chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Seizure
Clinical narrative: Patient was seen in ER on 7/8/2023 for seizure. Per mother, patient had episodic seizure witness by mother that lasted approximately 1 minute. She sat down to eat popsicle then slumped over. Mildly fatigued after seizure.
Age: 34.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: no side effects No further AE.; Pediatric dose given to adult.  VAQTA dosed 0.5ml  RECOMBIVAX 0.5ml  7/3/2023; This spontaneous report was received from a medical assistant referring to a 34-year-old male patient. The patient's medical history, historical drugs, concurrent conditions, past drug allergies or reactions, and concomitant drugs were not provided.   On 03-JUL-2023, the patient was vaccinated with Hepatitis A Vaccine, Inactivated (VAQTA) intramuscular injection (strength was reported as 25/0.5; 0.5 ml, one time; route of administration, lot #, and expiration date were not reported) and Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) intramuscular injection (strength: 10/0.1 mcg/ ml, 0.5 ml, one time; route of administration, lot #, and expiration date were not reported) both for prophylaxis. The dose administered was pediatric dose (incorrect dose administered). No side effects or further adverse events (AE) (no adverse event).
Age: 1.0
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No other AE; Second Dose Administered Too Early / Second dose of VAQTA that was administered 3 months early to a 15 month old. The first dose was administered at 12 months; This spontaneous report has been received from a physician, concerning a 15-month-old patient of unknown gender.  The patient's medical history, concurrent conditions, historical drugs, and concomitant therapies were not reported.  On an unknown date in 2023, when the patient was 12-month-old, was vaccinated with the 1st dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, and no symptoms were reported. On 06-JUL-2023, when the patient was 15-month-old, he/she received the 2nd dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 0.5 milliliter, administered as prophylaxis (lot numbers, expiration dates, routes of administration, and anatomical location were not provided). This 2nd dose of hepatitis a vaccine, inactivated (VAQTA) was administered 3 months early (Inappropriate schedule of product administration). No other adverse event (AE) was reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; Pain; This serious case was reported by a consumer and described the occurrence of vaccination failure in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15-MAR-2023, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and pain (Verbatim: Pain). The patient was treated with paracetamol (Tylenol). The outcome of the vaccination failure was unknown and the outcome of the shingles was resolved and the outcome of the pain was not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingrix.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingrix.   Additional Information: GSK receipt date: 8-JUL-2023 The patient received a dose of Shingrix and had shingles. The patient was diagnosed in emergency room and given prescription for percoset. The seriousness for shingles was reported as intervention required. The reporter consented to follow-up. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Autoimmune hepatitis, Blister, Herpes zoster, Pain
Clinical narrative: compromised autoimmune hepatitis; shingles; hurts; blisters; This serious case was reported by a consumer via interactive digital media and described the occurrence of autoimmune hepatitis in a 81-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (The patient had shingles really bad lasted for 8 days). Concurrent medical conditions included nerve pain (The patient was left with nerve ending pain and there was no cure for this).   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 autoimmune hepatitis (Verbatim: compromised autoimmune hepatitis) (serious criteria GSK medically significant), shingles (Verbatim: shingles), pain (Verbatim: hurts) and blister (Verbatim: blisters). The outcome of the autoimmune hepatitis, shingles, pain and blister were not reported.   It was unknown if the reporter considered the autoimmune hepatitis, shingles, pain and blister to be related to Shingrix.     It was unknown if the company considered the autoimmune hepatitis, shingles, pain and blister to be related to Shingrix.   Additional Information: GSK Receipt Date: 04-JUL-2023 This case was reported by a patient via interactive digital media. The patient got the Shingrix shot, when patient got the second shot that hurts, the patient did not think he/she would have shingles breakout.  15 days later, patient got shingles breakout. Not a lot of blisters but had them. Patient was told to isolate for 7 days. The patient mentioned all of them were different.  The patient had a compromised autoimmune hepatitis. The patient stated that vaccine did not keep you from getting shingles.  The patient reporter that if you get shingles they would not be as bad. So, guess we all deal with our situation the best way we could.  The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had shingles three times after vaccination/Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had once before vaccination).   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had shingles three times after vaccination/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 04-JUL-2023 This case was reported by a patient via interactive digital media. The patient reported that based on his or her experience do not get vaccinated. He or she received Shingles vaccine and experienced Shingles three times, so the vaccine is not effective or maybe shingles was in love with him or her because he or she had it in the same place every time. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Vaccination failure
