chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Acoustic stimulation tests abnormal, Hypoaesthesia, Tinnitus, Tympanometry normal
Clinical narrative: Information has been received from a nurse on 28-JAN-2015 referring to a 16 year old male patient with allergic rhinitis and no known drug reactions or allergies. The nurse was unsure of when the allergic rhinitis developed. The patient was vaccinated with the first and second doses of GARDASIL (lot number, dose and route were unknown) on 07-MAR-2013 and 19-SEP-2014, respectively and on 27-JAN-2015 the patient received the third 0.5 ml dose of GARDASIL (lot number K008931, expiration date 04-MAR-2017) intramuscularly. There were no concomitant medications. On 28-JAN-2015, the patient woke up in the morning and felt numbness in his right ear. Then after an hour the patient developed tinnitus in the right ear. The patient was seen by the physician the same day. A hearing tet and a tympanogram were done at the physician's office. The results of hearing test showed the patient's hearing was slightly abnormal in the right ear and the results of tympanogram were normal. No treatment was given for the patient. At the time of reporting, the patient had not recovered. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Pain, Pyrexia, Swelling, Tremor
Clinical narrative: Fever. Pain. Swelling. Shaking.
Age: 60.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Chills, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Fever, chills, pain and swelling right upper arm starting approximately 24 hr after injection.
Age: 49.0
Sex: M
Vaccine: ANTH
Symptoms: Pruritus generalised
Clinical narrative: The patient is a 51-year-old male with a history of medicine urticarial lesions temporally correlated with receipt of anthrax vaccine and relieved with BENADRYL. Per chart review the patient was seen at 1730 on the day of vaccine receipt, and in addition anthrax he also received a PPD. He presented with a complaint of generalized pruritus developing within 30 minutes of vaccine receipt but no urticarial lesions were observed. He had no other systemic symptoms and he was treated with diphenhydramine 50 mg IM and released.
Sex: M
Vaccine: HEPA
Symptoms: Incorrect product storage
Clinical narrative: This case was reported by a nurse and described the occurrence of incorrect storage of drug in a male patient who received HAVRIX. On an unknown date, the patient received HAVRIX at an unknown dose. On an unknown date, an unknown time after receiving HAVRIX, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. Additional information received: HAVRIX that was at 17 F was administered. No other information available. This case is one of the 2 cases reported by the same reporter for the same vaccine.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse concerning an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with improperly stored GARDASIL injection (route, dose, lot number and expiration date were not provided). Concomitant medications were not reported. No adverse effects were reported and there was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient medical history and drug reactions or allergies were not provided. On an unknown date, the patient was vaccinated with PROQUAD (Merck) (route, lot # and expiration date were not provided). Concomitant medication information was not provided. On an unknown date, the patient received PROQUAD (Merck) that was improperly stored. No adverse effects were reported. It was unknown if the patient sought medical attention. At the time of the report, the patient status was unknown. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: MMR
Symptoms: Adverse reaction
Clinical narrative: This spontaneous report was received from a consumer refers to an unspecified number of pubescent male patients of unspecified age. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with M-M-R II injection, (strength, dosage, route and lot# were not reported). Concomitant therapy was not reported. The consumer informed that on an unknown date an unspecified pediatrician told him that unspecified pubescent males experience more severe adverse reactions when given M-M-R II, also explained that the pediatrician told him that this experience was document in an unknown study. The outcome of the adverse reactions was unknown. Additional information is not expected because the reporter refused additional contact.
Sex: F
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age, Inappropriate schedule of drug administration
Clinical narrative: This case was reported by a consumer and described the occurrence of drug dose administration interval too long in a female patient who received DTaP vaccine. Co-suspect products included KINRIX. Previously administered products included DTaP, DTaP, DTaP and IPV. On an unknown date, the patient received DTaP vaccine. On 22nd August 2011, the patient received KINRIX. On an unknown date, an unknown time after receiving DTaP vaccine and KINRIX, the patient experienced drug dose administration interval too long and inappropriate age at vaccine administration. On an unknown date, the outcome of the drug dose administration interval too long and inappropriate age at vaccine administration were unknown.
