chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: M
Vaccine: MMR, TD
Symptoms: Arthralgia, Headache, Myalgia, Pyrexia, Rash
Clinical narrative: 101 fever, HA, rash, myalgia/arthralgias x 1 wk, began 2 days after injection, gradual improvement over next 7 days, although mild rash on trunk persisted.
Age: 20.0
Sex: M
Vaccine: HPV4
Symptoms: Bacterial test, CSF culture negative, Full blood count, Pyrexia, Rash
Clinical narrative: Pt was seen with redness-macula 4 mm base of penis. No other sx. No fever, felt well. Discussed STD and given GARDASIL #1. Later -STD next morning developed with fever -> 102, ST HA, SV, V came in - mod ill at rash, neck - CBC - WBL - 18, 000. Hospitalized - spinal tap normal all cultures.Treated with ROCEPHIN. Gradually got better. I do not known if related to vaccine. I know my pt would have a hard time getting #2/3.
Age: 20.0
Sex: M
Vaccine: HPV4
Symptoms: Streptococcus test, White blood cell count increased
Clinical narrative: Pt was seen with redness-macula 4 mm base of penis. No other sx. No fever, felt well. Discussed STD and given GARDASIL #1. Later -STD next morning developed with fever -> 102, ST HA, SV, V came in - mod ill at rash, neck - CBC - WBL - 18, 000. Hospitalized - spinal tap normal all cultures.Treated with ROCEPHIN. Gradually got better. I do not known if related to vaccine. I know my pt would have a hard time getting #2/3.
Sex: U
Vaccine: MMR
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 and gender. On 17-JUL-2013, the patient was vaccinated with a expired dose of M-M-R II (Lot number was reported 1003AA, expiry date was 28-JUN-2013, dose and route were not reported). No adverse effects reported. Additional information has been requested.
Age: 72.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Injection site erythema, Product quality issue, Product reconstitution issue
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 72 year old patient. On 19-JUL-2013 the patient was vaccinated with ZOSTAVAX (lot number reported as J001729. expiry date 20-OCT-2013). The finished volume of a dose of ZOSTAVAX that the reporter administered to the patient was 0.1 ml. The pharmacist attempted to reconstitute the dose of ZOSTAVAX, she first penetrated the stopper the a syringe with 0.7ml of air. She realized her error, and then she used a second vial of diluent from which she aspirated 0.4 ml of diluent. She used that volume of diluent, 0.4ml, to reconstitute the dose of ZOSTAVAX for the patient. She described "shaking the vial' to assist the missing of the lyophilized ZOSTAVAX with the 0.4 ml of diluent, and when she attempted to aspirate the finished volume of ZOSTAVAX, the solution was "foamy and gel-like". The volume of the finished solution was 0.1 ml, which she administered to the patient. The pharmacist was certain that the patient received the live-virus vaccine because the injection site immediately became reddened. The pharmacist placed an adhesive bandage over the injection site and the patient had not reported any other adverse effects. PQC filed for the under filled diluent vial. No treatment was given for adverse events. The adverse events was unknown. This is one of several reports from same source. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 62 year old female patient with herpes and no drug reactions/allergies. On 13-JUL-2013 the patient was vaccinated with a dose of ZOSTAVAX lot # J000783, expired date 30-APR-2014. Concomitant therapies included VALTREX. On 13-JUL-2013, the patient developed bad adverse events included a 3x3 red, itchy area, warm to the touch directly below the injection site, a 3x3 red, itchy area, warm to the touch directly below the injection site (no rash reported). No lab diagnostics studies were performed. The patient sought medical attention by contacting pharmacy and was treated with over the counter antihistamines (unspecified). At the time of reporting, the patient had not recovered. This is one case of the multiple patients received from the same source. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Adverse reaction
Clinical narrative: This spontaneous report was received from a nurse refers to an unspecified patient of unknown age. On an unknown date, the patient was vaccinated with a dose of unspecified PNEUMOVAX23 in November, December and in July. On an unknown date, the patient experienced unspecified adverse reaction. The outcome of unspecified adverse reaction was unknown. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 12 year old female patient. On 06-AUG-2012 and on 28-NOV-2012, the patient was previously vaccinated with the first and the second dose of GARDASIL. On 22-MAR-2013, the patient was vaccinated with third dose of GARDASIL (lot # 0459AE, expiry date was 13-DEC-2014, route and dose were not reported)that was improperly stored at temperature 29 Fahrenheit (F) to 29F. No reactions of any kind was reported. This is one of the four reports received from the same reporter (MARRS# 1305USA017145, 1306USA003145 and 1307USA014755). Additional information is not expected.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Body temperature increased, C-reactive protein normal, Carbon dioxide decreased, Culture urine
Clinical narrative: Took child to ER for temperature 101.4.
