chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a physician refers to unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with VARIVAX (Merck) (dose, frequency, lot# J012252 and expiration date 01-OCT-2015. On unknown date the patients experienced redness and swelling at the injection site. The physician believes most of the phone calls she received from the parents of children (who were vaccinated) are actually the usual type of reactions, which happen after a vaccination. The physician wanted to under if what she heard from parents concerning the injection side effects, their children had experienced, were worse than what was listed in the Prescribing Information, for frequently reported events. The physician stated she had not received any information from the company. The physician has no patient identifiers to share. The outcome of redness and swelling at the injection site was unknown. Causality was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Local swelling, Paraesthesia, Rash erythematous
Clinical narrative: Pt. states 2 days later noted all over both legs red pin-prickly rash with both feet swelling. Dermatologist 9/23/14 sts rxn to flu shot. Pt bought OTC CLARITIN for immune response.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Tremor
Clinical narrative: Pt received immunization in office, after 40-45 minutes, was at home called with chills, "shaking like a leaf".
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age. No current condition was reported. No historical medication was reported. Approximately in 2014, the patient was vaccinated with PNEUMOVAX 23 lot # J004387, expiration date- 04-JAN-2015 (dose strength and route was not reported). No concomitant medication was reported. Nurse stated that an unspecified number of patients received (unspecified doses in series) PNEUMOVAX 23 that was stored at 47F for 120 hours. Nurse also reported that temperature issue occurred on 29-JUN-2014 through 03-JUL-2014 so doses administered somewhere after 04-JUL-2014 and 23-SEP-2014. The outcome of PNEUMOVAX 23 stored at 47F for 120 hours was unknown. This is one of the several reports. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. No current condition was reported. No historical medication was reported. Approximately in 2014 the patient was vaccinated with M-M-R II lot # J010208, expiration date- 23-FEB-2015 (dose strength and route was unknown). No concomitant medication was reported. Nurse stated that an unspecified number of patients received (unspecified doses in series) M-M-R II that was stored at 47F for 120 hours. Nurse also reported that temperature issue occurred on 29-JUN-2014 through 03-JUL-2014 so doses administered somewhere after 04-JUL-2014 and 23-SEP-2014. The outcome of M-M-R II stored at 47F for 120 hours was unknown. This is one of the several reports. Additional information has been requested.
Age: 83.0
Sex: M
Vaccine: FLU3
Symptoms: Bone pain, Headache, Tremor
Clinical narrative: Pt called on 9/13 complaining of all his bones in body hurting. Lots of shaking on arms and legs. He also complained of a headache. He was given flu shot on 9/12/14 at 420 pm and by 8 pm was experiencing symptoms.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pyrexia
Clinical narrative: Pt stated she had reaction 3 hrs after the vaccine. Pt stated the area became red and a fever of 103. The red area increased in size.
Sex: U
Vaccine: MMR, MMRV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No pertinent medical history or drug reactions/allergies were provided. The nurse reported that, on 18-SEP-2014, the patient inadvertently received both MMR II (lot number not reported), 0.5 ml, subcutaneous, and (Oka-Merck) PROQUAD (dose, route and lot number not reported). No symptoms were reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 23-SEP-2014 the patient was vaccinated with an expired dose of PNEUMOVAX 23  (lot # J006242, expiration date 03-AUG-2014), 0.5 ml, intramuscular. No adverse events were reported. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. No pertinent medical history or drug reactions/allergies were provided. On 18-SEP-2014, the patient was vaccinated with PNEUMOVAX 23 inj (lot # J005067, expiration date 17-JAN-2015), 0.5 ml dose, once, intramuscular in the deltoid. No co-suspect or concomitant therapies were provided. On 18-SEP-2014, after the administration of PNEUMOVAX 23 was done, the patient experienced soreness and swelling at the injection site. The pharmacist reported that they put an icepack on the injection site and provided ibuprofen and this treatment made the events improve. The patient sought medical attention while still at the office, the patient sought no further medical attention. At the time of the report, the patient was recovering from the adverse events. Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Asthenia, Dehydration, Injection site mass
Clinical narrative: 9/13/14 - Vaccine administered, 9/14 - Lump at site of administration (LA), 9/15 - weak, went to ER. Fluids were administered for dehydration 9/19/14 - Symptoms resolved accept for lump still at administration site (LA).
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Hot flush, Influenza like illness, Rash, Throat tightness
Clinical narrative: Patient woke up in the middle of the night. Aprox 12 hours later with flu like symptoms. Felt tired next day, developed rash on neck, hot flashes, throat tightness around 24 hrs later. Went to ER around 6 pm. Received fluids and BENADRYL.
