chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site swelling, Joint swelling, Mass, Pain, Pain in extremity
Clinical narrative: Red irritated patch at injection site; Red irritated red patch at the injection site; Red irritated red patch at the injection site; pain down her left side; Shoulder to elbow painful; Shoulder to elbow swollen; Pain down her left side all the way to her LEFT thigh; Marshmallow size lump formed on her LEFT thigh; This case was reported by a consumer via call center representative and described the occurrence of swollen joints in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th August 2022, the patient received the 2nd dose of Shingrix (intramuscular). On 6th August 2022, 1 hr after receiving Shingrix, the patient experienced swollen joints, pain in extremity, mass, pain and shoulder pain. On 7th August 2022, the patient experienced injection site erythema, injection site rash and injection site irritation. On an unknown date, the outcome of the swollen joints, pain in extremity, mass, injection site erythema, injection site rash, injection site irritation, pain and shoulder pain were not recovered/not resolved.   It was unknown if the reporter considered the swollen joints, pain in extremity, mass, injection site erythema, injection site rash, injection site irritation, pain and shoulder pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 10-AUG-2022 Reporter's Comment: The reporter was a patient. The patient received Shingrix vaccine and an hour after experienced her left shoulder to elbow was extremely painful and swollen. The patient had pain down her left side to the left thigh and almost immediately after receiving vaccine marshmallow size lump formed on left thigh and had not resolved. On the next day of received vaccine the patient had red irritated red patch at the injection site and the rash had not resolved. The patient does not had a doctor and had not seen in 20 years. The reporter did not consent to follow up.
Age: 13.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Incorrect product formulation administered, Underdose
Clinical narrative: 13-year-old patient received a pediatric Pfizer dose instead of an adult Pfizer dose.
Age: 13.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Underdose
Clinical narrative: 13-year-old patient received a pediatric Pfizer dose instead of an adult Pfizer dose.
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chills, Headache, Lethargy, Nausea, Pain
Clinical narrative: Systemic: Body Aches Generalized-Severe, Systemic: Chills-Severe, Systemic: Dizziness/Lightheadedness-Severe, Systemic: Exhaustion/Lethargy-Severe, Systemic: Fever-Severe, Systemic: Flushed/Sweating-Severe, Systemic: Headache-Severe, Systemic: Joint Pain-Severe, Systemic: Weakness-Severe, Additional Details: Patient had these same symptoms following second COVID-19 Pfizer vaccination as well. Symptoms lasted 3 days after second dose.
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: Systemic: Body Aches Generalized-Severe, Systemic: Chills-Severe, Systemic: Dizziness/Lightheadedness-Severe, Systemic: Exhaustion/Lethargy-Severe, Systemic: Fever-Severe, Systemic: Flushed/Sweating-Severe, Systemic: Headache-Severe, Systemic: Joint Pain-Severe, Systemic: Weakness-Severe, Additional Details: Patient had these same symptoms following second COVID-19 Pfizer vaccination as well. Symptoms lasted 3 days after second dose.
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Asthenia, Chills, Dizziness, Fatigue
Clinical narrative: Systemic: Body Aches Generalized-Severe, Systemic: Chills-Severe, Systemic: Dizziness/Lightheadedness-Severe, Systemic: Exhaustion/Lethargy-Severe, Systemic: Fever-Severe, Systemic: Flushed/Sweating-Severe, Systemic: Headache-Severe, Systemic: Joint Pain-Severe, Systemic: Weakness-Severe, Additional Details: Patient had these same symptoms following second COVID-19 Pfizer vaccination as well. Symptoms lasted 3 days after second dose.
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Flushing, Headache, Hyperhidrosis, Lethargy, Pain
Clinical narrative: Systemic: Body Aches Generalized-Severe, Systemic: Chills-Severe, Systemic: Dizziness/Lightheadedness-Severe, Systemic: Exhaustion/Lethargy-Severe, Systemic: Fever-Severe, Systemic: Flushed/Sweating-Severe, Systemic: Headache-Severe, Systemic: Joint Pain-Severe, Systemic: Weakness-Severe, Additional Details: Patient had these same symptoms following second COVID-19 Pfizer vaccination as well. Symptoms lasted 3 days after second dose.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Acute promyelocytic leukaemia, Biopsy bone marrow abnormal
Clinical narrative: APL Leukemia
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Alopecia
Clinical narrative: After taking last booster shot on 12/23/21 about month later I started to notice 2 bald spots on my head. After a few months they grew back but 2 more large patches emerged.
