chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: Itchy palms on first night, developed more severe itching and hives on abdomen, back, thighs and neck over the next 24 hours.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Hypersensitivity
Clinical narrative: Patient felt lightheaded a few minutes after the flushot.  Over a few hours, it progressed into an allergic reaction and the patient went to an emergency room for treatment.
Age: 86.0
Sex: M
Vaccine: FLU3
Symptoms: Abasia, Immunoglobulin therapy, Muscular weakness, Nuclear magnetic resonance imaging spinal cord normal
Clinical narrative: NKDA. Possible Guillain-Barre Syndrome. Patient developed bilateral lower extremity weakness, no longer able to ambulate. Patient has received vaccines in past annually with no problem. On IVIG 0.4 grams/kg 5 days. Admitted to hospital.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Swelling, Urticaria
Clinical narrative: Swelling, redness, large hive 4 x 5.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Aphagia, Dysphagia, Oropharyngeal pain, Pharyngitis
Clinical narrative: Information has been received from a health professional concerning a 15 year old female patient who on 28-SEP-2011 was vaccinated IM with a 0.5ml dose of GARDASIL. On 28-SEP-2011 the patient experienced pharyngitis. Subsequently, the patient recovered from pharyngitis. It was unspecified if the patient sought medical attention. The reporter felt that pharyngitis was related to therapy with GARDASIL. Follow-up information has been received on 21-SEP-2012 from a physician (local reference # A201108242) concerning the same patient with no primary disease, concurrent conditions, past medical history or allergy. It was reported that on 28-SEP-2011 the patient was vaccinated with the first injection of 0.5 ml GARDASIL (batch # 9QN02R, lot # 0108AA, expiration date 26-JAN-2014) intramuscularly. There was no concomitant medication. From the evening (9 hours after vaccination) of 28-SEP-2011 the patient developed pain pharynx (so that she could not eat and swallow). On 29-SEP-2011, around noon, pain subsided and the patient could drink water. In the evening of 29-SEP-2011, the patient recovered from pain pharynx. On 28-NOV-2011, the patient received the second injection of GARDASIL (lot # not reported). The reporting physician felt that pain pharynx was definitely related to GARDASIL and there was no other factor. Physician's comment was stated as follows: The patient was not taking other medications and also judging from the temporal course of the onset and disappearance of the symptom, the event was considered to be adverse reaction to the vaccine. The reporting physician considered that pain pharynx was serious as other important medical event. Additional information is not expected.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: 9/25/12 - Rash on chest in evening, approx, 8 pm. 9/26/12 - Took CLARITIN & used Calamine lotion. 9/28/12 - Rash on chest cleared - rash noted in (AM) anticubital area 7 popliteal fossa area.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Crying, Irritability
Clinical narrative: Excessive crying and irritability for approx 10 hours.
Age: 86.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Rash
Clinical narrative: Pt has rash/injected. MD's treatment is KEFLEX 500 mg 1 TID.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Patient given HPV on 7/31/2012, returned to the office on 8/6/2012 with hives. Treated for the hives.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Mobility decreased
Clinical narrative: Sore/pain at injection site. Can't move /lift left hand.
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Cough, Throat tightness
Clinical narrative: Patient called the health dept 9/17/12 at about 1530 with a complaint of feeling as though her throat was tight. Patient denied shortness of breath, lightheadedness, itching or nausea. Patient & mother presented to health dept. on 9/17/12 at about 4:30 pm. Patient symptoms unchanged & now has developed paroxysmal dry coughing.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Injection site erythema
Clinical narrative: Red area in application site. Patient needed to visit doctor office. Patient is already on CEFADROXIL and TORADOL. Dx cellulitis.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pain in extremity, Skin warm
Clinical narrative: Pt reported to the pharmacy with redness, swelling, and slight pain on the arm - the injection was given (right). It extended down to the forearm & was warm to the touch. Counseled pt to f/u with Dr. if worsened & take BENADRYL for symptoms. No fever, SOB or add'l swelling present.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Hypersensitivity, Oedema peripheral, Pain in extremity
Clinical narrative: Pt reported to ED on 9-19-12 at 12:50 pm w/painful/swollen right proximal arm. No fever or reported itching. Pt tited for allergic rxn w/MEDROL dose pak. Onset began 12-hours prior to presenting.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Inflammation, Nodule, Pruritus
Clinical narrative: Patient complained of red, inflamed, itching nodule on back of arm. Dr instructed patient to take BENADRYL & use cool compress.
