chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.5
Sex: F
Vaccine: MMR
Symptoms: Convulsion, Scan brain, Type III immune complex mediated reaction
Clinical narrative: This spontaneous report as received from a consumer refers to a female patient now in her 30's reporting on herself. On an unknown date when the patient was 18 months old, the patient was vaccinated with combination of MMR (manufacturer unknown), (dose, route, lot number and expiration date not reported). On an unknown date the patient was hospitalized with seizures and she stated that she "almost died". Brain scan was done (results not provided). Patient visited different physicians and allergists and it had been determined that the patient experienced a severe immune reaction to the combination of measles and mumps in her body at the same time. At the time of the report the outcome of the events was unknown. She stated that her mother had a similar reaction after being infected with community acquired measles and mumps virus. Upon internal review the event of seizures was considered to be medically significant. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a female patient of unknown age. No concurrent conditions or medical history were provided. In 2012 (exact date unknown), the patient was vaccinated with a dose of ZOSTAVAX injection (strength, dose, route of administration, indication, lot# and expiry date unspecified). No concomitant medications were reported. The pharmacist reported that in 2012 (dates unspecified), the consumer developed Guillain-Barre post vaccination, was hospitalized for one month, and had to go through physical therapy. At the time of report, the patient was okay (date of recovery unknown). The relatedness between the event and ZOSTAVAX was not reported. Upon internal review the Guillain-Barre syndrome was considered to be medically significant. Additional information has been requested.
Age: 1.08
Sex: F
Vaccine: VARCEL
Symptoms: Blood culture negative, Computerised tomogram normal, Convulsion, Electroencephalogram normal, Lumbar puncture normal
Clinical narrative: This spontaneous report as received from a pharmacist refers to an approximately 13 month old female patient. No medical history was reported. Drug allergies/reactions was reported as none. On 17-SEP-2014, the physician vaccinated the patient with VARIVAX (Merck) (dose, route and frequency unknown). No concomitant medication is reported. On 01-OCT-2014, the patient experienced non-febrile seizure. The patient sought medical attention and was hospitalized the same day. On 01-OCT-2014, the following lab test was performed blood culture, urine screen, CAT scan, lumbar puncture, electroencephalogram (EEG) which was all normal. Oxygen was administered as intervention (the event considered to be medically significant by reporter). No treatment was provided for event. The patient recovered from the event on 01-OCT-2014 and was discharged on 03-OCT-2014. There was no product quality complaint. The causality for the event was not reported. Additional information has been requested.
Age: 1.08
Sex: F
Vaccine: VARCEL
Symptoms: Urine analysis normal
Clinical narrative: This spontaneous report as received from a pharmacist refers to an approximately 13 month old female patient. No medical history was reported. Drug allergies/reactions was reported as none. On 17-SEP-2014, the physician vaccinated the patient with VARIVAX (Merck) (dose, route and frequency unknown). No concomitant medication is reported. On 01-OCT-2014, the patient experienced non-febrile seizure. The patient sought medical attention and was hospitalized the same day. On 01-OCT-2014, the following lab test was performed blood culture, urine screen, CAT scan, lumbar puncture, electroencephalogram (EEG) which was all normal. Oxygen was administered as intervention (the event considered to be medically significant by reporter). No treatment was provided for event. The patient recovered from the event on 01-OCT-2014 and was discharged on 03-OCT-2014. There was no product quality complaint. The causality for the event was not reported. Additional information has been requested.
Age: 89.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Loss of consciousness, Nausea, Somnolence, Unresponsive to stimuli
Clinical narrative: Patient reportedly had severe chills, nausea, and passed out and could not be awaken.
