chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL, HPV4, MNQ, TDAP, VARCEL, HPV4, MNQ, TDAP, VARCEL, HPV4, MNQ, TDAP, VARCEL
Symptoms: Congenital anomaly, Foetal exposure during pregnancy, Pregnancy
Clinical narrative: This prospective pregnancy case was reported by a healthcare professional (nurse) and described the occurrence of congenital anomaly in a foetus subject of unspecified gender who was exposed to BOOSTRIX (GlaxoSmithKline), GARDASIL (non-gsk), meningococcal B C vaccine (non-gsk) and varicella virus vaccine (non-gsk) transplacentally when the mother was vaccinated. The mother's concurrent medical conditions included depression and shellfish allergy. The fetus was also exposed to Ondansetron and Prenatal vitamins transplacentally, which the mother took concurrently. On 4 October 2013 the 16-year-old mother of the fetal subject received a dose of BOOSTRIX (.5 ml, transplacentary, unknown), unspecified dose of GARDASIL (.5 ml, transplacentary, unknown), unspecified dose of Meningococcal B C vaccine (Non-GSK) (.5 ml, transplacentary, unknown), unspecified dose of Varicella virus vaccine (Non-GSK) (.5 ml, transplacentary, unknown). The mother's last menstrual period (LMP) occurred on 20 August 2013. The nurse reported the mother was exposed to with BOOSTRIX, GARDASIL, Meningococcal B C vaccine (Non-GSK) and Varicella virus vaccine (Non-GSK) at three to four weeks gestation, during the 1st trimester, however based on LMP she was calculated to be 6 weeks gestation. Estimated date of delivery was calculated to be 27 May 2014. On an unspecified date, within months of vaccination with BOOSTRIX, GARDASIL, Meningococcal B C vaccine (Non-GSK) and Varicella virus vaccine (Non-GSK), the fetus experienced congenital anomaly and maternal vaccine exposure. The nurse reported there was a possibility of congenital anomaly, specific details were not provided. At the time of reporting the outcome of the congenital anomaly was unspecified, the mother's pregnancy was ongoing. For the mother's case please see case A1061427A.
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL, HPV4, MNQ, TDAP, VARCEL, HPV4, MNQ, TDAP, VARCEL, HPV4, MNQ, TDAP, VARCEL
Symptoms: Exposure during pregnancy, Foetal disorder, Pregnancy test positive
Clinical narrative: This prospective pregnancy case was reported by a healthcare professional (nurse) and described the occurrence of congenital anomaly in a foetus subject of unspecified gender who was exposed to BOOSTRIX (GlaxoSmithKline), GARDASIL (non-gsk), meningococcal B C vaccine (non-gsk) and varicella virus vaccine (non-gsk) transplacentally when the mother was vaccinated. The mother's concurrent medical conditions included depression and shellfish allergy. The fetus was also exposed to Ondansetron and Prenatal vitamins transplacentally, which the mother took concurrently. On 4 October 2013 the 16-year-old mother of the fetal subject received a dose of BOOSTRIX (.5 ml, transplacentary, unknown), unspecified dose of GARDASIL (.5 ml, transplacentary, unknown), unspecified dose of Meningococcal B C vaccine (Non-GSK) (.5 ml, transplacentary, unknown), unspecified dose of Varicella virus vaccine (Non-GSK) (.5 ml, transplacentary, unknown). The mother's last menstrual period (LMP) occurred on 20 August 2013. The nurse reported the mother was exposed to with BOOSTRIX, GARDASIL, Meningococcal B C vaccine (Non-GSK) and Varicella virus vaccine (Non-GSK) at three to four weeks gestation, during the 1st trimester, however based on LMP she was calculated to be 6 weeks gestation. Estimated date of delivery was calculated to be 27 May 2014. On an unspecified date, within months of vaccination with BOOSTRIX, GARDASIL, Meningococcal B C vaccine (Non-GSK) and Varicella virus vaccine (Non-GSK), the fetus experienced congenital anomaly and maternal vaccine exposure. The nurse reported there was a possibility of congenital anomaly, specific details were not provided. At the time of reporting the outcome of the congenital anomaly was unspecified, the mother's pregnancy was ongoing. For the mother's case please see case A1061427A.
