chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.33
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Febrile convulsion, Head injury, Hypotonia, Injection site pain, Insomnia
Clinical narrative: Extreme leg pain (wouldn't walk, didn't want held, rolled around on floor in agony). Screamed and cried for 6 hours after shot. Fever started off and on for almost 2 weeks (up to 103 but don't know what the spike that caused the seizure was). Febrile seizure (7/5/17). Patient's paralysis RT side (7/5/17). Helicopter (7/5/17). Rash (7/7/17-7/9/17). Tylenol and Ibuprofen wasn?t controlling fever. Loss of appetite. Had to give her bottle to feed her. Stopped breathing (blue lips, limp body) (7/5/17). Had to do CPR (7/5/17). Irritable, moody, very unhappy, sad, cried for no apparent reason through the day and night, extremely tired but wouldn't sleep for 2 weeks after shots. Diarrhea for a week after shots. Throwing up 1-3 times per day after shots until 7/3/17. Wouldn't even take a bath without a screaming tantrum after vaccines until 7/10/17. Seizure caused her to fall off a chair and hit her head.
Age: 1.33
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Irritability, Mood altered, Nuclear magnetic resonance imaging normal, Postictal paralysis, Pyrexia
Clinical narrative: Extreme leg pain (wouldn't walk, didn't want held, rolled around on floor in agony). Screamed and cried for 6 hours after shot. Fever started off and on for almost 2 weeks (up to 103 but don't know what the spike that caused the seizure was). Febrile seizure (7/5/17). Patient's paralysis RT side (7/5/17). Helicopter (7/5/17). Rash (7/7/17-7/9/17). Tylenol and Ibuprofen wasn?t controlling fever. Loss of appetite. Had to give her bottle to feed her. Stopped breathing (blue lips, limp body) (7/5/17). Had to do CPR (7/5/17). Irritable, moody, very unhappy, sad, cried for no apparent reason through the day and night, extremely tired but wouldn't sleep for 2 weeks after shots. Diarrhea for a week after shots. Throwing up 1-3 times per day after shots until 7/3/17. Wouldn't even take a bath without a screaming tantrum after vaccines until 7/10/17. Seizure caused her to fall off a chair and hit her head.
Age: 1.33
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Rash, Respiratory arrest, Resuscitation, Screaming, Urine analysis normal
Clinical narrative: Extreme leg pain (wouldn't walk, didn't want held, rolled around on floor in agony). Screamed and cried for 6 hours after shot. Fever started off and on for almost 2 weeks (up to 103 but don't know what the spike that caused the seizure was). Febrile seizure (7/5/17). Patient's paralysis RT side (7/5/17). Helicopter (7/5/17). Rash (7/7/17-7/9/17). Tylenol and Ibuprofen wasn?t controlling fever. Loss of appetite. Had to give her bottle to feed her. Stopped breathing (blue lips, limp body) (7/5/17). Had to do CPR (7/5/17). Irritable, moody, very unhappy, sad, cried for no apparent reason through the day and night, extremely tired but wouldn't sleep for 2 weeks after shots. Diarrhea for a week after shots. Throwing up 1-3 times per day after shots until 7/3/17. Wouldn't even take a bath without a screaming tantrum after vaccines until 7/10/17. Seizure caused her to fall off a chair and hit her head.
Age: 1.33
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Vomiting
Clinical narrative: Extreme leg pain (wouldn't walk, didn't want held, rolled around on floor in agony). Screamed and cried for 6 hours after shot. Fever started off and on for almost 2 weeks (up to 103 but don't know what the spike that caused the seizure was). Febrile seizure (7/5/17). Patient's paralysis RT side (7/5/17). Helicopter (7/5/17). Rash (7/7/17-7/9/17). Tylenol and Ibuprofen wasn?t controlling fever. Loss of appetite. Had to give her bottle to feed her. Stopped breathing (blue lips, limp body) (7/5/17). Had to do CPR (7/5/17). Irritable, moody, very unhappy, sad, cried for no apparent reason through the day and night, extremely tired but wouldn't sleep for 2 weeks after shots. Diarrhea for a week after shots. Throwing up 1-3 times per day after shots until 7/3/17. Wouldn't even take a bath without a screaming tantrum after vaccines until 7/10/17. Seizure caused her to fall off a chair and hit her head.
