chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Varicella post vaccine
Clinical narrative: This spontaneous report as received from a nurse refers to a 7 year old female patient. It was reported that patient was not using concomitant medications and no medical history and no concurrent conditions. The reporter stated that patient was vaccinated with first dose of VARIVAX (Merck) on 28-JUL-2008. On 18-SEP-2012 the patient was vaccinated with second dose of VARIVAX (Merck) lot number G007850, expiration date 31-AUG-2013. The physician stated to the nurse that patient had spots on her arms and face on 01-MAY-2014 and that physician diagnosed as chickenpox. It was also reported that no treatment was given. The outcome of chickenpox was reported as recovered/resolved on an unspecified date. It was reported that Varicella zoster virus identification program (VZVIP) packet was declined. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse regarding a female patient of unknown age. Approximately on an unknown date in MAY-2014 the patient was vaccinated with GARDASIL dose 2 (dosing regimen unspecified). Approximately on an unknown date in MAY-2014 medication error was reported that the patient received her first dose of GARDASIL on an unknown date in August 2012 and was currently in office to receive her second dose. Nurse handed phone to physician assistant, but the physician assistant did not provide any additional information. No adverse effect reported. There was no product quality complaint involved. The outcome of the medication error unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Vaccination complication
Clinical narrative: This spontaneous report as received from a consumer refers to her daughter of unknown age. On an unknown date the patient was vaccinated with GARDASIL (dose, units, frequency, route of administrations, anatomical location, lot number not reported). On an unkown date the patient experienced unspecified side effects. The outcome of unspecified side effects was not reported. The relatedness between unspecified side effects and GARDASIL was not reported. Additional information is not expected.
Age: 11.0
Sex: U
Vaccine: VARZOS, MNQ, TDAP, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 11 year old patient. On 01-MAY-2014 the patient was vaccinated with a dose if ZOSTAVAX (lot#, dose and route unspecified) instead of VARIVAX. No adverse effect reported. Additional information has been requested.
Age: 11.0
Sex: U
Vaccine: VARZOS, MNQ, TDAP, VARZOS
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 11 year old patient. On 01-MAY-2014 the patient was vaccinated with a dose if ZOSTAVAX (lot#, dose and route unspecified) instead of VARIVAX. No adverse effect reported. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: VARZOS, MNQ, TDAP, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: None.
Age: 11.0
Sex: M
Vaccine: VARZOS, MNQ, TDAP, VARZOS
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None.
Sex: U
Vaccine: MMRV, VARCEL, VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report a received from a healthcare worker refers to a patient of unknown age. On an unknown date, the patient was vaccinated with PROQUAD (Merck) (lot number and expiry date not provided). Other suspect therapies included VARIVAX (merck) and ZOSTVAX. On an unknown date, temperature excursion to ZOSTAVAX, VARIVAX (Merck) and PROQUAD (Merck) which was supported and no product was administered. However, the healthcare worker then stated that the freezer has had episodes of cycling after which the practice had administered all three products. ZOSTAVAX, VARIVAX (Merck) and PROQUAD (Merck) all supported post cycling events described. The healthcare worker had no knowledge of adverse effects note by any patient post administration. The outcome of temperature excursion and ZOSTAVAX, VARIVAX and PROQUAD all supported post cycling events described were unknown. This is case 3 of 3. This case is related to case 1405USA1785 and 1405USA004770 (same reporter link). Additional information is requested.
Age: 4.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 11 month old patient. The nurse reported that on 29-DEC-2005, eight days prior to patient's birthday, initial doses of MMR II subcutaneous injection, therapy type HSA (dose, route and lot # not provided) and VARIVAX subcutaneous injection (dose, route, lot # not provided) were given (in the "usual route"). Patient received boosters for both VARIVAX and MMR II on 07-APR-2009. No adverse effect was reported. Additional information is not expected.
Age: 0.4
Sex: F
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an 18 week 4 days old female patient. On 22-APR-2014 the patient was inadvertently vaccinated with her first dose of ROTATEQ (lot# unknown) 2 ml, orally, at age 18 weeks, 4 days. No adverse effect reported. Additional information has been requested.
