chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Drug administered at inappropriate site, Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: The injection was administered very high up, at my shoulder. Pain started that evening. For the past 14 days I have had very limited ROM and severe pain in my left shoulder/deltoid - especially when abducting my arm away from my body. Going to see my doctor on 11/15.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Joint swelling, Pruritus, Urticaria
Clinical narrative: Hives, itching later that day, swollen ankles the next morning. Advised by after-hours  triage RN to take Benadryl.
Age: 78.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Musculoskeletal disorder
Clinical narrative: PAIN AT SITE OF INJECTION, IMMOBILITY OF  LEFT ARM. CAN'T LIFT OR USE THE LEFT ARM. SHE WENT TO ER AND FAMILY DOCTOR, BUT THEY DID NOT GIVE ANY TREATMENT.
Age: 22.0
Sex: M
Vaccine: FLU4
Symptoms: Bursitis, Injected limb mobility decreased, Injection site reaction
Clinical narrative: I got the flu shot in my left arm. The day after i couldn't move my arm at all. Its been almost a month now. I've had different medications. Also I'm going to physical therapy. Diagnosed with Shoulder Bursitis.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pruritus
Clinical narrative: Itchy, redness. Staff member seen at Employee Wellness Center.
Age: 13.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Headache, Injection site erythema, Injection site warmth, Pain in extremity, Pyrexia
Clinical narrative: About 24 hours post imz administration the patient complained of arm pain that radiates 1/2way to elbow and up to shoulder. Arm is hot and red about a palm sized area around site of injection. Patient is running a fever that has gotten as high as 103 degrees F. Mother gave Ibuprofen and Tylenol which would bring down the fever temporarily. Patient also complains of horrible headache. Headache is not relieved by Ibuprofen or Tylenol. Mother was en route to take patient to urgent care and will follow up with us regarding more information.
Age: 60.0
Sex: F
Vaccine: HEP, VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling, Injection site vesicles, Injection site warmth
Clinical narrative: About 6 inches around the shot had a raised red inflamed area that was warm to the touch the next day. By day 2 the area had spread to about 8 inches and became blistered. It took about a week for it to clear up. I never had any pain with it. I still have a red patch a month later where the skin had blistered. I have sensitive skin and I'm allergic to rubbing alcohol but the nurse did not use any when she gave me my shots. The other arm where I received the Hep b shot had no reaction.
Age: 68.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chest X-ray abnormal, Cough, Feeling abnormal, Pneumonia, Pyrexia
Clinical narrative: Patient received the PNEUMOVAX Vaccine on Monday 10/30/17 and reports having an itchy throat and feeling bad overall on Wednesday, 11/01/2017. He stated he progressively started feeling worse and had a fever accompanied by a cough that prompted him to see a physician at an urgent clinic on Saturday, 11/04/2017. He stated he was diagnosed with pneumonia by an exam and chest X-ray at the urgent clinic. The prescriber gave him an antibiotic, steroids, and breathing treatment solution.
Age: 68.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Throat irritation
Clinical narrative: Patient received the PNEUMOVAX Vaccine on Monday 10/30/17 and reports having an itchy throat and feeling bad overall on Wednesday, 11/01/2017. He stated he progressively started feeling worse and had a fever accompanied by a cough that prompted him to see a physician at an urgent clinic on Saturday, 11/04/2017. He stated he was diagnosed with pneumonia by an exam and chest X-ray at the urgent clinic. The prescriber gave him an antibiotic, steroids, and breathing treatment solution.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Back pain, Bone pain, Fatigue, Injection site reaction
Clinical narrative: Patient experienced extreme tiredness, whole body aches, even bones & joints, on Sat had red raised rash that ran from injection site to elbow, back & legs sore, hurt to touch her back, too tired to leave home. Now on Tues 11/14/17 she is still too tired to do normal activities and is sore, but not as much actively hurting.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Loss of personal independence in daily activities, Pain, Pain in extremity, Rash erythematous, Tenderness
Clinical narrative: Patient experienced extreme tiredness, whole body aches, even bones & joints, on Sat had red raised rash that ran from injection site to elbow, back & legs sore, hurt to touch her back, too tired to leave home. Now on Tues 11/14/17 she is still too tired to do normal activities and is sore, but not as much actively hurting.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Bone pain, Fatigue, Headache, Injection site reaction, Myalgia
Clinical narrative: Patient experienced extreme tiredness, whole body aches, even bones & joints, on Sat had red raised rash that ran from injection site to elbow, back & legs sore, hurt to touch her back, too tired to leave home. Now on Tues 11/14/17 she is still too tired to do normal activities and is sore, but not as much actively hurting.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Urticaria
Clinical narrative: Patient experienced extreme tiredness, whole body aches, even bones & joints, on Sat had red raised rash that ran from injection site to elbow, back & legs sore, hurt to touch her back, too tired to leave home. Now on Tues 11/14/17 she is still too tired to do normal activities and is sore, but not as much actively hurting.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Erythema, Peripheral swelling, Pyrexia
Clinical narrative: Today pt reported that she had swelling of the left arm, redness, experienced fever and chills starting the night of vaccination and lasting for one to one and one half days. She states that she is fine now with no lingering issues.