Age: 25.0
Sex: M
Vaccine: HPV4
Symptoms: Ear pain, Oropharyngeal pain
Clinical narrative: This spontaneous report was received from a nurse practitioner via company representative refers to a 25 year old male patient. Medical history and concurrent conditions were not reported. On 06-FEB-2015 the patient was vaccinated with the first dose of GARDASIL injection, 0.5 ml, intramuscular (lot # and expiration date were not reported). Concomitant therapy was not reported. The nurse practitioner informed that on 07-FEB-2015 (also reported as "a day after") the patient developed left side throat and ear pain, the patient went to the urgent care and was prescribed prednisone, the patient returned back to the health care professional office on 09-FEB-2015 and complained of the same symptoms and he was given ciprofloxacin and unspecified pain medication. The outcome of the left sided throat and ear pain was unknown. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Peripheral swelling
Clinical narrative: Arm swelling, rash at injection site.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Skin warm
Clinical narrative: Reports on 2/18/15, she had itching at site of vaccination and felt some bumps on (L) upper arm. States she rubbed her arm/area and did not look at it. Reports on 2/19/15 after waking up, she looked at her arm and it is red and warm to the touch. States redness is from 1 inch below (L) shoulder down around muscle, reporting the whole upper arm. No treatment applied by client.Cleint state she has called her primary doctor and is going to go by there later today for them to look at it. States it does not hurt or is painful. 2/19/15 630 pm Phone call to client to follow-up after dr visit. Client states she did not go to her Primary dr. after all. Reports that she ran into one her friends and friend' daughter that is "higher than an RN." Said she had that nurse look at it and she told client that "it was from the shot and it looked like a normal reaction from pneumonia vaccine" and recommended BENADRYL. Client states she started taking BENADRYL po this afternoon.
Age: 24.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: Fever chills and fatigue from evening of 2/11/15 until 2/13/15.
Age: 28.0
Sex: F
Vaccine: MENB
Symptoms: Headache, Injection site erythema, Injection site swelling, Malaise, Nausea
Clinical narrative: Nausea, headache, general malaise (R) upper arm red and swollen, symptoms started a few hours after injection and then subsided within 3 days. Symptoms 2/10/15-2/13/15.
Age: 24.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Fatigue, Injection site erythema, Injection site swelling, Malaise
Clinical narrative: Chills, fatigue, site of injection red and swollen, general malaise several hours after injection and subsided completely 3 days later. Symptoms 2/10/15-2/13/15.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest pain, Dyspnoea, Electrocardiogram normal, Lip swelling, Mouth swelling
Clinical narrative: Approximately 3:15 pt returned back to office with c/o lips/mouth swelling and SOB and chest pain. Noted to have hives, O2 Sat 98%, EKG nl - BENADRYL 50mg IM given at 3:42 pm. TX to ER - given prednisone and albuterol neb. Contacted pt 2/17/2015 and she was much improved.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Approximately 3:15 pt returned back to office with c/o lips/mouth swelling and SOB and chest pain. Noted to have hives, O2 Sat 98%, EKG nl - BENADRYL 50mg IM given at 3:42 pm. TX to ER - given prednisone and albuterol neb. Contacted pt 2/17/2015 and she was much improved.
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and redness at injection sites on left arm. Started 2 days after vaccines.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Site of injection is red and swollen about 4 inches in diameter.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Pt had shingles outbreak on right buttock.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient presented to Clinic walk in for treatment. Injection site was red and warm to touch, pain, swelling. Dx: cellulitis. Plan: Treat with oral antibiotics, warm, moist compresses 2-4 times a day, rest and elevation.
Age: 1.18
Sex: F
Vaccine: HIBV, MMRV, PNC13
Symptoms: Body temperature increased, Chest X-ray, Febrile convulsion, Full blood count, Urine analysis
Clinical narrative: Febrile seizure lasting 10 mins. resolved without medications (temp 104).
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unspecified patients. Patients medical history and current condition was not reported. Since an unknown date the patients were vaccinated with improperly stored GARDASIL injection (unknown dose and frequency) (Lot number and expiry date not reported) and sterile diluents. No adverse effects reported. The outcome of the event was unknown. This is one of the two reports received from the same reporter. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient was diagnosed with shingles in his ear by PCP on 2/18/15.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster oticus, Insomnia
Clinical narrative: Patient was diagnosed with shingles in his ear by PCP on 2/18/15.
Age: 43.0
Sex: M
Vaccine: HEPA, IPV, TDAP, HEPA, IPV, TDAP
Symptoms: Pain, Pyrexia
Clinical narrative: Developed fever 2/19/15-6 AM-100.7 to 101.4. Mild achy feeling. No N/V/D.
Age: 1.45
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Injection site erythema, Injection site induration, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Pt received DTAP vaccine 2/16, no reaction noted in office at time vaccine was administered. Mom noted swelling, redness and heat at vaccine site on Tues, this worsened and mom called office Wed pm. Pt was seen Thurs. AM 2/29/15. Visit (L) thigh was noted to be warm with induration and some mild erythema under injection site from of leg noted, no signs of cellulitis noted, palpation of area reveals only non tenderness probable pertussis reaction mom advised to apply compress and will monitor.
Age: 39.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Paraesthesia, Throat tightness, Tremor
Clinical narrative: Pt reported shaking, teeth chattering, throat felt like it was closing then tingling approximately 20 minutes after inj. Taken to ER by ambulance where she was given Epinephrine and IV BENADRYL. Pt reports she never lost consciousness.
