chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: M
Vaccine: FLU3
Symptoms: Acne, Injection site erythema, Injection site reaction, Purulent discharge
Clinical narrative: Red pimple-like raised area at injection site. Small amount of purulent drainage from area. No redness. warmth or swelling noted to area surrounding injection site.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Dizziness, Influenza virus test negative, Pain, Pain in extremity
Clinical narrative: 9/17/12 Tdap given at 4:32 pm. 9/18/12 2 am developed fever 102.6 F, chills, body aches, moderate left arm pain, swelling & dizziness. Tx: IVF NS 1 liter, TYLENOL, ice pack to left arm. Pt felt much better T 98.7.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia, Swelling
Clinical narrative: 9/17/12 Tdap given at 4:32 pm. 9/18/12 2 am developed fever 102.6 F, chills, body aches, moderate left arm pain, swelling & dizziness. Tx: IVF NS 1 liter, TYLENOL, ice pack to left arm. Pt felt much better T 98.7.
Age: 42.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Chills, Erythema, Oedema peripheral, Pyrexia, Vaccination complication
Clinical narrative: Reaction to Influenza immunization. Left arm is swollen and red. Started after Flu shot on 9/13/2012, fever, chills. Naproxen 500mg 1 tablet 2 times daily as needed. Ice 10 minutes 3-4 times a day.
Age: 27.0
Sex: M
Vaccine: FLUN3, TDAP
Symptoms: Hypoaesthesia
Clinical narrative: - Left of face numb after 20 hrs.
Age: 27.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Injection site warmth, Muscular weakness, Pyrexia
Clinical narrative: Fever, (right) pain warm from injection site to elbow. Weakness in right arm.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain
Clinical narrative: Pt got "red circle" at injection site that lasted few days, but also got "hard lump" under skin. He said it still feels sore, like a bruise several weeks after immunization.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus, Rash erythematous, Urticaria
Clinical narrative: Raise, red rash (whelps) on forehead, temples, chin itching.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Inflammation, Injection site inflammation, Injection site swelling, Oedema peripheral
Clinical narrative: Swelling and inflamed areas on site of injection and further areas on arm.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Back pain, Myalgia
Clinical narrative: Back pain, muscle soreness.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site scab
Clinical narrative: Noted slightly raise scab at injection site. No redness, swelling or warmth to touch noted to area surrounding injection site. No drainage reported, just scab which patient states he picked at. No signs of infection noted even after patient picked off scab. Area currently open to air without drainage or inflammation to area surrounding injection site.
Age: 35.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: Reported by the employee, "Received flu shot at around 1130 on Wednesday, 09/12/12. Woke up around 2330 with generalized severe urticaria. Called and spoke with Pharmacist and Dr who both offered to either see me in the ED as a patient or to call in scripts for allergic reaction. I chose to have scripts called in. I took the prescrbied meds and the itching subsequently resolved over the next couple days."
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Eye swelling, Fatigue, Hypersomnia, Lip swelling, Oedema mouth
Clinical narrative: Swelling of mouth, tongue, lips and eyes, wheezing, and extreme exhaustion. Occurred approximately 1-2 hours after vaccination and lasted about 24-36 hours. Took Benadryl and slept most of the time that symptoms lasted.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Swollen tongue, Wheezing
Clinical narrative: Swelling of mouth, tongue, lips and eyes, wheezing, and extreme exhaustion. Occurred approximately 1-2 hours after vaccination and lasted about 24-36 hours. Took Benadryl and slept most of the time that symptoms lasted.
Age: 22.0
Sex: F
Vaccine: FLUN3
Symptoms: Dizziness, Electrocardiogram, Hot flush, Nausea
Clinical narrative: LIGHTEDHEADEDINESS, NAUSEA, & HOT FLASHES.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Mobility decreased, Pain in extremity, Pyrexia
Clinical narrative: Fever, chills is taking ibuprofen around the clock.
Age: 25.0
Sex: M
Vaccine: TDAP
Symptoms: Chest X-ray normal, Chest pain, Contusion, Dizziness, Dyspnoea
Clinical narrative: Onset of dyspnea, leading to lightheadedness and fall resulting in low back contusions. Also chest pain with the dyspnea.
Age: 25.0
Sex: M
Vaccine: TDAP
Symptoms: Electrocardiogram normal, Fall, Fibrin D dimer normal, Full blood count normal, Metabolic function test normal
Clinical narrative: Onset of dyspnea, leading to lightheadedness and fall resulting in low back contusions. Also chest pain with the dyspnea.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site swelling, Pain in extremity
Clinical narrative: Patient reported pain through the entire arm vaccine given in and unable to lift arm. No redness reported though injection site slightly swollen. She took acetaminophen and applied heat and muscle rub. Symptoms began later in the day after receiving vaccine.
