chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 24.0
Sex: F
Vaccine: RAB
Symptoms: Lymphadenopathy
Clinical narrative: Person received rabies vaccine #3 on 12/10/12. Called in PM 12/12/12 to say she had swollen neck glands. No other complaints from 1st & 2nd vaccine. Advised to see MD/ER. Person was called 12/13/12 in AM, said she was better and did not go to ER or see MD.
Age: 44.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pyrexia, Skin irritation, Swelling
Clinical narrative: Both immunizations provided in same arm. Pt experienced redness, swelling, fever & irritation. Followed up w/ physician and was given antibiotics and is recovering.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Oedema peripheral
Clinical narrative: Painful red swelling of injection site and extensively down arm.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Painful red swelling of injection site and extensively down arm.
Age: 45.0
Sex: M
Vaccine: HEP
Symptoms: Injection site pain, Injection site reaction, Muscle twitching
Clinical narrative: During vacccination, he developed rapid muscle twitching of left deltoid (site of injection.  He complained of intense pain after vaccination which resolved within a few minutes.  I followed up with him by phone the next morning.  He reported no further symptoms, stating his arm felt good.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Hyperaemia, Hyperthermia, Pain, Pyrexia, Swelling
Clinical narrative: PAIN, SWELLING, HYPEREMIA, HYPERTHERMIA AT LT ARM, ELBOW AND FOREARM. FEVER.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Injection site erythema, Injection site swelling
Clinical narrative: Pt had almost instant bruising after injection of the high dose flu vaccine.  Pt reported redness and swelling starting from the site of injection to about 1 inch above the antecubital area that began the day of the injection.
Age: 0.2
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Crying
Clinical narrative: PER PARENTS INCONSOLABLE CRYING NUMEROUS HOURS.
Age: 31.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site induration, Injection site mass, Injection site warmth
Clinical narrative: The evening after my flu shot I noticed that the injection site had a quarter size hard warm lump. On 12/12/12, the lump had grown to the size of an egg. I have not had any previous reactions to any vaccines, including the flu shot. I reported this to my physician's office on Thursday, 12/13/12.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea
Clinical narrative: TAKEN TO HOSPITAL ER WITH BREATHING PROBLEMS LATER IN THE DAY AFTER HAVING A FLU VACCINE AND AFTER TAKING A DOSE OF NITROFURANTOIN MACROCRYSTALS 100 MG. UNSURE IF PT TOOK PYRIDIUM SHE WAS PRESCRIBED.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling, Lymphadenopathy, Pain
Clinical narrative: Generalized body aches, swollen lymph nodes, especially on side vaccine administered ie L side.  Localized inj. site pain and swelling also.
Age: 36.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Incorrect dose administered, Pruritus, Rash
Clinical narrative: Pt stated she developed rash and itching two days after vaccination and forgot to mention to the nurse she had "tetanus shot" previously after delivery on 7/13/12 and developed rash and itching few days afterwards.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain, Breast pain, Chest X-ray normal, Diarrhoea, Dizziness
Clinical narrative: Patient presented to ER with lightheadedness, pain under left breast, neausea, diarrhea, abdominal pain and headache. Patient was sent home from ER.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Electrocardiogram normal, Headache, Nausea
Clinical narrative: Patient presented to ER with lightheadedness, pain under left breast, neausea, diarrhea, abdominal pain and headache. Patient was sent home from ER.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Myalgia, Testicular swelling
Clinical narrative: 64 YO male received the influenza vaccine (Fluvirin) on 9/24/12. Patient called the clinic on 9/26/12 with complaints of myalgias and right testicular swelling, which began after the injection. Patient spoke to the clinic nurse. Patient denied difficulty breathing, chest pain, cough, or urinary problems. Care was managed at home with advice to use OTC analgesics, avoid restrictive clothing, and restrict salt. Patient was advised to call clinic if condition worsened or persisted. Patient did not seek further medical assistance.
Age: 33.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Itching at injection site, welt near injection site, swelling at injection site, redness surrounding injection site approximately 2 inches in circumference, itching on all of upper arm.
Age: 33.0
Sex: F
Vaccine: VARCEL
Symptoms: Urticaria
Clinical narrative: Itching at injection site, welt near injection site, swelling at injection site, redness surrounding injection site approximately 2 inches in circumference, itching on all of upper arm.
Age: 62.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Insomnia, Neuropathy peripheral, Nuclear magnetic resonance imaging normal, Paraesthesia
Clinical narrative: Pain injection site next day Left Arm. Pain intensified upper arm difficult to sleep. Pain intensified and tingling developed down arm. Dr visit said I had neuropathy. Predinsone given 2 weeks. Pain less still painful at night x4 Advil per night. MRI shoulder done no structure abnormalities(per office normal wear in shoulder). PT ordered for x3 weeks and need to Follow up after with PCP (first week in January). Have had x2 therapies so far so far.