Age: 38.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Hypersensitivity, Injection site pain, Injection site swelling
Clinical narrative: PPSV23 given to L deltoid IM on 10-13-14 AM. On 10-13-2014 reported to ER with C/O pain, swelling to L arm and C/O H/A and chill and C/O felt funny. On 10-14-2014 F/U at clinic with C/O elevated temp of 99, H/A and redness/edema to L arm with rash and itching.  Allergic reaction, cellulitis of upper arm. TX with TYLENOL #4 with codeine; Prednisone TID #15; ALLEGRA QDay
Age: 38.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Chills, Erythema, Feeling abnormal, Headache, Hypersensitivity
Clinical narrative: PPSV23 given to L deltoid IM on 10-13-14 AM. On 10-13-2014 reported to ER with C/O pain, swelling to L arm and C/O H/A and chill and C/O felt funny. On 10-14-2014 F/U at clinic with C/O elevated temp of 99, H/A and redness/edema to L arm with rash and itching.  Allergic reaction, cellulitis of upper arm. TX with TYLENOL #4 with codeine; Prednisone TID #15; ALLEGRA QDay
Age: 38.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injection site cellulitis, Oedema peripheral, Pain in extremity, Pruritus, Rash
Clinical narrative: PPSV23 given to L deltoid IM on 10-13-14 AM. On 10-13-2014 reported to ER with C/O pain, swelling to L arm and C/O H/A and chill and C/O felt funny. On 10-14-2014 F/U at clinic with C/O elevated temp of 99, H/A and redness/edema to L arm with rash and itching.  Allergic reaction, cellulitis of upper arm. TX with TYLENOL #4 with codeine; Prednisone TID #15; ALLEGRA QDay
Age: 38.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Swelling
Clinical narrative: PPSV23 given to L deltoid IM on 10-13-14 AM. On 10-13-2014 reported to ER with C/O pain, swelling to L arm and C/O H/A and chill and C/O felt funny. On 10-14-2014 F/U at clinic with C/O elevated temp of 99, H/A and redness/edema to L arm with rash and itching.  Allergic reaction, cellulitis of upper arm. TX with TYLENOL #4 with codeine; Prednisone TID #15; ALLEGRA QDay
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Paraesthesia
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a 68 year old male patient with no pertinent medical history and drug reactions/allergies. On 02-OCT-2014, at 11:45 AM, the patient was vaccinated with a dose of ZOSTAVAX, (lot # K007988. expire date 03-SEP-2014, 0.65ml, subcutaneously in the left deltoid). The patient took no concomitant medication. On 02-OCT-2014, "within 15 minutes" of receiving a dose of ZOSTAVAX, the patient started experiencing tingling in his left hand. The patient reported tingling in his left hand at 12:00 PM on 02-OCT-2014. The pharmacist did not provide any treatment for the patient, but the patient had been under observation at the pharmacist since he reporting the tingling. At the time of this report, 12:30 PM on 02-OCT-2014, the patient reported that the tingling was resolving. The seriousness criteria column of this report was not asked because the patient was conscious and oriented in the pharmacy at this time. Additional information has been requested.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Painful arm where injected.
Age: 50.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site rash, Rash, Viral rash
Clinical narrative: Approximately 2 days after receiving vaccine, patient noticed generalized rash at site of injection as well as opposite arm and torso. Dermatologist diagnosed him with vaccine related "viral exanthem". Not allergic reaction. No hives, no urticaria.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site reaction, Urticaria
Clinical narrative: Redness/soreness, welt the size of a deck of cards at site of injection, itching.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness
Clinical narrative: Patient felt lightheaded after flu shot leaving store. She sat down in aisle and used inhaler she carries. Sat for 10 minutes. Said she was okay - did not need assistance. She waited further about 20 min. She said she was okay and left. Called when she got home.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Hyperhidrosis, Nausea, Vomiting
Clinical narrative: Pt received FLUZONE HD at 11:30 AM on 10/14/14 - at 5:00 PM, pt experienced sweating, nausea and vomiting. At about 6:15 PM, pt is chill. She calls to the pharmacy and ask the pharmacist pt was advised to go to ER.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Blindness
Clinical narrative: Patient complains of loss of vision in right eye approximately 1 week after receiving flu vaccine (AFLURIA 2014-2015). On the date of reporting (10/10/14) patient states that the only improvement is a little brightness in peripheral vision.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site inflammation, Injection site rash, Injection site warmth
Clinical narrative: Left arm, injection site rash. At largest point (today), irregular circumference 2 inch by 3 inch. Redness, inflamed, hot to the touch. Pt states it is better today.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Injection site hypersensitivity, Injection site pain, Injection site pruritus, Injection site rash, Injection site reaction
Clinical narrative: Patient received 3 different vaccines on the same left arm. 3-4 hrs later patient experienced warmnss, tingling sensation, hot, pain and rash around the site of injection. Patient also experienced sensitivity and itchiness around the site of injection.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Injection site warmth, Paraesthesia
Clinical narrative: Patient received 3 different vaccines on the same left arm. 3-4 hrs later patient experienced warmnss, tingling sensation, hot, pain and rash around the site of injection. Patient also experienced sensitivity and itchiness around the site of injection.
