chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: M
Vaccine: TDAP
Symptoms: Musculoskeletal stiffness, Myalgia, Neck pain, Pain
Clinical narrative: 2 days Later Pain and stiffness in left rotator and shoulder muscles, becoming difficult to lay on left side, neck feels stiff on left side. After 4 weeks no improvement, extreme pain in shoulder and behind scapula and in hip and Knee and elbow, Left side of Body Feels sore and Stiff Overall tiredness for 8 weeks, extreme pain and discomfort at night min the left shoulder neck and scapula.\ 8 weeks in looks upper side effects of tetanus shot and finds Bracial Neurosis.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event
Clinical narrative: No adverse reaction noted.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Nausea, Vomiting
Clinical narrative: nausea and vomiting
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Dizziness, Fatigue, Malaise
Clinical narrative: Lasted 6 days - Major worsening of muscle and joint soreness, fatigue, malaise, stomach ache, mild nausea, dizziness.     My reaction has gotten worse and lasted longer each time I get this shot.   I had no reaction at all to the first two - except maybe sore arm.   The next one I had a bit of the symptoms listed above plus a weird heavy feeling in my legs (other family members had this too);  by the 4th one I had the above symptoms plus a very unpleasant full-body skin "soreness" (I've felt this a few times in my life and was told it has to do with the lymphatic system) - skin soreness lasted 1 day, other symptoms lasted a couple days.  This last one was 6 full days of being mostly in bed.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea
Clinical narrative: Lasted 6 days - Major worsening of muscle and joint soreness, fatigue, malaise, stomach ache, mild nausea, dizziness.     My reaction has gotten worse and lasted longer each time I get this shot.   I had no reaction at all to the first two - except maybe sore arm.   The next one I had a bit of the symptoms listed above plus a weird heavy feeling in my legs (other family members had this too);  by the 4th one I had the above symptoms plus a very unpleasant full-body skin "soreness" (I've felt this a few times in my life and was told it has to do with the lymphatic system) - skin soreness lasted 1 day, other symptoms lasted a couple days.  This last one was 6 full days of being mostly in bed.
Age: 66.0
Sex: F
Vaccine: FLU3, UNK
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 79.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Extra dose administered
Clinical narrative: Duplicate Flu and Covid vaccines.  Patient had received these two vaccines on 8/27/2024
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation error
Clinical narrative: Three year old patient was in for a flu and covid vaccine.   The nurse inadvertently gave her the entire vial of covid vaccine without diluting the vaccine.  Pt received the entire vial of covid (pfizer 6m- < 5 year dose),  without the 1.1 ml of dilution.  We reached out to the state, and we did inform family to watch for signs of redness around injection site, increased tiredness, or tenderness to injection site.
Age: 66.0
Sex: F
Vaccine: HEPAB, PNC15
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Patient had an allergic reaction. Patient experienced swelling, redness, itching, and pain at the injection site and surrounding area. Patient forgot, but was told a long time ago not to get the vaccine because of an allergy. She did not let us know prior to receiving, due to not remembering conversation she had when she was a nurse. I was told today about the allergic reaction, the 22nd. She had the vaccine on the 15th. She said it was healing, but it was still there. I recommended an antihistamine and hydrocortisone to help with the symptoms. Allergy added to patient's file.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Autopsy, Cardiac failure congestive, Death, Thrombosis
Clinical narrative: PATIENT DEVELOPED A CLOT IN HER LEG IN 2023 AND PASSED AWAY UNEXPECTEDLY IN MAY 2024, AUTOPSY REPORT STATED IT WAS FROM CONGESTIVE HEART FAILURE
Age: 69.0
Sex: M
Vaccine: COVID19, HPV9, UNK, UNK, VARZOS
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 50.0
Sex: F
Vaccine: COVID19, FLU3, COVID19, FLUX
Symptoms: Induration, Injection site mass, Injection site pain, Injection site pruritus, Sleep disorder
Clinical narrative: Morning after vaccination area where received was itchy and I felt a small lump (had some itchiness and soreness the evening before but no more than I've exp with prev COVID shots). As day went on the itching got worse and the lump became wider and harder. Area of arm was sore and when I checked in mirror saw a large welt?looked like a bad bug bite. By Sun evening had trouble sleeping due to the itchiness and tenderness at the site. Did some online research and read about Arthus reaction so made a virtual appt at clinic Mon morning. PA prescribed 3 days of Prednisone and Zyrtec.
