chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Burning sensation
Clinical narrative: watery blister on rib cage; burning sensations; This case was reported by a other health professional via call center representative and described the occurrence of blister in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 week after receiving Shingrix, the patient experienced blister and burning sensation. On an unknown date, the outcome of the blister and burning sensation were unknown.   It was unknown if the reporter considered the blister and burning sensation to be related to Shingrix.  Additional details were reported as follows: No data available from Batch number or expiration date. All patient identifiers were provided. The patient received Shingrix and developed watery blisters on her rib cage and burning sensations after one week.  Reporter consented to follow up.
Sex: M
Vaccine: PNC13
Symptoms: Near death experience
Clinical narrative: almost died from prevnar vaccine; This is a spontaneous report from a contactable consumer via a Pfizer-sponsored program. A male patient (grandson) of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported.  The reporter did not engage a doctor, health care professional or pharmacist to get vaccinated in the past 3 months as the patient almost died from prevnar vaccine. The outcome of the event was unknown.    No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Erythema, Swelling
Clinical narrative: local redness, swelling, erythema
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Insomnia, Pain
Clinical narrative: "pretty strong reaction to the 2nd shingles vaccine.  I ended up with body aches, a headache and a fever that spiked at 102.7.  It started about 4 hours after in injection with body aches and a fever, then came the chills and the fever spikes around 11pm.  I wasn't able to sleep much but my temp was down to 99.8 Saturday morning but I remained tired and achy throughout the day.  Sunday I was back to normal."
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: "pretty strong reaction to the 2nd shingles vaccine.  I ended up with body aches, a headache and a fever that spiked at 102.7.  It started about 4 hours after in injection with body aches and a fever, then came the chills and the fever spikes around 11pm.  I wasn't able to sleep much but my temp was down to 99.8 Saturday morning but I remained tired and achy throughout the day.  Sunday I was back to normal."
Age: 53.0
Sex: M
Vaccine: UNK
Symptoms: Blood glucose increased, Respiratory disorder
Clinical narrative: Very high glucose (>200 mg/dl) starting two days after the flu vaccine that persisted for two days and was dangerous due to the risk of DKA and history of vitreous hemorrhage and DME. Upper respiratory illness.   The manufacturer should provide a warning to diabetics and disclose the efficacy for the current year (a mere 9% for 2019). The amount of mercury in this flu vaccine should be disclosed and the ingredients on the CDC website should be accurate and not omit ingredients (eg, the neurotoxin mercury in any amount). A risk benefit analysis should be done to determine whether their is net benefit for the flu vaccine considering it has the most VAERS complaints of any vaccine.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Headache, Myalgia, Pain, Pruritus
Clinical narrative: Initial itching and muscle ache - then by the next morning noticed a hive approximately 5" x 3". The area is very warm to the touch, swollen, pink and sore.  Also a very slight headache.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Skin warm, Swelling, Urticaria
Clinical narrative: Initial itching and muscle ache - then by the next morning noticed a hive approximately 5" x 3". The area is very warm to the touch, swollen, pink and sore.  Also a very slight headache.
Age: 20.0
Sex: U
Vaccine: FLU4, HPV9
Symptoms: Dizziness, Loss of consciousness, Musculoskeletal stiffness, Pallor
Clinical narrative: Moments after receiving her HPV #3 and Flu vaccines patient felt Light headed and passed out. She was sitting on the exam table with the MA present to help Lower her to the table. She stiffened and developed pallor. VS were taken and she was observed for ~ 20 minutes pt reports that the same response occurred w/the same vaccines 11/18/17 when she was 18 year.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Rash erythematous
Clinical narrative: Patient presented to office 11.27.2019; rash started 11.26.2019 at 4:00pm. Started on abdomen, arms then legs. Today (11.27.19) rash spreading to back. Red Pin point rash that is blanchable. Patient advised to watch for trouble breathing and/or swelling of lips or tongue. Rash does not seem dangerous.
