chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Tenderness
Clinical narrative: Was told I should get the GARDASIL vaccine by a dermatologist because I had warts on my finger....first shot was fine back in December 2015. After the second shot at about a month after....I started getting serious pain in the injection arm, the pain only got worse through night time. Soon after it felt like a water pocket or swollen ball was in my arm. I went back to the doctor who gave it to me, they looked and could see and feel the swelling of my muscle and told me that it couldn't be from the shot....(I knew it was, but since they did not seem to find it serious I just left) now it was time for my third and last shot a few months later, this was middle of June 2016. I received it, all was well for a few weeks. Now on July 25th I woke up and my arm was so sore I could barely move it. Today is the 26th and I am in more pain then the second shot swelling ever gave me. I do not see a lump or swelling yet, but I feel it. I can not lift my arm past my chest area. It is stiff and the muscle hurts very badly. I have contacted my doctor again and am currently waiting on a response. I just feel I need to report this as it is something my doctor was not familiar with seeing. Again, at night it is the worst! Can not lay on it or be touched at all, it is about 6 inches around the shot area so the pain is in my shoulder down about half way on my upper arm. I hope this can be resolved and maybe have an answer for what it doing onto  my body a month after this vaccine. NOTE: I would have really loved to speak with someone with the GARDASIL company, but they DO NOT HAVE A PHONE NUMBER ANYWHERE...only the FDA.
Age: 5.0
Sex: M
Vaccine: MMR, TDAP
Symptoms: Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: MMR and TDAP immuniz, swelling and redness at site more that small localized reaction.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Activities of daily living impaired, Acupuncture, Blood test, Burning sensation, Electromyogram
Clinical narrative: I received the ZOSTAVAX vaccine for shingles in 2014 and on November 9 of 2015 I broke out in a 4 inch rash that traveled down my arm into the index finger and thumb causing two large bubbles of chickenpox like looking sores.  My arm burned like a hot curling iron had been run down it constantly. I immediately contacted my doctor and was given antibiotics and started on gabapentin which did not help and then LYRICA which also did  not help. I then went on to self help, vitamin E oil, aloe vera gel, DSMO salve, prescription pain cream VOLTAREN,  olive leaf extract, zinc, ALEVE,  peppermint oil, red light therapy by chiropractor, heat lamp costing $300, ice packs 24/7  pressure glove, electro stim patches, portable  TENS unit, for  the  arm  and  hand,  chiropractic neck decompression as C6 nerve  was involved, acupuncture and finally PERCOCET  5 x daily. My hand was affected and did not function, index finger and thumb was stiff and I could not do normal everyday household chores or drive and could not attach my seatbelt. I had to avoid hot stoves pans and could not curl my hair or insert my earrings. I needed help with everything. It has been nine months August of this year and my hand is numb and I cannot play the piano but do other things with great difficulty. The pain is gone but numbness has remained. I have endured MRI's  and EMG's,  x-rays, steroid hand injections, nerve blocks, too much time in doctors offices and referrals to neurosurgeons etc.  all to no avail. My activities are impaired and nothing can be done and no one cares and no one listens. The vaccine is dangerous and useless.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Impaired driving ability, Musculoskeletal disorder, Musculoskeletal stiffness, Nerve block
Clinical narrative: I received the ZOSTAVAX vaccine for shingles in 2014 and on November 9 of 2015 I broke out in a 4 inch rash that traveled down my arm into the index finger and thumb causing two large bubbles of chickenpox like looking sores.  My arm burned like a hot curling iron had been run down it constantly. I immediately contacted my doctor and was given antibiotics and started on gabapentin which did not help and then LYRICA which also did  not help. I then went on to self help, vitamin E oil, aloe vera gel, DSMO salve, prescription pain cream VOLTAREN,  olive leaf extract, zinc, ALEVE,  peppermint oil, red light therapy by chiropractor, heat lamp costing $300, ice packs 24/7  pressure glove, electro stim patches, portable  TENS unit, for  the  arm  and  hand,  chiropractic neck decompression as C6 nerve  was involved, acupuncture and finally PERCOCET  5 x daily. My hand was affected and did not function, index finger and thumb was stiff and I could not do normal everyday household chores or drive and could not attach my seatbelt. I had to avoid hot stoves pans and could not curl my hair or insert my earrings. I needed help with everything. It has been nine months August of this year and my hand is numb and I cannot play the piano but do other things with great difficulty. The pain is gone but numbness has remained. I have endured MRI's  and EMG's,  x-rays, steroid hand injections, nerve blocks, too much time in doctors offices and referrals to neurosurgeons etc.  all to no avail. My activities are impaired and nothing can be done and no one cares and no one listens. The vaccine is dangerous and useless.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Nuclear magnetic resonance imaging, Rash, Rash vesicular, Spinal decompression, X-ray