Age: 27.0
Sex: M
Vaccine: SMALL
Symptoms: Arthralgia, Blood uric acid increased, Bunion, Cellulitis, Gout
Clinical narrative: This 27 year old received primary SPV on 8/1/2014. Approximately 8/18/2014 he began to notice single red dots to his chest and right arm (SPV given to left deltoid). These "mosquito bite" like dots did itch. He denied any other lesions, macules or skin rashes, no chest pain, breathing difficulty, arthralgia, myalgia, headaches or other systemic reactions. His SPV site was still moist with gray like edges and a dark center. On 8/20/2014 these red dots spread to bilateral legs and fingers. The macules to his right upper chest seemed patchy but he had been scratching the site. There were no lesions to palms of hands or soles of feet with no systemic symptoms. He presented to nearby ER on 8/20/2014 after awakening with left ankle pain and pain to his great toe. He recalls being told his x-rays were negative and labs ("inflammatory studies") were borderline and to see a rheumatologist but he could have a bunion and his ankle may have cellulitis. He was prescribed BACTRIM for his "cellulitis", a tapering dose of prednisone (60-50-40-etc) for the rash and tramadol for the pain. On 8/21/, 8/25 and 8/29/2014 he reported his rash stabilized and was resolving (1-3 macules on arms/hands/legs). He had followed up with rheumatologist and was advised his red left ankle and later toe was diagnosed as gout (confirmed elevated uric acid). His SPV site was drying and beginning to scab after leaving open to air (while alone).
Age: 27.0
Sex: M
Vaccine: SMALL
Symptoms: Injection site discolouration, Injection site scab, Laboratory test normal, Pain in extremity, Rash erythematous
Clinical narrative: This 27 year old received primary SPV on 8/1/2014. Approximately 8/18/2014 he began to notice single red dots to his chest and right arm (SPV given to left deltoid). These "mosquito bite" like dots did itch. He denied any other lesions, macules or skin rashes, no chest pain, breathing difficulty, arthralgia, myalgia, headaches or other systemic reactions. His SPV site was still moist with gray like edges and a dark center. On 8/20/2014 these red dots spread to bilateral legs and fingers. The macules to his right upper chest seemed patchy but he had been scratching the site. There were no lesions to palms of hands or soles of feet with no systemic symptoms. He presented to nearby ER on 8/20/2014 after awakening with left ankle pain and pain to his great toe. He recalls being told his x-rays were negative and labs ("inflammatory studies") were borderline and to see a rheumatologist but he could have a bunion and his ankle may have cellulitis. He was prescribed BACTRIM for his "cellulitis", a tapering dose of prednisone (60-50-40-etc) for the rash and tramadol for the pain. On 8/21/, 8/25 and 8/29/2014 he reported his rash stabilized and was resolving (1-3 macules on arms/hands/legs). He had followed up with rheumatologist and was advised his red left ankle and later toe was diagnosed as gout (confirmed elevated uric acid). His SPV site was drying and beginning to scab after leaving open to air (while alone).
Age: 27.0
Sex: M
Vaccine: SMALL
Symptoms: Rash pruritic, X-ray normal
Clinical narrative: This 27 year old received primary SPV on 8/1/2014. Approximately 8/18/2014 he began to notice single red dots to his chest and right arm (SPV given to left deltoid). These "mosquito bite" like dots did itch. He denied any other lesions, macules or skin rashes, no chest pain, breathing difficulty, arthralgia, myalgia, headaches or other systemic reactions. His SPV site was still moist with gray like edges and a dark center. On 8/20/2014 these red dots spread to bilateral legs and fingers. The macules to his right upper chest seemed patchy but he had been scratching the site. There were no lesions to palms of hands or soles of feet with no systemic symptoms. He presented to nearby ER on 8/20/2014 after awakening with left ankle pain and pain to his great toe. He recalls being told his x-rays were negative and labs ("inflammatory studies") were borderline and to see a rheumatologist but he could have a bunion and his ankle may have cellulitis. He was prescribed BACTRIM for his "cellulitis", a tapering dose of prednisone (60-50-40-etc) for the rash and tramadol for the pain. On 8/21/, 8/25 and 8/29/2014 he reported his rash stabilized and was resolving (1-3 macules on arms/hands/legs). He had followed up with rheumatologist and was advised his red left ankle and later toe was diagnosed as gout (confirmed elevated uric acid). His SPV site was drying and beginning to scab after leaving open to air (while alone).
