chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: information has been received from a registered pharmacist concerning nine patients of unknown age and gender. On unspecified dates, the patients were vaccinated subcutaneously with a 0.65 ml ZOSTAVAX (frequency was not reported) (Lot #: H011427; Expiration date: 12-SEP-2013), that had been improperly stored, exposed to 40 F for 30 days. There were no adverse effects. follow up information has been received from pharmacist considering a 61 year old patient of unknown gender, who on 01-OCT-2012 was vaccinated with a dose of improperly stored ZOSTAVAX. Pharmacist reported that the vaccine excursion began on 26-SEP-2012, excursion was not discovered until 29-NOV-2012. This is one of several reports received from the same source (related MARRS numbers: 1212USA00449, 1212USA005678, 1212USA004579, 1212USA005680, 1212USA005681, 1212USA005682). Pharmacist reported that in the interim seven (not nine) patients were vaccinated with ZOSTAVAX that was improperly stored. Additional information is not expected.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This spontaneous report as received from a 70 years old female patient with high cholesterol refers to herself. She did not have drug reactions/allergies. The patient was vaccinated with ZOSTAVAX (lot number not provided) on 10-JAN-2010. No other co-suspects were reported, Concomitant medications included ZOCOR and simvastatin (manufacture unknown). Approximately in October 2011 the patient experienced shingles "14 months ago" lasting 3 weeks, outbreak happened on her hands and arms. On 08-DEC-2012 the patient experienced rash on her abdomen area going to her breast. Unspecified treatment was given for adverse event. The outcome of adverse events was unknown. The patient did not seek medical attention. Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Anogenital warts, Vaginitis bacterial
Clinical narrative: This spontaneous report as received from a physician refers to a 20 years old sexually active female patient with no known drug reactions or allergies. The patient was vaccinated with the first dose of GARDASIL (dose and lot # not reported) in June 2011, second dose of GARDASIL (dose and lot # not reported) in August 2012 and third dose of GARDASIL (dose and lot # not reported) on 17-DEC-2012. No other co-suspects were reported. No concomitant medications were reported. The physician reported that in July 2012, the patient went into the office for birth control check and yeast infection check. No yeast infection was found but the patient was diagnosed with bacterial vaginosis at that time. In August 2012 the patient was diagnosed with visible genital warts. The patient had trichloroacetic acid (TCA) treatment for condyloma HPV and was followed up with gyn specialists in January 2013. At the time of the report, the patient had not recovered. The relatedness for genital warts was unknown for GARDASIL. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: HEPA
Symptoms: Fatigue, Oedema mouth
Clinical narrative: This spontaneous report as received via a field representative from a physician refers to a 64 years old female patient. The patient was vaccinated with VAQTA (dose and lot number unknown, intramuscular) on 14-NOV-2012. No other co-suspects were reported. No concomitant medications were reported. On 21-NOV-2012 the patient experienced fatigue and swelling of the roof of the mouth which lasted for 10 days, 8 days after onset of therapy. It was further reported that the patient had come from another practice and it was noticed in her records that there were recommendations for her to receive VAQTA in 2/2010 and 8/2010, but the physician had no confirmation that the vaccine was actually administered. No treatment information was reported. The outcome of swelling of the roof of the mouth and fatigue was reported as recovered/resolved. The reporters relatedness for fatigue and swelling roof mouth is unknown for VAQTA. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Rash macular, Skin warm
Clinical narrative: This spontaneous report was received from a registered pharmacist concerning to a 71 years old female patient. On 11-DEC-2012, the patient was vaccinated subcutaneously with a dose of 0.65 ZOSTAVAX lot reported as H018088/Exp date: 04-JAN-2014. No other co-suspects were reported. No concomitant medications were reported. Pharmacist reported that the patient's injection arm was warm, and had multiple blotches. No treatment information was reported. The outcome of the event was reported as not recovered/not resolved. The relatedness for the event was unknown for ZOSTAVAX. Additional information has been requested.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Oral herpes
Clinical narrative: This spontaneous report as received from a 75 years old male patient regarding himself. The patients current conditions included cold sores on his mouth (which occurred every 3 months before vaccination) and allergy to NAPROXEN (reported as Neproxine). The patients medical history included precancerous skin growth. On 28-SEP-2011, the patient was vaccinated with a dose of ZOSTAVAX (lot # 671453/1057AA, expiry date was 05-OCT-2012 and dose was not reported) subcutaneously. No concomitant medications were reported. The patient went on to stated that the cold sores on his mouth appear now about every month since an unknown date in September 2011. No laboratory test was performed. The patient sought no medical attention and was treated with VALACICLOVIR HCL (reported as Valacyclvir). The outcome of the event was unknown. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Injection site reaction, Pyrexia
Clinical narrative: This spontaneous report was received from a physician via a company representative concerning a male patient of unknown age. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot number, expiry date, dose unspecified) intramuscularly. No concomitant medications were reported. On an unknown date, while on PNEUMOVAX 23, the patient experienced unspecified reaction at the injection site and fever. He sought an unspecified medical attention. The outcome of unspecified reaction at the injection site and fever was reported as resolving on therapy. The relatedness for unspecified reaction at the injection site and fever was unknown for PNEUMOVAX. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incomplete course of vaccination, Malaise