Age: 65.0
Sex: F
Vaccine: TDAP
Symptoms: Immediate post-injection reaction, Injection site haemorrhage, Swelling
Clinical narrative: Immediate swelling approximately the size of a quarter and about 1/2 inch raised. Also injection bled.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Ankylosing spondylitis, Anxiety, Arthralgia, Blood glucose decreased
Clinical narrative: GARDASIL lowered the immune system terribly and allowed her to contract diseases she otherwise wouldn't. She started with headaches, stomach aches, continuous nausea, low blood sugar, low blood pressure, general malaise, tiredness, sleep disturbances, lethargic, reflux, severe joint pain, brain fog, tingling, leg pain, depression, and anxiety. Previous to the vaccine she was a regular active child with no problems, very athletic. Now she can hardly run. This has been continuing since the vaccine to this current day. She has been diagnosed with Thyroid disease, Epstein-Barr Virus, PCOS, SMA Syndrome, Ankylosing Spondylitis, Herpes, etc.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Computerised tomogram, Decreased immune responsiveness, Depression, Epstein-Barr virus infection
Clinical narrative: GARDASIL lowered the immune system terribly and allowed her to contract diseases she otherwise wouldn't. She started with headaches, stomach aches, continuous nausea, low blood sugar, low blood pressure, general malaise, tiredness, sleep disturbances, lethargic, reflux, severe joint pain, brain fog, tingling, leg pain, depression, and anxiety. Previous to the vaccine she was a regular active child with no problems, very athletic. Now she can hardly run. This has been continuing since the vaccine to this current day. She has been diagnosed with Thyroid disease, Epstein-Barr Virus, PCOS, SMA Syndrome, Ankylosing Spondylitis, Herpes, etc.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Feeling abnormal, Gastrooesophageal reflux disease, Headache, Herpes virus infection
Clinical narrative: GARDASIL lowered the immune system terribly and allowed her to contract diseases she otherwise wouldn't. She started with headaches, stomach aches, continuous nausea, low blood sugar, low blood pressure, general malaise, tiredness, sleep disturbances, lethargic, reflux, severe joint pain, brain fog, tingling, leg pain, depression, and anxiety. Previous to the vaccine she was a regular active child with no problems, very athletic. Now she can hardly run. This has been continuing since the vaccine to this current day. She has been diagnosed with Thyroid disease, Epstein-Barr Virus, PCOS, SMA Syndrome, Ankylosing Spondylitis, Herpes, etc.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Hypotension, Laboratory test, Lethargy, Loss of personal independence in daily activities, Malaise
Clinical narrative: GARDASIL lowered the immune system terribly and allowed her to contract diseases she otherwise wouldn't. She started with headaches, stomach aches, continuous nausea, low blood sugar, low blood pressure, general malaise, tiredness, sleep disturbances, lethargic, reflux, severe joint pain, brain fog, tingling, leg pain, depression, and anxiety. Previous to the vaccine she was a regular active child with no problems, very athletic. Now she can hardly run. This has been continuing since the vaccine to this current day. She has been diagnosed with Thyroid disease, Epstein-Barr Virus, PCOS, SMA Syndrome, Ankylosing Spondylitis, Herpes, etc.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Nuclear magnetic resonance imaging, Pain in extremity, Paraesthesia, Polycystic ovaries
Clinical narrative: GARDASIL lowered the immune system terribly and allowed her to contract diseases she otherwise wouldn't. She started with headaches, stomach aches, continuous nausea, low blood sugar, low blood pressure, general malaise, tiredness, sleep disturbances, lethargic, reflux, severe joint pain, brain fog, tingling, leg pain, depression, and anxiety. Previous to the vaccine she was a regular active child with no problems, very athletic. Now she can hardly run. This has been continuing since the vaccine to this current day. She has been diagnosed with Thyroid disease, Epstein-Barr Virus, PCOS, SMA Syndrome, Ankylosing Spondylitis, Herpes, etc.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Sleep disorder, Superior mesenteric artery syndrome, Thyroid disorder, X-ray
Clinical narrative: GARDASIL lowered the immune system terribly and allowed her to contract diseases she otherwise wouldn't. She started with headaches, stomach aches, continuous nausea, low blood sugar, low blood pressure, general malaise, tiredness, sleep disturbances, lethargic, reflux, severe joint pain, brain fog, tingling, leg pain, depression, and anxiety. Previous to the vaccine she was a regular active child with no problems, very athletic. Now she can hardly run. This has been continuing since the vaccine to this current day. She has been diagnosed with Thyroid disease, Epstein-Barr Virus, PCOS, SMA Syndrome, Ankylosing Spondylitis, Herpes, etc.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Generalised tonic-clonic seizure
Clinical narrative: Patient received TDaP and MENVEO on 6-29-17. Had grand mal seizure on 7-9-17.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Chest pain, Laboratory test, Muscular weakness, Musculoskeletal chest pain, Musculoskeletal disorder
Clinical narrative: Saturday 10/15/2016 upon standing from chair right leg not working, basically stand realize leg not working hold on to chair, shake leg wait for motor return. Sunday night Monday - right Thoracic/Rib pain excruciating - continued intermittently with Right leg weakness.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Nuclear magnetic resonance imaging brain, Spinal X-ray
Clinical narrative: Saturday 10/15/2016 upon standing from chair right leg not working, basically stand realize leg not working hold on to chair, shake leg wait for motor return. Sunday night Monday - right Thoracic/Rib pain excruciating - continued intermittently with Right leg weakness.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Neuralgia, Pneumonia
Clinical narrative: Neuralgia on neck; 2 weeks after injection RUL pneumonia; still had neuralgia that's lowered her QOL.