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with GARDASIL. Dose, route, lot number and expiration date were not reported. The nurse reported that unspecified number of patients may have received GARDASIL outside the schedule listed in the prescribing information. No known adverse effects. This is one of two reports from the same source (other case # 1409USA008890). Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pruritus generalised, Rash, Skin warm, Swelling
Clinical narrative: -Had rash/swelling/pain and warm to touch -> treated w/BENADRYL (lasted 10 days) -Still has itching all over body and treating w/BENADRYL.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Cold sweat, Feeling hot, Headache, Hyperhidrosis, Nausea
Clinical narrative: Nausea, headache, felt hot, throat felt tight/swollen. Patient was clammy and diaphoretic.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Pharyngeal oedema, Throat tightness
Clinical narrative: Nausea, headache, felt hot, throat felt tight/swollen. Patient was clammy and diaphoretic.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Nodule, Throat tightness
Clinical narrative: Flu shot given 9/9/14 around 11AM. At 1300 sent to ED for possible allergic reaction. S/S: Knot in throat, progressively getting tighter since shot. Stable at time of triage to ED w/ symptom staying the same. Dc'd home w/ follow-up. Stable condition.
Sex: F
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a nurse to a female patient of unknown age. Medical history and concurrent conditions were not reported. On 06-JUN-2013 the patient was vaccinated with GARDASIL, intramuscular. Lot number and expiration date were not reported. Other suspect therapies included CERVARIX. Lot number and expiration date were not reported. The patient received CERVARIX on 13-JAN-2013. She received GARDASIL on 06-JUN-2013 and on 10-SEP-2014. No known adverse effects. This is one of two reports from the same source (other case # 1409USA013045). Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Rash, Skin warm
Clinical narrative: Patient developed rash on arm 5 days after vaccination. Pt states that it is just warm and not painful or itchy.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Anxiety, Feeling abnormal, Injection site erythema, Pain in extremity, Throat tightness
Clinical narrative: 20 seconds later, felt tight throat and "funny" feeling, had left pharmacy Rx. 30 seconds - arm sore, felt anxious. 45 seconds - had to clear throat often, took ALLEGRA allergy pill. Called Dr. told if got worse go to ER. 1 hour later, also felt tingling up arm (L) and down (L) leg. Felt better after 2 hours. Large red mark at injection site.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and unknown gender. Pertinent medical history, drug reactions or allergies were not reported. On 09-SEP-2014 the patient was administered with an expired dose of PNEUMOVAX 23 lot # J009827, expiration date 10-AUG-2014 (dose, dose number, route and anatomical location were unspecified). No adverse effect reported. No concomitant therapies were reported. The outcome of the event was unknown. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Discomfort, Swelling
Clinical narrative: He started complaining of discomfort after he got the vaccine, then noticed swelling the following morning after waking up. He denies fever, chills, n/v/d, redness or itchiness in the site.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. No medical history or concurrent conditions were reported. On 24-SEP-2014, the patient was vaccinated with PNEUMOVAX 23, 0.5 ml, intramuscular route (lot # reported as J009027; Exp. Date: 10-AUG-2014). No co-suspect or concomitant therapies were reported. The dose that the patient received was expired. No adverse effects reported. Additional information has been requested.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test, Unevaluable event
Clinical narrative: None stated.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a female patient of unknown age. Pertinent medical history, drug reactions or allergies were not reported. On an unknown date, a few months ago, the patient was vaccinated with ZOSTAVAX, 1 injection, (dose, dose number, route, anatomical location, lot number and expiration date were unspecified). No concomitant therapies were reported. On an unknown date, a few months ago, the patient "had come down with a bad case of shingles". An unknown topical cream and antiviral medication was given for the adverse event. The outcome of "had come down with a bad case of shingles" was unknown. The relatedness between shingles and ZOSTAVAX was not reported. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema
Clinical narrative: Redness x 2 weeks.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to unspecified number of patients of unknown ages and genders. On unspecified dates in 2014, doses of RECOMBIVAX HB (Lot# and expired date unspecified) and other vaccines (captured in MARRS 1409USA008659, 1409USA008512, 1409USA006676, 1409USA008510, 1409USA008511, 1409USA008514) were administered to unspecified patients (dose, frequency and route unspecified) after exposed to temperatures of 10 C degree for 37.5 hours/ temperature excursions on 08-AUG-2014, 13-AUG-2014 and 28-AUG-2014. No adverse effect has been reported. This is of the several reports from the same source. Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Nausea, Pyrexia, Rash, Vomiting
Clinical narrative: Large rash 20cm right arm, fevers, chills, nausea, vomiting.
Age: 57.0
Sex: M
Vaccine: PPV
Symptoms: Dysgeusia, Headache, Paraesthesia, Sensation of heaviness
Clinical narrative: Headache and metallic taste, tingling and heaviness of limbs.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Lip swelling, Paraesthesia, Paraesthesia oral, Urticaria
Clinical narrative: Within 3 minutes of flu shot administration patient complained of tingling lips which appeared to be swollen. Symptoms progressed to tingling hands and hives over five minutes. Patient was given one BENADRYL 50mg capsule at 11:50AM and taken to the emergency room.
