chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: incorrect product storage; This spontaneous report was received from a medical student concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 08-DEC-2021, the patient was vaccinated with an improperly stored of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) for prophylaxis (lot # T034380, has been verified to be a valid lot number measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, expiration date not reported, but upon internal validation establish as 08-JAN-2022) (strength, dose, route of administration and anatomical location were not provided).  The temperature of storage and time frame of the excursion were 66.6° Fahrenheit (F) for 13 hours respectively.  If a digital data logger was involved was not reported.  If the vaccine experienced a previous temperature excursion was reported as multiple.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: administration of expired PROQUAD (Lot: T025510; Exp: 23JAN2022) to a 4 year old male patient on 05FEB2022.; No additional AE reported; This spontaneous report was received from Other Health Professional and refers to a 4-year-old male. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 05-FEB-2022, the patient was vaccinated with the first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, route and anatomical location were not provided)  lot #T025510, expiration date: 23-JAN-2022 (Expired product administered) administered for prophylaxis The patient did not experienced additional adverse event.  It was confirmed that measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) had no prior temperature excursion and had be stored per the recommended storage range until administration.
Sex: F
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse event; Expired vaccine administered; This spontaneous report was received from a clinical director referring to a 12-month-old female. Information regarding the patient's medical history, concurrent conditions or concomitant medications was not provided.  On 27-JAN-2022, the patient was vaccinated with an expired varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milliliter, administered for prophylaxis (valid lot #T002847, expiration date: 23-JAN-2022) (route of administration, vaccination scheme frequency, and anatomical location were not provided). No additional adverse event was reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No other adverse experiences; Improperly stored VARIVAX; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, drug allergies/reactions or concomitant medications was not provided.  On 07-FEB-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 1 dose, for prophylaxis (valid lot #U015682, expiration date: 18-MAY-2023) (route of administration, vaccination scheme frequency, and anatomical location were not reported). The administered dose of the vaccine experienced a temperature excursion 9.7 degrees Fahrenheit (F) for 20 minutes. There was no other adverse experiences reported.  This is one of several reports received from the same reporter.
Sex: M
Vaccine: HPV9
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: No side effect noted; administration of Gardasil 9 to a 5 years old patient; This spontaneous report has been received from a nurse regarding to a 5-year-old male patient. The patient's concurrent conditions, medical history, concomitant therapies, drug allergies and reactions were not reported.    On 08-FEB-2022, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) 0.5 mL, lot # 1775808, expiration date reported as 20-AUG-2023, intramuscular in his left arm for prophylaxis with no side effect at the reporting time.
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: She received an HPV vaccine 10 years ago and received recently the first dose of Gardasil 9; no adverse event; She received an HPV vaccine 10 years ago and received recently the first dose of Gardasil 9; This spontaneous report has been received from a consumer regarding to herself a female patient of unknown age.  The patient's concurrent conditions, medical history, concomitant therapies, drug allergies and reaction were not reported.   In 2012 also reported as 10 years ago, the patient was vaccinated with a dose of unspecified hpv vaccine for prophylaxis. In 2022, the patient has recently vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot #, expiration date, dose, route of administration and anatomical location of vaccine were not reported) for prophylaxis by recommendation of her Obstetrics and Gynecology (OBGYN) . The reported said that she was on schedule for the second and third dose.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: Error: Wrong Route (SC, IM, etc.).
