chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: F
Vaccine: MMR
Symptoms: Pharyngeal oedema, Swelling face, Swollen tongue, Ultrasound scan normal, Vulvovaginal swelling
Clinical narrative: This spontaneous report as received from a 25 years old female patient with allergy to CIPRO and none pertinent medical history. On 24-MAY-2012, the patient was vaccinated subcutaneously with a second 0.5 ml dose of MMR II, lot number 669517/0037AA exp date 01-FEB-2013. No other co-suspects were reported. Concomitant medications included: hormonal contraceptives (unspecified). The patient reported that she received the second dose and on 02-JUN-2012, she experienced swelling under the chin and under the tongue (medically significant, upon internal review). The consumer was still experiencing swelling under the chin and under the tongue and at the time of the report, back of the tongue 3 times a day. The patient experienced this at anytime, whether she was when she first got up in the morning or exercising or eating. The attacks last from 45 minutes to one hour. She was having constricted breathing (medically significant, upon internal review). At the time of report, the patient had food allergies (medically significant, upon internal review), panic attacks (medically significant, upon internal review), her hands and feet were swollen (medically significant, upon internal review), and she got red (medically significant, upon internal review), her vagina swollen (medically significant, upon internal review) and got a yeast infection (medically significant, upon internal review). She had seen 4 different physicians and an allergist. She stated that at the time of report, she was "allergic to all things" (medically significant, upon internal review) and what she was experiencing was causing distress every day (medically significant, upon internal review) and she was a 2nd year graduate student and this was interfering with her life. The patient carried an epinephrine (medically significant, upon internal review) at the time of report, but had not need to use it yet. Prednisone (manufacturer unknown), CLARITIN, PEPCID and BENADRYL was given as treatment for the events. Food allergy test was performed and showed that the patient was allergic to almost everything, some food given were eggs, nuts, melon, mustard, tomatoes, peas, beans, everything in the legume family. Blood test was also performed and was normal. Ultrasound of throat taken showed slightly enlarged but normal. At the time of report, the patient had not recovered. Additional information has been requested.
Age: 0.85
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Dermatitis allergic, Hypersensitivity, Urticaria
Clinical narrative: Had allergic rash reported by mom. States she had hives all over her body & they took her to E.R. MD told her it was reaction to shots given steroid shot.
Age: 11.0
Sex: F
Vaccine: FLUN3
Symptoms: Oedema peripheral, Pain in extremity, Tenderness
Clinical narrative: Seen yesterday for MENACTRA vaccine. Arm was a little sore. Today arm was swollen and tender.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthropod bite, Eosinophil percentage, Erythema, Full blood count normal, Immediate post-injection reaction
Clinical narrative: Immediate local reaction next day had insect bite /? Right  3 days later a second large red area on same arm but away from injection - then developed non-pruritic maculopapular rash on abdomen back & thighs. No fever no malaise no oral symptoms. Also had had course of penicillin 8/14 - 8/21/12.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Local reaction, Rash maculo-papular, White blood cell count normal
Clinical narrative: Immediate local reaction next day had insect bite /? Right  3 days later a second large red area on same arm but away from injection - then developed non-pruritic maculopapular rash on abdomen back & thighs. No fever no malaise no oral symptoms. Also had had course of penicillin 8/14 - 8/21/12.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Bacterial infection, Erythema, Feeling hot, Pain, Product contamination microbial
Clinical narrative: 3 days after vaccine was administered a 3 1/2" hot red circle popped out - it was extremely painful. I saw my doctor who said it was a bacterial infection - not caused by the serum - but from improper handling.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Chills, Erythema, Rash
Clinical narrative: Pt. had redness, rash, chills, and joint pain. No treatment (except blankets and time).
Age: 12.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site mass, Injection site swelling, Injection site warmth
Clinical narrative: At 1710 - 08/28/12 - Mother reported "pea & golf ball sized bumps" on back of (R) arm; No fever; Child "felt fine"; red area on back of (R) arm; stated ice "makes it swell more"; instructed to see a healthcare provider; stated would "go tomorrow if worse" 8/29/12 at 1115 - mother states son "felt fine" & "sent to school"; states redness & swelling "from his shoulder to elbow"; states going to see doctor after school 8/29/12 at 1645 - in hospital ER; red area triangular in shape on back of (R) arm warm to touch, measures 10cm x 10cm at widest areas; no fever; no pain or discomfort; given antibiotics & told to take BENADRYL to use ice packs by ER healthcare provider.
