chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (incredible stiffness), PAIN IN EXTREMITY (pain in hips, knees, calves, and feet) and ARTHRALGIA (lower extremity joint pain/joint pain that lingers) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. Concomitant products included FAMOTIDINE (PEPCID [FAMOTIDINE]), ESCITALOPRAM and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for an unknown indication. On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (incredible stiffness), PAIN IN EXTREMITY (pain in hips, knees, calves, and feet) and ARTHRALGIA (lower extremity joint pain/joint pain that lingers). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, MUSCULOSKELETAL STIFFNESS (incredible stiffness), PAIN IN EXTREMITY (pain in hips, knees, calves, and feet) and ARTHRALGIA (lower extremity joint pain/joint pain that lingers) had resolved. It was reported that events starts a week after vaccination and lasts for months. This case was linked to MOD-2022-544380, MOD-2022-544381, MOD-2022-544382 (Patient Link).
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Incomplete course of vaccination, Nausea, Pyrexia
Clinical narrative: Severe headache, fever, chills, nausea. I have never had such a severe reaction to a vaccine! Worse than when I had influenza A. They have to do something to fix this. I cannot finish the series. This is debilitating and completely unacceptable. Should never have been approved knowing that these reactions are so common and so severe.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Somnolence
Clinical narrative: sleepiness, fever, body aches
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore left injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore left injection site arm) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced VACCINATION SITE PAIN (sore left injection site arm). At the time of the report, VACCINATION SITE PAIN (sore left injection site arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication were reported.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-546519 (Patient Link).
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE information; dose of Proquad administered to an adult; This spontaneous report was received from a pharmacy student referring to an adult patient of unknown gender. No patient's pertinent medical history, concurrent conditions, drug reactions or allergies, nor concomitant therapies were reported.      On 22-MAR-2022, the adult patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot # U016976, expiration date 24-NOV-2022, 0.5 milliliter, once, (route, anatomical location, and dose number were not reported), as prophylaxis (product administered to patient of inappropriate age). No additional adverse event was reported.
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: No adverse event; MMR-II was given on 22-AUG-2019 and VARIVAX given on 27-AUG-2019; This spontaneous report was received from physician and referring to a 6-year-old male patient. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 22-AUG-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), lot number: R031680, expiration date:1-NOV-2020 ,administered intramuscularly for prophylaxis (strength, and expiration date were not provided)(inappropriate schedule of product administration).  On 27-AUG-2019, the patient was vaccinated therapy with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous lot number: S002396, expiration date: 23-JAN-2021, administered intramuscularly for prophylaxis (strength was not provided). On 27-NOV-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), lot number: S017251, expiration date: 01-DEC-2020, administered for prophylaxis (strength, and route of administration were not provided).
Age: 1.5
Sex: F
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs were reported; an expired PROQUAD was given to a patient; This spontaneous report was received from a registered nurse concerning an 18-month-old female patient. The patient's medical history and concurrent conditions were not provided. The patient's birth weight was 6Ib 11oz. She had one brother and two sisters. The patient was vaccinated with hepatitis b vaccine (reported as Hep B), diphtheria vaccine toxoid (+) pertussis vaccine acellular (+) polio vaccine inact (+) tetanus vaccine toxoid (reported as Polio, DTaP), haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (reported as Hib) and pneumococcal vaccine conj (PNEUMOCOCCAL CONJUGATE VACCINE) (reported as PCV) on 11-MAR-2022.  On 25-MAR-2022, the patient came into office for a nurse visit to catch up on immunization. On that day, she was vaccinated by the nurse, with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 1 dose, (lot # T032144, expiration date: 20-MAR-2022, dose not reported) subcutaneously in the left vastus lateralis (also reported as left thigh) for prophylaxis (expired product administered). The nurse was trained and the vaccine was used according to the instruction leaflet. It was reported that the nurse realized the vaccine had expired 5 days prior upon charting. Pharmacy, supervisor, manufacturer and patient's mother were notified. The remaining doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) were disposed of. The patient had no reaction and no additional adverse event were reported (No adverse event).
