chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.02
Sex: M
Vaccine: FLU4, HIBV, PNC13
Symptoms: Blood culture negative, CSF culture negative, Convulsion, Culture urine negative, Febrile convulsion
Clinical narrative: Pt had GTC sz at 9:00 PM about 1 min and sz at 11:00 PM, went to ED. Pt was admitted for complex febrile sz follwing vaccines. Discussed the importance of preventing the fever from rising quickly, so when there is the first sign of a fever, mother should start measures to cool patient down.  This includes providing antipyretics. Acetaminophen and ibuprofen can be alternated up to every 3 hours if fever does not subside.
Age: 1.02
Sex: M
Vaccine: FLU4, HIBV, PNC13
Symptoms: Grand mal convulsion
Clinical narrative: Pt had GTC sz at 9:00 PM about 1 min and sz at 11:00 PM, went to ED. Pt was admitted for complex febrile sz follwing vaccines. Discussed the importance of preventing the fever from rising quickly, so when there is the first sign of a fever, mother should start measures to cool patient down.  This includes providing antipyretics. Acetaminophen and ibuprofen can be alternated up to every 3 hours if fever does not subside.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Body temperature increased, Bruxism, Muscle spasms, Pain in jaw, Tooth injury
Clinical narrative: Per Client description:  Had low grade temperature evening of 9/19/2014.  A.M., Saturday 9/20/2014 awoke to pain in left jaw area, "severe clenching of teeth, & spasms. The clenching of teeth continued through 9/21/14, jaw pain continues through today 9/24/14. Visited dentist 9/22/14, client indicated cracked filling or crown from severe teeth clenching.  Had visited dentist one week before and no problems had been noted.  No other treatment thus far. Advised to call MD and report s/s.
Age: 10.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Pyrexia, Vaccination site swelling
Clinical narrative: Redness and swelling around site of vaccine, and fever.  Started on the day of vaccination, and ended 3-4 days later.
Age: 2.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Decreased appetite, Injection site rash, Irritability, Pyrexia, Rash generalised
Clinical narrative: 9/24/14 patient's mother called in to report an adverse reaction to SQ MMR.  The mother stated the child started to develop a rash 5 hours after the vaccination in the left arm.  The rash has continued to worsen and is now on the left side of body -- arm, torso, axillary, and left leg.  The client has had fevers on and off from 99 to 100 degree F.  In addition the mom reports the child is fuzzy and has not been eating well.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Woke up several hours after adminstration with swelling, redness and heat at the injection site.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Soreness, redness, itching and swelling at injection site. Consider drawing a circle in pencil around redness on arm. Consider taking diphenhydramine 25mg orally if redness worsens or does not improve and to follow up with a visit to a health clinic.
Age: 0.18
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Muscle twitching
Clinical narrative: Child had three seperate episodes of twitching while awake. Each was rhythmic in nature and lasted at most 10 seconds. Child was seen in ER at time and evaluated. Physician had no concerns and dismissed them to home. Mom told us about the event at todays appt for 4 month checkup.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: The patient forgot that he recieved the Fluvirin shot on 8/12/14 and received it again 9/20/14. He did not experience any adverse reactions, but the duplicate vaccination needed to be reported. He actually needed to receive the Zostavax vaccination instead. Our computer system was not proficient in catching the duplicate claim for the vaccination and our corporate office is working on it.
Age: 1.0
Sex: F
Vaccine: FLU4, HIBV, PNC13, VARCEL
Symptoms: Injection site reaction, Pyrexia, Swelling face, Urticaria
Clinical narrative: Welt at site of varicella vaccine. Fever to 105 later that night; facial swelling.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Dysphagia, Heart rate increased, Oropharyngeal pain, Pain
Clinical narrative: Call from client reporting that he received his first Flu shot this morning and now he is having body aches, chills, head congestion, heart rate up to 86 and having a sore throat.  He reported he has a heart condition and that his heart rate is 20 beats higher than it usually is.  He has and internal defibrillator and was first instructed to call cardiologist and during conversation he said he had trouble swallowing and he was instructed to go to ED.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Respiratory tract congestion
Clinical narrative: Call from client reporting that he received his first Flu shot this morning and now he is having body aches, chills, head congestion, heart rate up to 86 and having a sore throat.  He reported he has a heart condition and that his heart rate is 20 beats higher than it usually is.  He has and internal defibrillator and was first instructed to call cardiologist and during conversation he said he had trouble swallowing and he was instructed to go to ED.