Age: 57.0
Sex: M
Vaccine: HEPAB
Symptoms: Pruritus, Rash generalised
Clinical narrative: Severe rash over chest, upper arms back & belly. Some of the bumps opened up causing extensive itching. None of the creams applied helped.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLUN3, MMR, VARCEL
Symptoms: Injection site erythema
Clinical narrative: MMR given on 8/28/12. Redness began at injection site and spread over left thigh. Area of redness was outlined 8/30/12. Patient given a dose of oral steroids and asked to return on 8/31/12 for evaluation.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Inflammation, Swelling
Clinical narrative: Inflammation & swelling noticeable after 24 hours, worsened overnight. Patient saw her doctor and was diagnosed with cellulitis and given Cephalexin at 48 hours post.
Age: 14.0
Sex: F
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Large red patch at the injection site. (R) post arm.
Age: 10.0
Sex: M
Vaccine: HEPA, TDAP, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Large red patch at injection site. (post. upper right arm).
Age: 8.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Red raised patch at the injection site on the (R).
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Rash generalised
Clinical narrative: Injection burned on administration - a couple hours after the injection noticed a general rash over body, took an antihistamine slowly resolved on 3rd day. At the injection site the redness and induration & tenderness peaked at 3cm size & resolved on 3rd day.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: Pt presented with rash, indicated receiving tx for possible cellulitis.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site rash, Injection site warmth, Pyrexia
Clinical narrative: Pt presented with rash, indicated receiving tx for possible cellulitis.
Age: 5.0
Sex: M
Vaccine: FLU3, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Oedema peripheral
Clinical narrative: (L) tricep area swollen, red and warm to touch. Approx. 3 1/2 cm in length 4 cm width. Arm circumference 20 cm (R) arm 19 cm. Mother was told by the school's bus driver that child's arm was swollen.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Eye pruritus, Fatigue, Ocular hyperaemia, Pain
Clinical narrative: By 5 PM on 8/27/12, patient felt tired, had itchy eyes, also red eyes. Low-grade fever, patient states 101 degrees. Chills, body aches.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: By 5 PM on 8/27/12, patient felt tired, had itchy eyes, also red eyes. Low-grade fever, patient states 101 degrees. Chills, body aches.
Age: 55.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Erythema, Inflammation, Swelling
Clinical narrative: Patient received live zoster SQ in post (L) upper arm. Noted swelling 1 day after vaccine. Increased today. Currently erythema & inflammation are 7.2 x 10.3 cm.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Chest pain, Injection site cellulitis, Pain in extremity
Clinical narrative: (L) upper arm cellulitis - (L) arm pain - down fingers & across chest - started on KEFLEX 500mg 1 QD x 7 days. ROCEPHIN 1 gm IM - ALEVE - ADVIL - heat/ice - VICODIN 5/500 1 po Q 4-6hrs. # 20 ER --> 600 mg CLEOCIN - BACTRIM also added.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Injection site urticaria, Pruritus, Rash
Clinical narrative: Patient was vaccinated with Meningococcal Conjugate vaccine in her left arm on 8/14/12. On 8/20/2012 she came to clinic complaining of rash and itching that started Sat. 8/18/12 in the morning, 8-10 hives noted on her Rt upper arm. 3-4 on her left arm & back BENADRYL given.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV4, MMR, MNQ, VARCEL
Symptoms: Injection site reaction, Skin lesion
Clinical narrative: Pt came in this am with a 3 cm lesion on (L) upper arm round in shape red in color, arrangement isolated and localized distribution, status is stable, pt had varicella # 2 in (L) upper arm yesterday reaction to site per Dr.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Visual impairment
Clinical narrative: Approximately 2 minutes after administration pt reports feeling dizzy & reports vision as being "pixelated". Had pt lay down, gave pt juice & cracker, Pt verbalized resolution of symptoms.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Urticaria
Clinical narrative: Pt received DTaP at about 9:15 am on 9/5/12 & later the same afternoon developed hives on lower back, buttocks & behind one knee - mom gave BENADRYL & called office 9/16 to report.
Age: 3.0
Sex: F
Vaccine: FLUN3, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: 3 yr old female got PREVNAR on left arm, now with worsening redness, swelling, pain, warmth on left arm surrounding injection site.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Petechiae, Rash
Clinical narrative: Pt had vaccine on 8-23 states rash on lower legs developed 2 days later. Denies being on any new meds. Pt came into clinic 9/6 and a red - petechiae rash noted over both lower legs.
Age: 11.0
Sex: F
Vaccine: HPV2, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Itching/redness distal to injection site (3-4 cm diameter).