Clinical narrative: I received the ZOSTAVAX vaccine for shingles in 2014 and on November 9 of 2015 I broke out in a 4 inch rash that traveled down my arm into the index finger and thumb causing two large bubbles of chickenpox like looking sores.  My arm burned like a hot curling iron had been run down it constantly. I immediately contacted my doctor and was given antibiotics and started on gabapentin which did not help and then LYRICA which also did  not help. I then went on to self help, vitamin E oil, aloe vera gel, DSMO salve, prescription pain cream VOLTAREN,  olive leaf extract, zinc, ALEVE,  peppermint oil, red light therapy by chiropractor, heat lamp costing $300, ice packs 24/7  pressure glove, electro stim patches, portable  TENS unit, for  the  arm  and  hand,  chiropractic neck decompression as C6 nerve  was involved, acupuncture and finally PERCOCET  5 x daily. My hand was affected and did not function, index finger and thumb was stiff and I could not do normal everyday household chores or drive and could not attach my seatbelt. I had to avoid hot stoves pans and could not curl my hair or insert my earrings. I needed help with everything. It has been nine months August of this year and my hand is numb and I cannot play the piano but do other things with great difficulty. The pain is gone but numbness has remained. I have endured MRI's  and EMG's,  x-rays, steroid hand injections, nerve blocks, too much time in doctors offices and referrals to neurosurgeons etc.  all to no avail. My activities are impaired and nothing can be done and no one cares and no one listens. The vaccine is dangerous and useless.
Sex: U
Vaccine: DTAPHEPBIP, DTAPIPVHIB
Symptoms: Wrong drug administered
Clinical narrative: A 6 month old was given PENTACEL and PEDIARIX in error. Should have gotten a PEDIARIX and HIB due to the PENTACEL shortage. Called the state immunization program to make sure this would not harm the infant. PCP and mother were informed. An epidemiologist from the state lab called back and said she would have a nurse from the immunization program to call back too. No recommendations given yet.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness, Face injury, Fall, Mouth injury, Nervousness
Clinical narrative: Patient was going to lay down on exam table but fell. Injury chin and braces injury mouth. Complain about being dizzy and body feeling shaky. Also shaking inside. Incident happen around 8:50 am. Dr assessment of situation. Gave fluids and cracker and check BP.
Sex: U
Vaccine: MMR, MNQ
Symptoms: Discomfort, No adverse event, Pyrexia, Wrong drug administered
Clinical narrative: My daughter was scheduled at her doctors appointment for her 15 month well child visit to receive the DTAP booster and MMR. The medical assistant gave me medication sheets for both vaccines and even instructed me on how she was to administer the vaccine slightly different for the MMR noting which of my daughter's legs would receive each vaccine. I received a phone call later that afternoon from our family practice physician apologizing that instead of the MMR my daughter received MENACTRA a meningococcal vaccine instead. After researching the dose, she received 0.5 ml of this vaccine via injection. When asked how this happened, I was informed that their "triple check" failed them. Additional comments: After researching MENACTRA my daughter could have experienced fainting or seizure like activity within the first 15 minutes after administration. I have had to do all my own research online in order to find out what to look for regarding side effect and long term effects. I also had to call my physician's office to find out which dose she indeed received as the medication for her age should have been divided and doses given 3 months apart. It was my research that brought to my attention that she received the dose normally given to 11-18 year olds. Mediation administered to or used by the patient: No. Outcome: Final outcome: Nothing/no harm Final outcome comment: At this time no adverse reactions have been noted. These happened as a result of the error: More medicine to reduce or relieve the possible bad effect of the error. Other explanation: I had to give additional infant TYLENOL for fever and discomfort. When and how was error discovered: I was informed by my physician via phone. Patient counseling provided: Unknown. Reporter's recommendations: The medical assistant should not have violated their policy and medication verification. I think in the future the vial of the vaccine should be brought into the room for parents viewing and verified. Relevant material provided: None.
Age: 11.0
Sex: M
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Dizziness, Loss of consciousness, Pallor, Syncope
Clinical narrative: Patient passed out a few seconds after receiving Tdap, MCV4, Hep A and HPV-9. Felt light headed, fainted and face turned white. Lips turned white pt came to, sat up, given crackers and juice.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Blood glucose, Face injury, Fall, Lip injury, Syncope
Clinical narrative: Patient was in office to receive BEXSERO #1. 3 mins. after vaccination was given had a syncopal episode. The patient fell from the exam table with injuries to the nose/chin/lower lip areas. The fall was not witnessed unsure of source that caused the injuries. Transferred to ER for further evaluation.