Age: 0.21
Sex: F
Vaccine: HIBV, RV5
Symptoms: Hyporesponsive to stimuli
Clinical narrative: hyporesponsive to parents - seemed "stoned"
Sex: U
Vaccine: MMRV, VARCEL, VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot number and expiry date not provided). Other suspect therapies included VARIVAX (Merck) and PROQUAD (Merck). On an unkonwn date, temperature excursion to ZOSTAVAX, VARIVAX (Merck) and PROQUAD (Merck) which was supported and no product was administered. However, the healthcare worker then stated that the freezer has had episodes of cycling after which the practice had administered all three products. ZOSTAVAX, VARIVAX (Merck) and PROQUAD (Merck) all supported post cycling events described. The healthcare worker had no knowledge of adverse effects note by any patient post administration. The outcome of temperature excursion and ZOSTAVAX, VARIVAX and PROQUAD all supported post cycling events described were unknown. This case is 1 of 3. This case is related to case 1405USA004770 and 1405USA004771 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age with no drug reactions or allergies and with no medical history reported. On 23-APR-2014, the patient was inadvertently administered a second dose of ZOSTAVAX, intramuscularly (dose, lot number unknown). No concomitant medications and laboratory tests were reported. It was not known when the first dose had been administered. There was no adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information was received from a pharmacist regarding one adult patient, age and gender unknown, who on 18-MAR-2014, may have received PROQUAD (Merck) (SDV, MDV or additive) in error, subcutaneously. Lot number J007205, expiration date of 02-DEC-2014. No known adverse effects. This is one of two reports from the same source (other case number 1404USA002356). Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via company representative refers to six patients of unknown age and gender. On an unknown date, the patients were vaccinated with ZOSTAVAX (dose, frequency, route, lot # and expiration date were not provided). The physician mentioned that he used to send his patients to a pharmacy for immunization but he no longer did that because six of his patients, within a six month period on an unknown date, came down with shingles after receiving the ZOSTAVAX. Doctor asked an employee of the pharmacy what procedures were in place when there was a power outage and he was told they kept the freezer door closed. Doctor was assuming they did not have a generator that was why they just kept the door closed. The patient's sought unspecified medical attention. At the time of the report, the patient's status was unknown. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Herpes zoster, Neuralgia, Nuclear magnetic resonance imaging, Rash
Clinical narrative: This spontaneous report as received from a 66 year old female patient refers to herself. Medical history was not specified. The patient had no drug reaction or allergies. On 14-JAN-2009, the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot number and expiry date not reported). Concomitant therapies included LYRICA "high power pain medication", naproxen (reported as naproxin), hydrocodone (reported as hydrocodine), DEMEROL (reported as demoral) and morphine. On 10-OCT-2013, the patient broke out with a case of the shingles. She had a nerve pain starting in her spine and going to her right breast (onset date reported as 10-OCT-2013). The nerve pain was spreading to her head so she returned to the ER (emergency) room (date not specified). The patient had MRI (magnetic resonance imaging) performed because of severe headaches (date not specified) The outcome of shingles, scars around the rash and severe headaches was unknown. The outcome of nerve pain starting in her spine and gong to her right breast and nerve pain spreading to her head was reported as not recovered/not resolved (still ongoing). The patient sought medical attention via visiting the doctor's office twice and returning to ER room. The relatedness between the events and ZOSTAVAX was not reported. Additional information is not expected.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Scar
Clinical narrative: This spontaneous report as received from a 66 year old female patient refers to herself. Medical history was not specified. The patient had no drug reaction or allergies. On 14-JAN-2009, the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot number and expiry date not reported). Concomitant therapies included LYRICA "high power pain medication", naproxen (reported as naproxin), hydrocodone (reported as hydrocodine), DEMEROL (reported as demoral) and morphine. On 10-OCT-2013, the patient broke out with a case of the shingles. She had a nerve pain starting in her spine and going to her right breast (onset date reported as 10-OCT-2013). The nerve pain was spreading to her head so she returned to the ER (emergency) room (date not specified). The patient had MRI (magnetic resonance imaging) performed because of severe headaches (date not specified) The outcome of shingles, scars around the rash and severe headaches was unknown. The outcome of nerve pain starting in her spine and gong to her right breast and nerve pain spreading to her head was reported as not recovered/not resolved (still ongoing). The patient sought medical attention via visiting the doctor's office twice and returning to ER room. The relatedness between the events and ZOSTAVAX was not reported. Additional information is not expected.
Age: 23.0
Sex: M
Vaccine: MMRV
Symptoms: Measles antibody positive, Mumps antibody test negative, No adverse event, Rubella antibody positive, Wrong drug administered
Clinical narrative: This spontaneous report as received from a medical assistant refers to a currently 23 year old male patient. On an unknown date in the past the patient was vaccinated with M-M-R II (dose and lot# not reported). On an unknown date, the patient was tested positive for measles and rubella titers and negative for immunity to mumps. Therefore the patient was advised by his physician to receive another dose of M-M-R II. On 07-MAY-2014, the patient was vaccinated with (Oka/Merck) PROQUAD instead of M-M-R II, due to an error of the facility. The Medical assistant confirmed that this error was not due to medication confusion but it was due to the products being placed in the incorrectly labeled spot in the storage compartment. The patient had not reported or demonstrated an adverse effect, he was otherwise healthy. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Blood test, Chest X-ray, Pyrexia, Urine analysis
Clinical narrative: Fevers 102, chest x-ray, blood, urine, ceftriaxone.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Certified Medical Assistant refers to a patient of unknown age. On 02-MAY-2014, the patient was vaccinated with both the VARIVAX (lot#J009992; exp: 12-AUG-2015) (dose and route of administration not provided) and MMR II (lot#J008533; exp: 12-JUL-2015) (dose and route of administration not provided) that were improperly stored. The reporter stated that VARIVAX was exposed to 10F for 9 hours and MMR II was exposed to 71F for 9 hours. No adverse symptoms reported. This is one of several reports from the same source. Additional information has been requested.