Age: 52.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Blood test, Computerised tomogram thorax abnormal, Dyspnoea, Hypertension, Lung disorder
Clinical narrative: Problems with breathing, moving around on 12/03/12 Monday. On 12/06/12, pt visited ER. BP = 230/196 too high, also breathing problems. Baseline BP: 160/ at ER, seen crystallization in lung.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse referring to a 63 year old female patient with hypertension, hyperlipidaemia and elevated blood sugar, who on 27-FEB-2014, was vaccinated with a dose of ZOSTAVAX (lot # J011829, expiration date 26-DEC-2014), 0.65 ml, subcutaneously. Concomitant therapies included vitamin D 50.000v units once per week and lisinopril (+) hydrochlorothiazide (manufacturer unknown) 20/12.5 mg daily. On 03-MAR-2014, the patient developed a rash with "small pinpoint blisters" that are "itchy" after receiving ZOSTAVAX. The nurse reported that the patient was seen by the physician on 11-MAR-2014, and the physician diagnosed the patient with shingles. The physician prescribed the patient valacyclovir and hydrocortisone cream on 11-MAR-2014. The nurse reported that the patient was taking BENADRYL on unspecified dates for the symptoms. No lab diagnostic studies were performed. The outcome of shingles was reported as not recovered/not resolved. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Herpes zoster, Pruritus, Rash
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse referring to a 63 year old female patient with hypertension, hyperlipidaemia and elevated blood sugar, who on 27-FEB-2014, was vaccinated with a dose of ZOSTAVAX (lot # J011829, expiration date 26-DEC-2014), 0.65 ml, subcutaneously. Concomitant therapies included vitamin D 50.000v units once per week and lisinopril (+) hydrochlorothiazide (manufacturer unknown) 20/12.5 mg daily. On 03-MAR-2014, the patient developed a rash with "small pinpoint blisters" that are "itchy" after receiving ZOSTAVAX. The nurse reported that the patient was seen by the physician on 11-MAR-2014, and the physician diagnosed the patient with shingles. The physician prescribed the patient valacyclovir and hydrocortisone cream on 11-MAR-2014. The nurse reported that the patient was taking BENADRYL on unspecified dates for the symptoms. No lab diagnostic studies were performed. The outcome of shingles was reported as not recovered/not resolved. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: FLU4, VARCEL
Symptoms: Anaphylactic reaction, Lip swelling, Skin test positive, Swollen tongue, Urticaria
Clinical narrative: Hives, wheezing, swelling of tongue and lips, all occurred within about 5 minutes of receiving vaccine (I am not sure what time his vaccine actually was, his appointment was at 3.45 pm). His pediatrician gave him a large dose of Benadryl. His pediatrician and an allergist confirmed that this was an anaphylactic reaction. We followed up with an intradermal skin test with an allergist today and he had a definitive reaction to Fluzone lot #UH953AB. He has had this vaccine at least 10 times before and has never had any trouble with this or any other vaccine.
Age: 18.0
Sex: M
Vaccine: FLU4, VARCEL
Symptoms: Wheezing
Clinical narrative: Hives, wheezing, swelling of tongue and lips, all occurred within about 5 minutes of receiving vaccine (I am not sure what time his vaccine actually was, his appointment was at 3.45 pm). His pediatrician gave him a large dose of Benadryl. His pediatrician and an allergist confirmed that this was an anaphylactic reaction. We followed up with an intradermal skin test with an allergist today and he had a definitive reaction to Fluzone lot #UH953AB. He has had this vaccine at least 10 times before and has never had any trouble with this or any other vaccine.
Sex: F
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from registered nurse, concerning a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies were not provided. On 07-MAR-2014, the patient was vaccinated with a dose of LIQUID PEDVAXHIB, 0.5 ml intramuscularly, (lot number and expiration date were not provided), which was exposed to a temperature of 47F for 10 minutes. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, FLU3, PNC13
Symptoms: Hypotonia, Motor dysfunction, Posture abnormal
Clinical narrative: Infant became hypo-tonic, he couldn't hold is head up as normal, head was flopping to both sides.  His motor control was decreased for several weeks.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Autoimmune disorder, Capillary fragility, Dermatomyositis, Laboratory test, Muscle atrophy
Clinical narrative: Within 2weeks major dev of juvenile dermatomyositis with muscle wasting and weakness. Developed Von Willebrand's disease. Among other symptoms of a autoimmune crisis.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Muscular weakness, Nuclear magnetic resonance imaging, Vaccination complication, Von Willebrand's disease
Clinical narrative: Within 2weeks major dev of juvenile dermatomyositis with muscle wasting and weakness. Developed Von Willebrand's disease. Among other symptoms of a autoimmune crisis.
Age: 33.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Oropharyngeal discomfort, Rash macular, Wheezing
Clinical narrative: Phone call from patient reports wheezing, splotchy rash on forehead, and throat feeling "funny". Patient instructed to call 911, fiancee was in home with patient.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Autism spectrum disorder, Convulsion, Developmental delay, Lethargy, Pyrexia
Clinical narrative: High fever followed by seizures admittance to hospital ER for 8 hrs. Vomiting. Lethargy.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Vomiting
Clinical narrative: High fever followed by seizures admittance to hospital ER for 8 hrs. Vomiting. Lethargy.
Age: 50.0
Sex: F
Vaccine: TD
Symptoms: Arthralgia, Blood test, Chest X-ray, Chest pain, Cough
Clinical narrative: PAIN IN ARM NECK UNDER ARM CHEST, BREATHING, COUGH, LIGHT HEADED, DIZZY, NAUSEA, STABBING PAIN IN CHEST AS I COUGH, TIRED VERY TIRED, ARM GOING NUMB, PAIN IN ALL JONITS, MUSCLE SPASM IN ARMS AND LEGS, SHORT OF BREATH, HEAD ACHES.
Age: 50.0
Sex: F
Vaccine: TD
Symptoms: Dizziness, Dyspnoea, Electrocardiogram, Fatigue, Headache
Clinical narrative: PAIN IN ARM NECK UNDER ARM CHEST, BREATHING, COUGH, LIGHT HEADED, DIZZY, NAUSEA, STABBING PAIN IN CHEST AS I COUGH, TIRED VERY TIRED, ARM GOING NUMB, PAIN IN ALL JONITS, MUSCLE SPASM IN ARMS AND LEGS, SHORT OF BREATH, HEAD ACHES.
