chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Nausea, Rash, Tremor
Clinical narrative: Patient said she felt a little woozy when she saw her daughter get her vaccine. She gets it every year without issues. I told her did she feel. Okay to get it or does she want to wait and she said she was fine. After she got it she said she felt like she was going to Throwup. She was shaking and broke Out in rash on her face and neck. I have her two Benadryl and orange juice and elevated her legs. She felt better. I took her blood Pressure it wS 170-100 ans she went to the emergency room.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Headache, Influenza like illness, Pain, Pyrexia
Clinical narrative: Patient called on 10/24/18 and said that the night of the flu shot (10/21/18) she started getting a fever, her back was hurting, her body was aching pretty bad, had a headache, flu like symptoms, she said she did not have any nausea, vomiting, no swelling, or diarrhea.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Bursitis, Joint range of motion decreased, Pain, Pain in extremity, X-ray limb
Clinical narrative: The vaccine was given high on the left arm causing pain and decreased range of motion. The injection (quadrivalent type but not sure of brand/maker) was given around 1:45pm in the Employee Health and Wellness Flu vaccine clinic. The injection hurt a little more than normal but it wasn't until a couple hours later that my left arm begin to hurt more. Within 48 hrs I had decreased ROM.
Age: 59.0
Sex: F
Vaccine: FLUC4
Symptoms: Chest discomfort, Dysgeusia, Hypoaesthesia, Nausea, Pain
Clinical narrative: Yesterday - nausea (thought I was going to have to run out of a meeting), right arm pain, chest heaviness, fingers numb, metallic taste in my mouth... before the metallic taste I thought maybe I was having a heart attack, then I remembered that earlier in the day I received a flu vaccine. Today - hurts to move fingers, especially thumb and into palm of hand - everything else the same except no metallic taste this is day 2 - symptoms should be resolving. They are not. Nausea has returned.
Age: 59.0
Sex: F
Vaccine: FLUC4
Symptoms: Pain in extremity
Clinical narrative: Yesterday - nausea (thought I was going to have to run out of a meeting), right arm pain, chest heaviness, fingers numb, metallic taste in my mouth... before the metallic taste I thought maybe I was having a heart attack, then I remembered that earlier in the day I received a flu vaccine. Today - hurts to move fingers, especially thumb and into palm of hand - everything else the same except no metallic taste this is day 2 - symptoms should be resolving. They are not. Nausea has returned.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Paraesthesia oral, Pharyngeal oedema
Clinical narrative: Immediately after receiving flu shot, patient complained of thickness in the throat on swallowing and tingling on roof of mouth. Patient given 25 mg benadryl with good effect. Sat for observation for 1/2 hour until feeling better.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea
Clinical narrative: Patient received vaccination on Friday, October 19 and later that evening she began to have difficulty breathing that lasted into the next day and then stopped.
Age: 27.0
Sex: M
Vaccine: FLUC4
Symptoms: Back pain, Musculoskeletal pain, Neck pain, Pain, Tendon pain
Clinical narrative: The patient's wife came in on 10/24/18 and reported that her husband was experiencing neck pain that he felt may be related to the flu vaccine he received on 10/21/18. I spoke with the patient and he stated that after he received the vaccine, his shoulder was hurting, which he said he knew could happen with a flu shot. He said that shortly after, he had pain in his neck that spread to his shoulders and back. When I spoke to the patient on 10/24/18, he said he continues to have pain and body aches and that the tendons in the front of his neck are sore to the touch.
Age: 66.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Myalgia
Clinical narrative: Patient received PNEUMOVAX 23 in left deltoid muscle. She experienced muscle soreness on 10/22 and 10/23, but on 10/24, she developed a warm, red, swollen area on her left arm above her elbow, but below the injection site. She didn't report pain or itching. She just said the area was hot.
Age: 42.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Pyrexia
Clinical narrative: Redness at the site of injection, warm to the touch, somewhate painful. He also has low grade fever which was resolved after taking Advil.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Patient called the pharmacy and stated that their entire upper arm was red and swollen. Advised the patient to seek medical treatment due to the severity of the swelling.
Age: 66.0
Sex: F
Vaccine: FLUA3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient said her arm is hurting, cannot lift arm, it's very painful.
Age: 57.0
Sex: F
Vaccine: FLUR4
Symptoms: Erythema, Injection site erythema, Injection site warmth, Limb mass, Pain in extremity
Clinical narrative: 10 minutes after the injection, my left arm became itchy for approx. 4 hrs and had a lump approx. the size of a plumb. The next day (Tues) slightly sore and a small reddened area. Wed my lt upper arm is red posterior ( 3/4 of my arm) and warm to the touch. I will be going to Employee Health in the morning.
Age: 57.0
Sex: F
Vaccine: FLUR4
Symptoms: Pruritus
Clinical narrative: 10 minutes after the injection, my left arm became itchy for approx. 4 hrs and had a lump approx. the size of a plumb. The next day (Tues) slightly sore and a small reddened area. Wed my lt upper arm is red posterior ( 3/4 of my arm) and warm to the touch. I will be going to Employee Health in the morning.
Age: 67.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Circumstance or information capable of leading to medication error, Pain in extremity
Clinical narrative: Patient came in for an influenza vaccination and pneumonia vaccination. During the injection, I counseled patient about possible side effects from the vaccines (mild cold, soreness of arm for a few days). Before patient was injected, I told her to hang her arm to the side so that the muscles in her arm were completely relaxed. I explained to the patient that when giving vaccines, hanging the arm to the side is the most relaxed position from my experience. As I injected the influenza vaccine using proper techniquie, the patient tensed up her left arm and then pulled back while the needle was in her arm. I said to the patient not to tense up or pull back because the needle was in her arm and if her arm was tense she would feel more pain. The vaccine was injected. I put the bandaid on and then the patient switched chairs. Patient left the store. We received a phone call at around 7:20 pm. Patient spoke with one of the technicians, with whom she complained. Patient was asking if she needed to get the second dose of the pneumonia shot in the same arm and mentioned that she never was asked to hang her arm to the side before to relax her arm. The technician then put the patient on hold because he wanted to confirm with the pharmacist the answers to her questions. As the pharmacist, I picked up the phone and the patient told me that she did not want to speak with me. I asked her if there was something I could help her with and she said that she has never been asked to hang her arm to the side when getting injections and that her arm hurt. She did not elaborate on what she meant by hurt. She said that I should ask other pharmacists how they give vaccinations. I explained to her that this was the way I was trained and I have watched many videos about injection technique and through experience I feel that having the patient hang their arm to the side is the best position so their arm is completely relaxed. I apologized and explained that I have never had someone complain. I apologized and explained again that in my experience that is the best way to have a relaxed arm so patients are not in pain and patient hung up.
Age: 45.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Inflammation, Rash, Skin warm
Clinical narrative: Rash, redness, inflammation, hot to the touch.
Age: 29.0
Sex: M
Vaccine: ANTH, FLU3
Symptoms: Back pain, Chills, Fatigue, Headache, Nausea
Clinical narrative: Nauseas approximately 3 hours after receiving vaccines. Felt tired went to sleep 3 hours after receiving vaccines. Pt woke up following morning with chills, headache, nausea & lower back pain.
Age: 0.0
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect route of product administration
Clinical narrative: Injection was administered IM instead of SC.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain
Clinical narrative: Patient came to pharmacy today expressing concern about left arm pain at the injection site of immunization received in August. She claims that the "sharp, shooting pain" comes and goes, but never completely went away after receiving SHINGRIX.
Age: 68.0
Sex: F
Vaccine: FLUA3
Symptoms: Urticaria
Clinical narrative: Pt states she experienced hives on both arms, her back, and her stomach. They resolved on their own after a few days.
Age: 65.0
Sex: F
Vaccine: FLUA3
Symptoms: Vaccination site bruising, Vaccination site pain, Vaccination site swelling
Clinical narrative: THE PATIENT REPORTED HAVING ADVERSE EFFECTS AFTER RECEIVING A FLUAD VACCINE. SHE COMPLAINED OF MUSCLE SWELLING AT AND AROUND THE SITE OF THE VACCINE ADMINISTRATION. SHE ALSO REPORTD THAT THERE WAS BRUISING AND SOME PAIN AROUND THE VACCINE ADMINISTRATION SITE.  I INSTRUCTED HER TO ICE THE SWELLING AND TAKE A PAIN RELIEVER IF NECESSARY OVER THE NEXT 2 TO 3 DAYS. I ALSO TOLD HER IF IT NOT GETTING BETTER OR YOU ARE VERY UNCOMFORTABLE TO CALL HER DOCTOR AS WELL AS THE PHARMACY AGAIN.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: Developed cold sores approximately 24 hrs after receiving the vaccine. I have never had a cold sore in my whole life. It isn't serious so I am just going to see if it heals on its own. I just wanted to report the side effect because I know cold sores are.
Age: 74.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain, Swelling
Clinical narrative: Patient's primary complaint was swelling and pain, but denied redness, rash, or itching, or changes in mobility or use. It started approximately the next day after the immunizations and has remained stable with neither worsening nor improvement of symptoms.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Blood creatinine increased, Blood test, Chest X-ray, Dehydration, Fatigue
Clinical narrative: Headache, fatigue, flushing initially. Weak muscles in legs (started in thighs). Went to hospital 10/19/18 after experiencing thick tongue and throat (stopped eating lunch). After blood work, low platelets, increased creatinine, increased sedimentation rate at hospital; pt received IV fluids...muscles resolved...MD said pt was dehydrated. As time went on, pt started to feel better and was discharged and is still slowly recovering at home.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Flushing, Headache, Muscular weakness, Pharyngeal oedema, Platelet count decreased
Clinical narrative: Headache, fatigue, flushing initially. Weak muscles in legs (started in thighs). Went to hospital 10/19/18 after experiencing thick tongue and throat (stopped eating lunch). After blood work, low platelets, increased creatinine, increased sedimentation rate at hospital; pt received IV fluids...muscles resolved...MD said pt was dehydrated. As time went on, pt started to feel better and was discharged and is still slowly recovering at home.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Red blood cell sedimentation rate increased, Scan brain, Tongue disorder
Clinical narrative: Headache, fatigue, flushing initially. Weak muscles in legs (started in thighs). Went to hospital 10/19/18 after experiencing thick tongue and throat (stopped eating lunch). After blood work, low platelets, increased creatinine, increased sedimentation rate at hospital; pt received IV fluids...muscles resolved...MD said pt was dehydrated. As time went on, pt started to feel better and was discharged and is still slowly recovering at home.
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect dose administered
Clinical narrative: Pt received 0.5ml of FLUZONE vaccine instead of 0.25ml IM on 10/22/18.
Age: 69.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Patient left deltoid and arm were very sore and itching and swollen patient came into office to have physician check out.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, FLU4, HEP, PNC13, RV5
Symptoms: Incorrect dose administered
Clinical narrative: Patient received 0.5ml of FLUZONE vaccine instead of 0.25ml on 10/22/2018.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Breast pain
Clinical narrative: Patient describes soreness under armpit radiating towards breast following SHINGRIX vaccination.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, FLU4, HEP, PNC13, RV5
Symptoms: Incorrect dose administered
Clinical narrative: Pt received 0.5ml of FLUZONE vaccine instead of 0.25ml on 10/22/18.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Patient came on 10/24/2018 and notified that she had arm stiffness, pain, and could not raise her arm after she was immunized on 09/18/2018. She said today, 10/24/2018, that she did notice improvement today. Advised patient to follow up with primary doctor. Patient stated that her daughter is a doctor and she spoke with her and that she thinks she will be ok.
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect dose administered
Clinical narrative: Pt received 0.5ml of FLUZONE vaccine instead of 0.25ml on 10/18/18.
Age: 75.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chills, Erythema, Limb discomfort, Nausea, Peripheral swelling
Clinical narrative: Redness down half of arm to elbow. Swollen and a little sore. Felt a little nauseated and chills the day after receiving vaccine. Said they felt ok today.
Age: 82.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Urticaria
Clinical narrative: Patient went to the urgent care for hives all over the body. (Hands, abdomen, back).
Age: 82.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Eyelids pruritus, Hypersensitivity, Pruritus, Rash
Clinical narrative: Patient went to the urgent care for hives all over the body. (Hands, abdomen, back).
Age: 82.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Skin discolouration, Urticaria
Clinical narrative: Patient went to the urgent care for hives all over the body. (Hands, abdomen, back).
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Pt stopped by pharmacy to report redness and warmth at injection site.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Pain in extremity
Clinical narrative: October 15, 2018 patient received SHINGRIX vaccination-upper left arm. That afternoon, pt began experiencing pain/swelling from site of injection to fingertips. Slept in recliner Monday night due to pain. Red streaks appeared in arm from inj. site. Patient came to pharmacy on October 17, streaks has disappeared but still had round red swelling at inj. site and said it was still itching. Pt had been taking Diphenhydramine and using BIOFREEZE on arm for relief. (Was improving on 10/17/19 planning to visit doctor).
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Sleep disorder
Clinical narrative: October 15, 2018 patient received SHINGRIX vaccination-upper left arm. That afternoon, pt began experiencing pain/swelling from site of injection to fingertips. Slept in recliner Monday night due to pain. Red streaks appeared in arm from inj. site. Patient came to pharmacy on October 17, streaks has disappeared but still had round red swelling at inj. site and said it was still itching. Pt had been taking Diphenhydramine and using BIOFREEZE on arm for relief. (Was improving on 10/17/19 planning to visit doctor).
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Joint range of motion decreased, Musculoskeletal pain, X-ray limb normal
Clinical narrative: Pain shoulder - Limited range of motion first vaccines given too high near shoulder joint.
Age: 69.0
Sex: F
Vaccine: FLUA3, FLUA3
Symptoms: Myalgia
Clinical narrative: About 5 hrs post vaccine, significant muscle soreness began-has persisted for 23 days, pain worse at night, taking OTC TYLENOL to help with pain.
Age: 69.0
Sex: F
Vaccine: FLUA3, FLUA3
Symptoms: Discomfort, Haemorrhage, Injected limb mobility decreased, Limb discomfort, Loss of personal independence in daily activities
Clinical narrative: About 5 hrs post vaccine, significant muscle soreness began-has persisted for 23 days, pain worse at night, taking OTC TYLENOL to help with pain.
Age: 69.0
Sex: F
Vaccine: FLUA3, FLUA3
Symptoms: Myalgia, Neck pain, Pain in extremity, Sleep disorder
Clinical narrative: About 5 hrs post vaccine, significant muscle soreness began-has persisted for 23 days, pain worse at night, taking OTC TYLENOL to help with pain.
Age: 39.0
Sex: F
Vaccine: FLUC4
Symptoms: Joint range of motion decreased, Musculoskeletal pain, X-ray limb normal
Clinical narrative: Pain near shoulder joint - limit ROM (Rt) shoulder. Concern for vaccine administered too high.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: At the time the shot was given, the patient reacted as though the shot was very painful. One week later she came back and advised that her arm was so sore that she was unable to raise it. I examined the shoulder and there was no sign of swelling or discoloration. I advised the patient to see her primary care and as soon as possible. I then called Dr.'s office to advise them of the reaction and spoke to staff.
Age: 40.0
Sex: F
Vaccine: FLUC4
Symptoms: Contusion, Immediate post-injection reaction, Mass, Swelling
Clinical narrative: Patient reported incident on 10/24/18. States localized swelling with lump and bruising was immediately following vaccination on 10/19/18. Patient states symptoms have started to resolve somewhat and slowly improving. Patient will utilize warm compresses and OTC pain relievers as needed and contact office if worsens or no continued improvement noted.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Induration, Skin warm
Clinical narrative: Mom described arm as warm and hard. No redness, no fever, and no difficulty breathing.
Age: 74.0
Sex: F
Vaccine: FLU3, FLUC4
Symptoms: Expired product administered, Extra dose administered, No adverse event, Product storage error
Clinical narrative: Product storage error; Revaccinated with Flucelvax Quadrivalent; Received Afluria expired; This spontaneous case initially received from other health professional (nurse) on 24-Oct-2018, concerns a 74-year-old, elderly female patient.  The patient's current illness was unknown and had not received any concomitant medications.  On 15-Oct-2018, the patient was administered an expired Afluria (TIV) Thiomersal [influenza vaccine, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid (arm), batch number: 14449221A, and expiry date: 30-Jun-2018] (explicitly coded as expired vaccine used) for influenza prophylaxis. The health authority preferred event included 'product storage error'.  It was reported that there was no adverse event after the vaccine administration, so on 30-Oct-2018, the patient was revaccinated with Flucelvax QIVc [influenza vaccine, subunit influenza virus vaccine polyvalent, cell-cultured derived, batch number: 252660, expiry date: 31-May-2019, dose, anatomical location and route of administration: not reported] (explicitly coded as extra dose administered) for an unknown indication.   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 experienced any adverse events afterward.  Follow up retrieved from VAERS (VAERS ID: 799244) reported to VAERS by other health professional (nurse) on 02-Apr-2019: New event 'product storage error' was added in the event tab. The verbatim 'revaccinated with Flucelvax Quadrivalent' was changed from inappropriate schedule of vaccine administered to extra dose administered in the event tab. Arm was added as anatomical location for Afluria (TIV) Thiomersal in the narrative. The patient's current illness was unknown and had not received any concomitant medications. The VAERS ID (799244) was added in the product tab and additional information tab. The narrative and case comment were amended accordingly.; Reporter's Comments: A 74-year-old, female patient was administered expired Afluria (TIV) Thiomersal vaccine (expired vaccine used) and revaccinated with company co-suspect vaccine Flucelvax QIVc in the same season (extra dose administered). The health authority preferred event included 'product storage error'.  The company assessed the causality of the events as not related to the suspect vaccines considering the events expired vaccine used and extra dose administered as accidental in nature and of the event product storage error as incidental in nature.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of injection site swelling in a female patient who received SHINGRIX for prophylaxis. On 9th October 2018, the patient received the 2nd dose of SHINGRIX. In October 2018, less than a week after receiving SHINGRIX, the patient experienced injection site swelling, injection site muscle pain, injection site itching and injection site erythema. On an unknown date, the outcome of the injection site swelling, injection site muscle pain and injection site erythema were recovering/resolving and the outcome of the injection site itching was unknown. It was unknown if the reporter considered the injection site swelling, injection site muscle pain, injection site itching and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: This case was reported by patient via an afterhours voicemail message. The age at vaccination was not reported. Four days prior to the date of reporting, the patient received SHINGRIX and experienced redness, swelling and muscle pain at site of injection all of which had almost resolved. Two days after receiving SHINGRIX, the patient had developed significant pruritus at the site of injection. No further details were provided in the voicemail message.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of injection site swelling in a female patient who received SHINGRIX for prophylaxis. On 9th October 2018, the patient received the 2nd dose of SHINGRIX. In October 2018, less than a week after receiving SHINGRIX, the patient experienced injection site swelling, injection site muscle pain, injection site itching and injection site erythema. On an unknown date, the outcome of the injection site swelling, injection site muscle pain and injection site erythema were recovering/resolving and the outcome of the injection site itching was unknown. It was unknown if the reporter considered the injection site swelling, injection site muscle pain, injection site itching and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: This case was reported by patient via an afterhours voicemail message. The age at vaccination was not reported. Four days prior to the date of reporting, the patient received SHINGRIX and experienced redness, swelling and muscle pain at site of injection all of which had almost resolved. Two days after receiving SHINGRIX, the patient had developed significant pruritus at the site of injection. No further details were provided in the voicemail message.
Age: 78.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of erythema in a 78-year-old female patient who received SHINGRIX (batch number A2JL7, expiry date 22nd March 2021) for prophylaxis. On 12th October 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 13th October 2018, 1 days after receiving SHINGRIX, the patient experienced erythema, skin warm and pain in arm. The patient was treated with paracetamol TYLENOL and medication unknown, Ice Pack (NOS). On an unknown date, the outcome of the erythema, skin warm and pain in arm were not recovered/not resolved. It was unknown if the reporter considered the erythema, skin warm and pain in arm to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX vaccine in left deltoid. The pharmacist suggested that the patient apply ice to the area which was below the injection site and she should take TYLENOL. The patient returned on Sunday and the area was larger than before.
Age: 78.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Pain in extremity, Skin warm
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of erythema in a 78-year-old female patient who received SHINGRIX (batch number A2JL7, expiry date 22nd March 2021) for prophylaxis. On 12th October 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 13th October 2018, 1 days after receiving SHINGRIX, the patient experienced erythema, skin warm and pain in arm. The patient was treated with paracetamol TYLENOL and medication unknown, Ice Pack (NOS). On an unknown date, the outcome of the erythema, skin warm and pain in arm were not recovered/not resolved. It was unknown if the reporter considered the erythema, skin warm and pain in arm to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX vaccine in left deltoid. The pharmacist suggested that the patient apply ice to the area which was below the injection site and she should take TYLENOL. The patient returned on Sunday and the area was larger than before.
Age: 4.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Anaphylactic reaction, Cyanosis central, Depressed level of consciousness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of anaphylactic reaction in a 4-year-old male patient who received FLULAVAL QUADRIVALENT (batch number 7M9A7, expiry date 30th June 2019) for prophylaxis. On 13th October 2018, the patient received FLULAVAL QUADRIVALENT (intramuscular) .5 ml. On 13th October 2018, immediately after receiving FLULAVAL QUADRIVALENT, the patient experienced anaphylactic reaction (serious criteria GSK medically significant). The patient was treated with epinephrine. On an unknown date, the outcome of the anaphylactic reaction was recovered/resolved. It was unknown if the reporter considered the anaphylactic reaction to be related to FLULAVAL QUADRIVALENT. Additional information was reported as follows: The patient's father reported the case. The patient was vaccinated with the vaccine at the doctor's office and had immediately rushed to the emergency room. The patient was given two injections of epinephrine. The patient's father stated that at the time of reporting, the patient had to keep EPI-PEN with him.
Age: 4.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Anaphylactic reaction
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of anaphylactic reaction in a 4-year-old male patient who received FLULAVAL QUADRIVALENT (batch number 7M9A7, expiry date 30th June 2019) for prophylaxis. On 13th October 2018, the patient received FLULAVAL QUADRIVALENT (intramuscular) .5 ml. On 13th October 2018, immediately after receiving FLULAVAL QUADRIVALENT, the patient experienced anaphylactic reaction (serious criteria GSK medically significant). The patient was treated with epinephrine. On an unknown date, the outcome of the anaphylactic reaction was recovered/resolved. It was unknown if the reporter considered the anaphylactic reaction to be related to FLULAVAL QUADRIVALENT. Additional information was reported as follows: The patient's father reported the case. The patient was vaccinated with the vaccine at the doctor's office and had immediately rushed to the emergency room. The patient was given two injections of epinephrine. The patient's father stated that at the time of reporting, the patient had to keep EPI-PEN with him.
Sex: U
Vaccine: FLU4, FLU4, FLU4, FLU4
Symptoms: Aggression, Amnesia, Anxiety, Blood glucose decreased, Blood magnesium decreased
Clinical narrative: Initial information received on 17-Oct-2018 regarding an unsolicited valid serious case received from a consumer. This case is linked to cases 2018SA290307, 2018SA296035, 2018SA296036, 2018SA295695 and 2018SA292898, same reporter. This case involves unknown age and gender patient who experienced diabetic coma, while received vaccine FLUZONE QUAD. The patient's past medical history, concomitant medication and family history were not provided. On 09-Oct-2018, the patient received injection of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED lot UJ009AA, expiry date 30-Jun-2019 via unknown route in unknown administration site. On an unknown date, the patient developed a serious diabetic coma with unknown latency following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. This event was assessed as medically significant. On an unknown date, the patient developed a serious hypoglycemia with unknown latency following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. This event was assessed as medically significant. On an unknown date, the patient developed a serious sweating profusely with unknown latency following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. This event was assessed as medically significant. Lab data was not provided. Final diagnosis was diabetic coma. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for diabetic coma, as Unknown for hypoglycemia and as Unknown for sweating profusely. List of documents held by sender- none. Sender's Comments: This case concerns an unknown age patient who developed diabetic coma, hypoglycemia and sweating profusely after vaccination with FLUZONE QUAD vaccine. The time to onset is unknown. However, there is no information regarding patient's past history, medical condition at time of vaccination and lab tests ruling out alternate etiologies. There was no information whether patient had a history of diabetes or not. Based upon the reported information, the role of the vaccine cannot be assessed.
Sex: U
Vaccine: FLU4, FLU4, FLU4, FLU4
Symptoms: Confusional state, Diabetic coma, Differential white blood cell count, Fear, Full blood count
Clinical narrative: Initial information received on 17-Oct-2018 regarding an unsolicited valid serious case received from a consumer. This case is linked to cases 2018SA290307, 2018SA296035, 2018SA296036, 2018SA295695 and 2018SA292898, same reporter. This case involves unknown age and gender patient who experienced diabetic coma, while received vaccine FLUZONE QUAD. The patient's past medical history, concomitant medication and family history were not provided. On 09-Oct-2018, the patient received injection of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED lot UJ009AA, expiry date 30-Jun-2019 via unknown route in unknown administration site. On an unknown date, the patient developed a serious diabetic coma with unknown latency following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. This event was assessed as medically significant. On an unknown date, the patient developed a serious hypoglycemia with unknown latency following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. This event was assessed as medically significant. On an unknown date, the patient developed a serious sweating profusely with unknown latency following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. This event was assessed as medically significant. Lab data was not provided. Final diagnosis was diabetic coma. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for diabetic coma, as Unknown for hypoglycemia and as Unknown for sweating profusely. List of documents held by sender- none. Sender's Comments: This case concerns an unknown age patient who developed diabetic coma, hypoglycemia and sweating profusely after vaccination with FLUZONE QUAD vaccine. The time to onset is unknown. However, there is no information regarding patient's past history, medical condition at time of vaccination and lab tests ruling out alternate etiologies. There was no information whether patient had a history of diabetes or not. Based upon the reported information, the role of the vaccine cannot be assessed.
Sex: U
Vaccine: FLU4, FLU4, FLU4, FLU4
Symptoms: Hyperhidrosis, Hypoglycaemia, Impaired driving ability, Metabolic function test, Troponin I
Clinical narrative: Initial information received on 17-Oct-2018 regarding an unsolicited valid serious case received from a consumer. This case is linked to cases 2018SA290307, 2018SA296035, 2018SA296036, 2018SA295695 and 2018SA292898, same reporter. This case involves unknown age and gender patient who experienced diabetic coma, while received vaccine FLUZONE QUAD. The patient's past medical history, concomitant medication and family history were not provided. On 09-Oct-2018, the patient received injection of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED lot UJ009AA, expiry date 30-Jun-2019 via unknown route in unknown administration site. On an unknown date, the patient developed a serious diabetic coma with unknown latency following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. This event was assessed as medically significant. On an unknown date, the patient developed a serious hypoglycemia with unknown latency following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. This event was assessed as medically significant. On an unknown date, the patient developed a serious sweating profusely with unknown latency following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. This event was assessed as medically significant. Lab data was not provided. Final diagnosis was diabetic coma. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for diabetic coma, as Unknown for hypoglycemia and as Unknown for sweating profusely. List of documents held by sender- none. Sender's Comments: This case concerns an unknown age patient who developed diabetic coma, hypoglycemia and sweating profusely after vaccination with FLUZONE QUAD vaccine. The time to onset is unknown. However, there is no information regarding patient's past history, medical condition at time of vaccination and lab tests ruling out alternate etiologies. There was no information whether patient had a history of diabetes or not. Based upon the reported information, the role of the vaccine cannot be assessed.
Sex: U
Vaccine: FLU4, FLU4, FLU4, FLU4
Symptoms: Urine analysis, Vision blurred
Clinical narrative: Initial information received on 17-Oct-2018 regarding an unsolicited valid serious case received from a consumer. This case is linked to cases 2018SA290307, 2018SA296035, 2018SA296036, 2018SA295695 and 2018SA292898, same reporter. This case involves unknown age and gender patient who experienced diabetic coma, while received vaccine FLUZONE QUAD. The patient's past medical history, concomitant medication and family history were not provided. On 09-Oct-2018, the patient received injection of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED lot UJ009AA, expiry date 30-Jun-2019 via unknown route in unknown administration site. On an unknown date, the patient developed a serious diabetic coma with unknown latency following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. This event was assessed as medically significant. On an unknown date, the patient developed a serious hypoglycemia with unknown latency following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. This event was assessed as medically significant. On an unknown date, the patient developed a serious sweating profusely with unknown latency following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. This event was assessed as medically significant. Lab data was not provided. Final diagnosis was diabetic coma. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for diabetic coma, as Unknown for hypoglycemia and as Unknown for sweating profusely. List of documents held by sender- none. Sender's Comments: This case concerns an unknown age patient who developed diabetic coma, hypoglycemia and sweating profusely after vaccination with FLUZONE QUAD vaccine. The time to onset is unknown. However, there is no information regarding patient's past history, medical condition at time of vaccination and lab tests ruling out alternate etiologies. There was no information whether patient had a history of diabetes or not. Based upon the reported information, the role of the vaccine cannot be assessed.
Sex: U
Vaccine: FLU4, FLU4, FLU4, FLU4
Symptoms: Blood glucose decreased, Diabetic coma, Hyperhidrosis, Hypoglycaemia, Impaired driving ability
Clinical narrative: Initial information received on 17-Oct-2018 regarding an unsolicited valid serious case received from a consumer. This case is linked to cases 2018SA290307, 2018SA296035, 2018SA296036, 2018SA295695 and 2018SA292898, same reporter. This case involves unknown age and gender patient who experienced diabetic coma, while received vaccine FLUZONE QUAD. The patient's past medical history, concomitant medication and family history were not provided. On 09-Oct-2018, the patient received injection of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED lot UJ009AA, expiry date 30-Jun-2019 via unknown route in unknown administration site. On an unknown date, the patient developed a serious diabetic coma with unknown latency following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. This event was assessed as medically significant. On an unknown date, the patient developed a serious hypoglycemia with unknown latency following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. This event was assessed as medically significant. On an unknown date, the patient developed a serious sweating profusely with unknown latency following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. This event was assessed as medically significant. Lab data was not provided. Final diagnosis was diabetic coma. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for diabetic coma, as Unknown for hypoglycemia and as Unknown for sweating profusely. List of documents held by sender- none. Sender's Comments: This case concerns an unknown age patient who developed diabetic coma, hypoglycemia and sweating profusely after vaccination with FLUZONE QUAD vaccine. The time to onset is unknown. However, there is no information regarding patient's past history, medical condition at time of vaccination and lab tests ruling out alternate etiologies. There was no information whether patient had a history of diabetes or not. Based upon the reported information, the role of the vaccine cannot be assessed.
Sex: U
Vaccine: FLU4, FLU4, FLU4, FLU4
Symptoms: Road traffic accident, Vision blurred
Clinical narrative: Initial information received on 17-Oct-2018 regarding an unsolicited valid serious case received from a consumer. This case is linked to cases 2018SA290307, 2018SA296035, 2018SA296036, 2018SA295695 and 2018SA292898, same reporter. This case involves unknown age and gender patient who experienced diabetic coma, while received vaccine FLUZONE QUAD. The patient's past medical history, concomitant medication and family history were not provided. On 09-Oct-2018, the patient received injection of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED lot UJ009AA, expiry date 30-Jun-2019 via unknown route in unknown administration site. On an unknown date, the patient developed a serious diabetic coma with unknown latency following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. This event was assessed as medically significant. On an unknown date, the patient developed a serious hypoglycemia with unknown latency following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. This event was assessed as medically significant. On an unknown date, the patient developed a serious sweating profusely with unknown latency following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. This event was assessed as medically significant. Lab data was not provided. Final diagnosis was diabetic coma. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for diabetic coma, as Unknown for hypoglycemia and as Unknown for sweating profusely. List of documents held by sender- none. Sender's Comments: This case concerns an unknown age patient who developed diabetic coma, hypoglycemia and sweating profusely after vaccination with FLUZONE QUAD vaccine. The time to onset is unknown. However, there is no information regarding patient's past history, medical condition at time of vaccination and lab tests ruling out alternate etiologies. There was no information whether patient had a history of diabetes or not. Based upon the reported information, the role of the vaccine cannot be assessed.
Sex: U
Vaccine: FLU4, FLU4, FLU4, FLU4
Symptoms: Diabetic coma, Hyperhidrosis, Hypoglycaemia
Clinical narrative: Initial information received on 17-Oct-2018 regarding an unsolicited valid serious case received from a consumer. This case is linked to cases 2018SA290307, 2018SA296035, 2018SA296036, 2018SA295695 and 2018SA292898, same reporter. This case involves unknown age and gender patient who experienced diabetic coma, while received vaccine FLUZONE QUAD. The patient's past medical history, concomitant medication and family history were not provided. On 09-Oct-2018, the patient received injection of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED lot UJ009AA, expiry date 30-Jun-2019 via unknown route in unknown administration site. On an unknown date, the patient developed a serious diabetic coma with unknown latency following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. This event was assessed as medically significant. On an unknown date, the patient developed a serious hypoglycemia with unknown latency following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. This event was assessed as medically significant. On an unknown date, the patient developed a serious sweating profusely with unknown latency following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. This event was assessed as medically significant. Lab data was not provided. Final diagnosis was diabetic coma. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for diabetic coma, as Unknown for hypoglycemia and as Unknown for sweating profusely. List of documents held by sender- none. Sender's Comments: This case concerns an unknown age patient who developed diabetic coma, hypoglycemia and sweating profusely after vaccination with FLUZONE QUAD vaccine. The time to onset is unknown. However, there is no information regarding patient's past history, medical condition at time of vaccination and lab tests ruling out alternate etiologies. There was no information whether patient had a history of diabetes or not. Based upon the reported information, the role of the vaccine cannot be assessed.
Age: 52.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Blood glucose decreased, Blood magnesium decreased, Blood potassium decreased, Hypertension
Clinical narrative: Initial information received on 17-Oct-2018 regarding an unsolicited valid serious case received from a consumer and additional information received on 18-Oct-2018. This case is linked to case 2018SA290310 (same reporter). This case involves a 52 years old female patient who experienced diabetic coma, while she received vaccine FLUZONE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Pancreatic carcinoma and only has one-half of a pancreas. On 09-Oct-2018 at 03:10 PM, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (lot UJ009AA and Exp. Date 30 Jun 2019) via unknown route in unknown administration site. On an unknown date, the patient developed a serious diabetic coma with blood sugar was 34, magnesium decreased, potassium decreased and did not feel well, following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. This event was assessed as medically significant. It was reported that her usual blood sugar was 115 to 120. She thought that she received an Insulin product instead of a flu shot because her blood sugar decreased. Specifically, she had later in the evening gone to a scheduled mammogram appointment at a local hospital. While there, she noted that she did not feel well so the department asked if she wanted to reschedule the mammogram appointment. Relevant tests included blood sugar was 34. Final diagnosis was not feel well and diabetic coma. The patient received unknown treatment for the event. The outcome of the event was not reported. It was reported that her blood sugar decreased like they did because she had pancreatic cancer. List of documents held by sender: none. Sender's Comments: This case concerns a patient with pancreatic cancer who presented with diabetic coma and other symptoms of hypoglycemia after vaccination with FLUZONE. The time to onset is not known. Moreover, there is no information regarding patient's blood sugar levels at time of vaccination, condition at time of vaccination and lab tests ruling out alternate etiologies of the events. Based upon the reported information, the role of the vaccine cannot be assessed.