Age: 1.18
Sex: M
Vaccine: MMRV
Symptoms: Varicella
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 17 month old male patient. Patient's medical history was not reported. On 07-JAN-2014 the patient was vaccinated with one dose of (Oka/Merck) PROQUAD (lot #: J002302, expiration date: 22-AUG-2014, dose, route of administration, anatomical location not provided). On 29-APR-2014 (also reported as: "2 days ago") the patient developed chickenpox. The patient had no fever. The outcome of the event was unknown. Patient sought medical attention (unspecified contact). The relatedness between the event and the therapy (Oka/Merck) PROQUAD was not reported. Additional information has been requested.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Certified Medical Assistant refers to a patient of unknown age. On 02-MAY-2014, the patient was vaccinated with both the VARIVAX (lot# J009992; exp: 12-AUG-2015) (dose and route of administration not provided) and MMR II (lot#J008533; exp: 12-JUL-2015) (dose and route of administration not provided) that were improperly stored. The reporter stated that VARIVAX was exposed to 10F for 9 hours and MMR II was exposed to 71F for 9 hours. No adverse symptoms reported. This is one of several reports from the same source. Additional information has been requested.
Sex: M
Vaccine: PNC13
Symptoms: Formication, Hallucination, Pruritus
Clinical narrative: This is a spontaneous report from a contactable nurse. This nurse (RN) reported that a male patient of unknown age received on an unspecified date PREVNAR 13 (lot number 641025, expiration date Dec2014) via an unspecified route. Medical history and concomitant medications were not reported. On the same date, 30 minutes after patient received vaccine, he began to hallucinate. The patient stated he saw and felt bugs crawling and jumping up and down his arms and on to his face. He also was very itchy. No hives present. As treatment, he received 50 mg IV BENADRYL and a neurologist was contacted. Outcome was unknown.
Age: 5.0
Sex: F
Vaccine: DTAP, MMRV
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: Redness, rash, itchy.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Pruritus, Rash, Rash erythematous, Urticaria
Clinical narrative: Child's arm began to break out in small red bumps which turned into red whelps from child's shoulder to the elbow. Very itchy, no shortness of breath, no fever.
Sex: M
Vaccine: TDAP
Symptoms: Presyncope
Clinical narrative: Initial report received from a nurse on 05-MAY-2014. A male patient, with no reported personal and family medical history and no reported concomitant therapies, had received a dose of Tdap (manufacturer, batch number, route and anatomical site of administration not reported) on an unspecified date. On an unspecified date post-vaccination, the patient experienced "vasovagal" response which lasted only a few minutes and then the patient had no symptoms. The outcome was reported as unknown. No further information was provided. Documents held by sender: None.
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Followed up on 05/09/14 after Tdap (per RN given) on 05/02/14 - left deltoid area red, hard core (3 x 2 cm) surrounded by 7 x 5 soft epidermal erythema. Pain w/ palpation. No fever - responding to warm/cool compresses and ibuprofen.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Angioedema, Injection site reaction
Clinical narrative: Localized angioedema site on injection.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Erythema, Induration, Mass, Pruritus
Clinical narrative: Pt developed a hard mass approximately 3" x 3". She had redness, swelling, very hot to the touch, incredible itching, rash up the arm, itchy legs and joint aches. Pt tried BENADRYL and cortisone with little if any relief. Symptoms developed hours after the shot and have not gone away 3 days later.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic, Skin warm, Swelling
Clinical narrative: Pt developed a hard mass approximately 3" x 3". She had redness, swelling, very hot to the touch, incredible itching, rash up the arm, itchy legs and joint aches. Pt tried BENADRYL and cortisone with little if any relief. Symptoms developed hours after the shot and have not gone away 3 days later.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4
Symptoms: Dizziness, Malaise, Vomiting
Clinical narrative: Pt. was given the drug and instructed to wait in the room for 15 mins and stay seated. Mother tried to take the child to waiting room. Pt got to the waiting room where he vomited x2, and started c/o dizziness and malaise. Pt was moved back to a room where he was monitored and released into his mother's care.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Vaccination site nodule, Vaccination site scab
Clinical narrative: Vaccination site has developed gray hard scab with a "knot" under skin. No redness, itching, or blisters. Patient does not complain of pain or any other symptoms only complains scab will not come off. Suggested cool compress and notify if any further complaint.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: 13 x 10cm area anterior right thigh indurated and warm, 3cm round area lateral left thigh erythematous and sl raised, not indurated. Treatment: cephalexin 250mg/5mL 1 tsp bid x 10 days. At DTaP site.
