chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Rash
Clinical narrative: Information has been received from a 38 year old female pharmacist with no pertinent medical history and no drug allergies/drug reactions. She reported that on 04-FEB-2013 when she pulled the syringe out of the ZOSTAVAX vial (lot # H018510, expiration date 15-JAN-20140, she got some of the liquid on her skin and a rash developed on the same day. There was no concomitant therapy reported. The reporter accepted VZVIP packet. Laboratory studies were not performed. At the time of the report the patient was recovering from the event. Additional information has been requested.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Tenderness
Clinical narrative: Pt. described slight tenderness & redness about baseball size. Does not really bothered but concerned about rxn.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Injection site pain, Mobility decreased, Pain in extremity
Clinical narrative: Shot was given at the top back side of left arm & was very painful as it was administered. The next day my whole arm was sore. Even now, 4 mths. later I have lost strength in that arm, arm pain & mobility difficulty.
Age: 28.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site reaction, Nausea, Rash macular
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 28 year old female patient. On 29-JAN-2013 the patient was vaccinated with a dose of live ZOSTAVAX (lot number unspecified). No other suspect therapy reported. No concomitant therapy reported. On an unspecified date the patient had a half dollar sized itchy and blotchy raised area at injection site. It also caused the patient to have nausea. No treatment was given to the adverse events. At the time of the report, the patient was not recovered from the events. The patient had called pharmacist for medical attention. The relatedness for the events to live ZOSTAVAX was unknown. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Headache
Clinical narrative: This spontaneous report as received from a reporter (details unspecified) refers to a 13 year old female patient with no medical history. On 08-JAN-2013, the patient was vaccinated with a first dose (1 dose) of GARDASIL, intramuscular. No concomitant medications were taken. On 08-JAN-2013, the patient who saw her menstrual cycle was complaining about abdominal pain and headache the same day after receiving the dose one of GARDASIL. No laboratory test was performed. The event menstrual cycle, abdominal pain and headache disappeared without treatment on 11-JAN-2013 (reported as after 3 days). The outcome of unexpected therapeutic was unknown. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Accidental exposure to product, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to himself. The pharmacist reports that some of the ZOSTAVAX (Lot# H019998, EXP January 2014) leaked on his own skin, when he was going to give it to a patient on an unknown date. No adverse effects occurred. Product quality complaint (PQC) was involved. It was unknown if the patient had sought medical attention. Additional information is not expected.
Age: 10.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Pyrexia, Vomiting
Clinical narrative: This spontaneous report as received from a reporter (details unspecified) refers to a 10 year old female patient with no medical history. On 15-JAN-2013 the patient was vaccinated with a first dose (1 dose) of GARDASIL (lot number expiry date and dose were not reported) intramuscular. No concomitant medication was taken. On 29-JAN-2013 (also reported as at fourteenth day after dose 1), the patient's fever was not quantified, the patient had headache and vomiting. No laboratory test was performed. The outcome of fever not quantified, headache and vomiting is unknown. Additional information is not expected.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Allergy test, Urticaria
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to approximately 2 year old female patient who was allergic to ZOFRAN. The patient had no pertinent medical history. On an unknown date in 1998, the patient was vaccinated with a dose of VARIVAX (merck) (lot number was reported as 1419E, expiry date, dose and route were not reported). Approximately on an unknown date in 1998, the patient developed hives post vaccination. Skin allergy test was performed on an unknown date (details were not specified). The patient sought medical attention and was treated with an unspecified treatment. On an unknown date, the event hives was resolved. This is one of reports from the same Same Reporter Link (MARRS# 1302USA005316). Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Allergy test, Skin test, Urticaria
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to approximately 14 year old female patient who was allergic to ZOFRAN. The patient had no pertinent medical history. On an unknown date in 2010, the patient was vaccinated with a dose of GARDASIL (lot number was reported as 1378Y, expiry date, dose and route were not reported). Approximately on an unknown date in 2010, the patient developed hives one hour post vaccination. Skin allergy test was performed on an unknown date (details were not specified). The patient sought medical attention and was treated with BENADRYL. On an unknown date, the event hives was resolved. This is one of reports from the Same Reporter Link (MARSS# 1302USA003808). Additional information is not expected.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Rash pruritic
Clinical narrative: This spontaneous report as received from a consumer refers to a 81 year old male patient with multiple myloma and prostate cancer. In 2010 the patient was vaccinated with ZOSTAVAX, subcutaneous. On 20-DEC-2012 patient's physician diagnosed him as having shingles. Patient had spots on right ear at first and developed into an itchy rash on his back and on to his chest all over. It went to his beltline. The outcome of shingles was unknown. The relatedness for shingles was not reported for ZOSTAVAX. Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia, Vomiting
Clinical narrative: This spontaneous report was received from a physician refers to a 10 year old female patient. The patient had no pertinent medical history. On an unknown date, the patient was vaccinated with a dose of 0.5 ml GARDASIL, (lot number, expiration date was not reported, route intramuscular). Concomitant medications were not reported. On 05-JAN-2013, the patient experienced fever and stated that the fever was not quantified. On 05-JAN-2013, the patient had many vomiting at day 18 of dose 1. The outcome of the events were unknown at the time of this report. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to unspecified patients of unknown age and gender. On an unknown date, the patients may have been vaccinated with PNEUMOVAX23 (Lot number, expiry date, route and dose were not reported) stored as low as 0 degree Fahrenheit for up to 26 hours. No adverse effect reported. Additional information has been requested.