Age: 4.0
Sex: F
Vaccine: DTAP, MMRV
Symptoms: Convulsion, Pyrexia
Clinical narrative: Seizure with fever to 102.9.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Itching on face, neck, scalp with urticara & errythema. Site of injection was not red or swollen. Benadryl 50mg orally & Zantac 150 mg orally & Solu Medrol 125 mg IM.
Age: 26.0
Sex: F
Vaccine: FLUX, RAB
Symptoms: Headache, Hypoaesthesia, Limb discomfort, Muscular weakness, Paraesthesia
Clinical narrative: Severe headache, fever, spinal pain, limb pressure, numbness, tingling, weakness (both arms, both legs). Headache fever spine pain day of vaccination and next day, limb numbness tingling pressure and weakness day 3.
Age: 26.0
Sex: F
Vaccine: FLUX, RAB
Symptoms: Pyrexia, Spinal pain
Clinical narrative: Severe headache, fever, spinal pain, limb pressure, numbness, tingling, weakness (both arms, both legs). Headache fever spine pain day of vaccination and next day, limb numbness tingling pressure and weakness day 3.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Breast swelling, Local swelling
Clinical narrative: Patient stated her arm swelled up from shoulder to elbow and swelling extended to breast.  Patient stated that she did not seek any medical treatment.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphonia, Oropharyngeal pain, Urticaria
Clinical narrative: 30 MINUTES AFTER INJECTION PATIENT NOTED HIVES ALL OVER HER BODY. 15 MINUTES LATER SHE HAD A SORE THROAT AND WAS VERY HOARSE. SHE RETURNED TO PHARMACY AT 3:45PM AND TOOK 25 MG OF BENADRYL AND WENT TO EMERGENCY CARE CLINIC WHERE SHE WAS GIVEN A STEROID SHOT AND A PRESCRIPTION FOR ORAL STEROIDS.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Anxiety, Decreased appetite, Headache, Insomnia, Muscular weakness
Clinical narrative: Patient described muscle weakness, anxiety, sleeplessness, nausea in AM, headache and appetite loss. Pt was informed that these are possible side effects of the vaccine and when we called to follow up with her 9/24 they had resolved. Patient wanted this reported.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea
Clinical narrative: Patient described muscle weakness, anxiety, sleeplessness, nausea in AM, headache and appetite loss. Pt was informed that these are possible side effects of the vaccine and when we called to follow up with her 9/24 they had resolved. Patient wanted this reported.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: Upper Left Arm (on side where injection occurred) turned red, had heat in the muscle and seemed slightly swollen over the entire upper left arm muscle and remains that way seeming worse as of 9/24/2014.  It looks as though it is a giant hive.
Age: 26.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Red, swollen, itchiness on left upper arm.
Age: 26.0
Sex: M
Vaccine: FLU4, TDAP, FLU4, TDAP
Symptoms: Lymphadenopathy
Clinical narrative: 2 cm right axillary node noted by nurse practitioner who saw pt for physical for EMT class. No fever.
Age: 26.0
Sex: M
Vaccine: FLU4, TDAP, FLU4, TDAP
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: 2 cm right axillary node noted by nurse practitioner who saw pt for physical for EMT class. No fever.
Age: 25.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Lymphadenopathy
Clinical narrative: The day after immunization pt noted new pea sized left supraclavicular node on same side as flu shot the day before--verified on exam by nurse practitioner during a physical for EMT class 9/15/14. No fever.
Age: 25.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Laboratory test, Lymph node pain, Lymphadenopathy, Nodule
Clinical narrative: The day after immunization pt noted new pea sized left supraclavicular node on same side as flu shot the day before--verified on exam by nurse practitioner during a physical for EMT class 9/15/14. No fever.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Oral herpes
Clinical narrative: Pt has developed what she calls a "cold sore". She has reportedly never had this issue before and is convinced that it is related to the flu shot.
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site streaking, Myalgia
Clinical narrative: Muscle extremely sore, red streaks radiating down to her elbow from injection site.
Age: 89.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chills, Nausea, Pain, Pyrexia
Clinical narrative: Chills. Aches. Fever. Vomiting. Nausea. Weakness.
Age: 89.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Chills. Aches. Fever. Vomiting. Nausea. Weakness.