Age: 26.0
Sex: M
Vaccine: TDAP
Symptoms: Burning sensation, Middle insomnia, Musculoskeletal discomfort, Musculoskeletal pain
Clinical narrative: Woke up in middle of night with left shoulder feeling of internal burning sensation and extreme pain and discomfort. This has been felt since day 1 after the vaccination, but it finally reached a point to where it was extremely painful, instead of gradually subsiding.
Age: 80.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Erythema of eyelid, Eye pain, Eyelid ptosis, Visual acuity reduced
Clinical narrative: The patient started with right eye pain at onset of adverse event. The next morning the pain had worsened along with a new adverse effect of eye drooping in the same eye (right). She also had decreased visual acuity and erythema around the eye. The patient saw her opthalmologist who thinks it is related to the Zostavax injection. Treatment with Systane Ultra.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Injection site reaction- redness, warm to touch, itchiness, tenderness.
Age: 11.0
Sex: F
Vaccine: FLUN3, HPV4, MNQ, TDAP
Symptoms: Erythema, Swelling
Clinical narrative: Large swollen area with redness. Treated with Benadryl and Motrin.
Age: 55.0
Sex: M
Vaccine: HEPA
Symptoms: Audiogram, Deafness, Nuclear magnetic resonance imaging, Tinnitus
Clinical narrative: Severe tinnitus and hearing loss.
Age: 57.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Asthenia, Back pain, Hypoaesthesia, Mobility decreased, Neck pain
Clinical narrative: My arm starting going numb, and extreme amount of pain, could not lift my arm as the day went on, very weak. The pain got worse as the day progressed, spreading up my neck and down my back.
Age: 57.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain in extremity
Clinical narrative: My arm starting going numb, and extreme amount of pain, could not lift my arm as the day went on, very weak. The pain got worse as the day progressed, spreading up my neck and down my back.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Asthenia, Erythema, Injection site pain, Pain, Swelling
Clinical narrative: Painful site of injection, swelling, reddening. Asthenia and overall body aches.
Age: 0.0
Sex: M
Vaccine: HEP
Symptoms: Cardiac monitoring, Chest X-ray, Computerised tomogram, Electrocardiogram, Heart rate decreased
Clinical narrative: Low heart rate, Low oxygen levels
Age: 0.0
Sex: M
Vaccine: HEP
Symptoms: Oxygen saturation decreased
Clinical narrative: Low heart rate, Low oxygen levels
Age: 3.0
Sex: M
Vaccine: DTAP, HEPAB, HIBV, MEN
Symptoms: Erythema multiforme
Clinical narrative: Developed and was diagnosed with Erythema multiforme minor by his doctor. Today is day 6 and the "rash" continues to reappear and fade throughout the day. Doctor said to use Ibuprofen and Benadryl to help with any discomfort from the "rash" or the joint pain. No other illness present.
Age: 51.0
Sex: M
Vaccine: FLUX
Symptoms: Chills, Dyspnoea, Headache, Heart rate increased, Pain
Clinical narrative: Fever, chills, violent shaking, rapid heart rate, breathing difficulties.  Head and body aches.
Age: 51.0
Sex: M
Vaccine: FLUX
Symptoms: Pyrexia, Tremor
Clinical narrative: Fever, chills, violent shaking, rapid heart rate, breathing difficulties.  Head and body aches.
Age: 43.0
Sex: M
Vaccine: FLU3
Symptoms: Cellulitis, Chest pain, Erythema
Clinical narrative: Patient woke up with pain on his right chest with redness. His physician diagnosis him with celluitis and told him it was possible from the flu vaccine (Afluria).
Age: 18.0
Sex: F
Vaccine: HPV4, TDAP, VARCEL, HPV4, TDAP, VARCEL
Symptoms: Antiacetylcholine receptor antibody positive, Balance disorder, Diplopia, Dysphagia, Electromyogram abnormal
Clinical narrative: Approximately 2 days after administration of vaccines, pt began to develop blurry vision, which progressed to diplopia, and inability to move left eye. Also progressively began having balance/gait disturbances, nausea, oral muscle weakness, arm weakness, difficulty swallowing. Visual disturbance progressed to rt. eye. Final diagnosis: Myasthenia Gravis.