Clinical narrative: Had shots still got it /suspected vaccination failure; Had shots still got it; one spot with blister; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure 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 vaccination failure (Verbatim: Had shots still got it /suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Had shots still got it) and blister (Verbatim: one spot with blister). The outcome of the vaccination failure was unknown and the outcome of the shingles and blister were not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and blister to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and blister to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 03-JUL-2023 This case was reported by consumer via interactive digital media. The reporter reported that he or she had a shots but still got it only one spot with blister and had it 6 weeks. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory details confirming shingles were unknown at a time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles/ she just got it again; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had it few years ago).   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles/ she just got it again). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 06-Jul-2023 This case was reported the patient via interactive digital media. The reporter's mother in law had shingles few years ago and even with the shot the patient just got it again last week. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up not possible as no contact details provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: I got the shots and have it now/ Suspected Vaccination Failure; I got the shots and have it now.; very painful; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included immune system disorder (low immune system because of rheumatoid arthritis medication).   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: I got the shots and have it now/ Suspected Vaccination Failure) (serious criteria GSK medically significant), shingles (Verbatim: I got the shots and have it now.) and pain (Verbatim: very painful). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK receipt date: 6 Jul 2023 This case was reported by a consumer via interactive digital media . The patient got the shots and had shingles now. It was on his/her back and very painful.  The patient had a low immune system because of rheumatoid arthritis medication. This case was considered as suspected vaccination failure since details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles was not reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 58-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (got it at the age of 23) and pain. Previously administered products included Zovirax (back in the 80s).   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 07-JUL-2023 This case was reported the patient via interactive digital media. It was painful when it got at the age of 23. In the present time the patient did not get the outbreak as often as it was when used received Zovirax back in 80s. Patient received shingles vaccine 5 years ago and wanted to confirm if it was helped as outbreaks did not came as often. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up not possible as no contact details provided.
Sex: U
Vaccine: VARZOS
Symptoms: Illness, Injection site bruising, Pain in extremity
Clinical narrative: I still have a bruise where I got the a shot; My arm still hurts bad; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site bruising in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of illness (1st dose January, reference case US2023AMR044368).   On 05-APR-2023, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced injection site bruising (Verbatim: I still have a bruise where I got the a shot) and pain in arm (Verbatim: My arm still hurts bad). The outcome of the injection site bruising and pain in arm were not resolved.   It was unknown if the reporter considered the injection site bruising and pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the injection site bruising and pain in arm to be related to Shingles vaccine.   Additional Information: GSK receipt date: 03-Jul-2023 This case was reported the patient via interactive digital media. The patient got the 2nd shot and still his or her arm hurt very bad. The patient still had a bruise where got the shot. Follow-up not possible as no contact details provided. For tolerance of 1st dose refer case US2023AMR044368, reported by same reporter.; Sender's Comments:  US-GSK-US2023AMR044368:Same patient, different dose
Sex: F
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: Not received 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 64-year-old female patient who received HAB (Twinrix) for prophylaxis.   Concomitant products included HEPATITIS A VACCINE + HEPATITIS B VACCINE (TWINRIX).   On an unknown date, the patient received the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: Not received 2nd dose). 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: 05-Jul-2023 The pharmacist reported a patient received 1st dose and coming in for the 2nd dose restart series. Till the date of reporting the patient did not receive the 2nd dose, which led to incomplete course of vaccination. The reporter did not consent to follow up.
