chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Chest pain, Electrocardiogram normal, Laboratory test normal, Troponin
Clinical narrative: This study case was received from the investigator on 16 August 2012. A male subject with medical history of smoking experienced on 10 August 2012 one brief episode of mild non-exertional chest pain 1 day after he had received on 09 August 2012 the following vaccines: ACAM2000 (lot number, route and site of administration not reported), and an injection of TYPHOID VACCINE (lot number, route and site of administration not reported), and an injection of Anthrax vaccine (lot number, route and site of administration not reported). On 16 August 2012, the subject was evaluated for follow-up of smallpox vaccination and reported that on 10 August 2012 while he was sitting smoking a cigarette he experienced one brief episode of mild chest pain. The subject did not take any medications to treat the SAE, and did not seek medical attention. Laboratory test revealed a negative "rapid" test, and an EKG revealed no signs of ischemia. Troponin results were to follow. The subject marked "no hurt" on Wong Baker scale. The subject was referred to his PCM (Primary Care Manager). The investigator reported that the chest pain was unlikely to be cardiac. It was noted the subject had a history of left ankle pain that began on 14 November 2011 (reported as 2012) and was being treated with Naproxen 1 tab 4 times a day that was started on 15 August 2012. This represents a case of potential myopericarditis per the Investigator and has subsequently been referred to the Adjudication Committee for assessment. Documents held by sender: none.
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Electrocardiogram normal, Troponin I increased, Troponin increased
Clinical narrative: This study case was received from the investigator on 16 August 2012. A male subject with no reported past medical history was found to have on 03 August 2012 mild, asymptomatic, transient elevated Troponin level of 0.11 ng/ml 9 days after the subject had received on 25 July 2012 the following vaccines: ACAM2000 (lot number, route and site of administration not reported) and an injection of Anthrax vaccine (manufacturer name, lot number, route and site of administration not reported). On 07 August 2012, the subject was notified of elevated Troponin level of 0.11 ng/ml, and a repeat Troponin-I level and ECG were performed the same day. Troponin result was reported as less than 0.10 ng/ml, and the ECG was normal. The subject received adequate follow-up from his PCM (Primary Care manager) and no further workup/treatments were necessary. No further information was available at the time of the report. The subject's outcome was recovered/resolved on 07 August 2012 (4 days after onset). The investigator considered the SAE to be possibly related to the vaccinations and was also considered to be an "other important medical event." This represents a case of potential myopericarditis per the Investigator and has subsequently been referred to the Adjudication Committee for assessment. Documents held by sender: none.
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Electrocardiogram normal, Troponin increased
Clinical narrative: This study case was received from the investigator on 16 August 2012. A male subject with no reported past medical history was found to have on 03 August 2012 mild, asymptomatic, transient elevated Troponin level of 0.11 ng/ml 9 days after the subject had received on 25 July 2012 the following vaccines: ACAM2000 (lot number, route and site of administration not reported) and an injection of Anthrax vaccine (manufacturer name, lot number, route and site of administration not reported). On 07 August 2012, the subject was notified of elevated Troponin level of 0.11 ng/ml, and a repeat Troponin-I level and ECG were performed the same day. Troponin result was reported as less than 0.10 ng/ml, and the ECG was normal. The subject received adequate follow-up from his PCM (Primary Care manager) and no further workup/treatments were necessary. No further information was available at the time of the report. The subject's outcome was recovered/resolved on 07 August 2012 (4 days after onset). The investigator considered the SAE to be possibly related to the vaccinations and was also considered to be an "other important medical event." This represents a case of potential myopericarditis per the Investigator and has subsequently been referred to the Adjudication Committee for assessment. Documents held by sender: none.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: Patient developed cellulitis from reaction to injection - placed on antibiotic - KEFLEX per MD. Seen on 8/20/12.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Chills, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Moderate injection site, pain, swelling, erythema, and heat/hot to touch. Body ache, chills, joint soreness. Reaction to Tdap vaccine.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site warmth, Pain
Clinical narrative: Moderate injection site, pain, swelling, erythema, and heat/hot to touch. Body ache, chills, joint soreness. Reaction to Tdap vaccine.
Age: 17.0
Sex: F
Vaccine: HPV4, IPV, MMR, MNQ, TDAP, VARCEL
Symptoms: Asthenia, Loss of consciousness, Nausea, Pallor
Clinical narrative: See page 2. 1250- Became pale and lost consciousness briefly - did not fall and was able to walk to the bed. Skin pale but dry. 1255 B/P 90/70 P-64 130 B/P 100/70 P- 64 1205 - BP 100/70 P-74 Awake oriented, but continued to feel weak and nauseous. Transported to hosp at 1310.