Age: 82.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Blood creatine phosphokinase, Full blood count, Malaise, Metabolic function test
Clinical narrative: Myalgias, Malaise, Generalized weakness starting 1 day after PNEUMOVAX 23.
Age: 82.0
Sex: F
Vaccine: PPV
Symptoms: Myalgia, Red blood cell sedimentation rate increased, Urine analysis normal
Clinical narrative: Myalgias, Malaise, Generalized weakness starting 1 day after PNEUMOVAX 23.
Age: 0.75
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product used for unknown indication
Clinical narrative: This spontaneous report was received from a Registered Medical Assistant (R.M.A) referring to a 9 month old patient of unknown gender. Medical history, concurrent conditions and concomitant therapies were not provided. The Medical Assistant reported that adult dose of RECOMBIVAX HB 10 Microgram/1 ml, intramuscularly, lot # reported as L0482009 with expiration date 31-MAR-2018, was administered to the patient on 30-JUL-2016. Anatomical location was not provided. No adverse event was reported. A product quality complaint was not involved. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information was received from a physician concerning a patient of unknown age and gender, who on an unknown date, was administered dose three of "GARDASIL 4" or GARDASIL 9 (dosages, routes of administration, lot numbers and expiration dates not provided) less than 12 weeks after the second dose. No further details were provided. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: MENB
Symptoms: Arthralgia, Malaise, Pain in extremity, Pyrexia
Clinical narrative: Overall malaise, sore arm, since vaccine admin. on 8/3/16. Fever, joint pain.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Feeling hot
Clinical narrative: Pt received MENVEO and approx. 5 min later felt dizzy, hot and faint. Pt was helped to a sitting position and given water. She was WNL again about 15 min post vaccine.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site warmth
Clinical narrative: Large rash, warm to touch, covering entire upper left arm radiating out from site of vaccination.
Age: 19.0
Sex: M
Vaccine: MMR
Symptoms: Measles antibody negative, Mumps antibody test negative, Rubella antibody negative
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 19 year old male patient. The patient had no pertinent medical history as well as no drug reactions or allergies. On an unknown date, as a child, the patient was vaccinated with 2 doses of MMR II (anatomical route of vaccination, lot number and expiration date were not provided). The patient was not taking any concomitant medication. On an unknown date, the patient's titers for measles, mumps and rubella were drawn, as he will be entering college this fall and the results came back low (measles antibody negative, rubella antibody negative and mumps antibody test negative). Furthermore, no treatment was provided for the adverse event and no product quality issue was involved. At the time of the report, the outcome of measles antibody negative, rubella antibody negative and mumps antibody test negative was unknown. Additionally, the reporter did not provide for a causality between the adverse events and vaccination with MMR II. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received from a registered nurse, who reported that multiple unspecified patients (demographics unknown) received oral ROTATEQ (dosages, routes of administration, lot numbers and expiration dates not provided) on multiple unspecified days, which had been improperly stored. No adverse effect reported. No additional information available. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received from a registered nurse, who reported that multiple unspecified patient (demographics unknown) received GARDASIL 9 (dosages, routes of administration, lot numbers and expiration dates not provided) on multiple unspecified days, which had been improperly stored. No adverse effect reported. No additional information available.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Nurse refers to multiple patients of unknown ages and genders. The patient's pertinent medical histories, concurrent conditions and drug reactions were not reported. On an unknown dates multiple patients were vaccinated with improperly stored GARDASIL 9 lot # M011117 (dose, route, anatomical location and expiration date were not provided). Temperature excursion 0.5 Celsius degrees; time frame 9 hours and 30 minutes. No previous temperature excursions and the digital data logger was not involved. No adverse effects were reported. No other suspect or concomitant medications were reported. No product quality complain was involved. Additional information has been requested.
