chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired drug administered, 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 an expired dose of ZOSTAVAX with lot # (670542/0619AA) (expiration date 26-JUL-2012) on 21-AUG-2012. No adverse symptoms reported. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain in extremity, Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 63 years old female patient with sulfa allergy. On 15-AUG-2012, the patient was vaccinated subcutaneously with a dose of ZOSTAVAX (lot # 0422AE Exp: 27/MAR/2013). No concomitant medications were reported. The pharmacist stated that on 18-AUG-2012, the patient developed shingles rash after receiving ZOSTAVAX. The patient had painful rash on right inner thigh. The patient saw the physician. Laboratory studies were not performed. At the time of the report the patient was recovering from shingles rash and painful rash on right inner thigh. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Syncope, Vomiting
Clinical narrative: This spontaneous report as received from a physician refers to a male patient of unknown age. The patient was vaccinated with GARDASIL in August 2012, "in the past 8 days". Lot#, route and specified date were not reported. It was reported that the patient experienced syncope and vomiting with in 5 minutes of receiving GARDASIL. The outcome of syncope and vomiting was unknown. The patient sought medical attention for the adverse event occurred in the physician's office. This is one of several reports received from the same source. (1209USA002964, 1209USA003021, 1209USA001616, 1209USA003023, 1209USA003024). Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Syncope, Vomiting
Clinical narrative: This spontaneous report as received from a physician refers to a male patient of unknown age. The patient was vaccinated with GARDASIL in August 2012, "in the past 8 days". Lot#, route and specified date were not reported. It was reported that the patient experienced syncope and vomiting with in 5 minutes of receiving GARDASIL. The outcome of syncope and vomiting was unknown. The patient sought medical attention for the adverse event occurred in the physician's office. This is one of several reports received from the same source. (1209USA002964, 1209USA003021, 1209USA003022, 1209USA003023, 1209USA00166). Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a physician refers to 3 patients of unknown age. The patient was vaccinated with GARDASIL in 2012 "the entire previous year". Lot#, date and route were unspecified. On unspecified dates, the 3 patients experienced syncope after receiving GARDASIL. The patients sought medical attention for the adverse event occurred in the physician's office. The outcome of patients were unknown. This is one of several reports received from the same source. (1209USA001616, 1209USA003021, 1209USA003023, 1209USA003024). Additional information has been requested. Attempt is being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
Sex: F
Vaccine: HPV4
Symptoms: Condition aggravated, Skin papilloma
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age with a prior history of warts on the face and hands (also reported as "no medical history") who on an unspecified date was vaccinated with the second dose of GARDASIL (Lot# and dose not reported), intramuscularly. On an unknown date the patient experienced after receiving her 2nd injection of GARDASIL warts had returned to her face and hands. The patient sought medical attention by her mother calling to the pharmacist. At the time of reporting, the patient had not recovered. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a patient of unknown age. The patient was inadvertently vaccinated with a 0.5 ml dose of PNEUMOVAX23 (lot # 667912/0933Z expiration date 25-FEB-2012) IM on 05-SEP-2012. No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a female patient of unknown age. The patient was vaccinated with first dose of GARDASIL in August 2007 (reported as "five years ago"), and received second dose "today" (22-AUG-2012). No other co-suspects were reported. No concomitant medications were reported. No known symptoms reported. The patient was not sure if she did received a dose of GARDASIL five years ago and was going to check with her other physician. It was unknown if the patient had sought medical attention. Additional information is not expected.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash generalised, Rash pruritic
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 82 years old female patient with no pertinent medical history and no drug reactions/allergies. The patient was subcutaneously(SQ) vaccinated with ZOSTAVAX (Lot# reported as 0172AE, Exp date: 18-APR-2013, single dose, dose/frequency unspecified) on 06-SEP-2012. There was no concomitant medications therapy. The pharmacist reported that the patient developed a widespread, itchy rash on her hands, legs, abdomen, and under her breast 3 hours after administration of ZOSTAVAX on 06-SEP-2012. The patient had sought medical attention via coming to pharmacy. No lab diagnostics studies performed. The patient was recommended to take BENADRYL and contact her physician if symptoms persist. The outcome was reported as not recovered/not resolved. Additional information is not expected.
Age: 47.0
Sex: M
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a licensed practical nurse concerning a 47 years old male patient who on 01-SEP-2012 was vaccinated with a dose of ZOSTAVAX (Lot# reported as "0242AE", EXP. 01-APR-2012) (SQ, .65ml) in place of prescribed VARIVAX. The patient did not experience any adverse effect. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Oral herpes
Clinical narrative: This spontaneous report as received from a consumer refers to a 68 years old female patient with FLAGYL allergy and cold sores. The patient was vaccinated with the first dose of ZOSTAVAX (lot number not reported) under the skin in her left arm in January 2012. No other co-suspects were reported. Concomitant medications included OTC vitamins (unspecified). In January 2012 the patient started getting a cold sore on her lip about once a week for several months after she received ZOSTAVAX in 2012. The patient reported that she was having a history of cold sores since she was born but said she was only getting them about 2 times per year before getting ZOSTAVAX. No treatment was received. No lab diagnostics was received. The outcome was reported as recovered/resolved in April 2012. The patient didn't sought medical attention. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: This spontaneous report was received from a physician concerning 2 patients who on unknown dates were vaccinated with a dose of VARIVAX (Merck) (dose, route and lot # not provided). On unknown dates, the patients were diagnosed with the varicella virus after receiving the VARIVAX (Merck) vaccine. The patient visited the emergency room for treatment and were not admitted. On unknown dates, the patients recovered from the event. The relatedness for the event was unknown for VARIVAX (Merck). Additional information has been requested.