Age: 18.0
Sex: F
Vaccine: FLU3
Symptoms: Fall, Syncope
Clinical narrative: After receiving the flu vaccine patient fainted within 5 minutes and fell on the ground. Emergency service was called and patient was taken to the hospital.
Age: 7.0
Sex: F
Vaccine: FLU3
Symptoms: Crying, Local swelling
Clinical narrative: The patient started crying and moving after I started the injection. The mother reported some local swelling the next day that was more than what she expected.
Age: 11.0
Sex: M
Vaccine: FLU3, HPV4, MNQ, TDAP
Symptoms: Dyskinesia, Presyncope
Clinical narrative: Patient almost fainted and had some jerking movement for 1-2 mins. Health Care Provider notified immediately and vital signs done. Patient stable after 5 mins, observed in clinic for 15 mins and release.
Age: 34.0
Sex: F
Vaccine: FLUC3
Symptoms: Chest discomfort, Flushing, Urticaria
Clinical narrative: Reported hives- both arms, facial flushing, mild chest, discomfort. Took BENADRYL- Resolved.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Local swelling, Nausea, Skin warm
Clinical narrative: Arm swelled, warm to touch, nausea, diarrhea.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Eye irritation, Headache, Lip swelling, Myalgia, Paraesthesia oral
Clinical narrative: 3 hr after vaccine, H/A, eyes burning, muscle achy, tingling lips, swelling lips and face. Sx continued x 3 days.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling face
Clinical narrative: 3 hr after vaccine, H/A, eyes burning, muscle achy, tingling lips, swelling lips and face. Sx continued x 3 days.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Blindness, Cough, Dyspnoea, Eye pain, Headache
Clinical narrative: Blurred vision changed to loss vision within 1 hour of vaccine, arm heavy, face puffy, eyes red and sore x 1 day, cough, difficulty breathing x 12 hr, headache x 4 days - no treatment.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Limb discomfort, Ocular hyperaemia, Swelling face, Vision blurred
Clinical narrative: Blurred vision changed to loss vision within 1 hour of vaccine, arm heavy, face puffy, eyes red and sore x 1 day, cough, difficulty breathing x 12 hr, headache x 4 days - no treatment.
Age: 51.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Blister, Generalised erythema, Pruritus, Skin discolouration, Swelling
Clinical narrative: All over redness, swelling, itchy, blisters, patch appearing as dark color.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia
Clinical narrative: 9/23/2014: Bilateral hip pain, the day after receiving flu vaccine, which still persists, until this day. Bilateral hip pain relieved with ADVIL.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dysstasia, Sleep disorder
Clinical narrative: Patient experienced severe chills to the point that she could barely stand. She experienced no other symptoms, but chills continued all night interfering with sleep. Symptoms spontaneously resolved morning of 10/14.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Anxiety, Chest discomfort, Headache, Hyperhidrosis, Urticaria
Clinical narrative: Hives scalp and face, chest tightness, anxiety, headache, diaphoresis. Onset less than 30 min after immunization. No prior rxn to flu vaccine. Rx BENADRYL 50 po, epinephrine 1/1000 s.c. 0.3 mL. This patient had previous similar rxns to many antibiotics.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Bacterial infection, Erythema, Local swelling, Skin warm
Clinical narrative: Bacterial infection - redness, warm to touch, swelling-spreading (upper arm). Emergency treatment - antibiotics and steroids.
Sex: M
Vaccine: FLU4
Symptoms: Hypoaesthesia oral, Paraesthesia oral
Clinical narrative: FLUZONE Quadrivalent administered approx. 4:00 p.m. Patient awakened at approx. 12:00 a.m. with numbness/tingling of tongue and lips. Symptoms resolved spontaneously after approx 1 hr.
Age: 1.26
Sex: M
Vaccine: DTAP, FLU3, HEPA, HIBV
Symptoms: Urticaria
Clinical narrative: Developed hives to his feet and chest. We observed him, family deferred antihistamines or other interventions at this time.
Age: 41.0
Sex: M
Vaccine: FLU4
Symptoms: Fatigue, Feeling abnormal, Pain, Pyrexia, Vomiting
Clinical narrative: Pt received FLUZONE Quad 10/13/14 and reported vomiting same night. Pt also had fever and "felt terrible" - aches and pains and run down/tired.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Migraine, Muscle spasms, Vaccine positive rechallenge
Clinical narrative: Pt received FLUZONE 0.5 ml 9-30-14. Migraine started same day. Muscle spasms severe 10/10/14. Had started earlier but not as severe.
