chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Biopsy muscle, Biopsy peripheral nerve abnormal, Chronic inflammatory demyelinating polyradiculoneuropathy, Electromyogram, Hypoaesthesia
Clinical narrative: Symptoms began slowly and progressively - numbness in toes and foot drop would begin after walking certain distances. Have been walking with a cane, with muscle weakness. Diagnosed with CIDP and a Multifocal Motor Neuropathy after the presence of Onion Bulbs were found in a nerve biopsy.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Laboratory test, Lumbar puncture, Multifocal motor neuropathy, Muscular weakness, Nuclear magnetic resonance imaging
Clinical narrative: Symptoms began slowly and progressively - numbness in toes and foot drop would begin after walking certain distances. Have been walking with a cane, with muscle weakness. Diagnosed with CIDP and a Multifocal Motor Neuropathy after the presence of Onion Bulbs were found in a nerve biopsy.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Peroneal nerve palsy, Walking aid user
Clinical narrative: Symptoms began slowly and progressively - numbness in toes and foot drop would begin after walking certain distances. Have been walking with a cane, with muscle weakness. Diagnosed with CIDP and a Multifocal Motor Neuropathy after the presence of Onion Bulbs were found in a nerve biopsy.
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Fatigue, Feeling abnormal, Rash pruritic
Clinical narrative: Unexplained fatigue, mental fog and itchy rash on collar bone. Followed up with nurse practitioner at occupational health and they claimed the rash was unrelated. I reported extreme fatigue and mental fog to the occupational nurse on 6/21/13 after receiving 2nd shot on 6/12/13. I inquired how long this rash was going to last as well as the fatigued. She claimed that they were unrelated, despite me pointing out that these are known reported reactions to this vaccine. The rash it now spreading up my neck.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Blindness, Dizziness, Muscle contracture, Posturing
Clinical narrative: Heart felt funny, light headed, 15 second tonic posturing where sustained contraction of muscles in the legs and arms occurred, loss of vision, unable to sit up.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Body temperature increased, Eye swelling, Ocular hyperaemia, Rash
Clinical narrative: Both eyes red and swollen; rash on face and neck; 100.9 temp.
Age: 1.5
Sex: M
Vaccine: DTAP, HEP, HIBV
Symptoms: Blood prolactin increased, Full blood count normal, Joint hyperextension, Metabolic function test normal, Musculoskeletal stiffness
Clinical narrative: 36 hours after vaccines had an event that may have been a seizure. He had 10 cycles lasting approximately 3 seconds of whole body stiffening including extension of limbs.
Age: 1.5
Sex: M
Vaccine: DTAP, HEP, HIBV
Symptoms: Seizure like phenomena
Clinical narrative: 36 hours after vaccines had an event that may have been a seizure. He had 10 cycles lasting approximately 3 seconds of whole body stiffening including extension of limbs.
Sex: U
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Induration
Clinical narrative: 8 cm x 6 induration on left thigh. No signs of infection.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: (L) arm/swollen, red, itchy. Med: KEFLEX.
Age: 1.05
Sex: F
Vaccine: MMR, PNC, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling (R) thigh > 48hr. Rx - cephalexin 100m tid, prednisone 9m daily x 5 days.
Age: 50.0
Sex: M
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant via a company representative refers to a 50 year old male patient. The reporter stated that the patient was vaccinated with a dose of GARDASIL, 0.5 ml (route and lot number not reported) at age 50. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with an unspecified dose of GARDASIL (route, lot number and expiration date not reported). Concomitant vaccinations included MENACTRA and Tdap (manufacturer unknown). The physician stated that the unspecified number of patients on an unknown date experienced fainting when GARDASIL was administered with MENACTRA and Tdap (manufacturer unknown). The outcomes of the events were unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: Redness and swelling at site of injection. Came in the day after reaction was localized.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with an unspecified dose of GARDASIL (INJ) (dose, route, lot number and expiration date not reported). There was no concomitant medication reported. The reporting physician stated that the patient received GARDASIL at an unspecified time in the past that was "off schedule". No adverse effects reported. Additional information has been requested.