Age: 0.08
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Wrong product administered
Clinical narrative: The patient is not showing any adverse event symptoms; inadvertent administration of Vaqta to a 1 month old (4.5 week old) patient; this 4.5 week old received Vaqta in the right thigh instead of Hepatitis B vaccine; This spontaneous report was received from a nurse and refers to a 1-month-old patient of unknown gender. No information regarding the patient's concurrent condition, medical history and concomitant medications was provided.  On 08-NOV-2019, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) lot # S002505, expiration date was not reported, but upon internal validation established as 04-APR-2020, in the right thigh (dose and route of administration were not provided) for prophylaxis instead of hepatitis b vaccine (recombinant) (manufacturer unknown) (lot #, expiration date, dose and route of administration were not provided) for prophylaxis. No adverse effect was reported. The outcome was unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular, Vaccination failure
Clinical narrative: The vaccine did not prevent shingles as intended; contracted a persistent strain of herpes zoster also known as shingles and other complications/was treated for a blistering vesicular outbreak that was diagnosed as severe herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On or about 03-DEC-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dosage regimen, route of administration, anatomical location, lot number and expiration date were not reported) as recommended for routine adult health maintenance for prevention of shingles, however on an unknown date the vaccine did not prevent shingles as intended (vaccination failure) and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. The patient was treated for a blistering vesicular outbreak that was diagnosed as severe herpes zoster. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, and/or despite receiving zoster vaccine live (ZOSTAVAX) for the long term prevention of shingles, the patient suffered painful injuries, damages, and required extensive medical care and treatment.  As a direct and proximate result of these malfunctions, the patient suffered painful injuries, damages and required extensive medical care and treatment.  As further proximate result, the patient had suffered and would continue to suffer significant medical expenses, and pain and suffering other damages.   The outcome of herpes zoster and vaccination failure was unknown. The reporter considered vaccination failure, and herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX).  Additional information has been requested. This is one of seven reports received from the same reporter.; Sender's Comments:  US-009507513-1911USA011066: US-009507513-1911USA011702: US-009507513-1911USA011705: US-009507513-1911USA011706: US-009507513-1911USA011703:
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular, Vaccination failure
Clinical narrative: The vaccine did not prevent shingles as intended/and/or despite receiving zoster vaccine live (ZOSTAVAX) for the long term prevention of shingles; contracted a persistent strain of herpes zoster also known as shingles and other complications/was treated for a blistering vesicular outbreak that was diagnosed as severe herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers female patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On an unknown date in 2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dosage regimen, route of administration, anatomical location, lot number and expiration date were not reported) as recommended for routine adult health maintenance for prevention of shingles. However the vaccine did not prevent shingles as intended (vaccination failure) and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, and/or despite receiving zoster vaccine live (ZOSTAVAX) for the long term prevention of shingles (vaccination failure).  The patient was treated for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles.  The outcome of herpes zoster and vaccination failure was unknown. The reporter considered vaccination failure, and herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX).    Additional information has been requested.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1911USA011066: US-009507513-1911USA011701: US-009507513-1911USA011705: US-009507513-1911USA011706: 1911USA011703:
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Exposure during pregnancy, Hypertension, Incomplete course of vaccination, Premature delivery