Age: 29.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Asthma, Condition aggravated, Dyspnoea, Eczema
Clinical narrative: Immediately after (same day) eczema flare up on forearms. then asthma symptoms started on august 1. both resolved within 10 days with otc treatment for eczema and an inhaler for asthma.
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Rash
Clinical narrative: She suffered and severe rash that spread over her entire body and up to her hair lines and turned her skin red.
Age: 13.0
Sex: F
Vaccine: IPV
Symptoms: Asthenia, Chest pain, Dizziness, Dyspnoea, Heart rate increased
Clinical narrative: Swollen tongue and face Rapid heartrate Trouble breathing Dizziness  Weakness Nausea and vomiting  Chest pain
Age: 13.0
Sex: F
Vaccine: IPV
Symptoms: Nausea, Swelling face, Swollen tongue, Vomiting
Clinical narrative: Swollen tongue and face Rapid heartrate Trouble breathing Dizziness  Weakness Nausea and vomiting  Chest pain
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Disturbance in attention, Fatigue, Muscle twitching
Clinical narrative: My right inner-ear muscle(s) will not stop twitching. It is annoying but it?s also becoming exhausting and also very difficult to concentrate. Sleep seems ok so far.
Age: 6.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; patient was administered improper stored dose of PROQUAD; This spontaneous report has been received from a registered nurse concerning 6-years-old female patient. The patient's medical history, concurrent conditions, concomitant medications, previous drug reactions and allergies were not provided.   On 25-NOV-2020, the patient was vaccinated with improperly stored measles, mumps, rubella, and varicella (Oka-Merck) virus vaccine live (rHA) (PROQUAD) injection, administered subcutaneously, in the left arm, lot number T012419 had been verified to be a valid number; expiration date reported and validated as 06-OCT-2021, for prophylaxis (dosage and frequency were not provided) (product storage error). There was a previous temperature excursion on 25-OCT-2020. No additional adverse events were reported in the patient.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2207USA002212:
Sex: U
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: No additional AEs; Caller reported expired dose of PNEUMOVAX 23 was administered.; This spontaneous report has been received from pharmacist and referring to a patient of an unknown age and gender. The patient's pertinent medical history, current conditions, drugs reactions or allergies and concomitant medication was not provided.  On 21-JUL-2022, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0.5 mL (lot number T033369 has been verified to be a valid lot number with expiration date reported and established as: 26-MAY-2022) administered intramuscularly for prophylaxis (strength was not provided). No additional adverse events (AEs) reported.
Age: 25.0
Sex: F
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: No additional AE reported.; a 25 year old female patient was administered PROQUAD on 22JUL2022.; This spontaneous report was received from nurse via company representative and refers to a 25-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 22-JUL-2022, 25-year-old female patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection (albumin status, strength, dose. lot #, expiry date, route of administration, and anatomical location were not provided) for prophylaxis (product administered to patient of inappropriate age). No additional information provided.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; VARIVAX was administered after a temperature excursion/Temperature: -13.6C; This spontaneous report was received from a healthcare business professional (HBP) referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported.  On 17-NOV-2021, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot # U008180 had verified to be a valid lot #, expiration date: 15-DEC-2023; strength, dose, anatomical location and route of administration were not provided) for prophylaxis. It was reported that the suspect vaccine was underwent temperature excursions of -13.6 degree Celsius (C) (the time frame was unknown) (product storage error). There were no previous temperature excursions. No additional adverse event (AE) was reported (no adverse event).
