chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Local reaction
Clinical narrative: This spontaneous report was received from a healthcare worker (also reported as secretary) regarding a 25 year old female patient. The patient had a medical history of osteomyelitis of the hip at four years of age (approximately in 2002). The patient had a history of local reaction (unspecified) while on prior therapy with VARIVAX (Merck) (reported in MARRS # 1407USA000891). On 27-JUN-2014, the patient was vaccinated at the camp check up with GARDASIL (dose, frequency, route, product lot/ expiry date unknown) and shortly after passed out (Hospitalization). The secretary stated the patient "eventually came to but then she had a terrible headache and we had to keep the lights off". The secretary stated Emergency Medical Team (EMT) was called and the patient was taken Emergency Room. The secretary stated she did not know how the patient was currently doing or if she has been admitted to Medical Center. When asked if the patient had any drug reactions or allergies the secretary reported that the patient had an unspecified local reaction after receiving VARIVAX, on an unspecified date (reported in MARRS # 1407USA000891). No treatment was given. No lab diagnostic studies were performed. The patient's present status was unspecified by reporter. The outcome of event was unknown. No product quality complaint (PQC) was reported. Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a health professional via a medical science liaison, described the occurrence of shingles in a 45-year-old female patient with systemic lupus erythematosus. In 2013 the patient was vaccinated with a dose of VARIVAX (Merck). Other suspect therapies included BENLYSTA. Concomitant therapies included prednisone (manufacturer unknown), PLAQUENIL and methotrexate (manufacturer unknown). The patient received her first infusion of BENLYSTA (Variable dose) for systemic lupus erythematosus in July 2013. She received her second infusion of BENLYSTA as scheduled 2 weeks later (date was unknown) and 48 hours later in July 2013 she had a shingles outbreak. The outbreak was treated with antiviral medication and resolved (date was unknown). One month after, in August 2013, the outbreak resolved she received the VARIVAX (Merck) (lot#, dose, frequency were unspecified). Six weeks after she received the vaccine she had her third infusion of BENLYSTA. Within 24 to 36 hours she had another shingles outbreak. The outbreak was treated again and resolved. She experienced shingles after 4-5 infusions total. She received the VARIVAX (Merck) after only the first outbreak of shingles. Every time the outbreak was treated and resolved before trying the next infusion. After a total of 5-6 infusions of BENLYSTA (there was no shingles after the first infusion) the decision was made to discontinue her from BENLYSTA. The shingles that occurred after her last infusion of BENLYSTA was still in the process of resolving, but it had improved. The patient never made it out of the loading phase for BENLYSTA because they would have to wait for her shingles to resolve before another dose was administered. Treatment with BENLYSTA was discontinued on an unknown date. The health professional considered the event to be probably related to BENLYSTA. The health professional considered the event to be disabling and clinically significant (or requiring intervention). Additional information has been requested.
Age: 11.0
Sex: U
Vaccine: MNQ
Symptoms: Syncope
Clinical narrative: Case number PHEH2014US012570 is an initial spontaneous report from the nurse received on 19 Jun 2014 with a follow up information received from a nurse on 19 Jun 2014. This case was initially reported as a multiple patient case (2 patients), but upon follow up, the patients became identifiable. This report refers to an 11-years-old patient whose gender was not reported. The patient's medical history and concomitant medications were not reported. This patient was vaccinated with an intramuscular dose of MENVEO (batch number: M13030, expiry date: Sep 2014) on an unknown date in Jun 2014. The nurse reported that the patient experienced a fainting episode, described as an in and out feeling after receiving MENVEO and had to lie down for 15 minutes before being able to leave the facility. Patient completely recovered after episode. The seriousness and causality of the events were not reported. Follow up information received from a nurse on 19 Jun 2014: Updated report type, patient demographics (age), suspect vaccine expiry date and date of administration and event onset date.
Sex: U
Vaccine: MNQ
Symptoms: Syncope
Clinical narrative: Case number PHEH2014US013337 is an initial spontaneous report from the nurse received on 19 Jun 2014. This report refers to a 17-19-years-old patient whose gender was not reported. The patient's medical history and concomitant medications were not reported. This patient was vaccinated with an intramuscular dose of MENVEO, (batch number: M13030, expiry date: Sep 2014) on an unknown date in Jun 2014. The nurse reported that the patient experienced a fainting episode, described as an in and out feeling after receiving MENVEO and had to lie down for 15 minutes before being able to leave the facility. Patient completely recovered after episode. The seriousness and causality of the events were not reported.
