chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Insomnia, Migraine, Syncope
Clinical narrative: This spontaneous report as received from an office manager refers to a 14 years old female patient with asthma. The patient was vaccinated with 3 doses of GARDASIL (lot# not reported) on 16-JUN-2009, 19-AUG-2009 and 18-DEC-2009, respectively. Concomitant medications included ZYRTEC, SINGULAIR, PULMICORT, SYMBICORT, VERAMYST and doxycycline. Since receiving GARDASIL, the patient had experienced migraines, fainting spells and could not sleep. The patient was hospitalized at some point but there was no information about the hospitalization or the name of the hospital. The patient contacted the physician. The outcome of migraines, fainting spells and could not sleep was reported as not recovered. The relatedness for migraines, fainting spells and could not sleep was unknown for GARDASIL. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a patient's mother refers to a 11 years old female patient who on an unknown date was improperly vaccinated with the 3rd dose of GARDASIL (dose, route and lot # not reported). No other co-suspects were reported. No concomitant medications were reported. The reporter stated that the patient was given the vaccine a month earlier outside of the recommended specification from the Pl. The patient did not seek medical attention. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Incorrect route of drug administration
Clinical narrative: This spontaneous report as received from a consumer refers to her niece. May be a week ago approximately on 11-DEC-2012 the patient was vaccinated subdermally with the first dose of GARDASIL (lot # not reported). 3 injections would be given over 6 months. May be a week ago approximately on 11-DEC-2012 after getting the first dose of vaccination the patient felt dizzy. No treatment was given for the event. The patient did not seek medical attention. The outcome of dizzy was unknown. Additional information is not expected.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Redness at site - about 3 inches diam itches, tender, hot.
Age: 1.06
Sex: F
Vaccine: FLU3, MMR, PNC, VARCEL
Symptoms: Skin lesion, Urticaria
Clinical narrative: Urticarial lesions present on abdomen and face.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site nodule, Injection site pruritus, Injection site swelling
Clinical narrative: Shortly after receiving the shot, she noticed a small knot at site & itching. Shot was given on top of tattoo which she thought was the problem. Patient treated with calamine lotion, is still having itching & small swelling.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site pain, Mobility decreased, Neck pain, Pain
Clinical narrative: This spontaneous report as received from a 50 years old female consumer with no pertinent medical history and no drug reactions or allergies refers to herself. 3 weeks ago on approximately 20-NOV-2012 the patient was vaccinated with ZOSTAVAX (lot # not reported intramuscularly not subcutaneously prevention of shingles. Concomitant medications included AMBIZ, CELEXA and multiple vitamins. It was reported 3 weeks ago on approximately 20-NOV-2012 the patient felt an immediate shot pain from the injection site up to her neck area. She stated her arm and neck area felt as though it was frozen in position and it was hard and painful to move her left arm. No lab diagnostics studies were performed. The patient sought medical attention through office visit. At the time of report, the outcome of the events was unknown. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discolouration, Injection site erythema
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 73 years old female patient with no drug allergy and no pertinent medical history. The patient was vaccinated with! vial of ZOSTAVAX (lot# reported as H017448,Exp 20-DEC-2012) subcutaneous on 30-NOV-2012. No other co-suspects were reported. Concomitant medications included DIOVAN, vitamins (unspecified) and fish oil. On approximately 14-DEC-2012, 2 weeks after the vaccination, the reporter stated that patient developed redness at the injection site after receiving a dose of ZOSTAVAX. The site was red but now it was getting better. The color of the injection site is now more "purple" than red. There was no treatment information and no lab information for the event. The patient had sought medical attention via saw the pharmacist. The outcome was reported as recovering. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a 80 years old female patient who had a medical condition of bronchiectasis. Patient had received her second dose of PNEUMOVAX 23 and developed an injection site reaction. Patient received her first dose of PNEUMOVAX 23 (Lot #, dose, route unspecified) on 18-OCT-2007, and she received a second dose of PNEUMOVAX 23 (in her left arm, Lot # reported as H018441, exp 28-FEB-2014, dose, route unspecified) on 19-DEC-2012. Patient called the practice on 21-DEC-2012 to state that she had some swelling in her left arm, but "it is getting better and I do not need to be seen." The reporting nurse would like to request a lot check for this lot of PNEUMOVAX 23, lot # H018441, exp 28-FEB-2014. This was one of several reports that received from the same source. Additional information has been requested.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Cough, Flank pain, Headache, Myalgia
Clinical narrative: Fever 102 plus F, chills, headache, cough, muscle aches, flank pain.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Fever 102 plus F, chills, headache, cough, muscle aches, flank pain.
Age: 36.0
Sex: F
Vaccine: DTAP, FLUX
Symptoms: Headache, Injection site erythema, Injection site swelling, Injection site urticaria, Lymph node pain
Clinical narrative: Red swollen welt around vaccination site radiating pain in neck and shoulder. Visibly swollen, sore axillary lymph nodes in same side arm only. Headache, achiness.
Age: 36.0
Sex: F
Vaccine: DTAP, FLUX
Symptoms: Musculoskeletal pain, Neck pain, Pain
Clinical narrative: Red swollen welt around vaccination site radiating pain in neck and shoulder. Visibly swollen, sore axillary lymph nodes in same side arm only. Headache, achiness.
Age: 47.0
Sex: F
Vaccine: HEP
Symptoms: Neck pain, Neuralgia, Pain
Clinical narrative: Nerve pain left side of face/left eye, left occipital pain, pain C-1-2. Shot given deltoid right under left shoulder bone.
Age: 30.0
Sex: F
Vaccine: TTOX
Symptoms: Myalgia
Clinical narrative: C/O MUSCLE PAIN IN LEFT ARM 2 HOURS AFTER INJECTION GIVEN.
Age: 38.0
Sex: M
Vaccine: FLU3
Symptoms: Arrhythmia, Echocardiogram normal, Electrocardiogram normal, Laboratory test normal, Malaise
Clinical narrative: Fever, nausea, emesis, general malaise, aches, cardiac arrhythmias.
Age: 38.0
Sex: M
Vaccine: FLU3
Symptoms: Monocyte count increased, Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: Fever, nausea, emesis, general malaise, aches, cardiac arrhythmias.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Blood test, Condition aggravated, Fatigue, Nausea
Clinical narrative: Began with low fevers and extremely upset stomach and severe nausea that lasted for 3 days.  Then turned to extreme fatigue and heart racing, and now my thyroid is crashing after being stable for past 15 years.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Palpitations, Pyrexia, Thyroid disorder
Clinical narrative: Began with low fevers and extremely upset stomach and severe nausea that lasted for 3 days.  Then turned to extreme fatigue and heart racing, and now my thyroid is crashing after being stable for past 15 years.
Age: 59.0
Sex: M
Vaccine: FLUX
Symptoms: Cough, Myalgia, Nasopharyngitis, Oropharyngeal pain, Respiratory tract congestion
Clinical narrative: Sore throat, muscle aches, congestion, coughing.  (No fever, no nausea, no diarrhea). Typical "cold" symptoms.  Symptoms persisted for 2 full weeks, then much lighter but still some congestion and runny nose after 3 full weeks.
Age: 59.0
Sex: M
Vaccine: FLUX
Symptoms: Rhinorrhoea
Clinical narrative: Sore throat, muscle aches, congestion, coughing.  (No fever, no nausea, no diarrhea). Typical "cold" symptoms.  Symptoms persisted for 2 full weeks, then much lighter but still some congestion and runny nose after 3 full weeks.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pain in extremity
Clinical narrative: Patient states she has had soreness in the arm the vaccine was administered in when she moves it that has persisted for over 2 months now.
Age: 41.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site urticaria
Clinical narrative: Hive localized at shot point, started small 2 inches, 24 hours later was 6 inches, another 24 hours later was 9 inches, lasted for 7 days.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Chills, Eyelid function disorder, Fatigue, Gait disturbance
Clinical narrative: Within 4 hours, had muscle aches, headache, chills, and fatigue as well as pain and redness at injection site. In the next 24 hours, developed a 101.5 fever, had trouble walking and hives/rash around injection site. Also had pins and needles pain in legs and arms and arthralgia. Developed muscle twitching in hands while asleep and cold barely open my eyes.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site rash, Injection site urticaria
Clinical narrative: Within 4 hours, had muscle aches, headache, chills, and fatigue as well as pain and redness at injection site. In the next 24 hours, developed a 101.5 fever, had trouble walking and hives/rash around injection site. Also had pins and needles pain in legs and arms and arthralgia. Developed muscle twitching in hands while asleep and cold barely open my eyes.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Muscle twitching, Myalgia, Pain in extremity, Paraesthesia, Pyrexia
Clinical narrative: Within 4 hours, had muscle aches, headache, chills, and fatigue as well as pain and redness at injection site. In the next 24 hours, developed a 101.5 fever, had trouble walking and hives/rash around injection site. Also had pins and needles pain in legs and arms and arthralgia. Developed muscle twitching in hands while asleep and cold barely open my eyes.
Age: 50.0
Sex: F
Vaccine: VARCEL
Symptoms: Dizziness, Nausea
Clinical narrative: Patient stated she was nauseous and dizzy all day the day after receiving the injection. Ok after that.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: This spontaneous report as derived from a newspaper article (02-DEC-2012) reported that according to a spokesman of the state Department of Health, an investigation into possible causes and contributing factors in a chickenpox outbreak is ongoing and will be for months. The patients were vaccinated with a chicken pox vaccine of Merck. No other co-suspects were reported. No concomitant medications were reported. In early October 2012, more than 100 patients experienced a chickenpox outbreak. the outbreak included 2 counties and an adjacent county in another state. With the exception of one city, this was primary a very rural area. The state and federal health official said that it did not appear that the outbreak was caused by a bad lot, or batch of the vaccine. There are numerous cases in elementary school children (age not provided), there have been 3 waves of cases, 2/3 of the cases had received 2 doses, but this was just a rough estimate. Not all cases are from one lot or one provider office. The reporter did not think there were any storage or handling issues with the vaccine. The index case was an unvaccinated child who attended school. Patients was vaccinated individual who subsequently developed a mild case of breakthrough disease (varicella) during the outbreak received multiple lots of chickenpox vaccine over several years. No treatment information was reported. The outcome of breakthrough disease chickenpox (varicella) was unknown. The relatedness for breakthrough disease chickenpox was not reported for varicella virus vaccine live (Merck). Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Biopsy skin, Pruritus, Rash generalised, Skin lesion, Sleep disorder
Clinical narrative: ITCHY SKIN AND RASH DIAGNOSED AS BULLOUS PEMPHIGOID.
Age: 71.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Urticaria
Clinical narrative: ITCHY SKIN AND RASH DIAGNOSED AS BULLOUS PEMPHIGOID.
Age: 71.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pemphigoid, Pruritus, Rash
Clinical narrative: ITCHY SKIN AND RASH DIAGNOSED AS BULLOUS PEMPHIGOID.
Age: 18.0
Sex: F
Vaccine: IPV, YF, IPV, YF
Symptoms: Arthralgia, Back pain, Dizziness, Fatigue, Feeling abnormal
Clinical narrative: Initial report was received on 18 December 2012 from a consumer who is also the patient's parent. An 18-year-old female patient with a history of autism spectrum disorder had received on 06 December 2012 a dose of IPOL, lot number H1305 (route and site not available) and a left deltoid injection of YF-VAX, lot number UH355AA (route of administration not reported) and on 12 December 2012 experienced back pain, lump in throat, legs tingly and fever. The patient was taken to the medical center where she was admitted with "neuropenia". The patient was seen by multiple physicians including an infectious disease doctor. Laboratory testing included a WBC (results not available). The patient was discharged after a "bone marrow shot" on 13 December 2012. The patient is being followed by a physician for "blood work". According to the reporter, all symptoms have resolved except the patient was "still tired". No further information was available at the time of the report. The patient's outcome was not recovered. Documents held by sender: none.
Age: 18.0
Sex: F
Vaccine: IPV, YF, IPV, YF
Symptoms: Headache, Leukopenia, Lymphadenopathy, Mobility decreased, Musculoskeletal stiffness
Clinical narrative: Initial report was received on 18 December 2012 from a consumer who is also the patient's parent. An 18-year-old female patient with a history of autism spectrum disorder had received on 06 December 2012 a dose of IPOL, lot number H1305 (route and site not available) and a left deltoid injection of YF-VAX, lot number UH355AA (route of administration not reported) and on 12 December 2012 experienced back pain, lump in throat, legs tingly and fever. The patient was taken to the medical center where she was admitted with "neuropenia". The patient was seen by multiple physicians including an infectious disease doctor. Laboratory testing included a WBC (results not available). The patient was discharged after a "bone marrow shot" on 13 December 2012. The patient is being followed by a physician for "blood work". According to the reporter, all symptoms have resolved except the patient was "still tired". No further information was available at the time of the report. The patient's outcome was not recovered. Documents held by sender: none.
Age: 18.0
Sex: F
Vaccine: IPV, YF, IPV, YF
Symptoms: Nausea, Neutropenia, Pain, Paraesthesia, Pyrexia
Clinical narrative: Initial report was received on 18 December 2012 from a consumer who is also the patient's parent. An 18-year-old female patient with a history of autism spectrum disorder had received on 06 December 2012 a dose of IPOL, lot number H1305 (route and site not available) and a left deltoid injection of YF-VAX, lot number UH355AA (route of administration not reported) and on 12 December 2012 experienced back pain, lump in throat, legs tingly and fever. The patient was taken to the medical center where she was admitted with "neuropenia". The patient was seen by multiple physicians including an infectious disease doctor. Laboratory testing included a WBC (results not available). The patient was discharged after a "bone marrow shot" on 13 December 2012. The patient is being followed by a physician for "blood work". According to the reporter, all symptoms have resolved except the patient was "still tired". No further information was available at the time of the report. The patient's outcome was not recovered. Documents held by sender: none.
Age: 18.0
Sex: F
Vaccine: IPV, YF, IPV, YF
Symptoms: Viral infection
Clinical narrative: Initial report was received on 18 December 2012 from a consumer who is also the patient's parent. An 18-year-old female patient with a history of autism spectrum disorder had received on 06 December 2012 a dose of IPOL, lot number H1305 (route and site not available) and a left deltoid injection of YF-VAX, lot number UH355AA (route of administration not reported) and on 12 December 2012 experienced back pain, lump in throat, legs tingly and fever. The patient was taken to the medical center where she was admitted with "neuropenia". The patient was seen by multiple physicians including an infectious disease doctor. Laboratory testing included a WBC (results not available). The patient was discharged after a "bone marrow shot" on 13 December 2012. The patient is being followed by a physician for "blood work". According to the reporter, all symptoms have resolved except the patient was "still tired". No further information was available at the time of the report. The patient's outcome was not recovered. Documents held by sender: none.
Age: 18.0
Sex: F
Vaccine: IPV, YF, IPV, YF
Symptoms: Back pain, Fatigue, Neutropenia, Paraesthesia, Pyrexia
Clinical narrative: Initial report was received on 18 December 2012 from a consumer who is also the patient's parent. An 18-year-old female patient with a history of autism spectrum disorder had received on 06 December 2012 a dose of IPOL, lot number H1305 (route and site not available) and a left deltoid injection of YF-VAX, lot number UH355AA (route of administration not reported) and on 12 December 2012 experienced back pain, lump in throat, legs tingly and fever. The patient was taken to the medical center where she was admitted with "neuropenia". The patient was seen by multiple physicians including an infectious disease doctor. Laboratory testing included a WBC (results not available). The patient was discharged after a "bone marrow shot" on 13 December 2012. The patient is being followed by a physician for "blood work". According to the reporter, all symptoms have resolved except the patient was "still tired". No further information was available at the time of the report. The patient's outcome was not recovered. Documents held by sender: none.
Age: 18.0
Sex: F
Vaccine: IPV, YF, IPV, YF
Symptoms: Sensation of foreign body, White blood cell count
Clinical narrative: Initial report was received on 18 December 2012 from a consumer who is also the patient's parent. An 18-year-old female patient with a history of autism spectrum disorder had received on 06 December 2012 a dose of IPOL, lot number H1305 (route and site not available) and a left deltoid injection of YF-VAX, lot number UH355AA (route of administration not reported) and on 12 December 2012 experienced back pain, lump in throat, legs tingly and fever. The patient was taken to the medical center where she was admitted with "neuropenia". The patient was seen by multiple physicians including an infectious disease doctor. Laboratory testing included a WBC (results not available). The patient was discharged after a "bone marrow shot" on 13 December 2012. The patient is being followed by a physician for "blood work". According to the reporter, all symptoms have resolved except the patient was "still tired". No further information was available at the time of the report. The patient's outcome was not recovered. Documents held by sender: none.
Age: 32.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Bilevel positive airway pressure, Cough, Dyspnoea, Intensive care, Paraesthesia
Clinical narrative: Initial report was received from a healthcare professional on 20 December 2012. A female patient (age and date of birth not reported) had received an intramuscular injection of FLUZONE, Sanofi Pasteur (lot number, site and date of administration not reported). The patient had a reaction after the vaccine and was treated with two doses of epinephrine, steroids and three days on BIPAP at an outside hospital. The patient was diagnosed with Guillain-Barre. Outcome was not reported. Documents held by sender: None.
Age: 32.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Bilevel positive airway pressure, Guillain-Barre syndrome
Clinical narrative: Initial report was received from a healthcare professional on 20 December 2012. A female patient (age and date of birth not reported) had received an intramuscular injection of FLUZONE, Sanofi Pasteur (lot number, site and date of administration not reported). The patient had a reaction after the vaccine and was treated with two doses of epinephrine, steroids and three days on BIPAP at an outside hospital. The patient was diagnosed with Guillain-Barre. Outcome was not reported. Documents held by sender: None.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Eyelid function disorder, Vaccination complication, Viral infection
Clinical narrative: Beginning 12/16/12, 2 days post flu vaccine, pt complained of dizziness which became progressively more severe. It's more of the eyelids flipping upwards/jumping movement. Per wife, hospital ruled out stroke, aneurysm and are leaning toward viral infection or flu vaccine adverse event as cause. It has not been determined.
Age: 1.6
Sex: F
Vaccine: DTAP, HIBV, MMR, PPV, VARCEL
Symptoms: Rash papular
Clinical narrative: 10days after MMR, Varicella, Pneumovax & DTaP administration, pt developed an erythematous papular rash mainly on trunk.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Eye swelling, Visual impairment
Clinical narrative: Initial report was received from a healthcare professional on 21 December 2012. A 71-year-old male patient had received an intramuscular injection in the left deltoid of FLUZONE, lot number UH716AB, on 11 December 2012 and that evening experienced swelling around the eyes. The patient was treated with BENADRYL and ice packs. The patient had ocular swelling for about 1 1/2 to 2 days. The ocular swelling was so severe that the patient's field of vision was impaired. The patient also had almonds that evening but he had eaten almonds before and never had reactions. Outcome was recovered. Documents held by sender: None.
Age: 1.26
Sex: F
Vaccine: HIBV
Symptoms: Haemophilus test positive
Clinical narrative: Initial report was received from a healthcare professional on 20 December 2012. A three-year-old female patient had received an intramuscular injection of Act-Hib, lot number UF880AB on 10 August 2010. The patient was admitted to the hospital on 09 December 2012, and diagnosed with a culture showing positive Haemophilus B. It was unknown if the patient had any illness at the time of vaccination or past medical history. Previous vaccines included PENTACEL, lot number C3387AA on 03 August 2009, 09 September 2009 and 05 November 2009. Outcome was not reported. Documents held by sender: None.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Oedema peripheral, Skin discolouration
Clinical narrative: Initial report was received from a consumer, who was also the patient, on 09 October 2012. A 76-year-old female patient had received a dose one intramuscular injection in the right deltoid of FLUZONE (lot number unknown) on 27 August 2012 and the same day the patient's left fingers got swollen and turned black and blue which then went all the way up her hand. The patient's little finger was still swollen at the time of the report. The patient's past medical history was unknown. The patient's outcome was not recovered. Follow-up information was received from a healthcare professional on 20 December 2012. Due to the new information received, this case has been upgraded to serious. The finger does not feel to be infected. Treatment included MEDROL 4 mg dose pack) and continued antibiotic therapy with a follow-up in ten days. It was unknown if the patient had any illness at the time of vaccination. Medical history type II or unspecified type diabetes mellitus without mention of complication, not stated as uncontrolled and essential hypertension, benign. Concomitant medications included alprazolam, ibuprofen, atenolol, LASIX, MAXZIDE, metformin, NIASPAN, PREVACID, simvastatin, SYNTHROID, nystatin-triamcinolone cream, KLOR-CON and meclizine. Outcome remained not recovered. Documents held by sender: None.
Sex: F
Vaccine: HIBV
Symptoms: Dyspnoea, Oedema peripheral, Pyrexia, Swelling, Urticaria
Clinical narrative: Initial report was received from a consumer on 14 December 2012, who is also the patient's mother. A female infant (age not reported) received an injection of Hib vaccine (manufacturer, lot number, route, site, and date of vaccination not reported) and an unspecified amount of time later experienced shortness of breath, hives, swelling, bad swelling in the legs, and fevers. Illness at time of vaccination was not reported. Pre-existing allergies and medical conditions were not reported. The patient's outcome was not reported. Documents held by sender: None.
Age: 7.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site mass, Injection site pain
Clinical narrative: Initial report was received from a consumer on 18 December 2012 with additional information received on 19 December 2012. A seven-year-old female patient had received an injection of FLUZONE, lot number UH721AD (route, site and date of administration not reported) and within 12 hours her arm had a greater than three inch red, very hot, swollen ring at the site of the shot. It looked like a burn on her arm. She also had pain at the site. Initially she had a granular lump form at the site, but within a few hours the other reaction described previously ensued. Then the situation worsened. The size of the circle was not over five inches, hot, swollen and hard. Treatment included BENADRYL every four hours. The patient's father is a physician and felt it was now cellulitis. Outcome was not reported. Documents held by sender: None.
Age: 7.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Initial report was received from a consumer on 18 December 2012 with additional information received on 19 December 2012. A seven-year-old female patient had received an injection of FLUZONE, lot number UH721AD (route, site and date of administration not reported) and within 12 hours her arm had a greater than three inch red, very hot, swollen ring at the site of the shot. It looked like a burn on her arm. She also had pain at the site. Initially she had a granular lump form at the site, but within a few hours the other reaction described previously ensued. Then the situation worsened. The size of the circle was not over five inches, hot, swollen and hard. Treatment included BENADRYL every four hours. The patient's father is a physician and felt it was now cellulitis. Outcome was not reported. Documents held by sender: None.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Erythema
Clinical narrative: Assessed client on 12/20/12 at 12 noon when he came to show nurse his left arm. Client received pneumococcal vaccine 12/18/12 in left arm. Redness measures 20cm length x 17cm width. No wheezing, throat swelling etc... Client denies itching. Advised BENADRYL.
Age: 8.0
Sex: M
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: Information has been received from a parent's consumer regarding to 8 years old male patient with autism. On 05-OCT-2012, the patient was vaccinated with dose 1 GARDASIL. No other co-suspects were reported. No concomitant medications were reported. Past drug therapy included hepatitis A virus vaccine (unspecified). On 05-OCT-2012, the patient had an appointment with his pediatrician to receive the second series of Hepatitis A Vaccine. However the pediatrician's office mistakenly administered the GARDASIL. At the time of the report, the outcome of pediatrician's office mistakenly administered the GARDASIL was unknown. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: Significant swelling, redness, bogginess of left arm from deltoid and up to 2 inches above elbow noted a day after KINRIX was given. Symptoms resolved 4 days later.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site reaction, Musculoskeletal stiffness, X-ray
Clinical narrative: Approx. 2 days after vaccination patient experienced pain, soreness and stiffness in arm where vaccine was given. Approx 2 weeks following. Pt saw pcp who referred her orthopedic dr. Ortho prescribed anti-inflamatory, x-ray and physical therapy.
Age: 1.72
Sex: M
Vaccine: HEPA
Symptoms: Rash generalised, Rash macular
Clinical narrative: Pt. presented to clinic with blotchy rash on body & legs. Placed on medication.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Rotator cuff syndrome
Clinical narrative: Tore Roto cuff (per patient).
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Red area at the injection site (quarter-diameter size) and moderate pain approximately 3 days after injection.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Dizziness, Feeling hot, Headache, Nausea
Clinical narrative: Vaccine given at noon. By 8 p.m., pt was having chills and shaking, then felt hot. Headache, dizziness, nausea, no vomiting. Vaccine site sore. No problems with urination, no sore throat, no cough or wheezing, hoarseness or body aches. Pt told to rest, take BENADRYL, lots of fluids, rest, call us PRN.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Tremor, Vaccination site pain
Clinical narrative: Vaccine given at noon. By 8 p.m., pt was having chills and shaking, then felt hot. Headache, dizziness, nausea, no vomiting. Vaccine site sore. No problems with urination, no sore throat, no cough or wheezing, hoarseness or body aches. Pt told to rest, take BENADRYL, lots of fluids, rest, call us PRN.
Age: 12.0
Sex: M
Vaccine: FLU3, HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Erythema, Local reaction
Clinical narrative: Localized reaction on (L) arm subq reddened area 40 mm x 90 mm. Ice pack applied to site / instructed to use ice at home.
Age: 17.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Dermatitis, Rash
Clinical narrative: Rash on (R) & (L) upper extremities, (R) & (L) lower extremities. Tx: OTC antihistamines PRN and triamcinolone acetonide topical cream 0.5%.
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Monoplegia
Clinical narrative: This spontaneous report as received from a physician refers to a male patient of unknown age. The patient was vaccinated with a dose of GARDASIL (Lot # not reported) in October 2012 "two months ago". No other co-suspects were reported. No concomitant medications were reported. The physician reported that in 2012 the patient had experienced continual paralysis in the arm that received the injection. The outcome of continual paralysis in the arm that received the injection was unknown. The relatedness of continual paralysis in the arm that received the injection was unknown for GARDASIL. Upon internal review continual paralysis in the arm was considered medically significant. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Paraesthesia, Post herpetic neuralgia
Clinical narrative: Pt. is taking HUMIRA & received ZOSTAVAX, 2 days after receiving vac. pt began experiencing itching, tingling & redness at inj. site on left arm. She contacted her Dr who prescribed VALTREX 1gm PO qd. Took VALTREX 10-31-12 thru 11-14-12. Her itching & tingling resolved after a few days of VALTREX. Pt experienced post-herpetic pain thru approximately 11-29-12. It resolved without treatment.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Abdominal discomfort, Chills, Decreased appetite, Mobility decreased, Pyrexia
Clinical narrative: Fever/chills upset stomach, loss of appetite for five days - could not leave bed.
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Antinuclear antibody increased, Arthralgia, Blood test, Fatigue, Feeling hot
Clinical narrative: Body felt like it was on fire but no fever; severe joint pain; extreme fatigue; dr visit 3 days later revealed blood work that showed my ANA over 5,120!  GP referred me to rheumatologist.
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Laboratory test
Clinical narrative: Body felt like it was on fire but no fever; severe joint pain; extreme fatigue; dr visit 3 days later revealed blood work that showed my ANA over 5,120!  GP referred me to rheumatologist.
Age: 14.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Blood test normal, Bone scan normal, Computerised tomogram normal, Nausea
Clinical narrative: Nausea, fever of 103 by days end with Motrin and Tylenol in her system, joint pain spreading to several joints - resulted in ER visit and referral to rheumatologist. She's still in pain and cause remains unknown.
Age: 14.0
Sex: F
Vaccine: FLUX
Symptoms: Nuclear magnetic resonance imaging normal, Pyrexia
Clinical narrative: Nausea, fever of 103 by days end with Motrin and Tylenol in her system, joint pain spreading to several joints - resulted in ER visit and referral to rheumatologist. She's still in pain and cause remains unknown.
Age: 46.0
Sex: F
Vaccine: PPV
Symptoms: Induration, Rash, Swelling
Clinical narrative: RASH, MILD SWOLLEN AND HARDEN AREA.
Age: 0.22
Sex: F
Vaccine: RV1
Symptoms: Rotavirus test positive
Clinical narrative: This patient was vaccinated but got the rotavirus via lab result.
Age: 60.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Arthralgia, Musculoskeletal pain, Myalgia
Clinical narrative: Bilat shoulder pain, diffuse myalgias and arthralgias. Treated with prn acetaminophen of ibuprofen, cool compresses and later warm compresses.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema
Clinical narrative: Big red circle on arm that is getting bigger.
Age: 54.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Culture, Neuralgia, Nuclear magnetic resonance imaging spinal, Rash
Clinical narrative: Began having nerve pain in right leg, then rashes began to appear following the same area as the nerve pain. Was prescribed Acyclovir 800mg 5 times per day, and Gabapentin and Percocet for pain.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Hyperaemia, Pyrexia, Syncope
Clinical narrative: After 4 hours of the vaccine, the patient had chills, hyperemia, fever up to 39 C. Had one syncope episode. The fever resolved in 12 hours.  The vaccine that was given 1 year ago (regular dose) did not cause any adverse reactions. This year high-dose vaccine was administered, which caused this reaction.
Age: 18.0
Sex: M
Vaccine: FLU3, HPV4, MNQ
Symptoms: Dizziness, Dyskinesia, Fall, Gaze palsy, Muscle rigidity
Clinical narrative: HPV given client states "I Feel Dizzy". Client falls backward into chair. Eyes roll backward into lids, body becomes stiff and rigid. Then jerking rhythmical movement starts.
Age: 18.0
Sex: M
Vaccine: FLU3, HPV4, MNQ
Symptoms: Musculoskeletal stiffness
Clinical narrative: HPV given client states "I Feel Dizzy". Client falls backward into chair. Eyes roll backward into lids, body becomes stiff and rigid. Then jerking rhythmical movement starts.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Dehydration, Diarrhoea, Dizziness, Dysstasia, Hypotension
Clinical narrative: Extreme vomiting & diarrhea, dizziness, passed out, unable to stand.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Loss of consciousness, Vomiting
Clinical narrative: Extreme vomiting & diarrhea, dizziness, passed out, unable to stand.
Age: 91.0
Sex: F
Vaccine: VARZOS
Symptoms: Biopsy, Rash, Scab
Clinical narrative: Severe, scaby rash following nerve where shot administered. Lasted until current time despite treatment with antibiotics, cortisone etc. Currently in remission.
Age: 25.0
Sex: F
Vaccine: ANTH
Symptoms: Chills, Injection site abscess, Injection site cellulitis, Injection site inflammation, Injection site pain
Clinical narrative: Started feeling nauseous and having body aches and chills these symptoms stopped 12/17/2012; site of injection became very sore and inflamed. Went to urgent care 12/18/2012 12:00pm was diagnosed with cellulitis and an abscess at site of injection. I was prescribed Doxycycline 100mg 2xs a day for 10 days. Followed up with Primary care Dec 19th 2:00pm was told to continue antibiotics and to come back in 5 days to see if they helped. Followed up with Primary care Dec 24th 8:00am and the cellulitis was clearing and abscess went down a significant amount. No further action was required.
Age: 25.0
Sex: F
Vaccine: ANTH
Symptoms: Nausea, Pain
Clinical narrative: Started feeling nauseous and having body aches and chills these symptoms stopped 12/17/2012; site of injection became very sore and inflamed. Went to urgent care 12/18/2012 12:00pm was diagnosed with cellulitis and an abscess at site of injection. I was prescribed Doxycycline 100mg 2xs a day for 10 days. Followed up with Primary care Dec 19th 2:00pm was told to continue antibiotics and to come back in 5 days to see if they helped. Followed up with Primary care Dec 24th 8:00am and the cellulitis was clearing and abscess went down a significant amount. No further action was required.
Age: 27.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pain, redness, swelling, tender to touch from acromian process of left deltoid radiating down 2/3 of left arm towards elbow. Continued to spread.
Age: 39.0
Sex: F
Vaccine: FLUX
Symptoms: Pain, Pain in extremity, Tenderness
Clinical narrative: The arm where I received the shot hurts on occasion.  The pharmacist said it would be sore for a few days but it's been almost 3 months.  Sometimes if I stretch it, it hurts. If I lay on it, it can hurt.
Age: 65.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Pt developed severe pain, swelling and redness 1 day after she received vaccine. Used both ice and heat to treat sx until resolved.
Age: 38.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Dizziness
Clinical narrative: Within the hour the vaccine was administered patient reported signs of lightheadedness, weakness doctor called to report.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Condition aggravated, Feeling abnormal, Herpes zoster, Injection site erythema, Injection site oedema
Clinical narrative: At 14:15, pt. called me (RN) to report she is "itching and my arm feels weird." Assessed to find Rt deltoid area reddened; warm to touch, edematous with some tenderness to touch. Area localized w/slight radiation to upper shoulder.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Pruritus
Clinical narrative: At 14:15, pt. called me (RN) to report she is "itching and my arm feels weird." Assessed to find Rt deltoid area reddened; warm to touch, edematous with some tenderness to touch. Area localized w/slight radiation to upper shoulder.
Age: 58.0
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Skin disorder, Vaccination site swelling
Clinical narrative: Pt developed red itchy bumpy skin condition at vaccination site. MD thought it might be cellulitis, prescribed amoxicillin.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Pt. called in reporting redness / rash / swollen slightly painful at injection site. Advised to take TYLENOL or Ibuprofen. Pt was contacted 3 days later, he reported the reaction was much better and was improving.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Cough, Diarrhoea, Pain, Pyrexia
Clinical narrative: Pt was ill with body aches, cough, diarrhea, fever/chills, chest congestion. Pt receives a split dose vaccine #1 given 11/9/12 #2 on 11/29/12.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Respiratory tract congestion
Clinical narrative: Pt was ill with body aches, cough, diarrhea, fever/chills, chest congestion. Pt receives a split dose vaccine #1 given 11/9/12 #2 on 11/29/12.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Local reaction
Clinical narrative: Localized rxn at injection site 10 cm2 induration. No systemic sx - no wheezing, fever etc.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Skin warm, Swelling, Tenderness
Clinical narrative: Influenza vaccine injected intradermally to patient. Patient developed swelling, erythema, warmth with tenderness. Treated with antibiotic with improvement.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Patient developed a rash within 24 hours of vaccine administration.
Age: 60.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Injection site swelling, Skin tightness
Clinical narrative: Vaccines administered Thursday 12/27/12. Client states reaction noticed Saturday morning 12/29/12. States "itching, 10 cm redness / swelling, & taut skin" around Zoster injection site. States "improving" Monday 12/31/12.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Initial information has been received from a pharmacist concerning a patient with an unspecified gender, age, pertinent medical history or drug reactions/allergies, who on 21-DEC-2012, the patient was vaccinated with a expired M-M-R II (exp date 18-DEC-2012) (route, dose were not reported). No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. No treatment information was reported. The patient's outcome was unknown. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site discomfort, Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a registered nurse concerning a 67 year old female with no pertinent medical history and drug reactions/allergies who on 12-DEC-2012 was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 intramuscular in left arm (lot number H014196, expiration date 19-MAR-2014). No other co-suspects were reported. No concomitant medications were reported. On 13-DEC-2012, the patient experienced from the injection site of the upper left arm to the elbow: redness, swelling and discomfort. The patient was seen by the physician on 13-DEC-2012 and sent home to ice the area, and take TYLENOL and to call the office if the reaction was worse. The patient's daughter called the office the next day on 14-DEC-2012 and stated that the left arm of the patient was worse. The patient's daughter was instructed to take the patient to the emergency room. (It was not reported if the patient was taken.) At the time of the report, the patient's outcome was not provided. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Ear pain, Incorrect dose administered, Neck pain
Clinical narrative: This spontaneous report as received from a physician refers to a female patient of unknown age with no drug reactions or allergies. The patient's medical history included uveitis. The patient was vaccinated intramuscularly with two doses of RECOMBIVAX HB (dose and lot number not reported) at the same time in different arms on 14-DEC-2012. No other co-suspects were reported. There were no concomitant medications. It was reported that on approximately 15-DEC-2012 (reported as "over the weekend") both sides of the patient's neck hurt and there was soreness behind both ears. The patient sought medical attention via phone. There was no treatment given for AE. No lab diagnostic studies were performed. The patient was concerned that the uveitis might return so she visited another unspecified physician who said that her uveitis did not return. At the time of the report the patient still had soreness behind both ears. The outcome of neck hurt was unknown. The relatedness for the events was unknown for RECOMBIVAX HB. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a 79 years old female patient. The patient was vaccinated with a dose of ZOSTAVAX (Lot # H016762, expiration date 11-DEC-2013) SQ on 21-DEC-2012. No concomitant medications were reported. The pharmacist reported that on 26-DEC-2012, the patient developed an itchy red rash on both legs. The patient did not receive treatment for the adverse event. There were no Lab diagnosis or studies performed. At the time of the report, the patient was recovering. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age who approximately two months prior to the second dose (approximately on 15-OCT-2012) was vaccinated orally with the first dose in the series of ROTTEQ (Lot Number and dose not reported). No co-suspects were reported. No concomitant medications were reported. The physician noted that a patient was inadvertently administered an expired dose of ROTATEQ (Lot # 670011/1393AA, Exp date: 03-DEC-2012) (dose not reported) on 15-DEC-2012. This was the second dose  in the ROTATEQ vaccination series this patient has received. No adverse effect reported. Patient's outcome was unknown. Action taken not applicable. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age. The patient was vaccinated intramuscularly with the three series doses of GARDASIL (Lot # and dose not reported) on 22-MAY-2012, 09-AUG-2012 and 21-SEP-2012. No adverse effect was reported. It was not known if the patient sought for medical attention. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to an unspecified number of unspecified patients. The Physician called to report that an unspecified number of unspecified patients may have been administered PROQUAD (Merck) (Lot #, dose/frequency, route unspecified) that were improperly stored on unspecified dates from May 2012 to December 2012 at an unspecified healthcare facility. No adverse effects reported. This was one of several reports that received from the same source. Additional information is not expected.
Age: 21.0
Sex: F
Vaccine: YF
Symptoms: Injection site pain, Vomiting
Clinical narrative: Severe vomiting.