Age: 1.09
Sex: F
Vaccine: VARCEL
Symptoms: Rash generalised, Rash pustular, Varicella post vaccine
Clinical narrative: Information has been received from a nurse concerning a 25 month old patient who on 16-MAY-2011 was vaccinated with a dose of VARIVAX (Merck) (lot# 667234/1378Z). The nurse mentioned that on 21-MAY-2012 the patient had outbreaks of varicella. The patient had contacted the office. At the time of the report, the patient's status was unknown. This was one of the several reports from the same source. A lot check has been initiated. Follow-up information has been received from the registered nurse via a completed B-form provided information that female patient with wheezing, Tinea Pedis and Onychomycosis, who at 3:30PM on 16-MAY-2011 was vaccinated with the first dose of VARIVAX (Merck) SC in the left leg, came to clinic on 21-MAY-2012 with a rash described as "moderate, generalized vesicules and pustules on face, scalp, upper/lower extremities", diagnosed as varicella. Lab diagnostic test were not performed. None illness at time of vaccination. Follow up visit on 26-JUN-2012 indicated that there were no rash and the patient recovered. This is one of several reports received from the same source. Additional information is not expected.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Blood test, Type 1 diabetes mellitus
Clinical narrative: This spontaneous report as received from a physician refers to a 5 years old male patient. On unknown date the patient was vaccinated with, 0.5ml VARIVAX (Merck) (lot# not reported) SC, once or twice. On an unknown date the patient experienced was diagnosed with type 1 diabetes 3 weeks after receiving VARIVAX (Merck). On unknown date blood test were performed. The patient sought unspecified medical attention. The outcome of patient was reported as not recovered/not resolved. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Nodule, Paraesthesia
Clinical narrative: This spontaneous report as received from a 71 years old female consumer concerned herself with diabetic, high blood pressure and allergy to morphine. The patient was subcutaneously vaccinated with a dose of ZOSTAVAX (lot # not reported) on 30-JUL-2012. Concomitant medications included hydrochlorothiazide (+) triamterene, COZAAR, clonidine hydrochloride, KLOR-CON, simvastatin, omega-3 marine triglycerides, glyburide, cyanocobalamin, gabapentin, vitamin D (unspecified), LANTUS, aspirin, "Pransdon HCL" and ZYRTEC. The reporter stated that on 01-AUG-2012 she had a sensation "like running a finger over your skin". She stated similar to a tickle, no pain, no itch. She had consulted her pharmacist and she was referred to her doctor. She also stated that she had a knot and redness after injection on her right arm. She stated that she had shingles prior, too. No treatment was given for adverse events. No lab diagnosis was performed. At the time of reporting, the outcome of adverse events was unknown. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash generalised, Rash pruritic
Clinical narrative: This spontaneous report was received from a nurse practitioner refers to a 60 years old female patient with hypertension and allergy to penicillin who on 30-AUG-2012, was vaccinated subcutaneously with a single dose of ZOSTAVAX (lot number H010656, Exp. Date: 01-SEP-2013) (dose not reported). No other co-suspects were reported. Concomitant medications included DIOVAN, BONIVA and calcium. The nurse practitioner reported that the patient on 31-AUG-2012, developed a rash. The patient came to the office for evaluation and was found to have a flat, red, itch rash on her neck, both arms, chest, abdomen and back. The patient was given DEPO-MEDROL injection and CLARITIN in the office. The patient was prescribed a MEDROL dose pack, CLARITIN and BENADRYL to be taken at home. No lab diagnostics studies were performed. At the time of the report, the patient had not recovered. The relatedness for patient was found to have a flat, red and itchy rash on her neck, both arms, chest, abdomen and back was unknown for ZOSTAVAX. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster ophthalmic
Clinical narrative: Received shingles vaccine 9/1/2010 - it gave me shingles in the eye. I've doctored for it for 2 years, incurring much expenses. Will likely have to use prednisone forever.
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blood test, Genital herpes, Skin lesion
Clinical narrative: Severe outbreaks of bumps all over body that have a lot of pain from them. These are continuous and have appeared on face, chin, penis, anus, groin, chest.
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Rash generalised
Clinical narrative: Severe outbreaks of bumps all over body that have a lot of pain from them. These are continuous and have appeared on face, chin, penis, anus, groin, chest.
Age: 59.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Blood blister, Contusion, Epistaxis, Immunoglobulin therapy, Oral mucosal blistering
Clinical narrative: Developed I.T.P, brain bleed, bruising. Treatments steroids, chemo, removal of spleen, ultrasounds, nose packs, blood transfusions. Nosebleeds, blood blisters in mouth, symptoms for 3 mo.