Age: 1.4
Sex: M
Vaccine: MMRV
Symptoms: Rash generalised
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse, referring to a 17 months old male patient. The patient's pertinent medical history, drug reactions and allergies were unknown by the reporter. On 21-JUL-2106 the patient was vaccinated with PROQUAD (lot # M004895, expiry date 26-JUL-2017). The dose and frequency reported as once, subcutaneously. There was no concomitant medication reported. On an unspecified date in 2016 the patient's mother took him to the emergency room because the patient had a "diffuse rash". The reporter did not know if any treatment was given to the patient. At the time of reporting, the outcome of "diffuse rash" was unknown. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Injection site hypoaesthesia, Injection site induration, Injection site pain
Clinical narrative: Information had been received on 18-JUL-2016 from a field representative who learned of the adverse event from a registered nurse. On an unknown date, a 17 year old female received an injection of GARDASIL 9 (dose not reported). The nurse called in to report that the patient's left arm where GARDASIL 9 was administered was sored, numbed and hard to the touch (date not reported). Outcome of events was not reported. Concomitant medication included MENVEO. No other information was provided for documentation. Additional information is not expected.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Hormone level abnormal, Premature menopause
Clinical narrative: Information has been received from a physician via a field representative referring to a 19 years old female patient. The patient's concurrent condition included attention-deficit hyperactivity disorder (ADHD). The patient's medical history included dizziness and syncope. The patient was not pregnant. Concomitant medication was not provided. On 24-OCT-2007, 02-JAN-2008 and 15-SEP-2008, the patient was vaccinated with the first, second and third doses of GARDASIL, intramuscularly (lot number, expiration date, dose unknown). On an unspecified date in 2013, the patient's mother took the patient to an emergency room which "triggered visits to the gynecology and fertility institution for evaluations". On an unknown date, the patient's mother reported the patient has been diagnosed with premature ovarian failure, and she "believes is the result of the GARDASIL vaccination". The patient had visited a reproductive specialist on an unspecified date and reported by the mother to have extremely high hormone levels. The outcome of premature ovarian failure was unknown. No product quality issue involved. The causal relationship between premature ovarian failure and GARDAIL was reported as related. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Hormone level abnormal, Laboratory test abnormal, Premature menopause
Clinical narrative: Information has been received from a physician via a field representative referring to a 19 years old female patient. The patient's concurrent condition included attention-deficit hyperactivity disorder (ADHD). The patient's medical history included dizziness and syncope. The patient was not pregnant. Concomitant medication was not provided. On 24-OCT-2007, 02-JAN-2008 and 15-SEP-2008, the patient was vaccinated with the first, second and third doses of GARDASIL, intramuscularly (lot number, expiration date, dose unknown). On an unspecified date in 2013, the patient's mother took the patient to an emergency room which "triggered visits to the gynecology and fertility institution for evaluations". On an unknown date, the patient's mother reported the patient has been diagnosed with premature ovarian failure, and she "believes is the result of the GARDASIL vaccination". The patient had visited a reproductive specialist on an unspecified date and reported by the mother to have extremely high hormone levels. The outcome of premature ovarian failure was unknown. No product quality issue involved. The causal relationship between premature ovarian failure and GARDAIL was reported as related. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a nurse refers to patient of unknown age and gender. The patient's concurrent and historical conditions were not reported. On 02-AUG-2016 the patient was vaccinated with a dose of PROQUAD (dose, route, lot# and expiration date unknown) instead of ENDERS-EDMONSTON, JERYL LYNN, M-M-R II. Concomitant therapy included VARIVAX. No adverse reactions were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare work (office manager) refers to an unspecified number of unspecified patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored VARIVAX (dose and route unknown, lot# K007974, exp 03-JUN-2016). No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: This spontaneous report as received on 18-JUL-2016 from a female physician who left a message on the voice mail of the male company representative refers to several unspecified patients of unknown age and gender who experienced syncope after administration of the vaccination GARDASIL 9 (Date of administration, dose, route of administration, anatomical location, lot # and expiry date were not specified). The patients' sought medical attention (unknown type of medical attention and unknown dates). No information about the patients' pertinent medical history or allergies was reported. No information was reported on concomitant medications. The outcome of the event of syncope was unknown. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received from a licensed practical nurse referring to multiple unspecified patient of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not reported. On multiple unspecified dates, the patients were administered 0.65 ml of improperly stored ZOSTAVAX (lot#L046899, expired on 23-FEB-2017, lot#L039096, expired on 01-JAN-2017, lot# reported as M00055, expired on 27-MAR-2017) (route unknown). The vaccines were exposed to 3 separate excursions as followed: 32 Fahrenheit degree (F) for 24 hours, 46 Fahrenheit degree (F) for 73 hours and currently 38 Fahrenheit degree (F) for 24 hours. Data logger was involved. No adverse event was reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker (office manager) refers to an unspecified number of unspecified patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored PROQUAD (dose and route unknown, lot# K011314, exp 14-FEB-2016). No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a registered nurse referring to the patients of unknown ages and genders. The patients' medical histories, concurrent conditions and concomitant therapies were not reported. On unknown dates in 2016 (reported as "after May 2016), the patient were vaccinated with improperly stored dose of VARIVAX (lot# L042266, expiration date 27-OCT-2017, dose and route not reported). The vaccine was improperly stored at 9.36 degree Fahrenheit for 10 hours. There was no data logger. Central monitoring was used. This is one of several reports received from the same reporter. Additional information is not expected as there is no permission to contact the physician.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to the patients of unknown ages and genders. The patient's medical histories, concurrent conditions and concomitant therapies were not reported. On unknown dates in 2016 (reported as "after May 2016"), the patients were vaccinated with improperly stored doses of ZOSTAVAX (lot # L040445, expiration date 15-JAN-2017, dose and route not reported). The vaccine was improperly stored at 9.36 degree Fahrenheit for 10 hours. There was no data logger. Central monitoring was used. There were no previous excursions. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected as there is no permission to contact the physician.