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE; PROQUAD administered to 14-year-old; This spontaneous report was received from a nurse referring to a 14-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.   On 07-FEB-2022, the patient was vaccinated with measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (rHA) (PROQUAD) injection, 0.5 milliliters (ml) by subcutaneous route as prophylaxis (lot number U029324 which has been verified to be valid, expiration date reported and validated as 19-MAR-2023) (anatomical site of injection was not reported) (product administered to patient of inappropriate age). No additional adverse events were reported in the patient.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dyspnoea, Flushing, Hyperhidrosis, Panic attack
Clinical narrative: Systemic: Patient stated trouble breathing but ended up not from allergic reaction but from anxiety and panic attack-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Shakiness-Medium, Additional Details: Patient has history of allergies to various fruits. Patient was worried about allergy, did not mention anxiety or panic attacks. After admin, patient stated was having trouble breathing, called 911 and administered oral Benadryl. Patient symptoms did not progress. Patient and family then commented she has anxiety and panic attacks and may be anxiety. Patient, family, myself, and EMTs after evaluation and monitoring felt was due to anxiety. Told patient and family will be drowsy and sedated from Benadryl.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence, Tremor
Clinical narrative: Systemic: Patient stated trouble breathing but ended up not from allergic reaction but from anxiety and panic attack-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Shakiness-Medium, Additional Details: Patient has history of allergies to various fruits. Patient was worried about allergy, did not mention anxiety or panic attacks. After admin, patient stated was having trouble breathing, called 911 and administered oral Benadryl. Patient symptoms did not progress. Patient and family then commented she has anxiety and panic attacks and may be anxiety. Patient, family, myself, and EMTs after evaluation and monitoring felt was due to anxiety. Told patient and family will be drowsy and sedated from Benadryl.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Mechanical urticaria, Pruritus, Urticaria
Clinical narrative: On Feb 23rd I began experiencing intense itching and hives all over my body. It has been over 1 week and I am still experiencing itching throughout my body and dermatographia. The welts caused by light touch are very uncomfortable and add on to the already intense itching. Called my doctor and was ordered 5 days of prednisone, but experienced no relief. Started taking allegra and it makes the itching less intense and my skin less reactive touch.
Age: 33.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Fatigue, Feeling cold, Headache, Nausea
Clinical narrative: Body aches, fatigue, cold chills, headache, nausea. Started evening of vaccine. Worse the next day.
Age: 33.0
Sex: F
Vaccine: UNK
Symptoms: Pain
Clinical narrative: Body aches, fatigue, cold chills, headache, nausea. Started evening of vaccine. Worse the next day.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Mobility decreased, Muscle tightness
Clinical narrative: Tightness in back started 03/03/22. Spread to the rest of the back and left chest on 03/04/22. Difficulty breathing and moving morning of 03/05/22.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Dyspnoea, Endotracheal intubation, Intensive care, Mechanical ventilation
Clinical narrative: I broke out in hives all over my body the morning of the December 29th. I contacted my dermatologist on December 29th and she instructed me to go to the emergency room. I went to the emergency room around 7pm or 8pm. I waited for 3 hours in the ER without being seen. I went home due to the long wait and took two benadryl around 11pm. I woke up the morning of the 30th at 2am with my throat closing where I couldn't breath. I was rushed back to the ER by my husband and was intubated. I was put on a ventalator for 4day in the ICU unit.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness, Urticaria
Clinical narrative: I broke out in hives all over my body the morning of the December 29th. I contacted my dermatologist on December 29th and she instructed me to go to the emergency room. I went to the emergency room around 7pm or 8pm. I waited for 3 hours in the ER without being seen. I went home due to the long wait and took two benadryl around 11pm. I woke up the morning of the 30th at 2am with my throat closing where I couldn't breath. I was rushed back to the ER by my husband and was intubated. I was put on a ventalator for 4day in the ICU unit.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported; patient received improperly stored vaccine; This spontaneous report was received from a medical assitant and refers to a 13-month-old (gender not reported). The patient's concurrent conditions, medical history or concomitant medications were not provided.   On 12-SEP-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 1 dosage form, lot #U024221, has been verified to be a valid lot number for varicella virus vaccine live, expiration date reported as 04-OCT-2023, but upon internal validation established as 04-AUG-2023)administered for prophylaxis (strength, and route of administration were not provided). The vaccine had been improperly stored at a temperature of 39.55F for a time fram of 10 hours. There was no previous temperature excursion. No adverse event was reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no other issues; ROTATEQ was improperly stored and administered; This spontaneous report was received from an office manager referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided.   On 08-FEB-2022, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot #1742464, expiration date 20-SEP-2022; strength, dose schedule, route and anatomical location were not provided) for prophylaxis (product storage error).  The administered dose of the vaccine experienced a temperature excursion in 47 Fahrenheit degrees (F) for 15 minutes. It was not reported whether there was previous temperature excursion or not. No other issues or concerns noted (no adverse event).  This is one of three reports received from the same reporter.; Sender's Comments:  US-009507513-2202USA003395: US-009507513-2202USA003391:
Age: 1.08
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported; a patient received improperly stored vaccine; This spontaneous report was received from a medical assistant referring to a 13-month-old patient of unknown gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided.   On 09-DEC-2021, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) 1 dose (lot # U015677, expiration date 18-MAY-2023; strength, route and anatomical location were not provided) for prophylaxis (product storage error).   The administered dose of the vaccine experienced a temperature excursion in 39.55 Fahrenheit degrees (F) for 10 hours. There was no previous temperature excursion. No additional adverse events (AEs) were reported.