Age: 5.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Joint range of motion decreased
Clinical narrative: 5YO FEMALE DEP BROUGHT INTO CLINIC BY MOTHER FOR RIGHT ARM SWELLING. PT RECIEVED VACCINE (SEASONAL INFLUENZA) DAY PRIOR AT OFF SITE INFLUENZA VACCINATION AT SCHOOL. NKA OR NKDA. MOTHER STATED EDEMA STARTED YESTERDAY EVENING BUT NOTICED IT WAS WORSE THIS MORNING AND GETTING BIGGER. PT HAS SEVERE SWELLING ABOUT 13CM IN LENGTH, STARTING 2 INCHES ABOVE ELBOW PROCEEDING OVER BICEP IN SHOULDER. SWOLLEN TISSUE WAS WARM TO TOUCH AND TENDER. MOM STATES NO MEDICATIONS WERE GIVEN. PT DID HAVE DECREASED RANGE OF MOTION. M.D. DID EVALUATE PATIENT. BORDER NEAR ELBOW WAS MARKED. MOTHER WAS INSTRUCTED THAT IF SWELLING PROCEEDED PAST MARKED BORDER SHE NEEDS TO BRING HER SON BACK INTO CLINIC.
Age: 72.0
Sex: M
Vaccine: FLU3, PPV, PPV
Symptoms: Chills, Impaired work ability, Insomnia, Malaise, Pain in extremity
Clinical narrative: At approximately 6 pm, pt. reports having an extremely sore left arm, fever, chills, being unable to sleep throughout the night, the next morning, he was "mostly better", but still not feeling well enough to go to work, but felt better throughout the day.
Age: 72.0
Sex: M
Vaccine: FLU3, PPV, PPV
Symptoms: Pyrexia
Clinical narrative: At approximately 6 pm, pt. reports having an extremely sore left arm, fever, chills, being unable to sleep throughout the night, the next morning, he was "mostly better", but still not feeling well enough to go to work, but felt better throughout the day.
Age: 72.0
Sex: M
Vaccine: FLU3, PPV, PPV
Symptoms: Chills, Injection site pain, Insomnia, Pyrexia
Clinical narrative: At approximately 6 pm, pt. reports having an extremely sore left arm, fever, chills, being unable to sleep throughout the night, the next morning, he was "mostly better", but still not feeling well enough to go to work, but felt better throughout the day.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Patient complains of painful arm (injection site) and difficult to raise and move the left arm after giving the injection. Patient applied ice and heat compress but no relief. Patient was advised to see her primary care but no one can drive her.
Age: 64.0
Sex: M
Vaccine: FLUC4, VARZOS
Symptoms: Diarrhoea
Clinical narrative: Patient experienced diarrhea lasting longer than a week that was not controlled by IMODIUM OTC. He then was instructed by his Doctor to do the BRAT diet and then BRAT diet plus a probiotic.
Age: 65.0
Sex: F
Vaccine: FLUA3, PPV, FLUX, PPV
Symptoms: Chills, Nausea, Pain in extremity
Clinical narrative: Pt. describes her arm as being "extremely sore" for three days. Approximately 8 hours after the vaccination, she experienced nausea, chills, and went to bed at 7:15, and woke up feeling "better", with the exception of the arm soreness.
Age: 65.0
Sex: F
Vaccine: FLUA3, PPV, FLUX, PPV
Symptoms: Chills, Injection site pain, Insomnia, Nausea, Pyrexia
Clinical narrative: Pt. describes her arm as being "extremely sore" for three days. Approximately 8 hours after the vaccination, she experienced nausea, chills, and went to bed at 7:15, and woke up feeling "better", with the exception of the arm soreness.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Cold sweat, Erythema, Injection site urticaria, Pain in extremity, Pruritus
Clinical narrative: By the evening, the patient reported having a very sore arm, hives around the site of the injection, cold sweat that lasted into the next morning. There was continued redness/itchiness and rash on the left arm for approximately 4 days.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Rash
Clinical narrative: By the evening, the patient reported having a very sore arm, hives around the site of the injection, cold sweat that lasted into the next morning. There was continued redness/itchiness and rash on the left arm for approximately 4 days.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Chills, Injection site pain, Insomnia, Pyrexia, Rash
Clinical narrative: By the evening, the patient reported having a very sore arm, hives around the site of the injection, cold sweat that lasted into the next morning. There was continued redness/itchiness and rash on the left arm for approximately 4 days.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Urticaria
Clinical narrative: By the evening, the patient reported having a very sore arm, hives around the site of the injection, cold sweat that lasted into the next morning. There was continued redness/itchiness and rash on the left arm for approximately 4 days.