Age: 0.51
Sex: M
Vaccine: DTAPIPVHIB, FLU3, HEP, PNC
Symptoms: Muscle twitching
Clinical narrative: 20 sec episode in TOTAL; pt looked to side, 8 repetitions of arm twitching; no LOC, back to baseline; no fever; no recurrence.
Age: 39.0
Sex: M
Vaccine: MMR
Symptoms: Rash, Rash pruritic
Clinical narrative: RASH ONSET 11/13/12 OF FACE AND CHEST; MILDLY PRURITIC. NO FEVER/ARTHALGIA.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Amnesia, Apnoea, Chest X-ray, Confusional state, Convulsion
Clinical narrative: Full body shakes consistent with seizures which lasted less than 1 minute. Pt immediately fell asleep and was somnolent for approximate 10 minutes until woken by parents when EMS arived. Amnesia and postical confusion. Mouth tensed, fists clenched, eyes rolled back, and apnea were also symptoms.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Dyskinesia, Gaze palsy, Postictal state, Somnolence, Tremor
Clinical narrative: Full body shakes consistent with seizures which lasted less than 1 minute. Pt immediately fell asleep and was somnolent for approximate 10 minutes until woken by parents when EMS arived. Amnesia and postical confusion. Mouth tensed, fists clenched, eyes rolled back, and apnea were also symptoms.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Urine analysis
Clinical narrative: Full body shakes consistent with seizures which lasted less than 1 minute. Pt immediately fell asleep and was somnolent for approximate 10 minutes until woken by parents when EMS arived. Amnesia and postical confusion. Mouth tensed, fists clenched, eyes rolled back, and apnea were also symptoms.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Biopsy site unspecified abnormal, Granuloma annulare, Injection site erythema, Injection site mass
Clinical narrative: I developed a big red lump on my arm 6 weeks after vaccination.  We weren't sure it was related to the intradermal flu shot but it was located near where the original vaccination was placed.  Biopsy turned out to be 'granuloma annulare'.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Gastrointestinal pain, Generalised erythema, Hyperhidrosis, Hypoaesthesia
Clinical narrative: Swelling of throat, hives, itching, severe intestinal pain, diarrhea, profuse sweating, redness of skin on entire body, wheezing, tingling and numbness of hands and feet. Epinephrine and Benadryl administered. Pain and diarrhea for 48 hours.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Paraesthesia, Pharyngeal oedema, Pruritus, Urticaria
Clinical narrative: Swelling of throat, hives, itching, severe intestinal pain, diarrhea, profuse sweating, redness of skin on entire body, wheezing, tingling and numbness of hands and feet. Epinephrine and Benadryl administered. Pain and diarrhea for 48 hours.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Wheezing
Clinical narrative: Swelling of throat, hives, itching, severe intestinal pain, diarrhea, profuse sweating, redness of skin on entire body, wheezing, tingling and numbness of hands and feet. Epinephrine and Benadryl administered. Pain and diarrhea for 48 hours.
Age: 32.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Mobility decreased, Musculoskeletal stiffness, Pain
Clinical narrative: Very painful when administered. Stiff and sore in the evening. Could hardly lift arm. Applied ice.
Age: 2.0
Sex: F
Vaccine: HEPA, PPV
Symptoms: Abasia, Cellulitis, Pyrexia, Swelling
Clinical narrative: Child at daycare. Daycare called mtr. to tell her child had fever of 102.8; and unable to walk. Mtr. states "leg went out". Mtr took child to Emergency Room and ER diag. Cellulitis-gave antibiotics inst. cold packs for swelling. 12/13/12 mtr states child better fever reduced, is able to walk, however not completely resolved.
Age: 65.0
Sex: F
Vaccine: PPV, TDAP, VARZOS
Symptoms: Chills, Fatigue, Injection site erythema, Pyrexia, Vomiting
Clinical narrative: 12/11/2012 vomited x 1, fatigued, fever and chills. Left arm red at injection site. 12/12/2012 vomited x 1, fatigued, fever and chills.
Age: 60.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site pain
Clinical narrative: PAIN AT INJECTION SITE.  NO REDNESS OR SWELLING.
Age: 7.0
Sex: M
Vaccine: FLUX
Symptoms: Chills, Pallor, Pyrexia, Sluggishness, Stomatitis
Clinical narrative: Sluggish, pale face, fever, chills, mouth sores (40+).