Clinical narrative: preterm labor; was born 4 to 6 weeks prematurely after she had been administered GARDASIL near the end of the second trimester of pregnancy; high blood pressure; Pregnant patient had been administered GARDASIL near the end of the second trimester of pregnancy; This spontaneous retrospective pregnancy report was received from a 14 years old female patient. The patient's concurrent conditions included asthma. There were not allergies or drug reactions. Her concomitant therapies included  prenatal vitamins. The patient's last menstrual period (LMP) was calculated as 20-JUN-2007.  In approximately in 2008 near the end of the second trimester of pregnancy, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) route "injection",(dose, frequency, vaccination site and dose number were not provided), for prevent human papillomavirus (HPV).  In 2008, the patient experienced high blood pressure a few days after vaccination and she never received another dose of  quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL)  after that. Unspecified bloodwork was done to investigate the high blood pressure but results were not provided.  In 2008, the patient was hospitalized for preterm labor at an unspecified hospital on an unspecified date and the labor was stopped.   The patient gave birth to a male baby who was born 4 to 6 weeks early at 34 weeks of gestation (40 weeks minus 6 considering the worst possible scenario) despite her estimated date of delivery (EDD) was calculated as 26-MAR-2008 (Child case captured in MARRS #1911USA012743) (premature delivery). It was reported that due to the events, she was kept home from school and that she recovered "a little while after giving birth".   At the time of reporting, the outcome of high blood pressure was unknown. The reporter did not provide a causality assessment between Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine(GARDASIL), the premature delivery, premature labor and high blood pressure.; Sender's Comments:  US-009507513-1911USA012743:
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Premature labour
Clinical narrative: preterm labor; was born 4 to 6 weeks prematurely after she had been administered GARDASIL near the end of the second trimester of pregnancy; high blood pressure; Pregnant patient had been administered GARDASIL near the end of the second trimester of pregnancy; This spontaneous retrospective pregnancy report was received from a 14 years old female patient. The patient's concurrent conditions included asthma. There were not allergies or drug reactions. Her concomitant therapies included  prenatal vitamins. The patient's last menstrual period (LMP) was calculated as 20-JUN-2007.  In approximately in 2008 near the end of the second trimester of pregnancy, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) route "injection",(dose, frequency, vaccination site and dose number were not provided), for prevent human papillomavirus (HPV).  In 2008, the patient experienced high blood pressure a few days after vaccination and she never received another dose of  quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL)  after that. Unspecified bloodwork was done to investigate the high blood pressure but results were not provided.  In 2008, the patient was hospitalized for preterm labor at an unspecified hospital on an unspecified date and the labor was stopped.   The patient gave birth to a male baby who was born 4 to 6 weeks early at 34 weeks of gestation (40 weeks minus 6 considering the worst possible scenario) despite her estimated date of delivery (EDD) was calculated as 26-MAR-2008 (Child case captured in MARRS #1911USA012743) (premature delivery). It was reported that due to the events, she was kept home from school and that she recovered "a little while after giving birth".   At the time of reporting, the outcome of high blood pressure was unknown. The reporter did not provide a causality assessment between Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine(GARDASIL), the premature delivery, premature labor and high blood pressure.; Sender's Comments:  US-009507513-1911USA012743:
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: No adverse event, Underdose
Clinical narrative: There was no adverse event related to the administration of the vaccine, but the vaccine that was given was dosed for the routine immunization administration dosing (0.5 mL) when it was supposed to be a booster related to a negative titer after a complete series. The dose that should have been given (per 2.5 in the pack insert) is 1.0 mL. The pharmacy was notified of the situation by me as well. The student will need to get a full booster to be in compliance according to the CDC email I received regarding this same scenario.
Age: 79.0
Sex: M
Vaccine: UNK
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Myalgia, Nausea, Pain in extremity
Clinical narrative: SORE ARM AS EXPECTED BY AFTERNOON (11/30); MUSCLE PAIN BECAME SHARPER AND THROUGHOUT MY BODY BY EVENING (9-10 HOURS AFTER SHOT).  CHILLS  AND FEVER INTO NEXT MORNING;  NAUSEA AND HEADACHE PERSISTED DURING SECOND DAY (12/1).  Today (12/2)  ALL SYMPTOMS ARE GONE. I DID NOT CONSULT A DR