Sex: U
Vaccine: HIBV, RV5
Symptoms: Product storage error
Clinical narrative: No additional AE; PEDVAX HIB and ROTATEQ administered after temperature excursion.; This spontaneous report has been received from a registered nurse concerning a unknown gender and age patient. No information regarding the patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications was provided.  On 25-JUL-2022, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) lot number U039951 had been verified to be a valid number; expiration date reported as 22-JUN-2023, and upon internal validation established as the same date, administered as prophylaxis ((strength, dose, units, vaccination scheme, frequency, route of administration and anatomical site of injection were not provided); and  rotavirus vaccine, live, oral, pentavalent (ROTATEQ), lot number W004502 had been verified to be a valid number; expiration date reported as 09-OCT-2023, and upon internal validation established as the same date, administered as prophylaxis (strength, dose, units, vaccination scheme, frequency, route of administration and anatomical site of injection were not provided). Both vaccines were stored at a temperature of 23.8 degree Celsius (C) for the time frame of 9 hours and 45 minutes (product storage error). There was no previous temperature excursion and no additional adverse events were reported.
Sex: U
Vaccine: HIBV, RV5
Symptoms: Product storage error
Clinical narrative: No additional AE.; PEDVAX HIB and ROTATEQ administred after temperature excursion.; This spontaneous report has been received from a nurse and refers to a patient of unknown gender and age.The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported.   On 25-JUL-2022, the patient was vaccinated with improperly storage dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) (lot number: W004502, which was determined to be valid, with an expiration date on 10-OCT-2023), and Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) (lot number: U039951, which was determined to be valid, with an expiration date on 22-JUN-2024). Both were administered as prophylaxis (strengths, doses, routes of administration, and anatomical sites of injection were not reported).   Administered doses were stored at a temperature of 23.8 degrees Celsius (C) during a time frame of 9 hours and 45 minutes (improper storage of product in use). There was no previous temperature excursion. No additional adverse events were reported in the patient.
Age: 0.08
Sex: F
Vaccine: RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE.; vaccine was administered after expiration; This spontaneous report was received from a medical assistant referring to a 7-week-old female patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 27-JUL-2022, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid (strength was not provided), 2 milliliter, lot #1821791, expiration date: 26-JUL-2022, administered orally for prophylaxis (Expired product administered).  Product was not involved in any temperature excursions. No additional adverse event (AE) or product quality complaint (PQC). The vaccine was not available for return due to disposed. The adverse event was previously reported to doctor and manufacturer.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Underdose
Clinical narrative: Caller is a nurse calling in to request information regarding revaccination recommendations for an infant to received ROTATEQ and regurgitated part of the dose(see request case 02215583 for details). Caller was a transfer; Caller is a nurse calling in to request information regarding revaccination recommendations for an infant to received ROTATEQ and regurgitated part of the dose(see request case 02215583 for details). Caller was a transfer from agent but; This spontaneous report was received from a registered nurse and refers to an infant patient of unknown gender. The exact age of the patient was not provided. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 25-JUL-2022, the patient was administered their first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 ml, lot # 1879860, expiration date: 13-OCT-2023, administered for prophylaxis (strength, and route of administration were not provided). The reporter stated that part of the dose was regurgitated (accidental underdose). The patient did not have any other adverse events after receiving their dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ). The outcome of the event of regurgitation was unknown.  The causal relationship between regurgitation and the suspect vaccine was not reported.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No other adverse events reported; Caller reports an expired dose of PNEUMOVAX 23 was administered to a patient today.; This spontaneous report has been received from a pharmacist concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and previous drug allergies were not provided.   On 29-JUL-2022 (also reported as today), the patient was vaccinated with expired dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) (lot number T033369 had been verified to be a valid number; expiration date reported and established as: 26-MAY-2022 (dose, route of administration, and anatomical location were not provided). The reporter confirmed dose was properly stored up through time of administration. No other adverse event were reported.