Age: 50.0
Sex: F
Vaccine: COVID19, FLU3, COVID19, FLUX
Symptoms: Urticaria
Clinical narrative: Morning after vaccination area where received was itchy and I felt a small lump (had some itchiness and soreness the evening before but no more than I've exp with prev COVID shots). As day went on the itching got worse and the lump became wider and harder. Area of arm was sore and when I checked in mirror saw a large welt?looked like a bad bug bite. By Sun evening had trouble sleeping due to the itchiness and tenderness at the site. Did some online research and read about Arthus reaction so made a virtual appt at clinic Mon morning. PA prescribed 3 days of Prednisone and Zyrtec.
Age: 50.0
Sex: F
Vaccine: COVID19, FLU3, COVID19, FLUX
Symptoms: Insomnia, Type III immune complex mediated reaction, Urticaria, Vaccination site mass, Vaccination site pain
Clinical narrative: Morning after vaccination area where received was itchy and I felt a small lump (had some itchiness and soreness the evening before but no more than I've exp with prev COVID shots). As day went on the itching got worse and the lump became wider and harder. Area of arm was sore and when I checked in mirror saw a large welt?looked like a bad bug bite. By Sun evening had trouble sleeping due to the itchiness and tenderness at the site. Did some online research and read about Arthus reaction so made a virtual appt at clinic Mon morning. PA prescribed 3 days of Prednisone and Zyrtec.
Age: 50.0
Sex: F
Vaccine: COVID19, FLU3, COVID19, FLUX
Symptoms: Vaccination site pruritus
Clinical narrative: Morning after vaccination area where received was itchy and I felt a small lump (had some itchiness and soreness the evening before but no more than I've exp with prev COVID shots). As day went on the itching got worse and the lump became wider and harder. Area of arm was sore and when I checked in mirror saw a large welt?looked like a bad bug bite. By Sun evening had trouble sleeping due to the itchiness and tenderness at the site. Did some online research and read about Arthus reaction so made a virtual appt at clinic Mon morning. PA prescribed 3 days of Prednisone and Zyrtec.
Age: 70.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Back disorder, Dysphonia, Headache, Injection site pain, Oropharyngeal pain
Clinical narrative: Sore arm at the injection site for 2 days, about a 6 out of 10.  My other symptoms of sore throat, allergy with running nose and hoarse voice and back issues as well as headache were mild in nature and occurred very shortly after injections. I cannot say whether the injection caused these or not, but they did occur.  They have mostly abated at this time.
Age: 70.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Rhinorrhoea
Clinical narrative: Sore arm at the injection site for 2 days, about a 6 out of 10.  My other symptoms of sore throat, allergy with running nose and hoarse voice and back issues as well as headache were mild in nature and occurred very shortly after injections. I cannot say whether the injection caused these or not, but they did occur.  They have mostly abated at this time.