Age: 9.0
Sex: F
Vaccine: HPV4
Symptoms: Vomiting
Clinical narrative: This spontaneous report was received from a physician refers to a 9 year old female patient. On 09-NOV-2012, the patient was vaccinated with second dose of 0.5ml (milliliter) GARDASIL, (lot number, expiry date and route was not reported). Concomitant medications not reported. On 10-NOV-2012, the patient experienced vomiting once. The outcome of vomiting was unknown. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: This spontaneous report as received from a consumer friend refers to approximately 55 years old female patient with no pertinent medical history and no drug allergies. On 05-FEB-2013, the patient was vaccinated with a single dose of ZOSTAVAX, 0.65 milliliter (ml), subcutaneously. Concomitant medications were none. On 06-FEB-2013, the patient experienced redness, swelling and a rash around the injection site. No laboratory test was performed. The pharmacists name and location of the pharmacy was not provided. The patient sought no medical attention and no treatment was given. The outcome of redness, swelling and a rash around the injection site was unknown. Additional information is not expected.
Age: 33.0
Sex: F
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This spontaneous report as received from a 33 years old female consumer regarding herself. On 07-DEC-2012, the patient was vaccinated with a first dose of GARDASIL (Lot number, expiry date route and dose were not reported) at the age of 33. The consumer reported that she would not with the subsequent vaccinations due to the cost of the vaccine. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Influenza
Clinical narrative: This spontaneous report as received from a consumer refers to a 70 year old male patient with diabetes. On an unknown date the patient was vaccinated with ZOSTAVAX for shingles vaccination and developed flu symptoms and headache. The outcome of flu symptoms and headache was reported as recovered. The relatedness for flu symptoms and headache was not reported for ZOSTAVAX. Additional information was not expected.
Age: 0.08
Sex: F
Vaccine: HEP
Symptoms: Poor sucking reflex
Clinical narrative: This spontaneous report was received from a nurse practitioner refers to a 1 month old female patient with none pertinent medical history, drug reactions or allergies. On 05-FEB-2013, the patient was vaccinated with RECOMBIVAX HB, 0.5 ml, intramuscular injection as prophylaxis (lot number not reported). Concomitant medication was not reported. On 05-FEB-2013, the patient exhibited significantly diminished suck response since administration of RECOMBIVAX HB. The patient was not treated. Laboratories test were not performed. The patient's mother called nurse practitioner office. At the time of the report, the outcome of significantly diminished suck response was reported as not recovered/not resolved. The event of significantly diminished suck response was unknown related to RECOMBIVAX HB. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacist via a field representative refers to a female patient in her 60s. Pertinent medical history was reported as none. On 18-JAN-2013, the patient was vaccinated subcutaneously with a single 0.65 milliliter (ml) dose of ZOSTAVAX (lot # not reported) for prevention of shingles. On 25-JAN-2013, the patient had a shingles outbreak on her nose. Patient received treatment with VALTREX. Patient sought medical attention (unspecified). The outcome of shingles outbreak on her nose was unknown. The causality for ZOSTAVAX with singles outbreak on her nose was unknown. Additional information has been requested.
Age: 44.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia oral
Clinical narrative: Participant lips and tongue was numb after receiving vaccine/ epi was administered/ participant reported improvement in numbness, returned to work/ no previous history of reaction to flu vaccine.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Abasia, Herpes zoster, Insomnia, Post herpetic neuralgia
Clinical narrative: This spontaneous report as received from a 77 year old female patient refers to herself. The patient did not have any pertinent medical history or drug reactions/allergies. Concomitant therapies included CELEXA, simvastatin, WELLBUTRIN and LEVOXYL. On 29-DEC-2011 the patient was vaccinated with ZOSTAVAX (route, dose and lot # were unknown) and developed a case of Shingles on Labor Day weekend, 2012 (05 MAY-2012). She had been dealing with the resulting Post herpetic neuralgia (PHN) since. She was in terrible pain. At first she sought medical attention via seeing her primary HCP (no demographics provided) and then she saw a dermatologist (no demographics provided). She was put on an unspecified antiviral drug (manufacturer unspecified) and OXYCONTIN (manufacturer unspecified) for treatment. She then started seeing a pain management specialist. He put her on Gabapentin (manufacturer unspecified). The patient could not sleep or walk and the nerve pain was horrendous. She would now be seeing a neurological pain management specialist (no demographics provided) and was trying physical therapy. The outcome of event was reported as not recovered/not resolved. Lab Diagnostics Studies Performed: MRIs (results not provided). Upon internal review, patient can not walk was determined to be disabling. Additional information has been requested.