Sex: F
Vaccine: PPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 21 month old twin girls received pneumococcal vaccine; Literature report:   This literature marketed report has been received from authors of the literature article entitled as stated above.   This report referred to a 21 months old female patient born at 35 weeks with 22q11.21 microduplication syndrome. The patient had aryngomalacia and congenital heart disease including patent ductus arteriosus (PDA) and pulmonary artery sling s/p repair at 3 months of age which was well tolerated. On an unknown date, the patient was vaccinated with diphtheria vaccine, hib vaccine and tetanus vaccine. The patient had slight speech delays. The patient was healthy without history of recurrent infections and was up to date on vaccines including live virals. No other physical abnormalities such as cleft lip or palate or known electrolyte abnormalities.  On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (dose, strength, route, lot# and expiration date were unknown) for prophylaxis (product administered to patient of inappropriate age.).  A copy of the published article is attached as further documentation of the patient's experience.  This is one of two reports obtained from the same literature (2203USA000036).; Sender's Comments:  US-009507513-2203USA000036:
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; an expired dose of GARDASIL 9 was administered to a patient on 6 DEC 2021; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.       On 06-DEC-2021, the patient was vaccinated with an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # S010729, expiration date 01-DEC-2021, 0.5 milliliter) for prophylaxis (expired product administered). The expired vaccine did not experience a temperature excursion. No adverse event was reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs; improperly stored vaccines; improperly stored vaccines; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 10-NOV-2021 and on 13-DEC-2021, the patient was vaccinated with an improper stored varicella virus vaccine live (oka/merck) (VARIVAX) vaccine subcutaneous injection, (lot # U010399, expiration date 01-APR-2023) (strength, dose and route were not provided) for prophylaxis. Temperature was recorded as 10 Farenheit (F), time duration was 350 hours and there was no previous temperature excursion. No further information was provided. No other adverse events was reported (no adverse event).
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs reported; VARlVAX that expired on 23JAN2022 was administered on 28JAN2022; This spontaneous report was received from a consumer, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 28-JAN-2022, the patient was vaccinated with an expired varicella virus vaccine live (oka/merck) (VARIVAX) injection (strength, vaccination scheme, anatomical site of vaccination, and route of administration were not reported; lot number T002842, expiration date reported and validated as 23-JAN-2022) as prophylaxis (expired product administered). No additional adverse events (AEs) reported.
Age: 0.42
Sex: M
Vaccine: HPV9
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: No further adverse events reported; Gardasil 9 was administered to a 5 month old patient; This spontaneous report was received from a certified medical assistant and refers to a 5-month-old male patient. The patient's concurrent conditions, drug reactions or allergies, pertinent medical history and concomitant therapy were not reported.      On 12-FEB-2022, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), lot # T026168, expiration date 04-DEC-2022, 0.5 milliliter (route not reported) for prophylaxis (product administered to patient of inappropriate age). No further adverse events were reported. There was no product quality complain.
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: a male patient missed the third dose of the GARDASIL 9 series; This spontaneous report was received from a student pharmacist referring to a male patient of unknown age. Information about medical history, concurrent conditions and concomitant therapies was not provided.     On an unknown date, the patient received two doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, dose, route, lot # and expiration date were not reported) for prophylaxis. On an unknown date, the patient missed the third dose (inappropriate schedule of product administration).