Age: 18.0
Sex: F
Vaccine: HPV4, TDAP, VARCEL, HPV4, TDAP, VARCEL
Symptoms: Eye movement disorder, Gait disturbance, Lumbar puncture normal, Muscular weakness, Myasthenia gravis
Clinical narrative: Approximately 2 days after administration of vaccines, pt began to develop blurry vision, which progressed to diplopia, and inability to move left eye. Also progressively began having balance/gait disturbances, nausea, oral muscle weakness, arm weakness, difficulty swallowing. Visual disturbance progressed to rt. eye. Final diagnosis: Myasthenia Gravis.
Age: 18.0
Sex: F
Vaccine: HPV4, TDAP, VARCEL, HPV4, TDAP, VARCEL
Symptoms: Nausea, Nuclear magnetic resonance imaging spinal cord normal, Scan with contrast normal, Vision blurred, Visual impairment
Clinical narrative: Approximately 2 days after administration of vaccines, pt began to develop blurry vision, which progressed to diplopia, and inability to move left eye. Also progressively began having balance/gait disturbances, nausea, oral muscle weakness, arm weakness, difficulty swallowing. Visual disturbance progressed to rt. eye. Final diagnosis: Myasthenia Gravis.
Age: 18.0
Sex: F
Vaccine: HPV4, TDAP, VARCEL, HPV4, TDAP, VARCEL
Symptoms: Antiacetylcholine receptor antibody positive, Computerised tomogram head, Diplopia, Dysphagia, Electromyogram
Clinical narrative: Approximately 2 days after administration of vaccines, pt began to develop blurry vision, which progressed to diplopia, and inability to move left eye. Also progressively began having balance/gait disturbances, nausea, oral muscle weakness, arm weakness, difficulty swallowing. Visual disturbance progressed to rt. eye. Final diagnosis: Myasthenia Gravis.
Age: 18.0
Sex: F
Vaccine: HPV4, TDAP, VARCEL, HPV4, TDAP, VARCEL
Symptoms: Eyelid ptosis, Gait disturbance, Headache, Lumbar puncture, Myasthenia gravis
Clinical narrative: Approximately 2 days after administration of vaccines, pt began to develop blurry vision, which progressed to diplopia, and inability to move left eye. Also progressively began having balance/gait disturbances, nausea, oral muscle weakness, arm weakness, difficulty swallowing. Visual disturbance progressed to rt. eye. Final diagnosis: Myasthenia Gravis.
Age: 18.0
Sex: F
Vaccine: HPV4, TDAP, VARCEL, HPV4, TDAP, VARCEL
Symptoms: Nuclear magnetic resonance imaging
Clinical narrative: Approximately 2 days after administration of vaccines, pt began to develop blurry vision, which progressed to diplopia, and inability to move left eye. Also progressively began having balance/gait disturbances, nausea, oral muscle weakness, arm weakness, difficulty swallowing. Visual disturbance progressed to rt. eye. Final diagnosis: Myasthenia Gravis.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Urticaria
Clinical narrative: Welts on face, lips, neck.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Burning sensation, Ear pain, Herpes zoster, Neck pain, Rash vesicular
Clinical narrative: Welts on face, lips, neck.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Varicella virus test positive
Clinical narrative: Welts on face, lips, neck.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Blood creatine phosphokinase, Muscle spasms, Myalgia, Pain
Clinical narrative: 09/19/12 Patient c/o excruciating pain "entire body hurts". Started 4 days after receiving Tdap. States every muscle in charley horsing & cramping pain --> Tx increased fluids, TYLENOL, FLEXERIL, check CK.
Age: 51.0
Sex: F
Vaccine: HEPAB
Symptoms: Dizziness, Feeling hot, Hyperhidrosis, Nausea, Presyncope
Clinical narrative: Patient said, ER Dr said vasovagal Rxn. Patient was seated for injection. After I gave the shot I asked if she was OK and she said she felt dizzy, nauseous, hot, sweaty. I had her put her head down. It seemed to come & go. The store manager called 911. They gave her oxygen and convinced her to go to ER. They took her to the hospital at 2 PM.
Age: 71.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling, redness, tenderness at injection site.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: Swollen on the site & goes to the neck.
Age: 0.4
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Convulsion
Clinical narrative: Patient was observed by parents to have a seizure. Pt was taken to ER. This clinic referred pt. to Neuro clinic and ordered EEG.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscular weakness
Clinical narrative: Pt reports "weakness in legs & dizziness on day 3 after ZOSTAVAX administration. No physician visit, tests, or treatment have be administered to my knowledge thus far.