Sex: F
Vaccine: HEP
Symptoms: Injection site discharge, Injection site discolouration, Injection site induration, Injection site swelling
Clinical narrative: Employee received 1 ml of Hepatitis B vaccine with a 1 1/2 inch syringe/needle. She reported that 1 day post vaccination she experienced some swelling at the same site. It came to a head in the center and reportedly drained a clear opaque "whitish" liquid x 2 days. The area was non tender, non erythematous but area around injection was slightly hardened. No temp was taken - Also reports area around injection was darkened no sign of infection noted.
Age: 0.67
Sex: F
Vaccine: DTAPIPV
Symptoms: Unevaluable event
Clinical narrative: Dr advised the parents the patient received a vaccine approved as a combo vaccine for 4-6 yrs of age. Pt tolerated the vaccine with no adverse affects post event. Dr gave the parents all the current information and documentation showing vaccine was same as if given separately.
Age: 58.0
Sex: F
Vaccine: FLUC3, FLUC3
Symptoms: Feeling cold, Full blood count normal, Malaise, Nerve conduction studies normal, Nuclear magnetic resonance imaging brain normal
Clinical narrative: My symptoms started the first week after the vaccine. I am a flight attendant, and each time I would get on the plane to work, I would "feel like I was coming down with something," each of the three days per week that I flew. At the end of each workday, I would lie in bed in my hotel room for the entire overnight, until the very last minute that I had to get up to go to work, and would have to take a Sudafed, a Mucinex, a Zyrtec and some Tylenol just to "get up under it" enough to complete each trip. This went on for the month of November. Over Thanksgiving weekend, the usual "coming down with" feeling turned into a horrible (flu? cold?) which was really bad by the end of the trip on November 30th. When I got home, it had gotten progessively worse and my scalp was tingling on the left side. It took me nearly two full weeks to get over it to the point where I could go back to work on December 18th. Fast forward to January 20th. I woke up that morning, at home, and my entire left side was tingling, from my scalp down to my toes. This went on steadily without let-up for three or four days, then continued off and on for another week, until it subsided somewhat, and became more sporadic, sort of moving over to the right side, eventually kind of "moving out the right side" by the last week of March. I still get sensations of a "chill" off and on in the right arm and shoulder. In the meantime, I went to a neurologist and got an MRI on my brain, a nerve conduction study, and a complete blood workup, to rule out a stroke or neurological disease. Fortunately they were ruled out, but I was still left to deal with these scary symptoms going on in my body. I have been a healthy person all of my life, with no major physical problems. I am not sure if this will be a permanent problem or not.
Age: 58.0
Sex: F
Vaccine: FLUC3, FLUC3
Symptoms: Paraesthesia
Clinical narrative: My symptoms started the first week after the vaccine. I am a flight attendant, and each time I would get on the plane to work, I would "feel like I was coming down with something," each of the three days per week that I flew. At the end of each workday, I would lie in bed in my hotel room for the entire overnight, until the very last minute that I had to get up to go to work, and would have to take a Sudafed, a Mucinex, a Zyrtec and some Tylenol just to "get up under it" enough to complete each trip. This went on for the month of November. Over Thanksgiving weekend, the usual "coming down with" feeling turned into a horrible (flu? cold?) which was really bad by the end of the trip on November 30th. When I got home, it had gotten progessively worse and my scalp was tingling on the left side. It took me nearly two full weeks to get over it to the point where I could go back to work on December 18th. Fast forward to January 20th. I woke up that morning, at home, and my entire left side was tingling, from my scalp down to my toes. This went on steadily without let-up for three or four days, then continued off and on for another week, until it subsided somewhat, and became more sporadic, sort of moving over to the right side, eventually kind of "moving out the right side" by the last week of March. I still get sensations of a "chill" off and on in the right arm and shoulder. In the meantime, I went to a neurologist and got an MRI on my brain, a nerve conduction study, and a complete blood workup, to rule out a stroke or neurological disease. Fortunately they were ruled out, but I was still left to deal with these scary symptoms going on in my body. I have been a healthy person all of my life, with no major physical problems. I am not sure if this will be a permanent problem or not.
Age: 58.0
Sex: F
Vaccine: FLUC3, FLUC3
Symptoms: Blood test, Chills, Feeling abnormal, Influenza, Nasopharyngitis
Clinical narrative: My symptoms started the first week after the vaccine. I am a flight attendant, and each time I would get on the plane to work, I would "feel like I was coming down with something," each of the three days per week that I flew. At the end of each workday, I would lie in bed in my hotel room for the entire overnight, until the very last minute that I had to get up to go to work, and would have to take a Sudafed, a Mucinex, a Zyrtec and some Tylenol just to "get up under it" enough to complete each trip. This went on for the month of November. Over Thanksgiving weekend, the usual "coming down with" feeling turned into a horrible (flu? cold?) which was really bad by the end of the trip on November 30th. When I got home, it had gotten progessively worse and my scalp was tingling on the left side. It took me nearly two full weeks to get over it to the point where I could go back to work on December 18th. Fast forward to January 20th. I woke up that morning, at home, and my entire left side was tingling, from my scalp down to my toes. This went on steadily without let-up for three or four days, then continued off and on for another week, until it subsided somewhat, and became more sporadic, sort of moving over to the right side, eventually kind of "moving out the right side" by the last week of March. I still get sensations of a "chill" off and on in the right arm and shoulder. In the meantime, I went to a neurologist and got an MRI on my brain, a nerve conduction study, and a complete blood workup, to rule out a stroke or neurological disease. Fortunately they were ruled out, but I was still left to deal with these scary symptoms going on in my body. I have been a healthy person all of my life, with no major physical problems. I am not sure if this will be a permanent problem or not.