Age: 16.0
Sex: M
Vaccine: HEP, HEPA, IPV, TDAP
Symptoms: Seizure like phenomena, Syncope
Clinical narrative: Syncopal episode with seizure-like activity of the extremities for 3-5 seconds.
Age: 40.0
Sex: F
Vaccine: HEP
Symptoms: Injection site pain, Limb discomfort, Musculoskeletal discomfort, Oedema peripheral, Pain in extremity
Clinical narrative: Describes injection site soreness, discomfort in hand & shoulder (L) staring 2 hours after injection - went to ED. Next day increasing discomfort & swelling of (L) hand. 6 days later reported to me - (L) hand still swollen - describes shooting pain (occasional) in both arms & legs (reaction) again went to ED - Neurologist referral.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Skin lesion
Clinical narrative: Lesions on body.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Lesions on body.
Age: 86.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt had extensive redness/swelling of heat from injection site in deltoid all the way to the pt's antecubicle space upon waiting day after vaccine given. Dr. her PCP was contacted and relayed treatment (left arm).
Age: 3.0
Sex: M
Vaccine: FLUN3
Symptoms: Diarrhoea, Influenza, Pyrexia, Vomiting
Clinical narrative: Pt. was diagnosed with influenza at UC. Vomiting, diarrhea, fever up to 106.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Pt had DTaP & Varicella vaccine 8/14/12 in (R) thigh 2 days later area was red, itchy & swollen (size of apricot per mom) Rx with hydrocortisone topical & ice) since then area has enlarged, still "itchy" & warming.
Age: 1.36
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: MMR 5/14. Rash & fever 103.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Cyanosis, Extrasystoles, Syncope
Clinical narrative: Pt had 2 syncopal episodes with in minutes of each other, the first being 1 min. after tdap given (L) deltoid. As NP was listening to apical pulse noted app. 10 sec pause in heart beat & pt. was cyanotic but then recovered. 911 was notified & pt was taken to hospital.
Age: 1.4
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Injection site induration, Injection site swelling
Clinical narrative: Localized swelling and induration (L) anterior thigh. Onset 24 hours 7cm Treating with NSAID & Antihistamine.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: 5cm local erythematous indurated pruritic lesion at site of varicella injection.
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Induration, Inflammation, Pain in extremity, Skin warm
Clinical narrative: Lt arm red & inflamed & indurated reaction 4" long & 4" wide - painful at times - warm to touch.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Pyrexia
Clinical narrative: Redness, swelling around injection site itching, fever.
Age: 65.0
Sex: F
Vaccine: TD, VARZOS
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Hot swollen rt upper arm x 5 days.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Rash papular
Clinical narrative: (L) deltoid with erythema & mild induration. Diffuse papular rash.
Age: 11.0
Sex: F
Vaccine: HPVX, TDAP
Symptoms: Nausea, Pyrexia, Tremor, Vomiting
Clinical narrative: Slight fever.  Trembling. Nauseous.  Eventually vomited.  Symptoms last appox 20 hours.
Age: 29.0
Sex: F
Vaccine: HEPA
Symptoms: Chills, Malaise, Myalgia
Clinical narrative: Slept 8 hours after injection.  Awoke with chills, malaise & sore muscles.  Took self to ER.  Was evaluated & released after few hours assessment.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Ear pain, Lymphadenopathy, Mass, Pain, Rash
Clinical narrative: 8-19-12 --> earache glands swollen 8/21/12 - Doctor visit no diagnosis. 8-23-12 bumps & rash in hair - not itchy, painful, lump in middle of head. Stabbing pain 8-24-12 - Doctor visit "doesn't look like shingles" take MOTRIN for pain antibiotic KEFLEX begun 8-28-12.