Age: 0.33
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13
Symptoms: Rash macular
Clinical narrative: Patient developed a macular erythematous rash on head a few minutes after giving the series of shots. No difficulty breathing nor vomiting, nor other lesions noted. No wheezing on examinations. Rashes were fading after 10-15 minutes of observation without any treatment.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age. On 18-JUN-2013 the patient was vaccinated with the third dose of GARDASIL (Lot # not provided) (dose, route not reported) No other co suspects were reported. No concomitant therapy was reported. The physician reported that the patient was administered the first two doses in the GARDASIL vaccination series on time five years ago, with the second dose being administered in 2008, and the third dose in the series was administered on 18-JUN-2013. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified number of patients. On unknown dates, the patients were vaccinated with GARDASIL (lot #, dose, route not reported), which were exposed to 31.5F during a period of 4.7 days in a physician's office. The reporter stated that the physician's office has twice told her that no vaccines were administered, but then told her that there were, however, she had no specified patient information or dates of administration. No adverse effect was reported at the time of report. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified number of patients. On unknown dates, the patients were vaccinated with RECOMBIVAX HB (lot #, dose, route not reported), which were exposed to 31.5F during a period of 4.7 days in a physician's office. The reporter stated that the physician's office has twice told her that no vaccines were administered, but then told her that there were, however, she had not specified patient information or dates of administration. No adverse effect was reported at the time of report. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified number of patients. On unknown dates, the patients were vaccinated with ROTATEQ (lot #, dose, route not reported), which were exposed to 31F over at least 10 days in a physician's office. The reporter stated that the physician's office has twice told her that no vaccines were administered, but then told her that there were, however, she had not specified patient information or dates of administration. No adverse effect was reported at that time of report. This is one of several reports received from the same source.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified number of patients. On unknown dates, the patients were vaccinated with M-M-R II (lot #, dose, route not reported), which were exposed to 31F over at least 10 days in a physician's office. The reporter stated that the physician's office has twice told her that no vaccines were administered, but then told her that there were, however, she had not specified patient information or dates of administration. No adverse effect was reported at the time of report. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified number of patients. On unknown dates, the patients were vaccinated with VAQTA (lot #, dose, route not reported), which were exposed to 31.5F during a period of 4.7 days in a physician's office. The reporter stated that the physician's office has twice told her that no vaccines were administered, but then told her that there were, however, she had not specified patient information or dates of administration. No adverse effect was reported at the time of report. This is one of several reports received from the same source. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Blister, Myalgia, Neuralgia, Pyrexia, Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 53 year old female patient with allergy to penicillin. On 30-MAY-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # J001009, expiration date 24-APR-2014) (0.65 ml, subcutaneous route). Concomitant therapies included pravastatin sodium. On 10-JUN-2013, reported as 12 days after the patient received ZOSTAVAX, the patient was diagnosed with shingles by her physician. It was offered VZV packet and accepted, the packet was faxed. The patent sought unspecified medical attention in an office visit and the shingles were treated with gabapentin, valacyclovir and ibuprofen. At the time of the report the patient was recovering from shingles. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 53 year old female patient with allergy to penicillin. On 30-MAY-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # J001009, expiration date 24-APR-2014) (0.65 ml, subcutaneous route). Concomitant therapies included pravastatin sodium. On 10-JUN-2013, reported as 12 days after the patient received ZOSTAVAX, the patient was diagnosed with shingles by her physician. It was offered VZV packet and accepted, the packet was faxed. The patent sought unspecified medical attention in an office visit and the shingles were treated with gabapentin, valacyclovir and ibuprofen. At the time of the report the patient was recovering from shingles. Additional information has been requested.
Age: 20.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Pt was given a DTaP instead of Tdap. Spoke w/ Health Dep't and was told this would be OK.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Crying, Injection site swelling, Injection site warmth
Clinical narrative: Child received vaccine. Mom states 30 mins after vaccine child crying, inconsolable. Legs swollen L>R warmth bilateral. Child admitted overnight for observation.
Age: 0.87
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Autopsy, Death, Fall, Respiratory tract congestion
Clinical narrative: Pt died at Hospital 5 days after imm received no adverse reactions reported after immunizations given. Baby reported to have fallen off of couch on June 24th and put to bed with a bottle propped. No obvious signs of trauma or aspirations. No problems that day besides some congestion. Has a history of being seen in the ER for febrile seizures never reported at the health department. Child was going the next day for 9 month old check up. No history of of problems with any vaccine.
Age: 10.0
Sex: M
Vaccine: FLU3, HEPA, VARCEL
Symptoms: Arthralgia, Burning sensation, Rash, Rash vesicular
Clinical narrative: Shingles like rash on left side of body from buttocks to knee. Burning rash with joint pain.
Age: 18.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Pain, Swelling
Clinical narrative: HAD BODY ACHES AND SWELLING UNDER RIGHT ARM.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Site reaction, seemed almost like a bug bite, itchy and swollen area about 2 inches in diameter, went away gradually over a couple days.
Age: 3.0
Sex: F
Vaccine: MMRV
Symptoms: Malaise, Myalgia, Pyrexia
Clinical narrative: High fever, aching muscles, malaise times 10 days.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Erythema, Feeling hot, Induration, Pruritus, Swelling
Clinical narrative: Swelling firm/taught erythema hot itchy. Rt arm. Measures 6 1/2" wide to the left and to the right. 10 1/2" circumf 7" long down and up
Age: 17.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Erythema, Oedema peripheral, Pain in extremity, Skin warm
Clinical narrative: The morning after the VARIVAX inj arm was painful and swelling and warm; seen in office 6/26/13 with painful, warm arm about 3.5 inches wide and 2.5 inches long (redness, swelling); no fever. Prescribed prednisone and amoxicillin (Rec'd this Rx and use if fever develops).