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse events were reported; Patient received an expired Proquad; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, drug reaction or allergies, pertinent medical history and concomitant therapy were not reported.    On 17-FEB-2022, the patient was vaccinated with 1 dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD), lot # T028298, expiration date 16-FEB-2022 (route not reported) for prophylaxis (expired product administered). No additional adverse events or product quality complain were reported.
Age: 19.0
Sex: F
Vaccine: HPV9
Symptoms: Anxiety, COVID-19
Clinical narrative: Missed the third dose of the vaccine; COVID-19; Mental anxiety; This spontaneous report was received from a consumer concerning her 19-year-old daughter with asthma, colitis microscopic and human papillomavirus (HPV) diagnosed on approximately 2008 (also reported at age 6). The patient's drug allergies included allergy to amoxicillin, penicillin and clindamycin. The patient did not take any concomitant therapy.  On 12-AUG-2021, the patient was vaccinated with her first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) as prevention against HPV (dose, strength, frequency, route of administration, anatomical location and lot number were not provided).   On 19-AUG-2021, the patient experienced mental anxiety.  On 15-OCT-2021, the patient was vaccinated with her second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) as prevention against HPV (dose, strength, frequency, route of administration, anatomical location and lot number were not provided). On 25-JAN-2022, she was diagnosed with COVID-19 (coronavirus disease 19); therefore, she missed the third dose of the vaccine that was programmed on 12-FEB-2022. The patient did not seek medical attention.  At the reporting time, the patient was recovering from mental anxiety and the outcome of the event COVID-19 was unknown. The reporter did not perform a causality assessment between the reported events and vaccination with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9).
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse event; Rotateq that underwent high and low temperature excursions was administered; This spontaneous report was received from a medical assistance referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, drug reactions or allergies were no reported.   On 22-FEB-2022, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (Lot# 1741381and expiration date 04-SEP-2022) (exact dose and frequency were not reported) as prophylaxis. (product storage error). The vaccine underwent a high and low temperature excursion below 36 Fahrenheit (35.4 Fahrenheit) for 0 hours 12 minutes and 0 seconds. Previous temperature excursion was above 47 Fahrenheit (51.4 Fahrenheit) for 1 hours 6 minutes and 0 seconds. No additional adverse event reported, no further information provided.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional AE filed; PROQUAD was involved in a temperature excursion on Jan 20, 2022. PROQUAD has been administered to multiple patients since the temperature excursion; This spontaneous report was received from a medical assistant referring to a 5-year-old female patient. No information was provided regarding the patient's historical conditions, previous drug reactions, allergies, concurrent conditions or concomitant medications      On 20-JAN-2022, measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin) (PROQUAD) was involved in a temperature excursion and on 21-JAN-2022, the patient was vaccinated with this improperly stored vaccine once at right thigh for prophylaxis (lot # U010745 with an expiration date on 03-OCT-2022; dose and route of administration, were not reported).   The freezer had a lot of ice, while it was being cleaned, the door was open for 15 minutes, and there was temperature excursion. The dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin) (PROQUAD) was exposed to a temperature excursion of 21.1 degrees Fahrenheit (°F) during a time frame of 2 hours 34 minutes. The temperature excursion occurred as a result of a reading from a Digital Data Logger. There was no prior temperature excursion and no adverse event was reported.  This is one of two reports received from the same reporter.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional AE filed; PROQUAD was involved in a temperature excursion on Jan 20, 2022. PROQUAD has been administered to multiple patients since the temperature excursion; This spontaneous report was received from a medical assistant referring to a 4-year-old male patient. No information was provided regarding the patient's historical conditions, previous drug reactions, allergies, concurrent conditions or concomitant medications      On 20-JAN-2022, measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin) (PROQUAD) was involved in a temperature excursion and on that day, the patient was vaccinated with this improperly stored vaccine once at left thigh for prophylaxis (lot # U010745 with an expiration date on 03-OCT-2022; dose and route of administration, were not reported).   The freezer had a lot of ice, while it was being cleaned, the door was open for 15 minutes, and there was temperature excursion. The dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin) (PROQUAD) was exposed to a temperature excursion of 21.1 degrees Fahrenheit (°F) during a time frame of 2 hours 34 minutes. The temperature excursion occurred as a result of a reading from a Digital Data Logger. There was no prior temperature excursion and no adverse event was reported.  This is one of two reports received from the same reporter.