Age: 58.0
Sex: F
Vaccine: FLUC3, FLUC3
Symptoms: Nerve conduction studies, Nuclear magnetic resonance imaging brain normal, Paraesthesia
Clinical narrative: My symptoms started the first week after the vaccine. I am a flight attendant, and each time I would get on the plane to work, I would "feel like I was coming down with something," each of the three days per week that I flew. At the end of each workday, I would lie in bed in my hotel room for the entire overnight, until the very last minute that I had to get up to go to work, and would have to take a Sudafed, a Mucinex, a Zyrtec and some Tylenol just to "get up under it" enough to complete each trip. This went on for the month of November. Over Thanksgiving weekend, the usual "coming down with" feeling turned into a horrible (flu? cold?) which was really bad by the end of the trip on November 30th. When I got home, it had gotten progessively worse and my scalp was tingling on the left side. It took me nearly two full weeks to get over it to the point where I could go back to work on December 18th. Fast forward to January 20th. I woke up that morning, at home, and my entire left side was tingling, from my scalp down to my toes. This went on steadily without let-up for three or four days, then continued off and on for another week, until it subsided somewhat, and became more sporadic, sort of moving over to the right side, eventually kind of "moving out the right side" by the last week of March. I still get sensations of a "chill" off and on in the right arm and shoulder. In the meantime, I went to a neurologist and got an MRI on my brain, a nerve conduction study, and a complete blood workup, to rule out a stroke or neurological disease. Fortunately they were ruled out, but I was still left to deal with these scary symptoms going on in my body. I have been a healthy person all of my life, with no major physical problems. I am not sure if this will be a permanent problem or not.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema
Clinical narrative: Localized erythema entire upper arm.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Dyspnoea, Injection site erythema, Injection site swelling, Myalgia, Nausea
Clinical narrative: fever of over 101 for 2 days, muscle aches and pains, nausea, difficulty breathing, wheezing, swollen arm at injection site and redness around the injection site.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia, Wheezing
Clinical narrative: fever of over 101 for 2 days, muscle aches and pains, nausea, difficulty breathing, wheezing, swollen arm at injection site and redness around the injection site.
Age: 0.5
Sex: M
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Pt received vaccine approved for 4-6 yrs of age. Pt tolerated the vaccine with on adverse affects post event. Last communicated with parents on 4.9.2014 by dr.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Immediate post-injection reaction, Local swelling, Mobility decreased, Musculoskeletal stiffness
Clinical narrative: Patient reports her arm became red and swollen immediately after flu shot and within a few days her arm became stiff and almost frozen. She did not report problem until March 21.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant via company representative who reported that an unspecified number of doses of ZOSTAVAX that my have been stored under conditions other than what is recommended in the prescribing information, may have been administered. No adverse effect reported. Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 60 year old female patient. On 28-APR-2014 the patient was vaccinated with ZOSTAVAX (lot # J000853, expired at 23-APR-2014, 19400 PFU, 0.5 ml, subcutaneous). No concomitant medications and no other relevant medical history were reported. The reporter stated that on 28-APR-2014 the patient received an expired vaccine. The patient received a 0.5 ml of ZOSTAVAX. No adverse effects were reported. No other relevant medical information was reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a patient (no demographics were provided) of unknown age. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot # and expiry date unknown). No concomitant medication was reported. On an unknown date (also reported as six months after vaccination), the patient developed shingles. No further event information was provided. There was no product quality complaint. Outcome of the reported event was unknown. Causality of the reported event was unknown for ZOSTAVAX. This case is related to 1405USA005041 (Same Reporter Link). Additional information has been requested.
Age: 27.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Rash pruritic
Clinical narrative: PRURITIC RASH ON BILATERAL ELBOW, SEEN BY PA ON 9MAY14- CONSULTED DR. VIA TELEPHONE/EMAIL THE SAME DAY. TREATED WITH TOPICAL STEROID AND PO ANTI-HISTAMINE
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Decreased appetite, Dizziness, Exposure during pregnancy, Fatigue, Nausea
Clinical narrative: Nausea, fatigue, lightheadedness, dizziness, loss of appetite. Note that patient was pregnant upon receipt of the vaccine.