Sex: U
Vaccine: FLU3
Symptoms: Eye colour change, Headache, Pyrexia, Rash generalised
Clinical narrative: Severe headache, high fever, rash entire body, blue eyes.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Injection site pain, Local swelling, Neck pain, Pain in extremity, Pyrexia
Clinical narrative: Received (3) IM injections yesterday: Tdap left arm, Flu and PNEUMOVAX in right arm. Few hrs later, reported tenderness upper left arm and a "throbbing" pain right arm, radiating down to fingers and up into neck. Reports low grade temp "just under 101', along with some swelling just above collar bone. Denies redness. Reassured her: some pain, redness, swelling and low grade fever are all normal symptoms for few days, after receiving IM injections. Took ibuprofen last night and again this morning. Wondering if she could take naproxen instead, since she ran out of ibuprofen. Informer her naproxen is only an anti-inflammatory, and will not help with the fever. Informed her she could take for the pain/swelling, but recommended TYLENOL for fever if needed. Also recommended ice to area of swelling, plenty of fluids and to call back if symptoms worsen and/or redness develops. Patient in agreement with plan.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness
Clinical narrative: Extreme dizziness 24 hrs after vaccine.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Headache, Local swelling, Malaise, Pain
Clinical narrative: Patient had severe tenderness, redness and swelling in arm in which injections were administered. He said he felt sick, achy and headache after he had the shots. Rxn last 2-3 days.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Tenderness
Clinical narrative: Patient had severe tenderness, redness and swelling in arm in which injections were administered. He said he felt sick, achy and headache after he had the shots. Rxn last 2-3 days.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pain in extremity
Clinical narrative: Shooting pain whenever I lifted my left arm. Severe for about 6 weeks. For the past 2 weeks it has been more minor pain with movement.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Local swelling, Skin warm
Clinical narrative: Shot given (PNEUMOVAX) 10/7/14. On 10/8/14 client calls complaining of swollen, hot upper arm. Patient told to see primary MD. MD prescribed KEFLEX, wants to perform MRI to rule out blood clot.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Local swelling, Skin warm
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 75 year old female patient with hypercholesteremia and hypertension. On 07-OCT-2014 the patient was vaccinated with the first dose of PNEUMOVAX23, 0.5ml, intramuscular (lot number reported as K006680, expiration date July 2015). Concomitant therapies included Simvastatin (manufacturer unknown) and Lisinopril. On 07-OCT-2014, after receiving the first dose of PNEUMOVAX23, her arm swelled, so that the circumference of her upper arm increased by an inch and was hot to the touch. No treatment was given for the event, nor laboratory test were performed. The patient had not recovered from the events. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal stiffness, Pallor, Paraesthesia, Peripheral coldness, Syncope
Clinical narrative: After approx. 15 sec. of flu administration pt. looked pale. Mom was by her side. She fainted briefly for 5-10 secs then came back to alertness. But her hands were stiff and cold. Complained of tingling sensations.
Age: 14.0
Sex: F
Vaccine: FLU3
Symptoms: Vagus nerve disorder
Clinical narrative: After approx. 15 sec. of flu administration pt. looked pale. Mom was by her side. She fainted briefly for 5-10 secs then came back to alertness. But her hands were stiff and cold. Complained of tingling sensations.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Confusional state, Decreased appetite, Ear pain, Hallucination, Productive cough
Clinical narrative: Coughing up brown stuff. Runny nose, ear ache. Loss of appetite. Confusion/hallucinations. Fever. Tx; rest and fluids.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Rhinorrhoea
Clinical narrative: Coughing up brown stuff. Runny nose, ear ache. Loss of appetite. Confusion/hallucinations. Fever. Tx; rest and fluids.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site mass, Injection site pain, Sensory disturbance
Clinical narrative: Bruising and lump at injection site for few days. Radiating sensation down arm and neck. Tender arm at injection site for approximately one week.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Limb discomfort
Clinical narrative: Pt complains of discomfort with movement of arm that was injected with vaccine.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Mass, Nausea, Pyrexia
Clinical narrative: She ran low grade fever, nausea. Lumps, bruising.
Age: 71.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Limb discomfort, Local swelling, Skin warm
Clinical narrative: Distinct red, raised circle on arm, warm to the touch, mild discomfort.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse via company representative refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with first dose of GARDASIL (dose and route of administration were not provided). Second dose was administered a year later on unspecified date. No adverse event reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site vesicles, Rash
Clinical narrative: Patient described non-injection site rash on leg. Rash was not raised. She went to hospital and they said it was just an immune response reaction (she also got one blister at injection site later in the day). Showing improvement.