Sex: M
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse event reported; Expired MMR II vaccine administered; This spontaneous report was received from a pharmacist referring to a 26-year-old male patient. The patient's concurrent conditions, pertinent medical history, concomitant medications, drug reactions or allergies were no reported.   On 17-FEB-2022, the patient was vaccinated with expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) recombinant human albumin (rHA) (Lot# S039316 and expiration date 04-DEC-2021) (exact dose and frequency were not reported) as prophylaxis. (expired product administered). There was no previous temperature excursion. No additional adverse event reported, no further information provided.
Sex: U
Vaccine: MMR
Symptoms: Vaccination complication
Clinical narrative: serious reaction to MMR; This literature marketed report was received from the authors of the published article as stated below, concerning a child (gender and age were not provided).  The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.  On unspecified date, the patient received a dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown) for prophylaxis.   It was reported that after immunization, the patient experienced a serious reaction to Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown). At the time of the report, the patient's outcome was not provided. According to the reporter, the event of reaction to Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown) was considered medically significant (serious). The authors considered the event to be related to suspect therapy.  Literature article:
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Anxiety, Eating disorder, Injury, Loss of personal independence in daily activities, Social problem
Clinical narrative: It may my life very hard/I had a hard time making friends/I could not play sports/ I could not attend to regular school; It made me worry about forever/It made me worry about the world collapsing; I have a hard time talking; I had to be careful of what I ate; This spontaneous report was received from the patient's mother referring to a 1-year-old male. The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  On an unknown date in 2003 (reported as "when I was one"), the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (dosage regimen, lot #, expiry date, and route of administration were not provided), administered as prophylaxis.  Since an unspecified date in 2003, the patient reported that was injured by the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) vaccine. He stated that made his life very hard, he had a hard time making friends, and could not attend regular school and not play sports (Unevaluable event). The vaccine made him me worry about forever, worry about the world collapsing (Anxiety). Also, he reported that had a hard time talking (Speech disorder) and he had to be careful of what he ate (Eating disorder). The patient saw a lots of doctors over the years to try to help him be healthier. At the time of the report, the outcome of the event were not provided.  The causal relationship all reported events and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was unknown.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Speech disorder
Clinical narrative: It may my life very hard/I had a hard time making friends/I could not play sports/ I could not attend to regular school; It made me worry about forever/It made me worry about the world collapsing; I have a hard time talking; I had to be careful of what I ate; This spontaneous report was received from the patient's mother referring to a 1-year-old male. The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  On an unknown date in 2003 (reported as "when I was one"), the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (dosage regimen, lot #, expiry date, and route of administration were not provided), administered as prophylaxis.  Since an unspecified date in 2003, the patient reported that was injured by the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) vaccine. He stated that made his life very hard, he had a hard time making friends, and could not attend regular school and not play sports (Unevaluable event). The vaccine made him me worry about forever, worry about the world collapsing (Anxiety). Also, he reported that had a hard time talking (Speech disorder) and he had to be careful of what he ate (Eating disorder). The patient saw a lots of doctors over the years to try to help him be healthier. At the time of the report, the outcome of the event were not provided.  The causal relationship all reported events and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was unknown.