Age: 39.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Bursitis, Hypoaesthesia, Joint crepitation, Muscular weakness
Clinical narrative: Extreme arm weakness, numbness in all 5 fingers.  Tingling in arm.  Pain in shoulder area.  Went to ER on 10/4/12.  Weakness improved, but pain in shoulder region has only gotten worse.  Soreness in rotator cuff area.  Examined by Physician Asst. in November.  Examined by primary care physician on 12/12/2012.  Physician recommends NSAIDS and soft tissue scan and refer to orthopedic specialist.  Possible nerve/rotator cuff injury.  Bursitis type symptoms are constant.  Shoulder "pops" and "snaps" loud enough to hear close to 100 times per day.
Age: 39.0
Sex: M
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Paraesthesia
Clinical narrative: Extreme arm weakness, numbness in all 5 fingers.  Tingling in arm.  Pain in shoulder area.  Went to ER on 10/4/12.  Weakness improved, but pain in shoulder region has only gotten worse.  Soreness in rotator cuff area.  Examined by Physician Asst. in November.  Examined by primary care physician on 12/12/2012.  Physician recommends NSAIDS and soft tissue scan and refer to orthopedic specialist.  Possible nerve/rotator cuff injury.  Bursitis type symptoms are constant.  Shoulder "pops" and "snaps" loud enough to hear close to 100 times per day.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Delirium, Dizziness, Headache, Pyrexia
Clinical narrative: Fever to 103, delirium, HA, lightheaded, dizziness.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Contusion, Pain in extremity
Clinical narrative: Bruising and soreness from Deltoid down to elbow.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Panic attack, Paralysis
Clinical narrative: NUMBNESS IN ALL LIMBS, THEN PARALYSIS IN HANDS FOR APPROX 5 MINS, NUMBNESS IN LIPS, THEN SUBSIDED, BUT THE NUMBNESS CONTINUED, WENT TO THE HOSPITAL, THYEY STATED IT WAS A PANIC ATTACK AND PRESCRIBED ATIVAN.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Neuralgia, Sensory disturbance
Clinical narrative: Sudden nerve pain made worse by stretching arm. Patient explains it as a tearing of the muscle sensation. Pain located about 5 inches south of the injection site on arm.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, FLU3, PNC, RV5
Symptoms: Pyrexia, Vomiting
Clinical narrative: Mother stated that last night child began to have voming/fever.
Age: 2.0
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Convulsion, Crying, Incorrect dose administered, Musculoskeletal stiffness
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of seizure in a 24-month-old male subject who was vaccinated with HAVRIX (GlaxoSmithKline). On 17 September 2012 at 08:14 the subject received 3rd dose of HAVRIX (.5 unknown, unknown). On 18 September 2012, less than one day after vaccination with HAVRIX, the subject experienced seizure, leg stiffness, cried all day and extra dose administered. The healthcare professional reported the subject experienced seizures following a HAVRIX vaccination received on 17 September 2012. That day the mother noticed that his legs got really stiff and he cried all day. The next day on 18 September 2012 he had a seizure. He has had a total of three episodes, but the reporter did not know the dates. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the seizure, legs stiff and cried all day were unspecified.
Age: 2.0
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Breath holding, Crying, Screaming, Seizure like phenomena
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of seizure in a 24-month-old male subject who was vaccinated with HAVRIX (GlaxoSmithKline). On 17 September 2012 at 08:14 the subject received 3rd dose of HAVRIX (.5 unknown, unknown). On 18 September 2012, less than one day after vaccination with HAVRIX, the subject experienced seizure, leg stiffness, cried all day and extra dose administered. The healthcare professional reported the subject experienced seizures following a HAVRIX vaccination received on 17 September 2012. That day the mother noticed that his legs got really stiff and he cried all day. The next day on 18 September 2012 he had a seizure. He has had a total of three episodes, but the reporter did not know the dates. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the seizure, legs stiff and cried all day were unspecified.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Influenza like illness, Pain, Pyrexia
Clinical narrative: Fever, body aches, flu-like symptoms. Treatment - TAMIFLU.
Age: 8.0
Sex: F
Vaccine: FLUN3
Symptoms: Urticaria, Vomiting
Clinical narrative: 1500 Inj given. 1630 Symptoms started. 1800 Pt vomited / hives began immed. 1839 Emergency Room. 1900 Triaged. 2000 Given 3 inj. 2 doses of Epi, 25 mg BENADRYL, liquid dose of Prednisone. Pt is to take meds x 5 days.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a Grandparent consumer refers to his grandchild of unknown age. On an unspecified date, the patient was vaccinated with dose 3 GARDASIL, inj (dose, frequency, therapy route, product lot number were not provided). No other co-suspects were reported. No concomitant medications were reported. The vaccine was administered outside the prescribing information. The patient received the series every two months for the 3 doses. No adverse effect reported. The outcome of the patient received the third dose two months after the second one and no adverse effect reported was unknown. Additional information is not expected.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Pain in extremity
Clinical narrative: Sore arm and "chills".