Age: 4.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain in extremity, Pyrexia
Clinical narrative: Fever, pain, erythema 6 x 8 cm (R) arm.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Fatigue
Clinical narrative: Pt took blood pressure & cholesterol meds at 7pm then started to read and felt tired. Started to have problems with breathing. Labored breathing until 4am.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Redness & swelling to left upper arm. Itching present. Site warm to touch - quarter size.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives & itching 2 hours following vaccine administration.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Migraine, Pyrexia
Clinical narrative: Fever 102 per pt report. Migraine HA.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, Urticaria
Clinical narrative: 3-4" swelling at inj. site, hot, raised, red, itchy. Hives on arms, legs & torso. - Treated with ATARAX, prednisone & Clobetasol.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Axillary pain, Inflammation, Musculoskeletal pain, Neck pain
Clinical narrative: Pt stated arm inflamed up into neck for up to 5 days after vaccination. Extreme pain in shoulder, armpit, & neck area.
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Macular degeneration, Pain, Rash
Clinical narrative: Information has been received from an approximately 80 year old male oral surgeon with no known drug allergies and a history of chickenpox (age 10) and having been vaccinated with ZOSTAVAX (Merck) (2007). On 13-SEP-2012, the physician reported he received an unspecified flu vaccine. The physician stated he received prostaglandin for his macular degeneration (no date reported). On 15-SEP-2012, the physician reported he had a painful rash which was mid stomach and went up into his back. He was treated with an unspecified antiviral medication, prednisone and topical medication (unspecified). The physician reported he was recovering. Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Condition aggravated, Eczema
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 72 years old male patient with eczema and no drug reactions or allergies. The patient was vaccinated SC. with a dose of 0.65 ml ZOSTAVAX on 21-SEP-2012. Other suspect therapies included Influenza Virus Vaccine (manufacturer unknown) on 21-SEP-2012. No concomitant medications were reported. The pharmacist stated that patient was having exacerbation of eczema now. The patient was prescribed prednisone for the exacerbation of eczema. The outcome of exacerbation of eczema was unknown. The patient had sought unspecified medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site rash, Rash generalised
Clinical narrative: Information has been received from a field representative concerning a female (age not provided). The representative was advised by the doctor that a patient had received her third dose of GARDASIL 0.5ml suspension intramuscular injection on 16AUG2012. On 17AUG2012 she had a "rash that had started out around the injection site and spread to rest of body". There were no reports of similar reactions for the first and second doses of GARDASIL (FEB2012 and APR2012). Outcome was not reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a physician concerning a female patient of unknown age. The patient's pertinent medical history and drug reactions or allergies were unknown. On an unspecified date, "a few years ago", the patient was vaccinated with the first dose of GARDASIL (dose, route and frequency were not reported) (lot # and expiration date were not reported). Then, on 31-AUG-2012, the patient received the second dose of GARDASIL (dose, route and frequency were not reported) (lot # and expiration date were not reported). There were no adverse effects reported. At the time of the report, the patient's outcome was unknown. Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Dyspnoea, Inappropriate schedule of drug administration, Pyrexia
Clinical narrative: Information has been received from a company representative who was told by a Nurse Practitioner, that on 18Sep2012 a patient was given her second dose of GARDASIL (lot # 672547/1745AA, expiration date 13Sep2014), .5ml. The patient concomitantly received the FLUARIX (GSK manufacturer). It was reported that the patient's first dose of GARDASIL was administered 2 years prior. The following day (19Sep2012) the patient went to an emergency room because she was short of breath and had a fever of 102.4 degrees. It was unspecified if the fever and shortness of breath started on the 18Sep2012 or the following day. After waiting in the hospital for four hours, the patient left without receiving treatment. The following day the patient returned to her physician's office. Her temperature and breath were back to normal. The physician recommended that she drink fluids and take MOTRIN if needed. It was reported that the medication was not reintroduced. Additional information has been requested.
Age: 19.0
Sex: M
Vaccine: HPV4
Symptoms: Fatigue, Hypersomnia
Clinical narrative: Information was received via telephone call from the mother of a 19 year old male with an unspecified psychiatric condition, who on 24-JUL-2012, was vaccinated with a dose of GARDASIL. Concomitant medication included RISPERDAL and lithium. On 26-JUL-2012, the patient experienced fatigue that had him sleeping almost 24 hours per day. At the time of the telephone call the patient had not recovered. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Blood pressure decreased, Syncope
Clinical narrative: Information was received from a field employee (MARRS# 1209USA005601) who reported that a nurse stated to her that a drop in blood pressure and fainted was first shot "has happened several times in this office" with GARDASIL. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 21 years old female patient. The patient was vaccinated with the first dose of GARDASIL (Lot # not reported) when she was 13 or 14 years of age in approximately 2004 and received her second dose of GARDASIL (Lot # not reported) on 26-SEP-2012. No adverse effect was reported. Additional information is not expected.
