afflicted, face upper right quadrant), numbness (Verbatim: Started numb), rash (Verbatim: rash), scab (Verbatim: Piercing crusty scabs), tingling (Verbatim: Ugly tingly) and pruritus (Verbatim: Itching). The outcome of the facial discomfort, numbness, rash, scab, tingling and pruritus were not reported.   It was unknown if the reporter considered the facial discomfort, numbness, rash, scab, tingling and pruritus to be related to Shingles vaccine.     It was unknown if the company considered the facial discomfort, numbness, rash, scab, tingling and pruritus to be related to Shingles vaccine.   Additional Information: GSK receipt date: 18-MAR-2023 The case was received from the patient interactive digital media. The patient had the shot and still afflicted the upper right quadrant of his/her face. The patient stated that it started numb, then rash, then crusty scabs, ugly, tingly, itching, piercing. The physician said imagine how it worked be of you had not received the shot. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Scab
Clinical narrative: Still afflicted, face upper right quadrant; Started numb; rash; Piercing crusty scabs; Ugly tingly; Itching; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of facial discomfort in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced facial discomfort (Verbatim: Still afflicted, face upper right quadrant), numbness (Verbatim: Started numb), rash (Verbatim: rash), scab (Verbatim: Piercing crusty scabs), tingling (Verbatim: Ugly tingly) and pruritus (Verbatim: Itching). The outcome of the facial discomfort, numbness, rash, scab, tingling and pruritus were not reported.   It was unknown if the reporter considered the facial discomfort, numbness, rash, scab, tingling and pruritus to be related to Shingles vaccine.     It was unknown if the company considered the facial discomfort, numbness, rash, scab, tingling and pruritus to be related to Shingles vaccine.   Additional Information: GSK receipt date: 18-MAR-2023 The case was received from the patient interactive digital media. The patient had the shot and still afflicted the upper right quadrant of his/her face. The patient stated that it started numb, then rash, then crusty scabs, ugly, tingly, itching, piercing. The physician said imagine how it worked be of you had not received the shot. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Additional patient notes included the relevant medical history or any additional safety information was unknown. Family history included shingles (patient's cousin).   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced fever (Verbatim: Fever). The outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingles vaccine.     It was unknown if the company considered the fever to be related to Shingles vaccine.   Additional Information: GSK receipt date: 09-Apr-2023  This case was reported by a patient via interactive digital media. The patient got the vaccine, and it caused him or her fever, and stated it was better to be protected. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination
Clinical narrative: Shingles; 2nd dose not received; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, 1 year after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Shingles) and incomplete course of vaccination (Verbatim: 2nd dose not received). The outcome of the shingles was not resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 18-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he or she received first dose of Shingles vaccine and experienced terrible reaction and one year later now he or she suffering from shingles. Till the time of reporting, the patient did not receive the 2nd dose of Shingles vaccine, which led to incomplete course of vaccination. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Shingles shot hurt like Hell; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: Shingles shot hurt like Hell). The outcome of the pain was not reported.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     It was unknown if the company considered the pain to be related to Shingles vaccine.   Additional Information: GSK receipt date: 19-MAR-2023 The case was received from the patient interactive digital media. The patient stated that the Shingles shot hurt like hell. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Very sore reaction; Red reaction; Swollen reaction; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles shot with an associated reaction of no adverse event (received first shot on an unknown date and had no trouble whatsoever).   In MAR-2023, the patient received the 2nd dose of Shingles vaccine. In MAR-2023, less than 3 weeks after receiving Shingles vaccine, the patient experienced pain (Verbatim: Very sore reaction), erythema (Verbatim: Red reaction) and swelling (Verbatim: Swollen reaction). The outcome of the pain, erythema and swelling were not reported.   It was unknown if the reporter considered the pain, erythema and swelling to be related to Shingles vaccine.     It was unknown if the company considered the pain, erythema and swelling to be related to Shingles vaccine.   Additional Information: GSK receipt date: 19-Mar-2023 The case was received from the patient via interactive digital media. The patient just got his or her second shingles shot Tuesday and have had a very sore and red swollen reaction to it. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Illness
Clinical narrative: sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   Family history included ophthalmic herpes zoster (patient's mother got it by her eyes) and shingles (patient's sister had it in back).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced sickness (Verbatim: sick). The outcome of the sickness was resolved.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the sickness to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 19-MAR-2023 The case was received from the patient interactive digital media. The patient stated that he/she never gotten it, but he/she know family members and old coworkers that had and they had all told him/her how horrible it was.  The patient's mother got it by her eyes and it caused such bad eye problems and she got surgery and she was much better.  The patient's sister got it early in her life, all over her back.  The patient had a coworker that was out five weeks, during covid.  The reporter asked if she had coronavirus.  She said she was on her stomach for weeks on end, and walked around her house topless because clothes hurt her back so much.  The patient stated that convinced him/her to get both shingles vaccines.  The patient stated that those vaccines both made him/her very sick, but he/she got over it.  The patient hoped that he/she never get shingles. The follow-up could not be possible as no contact details were available.