Age: 0.2
Sex: U
Vaccine: VARCEL
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from nurse refers to a 2 month old patient. On 22-JUL-2013, the patient was vaccinated with a first dose of VARIVAX (Merck) dose 1. No adverse symptoms reported. Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: HEP
Symptoms: Amnesia, Confusional state, Fatigue, Influenza like illness, Malaise
Clinical narrative: This case was reported by a consumer and described the occurrence of flu-like symptoms in a 33-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). A physician or other health care professional has not verified this report. On 6 March 2012 and 3 February 2012 the subject received 2nd dose and 1st dose of ENGERIX B (1 cc, unknown details, left arm). For each vaccination, the subject received 2 vials of the listed lot number, which is for a 0.5mL vial, to get a total of 1mL of the vaccine of ENGERIX B. In February 2012, within days of vaccination with ENGERIX B, the subject experienced flu-like symptoms. In March 2012, within days of vaccination with ENGERIX B, the subject experienced flu-like symptoms. In May 2012, 2 months after vaccination with ENGERIX B, the subject experienced sick (described as "chronically sick" and "pretty sick"), chronic fatigue, muscle weakness, nausea, neurological problem, abnormal thinking (described as "problems thinking"), abnormal speech (described as "problems speaking"), and confusion. Per the subject, "the symptoms have come and gone over the past year and a half or so. Some days are better than others, but when it is bad it is disabling." The subject was hospitalized for "these symptoms in September 2012 for 5 days." At the time of reporting the event of flu-like symptoms were resolved. The events of sick, chronic fatigue, muscle weakness, nausea, neurological problem, memory loss, abnormal thinking, abnormal speech, and confusion were unresolved.
Age: 33.0
Sex: F
Vaccine: HEP
Symptoms: Muscular weakness, Nausea, Nervous system disorder, Speech disorder, Thinking abnormal
Clinical narrative: This case was reported by a consumer and described the occurrence of flu-like symptoms in a 33-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). A physician or other health care professional has not verified this report. On 6 March 2012 and 3 February 2012 the subject received 2nd dose and 1st dose of ENGERIX B (1 cc, unknown details, left arm). For each vaccination, the subject received 2 vials of the listed lot number, which is for a 0.5mL vial, to get a total of 1mL of the vaccine of ENGERIX B. In February 2012, within days of vaccination with ENGERIX B, the subject experienced flu-like symptoms. In March 2012, within days of vaccination with ENGERIX B, the subject experienced flu-like symptoms. In May 2012, 2 months after vaccination with ENGERIX B, the subject experienced sick (described as "chronically sick" and "pretty sick"), chronic fatigue, muscle weakness, nausea, neurological problem, abnormal thinking (described as "problems thinking"), abnormal speech (described as "problems speaking"), and confusion. Per the subject, "the symptoms have come and gone over the past year and a half or so. Some days are better than others, but when it is bad it is disabling." The subject was hospitalized for "these symptoms in September 2012 for 5 days." At the time of reporting the event of flu-like symptoms were resolved. The events of sick, chronic fatigue, muscle weakness, nausea, neurological problem, memory loss, abnormal thinking, abnormal speech, and confusion were unresolved.
Age: 9.0
Sex: M
Vaccine: HEPA
Symptoms: Gianotti-Crosti syndrome
Clinical narrative: This spontaneous report was received from a nurse refers to an approximately 9 year old male patient. The patient's medical history included acne, sinusitis, and pharyngitis. No Drug reactions or allergies were reported. On 29-SEP-2008, the patient was vaccinated with a dose of hepatitis a vaccine, inactivated (Manufacturer unknown) (lot#, expiry not reported). On an unknown date, the patient experienced Gianotti-Crosti which lasted for several weeks, following the administration of a hepatitis A vaccine (Manufacturer unknown). No other adverse effects were reported. It was unspecified if the patient had sought medical attention or treatment. On an unknown date the patient recovered from Gianotti-Crosti rash. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On an unknown dates the patient was vaccinated with the first and second dose of GARDASIL (route and lot number not reported). The medical assistant reported that on an unspecified date the patient received the 3rd dose of GARDASIL (route and lot number not reported) which was 2 years after the patient received the 2nd dose. No adverse effects were reported. Additional information has been requested.