Age: 59.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Platelet count decreased
Clinical narrative: Developed I.T.P, brain bleed, bruising. Treatments steroids, chemo, removal of spleen, ultrasounds, nose packs, blood transfusions. Nosebleeds, blood blisters in mouth, symptoms for 3 mo.
Age: 59.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Biopsy bone marrow, Blood blister, Blood test, Cerebral haemorrhage, Chemotherapy
Clinical narrative: Developed I.T.P, brain bleed, bruising. Treatments steroids, chemo, removal of spleen, ultrasounds, nose packs, blood transfusions. Nosebleeds, blood blisters in mouth, symptoms for 3 mo.
Age: 59.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Contusion, Epistaxis, Idiopathic thrombocytopenic purpura, Nasal cavity packing, Oral mucosal blistering
Clinical narrative: Developed I.T.P, brain bleed, bruising. Treatments steroids, chemo, removal of spleen, ultrasounds, nose packs, blood transfusions. Nosebleeds, blood blisters in mouth, symptoms for 3 mo.
Age: 59.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Splenectomy, Transfusion, Ultrasound scan, X-ray
Clinical narrative: Developed I.T.P, brain bleed, bruising. Treatments steroids, chemo, removal of spleen, ultrasounds, nose packs, blood transfusions. Nosebleeds, blood blisters in mouth, symptoms for 3 mo.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Headache, Injection site pain, Injection site swelling, Nausea
Clinical narrative: Headache, nausea, fever, pain at injection site, swelling at injection site, fatigue.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Headache, nausea, fever, pain at injection site, swelling at injection site, fatigue.
Age: 1.01
Sex: M
Vaccine: VARCEL
Symptoms: Diet refusal, Pyrexia, Rash
Clinical narrative: Fever of 100-102 for 4-5 days, refusal to eat, ended up in a rash on day 5.
Age: 19.0
Sex: M
Vaccine: ANTH, JEV1, SMALL
Symptoms: Dizziness, Electrocardiogram, Hyperhidrosis, Tremor
Clinical narrative: Ten minutes after receiving Anthrax, JEV, and Smallpox vaccinations patient began to feel lightheaded. He then began to have tremors and started sweating profusely. Vital signs remained normal. Symptoms improved after receiving IVF and Morphine.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Body temperature increased, Chest discomfort, Injection site pain, Injection site swelling
Clinical narrative: Developed pain & swelling in the shoulder and arm of the injection. At 8:45pm felt nausea, vomited 2 time, temperature of 103 F that dropped to 101 all night. Heart rate and pulse remained same. Arm and shoulder extremely painful all night without relief, edema controled with ice packs. Denies shortness of breath or chest pain but did have chest pressure for a short period during the night. No fever the next morning but shoulder/arm remains swollen mildly and painful. General joint aches.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Musculoskeletal pain, Nausea, Oedema, Oedema peripheral, Pain in extremity
Clinical narrative: Developed pain & swelling in the shoulder and arm of the injection. At 8:45pm felt nausea, vomited 2 time, temperature of 103 F that dropped to 101 all night. Heart rate and pulse remained same. Arm and shoulder extremely painful all night without relief, edema controled with ice packs. Denies shortness of breath or chest pain but did have chest pressure for a short period during the night. No fever the next morning but shoulder/arm remains swollen mildly and painful. General joint aches.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Vomiting
Clinical narrative: Developed pain & swelling in the shoulder and arm of the injection. At 8:45pm felt nausea, vomited 2 time, temperature of 103 F that dropped to 101 all night. Heart rate and pulse remained same. Arm and shoulder extremely painful all night without relief, edema controled with ice packs. Denies shortness of breath or chest pain but did have chest pressure for a short period during the night. No fever the next morning but shoulder/arm remains swollen mildly and painful. General joint aches.
Age: 63.0
Sex: F
Vaccine: FLUX
Symptoms: Abdominal pain upper, Dizziness, Fatigue, Headache, Somnolence
Clinical narrative: Severe thirst, stomach pain, severe headaches, dizziness, lightheadedness, fatigue, sleepiness.
Age: 63.0
Sex: F
Vaccine: FLUX
Symptoms: Thirst
Clinical narrative: Severe thirst, stomach pain, severe headaches, dizziness, lightheadedness, fatigue, sleepiness.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Pyrexia, Respiratory tract congestion
Clinical narrative: Fever, diarrhea, congestion.
Age: 34.0
Sex: F
Vaccine: FLUX, MMR, TDAP
Symptoms: Cough, Pyrexia
Clinical narrative: Fever, coughing the following day.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Headache
Clinical narrative: Fatigue, headache.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Skin warm
Clinical narrative: Raised red rash approx 3in diameter, warm to the touch. No soreness.
Age: 41.0
Sex: M
Vaccine: TYP
Symptoms: Headache, Pain, Pyrexia, Urticaria
Clinical narrative: The adverse events happened after taking the second of four oral typhoid vaccine pills. The second dose was taken at 1pm on 9/8/2012. At 0700 on 9/10/12 I broke out in hives over most of my body. Later that day I also had a fever of 102.6, headache, and body aches. I was advised to not take the third and fourt doses. Benadryl helped with the hives but again on 9/11/2012 I awoke to severe hives. Also, on 9/4/2012 I had injections of both the Hep A and polio booster and have no clue who the manufacturer is.