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: only the liquid portion was administered; only the liquid portion was administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate dose of vaccine administered in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA764A, expiry date 31-DEC-2023) for prophylaxis.   On 03-APR-2023, the patient received Menveo. On 03-APR-2023, an unknown time after receiving Menveo, the patient experienced inappropriate dose of vaccine administered (Verbatim: only the liquid portion was administered) and inappropriate preparation of medication (Verbatim: only the liquid portion was administered). The outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were unknown.   Additional Information: GSK receipt date: 04-APR-2023 Nurse called to report only the liquid portion of Menveo was administered by mistake to a patient, which led to inappropriate dose of vaccine administered and inappropriate preparation of medication. The Vaccine Administration Facility is the same as Primary Reporter. The reporter consented to follow up via email.
Sex: U
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Expired Menveo administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received Men ACWY-CRM NVS (Menveo) (expiry date 31-MAR-2023) for prophylaxis.   On 03-APR-2023, the patient received Menveo. On 03-APR-2023, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: Expired Menveo administered). The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date:04-APR-2023 The Pharmacy called for the guidance as he/she stated they inadvertently administered an expired Menveo 2-vial  dose to a patient. Intern was unable to provide any additional vaccine or patient details. The reporter did not consent to follow up. The patient was administered with expired vaccine, which led to expired vaccine used.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Expired Bexsero administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 16-year-old female patient who received Men B NVS (Bexsero) (expiry date 28-FEB-2023) for prophylaxis.   On 05-APR-2023, the patient received Bexsero. On 05-APR-2023, an unknown time after receiving Bexsero, the patient experienced expired vaccine used (Verbatim: Expired Bexsero administered). 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: 06-APR-2023 The medical assistant reported that a patient was administered a dose of Bexsero and afterwards it was realized the dose had an expiration date. The reporter was unsure if this was the patient's first or second dose in the series.   The reporter did not had the lot number of the product and did not had patient initials.  At the time of reporting, the dose had not been repeated. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. The patient was administered an expired dose of Bexsero, which led to expired vaccine used.
Age: 0.83
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Kinrix given instead of Pediarix; Kinrix given to a 11-month-old; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 11-month-old female patient who received DTPa-IPV (Kinrix) for prophylaxis.   Concomitant products included DIPHTHERIA VACCINE TOXOID + PERTUSSIS VACCINE ACELLULAR + TETANUS VACCINE TOXOID (INFANRIX).   On 10-MAR-2023, the patient received Kinrix. On 10-MAR-2023, an unknown time after receiving Kinrix, the patient experienced wrong vaccine administered (Verbatim: Kinrix given instead of Pediarix) and inappropriate age at vaccine administration (Verbatim: Kinrix given to a 11-month-old). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 06-Apr-2023 The nurse reported that she was not sure what dose number this was for the patient but reported that the patient received Infanrix series 2 along with a full panel of vaccines (unknown vaccines).  The reporter did not had a lot or any further information for this administration.  On 6th January 2023, the patient was a new patient to their practice, and she had no previous information about the patient. The reporter consented to follow-up. The patient received a dose of Kinrix instead of Pediarix at an inappropriate age, which led to wrong vaccine administered.