Age: 22.0
Sex: M
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 22 year old male patient. On 17-JUL-2012 and on 11-JAN-2013, the patient received the first and the second dose of GARDASIL respectively. On 05-APR-2013, the patient was vaccinated with a third dose of GARDASIL (lot # 0459AE, expiry date was 13-DEC-2013, route and dose were not reported) that was improperly stored at temperatures 29 Fahrenheit (F) to 29F. No adverse reactions were reported. The patient remained healthy. This is one of the four reports received from the same reporter (MARRS# 1305USA017145, 1306USA003145 and 1307USA014754). Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Injection site coldness
Clinical narrative: This spontaneous report as received from a Licensed Vocational Nurse (L.V.N.) refers to a lot of adolescent patients (gender not reported). On an unknown date (dates) the patients were vaccinated with GARDASIL (dose, route and lot number were not reported). The patients complaint that GARDADSIL was cold after being injected in (date unspecified). The outcome of the patients was not reported. The relatedness between the event and GARDASIL was not reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age. On 22-APR-2013, the patient was vaccinated with dose 1 of PNEUMOVAX23 (lot number, expiry date and route was not reported). On 22-JUL-2013, the patient was vaccinated with dose 2 of PNEUMOVAX23 (lot number, expiry date and route was not reported). No adverse effect reported was reported. Additional information has been requested.
Age: 86.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Myalgia
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 86 year old male patient with allergy (allopurinol), high cholesterol, and "thyroid" who is also a physician. In approximately June 2013, about a month ago, the patient was vaccinated with PNEUMOVAX 23 0.5 ml, (lot number # H017759, expiration date 04-JULY-2014, route not specified). Concomitant therapies included SYNTHROID and LIPITOR. In approximately June 2013 also reported next day after receiving PNEUMOVAX 23 the patient developed muscle pain, redness and swelling at the injection site. The reported stated that symptoms lasted about three days and by the fourth day after receiving PNEUMOVAX 23 the patient was completely recovered. None of lab diagnostics studies was performed. There was no treatment given for the adverse events. The outcome of the events was reported as recovered/resolved in approximately June 2013. Relatedness between therapy with PNEUMOVAX 23 and events was not reported. This is one of several reports from the same source (report from the same reporter - MARRS # 1307USA002299). Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus, Sleep disorder
Clinical narrative: This spontaneous report as received from a consumer refers to a 60 year old female patient with no pertinent medical history and no drug reactions or allergies. On 29-JUN-2013 the patient was vaccinated with a dose of ZOSTAVAX (0.65 ml, one shot, route and site of administration were not reported). Concomitant therapies included levothyroxine sodium(manufacturer unknown). On 29-JUN-2013, on the evening, the patient developed an injection-site reaction to ZOSTAVAX. The injection site and the injection-site reaction were reported to be "in an unusual place" which was "on the back of" the patient's left arm. The reaction was reported to be "like a mosquito bite" and included lump, a little redness, and "mostly itching". On an unspecified date in 2013, the itching was bad enough to wake the patient from sleep. The patient was not yet fully recovered from the reaction, also reported the patient is recovering. No lab diagnostics were performed. The patient did not seek medical attention and no treatment was given for the adverse events. The relatedness between adverse events and ZOSTAVAX was not reported. Additional information is not expected.
Age: 59.0
Sex: U
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a female consumer approximately 59 year old (currently 66 year old at the time of report). In 2006 when she was not 60 years old before the expanded age group to 50 she was vaccinated with ZOSTAVAX dose 1, subcutaneously (lot number and exp. date not reported). The patient reported that she had no side effects. The outcome of the event was unknown. Additional information has been requested.
Age: 45.0
Sex: M
Vaccine: HEP
Symptoms: Fatigue, Feeling hot
Clinical narrative: Hep B vac first approximately 3-12. 2nd shot 8-1-12. Within 14 days severe fatigue and warming sensation from top of head down to shoulders. Continued severely for 2 months. Then off and on for several more months. Now occasional.
Age: 4.0
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report has been received from a health commissioner also reported as administrator who was referring to a 4 year and 10 months old female patient. Information on medical history was not reported. On 19-NOV-2009, the patient was vaccinated with the first dose of (Merck) VARIVAX. 0.5ml subcutaneously (lot# and exp not reported). It was reported that on 27-JUN-2013 the patient was vaccinated with an extra dose of varicella vaccine; single dose of both (Merck) VARIVAX (lot# expiry date not reported) 0.5 ml, subcutaneously, and (Merck) PROQUAD (lot# expiry date not reported) (dose, strength, frequency, route, indication not reported) were administered on the same day. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date RECOMBIVAX HB (lot#, expiration date and route not reported) that underwent an unspecified temperature excursion "may have been administered" to these patients. No adverse effects reported. This is one of the several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse refers to unspecified number of patients of unknown demographics. The GARDASIL (lot#, expiration date and route not reported) that underwent an unsupported temperature excursion "may have been administered" to these patients. No adverse effects were reported. This is one of the several reports from the same source. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: PPV
Symptoms: Blood uric acid increased, Erythema, Injection site swelling, Myalgia