Age: 63.0
Sex: M
Vaccine: DTP
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Rash, Urticaria Pruritus & no treatment.
Sex: U
Vaccine: FLUX, FLUX(H1N1)
Symptoms: Unevaluable event
Clinical narrative: Initial report was retrieved via the scientific literature on 28 August 2012. From the published article: "INTRODUCTION: Following the 2009 influenza A/H1N1 (pH1N1) pandemic, both seasonal and pH1N1 viruses circulated during the 2010-2011 influenza season; influenza vaccine effectiveness (VE) may vary between live attenuated (LAIV) and trivalent inactivated (TIV) vaccines as well as by virus subtype. MATERIALS AND METHODS: Vaccine type and virus subtype-specific VE were determined for military active component personnel for the period of September 1, 2010 through April 30, 2011. Laboratory-confirmed influenza-related medical encounters were compared to matched individuals with a non-respiratory illness (healthy controls), and unmatched individuals who experienced a non-influenza respiratory illness (test-negative controls). Odds ratios (OR) and VE estimates were calculated overall, by vaccine type and influenza subtype. RESULTS: A total of 603 influenza cases were identified. Overall VE was relatively low and similar regardless of whether healthy controls (VE = 26%, 95% CI: -1 to 45) or test-negative controls (VE = 29%, 95% CI: -6 to 53) were used as comparison groups. Using test-negative controls, vaccine type-specific VE was found to be higher for TIV (53%, 95% CI: 25 to 71) than for LAIV (VE = -13%, 95% CI: -77 to 27). Influenza subtype-specific analyses revealed moderate protection against A/H3 (VE = 58%, 95% CI: 21 to 78), but not against A/H1 (VE = -38%, 95% CI: -211 to 39) or B (VE = 34%, 95% CI: -122 to 80). CONCLUSION: Overall, a low level of protection against clinically-apparent, laboratory-confirmed, influenza was found for the 2010-11 seasonal influenza vaccines. TIV immunization was associated with higher protection than LAIV, however, no protection against A/H1 was noted, despite inclusion of a pandemic influenza strain as a vaccine component for two consecutive years. Vaccine virus mismatch or lower immunogenicity may have contributed to these findings and deserve further examination in controlled studies. Continued assessment of VE in military personnel is essential in order to better inform vaccination policy decisions." Documents held by sender: none.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site oedema, Injection site vesicles, Skin reaction, Skin test positive
Clinical narrative: Initial report received from scientific literature on 28 August 2012. The reporter for this case is the same as case number 2012-07951. The following is verbatim from the article: "A 5-year-old boy presented 2 months after DTaP vaccination for evaluation of subsequent exuberant cutaneous reaction that occurred 24 to 36 hours after immunization, relieved by oral prednisone. There was no known allergy to eggs. See Table 1 for description of these reactions and patch test reactions. Our institution's standard series of allergens for pediatric patients were not interpretable and obscured by a robust eczematous reaction." The patient's past medical history included hay fever, atopic dermatitis and allergy to nuts, cats and dogs. Family history was reported as atopy. The child received an injection of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE, manufacturer unknown; lot number route, site, dose in series were not reported) on an unspecified date. Symptoms developed 24 to 36 hours post vaccination included "erythema, edema and blistering at injection site." The patient had a positive patch test with resulting reactions reported as (3+) Aluminum chloride hexahydrate and (1+) Glutaraldehyde on an unspecified date. The patient's outcome was not reported. Documents held by sender: None.
Age: 54.0
Sex: F
Vaccine: DTP
Symptoms: Nodule, Rash
Clinical narrative: Rash & raised knot.