Age: 33.0
Sex: M
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: 33 years old patient received pediatric dose of Engerix B vaccine; 33 years old patient received pediatric dose of Engerix B vaccine; This non-serious case was reported by a nurse via call center representative and described the occurrence of underdose in a 33-year-old male patient who received HBV (Engerix B pediatric) (batch number 333M4, expiry date 07-APR-2024) for prophylaxis.   On 05-JUL-2023, the patient received the 2nd dose of Engerix B pediatric. On 05-JUL-2023, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: 33 years old patient received pediatric dose of Engerix B vaccine) and adult use of a child product (Verbatim: 33 years old patient received pediatric dose of Engerix B vaccine). The outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 05-JUL-2023 The reporter reported that the patient administered Engerix B vaccine and then realized that she had administered a pediatric dose after patient left the clinic. The reporter stated that at the time of reporting the dose had not been repeated. The vaccine administration facility was the same as primary reporter. The reporter did consent to follow up. The adult patient was administered a pediatric dose of Engerix B, which led to underdose and adult use of a child product
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Shingrix : shorter than recommended interval; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 19th January 2023, batch number:z9ad5 and expiry date:4th February 2023).   On 27-FEB-2023, the patient received the 2nd dose of Shingrix. On 27-FEB-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: Shingrix : shorter than recommended interval). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 05-JUL-2023 The reporter reported that a immunocompetent adult received a shingrix it showed that the patient got a 2nd dose of Shingrix 40 days later from another pharmacy but patient said that he did not receive a 2nd dose and needed a 2nd dose. The reporter consented to follow up. The patient received 2nd dose of Shingrix earlier than the recommended schedule, which led to shortening of vaccination schedule.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site irritation, Injection site warmth, Pain in extremity
Clinical narrative: Injection site 2 X 1 inch area that is very red; Injection site irritated; Hot like it has a fever in that area; Arm Sore; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 03-JUL-2023, the patient received the 2nd dose of Shingrix (right arm). On 04-JUL-2023, 1 days after receiving Shingrix, the patient experienced injection site erythema (Verbatim: Injection site 2 X 1 inch area that is very red), injection site irritation (Verbatim: Injection site irritated) and injection site warmth (Verbatim: Hot like it has a fever in that area). In JUL-2023, the patient experienced pain in arm (Verbatim: Arm Sore). The outcome of the injection site erythema, injection site irritation and injection site warmth were not resolved and the outcome of the pain in arm was resolved.   It was unknown if the reporter considered the injection site erythema, injection site irritation, injection site warmth and pain in arm to be related to Shingrix.     It was unknown if the company considered the injection site erythema, injection site irritation, injection site warmth and pain in arm to be related to Shingrix.   Additional Information: GSK Receipt Date: 05-JUL-2023 The patient self-reported this case. The patient reported that her arm was sore within 12 hours of receiving the vaccine but did not hurt on the day of reporting. The patient also reported that the next day of vaccination, just around the injection site there was a 2 X 1 inch area that was very red, irritated and hot like it had a fever in that area which was still all there on the day of reporting.  The vaccine administration facility was the same as primary reporter. The reporter consented to follow up with healthcare professional.
Age: 40.0
Sex: U
Vaccine: MMR
Symptoms: Product administration error, Product storage error
Clinical narrative: Inadvertent Administration; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 40-year-old patient who received MMR (Priorix) (batch number AA25SS, expiry date 01-NOV-2024) for prophylaxis.   On 15-JUN-2023, the patient received the 1st dose of Priorix (left deltoid). On an unknown date, an unknown time after receiving Priorix, the patient experienced incorrect storage of drug (Verbatim: Inadvertent Administration). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 5-JUL-2023 Nurse reports patient was administered priorix after a below temperature excursion inadvertently. The Vaccine Administration Facility was the same as primary reporter. Consented to follow up.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: Patient was inadvertently administered an expired Shingrix; 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 63-year-old female patient who received Herpes zoster (Shingrix) (batch number H2PE2, expiry date 19-MAY-2023) for prophylaxis.   On 01-JUN-2023, the patient received Shingrix (left deltoid). On 01-JUN-2023, an unknown time after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: Patient was inadvertently administered an expired Shingrix). The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 05-Jul-2023 The practice manager called to inquire if the patient needed to be revaccinate. The patient was inadvertently administered an expired Shingrix on June 01, 2023 which was expired on May 19, 2023, which led to expired vaccine used. The health care professional did not consent to follow up with the safety.