Sex: F
Vaccine: VARZOS
Symptoms: Dry skin, Herpes zoster, Rash, Rash erythematous, Rash vesicular
Clinical narrative: shingles/herpes zoster without complication; This spontaneous report was received from a nurse practitioner via medical records and a lawyer regarding a case in litigation and refers to a 62 year old female patient with allergy to penicillin and seasonal allergies. The patient's historical vaccinations included: H1N1 vaccine and influenza vaccine. On 11-JUN-2014 at 10:26am, the patient was vaccinated with a 0.65 mL dose of zoster vaccine live (ZOSTAVAX) (Lot # J014566 exp date 18-FEB-2015) subcutaneously in the right arm for long-term prevention of shingles for zoster-related conditions and a 0.5 mL dose of diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid at 10:24am.  On 31-OCT-2015, the patient presented to the ED due to rash that just started earlier on the same date as a red spot on her sternum and had spread under her right breast and around to her back. She stated it did not hurt or itch, but in the evening when she took her bra, she stated it became very irritating. The patient stated that when she was vaccinated for shingles she did not had symptoms. Skin examination showed skin was warm and dry. Rash was noted. Erythematous vesicular rash in patches along right side of chest and back. Did not cross midline. No weeping. The patient was diagnosed with herpes zoster without complication and was prescribed with acyclovir (ZOVIRAX) 200 mg capsule, 1 capsule 5 times a day. The patient was discharge to home/self-care. At the time of the report, the patient's outcome was unknown.  The lawyer consider shingles to be related to the use of zoster vaccine live (ZOSTAVAX).  The nurse did not assess the causality between shingles and zoster vaccine live (ZOSTAVAX).  All available medical records will be provided upon request.
Sex: F
Vaccine: VARZOS
Symptoms: Skin irritation, Skin warm
Clinical narrative: shingles/herpes zoster without complication; This spontaneous report was received from a nurse practitioner via medical records and a lawyer regarding a case in litigation and refers to a 62 year old female patient with allergy to penicillin and seasonal allergies. The patient's historical vaccinations included: H1N1 vaccine and influenza vaccine. On 11-JUN-2014 at 10:26am, the patient was vaccinated with a 0.65 mL dose of zoster vaccine live (ZOSTAVAX) (Lot # J014566 exp date 18-FEB-2015) subcutaneously in the right arm for long-term prevention of shingles for zoster-related conditions and a 0.5 mL dose of diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid at 10:24am.  On 31-OCT-2015, the patient presented to the ED due to rash that just started earlier on the same date as a red spot on her sternum and had spread under her right breast and around to her back. She stated it did not hurt or itch, but in the evening when she took her bra, she stated it became very irritating. The patient stated that when she was vaccinated for shingles she did not had symptoms. Skin examination showed skin was warm and dry. Rash was noted. Erythematous vesicular rash in patches along right side of chest and back. Did not cross midline. No weeping. The patient was diagnosed with herpes zoster without complication and was prescribed with acyclovir (ZOVIRAX) 200 mg capsule, 1 capsule 5 times a day. The patient was discharge to home/self-care. At the time of the report, the patient's outcome was unknown.  The lawyer consider shingles to be related to the use of zoster vaccine live (ZOSTAVAX).  The nurse did not assess the causality between shingles and zoster vaccine live (ZOSTAVAX).  All available medical records will be provided upon request.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: No additional AEs; an adult patient received a pediatric dose of VAQTA; an adult patient received a pediatric dose of VAQTA; This spontaneous report was received from a nurse referring to an adult patient of unknown age and gender. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.      On 23-FEB-2022, the adult patient received a pediatric dose (0.5 milliliter/once) of hepatitis a vaccine, inactivated (VAQTA) lot # U026536, expiration date 12-OCT-2022, for prophylaxis (incorrect dose administered, product administered to patient of inappropriate age). No additional adverse events were reported, no further information provided.
Sex: M
Vaccine: PNC13, PPV
Symptoms: Pneumonia
Clinical narrative: Pneumonia twice in the years of 2009-2014; This spontaneous report was received from a consumer regarding himself a 78-year-old male. The patient's medical history and concurrent conditions were not reported.  On an unknown dates in 2006 and 2009, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, lot #, expiry date, and route of administration were not provided) for prophylaxis. On an unknown date in 2014, the patient was vaccinated with pneumococcal vaccine CONJ 13V (CRM197) (PREVNAR 13).  On an unspecified dates in 2009 and 2014, the patient experienced pneumonia twice. The patient received antibiotics (unspecified) as treatment for the event. At the time of reporting, the patient recovered for the event.   The causal relationship between pneumonia and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was unknown.     Upon internal review, pneumonia was determined to be medically significant.