Age: 17.0
Sex: F
Vaccine: HPV4, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Pt. called nurse to report 1/2 dollar size, red, raised area on lateral Rt upper arm. Pt. reports hot and itching at site. Pt at school. Said reported to nurse in AM before school - no measures taken. Counseled cold compress 24 hours then warm - it resolved. BENADRYL PRN per nurse.
Age: 81.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Erythema, Pyrexia
Clinical narrative: Patient claimed started to have chills/fever after midnight the day after received the flu shot. Also stated face turned reddish color. Also stated this happens when he get steroid shots.
Age: 19.0
Sex: M
Vaccine: FLU3
Symptoms: Death
Clinical narrative: No adverse events after vaccine, but patient's mother reported he passed away in sleep.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Vaccination site cellulitis
Clinical narrative: Cellulitis at vaccine site.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Endotracheal intubation, Febrile convulsion, Pyrexia
Clinical narrative: 12 hours after vaccines had complex febrile seizure that resulted in intubation x 4 days. No cause of fever identified.
Age: 67.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Back pain, Injection site induration, Injection site pain, Pain in extremity
Clinical narrative: Right arm became hard and tender with pain radiating into upper back-Seen by on-call MD 16 days later (for different problem) (R) deltoid hard mild tender areas 4x3cm.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Convulsion, Lip blister, Myalgia, Oral mucosal blistering
Clinical narrative: Extreme chills, muscle aches, blisters in mouth, blisters on lips, convulsions.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Local swelling, Skin warm
Clinical narrative: Arm became red, swollen, hot. Got worse by Saturday morning. Went to urgent care. Doctor gave her antibiotic (sulfa) and antihistamine (hydroxyzine).
Age: 91.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Rash, Rash erythematous
Clinical narrative: 5-6 hours after administration, patient developed chills. He was evaluated in ER. He developed a red rash on chest, treated w/diphenhydramine. A few hours later reaction resolved and he returned home, feeling fine.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Chest X-ray, Computerised tomogram head, Convulsion, Cough, Dizziness
Clinical narrative: 6PM acute cough. 10:30PM OOB to BR c/o being light headed. Collapsed - muscle weakness, incontinent of urine. 40 sec struggled to get up. Collapsed again - looked like mild seizure 30 sec - struggled to get up again. Collapsed again 30 sec - muscle weakness continued for a few minutes after last collapsed. Remembered only collapsing 1st time -> to hospital.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Echocardiogram, Laboratory test, Muscular weakness, Syncope, Ultrasound Doppler
Clinical narrative: 6PM acute cough. 10:30PM OOB to BR c/o being light headed. Collapsed - muscle weakness, incontinent of urine. 40 sec struggled to get up. Collapsed again - looked like mild seizure 30 sec - struggled to get up again. Collapsed again 30 sec - muscle weakness continued for a few minutes after last collapsed. Remembered only collapsing 1st time -> to hospital.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Urinary incontinence
Clinical narrative: 6PM acute cough. 10:30PM OOB to BR c/o being light headed. Collapsed - muscle weakness, incontinent of urine. 40 sec struggled to get up. Collapsed again - looked like mild seizure 30 sec - struggled to get up again. Collapsed again 30 sec - muscle weakness continued for a few minutes after last collapsed. Remembered only collapsing 1st time -> to hospital.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Crying, Death, Disseminated intravascular coagulation, Dyspnoea, Enema administration
Clinical narrative: Fussiness and crying onset 9/12/14 early AM, blood in stool that AM. More lethargic 9/13/14, not tolerating feeds. Seen in Emergency Room 9/13/14 - 9/14/14 - diagnosed with right upper quadrant intussusception reduced with air enema. Symptoms of shock, disseminated intravascular coagulation, third spacing of fluid, difficulty ventilating and ultimate death on 9/15/14.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Food intolerance, Haematochezia, Intussusception, Irritability, Lethargy
Clinical narrative: Fussiness and crying onset 9/12/14 early AM, blood in stool that AM. More lethargic 9/13/14, not tolerating feeds. Seen in Emergency Room 9/13/14 - 9/14/14 - diagnosed with right upper quadrant intussusception reduced with air enema. Symptoms of shock, disseminated intravascular coagulation, third spacing of fluid, difficulty ventilating and ultimate death on 9/15/14.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Shock, Ultrasound abdomen abnormal
Clinical narrative: Fussiness and crying onset 9/12/14 early AM, blood in stool that AM. More lethargic 9/13/14, not tolerating feeds. Seen in Emergency Room 9/13/14 - 9/14/14 - diagnosed with right upper quadrant intussusception reduced with air enema. Symptoms of shock, disseminated intravascular coagulation, third spacing of fluid, difficulty ventilating and ultimate death on 9/15/14.