Clinical narrative: This spontaneous  report as received from a healthcare worker refers to a 62 year old male patient with hyperlipidemia, high uric acid count, arrythmia and no drug reaction or allergy. On 18-JUN-2013 the patient was vaccinated with PNEUMOVAX23 0.5ml, (lot number H017759, expiration date 04-JULY-2014, route not specified). Concomitant therapies included alprazolam, simvastatin (manufacturer unknown), PRILOSEC, and aspirin. On 19-JUN-2013 the patient developed muscle pain, swelling at the injection site and redness after receiving PNEUMOVAX23. The reported stated that symptoms lasted about three days. None of lab diagnostics studies was performed. The patient did not sought medical attention. The outcome of the events was reported as recovered/resolved on 22-JUN-2013. Relatedness between therapy with PNEUMOVAX23 and events was not reported. This is one of several reports from the same source (report from the same reporter MARRS#1307USA002309). Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Chills, Headache, Hyperhidrosis, Nausea, Pallor
Clinical narrative: This spontaneous report as received from a physician refers to a 13 year old female patient with no pertinent medical history and no drug reaction or allergies who on 23-JUL-2013, was vaccinated with the first dose of GARDASIL (lot # H021861, Exp. Date: 09-OCT-2015) in the left arm. Other suspect therapies included VAQTA administered in the right arm. The physician reported that the patient developed nausea, shivering, sweating, blurry vision with black spots in her vision field and was pale with-in 5 minutes of receiving the dose of GARDASIL on 23-JUL-2013. The patient started to feel better after about 15 minutes (from receiving the vaccine), but then on the same day developed a headache. The patient's symptoms (nausea, shivering, sweating, blurry vision with black spots in her vision and was pale) resolved with-in another 10 minutes (25 minutes from receiving the vaccine), but the headache persisted. The patient was sent to home with the headache. The physician recorded the patient's blood pressure during the adverse event as 90 over 60 and right before the patient was sent to home the patient's blood pressure was 100 over 65. Unspecified treatment was given for the experience. At the time of the report, the patient's outcome was reported as recovering. The patient sought medical attention through office contact. The relatedness for nausea, shivering, sweating, blurry vision with black spots in her vision field, headache and was pale and GARDASIL was unknown. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Vision blurred, Visual impairment
Clinical narrative: This spontaneous report as received from a physician refers to a 13 year old female patient with no pertinent medical history and no drug reaction or allergies who on 23-JUL-2013, was vaccinated with the first dose of GARDASIL (lot # H021861, Exp. Date: 09-OCT-2015) in the left arm. Other suspect therapies included VAQTA administered in the right arm. The physician reported that the patient developed nausea, shivering, sweating, blurry vision with black spots in her vision field and was pale with-in 5 minutes of receiving the dose of GARDASIL on 23-JUL-2013. The patient started to feel better after about 15 minutes (from receiving the vaccine), but then on the same day developed a headache. The patient's symptoms (nausea, shivering, sweating, blurry vision with black spots in her vision and was pale) resolved with-in another 10 minutes (25 minutes from receiving the vaccine), but the headache persisted. The patient was sent to home with the headache. The physician recorded the patient's blood pressure during the adverse event as 90 over 60 and right before the patient was sent to home the patient's blood pressure was 100 over 65. Unspecified treatment was given for the experience. At the time of the report, the patient's outcome was reported as recovering. The patient sought medical attention through office contact. The relatedness for nausea, shivering, sweating, blurry vision with black spots in her vision field, headache and was pale and GARDASIL was unknown. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age. On 22-JUL-2013, the patient was vaccinated with an expired dose of ROTATEQ (lot # 1710AA, expiry date 11-JUL-2013) route was not reported. Concomitant medications were not reported. No adverse effect was reported. Additional information has been requested.
Age: 13.0
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 13 years old patient. On 12-JUL-2013 the patient was vaccinated with a dose of PROQUAD (Merck) (lot #, dose and route unspecified). No adverse effect reported. Additional information has been requested.
Age: 6.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Somnolence
Clinical narrative: Pt was excessively sleepy the day after vaccine with significant (R) thigh redness, swelling and itching.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site vesicles
Clinical narrative: Pt was vaccinated on 7/22/13 - called me 7/23 and said her arm was red and sore at injection site. I told her if it persists to call her dr. She saw her dr on 7/24 and was given ZOSTAVAX cream which helped - then dr gave her a steroid on 7/26/13 -> area was red w/fluid filled vesicles on 7/26/13.
Age: 2.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient was given 1ML of Havrix- an adult dose, as opposed to 0.5mL(pediatric dose).  No adverse reactions reported as of now.
Age: 2.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Unevaluable event
Clinical narrative: Patient was given 1ML of Havrix- an adult dose, as opposed to 0.5mL(pediatric dose).  No adverse reactions reported as of now.
Age: 38.0
Sex: F
Vaccine: HEPAB
Symptoms: Brachial plexopathy, Electromyogram abnormal, Musculoskeletal pain, Nuclear magnetic resonance imaging, Pain
Clinical narrative: My scapular region was in pain almost every night. I would come home in pain after work every night. On 5/14/2013 I received my second dose. On June 16, I admitted myself to the emergency room. After many tests and many doctors I have finally been diagnosed. I spent a week at a facility. They did an array of tests to rule out the final diagnosis of vaccine induced brachial plexopathy. On July 25th, 2013 it was the official diagnosis from Dr. post vaccination-induced brachial plexopathy.