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; The nurse reported the patient received improperly stored vaccines; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 15-MAR-2022, the patient was vaccinated with an improperly stored of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) for prophylaxis (lot # U026217 has been verified to be a valid lot number haemophilus b conjugate vaccine (meningococcal protein conjugate), expiration date reported and establish as 02-NOV-2023) (strength, dose, route of administration and anatomical location were not provided).   The temperature of storage and time frame of the excursion were 34.3° Fahrenheit (C) for 55 minutes respectively.  If a digital data logger was involved was not reported.  The vaccine did not experience a previous temperature excursion.  No adverse event reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2204USA001821: US-009507513-2204USA001816: US-009507513-2204USA001791:
Sex: U
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported; The nurse reported that 33 patients received improperly stored vaccines; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 15-MAR-2022, the patient was vaccinated with an improperly stored of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) for prophylaxis (lot # U026664 and 1741817 has been verified to be a valid lot number rotavirus vaccine, live, oral, pentavalent, expiration date reported and establish as 24-FEB-2023, and 30-JUL-2022 respectively) (strength, dose, route of administration and anatomical location were not provided) and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) for prophylaxis (lot # U026217 has been verified to be a valid lot number haemophilus b conjugate vaccine (meningococcal protein conjugate), expiration date reported and establish as 02-NOV-2023) (strength, dose, route of administration and anatomical location were not provided).  The temperature of storage and time frame of the excursion were 34.3° Fahrenheit (C) for 55 minutes respectively.  If a digital data logger was involved was not reported.  The vaccines did not experience a previous temperature excursion.  No adverse event reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2204USA001821: US-009507513-2204USA001816: US-009507513-2204USA001791:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported; The nurse reported that 33 patients received improperly stored vaccines.; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 11-MAR-2022, the patient was vaccinated with an improperly stored of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) for prophylaxis (lot # U026217 has been verified to be a valid lot number haemophilus b conjugate vaccine (meningococcal protein conjugate), expiration date reported and establish as 02-NOV-2023) (strength, dose, route of administration and anatomical location were not provided).  The temperature of storage and time frame of the excursion were 34.3° Fahrenheit (C) for 55 minutes respectively.  If a digital data logger was involved was not reported.  The vaccines did not experience a previous temperature excursion.  No adverse event reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2204USA001821: US-009507513-2204USA001816: US-009507513-2204USA001791:
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; Expired dose of PROQUAD was administered to the patient on 12-APR-2022; This spontaneous report has been received from a medical assistant referring to a patient of unspecified age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies was not reported.  On 12-APR-2022, the patient was administered an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) 0.5 milliliters (ml) as prophylaxis (route of administration, anatomical site of vaccination and vaccine scheme were not reported; lot number T034828 has been verified to be valid, expiration date reported and established as 11-APR-2022) (expired product administered).   The vaccine was not exposed to any temperature excursion up to the date of administration. No additional adverse event was reported (no adverse event).
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse side effects reported; expired dose of MMR-II and VARIVAX that were administered to a patient today, 4/12/22.; This spontaneous report was received from a nurse concerning a 4 year old male patient. Information regarding the patient's medical history and concurrent conditions was not reported. Patient's concomitant medications included sterile diluent.        On 12-APR-2022, the patient was vaccinated with an expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) 0.5 milliliter, subcutaneously for prophylaxis (lot number T006167, has been determined to be valid for mumps, and rubella (wistar ra 27-3) virus vaccine, live, expiration date reported and established as 19-FEB-2022) (strength, and anatomical location were not provided) and varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 milliliter, subcutaneously for prophylaxis (lot number T000341, has been determined to be valid for mumps, and rubella (wistar ra 27-3) virus vaccine, live, expiration date reported and established as 05-JAN-2022) (strength, and anatomical location were not provided) (expired product administered).  No adverse event reported.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Overdose
Clinical narrative: a dose of PROQUAD was administered with VARIVAX; This spontaneous report was received from a pharmacy technician referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapies were not reported.  On 04-APR-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) 1 dose, lot #U024221, expiration date 04-AUG-2023 (strength and route were not provided), with measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human albumin (rHA) (PROQUAD) 1 dose, lot #U028179, expiration date 08-MAR-2023 (strength and route were not provided) for prophylaxis (overdose). The pharmacy technician reported the information was shared with her by a nurse at one of their facility's clinic. It was unknown if any product confusion occurred, that may have contributed to the error.   This is one of eight reports received from the same reporter.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Overdose