Age: 0.23
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Crying, Pain
Clinical narrative: Had shots around 10 AM at HD, went home and fell asleep and 1 hr. later woke up crying like in pain and has continued crying on and off. It is now 3:30 PM. Pt. was given Acetaminophen. Was seen by physician here at clinic.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Local swelling, Skin warm
Clinical narrative: Red, swollen, and warm to touch, size - larger than grapefruit.
Age: 24.0
Sex: M
Vaccine: TDAP
Symptoms: Dizziness, Hyperhidrosis
Clinical narrative: Became lightheaded, diaphoretic, slumped in chair.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Opisthotonus, Unresponsive to stimuli
Clinical narrative: Anxious about shot. 10 minutes after injection - arched back, lost ability to sit, became unresponsive for few second. Then responded appropriately, able to follow instruction, was not sleepy. Observed for 10 minutes BP 110/70 left office ambulating on own.
Age: 1.26
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration
Clinical narrative: Erythema and firmness at site of injection (R) thigh - (cellulitis) mildly.
Age: 32.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling, Pain
Clinical narrative: Large swollen area at injection site painful to move arm or touch.
Age: 59.0
Sex: F
Vaccine: IPV, MEN, TDAP
Symptoms: Arthralgia, Joint swelling, Pain in extremity
Clinical narrative: 6-20-13 call from pt. reports on 6-18-13 awoke with pain in (L) elbow and wrist. Used Ibuprofen for comfort 6-19-13 pain continued (L) elbow, wrist, index finger at evening time (L) knee also severe pain. No redness, swelling or change in range of motion. Used ALEVE 2 tabs 6-20-13 AM - pain persistent. 6-21-13 - 6-22-13 Bil knee pain and swelling resolved 6-23-13.
Age: 1.78
Sex: F
Vaccine: DTAP, HEPA, IPV
Symptoms: Injection site discolouration, Injection site oedema, Injection site vesicles
Clinical narrative: RT with evidence of blistering edema and discoloration 12cm by 14cm.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and redness (L) thigh secondary to DPT reaction. Rx prednisone 18 m daily x 5 days. Cephalexin 250 m bid x 10d. Avoid pertussis vaccine in future.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema
Clinical narrative: 18x11 cm area of redness surrounding injection site. Tx-ZYRTEC, cool packs as needed.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. On 04-MAR-2011 the patient was vaccinated with the first dose of GARDASIL, the second dose on 12-DEC-2012, and the third dose on 19-FEB-2013. No lot # was reported. No adverse effect reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a healthcare student refers to a female patient of unknown age. On 2004, the patient was vaccinated with ZOSTAVAX (lot number not provided) (route and dosage not provided). On 2012 the patient experienced two outbreaks of shingles, with the last outbreak occurring approximately 8 months ago. The outcome of two outbreaks of shingles is unknown. The reporter did not assess the relationship between the event and ZOSTAVAX. Additional information is not expected.
Age: 0.51
Sex: M
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Eye swelling, Lethargy, Unresponsive to stimuli, Wheezing
Clinical narrative: Symptoms as reported by his mother were swollen eyes, wheezing, lethargic, would not respond when she spoke to him for a short period of time. These symptoms were not reported to us until time for his next Tdap on 6/20/13. Symptoms lasted 4-5 day.
Age: 47.0
Sex: M
Vaccine: HEPAB
Symptoms: Blood pressure decreased, Dizziness, Heart rate decreased
Clinical narrative: Around 910 AM he got 1st dose of TWINRIX and felt dizzy his BP dropped to 80/60 pulse 40, IV started.