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Dyspnoea, Erythema, Hypoaesthesia oral, Swelling face
Clinical narrative: Swollen face/redness/numb lips coughing/tongue swelling trouble breathing.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Swollen tongue
Clinical narrative: Swollen face/redness/numb lips coughing/tongue swelling trouble breathing.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Immediate post-injection reaction, Neuralgia, Pain
Clinical narrative: Immediately upon administration, pt claimed a sharp shooting pain that continued/lasted after administration. Pt claimed a "nerve pain" from middle of arm to her neck on left side. (Additional info: dizziness).
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Pyrexia
Clinical narrative: Pt had a fever.
Age: 11.0
Sex: F
Vaccine: FLUN3, HEPA, MNQ, TDAP
Symptoms: Erythema, Injection site erythema, Injection site haematoma, Injection site oedema, Injection site pruritus
Clinical narrative: On 9/4/12 Tdap was given in (L) deltoid. One day later some swelling, redness, itching noted. 2 days later (9-6-12) came back to office with increased edema, erythema, warmth, bruising, small blister at site of injection increased pruritus. Pt received Hep A and Mening in (R) deltoid the same day.
Age: 11.0
Sex: F
Vaccine: FLUN3, HEPA, MNQ, TDAP
Symptoms: Injection site vesicles, Injection site warmth, Pruritus, Swelling
Clinical narrative: On 9/4/12 Tdap was given in (L) deltoid. One day later some swelling, redness, itching noted. 2 days later (9-6-12) came back to office with increased edema, erythema, warmth, bruising, small blister at site of injection increased pruritus. Pt received Hep A and Mening in (R) deltoid the same day.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Injection site swelling, Pruritus, Rash generalised
Clinical narrative: Pt received vaccine on 8/29/12. Pt. reported symptoms to pharmacist on 9/5/12. Pt. states full body rash, itching, severe headache within 30 minutes when she got home. She took 2 BENADRYL 8/29/12. Slight rash still visible. Some swelling in arm (L) deltoid. She is back at work. RPh told pt. to notify her physician.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Broke out with shingles approximately or equal to 24-48 hrs after vaccination.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Discomfort, Rash
Clinical narrative: Broke out with shingles approximately or equal to 24-48 hrs after vaccination.
Age: 6.0
Sex: M
Vaccine: FLUN3
Symptoms: Abdominal pain upper, Diarrhoea
Clinical narrative: Stomache diarrhea 2 hours after vaccine.
Age: 39.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Headache, Injection site induration, Nausea, Nuchal rigidity, Photophobia
Clinical narrative: High fever, nuchal rigidity, injection site induration, nausea, severe headaches, photophobia.
Age: 39.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Pyrexia
Clinical narrative: High fever, nuchal rigidity, injection site induration, nausea, severe headaches, photophobia.
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral, Pain in extremity
Clinical narrative: (L) arm pain, swelling.
Age: 37.0
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral, Tenderness
Clinical narrative: Swelling, (L) arm pain, tenderness in underarm. 8-27-12- went to urgent care.
Age: 40.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Pain in extremity, Swelling
Clinical narrative: Redness, arm soreness, swelling, warmness. Ibuprofen for treatment.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to an unspecified number of patients who on an unknown date, could have either been administered with a doses of GARDASIL (doses, routes and lot numbers not reported) that were exposed to temperature conditions that we could not support. No adverse reactions 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.
Age: 3.0
Sex: M
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a license practical nurse refers to a 42 months old male patient who was inadvertently vaccinated with a 0.5 ml dose of GARDASIL (lot # 672547/1745AA) on 13-AUG-2012, due to staff error. No adverse effects reported. Additional information has been requested.