Age: 71.0
Sex: M
Vaccine: HEP
Symptoms: Condition aggravated, Dialysis, Hepatitis B surface antibody negative
Clinical narrative: This spontaneous report as received from a licensed vocational nurse refers to a 71 year old male patient with diabetes, chronic kidney disease, hypertension and drug reactions or allergies to Benazepril hydrochloride. The patient will be getting a kidney transplant on an unspecified date. The patient's medical history included bypass surgery. The patient was vaccinated with dose 1 of 10 Microgram RECOMBIVAX HB (lot # 660951/0398X, expiration date 18-NOV-2010) intramuscularly on 28-JAN-2009, with dose 2 of 40 microgram (dialysis formulation) RECOMBIVAX HB (lot # reported as 1696X, expiration date 27-JUN-2011) on 02-MAR-2009, with dose 3 of 40 microgram (dialysis formulation) RECOMBIVAX HB (lot # reported as 1696X, expiration date 27-JUN-2011) on 24-AUG-2009 and with dose 4 of 40 microgram (dialysis formulation) RECOMBIVAX HB (lot # reported as 1696X, expiration date 27-JUN-2011) on 13-OCT-2009. No other co-suspects were reported. Concomitant medications included Sertraline hydrochloride, Clonazepam, LIPITOR and Diphenhydramine hydrochloride. On an unknown date, the patient was showing to be "non-immune" to hepatitis B. The reporting nurse explained that the patient had received dose 1 of RECOMBIVAX HB and shortly afterwards (unspecified date) the patient informed the physician that he would be going on dialysis ("patient is on dialysis" was also reported as pertinent medical history). No treatment information was reported. The patient sought unspecified medical attention. At the time of the report the patient's outcome of dialysis was unknown. The patient's present status was reported as "non-immune" to hepatitis B. Upon internal review, dialysis was considered to be an other important medical event. The patient also experienced drug allergy while on COZAAR on an unspecified date (MARRS #1209USA003112). Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Flushing, Injection site erythema, Injection site swelling, Injection site warmth, Nausea
Clinical narrative: This spontaneous report as received from a healthcare worker referred to a 74 years old female patient with allergy to gluten and wheat, allergy to penicillin and codeine. The patient's medical history included diabetes, hypothyroidism, hyperlipidemia and celiac disease. The patient was intramuscularly vaccinated with a dose of 0.5 ml PNEUMOVAX23 (lot # not reported) on 29-AUG-2012. Concomitant therapy included ARMOUR THYROID TABLETS, omega-3 marine triglycerides, kelp and multivitamins. The reporter stated that "five minutes ago," the patient received a dose of PNEUMOVAX23 and "was having a reaction right now." The patient's injection site was currently swelling and had already become "the size of a golf ball." The reporter stated that in addition to swelling, the injection site became red and warm. The patient also developed facial flushing and nausea. The caller stated that "911" was called and the patient was transported to Hospital (patient admitted) by the emergency squad. At the time of reporting, the outcome of the adverse events was reported as not recovered. Additional information has been requested.
Age: 1.3
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Mom states pt broke out with chicken pox Tuesday 9/4/12 pm. First VARIVAX given elsewhere.
Age: 1.3
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Blister, Rash
Clinical narrative: Mom states pt broke out with chicken pox Tuesday 9/4/12 pm. First VARIVAX given elsewhere.
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Blood immunoglobulin G, Blood immunoglobulin M, Computerised tomogram, Laboratory test, Neuroblastoma
Clinical narrative: This spontaneous report as received from a physician refers to a 3 years old female patient with none drug reactions/allergies. The patient was vaccinated with a dose of VARIVAX (Merck) (Lot number, dose and route not reported) in 2010. Concomitant medications included unspecified chemotherapy, induction therapy and blood transfusions. Physician reported that on 19-AUG-2012, 10 days ago, the patient was diagnosed with neuroblastoma. Physician noted that the patient had serologic testing on 23-AUG-2012 which revealed positive IgM and IgG levels for varicella, and patient had developed a fever and rash around her hair line and ear. Physician believed that this could be possible start of outbreak of varicella-zoster virus. On an unspecified date the patient was hospitalized. Computed tomography (CT) and other unspecified diagnostic tests were performed (results not provided). There was no treatment given for the events. At the time of the report, the patient had not recovered. The relatedness for neuroblastoma, possible start of outbreak of varicella-zoster virus, rash around her hair line and ear, fever and positive IgM and IgG levels for varicella was unknown for VARIVAX (Merck). Neuroblastoma, possible start of outbreak of varicella-zoster virus, rash around her hair line and ear, fever and positive IgM and IgG levels for varicella were considered disabling and life threatening by the reporter. Additional information has been requested.
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Rash, Serology positive, Varicella virus test positive
Clinical narrative: This spontaneous report as received from a physician refers to a 3 years old female patient with none drug reactions/allergies. The patient was vaccinated with a dose of VARIVAX (Merck) (Lot number, dose and route not reported) in 2010. Concomitant medications included unspecified chemotherapy, induction therapy and blood transfusions. Physician reported that on 19-AUG-2012, 10 days ago, the patient was diagnosed with neuroblastoma. Physician noted that the patient had serologic testing on 23-AUG-2012 which revealed positive IgM and IgG levels for varicella, and patient had developed a fever and rash around her hair line and ear. Physician believed that this could be possible start of outbreak of varicella-zoster virus. On an unspecified date the patient was hospitalized. Computed tomography (CT) and other unspecified diagnostic tests were performed (results not provided). There was no treatment given for the events. At the time of the report, the patient had not recovered. The relatedness for neuroblastoma, possible start of outbreak of varicella-zoster virus, rash around her hair line and ear, fever and positive IgM and IgG levels for varicella was unknown for VARIVAX (Merck). Neuroblastoma, possible start of outbreak of varicella-zoster virus, rash around her hair line and ear, fever and positive IgM and IgG levels for varicella were considered disabling and life threatening by the reporter. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Fatigue, Feeling hot, Heart rate increased, Hypotension
Clinical narrative: Initial report was received from a healthcare professional on 05 September 2012. A 65-year-old female patient received an intramuscular injection in the left deltoid of FLUZONE HIGH-DOSE, lot number U4491AA, on 04 September 2012. On 04 September 2012, the patient experienced hypotension, shortness of breath, myalgia, warm feeling in hands, fatigue and increased heart rate that persisted until 05 September 2012. The patient had a history of a shellfish allergy. The patient's outcome was reported as unknown. Documents held by sender: None.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia
Clinical narrative: Initial report was received from a healthcare professional on 05 September 2012. A 65-year-old female patient received an intramuscular injection in the left deltoid of FLUZONE HIGH-DOSE, lot number U4491AA, on 04 September 2012. On 04 September 2012, the patient experienced hypotension, shortness of breath, myalgia, warm feeling in hands, fatigue and increased heart rate that persisted until 05 September 2012. The patient had a history of a shellfish allergy. The patient's outcome was reported as unknown. Documents held by sender: None.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Bursa injury, Drug administered at inappropriate site, Injection site pain, Pain in extremity, Ultrasound scan
Clinical narrative: Received vaccine upon discharge from hospital stay. Within an hour after arriving at home intense pain began at site and spread to whole arm down to hand. Back to ER next morning.