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. On 29-MAY-2012 the patient was vaccinated with GARDASIL dose 3, .5 ml, intramuscular. This third dose was administered too closely to the second dose. First dose was administered on 28-DEC-2011, second dose on 28-FEB-2012 and third dose on 29-MAY-2012. No further information was available. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: This spontaneous unconfirmed report was received via company representative and refers to three patients of unknown age and gender. On an unknown dates, the patients were vaccinated with PNEUMOVAX23 (dose, route, site of administration and lot # not reported). On an unknown date, the patients experienced injection site swelling in an approximately 2 inch diameter area. Each patient felt the need to contact the office to inquire about the reaction. The outcome of injection site swelling is unknown. Additional information has been requested.
Age: 80.0
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Local swelling, Pain in extremity, Pain of skin
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 80 year old patient. On 04-FEB-2013 the patient was vaccinated with live ZOSTAVAX (0.65 ml, one shot, subcutaneous, lot # was unknown). On 06-FEB-2013 the patient experienced pain in her lower left arm and left shoulder joint pain. The skin on her left wrist was sore to touch (like nerve ending type) and behind her left ear lobe she had an area of pain and swelling. No demographics were provided for the patient. The outcome of event was unknown. The patient was told to take some ibuprofen. The patient sought medical attention via seeing the pharmacist. Additional information has been requested.
Age: 1.01
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 4 years old female patient with allergy to amoxicillin, with pertinent medical history, who  on 17-MAR-2009, was vaccinated subcutaneously with dose 1, 0.5 live (Merck) VARIVAX (Lot 662448/1785x EXP. 11-DEC-2010). No concomitant medications were reported. On 23-JAN-2013, the primary reporter, stated that a patient at the age of 12 months received live (Merck) VARIVAX and that on 23-JAN-2013, at the age of 4 years old was seen in the office and was diagnosed with widespread chickenpox. The patient subsequently recovered without requiring treatment in Jan. 2013. Additional information is not expected.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: This spontaneous report was received from a 54 year old male patient. No medical history, drug reactions or allergies. On an unknown date (approximately February 2013), the patient was vaccinated with live ZOSTAVAX (left arm injection) (lot#, dose and route not reported). There was no concomitant therapy. On 01-FEB-2012, where the vaccine was given itches and it was red and hurts when it gets touched. No treatment was given. The patient did not seek medical attention. The relatedness of the event with live ZOSTAVAX was not provided. Additional information is not expected.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 6 month old patient. On 05-FEB-2013, the patient was vaccinated with the first 2 ml dose of live, oral ROTATEQ (Lot # not reported). No adverse effect was reported. Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Neurological symptom
Clinical narrative: This spontaneous report as received from a nurse refers to 4 female patients of 11 to 12 year old. On an unknown date, the patients were vaccinated with a dose of GARDASIL, (lot number, expiry date and route was not reported). No concomitant medications reported. The nurse stated that another nurse told her that within the past year 4 patients have been hospitalized in hospital for several days due to neurological side effects after receiving GARDASIL. She also stated that she saw many reports in the internet that the vaccine causes severe side effects such as deaths. The outcome of neurological side effects was unknown. The patients sought medical attention(hospitalized for several days). Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome, Lumbar puncture, Nuclear magnetic resonance imaging brain, Nuclear magnetic resonance imaging spinal
Clinical narrative: Guillain Barre.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Needle issue, No adverse event, Underdose
Clinical narrative: This spontaneous report as received from a Doctor of pharmacy refers to a 64 year old female patient. On 02-FEB-2013 the patient was vaccinated with a 0.65 ml dose of live ZOSTAVAX (Lot # H019040 expiration date 17-JAN-214) subcutaneously in the left upper arm. The pharmacist reported that on 02-FEB-2013, during the administration of live ZOSTAVAX, the needle started to leak and the patient did not receive the full dose of the medication. The patient was not experiencing any adverse events. There were not Lab diagnosis or studies performed. Additional information has been requested.