Age: 37.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Local swelling, Pain in extremity, Skin warm
Clinical narrative: Approximately 10am on 6-25-13 patient received PNEUMOVAX vaccine to (R) deltoid. Approximately 3pm patient called and said arm sore and red. Had pt come to clinic and area size of a baseball red, slightly swollen and warm to touch. Pt. reports painful. HC cream applied (2.5%) area circled. MD notified and observed area. Instructed to apply ice and take pt's normal allergy med. Area rechecked on 6-26-13. Saw Dr. Initial area better but red, sl swollen area now lower. Pt. given prednisone.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from the director of a health department via a company representative refers to a female patient of unknown age. On an unknown date the patient fainted after receiving vaccination with a dose of GARDASIL (route, lot number and expiration date not reported) for prophylaxis and others unspecified shots (unspecified dose/frequency and unspecified manufacturer). The outcome of the event was unknown. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age. On 21-JUN-2013, the patient was vaccinated with GARDASIL, .5 ml, intramuscular (lot number 1397AA, expiry date 09-APR-2013) for prophylaxis. On 21-JUN-2013, the patient received an expired dose of GARDASIL. The outcome of received expired dose is unknown. The reporter considered received expired dose to be not related to GARDASIL. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age. On 19-JUN-2013, the patient was vaccinated with PNEUMOVAX23 (route and dose not provided) (lot number J000388, expiry date 21-FEB-2014). The nurse reported that PNEUMOVAX23 which was exposed to 25F for 14.5 hours was administered to a patient. No adverse effects reported. The outcome of PNEUMOVAX exposed to 25F for 14.5 hours and no adverse effects is unknown. Action taken with PNEUMOVAX23 was not reported. The reporter considered PNEUMOVAX exposed to 25F for 14.5 hours and no adverse effects to be not related to PNEUMOVAX23. Additional information has been requested.
Age: 0.53
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Rash
Clinical narrative: Mom brought baby in 6/26/13 with rash on legs. Previously received vaccines on 6/24/13. Dr Rx calamine lotion and TYLENOL if worse will come back 6/27 if not 6/28.
Sex: F
Vaccine: HPV4
Symptoms: Pruritus, Urticaria
Clinical narrative: This spontaneous report as received from a physician, via a company representative, refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with GARDASIL dose 1, .5ml, intramuscular for prophylaxis. The physician reported that he had a patient who experienced skin itching and hives after the first injection of GARDASIL. The physician reported the patient returned for the second injection; and, upon administration, again exhibited signs of hives and itching. The onset date of the AE was reported as 20-JUN-2013 (it is not clear if the onset date is related with the first or second injection of GARDASIL). The outcome of skin itching, exhibited signs of hives, hives and itching is unknown. The reporter did not assess the relationship between the events and GARDASIL. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Dizziness, Hyperhidrosis, Nausea, Pallor, Tinnitus
Clinical narrative: Pt received Hepatitis A #1 and HPV #1 vaccines at approximately 11:10am on 6/27/13. Within 5 minutes pt reported lightheadedness. I was called to the room, placed pt supine. Pt noted to be diaphoretic, pale. He reported lightheadedness, nausea, a "hum" in his ears. Pt's condition improved upon being supine. BP at onset 101/53 pulse 55. BP prior to release 115/56 pulse 48. Pt reported complete recovery. Was released after I had observed him x20 minutes.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a physician concerning a patient, who on 21-JAN-2013, was vaccinated with the first dose of GARDASIL, 0.5 ml, intramuscularly (lot # not reported). It was reported that the patient received the second dose of GARDASIL on 24-JUN-2013 ("today"). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEP, HEP
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from healthcare worker refers to a patient of unknown age (gender not reported). On 08-MAR-2013, the patient was vaccinated with the first dose of RECOMBIVAX HB, intramuscularly (dose and lot number not reported). On 20-JUN-2013, the patient was vaccinated intramuscularly with the second dose of RECOMBIVAX HB lot # 668558/0894AA that was expired (exp. date 17-MAY-2013). No adverse events were reported with either dose of RECOMBIVAX HB. The patient's outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: HEP, HEP
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age. On 20-JUN-2013 the patient was vaccinated with a doe of expired RECOMBIVAX HB, intramuscular (dose not reported: lot# 668558/0894; expiration date:17-MAY-2013). No known adverse effects. Additional information has been requested.
Age: 52.0
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Mass, Pruritus, Skin warm, Swelling
Clinical narrative: This spontaneous report as received from a physician refers to a 52 year old patient. On 17-JUN-2013 the patient was vaccinated with ZOSTAVAX. On 17-JUN-2013 (reported as since 2 days ago) the patient experienced heart lump, itching, warm, redness  and swelling. The outcome of heart lump, itching, warm, redness,  and swelling is unknown. Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Induration, Injection site erythema, Skin warm
Clinical narrative: Right arm very hot to touch red area all around where shots were given. Parents state it grew about 1/2 more in diameter today. It is about the size of a baseball and very hot, has hard spot in middle of it. Patient states that it is not painful and has not hurt at all. Has been cold gel pack on it and warm compresses. It measures 100mm x 80mm. Was given MCV4 and HPV in right arm. Per parents it is not as red today.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling of right upper arm, and pain.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Pain
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 65 year old male patient with diabetes and sulfa allergy. On 22-JUN-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot # J001008, expiry: 24-APR-2014), 0.65 ml, subcutaneously in the left arm. No concomitant medications were reported. On 23-JUN-2013, the patient was a little sore. The patient came back to the pharmacy on 25-JUN-2013, with redness around the injection site but not much pain. The patient sought medical attention. No treatment was given to patient. No laboratory diagnostic tests were performed. The outcome of the events was reported as not recovered. Additional information is not expected.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Raised redness and swelling from elbow to shoulder on the injection side of the arm.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site warmth, Pruritus
Clinical narrative: Reddened area hot to touch (right deltoid), approximately 3 inches in diameter noticed by mother 11:00 this AM. Patient evaluated by Dr. and given home care instructions..cool compresses, Benadryl for itching and call if worsens.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Erythema, Nodule, Oedema peripheral, Pain in extremity, Skin warm
Clinical narrative: On 06/26/2013 patient came to clinic complaining of right arm being red, swollen, warm to touch and sore to touch. Patient did see a provider was given Benadryl Cream.  Patient came back to clinic today complaining of right arm not being any better.  Also left arm is red, has a knot, warm to touch. She did see a provider again today.  Also yesterday temp was 99 oral, today it was 97.4 oral.  Today was given Atarax 10mg to use also.
