chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: M
Vaccine: FLUC4, FLUC4
Symptoms: Nausea, Neuritis, Pallor, Vestibular neuronitis, Vision blurred
Clinical narrative: Case number PHEH2016US025325, is an initial spontaneous report received from nurse on 29 Sep 2016. This report refers to a 48 years old male patient. Past medical history was not reported. Concomitant medications included as lisinopril and hydrochlorothiazide for hypertension (HTN) and ZYRTEC for allergies and hay fever. The patient was vaccinated with single dose of FLUCELVAX QUADRIVALENT (batch number: 185888) into left deltoid, at a dose of 0.5 ml, intramuscularly on 29 Sep 2016 at 07:15 AM. On the same day, the patient experienced dizziness, difficulty focusing, sweating increased, pale, severe nausea and vomiting after receiving vaccine. 30 minutes after receiving injection patient reported feeling dizzy, lightheadedness, sweaty, nauseous and vomited multiple times through day. By the next day felt off balance. The patient did vomit 1 day before injection but was not dizzy. Also had blurred vision plus double vision for 10 days after vaccination. The patient went to Ear Nose Throat specialist (ENT) and diagnosed with vestibular neuritis and prescribed with steroid VALIUM. It was reported that, 85 percent improved and he still felt off balance. The outcome of events was reported as condition unchanged. The seriousness of the events was reported as non-serious. The causality of the events was not reported. Seriousness of vestibular neuronitis was upgraded to serious (medically significant) based on the information available in the source document. Follow up report received from a nurse on 02 Nov 2016: Added patient demographics (Patient height and weight), concomitant medications, suspect drug information (batch number, vaccination site and time of vaccination), events (lightheadedness, felt off balance, blurred vision plus double vision and vestibular neuritis), treatment (steroid VALIUM) and reporter comments.
Age: 48.0
Sex: M
Vaccine: FLUC4, FLUC4
Symptoms: Vomiting
Clinical narrative: Case number PHEH2016US025325, is an initial spontaneous report received from nurse on 29 Sep 2016. This report refers to a 48 years old male patient. Past medical history was not reported. Concomitant medications included as lisinopril and hydrochlorothiazide for hypertension (HTN) and ZYRTEC for allergies and hay fever. The patient was vaccinated with single dose of FLUCELVAX QUADRIVALENT (batch number: 185888) into left deltoid, at a dose of 0.5 ml, intramuscularly on 29 Sep 2016 at 07:15 AM. On the same day, the patient experienced dizziness, difficulty focusing, sweating increased, pale, severe nausea and vomiting after receiving vaccine. 30 minutes after receiving injection patient reported feeling dizzy, lightheadedness, sweaty, nauseous and vomited multiple times through day. By the next day felt off balance. The patient did vomit 1 day before injection but was not dizzy. Also had blurred vision plus double vision for 10 days after vaccination. The patient went to Ear Nose Throat specialist (ENT) and diagnosed with vestibular neuritis and prescribed with steroid VALIUM. It was reported that, 85 percent improved and he still felt off balance. The outcome of events was reported as condition unchanged. The seriousness of the events was reported as non-serious. The causality of the events was not reported. Seriousness of vestibular neuronitis was upgraded to serious (medically significant) based on the information available in the source document. Follow up report received from a nurse on 02 Nov 2016: Added patient demographics (Patient height and weight), concomitant medications, suspect drug information (batch number, vaccination site and time of vaccination), events (lightheadedness, felt off balance, blurred vision plus double vision and vestibular neuritis), treatment (steroid VALIUM) and reporter comments.
Age: 65.0
Sex: M
Vaccine: FLUC4, FLU4
Symptoms: Rash erythematous, Swelling
Clinical narrative: Patient developed hives on back of neck and on top of head 4 days after vaccination. Was diagnosed with case of shingles next day.