Sex: M
Vaccine: VARZOS
Symptoms: Facial spasm, Muscle twitching, VIIth nerve paralysis
Clinical narrative: This spontaneous report as received from a physician regarding a male patient of unknown age. On an unknown date in 2014 the patient was vaccinated with ZOSTAVAX. Concomitant therapies included LIPITOR and CIALIS. On an unknown date in 2014 the patient experienced facial twitching and was seen by an urgent care facility. Urgent care facility diagnosed the patient with Bell's Palsy (medically significant). Patient was seen by the physician on 17-JUN-2014 and he complained of left hemi-facial spasms. No treatment was given. Physician stated that the patient returned to the physician's office on an unspecified date and the spasms were decreased in intensity. The outcome of Bell's Palsy and left hemi-facial spasms was reported as recovering. The relatedness of the events to the therapy with ZOSTAVAX was unknown. Upon internal review the event Bell's Palsy was considered medically significant. Additional information has been requested.
Age: 30.0
Sex: M
Vaccine: MMR
Symptoms: Computerised tomogram thorax abnormal, Lower respiratory tract inflammation, Pneumonitis, Rash morbilliform
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 30 year old male patient. The patient medical history included allergy to BACTRIM, allergy to KEFLEX and allergy to penicillin (manufacturers unspecified) and post stem cell transplantation. On 16-MAY-2014, the patient was vaccinated with M-M-R II (injection, subcutaneously, dose and frequency: not reported) (lot #, exp date: unknown). On approximately 06-JUN-2014 (reported as about 3 weeks after receiving M-M-R II, the patient developed pneumonitis and a measles like rash. The reporter stated that the patient had significant disability which was inflammation to the lung tissue. On an unknown date in 2014, computerized tomogram (CT) to diagnose pneumonitis was performed. The patient sought medical attention. He contacted physician (date unknown). On 01-JUL-2014, the patient was admitted to hospital. The outcome of inflammation to the lung tissue/pneumonitis and a measles like rash was unknown. Relatedness between inflammation to the lung tissue/pneumonitis and a measles like rash and M-M-R II was not reported. Inflammation to the lung tissue/pneumonitis and measles like rash were considered to be life-threatening and disabling by the reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site infection, Injection site pain, Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age with breast cancer and treatment with unspecified chemotherapeutic agent more than one year ago and hepatitis C. On 13-JUN-2014 the patient ws vaccinated with a dose of ZOSTAVAX (lot #, expiration date, dose, indication, route not reported). The patient's medically history included diverticulitis. On 14-JUN-2014, the patient went to an unspecified healthcare providers office due to suspected infection at the injection site, which was sore and reddened. The unspecified healthcare provider prescribed AUGMENTIN  On 19-JUN-2014, the patient had an area of redness and soreness surrounding the injection site described as "the size of a golf ball, and getting progressively worse". The patient also developed an unspecified rash, on an unspecified date in June 2014, which the reporter believed was still present. The outcome of the events was reported as not recovered. Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy test urine positive
Clinical narrative: This spontaneous pregnancy report as received from a registered nurse refers to a 28 year old female patient. The patient's medical history and current condition are not reported. On 11-JUN-2014 the patient was vaccinated with (Oka/Merck) VARIVAX (lot # J003219 and expiry date: 15-MAY-2015) of dose 0.5 ml, subcutaneous. Also vaccinated with M-M-R II (lot # J015503 and expiry date 05-DEC-2015) of dose 0.5 ml, subcutaneous on the same day. The patient became pregnant. A pregnancy urine test done on 21-JUN-2014 confirmed that the patient was pregnant. The last menstrual period and estimated date of conception are not reported. No adverse event is reported. Cancer and overdose are not reported. It was reported that the patient sought medical attention and contacted physicians office. Product quality issue was not reported. The outcome of drug exposure during pregnancy is unknown. Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy test urine positive
Clinical narrative: This spontaneous pregnancy report as received from a registered nurse refers to a 28 year old female patient. The patient's medical history and current condition are not reported. On 11-JUN-2014 the patient was vaccinated with (Oka/Merck) VARIVAX (lot # J003219 and expiry date 15-MAY-2015) of dose 5 ml subcutaneously. Also vaccinated with M-M-R II (lot # J015503 and expiry date 5-DEC-2015) of dose 5 ml, subcutaneously on the same day. The patient became pregnant. A pregnancy urine test was done on 21-JUN-2014 confirmed that the patient was pregnant. The last menstrual period and estimated date of conception are not reported. No adverse event is reported. Cancer and overdose are not reported. It was reported that the patient sought medical attention and contacted physicians office. Product quality issue was not reported. The outcome of drug exposure during pregnancy is unknown. Follow up information was received.  Lot number J015503 has been verified valid for V205C. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Scab