Age: 1.25
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Hand-foot-and-mouth disease, Pharyngitis, Pyrexia, Rash
Clinical narrative: Pt seen 7/5/17 with H-F-M disease. Pt seen on 7/10/17 with Acute Pharyngitis/rash secondary MMR with fever.
Age: 44.0
Sex: F
Vaccine: HEP, HEPA, PPV, TDAP
Symptoms: Diarrhoea, Mobility decreased, Pain in extremity, Pyrexia
Clinical narrative: High fever (102 degrees), sore arms (can't raise arms). Diarrhea.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling from injection site down to elbow, red and hot to the touch. PCP prescribed Cephalexin and MEDROL Dose Pak.
Age: 31.0
Sex: F
Vaccine: HEP, VARCEL, HEP, VARCEL
Symptoms: Dizziness, Pharyngeal oedema, Throat tightness
Clinical narrative: On May 1, 2017 I received the first Hepatitis B and varicella vaccine. After receiving the shot I left and on the drive home I began to feel intense burning and tightening in my throat. It got worse as the minutes went by. I then had a difficult time breathing and felt very light headed and dizzy. I also experienced tingling in my hands and feet. I was driving by a health clinic and I stopped and went in and told them how I was feeling. They took my blood pressure which was high and immediately gave my a epi shot along with benadryl and zantac. I was then taken to the ER for further evaluation. I was admitted to the ER where they gave me an IV to administer more benadryl and also steroids and pepcid. I was released to go home about 3 hours later.  I was instructed to take benadryl, prednisone, and pepcid for the next 5 days.
Age: 31.0
Sex: F
Vaccine: HEP, VARCEL, HEP, VARCEL
Symptoms: Allergy test negative, Blood pressure increased, Dizziness, Dyspnoea, Paraesthesia
Clinical narrative: On May 1, 2017 I received the first Hepatitis B and varicella vaccine. After receiving the shot I left and on the drive home I began to feel intense burning and tightening in my throat. It got worse as the minutes went by. I then had a difficult time breathing and felt very light headed and dizzy. I also experienced tingling in my hands and feet. I was driving by a health clinic and I stopped and went in and told them how I was feeling. They took my blood pressure which was high and immediately gave my a epi shot along with benadryl and zantac. I was then taken to the ER for further evaluation. I was admitted to the ER where they gave me an IV to administer more benadryl and also steroids and pepcid. I was released to go home about 3 hours later.  I was instructed to take benadryl, prednisone, and pepcid for the next 5 days.
Age: 31.0
Sex: F
Vaccine: HEP, VARCEL, HEP, VARCEL
Symptoms: Throat irritation, Throat tightness
Clinical narrative: On May 1, 2017 I received the first Hepatitis B and varicella vaccine. After receiving the shot I left and on the drive home I began to feel intense burning and tightening in my throat. It got worse as the minutes went by. I then had a difficult time breathing and felt very light headed and dizzy. I also experienced tingling in my hands and feet. I was driving by a health clinic and I stopped and went in and told them how I was feeling. They took my blood pressure which was high and immediately gave my a epi shot along with benadryl and zantac. I was then taken to the ER for further evaluation. I was admitted to the ER where they gave me an IV to administer more benadryl and also steroids and pepcid. I was released to go home about 3 hours later.  I was instructed to take benadryl, prednisone, and pepcid for the next 5 days.
Age: 69.0
Sex: U
Vaccine: FLU3, FLU3
Symptoms: Muscle disorder
Clinical narrative: Limited range of motion. Arm still sore 2 days after having flu shot. Called pharmacy, informed to take aspirin and it will go away. Arm has been sore since the shot, difficult to lift arm. Started water aerobics, pain still there but not quite as strong.