Age: 0.16
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Urticaria
Clinical narrative: Developed urticarial rash about 24 hrs after vaccines were given and about 8 hrs after dose of TYLENOL.
Age: 68.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Dizziness, Injection site swelling, Nausea, Vomiting
Clinical narrative: Patient had TDaP and Pneumococcal vaccine on 07/28/14, noticed swelling at the injection site next day, today (7/30/14) swelling has improved but moved to the elbow. Also feels nausea, had vomited x 1 and felt dizzy. Denies any sob, fever, chills. Dizziness, nausea, vomiting and injection site swelling, arm swelling. CIPROFLOXACIN 500 mg BID, Ibuprofen 600 mg TID
Age: 40.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Erythema multiforme, Rash
Clinical narrative: Rash, erythema multiform and cellulitis. Treatment: Amoxicillin/Clavulanate
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Joint range of motion decreased, Mobility decreased, Myalgia, Sleep disorder
Clinical narrative: Patient complained 9/24/14 to employee health services that she experienced muscle pain and loss of mobility of her arm after receiving the injection. The pain was intense enough that she could not sleep on her left side. She could not raise her arm past 45 degrees shoulder flexion.
Age: 1.04
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Rash
Clinical narrative: Rash covering 90% of body and 102 degree fever. Possible egg allergy - doing testing.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Dyspepsia
Clinical narrative: Patient called several hours later and said she had heartburn/chest pain. Pt was told to seek medical care immediately. Most likely not caused by vaccine.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Eye irritation, Headache
Clinical narrative: Patient reports getting cold chills, headache, burning sensation in eyes.
Sex: F
Vaccine: VARZOS
Symptoms: Nodule, Pruritus
Clinical narrative: This spontaneous report as received from a non-pregnant nurse (age unspecified) via a company representative refers to herself. Information about concurrent conditions, concomitant medication and medical history was not provided. "Last week", on an unspecified date of September 2014, the patient was vaccinated with a dose of ZOSTAVAX, (lot#, dose and route were not provided). And the patient experienced a "knot" in her arm which was itched on an unknown date of September 2014. No treatment was given for the adverse events. The outcome of the events was reported as recovering. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: This spontaneous report as received from a health care worker refers to 2 unspecified patients of unknown demographics. No information about medical history, drug reactions and allergies was specified. On an unknown date the patients were vaccinated with PNEUMOVAX 23 (unspecified lot# and expiration date, route, dose not reported). No concomitant medications were reported. The reporter states that she remembers reporting this to Merck "years ago" and requesting a lot# check because the unspecified patients developed fever and redness and swelling at the injection site after receiving PNEUMOVAX 23. The outcome of the events and causality is unknown. This is one of the 3 cases reported by the same reporter (same reporter link: 1409USA010810 and 1409USA012530). Additional information has been requested.
Sex: U
Vaccine: FLU3, PPV
Symptoms: Pyrexia
Clinical narrative: This spontaneous report as received from a healthcare worker refers to three unspecified patients of unknown demographics. No information about medical history, drug reactions or allergies were specified. On an unknown date in 2013 (reported as "last year" on unspecified dates) the three unspecified were vaccinated with PNEUMOVAX23 (lot #, dose, route not reported) and FLUVIRIN (manufacturer: Novartis) concomitantly. The healthcare worker reported that on an unknown date in 2013, "last year" on unspecified dates, three unspecified patients developed fevers after receiving the doses of suspect vaccine. The outcome of the events is unknown. The causality of the event was not specified by the reporter. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a female patient of unknown age. The patient had thyroid disorder reported as medical history. No information about medical history, drug reactions and allergies was specified. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (unspecified lot# and expiration date, dose and route not specified), dose 1. Concomitant medications included SYNTHROID. The healthcare worker reported that she "thinks" that she reported to Merck "about 5 or 6 years ago" that patient developed an adverse reaction (fever and redness and swelling at the injection site) after receiving PNEUMOVAX 23. Unable to find original service request. She states that she remembers reporting this to Merck "years ago" and requesting a lot# check because two other unspecified patients at that time also developed an adverse reaction to the same unspecified lot #. She requested that someone from safety contact her back as soon as possible with information in regards to if there is a report about this patient, from "5 or 6 years ago". She states that she can be reached at her phone number. The healthcare worker also reported that on 17-SEP-2014, this patient received a dose of PNEUMOVAX 23 (lot#J015868 and expiration: 25-FEB-2014, dose and route not specified) (healthcare worker thinks that this is the patient's second dose). And, a "couple of hours later" after receiving PNEUMOVAX 23, she developed a fever and redness and swelling at the injection site. The healthcare worker also reports that the patient is the wife of the physician so the physician examined the reaction on 17-SEP-2014 (the patient sought medical attention). The healthcare worker states that the physician said that the swelling has "spread" since an unspecified date and looks like cellulitis. There was no product quality complaint. The outcome of the events is unknown. The causality of the events was not specified by the reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. On 30-DEC-2010, the patient was vaccinated with the first dose of VAQTA (dose, route and lot # not reported) and received the second dose of VAQTA (dose, route and lot # not reported) too early, in approximately April 2011, at 4 months and 4 days after receiving the first dose. No adverse effects were reported. Additional information is not expected. The reported did not want to be contacted.