Clinical narrative: This spontaneous report was received from a 80 year old female patient regarding herself. Concurrent conditions included diabetes and high blood pressure. No information about drug reactions and allergies was specified. On an unknown date in 2012 (reported as around two years ago (unspecified date)) the patient was vaccinated with ZOSTAVAX 1 injection. Concomitant therapies included nateglinide. On an unknown date the patient developed a big blister, about as "round as a quarter" which her physician diagnosed as shingles. The reporter says the rash looks as if it is healing; the scabs fall off, then it shows up again. She says the spot is getting smaller now, however, The patient sought medical attention and treatment was given for the event. There was no product quality complaint. The outcome of shingles was reported as recovering. The causality of the event was not specified by the reporter. Additional information has been requested.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site rash, Injection site swelling, Laceration
Clinical narrative: This spontaneous report as received from a company representative reporting on a family member refers to a 54 year old male patient with hypertension and no drug reaction/allergies. On 20-JUN-2014, the patient was vaccinated with a dose of ZOSTAVAX vial injection on the arm (dose, lot number and expiration date not reported). Concomitant medications included unspecified medications for hypertension. On 20-JUN-2014, the reporter's family member developed a raised, red lump on his arm at the injection site and a rash and swelling that extended down to his fingers on that same arm, after receiving ZOSTAVAX (also reported as 21-JUN-2014. On 21-JUN-2014, the day after receiving ZOSTAVAX, the family member cut his finger (on the opposite arm of the ZOSTAVAX injection) and saw his physician and received a Tetanus injection in the same arm that ZOSTAVAX had been administered in. The physician evaluated the ZOSTAVAX injection site reaction at that time. No other information is available. The patient did not received treatment for red lump on his arm at the injection site and a rash and swelling. At the time of the report, outcome of red lump on his arm at the injection site and a rash and swelling and cut finger were unknown. No lab diagnostics were performed. Additional information has been requested.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Local swelling, Rash
Clinical narrative: This spontaneous report as received from a company representative reporting on a family member refers to a 54 year old male patient with hypertension and no drug reaction/allergies. On 20-JUN-2014, the patient was vaccinated with a dose of ZOSTAVAX vial injection on the arm (dose, lot number and expiration date not reported). Concomitant medications included unspecified medications for hypertension. On 20-JUN-2014, the reporter's family member developed a raised, red lump on his arm at the injection site and a rash and swelling that extended down to his fingers on that same arm, after receiving ZOSTAVAX (also reported as 21-JUN-2014. On 21-JUN-2014, the day after receiving ZOSTAVAX, the family member cut his finger (on the opposite arm of the ZOSTAVAX injection) and saw his physician and received a Tetanus injection in the same arm that ZOSTAVAX had been administered in. The physician evaluated the ZOSTAVAX injection site reaction at that time. No other information is available. The patient did not received treatment for red lump on his arm at the injection site and a rash and swelling. At the time of the report, outcome of red lump on his arm at the injection site and a rash and swelling and cut finger were unknown. No lab diagnostics were performed. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a female patient of unknown age. The patient's current conditions or medical history were not reported. The medical assistant reported that the patient receive doses of GARDASIL 0.5 ml (route, lot number and expiration date not reported) outside of the recommended schedule. She stated that the patient received her first dose in November 2012, her second dose in December 2013 and her third dose on 03-JUL-2014. No adverse effects reported. Additional information is not expected.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site induration, Injection site mass
Clinical narrative: Pt has a small pea size lump at the site of injection, harder to touch.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from Vaccines for Children Program (VFC) program coordinator refers to 9 patients of unknown age and gender. On an unknown date the patients were vaccinated with ROTATEQ (dose, route, anatomical location and lot # were not reported) that was improperly stored. No adverse effects were reported. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site reaction, Nausea, Pruritus, Spinal pain
