chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Lymphadenopathy, Rash
Clinical narrative: Pt reported node under armpit and rash on arms and underneath pectoral muscles. Pt to consult with physician. Started 2 days after administration.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous reprot as received from a pharmacy student refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date in 2012, the patient was vaccinated with a dose of ZOSTAVAX (dose, route of administration, lot # and expiration date were not reported). On an unknown date in 2015, the patient received another dose of ZOSTAVAX (dose, route of administration, lot # and expiration date were not reported). No adverse effects reported. Additional information has been requested.
Age: 17.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 17 year old patient of unknown gender. No information regarding the patient's pertinent medical history and concomitant medications was reported. On 16-APR-2015, the patient was vaccinated with an "adult dose" of VAQTA, 1 ml (route of administration, lot # and expiration date were not provided). As of 02-JUN-2015, no adverse effect was reported. Additional information has been requested.
Age: 11.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 11 years old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 12-JAN-2015, the patient was vaccinated with the dose of GARDASIL lot # K008213 (dose, strength, route of administration and expiration date were not reported) which had temperature excursion (incorrect product storage). No information on patient's concomitant medication was provided. Nurse practitioner confirmed that no adverse events were reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Fatigue, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: LEFT DELTOID AREA REDNESS, TENDERNESS, SWELLING, ITCHING, FATIGUE. 6/21/15-URGENT CARE VISIT- ICE PACKS, ARM ELEVATION, CORTISONE CREAM. 6/22/15 CELLUTIS OF LEFT ARM, CEFADROXIL 500MG TWICE A DAY.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site swelling
Clinical narrative: LEFT DELTOID AREA REDNESS, TENDERNESS, SWELLING, ITCHING, FATIGUE. 6/21/15-URGENT CARE VISIT- ICE PACKS, ARM ELEVATION, CORTISONE CREAM. 6/22/15 CELLUTIS OF LEFT ARM, CEFADROXIL 500MG TWICE A DAY.
Age: 68.0
Sex: M
Vaccine: PNC13
Symptoms: CSF test abnormal, Cryptococcus test positive, Meningitis cryptococcal
Clinical narrative: Positive cryptococcal menigitis s/p Prevnar 13.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history and current conditions were not provided. On 13-JUN-2015, the patient was inadvertently vaccinated with a dose of ZOSTAVAX (lot #, expiration date, dose and route were not reported) instead of VARIVAX (Merck). No adverse experience was reported. There was no product quality complaint (PQC) involved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discomfort, Injection site erythema, Injection site reaction, Injection site swelling, Skin exfoliation
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient's medical history included hypercholesterolemia. On an unknown date, the patient was vaccinated with ZOSTAVAX, 0.65 ml subcutaneous for prevention of shingles. Concomitant medication included pravastatin. On an unknown date, the patient experienced swelling and redness, approximately 6 inches in diameter, around the injection site, after receiving zoster vaccine live. The patient also experienced that her skin at the injection site appeared broken, like it peeled. The zoster vaccine live injection site was uncomfortable and patient took BENADRYL, which helped her comfort level. Action taken with ZOSTAVAX was not applicable. The patient was recovering from the events. The patient sought medical attention reported as saw the pharmacist. Causality was not reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown gender and age. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. On 27-MAY-2015, the patient was vaccinated with an expired dose of MMR II, HSA, 0.5 ml, subcutaneously (lot # J006185 and expiration date 24-MAY-2015). No adverse events were reported. No further information was available. Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Herpes zoster
Clinical narrative: 2 days after receiving PREVNAR, patient developed H. zoster rash.
Age: 75.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Rash/itching at injection site.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling of the right deltoid area.  Bright red and painful x 3 days.
Age: 12.0
Sex: M
Vaccine: HEPA, PPV
Symptoms: Crying, Injection site erythema, Injection site induration, Injection site movement impairment, Pain
Clinical narrative: Fever spiking to 104, redness at injection site, hardness at injection site, pain causing wincing and crying, toddler not using arm when at all possible.