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: SORE ARM AS EXPECTED BY AFTERNOON (11/30); MUSCLE PAIN BECAME SHARPER AND THROUGHOUT MY BODY BY EVENING (9-10 HOURS AFTER SHOT).  CHILLS  AND FEVER INTO NEXT MORNING;  NAUSEA AND HEADACHE PERSISTED DURING SECOND DAY (12/1).  Today (12/2)  ALL SYMPTOMS ARE GONE. I DID NOT CONSULT A DR
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Patient has pain on arm that was injected and has been constant for 2 weeks.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV, VARZOS
Symptoms: Arthralgia, Body temperature fluctuation, Chills, Contusion, Erythema
Clinical narrative: 11/22/19 - received vaccinations about approx 12:15 pm 11/22/19 - 8-9 pm - feeling tired with down and out feeling 11/23/19 - 3:30 am - awoke shivering violently, lasted 20 minutes; 7 am - extreme flue conditions (not GI) - strep throat type nausea with sore joints and muscles throughout body. Temp fluctuated between 100.3 and 101.5 throughout day; covered with blankets to avoid goosebumps and shivering. Slept 4-5 hours intermittently. Same through evening. Went to bed at 10:30 pm - still had chills. 11/24/19 - awoke with  temperature heading back to normal range; symptoms diminishing by noon and by evening - feeling more or less back to normal.   Local reaction: Right arm.  Extremely sore and felt severely bruised, reddened and bruise like feeling spread around the side and fron of bicep area in band like appearance about 4-4.5 inches wide.   11/25, all symptoms receded 11/26/19 - bruise like feeling and redness in right bicep diminished to 50% of peak by this date.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV, VARZOS
Symptoms: Fatigue, Feeling abnormal, Influenza, Myalgia, Nausea
Clinical narrative: 11/22/19 - received vaccinations about approx 12:15 pm 11/22/19 - 8-9 pm - feeling tired with down and out feeling 11/23/19 - 3:30 am - awoke shivering violently, lasted 20 minutes; 7 am - extreme flue conditions (not GI) - strep throat type nausea with sore joints and muscles throughout body. Temp fluctuated between 100.3 and 101.5 throughout day; covered with blankets to avoid goosebumps and shivering. Slept 4-5 hours intermittently. Same through evening. Went to bed at 10:30 pm - still had chills. 11/24/19 - awoke with  temperature heading back to normal range; symptoms diminishing by noon and by evening - feeling more or less back to normal.   Local reaction: Right arm.  Extremely sore and felt severely bruised, reddened and bruise like feeling spread around the side and fron of bicep area in band like appearance about 4-4.5 inches wide.   11/25, all symptoms receded 11/26/19 - bruise like feeling and redness in right bicep diminished to 50% of peak by this date.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV, VARZOS
Symptoms: Pain
Clinical narrative: 11/22/19 - received vaccinations about approx 12:15 pm 11/22/19 - 8-9 pm - feeling tired with down and out feeling 11/23/19 - 3:30 am - awoke shivering violently, lasted 20 minutes; 7 am - extreme flue conditions (not GI) - strep throat type nausea with sore joints and muscles throughout body. Temp fluctuated between 100.3 and 101.5 throughout day; covered with blankets to avoid goosebumps and shivering. Slept 4-5 hours intermittently. Same through evening. Went to bed at 10:30 pm - still had chills. 11/24/19 - awoke with  temperature heading back to normal range; symptoms diminishing by noon and by evening - feeling more or less back to normal.   Local reaction: Right arm.  Extremely sore and felt severely bruised, reddened and bruise like feeling spread around the side and fron of bicep area in band like appearance about 4-4.5 inches wide.   11/25, all symptoms receded 11/26/19 - bruise like feeling and redness in right bicep diminished to 50% of peak by this date.
Age: 43.0
Sex: F
Vaccine: PPV
Symptoms: Chest pain, Mouth ulceration, Neck pain, Pain in extremity
Clinical narrative: neck pain, chest pain, arm pain and oral ulcers
Age: 56.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site pain, Mobility decreased, Pain in extremity
Clinical narrative: The patient experience some soreness to the arm and it was difficult to raise his arm. The site has gotten better since then, but still experiencing a little soreness to the area.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site discomfort, Injection site pain, Joint range of motion decreased, Limb discomfort, Pain in extremity
Clinical narrative: Patient has experienced pain and discomfort in right arm since vaccine was administered.  She feels this has spread from the injection site to her shoulder and down her upper arm.  Also states she no whas limited range of motion with arm. Patient is planning to see her doctor for treatment.