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; a dose of expired MMR II was inadvertently administered to a patient/expired 9/7/2024 and administered on 9/30/2024; This spontaneous report was received from a nurse and refers to a 12-month-old patient of unknown gender.  The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not reported.  On 30-SEP-2024, the patient was vaccinated with an expired dose (expired product administered) of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin) (M-M-R II) 0.5 milliliter, lot # reported and confirmed as: W019425, expiration date reported as 07-SEP-2024 however upon internal validation it was established as: 07-JAN-2024 (strength, site and route of administration were not provided) for prophylaxis. No additional adverse event was reported.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Confirmed no symptomatic adverse events; Pharmacist did not know exact dates of administration for first two doses but states they were in 2020. Patient stated that she forgot to get the 3rd dose. Pharmacist states patient received her 3rd dose of GARDASIL-9 on 14-OCT-2024.; This spontaneous report has been received from a pharmacist regarding a 25-year-old female patient. Information regarding medical history, concurrent conditions and concomitant therapies was not reported.  On unespecified dates in 2020, the patient was vaccinated with the first and second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection for prophylaxis (strengths,  lot numbers, expiry dates, anatomical sites and routes of administration were not provided).  On 14-OCT-2024, the patient was vaccinated with third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection for prophylaxis (strength,  lot number, expiry date, anatomical site and route of administration were not provided). Patient stated that she forgot to get the third dose (innapropriate schedule of vaccine administered). No symptomatic adverse events were reported.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE; HCP states patient received delayed administration of GARDASIL 9.  First dose 9/2022, second dose 8/2023 and 3rd dose 3/2024.  No other information provided.  No additional AE. No PQC.; This spontaneous report was received from a nurse and refers to a patient with 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. On an unknown date in September 2022, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, was vaccinated with second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection on an unknown date in August 2023 and was vaccinated with third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection an unknown date in March 2024,  all doses administered for prophylaxis (strength, doses, lots #, expiry date, and route of administration were not provided). No other information provided.  No additional adverse event (AE) (No adverse event).  lots # is being requested and will be submitted if received.
Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: No additional AE/no PQC; 33 year old female who received first varicella vaccine in 2008. Patient received VARIVAX as a 2nd varicella vaccine on 09/17/2024. Caller wanted to know if the two doses that were administered were enough of if they should administer a third dose.; This spontaneous report was received from Pharmacist and refers to a 33-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date in 2008, the patient was vaccinated with the first dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). On 17-SEP-2024, the patient received the second dose of varicella virus vaccine live (oka/merck) (VARIVAX). The reporter wanted to know if the two doses that were administered were enough of if they should administer a third dose, due to the length of time  between administered doses.  Lot # is being requested and will be submitted if received.
Age: 37.0
Sex: F
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: no additional AE; HCP called to report that a dose of VARIVAX was administered after the expiration date.; This spontaneous report was received from a consumer, referring to a 38-year-old female patient.  The patient's pertinent medical history, concurrent conditions, drug reactions/allergies, and concomitant therapies were not reported.  On 17-OCT-2024 (also reported as 17-OCT-2025, conflicting information), the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 milliliter, lot #W031810, expiration date: 05-OCT-2024, administered for prophylaxis (strength, and route of administration were not provided) after the expiration date (Expired product administered). The vaccine did not undergo any temperature excursions. No side effects or symptoms reported. No additional adverse event (no adverse event).
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Colitis, Computerised tomogram abnormal, Computerised tomogram intestine, Diarrhoea, Incomplete course of vaccination
Clinical narrative: rectum bleeding; inflamed colon/She states that neither her nor her doctor is sure that Shingrix caused the problems she wrote about; nausea; vomitting; diarrhea; Patient received dose 1 of Shingrix in Feb 2020.  She has not yet received dose 2; This serious case was reported by a consumer via call center representative and described the occurrence of rectal bleeding in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In FEB-2020, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced rectal bleeding (Verbatim: rectum bleeding) (serious criteria GSK medically significant), colon inflammation (Verbatim: inflamed colon/She states that neither her nor her doctor is sure that Shingrix caused the problems she wrote about) (serious criteria GSK medically significant), nausea (Verbatim: nausea), vomiting (Verbatim: vomitting), diarrhea (Verbatim: diarrhea) and incomplete course of vaccination (Verbatim: Patient received dose 1 of Shingrix in Feb 2020.  She has not yet received dose 2). The outcome of the rectal bleeding, colon inflammation, nausea, vomiting and diarrhea were resolving and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the rectal bleeding, colon inflammation, nausea, vomiting and diarrhea to be related to Shingrix.     The company considered the rectal bleeding and colon inflammation to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the nausea, vomiting and diarrhea to be related to Shingrix.   Additional Information: GSK Receipt Date: 14-OCT-2024 This case reported by patient itself. The patient received first Shingrix vaccine and had horrible side effects such as nausea, vomiting, and diarrhea. The patient started bleeding from rectum and then went to the emergency room. In the emergency room, was given a Computerized tomogram scan which found that had an inflamed colon. The patient was given antibiotics and eventually got better. Now, the patient's primary care physician wants me to get the second dose.  The patient asked-should get the second dose since it was close to five years since the first dose. The patient did not want to get sick again. She has not yet received dose, which led incomplete course of vaccination. She states that neither her nor doctor was sure that Shingrix caused the problems she wrote about, but she concerned that if she gets the second dose that she would experience negative side effects. Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.; Sender's Comments: Rectal haemorrhage and Colitis are unlisted events which are considered unrelated to GSK vaccine Shingrix (Dose 1 and Dose 2).