Age: 12.0
Sex: M
Vaccine: HEPA, PPV
Symptoms: Pyrexia
Clinical narrative: Fever spiking to 104, redness at injection site, hardness at injection site, pain causing wincing and crying, toddler not using arm when at all possible.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Muscular weakness, Pyrexia, Rash, Skin tightness
Clinical narrative: TIGHTNESS/WEAKNESS IN ARM, BUMPS IN ARM, FEVER/CHILLS.
Age: 3.0
Sex: F
Vaccine: HEPA
Symptoms: Status epilepticus
Clinical narrative: Status epilepticus for 1 hours.
Age: 0.82
Sex: M
Vaccine: HPV4
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Local reaction, Pyrexia
Clinical narrative: HPV given.  Local reaction- leg sore, swollen, warm x 5 days.  Low-grade fever, under 100 degrees, x 2 days.
Age: 53.0
Sex: F
Vaccine: HEP
Symptoms: Hypoaesthesia, Intranasal hypoaesthesia, Pharyngeal hypoaesthesia, Tremor
Clinical narrative: Numbness in the arms, legs, nose, and throat. Also, shakiness.
Age: 11.0
Sex: F
Vaccine: HPV4, MEN
Symptoms: Back pain, Body temperature increased, Fatigue, Headache, Hypoaesthesia
Clinical narrative: Arm pain, numbness in fingers, extreme fatigue, raising temperature 99.8-100.2 with Tylenol and Advil, vomiting following morning 2x, back pain following afternoon, followed by neck pain and stiffness for 48 hours and counting, sore throat started after 36 hours and still remains, headache followed after 48 hours.
Age: 11.0
Sex: F
Vaccine: HPV4, MEN
Symptoms: Musculoskeletal stiffness, Neck pain, Oropharyngeal pain, Pain in extremity, Vomiting
Clinical narrative: Arm pain, numbness in fingers, extreme fatigue, raising temperature 99.8-100.2 with Tylenol and Advil, vomiting following morning 2x, back pain following afternoon, followed by neck pain and stiffness for 48 hours and counting, sore throat started after 36 hours and still remains, headache followed after 48 hours.
Age: 0.51
Sex: M
Vaccine: DTAP
Symptoms: Crying, Middle insomnia
Clinical narrative: Baby woke up in the middle of the night and started crying hysterically. He was inconsolable. It took a while to calm him down and put back to sleep. The same happened the night after.
Sex: F
Vaccine: HPV4
Symptoms: Seizure
Clinical narrative: Information has been received from a physician via a field employee referring to a currently 17 year old female patient who was not pregnant. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not reported. On an unknown date the patient was vaccinated with GARDASIL (strength, dosage, dose number and frequency unspecified), intramuscularly. On an unknown date the patient developed an unspecified seizure disorder after she received the unspecified number of doses of GARDASIL. The patient's mother told the physician the patient had been consulting with an unspecified neurologist regarding the patient's seizure disorders, but she did not specified whether the neurologist had officially confirmed the diagnoses. The outcome of the event was reported as not recovered/not resolved. Causality was not reported. Upon internal review, the event of seizure disorder was considered to be medically significant. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Seizure
Clinical narrative: Information has been received from a physician via a field employee referring to a female patient of unknown age who was not pregnant. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not reported. On an unknown date the patient was vaccinated with GARDASIL (strength, dosage, dose number and frequency unspecified), intramuscularly. On an unknown date the patient developed an unspecified seizure disorder after she received the unspecified number of doses of GARDASIL. The patient's mother told the physician the patient had been consulting with an unspecified neurologist regarding the patient's seizure disorders, but she did not specified whether the neurologist had officially confirmed the diagnoses. The outcome of the event was reported as not recovered/not resolved. Causality was not reported. Upon internal review, the event of seizure disorder was considered to be medically significant. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with 2 ml doses of ROTATEQ (lot # K007246) orally that was improperly stored. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMR
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. Medical history and concurrent conditions were not reported. On 10-JUN-2015, the patient was vaccinated with a dose of improperly stored MMR II (Albumin status of HSA (human serum albumin)), lot number K015374, expiration date 18-SEP-2016. No adverse symptoms reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. On 11-JUN-2015 the patient was vaccinated with an expired dose of M-M-R II (lot # J006953, expire date 07-JUN-2015, 0.5 ml) subcutaneously (Expired vaccine used). No adverse effects were reported. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: DTAPIPVHIB, MMR, VARCEL
Symptoms: Pyrexia, Rash generalised, Upper respiratory tract infection
Clinical narrative: Fever off and on with URI symptoms that started 6/8/15. Last fever 6/17/15 with Tmax 101. Rash started to abdomen on 6/18/15. Rash spread to entire body including face on 6/19/15.