Age: 56.0
Sex: F
Vaccine: FLUC4
Symptoms: Pain
Clinical narrative: Patient started to experience some soreness the following day. They have tried aleve once and have not tried icing in. The soreness has gotten better, but is it not completely gone.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Injection site rash, Rash
Clinical narrative: PATIENT RECEIVED 4 MONTH VACCINES ON LEFT LEG, PATIENT STARTED TO DEVELOPED A RASH ON LEFT LEG AND FACE, DR WAS ADVISED.  PER DR GAVE PATIENT BENADRYL. RASH WENT AWAY PER DR PATIENT OK TO GO HOME.
Age: 82.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: PATIENT REPORTS HAVING A SORE ARM SINCE RECEIVING VACCINE ON 10/1/19. HE STATED HE ALSO HAD A FALL TWO WEEKS PRIOR TO VACCINE. NO BRUISING REPORTED FROM VACCINE.
Sex: M
Vaccine: HPV4
Symptoms: Asthma, Cognitive disorder, Crying, Electroencephalogram normal, Foetal exposure during pregnancy
Clinical narrative: her son experienced seizures on unspecified dates before his first birthday; unspecified speech issues his whole life; minor unspecified cognitive issues; asthma; was born 4 to 6 weeks prematurely; a rash in his genital area; excessive crying; His mother received GARDASIL near the end of the second trimester of pregnancy; This spontaneous report was received from the patient's mother and refers to a neonate male patient. The patient's concurrent conditions and concomitant therapies were not reported. The patient's mother was vaccinated approximately in 2007 near the end of the second trimester of pregnancy, with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) (dose, frequency, route, vaccination site and dose number were not provided), for prophylaxis (captured on 1911USA012638). Her concurrent conditions included asthma and premature labour in 2008 with a Last Menstrual Period (LMP) was calculated as 20-JUN-2007.  On 13-FEB-2008, the patient was born 4 to 6 weeks prematurely (premature baby). The patient weighed 5 pounds when he was discharged from the hospital (low birth weight baby) wich was prolongued due to the event, after that he also had a rash in his genital area (genital rash) and experienced excessive crying when he was discharged from  the hospital after his birth approximately in 2008.   On unspecified dates before his first birthday, the patient experienced seizures and he was resuscitated at the time of a seizure on two separate occasions which occurred on unspecified dates. Therefore, he underwent  several electroencephalograms (EEGs) and no brain damage from the seizures was found and no treatment was ever given for the seizures and the seizures stopped occurring on an unspecified date.  On an unknown date (reported as "recently"), he began taking an unspecified medication for asthma and he has had some minor unspecified cognitive issues (cognitive disorder) and has had significant unspecified speech issues his whole life (speech disorder).  At the time of reporting, the patient had not recovered from premature baby, cognitive disorder and speech disorder. The outcome of genital rash,  low birth weight , asthma and crying  was unknown.   The reporter did not provide a causality assessment between Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine(GARDASIL) and the events. It was reported that the doctors believed his speech problems were a result of his premature birth.   Upon internal review, seizure was determined to be a medically significant event.   This is one of two cases from  the same reporter.; Sender's Comments:  US-009507513-1911USA012638:
Sex: M
Vaccine: HPV4
Symptoms: Genital rash, Low birth weight baby, Premature baby, Resuscitation, Seizure
Clinical narrative: her son experienced seizures on unspecified dates before his first birthday; unspecified speech issues his whole life; minor unspecified cognitive issues; asthma; was born 4 to 6 weeks prematurely; a rash in his genital area; excessive crying; His mother received GARDASIL near the end of the second trimester of pregnancy; This spontaneous report was received from the patient's mother and refers to a neonate male patient. The patient's concurrent conditions and concomitant therapies were not reported. The patient's mother was vaccinated approximately in 2007 near the end of the second trimester of pregnancy, with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) (dose, frequency, route, vaccination site and dose number were not provided), for prophylaxis (captured on 1911USA012638). Her concurrent conditions included asthma and premature labour in 2008 with a Last Menstrual Period (LMP) was calculated as 20-JUN-2007.  On 13-FEB-2008, the patient was born 4 to 6 weeks prematurely (premature baby). The patient weighed 5 pounds when he was discharged from the hospital (low birth weight baby) wich was prolongued due to the event, after that he also had a rash in his genital area (genital rash) and experienced excessive crying when he was discharged from  the hospital after his birth approximately in 2008.   On unspecified dates before his first birthday, the patient experienced seizures and he was resuscitated at the time of a seizure on two separate occasions which occurred on unspecified dates. Therefore, he underwent  several electroencephalograms (EEGs) and no brain damage from the seizures was found and no treatment was ever given for the seizures and the seizures stopped occurring on an unspecified date.  