Sex: M
Vaccine: FLU3
Symptoms: Cardiac death
Clinical narrative: Initial report was received on 19 September 2014 from a health care professional. A male patient reported over the age of 65 years (date of birth not reported) had received on an unspecified date FLUZONE HIGH DOSE, (lot number, route and site of administration not reported) and within 24 hours of receiving the vaccine suffered cardiac death. Outcome was fatal. Documents held by sender: none.
Age: 1.25
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 15 month old patient of unknown gender. On 22-SEP-2014 the patient received the first dose of (Oka/Merck) VARIVAX (lot # K003412, expiration date 06-MAR-2016, dose 0.5 ml, once, subcutaneously) that was stored at -2.3C for 13 hours, 23 minutes. Concomitant medications were not provided. No adverse effects were reported. This is one of two reports received from the same reporter (other MARRS# 1409USA011805). Additional information has been requested.
Age: 14.0
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a healthcare worker (medical assistant) refers to a 14 year old patient of unknown gender. The patient had received the first dose of (Oka/Merck) VARIVAX before. The healthcare worker confirmed that ZOSTAVAX was mistakenly shipped to this office instead of (Oka/Merck) VARIVAX. On an unknown date the patient was then inadvertently vaccinated with a dose of ZOSTAVAX (dose, route not reported, lot # K007986, expiration date 03-SEP-2015) instead of (Oka/Merck) VARIVAX, "within this past week", in approximately in September 2014. Concomitant medications were not provided. No adverse effects were reported. This is one of eight reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Autoimmune disorder, Malaise
Clinical narrative: This spontaneous report as received from a consumer via a market research program refers to 1000's of female patients of unknown age. On an unknown date, the patients were vaccinated with GARDASIL and became ill with autoimmune based disorders after receiving the vaccine and these disorders were not present before receiving the vaccine. On an unknown date the consumer was referred to a rheumatologist who had seen causes like this a lot lately. Healthy girls falling ill after receiving the vaccine. The outcome of healthy girls falling ill and becoming ill with autoimmune based disorders was unknown. Causality was not provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. No information about medical history, drug reactions and allergies was specified. The medical assistant reported that the patient was inadvertently administered ZOSTAVAX (lot# J011212, dose not reported) subcutaneous on 19-SEP-2014 that had expired on 29-AUG-2014. No concomitant medications were reported. No adverse effects reported. There was no product quality complaint. The outcome is unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Cerebrovascular accident, Death, Expired drug administered
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. No information about medical history, drug reactions and allergies was specified. The medical assistant reported that the patient was inadvertently administered ZOSTAVAX (lot# J011212, dose not reported) subcutaneous on 19-SEP-2014 that had expired on 29-AUG-2014. No concomitant medications were reported. No adverse effects reported. There was no product quality complaint. The outcome is unknown. Additional information has been requested.
Age: 26.0
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 26 year old patient. On 08-SEP-2014 the patient was vaccinated with third dose of GARDASIL (dose and route of administration were not reported). Reporter stated that patient received first and second dose on unspecified dates in 2009. No adverse effect reported. Additional information has been requested.
Age: 1.45
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 17 month old patient of unknown gender. On 18-SEP-2014 the patient received improperly stored (Oka/Merck) VARIVAX (lot# not reported, dose 0.5 ml, subcutaneously) exposed to -14C for 3.5 hours. Concomitant medications were not provided. No adverse effect was reported. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report has been received from a medical assistant refers to a 14 year old female patient. On 27-JUN-2014 at 05:08 PM the patient was vaccinated with the first dose of GARDASIL (dose and route not reported, lot # J013323, expired date: 12-FEB-2016) in the right deltoid that was improperly stored. There was no illness at time of vaccination or pre-existing allergies, birth defects, medical conditions. There was no adverse event following prior vaccination. Medical assistant confirmed that GARDASIL was administered according to the dose and route recommended in the prescribing information. No adverse effect were reported. No product quality complaint (PQC) was reported. This is one of several reports from the same source. Additional information is not expected.