Age: 16.0
Sex: F
Vaccine: MENB, UNK
Symptoms: Injection site swelling, Mobility decreased, Myalgia
Clinical narrative: deltoid area of her left arm is swollen; hard to move from muscle pain; This non-serious case was reported by a nurse via call center representative and described the occurrence of swelling arm in a 16-year-old female patient who received Men B NVS (Bexsero) (batch number 5P2P7, expiry date 31-JAN-2026) for prophylaxis.   Co-suspect products included MENQUADFI (MENINGOCOCCAL ACYW VACCINE) for prophylaxis.   On 27-JUN-2023, the patient received the 1st dose of Bexsero (intramuscular, left arm) and MENQUADFI (MENINGOCOCCAL ACYW VACCINE) (right arm). On an unknown date, an unknown time after receiving Bexsero, the patient experienced swelling arm (Verbatim: deltoid area of her left arm is swollen) and myalgia upper extremities (Verbatim: hard to move from muscle pain). The outcome of the swelling arm and myalgia upper extremities were not resolved.   It was unknown if the reporter considered the swelling arm and myalgia upper extremities to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     It was unknown if the company considered the swelling arm and myalgia upper extremities 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: 06-JUL-2023 The reporter also stated that the patient received her Menquadfi vaccine on the same day as Bexsero. A Nurse practitioner reported that the patient came into the doctor's office yesterday, 5-JUL-2023, because the patient's entire deltoid area of her left arm was swollen and hard to move from muscle pain. The patient did not provide a date when these adverse reactions started. It was unknown if the reporter considered the adverse events to be related to Menquadfi vaccine. The reporter was consented to follow up.
Age: 21.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Shingrix + administration of 2nd dose in less than recommended interval; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 21-year-old female patient who received Herpes zoster (Shingrix) (batch number 5954H, expiry date 15-AUG-2025) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On 06-JUL-2023, the patient received the 2nd dose of Shingrix. On 06-JUL-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: Shingrix + administration of 2nd dose in less than recommended interval). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 06-JUL-2023 The reporter reported that patient received second dose of Shingrix vaccine 2 days after received first dose. The vaccine administration facility was the same as primary reporter. The reporter did consent to follow up. The patient received 2nd dose of Shingrix early than recommended time frame, which led to shortening of vaccination schedule.
Sex: U
Vaccine: MNQ
Symptoms: Product complaint, Product preparation issue
Clinical narrative: the MenCYW-135 liquid conjugate component were inadvertently mixed together; Product Complaint; 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 Men ACWY-CRM NVS (Menveo) (batch number amva975a, expiry date 31-JUL-2024) for prophylaxis. This case was associated with a product complaint.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: the MenCYW-135 liquid conjugate component were inadvertently mixed together) and pharmaceutical product complaint (Verbatim: Product Complaint). The outcome of the inappropriate preparation of medication and pharmaceutical product complaint were unknown.   Additional Information: GSK receipt date: 06-Jul-2023 and 07-Jul-2023 The health care professional stated that when the Menveo vaccine 2 vials containing the MenCYW-135 liquid conjugate component were inadvertently mixed together (inappropriate reconstitution technique). The reporter examined that the caps and vials and realized that two of the liquid conjugate were in the package without the MenA lyophilized conjugate component (missing components - Injection -0050). The following questions were asked to access the scenario: there was no evidence of tampering upon receipt, the blister tray was correctly sealed, the product was stored (original box or vials removed and stored separately) as original box and the product was purchased directly from GlaxoSmithKline. As per content the suspect product did not need to be sent back to GlaxoSmithKline.   The reporter was advised to throw away the suspect product.   The GlaxoSmithKline will credit the wholesaler account. The adverse event and product quality complaint was shared the same case number. No adverse event information was reported. The reporter consented to follow-up. The Menveo vaccine 2 vials containing the MenCYW-135 liquid conjugate component were inadvertently mixed together, which led to inappropriate preparation of medication.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient took the first and second dose of the Shingrix vaccine within a 5 week interval; 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 female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (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 drug dose administration interval too short (Verbatim: patient took the first and second dose of the Shingrix vaccine within a 5 week interval). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK receipt date: 7-JUL-2023 Pharmacist reported a patient took the first and second dose of the Shingrix vaccine within a 5 week interval. Patient received vaccine at a different facility.  Reporter did not administer vaccine to patient so did not have too many details.