On an unknown date (reported as "recently"), he began taking an unspecified medication for asthma and he has had some minor unspecified cognitive issues (cognitive disorder) and has had significant unspecified speech issues his whole life (speech disorder).  At the time of reporting, the patient had not recovered from premature baby, cognitive disorder and speech disorder. The outcome of genital rash,  low birth weight , asthma and crying  was unknown.   The reporter did not provide a causality assessment between Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine(GARDASIL) and the events. It was reported that the doctors believed his speech problems were a result of his premature birth.   Upon internal review, seizure was determined to be a medically significant event.   This is one of two cases from  the same reporter.; Sender's Comments:  US-009507513-1911USA012638:
Sex: M
Vaccine: HPV4
Symptoms: Speech disorder
Clinical narrative: her son experienced seizures on unspecified dates before his first birthday; unspecified speech issues his whole life; minor unspecified cognitive issues; asthma; was born 4 to 6 weeks prematurely; a rash in his genital area; excessive crying; His mother received GARDASIL near the end of the second trimester of pregnancy; This spontaneous report was received from the patient's mother and refers to a neonate male patient. The patient's concurrent conditions and concomitant therapies were not reported. The patient's mother was vaccinated approximately in 2007 near the end of the second trimester of pregnancy, with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) (dose, frequency, route, vaccination site and dose number were not provided), for prophylaxis (captured on 1911USA012638). Her concurrent conditions included asthma and premature labour in 2008 with a Last Menstrual Period (LMP) was calculated as 20-JUN-2007.  On 13-FEB-2008, the patient was born 4 to 6 weeks prematurely (premature baby). The patient weighed 5 pounds when he was discharged from the hospital (low birth weight baby) wich was prolongued due to the event, after that he also had a rash in his genital area (genital rash) and experienced excessive crying when he was discharged from  the hospital after his birth approximately in 2008.   On unspecified dates before his first birthday, the patient experienced seizures and he was resuscitated at the time of a seizure on two separate occasions which occurred on unspecified dates. Therefore, he underwent  several electroencephalograms (EEGs) and no brain damage from the seizures was found and no treatment was ever given for the seizures and the seizures stopped occurring on an unspecified date.  On an unknown date (reported as "recently"), he began taking an unspecified medication for asthma and he has had some minor unspecified cognitive issues (cognitive disorder) and has had significant unspecified speech issues his whole life (speech disorder).  At the time of reporting, the patient had not recovered from premature baby, cognitive disorder and speech disorder. The outcome of genital rash,  low birth weight , asthma and crying  was unknown.   The reporter did not provide a causality assessment between Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine(GARDASIL) and the events. It was reported that the doctors believed his speech problems were a result of his premature birth.   Upon internal review, seizure was determined to be a medically significant event.   This is one of two cases from  the same reporter.; Sender's Comments:  US-009507513-1911USA012638:
Age: 44.0
Sex: M
Vaccine: FLUX
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: headache; tired; temperature of 102; chills, shivering/shaking.; body aches; Initial information received on 08-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 44 years old male patient who experienced headache (headache), temperature of 102 (Pyrexia), chills, shivering /shaking (Chills), body aches (body pain) and tired (tiredness), while he received vaccine INFLUENZA VACCINE..  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 08-Oct-2019 at 9.00 am, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.  On 08-Oct-2019, at, 3 pm experienced severe chills and body aches, 6 hours post vacccination. He get into bed at 5:30 pm and could not stop shivering/shaking. At 6:30 pm, 9 hours 30 minutes post vaccination, his temperature 102. Later, he took Tylenol to treat the fever. The severe shivering/shaking went on for several hours. At 11:30 pm his temperature was 100.5.   On 09-Oct-2019, 1 day post vaccination, he was feeling better but his temperature has remained in 99 range, still feeling achy, a headache and generally tired.  (Other relevant tests included No Lab data..)  Final diagnosis was headache, pyrexia, chills, body pain and tiredness.   The patient was treated with PARACETAMOL (TYLENOL) for Pyrexia.  The patient was recovering from events fever and chills. As of 9-Oct-19, patient was not yet recovered from other events.  Information on the batch number was requested.