Age: 65.0
Sex: M
Vaccine: FLUC4, FLU4
Symptoms: Herpes zoster, Urticaria
Clinical narrative: Patient developed hives on back of neck and on top of head 4 days after vaccination. Was diagnosed with case of shingles next day.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site discolouration, Injection site erythema, Injection site reaction, Skin hypertrophy
Clinical narrative: Information has been received from a pharmacy student concerning a 65 year old female patient. The had not pertinent medical history. Concurrent conditions included penicillin allergy. On 01-APR-2016, the patient was vaccinated with ZOSTAVAX lot # L046900, expiration date 23-FEB-2017, 0.65 ml administered per subcutaneous route. Concomitant therapies included levothyroxine sodium (manufacturer unknown). It was reported that on unspecified time after receiving the ZOSTAVAX, in approximately April of 2016, the patient developed soreness and a pinkish purple mark pain at the injection site which was 1 centimeter by 3.5 centimeters in size and thick in texture. The reporter stated that the soreness lasted a week, however the patient still had the mark at the ZOSTAVAX injection site. The reported informed that the patient went to the pharmacy on unspecified date to report the reaction. No laboratory diagnostic studies were performed and no treatment was given for adverse events. The outcome of soreness at the injection site was reported as recovered on unspecified date in 2016. The outcome of a pinkish purple mark pain at the injection site was not recovered at the time of the report. The causal relationship between the adverse events and ZOSTAVAX was not reported. There was no cancer, overdose or product quality complaint (PQC) involved. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a pharmacy student concerning a 65 year old female patient. The had not pertinent medical history. Concurrent conditions included penicillin allergy. On 01-APR-2016, the patient was vaccinated with ZOSTAVAX lot # L046900, expiration date 23-FEB-2017, 0.65 ml administered per subcutaneous route. Concomitant therapies included levothyroxine sodium (manufacturer unknown). It was reported that on unspecified time after receiving the ZOSTAVAX, in approximately April of 2016, the patient developed soreness and a pinkish purple mark pain at the injection site which was 1 centimeter by 3.5 centimeters in size and thick in texture. The reporter stated that the soreness lasted a week, however the patient still had the mark at the ZOSTAVAX injection site. The reported informed that the patient went to the pharmacy on unspecified date to report the reaction. No laboratory diagnostic studies were performed and no treatment was given for adverse events. The outcome of soreness at the injection site was reported as recovered on unspecified date in 2016. The outcome of a pinkish purple mark pain at the injection site was not recovered at the time of the report. The causal relationship between the adverse events and ZOSTAVAX was not reported. There was no cancer, overdose or product quality complaint (PQC) involved. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: FLUX
Symptoms: Dyspnoea, Erythema, Peripheral swelling, Pyrexia, Skin tightness
Clinical narrative: Arm swelling from shoulder to elbow, tight redness and hot to touch. Brought to ER 11/10 for difficulty breathing. High fever.
Age: 5.0
Sex: M
Vaccine: FLUX
Symptoms: Skin warm
Clinical narrative: Arm swelling from shoulder to elbow, tight redness and hot to touch. Brought to ER 11/10 for difficulty breathing. High fever.
Age: 15.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Discomfort, Dizziness, Headache, Musculoskeletal pain
Clinical narrative: Fever, chills, severe headache and pressure, shoulder pain, dizzy.
Age: 15.0
Sex: M
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: Fever, chills, severe headache and pressure, shoulder pain, dizzy.
Age: 52.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Redness, soreness and itching at injection site.
Age: 73.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Abdominal discomfort, Hyperhidrosis, Mobility decreased, Myalgia, Pyrexia
Clinical narrative: Upset stomach- fever- profuse sweating-muscle ache-unable to move.
Age: 73.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Hyperhidrosis, Influenza like illness, Malaise, Mobility decreased, Myalgia
Clinical narrative: Upset stomach- fever- profuse sweating-muscle ache-unable to move.
Age: 73.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Pain, Pyrexia
Clinical narrative: Upset stomach- fever- profuse sweating-muscle ache-unable to move.
Age: 73.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Abdominal discomfort, Hyperhidrosis, Mobility decreased, Myalgia, Pyrexia
Clinical narrative: Inability to move out of bed due to soreness and muscle ache. Flu-like symptoms including fever and sweats, malaise started the evening of administration and subsided the following morning. However, symptoms persisted until Friday evening, when she finally felt better. HD flu was administered Thursday.
Age: 73.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Hyperhidrosis, Influenza like illness, Malaise, Mobility decreased, Myalgia
Clinical narrative: Inability to move out of bed due to soreness and muscle ache. Flu-like symptoms including fever and sweats, malaise started the evening of administration and subsided the following morning. However, symptoms persisted until Friday evening, when she finally felt better. HD flu was administered Thursday.
Age: 73.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Pain, Pyrexia
Clinical narrative: Inability to move out of bed due to soreness and muscle ache. Flu-like symptoms including fever and sweats, malaise started the evening of administration and subsided the following morning. However, symptoms persisted until Friday evening, when she finally felt better. HD flu was administered Thursday.
Age: 48.0
Sex: M
Vaccine: FLUX
Symptoms: Back pain, Neck pain
Clinical narrative: Severe neck and lower back pain.
Age: 51.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Headache
Clinical narrative: Headache. Severe Dizziness.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Asthenia, Breast pain, Flank pain, Influenza like illness
Clinical narrative: Flu-like symptoms, weakness, joint pain that evening. Next morning that was gone, but there was a red rash at the injection site and it still is visible 3 days later. Site bled after injection, rash site was warm to touch. My whole left side (side where injection was given) was sore, even into my left breast.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Injection site haemorrhage, Injection site reaction, Injection site warmth, Rash erythematous
Clinical narrative: Flu-like symptoms, weakness, joint pain that evening. Next morning that was gone, but there was a red rash at the injection site and it still is visible 3 days later. Site bled after injection, rash site was warm to touch. My whole left side (side where injection was given) was sore, even into my left breast.
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Anxiety, Fatigue, Myalgia, Pyrexia
Clinical narrative: Muscle pain, severe fatigue, fever, anxiety.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Blood blister, Injection site haemorrhage
Clinical narrative: Very excessive bleeding upon administration of Tdap (Boostrix) vaccine; development for blood blister.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Blood glucose normal, Blood pressure normal, Loss of consciousness
Clinical narrative: Patient lost consciousness approximately 10 minutes after flu vaccination was administered. She gained consciousness in less than 3 minutes.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Malaise, Vaccination site pain
Clinical narrative: Pain at site of vaccination, malaise continuing into 11/12. First time I received higher dosage vaccine for 65 and over.
Age: 3.0
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Rash generalised, Rash macular, Urticaria
Clinical narrative: My daughter got full hives within three hours of receiving the FLU shot at her pediatricians office. She had raised red, blotchy hives on her face and neck, and sand-paper like rash on the rest of her body. We called her Peds office and got the o/c doctor and was instructed to watch her and give her Benadryl.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site induration, Injection site pain
Clinical narrative: Later in the day the patient noticed she had a large rash (about 6" diameter) around the injection site, as well as a raised "welt" that is hard to the touch, pain and itching at injection site; had a fever (101, same day only), chills, general malaise and fatigue, headache for the last 4 days; patient said rash and swelling is getting better, peaked about 24-36 hours after administration. 11/12 is the first day she has not been tired.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site rash, Malaise, Pyrexia
Clinical narrative: Later in the day the patient noticed she had a large rash (about 6" diameter) around the injection site, as well as a raised "welt" that is hard to the touch, pain and itching at injection site; had a fever (101, same day only), chills, general malaise and fatigue, headache for the last 4 days; patient said rash and swelling is getting better, peaked about 24-36 hours after administration. 11/12 is the first day she has not been tired.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: SITE OF VACCINE SWOLLEN, PINK, WARM, PAINFUL-ABOUT 1CM DIAMETER.
Age: 19.0
Sex: F
Vaccine: FLU4
Symptoms: Anaphylactic reaction, Angioedema, Dyspnoea, Flushing, Nausea
Clinical narrative: Anaphylactic, nausea, flushing, angio-edema, and SOB.
Age: 47.0
Sex: M
Vaccine: FLU4
Symptoms: Biopsy, Blood pressure increased, Drug intolerance, Fatigue, Immune system disorder
Clinical narrative: Body rejecting different (tried 4) medications, fatigue, immune function appears impaired. Raised blood pressure, unable to tolerate BP medication. Waiting on labs and appointment with rheumatologist.
Age: 47.0
Sex: M
Vaccine: FLU4
Symptoms: Immunology test
Clinical narrative: Body rejecting different (tried 4) medications, fatigue, immune function appears impaired. Raised blood pressure, unable to tolerate BP medication. Waiting on labs and appointment with rheumatologist.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Influenza like illness, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Flu like symptoms, stayed in bed. Swelling, warm, large red area around injection site. Approximately 2.5 inches in diameter.
Age: 32.0
Sex: F
Vaccine: FLU4, VARCEL
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: On 11/11/16 pt noticed that the area was raised, hot, itchy and red. Patient has taken no action at this time.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Cold sweat, Feeling abnormal, Hyporesponsive to stimuli
Clinical narrative: Vaccine was administered at a health fair. Pt was calm during vaccine and said it didn't hurt but 5 min later said she didn't feel good.  She then became clammy and responsiveness was minimal.  MDs were present and called over for help - patient was moved from chair to floor and feet were elevated.  Pt became alert and stated she felt some better. 911 was called and paramedics arrived.  Pt was brought to standing position but her condition worsened again so she was taken by ambulance to ER for further evaluation.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, Swelling and warm at injection sight. Patient took Tylenol for pain. I recommended patient take 1 dose of Motrin/Advil/ibuprofen. I will follow up with her in 24 hours to ensure swelling is going down. Patient states that the swelling is less today than it was yesterday.
Age: 56.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Painful, red, swelling to right upper arm.  Patient visited urgent care clinic on 11/11/16 and is still seeking treatment.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Fever.
Age: 22.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Reported to Pharmacy with swelling and pain at injection site.  Treatment with cold compress, Ibuprofen, and diphenhydramine.  Sent home from work to rest.
Age: 72.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Chills, Headache, Muscle spasms, Tremor
Clinical narrative: HEADACHE, CHILLS, SHAKY, MUSCLE CRAMPS.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Peripheral swelling, Rash
Clinical narrative: LARGE RASH/RED/SWELLING OF FULL UPPER ARM.
Age: 77.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: Patient said that the evening after his shingles vaccination he developed an itchy rash in the upper arm.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain, Peripheral swelling
Clinical narrative: Large area on upper am red and swollen. Pain with movement of hand.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: Hours after the vaccine was administered the patient complained of redness at injection site and pain. The next day she had a fever of 101 F and worsening pain and redness. The next day the patient went to the ER and was diagnosed with cellulitis on left arm extending to upper left chest.
Age: 1.42
Sex: M
Vaccine: FLUX
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: Febrile seizure.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site ulcer, Injection site vesicles, Skin discolouration, Skin ulcer
Clinical narrative: Patient presented to the pharmacy with a type of sore/blister in the exact spot where the vaccine was administered. The patient noticed the sore 1 week after the vaccine was administered and still currently has the sore. It hasn't worsened, is not painful and does not itch.  She did report 2 other spots (had the appearance of a darker purple color) on her hands, but they had a different appearance than the sore on her arm. No other symptoms were reported.
Age: 72.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pain, Pyrexia
Clinical narrative: Patient has body aches and a fever that has increased over the day to 101.2 degrees Fahrenheit currently.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Injection site swelling
Clinical narrative: Arm was red and swollen from injection site to elbow and shoulder area. Swelling occurred day after vaccination, patient stated that at doctor visit was informed it was an allergic reaction.
Age: 73.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site swelling
Clinical narrative: Arm became red and swollen from injection so to elbow and to the axilla area. Reaction began the day following vaccine administration. Patient stated that at doctor visit was told it was an allergic reaction.
Age: 4.0
Sex: F
Vaccine: DTAP, FLUX
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness heat and swelling around injection site appeared, gave BENADRYL and applied Hydrocortisone cream to site.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site urticaria
Clinical narrative: Red, painful, itchy welt at injection site.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Cardiac stress test normal, Chest X-ray normal, Dyspnoea, Electrocardiogram, Heart rate increased
Clinical narrative: Pt received vaccine on 11/9/16 approximately 5:15 PM. At about 12:00AM 11/10/16 pt woke up feeling like she couldn't breathe. Pt went to hospital where her heart rate > 180. Pt received MRI, chest X-ray, stress test. Results came back negative-nothing to show.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging normal
Clinical narrative: Pt received vaccine on 11/9/16 approximately 5:15 PM. At about 12:00AM 11/10/16 pt woke up feeling like she couldn't breathe. Pt went to hospital where her heart rate > 180. Pt received MRI, chest X-ray, stress test. Results came back negative-nothing to show.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Syringe issue
Clinical narrative: The needle wasn't latch on tightly to the syringe, vaccine was leaked out about 2/3 of the volume during administration. Syringe removed and patient was given another injection without complication.