Sex: U
Vaccine: FLUX, HPV4, MNQ
Symptoms: Convulsion
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age. On an unspecified date the patient was vaccinated intramuscularly with a dose of GARDASIL (Lot# and dose not reported). Concomitant medications included influenza virus vaccine (unspecified) and MENACTRA. On an unknown date the patient experienced seizure after having GARDASIL. The patient did not seek for medical attention. No treatment was give. At the time of this report the patient had recovered from seizure. Upon internal review, seizure was determined to be an other important medical event. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: PPV, TDAP, VARZOS
Symptoms: Nodule, Pain, Pyrexia, Rash
Clinical narrative: Fever 102. Body aches rash on arm with knot.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Chest pain, Musculoskeletal pain, Oedema peripheral, Pruritus
Clinical narrative: Two days after receiving shingles upper arm begin, to swell (softball size). Secondary swelling occurred throughout arm. Arm was itching, burning, aching to shoulder and chest. Pt received prednisone and BENADRYL from doctor and adverse event subsided. Pt doing fine.
Age: 4.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus, Rash erythematous
Clinical narrative: Pt. rec. flu vaccine 9-13-12 - with mother - pt. went to father's house - mom didn't see her for 2 days - pt. returned home c/o itching to site - mother noticed red rash.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Varicella
Clinical narrative: Developed chicken pox.
Age: 0.14
Sex: F
Vaccine: DTAPIPVHIB, IPV, PNC13
Symptoms: Drug administration error
Clinical narrative: Misadministration --> inadvertently received PENTACEL and IPOL injections.
Sex: U
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 patient of unknown age. The patient received the first two doses of GARDASIL (lot # not reported) in 2009 (dates of the first two doses were unspecified). The patient was in the office on 13-AUG-2012 to receive the third dose of GARDASIL (lot # not reported). No adverse event reported. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner refers to a multiple patients of unknown ages who on an unknown dates, were vaccinated with the third dose of GARDASIL (doses, routes and lot numbers not reported). The third dose of GARDASIL was administered eight weeks after the second dose. No adverse symptoms were reported. Attempts are being made to obtain additional information identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a patient of unknown age who on 12-SEP-2012, was vaccinated with the first dose of GARDASIL (dose, route and lot number not reported) that could not have been improperly stored. No adverse events were reported. This is one of several reports from the same source. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a patient of unknown age who on 28-JUN-2012, was vaccinated with the third dose of GARDASIL (dose, route and lot number not reported) that could have been improperly stored. No adverse events were reported. This is one of several reports from the same source. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a patient of unknown age who on 03-JUL-2012, was vaccinated with the second dose of GARDASIL (dose, route and lot number not reported) that could have been improperly stored. No adverse events were reported. This is one of several reports from the same source. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a patient of unknown age who on 13-AUG-2012, was vaccinated with the second dose of GARDASIL (dose, route and lot number not reported) that could have been improperly stored. No adverse events were reported. This is one of several reports from the same source. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a patient of unknown age who on 13-AUG-2012, was vaccinated with the third dose of GARDASIL (dose, route and lot number not reported) that could have been improperly stored. No adverse events were reported. This is one of several reports from the same source. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a patient of unknown age who on 28-JUL-2012, was vaccinated with the third dose of GARDASIL (dose, route and lot number not reported) that could have been improperly stored. No adverse events were reported. This is one of several reports from the same source. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant (also reported as healthcare worker, C.M.A.) refers to a 18 years old female patient. It was reported that the patient received the second dose of GARDASIL (lot # not reported) in November 2010 and asked if she could be administered the third dose of GARDASIL on 13-SEP-2012. No adverse events were reported. It was unspecified whether the patient sought for medical attention. The outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a patient of unknown age who on 10-SEP-2012, was vaccinated with the first dose of GARDASIL (dose, route and lot number not reported) that could have been improperly stored. No adverse events were reported. This is one of several reports from the same source. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a female patient of unknown age. The patient was intramuscularly vaccinated with first dose of GARDASIL (lot number not reported) on 09-SEP-2011 and would be administered the second dose on 14-SEP-2012. No other co-suspects or concomitant medications were reported. No adverse effect reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Injection site haemorrhage
Clinical narrative: This spontaneous report was received from a registered pharmacist refers to a 65 years old male patient with no pertinent medical history and no drug reactions or allergies who on 23-AUG-2012, was vaccinated subcutaneously with a dose of ZOSTAVAX (lot number 0364AE, Exp. Date: 16-MAR-2013). No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that on 23-AUG-2012, the patient bled a little at the injection site during the administration of ZOSTAVAX. It was stated that the patient also received less than the recommended dose of ZOSTAVAX because some of the solution leaked out between the syringe and the needle. No treatment was given for the experience. No lab diagnostic studies were performed. The patient recovered on 23-AUG-2012. The patient sought medical attention by seeing the pharmacist. The relatedness for patient bled a little at the injection site during the administration of ZOSTAVAX was unknown for ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: HIV test positive
Clinical narrative: This spontaneous report was received from a doctor of pharmacy concerning a patient with unspecified gender, age, pertinent medical history or drug reactions / allergies. Pharmacist reported that two weeks ago on 24-AUG-2012, the patient was vaccinated with MMR II and VARIVAX (Merck) (dose, route were not reported). No concomitant medications were reported. On an unknown date, the patient recently tested positive for HIV from a rapid test. The patient sought unspecified medical attention. Treatment was not reported. At the time of report, the patient's outcome was unknown. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster, Rash
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 14 years old female patient. The patient was vaccinated with a 0.5ml dose 1 and a 0.5ml dose 2 of (Merck) VARIVAX (lot # and route not reported) on 08-MAR-1999 and 04-MAR-2008 respectively. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient went into the office with a rash that was identified as shingles. No treatment information was reported. The outcome of rash that was identified as shingles was reported as recovered on an unspecified date. The relatedness for rash that was identified as shingles was not provided for (Merck) VARIVAX. This is one of several reports received from the same source. Additional information has been requested.