Age: 0.2
Sex: U
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Abnormal faeces, Chills, Faeces discoloured, Pyrexia
Clinical narrative: This spontaneous report as received from a physician' medical assistant, a nurse refers to a 2 months old patient. The patient was vaccinated with the first dose of 2 ml ROTATEQ (lot# unspecified) orally in July 2012, "at 2 months of age". It could not be verified that the entire 2ml vial of ROTATEQ was administered. Concomitant medications included PREVNAR and PENTACEL. It was reported that the patient got vaccination. Child developed "neon green" foul smell stools, a fever and chills and was taken to the unspecified local urgent care center, but was not hospitalized. Child was given dextrose, electrolytes (unspecified) (PEDIALYTE) for treatment. The child was sick for 7 days but was recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Pregnancy test negative
Clinical narrative: This spontaneous report as received from a consumer refers to her. The patient was vaccinated IM with dose 1, 0.5 ml GARDASIL (lot # not reported) on 2009, the second dose in July 2012 and third dose on 29-AUG-2012. The patient referred to her physician to provide information on the effectiveness of the vaccinations she's had, and any related information on the risks involved with becoming pregnancy within the 6 month period before she would have her last dose of the re-started regimen scheduled in December. Patient explained that she had a pregnancy test on 29-AUG-2012 that was negative. No further AE information was provided. 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 medical assistant refers to a patient of unknown age. The patient was vaccinated with the first dose of GARDASIL (lot# unspecified) on 12-MAY-2009. It was reported that the patient is in the office for the second dose of GARDASIL (lot# unspecified) late at time of the report on 30-AUG-2012. The patient was not experiencing any known symptoms. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Menstruation irregular
Clinical narrative: This spontaneous report as received from a patient's mother who worked in a physician's office refers to her daughter with no drug reactions/allergies or pertinent medical history. The patient was vaccinated with dose 1, 0.5 ml GARDASIL (Lot # not reported) in 2007 and dose 2, 0.5 ml (Lot # not reported) in 2010 and dose 3, 0.5 ml (Lot # not reported) in 2012. There was no concomitant medication. The mother reported that the patient began having irregular periods after her first shot of GARDASIL in 2007, and had a loss of period after her second dose of GARDASIL given to her in 2010. The patient's 3rd dose of GARDASIL was given to her in 2012. The patient did not seek medical attention. No treatment was given. No lab diagnostics studies were performed. At the time of reporting, the patient was not recovered. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Headache, Nausea
Clinical narrative: This spontaneous report as received from a consumer refers to her 16 years old daughter. The patient was vaccinated with the first dose of GARDASIL (dose, route and lot# not reported) on 28-AUG-2012. On 29-AUG-2012 the patient experienced nausea, dizziness and headache, 24 hours after therapy. The outcome of nausea, dizziness and headache was reported as not recovered/not resolved. Additional information is not expected.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare workers refers to a 19 years old female patient. The patient was vaccinated with the first, the second and the third dose of GARDASIL (dose, route, lot# unknown) respectively on 15-MAR-2012, 30-MAY-2012 and 15-AUG- 2012. No other co-suspects were reported. The healthcare worker stated client got the patient's third of GARDASIL early. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a physician concerning a patient of unknown gender and age. On 22-APR-2011, the patient vaccinated with a dose of GARDASIL, intramuscular, (dose and lot number were not provided). On 17-AUG-2012, the patient was vaccinated with a dose of GARDASIL. No known adverse effects. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a physician refers to a 6 patients of unknown age who were vaccinated with doses of ZOSTAVAX (lot# not reported). Physician had mentioned that 6 other patients who were given ZOSTAVAX had had some reactions at the injection site like "redness and swelling." At the time of reporting, the patient outcome was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Injection site rash, Rash vesicular
Clinical narrative: This spontaneous report was received from a 77 years old female patient who was allergic to sulfur drugs and cholesterol medications. The patient's medical history included hypothyroid. The patient was vaccinated SQ with a dose of ZOSTAVAX (dose, lot # unknown) on 14-AUG-2012. Concomitant medications included thyroid medications. On 14-AUG-2012 the patient had itching and a red circular ash at the site of injection. The patient stated it was oval and 3 inches long. It was reported on 19-AUG-2012 the patient had a breaking out of blistered rash, similar to what she called chickenpox, on her upper right leg. The patient was not sure if she had chickenpox before. No treatment was given for the AE. There was no lab diagnostics studies performed. The outcome of the patient was unknown. The patient did not seek medical attention. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 12 years old patient who on 22-AUG-2012, was inadvertently vaccinated with a 0.65 ml dose of ZOSTAVAX subcutaneously (lot number not reported). The registered nurse stated that this was not product confusion but was related to staff error. No adverse effects were reported. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site reaction, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 67 years old female patient. The patient was vaccinated with ZOSTAVAX (lot # reported as 0567AE. Exp date 14-APR-2013, dose/frequency and route were unspecified) on 27-AUG-2012 in the afternoon. Pharmacist reported that the patient called the pharmacy this morning, 29-AUG-2012, to report that she noticed that she had developed an "injection site reaction", including "mild pain and the surrounding area was raised slightly warm to the touch". The patient had not contacted the physician who prescribed ZOSTAVAX. VZVIP packet not offered because the pharmacist stated that she didn't think the patient was experiencing a rash. The patient had sought medical attention via consulting pharmacist. No treatment was given for the adverse event. The outcome was reported as not recovered/not resolved. Additional information is not expected.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Biopsy skin abnormal, Inflammation, Rash erythematous, Rash pruritic, Skin lesion
