chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Blood test, Dyspnoea, Fluid retention, Laboratory test
Clinical narrative: Increased dyspnea,  fluid retention, & increae have continued since 9/2022
Age: 5.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site bruising, Injection site rash, Pain, Pyrexia
Clinical narrative: Fever, body aches, large rash and bruising at injection site
Age: 14.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: 14 y.o patient was given adult dose of Hepatitis A instead of pediatric dose. Provider notified, practice manager notified, health department contacted, Pts mother called and informed of situation and given adverse reaction warning signs. Pts mother stated pt was not experiencing any adverse reactions. Pt did receive Covid Vaccine and was experiencing normal post injection symptoms including fatigue, arm soreness, and body aches.
Age: 77.0
Sex: F
Vaccine: FLUC4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: PATIENT GIVEN A SECOND DOSE OF SEASONAL FLU VACCINE 23-24. NO ADVERSE EVENT TO REPORT
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Appendicectomy, Appendicitis, Nausea, Pyrexia
Clinical narrative: Hospitalized 12/5/22-12/6/22 Appendicitis, fever, nausea without vomiting, discharged after appendectomy
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC20, RV5
Symptoms: Unevaluable event
Clinical narrative: RSV Vaccine administered.  Mother disclosed she had the RSV vaccine during pregnancy.
Age: 48.0
Sex: F
Vaccine: COVID19-2
Symptoms: Asthenia, Diarrhoea, Nausea
Clinical narrative: Bad nausea, diarrhea, weakness
Age: 12.0
Sex: F
Vaccine: MENB
Symptoms: Unevaluable event
Clinical narrative: Patient was notified that an early injection was given to her. Patient aware to follow up for second dose.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Anaemia, Asthenia, Dizziness, Dyspnoea, Fibrin D dimer increased
Clinical narrative: Hospitalized 12/7/22-12/15/22 Hypoxia, SOB, productive cough, dizziness, wheezing, respiratory failure, elevated d-dimer, PE, PNA, anemia, debility,
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoxia, Pneumonia, Productive cough, Respiratory failure, Wheezing
Clinical narrative: Hospitalized 12/7/22-12/15/22 Hypoxia, SOB, productive cough, dizziness, wheezing, respiratory failure, elevated d-dimer, PE, PNA, anemia, debility,
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Injection site erythema, Injection site mass, Injection site swelling
Clinical narrative: Redness and swelling at the site of injection. There is a 2x2 cm mass can be felt as subcutaneous mass at the site if injection.
Age: 20.0
Sex: F
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: Patient received a pediatric dose of hep A.
Age: 64.0
Sex: F
Vaccine: RSV
Symptoms: Decreased appetite, Dysphonia, Memory impairment, Pain, Vocal cord thickening
Clinical narrative: She got her vaccine, didn't have a reaction, had a pain and took Tylenol.  Then this morning she noticed that her voice was raspy sounding to her.  Just not her normal voice.  She has loss of appetite as well.  She has nodules in her throat that she did not have before.  She says she forgets things, cannot remember what she's doing and has to backtrack to get things done, like where did she put the shovel working in the yard, and forgetting to do things she was asked to do.  Not able to complete tasks, and kept forgetting things that were going on this morning.  This she did not have this problem prior to the vaccine.
Age: 39.0
Sex: M
Vaccine: PNC20
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient recieved Prevnar 20 on 6/02/23 and was repeated again in error on 1/22/2024. No adverse side effects noted. Patient aware.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Acute kidney injury, Asthenia, Dyspnoea, Hypoxia, Nausea
Clinical narrative: Hospitalized 12/10/22-12/14/22 nausea, SOB, weakness, hypoxia, productive cough, wheezing, dyspnea, PNA, respiratory failure, AKI,
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pneumonia, Productive cough, Respiratory failure, Wheezing
Clinical narrative: Hospitalized 12/10/22-12/14/22 nausea, SOB, weakness, hypoxia, productive cough, wheezing, dyspnea, PNA, respiratory failure, AKI,
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Pain
Clinical narrative: Patient reported pain, and difficulty moving the arm, especially at the shoulder area.