Age: 65.0
Sex: M
Vaccine: PNC13, VARZOS
Symptoms: Joint range of motion decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: 2/16/15 2 hrs after receiving injection, patient developed left arm pain and decreased motion. 2/18/15 patient evaluated by MD, exam shows pain at left shoulder with limited ROM due to pain, treatment: ibuprofen, ice/heating pad prn, rotator cuff exercises to aid w/ ROM. Follow up visit scheduled for 2/23/15.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Crying, Tremor
Clinical narrative: 3-4 hour after vaccination, child had inconsolable cry w/body shaking per mom. TYLENOL given and symptoms resolved about 2-3 h after.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Pain, Rash erythematous
Clinical narrative: Red sore bumps for 3 days right arm.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Injection site swelling, Musculoskeletal chest pain, Nausea, Swelling
Clinical narrative: Pt developed severe pain and swelling i(RA) in injection arm extending to chest wall requiring a visit and narcotic pain control also nausea.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: White blood cell count increased
Clinical narrative: Pt developed severe pain and swelling i(RA) in injection arm extending to chest wall requiring a visit and narcotic pain control also nausea.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Rash erythematous
Clinical narrative: Small amt redness around injection site 2 days post injection. Advised to use ice and take BENADRYL to decrease redness. 2 hours later red spots began to show up in other areas. Advised pt to call Dr immediately or go to ER. Dr called in prednisone.
Age: 51.0
Sex: F
Vaccine: MMR
Symptoms: Abdominal pain upper, Pyrexia, Rash generalised
Clinical narrative: Client was given MMR vaccine at a clinic. She was not ill at the time of injection 1/30/15. On 2/9/15, she began having stomach pains and fever. On 2/13/15, she developed a body rash. Client did begin taking a chemo cream EFUDEX on 2/6/15.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Platelet count decreased, Rash
Clinical narrative: Pain at injection site, redness, within the week, redness, pain, swelling from shoulder to elbow, by 1st evening was sore-to-touch, later in week, a rash on effected arm. Worst shot ever. Had CBC 11/19/14 Platelet count depressed (< 48,000 K/ul). Had CBC's 11/28/14, 12/8/14, 12/15/14, 1/2/15, 1/9/15, 1/16/15, 1/23/15, 1/30/15. Platelet count less than or equal to 48,000. Referred to Hematologist.
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Induration, Rash, Skin hyperpigmentation
Clinical narrative: Rash on chest, upper arms bilateral, 2MNS diameter. Hyperpigmentation and slight firmness upper rear left arm measures 2cm by 2cm diameter.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Rash and urticaria pruritus PREDNISON 5 MD UD, hydroxyzine 25 MG QID
Age: 12.0
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a currently 12 year old patient (gender was not reported). Information regarding drug reactions or allergies and medical history was not reported. The nurse reported that the patient received the first two doses of RECOMBIVAX HB 5mcg/0.5ml in 2002 and 2003 (exact dates not reported). The third dose of RECOMBIVAX HB 10 mcg/1ml was administered on 10-FEB-2015 (intramuscular, 1ml, anatomical location, lot#, expiration date were not reported). Concomitant therapies were not reported. No adverse effect was reported. 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 healthcare worker refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 08-JUL-2013 the patient was vaccinated with first dose of GARDASIL (dose/frequency: 0.5 ml) intramuscularly. On 09-JUL-2014, the patient was vaccinated with second dose and on 15-SEP-2014, the patient was vaccinated with third dose of GARDASIL. No adverse effect reported. No product quality complaint (PQC) was reported for GARDASIL. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a child patient of unknown gender. On 13-FEB-2015, the patient was vaccinated with a dose of VAQTA 0.5 ml, intramuscular which was expired on 24-JAN-2015 (lot number was not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions and allergies were not reported. On an unknown date, the patient received a dose of ZOSTAVAX (dose, route of administration, lot number and expiration date were not provided), that underwent a supported temperature excursion. No adverse experience was reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacy technician refers to a patient of unknown age and gender. Information about patient's medical history was not provided. On 17-FEB-2015, the patient was vaccinated with a dose of ZOSTAVAX (dose, frequency, indication, route of administration and lot # were not specified) which was improperly stored. No adverse effect was reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site rash
Clinical narrative: This spontaneous report as received from a physician refers to a 59 year old female patient. The patient's pertinent medical history included back pain and allergy to penicillin. On 14-FEB-2015, the patient was vaccinated with ZOSTAVAX lot # K018172, expiration date: 02-DEC-2015, 0.65 ml, subcutaneous for routine vaccination. Concomitant therapies included MEDROL. On 15-FEB-2015, less than 24 hours after receiving ZOSTAVAX, the patient developed an injection-site rash. The rash was described as painful, red, and slightly indurated. The patient did not received any treatment for the adverse event and no lab diagnostics studies were performed. The patient sought medical attention by contacted physician. The outcome of the event was reported as not recovered/not resolved. The relatedness between the event and the vaccination with ZOSTAVAX was not provided. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Extra dose administered