Sex: M
Vaccine: PPV
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: yearly vaccine; This spontaneous report has been received from a lawyer, via a Plaintiff Fact Sheet from a case in litigation for zoster vaccine live (ZOSTAVAX) (MARRS # 2110USA007820), concerning an approximately 60-year-old male patient. Concurrent condition, medical history and concomitant medication were not reported.  On an unknown date in 2008, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown) for prophylaxis (strength, dose, route, lot#, and expiration date were not reported). The vaccine was administered yearly to present (inappropriate schedule of product administration).; Sender's Comments:  US-009507513-2110USA007820:
Sex: M
Vaccine: VARZOS
Symptoms: Eye irritation, Eye pain, Lacrimation increased, Ophthalmic herpes zoster, Vision blurred
Clinical narrative: burning, irritation, painful and tearing sensation in the left eye with blurred vision and was later diagnosed with Zoster Keratitis of the left eye; Information has been received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Information about concurrent condition, history condition and concomitant medication was not reported. On or around 03-APR-2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered a burning, irritation, painful and tearing sensation in the left eye with blurred vision and was later diagnosed with zoster keratitis of the left eye. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms had resulted in physical limitations not present prior to using the vaccine. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was considered to be not recovered and causal relationship was assessed as related.  The lawyer considered the event to be disability.  Upon internal review, the event was considered to be medically significant.
Sex: F
Vaccine: HPV9
Symptoms: Incomplete course of vaccination
Clinical narrative: 48-year-old patient who need to receive GARDASIL 9; No other AE; Spontaneous information has been received from a consumer regarding a 48-year-old female patient who needed to receive HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9). The patient was on unspecified immunosuppressants due to a lung transplant and a "leep procedure". It was confirmed that at the time of reporting, the patient had not received a dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9). No other adverse event was reported.
Sex: F
Vaccine: PPV
Symptoms: Product administered to patient of inappropriate age, Viral titre decreased
Clinical narrative: She had low pneumococcal titers with good response to booster; 21 month old twin girls received pneumococcal vaccine; Literature report:  This literature marketed report has been received from authors of the literature article entitled as stated above.   This report referred to a 21 months old female patient born at 35 weeks with 22q11.21 microduplication syndrome. The patient had narrow aorta without surgical intervention required and with normal immune system. The patient had slight speech delays. The patient was healthy without history of recurrent infections and was up to date on vaccines including live virals. No other physical abnormalities such as cleft lip or palate or known electrolyte abnormalities.  On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (dose, strength, route, lot# and expiration date were unknown) for prophylaxis (product administered to patient of inappropriate age.).  On an unknown date, the patient experienced low pneumococcal titers with good response to booster. The outcome of low pneumococcal titers was unknown. The reporter considered low pneumococcal titers to be related to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown).  A copy of the published article is attached as further documentation of the patient's experience.  This is one of two reports obtained from the same literature (2202USA003399).; Sender's Comments:  US-009507513-2202USA003399:
Age: 1.0
Sex: M
Vaccine: HPV9
Symptoms: Incorrect route of product administration, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 1-year-old was vaccinated with GARDASIL 9 subcutaneously; 1-year-old was vaccinated with GARDASIL 9 subcutaneously; 1-year-old was vaccinated with GARDASIL 9 subcutaneously; This spontaneous report has been received from a physician and an office manager, concerning a 1-year-old male patient. The patient's concomitant vaccines were Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) and pneumococcal vaccine conj 13v (crm197) (PREVENAR 13). No information was provided regarding the patient's pertinent medical history, current conditions, previous drug reactions, or allergies.  On 28-FEB-2022, the patient was vaccinated mistakenly with one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) administered subcutaneously (product administered to patient of inappropriate age, incorrect route of product administration) as prophylaxis (lot number T028583 has been verified to be a valid lot number, expiration date reported and established as 04-MAR-2023) (exact dose, route and anatomical location of administration were not reported). No other adverse events (AE) reported (no adverse event).