Sex: U
Vaccine: DTAPHEPBIP, HEP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 18-SEP-2014 the patient was vaccinated with a dose of 0.5 ml RECOMBIVAX HB (strength and lot # unknown), injection, intramuscular. Other suspect therapies included PEDIARIX (strength, dose and route unknown) which was manufactured by GlaxoSmithKline, started on 18-SEP-2014. No adverse effected reported. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a male patient of unknown age. No concurrent conditions or medical history were provided. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX injection (strength, dose, route of administration, lot # and expiry date unspecified). No concomitant medications were reported. On an unknown date, after receiving ZOSTAVAX, the patient was diagnosed with shingles. The patient sought medical attention via visiting the office on an unspecified date. The outcome of the event was reported as recovered (date unknown). The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age. On an unknown dates the patients were vaccinated with a doses of improperly stored M-M-R II (dose, route of administration, lot number were not reported). There was no adverse effects reported. Product Quality Complaint (PQC) was not involved. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Red tender swollen area around the injection site.
Age: 1.85
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. Medical history and drug reactions or allergies were not specified. On an unknown date, unspecified number of patients were administered doses of VARIVAX (Merck) injection (dose, route and lot number were not reported) that were improperly stored. Concomitant medications were not specified. No adverse events were reported. This is one of several reports received from the same reporter. All telephone attempts to obtain follow-up information have been unsuccessful. Follow up information has been received from a nurse. The nurse provide the patient's demographics. This case concerning 22 months old female patient. On 09-SEP-2014 at 14:05, the patient was vaccinated with improperly stored VARIVAX (Merck) subcutaneous (lot # J-14407, expiration date: 13-NOV-2015). This is one of several reports received from the same reporter. Additional information is not expected as all information has been obtained.
Age: 83.0
Sex: F
Vaccine: PPV
Symptoms: Unevaluable event
Clinical narrative: None stated.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event, Product reconstitution issue
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a patient of unknown age and gender. The pharmacist reported that ZOSTAVAX 19,400 unit 1 standard package vial of 1 (dose, route, lot number and expiration date not reported) was reconstituted with an expired sterile diluent (lot number and expiration date not reported). There was no concomitant medication reported. Then on an unknown date the patient was vaccinated with this ZOSTAVAX. No adverse effects were noted. Additional information is not expected due to no permission to contact pharmacist was given.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site inflammation, Injection site pain, Nausea
Clinical narrative: Upper left arm inflamed and sore. Pt experienced nausea and went to hospital and received BENADRYL and a shot. Came to pharmacy today to report.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. On an unknown dates the patients were vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX (dose, route of administration, lot number were not reported). There was no adverse effects reported. Product Quality Company (PQC) was not involved. Additional information has been requested.
Age: 12.0
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 12 year old female patient. The nurse reported that the first in the series of GARDASIL (dose, lot number and expiration date were not provided) was administered to a patient of a year ago on an unspecified date (approximately in 2013) and the second dose of GARDASIL was administered on 10-OCT-2014 (dose, lot number and expiration date were not provided). No adverse effects were reported. The patient's outcome was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. No pertinent medical history was reported. Nurse reported that she had unspecified patients that received on an unspecified dates, their first dose of GARDASIL (dose, route, lot# were not reported) and then came back a year later on unspecified dates and received their second dose of GARDASIL. No adverse effects was reported. No Product quality Complaint (PQC) was involved. Additional information has been requested.