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No futher adverse events; Caller is reporting administered dose of expired VAQTA.; This spontaneous report was received from the office manager referring to a patient of an unknown age and gender. The patient's pertinent medical history, concurrent conditions, drugs reactions or allergies and concomitant therapies was not provided.  On 29-JUL-2022, the patient was vaccinated with one expired dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, administered as prophylaxis (exact, dose, vccination scheme frequency, anatomical vaccination site and route of administration were not provided; lot number T023913 has been verified to be a valid lot number hepatitis a vaccine, inactivated (VAQTA) prefilled syringe, expiration date reported and upon internal validation established as 31-MAR-2022) (expired product administered). There was no previous temperature excursion. No adverse events reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs; Caller reported VARIVAX was administered after temperature excursion.; This spontaneous report was received from a physician via office manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 25-JUL-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) 0.5ml subcutaneously, lot # U026207, expiration date 24-AUG-2023, for prophylaxis. The vaccine had been improperly stored in the temperature of 41.5 Fahrenheit degrees (F) for 2 hours and 45 minutes with no previous temperature excursion. It was unknown if digital data logger was involved. No adverse events were reported.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Nurse calling for TE evaluation in TE case 02216792 reports 1 dose of PNEUMOVAX 23 administered to 1 patient.    Names of vaccines involved (including lot/exp) PNEUMOVAX 23 PFS  U034712  7/30/2023        ?    Temperature 0.6C        ?    Time fra; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 28-JUL-2022, the patient was vaccinated with improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, lot #U034712, expiration date: 30-JUL-2023 (strength, route of administration, and indication were not provided) administered for prophylaxis (Product storage error).  Administered dose of vaccine experienced the temperature excursion of 0.6 degrees Celsius for 23 hours. There was no previous temperature excursion.  There was no adverse event reported (No adverse event).
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AEs or PQC reported; Caller reported VARIVAX was administered after temperature excursion.; This spontaneous report was received from an office manager referring to a patient of an unknown age and gender. The patient's pertinent medical history, concurrent conditions, drugs reactions or allergies and concomitant therapies was not provided.  On 06-JUL-2022, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milliliters (ml) lot #U030161 has been verified to be a valid lot number with expiration date on 28-SEP-2023, administered subcutaneously (SQ) for prophylaxis (strength, vaccination scheme frequency and anatomical location were not provided).  The administered vaccine experienced the temperature excursion of 41.5 degrees Fahrenheit (F) for a timeframe of frame 2 hours and 45 minutes. There was no previous temperature excursion. No adverse events (AEs) were reported.
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: No additional AEs; HCP called in to report a temperature excursion and also reported that the vaccine, ROTATEQ was administered.; This spontaneous report was received from nurse referring to an unknown age and girder patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant therapies were not reported.  On 01-AUG-2022, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot number 1837118, which was determined to be valid, with an expiration date: 25-MAR-2023, administered orally for prophylaxis (strength, dose, anatomical site were not provided) (product storage error).  No additional adverse event (AE) information was provided (no adverse event).
Age: 13.0
Sex: U
Vaccine: HPV9, MNQ
Symptoms: Extra dose administered, Injection site rash, Injection site swelling, Injection site warmth, Rash
Clinical narrative: 10 cm localized raised, hot rash to the left arm site where MENVEO vaccine was administrated; 10 cm localized raised, hot rash to the left arm site where MENVEO vaccine was administrated; 10 cm localized raised, hot rash to the left arm site where MENVEO vaccine was administrated; Per doctor a patient was given two doses of GARDASIL 9 at the same time on 8/3/2022.; This spontaneous report was received from a physician and refers to a 13-year-old patient of unknown gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not reported.  On 03-AUG-2022, the patient was vaccinated at the same time with two doses (overdose) of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) to right arm (exact doses, strengths, formulations, lot #, expiration dates and route of administration were not provided) for prophylaxis. On an unknown date in 2022, the patient was vaccinated with a dose of meningococcal vaccine a/c/y/w conj (crm197) (MENVEO) to left arm (exact dose, strength, formulation, lot #, expiration date, route of administration and indication were not provided).  On 05-AUG-2022 (reported as now), the patient developed 10 cm localized raised, hot rash to left arm site where meningococcal vaccine a/c/y/w conj (crm197) (MENVEO) vaccine was administered. Outcome of events was not provided.   The relatedness between the events and suspect therapies was not provided.