Clinical narrative: This spontaneous report as received from a 80 years old male patient refers to himself with CIPRO allergy, penicillin allergy and no medical history. He was subcutaneously vaccinated with ZOSTAVAX (lot# was unspecified) in approximately June 2012, "about 2 months ago". Concomitant medications included SYNTHROID, unspecified cholesterol medication and lisinopril. In approximately July 2012, "4 weeks after receiving ZOSTAVAX", he developed raised, red, itchy lesions on his arms, legs and back. He was treated with a MEDROL Dose Pack, and the lesions resolved, but then returned. The physician saw an unspecified dermatologist who prescribed an unspecified oral cortisone (30 mg daily for 1 week and then dose tapered down) medication. Symptoms resolved on this medication but returned after stopping medication. The physician was using a topical steroid with some improvement medication at reporting time, but lesions continued to recur. The physician biopsied the lesions and the unspecified dermatologist also biopsied the lesions, the results of both biopsies showed inflammation. The outcome of patient was reported as not recovered/not resolved. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician refers to a 87 years old male patient who an unspecified date a couple of years ago, was vaccinated with a single dose of 0.65 ml subcutaneous injection of ZOSTAVAX (lot number not reported). No other co-suspects were reported. No concomitant medications were reported. The patient developed a case of shingles a couple of years later on 02-NOV-2011. The patient sought medical attention. The patient was prescribed with VALTREX for adverse event. On an unspecified date, the patient recovered from adverse event. The relatedness for the adverse event was unknown for ZOSTAVAX. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: MMR
Symptoms: Measles
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 36 months old male patient with no pertinent medical history and drug reactions. The patient was vaccinated with the first dose of MMRI II (lot number not reported) on 24-APR-2006. No other co-suspects were reported. No concomitant medications were reported. On 02-MAY-2006 the patient experienced measles. The patient was taken BENADRYL and oatmeal bath for the treatment of measles. The patient was recovered on an unspecified date. No labs diagnostics were performed. The patient had contact another unspecified HCP for medical attention. Additional information is not expected.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to an unspecified number of patients who on an unknown date, could have either been administered with a doses of VAQTA (doses, routes and lot numbers not reported) that were exposed to temperature conditions that we could not support. No adverse reactions 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.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a licensed practitioner nurse reporting on a 61 years old female patient with no pertinent medical history and no drug reactions/allergies who on 17-AUG-2012, was vaccinated with a dose of ZOSTAVAX (lot# H009779, exp March 2013, dose and route not reported). It was reported that on 18-AUG-2012, the patient developed an injection site reaction following vaccination with ZOSTAVAX. The patient developed an injection site reaction described as a 2x2 inch red, swollen area at the injection site that was warm to the touch without rash, but a little bit itchy during an office visit on 20-AUG-2012. The patient was treated with ice packs, BENADRYL and OTC cortisone cream (unspecified). At the time of the report, the patient was recovering from adverse events. The patient sought medical attention-office visit. The relatedness for 2x2 inch red, little bit itchy, out rash, warm to touch and swollen area at injection site were unknown for ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to an unspecified number of patients who on an unknown date, could have either been administered with a doses of RECOMBIVAX HB (doses, routes and lot numbers not reported) that were exposed to temperature conditions that we could not support. No adverse reactions 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: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker who reported that on an unspecified date, an unknown number of doses of PNEUMOVAX23 (lot number, dose and route not reported) were improperly stored at 10 degrees C., that may have been administered. No adverse effect was reported. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with a dose of VARIVAX (lot # not reported) subcutaneously instead of ZOSTAVAX on 14-AUG-2012. No adverse effect reported. Whether the patient sought for medical attention was not reported. The outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a licensed vocational nurse refers to a patient of unknown age who on 23-AUG-2012, was vaccinated with a dose of MMR II (dose, route and lot number not reported) that was exposed to 10 degrees C for nine hours. The patient was not experiencing any known symptoms. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Pericarditis
Clinical narrative: This spontaneous report as received from a physician refers to a male patient of unknown age. The patient was vaccinated with a single dose of 0.65 ml ZOSTAVAX (Lot# and exp date unspecified) subcutaneously "about a year ago" in approximately 2011. No other co-suspects were reported. No concomitant medications were reported. "About a year ago" in approximately 2011, the patient experienced pericarditis. The patient had performed unspecified lab diagnostics (result not reported). The outcome of pericarditis was reported as recovered/resolved "for about 6 months" in approximately February 2012. The patient has sought unspecified medical attention. Additional information is not expected.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Skin lesion
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age. In August (reported as "last week"), the patient was vaccinated with a single dose of 0.65 ml ZOSTAVAX (lot # not reported) subcutaneous. No other co-suspects were reported. On 27-AUG-2012 the patient experienced several lesions on the right torso area. There was no treatment information because patients had not yet been seen by the health professional. The patients had sought unspecified medical attention. The outcome was reported as not recovered. Follow up information has been received from the nurse practitioner refers to the patient, the nurse stated that the patient "now has full blown shingles all over the body." The nurse will now start treating the patient with acyclovir and TYLENOL. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist reported that he heard from an unspecified nurse that a male patient of unknown age, who was vaccinated with ZOSTAVAX (lot number reported) "a few year ago", was diagnosed with shingles. No other co-suspects or concomitant medications were reported. The patient had sought medical attention via office visit. No treatment information was reported. The outcome of shingles was unknown. Additional information is not expected.