Age: 18.0
Sex: F
Vaccine: HEP, MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: 18 y/o female reports to medical for a reaction to an injection. Pt complains of redness, pruritus, and pain at site of injection received 3 days ago in her left arm. Pain is 2/10 pain described as burning or stinging. No aggravating or alleviating factors. Pain does not radiate. No further complaints at this time.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a multiple patients of unknown ages and genders. Pertinent medical histories, concurrent conditions and drug reactions were not provided. On an unknown dates the patients were vaccinated with improperly stored PROQUAD lot # L051098, expiration date 17-JUN-2017, once, subcutaneously, (Dose and anatomical location were not provided). No adverse events were reported. No product quality complain was involved. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella virus test negative
Clinical narrative: Information has been received from a Nurse Practitioner (also reported as Nurse prescriber) concerning to an 18 year old female patient. No pertinent medical history, drug reactions, allergies or concurrent conditions were reported. On unknown dates, the patient was vaccinated with the first and second dose of VARIVAX, via subcutaneous route (lot number and expiration date were not reported). Then, on 04-MAY-2016, the patient was vaccinated with the third dose (last booster) of VARIVAX, via subcutaneous route, (lot number and expiration date were not provided). Other suspect and concomitant medications were not reported. On 16-JUL-2016, the patient was performed an antibodies test and "none were detected" (Varicella virus test negative). It was reported that the patient sought medical attention (unspecified), on an unspecified date in JULY 2016. The reporter asked for guidance. The outcome of the varicella virus test negative was unknown. The relatedness between the event and therapy with VARIVAX was not reported. No product quality complaint was involved. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to an unspecified number of patients of unknown ages and genders. Pertinent medical histories, concurrent conditions and drug reactions were not provided. On an unknown dates the patients were vaccinated with improperly stored VARIVAX (lot # L041204, expiration date 20-OCT-2017 (Dose, route and anatomical location were not provided). No other suspect or concomitant therapies were provided. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse referring an unknown number of patients of unknown age and gender. Pertinent medical history, concurrent conditions and concomitant therapies were not provided. The Nurse reported that the patients were administered improperly stored doses of VARIVAX (Lot # reported as M012991, Exp date: 14-MAR-2018 and Lot # reported as M005974, Exp. date: 02-FEB-2018) on unknown dates "since last week" (prior to 29-JUL-2016). She also reported that excursion details were not yet available. The report was due to a data logger. No adverse events were reported. There was not a product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse, who reported that multiple unspecified patients (demographics unknown) received LIQUID PEDVAXHIB (dosages, routes of administration, lot numbers and expiration dates not provided) on multiple unspecified days, which had been improperly stored. No adverse effect reported. No additional information available. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician, via a company representative, concerning to a male patient in his 60s. The patient's pertinent medical history and concurred conditions were not provided. It was reported that in 2012, reported as "4 years ago", the patient was vaccinated with one time injection of ZOSTAVAX (lot #, dose, route and expiration date were not provided). Concomitant therapies were not reported. On an unknown date, the patient got shingles and he sought unspecified medical attention on an unreported date. The outcome of shingles was unknown at the time of the report. Additional information is not expected as no consent for follow up was given.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner referring to a multiple unknown patients. Patient's demographics pertinent medical history drug reactions and allergies were not reported. On multiple unknown dates the patients were administered with improperly stored (temperature: 51 F; time frame 2 hours) doses of ROTATEQ (lot # L035510, expiry date 13-MAY-2017) orally. Doses of administration were not reported. No adverse effects were reported. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Myalgia, Pyrexia
Clinical narrative: Vomiting and a fever of 102, myalgias, injection site soreness, redness and swelling for three days.
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Vomiting
Clinical narrative: Vomiting and a fever of 102, myalgias, injection site soreness, redness and swelling for three days.