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No other AE; An expired dose of GARDASIL9 was administered to a patient; This spontaneous report has been received from a medical assistant, concerning patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, current conditions, previous drug reactions, or allergies.  On 28-FEB-2022, the patient was vaccinated with an expired dose as the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) as prophylaxis (lot number R030453 has been verified to be a valid lot number, expiration date reported and established as 23-JUL-2021) (exact dose, route and anatomical location of administration were not reported) (expired product administered). No other adverse events (AE) reported (no adverse event), no temperature excursion.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect route of product administration
Clinical narrative: it was admin to a patient via IM injection instead of subcutaneously; This spontaneous report was received from a medical assistant referring to a patient of unreported age and gender.   No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 28-FEB-2022 the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) via intramuscular injection instead of subcutaneously (incorrect route of product administration) for prophylaxis (lot number: u028181, expiration date: 08-MAR-2023; concentration, dose, vaccination scheme frequency, and anatomical location were not reported).
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; an expired dose of PROQUAD was inadvertently administered to a patient; Spontaneous information has been received from a nurse referring to patient of unknown age or gender. Information regarding the patient' medical history, concurrent conditions, concomitant therapies and drug allergies or reactions were not provided.   On 28-FEB-2022, the patient was inadvertently administered an expired dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (dose and route not reported; lot # T029102, expiration date: 23-FEB-2022). It was confirmed that the vaccine was not involved in any temperature excursion prior to the administration and had been stored in the recommended storage range until the administration. No additional adverse event was reported.
Sex: M
Vaccine: PPV
Symptoms: Antibody test abnormal
Clinical narrative: Titers to Pneumococcal strains were protective in only 2/13 stains/Six months later, his pneumococcal titers were 13/14; Received extra doses of Pneumococcal vaccine; This literature marketed report has been received from the authors of a published literature article, titled as stated below concerning to a 4-year-old boy. The patient's concurrent conditions included Mowat-Wilson Syndrome (MWS), Hirschsprung's disease, specific antibody deficiency (memory phenotype), and he suffered frequent infections: gastroenteritis, otitis media, respiratory syncytial virus (RSV) bronchiolitis, streptococcal pharyngitis, hand foot and mouth disease, preseptal cellulitis, and influenza. The patient's medical history included five sets of tympanostomy tubes insertion and adenoidectomy. Due to the frequent bouts of gastroenteritis, including one requiring hospitalization and he had a colostomy at age two. Concomitant vaccines included diphtheria vaccine toxoid (+) pertussis vaccine acellular (+) tetanus vaccine toxoid (DTaP).  On an unknown date, the patient was vaccinated with pneumococcal vaccine polyvalent (23-valent) (Also reported as "PPSV-23") (manufacturer unknown) (strength, dose, route of administration, anatomical location, lot number and expiration date were not reported) for prophylaxis. The patient's mother stated the patient had responded well. Outside records confirmed post-PPSV-23 titers were adequate two years ago (date not specified).   On an unknown date, the titers to Pneumococcal strains were protective in only 2/13 stains (Antibody test abnormal). The patient was again vaccinated with PPSV-23 (manufacturer unknown) (strength, dose, route of administration, anatomical location, lot number and expiration date were not reported). On an unknown date, six months later, his pneumococcal titers were 13/14 protective. At the reporting time, the outcome of the event antibody test abnormal was recovering.   The authors considered the antibody test abnormal to be related to pneumococcal vaccine polyvalent (23-valent) (manufacturer unknown). The patient with MWS and specific antibody deficiency, memory phenotype. While asplenia has been described in one individual with MWS, there is nothing in the medical literature suggesting that humoral immunodeficiencies are associated with MWS. The patient's parents know of several other children with MWS around the world who have gotten extra vaccines or who get IgG replacement therapy. This suggests that there may be more to learn about the immune systems of patients with this condition.   A copy of the published article is attached as further documentation of the patient's experience.