Age: 69.0
Sex: U
Vaccine: FLU3, FLU3
Symptoms: Joint range of motion decreased, Mobility decreased, Pain in extremity
Clinical narrative: Limited range of motion. Arm still sore 2 days after having flu shot. Called pharmacy, informed to take aspirin and it will go away. Arm has been sore since the shot, difficult to lift arm. Started water aerobics, pain still there but not quite as strong.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash, Stomatitis
Clinical narrative: 5/23/17 shingle by left eye. 5/24/17 Pustules formed at injection site along w/burning and pain. 5/27 second pustule appears by left eye and 2 appear inside upper top lip. 5/30/17 urgent care visit to obtain anti-viral meds and cream. 6/01/17 Cornea specialist checked vision. Shingles breakout was confirmed at three locations -eye, mouth and site of injection.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Injection site pain, Injection site pustule, Ophthalmic herpes zoster, Rash pustular
Clinical narrative: 5/23/17 shingle by left eye. 5/24/17 Pustules formed at injection site along w/burning and pain. 5/27 second pustule appears by left eye and 2 appear inside upper top lip. 5/30/17 urgent care visit to obtain anti-viral meds and cream. 6/01/17 Cornea specialist checked vision. Shingles breakout was confirmed at three locations -eye, mouth and site of injection.
Age: 19.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: This spontaneous report has been received from a Licensed Practical Nurse referring to a 19 year old patient of unknown gender. The patient's medical history, concurrent conditions, drugs reactions or allergies and concomitant therapies were not provided. On an unknown date, the patient was inadvertently vaccinated with ZOSTAVAX 19400 PFU lot number M041511 and expiration date of 08-JAN-2018 subcutaneously (dose and anatomical location were not provided, frequency reported as "single dose") for prophylaxis in combination with sterile diluent lot number N008378 and expiration date 08-JUN-2018, instead of VARIVAX due to product confusion. Nurse stated "I ordered wrong product, not realizing and when received it, put in freezer then administered, not realizing wrong product". No adverse effects reported.
Age: 19.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report has been received from a Licensed Practical Nurse referring to a 19 year old patient of unknown gender. The patient's medical history, concurrent conditions, drugs reactions or allergies and concomitant therapies were not provided. On an unknown date, the patient was inadvertently vaccinated with ZOSTAVAX 19400 PFU lot number M041511 and expiration date of 08-JAN-2018 subcutaneously (dose and anatomical location were not provided, frequency reported as "single dose") for prophylaxis in combination with sterile diluent lot number N008378 and expiration date 08-JUN-2018, instead of VARIVAX due to product confusion. Nurse stated "I ordered wrong product, not realizing and when received it, put in freezer then administered, not realizing wrong product". No adverse effects reported.
Age: 18.0
Sex: F
Vaccine: MMR, MNQ, VARCEL, MNQ, VARCEL
Symptoms: Cellulitis, Erythema, Pain, Skin warm, Swelling
Clinical narrative: This spontaneous report as received from a other refers to a patient of unknown age. On 26-JUN-2017 the patient was vaccinated with VARIVAX lot # M040137 for prophylaxis. Concomitant therapies included sterile diluent. On 26-JUN-2017, 1 day after onset of therapy the patient experienced incorrect product storage. On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to VARIVAX. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: MMR, MNQ, VARCEL, MNQ, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other refers to a patient of unknown age. On 26-JUN-2017 the patient was vaccinated with VARIVAX lot # M040137 for prophylaxis. Concomitant therapies included sterile diluent. On 26-JUN-2017, 1 day after onset of therapy the patient experienced incorrect product storage. On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to VARIVAX. Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: HEPAB, HEPAB
Symptoms: Allergy test, Arthralgia, Asthenia, Carpal tunnel syndrome, Impaired driving ability
Clinical narrative: 7/12/2017 PT REPORTS PAIN IN RIGHT ARM ON VACCINE DAY AND DAYS LATER. SHE REPORTS PAIN STARTED TO BEGIN IN JOINTS ON BODY.
Age: 28.0
Sex: F
Vaccine: HEPAB, HEPAB
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: 7/12/2017 PT REPORTS PAIN IN RIGHT ARM ON VACCINE DAY AND DAYS LATER. SHE REPORTS PAIN STARTED TO BEGIN IN JOINTS ON BODY.
Age: 28.0
Sex: F
Vaccine: HEPAB, HEPAB
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: 7/12/2017 PT REPORTS PAIN IN RIGHT ARM ON VACCINE DAY AND DAYS LATER. SHE REPORTS PAIN STARTED TO BEGIN IN JOINTS ON BODY.