Age: 37.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Abscess, Feeling hot, Pruritus, Rash erythematous
Clinical narrative: Red rash, hot, abscess, given prescription for antibiotics (KEFLEX), itchy.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Discomfort, Injected limb mobility decreased, Pain in extremity
Clinical narrative: Patient reports arm soreness in the left arm and reports not being able to raise her arm. She reports being in great discomfort. Report to adverse/med reporting line for pharmacy.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Activities of daily living impaired, Feeling abnormal, Injection site erythema, Pyrexia, Vaccination site swelling
Clinical narrative: Patient reported significant fever, felt like "crap", stayed in bed all day after receiving vaccine, vaccine site was swollen and red over the weekend.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Blister, Pyrexia, Rash generalised, Rash vesicular, Scab
Clinical narrative: Child had a fever of 101 F and over 100 chickenpox like spots all over body that blistered, dried and crusted. Spots lasted a couple days according to the mother. This all happened 2 weeks post vaccination.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain upper, Back pain, Chills, Cold sweat, Fatigue
Clinical narrative: Symptoms began with headache, fatigue and stomach pain but increased with time. I was able to go out the day of the vaccination. However, as the evening wore on, the stomach pain became intense and low back pain began. During the night both intensified. By morning I had body aches, chills and a fever of 100.9 (ear). My hands were cold and clammy and then hot. I fell asleep for four hours, awakening covered in sweat but the stomach and low back pain, as well as the other symptoms, are now subsiding, a little more than 24 hours later.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Feeling hot, Headache, Hyperhidrosis, Pain, Peripheral coldness
Clinical narrative: Symptoms began with headache, fatigue and stomach pain but increased with time. I was able to go out the day of the vaccination. However, as the evening wore on, the stomach pain became intense and low back pain began. During the night both intensified. By morning I had body aches, chills and a fever of 100.9 (ear). My hands were cold and clammy and then hot. I fell asleep for four hours, awakening covered in sweat but the stomach and low back pain, as well as the other symptoms, are now subsiding, a little more than 24 hours later.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Symptoms began with headache, fatigue and stomach pain but increased with time. I was able to go out the day of the vaccination. However, as the evening wore on, the stomach pain became intense and low back pain began. During the night both intensified. By morning I had body aches, chills and a fever of 100.9 (ear). My hands were cold and clammy and then hot. I fell asleep for four hours, awakening covered in sweat but the stomach and low back pain, as well as the other symptoms, are now subsiding, a little more than 24 hours later.
Age: 25.0
Sex: M
Vaccine: HEPA
Symptoms: Convulsion, Dizziness, Heart rate decreased, Hyperhidrosis, Laboratory test normal
Clinical narrative: Patient became pale, and felt he may pass out. Then appeared to have a mild seizure with syncope. Patient was lied down by this provider and quickly recovered and became very lucid. Also more diaphoretic after episode. Did not remember losing consciousness. Heart rate during syncope/seizure decreased to approx 45/minute. Ambulance was called and Patient taken to local ER for evaluation.  Evaluation was negative for any illness or medical condition. Patient taken to ER for thorought evaluation, not because he was compromised by syncope/seizure. Patient called 102d MDG after several hours to report he was fine and all ER tests/evaluation was negative.
Age: 25.0
Sex: M
Vaccine: HEPA
Symptoms: Pallor, Syncope
Clinical narrative: Patient became pale, and felt he may pass out. Then appeared to have a mild seizure with syncope. Patient was lied down by this provider and quickly recovered and became very lucid. Also more diaphoretic after episode. Did not remember losing consciousness. Heart rate during syncope/seizure decreased to approx 45/minute. Ambulance was called and Patient taken to local ER for evaluation.  Evaluation was negative for any illness or medical condition. Patient taken to ER for thorought evaluation, not because he was compromised by syncope/seizure. Patient called 102d MDG after several hours to report he was fine and all ER tests/evaluation was negative.
Age: 5.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Erythema, Feeling hot, Local reaction, Swelling
Clinical narrative: Local reaction-redness, warmth and swelling.
Age: 4.0
Sex: F
Vaccine: DTIPV
Symptoms: Inflammation, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Injection site very swollen, red, warm.  Local inflammatory reaction, not infectious process.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Body temperature increased, Injection site erythema, Injection site induration, Injection site inflammation, Injection site warmth
Clinical narrative: "Tennis ball sized inflammed and red area at the site of the vaccination; temp 100.3; evaluated in office today 08/29/2011 and redness is 5x6cm and hot and indurated, nontender at site of injection.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Condition aggravated, Grand mal convulsion, Injection site erythema, Injection site swelling
Clinical narrative: L arm became red, swollen (size of baseball) at site of Tdap and Menactra/ Pt also had a light Grand Mal seizure at school today (she gets them about once a month).