Clinical narrative: a dose of PROQUAD was administered with VARIVAX; This spontaneous report was received from a pharmacy technician referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapies were not reported.  On 08-APR-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) 1 dose, lot #U024221, expiration date 04-AUG-2023 (strength and route were not provided), with measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human albumin (rHA) (PROQUAD) 1 dose, lot #U028179, expiration date 08-MAR-2023 (strength and route were not provided) for prophylaxis (overdose). The pharmacy technician reported the information was shared with her by a nurse at one of their facility's clinic. It was unknown if any product confusion occurred, that may have contributed to the error.   This is one of eight reports received from the same reporter.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: No additional AE details; expired MMR II was administered; MMR II experienced temperature excursion in the past; This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. Concomitant medication included sterile diluent. Pertinent medical history and drug reactions/allergies were not reported.  On 15-FEB-2022, the patient was vaccinated with expired and improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin (rHA)) (M-M-R II) (lot #T001212, expiration date: 12-JAN-2022) for prophylaxis (strength, dose, and route of administration were not provided) (expired product administered and product storage error). Regarding the temperature excursion details were not available. Informed nurse stability date could not be given until having temperature excursion details.  No additional adverse event details were reported (no adverse event).  This is one of the two cases reported by the same reporter.; Sender's Comments:  US-009507513-2204USA006165:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles and other zoster-related conditions.; shingles and other zoster-related conditions.; This spontaneous report was received from a lawyer and a patient (Pt) of unknown age and gender, regarding a case in litigation on 18-APR-2022, via legal memo. The Pt's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported. On or about 2017, the Pt was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (lot #, expiration date, strength, route of administration, anatomical location not provided) for the long-term prevention of shingles and zoster-related conditions. Subsequently, on an unspecified date, the Pt was treated at the hospital for the following injuries resulting from zoster vaccine live (ZOSTAVAX) vaccination: shingles and other zoster-related conditions. At the reporting time, the outcome of the events was unknown. The reporters considered herpes zoster and other zoster-related conditions to be related to Zoster Vaccine Live (ZOSTAVAX).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE information provided.; temperature excursion; This spontaneous report was received from a physician, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent condition, drug reactions/allergies and concomitant medication was not provided.  On 19-MAR-2022, the patient was vaccinated with improper stored varicella virus vaccine live (oka/merck) (VARIVAX) (0.5 ml, lot #U015689, expiration date: 18-MAY-2023, strength, and route of administration were not provided) for prophylaxis. The vaccine administered experienced temperature excursions of -14 Degree Celsius to -10 Degree Celsius with average of -14.5 Degree Celsius for 5 minutes (product storage error). No additional adverse event information provided.  This is one of two cases from same reporter.; Sender's Comments:  US-009507513-2204USA006500:
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No other issues or concerns noted; Varivax had a temperature excursion and had been administered; This spontaneous report was received from an office manager, referring to a 4 year old patient of unknown gender. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported.  On 07-APR-2022, a temperature excursion was of -6.9 Centigrade degrees (°C), during 9 minutes occurred. A previous temperature excursion was not reported.   On 15-APR-2022, the patient was vaccinated with an improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) lot# U008180, expiration date reported as 12-DEC-2023, for prophylaxis (strength, dose, route and frequency were not reported). No other issues or concerns noted.  This is one of 4 reports received from the same reporter.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; one dose of ROTATEQ was administered after the excursion occured; This spontaneous report was received from an office manager and referred to a patient of unknown age and gender. Concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 13-APR-2022, the patient was vaccinated with 1 dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (2 milliliter, lot #1821791, expiration date: 26-JUL-2022) orally for prophylaxis (strength was not provided) (product storage error).  It was reported that the suspect vaccine was exposed to a temperature of 51.4 F for a time frame of 15 minutes. There were no previous temperature excursions.   No additional adverse event (AE) information was provided.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No additional AE reported.; Nurse called and reported that PROQUAD was administered Intramuscularly rather than subcutaneously to a 12 month old female.; This spontaneous report was received from a registered nurse, referring to a 12-month-old female patient. Information regarding the patient's concurrent conditions, concomitant medications, pertinent medical history or drug reactions/allergies was not provided.  On 20-APR-2022, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (recombinant human albumin, rHA) (PROQUAD) dose of 0.5 mL, lot number: U029322 was confirmed to be valid, expiration date: 19-MAR-2023, administered intramuscularly (anatomical location was not reported) for prophylaxis (incorrect route of product administration). No additional adverse event (AE) reported (no adverse event). No product quality complaint (PQC) reported. No additional information provided.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Took a shot Wednesday and my arm is still sore; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 13th April 2022, the patient received Shingles vaccine. In April 2022, less than a week after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 15-APR-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient received dose of Shingles vaccine on wednesday and his/her arm was still sore. Additional supportive information: The follow-up would not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Pruritus, Vaccination failure