Age: 33.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Facial paralysis
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of Bell's palsy in a 33-year-old male patient who received MENVEO (batch number M16096, expiry date 31st March 2018). The patient's past medical history included Bell's palsy (experienced in 2013). Concurrent medical conditions included HIV infection (well-controlled with GENVOYA). Concomitant products included GENVOYA. On 5th June 2017, the patient received MENVEO. On 17th June 2017, 12 days after receiving MENVEO, the patient experienced Bell's palsy (serious criteria GSK medically significant). The patient was treated with VALTREX and prednisone. On an unknown date, the outcome of the Bell's palsy was recovering/resolving. The reporter considered the Bell's palsy to be possibly related to MENVEO. Additional details were reported as follows: At the time of report, the patient was 34 year old. There were no concomitant vaccines. The patient received MENVEO in the left deltoid. The reporting pharmacist stated that no hospitalization was required for the patient, and only doctor's office visits were necessary.
Age: 32.0
Sex: M
Vaccine: ANTH
Symptoms: Chills, Night sweats, Productive cough, Pyrexia
Clinical narrative: Fevers, chills, night sweats, productive cough.
Sex: F
Vaccine: HPV4
Symptoms: Adverse event
Clinical narrative: This spontaneous report was received from an unspecified reporter via social media via a company representative, concerning eighteen female patients of unknown age. There were no concurrent conditions, medical history or concomitant medications reported. On unspecified dates, the patients were vaccinated with GARDASIL (dose, frequency, route, lot # and expiration date were not reported) for prophylaxis. On unspecified dates, the patients experienced acute physical side effects (adverse event). At the time of the report, it was unknown the outcome of the adverse events. The causality between the adverse events and GARDASIL was considered as related.; Sender's Comments: US-009507513-1706USA000483: US-009507513-1706USA000478: US-009507513-1706USA000486:
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: The series were very painful; This spontaneous report was received from an unspecified reporter, via a company representative, concerning a female patient of an unknown age. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On unspecified dates, the patient was vaccinated with the entire series of GARDASIL (dose, strenght, frequency, route of administration, anatomical location, lot # and expiration date were not reported), for prophylaxis. It was reported that the series were very painful  (also reported as "she did not have any adverse reactions"). Neither the patient's outcome nor the causality assessment between GARDASIL and the adverse event was reported. This is one of several related reports.; Sender's Comments: US-009507513-1706USA000467: US-009507513-1706USA000483: US-009507513-1706USA000486:
Sex: F
Vaccine: HPV4
Symptoms: Malaise
Clinical narrative: This spontaneous report was received from the patient's parent via social media via a company representative, concerning a female patient of an unknown age. There were no concurrent conditions, medical history or concomitant medications reported. On unspecified dates, the patient was vaccinated with the GARDASIL series (dose, frequency, route, lot # and expiration date were not reported) for prophylaxis. It was reported that each shot in the series got worse for the patient and she was so sick. At the time of the report, it was unknown the outcome of the malaise. The causality between the adverse event and GARDASIL was unknown.; Sender's Comments:  US-009507513-1706USA000467: US-009507513-1706USA000478: US-009507513-1706USA000483:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant concerning an unknown number of patients; demographics were unknown. The patients' medical history, concurrent conditions, drug reactions and allergies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX for prophylaxis, lot # L023592 and expiration date: 26-JUN-2017 (dose, frequency and route of administration were not reported), reconstituted with a sterile diluent (manufacturer unknown). The sterile diluent was not involved in the temperature excursions. No adverse effects were reported. It was reported that on an unspecified date, the vaccines were exposed to a temperature between 15 Fahrenheit degrees and 46 Fahrenheit degrees for 1 hour and 18 minutes. The vaccines were also exposed to a temperature between 15 Fahrenheit degrees and 46 Fahrenheit degrees for 1 hour, a temperature between 6 Fahrenheit degrees and 14 Fahrenheit degrees for 30 minutes and finally, a temperature between -50° Celsius (C) and -15° C for 54 minutes. The medical assistant reported that there was no previous temperature excursion. The call was placed because of a Digital Data logger report. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1706USA010994.
