chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.04
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pyrexia, Somnolence
Clinical narrative: This spontaneous report as received from a registered nurse who was the mother of a 12 month old male patient. The patient's medical history included food protein-induced enterocolitis syndrome. No drug allergies was reported. On 08-MAY-2015, the patient was vaccinated with VARIVAX (Merck) (Lot number, dose, unit and route were unspecified). On the same day, the patient was vaccinated with M-M-R II and hepatitis a vaccine (Lot number, dose, unit and route were unspecified) and VAQTA (Lot number, dose, unit and route were unspecified). Concomitant therapies included ZANTAC and PERIACTIN. On 15-MAY-2015, 8 days after onset of therapy the patient experienced pyrexia which she treated with TYLENOL cold sweat, also her son experienced symptoms similar to his preexisting condition (food-protein-induced enterocolitis syndrome) such as diarrhea, mucusy and stringy stool. She also noted that her son has been sleepy, sweaty and clammy although the although the fever had resolved. No lab diagnostics studies were performed. The patient had called pediatrician office and sought medical attention. No product quality complaint involved. The outcome of events was reported as not recovered/not resolved. Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Musculoskeletal pain, Nausea, Vomiting
Clinical narrative: Shoulder pain, nausea, vomiting.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Photosensitivity reaction, Rash erythematous, Rash generalised, Urticaria
Clinical narrative: 2 days after PREVNAR adminisitered, smlal red patch on (L) side forehead-then progressive areas of urticarial type patches (+) sun photosensitivity rash and chest 10d post vaccine- pt getting new lesions still on UE and torso-topical cortisone prescribed and ZYRTEC po. Still getting rash break outs in new spots.
Age: 3.0
Sex: M
Vaccine: RAB
Symptoms: Anger, Pyrexia
Clinical narrative: Fever today in a 3 y/o previously healthy male with h/o bat exposure. He is otherwise well appearing and in no distress. Likley the fever is from a concurrent viral illness.  It is unknown if the bad made any contact with the child, there are no visible wounds/scratches but it is possible that a bat can leave no mark.  Bats are high risk for rabies transmission.  Discussed risks/benefits of rabies vaccine and HRIG.  Discussed that rabies is a potentially preventable illness which can be highly fatal.  Parents agree with vaccine and HRIG administration. Patient described as "angry" by parents starting on the day prior to the second dose of the rabies series (2nd dose given on 5/28/15) and has persisted through the visit for the 3rd vaccination on 6/1/15.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Rash erythematous, Skin warm
Clinical narrative: Patient was vaccinated on 6/2/2015. Wednesday evening, after mowing his lawn and showering, he noticed itching and saw redness. Today (6/4/2015) at 12 PM, he said he noticed 3/4th inch of red, lumpy rash surrounded by about an inch of redness. Patient reports it is hot to the touch. He was instructed to tell us if the redness gets worse, and that Benadryl would be ok for the itching.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Paraesthesia
Clinical narrative: Sensation of needle pricks that lasted less than a second all over her body with some erythema.  She came in on 5/8/15 and said it was getting worse.  I told her to call Dr. and have him look at it so he could prescribe medication.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Pearly penile papules
Clinical narrative: Papules to penile shaft 1 day after HPV vaccine.
Age: 59.0
Sex: F
Vaccine: HEP, PPV
Symptoms: Fatigue, Injection site pain, Injection site swelling, Local swelling, Tenderness
Clinical narrative: Pt reported swelling and pain at site at Hep B injection (left deltoid) awaking from a nap 3 hours after the injection. Patient arrived back at the clinic with local swelling, tenderness, and fatigue. Patients vitals were taken and were within normal response. Ice was applied to the site and patient was monitored for 30 minutes after seeing dr. Patient discharged with home care instructions and given VAERS number.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to 10 patients of unknown age and gender. Pertinent medical history or drug allergic/drug reactions were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored PROQUAD (Lot # K023365, expiration date 20-MAY-2015 and L002420, expiration datte 23-JUL-2016), (dose number, route and dosage were not provided). There was no concomitant medication reported. No adverse event was reported. This is one of two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to 10 patients of unknown age and gender. Pertinent medical history or drug allergies/drug reactions were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored (Oka/Merck) VARIVAX (Lot # K021483, expiration date 03-NOV-2016 and Lot# L000456, expiration date 06-JAN-2017), (dose number, route, dosage and frequency were not provided). There was no concomitant medication reported. No adverse event was reported. This is one of two reports received from the same source. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Crying
Clinical narrative: Crying for over 3 hours; Went to ER.