Age: 44.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Abdominal pain upper, Abdominal tenderness, Diarrhoea, Dizziness, Eosinophil count normal
Clinical narrative: Evening of the vaccine, patient states he experienced nausea, diarrhea, abdominal tenderness, stomach cramps.  Patient experienced dizziness the following day.  Patient states he almost passed out on two seperate occasions on the morning of the 7th of June.
Age: 44.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Full blood count, Metabolic function test, Nausea, Presyncope, White blood cell count increased
Clinical narrative: Evening of the vaccine, patient states he experienced nausea, diarrhea, abdominal tenderness, stomach cramps.  Patient experienced dizziness the following day.  Patient states he almost passed out on two seperate occasions on the morning of the 7th of June.
Age: 57.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Feeling hot, Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: SWOLLEN, RED AND PAINEFUL TO SIGHT.  UNABLE TO MOVE RIGHT ARM.  PATIENT STATES THAT WHEN ADMINISTERED SHE FELT WARM AND TINGLING SENSTION THROUGH OUT ARM BUT SUBSIDED SOON AFTER.  PATIENT WILL COME BACK 6/28 FOR FOLLOWUP. PATIENT TO APPLY WARM COMPRESSES TO SIGHT AND TO TAKE PAIN MEDICATION FOR PAIN.
Age: 57.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Paraesthesia
Clinical narrative: SWOLLEN, RED AND PAINEFUL TO SIGHT.  UNABLE TO MOVE RIGHT ARM.  PATIENT STATES THAT WHEN ADMINISTERED SHE FELT WARM AND TINGLING SENSTION THROUGH OUT ARM BUT SUBSIDED SOON AFTER.  PATIENT WILL COME BACK 6/28 FOR FOLLOWUP. PATIENT TO APPLY WARM COMPRESSES TO SIGHT AND TO TAKE PAIN MEDICATION FOR PAIN.
Age: 48.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Dry skin, Infection, Injection site erythema, Injection site nodule, Injection site pain
Clinical narrative: 2cm palpable nodule on left deltoid, with annular red area. The center has a 0.5cm open area that is dry with no drainage but is black in color. The area was painful to touch and warm to touch and swelling was present.
Age: 48.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Local swelling, Skin discolouration, Skin warm
Clinical narrative: 2cm palpable nodule on left deltoid, with annular red area. The center has a 0.5cm open area that is dry with no drainage but is black in color. The area was painful to touch and warm to touch and swelling was present.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Ageusia, Anosmia, Atypical pneumonia, Chills, Cough
Clinical narrative: Walking pneumonia, fever, cough, chills. Ten days. Rest, and water, over the counter drugs. After that, loss of smell, and taste. At this time has not returned. Doctor checking into it with my other RX's.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Walking pneumonia, fever, cough, chills. Ten days. Rest, and water, over the counter drugs. After that, loss of smell, and taste. At this time has not returned. Doctor checking into it with my other RX's.