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with dose 1 of ROTATEQ (lot number and route unknown0. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient got sick shortly before the appointment to receive Dose 2 of ROTATEQ so the patient did not receive Dose 2. This occurred sometime in the past (unspecified date) and the patient never returned for Dose 2. The nurse reports that at the present time the patient is older than 32 weeks of age. So far the patient has received only one dose total of ROTATEQ and will not be receiving any further doses. Dose 1 of ROTATEQ was administered correctly according to the prescribing information. No treatment information was reported. The outcome of got sick and patient is unknown. The relatedness for got sick is unknown for ROTATEQ. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from Novartis and was assigned manufacturer report # PUS2012US134816 refers to an approximately 70 years old female patient. The patient was vaccinated with a dose of zoster vaccine live (manufacturer unknown) on an unspecified date.No other co-suspects were reported. No concomitant medications were reported. About a year ago, in approximately December 2011, the patient experienced reactions to the zoster vaccine live (manufacturer unknown). The patient felt she had shingles after getting the vaccine. At the time of the report, the patient's outcome was unknown. The relatedness for felt she had shingles after getting the vaccine was unknown for zoster vaccine live (manufacturer unknown). This was originally reported by a consumer. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to an unspecified number of patients of unknown ages. The patients were vaccinated with improperly stored doses 9exposed to 31.1 F for 8 hours 10 minutes) of LIQUID PEDVAXHIB (Lot # not reported) on an unspecified date. No known adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested,.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypertension
Clinical narrative: This spontaneous report was received from a non health professional (query pending) concerning a 69 year old female patient with no drug reactions/allergies. On 05-NOV-2012, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiration date, dose, route unspecified). Concomitant medication included 10 milligrams (mg) LIPITOR. Normally the patient had a blood pressure of 110-115 (units unspecified). On 14-NOV-2012 (reported as when she went to the doctor's office a few weeks after receiving the shot), she had high blood pressure of 143 (units unspecified). The patient did not seek any medical attention. No treatment was provided. The outcome of high blood pressure was unknown. No lab studies were performed. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Injection site reaction, Injection site swelling
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 60 years old female patient. The patient was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (lot # not reported) in September 2012. No other co-suspects were reported. No concomitant medications were reported. The medical assistant reported that a patient had a mild allergic reaction to ZOSTAVAX and an exaggerated injection site reaction the day following vaccination in September 2012. The medical assistant thought the reaction was anaphylactic, but then clarified that it was only an allergic reaction. The patient had swelling from the injection site down to elbow. The patient went to the health care professional and was given unspecified treatment. The outcome of the events was unknown. The relatedness for exaggerated injection site reaction and swelling from the injection site down to elbow was not provided for ZOSTAVAX. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: MMR
Symptoms: Rubella antibody positive
Clinical narrative: This spontaneous report was received from a registered nurse concerning to a 23 year old female patient. Nurse mentioned that on an unknown date, the patient was received MMR II or monovalent vaccine as rubella, mumps and measles as a child and then in 1988 the patient had a child and received a rubella vaccine post-partum. No other co-suspects were reported. No concomitant medications were reported. The nurse stated one vaccination record had a date next to MMR and another vaccination record had a date next to rubella, mumps, and measles therefore nurse did not know if the patient received the MMR II or monovalent vaccines, rubella, mumps and measles. No treatment information was reported. The patient had another child in 2005 and had a rubella titer that was positive in March 2005. The outcome of the event was unknown. Additional information has been requested.
Age: 30.0
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 30 years old patient. The patient was vaccinated with a dose of ZOSTAVAX (lot #, dose and route not reported) on 14-DEC-2012. No other co-suspects were reported. No concomitant medications were reported. The nurse reported that possibly a 30 year old patient received a dose of ZOSTAVAX instead of influenza virus vaccine (manufacturer unknown) due to a human error. No adverse effect was reported. Additional information has been requested.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Burning sensation, Erythema, Pain in extremity
Clinical narrative: This spontaneous report was received regarding a 77 year old consumer from his wife. Patient had no drug reactions or allergies. Concurrent condition of the patient included an unspecified cardiac disorder. On 22-AUG-2012, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose, route unspecified). Concomitant medications included unspecified cardiac medications. On 09-DEC-2012, the patient experienced redness, burning, pain and blisters that developed on both his legs. The patient went to dermatologist. He was treated with prednisone and bacitracin zinc, neomycin sulfate, POLYSPORIN. No laboratory diagnostic tests were performed. The outcomes of redness, burning, pain and blisters that developed on both his legs were unknown. The relatedness for redness, burning, pain and blisters that developed on both his legs was unknown for ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse concerning a patient of unknown age and gender. On 10-DEC-2012, the patient was vaccinated subcutaneously with an expired dose of 0.65 milliliter ZOSTAVAX (lot number 671018/0748AA and expiry date 18-AUG-2012). No concomitant medications were reported. No adverse effect was reported. Additional information is not expected.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Erythema, Oedema peripheral
Clinical narrative: This spontaneous report was received from a company representative concerning a 5 year old 9reported as 5 years and 2 months of age) female patient. On 03-DEC-2012, the patient was vaccinated with a dose of VARIVAX (lot number reported as 11011416, expiry date unspecified) (dose, route unspecified). No concomitant medications were reported. On 03-DEC-2012, the patient developed 2 vesicles on the arm swollen and red, a few hours after the administration of the vaccine. Patient sought medical attention (unspecified). She was treated with TYLENOL. It was unspecified if the laboratory diagnostic tests were performed. The outcomes of the events were unknown. Additional information has been requested.