Age: 91.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Herpes zoster ophthalmic, Rash erythematous, Rash macular
Clinical narrative: This spontaneous report as received from a physician (then the physician handed to the phone to the healthcare worker for additional reporting) refers to a 91 years old male patient with none pertinent medical history and none drug reactions/allergies, who was vaccinated with a dose of ZOSTAVAX (lot #, dose and route not reported) on 08-AUG-2012. On 20-AUG-2012 the patient developed shingles following vaccination. The physician described the rash as a red, macular rash in the right trigeminal area of the face, right eye and temple are. The physician reported that the rash was migrating over to the left side. The patient sought medical attention, by office visit on 22-AUG-2012. Antivirals (unspecified) and corticosteroids (unspecified) were given as a treatment. None lab diagnostics studies were performed. At the time of report the patient's status was not recovered. The relatedness for shingles was not reported for ZOSTAVAX by reporting physician. Additional information has been requested.
Age: 60.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 60 years old patient. The patient was vaccinated with (Merck) VARIVAX inadvertently instead of intended ZOSTAVAX on 24-SEP-2012. Lot# and route were unspecified. NO adverse effects reported. Additional information has been requested.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient was vaccinated subcutaneous in left arm with 0.65 ml expired ZOSTAVAX (lot # 671004/0729AA, expiration date 17-AUG-2012) on 07-SEP-2012. 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 has been requested. This is one of the several reports received from the same source.
Age: 85.0
Sex: M
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. The patient was vaccinated subcutaneously in right arm with 0.65ml expired ZOSTAVAX (lot # 671004/0729AA, expiration date 17-AUG-2012) on 07-SEP-2012. 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 has been requested. This is one of the several reports received from the same source.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 77 years male patient. The patient was vaccinated SC, with a dose of 0.65 ml ZOSTAVAX on 16-AUG-2012. No other co-suspects were reported. Concomitant therapy included unspecified blood pressure, thyroid, pain and cholesterol medications. On 16-AUG-2012 the patient experienced full body shaking. The patient then called poison control for information on treatment. No treatment information was performed. The patient's symptoms resolved later on that day(16-AUG-2012). Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: Information has been received from a pharmacist concerning 3 patients, who on unknown dates, were vaccinated with a dose of ZOSTAVAX (dose, route and lot numbers not reported). It was reported that, on unknown dates, the patients experienced injection site reactions which included redness and swelling. At the time of the report, the patients' outcome was unknown. Additional information is not expected.
Age: 66.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site induration, Injection site mass, Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient was vaccinated with ZOSTAVAX on 20-JUL-2012, via IM route instead of SC route (dose, site of administration and lot # not reported). No adverse effect reported. Follow up information was received from the pharmacist concerning the 66 years old female patient with hypertension and allergy to lisinopril (MARRS 1209USA006456) who on 20-JUL-2012 was vaccinated intramuscularly with the first dose of ZOSTAVAX (lot number reported as 0256AE, dose not reported) and concomitantly with the first dose of BOOSTRIX via subcutaneous route (lot number AC52B85BA, dose not reported). On 21-JUL-2012, the patient experienced redness, pain and a hard lump at subcutaneous site (from BOOSTRIX). On an unknown date the patient recovered. This is one of several reports concerning the same patient (cross-referenced report number 1209USA006456). Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient was vaccinated with ZOSTAVAX on 20-JUL-2012, via IM route instead of SC route (dose, site of administration and lot # not reported). No adverse effect reported. Follow up information was received from the pharmacist concerning the 66 years old female patient with hypertension and allergy to lisinopril (MARRS 1209USA006456) who on 20-JUL-2012 was vaccinated intramuscularly with the first dose of ZOSTAVAX (lot number reported as 0256AE, dose not reported) and concomitantly with the first dose of BOOSTRIX via subcutaneous route (lot number AC52B85BA, dose not reported). On 21-JUL-2012, the patient experienced redness, pain and a hard lump at subcutaneous site (from BOOSTRIX). On an unknown date the patient recovered. This is one of several reports concerning the same patient (cross-referenced report number 1209USA006456). Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Maternal exposure before pregnancy, Viral test negative