Age: 1.0
Sex: M
Vaccine: DTAPHEPBIP, HEP
Symptoms: Incorrect dose administered
Clinical narrative: Pediarix and Engerix given on the same day; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of overdose in a 13-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number N7HL3, expiry date 15-APR-2024) for prophylaxis.   Co-suspect products included HBV (Engerix B 10 mcg) (batch number 34G75, expiry date 15-FEB-2024) for prophylaxis.   The patient's past medical history included febrile seizure (Febrile seizures as prior medical history). Concomitant products included Pentacel.   On 06-APR-2023, the patient received the 1st dose of Pediarix and the 2nd dose of Engerix B 10 mcg. On 06-APR-2023, an unknown time after receiving Pediarix and Engerix B 10 mcg, the patient experienced overdose (Verbatim: Pediarix and Engerix given on the same day). The outcome of the overdose was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 06-APR-2023 The clinical pharmacist enquired any guidance? Any concern for the patient? The registered pharmacist (RPH) reported a patient received both Pediarix and Engerix doses administered on the day of reporting. The RPH mentioned had concern with too much Hepatitis B for the patient. The patient previously received Pentacel. The reporter did not consent to follow-up.    The patient received Pediarix and Engerix-B on the same day, which led to overdose
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Administration of only the adjuvant; Administration of only the adjuvant; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Administration of only the adjuvant) and inappropriate dose of vaccine administered (Verbatim: Administration of only the adjuvant). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 06-APR-2023 A vaccine coordinator called in to report that 2 out of 10 patients that received the AS01B adjuvant only of Shingrix. The reporter asked if the patients had to receive a properly reconstituted Shingrix dose. The reporter mentioned that they were not able to identify who the 2 patients were who received the AS01B adjuvant only. Therefore, the reporter did not provide patients identifiers as well as vaccine data (lot number, exp date, date of administration). The reporter consented to follow-up. The case was linked with case US2023AMR051204, reported by same reporter for different patient. The patient received the AS01B adjuvant of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.; Sender's Comments:  US-GSK-US2023AMR051204:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 2 years ago, 2nd dose not received; This non-serious case was reported by a physician via sales rep 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 2 years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: 1st dose 2 years ago, 2nd dose not received). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 06-APR-2023 The reporter asked that do he/she need to restart the series or could just give the second dose? The reporter was advised to follow up with the sales representative for additional information.  It was unknown whether or not this had already been reported.  No additional information could be provided. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: small red patch on Right flank/side; This non-serious case was reported by a consumer via call center representative and described the occurrence of skin red in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 05-APR-2023, the patient received the 1st dose of Shingrix (intramuscular, left arm). On 06-APR-2023, 1 days after receiving Shingrix, the patient experienced skin red (Verbatim: small red patch on Right flank/side). The outcome of the skin red was not reported.   It was unknown if the reporter considered the skin red to be related to Shingrix.     It was unknown if the company considered the skin red to be related to Shingrix.   Additional Information: GSK receipt date: 07-APR-2023 The reporter was Consumer. The reporter reported that she received first dose of SHINGRIX on 5 April 2023 in left arm  and experienced a small red patch on the right side, flank area. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered
Clinical narrative: A drop leaked while administering; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 07-APR-2023, the patient received the 2nd dose of Shingrix. On 07-APR-2023, an unknown time after receiving Shingrix, the patient experienced incomplete dose administered (Verbatim: A drop leaked while administering). The outcome of the incomplete dose administered was unknown.   Additional Information: GSK receipt date: 07-Apr-2023 The patient received a drop of Shingrix leaked while administering the vaccine.  There was no information on patient or vaccine reported. The reporter did not consented to follow up. The patient received a drop of Shingrix leaked while administering the vaccine, which led to incomplete dose administered.