Age: 42.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Cough, Headache, Pain, Pruritus
Clinical narrative: I had the Chickenpox as a child. During pre-employment blood screening it was determined I did not have immunity to chickenpox and I was instructed to receive a vaccine. I received this vaccine on 10/26/2017. 11/11/2017 I started with headache, low grade fever, cough and body aches. 11/12/2017 I began to break out on my scalp and arms. Approximately 10 spots were counted. 11/13/2017 I began to break out on my back and abdomen. Approximately 30 spots were counted. 11/14/2017 spots are breaking out all over my body, 50 or so at present. Some now have small blisters. Itching is becoming intense. Moderate headache, body aches, cough.
Age: 42.0
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: I had the Chickenpox as a child. During pre-employment blood screening it was determined I did not have immunity to chickenpox and I was instructed to receive a vaccine. I received this vaccine on 10/26/2017. 11/11/2017 I started with headache, low grade fever, cough and body aches. 11/12/2017 I began to break out on my scalp and arms. Approximately 10 spots were counted. 11/13/2017 I began to break out on my back and abdomen. Approximately 30 spots were counted. 11/14/2017 spots are breaking out all over my body, 50 or so at present. Some now have small blisters. Itching is becoming intense. Moderate headache, body aches, cough.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site pruritus, Injection site swelling
Clinical narrative: Patient complained of excessive bruising, swelling, and itching in her arm starting about 2 inches below the injection site and extending down her arm.
Age: 27.0
Sex: M
Vaccine: TD
Symptoms: Chills, Cold sweat, Nausea, Pain
Clinical narrative: Vaccine was administered around 0830 hours on 11/08/17. At around 2330 that night I awoke with the chills, entire body aches, nausea, and pains. I fell back asleep and awoke around 0330 the next morning drenched in a cold sweat. I felt the chills, body aches, nausea, and pains until I woke up on 11/10/17 at which time I felt fine.
Age: 42.0
Sex: F
Vaccine: FLUC4
Symptoms: Arthralgia, Contusion, Hypoaesthesia, Influenza like illness, Mobility decreased
Clinical narrative: Flu like symptoms that night. Woke up with bruised feeling. Progressed into severe cramping. Could not use arm. Limited mobility. Can lift anything. Can't lay on it. Lay on right side and left arm in continuous pain. Goes numb and fingers swell. Pain has progressed to shoulder joint up to my neck and collar bone. Worst pain ever.
Age: 42.0
Sex: F
Vaccine: FLUC4
Symptoms: Muscle spasms, Neck pain, Pain in extremity, Peripheral swelling
Clinical narrative: Flu like symptoms that night. Woke up with bruised feeling. Progressed into severe cramping. Could not use arm. Limited mobility. Can lift anything. Can't lay on it. Lay on right side and left arm in continuous pain. Goes numb and fingers swell. Pain has progressed to shoulder joint up to my neck and collar bone. Worst pain ever.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Erythema, Headache, Peripheral swelling, Pruritus
Clinical narrative: Patient experienced swelling, red welts and itching in the right arm (the vaccinated arm). She also complained of fever, chills and headache that lasted for a couple days after vaccination.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia, Urticaria
Clinical narrative: Patient experienced swelling, red welts and itching in the right arm (the vaccinated arm). She also complained of fever, chills and headache that lasted for a couple days after vaccination.
Age: 32.0
Sex: F
Vaccine: FLU4, HEPA
Symptoms: Pain in extremity
Clinical narrative: PATIENT WAS ADMINISTERED HAVRIX AND FLUARIX INTRAMUSCULARLY AT HER WORKPLACE ON 10/12/2017. PATIENT CALLED THE PHARMACY TODAY 11/14/2017 TO INFORM THAT HER ARM IS SORE AND PAINFUL. I ADVISED HER TO CALL HER DOCTOR FOR EVALUATION AND INFORMED HER THAT I WOULD BE SUBMITTING VAERS FORM.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, FLU4, HIBV, PNC13
Symptoms: Rash erythematous, Rash generalised, Rash macular
Clinical narrative: Within minutes of receiving the injection, patient developed erythematous macular rash over entire body. Did not appear to be urticaric. No swelling of face, tongue. No airway involvement. No GI distress. PO BENADRYL given- rash began to resolve within 15 minutes. Patient also received PEDIARIX, ACTHIB, PREVNAR 13 at the same time- had 2 prior doses of each of those without problem.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Arthralgia, Chills, Erythema, Feeling abnormal, Headache
Clinical narrative: 18 hours later, woke up with headache, fever, arm very hard & some swelling. Four hours later, temperature for 101, extreme headache, chills, extreme joint pain. Arm now swollen to elbow & extremely hot and bright red skin on outside and underside of arm. Twenty four hours later, symptoms have all diminished a little but still miserable & inner arm is extremely itchy. Ten days later swelling gone & redness but still hard at injection site and inner arm still itchy at times. (No other reason for itchiness).