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a female patient of unknown age. The patient was vaccinated with dose 2, 1 DF GARDASIL on NOV-2012 and dose 1, 1 DF on DEC-2012. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced inappropriate schedule. No treatment information was reported. The outcome of inappropriate schedule is unknown. Inappropriate schedule is not related to GARDASIL. No symptoms reported. No other details provided.
Sex: U
Vaccine: HPV4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with GARDASIL (Lot # 0768Z/ 10/17/2012) on 05-DEC-2012. No other co-suspects were reported. No concomitant medications were reported. On 05-DEC-2012 the patient experienced expired drug administered, 1 day after onset of therapy. No treatment information was reported. The outcome of expired drug administered is unknown. Expired drug administered is not related to GARDASIL. No adverse symptoms reported. No further information provided. Additional information is not expected.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Chest pain, Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: Vaccine given in right arm. Pain started just after leaving doctor's office. Pain extended from right shoulder and shoulder blade down arm to fingers. This pain was strong and lasted about one week. Pain also radiated into front chest shoulder area and into back. Pain lasted like this for at least 4 months, then has continued since then if arm lifted to certain degree or if over used.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: X-ray limb
Clinical narrative: Vaccine given in right arm. Pain started just after leaving doctor's office. Pain extended from right shoulder and shoulder blade down arm to fingers. This pain was strong and lasted about one week. Pain also radiated into front chest shoulder area and into back. Pain lasted like this for at least 4 months, then has continued since then if arm lifted to certain degree or if over used.
Age: 68.0
Sex: F
Vaccine: TD, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Lethargy
Clinical narrative: Shot 2 PM Thurs - 24 hr later I felt very lethargic, slept 12 hrs straight - another 24 hrs and the area of shot became very warm - another 24 hrs area was very very very warm and swelled and turned bright red - took BENADRYL 1 day - all seems to slowly go away.
Age: 5.0
Sex: F
Vaccine: DTAPHEPBIP, FLUN3, HEPA, MMR, VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Denies any adverse reactions. FLUMIST expired 12/3/12 & was given on 12/10/12.
Age: 8.0
Sex: F
Vaccine: FLUN3, HEP, HEPA, IPV, MMR, TD, VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Denies any adverse reactions. FLUMIST expired on 12/3/12 & was given on 12/10/12.
Age: 4.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: FLUMIST expired on 12/3/12 & was given on 12/10/12. Mother denies any adverse reactions.
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Rash
Clinical narrative: Had vaccines on 12/11/12, DAPTACEL and PEDVAXHIB. Developed fine rash on the next day. Advised to watch for urticarial lesions as discussed at Dr's appt today.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Oedema peripheral, Pain in extremity
Clinical narrative: Pt states had more swelling of arm than normal, but no fever. Stomach cramps and sore arm. Saw Dr. 12-13 for unrelated prob & he was not concerned.
Age: 5.0
Sex: U
Vaccine: DTAP, FLU3
Symptoms: Rash macular
Clinical narrative: Minimal erythema macular lesion to cheeks bilateral with 5-10 min of Influenza vaccine administration treated with Diphenhydramine.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site urticaria
Clinical narrative: 12-12-12 PM noted redness at injection site. 12-13-12 AM 5cm "itchy" wheal surrounding injection site. Tx: hydrocortisone 1% cream topical and BENADRYL po.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Pain
Clinical narrative: Client reports she experienced pain approximately 48 hours after injection which required steroid injection, FLEXERIL, naproxen & VOLTAREN gel - has MRI scheduled.
Age: 13.0
Sex: M
Vaccine: FLU3
Symptoms: Body temperature increased
Clinical narrative: Pt seen for well child check by provider at 8 AM 12/12/12. Mother reported 12/13/12 that he had a temp of 103 8PM (approx 12 hrs later). Resolved with fever reducer obtained over the counter.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Ophthalmological examination, Pain, Paraesthesia, Rash, Vision blurred
Clinical narrative: Pt. c/o spots that were stinging on right side of face and came into clinic 12/11/12. Describes pins and needles pain. Vision slightly blurry in (L) eye.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral, Pruritus
Clinical narrative: Swelling and itching in the entire arm of pneumonia shot.
Age: 46.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: (R) arm approx 6" x 6" red area - very sore - 8 hours after injection - in bed. LCL from inj - hot - sore - visibly swollen/red.