Age: 51.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Patient was given an expired dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 51-year-old female patient who received HAV (Havrix) (batch number H4H53, expiry date 30-JAN-2023) for prophylaxis.   On 07-APR-2023, the patient received Havrix. On 07-APR-2023, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: Patient was given an expired dose). The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 07-Apr-2023  The medical assistant stated that the patient was inadvertently administered with an expired dose of Havrix on the day of reporting. The vaccine administration facility was the same as primary reporter. The medical assistant preferred follow up from safety via email.  There was no further details provided. The reporter consented to follow up. The patient inadvertently received an expired dose of Havrix, which led to expired vaccine used.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Dose 1 in 2019 and dose 2 in 2022; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 55-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.  Previously administered products included Shingrix (1st dose was received in 2019).  In DEC-2022, the patient received the 2nd dose of Shingrix. In DEC-2022, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Dose 1 in 2019 and dose 2 in 2022). The outcome of the drug dose administration interval too long was unknown.  Additional Information: GSK Receipt Date: 07-APR-2023 The patient reported that he received the second dose in December 2022.  Education was provided to patient. The reporter had denied consent to follow-up. The patient had received the second dose later than the recommended interval, which had led to lengthening of vaccination schedule.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Administration of an expired Bexsero dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 16-year-old male patient who received Men B NVS (Bexsero) (batch number ABXC08AA, expiry date 31-MAR-2023) for prophylaxis.  On 07-APR-2023, the patient received Bexsero. On 07-APR-2023, an unknown time after receiving Bexsero, the patient experienced expired vaccine used (Verbatim: Administration of an expired Bexsero dose). The outcome of the expired vaccine used was unknown.  This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional Information: GSK Receipt Date: 07-APR-2023 A nurse had called in to report the administration of an expired Bexsero dose patient.  The Healthcare Professional (HCP) had asked if they had to repeat the dose. The reporter had consented to follow-up.  At the time of reporting, the patient received a dose of expired Bexsero vaccine, which had led to expired vaccine used.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Patient received Menveo second dose; Menveo reconstituted with sterile diluent; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate dose of vaccine administered in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA765A, expiry date 31-DEC-2023) for prophylaxis.   On 05-APR-2023, the patient received Menveo. On 05-APR-2023, an unknown time after receiving Menveo, the patient experienced inappropriate dose of vaccine administered (Verbatim: Patient received Menveo second dose) and inappropriate preparation of medication (Verbatim: Menveo reconstituted with sterile diluent). The outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were unknown.   Additional Information: GSK Receipt Date: 10-APR-2023 Medical Assistant reported that, the patient received Menveo second dose (2 vials presentation), which was reconstituted with sterile diluent. The reporter had consented to follow-up via mail. At the time of reporting, the patient only had received the vaccine which was reconstituted with sterile diluent, which had led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Cough, Joint swelling, Malaise
Clinical narrative: Shaking; Swollen ankles; Cough; Joint pain; Chills; Low grade fever; Malaise; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of tremor in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.  Concurrent medical conditions included osteoporosis.  On 31-MAR-2023, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced tremor (Verbatim: Shaking), ankle swelling (Verbatim: Swollen ankles), cough (Verbatim: Cough), joint pain (Verbatim: Joint pain), chills (Verbatim: Chills), low grade fever (Verbatim: Low grade fever) and malaise (Verbatim: Malaise). The patient was treated with paracetamol (Tylenol). The outcome of the tremor and chills were resolved and the outcome of the ankle swelling, cough, joint pain, low grade fever and malaise were not resolved.  It was unknown if the reporter considered the tremor, ankle swelling, cough, joint pain, chills, low grade fever and malaise to be related to Shingrix.  It was unknown if the company considered the tremor, ankle swelling, cough, joint pain, chills, low grade fever and malaise to be related to Shingrix.  Additional Information: GSK Receipt Date: 10-APR-2023 The case was self-reported by the patient who was also a retired pharmacist. She stated that, she had received her first dose of Shingrix and she had experienced chills, shaking, low grade fever, malaise, swollen ankles, cough, and joint pain.  She was currently taking Tylenol for her fever. Chills and shaking had resolved, but all other symptoms were still present. The reporter did not consent to follow up.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Tremor
Clinical narrative: Shaking; Swollen ankles; Cough; Joint pain; Chills; Low grade fever; Malaise; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of tremor in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.  Concurrent medical conditions included osteoporosis.  On 31-MAR-2023, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced tremor (Verbatim: Shaking), ankle swelling (Verbatim: Swollen ankles), cough (Verbatim: Cough), joint pain (Verbatim: Joint pain), chills (Verbatim: Chills), low grade fever (Verbatim: Low grade fever) and malaise (Verbatim: Malaise). The patient was treated with paracetamol (Tylenol). The outcome of the tremor and chills were resolved and the outcome of the ankle swelling, cough, joint pain, low grade fever and malaise were not resolved.  It was unknown if the reporter considered the tremor, ankle swelling, cough, joint pain, chills, low grade fever and malaise to be related to Shingrix.  It was unknown if the company considered the tremor, ankle swelling, cough, joint pain, chills, low grade fever and malaise to be related to Shingrix.  Additional Information: GSK Receipt Date: 10-APR-2023 The case was self-reported by the patient who was also a retired pharmacist. She stated that, she had received her first dose of Shingrix and she had experienced chills, shaking, low grade fever, malaise, swollen ankles, cough, and joint pain.  She was currently taking Tylenol for her fever. Chills and shaking had resolved, but all other symptoms were still present. The reporter did not consent to follow up.