Age: 60.0
Sex: F
Vaccine: RSV
Symptoms: Urticaria
Clinical narrative: patient had hives on torso and arm
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Muscular weakness, Myalgia, Pyrexia
Clinical narrative: She had the second Shingrix vaccine administered in clinic that day. Later that night, she had myalgias, chills, fevers. The next day she felt weakness of her right leg and pain in her right knee. She was evaluated for this on 3/28 in clinic. She had a 4/5 strength with right hip flexion and knee extension compared to contralateral side. She had normal reflexes. No fevers. Normal neuro exam. Clinical presentation did not resemble GBS. Treated with ibuprofen 600mg and rest. The myalgias and fevers/chills resolved.
Age: 68.0
Sex: M
Vaccine: RSV
Symptoms: No adverse event
Clinical narrative: Shot was given when not needed. Patient states no adverse reactions.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Pt was given 1 ml dose of Hep B instead of 0.5 ml dose for her age.  No symptoms noted after vaccine given, pt stayed in clinic for 1 hour after this happened.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Peripheral swelling, Rash
Clinical narrative: the Vaccine was given at approximately 3:15 in the afternoon on 3/27/24. The next morning on 3/28/24 the patient called and reported the adverse reaction stating she had rash, swelling, heat, and redness the extended from her shoulder to 4 inches past her elbow.  We recommended going to a clinic to get a prophylactic antibiotic. She went and was prescribed doxycycline and Medrol pack.  Follow up call on 3/29/24 at 2:45PM the patient reported the redness had receded a little but was still past the elbow. She had not started ABX but decided to do so.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Inappropriate schedule of product administration
Clinical narrative: All 3 vaccines were given mistakenly 9 days after previous dose on 8/22/23.
Age: 82.0
Sex: M
Vaccine: HEPA
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Vomiting and loose stool
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Arthritis, Injected limb mobility decreased, Injection site pain, Pain, Sleep disorder
Clinical narrative: PATIENT EXPERIENCED MILD TO MODERATE PAIN UPON INJECTION WHICH BECAME INCREASINGLY INTENSE OVER SEVERAL DAYS. MOVEMENT, PARTICULARLY AT NIGHT CAUSES PAIN INTENSE ENOUGH TO AWAKEN. RANGE OF MOTION IS LIMITED BY PAIN.
Age: 67.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Blood test, Crying, Fall, Feeding disorder
Clinical narrative: She got her vaccine, everything was fine until 2 days later when she woke up in the morning in excruciating pain.  The pain was so bad for 3 months and is still bad but not quite as bag.  She would gag, shake, vomit.  Could not do anything, her arms would just not move.  She had 0 range of motion, could not drive. She could barely take care of her hygiene and forced herself to do it, and make her gag.  She could not go shopping, cook or do anything.  The pain was outrageous in her shoulders primarily, but at times it would move down into her upper arm, and sometimes it would go into her lower arm.  It was also in her hips.  She went to her doctor who wanted her to see a rheumatologist and then he wanted her to see an orthopedist.  She saw those doctors and the rheumatologist said she had frozen shoulders, and the orthoedist was very young and her report did not supply much information and did not say one way or the other if she felt the rheumatologist was correct.  They treated her with percocet a few times, and then cortisone shots.  They wanted her to go to pain management, physical thearpy when she went to pain management, and she was not a fit.  She did not go back to pain management.  By this time she started to feel somewhat better, and her PCP gave her some exercises which she has been doing.  She has not had a chance to get to PT due to family issues that have come up and not sure if she's going to do PT or not.  She is somewhat at a standstill at this point.   She went to the ER as she had fallen and she was telling them about the pain and they put her in a psychiatric ward.  She is convinced that it is a vaccine, and has gotten every vaccine that was out there, but will never get another one.  She was kept there for 5 days due to it being the weekend, and did not need to be there.  She was robbed while she was in there and was supposed to be on a suicide watch and not one member of the staff spoke to her.  She had fallen and the pain was ungodly and called the paramedics and they would not take her to the ER and they did not want her there because of COVID.  She was telling them about the pain and trying to get him to understand the depths and density of the pain.  She made the comment that the pain was so bad that she wanted to jump off a bridge, and they put her in the psychiatric ward.   There were some other false reporting on that as well as far as how many times she had been in the hospital.   She was full of inflammation and the rheumatologist informed her that he felt the vaccine kicked off the inflammation.  The rheumatologist also put her on Prednisone and nothing helped her pain.  She would cry and scream due to the pain and could not eat anything, and had a weight loss of 26#.   Even with the use of Percocet it did not relieve the pain.