Age: 20.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Acne, Cellulitis, Facial pain, Nausea, Pain of skin
Clinical narrative: Member states he woke up and noticed some bumps on his face and scalp that were somewhat painful. He states his mouth was ver watery too. He states that since waking, he has felt nauseous. Seen at Hospital - Provider states seeing"small red bump on the left occipital scalp similar appearance to acne, smallwhite head visualized. Tender to palpation, Tender red bump below the lower lip in midline chin, No abscesses. Prescribed Keflex Diagnosed at hospital with Cellulitis. Member came into clinic on 9 May 2014 and states the Keflex worked and everything cleared up.
Age: 20.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Rash, Rash erythematous, Salivary hypersecretion, Tenderness
Clinical narrative: Member states he woke up and noticed some bumps on his face and scalp that were somewhat painful. He states his mouth was ver watery too. He states that since waking, he has felt nauseous. Seen at Hospital - Provider states seeing"small red bump on the left occipital scalp similar appearance to acne, smallwhite head visualized. Tender to palpation, Tender red bump below the lower lip in midline chin, No abscesses. Prescribed Keflex Diagnosed at hospital with Cellulitis. Member came into clinic on 9 May 2014 and states the Keflex worked and everything cleared up.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Live shingles infection.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Injection site discolouration, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Live shingles infection.
Age: 18.0
Sex: M
Vaccine: HPV4
Symptoms: Abasia, Anxiety, Arthralgia, Blood test normal, Chest X-ray
Clinical narrative: Joint pain, aching muscles unable to walk, tremors like seizure disorder, shortness of breath, severe chest pain, throat pain, severe neck pain sensible to touch, confusion, anxiety
Age: 18.0
Sex: M
Vaccine: HPV4
Symptoms: Chest pain, Computerised tomogram, Confusional state, Dyspnoea, Hyperaesthesia
Clinical narrative: Joint pain, aching muscles unable to walk, tremors like seizure disorder, shortness of breath, severe chest pain, throat pain, severe neck pain sensible to touch, confusion, anxiety
Age: 18.0
Sex: M
Vaccine: HPV4
Symptoms: Myalgia, Neck pain, Nuclear magnetic resonance imaging brain, Oropharyngeal pain, Scan with contrast
Clinical narrative: Joint pain, aching muscles unable to walk, tremors like seizure disorder, shortness of breath, severe chest pain, throat pain, severe neck pain sensible to touch, confusion, anxiety
Age: 18.0
Sex: M
Vaccine: HPV4
Symptoms: Seizure like phenomena, Spinal X-ray, Tremor
Clinical narrative: Joint pain, aching muscles unable to walk, tremors like seizure disorder, shortness of breath, severe chest pain, throat pain, severe neck pain sensible to touch, confusion, anxiety
Age: 1.01
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Blood lead normal, Full blood count normal, Glassy eyes, Muscle twitching, Musculoskeletal stiffness
Clinical narrative: Daycare notified mom that child had 102 fever. Mom picked him up from daycare that afternoon. That evening he had a brief episode of twitching that resolved quickly. Mom placed him in a bath and he became glassy-eyed, body stiffened, and unresponsive. He was immediately brought to ER, episode lasted approximately 45 minutes.
Age: 1.01
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pyrexia, Unresponsive to stimuli
Clinical narrative: Daycare notified mom that child had 102 fever. Mom picked him up from daycare that afternoon. That evening he had a brief episode of twitching that resolved quickly. Mom placed him in a bath and he became glassy-eyed, body stiffened, and unresponsive. He was immediately brought to ER, episode lasted approximately 45 minutes.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV, MMR, VARCEL
Symptoms: Abnormal behaviour, Erythema, Induration, Lethargy, Swelling
Clinical narrative: Warm to touch, raised, red, hard area. Behavior changed-lethargic,  Seen today by Dr no temperture noted.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV, MMR, VARCEL
Symptoms: Abnormal behaviour, Erythema, Induration, Lethargy, Local swelling
Clinical narrative: Warm to touch, raised, red, hard area. Behavior changed-lethargic,  Seen today by Dr no temperture noted.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV, MMR, VARCEL
Symptoms: Skin warm
Clinical narrative: Warm to touch, raised, red, hard area. Behavior changed-lethargic,  Seen today by Dr no temperture noted.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV, MMR, VARCEL
Symptoms: Abnormal behaviour, Erythema, Induration, Lethargy, Swelling
Clinical narrative: Warm to touch, hard, red, raised area. Behavior change - lethargic, taken to ER - given antibiotics, told to see PCP if gets larger.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV, MMR, VARCEL
Symptoms: Abnormal behaviour, Erythema, Induration, Lethargy, Local swelling
Clinical narrative: Warm to touch, hard, red, raised area. Behavior change - lethargic, taken to ER - given antibiotics, told to see PCP if gets larger.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV, MMR, VARCEL
Symptoms: Skin warm
Clinical narrative: Warm to touch, hard, red, raised area. Behavior change - lethargic, taken to ER - given antibiotics, told to see PCP if gets larger.