Age: 28.0
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 28 year old patient. The first two doses of RECOMBIVAX HB were administered several years ago, perhaps in 2007 or 2009, but the third dose in the series had never been administered. There was no adverse effect reported. No further information was available. Additional information has been requested.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Abasia, Activities of daily living impaired, Diaphragmatic disorder, Dyspnoea, Exercise tolerance decreased
Clinical narrative: Initial report was received on 04 February 2013 from an unverified source via a company website from a consumer. A 56-year-old male patient received an injection of INFLUENZA VACCINE, manufacturer unknown, (lot number, route, site, side and dose in series not reported) on unspecified date in November, year not specified. On 11 November (year not specified), eight days post vaccination; the patient was diagnosed with Guillain-Barre syndrome (GBS). The patient felt tingling in his fingers and toes, and at end of day, knew something was wrong (date not specified). "The next morning, he could not walk" and "was staggering around like he was drunk". On an unspecified date, the patient had trouble breathing. His wife dialed 911. Shortly after the arrival of paramedics, the patient passed out. He was transported to a hospital. After an hour, his diaphragm shut down and he received a tracheotomy, "doctors cut a hole in his throat and put him on a breathing machine. Then his nervous system went haywire". The patient's past medical history was not reported. Three months prior to vaccination, the patient "could bench-press 275 pounds". The patient's outcome was reported as not recovered, "it will be many months before he can return to work", (also reported as recovering). Documents held by sender: None.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Gait disturbance, Guillain-Barre syndrome, Loss of consciousness, Mechanical ventilation, Nervous system disorder
Clinical narrative: Initial report was received on 04 February 2013 from an unverified source via a company website from a consumer. A 56-year-old male patient received an injection of INFLUENZA VACCINE, manufacturer unknown, (lot number, route, site, side and dose in series not reported) on unspecified date in November, year not specified. On 11 November (year not specified), eight days post vaccination; the patient was diagnosed with Guillain-Barre syndrome (GBS). The patient felt tingling in his fingers and toes, and at end of day, knew something was wrong (date not specified). "The next morning, he could not walk" and "was staggering around like he was drunk". On an unspecified date, the patient had trouble breathing. His wife dialed 911. Shortly after the arrival of paramedics, the patient passed out. He was transported to a hospital. After an hour, his diaphragm shut down and he received a tracheotomy, "doctors cut a hole in his throat and put him on a breathing machine. Then his nervous system went haywire". The patient's past medical history was not reported. Three months prior to vaccination, the patient "could bench-press 275 pounds". The patient's outcome was reported as not recovered, "it will be many months before he can return to work", (also reported as recovering). Documents held by sender: None.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Paraesthesia, Tracheostomy
Clinical narrative: Initial report was received on 04 February 2013 from an unverified source via a company website from a consumer. A 56-year-old male patient received an injection of INFLUENZA VACCINE, manufacturer unknown, (lot number, route, site, side and dose in series not reported) on unspecified date in November, year not specified. On 11 November (year not specified), eight days post vaccination; the patient was diagnosed with Guillain-Barre syndrome (GBS). The patient felt tingling in his fingers and toes, and at end of day, knew something was wrong (date not specified). "The next morning, he could not walk" and "was staggering around like he was drunk". On an unspecified date, the patient had trouble breathing. His wife dialed 911. Shortly after the arrival of paramedics, the patient passed out. He was transported to a hospital. After an hour, his diaphragm shut down and he received a tracheotomy, "doctors cut a hole in his throat and put him on a breathing machine. Then his nervous system went haywire". The patient's past medical history was not reported. Three months prior to vaccination, the patient "could bench-press 275 pounds". The patient's outcome was reported as not recovered, "it will be many months before he can return to work", (also reported as recovering). Documents held by sender: None.
Sex: M
Vaccine: FLU3
Symptoms: Lip swelling, Oedema peripheral
Clinical narrative: Initial report was received from a healthcare professional on 05 February 2013. A male patient (age and date of birth not reported) had received an intradermal injection of FLUZONE Intradermal (lot number, site and date of administration unknown) and an unspecified amount of time later experienced swelling of the lips and hands. Outcome was not reported. Documents held by sender: None.
Age: 24.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Chest discomfort, Electrocardiogram normal, Troponin normal
Clinical narrative: This study case was received from the investigator in the trial on 31 January 2013. A male subject (birth date not reported, age reported as 24 years old on electrocardiogram) had received the ACAM2000 (lot number, and route not reported) in the left arm on 08 January 2013. The subject had also received the following vaccinations on 08 January 2013: anthrax vaccine (manufacturer, lot number, route and site not reported) and typhoid vaccine (manufacturer, lot number, route and site not reported). The subject with unremarkable medical history reported on and off chest tightness in the middle of his chest with no obvious exacerbating or mitigating factors. The chest tightness started on 15 January 2013 and lasted through 17 January 2013. Symptoms were not exercise induced. No other adverse events were reported. Rapid Troponin test on 18 January 2013 was normal (result < 0.10 ng/mL). Preliminary electrocardiogram (ECG) from 18 January 2013 read normal. The subject did not take any medications to treat the adverse event and did not have any medical history relevant to the adverse event. The subject did have a medical history of "PRK" procedure in September 2011 and took topical steroid drops for it. The subject's outcome was reported as recovered on 17 January 2013. According to the investigator, the event of possible myopericarditis was considered possibly related to vaccination. Documents held by sender: none.