Age: 67.0
Sex: F
Vaccine: RSV
Symptoms: Impaired driving ability, Inflammation, Joint range of motion decreased, Loss of personal independence in daily activities, Musculoskeletal disorder
Clinical narrative: She got her vaccine, everything was fine until 2 days later when she woke up in the morning in excruciating pain.  The pain was so bad for 3 months and is still bad but not quite as bag.  She would gag, shake, vomit.  Could not do anything, her arms would just not move.  She had 0 range of motion, could not drive. She could barely take care of her hygiene and forced herself to do it, and make her gag.  She could not go shopping, cook or do anything.  The pain was outrageous in her shoulders primarily, but at times it would move down into her upper arm, and sometimes it would go into her lower arm.  It was also in her hips.  She went to her doctor who wanted her to see a rheumatologist and then he wanted her to see an orthopedist.  She saw those doctors and the rheumatologist said she had frozen shoulders, and the orthoedist was very young and her report did not supply much information and did not say one way or the other if she felt the rheumatologist was correct.  They treated her with percocet a few times, and then cortisone shots.  They wanted her to go to pain management, physical thearpy when she went to pain management, and she was not a fit.  She did not go back to pain management.  By this time she started to feel somewhat better, and her PCP gave her some exercises which she has been doing.  She has not had a chance to get to PT due to family issues that have come up and not sure if she's going to do PT or not.  She is somewhat at a standstill at this point.   She went to the ER as she had fallen and she was telling them about the pain and they put her in a psychiatric ward.  She is convinced that it is a vaccine, and has gotten every vaccine that was out there, but will never get another one.  She was kept there for 5 days due to it being the weekend, and did not need to be there.  She was robbed while she was in there and was supposed to be on a suicide watch and not one member of the staff spoke to her.  She had fallen and the pain was ungodly and called the paramedics and they would not take her to the ER and they did not want her there because of COVID.  She was telling them about the pain and trying to get him to understand the depths and density of the pain.  She made the comment that the pain was so bad that she wanted to jump off a bridge, and they put her in the psychiatric ward.   There were some other false reporting on that as well as far as how many times she had been in the hospital.   She was full of inflammation and the rheumatologist informed her that he felt the vaccine kicked off the inflammation.  The rheumatologist also put her on Prednisone and nothing helped her pain.  She would cry and scream due to the pain and could not eat anything, and had a weight loss of 26#.   Even with the use of Percocet it did not relieve the pain.
Age: 67.0
Sex: F
Vaccine: RSV
Symptoms: Pain, Pain in extremity, Periarthritis, Retching, Screaming
Clinical narrative: She got her vaccine, everything was fine until 2 days later when she woke up in the morning in excruciating pain.  The pain was so bad for 3 months and is still bad but not quite as bag.  She would gag, shake, vomit.  Could not do anything, her arms would just not move.  She had 0 range of motion, could not drive. She could barely take care of her hygiene and forced herself to do it, and make her gag.  She could not go shopping, cook or do anything.  The pain was outrageous in her shoulders primarily, but at times it would move down into her upper arm, and sometimes it would go into her lower arm.  It was also in her hips.  She went to her doctor who wanted her to see a rheumatologist and then he wanted her to see an orthopedist.  She saw those doctors and the rheumatologist said she had frozen shoulders, and the orthoedist was very young and her report did not supply much information and did not say one way or the other if she felt the rheumatologist was correct.  They treated her with percocet a few times, and then cortisone shots.  They wanted her to go to pain management, physical thearpy when she went to pain management, and she was not a fit.  She did not go back to pain management.  By this time she started to feel somewhat better, and her PCP gave her some exercises which she has been doing.  She has not had a chance to get to PT due to family issues that have come up and not sure if she's going to do PT or not.  She is somewhat at a standstill at this point.   She went to the ER as she had fallen and she was telling them about the pain and they put her in a psychiatric ward.  She is convinced that it is a vaccine, and has gotten every vaccine that was out there, but will never get another one.  She was kept there for 5 days due to it being the weekend, and did not need to be there.  She was robbed while she was in there and was supposed to be on a suicide watch and not one member of the staff spoke to her.  She had fallen and the pain was ungodly and called the paramedics and they would not take her to the ER and they did not want her there because of COVID.  She was telling them about the pain and trying to get him to understand the depths and density of the pain.  She made the comment that the pain was so bad that she wanted to jump off a bridge, and they put her in the psychiatric ward.   There were some other false reporting on that as well as far as how many times she had been in the hospital.   She was full of inflammation and the rheumatologist informed her that he felt the vaccine kicked off the inflammation.  The rheumatologist also put her on Prednisone and nothing helped her pain.  She would cry and scream due to the pain and could not eat anything, and had a weight loss of 26#.   Even with the use of Percocet it did not relieve the pain.