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Induration, Injection site induration, Peripheral swelling, Pruritus, Pyrexia
Clinical narrative: 18 hours later, woke up with headache, fever, arm very hard & some swelling. Four hours later, temperature for 101, extreme headache, chills, extreme joint pain. Arm now swollen to elbow & extremely hot and bright red skin on outside and underside of arm. Twenty four hours later, symptoms have all diminished a little but still miserable & inner arm is extremely itchy. Ten days later swelling gone & redness but still hard at injection site and inner arm still itchy at times. (No other reason for itchiness).
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Skin warm
Clinical narrative: 18 hours later, woke up with headache, fever, arm very hard & some swelling. Four hours later, temperature for 101, extreme headache, chills, extreme joint pain. Arm now swollen to elbow & extremely hot and bright red skin on outside and underside of arm. Twenty four hours later, symptoms have all diminished a little but still miserable & inner arm is extremely itchy. Ten days later swelling gone & redness but still hard at injection site and inner arm still itchy at times. (No other reason for itchiness).
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Peripheral swelling
Clinical narrative: PATIENT REPORTED A BULGE ON HER LEFT ARM 4 DAYS AFTER VACCINATION. NO PAIN OR REDNESS REPORTED.
Age: 17.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injection site hypoaesthesia, Injection site pain, Paraesthesia
Clinical narrative: Pain at injection site, numbness from injection site to fingers, tingling in fingers (all of the vaccine arm only).
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site mass, Injection site pain, Injection site rash, Injection site swelling, Urticaria
Clinical narrative: Pt said she got hives, lump at site, swelling at site and a rash plus very sore.
Age: 24.0
Sex: F
Vaccine: HPV9
Symptoms: Blood pressure decreased, Chest discomfort, Dizziness, Dyspnoea
Clinical narrative: Pt at 5 minutes after vaccine administration reports chest tightness, difficulty breathing, lightheadness, BP dropped. Pt felt normal after 15 minutes.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Hypersensitivity, Pain, Pruritus, Pyrexia
Clinical narrative: Patient presented on 11/13/17 to pharmacist with signs of allergic reaction: rash, itching, pain, swelling, redness, fever. Patient was taking 2 BENADRYL every 6 hrs as needed and patient stated he is getting better. Follow up call on 11/15/17 also suggested patient take ZYRTEC in place of BENADRYL and to apply cool compresses.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Rash, Swelling
Clinical narrative: Patient presented on 11/13/17 to pharmacist with signs of allergic reaction: rash, itching, pain, swelling, redness, fever. Patient was taking 2 BENADRYL every 6 hrs as needed and patient stated he is getting better. Follow up call on 11/15/17 also suggested patient take ZYRTEC in place of BENADRYL and to apply cool compresses.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Erythema, Influenza, Peripheral swelling, Skin warm
Clinical narrative: Received PNEUMOVAX 23 shot, began to have pain in elbow area within 2 hrs. Entire arm was swollen, red, feverish by late evening. Also had mild flu symptoms. Went to doctor next day, was told to watch for more swelling and to go to ER if it happened. Three days after getting shot, arm is still swollen but not as much. Side effects warnings should be more specific and emphasized more.
Age: 59.0
Sex: F
Vaccine: FLUC4
Symptoms: Rash generalised
Clinical narrative: Pt describes generalized rash all over body after getting flu shot.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Adverse reaction, Erythema
Clinical narrative: Pt waited 15 minutes. Pt had a reaction, area was flat and red.
Age: 49.0
Sex: F
Vaccine: FLU4, UNK
Symptoms: Dyspnoea, Swelling, Urticaria
Clinical narrative: Hives, SOB and swelling approx 2 hrs. after administration of influenza vaccine. Taken to ER via ambulance. TX included oral and IV BENADRYL. At ER IV fluid and IV SOLUMEDROL administered.
Age: 49.0
Sex: F
Vaccine: FLU4, UNK
Symptoms: Anxiety, Chest discomfort, Chest pain, Dysphagia, Dyspnoea
Clinical narrative: Hives, SOB and swelling approx 2 hrs. after administration of influenza vaccine. Taken to ER via ambulance. TX included oral and IV BENADRYL. At ER IV fluid and IV SOLUMEDROL administered.
Age: 49.0
Sex: F
Vaccine: FLU4, UNK
Symptoms: Heart rate increased, Immediate post-injection reaction, Peripheral swelling, Pruritus, Rash
Clinical narrative: Hives, SOB and swelling approx 2 hrs. after administration of influenza vaccine. Taken to ER via ambulance. TX included oral and IV BENADRYL. At ER IV fluid and IV SOLUMEDROL administered.