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site induration, Injection site pruritus, Injection site warmth
Clinical narrative: HEADACHE, LOCALIZED RASH INDURATION, REDNESS, WARMTH, AND ITCHING OVER THE INJECTION SITE.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: HEADACHE, LOCALIZED RASH INDURATION, REDNESS, WARMTH, AND ITCHING OVER THE INJECTION SITE.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Fall, Head injury, Loss of consciousness
Clinical narrative: "Following the 4 immunizations, pt sat in chair for a few minutes. Upon standing up, patient lost consciousness & fell. Pt was partially caught by the nurse but continued to fall, striking her head on the edge of the counter. Immediate assistance was provided by nurses and NP. Vitals were obtained smelling salts were used, O2 was administered via nasal canula".
Age: 62.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Immediate post-injection reaction, Injection site mass, Injection site swelling
Clinical narrative: After vaccinating patient, the injection site immediately began to swell in a lump. I advised the pt to take BENADRYL and when I called several hours later she said it had stabilized.
Age: 68.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Hypokinesia, Pain
Clinical narrative: Per pt, within 2h, she started to experience achiness & inability to move her arm. Now she still having trouble raising her elbow to shoulder height. Not sure if pt is seeing Dr.
Age: 68.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Per pt, within 2h, she started to experience achiness & inability to move her arm. Now she still having trouble raising her elbow to shoulder height. Not sure if pt is seeing Dr.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: After the vaccine was given pt "passed out" in the exam room, mom witnessed it. ARNP evaluated him afterwards, no further treatment needed. Pt was observed x 20 min in exam room.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site urticaria
Clinical narrative: 60mm x 60 mm erythematous, whealed area to (L) post arm - around injection site.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Blister, Injection site oedema, Injection site warmth, Rash
Clinical narrative: Pt received MCV4 VZV vaccine and TDAP on 8/23/12 PM. Pt reported to have had warmth to both upper arms that night with large area of edema noted approx 3+ inches round Friday PM & then began to experience smaller raised areas with blister like appearance to bilateral arms & legs, upper back and chest. Clear fluid noted to blister centers. Mother giving BENADRYL 25 mg q 6 hours & AVENO bath. No fever c/o nasal congestion only.
Age: 9.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Started with red area size of quarter (at site of flu injection on L deltoid) on evening of 8-27-12. On 8-28-12 Parent noted L deltoid area swollen and red over large area. 8-29-12 L deltoid reddened area with 100mm X 85mm and swollen.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness, Seizure like phenomena
Clinical narrative: This spontaneous report as received from nurse refers to a 12 years old female patient. In June of 2012 (reported as 2 months ago), the patient was vaccinated with the first dose of GARDASIL (dose, route and lot number not reported). No other co-suspects were reported. Concomitant medications included a total of 5 vaccines (unspecified) that she received "that day" (in June of 2012). Nurse informed that a patient came back for routine second dose of GARDASIL (dose, route and lot number not reported, date unspecified) and the patient's mother reported to the nurse that after the first dose (in June of 2012), her daughter "passed out and had what appeared to be a seizure". The patient did continue with her second dose of GARDASIL and seemed to do fine after the second dose. No treatment was given for the patient's events. It was reported that the patient did not seek medical attention. At the time of report, the patient was recovered. The relatedness for the patient's event was not reported for GARDASIL. Upon internal review, the patient's events of "passed out and had what appeared to be a seizure" were considered to be other important medical events. Additional information has been requested.
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Constipation, Lumbar puncture normal, Muscular weakness, Paraesthesia
Clinical narrative: Information has been received from a Certified Medical Assistant (Local reference number US12-040775) concerning a male patient of unknown age. On an unspecified date, the patient was vaccinated with dose 1 GARDASIL (Lot number, dose and route not reported). It was reported that the patient was admitted to the hospital for a lower extremity tingling that moved up his right leg and got worse. Approximately 30 days after vaccination with GARDASIL, the patient presented tingling left foot, went up leg, migrated to both sides, into buttocks. The patient also developed constipation and muscle weakness. Guillain Barre and neurological injury was ruled out and spinal tap was clear. At the time, the patient was getting better. Health department indicated that lumbar puncture (LP) was done too soon for west nile virus to be detected. The physician requested information in a few days. The relatedness for tingling left foot, went up leg, migrated to both sides, into buttocks, muscle weakness and constipation was unknown for GARDASIL. Additional information is not expected.