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 13-SEP-2014, the patient was vaccinated with PNEUMOVAX 23 intramuscular, expiration date 22-AUG-2014 (dose, strength, frequency and lot number were not reported). Secondary and concomitant therapies were not reported. On 13-SEP-2014, a dose of PNEUMOVAX 23 which was expired (on 22-AUG-2014) was inadvertently administered to patient. No adverse effects reported. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 70 year old female patient. The patient's pertinent medical history, drug reactions/allergies were not provided. Three or four years ago, approximately in 2010, the patient was vaccinated with a dose of ZOSTAVAX (route, lot number and expiration date were not provided). Co-suspect therapy and concomitant medications were not provided. It was reported that last year, in 2013 the patient was diagnosed with a mild case of shingles. It was unspecified if patient received any treatment for the event, or if the patient performed any lab diagnostic test. On an unspecified date, the patient recovered from adverse event. The relatedness between the event and suspect therapy was not provided. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. On an unknown date in 2014, PROQUAD (Merck) underwent a temperature excursion. On 26-AUG-2014, the patient was vaccinated with PROQUAD (Merck) 0.5 ml, subcutaneous. No adverse effect reported. This is one of several reports report form the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. On an unknown date in 2014, GARDASIL underwent a temperature excursion. On 27-AUG-2014, the patient was vaccinated with GARDASIL, 0.5 ml, intramuscular. No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. On an unknown date in 2014, PROQUAD underwent a temperature excursion. On 21-AUG-2014, the patient was vaccinated with PROQUAD 0.5 ml, subcutaneous. No adverse effect reported. This is one of several reports report 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 was received from a registered nurse refers to a patient of unknown age and gender. On an unknown date in 2014, VARIVAX, underwent a temperature excursion. On 27-AUG-2014, the patient was vaccinated with VARIVAX, 0.5 ml, subcutaneous. No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received form a registered nurse refers to a patient of unknown age and gender. On an unknown date in 2014, GARDASIL underwent a temperature excursion. On 11-AUG-2014, the patient was vaccinated with GARDASIL, 0.5 ml, intramuscular. No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. On an unknown date in 2014, (Oka-Merck) PROQUAD underwent a temperature excursions. On 26-AUG-2014, the patient was vaccinated with (Oka-Merck) PROQUAD, 0.5 ml, subcutaneous. No adverse effect reported. This is one of several reports report from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. On an unknown date in 2014, GARDASIL underwent a temperature excursion. On 05-AUG-2014, the patient was vaccinated with GARDASIL, 0.5 ml, intramuscular. No adverse effect reported. This is one report from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. On an unknown date in 2014, PROQUAD underwent temperature excursion. On 19-AUG-2014, the patient was vaccinated with PROQUAD 0.5 ml, subcutaneous. No adverse effect reported. This is one of several reports report from the same source. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: PNC13
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 62 year old female patient. On 19-SEP-2014, the patient was vaccinated with a dose of PREVNAR (dose, route, lot # and expiration date were not provided) instead of PNEUMOVAX 23 which was the intended vaccine. The licensed practical nurse did not clarify how or why the error occurred, whether it was medication confusion or healthcare provider error. She reported that this patient did not experience any adverse effects. It was unknown if the patient sought medical attention. At the time of the report, the patient's
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. On an unknown date in 2014, (Oka-Merck) PROQUAD underwent a temperature excursion. On 27-AUG-2014, the patient was vaccinated with (Oka-Merck) PROQUAD 0.5 ml, subcutaneous. No adverse effect reported. This is one of several reports report from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. On an unknown date in 2014, PROQUAD (Merck) underwent a temperature excursion. On 21-AUG-2014, the patient was vaccinated with PROQUAD (Merck) 0.5 ml, subcutaneous. No adverse effect reported. This is one of several reports report from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. On an unknown date in 2014, PROQUAD (Merck) 0.5 ml, subcutaneous. No adverse effect reported. This is one of several reports report from the same source. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site infection
Clinical narrative: This spontaneous report as received from an administrator refers to a female non-pregnant patient of unknown age. The patient had no pertinent medical history or drug reactions/allergies. On 23-JUN-2014, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # J011799, expiration date 09-FEB-2015, subcutaneous injection, dose and dose number were not reported). On an unspecified date, approximately in June 2014, the patient experienced skin surface infection below the injection site after receiving PNEUMOVAX 23. The patient sought medical attention by visiting the office on 25-JUN-2014. The event was treated with cephalexin (unspecified dose and frequency). No lab diagnostics study was performed. The outcome of the event was reported as not recovered. The relatedness between the event and PNEUMOVAX 23 was not reported. Follow up information has been received from a physician regarding the 65 year old female patient. On 23-JUN-2014 at 3:18 PM the patient was vaccinated with a first dose PNEUMOVAX 23 in the deltoid of left arm, intramuscularly (previously was reported as subcutaneously). On 24-JUN-2014, the patient experienced superficial skin infection below the intramuscular injection site. The patient recovered on an unspecified date of 2014. The patient required medical intervention (antibiotic treatment) to prevent death, hospitalization or other serious adverse events. This is one of several reports received from the same source. Additional information is not expected because all follow ups requested to complete the case were received.