Age: 46.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: (R) arm approx 6" x 6" red area - very sore - 8 hours after injection - in bed. LCL from inj - hot - sore - visibly swollen/red.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered pharmacist refers to patient of unknown age (gender unspecified). On 29-NOV-2012, the patient was vaccinated with 0.65 ml ZOSTAVAX, (lot number reported as 1269AA, expiration date 05-NOV-2012), subcutaneously which had expired on 05-NOV-2012. No concomitant medications were reported and no adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered pharmacist refers to a patient of unknown age (gender unspecified). The pharmacist reported that he received a call from long term care facility stating that on an unknown date in November 2012, the patient was vaccinated with a dose of PNEUMOVAX23 (lot number, expiration and route not reported) and another dose this week ((November 2012)). The doses were given approximately one week apart. The name of the long term care facility was unknown. No symptoms were reported. No concomitant medications were reported. It was unspecified if patient sought medical attention. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to multiple unspecified patients of unknown age (gender unspecified). The nurse reported that approximately on an unknown date in November 2012, the patients may have received doses of PNEUMOVAX 23, (lot number, expiration date and route was not reported) that had been exposed to unsupportable cold temperatures. No concomitant medications were reported. It was unknown if or not any individual patient might have received more than one of the affected vaccines. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age. The patient was vaccinated with first dose of VARIVAX (merck) (Lot#, dose, route unspecified) on 09-NOV-2012. On 10-DEC-2012 the patient received an expired dose of VARIVAX (merck) (Lot# reported as 1695z, Exp date as 09-DEC-2012, dose, route unspecified) which was the patient's second dose. No adverse effect reported. No treatment information was reported. The outcome was unknown. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Local reaction, Tenderness
Clinical narrative: This spontaneous report as received from a consumer refers to a 55 years old female pharmacy technician concerning herself. The patient was vaccinated with a dose of 0.65 ml ZOSTAVAX (subcutaneous injection, lot and batch number not reported) in OCT-2012. No other co-suspects were reported. No concomitant medications were reported. In October 2012 within 48 hours of receiving the vaccine the patient experienced a local reaction. The reaction was an oval shaped "atrusion" from her arm. The site was 2 inches long by one inch and a half wide. This reaction lasted for about a month, and is still sensitive to touch. The patient asked a pharmacist, where she works and location where she received the vaccine, for advice. No treatment was given. The outcome of local reaction: an oval shaped "atrusion" from her arm was unknown. The outcome of sensitive to touch was reported as not recovered/not resolved. The relatedness for local reaction: an oval shaped "atrusion" from her arm and sensitive to touch is unknown for ZOSTAVAX. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report as received from an office administrator via company representative refers to a female patient of unknown age. On an unspecified date, the health care professional gave the patient with one of the expired ZOSTAVAX (lot number, expiry date, dose and route were not reported) before realizing it that it was expired. It was probably a couple weeks past the expiration date. No concomitant medications were reported. The patient was advised to come back and get another one but was wondering if that was necessary or if it would still be effective in protecting the patient. It was unspecified if the patient unspecified if the patient sought medical attention. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: This spontaneous report as received from a consumer refers to a 73 years old female patient with high cholesterol and penicillin allergy. On 27-NOV-2012, the patient was vaccinated with a dose of ZOSTAVAX (Lot number, expiry date and dose were unspecified) subcutaneously. Concomitant medications included CRESTOR, SYNTHROID, omega-3 marine triglycerides (fish oil), calcium (unspecified) and aspirin (Baby aspirin). On 30-NOV-2012, the patient experienced itching on her back. The patient stated that the event was not bad and she would advise her doctor. It was unspecified if the patient sought medical attention. No treatment was given. The outcome of itching on her back was unknown. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Respiratory tract infection
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender with no pertinent medical history and drug allergies reported, who on 01-DEC-2012, was vaccinated with ZOSTAVAX (lot #, dose and route note provided). No concomitant medications were reported. The pharmacist stated that on unspecified date, a patient who received ZOSTAVAX on 01-DEC-2012 presented to the pharmacy to fill a prescription for Prednisone 60 mg daily for 5 days and an unspecified antibiotic to treat a respiratory infection. There was not specified if the patient developed the symptoms after receipt of ZOSTAVAX. The pharmacist stated that the patient's respiratory infection was not related to the receipt of ZOSTAVAX. The patient sought medical attention by physician examination. The outcome of respiratory tract infection was reported as not recovered/not resolved. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Headache, Injection site cellulitis, Pain, Pyrexia