Age: 88.0
Sex: M
Vaccine: PPV
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 88 year old male patient. The patient's medical history and current conditions are not reported. On 08-SEP-2014 the patient was vaccinated with PNEUMOVAX 23 of dose 0.5 ml, intramuscular in the right arm (lot 3 J009827 and expiry date 10-AUG-2014). Concomitant therapies included (unspecified) INFLUENZA VIRUS VACCINE UNSPECIFIED in the left arm. It was reported that the patient was vaccinated with expired PNEUMOVAX 23. Product quality complaint was not reported. The outcome of expired vaccine administered is unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a Registered nurse and refers to a currently 19 year old male patient. On 01-AUG-2013, the patient was vaccinated with the first dose of pediatric VAQTA (dose, route, lot and batch number, expiration date not reported). On 13-AUG-2014, the patient was routinely vaccinated with the second dose of pediatric VAQTA (dose, route, lot and batch number, expiration date not reported). No adverse effects were reported. The patient's outcome was unkonwn. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist via agency refers to a 65 year old female patient. On 19-SEP-2014, the patient was inadvertently vaccinated with an expired dose of PNEUMOVAX 23 (expiration date August 2014) for immunization for prevention of pneumonia (dose, route and strength not reported). The patient's relevant medical history, relevant concomitant medications and relevant past drug history were unknown to the reporter. There was no relevant lab data. The patient did not report any problems after receiving PNEUMOVAX 23. As of 20-SEP-2014, it was unknown if the patient was still on PNEUMOVAX 23 and the outcome of receiving PNEUMOVAX 23 was unknown. The lot number was unknown to this pharmacist. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Fall, Head injury, Syncope
Clinical narrative: This spontaneous report as received from a registered nurse via field representative refers to a child patient of unknown age. On an unspecified date, the patient was vaccinated with a dose of GARDASIL injection (dose, frequency, route and lot # unknown). On an unknown date in 2013 (reported as "in the past year"), the patient fainted after receiving the dose of GARDASIL and fell, and "bumped their head". The outcome of the events was reported as recovered/resolved on an unspecified date. The causality was not reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Blister, Pruritus, Rash, Skin discolouration
Clinical narrative: This spontaneous report as received from a female patient of unknown age refers to herself. On an unspecified date in August 2014 (reported as "on an unspecified date a month ago"), the patient was vaccinated with a dose of ZOSTAVAX, 1 single shot (route and lot # unknown). A little while after receiving ZOSTAVAX the patient developed an ugly raised rash of big dark itchy blisters on the side of her leg. The patient was experiencing joint pain in her arms which she was going to physical therapy for. The patient sought medical attention. The patient's physician gave her an unspecified cream to put on it but it did not work. The outcome of events was unknown. The causality was not reported. Additional information is not expected.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Pain, Pain in extremity
Clinical narrative: At the time of shot, pt felt burning immediately as shot was given. For 2 days after had no use of the arm. She was in pain the entire time. After 3 plus weeks pt still feels pain, has minimal use of her arm and had and cannot lie down on this arm. TYLENOL extra strength makes it feel 75% better for a short time.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Incorrect dose administered
Clinical narrative: This spontaneous report as received from a Certified Medical Assistant refers to a patient of unknown age and gender. On 19-FEB-2013 the patient was vaccinated with first dose of GARDASIL (dose, route, lot # not reported). On 21-FEB-2014 the patient received second dose and on 24-APR-2014 received a third dos of GARDASIL (dose, route, lot # not reported). On unknown date the patient was vaccinated with inappropriate schedule of GARDASIL. Moreover on 11-SEP-2014 (reported as "now") the patient was in the doctor's office to possibly receive a fourth dose of GARDASIL. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a register nurse refers to a newborn female patient. On 01-JUL-2014 at 19:04pm, the patient was vaccinated with RECOMBIVAX HB lot # J012520, expiration date 30-JAN-2016, intramuscular. On 01-JUL-204 the patient received improperly stored RECOMBIVAX HB. Vaccine storage temp dipped to 0-1 X 18 different episodes according to min/max. All recorded temps are within 2-8 deg. This is one of several reports from the same source. Additional information is not expected. All follow up requested to complete the case were received.