Age: 4.0
Sex: M
Vaccine: DTAP, MMRV
Symptoms: Pruritus, Rash erythematous, Rash generalised
Clinical narrative: Broke out in red bumps all over body. Progressively worsened and itch.  They are still present from head to toe. Dr. didn't request to see patient, just treating with 2.5% hydrocortisone ointment.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Aplastic anaemia, Biopsy bone marrow normal, Contusion, Cytogenetic analysis normal, Dizziness
Clinical narrative: Shortness of breath. Pale skin. Bruising. Petechia. Headache. Light headedness.  ventually, diagnosis of aplastic anemia. Began insidiously, became progressively worse until diagnosis due to almost passing out during exercise in late February of 2013. Hospitalized March 6, 2013.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Dyspnoea, Flow cytometry, Full blood count normal, Headache, Pallor
Clinical narrative: Shortness of breath. Pale skin. Bruising. Petechia. Headache. Light headedness.  ventually, diagnosis of aplastic anemia. Began insidiously, became progressively worse until diagnosis due to almost passing out during exercise in late February of 2013. Hospitalized March 6, 2013.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Petechiae, Presyncope
Clinical narrative: Shortness of breath. Pale skin. Bruising. Petechia. Headache. Light headedness.  ventually, diagnosis of aplastic anemia. Began insidiously, became progressively worse until diagnosis due to almost passing out during exercise in late February of 2013. Hospitalized March 6, 2013.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia, Urticaria
Clinical narrative: Hives, Pyrexia, Fever >100.0. Claritin was given PO upon onset. Ibruprofen 800 mg PO immediately.
Age: 17.0
Sex: F
Vaccine: HPVX
Symptoms: Anxiety, Blood test, Dizziness, Palpitations, Urine analysis
Clinical narrative: Dizzy, feeling faint, heart palpitations, severe feeling of dread/doom.
Sex: F
Vaccine: PER
Symptoms: Hypotonia, Pallor
Clinical narrative: Initial report was received from a consumer, who was also the patient's parent, on 13 June 2013. A female patient had received an injection of pertussis vaccine (manufacturer, lot number, route, site and date of administration not reported) and an hour later became very white and limp. She was taken to the doctor. The patient's outcome was not reported. Documents held by sender: None.
Age: 0.4
Sex: M
Vaccine: DTP, HIBV, IPV, PPV, RVX
Symptoms: Histamine level, Laboratory test abnormal, Liver function test normal, Papule, Peau d'orange
Clinical narrative: Initial report received via a scientific literature search on 11 June 2013 via the affiliate. An unidentified 5 month old male patient was evaluated on an unreported date for raised apparently pruritic rash with episodic blisters. He was vaccinated on an unreported date with his scheduled 4 month vaccinations, including Hib; IPV; DTP and rotavirus vaccine. The vaccine manufacturers, date of vaccination, route of administration and batch numbers were not reported. Within 12 hours of vaccine administration, on an unreported date, he became colicky. A day later he began developing blisters filled with clear fluid that became confluent. The areas most affected included the back (which was covered with extensive bullae), skin fold areas of the upper arms and the lower abdomen distant from the area of injection. He had no fever and was in no acute distress. The patient history included an uncomplicated, full term pregnancy with normal delivery. At 2 months of age, the skin of his abdomen and back became progressively rough and stiff with wheal formation surrounded by "raw" red areas of flare at the site of physical stroking. A skin biopsy on an unreported date from the right flank was taken to confirm a suspected diagnosis of diffuse cutaneous mastocytosis (DCM). The patient also has a history of colicky abdominal pain. He was following his growth curve and reached all age-appropriate developmental milestones. There is no history of wheezing loss of consciousness, diarrhea, vomiting or abdominal distention. A physical examination on an unreported date showed an alert, well appearing boy in no evident distress, appropriately interactive. No lymphadenopathy or organomegaly was observed. The skin was notable for confluent skin-coloured papules and plaques with peau d'orange appearance covering his trunk with urtication on minimal touch. Hyperpigment patches of several centimeters in diameter were present on the extremities. Laboratory result on an unreported date showed a 24 hour collection urinary histamine level of 373 ug/g creatinine, total serum tryptase of 75 ng/mL and maturetryptase of 3.1 ng/mL. Blood cell counts were 12,000 white blood cell/uL, 4,690 red blood cells/uL, and 473,000 platelets/uL with mild eosinophilia of 550 cells/uL, and otherwise normal differential. Liver function tests were normal (alanine aminotransferase 23 ukat/L; aspartate aminotransferase 34 ukat/L). Lesional skin biopsy showed a patchy band-like infiltrate of mononuclear cells in the superficial dermis. Immunostaining for tryptase and CD117 was positive, confirming that the infiltrate primarily consisted of mast cells. He was treated with a 5 day course of low dose oral steroids and recovered with no residual skin changes. Since then, he has had 2 additional episodes of blistering associated with vaccination and viral illness. These episodes have become milder after initial regimen with oral and topical sodium cromolyn. The patient outcome is not recovered. Documents held by sender: None.