Age: 1.24
Sex: M
Vaccine: DTAP, MMR, PNC13
Symptoms: Body temperature increased, Crying, Flatulence, Full blood count normal, Insomnia
Clinical narrative: Pt. presented at office afebrile, fussy at 0923 2/9/13. Per father, pt. had been fussy/gassy x24 hours. Decreased sleep, inconsolable, crying. Father reported a rectal temp of 103.6 degrees.
Age: 1.24
Sex: M
Vaccine: DTAP, MMR, PNC13
Symptoms: Irritability, Streptococcus test negative
Clinical narrative: Pt. presented at office afebrile, fussy at 0923 2/9/13. Per father, pt. had been fussy/gassy x24 hours. Decreased sleep, inconsolable, crying. Father reported a rectal temp of 103.6 degrees.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: This spontaneous report was received from a health professional via company representative refers to a 53 year old female patient. The patients medical history included an episode of shingles about twelve years ago. On an unknown date in NOV-2012, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date and route was not reported). No concomitant medications reported. ON an unknown date in NOV-2012, the patient stated that one day after receiving ZOSTAVAX, the patient developed soreness and redness around the injection site. The next day the redness around the injection site spread to about 4 inches in diameter. Additionally the patient developed three blisters that did not open. On the fourth day, the patient experienced severe burning and itching around the injection site that extended down to the elbow. By the fifth day after receiving ZOSTAVAX, the adverse symptoms disappeared. There was no lab diagnostics performed. There was no treatment rendered for the events. The outcome of the reported events were recovered at the time of this report. The patient did not seek medical attention. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with PNEUMOVAX 23 for an unknown indication. Patient received PNEUMOVAX 23 two years in a row. There were no adverse effects reported. No further information was reported. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Rash pruritic, Swelling face
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown gender and age. On an unknown date the patient was vaccinated with GARDASIL. On an unknown date the patient experienced itchy rash and swelling on her face. The outcome of itchy rash and swelling on her face is unknown. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness
Clinical narrative: Dizzy spell lasting about 40 minutes -- debilitating enough so I had to sit/lie down immediately. Second event 02/12/2013 lasted approx 5 minutes and also required me to sit down until it passed.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling hot, Heart rate increased
Clinical narrative: Participant experienced increased heart rate, and feeling hot about 2 hours after vaccinated/ no epi administered/ after ice pack to neck and resting, participant felt better.
Age: 39.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Movement disorder
Clinical narrative: Participant was dizzy and unable to move after receiving vaccine/ no epi administered/ rested and put ice pack on back of neck.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Discomfort, Gait disturbance, Injection site warmth, Pyrexia, Vaccination site swelling
Clinical narrative: Duration of approximately 1 week. Localized swelling of vaccination site.  Fever, and warm to touch at site.  Swelling measured approximately five inches by three inches, encompassing most of patient's thigh.  Interfered with walking and comfort for approximately six days.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling hot, Rash
Clinical narrative: Participant reported warm feeling & had rash on left arm/ no epi administered/ after monitoring participant for several minutes, symptoms decreased.
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Axillary pain, Chest pain, Myalgia, Rash erythematous, Rash macular
Clinical narrative: About 3-4 hours after receiving the vaccine I had localized pain in my upper left chest area and in the exact same location on my back. It was definitely a muscular pain. Periodically I have a sharp pain in the underside of my left upper arm. I received the vaccine on my left arm. Additionally, the next day I woke up this morning with a red splotchy rash on my cheeks, chin and forehead that eventually faded away.
Age: 20.0
Sex: M
Vaccine: FLU3
Symptoms: Syncope
Clinical narrative: Participant fainted after receiving vaccination; participant responsive after 5 - 7 seconds; after lying down participant returned to work.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Customer Safety Compromised: Pregnant/Nursing Mother-Flu vaccination give to pregnant/nursing mother per doctors note.
Age: 36.0
Sex: M
Vaccine: FLU3
Symptoms: Exposure during breast feeding
Clinical narrative: Customer Safety Compromised: Nursing Mother-flu shot was given to a nursing mother, doctors note approved for participant to receive flu shot.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during breast feeding
Clinical narrative: Customer Safety Compromised: Nursing Mother-flu shot was given to a nursing mother, doctors note approved for participant to receive flu shot.
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Intense pain, at site of administration, redness 1/2cm at site.
Age: 60.0
Sex: M
Vaccine: DTP, VARZOS
Symptoms: Injection site anaesthesia, Injection site pain
Clinical narrative: Following ~1 month of intense soreness in left deltoid muscle after administration of whooping cough booster and Zostavax vaccines, I awoke to sharp burning pain along the left bicep, especially upon extension of the arm. Within 4-5 days, bicep became progressively and increasingly numb. No treatment.