Age: 44.0
Sex: M
Vaccine: FLUX
Symptoms: Tremor
Clinical narrative: headache; tired; temperature of 102; chills, shivering/shaking.; body aches; Initial information received on 08-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 44 years old male patient who experienced headache (headache), temperature of 102 (Pyrexia), chills, shivering /shaking (Chills), body aches (body pain) and tired (tiredness), while he received vaccine INFLUENZA VACCINE..  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 08-Oct-2019 at 9.00 am, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.  On 08-Oct-2019, at, 3 pm experienced severe chills and body aches, 6 hours post vacccination. He get into bed at 5:30 pm and could not stop shivering/shaking. At 6:30 pm, 9 hours 30 minutes post vaccination, his temperature 102. Later, he took Tylenol to treat the fever. The severe shivering/shaking went on for several hours. At 11:30 pm his temperature was 100.5.   On 09-Oct-2019, 1 day post vaccination, he was feeling better but his temperature has remained in 99 range, still feeling achy, a headache and generally tired.  (Other relevant tests included No Lab data..)  Final diagnosis was headache, pyrexia, chills, body pain and tiredness.   The patient was treated with PARACETAMOL (TYLENOL) for Pyrexia.  The patient was recovering from events fever and chills. As of 9-Oct-19, patient was not yet recovered from other events.  Information on the batch number was requested.
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Vaccination site hypersensitivity
Clinical narrative: Redness on left thigh with induration at site of flu shot, hypersensitivity; Redness on left thigh with induration at site of flu shot; Redness on left thigh with induration at site of flu shot; Based on follow-up information received on 05-Nov-2019, this case now become a valid case (patient identifier was reported).  Initial information received on 07-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA279683.  This case involves a 2 years old female patient who experienced vaccination site hypersensitivity while she received vaccine INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (Fluzone).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 02-OCT-2019, patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (lot UJ223AA, expiry date: 30-Jun-2020) via intramuscular route in the left vastus lateralis.  On 02-OCT-2019, the patient experienced redness on left thigh with induration at site of flu shot (vaccination site hypersensitivity) same day following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED.  Other relevant tests included no lab data was provided.  Final diagnosis was redness on left thigh with induration at site of flu shot.   The patient was treated with ibuprofen (Ibuprofen) and ice.  The patient was recovered from event on 04 Oct 2019.  Additional information received on 05-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.  Gender was updated, case classification was updated and dose regimen of the Vaccine was updated. Events were added. Outcome updated, Treatment medication was added.