Age: 67.0
Sex: F
Vaccine: RSV
Symptoms: Suicidal ideation, Tremor, Vomiting, Weight decreased, X-ray
Clinical narrative: She got her vaccine, everything was fine until 2 days later when she woke up in the morning in excruciating pain.  The pain was so bad for 3 months and is still bad but not quite as bag.  She would gag, shake, vomit.  Could not do anything, her arms would just not move.  She had 0 range of motion, could not drive. She could barely take care of her hygiene and forced herself to do it, and make her gag.  She could not go shopping, cook or do anything.  The pain was outrageous in her shoulders primarily, but at times it would move down into her upper arm, and sometimes it would go into her lower arm.  It was also in her hips.  She went to her doctor who wanted her to see a rheumatologist and then he wanted her to see an orthopedist.  She saw those doctors and the rheumatologist said she had frozen shoulders, and the orthoedist was very young and her report did not supply much information and did not say one way or the other if she felt the rheumatologist was correct.  They treated her with percocet a few times, and then cortisone shots.  They wanted her to go to pain management, physical thearpy when she went to pain management, and she was not a fit.  She did not go back to pain management.  By this time she started to feel somewhat better, and her PCP gave her some exercises which she has been doing.  She has not had a chance to get to PT due to family issues that have come up and not sure if she's going to do PT or not.  She is somewhat at a standstill at this point.   She went to the ER as she had fallen and she was telling them about the pain and they put her in a psychiatric ward.  She is convinced that it is a vaccine, and has gotten every vaccine that was out there, but will never get another one.  She was kept there for 5 days due to it being the weekend, and did not need to be there.  She was robbed while she was in there and was supposed to be on a suicide watch and not one member of the staff spoke to her.  She had fallen and the pain was ungodly and called the paramedics and they would not take her to the ER and they did not want her there because of COVID.  She was telling them about the pain and trying to get him to understand the depths and density of the pain.  She made the comment that the pain was so bad that she wanted to jump off a bridge, and they put her in the psychiatric ward.   There were some other false reporting on that as well as far as how many times she had been in the hospital.   She was full of inflammation and the rheumatologist informed her that he felt the vaccine kicked off the inflammation.  The rheumatologist also put her on Prednisone and nothing helped her pain.  She would cry and scream due to the pain and could not eat anything, and had a weight loss of 26#.   Even with the use of Percocet it did not relieve the pain.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: Cough started 9 days after vaccine.  Tight, non-productive.  Used Albuterol inhaler for a week, then contacted MD office about symptoms, and they prescribed a steroid inhaler in addition to the Albuterol.
Age: 22.0
Sex: M
Vaccine: HEP, HPV9
Symptoms: Wrong product administered
Clinical narrative: Patient indicated on vaccine consent form and verbally that he required HPV vaccine. After administering HPV vaccine the patient indicated that he actually needed HBV vaccine. HBV vaccine was administered
Age: 9.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Middle right arm red and swollen. At injection site is swollen and red. Under injection site is firm "ball", swollen, red,  hot and itchy. Mom administered 12.5mg on Benadryl, 7.5ml Advil, on  03/28/24.  Chewable Claritin, Tylenol, and warm compress 03/29/24 which has helped with the itchiness. Arm is still swollen, red, and firm as of 03/29/24. Mom has made patient an appointment with FNP at Family Medicine on 04/12/24.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Decreased appetite, Dysphonia, Electrocardiogram normal
Clinical narrative: Chills, shakes, tiredness, cannot drink or eat, nauseous, difficulty walking, headaches, off/on chest pains.  It's now a week later, still feeling tired, walking slower but better than before. Appetite is back but not fully. Voice sounds shaky and as though I can't catch my breath.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Gait disturbance, Headache, Nausea, Palpitations
Clinical narrative: Chills, shakes, tiredness, cannot drink or eat, nauseous, difficulty walking, headaches, off/on chest pains.  It's now a week later, still feeling tired, walking slower but better than before. Appetite is back but not fully. Voice sounds shaky and as though I can't catch my breath.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Chills, shakes, tiredness, cannot drink or eat, nauseous, difficulty walking, headaches, off/on chest pains.  It's now a week later, still feeling tired, walking slower but better than before. Appetite is back but not fully. Voice sounds shaky and as though I can't catch my breath.