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus generalised
Clinical narrative: Information has been received on 14-JUN-2017 from a medical assistant via a company representative regarding a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX, (lot number and expiration not reported) subcutaneous for prophylaxis. Concomitant therapy included sterile diluent. The medical assistant reported that on an unknown date, the patient had a reaction of extreme itching all over her entire body. The patient sought treatment by contacting the office. No further information was provided. Additional information was received on 15-JUN-2017 from a company representative. The patient has been itching for 4 months. The patient has been referred to a dermatologist and an allergist. The patient is still itching as of the date of this report. The patient was not vaccinated in the reporting office and the location of the vaccination could not be confirmed. The patient is between 50 and 60 years old. The patient is attributing the itching to the ZOSTAVAX as the itching was first experienced right after the ZOSTAVAX. The patient was being seen by a primary care physician in the office. The physician did not provide a causality assessment. The outcome of extreme itching all over her entire body was reported as not recovered/not resolved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions, drug and allergy history were not reported. On unspecified dates, the patients were vaccinated with improperly stored injections of two different lot # of PNEUMOVAX23  lot # M032635, expiration date 05-MAY-2018 and/or lot # M038359, expiration date 13-MAY-2018 (strength, dose and route of administration were not provided) for prophylaxis. The patients' concomitant therapies were not reported. On an unspecified date, the vaccines were exposed to temperature ranges between 47° Fahrenheit (F) and 77°F during a time frame of 8 hours and 20 minutes , which was called by a data logger. There was not previous temperature excursion. Adverse effects were not reported. This is one of two reports received from the same source.; Sender's Comments:  US-009507513-1706USA005650:
Sex: U
Vaccine: VARCEL
Symptoms: Poor quality drug administered, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age.  On an unknown date the patient was vaccinated with VARIVAX for prophylaxis. On an unknown date the patient experienced incorrect product storage and poor quality drug administered. The outcome of poor quality drug administered is unknown.   The reporter considered incorrect product storage and poor quality drug administered to be not related to VARIVAX.  Sender's Comments: US-009507513-1707USA001044: US-009507513-1707USA001045: US-009507513-1707USA001046:
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On an unknown date, the patient was inadvertently vaccinated with an expired dose of GARDASIL as prophylaxis (Strength, dose, route, lot # and expiration date were not reported). No adverse effects were reported.
Age: 31.0
Sex: F
Vaccine: VARZOS
Symptoms: Exposure via eye contact, Eye irritation
Clinical narrative: This spontaneous report was received from a female pharmacist of unknown age via company representative reporting on herself. The patient's medical history was not reported. Concomitant therapies included sterile diluent (STERILE DILUENT). On 15-JUN-2017, when the pharmacist administered a dose of ZOSTAVAX (anatomical location, lot# and expiration date were not reported) for prophylaxis , "some of the vaccine got into her eye"exposure via eye contact ).  The pharmacist stated "the needle did not touch her eye and she flushed her eye out with water". No treatment was given. There was no product quality complaint (PQC) involved.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product preparation error
Clinical narrative: This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On 15-JUN-2017, the patient was vaccinated with a dose of ZOSTAVAX as prophylaxis (Strength, dose, route, lot # and expiration date were not reported), which was reconstituted with another company sterile diluent (Strength, dose, route, lot # and expiration date were not reported). No adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Exposure via eye contact, Eye pain
Clinical narrative: Information has been received from a physician concerning a female pharmacist of unknown age who was a friend of the physician. The pharmacist had no concomitant medication, medical history and drug allergy. On 16-JUN-2017, the pharmacist was administering a dose of ZOSTAVAX to an unknown patient (route, lot# and expiry date were unknown) for routine vaccine, when some of the ZOSTAVAX squirted in the eye of the pharmacist. She had "pain in her eye" lasting for 5 minutes after the ZOSTAVAX squirted in her eye. The physician reported that she instructed the pharmacist to "flush her eye with water." And the pharmacist had fully recovered. Causality was not reported. The physician was unaware if the patient received the full dose of ZOSTAVAX (captured in a case MARRS# 1707USA001054).; Sender's Comments: US-009507513-1707USA001054:
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacist referring to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On unknown dates, the patients were vaccinated with the improperly stored doses of ZOSTAVAX (dose, frequency, route, lot # and expiration date were not reported) reconstituted with properly stored sterile diluent(manufacturer unknown) (dose, frequency, route, lot # and expiration date were not reported) for prophylaxis(Incorrect product storage). There were no adverse effects reported. The temperature excursion, time frame, previous temperature excursion were unknown. There were no data logger was involved. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1707USA001111:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse referring to unspecified patients of unknown age and gender. There was no information about medical history, concomitant medication or concurrent condition. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (dose and route unknown, lot# reported as N002204, expiration date 19-JAN-2019) for prophylaxis. The vaccine was exposure to 15 Fahrenheit degree (F) to 46F for 2 hours. The previous excursion was 6F to 14F for 12 hours. Data logger was involved. No adverse event was reported. This is one of the reports received from the same reporter (MARRS# 1707USA001059).; Sender's Comments: US-009507513-1707USA001059:
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report as received from a consumer refers to a 60 year old male patient. On 13-JUN-2017 the patient was vaccinated with ZOSTAVAX for prophylaxis. Concomitant therapies included telmisartan(MICARDIS).  On 14-JUN-2017, 2 days after onset of therapy the patient experienced injection site erythema. The outcome of injection site erythema was reported as not recovered/not resolved. Causality was not provided.