Age: 18.0
Sex: F
Vaccine: FLU3
Symptoms: Loss of consciousness
Clinical narrative: Pt. was sitting in a chair before, during, and after vaccination and after about 5 mins after vaccination, she seemed to lose consciousness for about 5-10 seconds and became conscious quickly. Said she was okay and had her relaxed for a awhile and had he boyfriend picked her up and she said she'll will follow up w/her primary doctor.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Cellulitis, Erythema, Nodule, Skin lesion, Skin warm
Clinical narrative: 11 y/o male who developed cellulitis on the right arm following Meningococcal vaccine administration on June 8th, 2016. Lesion is warm, nodular and tender to touch. Patient's mother gave him BENADRYL that evening but the redness progressed so they came to the hospital the next morning. Patient was treated with Clindamycin 150mg 2 caps QID x7 days.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Tenderness
Clinical narrative: 11 y/o male who developed cellulitis on the right arm following Meningococcal vaccine administration on June 8th, 2016. Lesion is warm, nodular and tender to touch. Patient's mother gave him BENADRYL that evening but the redness progressed so they came to the hospital the next morning. Patient was treated with Clindamycin 150mg 2 caps QID x7 days.
Age: 17.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Dizziness
Clinical narrative: Pt given MENACTRA and TRUMENBA 7/23/16 since being immunized started having dizziness that has not resolved possibly reactivated pts POTS. Postural Orthostatic Tachycardia Syndrome.
Age: 69.0
Sex: M
Vaccine: FLU3, PNC
Symptoms: Asthenia, Muscular weakness, Paraesthesia
Clinical narrative: Initial unsolicited misuse report received from a pharmacist on 17-Nov-2015. This case involves 69-year-old male patient who was vaccinated with a intramuscular injection of FLUZONE HD (batch number- UI442AA, expiry date- 06-Apr-2016) in right deltoid, 0.5 ml intramuscular injection of PREVNAR 13 (manufacturer: Wyeth batch number- L87117, expiry date- Feb 2017) in left deltoid on 24-Sep-2015 at 10:00 Am. No other medications. Other medical conditions unknown, medical history was unknown and patient had no illness at the time of vaccination. it was reported that patient had reported this events previously without any problem. On 24-Sep-2015, 5 hours after vaccination at 15:00 hours, patient experienced tingling in hands and muscle weakness all over. Patient had received FLUZONE  HD last year also. Patient required ER/ doctor visit. Lab tests were unknown and patient received unspecified treatment in emergency room. On 28-Sep-2015, events were resolved. Reporter considered the casuality as that it was possible the adverse event (Tingling in hands) was related to the PREVNAR 13 vaccine and he was unsure about the High dose flu shot being related to the adverse event (Tingling in hands), because the patient received it last year with no problem. Documents held by sender: none.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Balance disorder, Blood pressure increased, Blood test, Cough, Dizziness
Clinical narrative: Initial unsolicited report received from a consumer on 26-Oct-2015. This case involves a 67-year-old female patient, who was vaccinated with a dose of Fluzone HD (batch number: unknown, dose, route of administration were not reported) in left arm on 14-Sep-2015. Patient had no illness at the time of vaccination and had history of allergy to lansoprazole (itching, swollen mouth) Vicks Daycare, had high blood pressure (not taking medication) and type II diabetes- diet controlled. Concomitant medication was not reported. On 14-Sep-2015, same day two hours after vaccination patient experienced sneezing (5 times). On 15-Sep-2015, next day patient experienced light headed. On 16-Sep-2015, patient was diagnosed with vertigo, experienced dizziness and losing her balance. On unspecified date, patient experienced pain in her head, runny nose and dry cough and patient stated that she got ill because of flu shot. It was reported that the patient required ER/doctor visit. On 22-Sep-2015, patient called the nurse on insurance card regarding dizziness and was not feeling well. On 24-Sep-2015, blood pressure was checked, which was elevated and on 25-Sep-2015 patient was taken to chestnut hill hospital ER via ambulance and brain scan, blood work was performed. It was also reported that patient saw Dr on 21-Oct-2015 for further follow-up. It was reported that the patient had prescribed unspecified corrective treatment. At the time of this report patient was recovering from the events sneezing, light headed, vertigo, dizziness and losing her balance. The outcome of the events pain in head, runny nose and dry cough was reported as unknown. Documents held by Sender: none.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Gait disturbance, Headache, Malaise, Rhinorrhoea, Scan brain
Clinical narrative: Initial unsolicited report received from a consumer on 26-Oct-2015. This case involves a 67-year-old female patient, who was vaccinated with a dose of Fluzone HD (batch number: unknown, dose, route of administration were not reported) in left arm on 14-Sep-2015. Patient had no illness at the time of vaccination and had history of allergy to lansoprazole (itching, swollen mouth) Vicks Daycare, had high blood pressure (not taking medication) and type II diabetes- diet controlled. Concomitant medication was not reported. On 14-Sep-2015, same day two hours after vaccination patient experienced sneezing (5 times). On 15-Sep-2015, next day patient experienced light headed. On 16-Sep-2015, patient was diagnosed with vertigo, experienced dizziness and losing her balance. On unspecified date, patient experienced pain in her head, runny nose and dry cough and patient stated that she got ill because of flu shot. It was reported that the patient required ER/doctor visit. On 22-Sep-2015, patient called the nurse on insurance card regarding dizziness and was not feeling well. On 24-Sep-2015, blood pressure was checked, which was elevated and on 25-Sep-2015 patient was taken to chestnut hill hospital ER via ambulance and brain scan, blood work was performed. It was also reported that patient saw Dr on 21-Oct-2015 for further follow-up. It was reported that the patient had prescribed unspecified corrective treatment. At the time of this report patient was recovering from the events sneezing, light headed, vertigo, dizziness and losing her balance. The outcome of the events pain in head, runny nose and dry cough was reported as unknown. Documents held by Sender: none.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Sneezing, Vertigo