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Nausea, Rectal haemorrhage, Vomiting
Clinical narrative: rectum bleeding; inflamed colon/She states that neither her nor her doctor is sure that Shingrix caused the problems she wrote about; nausea; vomitting; diarrhea; Patient received dose 1 of Shingrix in Feb 2020.  She has not yet received dose 2; This serious case was reported by a consumer via call center representative and described the occurrence of rectal bleeding in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In FEB-2020, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced rectal bleeding (Verbatim: rectum bleeding) (serious criteria GSK medically significant), colon inflammation (Verbatim: inflamed colon/She states that neither her nor her doctor is sure that Shingrix caused the problems she wrote about) (serious criteria GSK medically significant), nausea (Verbatim: nausea), vomiting (Verbatim: vomitting), diarrhea (Verbatim: diarrhea) and incomplete course of vaccination (Verbatim: Patient received dose 1 of Shingrix in Feb 2020.  She has not yet received dose 2). The outcome of the rectal bleeding, colon inflammation, nausea, vomiting and diarrhea were resolving and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the rectal bleeding, colon inflammation, nausea, vomiting and diarrhea to be related to Shingrix.     The company considered the rectal bleeding and colon inflammation to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the nausea, vomiting and diarrhea to be related to Shingrix.   Additional Information: GSK Receipt Date: 14-OCT-2024 This case reported by patient itself. The patient received first Shingrix vaccine and had horrible side effects such as nausea, vomiting, and diarrhea. The patient started bleeding from rectum and then went to the emergency room. In the emergency room, was given a Computerized tomogram scan which found that had an inflamed colon. The patient was given antibiotics and eventually got better. Now, the patient's primary care physician wants me to get the second dose.  The patient asked-should get the second dose since it was close to five years since the first dose. The patient did not want to get sick again. She has not yet received dose, which led incomplete course of vaccination. She states that neither her nor doctor was sure that Shingrix caused the problems she wrote about, but she concerned that if she gets the second dose that she would experience negative side effects. Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.; Sender's Comments: Rectal haemorrhage and Colitis are unlisted events which are considered unrelated to GSK vaccine Shingrix (Dose 1 and Dose 2).
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pyrexia, Swelling
Clinical narrative: fever; Swelling; Erythema; This non-serious case was reported by a other health professional and described the occurrence of fever in a 55-year-old female patient who received Herpes zoster (Shingrix) (batch number FJ9A7, expiry date 16-JUL-2026) for prophylaxis.   On 02-OCT-2024, the patient received Shingrix .5 ml. On 02-OCT-2024, less than a day after receiving Shingrix, the patient experienced fever (Verbatim: fever), swelling (Verbatim: Swelling) and erythema (Verbatim: Erythema). On 05-OCT-2024, the outcome of the fever, swelling and erythema were resolved.   It was unknown if the reporter considered the fever, swelling and erythema to be related to Shingrix.     It was unknown if the company considered the fever, swelling and erythema to be related to Shingrix.   Additional Information: GSK Receipt Date: 07-OCT-2024 The other health professional reported that the patient received Shingrix. The patient had swelling, erythema, fever. The other health professional reported that the symptoms  were treated.