Sex: U
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, concerning a patient of an unknown age and gender. There were no concurrent conditions, medical history, drug reactions, allergies or concomitant medications reported. On unspecified dates, the patient was vaccinated with the first, second and third dose of GARDASIL 9 injection (dose, frequency, route of administration, lot number and expiration date were not reported) for an unknown indication. On 05-JUN-2017, the patient received a fourth dose of GARDASIL 9 injection (dose, frequency and route of administration were not reported) lot # N001533 with an expiration date of 16-OCT-2019, for prophylaxis. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 15-JUN-2017 the patient was vaccinated with an improperly stored dose of VARIVAX (lot # M002063; expiration date: 12-JAN-2018) (dose and route was not reported) for prophylaxis. Concomitant therapies included sterile diluent (lot # M006117; expiration date: 24-AUG-2048).  It was reported that the sterile diluent used to reconstitute the VARIVAX was properly stored. No symptoms were reported. Temperature that the vaccine was exposed was at 9 degrees Celsius to 25 degrees Celsius during 2 days. No previous temperature excursion was reported. Data Logger was not involved.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product preparation error
Clinical narrative: This spontaneous report has been received from a pharmacist and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with M-M-R II lot # reported as M045400, expiration date 14-NOV-2018 (dose and route of administration were not reported). It was unknown what was used to reconstitute the vaccine and reported that it was "something other than sterile diluent" (unspecified date). No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Disorientation, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report was received from a physician via a company representative, who referred to herself, a female of unknown age. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided. On an unknown date, the physician was vaccinated with ZOSTAVAX (dose, route of administration, lot# and expiration date were not reported) for prevention of shingles. On unknown date, the physician experienced a slight headache for 3 days, was disoriented, very tired, her arm swelled up from the injection site down to the elbow and was red and very painful after receiving ZOSTAVAX . The physician recovered on an unknown date. No product quality complaint was involved. The relatedness between the events and ZOSTAVAX was not reported. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1707USA001001:
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report was received from a physician via a company representative, who referred to herself, a female of unknown age. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided. On an unknown date, the physician was vaccinated with ZOSTAVAX (dose, route of administration, lot# and expiration date were not reported) for prevention of shingles. On unknown date, the physician experienced a slight headache for 3 days, was disoriented, very tired, her arm swelled up from the injection site down to the elbow and was red and very painful after receiving ZOSTAVAX . The physician recovered on an unknown date. No product quality complaint was involved. The relatedness between the events and ZOSTAVAX was not reported. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1707USA001001:
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with the first dose of VAQTA (lot number M038572 and expiration date 11-MAR-2018). On an unknown date, three months after receiving the first dose, the patient was vaccinated with the second dose of VAQTA (lot number reported as N039202 and expiration date 11-MAR-2018). No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 39-year-old patient. On 10-NOV-2016 and on 10-NOV-2016, the adult patient received a doses of pediatric formulation of RECOMBIVAX HB lot # M020926, expiration date 11-AUG-2018. No adverse effects were reported.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # M034780, expiration date 15-APR-2019 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of GARDASIL 9 experienced the temperature excursion from 32 to 35 degrees Fahrenheit for 8 hours and form 47 to 77 degrees Fahrenheit for 8 hours. Data logger was not involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1707USA001092: US-009507513-1707USA001093: US-009507513-1707USA001091:
Sex: F
Vaccine: VARCEL
Symptoms: Accidental exposure to product, Exposure via skin contact, Maternal exposure during pregnancy, No adverse event, Occupational exposure to product
Clinical narrative: This spontaneous prospective pregnancy report as received from a other health professional refers to a female patient of unknown age. On an unknown date the patient was vaccinated with VARIVAX for prophylaxis.  The patient became pregnant. The LMP and EDD is not known. The patient delivered a infant. The pregnancy outcome was unknown. On an unknown date the patient experienced occupational exposure to product, exposure via skin contact, accidental exposure to product, no adverse event and maternal exposure during pregnancy. The outcome of occupational exposure to product, no adverse event, maternal exposure during pregnancy, exposure via skin contact and accidental exposure to product is unknown. The reporter considered occupational exposure to product, exposure via skin contact, accidental exposure to product, no adverse event and maternal exposure during pregnancy to be not related to VARIVAX. {Additional information has been requested. / Additional information is not expected.}