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: if they have only received one shot of Shingrix and the time has past is over a year or more?; This non-serious case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received only one dose on an unknown date).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: if they have only received one shot of Shingrix and the time has past is over a year or more?). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 06-Jul-2023 The reporter asked that what patient should do if he or she had only received one shot of Shingrix and the time had past was over a year or more, the efficacy was with only a one shot series. No further information or clarification was provided. This was a sales representative submitted request and has the potential of being a duplicate report. It was being submitted out of an abundance of caution.  All available details had been submitted by medical information and medical information team had no further information available. The reporter consented to follow-up. Till the time of reporting, the patient did not receive the 2nd shot of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: a patient that received the first dose of Shingrix; This non-serious case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: a patient that received the first dose of Shingrix). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 07-JUL-2023 The reporter reported that the patient received the first dose of Shingrix and it had been longer than 12 months. The reporter wanted to know if it was recommended they start over or just get the second dose.  Also, what was the efficacy of 1 dose only. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: DTAPHEPBIP, DTAPIPVHIB
Symptoms: Extra dose administered
Clinical narrative: administered Pediarix and Pentacel on the same day; This non-serious case was reported by a other health professional via call center representative and described the occurrence of overdose in a 2-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number PE24L, expiry date 11-APR-2025) for prophylaxis.   Co-suspect products included PENTACEL for prophylaxis.   On 07-JUL-2023, the patient received Pediarix and PENTACEL. On 07-JUL-2023, an unknown time after receiving Pediarix, the patient experienced overdose (Verbatim: administered Pediarix and Pentacel 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: 07-JUL-2023 The reporter consented to follow up. The patient was administered Pediarix and Pentacel on the same day, which led to overdose.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: late 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in April 2022).   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: late 2nd dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 7-Jul-2023 A pharmacist did not had the exact date of the 1st dose and the patient's date of birth was not asked. The reporter consented to follow-up via postal mail. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 20.0
Sex: M
Vaccine: MNQ
Symptoms: Product preparation issue
Clinical narrative: patient only received the liquid CYW-135 component; patient only received the liquid CYW-135 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 20-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 06-JUL-2023, the patient received Menveo. On 06-JUL-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: patient only received the liquid CYW-135 component) and inappropriate dose of vaccine administered (Verbatim: patient only received the liquid CYW-135 component). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 7-JUL-2023 Pharmacist reported she administered a dose of Menveo to a patient, without realizing there were 2 vial components. The patient only received the liquid CYW-135 component. At the time of reporting, the pharmacist did not have the lot number/expiration date available, and did not have the patient initials.  A report dose had not yet been administered.  The Vaccine Administration Facility was the same as Primary Reporter. Reporter gave permission for follow-up. Consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 86-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included Shingrix (1st dose received on 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: Patient received first dose on 2019). The outcome of the incomplete course of vaccination was unknown. Additional Information: GSK Receipt Date: 07-JUL-2023. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination. The reporter did consent to follow up.
Age: 19.0
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: female patient received an intramuscular injection of Priorix on 07Jul2023; This non-serious case was reported by a nurse via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a 19-year-old female patient who received MMR (Priorix) (batch number 75S93, expiry date 11-MAY-2024) for prophylaxis.   On 07-JUL-2023, the patient received Priorix (intramuscular). On 07-JUL-2023, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: female patient received an intramuscular injection of Priorix on 07Jul2023). The outcome of the subcutaneous injection formulation administered by other route 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-JUL-2023 No symptoms were reported. The reporter consented to follow up via email. The reporter reported that a patient received an intramuscular injection of Priorix, which led to subcutaneous injection formulation administered by other route.