Sex: U
Vaccine: MMR
Symptoms: Incorrect dose administered, Incorrect route of product administration, No adverse event
Clinical narrative: No additional AEs reported; Nurse reports the administration of MMR II intramuscularly versus subcutaneously.; Dose frequency: 0.7 mL; This spontaneous report was received from a register nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications were not provided.   On 03-AUG-2022, the patient was vaccinated with mumps, and rubella (wistar ra 27-3) virus vaccine, live rHA (recombinant human albumin) (M-M-R II) (lot number W009105, that was verified to be a valid number with an expiration date reported and established as 04-DEC-2023), administered at dose 0.7 milliliters (ml) (incorrect dose administered), intramuscularly versus subcutaneously (incorrect route of product administration), with a 25 gauge (G) 5/8 inch subcutaneous needle in the deltoid region, for prophylaxis (strength and vaccination scheme were not provided). No additional adverse events were reported.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event, Product availability issue
Clinical narrative: No additional AEs; customer missed 3rd dose due to unavailability of product; customer missed 3rd dose due to unavailability of product; This spontaneous report was received from a pharmacist and refers to a 32-year-old female patient. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not reported.  On unknown dates, the patient was vaccinated with the first and the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 ml (strengths, formulations, lot #, expiration dates, sites and routes of administration were not provided) as 3-dose schedule for prophylaxis.   On 24-JUL-2022, the patient missed 3rd dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) due to unavailability of product (product availability issue; inappropriate schedule of product administration). There was no additional adverse event reported.
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events.; Caller is medical assistant requesting four doses administered of improperly stored MMR II. No additional information available. No additional adverse events. No product quality complaints.   See related AEs for other patients:  02220156, 02220157, 0; This spontaneous report was received from a medical assistant and refers to a 12-month-old patient of unspecified gender. The patient's concomitant medications, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported.  On 27-JUL-2022, the patient was vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) subcutaneous injection, 1 dose, lot #U023829, expiration date: 30-JUL-2023 (exact dose, vaccination schedule, site and route of administration were not provided) for prophylaxis. The vaccine underwent excursion in 10.1 Celsius degrees (C) in a time frame of 15 minutes. No additional adverse events were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2208USA003406: US-009507513-2208USA003578: US-009507513-2208USA003711:
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Caller is medical assistant reporting administered doses of improperly stored vaccines; This spontaneous report has been received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant therapies and drug/allergy history were not reported.  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) (lot # U006485, has been verified to be a valid lot number for measles, mumps, and rubella [wistar ra 27-3] virus vaccine, live [rHA] [M-M-R II], expiration date reported and upon internal validation established as 26-FEB-2023) (dose, anatomical location, route of administration, lot#, and expiration date were not reported) and varicella virus vaccine live (oka/merck) (VARIVAX) (lot # U002400, has been verified to be a valid lot number for varicella virus vaccine live [oka/merck] [VARIVAX], expiration date reported and upon internal validation established as 22-JAN-2023) (dose, anatomical location, route of administration, lot#, and expiration date were not reported). Both vaccine doses were given as prophylaxis and were improperly stored (Product storage error) on 20-JUL-2022 as following: measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II): Above 8 Celsius degrees (°C) (8.8C) for 1 hour 27 minutes and 0 seconds; above 8C (8.5C) for 6 hours 39 minutes and 0 seconds; above 8C (8.8C) for 8 hours 45 minutes and 0 seconds; above 8C (10.7C) for 11 hours 42 minutes and 0 seconds; above 8C (9.83C) for 18 hours 48 minutes and 0 seconds; above 8C (9.5C) for 14 hours 10 minutes and 0 seconds; above 8C (9.0C) for 9 hours 24 minutes and 0 seconds and varicella virus vaccine live (oka/merck) (VARIVAX) at a temperature of -14°C up to -10°C (-13.1C) for 18 minutes and -14°C up to -10°C (-11.9C) for 21 minutes. The vaccines did not have previous temperature excursions.  No additional adverse events were reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Nurse reporting AE for improperly stored PROQUAD administered; This spontaneous report was received from a nurse and refers to a patient of unspecified age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 03-AUG-2022, the patient was vaccinated with an improper storage dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live, live recombinant Human Albumin (rHA) (PROQUAD) lot # W002783, expiration date: 24-JUL-2023 (strength, dose frequency, anatomical location and route of administration were not provided) administered as prophylaxis (Product storage error).   The improper storage lot # underwent a temperature excursion of -14.5 degrees Celsius (C) for 10 minutes without previous excursions. No adverse events were reported.  This is one of three reports received from the same reporter.; Sender's Comments:  US-009507513-2208USA003994:Case # 02220598 US-009507513-2208USA004112:Case # 02220597