Age: 1.36
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Wrong drug administered
Clinical narrative: My 16 month old baby was given three doses of the Gardasil/HPV Vaccine when she was suppose to get her 15 month vaccines, the doctor said this was given to her by accident as this vaccine was suppose to be given to another child in another room. He advised that I had nothing to worry about. The vaccine was given on her thigh 2 on the right leg and 1 on the left leg.
Age: 1.36
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Drug administered to patient of inappropriate age, Incorrect dose administered, No adverse event
Clinical narrative: My 16 month old baby was given three doses of the Gardasil/HPV Vaccine when she was suppose to get her 15 month vaccines, the doctor said this was given to her by accident as this vaccine was suppose to be given to another child in another room. He advised that I had nothing to worry about. The vaccine was given on her thigh 2 on the right leg and 1 on the left leg.
Age: 1.36
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: My 16 month old baby was given three doses of the Gardasil/HPV Vaccine when she was suppose to get her 15 month vaccines, the doctor said this was given to her by accident as this vaccine was suppose to be given to another child in another room. He advised that I had nothing to worry about. The vaccine was given on her thigh 2 on the right leg and 1 on the left leg.
Age: 0.16
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Rotarix vaccine drawn up with live virus only and given IM.
Age: 20.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Grip strength decreased, Impaired driving ability, Laboratory test
Clinical narrative: Severe joint pain of hands, fingers, feet and toes. Unable to hold even a glass of water or drive.
Age: 26.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus, Skin warm, Swelling
Clinical narrative: SEVERE ITCHING, MILD SWELLING, AND WARM.
Age: 0.17
Sex: M
Vaccine: DTPPHIB, HEP, PNC13, RV5
Symptoms: Abdominal X-ray, Abdominal distension, Haematemesis, Intussusception, Ultrasound abdomen abnormal
Clinical narrative: Bloody vomiting, bloated belly
Age: 0.17
Sex: M
Vaccine: DTPPHIB, HEP, PNC13, RV5
Symptoms: X-ray abnormal, X-ray gastrointestinal tract abnormal
Clinical narrative: Bloody vomiting, bloated belly
Age: 1.07
Sex: M
Vaccine: MMR, PPV, VARCEL
Symptoms: Hyperhidrosis, Influenza virus test negative, Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: Wednesday vaccinations at 3:45. By 4:30 fever of 102, doesn't rise and dips some so no treatment. Thursday 6 am 102 fever, ibuprofen. Thursday 12:15 pm 102 fever, ibuprofen. Fever doesn't come down and is up to 104.3 by 4:30. ER visit Thursday night, fever spikes again while there. Flu test neg, blood work normal, IV fluids given and prescription for antibiotic because of concern of infection at injection site. Site of Prevnar injection is red and extremely sore to the touch. Patient violently shakes when Dr presses injection site and shakes even if his leg is moved.  Friday am still 101 fever, ibuprofen  Fever breaks at 8 am, pool of sweat under him in bed  11:00 nurse says 98.5 fever 11:30 fever up to 103.7 11:45 Tylenol given at dr office 3:00 101 fever 2.5 ml ibuprofen  4:59 fever may be breaking. He's sweating profusely
Age: 1.07
Sex: M
Vaccine: MMR, PPV, VARCEL
Symptoms: Tremor
Clinical narrative: Wednesday vaccinations at 3:45. By 4:30 fever of 102, doesn't rise and dips some so no treatment. Thursday 6 am 102 fever, ibuprofen. Thursday 12:15 pm 102 fever, ibuprofen. Fever doesn't come down and is up to 104.3 by 4:30. ER visit Thursday night, fever spikes again while there. Flu test neg, blood work normal, IV fluids given and prescription for antibiotic because of concern of infection at injection site. Site of Prevnar injection is red and extremely sore to the touch. Patient violently shakes when Dr presses injection site and shakes even if his leg is moved.  Friday am still 101 fever, ibuprofen  Fever breaks at 8 am, pool of sweat under him in bed  11:00 nurse says 98.5 fever 11:30 fever up to 103.7 11:45 Tylenol given at dr office 3:00 101 fever 2.5 ml ibuprofen  4:59 fever may be breaking. He's sweating profusely
Age: 1.01
Sex: M
Vaccine: HEPA, HIBV, MMR, VARCEL
Symptoms: Chest X-ray normal, Cyanosis, Dyspnoea, Electrocardiogram normal, Full blood count normal
Clinical narrative: Patient received Hib, HepA, MMR, and Varicella vaccines on 5/8/14. Temperatures of 100 F on evening of 5/8/14. Mom gave Tylenol. Soon after, patient vomited and right after his eyes rolled back and he became floppy in his grandmother's arms. Parents deny any shaking of arms or legs or stiffness.  Mom attempted to clean vomit from his mouth and noted that his lips were blue and he wasn't breathing. Family called 911 and he was unresponsive for 1-2 minutes when they were advised to start CPR by EMS, given the report that he was not breathing.  Uncle of patient who is trained in CPR started chest compressions and gave rescue breaths for 3 minutes until the ambulance arrived.  He states the baby was breathing during CPR, but it seemed hard for him to breathe.  He also was not completely awake and only seemed to perk up towards the end of the CPR.  When EMS arrived, patient was awake and alert, CPR was not continued.  Initial O2 sat was 93%, which improved to 96% with blow-by. Patient returned to normal state and was admitted to hospital for observation. The following day 5/9/14 patient had fevers up to 39C and was discharged later that day on Tylenol as needed for fever.