Age: 19.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a 19 years old patient. The patient was vaccinated with a pediatric 0.5 ml dose of VAQTA (Lot # not reported) on 13-SEP-2012. No adverse effects were reported. Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report was received from a medical assistant refers to a 48 years old female patient with no pertinent medical history and not drug reaction or allergies who on 02-JUL-2012, was vaccinated subcutaneously on right upper arm with a single dose of ZOSTAVAX (lot number 672676/0069AE, Exp. Date: 03-APR-2013) (dose not reported). No other co-suspects were reported. Concomitant medications included: progesterone cream. The medical assistant reported that on an unspecified date, in approximately July 2012, the patient developed redness at the injection site. The injection site reaction resolved in four days without requiring treatment. No lab diagnostics studies were performed. At the time of the report, the patient recovered (date not provided). The patient came to the office for a routine exam on 13-AUG-2012 and reported reaction at that time. The relatedness for redness at the injection site was unknown for ZOSTAVAX. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Confusional state, Headache, Injection site rash, Pain, Pyrexia
Clinical narrative: This spontaneous report as received from a 59 years old female patient reporting on herself. The patient was vaccinated with a dose of ZOSTAVAX (Dose, route and lot number not reported), Left arm on 28-JUN-2012. No other co-suspects were reported. Concomitant medications included NEURONTIN, cetirizine hydrochloride and gabapentin. On an unknown date the patient has pain, headache, fever, and rash from shoulder to shoulder to the left hand of side her neck, patient was also suffering with confusion. There was a treatment given for the events. The outcome of pain, headache, fever, and rash from shoulder to shoulder to the left hand of side her neck and patient was also suffering with confusion was reported as recovering/resolving. The relatedness for pain, headache, fever, and rash from shoulder to shoulder to the left hand of side her neck, patient was also suffering with confusion was unknown for ZOSTAVAX. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a 59 years old female patient reporting on herself. The patient was vaccinated with a dose of ZOSTAVAX (Dose, route and lot number not reported), Left arm on 28-JUN-2012. No other co-suspects were reported. Concomitant medications included NEURONTIN, cetirizine hydrochloride and gabapentin. On an unknown date the patient has pain, headache, fever, and rash from shoulder to shoulder to the left hand of side her neck, patient was also suffering with confusion. There was a treatment given for the events. The outcome of pain, headache, fever, and rash from shoulder to shoulder to the left hand of side her neck and patient was also suffering with confusion was reported as recovering/resolving. The relatedness for pain, headache, fever, and rash from shoulder to shoulder to the left hand of side her neck, patient was also suffering with confusion was unknown for ZOSTAVAX. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a doctor of pharmacy refers to a patient of unknown age who on 14-SEP-2012, was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (lot number 671004/0729AA) that was expired. The vaccine expired on 17-AUG-2012. No adverse effects were reported. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster, Rash
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 16 year old female patient. The patient was vaccinated with, a 0.5 ml dose of VARIVAX (Merck) (Lot # not reported) on 09-JUL-1998. No other co-suspects were reported. No concomitant medications were reported. The nurse reported that on an unknown date, the patient went to the office with rash that was identified as shingles. The outcome of shingles was reported as recovered/resolved. Additional information has been requested.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Rash
Clinical narrative: This spontaneous report as received from a registered nurse refers to her approximately 10 years old male son. The patient was vaccinated with (Merck) VARIVAX (dose, route and lot number not provided) some time in 1996. No other co-suspects were reported. No concomitant medications were reported. Shortly after receiving this vaccine, he had developed a minor rash in an unspecified location. The patient had 4 or 5 small blisters. It was unspecified if the patient had sought medical attention. No treatment was given for the adverse events. The patient was 16 years old and was fine at time of this report. At the time of the report the patient had recovered. Additional information is not expected.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Induration
Clinical narrative: This spontaneous report as received from a physician refers to a 63 years old male patient with no pertinent medical history and no drug reactions/allergies. The patient was vaccinated intradermally with ZOSTAVAX (lot number not reported) on 11-SEP-2012. No other co-suspects were reported. No concomitant medications were reported. On 12-SEP-2012 the patient developed 4 cm diameter in induration and blister. The patient had sought unspecified medical attention. No laboratory diagnostics studies were performed. Antibiotics were given for treatment. The outcome of the events was unknown. This is one of two patients received from the same reporter. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Induration