Age: 40.0
Sex: M
Vaccine: FLUX
Symptoms: Asthma, Condition aggravated
Clinical narrative: Asthma exacerbation.
Age: 55.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Body temperature increased, Erythema, Pruritus, Swelling
Clinical narrative: Painless swelling of R axilla that started Thursday, stopped on Friday. On Monday she noticed swelling, redness, and increased temperature of R upper arm aprox. 4 inches in diameter. Currently has no fever. Experienced some itching the day of vaccination but unable to recall is she had scratched area.
Age: 84.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Swelling
Clinical narrative: Got red & swollen.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Induration, Malaise, Nausea, Pain
Clinical narrative: Left upper arm is indurated and warm to touch. Arm is itchy. Intermittent shooting pains, achy joints, nausea & all over malaise.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pruritus, Skin warm
Clinical narrative: Left upper arm is indurated and warm to touch. Arm is itchy. Intermittent shooting pains, achy joints, nausea & all over malaise.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Cellulitis, Injection site induration, Injection site pruritus, Injection site warmth
Clinical narrative: Left upper arm is indurated and warm to touch. Arm is itchy. Intermittent shooting pains, achy joints, nausea & all over malaise.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Malaise, Nausea, Pain in extremity
Clinical narrative: Left upper arm is indurated and warm to touch. Arm is itchy. Intermittent shooting pains, achy joints, nausea & all over malaise.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Polymyalgia rheumatica
Clinical narrative: Profound generalized weakness bilateral shoulder weakness
Age: 46.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Neuralgia, Paraesthesia
Clinical narrative: Patient stated flu shot was administered too high on right arm - feels it went into joint - right after shot he had tingling in right hand and has had persistent nerve pain since then.
Age: 46.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Arthralgia, Burning sensation, Drug administered at inappropriate site, Immediate post-injection reaction, Joint crepitation
Clinical narrative: Patient stated flu shot was administered too high on right arm - feels it went into joint - right after shot he had tingling in right hand and has had persistent nerve pain since then.
Age: 46.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Joint injury, Musculoskeletal discomfort, Pain, Sensory disturbance
Clinical narrative: Patient stated flu shot was administered too high on right arm - feels it went into joint - right after shot he had tingling in right hand and has had persistent nerve pain since then.
Age: 31.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Malaise, Myalgia
Clinical narrative: Malaise, myalgia & erythema one day post immunization. Treatment: supportive care.
Age: 42.0
Sex: M
Vaccine: FLU3, MMR, TDAP
Symptoms: Dyspnoea, Throat tightness, Wheezing
Clinical narrative: SOB, wheezing, throat closing after receiving Tdap / MMR. Note: pt had sx's at home not at clinic.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site reaction, Injection site warmth, Joint range of motion decreased
Clinical narrative: Initial redness, warmth, and tight at injection site that resolved after a few days, but since then having progressive inability to use that arm - unable to flex/extend shoulder or elbow, biceps & triceps very tight, possible dystonia.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Skin tightness
Clinical narrative: Initial redness, warmth, and tight at injection site that resolved after a few days, but since then having progressive inability to use that arm - unable to flex/extend shoulder or elbow, biceps & triceps very tight, possible dystonia.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Chest discomfort, Dizziness, Feeling abnormal, Hypersensitivity, Paraesthesia oral
Clinical narrative: Relates - lips tingling, fat feeling, dizziness, tunnel vision - chest tightness approx. 10 minutes post influenza vaccine. BENADRYL 50mg/PO. B/P 142/90 P 80 R-15 transported / wc to ED for observation. Prednisone in ED administered.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Tunnel vision
Clinical narrative: Relates - lips tingling, fat feeling, dizziness, tunnel vision - chest tightness approx. 10 minutes post influenza vaccine. BENADRYL 50mg/PO. B/P 142/90 P 80 R-15 transported / wc to ED for observation. Prednisone in ED administered.
Age: 1.03
Sex: F
Vaccine: MMRV
Symptoms: Pyrexia, Rash erythematous, Rash generalised
Clinical narrative: Fever x2 days. Rash x1 day. No treatment. >100 red spots - head to toe.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Patient experienced intense pain in the arm the immunization was given. The pain was so intense she wasn't even able to lift her arm past her head. Patient claims she went for physical therapy for the pain in her arm.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Headache, Malaise, Oropharyngeal pain, Pyrexia
Clinical narrative: Headache, malaise, sore throat, congestion, fever, and weakness.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Respiratory tract congestion
Clinical narrative: Headache, malaise, sore throat, congestion, fever, and weakness.
Age: 0.41
Sex: F
Vaccine: HIBV, OPV, PPV, RVX
Symptoms: Asthenia, Decreased interest, Diet refusal, Dyskinesia, Irritability
Clinical narrative: Loss of interest, lethargic, sleepy, fever, listlessness, change in personality, not as vibrant and energetic, bottom lip quivering, open and closing of mouth seeming involuntary, playing and twisting of tongue, fussiness and crankiness, moving lips, opening closing jaw, rapid breathing, rejection of food.