Age: 50.0
Sex: F
Vaccine: TD
Symptoms: Hypoaesthesia, Muscle spasms, Nausea, Neck pain, Pain
Clinical narrative: PAIN IN ARM NECK UNDER ARM CHEST, BREATHING, COUGH, LIGHT HEADED, DIZZY, NAUSEA, STABBING PAIN IN CHEST AS I COUGH, TIRED VERY TIRED, ARM GOING NUMB, PAIN IN ALL JONITS, MUSCLE SPASM IN ARMS AND LEGS, SHORT OF BREATH, HEAD ACHES.
Age: 50.0
Sex: F
Vaccine: TD
Symptoms: Pain in extremity, Urine analysis
Clinical narrative: PAIN IN ARM NECK UNDER ARM CHEST, BREATHING, COUGH, LIGHT HEADED, DIZZY, NAUSEA, STABBING PAIN IN CHEST AS I COUGH, TIRED VERY TIRED, ARM GOING NUMB, PAIN IN ALL JONITS, MUSCLE SPASM IN ARMS AND LEGS, SHORT OF BREATH, HEAD ACHES.
Age: 1.16
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Pyrexia
Clinical narrative: Pt presents with fever of 103, for 3 days.
Age: 1.22
Sex: M
Vaccine: DTAP, FLUX, HIBV, MMRV, PNC13, DTAP, FLUX, HIBV, MMRV, PNC13
Symptoms: Culture negative, Incisional drainage, Injection site swelling, Secretion discharge
Clinical narrative: This spontaneous report as received from a nurse refers to a 14 months old male patient with no Pertinent Medical History and no Drug Reactions/Allergies. On an unknown date the patient was vaccinated with three respective dose of PROQUAD (merck) (lot #, expiration date and dose unspecified), PEDVAXHIB (lot #, expiration date and dose unspecified) and PREVNAR 13 (lot #, expiration date and dose unspecified), they were all administered intramuscularly, and they were all administered right next to each other on the patient's right thigh. No concomitant medication included. The patient's parents brought him to see the physician as the area with the three injection sites swelled up "to the size of a golf ball". The swollen area was lanced by the physician and was filled with serous fluid. The fluid was sent for a culture, but was determined to be negative with no bacterial growth. The event outcome was reported as recovering. Additional information has been requested.
Age: 1.22
Sex: M
Vaccine: DTAP, FLUX, HIBV, MMRV, PNC13, DTAP, FLUX, HIBV, MMRV, PNC13
Symptoms: Bacterial test negative, Crying, Incisional drainage, Induration, Injection site abscess
Clinical narrative: This spontaneous report as received from a nurse refers to a 14 months old male patient with no Pertinent Medical History and no Drug Reactions/Allergies. On an unknown date the patient was vaccinated with three respective dose of PROQUAD (merck) (lot #, expiration date and dose unspecified), PEDVAXHIB (lot #, expiration date and dose unspecified) and PREVNAR 13 (lot #, expiration date and dose unspecified), they were all administered intramuscularly, and they were all administered right next to each other on the patient's right thigh. No concomitant medication included. The patient's parents brought him to see the physician as the area with the three injection sites swelled up "to the size of a golf ball". The swollen area was lanced by the physician and was filled with serous fluid. The fluid was sent for a culture, but was determined to be negative with no bacterial growth. The event outcome was reported as recovering. Additional information has been requested.
Age: 1.22
Sex: M
Vaccine: DTAP, FLUX, HIBV, MMRV, PNC13, DTAP, FLUX, HIBV, MMRV, PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain, Injection site reaction
Clinical narrative: This spontaneous report as received from a nurse refers to a 14 months old male patient with no Pertinent Medical History and no Drug Reactions/Allergies. On an unknown date the patient was vaccinated with three respective dose of PROQUAD (merck) (lot #, expiration date and dose unspecified), PEDVAXHIB (lot #, expiration date and dose unspecified) and PREVNAR 13 (lot #, expiration date and dose unspecified), they were all administered intramuscularly, and they were all administered right next to each other on the patient's right thigh. No concomitant medication included. The patient's parents brought him to see the physician as the area with the three injection sites swelled up "to the size of a golf ball". The swollen area was lanced by the physician and was filled with serous fluid. The fluid was sent for a culture, but was determined to be negative with no bacterial growth. The event outcome was reported as recovering. Additional information has been requested.
Age: 1.22
Sex: M
Vaccine: DTAP, FLUX, HIBV, MMRV, PNC13, DTAP, FLUX, HIBV, MMRV, PNC13
Symptoms: Injection site scab, Injection site swelling, Local swelling, Pyrexia, Scab
Clinical narrative: This spontaneous report as received from a nurse refers to a 14 months old male patient with no Pertinent Medical History and no Drug Reactions/Allergies. On an unknown date the patient was vaccinated with three respective dose of PROQUAD (merck) (lot #, expiration date and dose unspecified), PEDVAXHIB (lot #, expiration date and dose unspecified) and PREVNAR 13 (lot #, expiration date and dose unspecified), they were all administered intramuscularly, and they were all administered right next to each other on the patient's right thigh. No concomitant medication included. The patient's parents brought him to see the physician as the area with the three injection sites swelled up "to the size of a golf ball". The swollen area was lanced by the physician and was filled with serous fluid. The fluid was sent for a culture, but was determined to be negative with no bacterial growth. The event outcome was reported as recovering. Additional information has been requested.