Clinical narrative: This spontaneous report as received from a physician refers to a 63 years old female patient with no pertinent medical history and no drug reactions/allergies. The patient was vaccinated intradermally with ZOSTAVAX (lot number not reported) on 11-SEP-2012. No other co-suspects were reported. No concomitant medications were reported. On 12-SEP-2012 the patient developed 4 cm diameter in induration and blister. The patient had sought unspecified medical attention. No laboratory diagnostics studies were performed. Antibiotics were given for treatment. The outcome of the events was unknown. The is one of two patients received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an adolescent patient of unknown age. The patient was inadvertently vaccinated with a second dose of RECOMBIVAX HB (Lot # not reported) 7 days too early than recommended scheduled due date in series at an unspecified time. No adverse effect was reported. Additional information is not expected.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a 56 years old female registered pharmacist with no pertinent medical history and no drug reactions or allergies reporting on herself. The patient was vaccinated with a 0.65 ml dose of ZOSTAVAX (Lot # not reported) SQ on 11-SEP-2012. No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that on 13-SEP-2012, she experienced an injection site reaction of redness and swelling. The patient was treated with hydrocortisone cream. There were no Lab diagnosis or studies performed. The patient recovered on 17-SEP-2012. Additional information is not expected.
Age: 1.26
Sex: U
Vaccine: VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 1 years old patient who on 22-MAR-2012, was vaccinated with the first dose of (Merck) VARIVAX and on 14-JUN-2012, was vaccinated with the second dose (doses, routes and lot numbers not reported). No adverse events were reported. This is one of several reports from the same source. Additional information is not expected.
Age: 1.39
Sex: M
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Information has been received from a Bachelor of Science in Nursing (B.S.N.), concerning a 16 months old male child. The patient had no pertinent medical history and no known drug allergies. On 20-AUG-2012, the patient was vaccinated subcutaneously with a dose of (Merck) VARIVAX (lot #: 0045AE; Expiration date: 20-DEC-2013). There were no concomitant medications reported. On 29-AUG-2012, the patient developed "three spots on him". No treatment was given for the event. No lab diagnostic studies were performed. The patient sought medical attention through phone call to office. At the time of the report, the patient's outcome for the three spots on him was not recovered/not resolved. Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Accidental exposure, Burning sensation, Needle issue
Clinical narrative: This spontaneous report as received from a registered nurse refers to a female medical assistant of unknown age with sulfa allergy and no pertinent medical history. The medical assistant was administering a dose of lot # (1418AA; exp date 25-MAY-2013) PNEUMOVAX23 (dose not reported) to a patient on 11-SEP-2012 and some vaccine splashed in the right eye and face. No other co-suspects were reported. There were no concomitant medications. On 11-SEP-2012 the medical assistant's face was burning but the right eye had no symptoms. The nurse stated that the needle was not put on correctly. The right eye was flushed out for 5 minutes and was going to be flushed out for an additional 10 minutes and wash the face area that was burning. No lab diagnostic tests were performed. The patient sought unspecified medical attention. On 11-SEP-2012 the patient recovered from the reported events. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report was received from a doctor of pharmacy refers to a 66 years old female patient with no pertinent medical history, no drug reactions or allergies and a skin disorder who on 24-AUG-2012, was vaccinated subcutaneously with a 0.65 ml dose ZOSTAVAX (lot number not reported). No other co-suspects were reported. The patient using unspecified ointments and creams for her skin condition prior to vaccination with ZOSTAVAX. The pharmacist reported that the patient came into the pharmacy on 14-SEP-2012, with a prescription for prednisone 60 mg for 5 days and Z-PAK. The pharmacist did not feel that the prednisone and the Z-PAK were related to the patient receiving ZOSTAVAX. No labs diagnostics studies were performed. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Haemorrhage
Clinical narrative: This spontaneous report as received from a 60 years old female reporting on herself with no allergies, diabetes, high cholesterol and high blood pressure. The patient was vaccinated with dose 1 ZOSTAVAX (dose, route and lot # not reported) on 12-SEP-2012. No other co-suspects were reported. Concomitant medications included: SYNTHROID and LIPITOR. On an unknown date the patient bled after getting the ZOSTAVAX. No treatment information was reported. The outcome of patient bled was unknown. The relatedness for patient bled after getting the ZOSTAVAX was unknown for ZOSTAVAX. Additional information is not expected.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Immediate post-injection reaction