Clinical narrative: Information has been received from a Registered Nurse for VARIVAX (Merck), a Pregnancy Registry product, concerning an approximately 27 year old female patient with allergies (unspecified) and sulfa and aspirin allergies that recently had a baby who on 13-MAR-2008, was vaccinated SQ with a 0.5 ml first dose of VARIVAX (Merck) (Lot# 658967/1521U) (Expiration date: September 2009) because she wanted to get pregnant. Second 0.5 ml dose of VARIVAX (Merck) (Lot# 658518/1527U) (Expiration date: September 2009), SQ was given on 07-MAY-2008. Concomitant therapy included CLARITIN. The nurse mentioned that the patient was told recently by her Obstetrician/Gynecologist that she had to be revaccinated. Nurse was unsure if the Obstetrician/Gynecologist did titers since there was no record in their office of titers done after the two vaccinations. The last titer done at their office was in February 2008 which showed "titers were less than 0.9". The outcome of the patient was not reported. The patient sought medical attention by an office visit. Follow up information has been received from a registered nurse for VARIVAX (Merck), a Pregnancy Registry product, reported that her record had no documentation that the patient received any further (Merck) VARIVAX in their office. She stated there was nothing in the chart that suggested she went elsewhere for further vaccine administration. The received further information regarding (Merck) VARIVAX revaccination with low titers. She stated that if her OB-GYN had wanted her to get further vaccination 'although not recommended by Merck', she more than likely would have received vaccination here. The registered nurse stated they had no information regarding the health of the patient's infant or any dates surrounding her pregnancy, since they are an adult internal medicine office. Additional information is not expected.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 53 years years old female patient. The patient was vaccinated with one vial ZOSTAVAX (Lot number reported as 0070AE, expire date 03-APR-2013) subcutaneously on 15-SEP-2012. There were no pertinent medical history or drug reactions/allergies. No concomitant medications were received. On 20-SEP-2012 the patient developed redness and swelling at the injection site after receiving a dose of ZOSTAVAX. No treatment was received. No lab diagnostics performed. The outcome was reported as not recovered/not resolved. The patient had sought medical attention via saw the pharmacist. Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Insomnia, Neck pain
Clinical narrative: This spontaneous report as received from a 60 years old female consumer refers to herself. The patient's medical history included hormone replacement. The patient had no drug reactions/allergies. The patient was vaccinated with ZOSTAVAX (Lot # and expire date unspecified) subcutaneous on 22-JUN-2012. No other co-suspects were reported. Concomitant medication included "LAPENACIL". On 25-JUN-2012 the patient experienced joint pain in left shoulder. She mentioned that the joint pain interrupted rest. She had problems finding comfortability while resting on her left side. Now she believed that the pain was spreading to her neck. No treatment was given. No lab diagnostics study was performed. The outcome was reported as not recovered/not resolved. The patient did not seek medical attention. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Information has been received from a pharmacist who reported on 19Sep2012 she administered a MMR II (lot # 667244/1919Z, expiration date 17Jul2012), 0.5ml once subcutaneously, to a customer and then realized it was expired. No adverse effects were reported. No further information is expected.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus generalised
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 71 years old female patient with NSAIDs, codeine allergies. The patient was Subcutaneously vaccinated with 0.65 ml ZOSTAVAX (lot # 0566AE exp 01-APR-2013 as reported) on 14-AUG-2012 for vaccination. Pharmacist reported that the patient had been experiencing itching "all over her body" a couple days after receiving ZOSTAVAX. Pharmacist confirmed there was no rash. The patient called pharmacist for medical attention and unspecified steroid cream was given for adverse event. The outcome of itching" all over her body" was reported as not recovered/not resolved. Additional information has been requested.
Age: 58.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown demographics. On an unspecified date, the patient was inadvertently vaccinated with 0.5 milliliter (ml) VARIVAX (merck) who was indicated to receive ZOSTAVAX. Lot number and dosing details were not specified. No concomitant medications were reported. The physician stated that this was due to human error and not product confusion. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a practice manager and a healthcare worker, concerning 5 patients of unknown age and sex. On 11-MAY-2012, one of the patients was vaccinated with a dose of (Merck) VARIVAX (dose, route and frequency were not reported) (lot #: 1434AA Expiration date 13-SEP-2013) that was improperly stored in a refrigerator for more than 72 hours. There were no adverse effects reported. At the time of the report, the patient's outcome was unknown. This is one of several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age. The patient was vaccinated with dose 1 of RECOMBIVAX HB in March 2012 and then was vaccinated with dose 2 of RECOMBIVAX HB "at month 3" in June 2012, 1 ml dose, intramuscularly (lot # not reported), respectively. No other co-suspects were reported. No concomitant medications were reported. No adverse effects were reported. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 63 years old female patient. The patient had no pertinent medical history or drug reactions/allergies. The patient was vaccinated with 0.5 ml of PNEUMOVAX23 (lot # 1947AA, expire date 20-OCT-2013) intramuscular on 19-SEP-2012. Patient did not have any concomitant medication. On 19-SEP-2012 the patient developed pain, redness, and swelling at the injection site after receiving PNEUMOVAX23. No treatment was given. No lab diagnostics study was performed. The outcome was reported as not recovered/not resolved. The patient sought medical attention via called to the pharmacist. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from registered nurse refers to patients of unknown age. The patients were vaccinated with doses of (Merck) VARIVAX (Lot# and route not reported) in March 2012. No other co-suspects were reported. No concomitant medications were reported. The nurse called to report that approximately 5 to 9 unspecified patients received (Merck) VARIVAX which was reconstituted with expired sterile water diluent which expired in "February of 2012" and were administered in "March of 2012". No adverse effects reported. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Follow-up information has been received from a registered nurse concerning 9 patients, who received (Merck) VARIVAX, subcutaneously, which was reconstituted with an expired sterile water diluent (lot # of the diluent reported as E010104). this is one of the several reports received from the same source. The report is linked with cases 1207USA011490 and 1207USA011497. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose 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 vaccinated with a dose of ZOSTAVAX subcutaneously (dose, lot number not reported) on 16-APR-2012 and on 09-SEP-2012. No other co-suspects were reported. No concomitant medications were reported. No known adverse effects. Additional information has been requested.
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a physician concerning male patient of unknown age. The patient was vaccinated with the first dose of VAQTA, 0.5 ml, on 05JUL2006 and the second dose of VAQTA, 0.5 ml, was administered on 16AUG2006. No adverse effects were reported. No further information was provided. The outcome of the event was not specified. Additional information is not expected.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 64 years old female patient with none pertinent medical history and none drug reactions/allergies, who was vaccinated with a dose of ZOSTAVAX (lot# reported as 0242AE, Expiration date 01-APR-2013) (dose not reported) SQ in the left arm on 21-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. On 23-AUG-2012 the patient experienced rash at the injection site, 3 days after onset of therapy. The patient sought medical attention, she came to pharmacy. No treatment was given. No lab diagnostics studies were performed. The outcome of rash at the injection site was reported as not recovered/not resolved. The relatedness for rash at the injection site was not reported for ZOSTAVAX. Additional information is not expected.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B core antibody positive, Hepatitis B surface antibody negative
Clinical narrative: This spontaneous report was received from a pharmacy intern (healthcare student) refers to a patient of unknown demographics. On an unknown date the patient was vaccinated with RECOMBIVAX HB (lot number not reported) 10 micrograms per milliliter (mcg/ml). No concomitant medications were reported. Pharmacy intern reported that patient was tested for hepatitis B antibodies and result showed negative for surface antibody and positive for core antibody. She could not confirm when or how many doses of RECOMBIVAX HB patient might have received. No additional information provided. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Injection site pain, Product name confusion, Wrong drug administered
Clinical narrative: Information was received from a pharmacist regarding three patients who were inadvertently administered LIQUID PEDVAXHIB subcutaneously on 17AUG2012 as the vaccine "was mistaken for a meningococcal vaccine because Haemophilus b Conjugate Vaccine has Meningococcal Protein Conjugate in its name." The pharmacist noted all patients experienced "more pain in the injection site than normal." The pharmacist did not have any specific patient information on any of these patients. No further information was provided. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of currently 7 years old. The patient was vaccinated with, 0.5 ml SC VARIVAX (merck) on 28-AUG-2006. The second dose of 0.5 ml SC VARIVAX (merck) was taken on 09-OCT-2009. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced chicken pox. No treatment information was reported. The outcome of chicken pox was unknown. The relatedness for chicken pox was unknown for VARIVAX (Merck). This is one of several cases from the same source. Additional information has been requested.
Age: 12.0
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of currently 12 years old. The patient was vaccinated with, 0.5 ml SC (Merck) VARIVAX (Lot # 1770J) on 12-JUN-2000. The second dose of 0.5 ml SC (Merck) VARIVAX (Lot # 0012AA, in validation process) was taken on 28-JUN-2011. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced chicken pox. No treatment information was reported. The outcome of chicken pox was unknown. The relatedness for chicken pox was unknown for (Merck) VARIVAX. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a pharmacist regarding to a patient of unknown age and gender. On 17-AUG-2012, the patient was vaccinated with a dose of ZOSTAVAX, (lot # 672932/0599AE, expiration date 22-JUN-2013). No other co-suspects were reported. No concomitant medications were reported. On 17-AUG-2012, after received ZOSTAVAX, the patient had redness and a raised bump around the injection site after received ZOSTAVAX. The patient did not receive treatment for the adverse event. The patient call to pharmacy for medical attention. The patient did not recover from the adverse events. This is one of several reports from the same source. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HEPA, MMR, VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to a 4 years old male patient. The patient was vaccinated with a 0.5 ml dose of ZOSTAVAX (lot # 671775/0466AE expiration date 28-FEB-2013) SQ, a dose of MMR II (lot # not reported), a dose of PEDIARIX and a dose of Hep A vaccine (manufacturer unknown) on 25-SEP-2012. Concomitant therapy included FLUZONE. No adverse events were experienced. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Antibody test negative, Hepatitis B surface antibody negative
Clinical narrative: Information has been received from a registered nurse regarding to a dialysis patients (specific number of patient were unknown). On an unknown date, the patients were vaccinated with the completed doses of RECOMBIVAX HB vial 40mcg/mL (route and lot number was not provided). No other co-suspects were reported. No concomitant medications were reported. On an unknown date, the patients who completed RECOMBIVAX HB dialysis formulation were tested for antibody level and result came back less than 10 mIU/mL. It was unknown if the patients received treatment for the adverse event or sought medical attention. The patients outcome were unknown at the time of the report. The relatedness between RECOMBIVAX HB and the event was not reported. Additional information is not expected.
Sex: F
Vaccine: VARCEL
Symptoms: Accidental exposure, Blister, Rash erythematous
Clinical narrative: This spontaneous report was received from a female nurse reporting on herself. In August 2012 "two weeks ago", the nurse was administering subcutaneously a "standard" dose of VARIVAX (merck) (lot # not provided) to a patient and when the patient moved, the remaining portion squirted into the nurse's eye. The nurse developed two red, fluid-filled bumps around her eye, which lasted for two days and had since resolved. No treatment was given for the event. The nurse did not seek medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a patient of unknown age. The patient was vaccinated with an expired dose of ZOSTAVAX (Lot # not reported, expiration date 17-AUG-2012) on 25-SEP-2012. No adverse event was reported. Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Dizziness, Dyspnoea, Erythema, Nausea
Clinical narrative: This spontaneous report was received from a pharmacist concerning a 60 year old female patient with no known drug allergies who on 28-AUG-2012 was vaccinated with a dose of ZOSTAVAX (lot number 0171AE, expiration date 06-MAR-2013 (route was not provided). No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that on an unknown date, after receiving ZOSTAVAX, the patient experienced pain, redness, swelling and peeling of skin around the injection site, difficulty breathing, wheezing and dizziness. The patient spoke to the physician and was given BENADRYL and hydrocortisone cream as treatment for the events. No laboratory tests were performed. The patient had not recovered from pain and redness around the injection site. The outcome of the events swelling and peeling of skin around the injection site, difficulty breathing, wheezing and dizziness was not provided. Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Rash, Skin exfoliation, Swelling
Clinical narrative: This spontaneous report was received from a pharmacist concerning a 60 year old female patient with no known drug allergies who on 28-AUG-2012 was vaccinated with a dose of ZOSTAVAX (lot number 0171AE, expiration date 06-MAR-2013 (route was not provided). No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that on an unknown date, after receiving ZOSTAVAX, the patient experienced pain, redness, swelling and peeling of skin around the injection site, difficulty breathing, wheezing and dizziness. The patient spoke to the physician and was given BENADRYL and hydrocortisone cream as treatment for the events. No laboratory tests were performed. The patient had not recovered from pain and redness around the injection site. The outcome of the events swelling and peeling of skin around the injection site, difficulty breathing, wheezing and dizziness was not provided. Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dizziness, Dyspnoea, Injection site erythema, Injection site exfoliation, Injection site pain
Clinical narrative: This spontaneous report was received from a pharmacist concerning a 60 year old female patient with no known drug allergies who on 28-AUG-2012 was vaccinated with a dose of ZOSTAVAX (lot number 0171AE, expiration date 06-MAR-2013 (route was not provided). No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that on an unknown date, after receiving ZOSTAVAX, the patient experienced pain, redness, swelling and peeling of skin around the injection site, difficulty breathing, wheezing and dizziness. The patient spoke to the physician and was given BENADRYL and hydrocortisone cream as treatment for the events. No laboratory tests were performed. The patient had not recovered from pain and redness around the injection site. The outcome of the events swelling and peeling of skin around the injection site, difficulty breathing, wheezing and dizziness was not provided. Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site swelling, Wheezing
Clinical narrative: This spontaneous report was received from a pharmacist concerning a 60 year old female patient with no known drug allergies who on 28-AUG-2012 was vaccinated with a dose of ZOSTAVAX (lot number 0171AE, expiration date 06-MAR-2013 (route was not provided). No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that on an unknown date, after receiving ZOSTAVAX, the patient experienced pain, redness, swelling and peeling of skin around the injection site, difficulty breathing, wheezing and dizziness. The patient spoke to the physician and was given BENADRYL and hydrocortisone cream as treatment for the events. No laboratory tests were performed. The patient had not recovered from pain and redness around the injection site. The outcome of the events swelling and peeling of skin around the injection site, difficulty breathing, wheezing and dizziness was not provided. Additional information is not expected.
Age: 0.57
Sex: M
Vaccine: DTAPIPVHIB, FLU3, PNC13, RV5
Symptoms: Intussusception, Lethargy, Vomiting
Clinical narrative: Vomiting, lethargy.
Age: 1.97
Sex: F
Vaccine: DTAPH, IPV, MMRV, PER, UNK
Symptoms: Fatigue, Irritability, Ocular hyperaemia, Pyrexia
Clinical narrative: Mid-grade fever until Ibuprofen broke the fever, Red eyes, Overly tired, Very fussy,
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Dizziness, Dyspnoea, Pharyngeal oedema, Pruritus
Clinical narrative: 12:05 PM shortness of breath- used ventolin inhaler, 12:20 PM reported dizziness, checked BP- 167/85 pulse 82, 12:30 PM reported itching, chest tightness, throat swelling and closing, administered called 911 and administered 0.3mg autoinjector EpiPen. EMS arrived and administered diphenhydramine 50mg and took pt to hospital.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Throat tightness
Clinical narrative: 12:05 PM shortness of breath- used ventolin inhaler, 12:20 PM reported dizziness, checked BP- 167/85 pulse 82, 12:30 PM reported itching, chest tightness, throat swelling and closing, administered called 911 and administered 0.3mg autoinjector EpiPen. EMS arrived and administered diphenhydramine 50mg and took pt to hospital.
Age: 32.0
Sex: F
Vaccine: FLUX
Symptoms: Axillary pain, Fatigue, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Pain at injection site (upper right arm), hardness and swelling at and around injection site in 3" diameter (similar to size and shape of smallpox vaccine scar), pain in right armpit and inside of upper right arm, profound fatigue.
Age: 32.0
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: Pain at injection site (upper right arm), hardness and swelling at and around injection site in 3" diameter (similar to size and shape of smallpox vaccine scar), pain in right armpit and inside of upper right arm, profound fatigue.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: REDNESS AROUND INJECTION SITE, THAT BY DAY AFTER THE INJECTION EXPANDED TO COVER THE WHOLE UPPER ARM AND AROUND THE WHOLE UPPER ARM, WITH UPPER ARM BEING 30-40% INCREASE IN SIZE, ITCHING.
Age: 74.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Nausea, Pain
Clinical narrative: Mild nausea, Right deltoid red, swollen, arm aches and hurts more when moved, rash developed on upper arm.
Age: 74.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Pain in extremity
Clinical narrative: Mild nausea, Right deltoid red, swollen, arm aches and hurts more when moved, rash developed on upper arm.
Age: 65.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Abdominal pain upper, Chills, Erythema, Headache, Myalgia
Clinical narrative: Headache, chills, fever, nausea, stomach ache, Vomiting, Redness and swelling of arm, muscle aches, couldn't stay awake.  I slept for 48 hours, waking every few hours but falling right back to sleep.
Age: 65.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Nausea, Oedema peripheral, Pyrexia, Somnolence, Vomiting
Clinical narrative: Headache, chills, fever, nausea, stomach ache, Vomiting, Redness and swelling of arm, muscle aches, couldn't stay awake.  I slept for 48 hours, waking every few hours but falling right back to sleep.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Redness, edema, heat, itching and tenderness at injection site approx. 3 inch area day after injection worse by day two.
Age: 41.0
Sex: M
Vaccine: FLU3
Symptoms: Flushing, Hypoaesthesia oral, Injection site pain, Paraesthesia oral
Clinical narrative: Patient began feeling flush, numbing and tingling of lips, pain radiating from left elbow to shoulder.
Age: 78.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Dizziness, Erythema, Headache, Injection site swelling, Oedema peripheral
Clinical narrative: Right arm swollen from shoulder to above hand, fire red, skin hot and hard to the touch. Pain in arm. Slight dizziness and headache.
Age: 78.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain in extremity, Skin induration, Skin warm
Clinical narrative: Right arm swollen from shoulder to above hand, fire red, skin hot and hard to the touch. Pain in arm. Slight dizziness and headache.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Hypoaesthesia, Pain in extremity, Paraesthesia, Skin warm
Clinical narrative: As of 9/5/12-arm is red and warm. It hurts all the way down arm. Pinky finger has some numbness and tingling. On 9/29/12-patient reported that she was fine.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Hot flush, Injection site mass
Clinical narrative: Hot and cold chills, 6"x4" lump on right deltoid.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test, Chills, Cyanosis, Feeling cold, Headache
Clinical narrative: Extremely cold with chills, face lost color, lips purple, extreme body aches.  Headache.  Went to doctor at 11:15.  103 fever, change in vision, chills, aches, cold.  Sent to outpatient for blood work.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pallor, Pyrexia, Visual impairment
Clinical narrative: Extremely cold with chills, face lost color, lips purple, extreme body aches.  Headache.  Went to doctor at 11:15.  103 fever, change in vision, chills, aches, cold.  Sent to outpatient for blood work.
Age: 57.0
Sex: M
Vaccine: PPV
Symptoms: Feeling cold, Hyperhidrosis, Immediate post-injection reaction, Syncope
Clinical narrative: Patient fainted immediately after recieving pneumonia vaccine. Recovered then sweating and cold.
Age: 0.33
Sex: F
Vaccine: DTAP, HIBV, MEN, RVX
Symptoms: Injection site induration, Injection site mass
Clinical narrative: Found a large hard mass in her leg right where her shots were given.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chills, Condition aggravated, Convulsion, Epilepsy, Headache
Clinical narrative: Several Seizures episodes, fever/chills vomiting, severe headache, stuffy nose and extreme high blood pressure.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Hypertension, Laboratory test, Nasal congestion, Neurological examination abnormal, Pyrexia
Clinical narrative: Several Seizures episodes, fever/chills vomiting, severe headache, stuffy nose and extreme high blood pressure.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Vomiting
Clinical narrative: Several Seizures episodes, fever/chills vomiting, severe headache, stuffy nose and extreme high blood pressure.
Age: 54.0
Sex: F
Vaccine: FLUX, TDAP
Symptoms: Erythema, Pruritus, Swelling, Urticaria
Clinical narrative: Swelling and redness 3-4 inches below injection site, hives that itch in a large area across arm. Taking 40mg prednisone 3 days, Allegra 180, hydrocortisone cream.
Age: 47.0
Sex: M
Vaccine: FLUN3
Symptoms: Eye pruritus, Nasal congestion, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: Started with nasal irritation, then sore throat. Within 24 hours after onset of symptoms, Sore throat turned severe along with itchy eyes, runny nose, and heavy white mucous congestion. Aches and slight fever came a day later.
Age: 47.0
Sex: M
Vaccine: FLUN3
Symptoms: Rhinorrhoea, Skin irritation
Clinical narrative: Started with nasal irritation, then sore throat. Within 24 hours after onset of symptoms, Sore throat turned severe along with itchy eyes, runny nose, and heavy white mucous congestion. Aches and slight fever came a day later.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Oedema peripheral, Pain in extremity, Pruritus, Skin warm
Clinical narrative: Two hours post vaccination, arm was sore. By the following morning, arm was itchy, red, hot to the touch, and swollen to the size of a coke can.
Age: 74.0
Sex: M
Vaccine: FLUX
Symptoms: Arthralgia, Body temperature increased, Headache, Hyperhidrosis, Myalgia
Clinical narrative: Temp 103. Profuse sweating. Severe Headache. Achy joints, muscles. Runny nose, sneezing.
Age: 74.0
Sex: M
Vaccine: FLUX
Symptoms: Rhinorrhoea, Sneezing
Clinical narrative: Temp 103. Profuse sweating. Severe Headache. Achy joints, muscles. Runny nose, sneezing.
Age: 61.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chest pain, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Pt received PNEUMOVAX left arm SQ triceps area & AFLURIA 2012-13 flu shot IM left deltoid. 9/25 at 2:40 pm. Pt reported severe pain in triceps, fever 102 degrees & 140 BPM heart rate. 89/46 BP. Was taken to ER by ambulance 9/26 pm. Suffered chest pain. Nitroglycerin helped. She didn't have sepsis & cardiologist will be consulted Monday 10/1/12. Feeling better, still tender at triceps area but swelling down.