Clinical narrative: I'm hoping since I was vaccinated I'll be over them soon/Suspected vaccination failure; Now I have shingles; Pain is driving me crazy; Itching is driving me crazy; This 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 (Family History) (the patient's mother had shingles).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain and pruritus. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, pain and pruritus were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain and pruritus to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 18-APR-2022 Reporter's Comments: This case was reported by a consumer via interactive digital media. The case was reported by patient. The patient got the shingles vaccine as soon as he/she was eligible because the patient's mother had shingles and the patient didn't want them. At the time of reporting the patient had shingles and hoping he/she would over them soon, since the patient was vaccinated.  Pain and itching was driving patient crazy. Additional Supportive Information: This case was considered as suspected vaccination failure since details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles not given. The follow up would not be possible since no contact details provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: l got the vaccine, l just keep getting; shingles; This 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 neuropathy.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 18-APR-2022 Reporter's Comments: This case was reported by a consumer via interactive digital media. The case was reported by patient. The patient got the vaccine, but neuropathy had already done damage. So the patient just keep getting the shingles. The patient stated that 13 years now it was just a way of his/her life. Additional Supportive Information: This case was considered as suspected vaccination failure since details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles not given. The follow up would not be possible since no contact details provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I got the vaccine and shingles twice/Suspected vaccination failure; Shingles twice; This 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, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 18-APR-2022 Reporter's Comments: This case was reported by a consumer via interactive digital media. The case was reported by patient. The patient got vaccine and experienced shingles twice.  Additional Supportive Information: This case was considered as suspected vaccination failure since details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles not given. The follow up would not be possible since no contact details provided.
Age: 1.0
Sex: F
Vaccine: DTAPIPV, PNC
Symptoms: Crying, Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: Crying; 21 month old was administered Kinrix; administered Kinrix, should have been given DTaP and IPV separately; This case was reported by a nurse via call center representative and described the occurrence of crying in a 1-year-old female patient who received DTPa-IPV (Kinrix) (batch number H9FM5, expiry date 27th May 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis and PNEUMOCOCCAL 13 VALENT CONJUGATE VACCINE (PREVNAR) for prophylaxis.   Concomitant products included paracetamol (Tylenol).   On 14th April 2022, the patient received Kinrix, Kinrix Pre-Filled Syringe Device and PREVNAR. On 14th April 2022, less than a day after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced crying, inappropriate age at vaccine administration and inappropriate schedule of vaccine administered. On an unknown date, the outcome of the crying, inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were unknown.   It was unknown if the reporter considered the crying to be related to Kinrix and Kinrix 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: 14-APR-2022 Reporter's comment: The nurse reported a 21 month old patient was administered a dose of Kinrix.  The patient should have been given DTaP and IPV separately, but it was administered together as Kinrix. This was the patient's fourth dose of DTaP and IPV.  The reporter stated that, the patient had been crying since vaccines were administered. The patient also received Prevnar vaccination on the day of reporting.  The patient was given two doses of Tylenol 4 hours apart after the vaccines. The reporter consent to follow up. Additional Supportive Information: The nurse reported a 21 month old patient was administered a dose of Kinrix, and the patient should have been given DTaP and IPV separately, but it was administered together as Kinrix, which led to inappropriate age at vaccine administration. It was unknown if the reporter considered the crying to be related to Prevenar. The Vaccine Administration Facility is the same as primary reporter.
Age: 92.0
Sex: F
Vaccine: VARZOS
Symptoms: Off label use
Clinical narrative: patient that had been diagnosed with shingles, received the Shingrix vaccine to treat her; This case was reported by a pharmacist via call center representative and described the occurrence of off label use in a 92-year-old female patient who received Herpes zoster (Shingrix) (batch number N3S45, expiry date 27th May 2023) for prophylaxis.   Concurrent medical conditions included shingles.   On 18th February 2022, the patient received the 1st dose of Shingrix. On 18th February 2022, unknown after receiving Shingrix, the patient experienced off label use. On an unknown date, the outcome of the off label use was unknown.   Additional Information: GSK Receipt Date: 15-APR-2022 Reporter's comment: The registered pharmacist reported that a patient that had been diagnosed with shingles who came to pharmacy and received Shingirx vaccine to treat shingles. The patient denied at that time of vaccination having any illness but then later became aware of the situation. The reporter consented to follow up. Additional Supportive Information: The reporter said, a patient that had been diagnosed with shingles who came to pharmacy and received Shingirx vaccine to treat shingles, which led to off label use. The Vaccine Administration Facility is the same as primary reporter.