Sex: M
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a nurse via field representative refers to a male patient of unknown age. A couple of weeks ago, on an unknown date in 2014, the patient was vaccinated with GARDASIL (dosage information unknown). No concomitant medication was reported. The patient fainted after administration of GARDASIL. The patient sought medical attention (in office). The patient was given fluids and monitored in the office and recovered from the event within 1 hour. The causality of the event was unknown. A product quality complaint (PQC) was not involved. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: TYP
Symptoms: Eructation
Clinical narrative: Patient took 3rd dose with full glass of water before breakfast, two hours after taking the capsule patient burped the capsule intact. Capsule was very soft but swallowed it again with water.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a nurse via field representative refers to a female patient of unknown age. A couple of weeks ago, on an unknown date in 2014, the patient was vaccinated with GARDASIL (dosage information unknown). No concomitant medication was reported. The patient fainted after administration of GARDASIL. The patient sought medical attention (in office). The patient was given fluids and monitored in the office and recovered from the event with in 1 hour. The causality of the event was unknown. A product quality complaint (PQC) was not involved. Additional information has been requested.
Age: 37.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Accidental exposure to product, Eye burns, Ocular hyperaemia
Clinical narrative: This spontaneous report as received from a 37 year old female pharmacist refers to herself. Patients current condition included simple partial seizures. No relevant medical history has been reported. Her past drug history was unknown. On 10-SEP-2014, the patient was drawing up ZOSTAVAX lot # K003596 expiration date: 12-MAR-2015 (unknown dose, units and frequency) (also reported as accidentally, route left eye). Concomitant therapies included KEPRA. On 10-SEP-2014, patient accidentally squirted in her left eye as she was drawing up ZOSTAVAX and it had a retractable needle. On 10-SEP-2014, she also reported that her eye burned a little but then she flushed it briefly and after flushing, her eye was red. It was unknown if there was any relevant laboratory data. It was reported that as of 10-SEP-2014 it was unknown if she will accidentally get ZOSTAVAX in her eye again. The outcome of the event her eye burned a little was reported as resolved. The outcome of the event after flushing her eye was red was reported as not recovered/not resolved (also reported as her eye continues to be red) and the outcome of the event accidentally squirted in her left eye was not reported. Causality between ZOSTAVAX and the events were not reported. Additional information has been requested.
Age: 37.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Accidental exposure to product, Exposure via direct contact, Eye irrigation, Eye irritation, Ocular hyperaemia
Clinical narrative: This spontaneous report as received from a 37 year old female pharmacist refers to herself. Patients current condition included simple partial seizures. No relevant medical history has been reported. Her past drug history was unknown. On 10-SEP-2014, the patient was drawing up ZOSTAVAX lot # K003596 expiration date: 12-MAR-2015 (unknown dose, units and frequency) (also reported as accidentally, route left eye). Concomitant therapies included KEPRA. On 10-SEP-2014, patient accidentally squirted in her left eye as she was drawing up ZOSTAVAX and it had a retractable needle. On 10-SEP-2014, she also reported that her eye burned a little but then she flushed it briefly and after flushing, her eye was red. It was unknown if there was any relevant laboratory data. It was reported that as of 10-SEP-2014 it was unknown if she will accidentally get ZOSTAVAX in her eye again. The outcome of the event her eye burned a little was reported as resolved. The outcome of the event after flushing her eye was red was reported as not recovered/not resolved (also reported as her eye continues to be red) and the outcome of the event accidentally squirted in her left eye was not reported. Causality between ZOSTAVAX and the events were not reported. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Rash, Rash erythematous
Clinical narrative: Rash on middle of back spaced out red spots about 5 appeared 1 wk after injection painful.