Sex: F
Vaccine: PER, VARZOS
Symptoms: Injection site pruritus
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse concerning to a female patient of unknown age. A nurse told that the patient was administered ZOSTAVAX (dose, route and lot not reported) and an unspecified pertussis vaccine (unspecified) (manufacturer unspecified) at the same arm. No concomitant medications were reported. The patient developed itching at the injection sites. The outcome of the event was unknown. The relatedness for the event was unknown for ZOSTAVAX. Additional information is not expected.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Deafness unilateral, Ear disorder, Hearing aid user, Herpes zoster oticus
Clinical narrative: This spontaneous report was received from a 74 years old male patient with arthritis and atrial fibrillation, drug reactions or allergies to some shots and possible flu shot (MARRS # 1212USA009006). The patient noted he was administered ZOSTAVAX (dose, route and lot not reported) on 13-OCT-2009 and on 19-NOV-2009. No other co-suspects were reported. Concomitant medications included COUMADIN and CELEBREX. The patient had a gurgling in his right ear and the ear shut down. He developed a herpes infection of the nerve in the right ear. He lost hearing in the right ear and now uses a hearing aid. The patient was treated by a physician with oral antivirals and an antiviral injection in the ear. The patient status at the time of the phone call was unknown. The outcome of the events was reported as not recovered/not resolved. The relatedness for the events was unknown for ZOSTAVAX. Upon internal review lost in hearing in the right ear was considered medically significant. This is one report of several reports from the same source. Additional information has been requested.
Age: 19.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Pain
Clinical narrative: The patient reports that with every anthrax vaccination he developed flu-like symptoms that lasted 3-5 days. He also experienced a large local reaction, diarrhea, vomiting and joint pain. When he received vaccination # 2 he still had lingering joint pain from the previous dose. He also reports that he developed increasingly severe generalized joint pain with each subsequent dose as well as cognitive deficits which never resolved beginning after the 2nd shot. He sought no treatment and took no medications. After the 2004 dose, given with the smallpox vaccine, daily fatigue and tinnitus started. He reports that currently he continues with the original symptoms of arthralgias, cognitive deficits, and fatigue. He has subsequently developed multiple additional systemic symptoms over time that prevent him from obtaining full-time employment. He currently reports migraine headaches, hyperhidrosis, dyspnea on exertion, diarrhea, lightheadedness, post exertional malaise and significant joint pain in the knees, ankles, shoulders and hips that affect functioning. Most of these symptoms are documented in his Mar '12 records.
Age: 19.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Activities of daily living impaired, Amnesia, Arthralgia, Cognitive disorder, Diarrhoea
Clinical narrative: The patient reports that with every anthrax vaccination he developed flu-like symptoms that lasted 3-5 days. He also experienced a large local reaction, diarrhea, vomiting and joint pain. When he received vaccination # 2 he still had lingering joint pain from the previous dose. He also reports that he developed increasingly severe generalized joint pain with each subsequent dose as well as cognitive deficits which never resolved beginning after the 2nd shot. He sought no treatment and took no medications. After the 2004 dose, given with the smallpox vaccine, daily fatigue and tinnitus started. He reports that currently he continues with the original symptoms of arthralgias, cognitive deficits, and fatigue. He has subsequently developed multiple additional systemic symptoms over time that prevent him from obtaining full-time employment. He currently reports migraine headaches, hyperhidrosis, dyspnea on exertion, diarrhea, lightheadedness, post exertional malaise and significant joint pain in the knees, ankles, shoulders and hips that affect functioning. Most of these symptoms are documented in his Mar '12 records.
Age: 19.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Dizziness, Dyspnoea exertional, Fatigue, Full blood count, Hyperhidrosis
Clinical narrative: The patient reports that with every anthrax vaccination he developed flu-like symptoms that lasted 3-5 days. He also experienced a large local reaction, diarrhea, vomiting and joint pain. When he received vaccination # 2 he still had lingering joint pain from the previous dose. He also reports that he developed increasingly severe generalized joint pain with each subsequent dose as well as cognitive deficits which never resolved beginning after the 2nd shot. He sought no treatment and took no medications. After the 2004 dose, given with the smallpox vaccine, daily fatigue and tinnitus started. He reports that currently he continues with the original symptoms of arthralgias, cognitive deficits, and fatigue. He has subsequently developed multiple additional systemic symptoms over time that prevent him from obtaining full-time employment. He currently reports migraine headaches, hyperhidrosis, dyspnea on exertion, diarrhea, lightheadedness, post exertional malaise and significant joint pain in the knees, ankles, shoulders and hips that affect functioning. Most of these symptoms are documented in his Mar '12 records.
Age: 19.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Influenza like illness, Laboratory test, Local reaction, Malaise, Migraine
Clinical narrative: The patient reports that with every anthrax vaccination he developed flu-like symptoms that lasted 3-5 days. He also experienced a large local reaction, diarrhea, vomiting and joint pain. When he received vaccination # 2 he still had lingering joint pain from the previous dose. He also reports that he developed increasingly severe generalized joint pain with each subsequent dose as well as cognitive deficits which never resolved beginning after the 2nd shot. He sought no treatment and took no medications. After the 2004 dose, given with the smallpox vaccine, daily fatigue and tinnitus started. He reports that currently he continues with the original symptoms of arthralgias, cognitive deficits, and fatigue. He has subsequently developed multiple additional systemic symptoms over time that prevent him from obtaining full-time employment. He currently reports migraine headaches, hyperhidrosis, dyspnea on exertion, diarrhea, lightheadedness, post exertional malaise and significant joint pain in the knees, ankles, shoulders and hips that affect functioning. Most of these symptoms are documented in his Mar '12 records.
Age: 19.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Pain, Sleep disorder, Tinnitus, Vomiting, X-ray limb normal
Clinical narrative: The patient reports that with every anthrax vaccination he developed flu-like symptoms that lasted 3-5 days. He also experienced a large local reaction, diarrhea, vomiting and joint pain. When he received vaccination # 2 he still had lingering joint pain from the previous dose. He also reports that he developed increasingly severe generalized joint pain with each subsequent dose as well as cognitive deficits which never resolved beginning after the 2nd shot. He sought no treatment and took no medications. After the 2004 dose, given with the smallpox vaccine, daily fatigue and tinnitus started. He reports that currently he continues with the original symptoms of arthralgias, cognitive deficits, and fatigue. He has subsequently developed multiple additional systemic symptoms over time that prevent him from obtaining full-time employment. He currently reports migraine headaches, hyperhidrosis, dyspnea on exertion, diarrhea, lightheadedness, post exertional malaise and significant joint pain in the knees, ankles, shoulders and hips that affect functioning. Most of these symptoms are documented in his Mar '12 records.
Age: 62.0
Sex: M
Vaccine: FLUX
Symptoms: Influenza like illness, Rhinorrhoea, Sneezing
Clinical narrative: Started sneezing uncontrollably w/runny nose excreting lots of mucus like during a severe cold. General feeling like having a the flu.
Age: 1.14
Sex: M
Vaccine: FLU3, HEPA, PNC13, VARCEL
Symptoms: Injection site pain, Injection site reaction, Subcutaneous nodule
Clinical narrative: Developed tender, subcutaneous nodules both thighs where he had been given vaccines. Pt's twin received the same vaccines but had no reaction.
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: Irritability, Malaise, Pyrexia, Rash, Rash generalised
Clinical narrative: Has a low grade to mid grade fever up to 101.6 and generalized rash raised to chest & back. Irritability & malaise also.
Age: 1.56
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: Patient received Dtap vaccine 12/20/12 at approx 2:15pm. Parent reports early evening, hard lump developed at injection site and later evening erythema surrounded lump approx 2 inches in diameter. Reported 12/21/12 am to pediatrician. Borders marked with pen per RN advice. No oozing from site or drainage or fever present. Mom instructed to use warm compresses & light massage to knot area and return for appt if redness enlarged or fever or oozing developed.
Age: 0.31
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13
Symptoms: Injection site rash, Irritability
Clinical narrative: Rash on left thigh and fussy after immunizations.
Age: 22.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Hyperhidrosis, Panic attack, Vision blurred
Clinical narrative: Pt appeared to be having a reaction: sweating, blurred vision, dizziness. Administered EPIPEN. EMTs interviewed him. He was feeling better. It was decided that it was a panic attack, not a rxn to vaccine.
Age: 46.0
Sex: F
Vaccine: HEP
Symptoms: Culture, Erythema multiforme
Clinical narrative: Patient developed erythema multiforme post injections.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Paraesthesia, Paraesthesia oral
Clinical narrative: Patient experienced tingling in hands. Tingling sensation and numbness traveled to fingers. Patient then complained of tingling in lips. MD was trying to be contacted when tingling was in hands. Administered EPIPEN when reaction traveled to mouth, lips & 911 was called.
Age: 52.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Breast pain, Pain in extremity
Clinical narrative: Pt reports pain in right arm pt that spread to right breast then to left breast. Pt is unsure if vaccine is the cause, but pain has not subsided.
Age: 9.0
Sex: F
Vaccine: HEPA
Symptoms: Papule, Urticaria
Clinical narrative: Facial/systemic hives w/papules gave BENADRYL and MEDROL.
Age: 46.0
Sex: M
Vaccine: TDAP
Symptoms: Myocarditis
Clinical narrative: Myocarditis.
Age: 10.0
Sex: M
Vaccine: FLU3
Symptoms: Axillary pain, Erythema, Pain, Swelling
Clinical narrative: Pt c/o of swelling, pain and pain with movement, redness, and left sided armpit pain.
Age: 29.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Chills, Diarrhoea, Dyspnoea, Heart rate decreased
Clinical narrative: Chills, sweats, difficulty breathing, joint pain and stiffness, diarrhea.  Went to GP on 12/17.  BP was low, pulse was low.
Age: 29.0
Sex: M
Vaccine: TDAP
Symptoms: Hyperhidrosis, Hypotension, Joint stiffness
Clinical narrative: Chills, sweats, difficulty breathing, joint pain and stiffness, diarrhea.  Went to GP on 12/17.  BP was low, pulse was low.
Age: 23.0
Sex: F
Vaccine: ANTH, SMALL, TYP
Symptoms: Blood creatine phosphokinase, Chest pain, Dyspnoea, Electrocardiogram, Laboratory test
Clinical narrative: A day after vaccination, I began to have a hard time breathing and chest pain. My parents drove me to the hospital- Emergency Room. I was admitted and given muscle relaxers and pain medication. They drew labs, also. They said the the lining of my chest and lungs has swelled.
Age: 23.0
Sex: F
Vaccine: ANTH, SMALL, TYP
Symptoms: Swelling
Clinical narrative: A day after vaccination, I began to have a hard time breathing and chest pain. My parents drove me to the hospital- Emergency Room. I was admitted and given muscle relaxers and pain medication. They drew labs, also. They said the the lining of my chest and lungs has swelled.
Age: 26.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site pruritus, Injection site reaction, Injection site urticaria, Rash erythematous
Clinical narrative: This 26 year old was referred for site reaction after receipt of AVA vaccine and assistance in VAERS filing. Prior AVA vaccines were given 1/11/11, 2/11/11, 7/12/11, and 6/18/12 with soreness to site and arm for 1-2 days. He received AVA #5 to left deltoid on 12/17/12 (AVA FAV 309) - this was given 6 months from previous dose (per AVA schedule).  He denied any trauma, exercising or injury to left deltoid. Approximately 24 hours after receipt of AVA vaccine, the vaccine site began to itch. On day 2 (12/19/12) the vaccine site had a "2.5 inch circular red raised rash".  He presented to medical and was diagnosed with urticaria lesion to left shoulder. Pt had not been taking any medication for the itching or site redness and advised provider he did not want/require Benadryl or topical steroid cream at this time (does not like to take medication unless needed). Pt advised on 12/20/12 the sited was still red but not as severe as yesterday. (Picture sent by pt...see below). Denied any contact with new clothing, detergents, deodorants, soaps, was not hiking, around animals, no new foods, no recent exercise/trauma to arm.
Age: 54.0
Sex: M
Vaccine: FLUX, MM, TDAP
Symptoms: Arthralgia, Oropharyngeal pain, Pruritus, Rash
Clinical narrative: Itching on hands; Rash on back and chest; Sore Throat; soreness of the joints. Symptons still evident after 6 days.
Age: 23.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, Malaise
Clinical narrative: Patient states her left arm was swollen, red, warm to the touch, and itchy below shoulder and above elbow.  Patient also states she felt sick that evening and had a couple episodes of vomiting.
Age: 23.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Vomiting
Clinical narrative: Patient states her left arm was swollen, red, warm to the touch, and itchy below shoulder and above elbow.  Patient also states she felt sick that evening and had a couple episodes of vomiting.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia
Clinical narrative: Beginning a week after the flu vaccination, I experienced arthritis-like pain in the upper left arm and shoulder. About a month after the vaccination the pain spread to tenderness in the joints of my left thumb. I have no history of prior arthritic pain.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Impaired healing, Injection site discharge, Injection site erythema, Injection site vesicles
Clinical narrative: Injection site with approx 2 cm "blister" filled with serous drainage, surrounded by reddened area, perhaps as large as 10 cm. Reported light-headed and near-syncope. Afebrile. Taken to ARNP in clinic. He did not feel that near-syncope was related to vaccine and referred pt to ER. See in ER by Dr., who also stated that there was probably no relation between local reaction on arm and near-syncope. Patient has apparently been treating wound on left arm at home and recently visited Dr. due to non-healing. He anticipates several weeks of treatment to wound.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Local reaction, Presyncope
Clinical narrative: Injection site with approx 2 cm "blister" filled with serous drainage, surrounded by reddened area, perhaps as large as 10 cm. Reported light-headed and near-syncope. Afebrile. Taken to ARNP in clinic. He did not feel that near-syncope was related to vaccine and referred pt to ER. See in ER by Dr., who also stated that there was probably no relation between local reaction on arm and near-syncope. Patient has apparently been treating wound on left arm at home and recently visited Dr. due to non-healing. He anticipates several weeks of treatment to wound.
Age: 15.0
Sex: F
Vaccine: FLUN3
Symptoms: Eyelid oedema
Clinical narrative: Swollen left eyelid. Applied cold compress.
Age: 1.04
Sex: M
Vaccine: DTAP, MMR, PPV
Symptoms: Pyrexia
Clinical narrative: Fever 102.4 F/ 39.1 C lasting 3 1/2 days.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: L deltoid red/tender, swollen, feverish to touch. Measuring approx. 8"X2.5" Fever 101, per clt. All S&S much decreased upon conversation w/ clt. on 12/20/2012, after using alternating moist heat/cold pks, ibuprofen and Keflex X 3 days.
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Erythema, Warmth, Pain to site of injection (Cellulitis).
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Urticaria
Clinical narrative: Hives on right leg.
Age: 0.71
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC
Symptoms: Crying, Hypersomnia, Irritability
Clinical narrative: "Parents brought their 8 months old baby for 3rd shots. Said she felt well today. She was a client, but they didn't like their provider. When asked if baby had problems with shots before, they said that she had trembling of her hands after she was given 1st and 2nd set of shots.  Info on Pentacel, Prevnar and Hep B was given.  Explained that baby's leg will be sore and she might have fever. They said that facility never told them about Prevnar vaccine.  No other complains of problems with vaccines was voiced.  No antibiotics were mentioned during immunization interview".  Mother called (11/7/12) and spoke to this nurse stating child slept most of yesterday 11/6/12. She was fine but very cranky, more cranky than usual and was crying on and off all day.  Was told to give her Tylenol and cool compresses to leg. Also told her to call her dcotor.  Try to call her several days later was unable to,  finally was able to contact mother a few weeks later and she said baby was fine.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Fatigue, Oedema peripheral, Pain, Pyrexia, Urticaria
Clinical narrative: Soreness; Fever; Hives on arm; swelling of arm; Extreme Fatigue.
Age: 0.51
Sex: F
Vaccine: DTAPIPVHIB, FLU3, HEP, RV5
Symptoms: Allergy test, Radioallergosorbent test, Urticaria
Clinical narrative: Infant broke out in hives all over body. Began an hour after the vaccinations and still continues through the present time a week later. Infant receiving Benadryl.
Age: 19.0
Sex: M
Vaccine: TTOX
Symptoms: Dizziness, Head injury, Hyperhidrosis, Local swelling, Neck pain
Clinical narrative: Donor had just recieved shot 15 min prior to him feeling faint and then landing on the floor where he hit his head. He got up and walked to the office. He then was very sweaty and had a large bump on the back of his head and stated that his neck hurt. EMS was called and an IV was started. Donor was responsive to the saline how ever EMS was concerned about his neck, so he was transported to the hospital for further evaluation.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Chills, Feeling hot, Pyrexia
Clinical narrative: Fever  >101; chills/ hot; arthralgia.
Age: 1.57
Sex: M
Vaccine: PPV
Symptoms: C-reactive protein increased, Febrile convulsion, Injection site movement impairment, Injection site oedema, Injection site reaction
Clinical narrative: 3-4 hrs postvaccination, he had febrile seizure with Tempt of 106 and cervical lymphadenopathy. Next morning refused to bear weight on his right leg nor straighten his leg. Fever never went away.
Age: 1.57
Sex: M
Vaccine: PPV
Symptoms: Lymphadenopathy, Myositis, Nuclear magnetic resonance imaging abnormal, Panniculitis, Pyrexia
Clinical narrative: 3-4 hrs postvaccination, he had febrile seizure with Tempt of 106 and cervical lymphadenopathy. Next morning refused to bear weight on his right leg nor straighten his leg. Fever never went away.
Age: 1.57
Sex: M
Vaccine: PPV
Symptoms: Weight bearing difficulty, White blood cell count normal
Clinical narrative: 3-4 hrs postvaccination, he had febrile seizure with Tempt of 106 and cervical lymphadenopathy. Next morning refused to bear weight on his right leg nor straighten his leg. Fever never went away.
Age: 1.03
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Diagnosed with varicella.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Headache, Influenza like illness, Oedema peripheral, Pain
Clinical narrative: PATIENT REPORTS/DEMONSTRATES RED SWOLLEN ARM (DARK BAND AROUND ARM-BELOW INJECTION SITE), REDNESS FROM SHOULDER TO ELBOW, (BLOTCHY NOT NECESSARILY AT THE INJECTION SITE), HEADACHE, FLU-LIKE SYMPTOMS, PAIN WHEN ARM IS RAISED.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Rash macular
Clinical narrative: PATIENT REPORTS/DEMONSTRATES RED SWOLLEN ARM (DARK BAND AROUND ARM-BELOW INJECTION SITE), REDNESS FROM SHOULDER TO ELBOW, (BLOTCHY NOT NECESSARILY AT THE INJECTION SITE), HEADACHE, FLU-LIKE SYMPTOMS, PAIN WHEN ARM IS RAISED.
Age: 4.0
Sex: F
Vaccine: FLUX
Symptoms: Aphagia, Drooling, Fluid intake reduced, Glossodynia, Muscle disorder
Clinical narrative: Face started to look like she had a stroke on or near Monday evening 11/26/2012 but I wasn't sure. She was complaining of tooth and tongue pain and then no pain a day later. I thought she was having a tooth ache or teeth coming in. Then I noticed she would not eat or drink because of poor muscle movement and facial control. She drooled when she drank and could barely drink from a straw - partial facial paralysis.
Age: 4.0
Sex: F
Vaccine: FLUX
Symptoms: Toothache, VIIth nerve paralysis
Clinical narrative: Face started to look like she had a stroke on or near Monday evening 11/26/2012 but I wasn't sure. She was complaining of tooth and tongue pain and then no pain a day later. I thought she was having a tooth ache or teeth coming in. Then I noticed she would not eat or drink because of poor muscle movement and facial control. She drooled when she drank and could barely drink from a straw - partial facial paralysis.
Age: 10.0
Sex: F
Vaccine: HPV4
Symptoms: Rash erythematous, Vaccination complication
Clinical narrative: Noticed some red spots on her chest and face. They kept getting worse as the night went on. Thought it was chicken pox, called the after hours dr. phone number and they said it was probably a reaction to the vaccine and prescribed Benadryl.
Age: 30.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Given 12/17 developed chills that evening. 12/18 fever of 103, pain and swelling at site. Same symptoms 12/19. 12/20 102 fever, continued pain, redness and swelling. MD appt 12/21 tx KEFLEX 500mg qid x 10 days as of 12/21 at appt. Pain and fever swelling less.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Feeling hot, Malaise, Rash generalised, Rosacea
Clinical narrative: Pt became ill and warm all over. He described a rosacea-like rash on chest, armpit, face, neck & back. Pt still had rash on 12/19/12. On 12/20/12 pt was back to normal. Pt saw his practitioner on 12/18/12 & suggest he should take diphenhydramine.
Age: 60.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Myalgia, Pyrexia, Vomiting
Clinical narrative: Chills, myalgia, fever, vomiting x3 days.
Age: 54.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: C/O (L) arm pain and swelling from injection site ((L) deltoid) to elbow. Area is red & warm. Pt advised to go to ER & apply cold pack.
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Feeling hot, Hypoaesthesia
Clinical narrative: About 5 mins after admin, pt felt hot in face and ears. Feet started to feel numb. Resolved in approx. 10-15 mins.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site rash
Clinical narrative: Rash at site of injection only x 6 days.
Sex: F
Vaccine: FLU3
Symptoms: Dysgeusia, Headache, Throat irritation, Wheezing
Clinical narrative: About 15-20 minutes after injection, complained of wheezy, scratchy throat with metallic taste. Also complained of headache.
Sex: F
Vaccine: FLU3
Symptoms: Feeling abnormal, Influenza, Influenza A virus test positive, Vaccination failure
Clinical narrative: This case was reported by a consumer (GSK employee) and described the occurrence of influenza a in an adult female subject who was vaccinated with FLUARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. In October 2012 the subject received a dose of FLUARIX (unknown details). On 14 December 2012, within months of vaccination with FLUARIX, the subject experienced influenza a, feeling miserable and vaccination failure ("lack of effect"). The subject stated that she had "just tested positive for A/flu (rapid test)" and that she feels "absolutely miserable." This case was assessed as medically serious by GSK. Relevant test results included influenza a virus test positive on 14 December 2012. At the time of reporting the outcome of the events were unspecified.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Injection site rash, Lethargy, Nausea, Pain
Clinical narrative: Rash at injection site 1 day after shot. Dizzy, nauseous, achy, lethargic 4 days after injection and remains this way for 1-2 wks.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Culture stool negative, Diarrhoea, Full blood count abnormal, Haematochezia, Occult blood positive
Clinical narrative: Initial information has been received from a pharmacist concerning his son, a 2 months old male patient, with no pertinent medical history or drug reaction / allergies. On 27-NOV-2012, the patient was vaccinated with ROTATEQ. No other co-suspects were reported. Concomitant medications included: VITAMIN D3. On 05-DEC-2012, the patient developed hematochezia after receiving a first dose of ROTATEQ. The patient had loose stools that contain a varying amount of blood. The reporter stated that the patient had been having bloody stools for one and one half weeks post vaccination with ROTATEQ. The patient had a complete blood cell count that showed an elevated white blood cell count, a stool culture that was negative and an occult blood test that was positive. No treatment information was reported. At the time of report, the patient had not recovered. It was reported that the patient sought medical attention. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: White blood cell count increased
Clinical narrative: Initial information has been received from a pharmacist concerning his son, a 2 months old male patient, with no pertinent medical history or drug reaction / allergies. On 27-NOV-2012, the patient was vaccinated with ROTATEQ. No other co-suspects were reported. Concomitant medications included: VITAMIN D3. On 05-DEC-2012, the patient developed hematochezia after receiving a first dose of ROTATEQ. The patient had loose stools that contain a varying amount of blood. The reporter stated that the patient had been having bloody stools for one and one half weeks post vaccination with ROTATEQ. The patient had a complete blood cell count that showed an elevated white blood cell count, a stool culture that was negative and an occult blood test that was positive. No treatment information was reported. At the time of report, the patient had not recovered. It was reported that the patient sought medical attention. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Rash macular
Clinical narrative: Next day underarm red, splotch. Took BENADRYL and ice to area.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Heart rate increased, Insomnia
Clinical narrative: Case number PHEH2012US025005 is an initial spontaneous report received from a pharmacist on 14 Dec 2012. This case refers to a 48-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1207201) intramuscularly on 13 Dec 2012. Few hours later, she began to experience an accelerated heart rate that resulted in not being able to sleep. The reporter stated that this patient was not familiar to her, so the reporter does not know if the patient had any underlying health condition that might have contributed to this event. The events were ongoing at the time of this report. No other information was reported.
Age: 46.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain in extremity, Rash macular
Clinical narrative: 12/18/12 vaccine given 12/18/12 pm c/o (L) arm sore, red blotches.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site reaction, Lymph node pain, Lymphadenopathy, Macular oedema
Clinical narrative: Round, erythematous, macular edema measuring approximately 5 inches diameter on left anterior upper thigh. Inguinal lymph node enlargement, tenderness left side. After 48 hours patient treated with ORAPRED PO BID. Symptoms resolved at follow-up after 24 hours ORAPRED.
Age: 40.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Injection site erythema, Injection site pain, Injection site streaking
Clinical narrative: Pain and erythema at immunization area and streaking down arm. Patient returns to clinic 12/21/12 and treated with BENADRYL & KEFLEX. Patient will return for f/u.
Age: 38.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Anti-cyclic citrullinated peptide antibody positive, Polyarthritis, Rheumatoid factor positive, Synovitis, X-ray normal
Clinical narrative: Polyarthritis hands, feet about 4 wk after MMR. Has positive Rheumatoid Factor and positive anti-CCP. Synovitis in wrists 4 wks after onset.
Age: 40.0
Sex: F
Vaccine: HEPA
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Hepatitis A vaccine given that was expired in 2010. Patient has had no adverse reaction to date.
Age: 1.03
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a consumer refers to her daughter a 1 years old female patient with no drug reactions or allergies and no pertinent medical history, who on 10-DEC-2012, was vaccinated with PROQUAD (dose, route and lot # not provided). Other suspect therapies included on 10-DEC-2012 varicella virus vaccine live (unspecified0 (dose, route and lot # not provided). No concomitant medications were reported. The consumer stated that a her daughter was concomitantly vaccinated with PROQUAD and varicella virus vaccine live (unspecified). The consumer reported that her daughter was perfectly fine. No adverse event to report. The patient did not sought medical attention and did not received any treatment for adverse event. Additional information has been requested.
Age: 67.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist concerning a 67 year old healthy patient of unknown gender with no pertinent medical history. On 11-DEC-2012, the patient was vaccinated with a first dose of GARDASIL (lot number and expiry date were reported as H015863 and 24-FEB-2015 respectively) that was exposed to 74 degree Fahrenheit (reported as 74F) for 5 days (dose, route unspecified) by the registered nurse. No concomitant medications were reported. No adverse effect was observed or reported. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Amnesia, Aphagia, Fatigue, Malaise, Maternal exposure during pregnancy
Clinical narrative: Information has been received from a consumer, for GARDASIL, a Pregnancy Registry product, concerning a 26 years old female patient with no pertinent medical history and no drug reactions or allergies who was vaccinated with a dose of GARDASIL on 08-SEP-2012 (lot #, dose and site of administration were not provided). No other co-suspects were reported. No concomitant medications were reported. On 09-SEP-2012, the consumer stated that after the administration of GARDASIL, she experienced soreness in her arm, short term memory, fatigue, and not able to eat. She has also really sick for 2 to 3 months. No treatment was given for the adverse events. No lab diagnostic test was performed. The patient did not seek medical attention. The patient LMP and EDD were not provided. At the time of the report, the patient outcome was unknown. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a consumer, for GARDASIL, a Pregnancy Registry product, concerning a 26 years old female patient with no pertinent medical history and no drug reactions or allergies who was vaccinated with a dose of GARDASIL on 08-SEP-2012 (lot #, dose and site of administration were not provided). No other co-suspects were reported. No concomitant medications were reported. On 09-SEP-2012, the consumer stated that after the administration of GARDASIL, she experienced soreness in her arm, short term memory, fatigue, and not able to eat. She has also really sick for 2 to 3 months. No treatment was given for the adverse events. No lab diagnostic test was performed. The patient did not seek medical attention. The patient LMP and EDD were not provided. At the time of the report, the patient outcome was unknown. Additional information has been requested.