Age: 0.6
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 6 months old patient. The patient was vaccinated with the third dose of RECOMBIVAX HB (Lot # and exp date unspecified) (vaccination site unknown) "3 days earlier" on an unknown date. No other co-suspects were reported. No concomitant medications were reported. No adverse effects reported. It was unspecified if the patient had sought medical attention. Additional information is not expected.
Sex: U
Vaccine: PPV
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 intramuscularly with 0.5 ml PNEUMOVAX 23 (lot # 667912/0933Z, exp. 25-FEB-2012) on 04-SEP-2012. No adverse effect reported. The outcome of patient was unknown. It was unspecified if the patient sought medical attention. Additional information has been requested.
Age: 10.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Loss of consciousness, Rash generalised
Clinical narrative: Within 5 min after SubQ injection, pt stated "he felt sick". Then he said "I can't see". Pt fell to ground & turned bright red & hot. Pt started hyperventilating & became lethargic. Consciousness remained intact. Jr. EPIPEN administered to (L) thigh. Pt stable upon ED transport.
Age: 10.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Blindness, Erythema, Fall, Feeling hot, Hyperventilation
Clinical narrative: Within 5 min after SubQ injection, pt stated "he felt sick". Then he said "I can't see". Pt fell to ground & turned bright red & hot. Pt started hyperventilating & became lethargic. Consciousness remained intact. Jr. EPIPEN administered to (L) thigh. Pt stable upon ED transport.
Age: 10.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Lethargy, Malaise
Clinical narrative: Within 5 min after SubQ injection, pt stated "he felt sick". Then he said "I can't see". Pt fell to ground & turned bright red & hot. Pt started hyperventilating & became lethargic. Consciousness remained intact. Jr. EPIPEN administered to (L) thigh. Pt stable upon ED transport.
Age: 11.0
Sex: M
Vaccine: MEN
Symptoms: Erythema, Pain
Clinical narrative: Patient had red area within minute of shot and pain that night. 9/5 the redness was expanding. 9/6 red area was even larger despite ice and Motrin. Went to MD's office where vaccine was administered and he was given Benadryl and a circle was drawn around it.  Tonight, the redness had spread beyond the line and was an area about 6x6 inches.  He came to ER and was diagnosed with possible cellulitis vs vaccine reaction.  He was given Keflex as a discharge Rx.  Only reaction to vaccine was redness.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Dizziness, Fatigue, Gait disturbance, Injection site pain
Clinical narrative: This spontaneous report was received from a female consumer concerning her 17 years old daughter with no pertinent medical history or drug reactions. The patient was vaccinated with dose 1 GARDASIL on 14-JUN-2012. On 27-AUG-2012, the patient was vaccinated with the second dose of GARDASIL. No other co-suspects were reported. There was no concomitant medication. On 27-AUG-2012, approximately 1 minute after received the second dose, the patient had seizure (medically significant) in the physician's office. The consumer mentioned her daughter did not have a history of seizures. The reporter mentioned that her daughter was retained in the physician's office for 2 hours following the vaccine administration. When the patient was sent home from the physician's office, she felt lightheaded, dizzy, and fatigued and had difficulty walking to the parking lot where her mother's car was parked. The consumer stated her daughter vomited in the physician's parking lot and "looked extremely pale". The patient continued to feel extremely fatigued and that she had soreness in the arm where she received GARDASIL. Upon internal review, seizure was considered to be an other important medical event. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Pallor, Vomiting
Clinical narrative: This spontaneous report was received from a female consumer concerning her 17 years old daughter with no pertinent medical history or drug reactions. The patient was vaccinated with dose 1 GARDASIL on 14-JUN-2012. On 27-AUG-2012, the patient was vaccinated with the second dose of GARDASIL. No other co-suspects were reported. There was no concomitant medication. On 27-AUG-2012, approximately 1 minute after received the second dose, the patient had seizure (medically significant) in the physician's office. The consumer mentioned her daughter did not have a history of seizures. The reporter mentioned that her daughter was retained in the physician's office for 2 hours following the vaccine administration. When the patient was sent home from the physician's office, she felt lightheaded, dizzy, and fatigued and had difficulty walking to the parking lot where her mother's car was parked. The consumer stated her daughter vomited in the physician's parking lot and "looked extremely pale". The patient continued to feel extremely fatigued and that she had soreness in the arm where she received GARDASIL. Upon internal review, seizure was considered to be an other important medical event. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Erythema