Age: 65.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site infection, Injection site streaking
Clinical narrative: This spontaneous report as received from an administrator (also mentioned as representative and healthcare worker) refers to a female non-pregnant patient of unknown age. The patient had no pertinent medical history or drug reactions/allergies. On 09-JUN-2014, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # J011799, expiration date 09-FEB-2015, subcutaneous injection, dose and dose number were not reported). On an unspecified date in June 2014 the patient experienced skin surface infection below the injection site and streaking down her arm. On 11-JUN-2014, the patient sought medical attention by visiting the office. No lab diagnostics study was performed. The patient was treated with Cephalexin (reported as "ephalexin"). The outcome of the event was not reported. Relatedness between skin surface infection below the injection site and streaking down her arm and therapy with PNEUMOVAX 23 was not provided. Follow up information has been received from a physician regarding the 65 year old female patient. On 09-JUN-2014 at 12:32 PM the patient was vaccinated with a first dose of PNEUMOVAX 23 in the deltoid of right arm, intramuscularly (previously was reported as subcutaneously). On 10-JUN-2014, the patient experienced superficial skin infection below the intramuscular injection site. The patient recovered on an unspecified date of 2014. The patient required medical intervention (antibiotic treatment) to prevent death, hospitalization or other serious adverse events. This is one of several reports received from the same source. Additional information is not expected because all follow ups requested to complete the case were received.
Age: 0.08
Sex: M
Vaccine: DTAPH, HEP, RVX, DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Nuclear magnetic resonance imaging, VIIth nerve paralysis
Clinical narrative: Facial Palsy.  Resolved in about 5 weeks. MRI showed slight inflammation in facial nerve.
Age: 0.08
Sex: M
Vaccine: DTAPH, HEP, RVX, DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Nuclear magnetic resonance imaging abnormal, VIIth nerve paralysis
Clinical narrative: Facial Palsy.  Resolved in about 5 weeks. MRI showed slight inflammation in facial nerve.
Age: 10.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL, IPV, MMR, TDAP, VARCEL
Symptoms: Headache, Pyrexia, Rash erythematous, Varicella post vaccine
Clinical narrative: 9-21-14 started with fever, by 9-22-14 patient had rash >250 spots.  Saw family physician diagnosis was Cpox.  Cortisone cream for rash.
Age: 10.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL, IPV, MMR, TDAP, VARCEL
Symptoms: Pyrexia, Rash, Varicella post vaccine
Clinical narrative: 9-21-14 started with fever, by 9-22-14 patient had rash >250 spots.  Saw family physician diagnosis was Cpox.  Cortisone cream for rash.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site erythema
Clinical narrative: Redness that night which turned to bruising and kept creeping down her arm over the next few days.  Area is 3" below injection site.  She came in 9/21 & talked to me.  Told her to ice it & use the Advil she had been using.  Called MD's office Mon 9/22 to let them know she had some bruising and may call them.  Whether brusing is related to shot or just a coincidence is unknown.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness
Clinical narrative: Mild lightheadedness.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness
Clinical narrative: Mild light headedness.
Age: 55.0
Sex: F
Vaccine: PNC13, PPV
Symptoms: Abnormal behaviour, Aggression, Angina pectoris, Asthenia, Chest pain
Clinical narrative: Nausea, vomiting, trouble breathing, angina (chest pain), muscle aches, dizziness, high fever, weakness, excessive ear aches, neck stiffness, diarrhea, blurred vision, weight loss, hives, hoarse voice, rapid heart beat, behavior changes as far as aggressiveness and suicidal thoughts, fatigue. Frequent doctor/hospital visits, but no results. Has been healthy majority of lifespan prior to shot being given.