Clinical narrative: This spontaneous report was received from the patient's mother refers to her daughter a 17 month old female patient. Concurrent conditions, medical history and allergies were not reported. On an unknown date, the patient was vaccinated with a first dose of VARIVAX (Merck), (strength, dose, route, anatomical location, lot number and expiration date were not reported). It was reported that the patient received a second dose of VARIVAX (Merck) on an unknown date with 5 weeks between vaccinations. The reporter query if they should had another vaccination to maximize immunity. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: MMR
Symptoms: Injection site pain, Pruritus, Pyrexia, Rash generalised, Rash macular
Clinical narrative: MMR vaccine given 1-29-15. No prior MMR vaccination. 9 days later pt developed extensive rash over entire body with splotches on face. Mild fever, pain in knee/leg at injection site but no swelling or redness at the site. Rash now improved, still with pruritus.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Injection site rash
Clinical narrative: One day after patient received PNEUMOVAX 23 a rash was developed 3 inches below the injection site. Patient was advised to have BENADRYL 25 mg orally to relieve the symptom, and apply hydrocortisone 1% to rash area.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Swelling, red, itching treating with antibiotics.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling, Myalgia, Pyrexia
Clinical narrative: Fever x 2 days. Muscle pain (R) thigh. Redness and swelling (R) thigh with bruise.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning unspecified patients of unknown age and gender. On an unknown date, unspecified patients were vaccinated with multiple doses of (Oka/Merck) VARIVAX (dose, strength, route not reported, indication) which were all post supported temperature excursion. No adverse effects were reported by any patient. This is one of the several reports from the same reporter. (Linked to MARRS# 1502USA004718). Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Injection site discomfort, Injection site pain
Clinical narrative: Patient having discomfort and pain at injection right arm. Reported by patient at 9:10 am 2/18/2015. Started 24 hours previously. Claimed symptoms worsening. Advised if gets worse go to primary MD/ER.
Sex: F
Vaccine: DTAP, HIBV, PNC
Symptoms: Pyrexia, Tremor
Clinical narrative: Information has been received from a consumer referring to her daughter. In FEB-2006, at the same office visit 9 years ago, the patient was vaccinated with LIQUID PEDVAXHIB (lot #, expiration date, dose and route unspecified)0, DTaP (lot #, expiration date, dose and route unspecified) and PREVNAR (lot #, expiration date, dose and route unspecified). On an unknown date the patient developed high fever of three days as well as tremors that lasted for four months. The outcome of events was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. On 09-FEB-2015 the patient was vaccinated with a dose of VARIVAX (Merck), 0.5 ml, subcutaneously (lot# was not reported) which underwent a supported temperature excursion. No adverse experience was reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a pharmacist via company representative referring to two patients of unknown age and gender. The pertinent medical history and drug reactions or allergies were unspecified by the reporter. In the last two years, the two patients developed pain, erythema and swelling at the injection site within 2 days after administration of ZOSTAVAX. Both patients contacted the pharmacist and were referred to be evaluated by their unspecified physicians. Both patients were treated with unspecified antibiotic medication and recovered form the events. The causality of the events was unknown. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: Information has been received from a pharmacist referring to a 63 year old male patient. On 14-JAN-2015, the patient was vaccinated with a dose of ZOSTAVAX, (strength was not reported), (lot number was J016325 which was an invalid lot number for ZOSTAVAX, expiry date was reported as 24-DEC-2015), 0.65 ml, subcutaneously. On 14-JAN-2015, the patient experienced swelling at the injection site "as big as a baseball". The patient didn't seek medical attention. There were no lab diagnostics studies performed. On 19-JAN-2015, the swelling resolved without treatment. Additional information has been requested.
Age: 34.0
Sex: M
Vaccine: MMR
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a pharmacist on 11-FEB-2015 referring to a 34 year old male patient. On 10-FEB-2015 the patient received a dose of M-M-R II (route, lot number and dose were unknown). The patient called the pharmacy on 11-FEB-2015 and stated that he should have requested an unspecified meningitis vaccine not the M-M-R II vaccine. He stated that he requested the incorrect vaccine yesterday, 10-FEB-2015. No adverse effect reported. Additional information is not expected because the reporter did not want to be contacted.
Sex: U
Vaccine: DTAP, HEP, HEPA
Symptoms: Incorrect product storage
Clinical narrative: This case was reported by a nurse and described the occurrence of incorrect storage of drug in a patient who received ENGERIX B. Co-suspect products included HAVRIX and INFANRIX. On an unknown date, the patient received ENGERIX B at an unknown dose, HAVRIX at an unknown dose and INFANRIX at an unknown dose. On an unknown date, an unknown time after receiving ENGERIX B, HAVRIX and INFANRIX, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. Additional information received: Patients may have been given these vaccines that were exposed to temps above the range for 563 hrs (Still investigating).