Age: 1.08
Sex: M
Vaccine: HEPA, MMR, PNC13
Symptoms: Dyskinesia, Movement disorder, Nuclear magnetic resonance imaging normal, Screaming
Clinical narrative: Pt woke on 6/18/15 at 11 pm screaming, not moving, then started jerking for at 5 min, no fever.
Age: 41.0
Sex: F
Vaccine: HEP, HEPA, TDAP
Symptoms: Chest discomfort, Malaise, Swollen tongue
Clinical narrative: 6-18-15 Client reports "not feeling well" 6/17, evening, with "slight swelling of my tongue". States 6/18, AM, symptoms worse with "more tongue swelling and a tightness in chest". Was being taken to Emergency Room when she called.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Developed pain, redness, decreased ROM, swelling in LUA at site of injection less than 12 hours from TD injection. Redness/warm in circular 6x6 cm pattern at distal deltoid.
Age: 71.0
Sex: F
Vaccine: PNC13, TDAP, TYP
Symptoms: Rash, Rash pruritic
Clinical narrative: Rashes neck, arm and face, it is very itchy.
Age: 1.14
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pruritus, Pyrexia, Rash pustular, Varicella post vaccine
Clinical narrative: Fever 101.8 and broke out with rash that mother felt was chickenpox so took child to ER on 6-14-15-Dr felt insect bites but took child back to see NP on 6-16 et "bites" had white pustules et couple broke open-mother was told child does have chickenpox from Varicella vaccine told to alternate TYL et MOTRIN for fever et calamine for itching.
Age: 28.0
Sex: M
Vaccine: SMALL
Symptoms: Rash, Rash erythematous
Clinical narrative: He developed a rash 10 days post smallpox vaccination. He describes it as tiny, red, flat spots above the SPV site, up the shoulder and neck on that side and a few on his chest. The ones on my chest are raised. No discomfort, pruritus, malaise. Feeling well otherwise. No F, C, SOB, chest pain. The SPV site is the size of a nickel and unremarkable.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pyrexia, Rash, Swelling, Swelling face
Clinical narrative: Severe headache, excessive facial and scapula swelling. Low grade fever, occasional rash.
Age: 48.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Body temperature increased, Injection site erythema, Pain
Clinical narrative: All over body aches, temperature 101.4, 1 1/2 inch flat reddened area at vaccine site (left deltoid). Cool compress (L) deltoid, TYLENOL/MOTRIN PRN, fluids, rest.
Age: 24.0
Sex: M
Vaccine: ANTH
Symptoms: Axillary pain, Erythema, Injection site erythema, Injection site swelling, Laboratory test normal
Clinical narrative: Vaccine was administered to right shoulder on the 30th of May. On the 6-7th of June, redness and slight swelling began to occur on the right bicep and right armpit area. On the 8th the local hospital administered antibiotics intravenously and symptoms began to decrease the following 1-2 days with antihistamines. Other symptoms itching (localized) and pain in the armpit region.
Age: 24.0
Sex: M
Vaccine: ANTH
Symptoms: Oedema peripheral, Pruritus
Clinical narrative: Vaccine was administered to right shoulder on the 30th of May. On the 6-7th of June, redness and slight swelling began to occur on the right bicep and right armpit area. On the 8th the local hospital administered antibiotics intravenously and symptoms began to decrease the following 1-2 days with antihistamines. Other symptoms itching (localized) and pain in the armpit region.
Age: 7.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Patient was seen on 6/8/2015 for her 7 year old well child check with no concerns other than a rash which occurred around her mouth the week prior. A flu vaccine was administered. She developed hives later that day which were examined by a physician on 6/9/2015 told mom to follow-up if hives persisted for > 48 hours, but patient did not return. No other known triggers for rash.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, IPV, MMR, VARCEL
Symptoms: Erythema, Head injury, Nausea, Neurological examination normal, Retching
Clinical narrative: 12 y/o 2 minutes after vaccination, walking to waiting area and syncopized, right side of head struck adjacent wall. Taken to chair. Nausea with dry heave. Normal neurologic exam. Minor erythema to right eyebrow. Monitored for 40 min.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, IPV, MMR, VARCEL
Symptoms: Syncope
Clinical narrative: 12 y/o 2 minutes after vaccination, walking to waiting area and syncopized, right side of head struck adjacent wall. Taken to chair. Nausea with dry heave. Normal neurologic exam. Minor erythema to right eyebrow. Monitored for 40 min.
Age: 56.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Nausea, Vision blurred
Clinical narrative: At 10 mins after injection pt c/o of nausea, dizziness and blurred vision. Given water and ice pack to back of neck. Pt. sat until able to walk. Moved to exam room. Pt. laid on exam table for at 20 min. Seen by MD at 1 hr after vaccine. Still had dizziness and blurred vision. BP was WNL at each check. Pt left at 2 hrs. Advised to see PMD if still feels bad. When pt left had slight blurry vision, no nausea, slight dizziness.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: From injection site down to elbow of left arm tissue was hard, swollen, red, and itching. Started within 24 hours of injection and continued past 4 days post injection. OTC ibuprofen and BENADRYL helped symptoms.
Age: 1.29
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: Fever started 2 days after vaccination.
Age: 19.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Pt. returned to office approx. 48 hours after receiving VARIVAX 6-16-15 to post Rt. upper arm. Site became itchy, red and warm to touch 24 hours after admin. Red, warm, mildly swollen circular area measured 30 mm diameter. Advised to seek tx if swelling or redness increase.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Circumstance or information capable of leading to medication error, Injection site rash, Rash, Scratch
Clinical narrative: Patient moved and leg got scratched. Also rash on leg and spread to arms and on face.
Age: 75.0
Sex: M
Vaccine: PNC13
Symptoms: Pain, Swelling
Clinical narrative: 75 y/o gentleman who is also a diabetic who received a PCV injection at the site of interest, right deltoid 3 days ago. He reports within 12 hrs. feeling pain, swelling.
Age: 38.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Blood test, Influenza like illness, Injection site erythema, Pain, Pain in extremity
Clinical narrative: Patient reports she received varicella vaccination in right upper arm 6-19-15 (AM). By 9:30 PM on 6-19-15, pt c/o pains on left side (legs and arms), followed by flu-like symptoms (aching over entire body). Pt was seen at urgent care facility on 6-20-15 and was given injection of PHENERGAN and blood work done. Awoke on 6-21-15 with redness at injection site approx 90 x 90 mm. Swelling and slight vesicular area approx 20-30 mm. Pt reports this is first varicella vaccination. Has appt on 6/23/15 with primary MD.
Age: 38.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash vesicular, Swelling
Clinical narrative: Patient reports she received varicella vaccination in right upper arm 6-19-15 (AM). By 9:30 PM on 6-19-15, pt c/o pains on left side (legs and arms), followed by flu-like symptoms (aching over entire body). Pt was seen at urgent care facility on 6-20-15 and was given injection of PHENERGAN and blood work done. Awoke on 6-21-15 with redness at injection site approx 90 x 90 mm. Swelling and slight vesicular area approx 20-30 mm. Pt reports this is first varicella vaccination. Has appt on 6/23/15 with primary MD.
Age: 44.0
Sex: M
Vaccine: ANTH, JEV1, TYP
Symptoms: Injection site pain, Middle insomnia, Tendonitis
Clinical narrative: Received the anthrax vaccine (AVA) 10 weeks ago. Since then he has had ongoing tendonitis in his left shoulder near the site. The area began to be uncommonly painful 1-2 hours after the injection and has awakened him from sleep.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain, Swelling, Tenderness
Clinical narrative: Redness, swelling, tenderness began 2 days after receiving "the most painful shot I've ever had". Continues with minimal redness, itchiness at day 7. Using cold compression.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Patient presented 2 days after vaccine administration with area of swelling, redness, and itching that was warm to the touch. Area was about 4" in diameter below the injection site.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not provided. On unknown dates, the patients were vaccinated with doses of PNEUMOVAX23 (route, lot numbers and expiration dates were not provided). On unknown dates, there was incorrect product storage as an unspecified number of patients received doses of PNEUMOVAX23 improperly stored. No adverse effect was reported. It was unknown if the patients sought medical attention. At the time of the report, the patients status was unknown. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a female patient of unknown age. No concurrent condition or medical history reported. On an unknown date, the patient was vaccinated with the complete series of 3 doses with RECOMBIVAX HB vial SD, intramuscularly. On 14-NOV-2014, the patient had a blood titer that was low for Hepatitis B antibodies which was confirmed by the blood titer test which was done on the same day. Action taken with the RECOMBIVAX HB was not applicable. The patient's present status was unspecified. No treatment was provided for the event. No product quality complaint reported. Causality was not provided. Additional information is not expected as the physician did not wish for further contact.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 9 patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with a dose of ZOSTAVAX, subcutaneous (dose, lot number and expiration date were not reported). No co-suspect and concomitant therapies were reported. ZOSTAVAX was exposed to a temperature excursion of 35F for 3 hours. No adverse effect reported. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site cellulitis
Clinical narrative: Developed cellulitis in (L) shoulder following pneumococcal 23-valent treated Kw 7 days of dicloxacillin 500mg.
Age: 16.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 16 years old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 05-JAN-2015, the patient was vaccinated with the dose of GARDASIL lot # K006191 (dose, strength, route of administration and expiration date were not reported) which had temperature excursion (incorrect product storage). No information on patient's concomitant medication was provided. Nurse practitioner confirmed that no adverse events were reported. This is one of several reports 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 Licensed Vocational Nurse refers to multiple unspecified patients of unknown age and gender with no pertinent medical history, drug reactions or allergies reported. On unknown dates, the patients were vaccinated with doses of PROQUAD (Merck) (dose, route and lot number were not provided) which was stored improperly. No adverse effect was reported. This is one of two cases received from the same source. Additional information has been requested.
Age: 13.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 13 years old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 05-JAN-2015, the patient was vaccinated with the dose of GARDASIL lot # K008213 (dose, strength, route of administration and expiration date were not reported) which had temperautre excursion (incorrect product storage). No information on patient's concomitant medication was provided. Nurse practitioner confirmed that no adverse events were reported. This is one of several reprots from the same reporter. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Decreased appetite, Pain
Clinical narrative: Achy, chills, (-) appetite x 7 days.
Age: 1.25
Sex: M
Vaccine: DTAP
Symptoms: Urticaria
Clinical narrative: Received DTaP vaccine 2/13/2015. Mom reported that child developed hives 2/15/15. Child not evaluated by any medical professional for the rash.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Feeling abnormal, Generalised tonic-clonic seizure, Loss of consciousness, Syncope
Clinical narrative: Pt given Tdap within 30 sec. pt. stated she didn't "feel" good. Within 2 min. passed out and had petit grand mal seizure. EMS arrived. Pt had another syncopal episode and seizure. Medics took to hospital.
Age: 88.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Symptoms started 4-5 days after vaccination. Symptoms include swelling, redness and itchiness at the injection site.
Age: 45.0
Sex: F
Vaccine: MMR
Symptoms: Musculoskeletal pain, Pain in extremity, Peripheral swelling, Rash generalised
Clinical narrative: 6/3/15 Reported fine rash all over body and pain in fingers and right shoulder. Fingers are also swollen. 6/9/15 Rash and pain/swelling in fingers has resolved. Pain continues in right shoulder.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Autoimmune disorder, Eye pain, Eye swelling, Nausea
Clinical narrative: Swollen eye, nausea, eye pain. 60mg of steroids given daily since.
Age: 76.0
Sex: F
Vaccine: UNK
Symptoms: Mass, Pain, Pruritus, Rash, Skin discolouration
Clinical narrative: Swollen, itchy, rashy, painful and still discolored and looks like bloody pinpricks around my shoulder. The lump from the shot has gone down.
Age: 76.0
Sex: F
Vaccine: UNK
Symptoms: Swelling
Clinical narrative: Swollen, itchy, rashy, painful and still discolored and looks like bloody pinpricks around my shoulder. The lump from the shot has gone down.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Haematochezia, Intussusception, Ultrasound abdomen abnormal
Clinical narrative: Blood in stool. Small bowel-small bowel intussusception found on US.
Age: 17.0
Sex: F
Vaccine: TYP
Symptoms: Eyelid oedema, Swelling face, Throat irritation
Clinical narrative: Client's mother states that her daughter had swelling on eyelids and puffiness on her face. Also that she experienced itching in her throat. Started taking oral typhoid on 6/1/15 finished on 6/8/15. Symptoms started on 6/9/15. According to mother currently client's symptoms reduced, she feels better.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling, Wrong drug administered
Clinical narrative: Patient requested PREVNAR 13 but was mistakenly given PNEUMOVAX 23. She has already had this vaccine several years back. Ended up going to MD 3 days later for large, swollen, painful arm. Had began to improve after 6 days.
Age: 87.0
Sex: M
Vaccine: PNC13
Symptoms: Atrial fibrillation, Dizziness, Extrasystoles, Headache, Neuropathy peripheral
Clinical narrative: Bld press (120's norm) to 172 - 36 hrs. Severe headache. Dizziness. Atrial Fib-skip beats. Neuropathy-incr. Allergies-ZYRTEC. None wheezing.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, HEPA, HPV4
Symptoms: Injection site erythema, Vaccination site warmth
Clinical narrative: Redness/warmth in arm where vaccine was given. To ER-was advised to take BENADRYL and was given a steroid by ER. No signs of respiratory distress.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, HEPA, HPV4
Symptoms: Injection site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Redness/warmth in arm where vaccine was given. To ER-was advised to take BENADRYL and was given a steroid by ER. No signs of respiratory distress.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Pt had injection on 6/10/15, pt said upper arm to elbow swelled, was red, had a rash, and felt a lump. Pt's arm now on 6/13/15 has decreased in swelling and has a 3 inch diameter circular rash. Pt says it itches.
Age: 33.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Erythema and swelling at varicella vaccine injection site.
Age: 0.3
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of incorrect storage of drug in a infant unk patient who received ENGERIX B pediatric. On an unknown date, the patient received ENGERIX B pediatric at an unknown dose. On an unknown date, an unknown time after receiving ENGERIX B pediatric, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. Additional information provided: An about 12 week-old infant was vaccinated with ENGERIX B in hospital at birth. The ENGERIX-B vaccine was stored at too cold of a temperature.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to unspecified patients of unknown age and gender. No current or historical conditions were reported. Since the excursion on 04-JUN-2015, specified date unknown, the patients were vaccinated with doses of VARIVAX (Merck) (strength, dose and route unknown), lot# K006135, expiration date 11-JUN-2016; lot# K021483, expiration date 03-NOV-2016; lot# reported as K010319, expiration date 22-JUL-2016; lot# K008818, expiration date 19-JUN-2016), which were exposed to temperatures outside of the recommended range (incorrect product storage). No adverse effects were reported. Lot # K010319 is an invalid lot number for VARIVAX (Merck). Additional information has been requested.
Age: 13.0
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a nurse referring to a 13 year old patient of unknown gender. No concurrent or historical conditiosn were reported. On 17-APR-2005, the patient was vaccinated with the first dose of RECOMBIVAX HB (strength, dose, route, lot# and expiration date unknown). over 6 years later, on 14-OCT-2011, the patient was vaccinated with the second dose of RECOMBIVAX HB (strength, dose, ruote, lot# and expiration date unknown) (inappropriate schedule of drug administration). No adverse experience reported. Additional information has been requested.
Sex: U
Vaccine: MMR
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. Medical history and concurrent conditions were not reported. On 12-JUN-2015, the patient was vaccinated with a dose of improperly stored M-M-R II, lot number K015374, expiration date 18-SEP-2016 (dose and route were not reported). No adverse symptoms reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous reprot as received from a registered nurse refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 08-JUN-2015, the patient was vaccinated with a dose of improperly stored M-M-R II, lot number K015374, expiration date 18-SEP-2016. No adverse symptoms reported. This is one of several reports from the same source. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Vaccine administered Friday 6/19/15. Pt called 6/22/15 to report large, red, swollen, itching at injection site. Denies fever or any other symptoms. Says resolved now.
Sex: U
Vaccine: MMR
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. Medical history and concurrent conditions were not reported. On 11-JUN-2015, the patient was vaccinated with a dose of improperly stored M-M-R II, lot number K015374, expiration date 18-SEP-2016 (dose and route were not reported). No adverse symptoms reported. This is one of several reports from the same source. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: This spontaneous report was received from a pharmacist via company representative and refers to a 75 year old female patient. There was no information about concomitant medications, concurrent conditions and medical history provided. On 05-JUN-2015, the patient was vaccinated with ZOSTAVAX (dose, lot#, expiration date, route of administration not provided) in the left deltoid. Approximately in June 2015, the patient experienced a "shingles-like rash" on the right side of her face. She sought medical attention and visited the pharmacist and her primary care physician, however no treatment was given for the event. The outcome of the event was reported as not recovered. The relatedness between the event and ZOSTAVAX was not provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Vocational Nurse refers to multiple unspecified patients of unknown age and gender with no pertinent medical history, drug reactions or allergies reported. On unknown dates, the patients were vaccinated with doses of VARIVAX (Merck) (dose, route and lot number were not provided) which were stored improperly. No adverse effect was reported. This is one of two cases received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: A spontaneous report was received on 18JUN2015 from a medical assistant who stated that an unspecified dose of improperly stored VAQTA 25/0.5 (lot # L09445 expiration 01JUN2017), was administere4d on 18JUN2015 to an unspecified patient. No adverse effects reported. No further information provided. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: FLUN4, HPV4
Symptoms: Disturbance in attention, Dizziness, Hypersomnia, Major depression, Nausea
Clinical narrative: Parent concerned for reaction/illness from GARDASIL vaccine. States that since the vaccine has had syncopal episodes, dizziness, vomiting, nausea, chest palpitations, excess sleep, lack of concentration, suicide attempt, major depression. FH: + depression, + sibling Asperger's.
Age: 13.0
Sex: F
Vaccine: FLUN4, HPV4
Symptoms: Palpitations, Suicide attempt, Syncope, Vomiting
Clinical narrative: Parent concerned for reaction/illness from GARDASIL vaccine. States that since the vaccine has had syncopal episodes, dizziness, vomiting, nausea, chest palpitations, excess sleep, lack of concentration, suicide attempt, major depression. FH: + depression, + sibling Asperger's.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant referring to an unspecified number of unspecified patients of unknown age and gender. Concurrent conditions or pertinent medical history were not reported. It was stated by the medical assistant that on unspecified dates since 02-JUN-2015, the patients were administered with an unspecified number of improperly stored doses of PROQUAD (Merck) (lot #, expiration date and frequency were not reported), subcutaneous injection. No adverse effects were reported. Concomitant therapies were unknown. This is one of two reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from the nurse refers unspecified number of patients of unspecified age and gender. Medical history and concurrent conditions were not reported. In 2015 (reported as unspecified dates since 04-MAY-2015), the patients were vaccinated with VAQTA (lot number: K010579 and expiry date: 12-FEB-2017) (dose, frequency and route of administration were not reported) which was exposed to temperatures outside of the recommended range. No adverse effects have been reported. The outcome of the reported event was unknown. The causality of the suspected product was considered to be not related to the event. No product quality complaint (PQC) was filed. No additional information was provided. This is one of several reports from the same reporter. Additional information has been requested.
Age: 11.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 11 years old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided.On 12-JAN-2015, the patient was vaccinated with the dose of GARDASIL lot # K008213 (dose, strength, route of administration and expiration date were not reported) which had temperature exucrsion (incorrect product storage). No information on patient's concomitant mediation was provided. Nurse practitioner confirmed that no adverse events were reported. This is one of several reports from the same reporter. Additional information has been requested.
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 an unspecified number of patients of unknown ages and genders with no pertinent medical history and no drug allergies or reactions reported. On an unknown date, the patients received an improperly stored dose of (Oka/Merck) VARIVAX, 0.5 ml, subcutaneous exposed to 23.9F for 103.58 hours (lot# and expiration date were not reported). There was no concomitant therapy reported. No adverse effects were reported. It was unknown if the patients sought medical attention. Additional information has been requested.