Age: 29.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Upon reviewing inventory today it was discovered that the patient was administered a Spokevax 2023/24 formulation vaccine that was beyond its beyond use date.  The manufacturer expiration date is 3/25/2024; however, the product was moved from the freezer to refrigerator on 1/26/2024 and had a beyond use date of 2/25/2024.   We have offered to revaccinate the patient due to unknown efficacy of administration after beyond use dating.
Age: 19.0
Sex: M
Vaccine: DTAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Dtap given instead of Tdap. no adverse reactions noted
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive
Clinical narrative: was positive to serotype 16; This spontaneous report was received from a physician referring to a 20-year-old female patient. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On unknown date, the patient was vaccinated with quadrivalent human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) injection (strength, dose, route of administration, lot#, and expiration date were not reported) for prophylaxis.  On an unknown date, the patient was tested positive to serotype 16. The outcome of the event was unknown at the time of reporting.   The causal relationship between the event and quadrivalent human papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) was not reported.    This is one of two reports from the same reporter.
Age: 9.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; temperature excursion; This spontaneous report was received from an nurse practitioner and referred to a 9-year-old patient of unknown gender. The patient's concurrent conditions, concomitant therapies, historical drugs and historical conditions were not reported.  On 01-NOV-2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin [rHA]) (M-M-R II) injection, lot #W031980, expiration date was reported as 16-OCT-2024 but upon internal validation established as 06-OCT-2024, administered subcutaneously for prophylaxis (strength, dose and anatomical site of administration were not provided). The administered vaccine was exposed to the multiple temperature excursions from 19-OCT-2023 to 22-JAN-2024 (product storage error). No additional adverse event (AE) reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2401USA016206:
Age: 5.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; temperature excursion; This spontaneous report was received from an nurse practitioner and referred to a 5-year-old patient of unknown gender. The patient's concurrent conditions, concomitant therapies, historical drugs and historical conditions were not reported.  On 08-NOV-2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin [rHA]) (M-M-R II) injection, lot #W031980, expiration date was reported as 16-OCT-2024 but upon internal validation established as 06-OCT-2024, administered subcutaneously for prophylaxis (strength, dose and anatomical site of administration were not provided). The administered vaccine was exposed to the multiple temperature excursions from 19-OCT-2023 to 22-JAN-2024 (product storage error). No additional adverse event (AE) reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2401USA016206:
Age: 13.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; temperature excursion; This spontaneous report was received from an nurse practitioner and referred to a 13-year-old patient of unknown gender. The patient's concurrent conditions, concomitant therapies, historical drugs and historical conditions were not reported.  On 08-NOV-2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin [rHA]) (M-M-R II) injection, lot #W031980, expiration date was reported as 16-OCT-2024 but upon internal validation established as 06-OCT-2024, administered subcutaneously for prophylaxis (strength, dose and anatomical site of administration were not provided). The administered vaccine was exposed to the multiple temperature excursions from 19-OCT-2023 to 22-JAN-2024 (product storage error). No additional adverse event (AE) reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2401USA016206:
Age: 17.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; temperature excursion; This spontaneous report was received from an nurse practitioner and referred to a 17-year-old patient of unknown gender. The patient's concurrent conditions, concomitant therapies, historical drugs and historical conditions were not reported.  On 08-NOV-2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin [rHA]) (M-M-R II) injection, lot #W031980, expiration date was reported as 16-OCT-2024 but upon internal validation established as 06-OCT-2024, administered subcutaneously for prophylaxis (strength, dose and anatomical site of administration were not provided). The administered vaccine was exposed to the multiple temperature excursions from 19-OCT-2023 to 22-JAN-2024 (product storage error). No additional adverse event (AE) reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2401USA016206:
Age: 5.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; temperature excursion; This spontaneous report was received from an nurse practitioner and referred to a 5-year-old patient of unknown gender. The patient's concurrent conditions, concomitant therapies, historical drugs and historical conditions were not reported.  On 20-NOV-2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin [rHA]) (M-M-R II) injection, lot #W031980, expiration date was reported as 24-OCT-2024 but upon internal validation established as 06-OCT-2024, administered subcutaneously for prophylaxis (strength, dose and anatomical site of administration were not provided). The administered vaccine was exposed to the multiple temperature excursions from 19-OCT-2023 to 22-JAN-2024 (product storage error). No additional adverse event (AE) reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2401USA016206:
Age: 11.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; temperature excursion; This spontaneous report was received from an nurse practitioner and referred to a 11-year-old patient of unknown gender. The patient's concurrent conditions, concomitant therapies, historical drugs and historical conditions were not reported.  On 08-NOV-2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin [rHA]) (M-M-R II) injection, lot #W031980, expiration date was reported as 16-OCT-2024 but upon internal validation established as 06-OCT-2024, administered subcutaneously for prophylaxis (strength, dose and anatomical site of administration were not provided). The administered vaccine was exposed to the multiple temperature excursions from 19-OCT-2023 to 22-JAN-2024 (product storage error). No additional adverse event (AE) reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2401USA016206:
Age: 12.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; temperature excursion; This spontaneous report was received from an nurse practitioner and referred to a 12-year-old patient of unknown gender. The patient's concurrent conditions, concomitant therapies, historical drugs and historical conditions were not reported.  On 13-DEC-2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin [rHA]) (M-M-R II) injection, lot #W031980, expiration date was reported as 16-OCT-2024 but upon internal validation established as 06-OCT-2024, administered subcutaneously for prophylaxis (strength, dose and anatomical site of administration were not provided). The administered vaccine was exposed to the multiple temperature excursions from 19-OCT-2023 to 22-JAN-2024 (product storage error). No additional adverse event (AE) reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2401USA016206:
Age: 14.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; temperature excursion; This spontaneous report was received from an nurse practitioner and referred to a 14-year-old patient of unknown gender. The patient's concurrent conditions, concomitant therapies, historical drugs and historical conditions were not reported.  On 27-DEC-2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin [rHA]) (M-M-R II) injection, lot #W031980, expiration date was reported as 24-OCT-2024 but upon internal validation established as 06-OCT-2024, administered subcutaneously for prophylaxis (strength, dose and anatomical site of administration were not provided). The administered vaccine was exposed to the multiple temperature excursions from 19-OCT-2023 to 22-JAN-2024 (product storage error). No additional adverse event (AE) reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2401USA016206:
Age: 16.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; temperature excursion; This spontaneous report was received from an nurse practitioner and referred to a 16-year-old patient of unknown gender. The patient's concurrent conditions, concomitant therapies, historical drugs and historical conditions were not reported.  On 08-JAN-2024, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin [rHA]) (M-M-R II) injection, lot #W031980, expiration date was reported as 16-OCT-2024 but upon internal validation established as 06-OCT-2024, administered subcutaneously for prophylaxis (strength, dose and anatomical site of administration were not provided). The administered vaccine was exposed to the multiple temperature excursions from 19-OCT-2023 to 22-JAN-2024 (product storage error). No additional adverse event (AE) reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2401USA016206:
Age: 4.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; temperature excursion; This spontaneous report was received from an nurse practitioner and referred to a 4-year-old patient of unknown gender. The patient's concurrent conditions, concomitant therapies, historical drugs and historical conditions were not reported.  On 10-JAN-2024, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin [rHA]) (M-M-R II) injection, lot #W031980, expiration date was reported as 16-OCT-2024 but upon internal validation established as 06-OCT-2024, administered subcutaneously for prophylaxis (strength, dose and anatomical site of administration were not provided). The administered vaccine was exposed to the multiple temperature excursions from 19-OCT-2023 to 22-JAN-2024 (product storage error). No additional adverse event (AE) reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2401USA016206:
Age: 13.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; temperature excursion; This spontaneous report was received from an nurse practitioner and referred to a 13-year-old patient of unknown gender. The patient's concurrent conditions, concomitant therapies, historical drugs and historical conditions were not reported.  On 10-JAN-2024, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin [rHA]) (M-M-R II) injection, lot #W031980, expiration date was reported as 16-OCT-2024 but upon internal validation established as 06-OCT-2024, administered subcutaneously for prophylaxis (strength, dose and anatomical site of administration were not provided). The administered vaccine was exposed to the multiple temperature excursions from 19-OCT-2023 to 22-JAN-2024 (product storage error). No additional adverse event (AE) reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2401USA016206:
Age: 6.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; temperature excursion; This spontaneous report was received from an nurse practitioner and referred to a 6-year-old patient of unknown gender. The patient's concurrent conditions, concomitant therapies, historical drugs and historical conditions were not reported.  On 17-JAN-2024, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin [rHA]) (M-M-R II) injection, lot #W031980, expiration date was reported as 16-OCT-2024 but upon internal validation established as 06-OCT-2024, administered subcutaneously for prophylaxis (strength, dose and anatomical site of administration were not provided). The administered vaccine was exposed to the multiple temperature excursions from 19-OCT-2023 to 22-JAN-2024 (product storage error). No additional adverse event (AE) reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2401USA016206:
Age: 11.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; temperature excursion; This spontaneous report was received from an nurse practitioner and referred to a 11-year-old patient of unknown gender. The patient's concurrent conditions, concomitant therapies, historical drugs and historical conditions were not reported.  On 22-JAN-2024, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin [rHA]) (M-M-R II) injection, lot #W031980, expiration date was reported as 16-OCT-2024 but upon internal validation established as 06-OCT-2024, administered subcutaneously for prophylaxis (strength, dose and anatomical site of administration were not provided). The administered vaccine was exposed to the multiple temperature excursions from 19-OCT-2023 to 22-JAN-2024 (product storage error). No additional adverse event (AE) reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2401USA016206:
Age: 16.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; temperature excursion; This spontaneous report was received from an nurse practitioner and referred to a 16-year-old patient of unknown gender. The patient's concurrent conditions, concomitant therapies, historical drugs and historical conditions were not reported.  On 24-JAN-2024, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin [rHA]) (M-M-R II) injection, lot #W031980, expiration date was reported as 16-OCT-2024 but upon internal validation established as 06-OCT-2024, administered subcutaneously for prophylaxis (strength, dose and anatomical site of administration were not provided). The administered vaccine was exposed to the multiple temperature excursions from 19-OCT-2023 to 22-JAN-2024 (product storage error). No additional adverse event (AE) reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2401USA016206:
Age: 10.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; temperature excursion; This spontaneous report was received from an nurse practitioner and referred to a 10-year-old patient of unknown gender. The patient's concurrent conditions, concomitant therapies, historical drugs and historical conditions were not reported.  On 24-JAN-2024, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin [rHA]) (M-M-R II) injection, lot #W031980, expiration date was reported as 16-OCT-2024 but upon internal validation established as 06-OCT-2024, administered subcutaneously for prophylaxis (strength, dose and anatomical site of administration were not provided). The administered vaccine was exposed to the multiple temperature excursions from 19-OCT-2023 to 22-JAN-2024 (product storage error). No additional adverse event (AE) reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2401USA016206:
Age: 11.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; temperature excursion; This spontaneous report was received from an nurse practitioner and referred to a 11-year-old patient of unknown gender. The patient's concurrent conditions, concomitant therapies, historical drugs and historical conditions were not reported.  On 24-JAN-2024, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin [rHA]) (M-M-R II) injection, lot #W031980, expiration date was reported as 16-OCT-2024 but upon internal validation established as 06-OCT-2024, administered subcutaneously for prophylaxis (strength, dose and anatomical site of administration were not provided). The administered vaccine was exposed to the multiple temperature excursions from 19-OCT-2023 to 22-JAN-2024 (product storage error). No additional adverse event (AE) reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2401USA016206:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported; patient received improperly stored vaccine.; This spontaneous report was received from Other Health Professional and refers to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. Previous temperature excursion: No.  On 26-MAR-2024, the patient was vaccinated with the first dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection (improperly stored: temperature: (-0.3 degree Celsius); Time frame: 4 hours 26 minutes), 1 dose for prophylaxis (lot #x024543, expiration date: 10-OCT-2025, strength and route of administration were not provided) (Product storage error). No additional AEs were reported (no adverse event).
Sex: M
Vaccine: RSV
Symptoms: Pneumonia
Clinical narrative: Patient received the AREXVY vaccine and caught pneunomia.; This serious case was reported by a consumer via patient support programs and described the occurrence of pneumonia in a 64-year-old male patient who received fluticasone furoate, umeclidinium bromide, vilanterol trifenatate (Trelegy Ellipta) inhalation powder (batch number EK2D, expiry date DEC-2024) for chronic obstructive pulmonary disease.   Co-suspect products included RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Additional patient notes included Other Condition not Provided.   On an unknown date, the patient started Trelegy Ellipta and Arexvy. On an unknown date, an unknown time after starting Trelegy Ellipta and an unknown time after receiving Arexvy, the patient experienced pneumonia (Verbatim: Patient received the AREXVY vaccine and caught pneunomia.) (serious criteria GSK medically significant). Trelegy Ellipta was continued with no change. The outcome of the pneumonia was unknown.   It was unknown if the reporter considered the pneumonia to be related to Trelegy Ellipta, Trelegy Ellipta Dry Powder Inhaler Device and Arexvy.   It was unknown if the company considered the pneumonia to be related to Trelegy Ellipta, Trelegy Ellipta Dry Powder Inhaler Device and Arexvy.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   GSK Receipt Date: 20-MAR-2024  This report was submitted by GSK Patient Assistance Program. Patient received the arexvy vaccine and caught pneunomia.
Sex: F
Vaccine: MENB
Symptoms: Immunisation reaction
Clinical narrative: She had a severe adverse reaction, and has been battling for 41 days. In and out of the hospital; This serious case was reported by a consumer via interactive digital media and described the occurrence of hospitalization in a 17-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced hospitalization (Verbatim: She had a severe adverse reaction, and has been battling for 41 days. In and out of the hospital) (serious criteria hospitalization). The outcome of the hospitalization was not reported.   It was unknown if the reporter considered the hospitalization to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     It was unknown if the company considered the hospitalization to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 22-MAR-2024 This case was reported by a patient's mother via interactive digital media. The reporter stated that on 25th January (year unspecified), the patient received a vaccine for Meningitis B. The name of the vaccine was Bexsero. It was approved for use in 2015. The patient had a severe adverse reaction and had been battling for 41 days in and out of the hospital. The reporter always tried the best to be diligent and responsible when it came to health care. The reporter also followed recommendations from the Pediatrician.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Patient still got shingles after vaccination/Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Patient still got shingles after vaccination/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 24-MAR-2024 This case was reported by a patient via interactive digital media. The patient stated that he/she still got shingles after the vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Patient had both of the vaccine and still got them/suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Patient had both of the vaccine and still got them/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 24-MAR-2024 This case was reported by a patient via interactive digital media. The patient stated that he/she had both of the most recent vaccines and still got it. The patient thought it could had been worse, if not for vaccine. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.
Sex: F
Vaccine: RSV
Symptoms: Injection site swelling
Clinical narrative: Non-painful bump at injection site; This non-serious case was reported by a nurse via sales rep and described the occurrence of injection site swelling in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received the 1st dose of Arexvy (unknown arm). On an unknown date, an unknown time after receiving Arexvy, the patient experienced injection site swelling (Verbatim: Non-painful bump at injection site). The outcome of the injection site swelling was not resolved.   It was unknown if the reporter considered the injection site swelling to be related to Arexvy.     It was unknown if the company considered the injection site swelling to be related to Arexvy.   Additional Information: GSK Receipt Date: 13-MAR-2024 The nurse practitioner reported that the patient received the vaccine but unsure whether the vaccine given was Arexvy or Abryvso and she experienced non-painful bump at injection site, and it was ongoing and worsened. It was not serious. It was unknown if the reporter considered the injection site swelling to be related to Abrysvo.