Age: 33.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, Ultrasound abdomen abnormal
Clinical narrative: This spontaneous prospective pregnancy report as received from a physician refers to a 33 year old female patient. The physician stated that the patient received VARIVAX (Merck) (lot#, dose, route not reported) on 03-JUN-2014. The patient was determined to be pregnant, with conception 1 week before the administration of the VARIVAX (Merck) on an unspecified time. An ultrasound was performed on 13-AUG-2014 which confirmed conception the week prior to 03-JUN-2014. The Date of Conception was on 27-MAY-2014. The Last Menstrual Period (LMP) was on 13-MAY-2014. The Estimated date of delivery (EDD) was estimated on 17-FEB-2015. No treatment was given. The patient had sought medical attention via an unspecified way. The outcome of the pregnancy was unknown. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 4 year old female patient. Patient's concurrent conditions and relevant medical history was unknown. On 09-SEP-2014 the patient was vaccinated simultaneously with (Oka/Merck) VARIVAX (dose 2, 0.5 ml) (lot number: K002927 with expiry date of 16-FEB-2016), subcutaneously for prophylaxis and (Oka-Merck) PROQUAD (dose and route unspecified) (lot number: K007799 with expiry date of 29-NOV-2015). No adverse effects were reported. The nurse also reported that the patient received initial (Oka/Merck) VARIVAX at younger age, near 15 months. The patient also received MMR II at younger age near 15 months. The outcome of the events was unknown. The causality of the events with (Oka/Merck) VARIVAX and (Oka-Merck) PROQUAD was not reported. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 4 year old patient of unknown gender. On 22-SEP-2014 the patient received the first dose of PROQUAD (Merck) (dose, route not reported, lot # reported as K006217, expiration date not provided) that was stored at -2.3C for 13 hours, 23 minutes. Concomitant medications were not provided. No adverse effects were reported. This is one of two reports received from the same reporter (other MARRS# 1409USA011630). Additional information has been requested.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: 10 x 8 cm area erythema, swelling and induration at injection site (left deltoid). 6 cm x 6 cm area erythema at left forearm. Treatment -MEDROL dose pack, BENADRYL.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On an unknown date in September 2008 (6 years ago), the patient was vaccinated with ZOSTAVAX, 19400 PFU, intramuscular (lot number not provided). On an unknown date the patient experienced rash between his thighs. The pharmacist had not inspected the patient's rash, and therefore, could not provide a description of the rash. She did not know if the patient reported the rash to his healthcare provider, and she did not know when the rash started. She was not in a position to collect a specimen. The outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 03-JUL-2014 the patient was vaccinated with first dose of VAQTA 50/1.0 U/ml, dose: 1 ml, intramuscularly. On 23-SEP-2014, the patient was administered the second dose of VAQTA on 23-SEP-2014. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unkonwn age and gender. The patient's pertinent medical history, drug reactions/allergies were not provided. On 02-SEP-2014, the patient received a first dose of ZOSTAVAX, .65 ml subcutaneous, (Lot # and expiration date were not provided). Co-suspect therapy and concomitant medications were not provided. It was reported that patient accidentally received two doses of ZOSTAVAX. One dose on 02-SEP-2014 and the second dose was administered on 15-SEP-2014. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 11-SEP-2014 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # J009827, expiration date 10-AUG-2014, dose, route and frequency were unknown) which was expired on 10-AUG-2014. No adverse events were reported. Additional information has been requested.
Age: 0.36
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Injection site erythema, Injection site nodule
Clinical narrative: <1cm erythematous right thigh nodule present without warmth to touch.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with ZOSTAVAX reported as (vial 19,400 unit 1 standard package vial of 1) (dose, route and lot number were not provided). On an unknown date, the nurse reported that since unspecified date, improperly stored ZOSTAVAX was administered to patients and no adverse effects were noted. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 18-SEP-2014 the patient was vaccinated with a improperly stored dose of (Oka-Merck) PROQUAD (lot#, strength, dosage and route unknown). No adverse symptoms reported. The temperature excursion for the (Oka-Merck) PROQUAD was supported with in-house stability data. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with PROQUAD (Merck) (dose, route and lot number were not provided). On an unknown date, the nurse reported that since unspecified date, improperly stored PORQUAD (Merck) was administered to patients and no adverse effects were noted. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker who refers to unspecified group of patients of unknown age and gender. On an unknown date in 2014 (exact date was not reported), the patients were vaccinated with doses of VARIVAX (Merck) (dose, frequency and lot #: not provided) that were exposed to supported temperature excursions also reported as "temperatures of 10F for a cumulative time of 8 hours" in "May and August 2014". No adverse effect has been reported. No product quality complaint (PQC) was involved. 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 pharmacist refers to a patient of unknown age and gender. On 18-SEP-2014, the patient was vaccinated with ZOSTAVAX lot # J001009, expiration date 24-APR-2014, 0.65 ml, subcutaneous. On 18-SEP-2014, the patient was administered an expired dose of ZOSTAVAX. No adverse events were reported. It was unknown if the patient sought medical attention. At the time of the report, the patient's status was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a unknown number of patiens (gender and age unknown). On an unknown date the patients were vaccinated with VARIVAX (Merck) (dose and route of administration were not provided). On an unknown date the patients developed rash after administration of VARIVAX (Merck). Patients sought medical attention. The outcome of rash was unknown. Relatedness between rash and vaccination with VARIVAX (Merck) was not reported. Additional information is not expected. Reporter did not wish to be contacted.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper
Clinical narrative: This spontaneous report as received from a nurse via company representative refers to a 11 year old female patient. The patient had none pertinent medical history and none drug reactions or allergies. On 16-SEP-2014, the patient was vaccinated with her first dose of GARDASIL (dose, route of administration, lot # and expiration date were not reported) for prevention of HPV. Concomitant therapies included DTaP, TDAP vaccine and MENVEO. On 16-SEP-2014, the patient experienced a stomach ache. There was none treatment given for the adverse event and none lab diagnostic studies performed. The outcome of the stomach ache was unknown. The relatedness between the event and GARDASIL was unknown. The patient sought medical attention. Additional information has been requested.