Age: 1.22
Sex: M
Vaccine: DTAP, FLUX, HIBV, MMRV, PNC13, DTAP, FLUX, HIBV, MMRV, PNC13
Symptoms: Staphylococcal infection, Streptococcus test negative, Tenderness, Weight bearing difficulty
Clinical narrative: This spontaneous report as received from a nurse refers to a 14 months old male patient with no Pertinent Medical History and no Drug Reactions/Allergies. On an unknown date the patient was vaccinated with three respective dose of PROQUAD (merck) (lot #, expiration date and dose unspecified), PEDVAXHIB (lot #, expiration date and dose unspecified) and PREVNAR 13 (lot #, expiration date and dose unspecified), they were all administered intramuscularly, and they were all administered right next to each other on the patient's right thigh. No concomitant medication included. The patient's parents brought him to see the physician as the area with the three injection sites swelled up "to the size of a golf ball". The swollen area was lanced by the physician and was filled with serous fluid. The fluid was sent for a culture, but was determined to be negative with no bacterial growth. The event outcome was reported as recovering. Additional information has been requested.
Age: 0.7
Sex: M
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to an approximately 8 month old patient. On 19-AUG-2013, the patient was vaccinated with oral ROTATEQ, (lot number, expiry date was unknown) dose 1. On 21-Oct-2013, the patient was vaccinated with oral ROTATEQ, (lot number, expiry date was unknown) dose 2. On 07-Mar-2014, the patient was vaccinated with oral ROTATEQ, (lot number, expiry date was unknown) dose 3. No adverse event reported was reported. Additional information is not expected.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacy intern (healthcare student) refers to an adult consumer of unknown age and gender. On an unspecified date the adult patient received the series of RECOMBIVAX HB (Lot#unspecified) dose, frequency and location unspecified for vaccination in a shorter than recommended time frame- the time period between dose two and three was only 30 days. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified amount of patients. On an unknown date the patients were vaccinated with improperly stored ZOSTAVAX. Administration route, date and lot number were not reported. The nurse reported that the ZOSTAVAX was exposed to a temperature of 1.4C for 30 hours. She also reported that the ZOSTAVAX had multiple excursions in which it was exposed to a temperature between above -15C to -10C for an unspecified amount of hours which she "believes" was due to defrost cycles. No adverse effect reported. This is one of three reports received from the same source. 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 a healthcare student refers to a patient of unknown age. On an unknown date in 2012 the patient was vaccinated with first dose of GARDASIL (dose, route and frequency were not reported0. On 11-MAR-2014, the patient was in the office to receive the second dose of GARDASIL. No adverse effect reported. No further information was provided. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: This spontaneous report as received from a retired medical assistant refers to a female nurse patient with currently 57 years old, with medical history of hives due to BACTRIM and current conditions including osteoporosis, Crohn's disease and family history of heart disease. On 13-FEB-2014 the patient was given a prescription for ZOSTAVAX and on an unspecified date in 2014 at an unspecified pharmacy the patient received a dose of ZOSTAVAX (Lot #, exp date, dose and route not reported, right above the elbow). Concomitant therapy included aspirin, PROTONIX, minerals (unspecified), CENTRUM SILVER, calcium, ferrous gluconate, FIBERCON and DELZICOL. In 2014 the injection site area got red and inflamed. The patient mentioned the reaction in a routine visit to physician and no treatment was given for the adverse events. Laboratory diagnostic studies were not performed. The patient recovered from adverse events on an unspecified date. 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 healthcare professional refers to a female patient of unknown age. No information regarding the patient's medical history was provided. On an unknown date in June 2013 the patient was vaccinated with the first dose of GARDASIL. On date of this report (reported as currently) the patient was in the office to receive her second dose. No concomitant medication was reported. No adverse effects were reported. No outcome was reported. Additional information has been requested.
Age: 38.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous prospective pregnancy report as received from a pharmacist refers to a 38 year old female patient. On 07-MAR-2014 the pregnant patient was inadvertently received a dose of GARDASIL (lot #, expiration date and dose unspecified), intramuscular instead of TDAP. No adverse effect was reported. The patient became pregnant with last Menstrual Period (LMP) of 09-AUG-2013 and Estimated date of delivery (EDD) of 16-MAY-2014. Initial exposure to GARDASIL was at 30 weeks. The pregnancy outcome was outcome pending. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Vaccination error
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. On 03-MAR-2014 the patient was vaccinated with PNEUMOVAX 23 (SDV, MDV or additive) (EA) 25, (dose, dose number, lot number and expiry date unknown) intramuscularly in error. No known adverse effects were reported. The outcome of received PNEUMOVAX 23 in error and no known adverse effects was unknown. This case # 1403USA006268 is linked to case # 1403USA006361 via same patient link. 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 pharmacist refers to a patient of unknown demography. The Pharmacist reported that improperly stored ZOSTAVAX (dose, route and frequency were not reported) may have been administered to the patient on an unknown date. It was reported that the ZOSTAVAX was stored with dry ice in January 2014. No adverse event reported. No other information was reported. It was also reported that the professional information request has been sent. Additional information is not expected.