Clinical narrative: This spontaneous report was received from a 71 years old female patient with allergy to COMPAZINE and no pertinent medical history. The patient was vaccinated subdermally with a dose of ZOSTAVAX on 04-JUL-2012. Concomitant medication included "cholesterol medication and a slow metabolism". The patient reported that she got shingles immediately after getting the vaccine and had had the shingles on her body since 12-JUL-2012. The outbreak was on the back, chest and upper left arm. The patient had sought unspecified medical attention. The outcome of shingles was unknown. Additional information has been requested.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from an advance registered nurse practitioner refers to a 84 years old female patient who on 13-SEP-2012, was vaccinated subcutaneously on her upper right arm with a 0.65 ml dose of ZOSTAVAX (lot number 667609/1354Z) that was expired. The vaccine expired on 26-OCT-2011. No adverse effects were reported. Additional information is not expected.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired drug administered, Feeling abnormal, Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a an approximately 59 year old female patient with penicillin allergy and no pertinent medical history. On 20-AUG-2012, the patient was vaccinated subcutaneously in the left arm with, 0.65 ml ZOSTAVAX lot: 0071AE exp: 03-APR-2012. No concomitant medications were reported. Pharmacist stated a patient received ZOSTAVAX and at the injection site it looked like a "bee sting". The size was 2.5 inch diameter across at the injection site. Within the 2.5 inch diameter across at the injection site, the middle portion was red, raised and 1.5 to 2 inches in diameter surrounded by another 1/2 inch diameter that was lighter in color. The patient also was not feeling perfect. The patient sought medical attention by visiting the pharmacy. Labs were not performed. No treatment for the event was given. At the time of the report, the patient was recovering. Additional information has been requested.
Age: 67.0
Sex: U
Vaccine: PPV
Symptoms: Incorrect dose administered, Needle issue, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning to a 67 years old patient who in 2006 was vaccinated IM with a dose of PNEUMOVAX 23 (dose and lot # not provided) and on 24-AUG-2012, the patient received a second dose of PNEUMOVAX 23 (dose and lot # not provided). The nurse stated that during the vaccination on 24-AUG-2012, the hub of the needle became loose. The vaccine leaked from the hub, resulting in a partial dose of PNEUMOVAX 23 administered to the patient. No adverse effect was reported. This is one of several reports received from the same source. Additional information is not expected.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: This spontaneous report was received from a registered pharmacist concerning a 70 years old female patient with high cholesterol and diabetes and no known drug reactions/allergies who on 21-AUG-2012 was vaccinated with a dose of ZOSTAVAX 0.65 mL subcutaneous (lot# not provided). Concomitant therapy included "a lot of medications" (unspecified). On 24-AUG-2012, the patient developed "1/2 dollar size" around the injection site that was red, tender and hot. No treatment was given for the events and no event. The relatedness for the events was unknown for ZOSTAVAX. Additional information is not expected.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Blood pressure increased, Expired drug administered, Malaise
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 65 years old female patient. On 10-SEP-2012 the patient was vaccinated with a dose of 0.5 ml PNEUMOVAX 23 (lot # 669579/0595AA) that expired on 30-AUG-2012 intramuscularly in deltoid. It was reported that the patient had called the pharmacy on 13-SEP-2012 complaining that she "wasn't feeling well" and that she thought her blood pressure might be elevated. The patient did not seek medical attention. The outcome was unknown. Additional information has been requested.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Chest pain, Sleep disorder, Spinal pain
Clinical narrative: This spontaneous report as received from a consumer concerning her 75 years old husband. The patient's medical history included 4 operations in his back and 2 hernias. The patient was vaccinated with a dose of ZOSTAVAX (Lot # not reported) in 2008. No other co-suspects were reported. Concomitant medications included simvastatin (manufacturer unknown), LANOXIN and allopurinol. The consumer reported that since 2008, the patient had been in pain up to this time. He had pain on the right side of his chest and along his spinal cord. He also had hard time resting. His sleep patterns were on and off. The patient was treated with laser injections and acupuncture. The patient sought unspecified medical attention. At the time of the report, the patient had not recovered. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site vesicles
Clinical narrative: This spontaneous report was received from a registered nurse concerning a female patient who on an unknown date was vaccinated with a dose of ZOSTAVAX, 0.65 mL (route and lot # not provided). On an unknown date, the patient developed an injection site rash and just a few vesicles. At the time of the report, the event outcomes were unknown. It was unspecified if the patient sought medical attention. The relatedness for the events was unknown for ZOSTAVAX. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Injection site haematoma, Injection site pain, Pain in extremity