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Lumbar puncture normal, Nuclear magnetic resonance imaging spinal cord normal, Paraesthesia, Walking aid user
Clinical narrative: Information has been received from a Certified Medical Assistant (Local reference number US12-040775) concerning a male patient of unknown age. On an unspecified date, the patient was vaccinated with dose 1 GARDASIL (Lot number, dose and route not reported). It was reported that the patient was admitted to the hospital for a lower extremity tingling that moved up his right leg and got worse. Approximately 30 days after vaccination with GARDASIL, the patient presented tingling left foot, went up leg, migrated to both sides, into buttocks. The patient also developed constipation and muscle weakness. Guillain Barre and neurological injury was ruled out and spinal tap was clear. At the time, the patient was getting better. Health department indicated that lumbar puncture (LP) was done too soon for west nile virus to be detected. The physician requested information in a few days. The relatedness for tingling left foot, went up leg, migrated to both sides, into buttocks, muscle weakness and constipation was unknown for GARDASIL. Additional information is not expected.
Age: 55.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Induration, erythema, swelling & warmth around injection site. 2nd pt to have same with this lot.
Age: 17.0
Sex: M
Vaccine: MNQ, PPV
Symptoms: Erythema, Myalgia, Oedema, Pyrexia, Vomiting
Clinical narrative: Local erythema and edema, fever 103.6 vomiting, generalized myalgia for 5 days supportive care, ibuprofen, ice, topical hydrocortisone.
Age: 1.27
Sex: F
Vaccine: HEP, HEPA, MMR, VARCEL
Symptoms: Body temperature increased, Urticaria
Clinical narrative: Urticaria 24 hours after immunization. Temperature of 101.5 36 hours after immunization.
Age: 0.16
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Haematochezia
Clinical narrative: 6/20/12 mom called office because pt had blood in stool. No treatment necessary. Adv to start neocate or elecare formula if continued. *Recommended by nutritionist.
Age: 55.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Blood test, Injection site erythema, Oedema peripheral, Pain in extremity, Pyrexia
Clinical narrative: High fever - high as 104.1, then 103.3 - fluctuating. Right arm swelled, turned red from shoulder (top) to bellow elbow - constant, unrelenting pain. Still pain.
Age: 60.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: (R) upper arm. Within 24 degrees of receiving vaccine, pt reports area around site with increase redness, tenderness to touch & low grade fever. By day 3, redness area increasing in size. Pt had appt & treated with KEFLEX as questioning cellulitis vs allergic reaction.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Nausea, Pyrexia
Clinical narrative: Fever 102 degrees, nausea, diarrhea from 8/24/12 till current. Nurse notified & will have pt. go in for check.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Erythema, Feeling hot, Pain, Swelling
Clinical narrative: Imms give 8/2/12 in (L) mid. tricep. Pt come on 8/4/12 with c/o pain and swelling redness and warmth treatment ice & OTC medication check back as needed.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site induration
Clinical narrative: Induration left deltoid. Distal extremely grossly normal.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Abdominal discomfort, Dizziness, Erythema, Fatigue, Headache
Clinical narrative: 1 Day post-little redness, upset stomach, tiredness, headache, light headedness, spot hot to touch. 2 day post-fist sized redness along w/day 1 symptoms.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Skin warm
Clinical narrative: 1 Day post-little redness, upset stomach, tiredness, headache, light headedness, spot hot to touch. 2 day post-fist sized redness along w/day 1 symptoms.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a female patient of unknown age. The patient was vaccinated intramuscularly with the first and second 0.5 ml dose of GARDASIL respectively on 18-AUG-2011 and 23-AUG-2012 (Lot# not reported). No adverse effects reported. It was not known if the patient sought for medical attention. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse refers to an unknown number of patients that might have been vaccinated with a doses of GARDASIL (doses, route and lot numbers not reported) that were improperly stored. It was noted that the nurse was not sure how many patients would be involved and dates of administration were not available at the time of the report. No adverse events were reported. Attempts are being made to obtain additional information identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age. The patient was vaccinated with dose 1 GARDASIL on 2010 (lot# and dose not reported) and the second dose of GARDASIL (lot# and dose not reported) on 22-AUG-2012. No adverse effect reported. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Rash erythematous