Age: 35.0
Sex: F
Vaccine: FLU3, HEP
Symptoms: Dysphagia, Injection site erythema, Injection site swelling, Oedema mouth, Pharyngeal oedema
Clinical narrative: Initial report was received on 30 August 2012 from a non-health care professional. A female patient (age not reported) with a history of migraines had received on 29 August 2012 an intradermal right deltoid injection of FLUZONE Intradermal, lot number UT4470AA (invalid) and an intramuscular left deltoid injection of Hepatitis B, lot number AHBVC111AA and "within one hour" after vaccination, experienced a one inch in diameter red, swollen area at the right deltoid. The patient also reported that her mouth and throat felt like they were swelling. The patient reported no difficulty breathing or swallowing, but stated her swallowing felt "different". According to the reporter, the tongue appeared slightly swollen and had a white coating on it. The was to be evaluated by a physician. No treatments or concomitant medications were reported. The patient had no illness at the time of vaccination. No other information was available at the time of the report. The patient's outcome was not recovered. Documents held by sender: none.
Age: 35.0
Sex: F
Vaccine: FLU3, HEP
Symptoms: Swollen tongue, Tongue coated
Clinical narrative: Initial report was received on 30 August 2012 from a non-health care professional. A female patient (age not reported) with a history of migraines had received on 29 August 2012 an intradermal right deltoid injection of FLUZONE Intradermal, lot number UT4470AA (invalid) and an intramuscular left deltoid injection of Hepatitis B, lot number AHBVC111AA and "within one hour" after vaccination, experienced a one inch in diameter red, swollen area at the right deltoid. The patient also reported that her mouth and throat felt like they were swelling. The patient reported no difficulty breathing or swallowing, but stated her swallowing felt "different". According to the reporter, the tongue appeared slightly swollen and had a white coating on it. The was to be evaluated by a physician. No treatments or concomitant medications were reported. The patient had no illness at the time of vaccination. No other information was available at the time of the report. The patient's outcome was not recovered. Documents held by sender: none.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Computerised tomogram head normal, Hyperhidrosis, Laboratory test normal, Nausea, Vertigo
Clinical narrative: 1 week after vaccine extreme vertigo, had nausea, diaphoresis - seen in ER, adm.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site inflammation, Pyrexia
Clinical narrative: Arm at inj site inflamed and red. Pt. developed fever. Went to Dr and treated for cellulitis with Cephalexin 500 mg 1 TID for infection and Ibuprofen & TYLENOL for fever 7 day treatment.
Age: 5.0
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Blister, Erythema, Oedema peripheral, Wound secretion
Clinical narrative: Arm became red swollen & blistered oozing in to staph.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test normal, Computerised tomogram normal, Convulsion, Electroencephalogram normal, Hypoaesthesia
Clinical narrative: Tingling, numbness, weakness & pain in right leg beginning 8/13/12 & 8/14/12 leading to several seizures on 8/15/12 & another on 8/21/12. As of today 9/4/12, my daughter still experiences tingling, numbness, weakness, & pain.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Muscular weakness, Nuclear magnetic resonance imaging normal, Pain in extremity, Paraesthesia
Clinical narrative: Tingling, numbness, weakness & pain in right leg beginning 8/13/12 & 8/14/12 leading to several seizures on 8/15/12 & another on 8/21/12. As of today 9/4/12, my daughter still experiences tingling, numbness, weakness, & pain.