Sex: M
Vaccine: HEPA
Symptoms: Incorrect product storage
Clinical narrative: This case was reported by a nurse and described the occurrence of incorrect storage of drug in a male patient who received HAVRIX. On an unknown date, the patient received HAVRIX at an unknown dose. On an unknown date, an unknown time after receiving HAVRIX, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unkonwn. Additional information received: HAVRIX that was at 17 F was administered. No other information available. This case is one of the 2 cases reported by the same reporter for the same vaccine.
Sex: M
Vaccine: DTAP, DTAPHEPBIP
Symptoms: Accidental overdose
Clinical narrative: This case was reported by a nurse and described the occurrence of accidental overdose in a 6-month-old male patient who received PEDIARIX (batch number L9L2K, expiry date 5th June 2016). Concomitant products included INFANRIX. On an unknown date, the patient received PEDIARIX. On an unknown date, an unknown time after receiving PEDIARIX, the patient experienced accidental overdose. On an unknown date, the outcome of the accidental overdose was unknown. Additional information received: A 6 month old was inadvertently given PEDIARIX and an additional dose of IPV on the same day. The lot # for the IPV is K1330-1 and EXP date: 6/20/2016.
Sex: F
Vaccine: FLU4
Symptoms: Adverse reaction
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of severe adverse reaction in a female subject of unspecified age who was vaccinated with FLUARIX QUADRIVALENT (GlaxoSmithKline). On an unspecified date, the subject received unspecified dose of FLUARIX QUADRIVALENT (unknown route, injection site and batch number). At an unspecified time after vaccination with FLUARIX QUADRIVALENT, the subject experienced severe adverse reaction. At the time of reporting, the outcome of the event was unspecified.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Extra dose administered
Clinical narrative: Combination vaccination MMR and Varicella given in addition to single dose of Varicella.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Diarrhoea
Clinical narrative: Combination vaccination MMR and Varicella given in addition to single dose of Varicella.
Age: 26.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Fatigue, Injected limb mobility decreased, Injection site erythema, Lymphadenopathy
Clinical narrative: Quarter size redness at injection site, moderate muscle aches in injection arm, swollen axillary lymph nodes in injection arm, difficulty lifting injection arm, chills, moderate fatigue.
Age: 26.0
Sex: F
Vaccine: PPV
Symptoms: Myalgia
Clinical narrative: Quarter size redness at injection site, moderate muscle aches in injection arm, swollen axillary lymph nodes in injection arm, difficulty lifting injection arm, chills, moderate fatigue.
Age: 1.01
Sex: M
Vaccine: FLU3, MMR, VARCEL
Symptoms: Autism, Feeling abnormal, Regressive behaviour
Clinical narrative: Patient was automatically in a daze from that day onward. He couldn't even find his mouth when he went to out food into his mouth that evening.
Age: 1.05
Sex: M
Vaccine: MMR
Symptoms: Convulsion, Crying, Emotional disorder, Head banging, Hypotonia
Clinical narrative: Screaming that could not be stopped. Shaking. Seizure without fever, and hitting his own head for more than three weeks after shot on 3/2011. He also has had years of diagnosed but unresolved swelling and pain. However night time is often the worst. He will cry out and wake sobbing in pain. This has been almost three years of night time pain in which we have sought help at several of the specialists at hospital. Loss of muscle tone and now physical delays.
Age: 1.05
Sex: M
Vaccine: MMR
Symptoms: Nuclear magnetic resonance imaging, Pain, Screaming, Sensory disturbance, Swelling
Clinical narrative: Screaming that could not be stopped. Shaking. Seizure without fever, and hitting his own head for more than three weeks after shot on 3/2011. He also has had years of diagnosed but unresolved swelling and pain. However night time is often the worst. He will cry out and wake sobbing in pain. This has been almost three years of night time pain in which we have sought help at several of the specialists at hospital. Loss of muscle tone and now physical delays.
Age: 1.05
Sex: M
Vaccine: MMR
Symptoms: Tremor
Clinical narrative: Screaming that could not be stopped. Shaking. Seizure without fever, and hitting his own head for more than three weeks after shot on 3/2011. He also has had years of diagnosed but unresolved swelling and pain. However night time is often the worst. He will cry out and wake sobbing in pain. This has been almost three years of night time pain in which we have sought help at several of the specialists at hospital. Loss of muscle tone and now physical delays.
Age: 0.95
Sex: M
Vaccine: DTAP
Symptoms: Injection site pain, Injection site reaction, Injection site swelling, Rash erythematous
Clinical narrative: Swelling of thigh (looked like entire quadriceps muscle was swollen) and red rash distal and medial to injection site, about 2.5 inches long and 2 inches wide.  Tenderness to the touch.