Sex: U
Vaccine: HEP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a adult (age not specified) patient of unknown gender. The reporter stated that on 28-FEB-2014 the patient inadvertently received a pediatric dose of RECOMBIVAX (0.5 ml, intramuscular, site of administration not reported). No adverse effects reported. 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 registered nurse refers to unspecified amount of patients. On an unknown date the patients were vaccinated with improperly stored PROQUAD (merck). Administration route, date and lot number were not reported. The nurse reported that the PROQUAD (merck) was exposed to a temperature of 1.4C for 30 hours. She also reported that the PROQUAD (merck) had multiple excursions in which it was exposed to a temperature between above -15C to -10C for an unspecified amount of hours which she "believes" was due to defrost cycles. No adverse effect reported. This is one of three reports received from the same source. 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 registered nurse refers to unspecified amount of patients. On an unknown date the patients were vaccinated with improperly stored VARIVAX. Administration route, date and lot number were not reported. The nurse reported that the VARIVAX was exposed to a temperature of 1.4C for 30 hours. She also reported that the VARIVAX had multiple excursions in which it was exposed to a temperature between above -15C to -10C for an unspecified amount of hours which she "believes" was due to defrost cycles. No adverse effect reported. This is one of three reports received from the same source. Additional information has been requested.
Age: 0.83
Sex: U
Vaccine: HEPA, HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a Nurse refers to a 10 months old patient of unknown demography. The nurse reported that on an unknown date in January 2011, the 10 months old patient was vaccinated with the first dose of VAQTA (Strength: 25/0.5 U/mL) 0.5 ml doe (route was not reported). On an unknown date in August 2011, the patient was vaccinated with a second dose of VAQTA (0.5 ml) (route was not reported). No adverse events were reported. No further information was provided. Additional information has been requested.
Age: 0.83
Sex: U
Vaccine: HEPA, HEPA
Symptoms: No adverse event, Vaccination error
Clinical narrative: This spontaneous report was received from a Nurse refers to a 10 months old patient of unknown demography. The nurse reported that on an unknown date in January 2011, the 10 months old patient was vaccinated with the first dose of VAQTA (Strength: 25/0.5 U/mL) 0.5 ml doe (route was not reported). On an unknown date in August 2011, the patient was vaccinated with a second dose of VAQTA (0.5 ml) (route was not reported). No adverse events were reported. No further information was provided. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: Pt received KINRIX and PROQUAD 3/10/14 then presented in office visit 3/11/14 with vomiting, nausea, fever. Pt had previously received KINRIX and PROQUAD 6/11/13 with no reactions. ZOFRAN prescribed for nausea/vomiting.
Age: 34.0
Sex: F
Vaccine: PPV
Symptoms: Axillary pain, Erythema, Injection site erythema
Clinical narrative: Patient called office 3/13/14 AM reporting she started experiencing left underarm pain early AM of 3/12/14 - Now has redness at site of injection and underarm. Adv. to take ibuprofen every 6 hours and apply cold compress to underarm and site.
Age: 49.0
Sex: M
Vaccine: TYP
Symptoms: Chills, Fatigue, Muscle spasms, Vision blurred
Clinical narrative: Cramps, tiredness, chills, blurred vision.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, Pregnancy test positive
Clinical narrative: This spontaneous prospective pregnancy report was received from a Nurse practitioner refers to a 22 year old female patient. On 04-MAR-2014, the patient was vaccinated with first dose of GARDASIL lot # H021346 (Expiry: 01-OCT-2015) 0.5 ml, intramuscular. The LMP was reported as 05-FEB-2014. The EDD was estimated as 12-NOV-2014. On 11-MAR-2014, the patient was seen in the office and had a pregnancy test. The pregnancy test result read positive. No further information was provided. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMRV
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: Redness, warmth, swelling lasted 48 hrs.
Age: 11.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Injection site discolouration, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Injection site swollen, warm to touch, red/purple in color.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a consumer refers to approximately 27 year old female patient. Patient was not pregnant. Patient was allergic to antibiotics containing cephalosporin (manufacturer unknown). In July 2013, the patient was vaccinated with 3rd dose of GARDASIL, intramuscular. Concomitant therapies included ZOVIA. Patient received a recall letter from her physician which stated that she received the recalled lot (J007354) of GARDASIL, the recalled lot of GARDASIL was distributed between 20-AUG-2013 and 09-OCT-2013, therefore it was unkonwn how the patient would have received it, considering she reported she received her last dose sometime in July 2013. On an unknown date, after receiving GARDASIL the patient experienced shingles, patient stated that she do not know whether she developed shingles after first dose or second dose of GARDASIL. The patient was prescribed an antiviral medication (unspecified name, dose/frequency, and manufacturer), but it did not work. The outcome of the event was reported as recovering. Patient sought medical attention by visiting the office on an unknown date. No product quality issue was reported. Additional information has been requested.
Age: 30.0
Sex: M
Vaccine: VARZOS
Symptoms: Paraesthesia, Swelling face
Clinical narrative: Tingling, swelling left side of face and jaw (as reported by patient).
Age: 64.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Chills, Dizziness, Injection site erythema, Injection site pain, Myalgia
Clinical narrative: 3pm 3/12/14 - HA tx - ADVIL. Evening 3/12/14 - pain at injection site, redness at injection site, nausea, (R) sided neck pain, body myalgias, chills, fever as high as 102.6 tx - ADVIL, dizziness, irregular breathing. 10am 3/13/14 - fever 100.4, soreness and redness at inj. site tx - ADVIL.
Age: 64.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Nausea, Neck pain, Pyrexia, Respiratory disorder
Clinical narrative: 3pm 3/12/14 - HA tx - ADVIL. Evening 3/12/14 - pain at injection site, redness at injection site, nausea, (R) sided neck pain, body myalgias, chills, fever as high as 102.6 tx - ADVIL, dizziness, irregular breathing. 10am 3/13/14 - fever 100.4, soreness and redness at inj. site tx - ADVIL.