Clinical narrative: This spontaneous report was received from a 73 years old female patient. There was not medical history. On 19-JUN-2014 the patient was vaccinated with ZOSTAVAX (dose, route and lot # were not provided). Concomitant therapies included blood pressure medicines (unspecified). There were not drug reactions and allergies. On 20-JUN-2014 the patient experienced itching and marks at the injection site, nausea, chills, severe spinal pain after receiving ZOSTAVAX. On unknown date X-ray test was performed (results were not provided). ON 23-JUN-2014, the patient sought medical attention (office visit). The patient did not receive any treatment. The outcome of the events was reported as not recovered/not resolved. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: X-ray
Clinical narrative: This spontaneous report was received from a 73 years old female patient. There was not medical history. On 19-JUN-2014 the patient was vaccinated with ZOSTAVAX (dose, route and lot # were not provided). Concomitant therapies included blood pressure medicines (unspecified). There were not drug reactions and allergies. On 20-JUN-2014 the patient experienced itching and marks at the injection site, nausea, chills, severe spinal pain after receiving ZOSTAVAX. On unknown date X-ray test was performed (results were not provided). ON 23-JUN-2014, the patient sought medical attention (office visit). The patient did not receive any treatment. The outcome of the events was reported as not recovered/not resolved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. Pharmacist reported that in 1999, the patient was vaccinated with first dose of (Oka/Merck) VARIVAX (dose, strength, frequency, lot number and expiration date were not reported) and on 26-JUN-2014, the patient was vaccinated with second dose of (Oka/Merck) VARIVAX 0.65 ml, subcutaneous (strength, lot number and expiration date were not reported). Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and unknown gender. Drug reactions or allergies and pertinent medical history were unspecified. On 23-JUN-2014 an unspecified number of patients were vaccinated with improperly stored GARDASIL (strength, dose, dose number, route and lot number were unspecified). No adverse symptoms reported. Concomitant therapies were unspecified. The outcome of received improperly stored vaccine was unknown. This is one of several reports received from the same reporter where other patients were vaccinated with improperly stored MMR II (MARRS # 1406USA011509) and ROTATEQ (MARRS # 1407USA001948). Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with VARIVAX (Merck) (dose, route and lot # were not reported). On an unknown date the patient was administered VARIVAX (Merck) which had been improperly stored. No adverse effects were reported. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 64 year old female patient with hypertension, cardiac dysrhythmia, hyperlipidemia and impaired fasting glucose. The patient's medical history included facial swelling after taking aspirin (unspecified). On 04-JUN-2014 the patient was vaccinated with PNEUMOVAX 23, lot # K004207, intramuscular in the arm. Concomitant therapies included atorvastatin and hydrochlorothiazide (manufacturer unknown) (reported as HCTZ). On 04-JUN-2014, that same day, the patient experienced pain at the site of PNEUMOVAX 23 injection. In approximately June 2014 the patient experienced the pain spread over the entire arm and difficulty moving the arm. The patient took ibuprofen or ALEVE for the pain on unspecified dates. The patient sought medical attention, she called the physician. No laboratory tests were performed. The outcome of the events was reported as recovered on 18-JUN-2014. The reporter requested a lot check for PNEUMOVAX 23. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and unknown gender. Drug reactions or allergies and pertinent medical history were unspecified. On 23-JUN-2014 an unspecified number of patients were vaccinated with improperly stored M-M-R II (strength, dose, dose number, route and lot number were unspecified). No adverse symptoms reported. Concomitantly therapies were unspecified. The outcome of received improperly stored vaccine was unknown. This is one of several reports received from the same reporter where other patients were vaccinated with improperly stored GARDASIL (MARRS # 1407USA001947) and ROTATEQ (MARRS # 1407USA001948). Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report was received from an office manager refers to a 4 year old patient of an unknown gender. Medical history was not reported. On 06-MAY-2014 the patient was vaccinated with M-M-R II also reported as (M-M-R-B) lot number: K000712, expiration date 16-JUL-2015, strength, dosage and route were not provided. Concomitant therapy was not reported. The reporter also stated that the vaccine was involved in the 10 hour temperature excursion. This is a several reports received from the same reporter. Lot number K000712 is an invalid lot number for M-M-R II. 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. The patient's pertinent medical history and drug allergies were unknown. On an unknown date, on 2011 the patient was vaccinated with her first dose of GARDASIL, route not reported. There was no information of concomitant medications. The nurse stated that the patient received her first dose of GARDASIL on an unknown date in 2011, and on 26-JUN-2014, patient came into the office to receive her second dose of GARDASIL. No adverse effects was reported. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Drug administered at inappropriate site, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On an unknown date the patient was vaccinated with a dose of PNEUMOVAX 23 (lot #, expiration date and dose unspecified) "In the back lower area of the arm" instead of in the deltoid muscle. No adverse effects reported. Additional information is not expected because reporter refused additional contact.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unspecified number of patients of unknown age and gender. The reporter stated that ROTATEQ was improperly stored and administered (dose, units, anatomical location, route of administration, lot number were not reported) to unspecified number of patients on unspecified dates. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Pruritus, Rash, Skin exfoliation, Urticaria