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 62 years old female patient. It was noted by the pharmacist that "the patient stated she does bruise easily". The patient had drug allergies to codeine and acetaminophen, PERCOCET. On 07-AUG-2012 the patient was vaccinated with ZOSTAVAX (lot # reported as 0562AE, expiration date reported as 20-MAR-2013) subcutaneously. Concomitant medications included SAVELLA, alprazolam, estrogens, MENEST, gabapentin and hydrocodone bitartrate, ibuprofen (reported as hydrocodone with ibuprofen). Some unspecified date after being administered ZOSTAVAX, the patient developed "bruising and soreness over the entire arm where the vaccine was administered, no just at the injection site". The patient sought for medical attention by visiting the pharmacy. No treatment was given. Lab diagnostics studies performed were reported as none. The patient's status was not recovered at the time of reporting. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: This spontaneous report was received from a physician concerning her child - a female of unknown age, who in 2010 was vaccinated with the second dose of VARIVAX (Merck) 0.5 mL (route and lot not reported). No other co-suspects were reported. NO concomitant medications were reported. It has been reported that in 2010 the patient developed chickenpox after receiving the second dose of VARIVAX (Merck). No treatment was given. The outcome of developed chickenpox was reported as recovered/resolved. No laboratory diagnostic studies were performed. The patient did not seek medical attention. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified patient. The patient was vaccinated with a dose of ZOSTAVAX (lot # 669746/0356AA) on 11-SEP-2012, which had expired on 09-JUN-2012. No adverse effect reported. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 62 years old female patient with no pertinent medical history and no drug reactions/allergies. The patient was vaccinated subcutaneously with 0.65 ml ZOSTAVAX (lot number not reported) on an unspecified date in early June 2012. There were no concomitant medications. Subsequently the arm in which the vaccine was administered turned red and swelled from elbow to shoulder. The patient had sought unspecified medical attention. No treatment information was reported. Cellulitis was ruled out. The patient recovered on an unspecified date. This is one of several reports received from the same source. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a 78 years old female patient with allergies to TEQUIN, mobeck, Sulfur and CIPRO. "Five years ago" in approximately September 2007, the patient was vaccinated subcutaneously with a single dose of ZOSTAVAX (Lot# and dose not reported). In April 2012 the patient experienced a diagnosed case of the shingles after getting the vaccine. She had the shingles on her back, but stated it was a mild case. The patient sought for unspecified medical attention and was given oral medications for treatment. The patient's status was not reported. Additional information has been requested.
Age: 1.2
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 14 months old patient. On 04-SEP-2012 the patient was vaccinated with a 0.5 ml dose of ZOSTAVAX (Lot # 672675/0068AE, expired date 03-APR-2013) (route not reported). No adverse symptoms reported. It was not known if the patient sought for medical attention. Additional information has been requested.
Age: 89.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: This spontaneous report was received from a registered pharmacist refers to a 89 years old female patient with no pertinent medical history and allergy to tetracycline who on 11-SEP-2012, was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (lot number 0365AE, Exp. Date: 23-MAR-2013). No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that on 14-SEP-2012, the patient developed injection site red spots, rash and itching. It was also noted that the patient stated of a possible rash around her wrist, as well. No treatment was given for the experience. No lab diagnostics studies were performed. At the time of the report, the patient had not recovered. The patient sought medical attention by contacted the pharmacist. The relatedness for patient developed injection site red spots, rash and itching and possible rash around her wrist was unknown for ZOSTAVAX. Additional information is not expected.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a 77 years old female patient with no pertinent medical history and no drug reactions/allergies. The patient was vaccinated subcutaneously with 0.65 ml ZOSTAVAX (lot number not reported) on 02-AUG-2012. There was no concomitant medications. In August 2012, a couple of days after injection of ZOSTAVAX the patient developed rash at the injection site. No treatment was given for the event. No lab diagnostics studies were performed. The patient sought medical attention by contacting the pharmacist. The outcome of rash at the injection site was reported as not recovered/not resolved. The causal relationship between the rash at the injection site and ZOSTAVAX was not reported. Additional information is not expected.