Age: 1.01
Sex: F
Vaccine: DTAP, HEPA, HIBV, PNC13
Symptoms: Urticaria
Clinical narrative: 3/10/14 Developed urticarial rash at 9am. Diphenhydramine PO recommended.
Age: 21.0
Sex: M
Vaccine: FLUX
Symptoms: Pyrexia, Sneezing, Tenderness
Clinical narrative: Tenderness of the underarm (Same side as injection). Sneezing. Low Grade Fever.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling and heat over large area of arm where injection was administered.
Age: 0.74
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC13
Symptoms: Abdominal X-ray, Hypophagia, Pyrexia, Urine output decreased
Clinical narrative: 2-3 days of fever up to 105 degrees, decrease oral intake, decrease urine output.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Back pain, Burning sensation, Headache, Pyrexia
Clinical narrative: Burning down left arm, headache, fever, joint pain in ankles and back pain.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Angina pectoris, Aspartate aminotransferase normal, Blood albumin decreased, Blood immunoglobulin E normal, Forced expiratory volume
Clinical narrative: Within 24 hours of Fluzone quadrivalent vaccine administration, he developed severe hives, swelling, some fullness of the throat. No resp or GI. Hives have continued daily since then (4 months). Seen by allergy 12/3/13. To ER 12/8/13 for "heart pains," swelling and throat closing. Ruled out for myocardial infarction. Allergist rx Prednisone 12/9-14, Zyrtec, Zantac.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Forced vital capacity, Metabolic function test normal, Spirometry abnormal, Swelling, Throat tightness
Clinical narrative: Within 24 hours of Fluzone quadrivalent vaccine administration, he developed severe hives, swelling, some fullness of the throat. No resp or GI. Hives have continued daily since then (4 months). Seen by allergy 12/3/13. To ER 12/8/13 for "heart pains," swelling and throat closing. Ruled out for myocardial infarction. Allergist rx Prednisone 12/9-14, Zyrtec, Zantac.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Within 24 hours of Fluzone quadrivalent vaccine administration, he developed severe hives, swelling, some fullness of the throat. No resp or GI. Hives have continued daily since then (4 months). Seen by allergy 12/3/13. To ER 12/8/13 for "heart pains," swelling and throat closing. Ruled out for myocardial infarction. Allergist rx Prednisone 12/9-14, Zyrtec, Zantac.
Age: 0.98
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC
Symptoms: Febrile convulsion, Hypertonia, Muscle spasticity
Clinical narrative: Convulsion from fever.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Redness and warmth to injection site.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Dizziness, Dizziness postural, Musculoskeletal stiffness
Clinical narrative: Post-Medication Assessment performed by LPN at 4:13 PM. Adverse Reaction - After shot, pt stood up and needed to sit back down because he felt like he was going to faint, he then had a "stiffening event" but did not pass out. Monitored by Dr. and released after monitoring.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site pruritus, Vaccination site rash
Clinical narrative: The night of the vaccine the pt reported chills for 2 days. 3/13/2014 pt contacted clinic to report red raise itchy rash the size of her hand around the vaccine site.
Age: 35.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site swelling, Musculoskeletal pain, Neck pain, Pain in extremity, Paraesthesia
Clinical narrative: Swelling in area where administered and pain in the arm progressing to tingling and stabbing pain when the arm is touched or the fingers are moved. Finally started affecting the shoulder and neck on same side after Physician visit then went to emergency and release after 5 hours with pain medication. Pain still persist at the time of this report. Physician claims will take "couple" of days to clear.
Age: 35.0
Sex: F
Vaccine: DTAP
Symptoms: Ultrasound scan normal
Clinical narrative: Swelling in area where administered and pain in the arm progressing to tingling and stabbing pain when the arm is touched or the fingers are moved. Finally started affecting the shoulder and neck on same side after Physician visit then went to emergency and release after 5 hours with pain medication. Pain still persist at the time of this report. Physician claims will take "couple" of days to clear.
Age: 20.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Cellulitis, Dizziness, Feeling hot, Injection site pruritus
Clinical narrative: First felt "hot and dizzy" on 10 Mar.  Itchy at injection site on 12 Mar.  Dx's with cellulitis on 12 Mar and treated with Keflex.
Age: 2.0
Sex: F
Vaccine: HIBV, VARCEL
Symptoms: Blood creatinine decreased, Blood urea normal, Carbon dioxide decreased, Convulsion, Pyrexia
Clinical narrative: Convulsion and high fever.
Age: 32.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Induration, Pruritus
Clinical narrative: Redness, itching, induration.
Age: 89.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Local reaction, Pyrexia
Clinical narrative: Patient reported feeling feverish on 3/12/2014. Local reaction at site: erythema, warmth, tenderness.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Hyperhidrosis, Impaired work ability, Lethargy, Malaise
Clinical narrative: Felt lethargic, diaphoretic; didn't check temp.  Felt worse over the week, so called in sick 2/10, 2/11, tried to work 2/12, 2/13, and 2/14 but went home early all 3 days.  Felt back to normal 2/16.