Clinical narrative: This spontaneous report was received from a registered pharmacist concerning a 66 year old female patient with no drug reactions/allergies. Concomitant condition of the patient included chronic obstructive pulmonary disease. On 15-NOV-2012, the patient was vaccinated with 0.65 milliliter (ml0 ZOSTAVAX (lot number reported as H013023, expiry date: October 2013), subcutaneously. Patient received oxygen concomitantly, unspecified volume per minute. On an unknown date in November 2012, after the receiving the dose of ZOSTAVAX, the patient experienced headache, body ache and a low grade fever of unspecified temperature. She also reported a large red welt (unspecified measurement) which was too hot to touch for which she saw a physician. Patient sought medical attention (office visit). She was diagnosed with cellulitis at injection site and she was prescribed with unspecified antibiotics (manufacturer unknown). The outcome of body ache, low grade fever of unspecified temperature, headache and cellulitis at injection site was unknown. The relatedness for cellulitis at injection site, low grade fever of unspecified temperature, body ache and headache was unknown for ZOSTAVAX. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm, Urticaria
Clinical narrative: This spontaneous report was received from a registered pharmacist concerning a 66 year old female patient with no drug reactions/allergies. Concomitant condition of the patient included chronic obstructive pulmonary disease. On 15-NOV-2012, the patient was vaccinated with 0.65 milliliter (ml0 ZOSTAVAX (lot number reported as H013023, expiry date: October 2013), subcutaneously. Patient received oxygen concomitantly, unspecified volume per minute. On an unknown date in November 2012, after the receiving the dose of ZOSTAVAX, the patient experienced headache, body ache and a low grade fever of unspecified temperature. She also reported a large red welt (unspecified measurement) which was too hot to touch for which she saw a physician. Patient sought medical attention (office visit). She was diagnosed with cellulitis at injection site and she was prescribed with unspecified antibiotics (manufacturer unknown). The outcome of body ache, low grade fever of unspecified temperature, headache and cellulitis at injection site was unknown. The relatedness for cellulitis at injection site, low grade fever of unspecified temperature, body ache and headache was unknown for ZOSTAVAX. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chest pain, Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 72 years old female patient. The patient was vaccinated with dose ZOSTAVAX in DEC-2011 (Lot number and route unknown). No other co-suspects were reported. No concomitant medications were reported. In DEC-2012 the patient developed stomach upset, pain in chest area and rash since receiving ZOSTAVAX. No treatment information was reported. The outcome of stomach upset, rash and pain in chest area was reported as not recovered. The relatedness for stomach upset, pain in chest area and rash was not reported for ZOSTAVAX. Discrepant information: onset date was "last couple of days" but in the narrative it was reported since receiving ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: VARCEL
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 and gender with no drug reactions or allergies and no pertinent medical history who on unspecified date, was vaccinated with VARIVAX (merck) (lot # and dose not provided). No concomitant medications were reported. The physician stated that on unspecified date, a patient received 2 doses of VARIVAX (merck) separated by 21 days, the dates of administration were unspecified. No known adverse effects. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician refers to two patients of unknown age. The patient were vaccinated with a dose of ZOSTAVAX (lot #, dose and route not reported) on unspecified dates. No other co-suspects were reported. No concomitant medications were reported. The physician reported that the patients were administered ZOSTAVAX and subsequently developed shingles on unspecified dates. No treatment information was reported. The patients sought unspecified medical attention and the physician was aware of both cases. The outcome of shingles is unknown. The relatedness for shingles was not provided for ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: PPV, VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse reported that she had two providers at separate locations, administered expired vaccine. These two cases might have been already reported to MNSC but the nurse did not have any specific information regarding two cases and cases could not be located in USCC. PNEUMOVAX was administered two days past expiration date and ZOSTAVAX was administered 2 months past expiration date (lot # and exp date unspecified). No adverse effects reported. No treatment information was reported. The relatedness for used expiration vaccine is unknown for PNEUMOVAX 23 and ZOSTAVAX. The outcome of used expired vaccine is unknown. No additional information was provided. All drop-down fields apply for both PNEUMOVAX 23 and ZOSTAVAX.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an adult patient of unknown age. The patient was vaccinated with an expired dose of MMR II (lot # 1089Z exp date 24-AUG-2012) (dose and route not reported) on 11-DEC-2012. No other co-suspects were reported. No concomitant medications were reported. The medical assistant mentioned that the patient said he received MMR II as a child but did not know the total number of doses. Because the patient's past vaccination record was unavailable the physician decided to give him one dose of MMR II (which was the expired dose). No symptoms were reported. Additional information is not expected.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Muscular weakness, Neuralgia, Vomiting
Clinical narrative: This spontaneous report was received from a 78 years old male patient reporting on himself with no pertinent medical history, drug reactions or allergies. The patient was vaccinated with a dose of ZOSTAVAX (lot #, dose and route not reported) on 27-NOV-2012. No other co-suspects were reported. No concomitant medications reported. It was reported that the day after the patient received the vaccine on 28-NOV-2012, his legs felt weak and was followed by vomiting. The patient also had nerve pain on his back "middle of the back". It was unknown if the patient sought medical attention. No treatment was given for the events and no lab diagnostic tests were performed. The outcome of legs felt weak, vomiting is unknown and nerve pain on his back. The relatedness for the reported events was not provided for ZOSTAVAX. Additional information is not expected.
Age: 67.0
Sex: F
Vaccine: HEP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to an adult patient of unknown age. The patient was vaccinated with dose 1, dose 2 and dose 3 of RECOMBIVAX HB (lot #, dose and route not reported) on 23-SEP-2012, 23-OCT-2012 and 24-NOV-2012 respectively. No other co-suspects were reported. No concomitant medications were reported. No adverse symptoms were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age with immunization. The patient was vaccinated with .65 ml ZOSTAVAX on MAY-2012. No other co-suspects were reported. Concomitant medications included: ENTOCORT. On NOV-2012 the patient experienced shingles. No treatment information was reported. The outcome of shingles is unknown. The relatedness for shingles is unknown for ZOSTAVAX. Reporter declined to give patient information or any information about the physician, but reported that physician had reported the AE to manufacturer, had received and collected VZV samples, and was waiting for the results. Unable to locate prior case. No further information provided. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a Registered pharmacist concerning a patient of unknown age who was vaccinated with a dose of 0.5 ml (Merck) VARIVAX, SQ (lot # not provided) on 08-DEC-2012 when suppose to get ZOSTAVAX. The patient was not experiencing any known symptoms. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Erythema, Induration, Pain in extremity, Pyrexia
Clinical narrative: This spontaneous report as received from a consumer refers to a 73 years old female patient. The patient was vaccinated with PNEUMOVAX23 on 05-DEC-2012 (Lot # unspecified). No other co-suspects were reported. No concomitant medications were reported. By 11.00 pm on 05-DEC-2012 the patient experienced 102F fever and chills, arm was red, hard and painful from her shoulders to her elbow. The patient contacted the pharmacy on 26-DEC-2012 for medical recommendation. Two BENADRYL tablets were taken for treatment. The outcome of fever and chills was reported as recovered/resolved by the morning of 06-DEC-2012. The outcome of arm was red and painful was reported as not recovered/not resolved. The relatedness for fever and chills and arm was painful and red is unknown for PNEUMOVAX23. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Erythema, Local reaction, Pain in extremity, Vaccination complication
Clinical narrative: This spontaneous report as received from a consumer refers to a 68 years old male patient. The patient's medical history included penicillin allergy. The patient was vaccinated with ZOSTAVAX on 03-DEC-2012 [Lot # unspecified]. The consumer stated that a pneumonia vaccine was given at the same time as ZOSTAVAX. No other co-suspects were reported. Concomitant medications included SINOPRYL, pravastatin sodium, and diltiazem hydrochloride. On 04-DEC-2012 the patient experienced pain and redness on his left arm. The patient was seen by a nurse who advised it was a local reaction to the vaccine. The patient stated the pain has subsided but the redness is from his elbow to just below his elbow. The patient reported the redness has started to subside. No treatment information was reported. The outcome of pain in his left arm was reported as recovered/resolved. The outcome of redness on his left arm was reported as recovering/resolving. The relatedness for pain in his left arm and redness on his left arm is unknown for ZOSTAVAX. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Rash, Tremor
Clinical narrative: Patient reported, who declined to provide demographics, reports that he received ZOSTAVAX on an unspecified date described as approximately three weeks ago, and subsequently developed a disseminated upper body rash as well as worsening of an arm tremor he has had since birth. Patient reports that the rash spontaneously resolved approximately two weeks after it started, but that the worsened arm tremor remains. Patient declined to provide his physician's identity and disconnected the call before all questions could be asked. Patient reports that he has been allergic to all antibiotics since experiencing a bout of Stevens-Johnson Syndrome in 2003. Patient also reports that following administration of an unspecified antibiotic, during an unspecified surgery on an unspecified date in 2011, he experienced a disseminated and severe rash over the entire body that persisted for weeks before resolving. No further information is available.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Urine analysis, Viral titre
Clinical narrative: This spontaneous report was received from an approximately 61 year old (reported as over 60 years) female patient of with no pertinent medical history and no drug reactions/allergies. On 10-JUN-2008, the patient was vaccinated with 0.65 milliliter (ml) ZOSTAVAX (lot number and expiry date unspecified), subcutaneously. She received the vaccine after telling her physician that she was not sure if she had ever had chickenpox and requested a titer test. The physician told her that the titer test was not necessary. No concomitant medications were reported. Approximately in June 2008, soon after receiving the ZOSTAVAX, she experienced itching along the temples, face, jaw and neck. She went to another physician. She was treated with an unspecified antibiotic but it was discontinued on an unknown date. On 10-DEC-2010, she received a titer test that listed her titer value as 1.79. She also received a physical test and urine analysis on an unknown date and the results were unknown. The patient reported that the itching had diminished. The relatedness for itching along the temples, face, jaw and neck is unknown for ZOSTAVAX. Additional information has been requested.
Age: 1.08
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Scab, Varicella post vaccine
Clinical narrative: This spontaneous report as received from a nurse refers to a 13 months old female patient who on an unspecified date was vaccinated subcutaneously with a dose of 0.5 ml VARIVAX (Merck) (lot number was not reported). No other co-suspects were reported. No concomitant medications were reported. The nurse reported that the patient was scheduled to receive VARIVAX (Merck) at 12 and 13 months of age (also reported as weeks) but she was diagnosed with chicken pox. Treatment was given by physician (treatment regimen was unspecified) and VARIVAX (Merck) was given at 13 months of age once the vesicles had crusted over. No adverse reaction reported. At the time of the report, the patient's outcome for the adverse event was unknown. The relatedness for the adverse event was unknown for VARIVAX (Merck). Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site vesicles
Clinical narrative: This spontaneous report as received from a other health professional refers to a 73 years old female patient. The patient was vaccinated with ZOSTAVAX on 17-SEP-2012. No other co-suspects were reported. No concomitant medications were reported. On 18-SEP-2012 the patient experienced redness around the injection site, 2 days after onset of therapy. No treatment information was reported, patient made phone call to medical office. The outcome of redness around the injection site was reported as recovered/resolved. The relatedness for redness around the injection site is unknown for ZOSTAVAX. No further information was provided.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report as received from a other health professional refers to a 73 years old female patient. The patient was vaccinated with ZOSTAVAX on 17-SEP-2012. No other co-suspects were reported. No concomitant medications were reported. On 18-SEP-2012 the patient experienced redness around the injection site, 2 days after onset of therapy. No treatment information was reported, patient made phone call to medical office. The outcome of redness around the injection site was reported as recovered/resolved. The relatedness for redness around the injection site is unknown for ZOSTAVAX. No further information was provided.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Injection site erythema, Injection site vesicles
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 73 years old female patient with DEMEROL allergy and VICODIN allergy. The patient was vaccinated with, 1 vial ZOSTAVAX on 06-DEC-2012, product Lot/expiry date: H013938, Exp 25-OCT-2013. No other co-suspects were reported. No concomitant medications were reported. On 07-DEC-2012 the patient experienced redness at the back of the arm to "cherry" red from elbow to arm pit and a burning, painful,and itchy blister at the injection site, 2 days after onset of therapy. It was reported that treatment given for the adverse events was steroid. The outcome of redness at the back of the arm grown to "cherry" red from elbow to arm pit and a burning, painful, and itchy blister at the injection site was reported as not recovered/not resolved. The reporters relatedness for redness at the back of the arm grown to "cherry" red from elbow to arm pit and a burning, painful, and itchy blister at the injection site is unknown for ZOSTAVAX. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Injection site pain, Injection site pruritus, Injection site vesicles, Pain in extremity
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 73 years old female patient with DEMEROL allergy and VICODIN allergy. The patient was vaccinated with, 1 vial ZOSTAVAX on 06-DEC-2012, product Lot/expiry date: H013938, Exp 25-OCT-2013. No other co-suspects were reported. No concomitant medications were reported. On 07-DEC-2012 the patient experienced redness at the back of the arm to "cherry" red from elbow to arm pit and a burning, painful,and itchy blister at the injection site, 2 days after onset of therapy. It was reported that treatment given for the adverse events was steroid. The outcome of redness at the back of the arm grown to "cherry" red from elbow to arm pit and a burning, painful, and itchy blister at the injection site was reported as not recovered/not resolved. The reporters relatedness for redness at the back of the arm grown to "cherry" red from elbow to arm pit and a burning, painful, and itchy blister at the injection site is unknown for ZOSTAVAX. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash pruritic
Clinical narrative: This spontaneous report as received from a pharmacist refers to a  66 years old female patient with penicillin allergy, and none pertinent medical history. The patient was vaccinated with a dose of ZOSTAVAX (lot # 672605/1658AA), SQ on 05-AUG-2012. Concomitant medications included oxycodone, acetaminophen, VICODIN, doxycycline and BACTROBAN. On 12-AUG-2012 (one to two weeks after vaccination) the patient experienced rash all over the body. The patient went to an emergency room to see the doctor but was not admitted. A cream was used for the itching. The outcome of rash all over the body was reported as not recovered/not resolved. The relatedness for rash all over the body was unknown for ZOSTAVAX. Additional information is not expected.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pruritus, Rash generalised
Clinical narrative: This spontaneous report as received from a pharmacist refers to a  66 years old female patient with penicillin allergy, and none pertinent medical history. The patient was vaccinated with a dose of ZOSTAVAX (lot # 672605/1658AA), SQ on 05-AUG-2012. Concomitant medications included oxycodone, acetaminophen, VICODIN, doxycycline and BACTROBAN. On 12-AUG-2012 (one to two weeks after vaccination) the patient experienced rash all over the body. The patient went to an emergency room to see the doctor but was not admitted. A cream was used for the itching. The outcome of rash all over the body was reported as not recovered/not resolved. The relatedness for rash all over the body was unknown for ZOSTAVAX. Additional information is not expected.