Clinical narrative: This spontaneous report as received from a consumer refers to a female patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX, (dose, frequency, route and site of administration were not reported). Concomitant therapy was not reported. The patient reported that on an unknown date she developed an injection site rash that later spread to her legs and back. The patient's legs had these bumps and welts on them and all of her skin was so flaky and itchy and it flaked off. The patient used about 10 bottles of an unspecified lotion and it was not helping and she was so very itchy. The patient did not recover from adverse events. The relatedness between therapy with ZOSTAVAX was not reported. Additional information has been requested.
Age: 20.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: This spontaneous report as received from a nurse regarding a 20 year old male patient. On an unknown date the patient was vaccinated with RECOMBIVAX HB (lot #, dosage regimen were unspecified). Concomitant medications were not reported. On an unknown date the patient had titers drawn at unspecified physician office which indicated he has not responded to the series of hepatitis B vaccine which he received. Reporter stated that vaccine series were administered by another physician practice (unspecified), and she had no original vaccination series data and original product used for patient vaccination. Patient had not experienced any adverse effect due to low titers. The causality and outcome of event was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 23-JUN-2014 the patient was vaccinated with a dose of ZOSTAVAX, 0.65 ml, subcutaneous (lot# not reported) that had expired on 07-JUN-2014. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified pharmacist of unknown age and unknown gender. None pertinent medical history and drug reactions or allergies were not reported. On an unknown date the pharmacist, during the administration of ZOSTAVAX 19400 PFU, (strength and lot number were unspecified), inadvertently dripped some of the reconstituted ZOSTAVAX vaccine on his hand. Following the exposure of ZOSTAVAX, the unspecified pharmacist developed shingles on that same area of his hand. Concomitant therapies and treatments given were not reported. The outcome of developed shingles was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from medical assistant refers to a patient of unknown age and gender. Medical history was not reported. The patient was vaccinated with the first, second and third dose of GARDASIL (route, dosage, lot number and expiration dates were not reported), on 12-SEP-2013, 06-MAY-2014 and 30-JUN-2014 respectively. No adverse reactions were reported. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacy technician refers to 2 unspecified patients of unknown gender and age. On 17-JUN-2014, the patients were vaccinated with an expired doses of VARIVAX (merck) lot # H011913, expiration date: 14-JUN-2014 (dose, dose number, indication not reported). It was reported that the vaccines have not have any previous temperatures excursions. No adverse symptoms were reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and unknown gender. Drug reactions or allergies and pertinent medical history were unspecified. On 23-JUN-2014 an unspecified number of patients were vaccinated with improperly stored ROTATEQ oral, (strength, dose, dose number and lot number were unspecified). No adverse symptoms reported. Concomitant therapies were unspecified. The outcome of received improperly stored vaccine was unknown. This is one of several reports received from the same reporter where other patients were vaccinated with improperly stored MMR II (MARRS # 1406USA011509) and GARDASIL (MARRS # 1407USA001947). Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 66 year old female patient, with none pertinent medical history or drug reaction allergies. On 06-JUN-2014 the patient was vaccinated with a dose of ZOSTAVAX (lot # J002869, exp. date 14-JUN-2014, dose and route not reported). There were no concomitant therapies. The patient returned to the pharmacy on either 26-JUN-2014 or 27-JUN-2014 to report that she had pain, redness and warmth at the injection site and also experienced headaches following the ZOSTAVAX administration (in June 2014). The patient sought medical attention by a pharmacy visit and did not receive any treatment for the adverse events. Laboratory diagnostic studies were not performed. The outcome of headache, warmth at the injection site, redness at the injection site and pain at the injection site was unknown. Additional information has been requested.