Age: 34.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: female patient received  a dose of Havrix that had expired; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 34-year-old female patient who received HAV (Havrix) (batch number H4H53, expiry date 30-JAN-2023) for prophylaxis.   On 07-APR-2023, the patient received Havrix. On 07-APR-2023, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: female patient received  a dose of Havrix that had expired ). 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: 10-APR-2023 The pharmacist reported that patient received on 7th April 2023 a dose of Havrix that had expired on 30th January 2023, which led to led expired vaccine used It was asked whether patient should revaccinate. The reporter did not consent to follow-up.  The vaccine administration facility is the same as primary reporter.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Myalgia, Pyrexia, Rash, Rash erythematous
Clinical narrative: Fever; Chills; Pain in left deltoid; Red rash in left arm; This non-serious case was reported by a nurse via sales rep and described the occurrence of fever in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number EN939, expiry date 31-OCT-2024) for prophylaxis.   On 14-MAR-2023, the patient received Bexsero (left deltoid). On 15-MAR-2023, 1 days after receiving Bexsero, the patient experienced fever (Verbatim: Fever), chills (Verbatim: Chills) and localized muscle pain (Verbatim: Pain in left deltoid). On 16-MAR-2023, the patient experienced red rash (Verbatim: Red rash in left arm). The outcome of the fever, chills, localized muscle pain and red rash were resolved (duration 24 hrs).   It was unknown if the reporter considered the fever, chills, localized muscle pain and red rash to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     It was unknown if the company considered the fever, chills, localized muscle pain and red rash to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 10-APR-2023 Reporter was a nurse  Nurse reported that female patient received Bexsero vaccine in her left deltoid then 24 hours later the patient started with fever, chills and pain in left deltoid. Reporter also informed 48 hours after the administration the patient experienced a red rash in her left deltoid.  All symptoms went away in 24 hours.  The reporter was consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Diluent without lyophilized component; Patient received the diluent portion of Shingrix without the lyophilized component; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number AT772, expiry date 05-OCT-2023) for prophylaxis.  On 08-FEB-2023, the patient received the 1st dose of Shingrix. On 08-FEB-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Diluent without lyophilized component) and inappropriate dose of vaccine administered (Verbatim: Patient received the diluent portion of Shingrix without the lyophilized component). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional Information: GSK Receipt Date: 10-APR-2023 A pharmacist called in to report that a patient had received the diluent portion of Shingrix without the lyophilized component. They wished to know what information was available and gave information about adverse event. The vaccine administration facility was the same as primary reporter.  The reporter had consented to follow-up. At the time of reporting, the patient only had received patient had received the diluent portion of Shingrix without the lyophilized component, which had led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: U
Vaccine: VARZOS
Symptoms: Neoplasm malignant
Clinical narrative: cancer after full Vx schedule; This serious case was reported by a pharmacist via call center representative and described the occurrence of cancer in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced cancer (Verbatim: cancer after full Vx schedule) (serious criteria GSK medically significant). The outcome of the cancer was unknown.   It was unknown if the reporter considered the cancer to be related to Shingrix.     It was unknown if the company considered the cancer to be related to Shingrix.   Additional Information: GSK Receipt Date: 10-APR-2023 The pharmacist mentioned that she had a patient who finished the full series of Shingrix (2 doses of Shingrix) in 2019, and after that patient started a cancer treatment.  The health care professional did not mentioned when the cancer started or was discovered.  The reporter permission for a follow-up was not asked during the interaction by phone with the pharmacist. The pharmacist called to ask about information of Shingrix and the number of doses approve by GSK.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Myalgia, Pyrexia
Clinical narrative: Severe Chills; Fever; Muscle Aches; severe flu-like symptoms; This non-serious case was reported by a nurse via sales rep and described the occurrence of chills in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In JAN-2021, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced chills (Verbatim: Severe Chills), fever (Verbatim: Fever), muscle pain (Verbatim: Muscle Aches) and influenza-like symptoms (Verbatim: severe flu-like symptoms). The outcome of the chills, fever and muscle pain were unknown and the outcome of the influenza-like symptoms was resolved (duration 24 hrs).   It was unknown if the reporter considered the chills, fever, muscle pain and influenza-like symptoms to be related to Shingrix.     It was unknown if the company considered the chills, fever, muscle pain and influenza-like symptoms to be related to Shingrix.   Additional Information: GSK Receipt Date: 10-APR-2023 The reporter reported an adverse event from an in-office staff member. The reporter did not consent for follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Some pretty serious hives, getting worse; This serious case was reported by a consumer via call center representative and described the occurrence of hives in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included immunocompromised (condition).   