Age: 9.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: patient received 2 doses of flulaval 3 days apart; This non-serious case was reported by a nurse via sales rep and described the occurrence of extra dose administered in a 9-year-old female patient who received Flu Seasonal TIV Quebec (Flulaval) for prophylaxis.   Concomitant products included Influenza vaccine inact split 3v (Flulaval).   On 12-OCT-2024, the patient received the 2nd dose of Flulaval. On 12-OCT-2024, an unknown time after receiving Flulaval, the patient experienced extra dose administered (Verbatim: patient received 2 doses of flulaval 3 days apart). The outcome of the extra dose administered was unknown.   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: 12-OCT-2024 The nurse reported that the patient received 2 doses of flulaval 3 days apart which led to extra dose administered.
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Influenza
Clinical narrative: flu; joint pain; chills; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of influenza in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced influenza (Verbatim: flu), joint pain (Verbatim: joint pain) and chills (Verbatim: chills). The outcome of the influenza, joint pain and chills were resolved (duration 24 hrs).   It was unknown if the reporter considered the influenza, joint pain and chills to be related to Shingles vaccine.     It was unknown if the company considered the influenza, joint pain and chills to be related to Shingles vaccine.   Additional Information: GSK receipt date: 10-OCT-2024 This case was reported by a patient via interactive digital media. The patient just had his/her 1st shot and both times it felt like he/she had the flu by the second day and experienced Joint pain and chills that lasted 24 hours. The reporter mentioned that day 3 post injection patient back to normal.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: got a little sick after the first dose; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: got a little sick after the first dose). The outcome of the sickness was not reported.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     It was unknown if the company considered the sickness to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2024AMR129237   Additional Information: GSK Receipt Date: 10-OCT-2024 This case was reported by a patient via interactive digital media. The patient got a little sick. This case had been link with US2024AMR129237, reported by the same reporter.; Sender's Comments:  US-GSK-US2024AMR129237:Same patient/Second dose
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; severe case of shingles; This serious case was reported by a physician via sales rep and described the occurrence of vaccination failure in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 11-FEB-2021, the patient received the 2nd dose of Shingrix. On 15-SEP-2020, the patient received the 1st dose of Shingrix. On 19-SEP-2024, 1316 days after receiving Shingrix and 1465 days after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: severe case of shingles). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     The company considered the vaccination failure and shingles to be unrelated to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 15-OCT-2024 The physician reported that one of her patients who had a severe case of shingles even having both doses of Shingrix. This case was considered as suspected vaccination failure since the details regarding the laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: Herpes zoster is an unlisted event which is considered unrelated to GSK vaccine Shingrix.  Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix.
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Pruritus, Swelling face
Clinical narrative: swelling in his face; swelling in his hands and arms; around his neck and chest he is experiencing the worst itching; redness on his face, hands, and arms; This non-serious case was reported by a consumer via call center representative and described the occurrence of facial swelling in a 87-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Influenza vaccine for prophylaxis.   The patient's past medical history included shingles (as a young boy had shingles and given a vaccine (unknown name/date) at that time for shingles). Previously administered products included Shingles vaccine (received on an unknown date as a young boy), Shingles vaccine (received another shingles vaccine (unknown name/date) prior to 1st dose of Shingrix) and Flu vaccine with an associated reaction of no adverse event (had the flu shot every year).   In SEP-2024, the patient received the 1st dose of Shingrix and Influenza vaccine. In SEP-2024, less than a week after receiving Shingrix, the patient experienced facial swelling (Verbatim: swelling in his face), peripheral swelling (Verbatim: swelling in his hands and arms), pruritus (Verbatim: around his neck and chest he is experiencing the worst itching) and erythema (Verbatim: redness on his face, hands, and arms). The patient was treated with hydrocortisone butyrate (Hydrocortisone). The outcome of the facial swelling, peripheral swelling, pruritus and erythema were not resolved.   It was unknown if the reporter considered the facial swelling, peripheral swelling, pruritus and erythema to be related to Shingrix.     It was unknown if the company considered the facial swelling, peripheral swelling, pruritus and erythema to be related to Shingrix.   Additional Information: GSK Receipt Date: 23-SEP-2024 The patient self-reported this case. The patient had his first shingles shot administered last week (from the reporting date) as well as a flu shot (unknown name) and in the past two days he had been experiencing swelling in his face, hands and arms. States around his neck and chest he was experiencing the worst itching he had ever had. States he applied hydrocortisone cream to those areas and that seemed to make the itching not as severe. Consumer states that he was experiencing redness on his face, hands, ands arms. The patient stated that this reaction was not from the flu vaccine he received concomitantly as he had the flu shot every year and no symptoms such as he was experiencing now (at the time of reporting).