Age: 61.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Erythema, Extra dose administered, Injected limb mobility decreased, Pain in extremity, Syringe issue
Clinical narrative: This spontaneous report as received from a certified medical assistant (also reported as nurse) via a field representative refers to a 61 year old male patient. The patient's concurrent condition included diabetes. On 18-DEC-2014 (also reported as 18-DEC-2015) the patient was vaccinated with PNEUMOVAX 23, 0.5 ml dose (strength, route and lot number not specified). There was a failure with the needle syringe, resulting in the medicine leaking out and running down the patient's arm. The medical assistant and the physician were not sure if the patient got enough medicine so they re-administered a full dose of PNEUMOVAX 23. The patient was also given a flu shot, concomitantly in the opposite arm. On 15-JAN-2015, the patient went to the office complaining of arm pain. The medical assistant noticed mild redness on the arm as well. The patient sought medical attention - he was prescribed prednisone. The patient was still complaining of pain and had not been using his arm due to soreness (disability) and hence the physician recommended physical therapy. The patient had not recovered from the arm pain and redness in arm. Causality assessment was not provided. There was no product quality complaints (PQC) involved. Additional information has been requested.
Age: 0.36
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Crying, Fatigue, Hypotonia, Injection site erythema, Injection site reaction
Clinical narrative: Mother related in a text child was crying very hard would not bear weight on legs, and is very pale. Areas where shots were given were welts and were red and hot. Child's arms and legs were just limp. Color had come back some and child was whimpering and looked exhausted. Mother related giving Tylenol just before 7:00 pm. I called mother and child was getting color back and started to move arms. Mom related he seemed to get better more all the time we talked. Talked to mom this am at 8:30 and she related child nursed well throughout the night and had several stool diapers. Child is very warm this morning but had just given him Tylenol and he was laying on mat and playing like normal.
Age: 0.36
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Injection site warmth, Pallor, Skin warm, Urticaria, Weight bearing difficulty
Clinical narrative: Mother related in a text child was crying very hard would not bear weight on legs, and is very pale. Areas where shots were given were welts and were red and hot. Child's arms and legs were just limp. Color had come back some and child was whimpering and looked exhausted. Mother related giving Tylenol just before 7:00 pm. I called mother and child was getting color back and started to move arms. Mom related he seemed to get better more all the time we talked. Talked to mom this am at 8:30 and she related child nursed well throughout the night and had several stool diapers. Child is very warm this morning but had just given him Tylenol and he was laying on mat and playing like normal.
Age: 18.0
Sex: F
Vaccine: TDAP
Symptoms: Diarrhoea, Pyrexia, Vomiting, Wheezing
Clinical narrative: Severe, persistent vomiting, wheezing, diarrhea and high fever.
Age: 2.0
Sex: F
Vaccine: DTAP, PPV, VARCEL
Symptoms: Erythema, Induration, Nodule, Pyrexia, Skin warm
Clinical narrative: A hard knot developed. It is red and warm to the touch. She is also running a low grade fever.
Age: 0.57
Sex: M
Vaccine: DTAPIPVHIB, FLU3, HEP, PNC13, RV5, DTAPIPVHIB, FLU3, HEP, PNC13
Symptoms: Erythema, Swelling face, Urticaria
Clinical narrative: Swelling of the face. The Next Morning hives were seen all over the body and swelling to the face. Doctor administered Benadryl and steroids orally. 2 hours later, redness and hives disappeared. Around 8pm that night, couple dots of redness showed on the face. Again, the next morning baby had same symptoms. I gave him Benadryl and steroids again per doctor. I also gave him Benadryl every 6 hours prior.
Age: 0.57
Sex: M
Vaccine: DTAPIPVHIB, FLU3, HEP, PNC13, RV5, DTAPIPVHIB, FLU3, HEP, PNC13
Symptoms: Swelling face, Urticaria
Clinical narrative: Swelling of the face. The Next Morning hives were seen all over the body and swelling to the face. Doctor administered Benadryl and steroids orally. 2 hours later, redness and hives disappeared. Around 8pm that night, couple dots of redness showed on the face. Again, the next morning baby had same symptoms. I gave him Benadryl and steroids again per doctor. I also gave him Benadryl every 6 hours prior.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Injection site pain, Local reaction, Pain in extremity
Clinical narrative: Large local reaction on the arm; spreading erythema down the arm, painful; injection site very painful.
Sex: U
Vaccine: FLU4
Symptoms: Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: This case was reported by a pharmacist and described the occurrence of swelling injection site in an adult subject of unspecified gender who was vaccinated with FLUARIX, (GlaxoSmithKline). On an unspecified date, the subject received unspecified dose of FLUARIX (unknown route and injection site). On an unspecified date, 2 days after vaccination with FLUARIX, the subject experienced swelling injection site, injection site warmth and injection site hives. At the time of reporting, the events were improved. The pharmacist considered the events were probably related to vaccination with FLUARIX. This case is one of the 5 cases reported by the same reporter for the same vaccine.
Sex: U
Vaccine: FLUX
Symptoms: Unevaluable event
Clinical narrative: Initial unsolicited literature report received on 10 Feb 2015. Abstract: Introduction: Observational studies of influenza vaccine effectiveness often study persons seeking medical care for acute respiratory infection (ARI). We conducted a pilot study to determine if vaccine effectiveness could be estimated in the general population with a novel rolling cross-sectional survey sampling design and laboratory confirmation of influenza. Methods: Cross-sectional samples were selected weekly from defined populations from January through April, 2011 (12 weeks). Persons were telephoned and asked about the occurrence of ARI in the past week. Nasal and throat swabs were obtained from consenting individuals with ARI and tested by real-time reverse transcription polymerase chain reaction (RT-PCR). Vaccine effectiveness (VE) was defined as (100 x [1 OR]) for vaccination in a logistic regression model that adjusted for age, calendar week, and site. The comparison group included all study participants without RT-PCR confirmed influenza, including those who were not ill. Results: Study personnel contacted 9537 (62%) of 15,303 persons sampled; the primary analysis included 5678 subjects. Of these, 193 (3%) reported an ARI and agreed to be tested for influenza; 13 (7%) were influenza positive. The adjusted effectiveness of the influenza vaccine was 1% (95% confidence limits 239-70%). Conclusions: The rolling cross-sectional design is methodologically feasible and may be useful as a complement to clinic-based VE studies. This pilot study did not have sufficient power to detect significant vaccine effectiveness during a mild influenza season, but this approach may facilitate rapid estimation of VE in a pandemic setting when normal patterns of health care utilization are disrupted. It was reported that acute respiratory illness was identified in 94 patients, out of which 6 were influenza positive whose medical history and concomitant medication were not reported, had received a dose of Seasonal influenza vaccine (batch number, route and site of vaccination was not reported) on an unspecified date. On an unspecified date, 6 patients were identified as influenza vaccine positive. Corrective treatments and laboratory investigations were not reported. At the time of this report, the outcome of the event was reported as unknown. List of documents held by sender: None.
Sex: F
Vaccine: FLU3
Symptoms: Ageusia, Anosmia, Arthropathy, Body temperature abnormal, Decreased vibratory sense
Clinical narrative: Upon follow-up information received on 13 February 2015, the case was upgraded from non-serious to serious. Initial unsolicited report received from a healthcare professional on 09 February 2015. A patient, whose age, gender, concomitant medications was not reported and medical history was unknown, had received a dose of FLUZONE (batch number, dose, dose in series, route of administration and site of administration was not reported) on unspecified date. On an unknown date, 90 hours after vaccination, the patient may had experienced neurological symptoms. The patient had required ER/doctor visit. Laboratory investigations and corrective treatments were not reported. At the time of this report the outcome of event was unknown. Follow-up information received for this unsolicited case from a healthcare professional on 13 February 2015: The patient was a female. Lot number for the dose of FLUZONE received was UH745AD. The working diagnosis for the patient was reported to be "global altered sensory disease", which was characterized by loss of taste/smell, altered body temp, decreased sweating, diminished pin prick sensation, prominent loss of vibration sense, and joint position. Apparently onset of symptoms began within 12 hours of vaccination and got progressively worse since. Of note, during the course of her illness, the patient was diagnosed with severe depression (has had suicidal attempts x 4 and Electroconvulsive (ECT) treatments x 15). Case was upgraded to serious. Patient's outcome was not reported. Documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Depression, Electroconvulsive therapy, Hypohidrosis, Neurological symptom, Sensory disturbance
Clinical narrative: Upon follow-up information received on 13 February 2015, the case was upgraded from non-serious to serious. Initial unsolicited report received from a healthcare professional on 09 February 2015. A patient, whose age, gender, concomitant medications was not reported and medical history was unknown, had received a dose of FLUZONE (batch number, dose, dose in series, route of administration and site of administration was not reported) on unspecified date. On an unknown date, 90 hours after vaccination, the patient may had experienced neurological symptoms. The patient had required ER/doctor visit. Laboratory investigations and corrective treatments were not reported. At the time of this report the outcome of event was unknown. Follow-up information received for this unsolicited case from a healthcare professional on 13 February 2015: The patient was a female. Lot number for the dose of FLUZONE received was UH745AD. The working diagnosis for the patient was reported to be "global altered sensory disease", which was characterized by loss of taste/smell, altered body temp, decreased sweating, diminished pin prick sensation, prominent loss of vibration sense, and joint position. Apparently onset of symptoms began within 12 hours of vaccination and got progressively worse since. Of note, during the course of her illness, the patient was diagnosed with severe depression (has had suicidal attempts x 4 and Electroconvulsive (ECT) treatments x 15). Case was upgraded to serious. Patient's outcome was not reported. Documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Sensory loss, Suicide attempt