Age: 0.35
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV1
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This case was reported by two separate healthcare professionals (CMAs) and described the occurrence of inappropriate route of vaccination in a 4-month-old subject of unspecified gender who was vaccinated with ROTARIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of ROTARIX intramuscularly. The subject experienced inappropriate route of vaccination. No additional details were provided. The reporter had no further information. Follow up received from a healthcare professional (CMA) on 17 July 2012. Concurrent vaccination included PENTACEL, Sanofi Pasteur; unknown; unknown given on 17 July 2012; PREVNAR, PFIZER; unknown; unknown given on 17 July 2012. The healthcare professional reported the 4-month-old female received the 2nd dose of ROTARIX (1 ml, intramuscular, unknown site) on 17 July 2012 at 12:30. She explained that the subject received the 2nd dose of ROTARIX by the intramuscular route inadvertently instead of the oral route due to new employee mistake. The employee stated it was a powder that had to be reconstituted, but the lot number was that of ROTATEQ, so the healthcare professional was assuming that the lot number was incorrectly transcribed. It was noted that the vaccination series was delayed. The healthcare professional was concerned and upset about safety for the subject. On 08 August 2012, follow-up was received from a healthcare professional (nurse practitioner). The event was reported as an erroneous administration and was not considered as serious. The concomitant vaccinations, PENTACEL and PREVENAR, were administered intramuscularly. It was reported that the subject received a 2nd dose of ROTATEQ orally after the ROTARIX was given. It was confirmed that on 17 July 2012, ROTARIX was administered via an incorrect route (intramuscularly) in private consultation. The nurse practitioner reported that the method used to inject the ROTARIX vaccine was by syringe. In her opinion, it was that the oral vaccine was in a vial and not in an oral tube that led to the maladministration. No adverse events occurred following the incorrect route of administration of ROTARIX. Follow-up information was received on 05 September 2012 via healthcare professional. The vaccine was administered on 17 July 2012, no adverse reaction to inappropriate dosing. The parent was called twice that day and the following week. No reaction occurred. The healthcare professional confirmed ROTARIX was administered on 12 July 2012 ROTARIX was administered via an incorrect route (intramuscularly) in private consultation. The oral vaccine was placed in an intramuscular syringe with head was the method of injection. In the healthcare professional's opinion what lead to the maladministration was "medical assistant confusion, other type was injectable". Immunization series was not discontinued or delayed. The reporting healthcare professional considered the event serious. Lot number reported as "841FB226A".
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Swelling
Clinical narrative: Swelling and redness on right arm. Treatment: BACTRIM DS.
Age: 17.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Condition aggravated, Fall, Syncope
Clinical narrative: Pt received two of five required vaccines due to lack of records. Pt received Hep A pediatric dose and MCV4 in left deltoid muscle. Pt fainted, fell from seated position onto floor. Pt landed on right shoulder.  Pt turned onto back, awoken with amnonia capsule. BP 100/70, pulse 80. Pt given ice pack, remained supine until felt able to sit up. Given juice and when recovered, Td; IPV; and HPV adm in right arm. Pt reports HX of Fainting related to "taking medication." No further details provided.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash
Clinical narrative: Rash on face, neck, and trunk and severe itching.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: REDNESS, SWELLING
Age: 30.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Significant swelling, redness, and heat at site of immunization. Swelling approximately the size of a baseball. Appears similar to side effects from an Anthrax immunization. Treatment: rest, cool packs, anti-inflammatory.
Age: 13.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Unevaluable event
Clinical narrative: Parent called on 9/10/2012.
Age: 0.19
Sex: M
Vaccine: DTAPIPV, IPV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: 2 doses of IPV given - 1 single vaccine, and 1 combo with Dtap and IPV. No adverse reactions noted.
Age: 63.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Arthralgia, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Slight fever, redness and swelling around injection sight, joint aches.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Muscular weakness, Urticaria, Visual impairment
Clinical narrative: Red hives, black out of vision, muscle weakness.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Patient has a localized reaction consisting of a large 4 inch by 6 inch raised, itchy, red, and warm area at injection site. She says that over the past 5 days the redness has subsided but that the area is still raised and warm. Vaccine administrator counseled patient to keep monitoring her arm and to report any changes to her doctor.
Age: 31.0
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Feeling hot, Flushing, Pruritus, Rash erythematous
Clinical narrative: Symptoms began with feeling hot, flushed, and itchy on neck and scalp. At 9:00PM small red marks could be seen below the breasts, across the abdomen, and on the should blades. By 6:30 AM hives were all over my body with rings of red under the breasts and around the back, around my lower abdomen across the hips and around my lower back, along the backside, shoulders and shoulderblades. My hands were red, hot, and itchy. My ears were red, hot, and swollen. There were red marks all over my body in various sizes and visual patterns. I felt very hot and incredibly itchy. I managed the impulse to avoid scratching uncontrollably. At 7:15 AM I took 50mg of Benadyll and again at 1:30 PM. My hives subsided gradually and were visible through Sunday morning.
Age: 31.0
Sex: F
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: Symptoms began with feeling hot, flushed, and itchy on neck and scalp. At 9:00PM small red marks could be seen below the breasts, across the abdomen, and on the should blades. By 6:30 AM hives were all over my body with rings of red under the breasts and around the back, around my lower abdomen across the hips and around my lower back, along the backside, shoulders and shoulderblades. My hands were red, hot, and itchy. My ears were red, hot, and swollen. There were red marks all over my body in various sizes and visual patterns. I felt very hot and incredibly itchy. I managed the impulse to avoid scratching uncontrollably. At 7:15 AM I took 50mg of Benadyll and again at 1:30 PM. My hives subsided gradually and were visible through Sunday morning.
Age: 39.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pruritus, Injection site reaction, Injection site swelling, Skin tightness, Urticaria
Clinical narrative: 6 hours after receiving the PNEUMOVAX 23 vaccine patient reported a 5 inch in diameter itchy welt at the injection site. F/u 9/11, patient's whole arm, shoulder to elbow, is swollen and tight.