On 09-APR-2023, the patient received the 1st dose of Shingrix (left arm). In APR-2023, 30 hrs after receiving Shingrix, the patient experienced hives (Verbatim: Some pretty serious hives, getting worse) (serious criteria other: Serious by reporter). The outcome of the hives was not resolved.   It was unknown if the reporter considered the hives to be related to Shingrix.     It was unknown if the company considered the hives to be related to Shingrix.   Additional Information: GSK Receipt date:11-APR-2023. Patient stated that she got the vaccine at a pharmacy location.  Patient reported that 30 hours after the vaccine she developed some pretty serious hives.  Patient believes she might be prescribed prednisone by her doctor because she have a Immunocompromise condition that causes hives. Patient reported the hives were getting worse. The reporter did not consent to follow-up.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Rash like vesicular, (shingles like) varicella rash; This non-serious case was reported by a physician via call center representative and described the occurrence of vesicular rash in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 06-APR-2023, the patient received the 2nd dose of Shingrix. On 09-APR-2023, 3 days after receiving Shingrix, the patient experienced vesicular rash (Verbatim: Rash like vesicular, (shingles like) varicella rash). The outcome of the vesicular rash was not resolved.   It was unknown if the reporter considered the vesicular rash to be related to Shingrix.     It was unknown if the company considered the vesicular rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 11-APR-2023 The emergency room doctor reported the 60 years old patient received Shingrix on Thursday 6th April 2023 and had a rash that started on Sunday 9th April 2023 which looked like vesicular, it was bilateral and appeared to be a (shingles like) varicella rash.  This was her second dose of Shingrix. Emergency room visit Required. Pharmacy at address above in vaccine facility details was who administered the Shingrix to this patient, forgot to ask the doctor if follow up could be done with him but the ER address was in HCP details.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Possible 1st dose 2019, no 2nd dose yet; This non-serious case was reported by a nurse via sales rep 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 in 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Possible 1st dose 2019, no 2nd dose yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date:11-APR-2023 The case was reported by sales representative on behalf of nurse practitioner (customer relationship management). No second dose administered. No additional adverse event details available at this time.
Age: 1.0
Sex: M
Vaccine: HIBV
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: vaccine administered to a patient using another diluent different that the one provided; vaccine administered to a patient using another diluent different that the one provided; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 12-month-old male patient who received Hib (Hiberix) (batch number EK5Y2, expiry date 25-MAY-2023) for prophylaxis.   On 11-APR-2023, the patient received Hiberix. On 11-APR-2023, an unknown time after receiving Hiberix, the patient experienced wrong solution used in drug reconstitution (Verbatim: vaccine administered to a patient using another diluent different that the one provided) and incorrect dose administered (Verbatim: vaccine administered to a patient using another diluent different that the one provided). The outcome of the wrong solution used in drug reconstitution and incorrect dose administered were unknown.   Additional Information: GSK Receipt Date: 11-APR-2023 The pharmacist called to report a non-provided diluent may had been used to reconstitute and administer Hiberix.  The pharmacist reported an inconsistency between the powder vials and the diluent vials so suspects a vaccine was reconstituted and administered to a patient using another diluent different that the one provided but had not confirmed the situation. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up via email. The patient received Hiberix vaccine using another diluent different that the one provided, which led to wrong solution used in drug reconstitution and incorrect dose administered.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received HAV (Havrix) (expiry date DEC-2022) for prophylaxis.   On 12-APR-2023, the patient received Havrix. On 12-APR-2023, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: Expired Havrix administered). The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 12-APR-2023 The reporter consented to follow up.  No additional details provided. The patient received an expired dose of Havrix, which led to expired vaccine used.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose 04Apr2023, 2nd 09Apr2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 63-year-old male patient who received Herpes zoster (Shingrix) (batch number 3FE44, expiry date 17-JUN-2024) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On 09-APR-2023, the patient received the 2nd dose of Shingrix. On 09-APR-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: 1st dose 04Apr2023, 2nd 09Apr2023). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 12-APR-2023 The pharmacist reported that the patient was not immunocompromised. The reporter reported that the patient received second dose of Shingrix early. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up by email. The patient received the second dose of Shingrix earlier than the recommended interval, which led to shortening of vaccination schedule.