Age: 5.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to a patient of age 5 (unspecified units) (unknown gender). No pertinent medical history was reported. On 29-SEP-2014, the patient was vaccinated with (Oka/Merck) VARIVAX (lot # K002920 and expiration dates was 26-FEB-2016) dose 0.5 m, subcutaneous injection. Concomitant medications was not reported. The physician reported that temperature excursions beginning 11-AUG-2014, with worst case exposure to -3.9C for 110 hours affecting (Oka/Merck) VARIVAX with lot # K02920 and expiration date 26-FEB-2016. Excursion supported for use within 3 months. No adverse effects reported. Patient did not sought medical attention. No Product Quality Complaint (PQC) was involved. This is one of the several patients from the same source. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to a patient of 13 months old with unknown gender. No pertinent medical history was reported. On 18-SEP-2014, the patient was vaccinated with (Oka/Merck) VARIVAX (lot # K002920 and expiration date was 26-FEB-2016) dose 0.5 ml, subcutaneous injection. Concomitant medications was not reported. The physician reported that temperature excursions beginning 11-AUG-2014, with worst case exposure to -3.9C for 110 hours affecting (Oka/Merck) VARIVAX with lot # K002920 and expiration date 26-FEB-2016. Excursion supported for use within 3 months. No adverse effects reported. Patient did not sought medical attention. No Product Quality Complaint (PQC) was involved. This is one of the several reports from the same source. 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 medical assistant refers to a patient of unknown age and gender. On 13-OCT-2014 the patient was inadvertently vaccinated with an expired ZOSTAVAX (lot # J007301, expiry date: 20-SEP-2014, dose, units, route of administration, anatomical location were not reported). No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with PNEUMOVAX 23. Dose, route, lot number and expiration date were not reported. The nurse reported that PNEUMOVAX 23 was improperly stored and was administered to unspecified number of patients. No adverse effects reported. This is one of several reports from the same source. Additional information is not expected. No allowed to contact physician.
Sex: U
Vaccine: PPV
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. On 09-OCT-2014 the patient was vaccinated with an expired dose of PNEUMOVAX 23 (lot # J007786, expiration date 29-SEP-2014, 0.5 ml, intramuscularly). No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age and gender. No pertinent medical history was reported. On 24-SEP-2014, the patient was vaccinated with (Oka/Merck) VARIVAX (lot # K002920 and expiration date was 26-FEB-2016) dose 0.5 ml, subcutaneous injection. Concomitant medications was not reported. The physician reported that temperature excursions beginning 11-AUG-2014, with worst case exposure of -3.9C for 110 hours affecting (Oka/Merck) VARIVAX with lot # K002920 and expiration date 26-FEB-2016. Excursion supported for use within 3 months. No adverse effects reported. Patient did not sought medical attention. No Product Quality Complaint (PQC) was involved. This is one of several patients from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to a patient of age 6 (unspecified units) (unknown gender). No pertinent medical history was reported. On 04-SEP-2014, the patient was vaccinated with VARIVAX (Merck) (lot # K002920 and expiration date was 26-FEB-2016) dose 0.5 ml, subcutaneous injection. Concomitant medications was not reported. The physician reported that temperature excursions beginning 11-AUG-2014, with worst case exposure of -3.9C for 110 hours affecting VARIVAX (Merck) with lot # K002920 and expiration date 26-FEB-2016. Excursion supported for use within 3 months. No adverse effects reported. Patient did not sought medical attention. No Product Quality Complaint (PQC) was involved. This is one of the several patients from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with GARDASIL. Dose, route, lot number and expiration date were not reported. The nurse reported that GARDASIL was improperly stored and was administered to unspecified number of patients. No adverse effects reported. This is one of several reports from the same source. Additional information is not expected. No allowed to contact physician.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with MMR II. Dose, route, lot number and expiration date were not reported. The nurse reported that MMR II was improperly stored and was administered to unspecified number of patients. No adverse effects reported. This is one of several reports from the same source. Additional information is not expected. No allowed to contact physician.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to a patient of age 5 (unspecified units) (unknown gender). No pertinent medical history was reported. On 06-OCT-2014, the patient was vaccinated with VARIVAX (Merck) (lot # K002920 and expiration date was 26-FEB-2016) dose 0.5 ml, subcutaneous injection. Concomitant medications was not reported. The physician reported that temperature excursions beginning 11-AUG-2014, with worst case exposure of -3.9C for 110 hours affecting VARIVAX (Merck) with lot # K002920 and expiration date 26-FEB-2016. Excursion supported for use within 3 months. No adverse effects reported. Patient did not sought medical attention. No Product Quality Complaint (PQC) was involved. This is one of the several patients from the same source. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to an 80 year old female patient. On 07-OCT-2014 the patient was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 (lot # J014399, exp date 20-NOV-2014) via intramuscular route. On 07-OCT-2014, the patient experienced swelling, redness and pain after receiving PNEUMOVAX 23. The outcome of the events was unknown. Pharmacist declined to request a Lot check. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site joint pain, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: This spontaneous report as received from a medical assistant via a company representative refers to a 73 year old female patient with a penicillin allergy. The patient's medical history included breast cancer. On 08-OCT-2014 the patient was vaccinated with PNEUMOVAX 23 (single dose, 0.5 ml, intramuscular, in the left deltoid, lot number reported as: K009106, expiry date reported as: 25-FEB-2016). Concomitant therapies included NOVOLOG FLEXPEN. On 09-OCT-2014 the patient experienced redness, swelling, pain in the left deltoid at the injection site and developed a 101.2 (units not provided) fever. At a follow-up visit (in October 2014, date unspecified) the patient's fever had gone down at 99.3 (units not provided) and the adverse event was 80% resolved but the elbow was by that time still tender. The patient was given CELEBREX 200 mg, bid for five days and hydrocodone 10-325 as a treatment for adverse events. The patient sought medical attention (unspecified). The outcome of events was reported as recovering. The relatedness between events and PNEUMOVAX 23 was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age. On an unknown dates the patients were vaccinated with a dose of improperly stored GARDASIL (dose, route of administration, lot number were not reported). There was no adverse effects reported. Product Quality Complaint (PQC) was not involved. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Ocular hyperaemia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 year old female patient. None of pertinent medical history was reported. None of drug reactions/allergies was reported. On 30-SEP-2014 the patient was vaccinated with a dose of ZOSTAVAX, dose/frequency:0.65ml/once, subcutaneous (dose number and lot# not reported). Secondary suspect therapies included PNEUMOVAX 23, which was vaccinated on 07-OCT-2014 (dosage, dose number, route, lot # not reported). Concomitant therapies included simvastatin (manufacturer unknown), tramadol hydrochloride, hydrochlorothiazide, DIOVAN HCT, atenolol and venlafaxine. On 01-OCT-2014, the patient experienced "blood shot eye". The patient also received PNEUMOVAX 23  on 07-OCT-2014 while she still had the "blood shot eye." She was not seeking medical attention from the pharmacist. She just happened to mention to the pharmacist that she had the "blood shot eye" when she came in to pick up a prescription. No treatment was given for "blood shot eye". The outcome of "blood shot eye" was reported as not recovered/not resolved. Additional information is not expected because the reporting pharmacist gave no consent to be contacted.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to an unspecified number of patient of unknown age and gender. The nurse reported that the vaccine GARDASIL underwent a temperature excursion, then on an unknown date unspecified amount of patients were vaccinated with this GARDASIL (dose 0.5 ml, lot number and expiration date not reported) intramuscular. There was no concomitant medication reported. No adverse effect reported. This is one of two reports from the same source. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX 19400 PFU (dosing regimen unspecified). No concomitant medications were reported. On an unknown date pharmacist reported that 2 patients experienced a good amount of swelling about 5 to 6 inches long at the injection site after receiving ZOSTAVAX. Pharmacist reported the injection site was red and warm. Pharmacist reported physician thought it could be cellulitis and prescribed KEFLEX as a prophylactic. The outcome of cellulitis, pharmacist reported the injection site was red and warm and a good amount of swelling about "5 to 6 inches long" at the injection site after receiving ZOSTAVAX was reported as recovered/resolved on an unknown date. There was no product quality complaint (PQC) involved. Patient sought medical attention and saw the doctor. Causality assessment was not provided. This case is linked to: 1410USA000642 (Same reporter). Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a physician via a field employee refers to a young girl of unknown age. On an unspecified date at an unspecified time, the patient was vaccinated with a dose of GARDASIL injection, 0.5 ml, once, intramuscular (lot # and expire date were not reported). Concomitant therapy was not reported. The patient waited 30 minutes in office post vaccination then went to a local restaurant nearby (unspecified) where she fainted. An ambulance was called by restaurant personnel, the patient was determined to be "fine" and did not go to emergency department. A report of incident was made to an unspecified source. The patient present status was reported as "doing fine". The relationship between adverse event and GARDASIL was not reported. All telephone attempts to obtain follow-up information have been unsuccessful. This is one of several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX 19400 PFU (dosing regiment unspecified). No concomitant medications were reported. On an unknown date pharmacist reported that 2 patients experienced a good amount of swelling about 5 to 6 inches long at the injection site after receiving ZOSTAVAX. Pharmacists reported the injection site was red and warm. Pharmacist reported physician thought it could be cellulitis and prescribed KEFLEX as a prophylactic. The outcome of cellulitis, pharmacist reported the injection site was red and warm and a good amount of swelling about "5 to 6 inches long" at the injection site after receiving ZOSTAVAX was reported as recovered/resolved on an unknown date. There was no product quality complaint (PQC) involved. Patient sought medical attention and saw a doctor. Causality assessment was not provided. This case is linked to: 1410USA006526 (same reporter). Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 12 month old female patient. On 23-APR-1997, the patient was vaccinated with the first dose of MMR II for prophylaxis (lot#, expiration date, strength, dose and route not reported) and then the patient was vaccinated with her first dose of (Oka/Merck) VARIVAX (lot#, expiration date, strength, dose and route not reported) on 30-APR-1997. The patient received her second dose of MMR II (lot#, expiration date, strength, dose and route not reported) on 21-DEC-2000, and she received her second dose of (Oka/Merck) VARIVAX on 07-JUL-2011. The patient had not experienced any adverse effects. It was unspecified if the patient sought medical attention. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. Information about concurrent conditions, concomitant mediation and medical history was not provided. On 06-OCT-2014 the patient was vaccinated with 0.5 ml single dose of PNEUMOVAX 23 (injection, lot # J014399, expiration date 20-NOV-2014) intramuscular for prevention of pneumonia. On 06-OCT-2014 the patient was vaccinated with 0.5ml single dose of PNEUMVOVAX 23 (injection, lot # J014399, expiration date 20-NOV-2014) intramuscularly for prevention of pneumonia. On 06-OCT-2014, the patient experienced swelling, redness and pain after receiving PNEUMOVAX 23. The patient sought medical attention by office visit on an unspecified date. Treatment included antibiotics (unspecified name, dose/frequency and manufacturer) was given for the adverse event. The pharmacist declined to request a LOT check. The outcome of the events was not provided. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patiens were vaccinated with ROTATEQ. Dose, route, lot number and expiration date were not reported. The nurse reported that ROTATEQ was improperly stored and was administered to unspecified number of patients. No adverse effects reported. This is one of several reports from the same source. Additional information is not expected. No allowed to contact physician.
Sex: F
Vaccine: HEP
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to an adult female patient of unknown age. On 06-OCT-2014 (today) the patient was vaccinated with an expired dose of RECOMBIVAX HB 10/1.0 microgram/ml (dose 1 ml, lot # J001183, expiration date 08-SEP-2014), intramuscular in the left arm. There was no concomitant medication reported. No adverse effects reported at this time. Additional information is not expected due to no permission to contact reporter was given.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to 2 patients of unknown demographics. No concurrent conditions or medical history were provided. On unknown date, those patients were vaccinated with a doses of PNEUMOVAX 23 injection (strength, dose, route of administration, indication, lot# and expiry date unspecified), that were improperly stored. No concomitant medications were reported. No adverse effects were reported. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired drug administered, Injection site pain
Clinical narrative: This spontaneous report as received from a 53 year old female patient, who was also health care worker (Magnetic Resonance Imaging (MRI) technician) refers to herself. The patient had none pertinent medical history and none drug reactions or allergies. On 03-OCT-2014, the patient was vaccinated with ZOSTAVAX (dose, route of administration, lot # were not reported) that had passed expiration date by two days (expiration date: approximately 01-OCT-2014). The patient did not take any concomitant medication. On 03-OCT-2014, the patient experienced soreness at the site of administration after the dose was administered. No treatment was reported. No labs diagnostics studies were performed. The reporter stated that she was recovering from adverse event, described as the site of administration was only sore if she pressed on the site. The relatedness between the event and the vaccination with ZOSTAVAX was unknown. The patient did not seek medical attention. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to an unspecified number of patient of unknown age and gender. The nurse reported that the vaccine PEDVAXHIB underwent a temperature excursion, then on an unknown date unspecified amount of patients were vaccinated with this PEDVAXHIB (dose 0.5 ml, lot number and expiration date not reported) intramuscular. There was no concomitant medication reported. No adverse effect reported. This is one of two reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician assistant via a company representative refers to a patient of unknown demographics. No concurrent conditions or medical history were provided. The physician assistant stated the patient was vaccinated with a dose of GARDASIL 120 Y injection (strength, dose, route of administration, indication, lot# and expiry date unspecified) on 24-SEP-2014 and then on 10-OCT-2014. No concomitant medications were reported. No adverse symptoms were reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to 4 children patients of unknown age and gender. On an unknown date those patients were vaccinated with an improperly stored PEDVAXHIB (dose, units, route of administration, anatomical location, lot number were not reported). No adverse effects were reported at the time of reporting. Additional information has been requested.