Age: 50.0
Sex: F
Vaccine: MMR
Symptoms: Acupuncture, Asthenia, Autoimmune disorder, Balance disorder, Blindness
Clinical narrative: Stiff neck, headache, sore throat, fever, eyes hurt. Woke feeling ill. Stayed in bed all day, into the next day taking OTC medications for fever and pain. Symptoms increased resulting in doctor visit confirming case of measles. Subsequently mumps developed followed by rubella, which resulted in hospitalization. Vision loss and hearing loss, both permanent developed. Treatment in hospital was IV steroids, 1000 mg daily for eight days to stop or attempt to stop autoimmune reaction. Demyelination of nerves occurred in brain along with optic neuritis in right eye and vestibular neuritis in right ear. Rash, joint swelling, fever, head pain, fatigue, sensitivity to light, nausea, dizziness, light-headed, poor balance, poor appetite. Doctor prescribed medications for nerve pain, nausea, inner ear motion illness, depression, steroids. Acupuncture for symptoms. Physical therapy for weakness. Pain management for nerve pain. Follow-up doctor appointments with infectious disease, neuro-opthalmologist, optometrist, ENT, Occupational Medicine, Workmens Comp QME with neurologist, neurologist(s). Adverse symptoms remain constant with increasing weakness and body inflammation and overall pain. Symptoms mimic those of MS. Hearing aids have been prescribed. I remain off of work.
Age: 50.0
Sex: F
Vaccine: MMR
Symptoms: Blood test, Computerised tomogram head, Deafness, Decreased appetite, Demyelination
Clinical narrative: Stiff neck, headache, sore throat, fever, eyes hurt. Woke feeling ill. Stayed in bed all day, into the next day taking OTC medications for fever and pain. Symptoms increased resulting in doctor visit confirming case of measles. Subsequently mumps developed followed by rubella, which resulted in hospitalization. Vision loss and hearing loss, both permanent developed. Treatment in hospital was IV steroids, 1000 mg daily for eight days to stop or attempt to stop autoimmune reaction. Demyelination of nerves occurred in brain along with optic neuritis in right eye and vestibular neuritis in right ear. Rash, joint swelling, fever, head pain, fatigue, sensitivity to light, nausea, dizziness, light-headed, poor balance, poor appetite. Doctor prescribed medications for nerve pain, nausea, inner ear motion illness, depression, steroids. Acupuncture for symptoms. Physical therapy for weakness. Pain management for nerve pain. Follow-up doctor appointments with infectious disease, neuro-opthalmologist, optometrist, ENT, Occupational Medicine, Workmens Comp QME with neurologist, neurologist(s). Adverse symptoms remain constant with increasing weakness and body inflammation and overall pain. Symptoms mimic those of MS. Hearing aids have been prescribed. I remain off of work.
Age: 50.0
Sex: F
Vaccine: MMR
Symptoms: Depression, Dizziness, Eye pain, Fatigue, Headache
Clinical narrative: Stiff neck, headache, sore throat, fever, eyes hurt. Woke feeling ill. Stayed in bed all day, into the next day taking OTC medications for fever and pain. Symptoms increased resulting in doctor visit confirming case of measles. Subsequently mumps developed followed by rubella, which resulted in hospitalization. Vision loss and hearing loss, both permanent developed. Treatment in hospital was IV steroids, 1000 mg daily for eight days to stop or attempt to stop autoimmune reaction. Demyelination of nerves occurred in brain along with optic neuritis in right eye and vestibular neuritis in right ear. Rash, joint swelling, fever, head pain, fatigue, sensitivity to light, nausea, dizziness, light-headed, poor balance, poor appetite. Doctor prescribed medications for nerve pain, nausea, inner ear motion illness, depression, steroids. Acupuncture for symptoms. Physical therapy for weakness. Pain management for nerve pain. Follow-up doctor appointments with infectious disease, neuro-opthalmologist, optometrist, ENT, Occupational Medicine, Workmens Comp QME with neurologist, neurologist(s). Adverse symptoms remain constant with increasing weakness and body inflammation and overall pain. Symptoms mimic those of MS. Hearing aids have been prescribed. I remain off of work.
Age: 50.0
Sex: F
Vaccine: MMR
Symptoms: Hearing aid user, Impaired work ability, Inflammation, Inner ear disorder, Joint swelling
Clinical narrative: Stiff neck, headache, sore throat, fever, eyes hurt. Woke feeling ill. Stayed in bed all day, into the next day taking OTC medications for fever and pain. Symptoms increased resulting in doctor visit confirming case of measles. Subsequently mumps developed followed by rubella, which resulted in hospitalization. Vision loss and hearing loss, both permanent developed. Treatment in hospital was IV steroids, 1000 mg daily for eight days to stop or attempt to stop autoimmune reaction. Demyelination of nerves occurred in brain along with optic neuritis in right eye and vestibular neuritis in right ear. Rash, joint swelling, fever, head pain, fatigue, sensitivity to light, nausea, dizziness, light-headed, poor balance, poor appetite. Doctor prescribed medications for nerve pain, nausea, inner ear motion illness, depression, steroids. Acupuncture for symptoms. Physical therapy for weakness. Pain management for nerve pain. Follow-up doctor appointments with infectious disease, neuro-opthalmologist, optometrist, ENT, Occupational Medicine, Workmens Comp QME with neurologist, neurologist(s). Adverse symptoms remain constant with increasing weakness and body inflammation and overall pain. Symptoms mimic those of MS. Hearing aids have been prescribed. I remain off of work.