Age: 1.01
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Rash generalised, Rash maculo-papular
Clinical narrative: Patient came into office with macular papular rash scattered over body. Had fever. Patient instructed to monitor and call if worsens.
Age: 10.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Arm red, swollen and tender at injection site. Advised to try Motrin, Ice and call if worsens.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Headache, Myalgia
Clinical narrative: Severe Headache joint and muscle pain.
Age: 29.0
Sex: F
Vaccine: TTOX
Symptoms: Immediate post-injection reaction, Laboratory test normal, Mobility decreased, Musculoskeletal pain, Pain
Clinical narrative: Extreme pain in shoulder immediately following the injection. Limited mobility, dull aching for weeks, inability to lift light objects, inability to use arm to full capacity. I was recommended and administered treatment of Motrin as needed, a steroid injection (in the hip), oral steroids, naproxen prescription (upon follow-up visit when there was no improvement). Referred to orthopedic doctor and they have now ordered an MRI.
Age: 29.0
Sex: F
Vaccine: TTOX
Symptoms: Weight bearing difficulty, X-ray normal
Clinical narrative: Extreme pain in shoulder immediately following the injection. Limited mobility, dull aching for weeks, inability to lift light objects, inability to use arm to full capacity. I was recommended and administered treatment of Motrin as needed, a steroid injection (in the hip), oral steroids, naproxen prescription (upon follow-up visit when there was no improvement). Referred to orthopedic doctor and they have now ordered an MRI.
Age: 46.0
Sex: M
Vaccine: PPV
Symptoms: Dizziness, Paraesthesia oral
Clinical narrative: Patient (associate) came back to pharmacy after eating his lunch stating he felt a little dizzy and his mouth a little tingling. He wanted to know if the Pneumovax interacted with his blood pressure medicine, amlodipine. The pharmacist called his doctor and store management sent patient to the immediate care center across the street from the store. This patient denied wanting to use a scooter for transport around the store and denied taking any diphenhydramine offered by the pharmacist.
Age: 0.67
Sex: M
Vaccine: HIBV, PNC
Symptoms: Pyrexia, Rash, Urticaria, Vomiting
Clinical narrative: Vomiting and hives rash on torso spreading to arms, legs and up the back of his neck within 24 hours of vaccine. 101 fever followed a few hours after the above incident. Approx. 29 hours after vaccine was injected.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Cyanosis, Pallor, Seizure
Clinical narrative: Son had a seizure in my arms, turned pale, lips blue, lasted 5mins or so.  No treatment, called ambulance, took to doctor after.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Redness swelling and warmth to upper Left deltoid around where immunization was given. Also soreness reported.
Age: 1.04
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Seizure
Clinical narrative: Child became febrile up to 103 degrees F and had a seizure.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Acne conglobata, Arthralgia, Dermatitis, Ear swelling, Erythema
Clinical narrative: Pt received tetanus booster on 1/27/15 for thumb laceration, ~ 30 min later developed scalp edema and erythema preauricualarly. That night she felt bad and took ibuprofen for a fever of 104 F. Swelling has since spread across her entire head spanning from occiput to below both eyes and including her ears. Scalp is exquisitely tender to touch. Never happened before, no aggravating or alleviating factors. No recollection of a perceived cause, no insect contact, no new cosmetic exposures, no new meds. This morning patient states the swelling and pain have worsened. Reports pain in her joints that is constant. On 1/29/15 she was admitted to the hospital with scalp cellulitis. It is unsure at this time whether this is truly a bacterial cellulitis, however is supported clinically with erythema, edema, fever, mild leukocytosis and appears to originate from a scab on the scalp. Differential diagnosis includes allergic type reaction to the tetanus shot that she received due to the temporal nature of her symptoms. However, patient with no eosinophilia on CBC, no pruritus, or no urticaria. Dermatology was consulted; determined facial dermatitis due to acute drug reaction from Tdap vaccine, therefore recommended antibiotics be d/c and the prescribed topical triamcinolone cream and prednisone in discharged on 2/3/15.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Leukocytosis, Oedema, Pain, Pain of skin, Pyrexia
Clinical narrative: Pt received tetanus booster on 1/27/15 for thumb laceration, ~ 30 min later developed scalp edema and erythema preauricualarly. That night she felt bad and took ibuprofen for a fever of 104 F. Swelling has since spread across her entire head spanning from occiput to below both eyes and including her ears. Scalp is exquisitely tender to touch. Never happened before, no aggravating or alleviating factors. No recollection of a perceived cause, no insect contact, no new cosmetic exposures, no new meds. This morning patient states the swelling and pain have worsened. Reports pain in her joints that is constant. On 1/29/15 she was admitted to the hospital with scalp cellulitis. It is unsure at this time whether this is truly a bacterial cellulitis, however is supported clinically with erythema, edema, fever, mild leukocytosis and appears to originate from a scab on the scalp. Differential diagnosis includes allergic type reaction to the tetanus shot that she received due to the temporal nature of her symptoms. However, patient with no eosinophilia on CBC, no pruritus, or no urticaria. Dermatology was consulted; determined facial dermatitis due to acute drug reaction from Tdap vaccine, therefore recommended antibiotics be d/c and the prescribed topical triamcinolone cream and prednisone in discharged on 2/3/15.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Scab, Swelling, Vaccination complication
Clinical narrative: Pt received tetanus booster on 1/27/15 for thumb laceration, ~ 30 min later developed scalp edema and erythema preauricualarly. That night she felt bad and took ibuprofen for a fever of 104 F. Swelling has since spread across her entire head spanning from occiput to below both eyes and including her ears. Scalp is exquisitely tender to touch. Never happened before, no aggravating or alleviating factors. No recollection of a perceived cause, no insect contact, no new cosmetic exposures, no new meds. This morning patient states the swelling and pain have worsened. Reports pain in her joints that is constant. On 1/29/15 she was admitted to the hospital with scalp cellulitis. It is unsure at this time whether this is truly a bacterial cellulitis, however is supported clinically with erythema, edema, fever, mild leukocytosis and appears to originate from a scab on the scalp. Differential diagnosis includes allergic type reaction to the tetanus shot that she received due to the temporal nature of her symptoms. However, patient with no eosinophilia on CBC, no pruritus, or no urticaria. Dermatology was consulted; determined facial dermatitis due to acute drug reaction from Tdap vaccine, therefore recommended antibiotics be d/c and the prescribed topical triamcinolone cream and prednisone in discharged on 2/3/15.
Age: 18.0
Sex: M
Vaccine: MEN
Symptoms: Hyperhidrosis, Nausea, Syncope
Clinical narrative: I became very nauseous and fainted as I exited the doctor's office about 20 minutes after administration of the vaccine. When I awoke after fainting I was still very nauseous and was sweating profusely.
Age: 11.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Injection site swelling
Clinical narrative: Swelling at site.
Age: 24.0
Sex: F
Vaccine: MMR
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Muscular weakness, Paraesthesia
Clinical narrative: Muscle weakness, numbness, tingling in entire arm immediately after the SQ injection to the posterior upper arm.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient presented to After Hours clinic with moderate redness, swelling, and warmth to the right deltoid area, just under injection site.
Age: 21.0
Sex: M
Vaccine: TDAP
Symptoms: Asthenia, Eye movement disorder, Flushing, Loss of consciousness
Clinical narrative: 06/03/2015 4:50 PM patient came to the clinic to get Tdap. States no allergies but is scared of needles. Never had any allergic reaction to any vaccine or any medications in the past. Discussed in detail medical hx, meds and allergies. Patient sitting in the chair and vaccine consent signed. No interactions identified. Tdap administered as per clinic guidelines. 4:55PM Patient talking about school and suddenly eyes rolled back, patient became unconscious, Face flushed. Medical alert button pressed. Helped called immediately. Patient regained consciousness within less than 1 minute. Patient states what happened ? Discussed with patient that he passed out. 5:00 PM Vs taken temp 99.4 oral, pulse 92, resp 18, bp 120/60 and O2 sat 98% Pharmacy Manager and store manager in the room. Requested pharmacy manger to leave if needed will call back. Store Manager in the room. Helped patient to walk to the exam table and lie down. Patient talking and alert x oriented x 3. Called MOC; update given. Will monitor patient for next 20 minutes. Asked patient if this has happened in the past ever. Patient states one time he was watching a movie with needles and this happened and thought it was not a big deal but has never passed out with seeing a real needle. Water bottle given to patient. 5:05 PM Patient drinks half the water bottle. Skin color light pink. Vs taken again. 5:10 PM Temp 98.6, pulse 78, resp 18, bp 120/70 and O2 sat 97%. Store manager left. Discussed with manager will all if needed. Discussed with patient to call some one to drive him home. States he will call his friend. Patient drinking water and talking on the phone. 5:20 pm vs taken temp 98.5, pulse 78, resp 18, O2 sat 98%, bp 120/70. Skin color a little pale. Patient states feel a little weak but alert. 5:25PM vs taken temp 98.6, temp 74, resp 18, O2 sat 98%, blp 120/70. Skin color pink and patient feels much better. States friend has arrived and he is going to drive his car and friend will follow him. Patient stands up out of exam table without any difficulty. Standing and states feels so much better. Drinking water. 5:30 pm discharged with friend to follow him home. Patient verbalizes undersanding to keep easy tonight, drink extra fluids. Do not watch movies with needles. Patient verbalizes understanding. Will follow up. 06/04/2015 2:20 PM called patient on his cell to follow up. Patient states feeling much better today. Drink exta fluids. Will follow up with urgent care clinic or ER if any problems. Will call insurance company to find a PCP to follow up. Patient verbalizes understanding to tell in the future that he has passed out with a viewing a movie with needles and passed out after getting a Tdap shot. Patient verbalizes understanding.
Age: 31.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Rash erythematous, Rash generalised, Rash pruritic
Clinical narrative: On 06/02/2015 client called PHN stating a couple of hours after she received the vaccinations, while she was at home she started to develop small red itchy bumps all over, mostly on her trunk, not much on arms or wrists. Denied fever/chills. Denied any breathing problems, denied itchy throat . PHN referred client to see her local HCP that day and to call PHN back with report from MD. Client saw a doctor that afternoon who told client she was not sure what was going on, unsure if from vaccination or if client developed an allergy to latex. MD recommended client not get the next, 2nd Hepatitis B shot. Client denied any allergies to anything.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a female patient, above 60 years of age, with no pertinent medical history, drug reactions or allergies reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot # were not reported). Concomitant therapy was unspecified. On an unknown date, after vaccination, the patient experienced a mild local rash which was treated with hydrocortisone at an unspecified dose. The patient sought medical attention by calling the pharmacist. At the time of this report, the pharmacist did not have specific information to provide. The outcome of mild local rash was reported as recovered on an unknown date. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Urticaria after GARDASIL inj (4 days).
Age: 2.0
Sex: M
Vaccine: DTAP, MMRV
Symptoms: Hypotonia, Pyrexia, Tremor, Unresponsive to stimuli
Clinical narrative: 10:15 p.m. Mother noted he was running a fever she went to get the thermometer when she came back she said her child was shaky, unresponsive and was limp. She called the EMS. When EMS arrive child was moving his eyes spontaneously and took a toy appropriately from them. In the ER temp was 103.4 O2 98% P 166. Child did not look postictal no tonic-clonic activity. Given MOTRIN with good response watch for 1 hr temp down to 101 alert and interactive-discharged to home.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Back pain, Injection site erythema, Injection site pain, Injection site warmth, Neck pain
Clinical narrative: Pt c/o soreness, pain, redness and heat at injection site that started 24 hours after Tdap was given. Pt states that the pain and soreness have continued to spread and is now affecting her neck, back and entire arm.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity
Clinical narrative: Pt c/o soreness, pain, redness and heat at injection site that started 24 hours after Tdap was given. Pt states that the pain and soreness have continued to spread and is now affecting her neck, back and entire arm.
Sex: U
Vaccine: HPV4
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 patients of unknown age and gender. Concurrent conditions or pertinent medical history were not reported. It was stated that doses of GARDASIL (lot # K006960, expiration date: 19-FEB-2017) (dose and route of administration were not reported), which had been exposed to a temperature outside of the recommended storage temperature, had been administered to the patients on unspecified dates since the temperature excursion (incorrect product storage). Concomitant therapies were not reported. No adverse experiences had been reported. At the time of the report, no additional information was provided. This is one of two reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to unspecified number of patients of unknown age and gender. The patient's medical history was not reported. On an unknown date the patients were vaccinated with improperly stored doses of GARDASIL (dose, route, strength and lot# unknown). No concomitant medication was reported. No adverse effects reported. It was unknown if the patients had sought medical attention. No product quality issue (PQC) was involved. Action taken and outcome were not provided. This is one of several reports received from the same source. Additional information has been requested.
Age: 55.0
Sex: M
Vaccine: PPV
Symptoms: Pneumonia
Clinical narrative: "I had PNEUMOVAX 2 years ago when I was diagnosed with asthma." He had pneumonia on 3/4/2015. "At the end of March 2015, they gave me PREVNAR 13."
Age: 45.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site erythema, Pain, Pain in extremity
Clinical narrative: 3 days post vaccine area of erythema to injection site, pain with right arm movement.
Sex: F
Vaccine: HPV4
Symptoms: Headache
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of age between 22 to 25 years old with no pertinent medical history/drug allergies or drug reactions reported. On 27-APR-2015, reported as "2 weeks ago since the time of the report" the patient was vaccinated with the second dose GARDASIL (route, anatomical location, lot# and expiration date were not reported), for prevention of HPV. The patient reported since she receivee the 2nd dose of GARDASIL she experienced headaches. The patient received treatmentt with TYLENOL and MOTRIN. The pharmacist reported that the patient was not vaccinated at his pharmacy so he did not know the specific dates of vaccine administration or the specific product if was GARDASIL or GARDASIL 9. Patient sought medical attention: pharmacy visit. The outcome of headache was reported as not recovered/not resolved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to unspecified number of patients of unknown age and gender. The patients' medical history was not reported. On an unknown date the patients were vaccinated with improperly stored doses of, oral, ROTATEQ (dose, strength and lot# unknown). No concomitant medication was reported. No adverse effects reported. It was unknown if the patients had sought medical attention. No product quality issue (PQC) was involved. Action taken and outcome were not reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to unspecified number of patients of unknown age and gender. The patients' medical history was not reported. On an unknown date the patients were vaccinated with improperly stored doses of GARDASIL 9 (dose, route, strength and lot# unknown). No concomitant medications was reported. No adverse effects reported. It was unknown if the patients has sought medical attention. No product quality issue (PQC) was involved. Action taken and outcome were not provided. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to unspecified number of patients of unknown age and gender. The patient's medical history was not reported. On an unknown date the patients were vaccinated with improperly stored VAQTA (dose, route, strength and lot# unknown). No concomitant medication was reported. No adverse effects reported. It was unknown if the patients had sought medical attention. No product quality issue (PQC) was involved. Action taken and outcome were not provided. 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: Information has been received from a healthcare worker referring to unspecified number of patients of unknown age and gender. The patients' medical history was not reported. On an unknown date the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (dose, strength, lot# and therapy type unknown). No concomitant medication was reported. No adverse effects reported. It was unknown if the patients had sought medical attention. No product quality issue (PQC) was involved. Action taken and outcome was not provided. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4, MMR
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 patients of unknown age and gender. Concurrent conditions or pertinent medical history were not reported. It was stated that doses of MMR II (lot # K000174, expiration date: 08-JAN-2016) (dose and route of administration were not reported), which had been exposed to a temperature excursion outside of the recommended storage temperature, had been administered to the patients on unspecified dates since the temperature excursion (incorrect product storage). Concomitant therapies were not reported. No adverse experiences had been reported. At the time of the report, no additional information was provided. This is one of two reports form the same source. 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 certified medical assistant referring to a 14 year old patient of unknown gender. No medical history, concurrent conditions and concomitant medications were reported. On 15-JAN-2015 the patient was vaccinated with the 1st dose of GARDASIL (strength, dose and route not reported), lot # H020901 with an expiration date of 05-JUL-2015 (also reported as 08-JUL-2015) which experienced a temperature excursion (incorrect product storage). No adverse effects reported. This is one of the two reports received from the same reporter. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: MMR
Symptoms: Antibody test negative, Measles antibody negative, Migraine, Mumps antibody test negative
Clinical narrative: Information has been received from a registered nurse concerning a currently 32 year old female patient. On 16-AUG-2000 the patient was vaccinated with a dose of MMR II (lot#, expiration date, dose and route not reported). The nurse stated the patient "showed delinquent for measles and mumps components but had been reviewed for rubella at an unspecified time in the past. Also there was no varicella in her (patient's) records." On an unknown date, the patient experienced migraines and she took TOPOMAX for treating it and she was also allergic to "other migraine medication" (names unspecified). The outcome of the events was unknown. On 06-MAY-2015, the patient was vaccinated with a dose of (Oka-Merck) PROQUAD, 0.5 ml, subcutaneously (capture into MARRS# 1505USA004606). Additional information has been requested.
Age: 32.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Blister, Post vaccination autoinoculation, Rash macular
Clinical narrative: This unsolicited case was received on 22-May-2015 via a third party query tool search on the VAERS database, under reference number: 563996. A 32-year-old male patient received a first dose of ACAM2000 (lot number was not reported, manufacturer: Sanofi Pasteur Biologics Co) in the left arm via unknown route on 22-Jan-2015. The patient did not have any medical history and current illnesses. Other medications and prior vaccination details were not provided. On 06-Feb-2015, 15 days post-vaccination, he developed macular rash and three vesicles on left lateral elbow (the same arm as smallpox vaccine) when he awoke after sleeping near a space heater. There was a possible autoinoculation versus thermal burn and the pattern of rash was not consistent with most thermal burns so it was treated as an autoinoculation. Laboratory data and corrective treatment was not provided. At the time of this report, the outcome was not reported. List of Documents held by sender: none.
Age: 32.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Injection site reaction, Injection site vesicles, Post vaccination autoinoculation, Rash macular
Clinical narrative: This unsolicited case was received on 22-May-2015 via a third party query tool search on the VAERS database, under reference number: 563996. A 32-year-old male patient received a first dose of ACAM2000 (lot number was not reported, manufacturer: Sanofi Pasteur Biologics Co) in the left arm via unknown route on 22-Jan-2015. The patient did not have any medical history and current illnesses. Other medications and prior vaccination details were not provided. On 06-Feb-2015, 15 days post-vaccination, he developed macular rash and three vesicles on left lateral elbow (the same arm as smallpox vaccine) when he awoke after sleeping near a space heater. There was a possible autoinoculation versus thermal burn and the pattern of rash was not consistent with most thermal burns so it was treated as an autoinoculation. Laboratory data and corrective treatment was not provided. At the time of this report, the outcome was not reported. List of Documents held by sender: none.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Joint injury, Mobility decreased
Clinical narrative: Case number PHHY2015US066899, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 570455) website on 27 May 2015. This report refers to a female patient of an unspecified age. Medical history and concomitant medication were not reported. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on an unknown date. On an unknown date, after vaccination, she suffered from a shoulder injury and really could not move her arm. It was reported that she needed surgery to fix the damage to her shoulder. Outcome of the events was condition unchanged (not recovered). Events were reported as non serious. Causality was not reported. Seriousness assessment of the events (shoulder injury and cannot move her arm) was upgraded based on the available information in the source document.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Injected limb mobility decreased, Joint injury
Clinical narrative: Case number PHHY2015US066899, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 570455) website on 27 May 2015. This report refers to a female patient of an unspecified age. Medical history and concomitant medication were not reported. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on an unknown date. On an unknown date, after vaccination, she suffered from a shoulder injury and really could not move her arm. It was reported that she needed surgery to fix the damage to her shoulder. Outcome of the events was condition unchanged (not recovered). Events were reported as non serious. Causality was not reported. Seriousness assessment of the events (shoulder injury and cannot move her arm) was upgraded based on the available information in the source document.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: Started with what I thought were insect bites but they were numerous. By 2nd day the bites became several rashes.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash generalised
Clinical narrative: Started with what I thought were insect bites but they were numerous. By 2nd day the bites became several rashes.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Redness, swelling, and rash at injection site.
Age: 31.0
Sex: M
Vaccine: HEPAB, TYP
Symptoms: Asthenia, Dizziness, Fall, Presyncope
Clinical narrative: Shortly received TWINRIX and TYPHIM injections pt complained of dizziness and weakness. Pt fell to the floor. He almost fainted bit was coherent the whole time. Called 911 for pt. BP was checked BP 133/89 P: 81. Pt was taken into hospital to follow up.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Dyspnoea, Headache, Injection site bruising, Injection site erythema
Clinical narrative: Typical reaction to the shingles vaccine, according to the Internet sites, but I want to report because I wonder if the occurrence is indeed 1 in 3 and not MORE prevalent. At the injection site, or actually beside it, there is a 1.5" X 3" oval red rash that is hot and itchy and thick like a bruise -- but without little bumps -- just flat and red. Surrounding this oval red rash is a larger oval, pink area of raised skin -- looks like a welt. It was smaller at first but "spread" as the days wore on. It has been four days. On day #2, I had a slight headache. I noticed online, in the ingredients, that there is MSG -- something I avoid since I had an adverse reaction to soup years ago. I had shortness of breath and a burning sensation around my neck. I was not asked if I were allergic to MSG before the injection. Why is this even IN the vaccine? I hope this diminishes soon. Thank you.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: Typical reaction to the shingles vaccine, according to the Internet sites, but I want to report because I wonder if the occurrence is indeed 1 in 3 and not MORE prevalent. At the injection site, or actually beside it, there is a 1.5" X 3" oval red rash that is hot and itchy and thick like a bruise -- but without little bumps -- just flat and red. Surrounding this oval red rash is a larger oval, pink area of raised skin -- looks like a welt. It was smaller at first but "spread" as the days wore on. It has been four days. On day #2, I had a slight headache. I noticed online, in the ingredients, that there is MSG -- something I avoid since I had an adverse reaction to soup years ago. I had shortness of breath and a burning sensation around my neck. I was not asked if I were allergic to MSG before the injection. Why is this even IN the vaccine? I hope this diminishes soon. Thank you.
Sex: U
Vaccine: HPV4
Symptoms: Extra dose administered, Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding a patient of unknown demographics. No medical history or concurrent conditions were reported. On 30-OCT-2013, the patient was vaccinated with the first dose of GARDASIL, (HPV-4), the patient was vaccinated with the second dose on 30-DEC-2013 and the third dose on 21-JAN-2015 (inappropriate schedule of drug administration). On 28-MAY-2015, the patient was vaccinated with the fourth dose of GARDASIL, 0.5 ml, intramuscularly (extra dose administered). No adverse events were reported. The outcome of the event was unknown. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker (also reported as a certificated medical assistant) referring to an unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored VAQTA (strength 25/0.5 (unit unknown), lot#, expiration date, dose and route were unknown). The temperature excursion for VAQTA was not supported with in-house stability data. No adverse symptoms were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. On 06-APR-2015 the patient was vaccinated with an improperly stored dose of VAQTA (dose, frequency, lot# and route were not reported). No symptoms were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Neuralgia, Pain in extremity
Clinical narrative: Sustained soreness in arm "nerve" related.
Age: 63.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Hypoaesthesia, Injection site hypoaesthesia, Injection site pain, Pain in extremity, Product administered at inappropriate site
Clinical narrative: Sustained soreness in arm "nerve" related.
Age: 63.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: X-ray
Clinical narrative: Sustained soreness in arm "nerve" related.
Age: 33.0
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a Registered Nurse referring to a 33 year old patient of unknown gender. Information regarding concurrent conditions and medical history was not provided. On 02-JUN-2015 the patient was inadvertently administered a dose of PROQUAD (Merck), subcutaneous (dose, dose #, lot # and application site were not reported) (inappropriate schedule of drug administration). Concomitant therapy was not reported. No adverse effects reported. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: MMR
Symptoms: Measles antibody negative, Mumps antibody test, Rubella antibody test
Clinical narrative: This spontaneous report as received from a medical assistant refers to a currently 20 years old female patient. The patient had allergy to amoxicillin, AUGMENTIN. The patient's pertinent medical history and concomitant medications were not provided. On an unspecified date (as a child), the patient was vaccinated with the first dose of MMR II (dose, route, therapy type, lot # and expiration date were not reported). On an unspecified date, the patient had titers drawn and the result for measles came back as negative. On 21-MAY-2015, the patient was vaccinated with the second dose of MMR II (dose, route, therapy type, lot # and expiration date were not reported) as a treatment for the adverse event. The patient's outcome was unknown. The relatedness between the event and MMR II was not provided. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of drug administration, Measles antibody negative, Mumps antibody test negative, No adverse event, Rubella antibody negative
Clinical narrative: This spontaneous report as received from a registered nurse refers to a female patient of unknown age. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with M-M-R II (dose and frequency were not reported). On unspecified dates, patient had negative titers for measles, mumps and rubella on a recent blood test. Nurse reported that the patient then received two additional "booster" doses of M-M-R II. One administered on 24-JAN-2013 was inadvertently given by the intramuscular rather than subcutaneous route (lot number 0599AA expiration date 24-JAN-2013). No adverse effects were reported by this incident. The second booster administration date was unspecified. Outcome of events was unknown. Causality was not provided. No product quality complaint (PQC) was involved. No further information provided. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Condition aggravated, Osteoarthritis
Clinical narrative: Pt experienced joint pain in her knuckle closer to fingernail ring finger (both) also joint pain left hand same side as injection site pt has osteoarthritis the injection made it worse pt receives cortisone injection every 6 months seem to help until she got the vaccine it usually last 5-6 months.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Leukaemia, Oral disorder, Weight decreased
Clinical narrative: Information has been received from a nurse practitioner referring to a 78 year old female patient with rheumatoid arthritis and leukemia. No other relevant medical history or concurrent conditions were reported. On an unknown date the patient was vaccinated with ZOSTAVAX for rheumatoid arthritis (dose, route, lot#, expiration date were not reported) (drug maladministration). Concomitant therapies included methotrexate (manufacturer unknown). On an unknown date the patient experienced an outbreak of shingles all through her body after receiving ZOSTAVAX. Her leukemia was also deteriorating and she had lost 15 pounds. The patient was experiencing oral lesions and it was unsure if the lesions were from the ZOSTAVAX vaccine or from a complication of the Leukemia. The patient was hospitalized due to the events on an unknown date. The patient sought unspecified medical attention on an unknown date and her present status was reported as not recovered. The reporter considered the events to be life threatening. Additional information has been requested.
Age: 0.08
Sex: M
Vaccine: HEP
Symptoms: Body temperature increased, Crying, Hypopnoea, Hypotonia, Sepsis
Clinical narrative: Vaccine (HepB) admin around 10:46am, cried, had 2 oz bottle prior to vaccine. Fed baby at home, held him in transverse/lat position, around 4pm baby unresponsive, limp, shallow breathing, last about 20 min, police arrived, then EMS, temp 100.5 rectal in ED, admitted for full sepsis w/u.
Age: 0.08
Sex: M
Vaccine: HEP
Symptoms: Unresponsive to stimuli
Clinical narrative: Vaccine (HepB) admin around 10:46am, cried, had 2 oz bottle prior to vaccine. Fed baby at home, held him in transverse/lat position, around 4pm baby unresponsive, limp, shallow breathing, last about 20 min, police arrived, then EMS, temp 100.5 rectal in ED, admitted for full sepsis w/u.
Sex: F
Vaccine: VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unknown age female patient with unspecified medical history or concurrent conditions. On 11-JUL-2008, the patient was vaccinated with the first dose of (Oka/Merck) VARIVAX (dose, route and lot # were not reported). On 28-JUL-2011, the patient was possibly vaccinated with the second dose of (Oka/Merck) VARIVAX (dose, route and lot # were not reported) and on 15-MAY-2015, the patient was vaccinated with a third dose of (Oka/Merck) VARIVAX (dose, route and lot # were not reported). Concomitant therapy was not reported. No adverse effect reported. This is one of two reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacy technician (also reported as a healthcare worker) referring to an unspecified number of patients of unknown age and gender. There was no information about pertinent medical history and drug reaction/drug allergies. On unknown dates the patients were vaccinated with improperly stored MMR II (lot # K008625, expiration date 16-JUN-2016; another lot# was reported as K010319, expiration date 22-JUL-2016; dose and route were not reported. No concomitant medication was reported. No adverse effects were reported. This is one of two reports from the same reporter. Additional information has been requested.
Age: 83.0
Sex: F
Vaccine: PPV
Symptoms: Abdominal pain upper, Back pain
Clinical narrative: Information has been received from a nurse referring to a 83 year old female patient with allergies to codeine, DEMEROL and LORTAB. There was no pertinent medical history. On 21-MAY-2015 the patient was vaccinated with PNEUMOVAX23, (dose and strength were not reported) (Lot number K023328, expire date 23-JUN-2016), intramuscularly in the upper left deltoid. There was no concomitant medication. After being administered the PNEUMOVAX23, the patient experienced severe stomach pain that radiated to her lower lumbar region upon standing and leaving the examining room. The patient was assisted back to the examining room and provided an ice pack for her back pain. Also, she was given two TYLENOL tablets (dose was unspecified). The patient was observed for 10 minutes and was able to get up without any further pain or discomfort and leave the physician's office. On 21-MAY-2015, the outcome of stomach pain and lower lumbar region pain was reported as recovered. The patient sought medical attention. At the time of reporting, the causality was not reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's relevant medical history and concomitant medication were not reported. On 20-MAY-2015, the patient was vaccinated with a dose of PROQUAD (Merck) (dose and route were not reported), which underwent supported temperature excursions (date the excursion occurred was on 14-MAY-2015). The patient might have received the following lot numbers and expiration dates of PROQUAD (Merck): lot# L002419 with expiration date 23-JUL-2016 or lot# reported as L005293 with expiration date 17-AUG-2016. No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a female consumer of unknown age refers to herself. The consumer's medical history, concurrent conditions and concomitant medications were not reported. In November (year not specified), the consumer was vaccinated with a dose of ZOSTAVAX (dose, route of administration, lot # and expiration date were not reported). In May (year not specified), the consumer experienced shingles after the vaccine. The outcome of the adverse event was unknown. The relatedness between the adverse event and the vaccination with ZOSTAVAX was not reported. Additional information is not expected, no reporter contact details.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Eyelid function disorder, Somnolence
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 72 year old female patient. The patient's medical history included shingles which affected her left eye (on an unspecified date) and psychosis. None drug reactions/allergies were reported. Concomitant therapies included DEPAKOTE and risperidone. On 12-MAY-2015, the patient was vaccinated with a dose of ZOSTAVAX (subcutaneous, lot # K020187, expiration date 27-JAN-2016, dose was not reported). On an unknown date in May 2015 (reported as shortly after receiving ZOSTAVAX the patient complained of feeling groggy and her left eyelid has been sticking (which was similar to what she experienced when she originally had the shingles). The patient saw an eye physician who suggested surgery, but the patient declined. No treatment was given for the adverse events. The outcome of the adverse events and the vaccination with ZOSTAVAX was not reported. Additional information has been requested.