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Anxiety, Balance disorder, Diplopia, Headache
Clinical narrative: This spontaneous report was received from a male patient of unknown age. On 12-Sep-2013 the patient was vaccinated with ZOSTAVAX (dose, lot # and route of administration were not reported. Other suspect therapies included PNEUMOVAX 23 (dose, lot #, route of administration and indication were not reported). On 12-SEP-2013, 5 hours later, the patient experienced double vision. On13-SEP-2013 (the next day) the patient experienced issues with his equilibrium and balance. On an unknown date the patient experienced heightened anxiety and frequent headaches. The outcome of all of the events mentioned above was reported as not recovered/not resolved. Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain lower, Back pain, Constipation
Clinical narrative: Low back pain radiating to right lower abdomen.  Constipation.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Autism, Disturbance in social behaviour, Muscular weakness, Pain in extremity, Sarcopenia
Clinical narrative: After receiving a Tdap injection, my arm became very sore, and I was unable to lift weights. I remained in this condition for almost a week. Therefore the Tdap caused sarcopenia. Also, I felt my social skills decreasing, and I fear that this injection has caused me to have autism.
Age: 1.02
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site reaction, Skin lesion
Clinical narrative: Red lesion at injection site.
Age: 57.0
Sex: M
Vaccine: HEP
Symptoms: Chills, Nausea, Pyrexia, Vomiting
Clinical narrative: Patient has experienced nausea & vomiting, fever & chills that have lasted for 10 days.
Age: 69.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Hypersensitivity, Local swelling, Pain, Pruritus
Clinical narrative: Swelling in left arm, some pain and itching. Went to urgent care facility and was advised that symptoms indicated an allergic reaction, probably to the immunizations that I had received the previous day.
Age: 0.35
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Blood test, Convulsion, Electroencephalogram, Influenza virus test, Lumbar puncture
Clinical narrative: Seizures. Treatment: Ativan & Phenobarbital.
Age: 0.35
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Nuclear magnetic resonance imaging, Urine analysis
Clinical narrative: Seizures. Treatment: Ativan & Phenobarbital.
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report as received from a physician refers to a female patient of unknown age. No information about medical history, concurrent conditions and concomitant medications were reported. The reporter stated that on an unknown date in third trimester of her pregnancy the patient was vaccinated with GARDASIL (therapy dates, dose, route not reported). The last menstrual pregnancy (LMP) and estimated date of delivery (EDD) is not known. The outcome of event reported is unknown. No product quality complaint was involved. Additional information is not expected.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Varicella
Clinical narrative: This spontaneous report as received from a pharmacist regarding herself refers to approximately 62 year old female patient with drug reactions/allergies to salicylic acid topically. Concomitant therapies included SYNTHROID, EVISTA, CRESTOR, bupropion hydrochloride, estradiol (manufacturer unknown) and progesterone (manufacturer unknown). On 23-JUN-2014 the patient was vaccinated with ZOSTAVAX lot # J014568 expiration date 18-FEB-2015, dose 0.65 ml, route subcutaneous in the left arm. The reporter stated that on 23-JUN-2014 after receiving ZOSTAVAX, she developed redness, soreness at injection site (back of left arm) and injection site was hot also. The pharmacist stated that she developed chicken pox. The reporter stated that area is improving but still a little tender. The reporter also stated that she had chicken pox 25 years ago then her child recently (time frame unspecified) brought them (chicken pox) home. The outcome of events reported was reported as recovering/resolving. The patient sought no medica attention. No product quality complaint was involved. Additional information has been requested.