Age: 0.41
Sex: F
Vaccine: HIBV, OPV, PPV, RVX
Symptoms: Lethargy, Listless, Personality change, Pyrexia, Respiratory rate increased
Clinical narrative: Loss of interest, lethargic, sleepy, fever, listlessness, change in personality, not as vibrant and energetic, bottom lip quivering, open and closing of mouth seeming involuntary, playing and twisting of tongue, fussiness and crankiness, moving lips, opening closing jaw, rapid breathing, rejection of food.
Age: 0.41
Sex: F
Vaccine: HIBV, OPV, PPV, RVX
Symptoms: Somnolence
Clinical narrative: Loss of interest, lethargic, sleepy, fever, listlessness, change in personality, not as vibrant and energetic, bottom lip quivering, open and closing of mouth seeming involuntary, playing and twisting of tongue, fussiness and crankiness, moving lips, opening closing jaw, rapid breathing, rejection of food.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: 01/22/2013 Noticed redness and swelling the following morning with itching. That morning the area measured approx 2 inch dia to 6 inch diameter by the second day. The area still has redness, swelling, heat, and itch on 4th day 01/25/2013.
Age: 42.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site warmth, Nodule, Tenderness
Clinical narrative: Redness with heat at site approx 140mm x 70mm on left arm.  Approximately 2cm nodule left axilla and tender to touch.  Will see Physician today, 2-14-2013.
Age: 19.0
Sex: M
Vaccine: FLU3, HPV4
Symptoms: Fall, Head injury, Pallor, Syncope
Clinical narrative: Patient received two vaccines in the office; from the chart notes, it appears he received his flu vaccine prior to the provider seeing him, but they discussed the HPV vaccine.  Approximately 5 minutes after he received the HPV vaccine, he was leaving the clinic.  While leaving through the waiting room (accompanied by his mother), his mother noticed he became pale, started to take another step and immediately fell to the floor (syncope) and hit his head on a doorjam.  Pt. was brought back to an exam room where the physician examined him; patient rested for 15 minutes until he felt well enough to leave.  Provider gave follow-up instructions to patient/mother of concerns to report.  Pt reported to provider no problems with vaccines in the past other than some mild soreness.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Chills, Crying, Culture negative, Dizziness, Fatigue
Clinical narrative: Fatigue, which worsened as the day went on; headache; nausea; chills; temp 99.7; ringing in her ears, skin hypersensitive; leg pain; body aches; dizziness; crying uncontrollably; lightheadedness.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Hyperaesthesia, Nausea, Pain, Pain in extremity
Clinical narrative: Fatigue, which worsened as the day went on; headache; nausea; chills; temp 99.7; ringing in her ears, skin hypersensitive; leg pain; body aches; dizziness; crying uncontrollably; lightheadedness.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Streptococcus test negative, Tinnitus
Clinical narrative: Fatigue, which worsened as the day went on; headache; nausea; chills; temp 99.7; ringing in her ears, skin hypersensitive; leg pain; body aches; dizziness; crying uncontrollably; lightheadedness.
Age: 18.0
Sex: F
Vaccine: FLU3
Symptoms: Malaise, Syncope, Unresponsive to stimuli
Clinical narrative: Patient told me she was beginning to not feel well and then fainted while sitting in the chair. She was non responsive for approx. 1 minute then woke up. I held her in the chair while she was unresponsive. After she woke up, we had her lay flat and observed her until she felt better. Dad was present at this time.
Age: 74.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pruritus
Clinical narrative: Itching at injection site.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Urticaria
Clinical narrative: Full body hives.  Treated with Benadryl.
Age: 0.16
Sex: F
Vaccine: 6VAX-F, RV1
Symptoms: Crying, Irritability, Pyrexia, Screaming
Clinical narrative: Nonstop screaming and unconsolable crying lasting more than 4 hrs. Fever. Irritability.
Age: 0.35
Sex: F
Vaccine: DT, HIBV, IPV, PNC, RV5
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: No adverse events. Patient was given a DT vaccine instead of a DTaP vaccine. Parents were notified and mother brought daughter in this office for a DTaP vaccine.
Age: 1.52
Sex: F
Vaccine: HEPA
Symptoms: Rash
Clinical narrative: Received vaccine 2/8/13 developed rash. Went to ER on 2/10/13. Monitored, given BENADRYL & discharged.
Age: 0.27
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Crying
Clinical narrative: Child received immunizations at 1130am on 2/13/2013. Took nap, woke up crying at 1300 - crying non stop. Slept 30 minute nap, woke up crying - continues to cry. Gave TYLENOL at 1620pm, no change, still crying. Radio MD call - patient ordered MOTRIN at 1940pm per MD - (client came to clinic at 1840 to be seen for crying).
Age: 32.0
Sex: U
Vaccine: VARCEL
Symptoms: Chills, Erythema, Influenza like illness, Pain, Swelling
Clinical narrative: Pain, redness, swelling, chills. Influenza type illness/reaction. TX: IV antibiotics, oral antibiotics, IV BENADRYL, Prednisone.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Vomiting
Clinical narrative: Vomited 5 minutes after GARDASIL given.
Age: 11.0
Sex: F
Vaccine: FLU3, HEPA, MNQ, TDAP
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: 3 1/2 inch x 3 1/2 inch red area around injection site. Slight swelling 2cm at site of injection site "itches". Right arm - Hep A.
Age: 1.01
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Blister, Papule, Pyrexia, Rash pustular, Vaccination complication
Clinical narrative: Mild case of papules, pustules, vesicles on head, neck & trunk, low grade fever 100 degrees F, suspect from VARIVAX 1/21/13.
Age: 9.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Local reaction
Clinical narrative: Large local reaction on arm at injection site.
Age: 0.54
Sex: F
Vaccine: DT, HIBV, IPV, PNC, RV5
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: No adverse events. Patient was given a DT vaccine instead of a DTaP vaccine. Parents were notified and mother brought her daughter in the office for the DTaP.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Discomfort, Feeling cold, Injection site erythema, Injection site nodule
Clinical narrative: Patient started to notice a large welt/knot from her left shoulder 3/4 down to her elbow. Welt raised with redness. She did not feel sick - this started the evening of Feb 5th. Next day - 2/6/13 the redness peaks on Lt. arm Pt. iced arm & took ADVIL & a BENADRYL per Dr. on 2/7 Pt. states feeling cold with chills all day. Lt. upper arm improving slowly Pt. states still has uncomfortable feeling & now has itching but no numbness or tingling down arm. Pt. called reporting reaction & advised to come in for Dr. visit 2/8.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site urticaria, Pruritus
Clinical narrative: Patient started to notice a large welt/knot from her left shoulder 3/4 down to her elbow. Welt raised with redness. She did not feel sick - this started the evening of Feb 5th. Next day - 2/6/13 the redness peaks on Lt. arm Pt. iced arm & took ADVIL & a BENADRYL per Dr. on 2/7 Pt. states feeling cold with chills all day. Lt. upper arm improving slowly Pt. states still has uncomfortable feeling & now has itching but no numbness or tingling down arm. Pt. called reporting reaction & advised to come in for Dr. visit 2/8.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a quality control individual control individual at a medical facility refers to a patient of unknown age. On 01-NOV-2012, the patient was vaccinated with a dose of M-M-R II (lot # 0644AE, exp: 27-MAR-2014) (Dose and route were not reported). No other co-suspects were reported. No concomitant medications were reported. The reported called for a patient who were administered M-M-R II that was exposed to an unsupported temperature excursion (10.1C for 96 hours). No adverse effect reported. This is one of seven reports from the same source. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 29 year old female patient who on 29-SEP-2012 at 12:25 pm, was vaccinated intramuscularly in the deltoid with the dose of LIQUID PEDVAXHIB (lot# H012570, dose and expiration date not reported). The patient received LIQUID PEDVAXHIB in error when she was supposed to get an unspecified Hepatitis B Vaccine. There was no adverse event. This is one of several reports received from the same source (other patients are captured under MARRS # 1211USA004476, 1302USA004703 and 1302USA004705). Additional information is not expected.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a quality control individual at a medical facility refers to a patient of unknown age. On 16-NOV-2012, the patient was vaccinated with a dose of M-M-R II (lot # 0234AE, exp: 26-JAN-2014) (Dose and route were not reported). No other co-suspects were reported. No concomitant medications were reported. The reported called for a patient who were administered M-M-R II that was exposed to an unsupported temperature excursion (10.1C for 96 hours). No adverse effect reported. This is one of seven reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a quality control individual at a medical facility refers to a patient of unknown age. On 12-NOV-2012, the patient was vaccinated with a dose of M-M-R II (lot # 0234AE, exp: 26-JAN-2014) (Dose and route were not reported). No other co-suspects were reported. No concomitant medications were reported. The reported called for a patient who were administered M-M-R II that was exposed to an unsupported temperature excursion (10.1C for 96 hours). No adverse effect reported. This is one of seven reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a quality control individual at a medical facility refers to a patient of unknown age. On 15-NOV-2012, the patient was vaccinated with a dose of M-M-R II (lot # 0234AE, exp: 26-JAN-2014) (Dose and route were not reported). No other co-suspects were reported. No concomitant medications were reported. The reported called for a patient who were administered M-M-R II that was exposed to an unsupported temperature excursion (10.1C for 96 hours). No adverse effect reported. This is one of seven reports from the same source. Additional information has been requested.