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: a dose of M-M-R II was administered to a 4-year-old patient after a temperature excursion; This spontaneous report has been received from a medical assistant concerning a 4-year-old patient of unknown gender. The patient's concurrent conditions, medical history and drug/allergy history were not reported. The patient's concomitant medication included varicella virus vaccine live (Oka/Merck) (VARIVAX) and Diphtheria vaccine toxoid (+) pertussis vaccine acellular 3-component (+) polio vaccine inact 3V (Vero) (+) tetanus vaccine toxoid (KINRIX).  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) (lot # U025199, has been verified to be a valid lot number for measles, mumps, and rubella [wistar ra 27-3] virus vaccine, live [rHA] [M-M-R II], expiration date reported and upon internal validation established as 13-AUG-2023) (dose, anatomical location and route of administration were not reported) for prophylaxis. On 02-AUG-2022, the vaccine had a temperature excursion during 10 minutes (temperature 48° Fahrenheit [F]) (Product storage error). The vaccine had a previous temperature excursion on 13-JUL-2022 for 5 minutes at a temperature of 47.1° F.
Age: 16.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: No additional AE reported.; Customer called and reported that PROQUAD was inadvertently administered to a 16 year old consumer rather than MMR and VARICELLA.; Customer called and reported that PROQUAD was inadvertently administered to a 16 year old consumer rather than MMR and VARICELLA.; This spontaneous report was received from a medical assistant regarding 16-year-old patient of an unspecified gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 04-AUG-2022, the patient was inadvertently vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (PROQUAD) subcutaneous injection, 0.5 milliliter, lot #W012743, expiration date: 16-OCT-2023 (strength, and route of administration were not provided) as prophylaxis, instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) and varicella virus vaccine live (oka/merck) (manufacturer unknown) (Wrong product administered and Product administered to patient of inappropriate age). No additional adverse event (AE) reported.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional adverse events; administered doses of improperly stored VARIVAX; This spontaneous report was received from a vaccine coordinator and refers to a patient of unknown age and gender.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 08-AUG-2022, the patient was vaccinated with 1 dose of an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #U039948, expiration date: 16-DEC-2023, administered for prophylaxis (strength, and route of administration were not provided) (product storage error). The vaccine was stored at a temperature between 6 to 14 Fahrenheit degrees (F) for 6 hours and 15 minutes, and between 14 F to 46 F (15.2 F) for 1 hour and 30 minutes. There was no other previous temperature excursion. No additional adverse events were reported.; Sender's Comments:  US-009507513-2208USA004566:
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: no adverse event; Caller is vaccine coordinator reporting administered doses of improperly stored VARIVAX; This spontaneous report was received from a vaccine coordinator and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unspecified date, doses of varicella virus vaccine live (oka/merck) (VARIVAX) Lot #U039948, expiration date: 16-DEC-2023, underwent a temperature excursion of 6 to 14 fahrenheit degree for 6 hours and 15 minutes, and from 14 to 46 fahrenheit degree during 1 hour and 30 minutes, with no previous temperature excursions.  On 08-AUG-2022, the patient was vaccinated with one dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot #U039948, expiration date: 16-DEC-2023(strength, dosage regimen, anatomical location, and route of administration were not provided), administered for prophylaxis (Product storage error). No adverse event was reported.  This is one of the several cases reported by the same reporter.; Sender's Comments:  US-009507513-2208USA004548:
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional AE reported; Patient received improperly stored dose of PROQUAD; This spontaneous report has been received from a registered nurse concerning 12-month-old female patient. The patient's medical history, concurrent conditions, concomitant medications, previous drug reactions and allergies were not provided.   On 15-APR-2021, the patient was vaccinated with improperly stored measles, mumps, rubella, and varicella (Oka-Merck) virus vaccine live (rHA) (PROQUAD) injection, administered subcutaneously, in the left arm, lot number T012419 had been verified to be a valid number; expiration date reported and validated as 06-OCT-2021, for prophylaxis (dosage and frequency were not provided) (product storage error). There was a previous temperature excursion on 25-OCT-2020. No additional adverse events were reported in the patient.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2207USA002212:
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; patient was administered with improper stored dose of PROQUAD; This spontaneous report has been received from a registered nurse concerning 5-years-old female patient. The patient's medical history, concurrent conditions, concomitant medications, previous drug reactions and allergies were not provided.   On 27-SEP-2021, the patient was vaccinated with improperly stored measles, mumps, rubella, and varicella (Oka-Merck) virus vaccine live (rHA) (PROQUAD) injection, administered subcutaneously, in the left arm, lot number T012419 had been verified to be a valid number; expiration date reported and validated as 06-OCT-2021, for prophylaxis (dosage and frequency were not provided) (product storage error). There was a previous temperature excursion on 25-OCT-2020. No additional adverse events were reported in the patient.  This is one of several reports received from the same reporter, ; Sender's Comments:  US-009507513-2207USA002212:
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; patient was administered improper stored dose of PROQUAD; This spontaneous report has been received from a registered nurse concerning 12-months-old male patient. The patient's medical history, concurrent conditions, concomitant medications, previous drug reactions and allergies were not provided.   On 22-SEP-2021, the patient was vaccinated with improperly stored measles, mumps, rubella, and varicella (Oka-Merck) virus vaccine live (rHA) (PROQUAD) injection, administered subcutaneously, in the left arm, lot number T012419 had been verified to be a valid number; expiration date reported and validated as 06-OCT-2021, for prophylaxis (dosage and frequency were not provided) (product storage error). There was a previous temperature excursion on 25-OCT-2020. No additional adverse events were reported in the patient.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2207USA002212:
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; patient was administered improper stored dose of MMRII and VARIVAX; This spontaneous report has been received from a registered nurse concerning 12-months-old male patient. The patient's medical history, concurrent conditions, concomitant medications, previous drug reactions and allergies were not provided.   On 15-SEP-2021, the patient was vaccinated with improperly stored measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R-II), albumin status of rHA (recombinant human albumin), for prophylaxis, subcutaneously, in the left thigh, (lot number T012419 is an invalid lot number for measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R-II)) (dosage and frequency were not provided). Additionally on an unknown date (conflicting information reported as 15-SEP-2022), the patient was vaccinated with improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX), for prophylaxis, subcutaneously, in the right thigh,(lot number T003706 had been verified to be a valid number; expiration date 30-JAN-2022, and upon internal validation established as the same date) (dosage and frequency were not provided). However the administered doses of measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II), and varicella virus vaccine live (Oka/Merck) (VARIVAX) were stored at an unspecified temperature, during an unspecified time frame (product storage error). There was a previous temperature excursion on 25-OCT-2020. No additional adverse events were reported in the patient.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2207USA002212:
Age: 5.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE reported; patient was administered improper stored dose of varivax and MMRII; This spontaneous report has been received from a registered nurse concerning 5-years-old male patient. The patient's medical history, concurrent conditions, concomitant medications, previous drug reactions and allergies were not provided.   On 15-SEP-2021, the patient was vaccinated with improperly stored measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R-II), albumin status of rHA (recombinant human albumin), for prophylaxis, subcutaneously, in the right thigh, lot number T012419 is an invalid (lot number for measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R-II)) (dosage and frequency were not provided). Additionally, on 15-SEP-2021, the patient was vaccinated with improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX), for prophylaxis, subcutaneously, in the left arm, (lot number T003706 had been verified to be a valid number; expiration date 30-JAN-2022), and upon internal validation established as the same date (dosage and frequency were not provided).  However the administered doses of measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II), and varicella virus vaccine live (Oka/Merck) (VARIVAX) were stored at an unspecified temperature, during an unspecified time frame (product storage error). There was a previous temperature excursion on 25-OCT-2020. No additional adverse events were reported in the patient.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2207USA002212:
Age: 14.0
Sex: F