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product distribution issue, Product storage error
Clinical narrative: delayed transit of Fluzone HD shipment was to be delivered on 10-Oct-2019 and was not received until 14-Oct-2019 with no AE; delayed transit of Fluzone HD shipment was to be delivered on 10-Oct-2019 and was not received until 14-Oct-2019 with no AE; Initial information received on 14-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2019SA287365 and 2019SA287333.  This case involves a 81 years old male patient who INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot: UJ283AB, expiry date: 29-May-2020), via intramuscular route in the right arm, on 14-Oct-2019.  The patient past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of incorrect product storage and product shipment delay due product was to be delivered on 10-Oct-2019 and was not received until 14-Oct-2019.  At the time of reporting, the patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 66.0
Sex: U
Vaccine: FLU3, FLUR4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: patient was administered with Flublok instead of Fluzone High-Dose, no AE; Initial information received on 21-Oct-2019 regarding an unsolicited valid non-serious case received from a Physician.   This case is linked to case 2019SA294437 (same reporter).  This case involves a 66 years old patient who received a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot and Expiry date were not reported) via an unknown route in an unknown administration site instead of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  It was a actual medication error case due to wrong vaccine administered.  It was reported that Physician had a 66 year old patient, that he thought was 56 years old. He administered Flublok to that patient rather than Fluzone High-Dose.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: Fluzone High Dose was left out at a room temp of 70 F for 1 hour and given to a patient with no AE; Initial information received on 21-Oct-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a patient of an unknown demographics who received a dose of vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] lot number, expiry date was not reported  which was left out at a room temp of 70 F for 1 hour.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to incorrect product storage.   At the time of the report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administered at inappropriate site, Product distribution issue, Product storage error
Clinical narrative: the office had already given vaccine to the patient from this shipment before they realized that the vaccines were not viable, no adverse event; received the shipment of Fluzone QID late with no AE; 7 years old patient received Fluzone QID in left thigh / no AE; Initial information received on 21-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer (office staff).  This case linked to 2019SA295194, 2019SA295209, 2019SA295207 and 2019SA290919.  This case involves a 7 years old female patient who received a 0.5 ml dose of vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot: UT6686LA, expiry date: 30-Jun-2020), via intramuscular route in the left thigh, on 17-Oct-2019.  Relevant medical history and concomitant were unknown.   It was an actual medication error due to incorrect product storage and vaccine administered at inappropriate site.  It was a case of product shipment delay.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.42
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: staff gave Fluzone Quad .25 to a female patient age 5 months with no AE; Initial information received on 22-Oct-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 5 months old female patient who received a 0.25 mL first dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (Lot no: UJ256AB, Expiry date: 30-Jun-2020) via intramuscular route in left Vastus Lateralis on 11-Oct-2019.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications included DIPHTHERIA VACCINE TOXOID, HIB VACCINE CONJ (TET TOX), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (MRC 5), TETANUS VACCINE TOXOID (PENTACEL) for Immunisation; PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation; and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation.  It was an actual medication error due to inappropriate age at vaccine administration.   It was reported that the staff gave Fluzone Quad .25 to a female patient age 5 months. Fluzone Quadrivalent 0.25ml was administered to a baby before her 6 month birthday.  At the time of reporting, the patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: FLU3, FLUR4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: brought mother to get her flu vaccine, asked for High-Dose, and when she looked at the receipt, she had been given Flublok, with no adverse event; Initial information regarding an unsolicited valid non-serious case received from a Pharmacist on 22-Oct-2019.   This case involves an unknown age female patient for whom  it was reported that mother was taken to get her flu vaccine, asked for INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE], and when she looked at the receipt, she had been given  and INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (wrong vaccine administered).  Medical history, concomitant therapies and family history not reported.  It was as a medication error case due to wrong vaccine administered.  At the time of reporting, No adverse event.  Final diagnosis was wrong vaccine administered.  Action taken and outcome was not applicable.  Batch number has been requested.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: patient received a Imovax injection 1 day late, No AE; Initial information received on 25-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a patient of unknown demographics who received a RABIES (HDC) VACCINE [IMOVAX RABIES] injection 1 day late (lot number, expiry date were not reported) via an unknown route in an unknown administration site on an unknown date.  Medical history, medical treatments, vaccinations and family history were not provided.  It was a case of actual medication error due to the inappropriate schedule of vaccine administered. It was reported that the a patient received a Imovax injection 1 day late.  At the time of reporting, the patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.
Age: 11.0
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Flublok Quadrivalent was administered to 11 year old, no AE; Initial information received on 28-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to case 2019SA301753 (same reporter).  This case involves a 11 years old male patient who received a 0.5 ml dose of vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot: QFAA1963, expiry date: 30-Jun-2020) via intramuscular route in the left deltoid on 24-Oct-2019.  Medical history, medical treatments, vaccinations and family history were not provided.  It was an actual medication error due to inappropriate age at vaccine administration.  At the time of reporting, the patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.