Age: 0.4
Sex: M
Vaccine: DTP, HIBV, IPV, PPV, RVX
Symptoms: Tryptase, Urticaria, Viral infection, White blood cell count normal
Clinical narrative: Initial report received via a scientific literature search on 11 June 2013 via the affiliate. An unidentified 5 month old male patient was evaluated on an unreported date for raised apparently pruritic rash with episodic blisters. He was vaccinated on an unreported date with his scheduled 4 month vaccinations, including Hib; IPV; DTP and rotavirus vaccine. The vaccine manufacturers, date of vaccination, route of administration and batch numbers were not reported. Within 12 hours of vaccine administration, on an unreported date, he became colicky. A day later he began developing blisters filled with clear fluid that became confluent. The areas most affected included the back (which was covered with extensive bullae), skin fold areas of the upper arms and the lower abdomen distant from the area of injection. He had no fever and was in no acute distress. The patient history included an uncomplicated, full term pregnancy with normal delivery. At 2 months of age, the skin of his abdomen and back became progressively rough and stiff with wheal formation surrounded by "raw" red areas of flare at the site of physical stroking. A skin biopsy on an unreported date from the right flank was taken to confirm a suspected diagnosis of diffuse cutaneous mastocytosis (DCM). The patient also has a history of colicky abdominal pain. He was following his growth curve and reached all age-appropriate developmental milestones. There is no history of wheezing loss of consciousness, diarrhea, vomiting or abdominal distention. A physical examination on an unreported date showed an alert, well appearing boy in no evident distress, appropriately interactive. No lymphadenopathy or organomegaly was observed. The skin was notable for confluent skin-coloured papules and plaques with peau d'orange appearance covering his trunk with urtication on minimal touch. Hyperpigment patches of several centimeters in diameter were present on the extremities. Laboratory result on an unreported date showed a 24 hour collection urinary histamine level of 373 ug/g creatinine, total serum tryptase of 75 ng/mL and maturetryptase of 3.1 ng/mL. Blood cell counts were 12,000 white blood cell/uL, 4,690 red blood cells/uL, and 473,000 platelets/uL with mild eosinophilia of 550 cells/uL, and otherwise normal differential. Liver function tests were normal (alanine aminotransferase 23 ukat/L; aspartate aminotransferase 34 ukat/L). Lesional skin biopsy showed a patchy band-like infiltrate of mononuclear cells in the superficial dermis. Immunostaining for tryptase and CD117 was positive, confirming that the infiltrate primarily consisted of mast cells. He was treated with a 5 day course of low dose oral steroids and recovered with no residual skin changes. Since then, he has had 2 additional episodes of blistering associated with vaccination and viral illness. These episodes have become milder after initial regimen with oral and topical sodium cromolyn. The patient outcome is not recovered. Documents held by sender: None.
Age: 1.6
Sex: F
Vaccine: PER
Symptoms: Convulsion, Intensive care
Clinical narrative: Initial report was received from a consumer, who was also the patient's parent, on 16 June 2013. This reporter reported another adverse event for the same patient which was captured in case number 2013-07002. A 19-month-old female patient had received an injection of PERTUSSIS VACCINE (manufacturer, lot number, route, site and date of administration not reported) and an unspecified amount of time later had a seizure. The patient was in the ICU. No other information was available. Outcome was not reported. Documents held by sender: None.
Sex: F
Vaccine: FLUX, HIBV
Symptoms: Convulsion
Clinical narrative: Initial report was received from a consumer, who was also the patient's parent, on 16 June 2013. This reporter reported another adverse event for the same patient which was captured in case number 2013-07003. A female patient had received an injection of HIB VACCINE (manufacturer, lot number, route, site and date of administration not reported) and an injection of INFLUENZA VACCINE (manufacturer, lot number, route, site and date of administration not reported) and an unspecified amount of time later had a seizure. No other information was available. Outcome was not reported. Documents held by sender: None.
Sex: U
Vaccine: TDAP
Symptoms: Cellulitis, Injection site erythema, Injection site mass, Injection site warmth
Clinical narrative: Initial report received from a health care professional on 18 June 2013. This case represents one unidentified patient who is part of a cluster of a total of 4 patients from the same reporter, who received the same vaccine ADACEL (lot number of C4344AB). One patient, represented in this serious case involved a serious event of cellulitis. The other 3 patients involved non-serious events of redness, warm to touch and lump at injection site, that are captured in non-serious case number 2013-07027. An unidentified patient with no concurrent illnesses, and who is part of a cluster of a total of 4 patients from the same reporter, had received an intramuscular injection of ADACEL (lot number C4344AB) on an unspecified date. The patient returned to the office after vaccination on an unspecified date with symptoms of redness, warm to touch, and a lump at the injection site. The patient was treated for cellulitis with unspecified treatment. At the time of this report, the patient had recovered. Documents held by sender: none.