Age: 55.0
Sex: F
Vaccine: PNC13, PPV
Symptoms: Diarrhoea, Dizziness, Dysphonia, Dyspnoea, Ear pain
Clinical narrative: Nausea, vomiting, trouble breathing, angina (chest pain), muscle aches, dizziness, high fever, weakness, excessive ear aches, neck stiffness, diarrhea, blurred vision, weight loss, hives, hoarse voice, rapid heart beat, behavior changes as far as aggressiveness and suicidal thoughts, fatigue. Frequent doctor/hospital visits, but no results. Has been healthy majority of lifespan prior to shot being given.
Age: 55.0
Sex: F
Vaccine: PNC13, PPV
Symptoms: Fatigue, Heart rate increased, Musculoskeletal stiffness, Myalgia, Nausea
Clinical narrative: Nausea, vomiting, trouble breathing, angina (chest pain), muscle aches, dizziness, high fever, weakness, excessive ear aches, neck stiffness, diarrhea, blurred vision, weight loss, hives, hoarse voice, rapid heart beat, behavior changes as far as aggressiveness and suicidal thoughts, fatigue. Frequent doctor/hospital visits, but no results. Has been healthy majority of lifespan prior to shot being given.
Age: 55.0
Sex: F
Vaccine: PNC13, PPV
Symptoms: Pyrexia, Suicidal ideation, Urticaria, Vision blurred, Vomiting
Clinical narrative: Nausea, vomiting, trouble breathing, angina (chest pain), muscle aches, dizziness, high fever, weakness, excessive ear aches, neck stiffness, diarrhea, blurred vision, weight loss, hives, hoarse voice, rapid heart beat, behavior changes as far as aggressiveness and suicidal thoughts, fatigue. Frequent doctor/hospital visits, but no results. Has been healthy majority of lifespan prior to shot being given.
Age: 55.0
Sex: F
Vaccine: PNC13, PPV
Symptoms: Weight decreased
Clinical narrative: Nausea, vomiting, trouble breathing, angina (chest pain), muscle aches, dizziness, high fever, weakness, excessive ear aches, neck stiffness, diarrhea, blurred vision, weight loss, hives, hoarse voice, rapid heart beat, behavior changes as far as aggressiveness and suicidal thoughts, fatigue. Frequent doctor/hospital visits, but no results. Has been healthy majority of lifespan prior to shot being given.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site nodule, Injection site pain, Injection site warmth
Clinical narrative: Nodule size of silver dollar a injection site. Redness radiating towards elbow. Hot to touch as well as painful at touch.
Age: 25.0
Sex: F
Vaccine: MMR
Symptoms: Periorbital oedema, Pruritus, Urticaria
Clinical narrative: Patient noticed devloping hive at arm that was inoculated. Within 5 minutes hives started spreading and patient started to develop periorbital edema. No breathing difficulties. Advises to reutrn to center for evaluation patient back in center and given Epineprhine at 14:56 and 17:18. Hives and itching diminished. Patient given Predniosone 60mg po x 1 and a Medrol dose pack taper as well as an Rx for Epipen and instructions to take Benadryl 50mg q6h prn.
Age: 1.54
Sex: M
Vaccine: HEPA
Symptoms: Convulsion, Pyrexia, Respiratory arrest
Clinical narrative: mom states slight fever, stopped breathing and had a seizure - 911 called
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient began experiencing redness, warmth, and swelling at the injection site, which began to travel down the arm. Reaction did not occur until 6 days after the injection.
Age: 33.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Abdominal pain, Blood uric acid normal, Exposure during pregnancy, Foetal disorder, Full blood count
Clinical narrative: Patient awoke with severe headache.  Progressed to abdominal pain which was band like across entire abdomen.  Patient presented to labor and delivery with severe hypertension and tachycardia---168/110 and hr 138. Fetal heart rate also tachycardic on presentation in the 180's.  Temp 99.4. Pain was treated with nubain and IV fluids.  Full work up for Cholecystitis, appendicitis, preterm labor, preeclampsia were all performed and were all normal.  After 12 hours of treatment with pain meds and IV fluids patient is at this time feeling better. Blood pressure and heart rate (both maternal and fetal) have returned to normal.  Pain was rated at 8/10 but is now 2/10. Patient remains with localized erythema and swelling at injection site on right arm.
Age: 33.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Headache, Hypertension, Injection site erythema, Injection site swelling, Metabolic function test normal
Clinical narrative: Patient awoke with severe headache.  Progressed to abdominal pain which was band like across entire abdomen.  Patient presented to labor and delivery with severe hypertension and tachycardia---168/110 and hr 138. Fetal heart rate also tachycardic on presentation in the 180's.  Temp 99.4. Pain was treated with nubain and IV fluids.  Full work up for Cholecystitis, appendicitis, preterm labor, preeclampsia were all performed and were all normal.  After 12 hours of treatment with pain meds and IV fluids patient is at this time feeling better. Blood pressure and heart rate (both maternal and fetal) have returned to normal.  Pain was rated at 8/10 but is now 2/10. Patient remains with localized erythema and swelling at injection site on right arm.
Age: 33.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Neutrophil percentage increased, Tachycardia, Tachycardia foetal, Ultrasound antenatal screen normal, Ultrasound biliary tract normal
Clinical narrative: Patient awoke with severe headache.  Progressed to abdominal pain which was band like across entire abdomen.  Patient presented to labor and delivery with severe hypertension and tachycardia---168/110 and hr 138. Fetal heart rate also tachycardic on presentation in the 180's.  Temp 99.4. Pain was treated with nubain and IV fluids.  Full work up for Cholecystitis, appendicitis, preterm labor, preeclampsia were all performed and were all normal.  After 12 hours of treatment with pain meds and IV fluids patient is at this time feeling better. Blood pressure and heart rate (both maternal and fetal) have returned to normal.  Pain was rated at 8/10 but is now 2/10. Patient remains with localized erythema and swelling at injection site on right arm.
Age: 33.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Ultrasound scan normal, White blood cell count increased
Clinical narrative: Patient awoke with severe headache.  Progressed to abdominal pain which was band like across entire abdomen.  Patient presented to labor and delivery with severe hypertension and tachycardia---168/110 and hr 138. Fetal heart rate also tachycardic on presentation in the 180's.  Temp 99.4. Pain was treated with nubain and IV fluids.  Full work up for Cholecystitis, appendicitis, preterm labor, preeclampsia were all performed and were all normal.  After 12 hours of treatment with pain meds and IV fluids patient is at this time feeling better. Blood pressure and heart rate (both maternal and fetal) have returned to normal.  Pain was rated at 8/10 but is now 2/10. Patient remains with localized erythema and swelling at injection site on right arm.
Age: 33.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Abdominal discomfort, Blood lactate dehydrogenase normal, Blood pressure increased, Blood uric acid normal, Body temperature increased
Clinical narrative: Patient awoke with severe headache.  Progressed to abdominal pain which was band like across entire abdomen.  Patient presented to labor and delivery with severe hypertension and tachycardia---168/110 and hr 138. Fetal heart rate also tachycardic on presentation in the 180's.  Temp 99.4. Pain was treated with nubain and IV fluids.  Full work up for Cholecystitis, appendicitis, preterm labor, preeclampsia were all performed and were all normal.  After 12 hours of treatment with pain meds and IV fluids patient is at this time feeling better. Blood pressure and heart rate (both maternal and fetal) have returned to normal.  Pain was rated at 8/10 but is now 2/10. Patient remains with localized erythema and swelling at injection site on right arm.
Age: 33.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Chest discomfort, Chills, Exposure during pregnancy, Full blood count normal, Headache
Clinical narrative: Patient awoke with severe headache.  Progressed to abdominal pain which was band like across entire abdomen.  Patient presented to labor and delivery with severe hypertension and tachycardia---168/110 and hr 138. Fetal heart rate also tachycardic on presentation in the 180's.  Temp 99.4. Pain was treated with nubain and IV fluids.  Full work up for Cholecystitis, appendicitis, preterm labor, preeclampsia were all performed and were all normal.  After 12 hours of treatment with pain meds and IV fluids patient is at this time feeling better. Blood pressure and heart rate (both maternal and fetal) have returned to normal.  Pain was rated at 8/10 but is now 2/10. Patient remains with localized erythema and swelling at injection site on right arm.
Age: 33.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Heart rate increased, Injection site erythema, Injection site inflammation, Laboratory test normal, Palpitations
Clinical narrative: Patient awoke with severe headache.  Progressed to abdominal pain which was band like across entire abdomen.  Patient presented to labor and delivery with severe hypertension and tachycardia---168/110 and hr 138. Fetal heart rate also tachycardic on presentation in the 180's.  Temp 99.4. Pain was treated with nubain and IV fluids.  Full work up for Cholecystitis, appendicitis, preterm labor, preeclampsia were all performed and were all normal.  After 12 hours of treatment with pain meds and IV fluids patient is at this time feeling better. Blood pressure and heart rate (both maternal and fetal) have returned to normal.  Pain was rated at 8/10 but is now 2/10. Patient remains with localized erythema and swelling at injection site on right arm.