Age: 49.0
Sex: F
Vaccine: FLU4, UNK
Symptoms: Tenderness, Urticaria
Clinical narrative: Hives, SOB and swelling approx 2 hrs. after administration of influenza vaccine. Taken to ER via ambulance. TX included oral and IV BENADRYL. At ER IV fluid and IV SOLUMEDROL administered.
Age: 72.0
Sex: F
Vaccine: FLUC4
Symptoms: Chest X-ray, Dizziness, Dyspnoea, Nausea, Rash
Clinical narrative: SOB, wheezing, rash, dizziness, nausea went to ER. Given to BENADRYL, Prednisone po. Given Albuterol.
Age: 72.0
Sex: F
Vaccine: FLUC4
Symptoms: Wheezing
Clinical narrative: SOB, wheezing, rash, dizziness, nausea went to ER. Given to BENADRYL, Prednisone po. Given Albuterol.
Age: 94.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Contusion, Swelling
Clinical narrative: Bruising of entire arm, swelling.
Age: 94.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Contusion, Injection site discolouration, Swelling
Clinical narrative: Bruising of entire arm, swelling.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: Patient received FLUVIRIN PF on 10/24/17. At time of shot and following two days patient had stinging in area of vaccine. After 2 days, patient had swelling and pain in that area. As of 11/14/17, patient will has some pain and swelling. Advised patient to receive medical attention. (Patient noted no redness around site).
Age: 56.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain, Injection site rash
Clinical narrative: Patient called pharmacy said she was having pain and rash at injection site.
Age: 48.0
Sex: U
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: On Oct 2, 2017, patient was given FLUARIX QUAD at pharmacy. Patient is complaining of pain down the left arm. Pain is still present today.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Dysphagia, Livedo reticularis, Rash, Rash generalised, Rash pruritic
Clinical narrative: Itchy generalized rash / abdomen / arms mottled skin on arms. Tongue swelling with difficulty swallowing. Pt. took herself to hospital and was treated with steroids and BENADRYL. D/C home same day.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Swollen tongue
Clinical narrative: Itchy generalized rash / abdomen / arms mottled skin on arms. Tongue swelling with difficulty swallowing. Pt. took herself to hospital and was treated with steroids and BENADRYL. D/C home same day.
Age: 53.0
Sex: U
Vaccine: FLUC4, PPV
Symptoms: Dyspnoea, Flushing
Clinical narrative: Shortness of breath, flushing, administered EPIPEN 0.3 mg IM and called 911. Transported to hospital for follow-up.
Age: 0.17
Sex: U
Vaccine: RV5, HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; An unknown number of unspecified patients have been administered doses of vaccines that were improperly stored; This spontaneous report as received from a physician refers to a 9 month old patient of unknown gender. The patient's concurrent conditions, concomitant medications, pertinent medical history and drug reactions or allergies were not provided.  On 08-SEP-2017, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB), lot # N003536 with expiration date on 02-NOV-2019 (dose and route of administration were not reported).  Since 21-JUN-2017, the administered dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) underwent multiple temperature excursions between 32 degrees Fahrenheit and 49 degrees Fahrenheit, which lasted for 49 hours. A digital data logger was not involved in recording the excursion. No adverse effects were reported. There was no product quality complaint involved.  This is one of several reports received from the same reporter.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; An unknown number of unspecified patients have been administered doses of vaccines that were improperly stored; This spontaneous report as received from a physician refers to a 16 month old patient of unknown gender. The patient's concurrent conditions, concomitant medications, pertinent medical history and drug reactions or allergies were not provided.  On 30-AUG-2017, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB), lot # N003536 with expiration date on 02-NOV-2019 (dose and route of administration were not reported).  Since 21-JUN-2017, the administered dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) underwent multiple temperature excursions between 32 degrees Fahrenheit and 49 degrees Fahrenheit, which lasted for 16 hours. A digital data logger was not involved in recording the excursion. No adverse effects were reported. There was no product quality complaint involved.  This is one of several reports received from the same reporter.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; An unknown number of unspecified patients have been administered doses of vaccines that were improperly stored; This spontaneous report as received from a physician refers to an 11 year old patient of unknown gender. No information on the patient's concurrent conditions, medical history and concomitant medications was reported. On 14-JUL-2017, the patient was vaccinated with an improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # M043731, expiry date 22-JUN-2019 (dose, route of administration were not provided). Data logger was not involved. No adverse event was reported. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1709USA012770: US-009507513-1709USA012767: US-009507513-1709USA012768: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA007325: US-009507513-1709USA012766:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; An unknown number of unspecified patients have been administered doses of vaccines that were improperly stored; This spontaneous report as received from a physician refers to an 11 year old patient of unknown gender. No information on the patient's concurrent conditions, medical history and concomitant medications was reported. On 17-JUL-2017, the patient was vaccinated with an improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # M043731, expiry date 22-JUN-2019 (dose, route of administration were not provided). Data logger was not involved. No adverse event was reported. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1709USA012770: US-009507513-1709USA012767: US-009507513-1709USA012768: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA007325: US-009507513-1709USA012766:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; An unknown number of unspecified patients have been administered doses of vaccines that were improperly stored; This spontaneous report as received from a physician refers to an 13 year old patient of unknown gender. No information on the patient's concurrent conditions, medical history and concomitant medications was reported. On 21-JUL-2017, the patient was vaccinated with an improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # M043731, expiry date 22-JUN-2019 (dose, route of administration were not provided). Data logger was not involved. No adverse event was reported. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1709USA012770: US-009507513-1709USA012767: US-009507513-1709USA012768: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA007325: US-009507513-1709USA012766:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; An unknown number of unspecified patients have been administered doses of vaccines that were improperly stored; This spontaneous report as received from a physician refers to an 14 year old patient of unknown gender. No information on the patient's concurrent conditions, medical history and concomitant medications was reported. On 26-JUL-2017, the patient was vaccinated with an improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # M043731, expiry date 22-JUN-2019 (dose, route of administration were not provided). Data logger was not involved. No adverse event was reported. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1709USA012770: US-009507513-1709USA012767: US-009507513-1709USA012768: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA007325: US-009507513-1709USA012766:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; An unknown number of unspecified patients have been administered doses of vaccines that were improperly stored; This spontaneous report as received from a physician refers to a 11 year old patient of unknown gender. The patient's concurrent conditions, concomitant medications, pertinent medical history and drug reactions or allergies were not provided.  On 23-AUG-2017, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), lot # M040412 with expiration date on 30-JUN-2019 (dose and route of administration were not reported).  Since 19-MAY-2017, the administered dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) underwent multiple temperature excursions between 33 degrees Fahrenheit and 50 degrees Fahrenheit, which lasted for 16, 40, 46 or 70 hours. A digital data logger was not involved in recording the excursion. No adverse effects were reported. There was no product quality complaint involved.  This is one of several reports received from the same reporter.
Sex: F
Vaccine: PPV, PPV
Symptoms: Feeling abnormal, Myalgia, Pain, Pyrexia, Tremor
Clinical narrative: This spontaneous report was received from a health care professional (also reported as an office manager) via Pfizer Inc (manufacturer control # 2017155426), concerning a female patient of unknown age. The patient's medical history and concurrent conditions were not reported. In 2015, the patient was vaccinated with a dose of PREVNAR 13 for prophylaxis (dose #, route of administration lot # and expiration date were unknown). Then, on 13-MAR-2017, the patient was vaccinated with a dose of PNEUMOVAX23, lot # N003993, expiration date: 20-OCT-2018, as well for prophylaxis (dose # and route of administration were unknown). Concomitant medications were not reported. On an unknown date, the patient possibly experienced an unspecified reaction. At the time of reporting, the outcome of the adverse reaction was unknown. The reporter considered adverse reaction to be related to PNEUMOVAX23. The patient also experienced an adverse event while on prednisone (manufacturer unknown) (case # 1711USA006099). Sender's Comments: US-009507513-1711USA006099.
Sex: F
Vaccine: PPV, PPV
Symptoms: Adverse event following immunisation
Clinical narrative: This spontaneous report was received from a health care professional (also reported as an office manager) via Pfizer Inc (manufacturer control # 2017155426), concerning a female patient of unknown age. The patient's medical history and concurrent conditions were not reported. In 2015, the patient was vaccinated with a dose of PREVNAR 13 for prophylaxis (dose #, route of administration lot # and expiration date were unknown). Then, on 13-MAR-2017, the patient was vaccinated with a dose of PNEUMOVAX23, lot # N003993, expiration date: 20-OCT-2018, as well for prophylaxis (dose # and route of administration were unknown). Concomitant medications were not reported. On an unknown date, the patient possibly experienced an unspecified reaction. At the time of reporting, the outcome of the adverse reaction was unknown. The reporter considered adverse reaction to be related to PNEUMOVAX23. The patient also experienced an adverse event while on prednisone (manufacturer unknown) (case # 1711USA006099). Sender's Comments: US-009507513-1711USA006099.
Age: 70.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Arthralgia
Clinical narrative: Severe muscle pain in hip(s), (Rt) knee, shoulder(s), wrist(s), hand(s). In order to function I'm on prednisone. Otherwise I'm disable to do normal everyday grooming, can't drive.
Age: 70.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Impaired driving ability, Loss of personal independence in daily activities, Myalgia
Clinical narrative: Severe muscle pain in hip(s), (Rt) knee, shoulder(s), wrist(s), hand(s). In order to function I'm on prednisone. Otherwise I'm disable to do normal everyday grooming, can't drive.
