chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site warmth
Clinical narrative: Red rash around the injection site, heat in it.
Age: 5.0
Sex: F
Vaccine: FLUN4, MMR
Symptoms: Diarrhoea, Rash pruritic, Vomiting
Clinical narrative: Emesis, diarrhea and itchy bumps to neck, back, belly for 4 days.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure decreased, Hyperhidrosis, Loss of consciousness, Pallor, Syncope
Clinical narrative: Snycope /w brief LOC, tonic/clonic movements, decreased BP, pallor, diaphoretic Place on exam table in trendelenburg position. Monitored vital signs
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Tonic clonic movements
Clinical narrative: Snycope /w brief LOC, tonic/clonic movements, decreased BP, pallor, diaphoretic Place on exam table in trendelenburg position. Monitored vital signs
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Demyelination, Dysaesthesia, Immunoglobulin therapy, Nuclear magnetic resonance imaging brain abnormal
Clinical narrative: By 11/22/13 patient began to experience ascending dysesthesias and eventual weakness.  MRI of brain and Spine revealed demyelination in the cervical spine and brain with evidence for active enhancing lesions.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging spinal abnormal
Clinical narrative: By 11/22/13 patient began to experience ascending dysesthesias and eventual weakness.  MRI of brain and Spine revealed demyelination in the cervical spine and brain with evidence for active enhancing lesions.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Pain
Clinical narrative: Pain.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Injection site pain, Pain
Clinical narrative: Pain in left shoulder near injection site. Pain in shoulder when lifting arm.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site anaesthesia, Injection site pain, Joint range of motion decreased
Clinical narrative: Vaccine given intra articularly in Left Shoulder.  Immediate numbness and severe pain.  Severe pain, loss of range of motion, and intermittent numbness in left upper extremity continue and are still present at the time of this report. Still unclear as to if permanent disability has occurred.
Age: 43.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site warmth, Lymphadenopathy
Clinical narrative: Redness and warmth at the site of vaccine, swollen left axillary lymph node.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, HEP, HEPA, IPV, MMRV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: PATIENT WAS GIVEN IPV AND KINRIX ON THE SAME DAY.  NO SYMPTOMS REPORTED
Age: 0.65
Sex: M
Vaccine: HIBV, RV
Symptoms: Paranasal sinus hypersecretion, Sinus congestion, Urticaria
Clinical narrative: Severe hives covering entire body, severe sinus congestion/drainage. Was treated with antihistamine.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Heart rate increased, Peripheral coldness, Tremor
Clinical narrative: Tremors of the right hand, right leg, and right foot.  Cold sensation in bilateral lower extremities.
Age: 12.0
Sex: M
Vaccine: FLU3, HPV4
Symptoms: Incorrect dose administered
Clinical narrative: Dosage administered was 1.5 to 2 ml.
Sex: M
Vaccine: PPV
Symptoms: Vaccination complication
Clinical narrative: Information has been received from a third party claims administrator on behalf of a pharmacy concerning a male patient, who on an unspecified date was vaccinated with PNEUMOVAX23 (lot # H012972, expiration date 09Mar2014). On 06NOV2013, the patient experienced an adverse reaction (not further specified) to the PNEUMOVAX23 vaccine. The patient received unspecified treatment for the adverse reaction. The outcome of the adverse reaction was unknown. Additional information has been requested.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Skin tightness
Clinical narrative: Burning and tightening sensation down arm.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLUN4, MMRV
Symptoms: Cellulitis, Injection site induration, Injection site swelling, Pyrexia, Vomiting
Clinical narrative: Pt given KINRIX (L) upper arm. Went to ED on 11-27 Dx with cellulitis. Discharged with clindamycin suspension. Had vomiting associated with med. Continued fever. Returned to ED 11/28 and was admitted and started Clindamycin IV. At discharge 11/29 was afebrile and had small induration at site and mild swelling well within previously drawn borders.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site rash, Rash
Clinical narrative: Rash on arm (injection site) to (L) deltoid rash on (L) neck area.
Sex: U
Vaccine: FLUX
Symptoms: Asthma, Influenza like illness, Vaccination complication
Clinical narrative: Reaction from Influenza vaccine, flu like symptoms. Asthma reaction due to vaccine.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Throat irritation
Clinical narrative: Patient reports itchy throat after flu shot given. Patient given BENADRYL 50 mg p.o. now. Patient to wait in the lobby for at least 30 minutes to see if this improves. Patient to take BENADRYL at time Q. 6 hours at home today. No throat swelling, erythema, rash, or difficulty breathing noted. Reports a chest cold guarded last week. Has some congestion type pressure in her chest. Diphenhydramine 25 MG QID.
Age: 40.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Injection site pain, Injection site swelling
Clinical narrative: 11/12/13 Pneumonia vaccine/flu vaccine administered. 11/13 MD note stated tenderness and slight swelling (L) upper arm after vaccine. KEFLEX 500 mg po QID started. 11/14 MD note: (L) arm redness decreased on antibiotics. Most likely due to vaccination continue antibiotics and MOTRIN.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Salivary gland disorder
Clinical narrative: Blocked salivary glands, bilateral.
Age: 80.0
Sex: F
Vaccine: FLUC3
Symptoms: Discomfort, Insomnia, Muscle injury, Musculoskeletal pain, Pain in extremity
Clinical narrative: Arm/shoulder area extremely sore from flu shot, having difficulty sleeping due to discomfort. Went to Dr after approximately 3 weeks. Dr suggested muscle damage and would heal over time.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Blood test, Flushing, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: This spontaneous report as received from a consumer refers to a 48 year old female patient with compromised immune system, drug reaction/allergies to penicillin and sulfa. Approximately in November 2007, 6 years ago, the patient received a pneumonia vaccine (assumed PNEUMOVAX23) and had no adverse reaction. On 04-NOV-2013, the patient was vaccinated with an other dose of PNEUMOVAX23 (Dose, route and lot number were not reported). No co-suspect drug was reported. Concomitant medication was reported but unspecified by the patient. On 04-NOV-2013, the patient reported that the injection site became painful probably within 1 hour. Several hours later the reaction had worsened. The injection site was painful, red, very hard, hot and the size of a baseball. The patient also felt flushed. The patient called physician's office and talked to anonymous nurse. At the time of this report the outcome was unknown. The patient was treated with TYLENOL and ZYRTEC. On 04-NOV-2013, 10-15 minutes after injection, a routine blood work was performed (result not provided). The causality was not reported. This is one of two reports from the same source (other case MARRS # 1311USA011367). Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth
Clinical narrative: This spontaneous report as received from a consumer refers to a 48 year old female patient with compromised immune system, drug reaction/allergies to penicillin and sulfa. Approximately in November 2007, 6 years ago, the patient received a pneumonia vaccine (assumed PNEUMOVAX23) and had no adverse reaction. On 04-NOV-2013, the patient was vaccinated with an other dose of PNEUMOVAX23 (Dose, route and lot number were not reported). No co-suspect drug was reported. Concomitant medication was reported but unspecified by the patient. On 04-NOV-2013, the patient reported that the injection site became painful probably within 1 hour. Several hours later the reaction had worsened. The injection site was painful, red, very hard, hot and the size of a baseball. The patient also felt flushed. The patient called physician's office and talked to anonymous nurse. At the time of this report the outcome was unknown. The patient was treated with TYLENOL and ZYRTEC. On 04-NOV-2013, 10-15 minutes after injection, a routine blood work was performed (result not provided). The causality was not reported. This is one of two reports from the same source (other case MARRS # 1311USA011367). Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Vaccination complication
Clinical narrative: This spontaneous report as received from a consumer that spoke with a nurse refers to several patients with unknown age. On an unknown date the patients were vaccine with a dose of PNEUMOVAX23. Dose, route and lot number were not reported. No co-suspect and concomitant therapies were reported. On an unknown date several patients had a reaction in regards to the vaccine. At the time of this report the outcome was unknown.  The causality was not reported. This is one of two reports from the same source (other case MARRS # 1311USA001563). Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Urticaria
Clinical narrative: Diffuse rash and urticaria about one hour after vaccine was given.  Treated with oral Benadryl and sent to emergency room.
Age: 24.0
Sex: F
Vaccine: HEP
Symptoms: Nausea, Vomiting
Clinical narrative: Nausea, Vomiting.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Ultrasound scan normal, Vaccination site pain, Vaccination site swelling
Clinical narrative: Left upper arm where vaccine was given became swollen, rede and painful. Patient complained of this for 2 days. Ultrasound of arm was negative.
Age: 25.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Injection site swelling, Myalgia, Pyrexia
Clinical narrative: Swelling and pain at injection site. Fever, muscle aches.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Patient has had persistent pain and soreness in her L deltoid. She has difficulty abducting her arm. exam reveals tenderness diffusely along deltoid, no e/o cellulitis or abscess, no induration or erythema.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Neuralgic amyotrophy, Radiculitis brachial
Clinical narrative: Parsonage-Turner syndrome/Brachial neuritis r shoulder.
Age: 5.0
Sex: M
Vaccine: DTAPHEPBIP, MMRV
Symptoms: Erythema, Urticaria
Clinical narrative: Large, red hives on face, chest and arms.  No breathing difficulties.  Administered Benadryl 25mg IM per emergency standing orders.  Hives went away within 15-20 minutes (we held patient to ensure response). Attempted to call Mom later in the week to follow-up, but no return phone call.  Unsure if child saw Dr. after the incident or if anything further occurred, at this time.
Age: 0.9
Sex: M
Vaccine: FLU3
Symptoms: Death
Clinical narrative: Infant was under the care of his Dad - information was obtained from Mom that was not present at the moment of the event. As per mom the infant was as usual in the morning and he went to take his nap from what he never woke up.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Local swelling
Clinical narrative: Pt rports having severe swelling of injection site arm and dispersed erythema that was roughly the size of a football.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Joint dislocation, Muscle disorder, Musculoskeletal disorder, Pain
Clinical narrative: The shot itself was not as painful as it usually is, but it was administered in the shoulder at the top of my left arm by a man standing over me while I was seated. About 2 hours later, I reached to pick up the glass I was drinking from the table to my left, and my left shoulder felt like it was dislocated. I had to pick up my arm with my other hand and set it back down by my side. I knew it was from the vaccine, but I thought it would only be sore for a few days. I couldn't use my left arm to do normal activities like washing my hair or pulling a shirt over my head while undressing. I haven't been able to sleep on my left side and ordinary movements cause pain to shoot down my arm. After about 2.5 weeks, I was concerned because it wasn't any better -- possibly worse -- so I decided to go see an orthopedic physician. He said that maybe it was just in the muscle and gave me two prescriptions -- a pill for pain and a special cream that the pharmacy made to rub on my shoulder. More than 6 weeks after the vaccine, my shoulder was still bothering me, so I went back to see the Orthopedic physician. He has requested that I have a contrast MRI to see if the problem is in the bursa, but I haven't had the MRI yet.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Aphasia, Eye pruritus, Heart rate increased, Ocular hyperaemia, Pharyngeal oedema
Clinical narrative: Swelling of the face and throat, difficulty talking, red and itchy eyes, fast heartbeat.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling face
Clinical narrative: Swelling of the face and throat, difficulty talking, red and itchy eyes, fast heartbeat.
Age: 44.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Asthenia, Back pain, Bone pain, Movement disorder
Clinical narrative: Bone pain in knees, elbows, painful to touch. Knees swollen. Severe hip and back pain. Was able to touch toes prior, now unable. Bones in toes hurt, painful to go up and down stairs. Pain in extending arms and legs. Unable to pick up heavy objects. Bleeding from vagina not time for my cycle lasting over a week.
Age: 44.0
Sex: F
Vaccine: MMR
Symptoms: Pain, Pain in extremity, Vaginal haemorrhage
Clinical narrative: Bone pain in knees, elbows, painful to touch. Knees swollen. Severe hip and back pain. Was able to touch toes prior, now unable. Bones in toes hurt, painful to go up and down stairs. Pain in extending arms and legs. Unable to pick up heavy objects. Bleeding from vagina not time for my cycle lasting over a week.
Age: 4.0
Sex: F
Vaccine: DTAP, FLUN4, IPV, MMRV
Symptoms: Rash papular, Rash vesicular, Skin lesion
Clinical narrative: Papular rash that then progressed to papulovesicles/ varicelliform rash.  Approximately 10 lesions total.
Age: 44.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Dysphonia, Dyspnoea, Insomnia
Clinical narrative: Insomnia- Up all night, severe coughing, difficulty breathing, hoarseness, possible fever-did not take temperature. Took 3 teaspoons of Children's Benadryl Allergy & Sinus.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Convulsion, Petit mal epilepsy
Clinical narrative: He started having seizures. I did not know why he was moving his face like that. I have not seen that before. Were petite mal seizures.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: 12/02/2013, Fainting after HPV2.
Age: 73.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Pain in extremity
Clinical narrative: Sore arm for weeks after shot, still having a sore arm, no swelling or redness (right arm).
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Cerebrovascular accident, Herpes zoster, Pain, Pruritus
Clinical narrative: This spontaneous report as received from an approximately 84 year old female consumer with medical history included shingles in 2008 before having the vaccine. Drug history of cefadroxil (manufacturer unknown) and aspirin reaction/allergy. In 2012 (reported as last year), the patient was vaccinated with ZOSTAVAX, route reported as injection, (lot and dose not reported) for prevention of shingles. There was no concomitant medication. In 2012 (reported as last year), the patient experienced a stroke. In approximately July 2013 (reported as approximately 3-4 months ago), the patient experienced painful, itching "shingles pimple" on her leg after having ZOSTAVAX last year. The outbreaks occurred when the patient got nervous or upset. The reactions last for approximately 2 days before resolving. The patient did not seek for medical attention. No lab diagnostics performed. The patient had been treating the outbreaks with a dried flour at home treatment and felt that salves and ointments did not help as much as keeping the area dry. The outcome of stroke was not reported. The outcome of painful, itching "shingles pimple" on her leg was reported as not recovered. Upon internal review stroke was considered to be medically significant. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient called a few days after receiving vaccine and reported a hot, swollen, painful upper arm (from injection site to elbow).
Age: 65.0
Sex: U
Vaccine: FLU3
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: This medically confirmed report (initial receipt 18-Nov-2013) concerns a 65 year old patient who had a medical history of chronic sinus infection and several food and drug allergies. Concomitant medications included SYNTHROID and ARMOUR THYROID. On the 13-Nov-2013, at 9.30am, the patient received AFLURIA (batch number 08949211A) 0.5 mL once, via the intramuscular route. On the same day, the patient had unspecified allergy testing completed. On the 13-Nov-2013, later on in the evening, the patient felt faint and then passed out. The patient notified the doctor's office the following day on the 14-Nov-2013. No treatment was sought by the patient, and it was reported that the patient was doing fine now. Outcome was recovered.
Age: 35.0
Sex: F
Vaccine: PPV
Symptoms: Cough, Dyspnoea, Erythema, Influenza virus test, Injection site pain
Clinical narrative: Erythema, cough, SOB, tenderness swelling and pain to injection site.
Age: 35.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Metabolic function test, Mononucleosis heterophile test, Streptococcus test, Urine analysis
Clinical narrative: Erythema, cough, SOB, tenderness swelling and pain to injection site.
Age: 28.0
Sex: F
Vaccine: FLU3, HEPA, PPV, TDAP
Symptoms: Dyspnoea, Injection site swelling, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Reaction following immunizations (Hepatitis A, Tdap/left deltoid arm IM and PNEUMOVAX, Influenza right deltoid arm IM. No reaction after 30 min but patient reported swelling, soreness, pain. Within 24 hours post injections/right arm very painful, some hives, tingling in right hand/right arm, some shortness of breath Wed night. Visited clinic on 11/30/13. Notes attached. Student treated with BENADRYL, ADVIL, ice. Returned to another clinic 12/2 - slight swelling still present. Still had slight < 20mm swollen area top of right arm.
Age: 28.0
Sex: F
Vaccine: FLU3, HEPA, PPV, TDAP
Symptoms: Swelling, Urticaria, Vaccination complication
Clinical narrative: Reaction following immunizations (Hepatitis A, Tdap/left deltoid arm IM and PNEUMOVAX, Influenza right deltoid arm IM. No reaction after 30 min but patient reported swelling, soreness, pain. Within 24 hours post injections/right arm very painful, some hives, tingling in right hand/right arm, some shortness of breath Wed night. Visited clinic on 11/30/13. Notes attached. Student treated with BENADRYL, ADVIL, ice. Returned to another clinic 12/2 - slight swelling still present. Still had slight < 20mm swollen area top of right arm.
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site pain
Clinical narrative: Extreme pain in upper right arm. Reported 11-29-13 she couldn't reach her Dr till 12-2-13. Told her to seek medical advice 11-30 or 12-1 if pain was too severe to tolerate.
Age: 1.0
Sex: F
Vaccine: FLU3, MMRV, PNC13
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Approx 1 inch red, raised, warm to touch cellulitis to left upper thigh. Treated with amoxicillin (400mg/5 ml) 5 ml po BID x 10 days.
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction
Clinical narrative: Injection site reaction for 10 days.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain in extremity, Tenderness
Clinical narrative: Pt states she has constant pain at injection site that radiates down arm to her wrist. Extremely painful when pressure applied to that arm.
Age: 18.0
Sex: M
Vaccine: FLUX, HPV4
Symptoms: Pallor, Presyncope, Skin discolouration, Unresponsive to stimuli, Yellow skin
Clinical narrative: This medically confirmed report (initial receipt 19-Nov-2013) concerns an 18 year old male, who had no pertinent medical history of drug reactions/allergies. Concomitant medications included topiramate. The patient had received the flu vaccine in the past with no problems. On 18-Nov-2013, the patient received an influenza virus vaccine (manufacturer and batch number not reported). On the same day, the patient also received GARDASIL (batch number not reported) first dose via the typical route, and typical dose. On 18-Nov-2013, whilst still in the doctor's office and sitting in the chair, the patient's face turned pale yellow/green and the patient would not respond to any questions and eyes were still open. The patient almost fainted. The patient was placed on his back on a table and legs were elevated. His vital signs such as blood pressure and pulse were taken. Outcome was reported as recovered on the 18-Nov-2013.
Age: 69.0
Sex: F
Vaccine: HEP
Symptoms: Flushing, Tongue disorder
Clinical narrative: Patient received her 2nd Hep B shot. When leaving building she told front desk that she felt flushed and tongue was thick. We admin EPIPEN and called 911. Also informed pt. sister in law.
Age: 73.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Pt. complained of itchiness surrounding area of injection. Inspected area, and it looked red. Not sure if that was from pt. scratching. Gave pt. a Ziploc filled with ice to apply to area and asked her to wait in store.
Age: 0.25
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Crying, Muscle rigidity
Clinical narrative: Extreme crying x 3 days after first set of immunizations, held body rigid.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Fatigue, Injection site erythema, Injection site swelling, Injection site warmth, Pain
Clinical narrative: This spontaneous report as received from a health professional refers to a 66 year old female patient with anxiety, diabetes, irritable bowel syndrome, macular degeneration and osteopenia. On 06-NOV-2013, the patient received her second dose of PNEUMOVAX 23 (lot # J010654, expiration date 17-OCT-2014, 0.5 ml, intramuscular). Concomitant therapy was not reported. In November 2013, the patient became tired and achy, had a fever of 101F and a 6 centimeter by 8 centimeter erythematous, slightly raised, warm area at the injection site. On 08-NOV-2013, the patient went to see the nurse practitioner and was told to use ice and naproxen to treat these adverse symptoms. The outcome of the events was unknown. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: This spontaneous report as received from a health professional refers to a 66 year old female patient with anxiety, diabetes, irritable bowel syndrome, macular degeneration and osteopenia. On 06-NOV-2013, the patient received her second dose of PNEUMOVAX 23 (lot # J010654, expiration date 17-OCT-2014, 0.5 ml, intramuscular). Concomitant therapy was not reported. In November 2013, the patient became tired and achy, had a fever of 101F and a 6 centimeter by 8 centimeter erythematous, slightly raised, warm area at the injection site. On 08-NOV-2013, the patient went to see the nurse practitioner and was told to use ice and naproxen to treat these adverse symptoms. The outcome of the events was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a female patient of unknown age. Medical history and drug allergies were not reported. The reporter stated that a patient was administered GARDASIL outside of recommended dosing schedule, as follows: On 01-AUG-2013 first dose, 19-SEP-2013 second dose and on 14-NOV-2013 the third dose. Concentration, dose and lot number were not reported for the three doses. No adverse effects reported. The patient did not sought medical attention. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. Medical history and drug reactions/allergies were not reported. On 19-NOV-2013, the patient was vaccinated with ZOSTAVAX lot # H014366, expiry date 06-NOV-2013, 0.65 ml, subcutaneous (it was expired). Concomitant medication was not reported. No adverse effects reported. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist refers to an approximately 65 year old male patient with codeine allergy. The patient's medical history included shingles. On 08-OCT-2013, the patient was vaccinated with ZOSTAVAX (lot # J001004, expiration date 24-APR-2014, 0.65 ml, subcutaneous. Concomitant therapies were reported as none. In October 2013, the patient developed shingles. The patient told the pharmacist he believes he was already in the beginning stages of a shingles episode at the time of administration because he already had 2 preexisting "spots" on his stomach when he received ZOSTAVAX. These two spots had developed shortly before receiving vaccination with ZOSTAVAX. The patient sought medical attention (office visit). No lab diagnostics studies were performed. The patient received treatment with VALTREX and gabapentin. The outcome of the event was reported as recovering. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Dermatitis allergic
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to two patients of unknown age and gender. Medical history and drug reactions/allergies were not reported. On an unknown date, the patients were vaccinated with ZOSTAVAX (vial 19400 PFU) (lot, dose and route not reported). Concomitant medication was not reported. On an unknown date, the patients experienced allergic dermatitis on their arms after receiving ZOSTAVAX. The outcome of allergic dermatitis on their arms was not reported. This is one of two reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. Medical history and drug reactions/allergies were not reported. On an unknown date, improperly stored dose of RECOMBIVAX HB (lot, dose and route not reported) might have been administered to a patient. Concomitant medication was not reported. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Dermatitis allergic
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers a patient of unknown age and gender. Medical history and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (Vial 19400 PFU) (lot, dose and route not reported). Concomitant medication was not reported. On an unknown date, the patient experienced allergic dermatitis on the arms after receiving ZOSTAVAX. The patient went to an unspecified physician and was placed on an unspecified steroid to treat the allergic dermatitis. The outcome of allergic dermatitis on the arms was not reported. This is one of two reports from the same source. Additional information has been requested.
Sex: M
Vaccine: HEPA, HPV4
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a nurse refers to a male patient of unknown age. The nurse reported that the male patient was due for his 3rd dose of GARDASIL. The patient might have received VAQTA (lot number and expiration date not reported). There was no concomitant medication reported. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. On 19-NOV-2013 the patient was vaccinated with a 0.65 ml expired dose of ZOSTAVAX (lot # H013946, expiry date: 25-OCT-2013) (Subcutaneous in patient's right arm). No adverse effect reported. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Confusional state, Dyskinesia, Fall, Loss of consciousness, Pallor
Clinical narrative: Case number PHHY2013US069304, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 489939) website on 03 Jul 2013, with the follow-up received from Quality Assurance Department (reference number: 239238) on 26 Nov 2013. This report refers to a 12-year-old female patient. Her medical history and concomitant medications was not reported. On 23 Apr 2013, she was vaccinated with MENVEO (batch number: M11081 and expiry date: Apr 2014) intramuscularly in left arm, ADACEL (batch number: C3974AA) intramuscularly in the left arm and GARDASIL (batch number: H012643) intramuscularly in the right arm. Thirty to forty five seconds after receiving GARDASIL, she began jerking, passed out and fell out of the chair. She was given juice and a cool towel for her head. She woke up in a confused state and was pale, but she was alert. She was observed for 20 minutes and was released to go home. The event outcome was reported as complete recovery. The seriousness and causality was not reported. Based on the investigation performed, QA department stated that, the MENVEO vaccine (batch number M11081) was manufactured in accordance with the approved internal procedures and it is in compliance with the cGMP requirements. No additional information was available. Follow-up received from Quality Assurance Department (reference number: 239238) on 26 Nov 2013: Updated batch review report.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, RV5
Symptoms: Haematochezia, Occult blood positive
Clinical narrative: Information was received from a physician regarding a 9 week old male infant. On 15-OCT-2013, the patient was vaccinated with his first dose of ROTATEQ. On 18-OCT-2013, the physician reported that the patient has experienced fresh blood in the stool. The outcome of fresh blood in the stool was reported as not recovered. No further information was provided. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, RV5
Symptoms: Haematochezia
Clinical narrative: Information was received from a physician regarding a 9 week old male infant. On 15-OCT-2013, the patient was vaccinated with his first dose of ROTATEQ. On 18-OCT-2013, the physician reported that the patient has experienced fresh blood in the stool. The outcome of fresh blood in the stool was reported as not recovered. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: This spontaneous report as received from a registered nurse refers to a large number of unspecified college students of unknown age. On unspecified dates, these college students had been vaccinated with all required doses of Hepatitis B vaccine (manufacturer unknown), could not rule out RECOMBIVAX HB (lot#, dose, strength, indication and anatomical location not reported). On unspecified dates and yet these college students were sero-negative in regarded to titer results for Hepatitis B. The outcome of sero-negative in regard to titer results for hepatitis b was unknown. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Injection site discomfort, Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a registered nurse via a company representative refers to a 55 year old female patient with allergy to Chantix (developed hypertension) and penicillin (developed swelling). The reporter reported the patient received one dose of PNEUMOVAX23 (lot# unspecified) (dose, route, frequency and indication unspecified). Concomitant therapies included Xanax and Alprazolam. Then patient developed swelling and discomfort in the upper left arm around the injections site, and erythema over "a good portion" of the upper arm on 14-NOV-2013. No treatment was given for the adverse event. Non lab diagnostics studies performed. The patient had sought medical attention by doctor's visit. The patient's present status was reported as recovering. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Pyrexia, Vomiting
Clinical narrative: This spontaneous report as received from a physician refers to a 22 year old female patient. On 15-NOV-2013 the patient was vaccinated with PNEUMOVAX23 25/0.5 Y, 0.5 ml, intramuscular. On 15-NOV-2013 the patient experienced redness around the injections site that spread down her arm and up her shoulder, severe vomiting, and fever. The patient sought medical attention by calling the physician. The patient was treated with Prednisone. The outcome of fever, redness around the injection site that spread down her arm and up her shoulder and vomiting was reported as not recovered/not resolved. Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Flushing, Paraesthesia oral, Pruritus, Throat irritation, Urticaria
Clinical narrative: Itching arm, chest, neck; hives on chest; flushed skin; mouth/lip tingling and puffy; itching in ears and throat; went to Emergency Room at 12:20pm.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 50 year old male patient with no known drug reactions/allergies. Medical history included shingles. On 15-OCT-2013, the patient was vaccinated with ZOSTAVAX (lot # J004311, exp. Date: 12-JUL-2014) 0.65 ml, subcutaneous. Concomitant therapies included Flexeril, Lisinopril (manufacturer unknown), Reglan, Celecoxib, Oxycodone, Diazepam, Lexapro and Ambien. On 15-OCT-2013, the patient developed a mild case of shingles. On an unknown date, the patient sought medical attention by office visit. No laboratory tests were performed. The patient was given Acyclovir as treatment for the event. On an unknown date, the patient recovered from shingles. Additional information has been requested.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Flank pain, Headache, Neck pain
Clinical narrative: After injection developed extreme headache and neck side and back pain. Went to see PCP and was told to take TYLENOL. At this date patient is finally going away.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health care student refers to patient 2 of 2 patients (no demographics provided). On 18-NOV-2013 the patient might have received improperly stored PNEUMOVAX23. Dosing information and route and administration were not provided. Lot number J005068, expire date 17-JAN-2015. No adverse event reported. This case is linked to patient 1 to 2 patients (1312USA000988-Pneumovax23) and linked to case from same reporter (1311USA008438-Afluria). Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health care student refers to patient 2 of 2 patients (no demographics provided). On 18-NOV-2013 the patient might have received improperly stored PNEUMOVAX23. Dosing information and route and administration were not provided. Lot number J005068, expire date 17-JAN-2015. No adverse event reported. This case is linked to patient 2 of 2 patients (1312USA000989-Pneumovax23) and linked to case from same reporter (1311USA008438-Afluria). Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Device difficult to use, No adverse event, Syringe issue
Clinical narrative: This spontaneous report as received from a nurse refers to 1 or possibly 2 patients of unknown age. On an unknown date the patient(s) were vaccinated with GARDASIL. Dosing information, route of administration and lot number(s) were not provided). The patient(s) were stuck with a syringe needle twice due to difficulty pushing the plunger of the syringe while attempting to administer GARDASIL (this was not a GARDASIL prefilled syringe). No adverse effect was reported. Additional information has been requested.
Sex: M
Vaccine: DTAP
Symptoms: Excessive eye blinking, Tic
Clinical narrative: Mother requests report. She believes tic behavior, eye blinking, associated with TD vaccine administered 10-11-13. Only other vaccines were 1st infant set on 10-1-07 due to parental refusal.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Culture, Diarrhoea haemorrhagic, Hypokalaemia, Parasitic test
Clinical narrative: Bloody diarrhea developed 48 hours later requiring inpt care.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Pain, Swelling
Clinical narrative: Pain and swelling x 2 weeks, limited mobility L arm. Therapy ordered today.
Age: 70.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Activities of daily living impaired, Arthralgia, Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: I usually have pain (aching) at the site of my flu vaccine (left upper arm); it usually goes away in maybe 3 days. (I usually carry on with whatever I have to do). This year was diffferent. My upper left arm, the site of the flu vaccine, ached and then the aches spread down my arm, even into the joint between my thumb and index finger. It hurt! It was so bad that for 2 or 3 days I could not lift my arm by myself to put on or take off clothes. I needed help to do that. I did not seek medical care because my husband said, "It will get better." The pain did not go entirely away. I was told that this flu vaccine had 4 parts.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 78 year old female patient. Her medical history was unknown. On 25-JUL-2011, the patient was vaccinated with ZOSTAVAX lot # 670383/0170AA. It was unknown if the patient took any concomitant medications. The patient informed the pharmacist that, on 02-NOV-2013, she experienced symptoms of shingles. The patient recovered from the symptoms of shingles after unspecified treatment. A causality assessment was not provided. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Injection site erythema, Injection site swelling, Mobility decreased, Pain in extremity
Clinical narrative: Arm was sore and joint was very sore - hard to reach - injection site was swollen and red - was gone in 5 days - still sore almost 2 months later - still hard to reach.
Age: 0.7
Sex: F
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Body temperature decreased, Staring, Tremor
Clinical narrative: Several hours after receiving vaccine, child had 3 episodes of brief head/upper trunk/arm shaking and staring; fell asleep shortly after episodes, then developed temperature of 103.1 degrees.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Red, itchy spot (pea-sized) at injection site. Is still present on her upper arm but much less pronounced. No fever or discharge from site.
Age: 0.37
Sex: F
Vaccine: HIBV, RV5
Symptoms: Diarrhoea
Clinical narrative: Diarrhea
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site mass, Injection site pain
Clinical narrative: Unusually high pain at site of administration lasting since 10/14/13. Lump still palpable at site of injection. Pain 8-8.5/10.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Asthma, Injection site erythema, Middle insomnia, Nausea, Night sweats
Clinical narrative: Initial report received on 22 November 2013 from a healthcare professional who is also the patient. The 33 year old female patient received FLUZONE intramuscularly into the right deltoid, batch # UH900AB on 13 November 2013. On Saturday 15 November 2013, the patient woke up during the night with sweats and had to change her clothes due to the sweats. She also had vomiting and nausea. This occurred again on 20 November 2013 and 21 November 2013. On 21 November, she also began wheezing and feels that this is an asthma exacerbation. The patient also experienced a red area at the injection site of a half dollar in size with no pain or swelling. The patient has a call into her physician for treatment of her symptoms. In the last 5 years, the patient received the flu vaccine, manufacturer unknown and in a week to two weeks developed asthma exacerbation and wheezing. Five years ago, the patient required hospitalization, but did not require hospitalization in subsequent years. The patient was told that FLUZONE does not contain eggs, so she was vaccinated. The patient has a medical history of asthma, allergies to milk, eggs, wheat and shrimp. Concomitant medications were not reported. The patient did not receive other vaccinations within the last 4 weeks. The patient denies illness at the time of vaccination. The patient outcome is not recovered. Documents held by sender: none.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting, Wheezing
Clinical narrative: Initial report received on 22 November 2013 from a healthcare professional who is also the patient. The 33 year old female patient received FLUZONE intramuscularly into the right deltoid, batch # UH900AB on 13 November 2013. On Saturday 15 November 2013, the patient woke up during the night with sweats and had to change her clothes due to the sweats. She also had vomiting and nausea. This occurred again on 20 November 2013 and 21 November 2013. On 21 November, she also began wheezing and feels that this is an asthma exacerbation. The patient also experienced a red area at the injection site of a half dollar in size with no pain or swelling. The patient has a call into her physician for treatment of her symptoms. In the last 5 years, the patient received the flu vaccine, manufacturer unknown and in a week to two weeks developed asthma exacerbation and wheezing. Five years ago, the patient required hospitalization, but did not require hospitalization in subsequent years. The patient was told that FLUZONE does not contain eggs, so she was vaccinated. The patient has a medical history of asthma, allergies to milk, eggs, wheat and shrimp. Concomitant medications were not reported. The patient did not receive other vaccinations within the last 4 weeks. The patient denies illness at the time of vaccination. The patient outcome is not recovered. Documents held by sender: none.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Pyrexia, Rash erythematous
Clinical narrative: On Tuesday 11/19/13 patient developed red spot at injection site with fever 3 inches in diameter. By Wednesday 11/20/13 the site had expanded to about 6 inches - patient started on 1/2 table of BENADRYL 25 mg twice daily on Wed, Thurs, and Fri. By Sat rash was resolved.
Age: 32.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia, Rash
Clinical narrative: Pt developed rash on arm and fever day after receiving FLUVIRIN and PNEUMOVAX went to ER, given IV fluids, BENADRYL and antibiotics.
Age: 81.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Inflammation, Nerve injury, Pain, Tendon injury
Clinical narrative: This case is received from a company. This case is administered for Pharmacy Family of Companies. Initial report received from a non-healthcare professional on 21 October 2013. A patient (demographical details was not reported), whose medical history and concomitant medications were not reported, had received a dose of Inactivated Influenza vaccine with Lot number: UE4781AA and Exp. date of 25 May 2016, route of administration and anatomical site of administration was not reported) on unspecified date. It was reported that the patient had adverse reaction. Complementary investigations and corrective treatment were not reported. The outcome of the adverse reaction was not reported. Documents held by sender: none. Follow-up report received from a healthcare professional on 25 November 2013. An 81-year-old male patient, had received high dose flu vaccine for seniors in shoulder on 23 September 2013 in public health clinic. The vaccine was put in wrong site above shoulder. On 26 September 2013, the patient experienced pain and inflammation. He had injury to nerve and tendons. The physician injected KENALOG into site to relief pain and advised physiotherapy on shoulder for 6 weeks. No other vaccine was administered. Documents held by sender: none.
Sex: M
Vaccine: PNC13
Symptoms: Inflammation, Local swelling, Pyrexia, Rash, Ulcer
Clinical narrative: This is a spontaneous report obtained from a contactable consumer. This consumer reported similar adverse events for three different patients. This is the third of three reports. A male patient of unknown age and race received on an unknown PREVNAR 13. Relevant medical history and concomitant medication were unknown. In Nov2013 the patient experienced fever and had rash, swelling and inflammation all on arm. It was also reported that since an unknown date in Nov2013 the patient had sores which lasted for seven days and due to which he was hospitalized on an unknown date in Nov2013. Relevant laboratory and therapeutic measures taken in response to the events were unknown. Patient recovered from "sores" on an unknown date in Nov2013 and clinical outcome of the other reported events was unknown at the time of report.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling hot, Immediate post-injection reaction, Local swelling, Pruritus, Skin reaction
Clinical narrative: Case number PHEH2013US024641, is an initial spontaneous report received from a physician on 21 Nov 2013. This report refers to a 39-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 13372P) intramuscularly on 18 Nov 2013. On the same day, immediately after vaccination she developed bad skin reaction and itching. After 10 minutes, her arm became hot and started swelling and within 15 minutes she developed facial swelling. The final outcome of the events was reported as completely recovered. The causality and seriousness of the event were not reported.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling face
Clinical narrative: Case number PHEH2013US024641, is an initial spontaneous report received from a physician on 21 Nov 2013. This report refers to a 39-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 13372P) intramuscularly on 18 Nov 2013. On the same day, immediately after vaccination she developed bad skin reaction and itching. After 10 minutes, her arm became hot and started swelling and within 15 minutes she developed facial swelling. The final outcome of the events was reported as completely recovered. The causality and seriousness of the event were not reported.