Age: 11.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 11 years old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 06-JAN-2015, the patient was vaccinated with the dose of GARDASIL lot # K008213 (dose, strength, route of administration and expiration date were not reported) which had temperature excursion (incorrect product storage). No information on patient's concomitant medication was provided. Nurse practitioner confirmed that no adverse events were reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 14.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 14 years old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. ON 26-JAN-2015, the patient was vaccinated with the dose of GARDASIL lot # K006191 (dose, strength, route of administration and expiration date were not reported) which had temperature excursion (incorrect product storage). No information on patient's concomitant medication was provided. Nurse practitioner confirmed that no adverse events were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not provided. On unknown dates, the patients were vaccinated with doses of oral, ROTATEQ (route, lot numbers and expiration dates were not provided). On unknown dates, there was incorrect product storage as an unspecified number of patients received doses of oral, ROTATEQ improperly stored. No adverse effect was reported. It was unknown if the patients sought medical attention. At the time of the report, the patients status was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 11.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 11 years old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 09-JAN-2015, the patient was vaccinated with the dose of GARDASIL lot # K008213 (dose, strength, route of administration and expiration date were not reported) which had temperature excursion (incorrect product storage). No information on patient's concomitant medication was provided. Nurse practitioner confirmed that no adverse events were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified patient of unknown age and gender. No concurrent condition and medical history were provided. On 05-JUN-2015, the patient was inadvertently administered with a dose of (Oka/Merck) VARIVAX (dose, anatomical location, lot number and expiration date not reported) subcutaneous for prophylaxis instead a dose of ZOSTAVAX. No adverse effects were reported. Laboratory diagnostics studies were not informed. At the time of the report the outcome of wrong drug administered was unknown. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 61 year old female patient with none drug reactions or allergies reported. On 13-JUN-2015, the patient was vaccinated with ZOSTAVAX, 0.65 ml, once, subcutaneous (lot number and expiration date were not reported). Concomitant medication was unspecified. On 15-JUN-2015, the patient experienced a rash at the injection following the administration of ZOSTAVAX. No treatment was given and none laboratory studies were performed. The patient sought medical attention by calling the pharmacy. The outcome of injection site rash was reported as not recovered. Additional information has been requested.
Age: 11.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 11 years old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 22-DEC-2014, the patient was vaccinated with the dose of GARDASIL lot # K006191 (dose, strength, route of administration and expiration date were not reported) which had temperature excursion (incorrect product storage). No information on patient's concomitant medication was provided. Nurse practitioner confirmed that no adverse events were reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 17.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 17 years old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 23-DEC-2014, the patient was vaccinated with the dose of GARDASIL lot # K006191 (dose, strength, route of administration and expiration date were not reported) which had temperature excursion (incorrect product storage). No information on patient's concomitant medication was provided. Nurse practitioner confirmed that no adverse events were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
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's medical history, concurrent conditions and concomitant medications were not reported. On 12-JUN-2015, the patient was administered a dose of improperly stored MMR II, subcutaneous (dose, injection site, lot number and expiration date were not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not provided. On unknown dates, the patients were vaccinated with doses of GARDASIL (route, lot numbers and expiration dates were not provided). On unknown dates, there was incorrect product storage as an unspecified number of patients received doses of GARDASIL improperly stored. No adverse effect was reported. It was unknown if the patients sought medical attention. At the time of the report, the patients status was unknown. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not provided. On unknown dates, the patients were vaccinated with doses of RECOMBIVAX HB (route, lot numbers and expiration dates were not provided). On unknown dates, there was incorrect product storage as an unspecified number of patients received doses of RECOMBIVAX HB improperly stored. No adverse effect was reported. It was unknown if the patient sought medical attention. At the time of the report, the patients status was unknown. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
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. Medical history and concurrent conditions were not reported. On 10-JUN-2015, the patient was vaccinated with a dose of improperly stored MMR II, lot number K015374, expiration date 18-SEP-2016 (dose and route were not reported). No adverse symptoms reported. This is one of several reports from the same source. Additional information has been requested.