Clinical narrative: This spontaneous report as received from a other health professional refers to a male patient of unknown age. The patient was vaccinated with dose 1 GARDASIL on an unknown date (dose, route, site of administration and lot number not reported). No other co-suspects were reported. No concomitant medications were reported. It was stated that on an unknown date, after receiving his first dose the patient had a red rash on his chest and neck a couple of hours later. No treatment information was reported. The outcome of red rash on his chest and neck is unknown. The relatedness for red rash on his chest and neck is unknown for GARDASIL. Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: FLUN3, HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a 13 years old female patient with no preexisting allergies, birth defects or medical conditions. The patient was vaccinated with lot # (669796/0840AA) dose 1 GARDASIL, right deltoid on 27-DEC-2011 at 16:53. No other co-suspects were reported. Concomitant medications included: FLUMIST (lot # YL2068). It was reported that the patient was administered an immunization that was stored at invalid temperatures, the immunization was stored at a temperature of 32 degrees F or less. No adverse reaction occurred. This is one of several reports from the same source. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a 12 years old female patient with no illness at the time of vaccination. The patient was vaccinated with lot # (668051/1262AA) dose 3 GARDASIL, IM on 30-DEC-2011 at 11:54 AM. No other co-suspects were reported. No concomitant medications were reported. It was reported that the patient received a vaccine that was stored at an improper temperature <32. There were no adverse reactions. This is one of several reports from the same source. Additional information is not expected.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure increased, Maternal exposure during pregnancy, Tremor
Clinical narrative: This spontaneous prospective pregnancy report was received from a registered nurse, for pregnancy registry GARDASIL, refers to a 22 years old female patient. The patient's history of previous pregnancies and live births was not known. It was reported the patient was vaccinated intramuscularly with a first 0.5 ml dose of GARDASIL lot # (671994/1628AA) on 18-APR-2012. Concomitant medications included buprenorphine hydrochloride, SUBOXONE, methadone hydrochloride and Alprazolam. The patient might have been pregnant at the time of the vaccination, about 4 weeks gestation (it was also reported that as of 02-AUG-2012 gestation was of 19 weeks). LPM was calculated as on approximately 18-MAR-2012 and EDD as 23-DEC-2012. The patient sought unspecified medical attention. No treatment was given for adverse event. At the time of the report patient's status was not recovered. Nurse also reported that patient experienced elevated blood pressure and shaking with CELEXA. 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 pharmacist refers to an unknown number of patient of unknown age. The patient were vaccinated with doses of GARDASIL (lot# not reported) store at high as 9 C several times a day for an unknown period of time. No adverse effect was reported. It was unknown if the patient sought medical attention. Follow up information has been received from the pharmacist stating that all patient information was recorded in the Immunization Registry. At the time of reporting, the pharmacist did not have access to the information that was listed in the Immunization Registry. The pharmacist stated that she would speak to her supervisor to see if patient identifiers could be supplied. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report was received from a male consumer refers to his daughter of unknown age. The reporter stated that his daughter did not follow the proper dosing schedule for GARDASIL. The patient received her first dose of GARDASIL on 10-AUG-2010 (dose, route and lot # not reported) and a second dose of GARDASIL on 19-JAN-2011 (dose, route and lot # not reported). The patient had not receive the third injection. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a healthcare worker concerning an unknown number of patients who were vaccinated with improperly stored GARDASIL (Lot #, dose and route not reported). The GARDASIL was exposed to 30 degrees F. No adverse effect was reported. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. All telephone attempts to obtain follow up information have been unsuccessful. Follow-up information was received from a Medical Assistant concerning a 12 years old female patient. The patient was vaccinated with a dose of GARDASIL lot# (670048/0963AA), IM right deltoid on 29-DEC-2011 at 03:51 PM. No other co-suspects were reported. No concomitant medications reported. It was reported that the patient was administered an immunization that was stored at invalid temperatures, the immunization was store at a temperature of 32 degrees F or less. No adverse reaction occurred. This is one of several reports from the same source. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant refers to a patient of unknown age and gender. The patient was vaccinated with a first dose and second dosed of GARDASIL, (dose, route and lot numbers not reported) on 01-JUN-2010 and 22-JUN-2012, respectively. The patient did not get the third dose yet. No adverse effect reported. Additional information has been requested.