Sex: F
Vaccine: MENB
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site induration, Injection site swelling, Pain
Clinical narrative: Site reaction that was red; Site reaction that was swollen; Site reaction that was hard; Body aches; Fever; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a adolescent female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 21st March 2022, the patient received the 1st dose of Bexsero (intramuscular) .5 ml and Bexsero Pre-Filled Syringe Device. On 21st March 2022, immediately after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced injection site erythema, injection site swelling and injection site induration. On 26th March 2022, the patient experienced general body pain and fever. On 24th March 2022, the outcome of the injection site erythema, injection site swelling and injection site induration were recovered/resolved. On an unknown date, the outcome of the general body pain and fever were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site induration, general body pain and fever 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: 15-Apr-2022 Reporter's comment: The caller was the mother of the patient.  The caller did not want to provide any further demographics. The patient did not want to supply the patient's birth date, but she mentioned her daughter was a senior in high school. The caller stated that her daughter got her first Bexsero vaccine in left arm and the patient immediately had a site reaction that was red, swollen, and hard for 3 days.   The patient then started with fever and body aches about 5 days later that lasted a week.  The patient was recovered from all these symptoms.   Did not consent to follow-up. No health care professional for follow up.
Sex: F
Vaccine: MENB
Symptoms: Pyrexia
Clinical narrative: Site reaction that was red; Site reaction that was swollen; Site reaction that was hard; Body aches; Fever; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a adolescent female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 21st March 2022, the patient received the 1st dose of Bexsero (intramuscular) .5 ml and Bexsero Pre-Filled Syringe Device. On 21st March 2022, immediately after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced injection site erythema, injection site swelling and injection site induration. On 26th March 2022, the patient experienced general body pain and fever. On 24th March 2022, the outcome of the injection site erythema, injection site swelling and injection site induration were recovered/resolved. On an unknown date, the outcome of the general body pain and fever were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site induration, general body pain and fever 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: 15-Apr-2022 Reporter's comment: The caller was the mother of the patient.  The caller did not want to provide any further demographics. The patient did not want to supply the patient's birth date, but she mentioned her daughter was a senior in high school. The caller stated that her daughter got her first Bexsero vaccine in left arm and the patient immediately had a site reaction that was red, swollen, and hard for 3 days.   The patient then started with fever and body aches about 5 days later that lasted a week.  The patient was recovered from all these symptoms.   Did not consent to follow-up. No health care professional for follow up.
Sex: M
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: Never received dose 2 and 3; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 57-year-old male patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 19th September 2021, batch number 75C72 and expiry date 13th June 2022).   On an unknown date, the patient did not receive the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 15-APR-2022 Reporter's comment: The pharmacist reported that a patient never received second and third dose of Twinrix.  The reporter consent to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd and 3rd dose of Twinrix, which led to incomplete course of vaccination.
Age: 11.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Extra dose administered, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 11 year old was administered PEDIARIX; Wrong vaccine administered; extra dose administered; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 11-year-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number B4722, expiry date 17th February 2024) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th April 2022, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 15th April 2022, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration, wrong vaccine administered and extra dose administered. On an unknown date, the outcome of the inappropriate age at vaccine administration, wrong vaccine administered and extra dose administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 15-APR-2022 Reporter's Comments: Reporter was office manager and medical assistant. The reporter reported that a 11 year old patient received a dose of Pediarix on the day of reporting. No other symptoms were reported.  The patient received Pediarix instead of the patient's Tdap dose.  The patient was up to date on their IPV and Hepatitis B vaccination series.  The administration of Pediarix was the patient's 5th dose of Hepatitis B. The reporter consented to follow up. Patient's initials were unavailable at the reporting time. Additional Supportive Information: The pharmacist stated that a 11 year old patient received an Pediarix dose instead of Tdap, which led to inappropriate age at vaccine administration and wrong vaccine administered. The administration of Pediarix was the patient's 5th dose of Hepatitis B, which led to extra dose administered. Per package insert Pediarix was approved as a 3 dose series for 6 weeks of age through 6 years of age. This case is linked with case US2022060303 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022060303:Same reporter
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Product administered to patient of inappropriate age
Clinical narrative: first dose 4 years ago, never received second; first dose 4 years ago, never received second; This case was reported by a consumer via call center representative and described the occurrence of inappropriate age at vaccine administration in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced inappropriate age at vaccine administration and incomplete course of vaccination. On an unknown date, the outcome of the inappropriate age at vaccine administration and incomplete course of vaccination were unknown.       Additional Information: GSK Receipt Date: 18th Apr 2022 Reporter's Comments: The case was reported by patient. The patient stated she received her first dose of SHINGRIX 4 years ago and never received the second dose (exact vaccination date unknown).  The patient stated she wanted to complete the series. The provided information based on content as well as recommendations on alternative dosing schedules. The reporter did not consent to follow-up. Additional Supportive Information: The patient received 1st dose 4 years ago which led to inappropriate age at vaccine administration. Till the time of reporting the patient did not received 2nd dose which led to incomplete course of vaccination. Note: As permission to follow up was denied the event inappropriate age at vaccine administration was coded conservatively.