Clinical narrative: This spontaneous report as received from a vendor refers to a male patient of unknown age. The patient was vaccinated with a dose of 0.5 ml PNEUMOVAX 23 (lot # reported as H00982G, expiration date February 2014) intramuscularly on an unknown date. It was reported that the patient developed redness down his back and along his chest and was hospitalized. Address, name, and phone number of the hospital were unspecified. The outcome was unknown. Additional information has been requested
Age: 11.0
Sex: M
Vaccine: MEN, TDAP
Symptoms: Acute disseminated encephalomyelitis, Back pain, Bacterial test negative, CSF culture negative, CSF glucose normal
Clinical narrative: Case number PHHY2012US076743 is an initial literature report received on 31 Aug 2012. The intent of the article was to discuss about a standardized algorithm that assist in collecting and interpreting data and that help in assessing the causality after individual adverse events following immunizations and presented the case of a patient who experienced acute disseminated encephalomyelitis following vaccination. This report refers to an 11-year-old male patient. It was reported that he was healthy previously. He was vaccinated with Meningococcal conjugate vaccine (manufacturer and batch number: not reported, hence conservatively taken as Meningococcal vaccine general INN) and tetanus diphtheria acellular pertussis vaccine (other manufacturer, batch number: not reported) through unspecified route and site on an unknown date. Five weeks after vaccination he developed headache, excessive sleeping and severe neck and back pain. On Cerebrospinal fluid (CSF) analyses, his WBC count was 109 WBC/mm3, protein was 67 mg/dl and glucose was 66 mg/dl. A CT scan of the head was performed which was normal. It was reported that the initial diagnosis was aseptic meningitis. His CSF, urine and blood bacterial cultures were done and yielded no growth. MRI of the brain and spine performed two days later revealed abnormalities consistent with acute disseminated encephalomyelitis (ADEM). It was reported that no viral cultures were obtained and there was no evidence of any other acute infections. The outcome of the event was not reported. The author reported that the causal relationship between the events and suspect vaccine could not be determined (indeterminate). The article was concluded stating that assessing causality in an individual patient was challenging because of the multiple factors that must be taken into consideration and due to the need for careful clinical evaluation and judgment.
Age: 11.0
Sex: M
Vaccine: MEN, TDAP
Symptoms: CSF protein increased, CSF white blood cell count increased, Computerised tomogram head normal, Culture urine negative, Headache
Clinical narrative: Case number PHHY2012US076743 is an initial literature report received on 31 Aug 2012. The intent of the article was to discuss about a standardized algorithm that assist in collecting and interpreting data and that help in assessing the causality after individual adverse events following immunizations and presented the case of a patient who experienced acute disseminated encephalomyelitis following vaccination. This report refers to an 11-year-old male patient. It was reported that he was healthy previously. He was vaccinated with Meningococcal conjugate vaccine (manufacturer and batch number: not reported, hence conservatively taken as Meningococcal vaccine general INN) and tetanus diphtheria acellular pertussis vaccine (other manufacturer, batch number: not reported) through unspecified route and site on an unknown date. Five weeks after vaccination he developed headache, excessive sleeping and severe neck and back pain. On Cerebrospinal fluid (CSF) analyses, his WBC count was 109 WBC/mm3, protein was 67 mg/dl and glucose was 66 mg/dl. A CT scan of the head was performed which was normal. It was reported that the initial diagnosis was aseptic meningitis. His CSF, urine and blood bacterial cultures were done and yielded no growth. MRI of the brain and spine performed two days later revealed abnormalities consistent with acute disseminated encephalomyelitis (ADEM). It was reported that no viral cultures were obtained and there was no evidence of any other acute infections. The outcome of the event was not reported. The author reported that the causal relationship between the events and suspect vaccine could not be determined (indeterminate). The article was concluded stating that assessing causality in an individual patient was challenging because of the multiple factors that must be taken into consideration and due to the need for careful clinical evaluation and judgment.
Age: 11.0
Sex: M
Vaccine: MEN, TDAP
Symptoms: Hypersomnia, Laboratory test normal, Meningitis aseptic, Neck pain, Nuclear magnetic resonance imaging brain abnormal
Clinical narrative: Case number PHHY2012US076743 is an initial literature report received on 31 Aug 2012. The intent of the article was to discuss about a standardized algorithm that assist in collecting and interpreting data and that help in assessing the causality after individual adverse events following immunizations and presented the case of a patient who experienced acute disseminated encephalomyelitis following vaccination. This report refers to an 11-year-old male patient. It was reported that he was healthy previously. He was vaccinated with Meningococcal conjugate vaccine (manufacturer and batch number: not reported, hence conservatively taken as Meningococcal vaccine general INN) and tetanus diphtheria acellular pertussis vaccine (other manufacturer, batch number: not reported) through unspecified route and site on an unknown date. Five weeks after vaccination he developed headache, excessive sleeping and severe neck and back pain. On Cerebrospinal fluid (CSF) analyses, his WBC count was 109 WBC/mm3, protein was 67 mg/dl and glucose was 66 mg/dl. A CT scan of the head was performed which was normal. It was reported that the initial diagnosis was aseptic meningitis. His CSF, urine and blood bacterial cultures were done and yielded no growth. MRI of the brain and spine performed two days later revealed abnormalities consistent with acute disseminated encephalomyelitis (ADEM). It was reported that no viral cultures were obtained and there was no evidence of any other acute infections. The outcome of the event was not reported. The author reported that the causal relationship between the events and suspect vaccine could not be determined (indeterminate). The article was concluded stating that assessing causality in an individual patient was challenging because of the multiple factors that must be taken into consideration and due to the need for careful clinical evaluation and judgment.
Age: 11.0
Sex: M
Vaccine: MEN, TDAP
Symptoms: Nuclear magnetic resonance imaging spinal cord abnormal
Clinical narrative: Case number PHHY2012US076743 is an initial literature report received on 31 Aug 2012. The intent of the article was to discuss about a standardized algorithm that assist in collecting and interpreting data and that help in assessing the causality after individual adverse events following immunizations and presented the case of a patient who experienced acute disseminated encephalomyelitis following vaccination. This report refers to an 11-year-old male patient. It was reported that he was healthy previously. He was vaccinated with Meningococcal conjugate vaccine (manufacturer and batch number: not reported, hence conservatively taken as Meningococcal vaccine general INN) and tetanus diphtheria acellular pertussis vaccine (other manufacturer, batch number: not reported) through unspecified route and site on an unknown date. Five weeks after vaccination he developed headache, excessive sleeping and severe neck and back pain. On Cerebrospinal fluid (CSF) analyses, his WBC count was 109 WBC/mm3, protein was 67 mg/dl and glucose was 66 mg/dl. A CT scan of the head was performed which was normal. It was reported that the initial diagnosis was aseptic meningitis. His CSF, urine and blood bacterial cultures were done and yielded no growth. MRI of the brain and spine performed two days later revealed abnormalities consistent with acute disseminated encephalomyelitis (ADEM). It was reported that no viral cultures were obtained and there was no evidence of any other acute infections. The outcome of the event was not reported. The author reported that the causal relationship between the events and suspect vaccine could not be determined (indeterminate). The article was concluded stating that assessing causality in an individual patient was challenging because of the multiple factors that must be taken into consideration and due to the need for careful clinical evaluation and judgment.
Age: 38.0
Sex: F
Vaccine: FLUX
Symptoms: Asthma, Condition aggravated, Fatigue, Headache, Injection site erythema
Clinical narrative: Swollen hot red itching injection site; Soreness, Fever, Aches, Headache, Fatigue, Triggered some mild asthmatic symptoms. Took over the counter medication, and rested. Attempted to call doctor's office this morning at 9am but there was no answer and sent fax to let them know.
Age: 38.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth, Pain, Pyrexia
Clinical narrative: Swollen hot red itching injection site; Soreness, Fever, Aches, Headache, Fatigue, Triggered some mild asthmatic symptoms. Took over the counter medication, and rested. Attempted to call doctor's office this morning at 9am but there was no answer and sent fax to let them know.