Age: 50.0
Sex: F
Vaccine: MMR
Symptoms: Malaise, Measles post vaccine, Multiple sclerosis, Mumps, Musculoskeletal stiffness
Clinical narrative: Stiff neck, headache, sore throat, fever, eyes hurt. Woke feeling ill. Stayed in bed all day, into the next day taking OTC medications for fever and pain. Symptoms increased resulting in doctor visit confirming case of measles. Subsequently mumps developed followed by rubella, which resulted in hospitalization. Vision loss and hearing loss, both permanent developed. Treatment in hospital was IV steroids, 1000 mg daily for eight days to stop or attempt to stop autoimmune reaction. Demyelination of nerves occurred in brain along with optic neuritis in right eye and vestibular neuritis in right ear. Rash, joint swelling, fever, head pain, fatigue, sensitivity to light, nausea, dizziness, light-headed, poor balance, poor appetite. Doctor prescribed medications for nerve pain, nausea, inner ear motion illness, depression, steroids. Acupuncture for symptoms. Physical therapy for weakness. Pain management for nerve pain. Follow-up doctor appointments with infectious disease, neuro-opthalmologist, optometrist, ENT, Occupational Medicine, Workmens Comp QME with neurologist, neurologist(s). Adverse symptoms remain constant with increasing weakness and body inflammation and overall pain. Symptoms mimic those of MS. Hearing aids have been prescribed. I remain off of work.
Age: 50.0
Sex: F
Vaccine: MMR
Symptoms: Nausea, Neuralgia, Nuclear magnetic resonance imaging brain, Optic neuritis, Oropharyngeal pain
Clinical narrative: Stiff neck, headache, sore throat, fever, eyes hurt. Woke feeling ill. Stayed in bed all day, into the next day taking OTC medications for fever and pain. Symptoms increased resulting in doctor visit confirming case of measles. Subsequently mumps developed followed by rubella, which resulted in hospitalization. Vision loss and hearing loss, both permanent developed. Treatment in hospital was IV steroids, 1000 mg daily for eight days to stop or attempt to stop autoimmune reaction. Demyelination of nerves occurred in brain along with optic neuritis in right eye and vestibular neuritis in right ear. Rash, joint swelling, fever, head pain, fatigue, sensitivity to light, nausea, dizziness, light-headed, poor balance, poor appetite. Doctor prescribed medications for nerve pain, nausea, inner ear motion illness, depression, steroids. Acupuncture for symptoms. Physical therapy for weakness. Pain management for nerve pain. Follow-up doctor appointments with infectious disease, neuro-opthalmologist, optometrist, ENT, Occupational Medicine, Workmens Comp QME with neurologist, neurologist(s). Adverse symptoms remain constant with increasing weakness and body inflammation and overall pain. Symptoms mimic those of MS. Hearing aids have been prescribed. I remain off of work.
Age: 50.0
Sex: F
Vaccine: MMR
Symptoms: Pain, Photophobia, Pyrexia, Rash, Rubella
Clinical narrative: Stiff neck, headache, sore throat, fever, eyes hurt. Woke feeling ill. Stayed in bed all day, into the next day taking OTC medications for fever and pain. Symptoms increased resulting in doctor visit confirming case of measles. Subsequently mumps developed followed by rubella, which resulted in hospitalization. Vision loss and hearing loss, both permanent developed. Treatment in hospital was IV steroids, 1000 mg daily for eight days to stop or attempt to stop autoimmune reaction. Demyelination of nerves occurred in brain along with optic neuritis in right eye and vestibular neuritis in right ear. Rash, joint swelling, fever, head pain, fatigue, sensitivity to light, nausea, dizziness, light-headed, poor balance, poor appetite. Doctor prescribed medications for nerve pain, nausea, inner ear motion illness, depression, steroids. Acupuncture for symptoms. Physical therapy for weakness. Pain management for nerve pain. Follow-up doctor appointments with infectious disease, neuro-opthalmologist, optometrist, ENT, Occupational Medicine, Workmens Comp QME with neurologist, neurologist(s). Adverse symptoms remain constant with increasing weakness and body inflammation and overall pain. Symptoms mimic those of MS. Hearing aids have been prescribed. I remain off of work.
Age: 50.0
Sex: F
Vaccine: MMR
Symptoms: Urine analysis, Vestibular neuronitis
Clinical narrative: Stiff neck, headache, sore throat, fever, eyes hurt. Woke feeling ill. Stayed in bed all day, into the next day taking OTC medications for fever and pain. Symptoms increased resulting in doctor visit confirming case of measles. Subsequently mumps developed followed by rubella, which resulted in hospitalization. Vision loss and hearing loss, both permanent developed. Treatment in hospital was IV steroids, 1000 mg daily for eight days to stop or attempt to stop autoimmune reaction. Demyelination of nerves occurred in brain along with optic neuritis in right eye and vestibular neuritis in right ear. Rash, joint swelling, fever, head pain, fatigue, sensitivity to light, nausea, dizziness, light-headed, poor balance, poor appetite. Doctor prescribed medications for nerve pain, nausea, inner ear motion illness, depression, steroids. Acupuncture for symptoms. Physical therapy for weakness. Pain management for nerve pain. Follow-up doctor appointments with infectious disease, neuro-opthalmologist, optometrist, ENT, Occupational Medicine, Workmens Comp QME with neurologist, neurologist(s). Adverse symptoms remain constant with increasing weakness and body inflammation and overall pain. Symptoms mimic those of MS. Hearing aids have been prescribed. I remain off of work.
Age: 91.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling at injection site which migrated distally with more redness, swelling, and heat at migratory site.
Age: 10.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Induration, Local swelling, Myalgia, Pain, Pain in extremity
Clinical narrative: Arm very swollen, size of softball, hard and very painful. Muscle pain and complaining of pain.