Age: 49.0
Sex: M
Vaccine: HEPA, TYP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender.  No information was provided regarding the patient's medical history, concurrent conditions, drug and allergy history. On 20-JUN-2017, the patient was vaccinated with an expired dose of VAQTA (route and dose were not provided) lot # M022556 , expiration date 26-MAY-2017, for prophylaxis. Patient's concomitant medications were not provided. No adverse effects were reported. No PQC was involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with VARIVAX lot # M007287 for prophylaxis. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to VARIVAX. Additional information has been requested.; Sender's Comments: US-009507513-1707USA001144:
Sex: U
Vaccine: HPVX
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with the first dose of GARDASIL 9 or GARDASIL (unspecified trade name) for prophylaxis. According to the physician assistant, the patient received the second dose of GARDASIL or GARDASIL 9 (trade name unspecified) 2 years after receiving the first dose. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date in September 2016, the patient started her series of GARDASIL. On an unknown date in June 2017 (reported as now), the patient would like a second dose of GARDASIL 9 (lot # M014929, expiration date: 22-MAY-2017) for prophylaxis. It was unspecified if the patient was in the office. There was no adverse effects reported. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a medical assistant via a company representative refers to a male patient of unknown age. No information regarding the patient's medical history or concurrent conditions was provided. On an unknown date, the patient was subcutaneously vaccinated with a dose of ZOSTAVAX injection (exact dose, lot# and expiry date were not reported) for the prevention of herpes zoster. There were no concomitant therapies reported. On an unknown date, reported as the next day, the patient experienced shingles, and visited a doctor's office due to the event. The outcome of the event was not reported. The relatedness between ZOSTAVAX and the event was not provided.  Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Injection site pain, Injection site swelling, Pain
Clinical narrative: This spontaneous report as received from a physician's assistant refers to a 23 year old female patient. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On 06-JUN-2017, the patient was vaccinated on an unspecified arm with GARDASIL 9 dose 2, lot # N001533 (expiry date, dosing details, route were unknown) for prophylaxis. The reported stated that the patient was seen in the office on 23-JUN-2017 and her arm was swollen and painful at the injection site; and the patient complained of the pain when she moved her arm. The patient's arm had "a 5 and 1/2 elevation". The outcome of the events was unknown. There were no product quality complaints (PQC) involved. The causality was not reported. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a nurse prescriber via a company representative refers to a 77-year-old female patient. In approximately June 2017, reported as "at an unspecified time last week", the patient was vaccinated with a dose of PNEUMOVAX 23 lot # N001007, expiration date: 19-SEP-2018, for revention of pneumonia. The day after the PNEUMOVAX 23 was administered, the patient visited the nurse prescriber and was experiencing swelling on the bicep of the arm in which the injection was administered. The swelling was closer to the elbow and hot to the touch. The swelling was not at the injection site. The following day after visiting the nurse prescriber about the swelling, the patient was seen in an unspecified emergency room, but was not admitted into the hospital. The outcome of the event and the relatedness between the event and PNEUMOVAX 23 were not reported.
Sex: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Discomfort, Emotional distress, Herpes zoster, Ophthalmic herpes zoster
Clinical narrative: This spontaneous report was received from a lawyer concerning a case in litigation and refers to a male patient of unknown age. Medical history, concurrent conditions and concomitant medications were not provided. On or about 10-MAR-2010, the patient was vaccinated with ZOSTAVAX as recommended for routine health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent and chronic strain of herpes zoster.  On or about 15-MAY-2015, the patient was treated by a physician for the onset of a vesicular rash accompanied symptoms of weakened immunity, and severe discomfort and distress, which was diagnosed as severe herpes on the face. The patient was referred to an ophthalmologist for this encounter, in which the blistering vesicles were in and around the eye. On or about 14-AUG-2015, the patient was treated by the physician for new and worsening outbreaks, which were diagnosed as herpes zoster. On or about 28-JAN-2016, he was again treated by the physician for shingles that had transferred to new locations on the body, including the arm and chest. On or about 06-JUN-2016, the patient was again treated for similar and worsening symptoms, at which time his condition was diagnosed as recurrent and chronic herpes zoster. He was prescribed acyclovir and acetaminophen and PERCOCET to manage his painful and persistent symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further and proximate result, the patient has suffered and will continue to suffer significant, medical expenses, pain and suffering, and other damages. The outcome of the events was not recovered. Upon internal review, ophthalmic herpes zoster was considered medically significant. Additional information has been requested.