Age: 70.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Arthralgia, Blood test normal, Impaired driving ability, Musculoskeletal pain, Neck pain
Clinical narrative: Severe muscle pain in hip(s), (Rt) knee, shoulder(s), wrist(s), hand(s). In order to function I'm on prednisone. Otherwise I'm disable to do normal everyday grooming, can't drive.
Age: 70.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Pain in extremity
Clinical narrative: Severe muscle pain in hip(s), (Rt) knee, shoulder(s), wrist(s), hand(s). In order to function I'm on prednisone. Otherwise I'm disable to do normal everyday grooming, can't drive.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Asthenia, Diarrhoea, Erythema, Induration
Clinical narrative: Pt reported GI distress about 1 hr after injection, then within 24 hrs itching and then progressed to painful then over the course of 7 week very red almost burn looking.. then resolved after 1 week.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Pt reported GI distress about 1 hr after injection, then within 24 hrs itching and then progressed to painful then over the course of 7 week very red almost burn looking.. then resolved after 1 week.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal discomfort, Erythema, Pain, Pruritus
Clinical narrative: Pt reported GI distress about 1 hr after injection, then within 24 hrs itching and then progressed to painful then over the course of 7 week very red almost burn looking.. then resolved after 1 week.
Age: 0.58
Sex: U
Vaccine: HEPA, HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to 7 months old patient of unknown gender. Pertinent medical history or concurrent conditions were not reported. On 25-APR-2017, the patient was vaccinated with improperly stored dose of VAQTA which had the lot # N005274, expiration date 03-APR-2018 (dosage information and route were not informed). Information regarding concomitant medication was not provided. Additionally, it was reported that the lowest temperature was 32°F and the higher was 54°F for 70 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one case from several cases from the same reporter.; Sender's Comments: US-009507513-1709USA012770: US-009507513-1709USA012767: US-009507513-1709USA007325: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA012764: US-009507513-1709USA012766: US-009507513-1709USA012768:
Age: 1.0
Sex: U
Vaccine: HEPA, HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician who referred to 12 months old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 23-MAY-2017, the patient was vaccinated with improperly stored dose of VAQTA lot #N005274, expiration date 03-APR-2018 (dose and route of administration were not reported) for prophylaxis. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion from 32 degrees Fahrenheit to 54 degrees Fahrenheit for 70 hours. Data logger was not involved. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1709USA012770: US-009507513-1709USA012767: US-009507513-1709USA007325: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA012764: US-009507513-1709USA012766: US-009507513-1709USA012768:
Age: 1.0
Sex: U
Vaccine: HEPA, HEPA, HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to 12 months old patient of unknown gender. Pertinent medical history or concurrent conditions were not reported. On 30-MAY-2017, the patient was vaccinated with improperly stored dose of VAQTA which had the lot # N005274, expiration date 03-APR-2018 (dosage information and route were not informed). Information regarding concomitant medication was not provided. Additionally, it was reported that the lowest temperature was 32°F and the higher was 54°F for 70 hours. Data logger was not involved.  No adverse effects were reported. There was no product quality complaint involved. This is one case from several cases from the same reporter.; Sender's Comments: US-009507513-1709USA012770:  US-009507513-1709USA012767: US-009507513-1709USA007325: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA012764: US-009507513-1709USA012766: US-009507513-1709USA012768:
Age: 1.08
Sex: U
Vaccine: HEPA, HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to 12 months old patient of unknown gender. Pertinent medical history or concurrent conditions were not reported. On 30-MAY-2017, the patient was vaccinated with improperly stored dose of VAQTA which had the lot # N005274, expiration date 03-APR-2018 (dosage information and route were not informed). Information regarding concomitant medication was not provided. Additionally, it was reported that the lowest temperature was 32°F and the higher was 54°F for 70 hours. Data logger was not involved.  No adverse effects were reported. There was no product quality complaint involved. This is one case from several cases from the same reporter.; Sender's Comments: US-009507513-1709USA012770: US-009507513-1709USA012767: US-009507513-1709USA007325: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA012764: US-009507513-1709USA012766: US-009507513-1709USA012768:
Age: 3.0
Sex: U
Vaccine: HEPA, HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to an unknown number of patients of unknown gender and age. Pertinent medical history or concurrent conditions were not reported. Since 23-MAY-2017 (also reported as since 10-APR-2017), the patients were vaccinated with improperly stored doses of VAQTA which had the lot # N005274, expiration date 03-APR-2018, N008823, expiration date 26-MAY-2018 and N014945, expiration date 31-AUG-2018, for prophylaxis (dosage information and route were not informed). Information regarding concomitant medication was not provided. Additionally, it was reported that the lowest temperature was 32°F and the higher was 54°F for 70 hours. Data logger was not involved.  No adverse effects were reported. There was no product quality complaint involved. This is one case from several cases from the same reporter.; Sender's Comments:  US-009507513-1709USA012770: US-009507513-1709USA012767: US-009507513-1709USA007325: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA012764: US-009507513-1709USA012766: US-009507513-1709USA012768:
Age: 1.25
Sex: U
Vaccine: HEPA, HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to 15 months old patient of unknown gender. Pertinent medical history or concurrent conditions were not reported. On 26-MAY-2017, the patient was vaccinated with improperly stored dose of VAQTA which had the lot # N005274, expiration date 03-APR-2018 (dosage information and route were not informed). Information regarding concomitant medication was not provided. Additionally, it was reported that the lowest temperature was 32°F and the higher was 54°F for 70 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one case from several cases from the same reporter.; Sender's Comments: US-009507513-1709USA012770: US-009507513-1709USA012767: US-009507513-1709USA007325: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA012764: US-009507513-1709USA012766: US-009507513-1709USA012768:
Age: 2.0
Sex: U
Vaccine: HEPA, HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to 2 years old patient of unknown gender. Pertinent medical history or concurrent conditions were not reported. On 27-MAY-2017, the patient was vaccinated with improperly stored dose of VAQTA which had the lot # N005274, expiration date 03-APR-2018 (dosage information and route were not informed). Information regarding concomitant medication was not provided. Additionally, it was reported that the lowest temperature was 32°F and the higher was 54°F for 70 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one case from several cases from the same reporter.; Sender's Comments: US-009507513-1709USA012770: US-009507513-1709USA012767: US-009507513-1709USA007325: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA012764: US-009507513-1709USA012766: US-009507513-1709USA012768:
Age: 1.0
Sex: U
Vaccine: HEPA, HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to 12 months old patient of unknown gender. Pertinent medical history or concurrent conditions were not reported. On 30-MAY-2017, the patient was vaccinated with improperly stored dose of VAQTA which had the lot # N005274, expiration date 03-APR-2018 (dosage information and route were not informed). Information regarding concomitant medication was not provided. Additionally, it was reported that the lowest temperature was 32°F and the higher was 54°F for 70 hours. Data logger was not involved.  No adverse effects were reported. There was no product quality complaint involved. This is one case from several cases from the same reporter.; Sender's Comments: US-009507513-1709USA012770: US-009507513-1709USA012767: US-009507513-1709USA007325: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA012764: US-009507513-1709USA012766: US-009507513-1709USA012768:
Age: 7.0
Sex: U
Vaccine: HEPA, HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician who referred to 7 years old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 03-JUN-2017, the patient was vaccinated with improperly stored dose of VAQTA lot #N005274, expiration date 03-APR-2018 (dose and route of administration were not reported) for prophylaxis. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion from 32 degrees Fahrenheit to 54 degrees Fahrenheit for 70 hours. Data logger was not involved. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1709USA012770: US-009507513-1709USA012767: US-009507513-1709USA007325: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA012764: US-009507513-1709USA012766: US-009507513-1709USA012768:
Age: 1.08
Sex: U
Vaccine: HEPA, HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician who referred to 13 months old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 07-JUN-2017, the patient was vaccinated with improperly stored dose of VAQTA lot #N005274, expiration date 03-APR-2018 (dose and route of administration were not reported) for prophylaxis. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion from 32 degrees Fahrenheit to 54 degrees Fahrenheit for 70 hours. Data logger was not involved. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1709USA012770: US-009507513-1709USA012767: US-009507513-1709USA007325: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA012764: US-009507513-1709USA012766: US-009507513-1709USA012768:
Age: 1.58
Sex: U
Vaccine: HEPA, HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician who referred to 18 months old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 07-jun-2017, the patient was vaccinated with improperly stored dose of VAQTA lot #N005274, expiration date 03-APR-2018 (dose and route of administration were not reported) for prophylaxis. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion from 32 degrees Fahrenheit to 54 degrees Fahrenheit for 70 hours. Data logger was not involved. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1709USA012770: US-009507513-1709USA012767: US-009507513-1709USA007325: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA012764: US-009507513-1709USA012766: US-009507513-1709USA012768:
Age: 1.58
Sex: U
Vaccine: HEPA, HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician who referred to 19 months old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 10-JUN-2017, the patient was vaccinated with improperly stored dose of VAQTA lot #N005274, expiration date 03-APR-2018 (dose and route of administration were not reported) for prophylaxis. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion from 32 degrees Fahrenheit to 54 degrees Fahrenheit for 70 hours. Data logger was not involved. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1709USA012770: US-009507513-1709USA012767: US-009507513-1709USA007325: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA012764: US-009507513-1709USA012766: US-009507513-1709USA012768: