chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Joint swelling, Peripheral swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of swelling of feet in a 55-year-old female patient who received SHINGRIX for prophylaxis.  The patient's past medical history included stem cell transplant. On 14th January 2019, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced swelling of feet and ankle swelling. On an unknown date, the outcome of the swelling of feet and ankle swelling were unknown. It was unknown if the reporter considered the swelling of feet and ankle swelling to be related to SHINGRIX. Additional details were reported as follows: This case was reported via online chat. The patient had swelling of the feet and ankles and had just wondered if anyone might had reported this as a side effect. The patient would be happy to know. The patient stated that, she also consulted her oncologist regarding this problem. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of nausea in a adult female patient who received SHINGRIX for prophylaxis. On 25th September 2018, the patient received the 1st dose of SHINGRIX. On 26th September 2018, 1 days after receiving SHINGRIX, the patient experienced nausea, vomiting, general body pain and fever. On 28th September 2018, the outcome of the nausea, vomiting, general body pain and fever were recovered/resolved. It was unknown if the reporter considered the nausea, vomiting, general body pain and fever to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX in an unknown deltoid. The reporter gave consent to follow up. This case has been linked to the case US2019007967, reported by the same reporter.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Extensive swelling of vaccinated limb, Injection site erythema
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 76-year-old female patient who received SHINGRIX (batch number H547E, expiry date 22nd February 2021) for prophylaxis. On 9th November 2018, the patient received the 1st dose of SHINGRIX. On 10th November 2018, 1 days after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb and injection site erythema. On an unknown date, the outcome of the extensive swelling of vaccinated limb and injection site erythema were recovered/resolved. It was unknown if the reporter considered the extensive swelling of vaccinated limb and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The patient experienced an area of swelling and redness from the injection site to the elbow. These symptoms persisted for 2 and half to 3 weeks and resolved. The reporter consented to follow up.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site discolouration, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a 72-year-old female patient who received SHINGRIX (batch number MG42F, expiry date 29th May 2021) for prophylaxis. On 14th January 2019, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. In January 2019, less than a week after receiving SHINGRIX, the patient experienced influenza-like symptoms, injection site induration, injection site discoloration, injection site warmth, injection site pain and injection site erythema. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved and the outcome of the injection site induration, injection site discoloration, injection site warmth, injection site pain and injection site erythema were not recovered/not resolved. It was unknown if the reporter considered the influenza-like symptoms, injection site induration, injection site discoloration, injection site warmth, injection site pain and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The batch number was updated from NG42F to MG42F as per sales data sheet. The pharmacist reports that the patient got her 2nd dose of SHINGRIX on Monday and She had flu like symptoms for a day or so, but those have resolved. The patient currently has a hard area on her arm where she got the vaccine that was red, except for being purple in the middle, and hot to the touch. The patient arm was also sore.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a 72-year-old female patient who received SHINGRIX (batch number MG42F, expiry date 29th May 2021) for prophylaxis. On 14th January 2019, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. In January 2019, less than a week after receiving SHINGRIX, the patient experienced influenza-like symptoms, injection site induration, injection site discoloration, injection site warmth, injection site pain and injection site erythema. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved and the outcome of the injection site induration, injection site discoloration, injection site warmth, injection site pain and injection site erythema were not recovered/not resolved. It was unknown if the reporter considered the influenza-like symptoms, injection site induration, injection site discoloration, injection site warmth, injection site pain and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The batch number was updated from NG42F to MG42F as per sales data sheet. The pharmacist reports that the patient got her 2nd dose of SHINGRIX on Monday and She had flu like symptoms for a day or so, but those have resolved. The patient currently has a hard area on her arm where she got the vaccine that was red, except for being purple in the middle, and hot to the touch. The patient arm was also sore.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of tingling in a elderly male patient who received SHINGRIX (batch number HM3NC, expiry date 13th April 2021) for prophylaxis. In December 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced tingling. On an unknown date, the outcome of the tingling was unknown. It was unknown if the reporter considered the tingling to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported but it could be 71 or 72 years old. After vaccination, the patient experienced tingling on one side of the head. The reporter consented to follow up.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Dry skin, Erythema, Pain in extremity, Skin exfoliation
Clinical narrative: Pt's arm is red and sore - in a 3 in radium from injection site - redness is still there 8 days after injection, soreness has gone away and redness has gotten better, pt's skin is very dry and almost peeling in a 1 in radium from injection site.
Age: 1.0
Sex: F
Vaccine: DTAPIPV, IPV
Symptoms: Extra dose administered, Product administered to patient of inappropriate age
Clinical narrative: The vaccines KINRIX and IPV here administered to a one year old female. Called resources to check on any reactions and informed mother and  she was educated on S/S to be aware of, she verbalized understanding. The error was due to the PHN not reading the vaccine label properly.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Allergy to vaccine, Erythema, Inflammation, Injection site erythema, Injection site swelling
Clinical narrative: Local injection redness/swelling started ~ 5 hrs after injection, and progressed without significant improvement over 2 days. Symptoms consisted of L arm swelling, erythema, pain, and slight pruritis. Slightly improved pain with ALEVE. No fevers, chills, or significant swelling/extension of erythema over last 24 hrs. Will treat as local inflammatory reaction secondary to vaccine with vaccine listed as allergy, with careful monitoring for potential development of cellulitis.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: Local injection redness/swelling started ~ 5 hrs after injection, and progressed without significant improvement over 2 days. Symptoms consisted of L arm swelling, erythema, pain, and slight pruritis. Slightly improved pain with ALEVE. No fevers, chills, or significant swelling/extension of erythema over last 24 hrs. Will treat as local inflammatory reaction secondary to vaccine with vaccine listed as allergy, with careful monitoring for potential development of cellulitis.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash
Clinical narrative: Patient developed rash 01/24/2019 13 post vaccines for MMR/ Var unknown which is causing, no treatment at this time.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Somnolence
Clinical narrative: Slept most of next day after shot and had very little appetite.
Age: 37.0
Sex: F
Vaccine: FLUC4
Symptoms: Bursitis, Injected limb mobility decreased, Injection site joint pain
Clinical narrative: Patient had severe soreness and pain at the right shoulder joint, it kept on worsening during the first 2 weeks after getting the shot. On the third week, she couldn't mover her right arm, She saw her orthopedist on 1/24/19, and she was diagnosed with Bursitis of the right shoulder joint. She received a cortisone shot and was prescribed Voltaren topical  gel 1%.
Age: 62.0
Sex: F
Vaccine: FLUC4, HEPA
Symptoms: Dizziness, Enlarged uvula, Hypersensitivity, Nasal congestion, Pain
Clinical narrative: 01/24/2019 1:00pm-Pt reported to Health Center Provider and HCM/RN that she had an allergic reaction 3-4 hours after receiving Hepatitis A and Influenza vaccinations at the Health Center 2 weeks ago on 01/14/2019. She states that she was lightheaded for a little while, her uvula swelled to 3 times its normal size, had severe body aches and some nasal congestion. Pt states that she went to her primary care physician who told her it was probably an allergic reaction to the preservatives in the vaccines. Nurse who administered the vaccines brought the vaccine boxes to show the patient that each box clearly stated "contains no preservatives.". Pt stated she wanted the reaction entered into her medical record. Pt was told that we will do this and file a VAERS report as it is a standard Premise practice. Pt was reassured and returned to work.
Age: 19.0
Sex: F
Vaccine: SMALL
Symptoms: Blood creatine phosphokinase MB increased, Chest X-ray, Chest discomfort, Electrocardiogram normal, Laboratory test
Clinical narrative: Patient received vaccine on 01/14/2019, Reported to clinic with chest discomfort /pressure x 2 days. No fever, shortness of breath or audible friction rub on auscultation. EKG was abnormal and indicated acute pericarditis. Lab showed very slight Troponin and CKMB elevation. Echo scheduled for Monday AM at 08:00. Patient started on anti-inflammatory. Patient advised not to exert himself and to report to ER over the weekend if symptomatic. Will follow up with PCM Monday after Echo for further eval.
Age: 19.0
Sex: F
Vaccine: SMALL
Symptoms: Pericarditis, Troponin increased
Clinical narrative: Patient received vaccine on 01/14/2019, Reported to clinic with chest discomfort /pressure x 2 days. No fever, shortness of breath or audible friction rub on auscultation. EKG was abnormal and indicated acute pericarditis. Lab showed very slight Troponin and CKMB elevation. Echo scheduled for Monday AM at 08:00. Patient started on anti-inflammatory. Patient advised not to exert himself and to report to ER over the weekend if symptomatic. Will follow up with PCM Monday after Echo for further eval.
Age: 12.0
Sex: F
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: Daughter was given TdaP,Hep B, Flu vaccine, Meningococcal, this same day at night developed huge hives. My daughter was put on Prednisone, I gave liquid BENADRYL,alternating ZYRTEC, BENADRYL cream and hydrocortisone cream.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Cellulitis, Pain in extremity, Rash erythematous
Clinical narrative: Patient sought out urgent medical treatment for a red rash and pain in the arm that received the injection. Patient was evaluated and diagnosed with cellulitis. Patient is undergoing an antibiotic therapy regimen.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Herpes zoster, Inflammation, Injection site hypoaesthesia, Injection site pain, Joint lock
Clinical narrative: Arm pain and numbness radiating from the point of injection up to the top of her shoulder. Patient says arm locks and makes a clicking noise when she rotates it. She also states she developed shingles 2 months later.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Joint noise
Clinical narrative: Arm pain and numbness radiating from the point of injection up to the top of her shoulder. Patient says arm locks and makes a clicking noise when she rotates it. She also states she developed shingles 2 months later.
Age: 36.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site warmth, Skin lesion
Clinical narrative: Pt, received vaccines on 12/03/2018, pt returned to clinic on 12/06/2018, with complaining of fever of L upper later arm after getting injections. Pt. Left lateral arm lesions erythema, warm to touch, flat surface, tenderness to touch, Pt received Keflex 500mg one cap po q 8hr  for 10 days. Ibuprofen 600, per pt symptoms improved in about 10 days.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Delirium, Fatigue, Influenza like illness, Injection site bruising, Injection site pain
Clinical narrative: Extremely high fever (105 +) that lasted for six hours and caused delirious speech. Extreme muscle pain for four days. Low grade fever for four days. Deep bruise and pain at injection site - still bruised. Extreme fatigue for three days. Flu-like symptoms for five days. Today, six days after SHINGRIX vaccination I have a cold sore on the corner of my mouth. First cold sore I've ever had in my life!
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Oral herpes, Pyrexia, Speech disorder
Clinical narrative: Extremely high fever (105 +) that lasted for six hours and caused delirious speech. Extreme muscle pain for four days. Low grade fever for four days. Deep bruise and pain at injection site - still bruised. Extreme fatigue for three days. Flu-like symptoms for five days. Today, six days after SHINGRIX vaccination I have a cold sore on the corner of my mouth. First cold sore I've ever had in my life!
Age: 60.0
Sex: F
Vaccine: PNC13
Symptoms: No adverse event, Wrong product administered
Clinical narrative: PREVNAR 13 was given to patient under 65 years old, instead of the PNEUMOVAX 23 since patient was smoker and has history of pneumonia. Pt did not have any adverse effects from the vaccination, just the vaccine was given at the wrong dosing schedule
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Nausea, Rash pustular
Clinical narrative: Patient states that in addition to feeling nauseous and weak, he developed 2 pustules on his abdomen that were small and fluid filled. They completely resolved within 48 hours (by his best estimate).
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis area approx. 1 inch below injection site area.
Age: 26.0
Sex: M
Vaccine: FLU4
Symptoms: Blood test, Hypoaesthesia, Mobility decreased, Muscular weakness, Paraesthesia
Clinical narrative: Monday, Jan 14 2019- went to doc because of bowel issues? Given flu shot. Numbness in fingers, feet on the day of, then went to legs and arms, and one spot on chest. On two separate nights woke up unable to feel foot, one night it was past the ankle. Called doctor office on 1/16/19 and they advised to go to ER. ER suggested I see neurologist and also offered steroid. I did not fill the prescription for steroid. Wednesday, Jan 16, 2019 called clinic to say experiencing numbness, tingling in hands, arms, legs, feet. Told to go to ER. ER: said to make appointment with neurologist, Rx for steroid, did not fill 1/17/19? symptoms felt worse, weakness in legs, arms. Moved neuro appt up to 1/18/19. Dr. Woke up during night and could not feel foot, or move it well. Wiggled and feeling came back Friday -  Dr. didn't feel it was GBS, ran reflex test, which was fine. Didn't feel there was any nerve damage. Said could get blood test and MRI. Saturday 19th feels like it is a bit worse, blood draw Monday- went to Dr, chiropractor, she believes this is reaction from flu shot. My parents believe so as well. Symptoms come and go, seems to be improving, but still hanging on. Very stressful 10-12 days.
Age: 26.0
Sex: M
Vaccine: FLU4
Symptoms: Reflex test normal, Stress
Clinical narrative: Monday, Jan 14 2019- went to doc because of bowel issues? Given flu shot. Numbness in fingers, feet on the day of, then went to legs and arms, and one spot on chest. On two separate nights woke up unable to feel foot, one night it was past the ankle. Called doctor office on 1/16/19 and they advised to go to ER. ER suggested I see neurologist and also offered steroid. I did not fill the prescription for steroid. Wednesday, Jan 16, 2019 called clinic to say experiencing numbness, tingling in hands, arms, legs, feet. Told to go to ER. ER: said to make appointment with neurologist, Rx for steroid, did not fill 1/17/19? symptoms felt worse, weakness in legs, arms. Moved neuro appt up to 1/18/19. Dr. Woke up during night and could not feel foot, or move it well. Wiggled and feeling came back Friday -  Dr. didn't feel it was GBS, ran reflex test, which was fine. Didn't feel there was any nerve damage. Said could get blood test and MRI. Saturday 19th feels like it is a bit worse, blood draw Monday- went to Dr, chiropractor, she believes this is reaction from flu shot. My parents believe so as well. Symptoms come and go, seems to be improving, but still hanging on. Very stressful 10-12 days.
Age: 26.0
Sex: M
Vaccine: FLUC4, TDAP
Symptoms: Dizziness, Flushing, Hyperhidrosis, Syncope
Clinical narrative: Pt stated he was starting to feel light headed and then fainted, broke out in sweat, and became flushed.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Computerised tomogram head, Computerised tomogram thorax abnormal, Gastric emptying study, Gastrointestinal tube insertion, Impaired gastric emptying
Clinical narrative: Early November continual respiratory issues. 2017 pleural effusion. January 2018. Gastroparesis.  Feeding tube 3 moths. April 2018. Possible POTS or mast cell disease. Continued histamine reactions. On azythromyzin for stomachmotility and daily iv fluid and Iv benedryl.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Pleural effusion, Respiratory disorder
Clinical narrative: Early November continual respiratory issues. 2017 pleural effusion. January 2018. Gastroparesis.  Feeding tube 3 moths. April 2018. Possible POTS or mast cell disease. Continued histamine reactions. On azythromyzin for stomachmotility and daily iv fluid and Iv benedryl.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Burning sensation, Erythema, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: The patient started to experience pain and swelling in the left arm the evening after the PNEUMOVAX vaccination. The next morning the patient had burning, redness, swelling and itching which lasted for 2 days. The patient did not seek treatment and on day three she said the reaction had subsided.
Age: 17.0
Sex: M
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: VASOVAGAL SYNCOPE- FAINT FOR A FEW SECONDS, BP-108/70, PR-68/ MIN. lAYED DOWN, FOR 10 MIN. AFTER 15 MIN, LEFT CLINIC WITH HIS DAD.
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Pt received PREVNAR on 10/21/2017 and a second dose on 11/05/2018. No adverse reaction to either dose but reporting due to second dose given.
Age: 39.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site pain, Injection site swelling, Pain, Pain in extremity
Clinical narrative: Arm very sore and very swollen. 2 inch larger arm circumference on the arm where I got the shot.  Hurts to move arm. The pain is the entire biceps muscle, and also the back of the arm near the injection site. Skin slightly red.
Age: 39.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: Arm very sore and very swollen. 2 inch larger arm circumference on the arm where I got the shot.  Hurts to move arm. The pain is the entire biceps muscle, and also the back of the arm near the injection site. Skin slightly red.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Erythema, Feeling abnormal, Injection site pain, Injection site rash, Pain in extremity
Clinical narrative: Patient said arm started hurting and she felt really bad and had fever on 1/23/2019. Patient called me the morning of 1/24/2019. Patient said her right arm hurt badly down to her elbow and also had a rash that ran down to her elbow which she noticed the morning of 1/24/2019. On the evening of 1/24/2019 she said her arm was really red and hot and she was feeling bad. On 1/25/2019 she said about 1/2 of the rash was gone after she said she applied alcohol on the rash. She was feeling better.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Pyrexia, Skin warm
Clinical narrative: Patient said arm started hurting and she felt really bad and had fever on 1/23/2019. Patient called me the morning of 1/24/2019. Patient said her right arm hurt badly down to her elbow and also had a rash that ran down to her elbow which she noticed the morning of 1/24/2019. On the evening of 1/24/2019 she said her arm was really red and hot and she was feeling bad. On 1/25/2019 she said about 1/2 of the rash was gone after she said she applied alcohol on the rash. She was feeling better.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Fatigue, Headache, Injection site pain
Clinical narrative: This was second round of vaccine. Initially developed chills and shivering that lasted through the night. Following day had moderate diffuse arthralgia, myalgia and fatigue. Also had mild headache and nausea. These symptoms lasted most of the day. Second night had sweats most of the night.  Second day felt back to normal other than soreness at injection site.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Nausea, Night sweats
Clinical narrative: This was second round of vaccine. Initially developed chills and shivering that lasted through the night. Following day had moderate diffuse arthralgia, myalgia and fatigue. Also had mild headache and nausea. These symptoms lasted most of the day. Second night had sweats most of the night.  Second day felt back to normal other than soreness at injection site.
Age: 65.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Bone pain, Musculoskeletal pain, Pain
Clinical narrative: Patient stated that 5 days after the injections, he started feeling pain not at the injection site, but it's an aching pain in his bone and radiate to his shoulder. He feels more pain when putting pressure on the shoulder.
Age: 1.5
Sex: M
Vaccine: MMR
Symptoms: Rash
Clinical narrative: Rash on foot. Treatment: 3ml of children's BENADRYL by mouth in office.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness, Nausea, Pallor
Clinical narrative: Pt. started feeling dizzy. Feeling nauseous and pale. Brought in to exam room. Asked pt. to lay on exam table and elevated feet by bending knees. Given alcohol and a piece of chocolate. Per pt. was feeling nervous before vacc admin.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Chills, Erythema, Injection site erythema, Injection site pain
Clinical narrative: Pt received PNEUMOVAX immunisation in left upper arm on 1-15-2019 and developed redness of left upper arm later that same day. Redness spread to involve entire left upper arm and extended to left upper chest on 1-16-2019. She also developed pain in left upper arm on 1-15-2019 and pain continued into 1-16-2019. She took a single dose of acetaminophen on 1-16-2019. Temp of 100.6 on 1-16-19. Had chills on 1-16-19, 1-17-19, 1-18-19.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Scab, Swelling
Clinical narrative: 8 erythemic raised areas across back and on left shoulder with central scabbing noted.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Pt indicates that she feels that experienced side effects after administration of 2nd dose of SHINGRIX. Patient says she experienced headache, chills, fever, and body aches.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Dizziness
Clinical narrative: Patient felt weak and faint the day after the vaccination was administered. She also felt dizzy and her blood pressure was 65/40 on that following morning. Patient went to lye down and fluids and major issues resolved in 10 minutes but felt weak til end of day.
Age: 0.5
Sex: M
Vaccine: FLU4, HEP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient was given flu vaccine for age 3 and above. No adverse reaction per mother.
Age: 0.5
Sex: M
Vaccine: FLU4
Symptoms: Injection site urticaria, Pyrexia
Clinical narrative: Evening of vaccination, mom noticed hives on left leg from mid shin to hip. Fever started on 11/8/18 (in the evening) and resolved after 48 hours. Tmax 103. Mom gave TYLENOL for fever. Symptoms self resolved.
Age: 13.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error, Vaccination error
Clinical narrative: This non-serious spontaneous case, initially received on 19-Mar-2018, was reported by other health professional and concerns a 13-year-old adolescent patient of an unspecified gender. It was reported that, on an unspecified date, the temperature of the refrigerator in which vaccine was stored, dropped to 32 F and was out of range for a total of 1 hour off and on for 2 weeks. On 15-Feb-2018, the patient was administered with FLUCELVAX QIV (route of administration: intramuscular, batch number: 195236, expiry date: 31-May-2018, dose and anatomical location: not reported) which was stored out of recommended temperature. The patient had no adverse reactions from the suspect vaccine that underwent temperature excursion. On 05-Mar-2018, the patient was re-vaccinated with FLUCELVAX QIV (route of administration: intramuscular, anatomical location: left deltoid, batch number: 195236, expiry date: 30-May-2018 and dose: not reported). Non-significant follow-up received on 07-May-2018: Upon internal review, it was realised that the expiry date was incorrect. Hence, the expiry date was changed from 31-May-2018 to 30-May-2018 in the product tab. The reporter confirmed that, the patient had no adverse reactions from the suspect vaccine that underwent temperature excursion. Narrative was amended accordingly.
Age: 2.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous case, initially received from other health professional on 24-Oct-2018, concerns a 2-year-old, male child patient. The patient had no medical history and did not administer any concomitant medications. On 24-Oct-2018, the patient (under age of 4 years) was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252664, and expiry date: 30-Jun-2019]. At the time of this report, no adverse events was reported after the vaccine administration and no treatment measures were taken. The reporter assessed this case as non-serious.
Age: 82.0
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error, Vaccination error
Clinical narrative: This spontaneous case, initially received from other non-health professional (consumer) on 26-Oct-2018, concerns an 82-year-old, elderly, female patient. On 16-Oct-2018, temperature excursion of the vaccine occurred. On an unspecified date in Oct-2018, the patient was inadvertently administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252664 and expiry date: 30-Jun-2019) that underwent temperature excursion. The patient did not experience any adverse events after vaccination. The reporter assessed this as non-serious. This case (201805006) was cross-linked to the case: 201805002 reported by the same reporter. Follow-up report received on 13-Nov-2018: The reporter refused to provide the patient's initials. The onset date of the event incorrect product storage was updated as 16-Oct-2018 and expiry date of the suspect vaccine was updated as 30-Jun-2019. The reporter confirmed that, the patient did not experience any adverse events after vaccination. The narrative and case comment were amended accordingly.
Age: 70.0
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error, Vaccination error
Clinical narrative: This spontaneous case, initially received from other non-health professional (consumer) on 26-Oct-2018, concerns a 70-year-old, elderly female patient. On 16-Oct-2018, the vaccine underwent temperature excursion. On an unspecified date in Oct-2018, the patient was inadvertently administered FLUCELVAX QIVc that underwent temperature excursion [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252664 and expiry date: 30-Jun-2019]. The patient did not experience any adverse events after vaccination. The reporter assessed this case as non-serious. This case (201805009) was cross-linked to the case: 201805002 due to same reporter. Follow-up report received from the reporter on 13-Nov-2018: The onset date of the event incorrect product storage was updated as 16-Oct-2018 and expiry date of the suspect vaccine was updated as 30-Jun-2019. The reporter confirmed that, the patient did not experience any adverse events after vaccination. The reporter refused to provide the patient's initials and date of vaccine administration. The narrative and case comment were amended accordingly.
Age: 83.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, initially received from other non-health professional (consumer) on 26-Oct-2018, concerns an 83-year-old, elderly male patient. On 16-Oct-2018, the vaccine underwent temperature excursion. On an unspecified date in Oct-2018, the patient was inadvertently administered FLUCELVAX QIVc that underwent temperature excursion [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252664 and expiry date: 30-Jun-2019]. The patient did not experience any adverse events after vaccination. The reporter assessed this case as non-serious. This case (201805007) was cross-linked to the original case 201805002 due to same reporter. Follow-up report received from the reporter on 13-Nov-2018: The onset date of the event incorrect product storage was updated as 16-Oct-2018 and expiry date of the suspect vaccine was updated as 30-Jun-2019. The reporter confirmed that, the patient did not experience any adverse events after vaccination. The reporter refused to provide the patient's initials and date of vaccine administration. The narrative and case comment were amended accordingly.
Age: 56.0
Sex: F
Vaccine: FLUC4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This non-serious spontaneous case, initially received from other health professional (nurse) on 19-Oct-2018, concerns a 56-year-old, adult, female patient. The patient had no relevant medical history and did not take any concomitant medications at the time of vaccination. On 09-Oct-2018, the patient was administered FLUCELVAX QIVc [dose: 1.5 ml instead of 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 252235, expiry date: 30-Jun-2019]. At the time of this report, no adverse events were reported. This case 201804684 was linked to the source case 201804657 due to the same reporter.
Age: 2.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This is a spontaneous case initially received from other health professional on 30-Oct-2018, concerning a 2-year-old, male child patient. The patient's historical condition included otitis media. On an unspecified date, the patient underwent frenulectomy. The patient did not administer any concomitant medications. On 26-Oct-2018, the patient (underage of 4 years) was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252672 and expiry date: 30-Jun-2019]. At the time of this report, no adverse events were reported after administration of the vaccine. The reporter assessed the case as non-serious.
Age: 3.0
Sex: U
Vaccine: FLUC4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous case, initially received from other non-health professional on 24-Oct-2018, concerning a 3-year-old, child patient of unspecified gender. On an unspecified date, the patient under (age of 4 years) administered with FLUCELVAX QIV (dose, route of administration, anatomical location, batch number and expiry date: not reported). At the time of this report, no adverse event was reported after the vaccine administration. The reporter assessed this case as non-serious.
Sex: M
Vaccine: FLUC4
Symptoms: Pain in extremity
Clinical narrative: This is a non-serious spontaneous case, initially received from a pharmacist on 29-Oct-2018, concerning a male patient of an unspecified age. On an unspecified date, the patient was administered FLUCELVAX QIVc [dose, route of administration, anatomical location, batch number and expiry date: not reported]. On an unspecified date after vaccination, the patient's arm started hurting. The outcome of the event was not reported at the time of this report. This case is linked to case 201805075 due to same reporter.
Age: 52.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, initially received from a pharmacist on 15-Oct-2018, (initial and follow-up 1 combinedly processed) concerns a 52-year-old, adult, male patient. On an unspecified date, FLUCELVAX QIVc was stored at a maximum temperature of 56 F for 8 hours following a power outage. On 14-Oct-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252668 and expiry date: 30-Jun-2019) which was stored inappropriately. At the time of this report, no adverse event was reported. The reporter assessed the case as non-serious. This case 201804551 was cross-linked to source case: 201804533 due to same reporter.
Age: 35.0
Sex: F
Vaccine: FLUC4
Symptoms: Expired product administered, Feeling hot, Paraesthesia
Clinical narrative: This is a spontaneous case, initially received from other non-health professional (consumer) on 24-Oct-2018, concerns a 35-year-old, adult, female patient. The patient's current conditions included: IgA deficiency, gluten intolerance and was allergic to peroxide based products and ROCEPHIN (reported as medical history). The concomitant medication included: Retinol (reported as retinol A) for an unknown indication. On an unspecified date in Oct-2018, the patient was administered expired FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number and expiry date: not reported). On an unspecified date in Oct-2018 (same day of vaccination), 10 minutes after vaccination, the patient experienced heat going up her neck and developed face tingling. The events lasted only for few minutes (reported as less than 10 minutes). The patient didn't receive any treatment associated with the events. At the time of the report, the patient had recovered from the events. The reporter assessed the case as non-serious.
Age: 77.0
Sex: M
Vaccine: FLUC4
Symptoms: Expired product administered, Pain
Clinical narrative: This is a spontaneous case, initially received from a pharmacist on 29-Oct-2018, concerning a 77-year-old elderly male patient. The patient's concomitant medications were unknown. On an unspecified date in Oct-2018 (reported as 3 weeks ago), the patient was administered expired FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252668 and expiry date: 29-Jun-2018]. On an unspecified date in Oct-2018 (within a couple of days as reported), after vaccination, the patient felt pain when he lifted his arm and was treated for possible shingles. At the time of this report, the outcome of the events was not reported. The reporter assessed the case as non-serious.
Age: 47.0
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, initially received from other non-health professional (consumer) on 26-Oct-2018, concerns a 47 year-old, adult female patient. On 16-Oct-2018, the vaccine underwent temperature excursion. On an unspecified date in Oct-2018, the patient was inadvertently administered FLUCELVAX QIVc that underwent temperature excursion [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252664 and expiry date: 30-Jun-2019]. The patient did not experience any adverse events after vaccination. The reporter assessed this as non-serious. This case (201805008) was cross-linked to the case: 201805002 reported by the same reporter. Follow-up received from other non-health professional on 13-Nov-2018: The onset date of the event incorrect product storage was updated as 16-Oct-2018 and expiry date of the suspect vaccine was updated as 30-Jun-2019. The reporter confirmed that, the patient did not experience any adverse events after vaccination. The reporter refused to provide the patient's initials and date of vaccine administration. The narrative and case comment were amended accordingly.
Age: 62.0
Sex: F
Vaccine: FLUC4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous case, initially received from other healthcare professional (nurse) on 26-Oct-2018, concerns a 62-year-old, adult female patient. The patient's current condition included chronic obstructive pulmonary disease (COPD). The patient's concomitant medications included, XARELTO, Torasemide, terbinafine, potassium chloride, PROAIR and iron. On 26-Oct-2018, the patient was administered expired vaccine FLUCELVAX QIVc [dose: 0.5 ml (frequency unknown), route of administration: intramuscular, anatomical location: deltoid, batch number: 195245, expiry date: 18-Jun-2018]. At the time of this report, no adverse event was reported after the vaccine administration. The reporter assessed this case as non-serious. This case was linked to case 201804880 owing to the same reporter.
Age: 68.0
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, initially received from other non-health professional (consumer) on 26-Oct-2018, concerns a 68-year-old, elderly female patient. On 16-Oct-2018, the vaccine underwent temperature excursion. On an unspecified date in Oct-2018, the patient was inadvertently administered FLUCELVAX QIVc that underwent temperature excursion [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252664 and expiry date: 30-Jun-2019]. The patient did not experience any adverse events after vaccination. The reporter assessed this case as non-serious. This case (201805013) was cross-linked to the case: 201805002 reported by the same reporter. Follow-up report received from the reporter on 13-Nov-2018: The onset date of the event incorrect product storage was updated as 16-Oct-2018 and expiry date of the suspect vaccine was updated as 30-Jun-2019. The reporter confirmed that, the patient did not experience any adverse events after vaccination. The reporter refused to provide the patient's initials and date of vaccine administration. The narrative and case comment were amended accordingly.
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This is a spontaneous case, initially received from physician on 30-Oct-2018, concerning a female patient of unspecified age. It was reported that there was a first time temperature excursion with MDV for two hours, which reached to maximum temperature 34 F. On an unspecified date, the patient administered FLUCELVAX (QIV) [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252225 and expiry date: 31-May-2019] which underwent temperature excursion. The patient did not experience any adverse events after vaccination. The reporter assessed the case non-serious.
Age: 47.0
Sex: F
Vaccine: FLUC4
Symptoms: Product storage error
Clinical narrative: This spontaneous case, initially received from other non-health professional (consumer) on 26-Oct-2018, concerns a 47-year-old adult female patient. On 16-Oct-2018, the FLUCELVAX QIVc vaccine underwent temperature excursion. On an unspecified date in Oct-2018, the patient was inadvertently administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252664 and expiry date: 30-Jun-2019] that underwent temperature excursion. The reporter assessed this as non-serious. This case (201805002) was cross-linked to the case: 201804745 reported by the same reporter. Follow up received from other non-health professional on 13-Nov-2018: The expiry date of the product (30-Jun-2019) was added in the product tab. The product start date (16-Oct-2018) was added in the product tab. The onset date of the events (16-Oct-2018) was added in the event tab. The narrative was amended accordingly. Significant case amendment (13-Nov-2018): The start date of the suspect product and event onset date was changed from '16-Oct-2018' to 'Oct-2018'. The narrative was amended accordingly.
Age: 47.0
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, initially received from other non-health professional (consumer) on 26-Oct-2018, concerns a 47-year-old, adult, female patient. On 16-Oct-2018, temperature excursion of the vaccine occurred. On an unspecified date in Oct-2018, the patient was inadvertently administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252664 and expiry date: 30-Jun-2019). The patient did not experience any adverse events after vaccination. The reporter assessed this case as non-serious. This case (201805014) was cross-linked to the case: 201805002 reported by the same reporter. Follow-up report received on 13-Nov-2018: The reporter refused to provide the patient's initials. The onset date of the event incorrect product storage was updated as 16-Oct-2018 and expiry date of the suspect vaccine was updated as 30-Jun-2019. The reporter confirmed that, the patient did not experience any adverse events after vaccination. The narrative and case comment were amended accordingly.
Age: 38.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, initially received from other non-health professional (consumer) on 26-Oct-2018, concerns a 38-year-old male patient. On 16-Oct-2018, the FLUCELVAX QIVc had underwent temperature excursion. On an unspecified date in Oct-2018, the patient was inadvertently administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252664 and expiry date: 30-Jun-2019) which underwent temperature excursion. The patient did not experience any adverse events after vaccination. The reporter assessed this case as non-serious. This case (201805011) was cross-linked to the case: 201805002 due to the same reporter. Follow-up report received on 13-Nov-2018: The reporter refused to provide the patient's initials. The onset date of the event incorrect product storage was updated as 16-Oct-2018 and expiry date of the suspect vaccine was updated as 30-Jun-2019. The reporter confirmed that, the patient did not experience any adverse events after vaccination. The narrative and case comment was amended accordingly.
Age: 59.0
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, initially received from other non-health professional on 26-Oct-2018, concerns a 59-year-old female patient. On 16-Oct-2018, the FLUCELVAX QIVc had underwent temperature excursion. On an unspecified date in Oct-2018, the patient was inadvertently administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252664 and expiry date: 30-Jun-2019) which underwent temperature excursion. The patient did not experience any adverse events after vaccination. The reporter assessed this case as non-serious. This case 201805015 was cross-linked to the case: 201805002 reported by the same reporter. Follow-up report received on 13-Nov-2018: The reporter refused to provide the patient's initials. The onset date of the event incorrect product storage was updated as 16-Oct-2018 and expiry date of the suspect vaccine was updated as 30-Jun-2019. The reporter confirmed that, the patient did not experience any adverse events after vaccination. The narrative and case comment were amended accordingly.
Age: 62.0
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, initially received from other non-health professional (consumer) on 26-Oct-2018, concerns a 62-year-old adult female patient. On 16-Oct-2018, the vaccine underwent temperature excursion. On an unspecified date in Oct-2018, the patient was inadvertently administered FLUCELVAX QIVc that underwent temperature excursion [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252664 and expiry date: 30-Jun-2019]. The patient did not experience any adverse events after vaccination. The reporter assessed this case as non-serious. This case (201805003) was cross-linked to the case: 201805002 reported by the same reporter. Follow-up report received from the reporter on 13-Nov-2018: The onset date of the event incorrect product storage was updated as 16-Oct-2018 and expiry date of the suspect vaccine was updated as 30-Jun-2019. The reporter confirmed that, the patient did not experience any adverse events after vaccination. The reporter refused to provide the patient's initials and date of vaccine administration. The narrative and case comment were amended accordingly.
Age: 74.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, initially received from other health professional (nurse) on 24-Oct-2018, concerns a 74-year-old, elderly female patient. On 15-Oct-2018, the patient was administered expired AFLURIA (TIV) Thiomersal [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 14449221A, and expiry date: 30-Jun-2018]. On 30-Oct-2018, the patient was revaccinated with FLUCELVAX QIVc [batch number: 252660, expiry date: 31-May-2019, dose, anatomical location and route of administration: not reported]. The patient did not experience any adverse events after vaccination. The reporter assessed this case as non-serious. Follow-up received from the other health professional on 26-Nov-2018: Added FLUCELVAX QIVc (co-suspect vaccine) in the product tab as the patient was revaccinated on 30-Oct-2018. Added new event inappropriate schedule of vaccine administered in the event tab. The reporter confirmed that patient did not experience any adverse events afterward.