Age: 82.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: SX: arm red, swollen, itchy, painful starting 2 days after injection, lasting approximately 7 days. TX: cephalexin 500 mg one PO BID times 10 days, diphenhydramine 25 mg one PO PRN.
Age: 89.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site erythema
Clinical narrative: Patient had large red area clearly defined around shoulder and arm where shot was administered. Recommended patient to call their physician, or go to ER if worse. Patient said it was better than yesterday.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Bacterial infection, Cellulitis, Injection site erythema, Injection site pruritus, Peripheral swelling
Clinical narrative: Patient developed mild redness and itchiness at site of injection w/in 1 hour of getting dose. When seen patient was scratching area of injection site on left upper arm. I went over VIS and explained redness and itching are common side effects and usually last 1 to 2 days. I told her not to scratch, but she kept clawing injection site. Next morning seen by MD and developed swollen arm and bacterial infection inclusion "cellulitis" and given AUGMENTIN.
Age: 71.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Fatigue, Mobility decreased, Pruritus, Rash
Clinical narrative: Pt felt very tired after shot for couple days, she couldn't hardly lift her arms, she feels itchy most of the day and has rash off and on. She uses steroid creams to control the itch. Her symptoms are still bothering her today.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis at site of injection. Currently on Rx, expect full recovery.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a 72 year old female patient. Patient's pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/ allergies were reported. On an unknown date in 2012, the patient was vaccinated with ZOSTAVAX, via injection route, (strength, dosing details, anatomical location, lot# and expiration date were unknown). Recently (approximately in 2016), the patient experienced shingles and the patient was in physician's office on 24-OCT-2016 (also reported as 'today'). Treatment was given for the adverse event. The outcome of shingles was reported as not recovered. Causality assessment was not provided. The physician was interested in VZV (Varicella Zoster Virus) Analysis by PCR (Polymerase Chain Reaction) and wants to send viral isolates. VZV kit was faxed to the reporting physician. No product quality complaint was involved. Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: PPV
Symptoms: Incorrect dose administered
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a 46 year old female patient. The current condition of the patient reported as hyperlipidemia, anxiety, asthma with chronic bronchitis, dizziness, type 2 diabetes, vitamin deficiency. The patient was allergic to the drugs ADVAIR, glimepiride and sulfa drugs. On 04-NOV-2016, while administering the patient a dose of PNEUMOVAX 23 (lot # M037669 and expiry date 09-MAY-2018), the patient "moved" an unspecified way for an unspecified reason and the patient "ended up not receiving a full dose of PNEUMOVAX 23). It was unknown of how much of the vaccine the patient received. Concomitant therapies included XANAX, XOPENEX, vitamin D (manufacturer unknown), albuterol (manufacturer unknown), sumatriptan (manufacturer unknown), CRESTOR, DIOVAN, FLONASE, metformin (manufacturer unknown), ONGLYZA, budesonide, SYMBICORT and SINGULAIR. No product quality complaint was filed. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and from a support services director via company representatives and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 25-FEB-2016, the patient was vaccinated with a dose of an improperly stored GARDASIL 9 (strength: 0.5 ml) lot # L014198 and expiration date: 05-SEP-2017 (dose, anatomical location and route of administration were not reported). No adverse effects were reported). The dose of the vaccine was exposed to a temperature excursion (date unspecified): lasting for 120 hours, with the highest recorded temperature of 53 degrees Fahrenheit (11.66 degrees Celsius). The vaccine was stored in a refrigerator. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPVX
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with GARDASIL as first dose of HPV series (dose, route, lot # and expiry date not reported) and on an unknown date, the patient received second dose of HPV series GARDASIL 9 (dose, route, lot # and expiry date not reported). No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and from a support services director via company representatives and refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 20-FEB-2016, the patient was vaccinated with a dose of an improperly stored GARDASIL 9 (strength: 0.5 ml) lot # L014198 and expiration date: 05-SEP-2017 (dose, anatomical location and route of administration were not reported). No adverse effects were reported. The dose of the vaccine was exposed to a temperature excursion (date unspecified): lasting for 120 hours, with the highest recorded temperature of 53 degrees Fahrenheit (11.66 degrees Celsius). The vaccine was stored in a refrigerator. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and from a support services director via company representatives and refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 29-OCT-2015, the patient was vaccinated with a dose of an improperly stored GARDASIL 9 (strength: 0.5 ml) lot # L014198 and expiration date: 05-SEP-2017 (dose, anatomical location and route of administration were not reported). No adverse effects were reported. The dose of the vaccine was exposed to different temperature excursions (date unspecified): lasting for 88, 320, 192, and 40 hours, with the lowest recorded temperature of 30, 29, 33, and 34 degrees Fahrenheit (-11.11, -1.66, 0.55, and 1.11) respectively; and lasting for 64 hours, with the highest recorded temperature of 48 degrees Fahrenheit (8.88 degrees Celsius). The vaccine was stored in a refrigerator. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received form a physician via company representative, concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 07-DEC-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot number L024129; expiration date 21-JAN-2017) "10 PK 0.5 ml SD-PFS LLok w tip" (route of administration and anatomical location were not reported). On an unspecified dates, the PNEUMOVAX 23 had one temperature excursion of 24 hours. The lowest recorded temperature was 34 F (1.111111111). No adverse effects reported and no product quality complaint was involved. The vaccine status was reported as "in excursion". The vaccine storage criteria and the storage type of excursion were reported as "Refrigerator(R)". This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician via company representative, concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 03-DEC-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot number L024129; expiration date 21-JAN-2017) "10 PK 0.5 ml SD-PFS LLok w tip" (route of administration and anatomical location were not reported). On an unspecified dates, the PNEUMOVAX 23 had one temperature excursion of 24 hours. The lowest recorded temperature was 34 F (1.1111111111 Celsius). No adverse effects reported and no product quality complaint was involved. The vaccine status was reported as "in excursion". The vaccine storage criteria and the storage type of excursion were reported as "Refrigerator(R)". This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician via a company representative, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 05-OCT-2015, the patient was vaccinated with an improperly stored dose of GARDASIL 9 "0.5m-10 Pk SD PFS-Luer-Lok" which had a lot number of L001312 and expiration date on 24-FEB-2017 (route of administration and anatomical location were not reported). There were no concomitant medications provided. No adverse effects reported. No product quality complaint was involved. On an unspecified dates, the GARDASIL 9 vaccine had six temperature excursions as follows: two for 64 hours each one with a lowest recorded temperature of 31 F (-0.555555556 Celsius) and a highest recorded temperature of 48 F (8.888888889 Celsius), one of 328 hours with a lowest recorded temperature of 29 F (-1.666666667 Celsius), one of 88 hours with a lowest recorded temperature 30 F (-1.111111111 Celsius), one for 64 hours with a lowest recorded temperature of 34 F (1.111111111 Celsius) and the other one for 264 hours with a lowest recorded temperature of 33 F (0.555555556 Celsius). The vaccine status was reported as "in excursion". The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician, via company representatives, and refers to a patient of unknown age and gender. Information about the patient's pertinent medical history, drug reactions or allergies and concomitant medications was not reported. On 05-JUL-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ 2 ml, 10 unit dose tub, which had the lot # K022995, with expiration date 22-JUL-2016, orally (dose and dosage number were not reported). No adverse effects were reported and no product quality complaint was involved. On unspecified dates, the vaccine experienced temperature excursion of 24 hours. The highest recorded temperature was 47 F (8.333333333 Celsius degrees), the lowest temperature was not reported. The vaccine status was reported as "in excursion". The vaccine storage criteria and the storage type were reported as "Refrigerator (R)". This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician via a company representative, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 15-SEP-2015, the patient was vaccinated with an improperly stored dose of GARDASIL 9 "0.5mL-10 Pk SD PFS-Luer-Lok" which had a lot number of L001312 and expiration date on 24-FEB-2017 (route of administration and anatomical location were not reported).  