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: patient was administered improper stored dose of VARIVAX; No additional AE reported; This spontaneous report has been received from a registered nurse concerning 14-years-old female patient. The patient's medical history, concurrent conditions, concomitant medications, previous drug reactions and allergies were not provided.  On 25-OCT-2020, there was a temperature excursion. On an unknown date (conflicting information reported as 15-SEP-2022), the patient was vaccinated with improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX), subcutaneously, in the left arm, (lot number T003706 had been verified to be a valid number; expiration date 30-JAN-2022, and upon internal validation established as the same date) administered as prophylaxis (dosage and frequency were not provided). However, this administered dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) was stored at an unspecified temperature, during an unspecified time frame (product storage error). No additional adverse events were reported in the patient.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2207USA002212:
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: patient was administered improper stored dose of VARIVAX; No additional AE reported; This spontaneous report has been received from a registered nurse concerning 7-years-old female patient. The patient's medical history, concurrent conditions, concomitant medications, previous drug reactions and allergies were not provided.   On 25-OCT-2020, there was a temperature excursion. On an unknown date (conflicting information reported as 15-SEP-2022), the patient was vaccinated with improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX), subcutaneously, in the left deltoid, (lot number T003706 had been verified to be a valid number; expiration date 30-JAN-2022, and upon internal validation established as the same date) administered as prophylaxis (dosage and frequency were not provided). However, this administered dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) was stored at an unspecified temperature, during an unspecified time frame (product storage error). No additional adverse events were reported in the patient.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2207USA002212:
Sex: U
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Missed the last dose and took it late; A spontaneous report was received from the pharmacist on 21JUL2022. It described a patient of unknown age and gender who "missed the last dose and took it late" (PT: Inappropriate schedule of product administration). The patient took the Vivotif (typhoid vaccine live oral Ty21A) (lot number: unknown) for immunisation. It was reported that the patient missed the last dose and took it late. Reportedly, the last dose was due on Friday (15JUL2022) and the patient did not take it until Tuesday (19JUL2022).  Action taken with Vivotif with respect to the reported event was not applicable.  The outcome of the reported event was unknown.  No additional information was reported.  Company comment: It was reported that a patient missed the last dose and took it late (inappropriate schedule of product administration). Vivotif dose should be taken every other day, and the causality of inappropriate schedule of product administration is assessed as not applicable to Vivotif considering the nature of the event.; Sender's Comments: It was reported that a patient missed the last dose and took it late (inappropriate schedule of product administration). Vivotif dose should be taken every other day, and the causality of inappropriate schedule of product administration is assessed as not applicable to Vivotif considering the nature of the event.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Rash, Vaccination failure
Clinical narrative: had both doses 3 years ago, developed shingles/ suspected Vaccination failure; have developed shingles; slight rash; pain was persistent, seek medical care; This case was reported by a consumer and described the occurrence of vaccination failure in a 72-year-old 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 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, rash and pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, rash and pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, rash and pain to be related to Shingrix and Shingrix.     Additional Information: GSK receipt date: 10-Aug-2022 Reporter's comment: The patient was 72 years old and in good health. The patient had both doses of the shingrex vaccine three years ago. The patient had developed shingles and been diagnosed and treated by his/her primary health care professional. The patient had only a very slight rash, but pain was persistent enough to make him/her seek medical care. The patient was disappointed that the patient had shingles, trying to avoid it by getting the vaccine. On the other hand, the patient heard many accounts of serious and painful bouts of shingles, and he/she consider his/her case light most likely due to having the vaccine. Additional supportive information: This case was considered as suspected vaccination failure as details regarding time to onset, laboratory test confirming shingles were unknown at the time of reporting. The reporter consent to follow up was unknown.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got shot and still had singles/Suspected vaccination failure; got shot and still had singles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male 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: 30-July-2022 Reporter's comment: The case was received from the patient's wife via interactive digital media. The patient got the shot and still had shingles. Additional supportive information: 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. The follow-up could not be possible as no contact details were available.