Age: 1.01
Sex: M
Vaccine: HEPA, HIBV, MMR, VARCEL
Symptoms: Gaze palsy, Hypotonia, Metabolic function test normal, Pyrexia, Respiratory arrest
Clinical narrative: Patient received Hib, HepA, MMR, and Varicella vaccines on 5/8/14. Temperatures of 100 F on evening of 5/8/14. Mom gave Tylenol. Soon after, patient vomited and right after his eyes rolled back and he became floppy in his grandmother's arms. Parents deny any shaking of arms or legs or stiffness.  Mom attempted to clean vomit from his mouth and noted that his lips were blue and he wasn't breathing. Family called 911 and he was unresponsive for 1-2 minutes when they were advised to start CPR by EMS, given the report that he was not breathing.  Uncle of patient who is trained in CPR started chest compressions and gave rescue breaths for 3 minutes until the ambulance arrived.  He states the baby was breathing during CPR, but it seemed hard for him to breathe.  He also was not completely awake and only seemed to perk up towards the end of the CPR.  When EMS arrived, patient was awake and alert, CPR was not continued.  Initial O2 sat was 93%, which improved to 96% with blow-by. Patient returned to normal state and was admitted to hospital for observation. The following day 5/9/14 patient had fevers up to 39C and was discharged later that day on Tylenol as needed for fever.
Age: 1.01
Sex: M
Vaccine: HEPA, HIBV, MMR, VARCEL
Symptoms: Resuscitation, Unresponsive to stimuli, Urine analysis normal, Vomiting
Clinical narrative: Patient received Hib, HepA, MMR, and Varicella vaccines on 5/8/14. Temperatures of 100 F on evening of 5/8/14. Mom gave Tylenol. Soon after, patient vomited and right after his eyes rolled back and he became floppy in his grandmother's arms. Parents deny any shaking of arms or legs or stiffness.  Mom attempted to clean vomit from his mouth and noted that his lips were blue and he wasn't breathing. Family called 911 and he was unresponsive for 1-2 minutes when they were advised to start CPR by EMS, given the report that he was not breathing.  Uncle of patient who is trained in CPR started chest compressions and gave rescue breaths for 3 minutes until the ambulance arrived.  He states the baby was breathing during CPR, but it seemed hard for him to breathe.  He also was not completely awake and only seemed to perk up towards the end of the CPR.  When EMS arrived, patient was awake and alert, CPR was not continued.  Initial O2 sat was 93%, which improved to 96% with blow-by. Patient returned to normal state and was admitted to hospital for observation. The following day 5/9/14 patient had fevers up to 39C and was discharged later that day on Tylenol as needed for fever.
Age: 5.0
Sex: M
Vaccine: DTAP, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: At this date and time, became aware that the upper arm where DTaP vaccine was administered 2 days prior was swollen, red, sore, and tender.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received form a physician via company representative refers to a patient (no demographics were provided) of unknown age. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot # and expiry date unknown) (also reported as) vaccine. No concomitant medication was reported. On an unknown date (also reported as six months after vaccination), the patient developed shingles.No further event information was provided. There was no product quality complaint. Outcome of the reported event was unknown. Causality of the reported event was unknown for ZOSTAVAX. This case related to 1404USA014474 (Same Reporter Link). Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: MMR
Symptoms: Blood test, Rash generalised, Rash morbilliform
Clinical narrative: This spontaneous report as received from a licensed practical nurse via company representative refers to a 16 year old female patient with no pertinent medical history. In February 1999, the patient was vaccinated with the first dose of M-M-R II (route, lot # and expiration date were no provided). In June 2000, the patient was vaccinated with the second dose of M-M-R II (route, lot # and expiration date were not provided). On 05-MAY-2014, the patient presented to the doctor's office with what looked like measles. The patient had a rash over the whole body. No treatment was given for the adverse event. On an unknown date, unspecified blood work was performed (results were not provided). At the time of the report, the patient had not recovered. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a physician regarding 3 patients of unknown age and gender with no pertinent medical history reported. It was reported that on an unknown date the patients were possibly vaccinated with ZOSTAVAX (lot number and expiration date not reported) (dose, route and frequency not reported), that was stored in the fridge door for a long time (unspecified what is a long time). No adverse effects reported. Additional information is not expected.
Age: 49.0
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 49 year old patient (gender not reported). On 28-APR-2014, the patient was vaccinated with an expired dose of PNEUMOVAX 23 (route not reported) lot number H014283, expiration date 17-APR-2014. No adverse effect reported. Additional information has been requested.