Sex: F
Vaccine: RV1
Symptoms: Expired product administered, No adverse event
Clinical narrative: the administration of an expired Rotarix dose to a 2 month old female patient.; This non-serious case was reported by a physician via call center representative and described the occurrence of expired vaccine used in a 2-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number K2FM7, expiry date 04-JUL-2023) for prophylaxis.   On 07-JUL-2023, the patient received Rotarix lyophilized formulation. On 07-JUL-2023, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced expired vaccine used (Verbatim: the administration of an expired Rotarix dose to a 2 month old female patient.). 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-JUL-2023 A Doctor of medicine (MD) called to report the administration of an expired Rotarix. The health care professionals (HCP) asked how to proceed with this patient. Patient received a dose of Rotarix on July 07, 2023 which was expired on July 04, 2023, which led to expired vaccine used. No side effect was reported. The reporter was not requested for follow up.
Sex: U
Vaccine: COVID19
Symptoms: Fall, Hepatic enzyme, Hypoaesthesia, Lymphadenopathy, Muscular weakness
Clinical narrative: FALLS; LEGS TO GIVE OUT AT TIMES; NUMBNESS TO FINGER TIPS AND FEET; ENLARGE LYMPH NODES ON AND OFF; RASHES IN DIFFERENT AREAS ON BODY DAILY; BURNING SKIN; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was essentially a healthy person until the adverse events started. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 31-AUG-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On 01-SEP-2021, the patient experienced burning skin, rashes in different areas on body daily, and enlarge lymph nodes on and off. Laboratory data included: Hepatic enzyme noticeably increased on several occasions. On an unspecified date, the patient experienced falls, legs to give out at times, and numbness to finger tips and feet. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from burning skin, rashes in different areas on body daily, enlarge lymph nodes on and off, numbness to finger tips and feet, falls, and legs to give out at times. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Rash, Skin burning sensation
Clinical narrative: FALLS; LEGS TO GIVE OUT AT TIMES; NUMBNESS TO FINGER TIPS AND FEET; ENLARGE LYMPH NODES ON AND OFF; RASHES IN DIFFERENT AREAS ON BODY DAILY; BURNING SKIN; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was essentially a healthy person until the adverse events started. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 31-AUG-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On 01-SEP-2021, the patient experienced burning skin, rashes in different areas on body daily, and enlarge lymph nodes on and off. Laboratory data included: Hepatic enzyme noticeably increased on several occasions. On an unspecified date, the patient experienced falls, legs to give out at times, and numbness to finger tips and feet. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from burning skin, rashes in different areas on body daily, enlarge lymph nodes on and off, numbness to finger tips and feet, falls, and legs to give out at times. This report was non-serious.
Age: 60.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse event; 17 patients may have received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml; This spontaneous case was reported by a physician and describes the occurrence of UNDERDOSE (17 patients may have received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml) and NO ADVERSE EVENT (No adverse event) in a 60-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7148B) for COVID-19 prophylaxis.     Patient had no allergies to medications, food and other products.  Concurrent medical conditions included Pain. Concomitant products included ACETAMINOPHEN from 03-Aug-2022 to an unknown date for Pain, TAMSULOSIN from 02-Dec-2022 to an unknown date and INFLUENZA VACCINE INACT SPLIT 3V (FLULAVAL) for an unknown indication.    On 02-Dec-2022 at 2:17 PM, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .25 milliliter. On 02-Dec-2022 at 2:17 PM,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced UNDERDOSE (17 patients may have received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (17 patients may have received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (17 patients may have received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml).    This case contains information about 5th patient out of 17 patients as described by the reporter.  Concomitant medication dose details of Acetominophen was reported as to take 1-2 tabs, by mouth every 6 hours, as needed for pain.  Concomitant medication dose details of Tamsulosin was reported as to take 2 capsules, by orally every day after half hour, following the same meal each  day.  On 10-Mar-2021, the patient received first dose of 0.5 ml of Moderna COVID-19 vaccine.  On 09-Apr-2021, the patient received second dose of 0.5 ml of Moderna COVID-19 vaccine.  The patient was administered with a wrong third dose and no other adverse event was reported.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-707980 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2023: Follow up received included Reporter added, patient details updated, suspect product dose details and narrative updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-707980:master case