Age: 47.0
Sex: F
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a 47 years old female consumer refers to herself. It was reported that on 17-APR-2012 the patient was vaccinated with a dose of GARDASIL (dose, route and Lot# not reported). Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a consumer. The consumer was very vague. It was reported she had shingles before and was vaccinated SC with 0.65 ml ZOSTAVAX. No other co-suspects were reported. No concomitant medications were reported. The patient reported she was having another episode of shingles and wanted to know how to define shingles. She stated she no longer had persistent pain that she had with previous bout of shingles and stated that the HCP would no longer identify her problem as being another round of shingles because of the non-persistent pain. The reporting consumer would at times say that this case was about her and at the other times, she denied having vaccine and was alluding to talking about a friend of hers. The outcome of shingles is unknown. The relatedness for shingles is unknown for ZOSTAVAX. Additional information is not expected.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthropod bite, Blister, Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: This spontaneous report as received from a 77 years old female patient with hypothyroidism and allergy to sulfa drugs and cholesterol medications refers to herself. The patient was vaccinated SC with a dose of ZOSTAVAX (lot # not reported) on 14-AUG-2012 to prevent shingles. Concomitant medications included thyroid medication. On 14-AUG-2012 the patient had itching and a red circular rash at the injection. It was oval, and 3 inches long. On 19-AUG-2012 the patient had a breaking out of blistered rash, similar to what she called chickenpox, on her upper right leg. She was not sure if she had chickenpox before. Later she found out the rash on her leg was caused by a bug bit. It was not a reaction from ZOSTAVAX . No treatment information was given. No laboratory test was performed. The outcome of the events is unknown. The patient did not seek medical attention. Additional information is not expected.
Age: 10.0
Sex: M
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 10 years old patient. The patient was inadvertently vaccinated with ZOSTAVAX instead of VARIVAX (Merck). No other co-suspects were reported. No concomitant medications were reported. No adverse effect is reported. 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 pharmacist refers to an unknown number of patient of unknown age. The patients were vaccinated with doses of PNUEMOVAX23 (lot# not reported) stored as high as 9 C several times a day for an unknown period of time. No adverse effect was reported. It was unknown if the patient sought medical attention. Follow up information has been received from the pharmacist stating that all patient information was recorded in the Immunization Registry. At the time of reporting, the pharmacist did not have access to the information that was listed in the Immunization Registry. The pharmacist stated that she would speak to her supervisor to see if patient identifiers could be supplied. 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 pharmacist refers to an unknown number of patient of unknown age. The patients were vaccinated with doses of VAQTA (lot# not reported) stored as high as 9 C several times a day for an unknown period of time. No adverse effect was reported. It was unknown if the patient sought medical attention. Follow up information has been received from the pharmacist stating that all patient information was recorded in the Immunization Registry. At the time of reporting, the pharmacist did not have access to the information that was listed inn the Immunization Registry. The pharmacist stated that she would speak to her supervisor to see if patient identifiers could be supplied. This is one of several reports received from the same source. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Chapped lips, Erythema, Lip dry, Pruritus
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 74 years old female patient with no drug reactions/allergies. The patient was vaccinated into right arm with a dose of ZOSTAVAX (lot # 0171AE, exp date: 20-MAR-2013) on 25-JUL-2012. No other co-suspects were reported. There was no concomitant medication. The pharmacist reported that on 25-JUL-2012 the patient developed a dry cracked lip, bright red face, a spot on the hand and a red blotch on the inner right thigh following vaccination with ZOSTAVAX. The dry cracked lip and bright red face occurred a few hours after receiving ZOSTAVAX. The bright red face was described as starting on the right side by the eye and traveling down the face to the chin and then back up the other side (left side) to the left eye. The red face was described as burning like sunburn and itchy. It was unclear just when the spot on the hand and red blotch on the inner right thigh developed. The patient went to her family physician (name unspecified) and also went to an emergency room (name unspecified). The patient reported that the symptoms were decreasing starting 30-JUL-2012. Treatment including CORICIDIN, BENADRYL and MEDROL dose pak was given for the events. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash macular
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 74 years old female patient with no drug reactions/allergies. The patient was vaccinated into right arm with a dose of ZOSTAVAX (lot # 0171AE, exp date: 20-MAR-2013) on 25-JUL-2012. No other co-suspects were reported. There was no concomitant medication. The pharmacist reported that on 25-JUL-2012 the patient developed a dry cracked lip, bright red face, a spot on the hand and a red blotch on the inner right thigh following vaccination with ZOSTAVAX. The dry cracked lip and bright red face occurred a few hours after receiving ZOSTAVAX. The bright red face was described as starting on the right side by the eye and traveling down the face to the chin and then back up the other side (left side) to the left eye. The red face was described as burning like sunburn and itchy. It was unclear just when the spot on the hand and red blotch on the inner right thigh developed. The patient went to her family physician (name unspecified) and also went to an emergency room (name unspecified). The patient reported that the symptoms were decreasing starting 30-JUL-2012. Treatment including CORICIDIN, BENADRYL and MEDROL dose pak was given for the events. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unknown number of patient of unknown age. The patients were vaccinated with dose of PEDVAXHIB (lot # not reported) stored as high as 9C several times a day for an unknown period of time. No adverse effect was reported. It was unknown if the patient sought medical attention. Follow up information has been received from the pharmacist stating that all patient information was recorded in the immunization registry. At the time of reporting, the pharmacist did not have access to the information that was listed in the immunization registry. The pharmacist stated that she would speak to her supervisor to see if patient identifiers could be supplied. This is one of several reports received from the same source. Additional information has been requested.