Clinical narrative: Initial unsolicited report received from a consumer on 26-Oct-2015. This case involves a 67-year-old female patient, who was vaccinated with a dose of Fluzone HD (batch number: unknown, dose, route of administration were not reported) in left arm on 14-Sep-2015. Patient had no illness at the time of vaccination and had history of allergy to lansoprazole (itching, swollen mouth) Vicks Daycare, had high blood pressure (not taking medication) and type II diabetes- diet controlled. Concomitant medication was not reported. On 14-Sep-2015, same day two hours after vaccination patient experienced sneezing (5 times). On 15-Sep-2015, next day patient experienced light headed. On 16-Sep-2015, patient was diagnosed with vertigo, experienced dizziness and losing her balance. On unspecified date, patient experienced pain in her head, runny nose and dry cough and patient stated that she got ill because of flu shot. It was reported that the patient required ER/doctor visit. On 22-Sep-2015, patient called the nurse on insurance card regarding dizziness and was not feeling well. On 24-Sep-2015, blood pressure was checked, which was elevated and on 25-Sep-2015 patient was taken to chestnut hill hospital ER via ambulance and brain scan, blood work was performed. It was also reported that patient saw Dr on 21-Oct-2015 for further follow-up. It was reported that the patient had prescribed unspecified corrective treatment. At the time of this report patient was recovering from the events sneezing, light headed, vertigo, dizziness and losing her balance. The outcome of the events pain in head, runny nose and dry cough was reported as unknown. Documents held by Sender: none.
Sex: U
Vaccine: FLU3, PPV
Symptoms: Erythema, Headache, Injection site nodule, Nausea, Pain
Clinical narrative: Initial unsolicited report received from a nurse on 26 October 2015. This case was linked with 2015SA176377 and 2015SA172486 (same lot number). This case involves a patient who was vaccinated with a dose of FLUZONE (batch number: unknown) (dose, route and site of administration were not reported) and with a dose of PNEUMOVAX 23 (batch number: L003188, expiry date: 06 July 2016) (dose, route of administration was not reported) in arm on unspecified date. Medical history and concomitant medications were not reported. On unspecified date, after vaccination, the patient had experienced nausea, headache, terribly achy body, fever, each of their arms were red and had a knot the size of baseball at the injection site. Laboratory investigation was not reported. It was reported that the patient had given unspecified corrective treatment. At the time of this report the outcome of the events was not reported. Follow up information received from a nurse on 21 December 2015. Lot number of the FLUZONE was updated as UI4422AA. Route and vaccination site of fluzone was updated as Intramuscular and left deltoid. It was reported that, have not received any notice of adverse reactions when given FLUZONE only. They had 4 out of 5 patients given a specific lot number of PNEUMOVAX that had reaction. Also received flu shot, but 3 of them had different lot number. Documents held by sender: none.; Sender's Comments: Loss of consciousness is unlisted after INFLUENZA VACCINE. Time to onset is not reported. In the current case, there is no information on medical history and complementary investigations. Insufficient information in this report precludes a complete medical assessment.
Sex: U
Vaccine: FLU3, PPV
Symptoms: Pyrexia
Clinical narrative: Initial unsolicited report received from a nurse on 26 October 2015. This case was linked with 2015SA176377 and 2015SA172486 (same lot number). This case involves a patient who was vaccinated with a dose of FLUZONE (batch number: unknown) (dose, route and site of administration were not reported) and with a dose of PNEUMOVAX 23 (batch number: L003188, expiry date: 06 July 2016) (dose, route of administration was not reported) in arm on unspecified date. Medical history and concomitant medications were not reported. On unspecified date, after vaccination, the patient had experienced nausea, headache, terribly achy body, fever, each of their arms were red and had a knot the size of baseball at the injection site. Laboratory investigation was not reported. It was reported that the patient had given unspecified corrective treatment. At the time of this report the outcome of the events was not reported. Follow up information received from a nurse on 21 December 2015. Lot number of the FLUZONE was updated as UI4422AA. Route and vaccination site of fluzone was updated as Intramuscular and left deltoid. It was reported that, have not received any notice of adverse reactions when given FLUZONE only. They had 4 out of 5 patients given a specific lot number of PNEUMOVAX that had reaction. Also received flu shot, but 3 of them had different lot number. Documents held by sender: none.; Sender's Comments: Loss of consciousness is unlisted after INFLUENZA VACCINE. Time to onset is not reported. In the current case, there is no information on medical history and complementary investigations. Insufficient information in this report precludes a complete medical assessment.