Age: 0.2
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC, RV1
Symptoms: Convulsion, Diarrhoea, Rotavirus infection, Rotavirus test positive, Stool analysis abnormal
Clinical narrative: This report was received from GlaxoSmithKline and was assigned manufacturer report number A1025426A concerning an infant (also reported as child) patient around 2 months of age of unspecified gender. On an unknown date the patient was vaccinated with the first dose of PEDVAXHIB (lot # and expiration date unspecified) (dose, route and anatomical location unspecified). Other concomitant vaccines included the first dose of all below, ROTARIX oral, PREVNAR and PEDIARIX (lot #, expiration date, dose, route and anatomical location unspecified for all). On an unknown date and an unspecified time after vaccination with the first dose of PEDVAXHIB, ROTARIX, PEDIARIX and PREVNAR, patient experienced seizure. On an unspecified date, around 4 months of age, patient received second dose of PEDVAXHIB, ROTARIX oral, PEDIARIX and PREVNAR (unknown details for all). The physician reported that the patient got their normal schedule of pediatric vaccines (2,4 months schedule). The physician reported that on an unspecified date, 4 days after vaccination with second dose of all vaccines, the patient experienced diarrhea and rotavirus infection. Relevant test results included a stool sample of the diarrhea. The "stool sample showed child was positive for rotavirus". At the time of the report, the outcome of convulsion, diarrhea and rotavirus infection was unknown. Upon internal review the case was considered to be medically significant because of convulsion. This was originally reported by a physician. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Injection site swelling, redness, tenderness and warm to the touch.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site mass, Injection site pain, Injection site pruritus
Clinical narrative: Itchy at site vacc. 1/2 hour after injection - quarter size lump at hs - 1 AM 6/26 (L) upper arm throbbed - site warm and red on 6/26 in AM - increased redness at noon - inner aspect (L) upper arm and lat. chest - started KEFLEX on 6/26/ pm. Dx: cellulitis of (L) arm.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth
Clinical narrative: Itchy at site vacc. 1/2 hour after injection - quarter size lump at hs - 1 AM 6/26 (L) upper arm throbbed - site warm and red on 6/26 in AM - increased redness at noon - inner aspect (L) upper arm and lat. chest - started KEFLEX on 6/26/ pm. Dx: cellulitis of (L) arm.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Patient here in clinic for PPD reading; noted varicella administered 6-25-13 in right arm, noted redness, swelling, c/o itching on 6-26-13. Patient stated applied ice pack, hydrocortisone cream, swelling and itching.
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Injection site abscess
Clinical narrative: This case was reported by a physician via sales representative and described the occurrence of injection site abscess in a subject of unspecified age and gender who was vaccinated with PEDIARIX (GlaxoSmithKline), KINRIX. On an unspecified date the subject received a dose of PEDIARIX (unknown details), a dose of KINRIX (unknown details). At an unspecified time after vaccination with either KINRIX or PEDIARIX, the subject experienced injection site abscess (described as "abscess near the injection site"). The physician mentioned that the suspect vaccine was PEDIARIX; however, one of the nurses mentioned KINRIX. No additional details were available at the time of reporting. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the event was unspecified.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 66 years old male patient with unknown medical history. On 12-JUN-2013 the patient was vaccinated with PNEUMOVAX23 (lot # 671555/1314AA, exp. date 02-MAY-2013). An administered dose of PNEUMOVAX23 was expired. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HIBV, HPV4
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report was received from a registered nurse regarding an unknown number of patients of unspecified gender and age. The registered nurse reported that doses of GARDASIL (lot number and expiration date not reported0 and PEDVAXHIB (lot number and expiration date not reported) exposed to multiple excursions to 30F since April 2013 (specific time frame unknown), were potentially administered to an unknown number of patients. Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site scab, Skin disorder
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 77 year old female patient. The patient had no drug reactions/allergies. On 08-AUG-2012 the patient was vaccinated with ZOSTAVAX (dose and lot# were unknown) by the intramuscular route. The patient had an indented area with small scab at the injection site. The outcome of events was unknown. No treatment was given for adverse event. The patient had sought medical attention via contact pharmacist. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Injection site cellulitis
Clinical narrative: Pt came into office with a look of cellulitis on left thigh.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, MNQ
Symptoms: Injection site oedema, Injection site pruritus, Injection site warmth
Clinical narrative: Case number PHEH2013US012000 is an initial spontaneous report received from a physician on 30 May 2013 and a follow up received from the physician on 24 Jun 2013. This report refers to a 12-year-old male patient. His medical history and concomitant medication were not reported. He was vaccinated with MENVEO (batch number: A11064) subcutaneously in his right arm on 28 May 2013. On 29 May 2013, he experienced localized reaction of redness, warmth and induration approximately 8 cm in his right upper arm. The patient was hospitalized on unspecified date due to these events. Two to three days later he had recovered completely from these events. Causality was not reported. Follow up information received from the physician on 24 Jun 2013: Updated site of vaccination, confirmed that the events redness, warmth and induration approximately 8 cm happened in right upper arm, onset date of events changed from 28 May 2013 to 29 May 2013, seriousness and outcome.