Age: 0.96
Sex: U
Vaccine: VARCEL
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 11 months old patient. The patient was vaccinated with the first dose of VARIVAX (lot# and route not reported) on 17-NOV-2000 when the patient was 11 months old. On 14-SEP-2006 the patient received a second dose of VARIVAX (lot# and route not reported). No adverse effect reported. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 12 years old patient. The nurse reported that the patient was intended to receive VARIVAX was inadvertently administered ZOSTAVAX subcutaneous on 13-AUG-2012. No treatment information was reported. No adverse effects reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unknown number of patient of unknown age. The patients were vaccinated with doses of M-M-R II (lot# not reported) stored as high as 9 C several times a day for an unknown period of time. No adverse effect was reported. It was unknown if the patient sought medical attention. Follow up information has been received from the pharmacist stating that all patient information was recorded in the Immunization Registry. At the time of reporting, the pharmacist did not have access to the information that was listed in Immunization Registry. The pharmacist stated that she would speak to her supervisor to see if patient identifiers could be supplied. This is one of several reports received from the same source. Additional information has been requested.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster, Pain
Clinical narrative: Information has been received from a physician assistant concerning a 9 year old male patient who on an unknown date was vaccinated SQ with 0.5 mL dose of VARIVAX (lot # not provided). The physician stated that the patient experienced shingles after getting VARIVAX, date was not provided. Therapy with VARIVAX was discontinued. At the time of the report, the patient was recovering. The patient sought unspecified medical attention. Follow up information has been received from a physician assistant refers to a 13 years old male patient. The patient had no a history of chickenpox and no recent exposure to chickenpox or herpes zoster. The patient was vaccinated with 2 doses of VARIVAX on 11-AUG-1999 and 08-AUG-2007 respectively (dose, route and lot # not reported). On 23-JUL-2012 the patient experienced shingles/herpes zoster on left axilla and left breast. There was no rash. Pain score was 1. No specimen was collected for PCR. The patient was treated with acyclovir for 5 days. It was reported that the patient's status was recovering (reported as "improving - only 3 days into symptoms"). Addition information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. It was reported that 1 or 2 weeks ago (approximately 17-JUL-2012) the patient was vaccinated with subcutaneously in right arm with a 0.5 ml dose of PNEUMOVAX23 (dose, route), lot# 1947AA. On an unknown date in 2012 the patient experienced red arm, swollen and painful arm. The outcome was not reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Rash generalised
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age and gender. On an unknown date in November 2011 the patient was vaccinated with a first dose of VARIVAX, (dose, route and Lot # not reported). On an unknown date the patient experienced generalized rash (after receiving a vaccine). The patient sought medical attention via doctor's office visit. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information was received from a female patient via a claims administrator who reported that she sustained a shingles outbreak after receiving the (zoster vaccine live) on 14-APR-2012. Additional information is expected.
Age: 56.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: This spontaneous report was received from a register nurse concerning a 56 year old female patient with not pertinent medical history or drug/reactions allergies who on 20-AUG-2012 was vaccinated with a dose of ZOSTAVAX, subcutaneous in her right arm (lot number reported as 0564AE, expiration date 21-MAR-2013) and diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid, intramuscular in her left arm. No other co-suspects were reported. The nurse stated that on 21-AUG-2012, the patient developed a 2 inch red area and lump around the injection site where the ZOSTAVAX was administered. The patient was given warm or cold compresses. At the time of the report, the patient was recovering form the events. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered pharmacist concerning a patient of unknown age who on 05-AUG-2012, was vaccinated SQ with an expired 0.65 ml dose of ZOSTAVAX (lot# 670754/0621AA, exp 26-JUL-2012). No adverse effect was reported. Additional information has been requested.