Clinical narrative: Upon follow-up information received on 13 February 2015, the case was upgraded from non-serious to serious. Initial unsolicited report received from a healthcare professional on 09 February 2015. A patient, whose age, gender, concomitant medications was not reported and medical history was unknown, had received a dose of FLUZONE (batch number, dose, dose in series, route of administration and site of administration was not reported) on unspecified date. On an unknown date, 90 hours after vaccination, the patient may had experienced neurological symptoms. The patient had required ER/doctor visit. Laboratory investigations and corrective treatments were not reported. At the time of this report the outcome of event was unknown. Follow-up information received for this unsolicited case from a healthcare professional on 13 February 2015: The patient was a female. Lot number for the dose of FLUZONE received was UH745AD. The working diagnosis for the patient was reported to be "global altered sensory disease", which was characterized by loss of taste/smell, altered body temp, decreased sweating, diminished pin prick sensation, prominent loss of vibration sense, and joint position. Apparently onset of symptoms began within 12 hours of vaccination and got progressively worse since. Of note, during the course of her illness, the patient was diagnosed with severe depression (has had suicidal attempts x 4 and Electroconvulsive (ECT) treatments x 15). Case was upgraded to serious. Patient's outcome was not reported. Documents held by sender: none.
Age: 14.0
Sex: F
Vaccine: FLU3, HPV4, MNQ, TDAP
Symptoms: Rash generalised
Clinical narrative: RASH OVER ENTIRE BODY THAT WAS INCREASING IN SIZE. MOM BROUGHT HER TO CLINIC FOR US TO SEE. ADVISED MOM TO TAKE HER TO THE DOCTOR RIGHT AWAY OR THE EMERGENCY ROOM IF RASH GOT WORSE.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Mobility decreased, Musculoskeletal stiffness, Peripheral swelling, Pruritus
Clinical narrative: Arm swollen from shoulder to elbow- severe swelling (looked like "Popeye").  Swelling continued for 3 days.  Red skin shoulder to elbow.  Then turned yellow after 3-4 days.  Painful to the touch.  Stiff arm, lack of flexibility.  Itching.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Tenderness, Yellow skin
Clinical narrative: Arm swollen from shoulder to elbow- severe swelling (looked like "Popeye").  Swelling continued for 3 days.  Red skin shoulder to elbow.  Then turned yellow after 3-4 days.  Painful to the touch.  Stiff arm, lack of flexibility.  Itching.
Age: 25.0
Sex: M
Vaccine: PPV
Symptoms: Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Induration, pain and heat at site of administration.
Age: 0.34
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Intussusception, Surgery, Ultrasound abdomen abnormal
Clinical narrative: Surgical procedure to correct intussusception.
Age: 71.0
Sex: M
Vaccine: MMR
Symptoms: Arthralgia, Joint swelling
Clinical narrative: Both knees ached and became swollen and has continued to this date with the recent addition of both wrists hurting.
Age: 1.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: 104 degree fever. Fever lasted 48 hours.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 15-SEP-2014, the patient ws vaccinated with (Oka/Merck) VARIVAX (dose strength and route was not reported) (lot # J014131 and expiry date: 07-NOV-2015, reported as 01-JUL-2015) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting (Oka/Merck) VARIVAX, nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for (Oka/Merck) VARIVAX. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Body temperature increased, Injection site erythema, Injection site pain
Clinical narrative: Started with some erythema and tenderness around injection site of Pneumovax23. By 24 hours after injection had temp of 102° and the redness extended in a 6" diameter around injection site.
Age: 1.53
Sex: M
Vaccine: DTAP, FLU4, HEPA
Symptoms: Wrong drug administered
Clinical narrative: I administered what I believed to be DTaP #4 , however previously a DTaP/IPV had been inappropriately given at another facility.
Age: 4.0
Sex: M
Vaccine: DTAP, MMRV
Symptoms: Pruritus, Swelling, Urticaria, Wheezing
Clinical narrative: Hives, itching, swelling, wheezing.
Age: 1.14
Sex: F
Vaccine: DTAPHEPBIP, HIBV, MMR, PNC13, VARCEL
Symptoms: Death, Resuscitation
Clinical narrative: Patient had alarms last night (02/19/2015), mother tried to stimulate and called 911. EMT's arrived and began transport to hospital, but patient arrested and was not able to be resuscitated in ED.
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Crying, Insomnia, Irritability, Pyrexia, Somnolence
Clinical narrative: Took to urgent care on 2/6. Was vomiting. Falling asleep and had fever of 103.