Age: 1.5
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to a patient of 15 months old. No information about medical history, concurrent conditions and concomitant medications were reported. The reporter stated that on 30-JUN-2014 the patient was vaccinated with PROQUAD, dose 0.5 ml, route subcutaneous and VARIVAX (route, dose was not reported). No adverse effects reported. The outcome of events reported is unknown. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to multiple unspecified patients. On unknown dates the patients were vaccinated with PROQUAD (lot #, expiration date, dose and route unspecified) that were stored improperly. No adverse effects reported. This is one of several reports received from same source. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Haematuria, Urine analysis abnormal
Clinical narrative: This spontaneous report as received from a pharmacist regarding her son refers to a 14 year old male patient with current condition of mood disorder, drug reactions/allergies to penicillin-hives. Concomitant therapies included WELLBUTRIN, TENEX, and BUSPAR. On 17-JUN-2014 the patient was vaccinated with second dose GARDASIL lot # H020901 expiration date 05-JUL-2015, dose 0.5 ml, route, intramuscular. On 23-JUN-2014, the patient developed gross hematuria. The reporter also stated that the patient was evaluated at a local emergency room on 28-JUN-2014, which was confirmed through the urinalysis. Lab investigations included urinalysis (28-JUN-2014) hematuria. It was also reported no diagnosis was made and the patient was advised to increase fluid intake. The outcome of gross hematuria was reported as not recovered/not resolved. The patient sought medical attention. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to multiple unspecified patients. On unknown dates the patients were vaccinated with VARIVAX (Merck) (lot #, expiration date, dose and route unspecified) that were stored improperly. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report as received from a physician via field representative refers to a patient of unknown age. The patient's drug allergies and medical history was unspecified. On an unknown date the patient was vaccinated with second dose of PNEUMOVAX 23. Concomitant medications were unspecified. On an unknown date the patient's arm was red, swollen and itchy from the injection site down to the elbow. The patient sought medical attention and was treated with unspecified antibiotic, BENADTYL. Lab diagnostics studies performed were unspecified. The outcome of patient's arm was red, swollen and itchy was unknown. The causality of arm was red, swollen and itchy was not reported. Intervention to prevent serious criteria was unspecified. Cancer and overdose were reported as no. No product quality complaint (PWC) was reported for PNEUMOVAX 23. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age. The patient's medical history was not reported. On 30-SEP-2013 the patient was vaccinated with first dose of GARDASIL. Concomitant medications were not reported. On 30-MAY-2014 the patient was vaccinated with second dose of GARDASIL. On 27-JUN-2014 the patient was vaccinated with third dose of GARDASIL. No adverse effect reported. Additional information is not expected.
Age: 29.0
Sex: M
Vaccine: FLUX, FLU3
Symptoms: Bursitis, Musculoskeletal pain, Pain in extremity, Ultrasound scan
Clinical narrative: Extreme pain in upper right deltoid/should, I got a flu shot injection that was administered to high and have developed bursitis.  I have received multiple steroid injections, but still have pain 8 months later!!!
Age: 29.0
Sex: M
Vaccine: FLUX, FLU3
Symptoms: Injection site pain, Joint crepitation
Clinical narrative: Extreme pain in upper right deltoid/should, I got a flu shot injection that was administered to high and have developed bursitis.  I have received multiple steroid injections, but still have pain 8 months later!!!
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Muscle twitching, Nausea, Pyrexia, Retching
Clinical narrative: High fever accompanied with some twitching overnight; in am nausea with heaves but no substantial emesis--fever resolved with one dose of Tylenol, but it is still early in the day; she rec'd DTaP, MMR, Polio and Varivax, so it is hard to know the cause of the reaction.
Age: 4.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Streptococcus test negative
Clinical narrative: Fever to 103.
Age: 1.25
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Convulsion, Grand mal convulsion, Pyrexia
Clinical narrative: Patient started running a fever in the afternoon and then experienced several short convulsions during dinner that we think were seizures. After consulting her pediatrician, we gave her Tylenol immediately (103 fever) and monitored her. Her temp came down to 100, and she went to bed. Her temp was still 100 at 11pm. At 1:45 am, she had a full tonic-clonic seizure lasting 3.5 mins. We again called the pediatrician and gave her Advil (103 temp). At the doctor's recommendation, we called 911 and went to the ER. Her temp came down quickly and all her vitals were normal at the hospital, so we brought her home. We visited a pediatrician on Friday. She was still doing well, responding to the fever meds and no other signes of seizures. We continued fever meds every 3 hours (alternating Tylenol and Advil) until Sunday morning to ensure that her fever wouldn't return. Her temp was normal from 2am on Saturday onwards. She now seems back to normal.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Computerised tomogram, Dyskinesia, Hypoaesthesia, Loss of consciousness, Syncope
Clinical narrative: When patient was leaving the exam room she fainted and had jerking movement of hand and foot on one side. She lost consciousness and was caught by the medical assistant. When she regained consciousness both hands and fingers were numb and she was unable to move her fingers for a brief period. In addition, she was slow to regain awareness of where she was and what had happened - approx 2 minutes.
Sex: U
Vaccine: PPV
Symptoms: Erythema
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified patients of unknown age and gender. On an unknown date these patients were vaccinated with a dose of PNEUMOVAX 23 (lot#, dose, route, indication not reported). Concomitant medications were not reported. On an unknown date these patients developed redness that was the size of a "half dollar" after receiving PNEUMOVAX 23. But the nurse stated that this was "rare". Outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Erythema, Flushing, Injection site erythema, Injection site induration
Clinical narrative: This spontaneous report was received from an approximately 66 year old female consumer with diabetes refers to herself. The patient reported she could not take "SSRI drugs" because they caused her to have a stroke years ago. On an unspecified date in March 2014 (reported as the end of March 2014) the patient was vaccinated with "one shot" ZOSTAVAX (lot # not provided)  route reported as injection. Other suspect therapies included MYRBETRIQ. Concomitant therapies included atenolol, metoprolol, LEVIMIR, NOVOLOG and other unspecified medications. She reported that, on an unspecified date around the time that she received ZOSTAVAX, she "switched from metoprolol to atenolol in order to be able to start MYRBETIQ. She had since switched back to metoprolol instead of atenolol and also stopping taking MYRBETRIQ. On an unspecified date in April 2014 (reported as a few days after receiving ZOSTAVAX, the patient experienced injection site reaction of "swelling, hardness, warmth, and redness" which "lasted 2 weeks". She reported that she had been and was still experiencing other reactions which began after the injection site reaction appeared (onset dates unspecified). These other reactions include "extreme itching" which was "everywhere" on he body but which was most pronounced and persistent on her upper body and especially in the areas of her chest, arms, and stomach. She also reported "redness" or "flushing" in her neck and face which was accompanied by itching and which "happened toward the end of the day". Since having had ZOSTAVAX she was also "sensitive to the sun" and experiencing aching and pain in her joints and fingers. She stated that the adverse effects she was till experiencing "seems to be getting better" slowly. She sought medical attention by calling her physician only about the flushing and itching of her face and neck. She did not mention her other adverse effects to her physician. The flushing and itching of her face and neck was originally suspected to be a reaction to MYRBETRIQ, which she began taking on an unspecified date after receiving ZOSTAVAX. None treatment was given for the adverse effects. The relationship between the events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Injection site swelling, Injection site warmth, Pain in extremity, Photophobia
Clinical narrative: This spontaneous report was received from an approximately 66 year old female consumer with diabetes refers to herself. The patient reported she could not take "SSRI drugs" because they caused her to have a stroke years ago. On an unspecified date in March 2014 (reported as the end of March 2014) the patient was vaccinated with "one shot" ZOSTAVAX (lot # not provided)  route reported as injection. Other suspect therapies included MYRBETRIQ. Concomitant therapies included atenolol, metoprolol, LEVIMIR, NOVOLOG and other unspecified medications. She reported that, on an unspecified date around the time that she received ZOSTAVAX, she "switched from metoprolol to atenolol in order to be able to start MYRBETIQ. She had since switched back to metoprolol instead of atenolol and also stopping taking MYRBETRIQ. On an unspecified date in April 2014 (reported as a few days after receiving ZOSTAVAX, the patient experienced injection site reaction of "swelling, hardness, warmth, and redness" which "lasted 2 weeks". She reported that she had been and was still experiencing other reactions which began after the injection site reaction appeared (onset dates unspecified). These other reactions include "extreme itching" which was "everywhere" on he body but which was most pronounced and persistent on her upper body and especially in the areas of her chest, arms, and stomach. She also reported "redness" or "flushing" in her neck and face which was accompanied by itching and which "happened toward the end of the day". Since having had ZOSTAVAX she was also "sensitive to the sun" and experiencing aching and pain in her joints and fingers. She stated that the adverse effects she was till experiencing "seems to be getting better" slowly. She sought medical attention by calling her physician only about the flushing and itching of her face and neck. She did not mention her other adverse effects to her physician. The flushing and itching of her face and neck was originally suspected to be a reaction to MYRBETRIQ, which she began taking on an unspecified date after receiving ZOSTAVAX. None treatment was given for the adverse effects. The relationship between the events and ZOSTAVAX was not reported. Additional information has been requested.