There were no concomitant medications provided. No adverse effects reported. No product quality complaint was involved. On an unspecified dates, the GARDASIL 9 had five temperature excursions as follows: one for 64 hours with a lowest recorded temperature of 34 F (1.111111111 Celsius), one of 264 hours with a lowest recorded temperature of 33 F (0.555555556 Celsius), one for 64 with a lowest recorded temperature of 31 F (-0.555555556 Celsius), one for 32 hours with a highest recorded temperature of 48 F (8.888888889 Celsius) and the other one for 328 hours with a lowest recorded temperature of 29 F (-1.666666667 Celsius). The vaccine status was reported as "in excursion". The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician, via company representatives, and refers to a patient of unknown age and gender. Information about the patient's pertinent medical history, drug reactions or allergies and concomitant medications was not reported. On 12-JUL-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ 2 ML, 10 unit dose tube, which had the lot # K022995, with expiration date 22-JUL-2016, orally (dose and dosage number were not reported). No adverse effects were reported and no product quality complaint was involved. On unspecified dates, the vaccine experienced temperature excursion of 24 hours. The highest recorded temperature was 47 F (8.333333333 Celsius degrees), the lowest temperature was not reported. The vaccine status was reported as "in excursion". The vaccine storage criteria and the storage type were reported as "Refrigerator(R)". This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician, via company representatives, and refers to a patient of unknown age and gender. Information about the patient's pertinent medical history, drug reactions or allergies and concomitant medication was not reported. On 25-JUN-2015, the patient was vaccinated with an improperly stored dose of VAQTA 10 Pk 25 U/0.5 ml SD Llok w Cap Ped, which had the lot # L001445, with expiration date 15-FEB-2016 (dose, dosage number and route of administration were not reported). No adverse effects were reported and no product quality complaint was involved. On an unspecified date the vaccine experienced a temperature excursions of 24 hours. The lowest recorded temperature was 34 F (1.111111111 Celsius degree). The vaccine status was reports as "in excursion". The vaccine storage criteria and the storage type were reported as "Refrigerator(R)". This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a 60 year old male patient. No pertinent medical history, drug reactions, allergies or concurrent conditions were reported. On approximately 03-OCT-2016 (reported as "four weeks ago"), the patient was vaccinated with ZOSTAVAX 19400 plaque-forming units (PFU) in an unspecified arm (dose, route, lot number and expiration date were not reported). Other suspect and concomitant medications were not provided. On approximately 24-OCT-2016 (reported as "one weeks ago"), the patient received an unspecified influenza virus vaccine in his left arm. On 29-OCT-2016, the patient developed an unspecified rash on his right arm. The patient sought medical attention by calling the physician on an unspecified date in October 2016, no laboratory studies were performed and no treatment was given for the adverse event. No product quality complaint was involved. The physician stated that the rash resolved "within 24 hours" on 30-OCT-2016. The relatedness between the event and therapy with ZOSTAVAX was not reported. Additional information is not expected because the reporter did not consent for further follow up.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to unspecified patients of unknown age and gender. The patients medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with PROQUAD lot # M001151, expiration date: 05-JUL-2016, lot # M014304, expiration date: 22-SEP-2017, lot # M022400, expiration date: 01-NOV-2017 (concentration, dose, frequency and route of administration were not reported) which were improperly stored at 8.6 Fahrenheit degrees for 1 hour and 15 minutes. This excursion was detected due to a digital data logger, however no previous temperature excursion was reported. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and from a support services director via company representatives and refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 05-JAN-2016, the patient was vaccinated with a dose of an improperly stored GARDASIL 9 (strength: 0.5 ml) lot # L014198 and expiration date: 05-SEP-2017 (dose, anatomical location and route of administration were not reported). No adverse effects were reported. The dose of the vaccine was exposed to different temperature excursions (date unspecified): lasting for 40, 88, 320, and 232 hours, with the lowest recorded temperature of 34, 30, 29, and 33 degrees Fahrenheit (1.11, -1.11, -1.66, and 0.55 degrees Celsius) respectively; and lasting for 64 hours, with the highest recorded temperature of 48 degrees Fahrenheit (8.88 degrees Celsius). The vaccine was stored in a refrigerator. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and from a support services director via company representatives and refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 28-JAN-2016, the patient was vaccinated with a dose of an improperly stored GARDASIL 9 (strength: 0.5 ml) lot # L014198 and expiration date: 05-SEP-2017 (dose, anatomical location and route of administration were not reported). No adverse effects were reported. The dose of the vaccine was exposed to different temperature excursions (date unspecified): lasting for 40, 232, 88, and 320 hours, with the lowest recorded temperature of 34, 33, 30, and 29 degrees Fahrenheit (1.11, 0.55, -1.11, and -1.66 degrees Celsius) respectively; and lasting for 64 hours, with the highest recorded temperature of 48 degrees Fahrenheit (8.88 degrees Celsius). The vaccine was stored in a refrigerator. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician via company representative, concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 22-JUL-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot number L024129; expiration date 21-JAN-2017) "10 PK 0.5 ml SD-PFS LLok w tip" (route of administration and anatomical location were not reported). On an unspecified dates, the PNEUMOVAX 23 had one temperature excursion of 144 hours. The highest recorded temperature was 12 F. No adverse effects reported and no product quality complaint was involved. The vaccine status was reported as "in excursion". The vaccine storage criteria and the storage type of excursion were reported as "Refrigerator(R)". This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and from a support services director via company representatives and refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. on 14-OCT-2015, the patient was vaccinated with a dose of an improperly stored GARDASIL 9 (strength: 0.5 ml) lot # L014198 and expiration date: 05-SEP-2017 (dose, anatomical location and route of administration were not reported). No adverse effects were reported. The dose of the vaccine was exposed to different temperature excursions (date unspecified): lasting for 88, 192, 320, and 40 hours, with the lowest recorded temperature of 30, 33, 29, and 34 degrees Fahrenheit (-1.11, 0.55, -1.66, and 1.11 degrees Celsius) respectively; and lasting for 64 hours, with the highest recorded temperature of 48 degrees Fahrenheit (8.88 degrees Celsius). The vaccine was stored in a refrigerator. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and from a support services director via company representatives and refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 28-DEC-2015, the patient was vaccinated with a dose of an improperly stored GARDASIL 9 (strength: 0.5 ml) lot # L014198 and expiration date: 05-SEP-2017 (dose, anatomical location and route of administration were not reported). No adverse effects were reported. The dose of the vaccine was exposed to different temperature excursions (date unspecified): lasting for 40, 88, 232, and 320 hours, with the lowest recorded temperature of 34, 30, 33, and 29 degrees Fahrenheit (1.11, -1.11, 0.55, and -1.66 degrees Celsius) respectively; and lasting for 64 hours, with the highest recorded temperature of 48 degrees Fahrenheit (8.88 degrees Celsius). The vaccine was stored in a refrigerator. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: This spontaneous report has been received from a physician via company representative referring to a 51 year old patient (gender unknown). Information about concurrent condition, medical history or concomitant therapy was not reported. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, frequency and lot# not reported), subcutaneous. On an unknown date the patient developed a rash around the injection site after receiving ZOSTAVAX. The patient sought medical attention by contacting the physician. The outcome of the patient was unknown. The causality was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and from a support services director via company representatives and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 06-FEB-2016, the patient was vaccinated with a dose of an improperly stored GARDASIL 9 (strength: 0.5 ml) lot # L014198 and expiration date: 05-SEP-2017 (dose, anatomical location and route of administration were not reported). No adverse effects were reported. The dose of the vaccine was exposed to a temperature excursion (date unspecified): lasting for 56 hours, with the highest recorded temperature of 53 degrees Fahrenheit (11.66 degrees Celsius). The vaccine was stored in a refrigerator. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and from a support services director via company representatives and refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 19-JAN-2016, the patient was vaccinated with a dose of an improperly stored GARDASIL 9 (strength: 0.5 ml) lot # L014198 and expiration date: 05-SEP-2017 (dose, anatomical location and route of administration were not reported). No adverse effects were reported. The dose of the vaccine was exposed to different temperature excursions (date unspecified): lasting for 320, 232, 88, and 40 hours, with the lowest recorded temperature of 29, 33, 30, and 34 degrees Fahrenheit (-1.66, 0.55, -1.11, and 1.11 degrees Celsius) respectively; and lasting for 64 hours, with the highest recorded temperature of 48 degrees Fahrenheit (8.88 degrees Celsius). The vaccine was stored in a refrigerator. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.