Age: 71.0
Sex: M
Vaccine: FLU3, PNC13, FLU3, PNC13
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Initial unsolicited report received from a pharmacist on 30 November 2015. This case involves a 71-year-old male patient who was vaccinated with an intramuscular dose of FLUZONE HD (batch number UI491AA, expiry date 08 June 2016) in left deltoid and also received intramuscularly a dose of PREVNAR (manufacturer: other, batch number and expiry date were not reported) in the right deltoid, both on 14 November 2015. Illness at time of vaccination was unknown and pre-existing physician diagnosed allergies, birth defects, medical conditions was penicillin allergy (PCN) and tramadol allergy. Concomitant medications were not reported. On 14 November 2015, same day following the vaccination patient experienced pain in the upper arm where given and difficulty lifting left arm above head and shoulders. The patient had previously received Fluzone HD vaccine in 2010. Laboratory investigation and corrective treatment were not reported. It was reported that the patient still experienced the above events. The outcome of event was reported as "recovered". List of documents held by sender: none.
Age: 71.0
Sex: M
Vaccine: FLU3, PNC13, FLU3, PNC13
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Initial unsolicited report received from a pharmacist on 30 November 2015. This case involves a 71-year-old male patient who was vaccinated with an intramuscular dose of FLUZONE HD (batch number UI491AA, expiry date 08 June 2016) in left deltoid and also received intramuscularly a dose of PREVNAR (manufacturer: other, batch number and expiry date were not reported) in the right deltoid, both on 14 November 2015. Illness at time of vaccination was unknown and pre-existing physician diagnosed allergies, birth defects, medical conditions was penicillin allergy (PCN) and tramadol allergy. Concomitant medications were not reported. On 14 November 2015, same day following the vaccination patient experienced pain in the upper arm where given and difficulty lifting left arm above head and shoulders. The patient had previously received Fluzone HD vaccine in 2010. Laboratory investigation and corrective treatment were not reported. It was reported that the patient still experienced the above events. The outcome of event was reported as "recovered". List of documents held by sender: none.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This spontaneous report was received from a 52 year old female patient, reporting on herself. The patient's medical history or concurrent conditions were not reported. On 11-NOV-2014, the patient was vaccinated with ZOSTAVAX subcutaneous (strength, dose, lot number and expiration date were not provided). Other suspect therapy included prednisone (manufacture unknown) tablet, orally (strength, dose, route, indication, lot number and expiration date were not provided) started on 04-MAY-2016. Concomitant medication included FLONASE, CLARITIN and unspecified hormone therapy. On 30-APR-2016, the patient developed a painful rash, which progressively got worse. On 03-MAY-2016, the patient went to her provider and was diagnosed with shingles. Therefore, the patient was given an unspecified antiviral for 7 days, the patient did not state how her treatment was working as she just started it. At the time of reporting, the outcome of shingles was reported as recovering. The action taken with prednisone (manufacture unknown) was unknown. Additionally, the patient stated that she did not know if prednisone (manufacture unknown) contributed to her symptoms. Follow up information has been received from a physician on 20-JUN-2016 referring to the patient. There was no pre-existing allergies, birth defects, medical conditions and no illness at the time of vaccination. On 11-NOV-2014 (at 10:20 am), the patient was vaccinated with the first dose of ZOSTAVAX (lot#K009770, in left deltoid/arm). On 01-MAY-2016, the patient was given prednisone (manufacturer unknown) (previously reported as suspect therapy) by ear, nose and throat(ENT) specialist for sinus infection (onset date unknown). On 03-MAY-2016 (at 3:15 pm) (previously reported as 30-APR-2016) the patient experienced probable shingles on the left upper eyelid (previously location was unspecified) and was treated with VALTREX. No relevant diagnostic tests and laboratory data was reported. The outcome of sinus infection was unknown. The physician considered the herpes zoster outbreak was not temporally associated with ZOSTAVAX. Upon internal review, shingles on the left upper eyelid was considered to be medically significant. Additional information is not expected as all attempts to obtain follow-up information had been received. Reporter information, patient information, product, event, serious criteria and narrative were updated.