Age: 1.0
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: early second dose of Havrix; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 18-month-old female patient who received HAV (Havrix 720) (batch number ep47e, expiry date 6th February 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included HEPATITIS A VACCINE (HAVRIX 720).   On 14th April 2022, the patient received the 2nd dose of Havrix 720 and Havrix Pre-Filled Syringe Device. On 14th April 2022, unknown after receiving Havrix 720 and Havrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.     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: 18-APR-2022 Reporter's Comments: The nurse reported that the patient received an early second dose of Havrix. The reporter consented to follow up. Additional Supportive Information: As the patient received an early second dose of Havrix, which led to shortening of vaccination schedule.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Expired product administered, Incorrect dose administered, Product preparation issue
Clinical narrative: reconstituted with expired powder portion and gave it to patient; reconstituted with expired powder portion and gave it to patient; reconstituted with expired powder portion and gave it to patient; This case was reported by a nurse via call center representative and described the occurrence of inappropriate dose of vaccine administered in a 53-year-old male patient who received Herpes zoster (Shingrix) (batch number 3R774, expiry date 8th March 2022) for prophylaxis.   On 18th April 2022, the patient received the 2nd dose of Shingrix. On 18th April 2022, unknown after receiving Shingrix, the patient experienced inappropriate dose of vaccine administered, inappropriate preparation of medication and expired vaccine used. On an unknown date, the outcome of the inappropriate dose of vaccine administered, inappropriate preparation of medication and expired vaccine used were unknown.       Additional Information: GSK Receipt Date: 18-APR-2022 Reporter's Comments: The registered nurse called on behalf another health care professional from the facility who reconstituted Shingrix with expired powder portion and gave it to a patient. Only powder portion of Shingrix was expired the diluent portion was not expired. The reporter consented to follow up. Additional Supportive Information: The patient received expired powder portion with diluent which led to inappropriate dose of vaccine administered, inappropriate preparation of medication and expired vaccine used.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose  about 2 years ago, has not yet received second shot; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose about 2 years ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.       Additional Information: GSK Receipt Date: 19-APR-2022 Reporter's Comments: The pharmacist stated his patient received his first dose of SHINGRIX about 2 years ago and had not received second shot.  Additional Supportive Information: Till the time of reporting the patient did not receive 2nd dose which led to incomplete course of vaccination. This case has been linked with the case US2022066899 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022066899:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: has not yet received second shot; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received over 6 months before the date of reporting).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 19-Apr-2022 Reporter's comments: The patient had not yet received second shot of Shingrix. The reporter provided limited information. The reporter did not have patient identifiers. Additional Supportive Information: Till the time of reporting the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. This case was linked with case US2022066898, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022066898:same reporter
Age: 2.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Expired product administered
Clinical narrative: expired dose was given/PEDIARIX: maladministration of expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 2-year-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number Z3YL4, expiry date 4th April 2022) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th April 2022, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 15th April 2022, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 19-APR-2022 Reporter's Comments: The reporter stated that, an expired dose of pediarix was given to the patient. The reporter consented to follow up. Additional Supportive Information: The patient received expired dose of Pediarix, which led to expired vaccine used. This case is one of three cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022066909:Same reporter US-GLAXOSMITHKLINE-US2022066910:Same reporter