Age: 38.0
Sex: F
Vaccine: HEPAB
Symptoms: Vaccination complication
Clinical narrative: My scapular region was in pain almost every night. I would come home in pain after work every night. On 5/14/2013 I received my second dose. On June 16, I admitted myself to the emergency room. After many tests and many doctors I have finally been diagnosed. I spent a week at a facility. They did an array of tests to rule out the final diagnosis of vaccine induced brachial plexopathy. On July 25th, 2013 it was the official diagnosis from Dr. post vaccination-induced brachial plexopathy.
Age: 32.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Pruritus, Swollen tongue
Clinical narrative: Swelling of tongue, swelling and redness at injection site, itching in arm and shoulders.
Age: 1.05
Sex: F
Vaccine: HIBV
Symptoms: Discomfort, Insomnia, Mood altered, Pyrexia, Rash
Clinical narrative: Developed a fever and mild rash. Rash worsened on the following day located mostly on hands / feet, then spreading to back, torso, then arms / legs and face.  Rash consisted of small red spots. Mild fever notable in afternoon. Difficulty sleeping at night, discomfort, and mood changes.
Age: 1.05
Sex: F
Vaccine: HIBV
Symptoms: Rash erythematous
Clinical narrative: Developed a fever and mild rash. Rash worsened on the following day located mostly on hands / feet, then spreading to back, torso, then arms / legs and face.  Rash consisted of small red spots. Mild fever notable in afternoon. Difficulty sleeping at night, discomfort, and mood changes.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Headache, Lymphadenopathy, Oropharyngeal pain, Pain
Clinical narrative: Swollen glands, sore throat, (lasted one week) chills, aches, headache (one day).
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site streaking, Injection site swelling
Clinical narrative: Mother brought patient to HC for TST reading. Left arm swollen and red from shoulder to elbow. One blister present at top of arm. Tender and warm to the touch. Areas of red streaks observed near antecubital area. Redness measures 110mm x 105mm. Mother reports pt. was febrile during the night. Mother took pt. to ER and was to return to Health Center Monday, 07/22/13. Mother did not have transportation, but reported by phone that ER gave pt. ointment to apply. Mother reports that arm is no longer swollen or painful. Remains bruised, but has improved.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site vesicles, Injection site warmth, Pyrexia
Clinical narrative: Mother brought patient to HC for TST reading. Left arm swollen and red from shoulder to elbow. One blister present at top of arm. Tender and warm to the touch. Areas of red streaks observed near antecubital area. Redness measures 110mm x 105mm. Mother reports pt. was febrile during the night. Mother took pt. to ER and was to return to Health Center Monday, 07/22/13. Mother did not have transportation, but reported by phone that ER gave pt. ointment to apply. Mother reports that arm is no longer swollen or painful. Remains bruised, but has improved.
Age: 19.0
Sex: F
Vaccine: RAB, TD
Symptoms: Dizziness, Dyspnoea, Erythema, Headache, Hypersensitivity
Clinical narrative: Tingling all over body, headache, drowsiness, dizziness, fainting, nausea, vomiting, redness and swelling of face, strained breathing/shortness of breath.
Age: 19.0
Sex: F
Vaccine: RAB, TD
Symptoms: Nausea, Paraesthesia, Somnolence, Swelling face, Syncope
Clinical narrative: Tingling all over body, headache, drowsiness, dizziness, fainting, nausea, vomiting, redness and swelling of face, strained breathing/shortness of breath.
Age: 19.0
Sex: F
Vaccine: RAB, TD
Symptoms: Vomiting
Clinical narrative: Tingling all over body, headache, drowsiness, dizziness, fainting, nausea, vomiting, redness and swelling of face, strained breathing/shortness of breath.
Age: 35.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Injection site erythema, Injection site induration
Clinical narrative: Initial reaction was small area of redness at injection site.  This progressed to area of erythema and induration measuring 6 cm by 6 cm.  There was surrounding erythema but no induration measuring 16 cm by 14 cm.