Sex: U
Vaccine: VARCEL
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, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with VARIVAX (Merck) (dose, route and lot number were not provided). On an unknown date, the nurse reported that since unspecified date, improperly stored VARIVAX (Merck) was administered to patients and no adverse effects were noted. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 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 ZOSTAVAX. Dose, route, lot number and expiration date were not reported. On an unknown date the patients developed shingles after receiving ZOSTAVAX. The outcome of shingles was unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Scar
Clinical narrative: This spontaneous report as received from a female patient of unknown age via field representative refers to herself. The patient was not pregnant. On an unspecified date in 2008 (reported as "about six years ago"), the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot # unknown). On an unspecified date in 2011 (reported as "about three years ago"), the patient experienced shingles. The patient had fully recovered from the shingles virus (date unspecified) although the patient did have scarring from the shingles virus. The patient had not recovered from the scarring from the shingles virus. The causality was not reported. Additional information is not expected since we do not have contact information.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a nurse refers to a 23 year old female patient. Medical history and concurrent conditions were not reported. In 2007, 7 year ago, the was vaccinated with the first dose of GARDASIL. Dose, route, lot number and expiration date were not reported. The second dose was on 19-SEP-2014, lot # K009202, expiration date 17-DEC-2016, 0.5 ml, intramuscular in the left deltoid. Additional information is not expected. No allowed to contact physician.
Age: 22.0
Sex: M
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: A few minutes after injection, pt felt dizzy. Vital signs taken every 5 minutes until stable over 15 minutes. Waited additional 15 minutes sitting in waiting area.
Age: 25.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Malaise
Clinical narrative: Pt was immunized and ambulated to inside waiting area. Ten minutes later c/o feeling sick. Vital signs were monitored every five minutes until stable and she felt well after 30 minutes.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: This spontaneous report as received from a registered nurse, via a sales representative, refers to a male patient in his 80's. The patient's pertinent medical history, drug reactions/allergies were not provided. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX, one injection (total dose, route, lot number and expiration date were not reported) for prevention of shingles. Co-suspect therapy and concomitant medications were not provided. The reporter stated that on an unknown date the patient had developed a herpes zoster outbreak on the neck which was fairly painful; after receiving ZOSTAVAX vaccine. it was not provided if any treatment was given for the adverse experience and if the patient sought medical attention. At the time of the report, the patient's outcome and the relatedness between the event and suspect therapy were not provided. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 19 year old female patient. In August 2007 patient was vaccinated with first dose of GARDASIL 0.5 ml, intramuscular in the left deltoid, second dose was given on October 2007 and third dose was given in February 2008. No concomitant medication was reported. In August 2014 the patient was vaccinated with 4th dose of GARDASIL 0.5 ml, intramuscular in the left deltoid. No adverse effects were reported. Product quality complaint was not involved. The outcome of events was unknown. 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 health care worker (also reported as representative) refers to unknown number of patients of unknown age from Vaccines for Children program. No information about medical history, concurrent conditions and concomitant medications were reported. On an unknown date the patients were vaccinated with GARDASIL, (therapy dates, dose strength not reported) that was improperly stored since 11-JUL-2014 on an unknown date in 2014. No adverse effects noted. The outcome of events reported is unknown. No product quality complaint was involved. This case is linked to the case 1409USA011690 via same reporter link. Additional information is not expected as the reporter refused additional contact.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker(also reported as representative) refers to unkonwn number of patients of unknown age from Vaccines for Children program. No information about medical history, concurrent conditions and concomitant medications were reported. On an unknown date the patient was vaccinated with ROTATEQ, (therapy dates, dose strength) not reported that was improperly stored since 11-JUL-2014. No adverse effects noted. The outcome of events reported is unknown. No product quality complaint was involved. This case is linked to the case 1409USA011984 via same reporter link. Additional information is not expected as the reporter refused additional contact.