Age: 21.0
Sex: M
Vaccine: ANTH, FLUX, SMALL, TYP, ANTH, FLUN3, SMALL, TYP
Symptoms: Chest pain, Pericarditis
Clinical narrative: Pericarditis, chest pain, treated with NSAIDS, rest.
Age: 21.0
Sex: M
Vaccine: ANTH, FLUX, SMALL, TYP, ANTH, FLUN3, SMALL, TYP
Symptoms: Cardiac imaging procedure abnormal, Echocardiogram abnormal, Pericardial disease, Troponin I increased
Clinical narrative: Pericarditis, chest pain, treated with NSAIDS, rest.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Polymyalgia rheumatica
Clinical narrative: Polymyalgia Rheumatica.
Age: 31.0
Sex: M
Vaccine: TDAP
Symptoms: Diarrhoea, Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: Body ache, fever, nausea, vomit, diarrhea.
Age: 14.0
Sex: M
Vaccine: FLU3, MNQ, VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Erythema entire upper arm-shoulder to elbow w/ indurations(2cm) at the injection sites(2).
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site exfoliation, Injection site inflammation, Injection site mass, Injection site pruritus, Injection site warmth
Clinical narrative: Became itchy the following morning and 24 hours after administration injection site became inflamed, a "large lump" that was hot and itchy and eventually peeled. Hive was approx. 3in. in diameter.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: Became itchy the following morning and 24 hours after administration injection site became inflamed, a "large lump" that was hot and itchy and eventually peeled. Hive was approx. 3in. in diameter.
Age: 35.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Chills, Diarrhoea, Electromyogram abnormal, Guillain-Barre syndrome
Clinical narrative: Severe weakness, a week later, diarrhea, chills, and fever, collapsed in hospital parking lot, flown to hospital where they did two spinal taps to confirm I had GBS. EMG showed I have a severe case and spent several weeks in different hospitals and rehabs.
Age: 35.0
Sex: M
Vaccine: FLU3
Symptoms: Lumbar puncture abnormal, Pyrexia, Syncope
Clinical narrative: Severe weakness, a week later, diarrhea, chills, and fever, collapsed in hospital parking lot, flown to hospital where they did two spinal taps to confirm I had GBS. EMG showed I have a severe case and spent several weeks in different hospitals and rehabs.
Age: 55.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Hypoaesthesia, Oedema peripheral, Paraesthesia, Wrong technique in drug usage process
Clinical narrative: Nurse mixed flu and pneumonia vaccine in the same syringe. Before drawing up vaccines nurse dropped capped syringe on the ground and used it. Arm became red, swollen and had numbness and tingling in the fingers. Called doctor and was sent to the ER at 9 PM on Sept 4, she received IV antibiotics and then was on 2 oral antibiotics.
Age: 60.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Feeling abnormal, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Left upper arm swollen, red, warm tender, patient febrile feels achey and generally poor.
Age: 60.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain, Pyrexia
Clinical narrative: Left upper arm swollen, red, warm tender, patient febrile feels achey and generally poor.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Anxiety, Dizziness, Dyspnoea, Hypersensitivity, Swollen tongue
Clinical narrative: From note by ED attending Dr.: The patient was seen and examined in the Hospital Emergency Department on 09/11/2012. I have discussed the management with him. I have also seen the patient personally and reviewed the ED record. This is an addendum to the record. HISTORY OF PRESENT ILLNESS:  This is a 64-year-old, who received Zostavax vaccine, she had then a sense that her tongue was swelling and felt dizzy and short of breath.  EMS was called, gave her 50 IM Benadryl and had difficulty establishing an IV and she was sent to the Emergency Department where she said she had no difficulty breathing, but did have some sense of tongue swelling. PAST MEDICAL HISTORY: As indicated. PHYSICAL EXAMINATION: The patient appeared anxious. Her tongue appeared mildly swollen, but her ABCs were intact. She is normocephalic and atraumatic. Chest is clear without wheezing. Heart is regular. Abdomen is soft and nontender. Extremities are nontender.  Neurologic: A&O x4. Cranial nerves, sensory, motor exam are normal. ASSESSMENT AND PLAN: This is a woman, who came in after an acute allergic reaction to zoster vaccine. We are notifying the pharmacy so any reporting can be addressed appropriately with regard to her care.  The patient received IV Solu-Medrol 125 emergently and also had epinephrine ready should she need IV therapy. As we treated her over the next half hour or so, the patient's tongue swelling improved and it was not necessary to give further IV epinephrine. Because of the critical nature of this patient's presentation, she required 40 minutes of my personal involvement in critical care by the bedside preparing medications and generally in her treatment. The patient is admitted to Observation having symptoms essentially resolved, but to watch her airway to be sure that this was safe and that she would not require admission and she is admitted to Observation Unit in stable condition. As an addendum: The patient was monitored in the ED observation unit after receiving 50mg IM Benadryl in the field and 125mg IV Solu-medrol in the ED as described above. Her tongue swelling improved, and she had no further shortness of breath or concerns for airway obstruction. She felt well. She was discharged home in good condition, with a course of PO prednisone 60mg x 3 days, with instructions to follow-up with her PCP.