Age: 1.26
Sex: M
Vaccine: HIBV, PNC13, VARCEL
Symptoms: Epistaxis, Injection site discomfort
Clinical narrative: Vaccines were given on 7/23/13 to this 24 lb, 8 oz male.  Mom called our office nurse phone line on 7/24/13 at 12:29 pm  documented phone call by nurse: " pt's mother who stated pt was seen for office visit yesterday and received 3 vaccinations. Mom stated pt had nosebleed in middle of night (1:00 am). Mom stated she contacted after-hours nurse and was given nosebleed instructions and was instructed to report nosebleed to provider today. Mother states pt has not had any further nosebleeds, has no other symptoms and no signs of any reaction to vaccines other mild discomfort at injection site. Mother inquires if nosebleed could have been caused as reaction to vaccines received yesterday? Provider's response at 2:57 pm: Please let mom know that nosebleeds are very unlikely to be related to his vaccines. More likely his nose was just dry and it was coincidental. Mom can use nasal saline drops to keep his nose moist or apply Vaseline to his nasal passages.  Call if nosebleeds persist. Mom informed at 3:05 pm and had no further questions or concerns.
Age: 64.0
Sex: M
Vaccine: TDAP
Symptoms: Headache, Malaise, Musculoskeletal pain, Pyrexia
Clinical narrative: Fever to 102.5°. No rash, no site swelling, shoulder hurts. Had headache, malaise, now better.
Age: 40.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Antibody test negative, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Over a 24 hour period she noticed increased swelling, tenderness, and warmth at the area of the injection site.
Age: 64.0
Sex: F
Vaccine: HEPA, TDAP, TYP, HEPA, TDAP, TYP
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Redness, swelling, bumps at injection site.
Age: 64.0
Sex: F
Vaccine: HEPA, TDAP, TYP, HEPA, TDAP, TYP
Symptoms: Injection site erythema, Injection site rash, Injection site reaction, Injection site swelling, Malaise
Clinical narrative: Redness, swelling, bumps at injection site.
Age: 64.0
Sex: F
Vaccine: HEPA, TDAP, TYP, HEPA, TDAP, TYP
Symptoms: Nervousness
Clinical narrative: Redness, swelling, bumps at injection site.
Age: 1.01
Sex: M
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site urticaria
Clinical narrative: Welt appeared inferior to the vaccination site on both legs.  Worsened over about 10 mins and then seemed to resolve over an additional 30mins.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Headache, Pruritus, Rash
Clinical narrative: Tuesday evening 07/23/2013- Headache. Wednesday AM- itching, rash on legs. Thursday rash more pronounced. Mother gave Benadryl dose x1- Rash completely gone within a couple of hours.
Age: 1.01
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Rash macular
Clinical narrative: Pt broke out in an upper body rash that was splotchy.
Age: 8.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site swelling, Oedema peripheral
Clinical narrative: Pt had entire arm swollen from site of injection to wrist after Proquad vaccine.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Dizziness, Vomiting
Clinical narrative: Pt received Gardasil and approx 90 minutes later felt faint, dizzy and vomited one time.  Lasting approx 15 minutes.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Body temperature increased, Chills, Fatigue, Hyperhidrosis, Pain
Clinical narrative: Vomiting, temperature between 101.8 and 102.8, sweating, chills, achy body. Unable to keep liquids down. Extreme fatigue. Symptoms persisting at time of reporting (1:30 PM).
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Vomiting
Clinical narrative: Vomiting, temperature between 101.8 and 102.8, sweating, chills, achy body. Unable to keep liquids down. Extreme fatigue. Symptoms persisting at time of reporting (1:30 PM).
Age: 10.0
Sex: M
Vaccine: HEPA, HPV4, TDAP
Symptoms: Hyperhidrosis, Pallor
Clinical narrative: Within minutes of recieving immunizations patient became pale and diaphoretic while sitting.  Nurse was next to patient monitoring for any adverse effects and placed a cool wash cloth, fan and assisted patient into a lying position with his legs up.  This episode took approximately 20 minutes for patient to recover to a standing position.  Sibling also responded the same to similar immunization administration during this time.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse refers to unspecified number of patients of unknown demographics. The nurse reported that an unspecified number of M-M-R II (lot #, expiration date and route not reported) doses "were probably administered" to unspecified patients after the M-M-R II underwent an unsupported temperature excursion. No adverse effects were reported. This is one of the several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse refers to unspecified number of patients of unknown demographics. The VAQTA (lot#, expiration date and route not reported) that underwent an unsupported temperature excursion "may have been administered" to these patients. No adverse effects were reported. This is one of the several reports from the same source. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, VARCEL
Symptoms: Dizziness, Hyperhidrosis, Pallor
Clinical narrative: Patient was known to feel faint after recieving immunizations at a school Tdap clinic in March so patient was lied down to administer immunizations.  Nurse monitored patient for any adverse effects of vaccine for 10 minutes then walked out to sit in the waiting room longer with mother while we gave immunizations to younger brother.  After a few minutes of sitting in the waiting room another RN noticed patient became pale and diaphoretic and put a cool wash cloth on him and gave him a cool glass of water.  Mother was present.  Additional monitoring took place for approximately 20 minutes.
Age: 57.0
Sex: F
Vaccine: TYP
Symptoms: Pharyngeal oedema
Clinical narrative: Swollen throat.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Computerised tomogram head normal, Fall, Head injury, Loss of consciousness, Spinal X-ray normal
Clinical narrative: Patient received immunizations today and had syncopal episode when checking out of clinic around 1015. Fell from standing and hit head on hard surface. Loss of consciousness for approximately 1 min. Vomit x1.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Syncope, Vomiting
Clinical narrative: Patient received immunizations today and had syncopal episode when checking out of clinic around 1015. Fell from standing and hit head on hard surface. Loss of consciousness for approximately 1 min. Vomit x1.
Age: 17.0
Sex: F
Vaccine: HEP, IPV, MMR, MNQ, TD
Symptoms: Chest discomfort, Dizziness, Dyspnoea, Fall
Clinical narrative: After vaccines pt stood up and became dizzy.  She said she felt like she was going to pass out.  Then complained of chest tightness and said it was hard to get a full breath.  Pt fell to floor.  Pt was alert & no SOB noted.  0.3 mg of Epi given in right arm and ems called.  EMS evaluated pt and mom refused transport since pt felt better.
Age: 7.0
Sex: F
Vaccine: HEPA
Symptoms: Excessive eye blinking, Tic
Clinical narrative: Patient started excessively blinking very hard on the ride home from the doctor's office.  I knew that she was very nervous about receiving the shot so I didn't worry so much until the next morning when she was still blinking hard.  I called her doctor in the morning and reported the situation with her.  She recommended I see an eye doctor, of which I did the same day.  She does have allergies but the hard blinking is not from that.  My daughter never did this. EVER.  7/25/13 I called the doctor again and told her that the blinking was still happening.  She suggested I call a neurologist and make an appointment.  7/26/13 Friday I called the doctor's office again and reported still the excessive blinking happening.  I took patient and my 3 year old, who also developed a cold 2 days after the shot, back to the doctor at 1:15 pm.The doctor examined patient and she told me it was a tic. Just a nervous reaction from getting the shot but probably not an allergic reaction. My husband and I believe that unusual behavior is an allergic reaction.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure increased, Urticaria
Clinical narrative: 30 MINUTES AFTER IMMUNIZATION WHEN PATIENT GOT HOME..A WELT ABOUT THE SIZE OF A BASEBALL APPEARED ON HER UPPER CHEST AND MOVED UP TO MOUTH AREA. WENT TO MD OFFICE WHO GAVE HER A EPIPEN SHOT...THE EPIPEN RAISED HER BP TO HIGH AND SHE WENT TO THE HOSPITAL WHERE THEY OBSERVED HER FOR 2 HOURS, THEN SENT HER HOME.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Dizziness, Dyspnoea, Presyncope, Vertigo
Clinical narrative: Approx. 3 hrs after getting vaccine, mother took child to hospital.  Child with difficulty breathing and complaints of dizziness.  Dr. diagnosed child with vasovagal reaction to the immunizations given at 0915 that morning.  Child was released home, but still having some vertigo/dizziness.
Age: 11.0
Sex: F
Vaccine: HPVX
Symptoms: Erythema, Induration, Oedema
Clinical narrative: Edema, erythema, induration -ice was used and reduced edema.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Pallor, Rash macular
Clinical narrative: Polymorphic annular blanching nonpruritic erythematous nonmigratory macules about the wrists, hands, ankles, axillae, and anteromedial proximal thighs. Fading after 3 days. Similar rash also 7 days after first dose of HPV vaccine.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site urticaria, Local swelling, Malaise, Pyrexia
Clinical narrative: Pt called clinic with questions about localized swelling to R arm and fever upon waking the day after immunizations were given. Pt was seen in clinic today because symptoms were not better. Pt also developed malaise and runny nose. Has been taking ibuprofen and Tylenol for fever, mother states initial fever was 101.4, has not let it go with out medication since, pt came to clinic with fever of 99.2 after receiving Tylenol 1.5 hours before visit. Ice packs have been applied consistently to arm. Reddened welted area approx. 10 cm in diameter to R deltoid (Menactra injection site), L deltoid with light red patch around injection site apporx. 4 cm in diameter (Tdap injection site).
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Rhinorrhoea
Clinical narrative: Pt called clinic with questions about localized swelling to R arm and fever upon waking the day after immunizations were given. Pt was seen in clinic today because symptoms were not better. Pt also developed malaise and runny nose. Has been taking ibuprofen and Tylenol for fever, mother states initial fever was 101.4, has not let it go with out medication since, pt came to clinic with fever of 99.2 after receiving Tylenol 1.5 hours before visit. Ice packs have been applied consistently to arm. Reddened welted area approx. 10 cm in diameter to R deltoid (Menactra injection site), L deltoid with light red patch around injection site apporx. 4 cm in diameter (Tdap injection site).
Age: 12.0
Sex: F
Vaccine: HEPA, MNQ, PPV, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Left upper arm reported as red, swollen, indurated and warm to touch-given BENADRYL, ice to arm, ibuprofen-went to ER as this did not improve condition.
Age: 17.0
Sex: M
Vaccine: HPV4, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: C/o itching, redness, swelling at injection site next day at 10 am right arm 1 1/2 inch x 1 1/4 inch area upper arm.
Age: 2.0
Sex: F
Vaccine: DTAP, HEPA, HIBV
Symptoms: Injection site mass, Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Erythema, swelling, and warm to touch at vaccination site (Right thigh). Pt prescribed BENADRYL and KEFLEX. Small lump at vaccination site.
Age: 24.0
Sex: M
Vaccine: TD
Symptoms: Activities of daily living impaired, Injection site pain, Pain in extremity
Clinical narrative: Patient is feeling pain in injected arm. He has missed 2 days of work and points to a pain point well above humerus - injection site.
Age: 23.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Dizziness, Dyspnoea, Sensation of heaviness
Clinical narrative: Feeling heavy and SOB, dizziness.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 5.75 X 5.25" area of erythema and swelling of right thigh.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Patient called pharmacy today and said she had a rash about 2x3" around the site of injection. Non-painful rash. Informed pt to contact MD if rash spreads or fever develops. Also told pt she could take BENADRYL to help reduce reaction.
Age: 12.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Drug administered to patient of inappropriate age, Herpes zoster, Pain, Rash
Clinical narrative: This spontaneous report as received from a physician refers to a 12 and a half years old male patient with wheezing. The patient did not have known allergies. On 11-DEC-2001, the patient received the first dose of VARIVAX (Merck) (Lot # not reported) (0.5ml, subcutaneous) and the second dose of VARIVAX (Merck) (Lot # not reported) (0.5ml, subcutaneous) was administered on 28-APR-2008. There was no concomitant medications. On 21-JUL-2013, the patient experienced a rash and then vesicles appeared with pain and the patient sought medical attention, was diagnosed with shingles at an unspecified medical clinic, the patient was not admitted to the hospital. At the time of the report the patient's outcome was unknown. It was reported that therapy with VARIVAX (Merck) was not discontinued. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 20 year old female patient with a pertinent medical history of Shingles. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot # not reported) (dose and route not reported). Concomitant therapy was not reported. On an unknown date the patient experienced recurrence of shingles. The outcome of recurrence of shingles was unknown. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a doctor of pharmacy refers to a patient of unknown age. On 21-JUL-2013, the patient was vaccinated with a dose of PNEUMOVAX23 (Lot # not reported) IM. On 22-JUL-2013, the patient received another dose of PNEUMOVAX23 (Lot # not reported) IM and on 23-JUL-2013, received one more dose of PNEUMOVAX23 (Lot # not reported) IM. No adverse effect was reported. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacists refers to a 65 year old female patient with no known allergies. On 19-JUL-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # J000493, exp date 14-APR-2014) (dose and route not reported). Concomitant therapy was not reported. On 20-JUL-2013, the patient developed an injection site reaction following vaccination with ZOSTAVAX. The injection site reaction was described as a large raised red area (rash) at the injection site that was painful. The red area had gotten larger since it started. The patient sought medical attention by contacted the pharmacist and no treatment was given for the adverse event. Laboratory diagnostic studies were not performed. At the time of the report the patient's outcome was not recovered. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from the patient's mother, refers to a diabetic 14 year old female patient. The patient had no pertinent drug reactions/allergies. The patient's mother reported a misuse adverse event in regards to GARDASIL injection. Reporter stated that the patient was administered the first shot of GARDASIL injection 9dose, route and lot number were not provided) for vaccination on 10-MAR-2013. The second shot of GARDASIL injection (dose, route and lot number were not provided) for vaccination, was administered on 08-MAY-2013. The third shot of GARDASIL injection (dose, route and lot number were not provided) for vaccination, was administered on 12-JUL-2013. Concomitant medications were not reported. Reporter stated that the third shot of the GARDASIL was given "two months too early". No adverse events were reported at this time. The patient saw the doctor. Patient performed a routine blood work (results not provided). No treatment was given for the adverse event. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Rash generalised
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a female patient in her 20's. On an unknown date, the patient was vaccinated with GARDASIL injection, first dose (dose, frequency and lot number were not reported). The patient who received the first dose of GARDASIL and developed rash all over her body. The patient mentioned this incident to this physician "in passing during an annual exam". No treatment was given. The patient did not receive medical attention. The patient's outcome was unknown. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Pharmacist reported that an expired dose of GARDASIL INJ (Lot # 668260/1570Z and expiration date 04/06/2013) (dose and route were not reported for prophylaxis, was administered to a patient on 21-JUL-2013. Concomitant medications were not reported. No adverse effect reported. Additional information has been requested.