Sex: U
Vaccine: FLU3
Symptoms: Incorrect dose administered
Clinical narrative: long FluLaval vaccines can be out of refrigeration; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a patient who received Flu Seasonal TIV Quebec (FluLaval 2024-2025 season) for prophylaxis.   In SEP-2024, the patient received FluLaval 2024-2025 season. On an unknown date, an unknown time after receiving FluLaval 2024-2025 season, the patient experienced incorrect storage of drug (Verbatim: long FluLaval vaccines can be out of refrigeration). The outcome of the incorrect storage of drug was unknown.   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: 23-SEP-2024 The reporter reported that it was discovered that a staff member was putting a little ice pack on flu vaccines and was giving throughout the day and the vaccines were not monitored for temperature, which led to incorrect storage of vaccine. A test revealed that the ice pack was good for might be an hour.  It was possible that the vaccines could have been out at room temperature up to 7 hours and they were most likely placed in and out of refrigeration.  The reporter would like to know how long FluLaval vaccines could be out of refrigeration and still be effective.  After reviewing inhouse stability data, the reporter did not believe the vaccines would have exceeded the extended stability conditions.  The vaccines were administered between 9th September 2024 to 20th September 2024. The reporter did not have patient details at the time of call and did not have the affected product lot numbers. The reporter consented to follow up.
Sex: U
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Maladministration of a pediatric dose  to an adult patient; Maladministration of a pediatric dose  to an adult patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult use of a child product in a adult patient who received HBV (Engerix B pediatric) for prophylaxis.   On an unknown date, the patient received Engerix B pediatric. On an unknown date, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: Maladministration of a pediatric dose  to an adult patient) and underdose (Verbatim: Maladministration of a pediatric dose  to an adult patient). The outcome of the adult use of a child product and underdose were unknown.   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: 23-SEP-2024 Health coach calls to ask about the maladministration of a pediatric dose of Engerix B in an adult patient which led to adult use of a child product and underdose.  Health coach wanted to how to proceed in this case. Health coach does not consent follow-up from the Safety Department and does not provide any detail about this situation: vaccination date and detail, patient demographics. No further information was provided from the Health coach in this call.
Sex: F
Vaccine: VARZOS
Symptoms: Product preparation error
Clinical narrative: CMA use normal saline diluent instead of the adjuvant suspension; CMA use normal saline diluent instead of the adjuvant suspension; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: CMA use normal saline diluent instead of the adjuvant suspension) and inappropriate dose of vaccine administered (Verbatim: CMA use normal saline diluent instead of the adjuvant suspension). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 02-OCT-2024 According to reporter, the patient age was over 50 years. A advanced practice registered nurse started a chat and informed that CMA used normal saline diluent instead of the adjuvant suspension which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter consented to follow up. The case is linked with US2024121558, same reporter different patient.; Sender's Comments:  US-GSK-US2024121558:male patient
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: patient who received a Shingrix dose 6 years ago but the patient cannot remember if the second dose was given.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received a dose 6 years ago ).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: patient who received a Shingrix dose 6 years ago but the patient cannot remember if the second dose was given.). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 07-OCT-2024 A pharmacist mentioned they have a patient who received a Shingrix dose 6 years ago but the patient could not remember if the second dose was given, which led to incomplete course of vaccination. The HCP requested a recommendation on this situation.
Sex: F
Vaccine: DTAP
Symptoms: Extra dose administered
Clinical narrative: inadvertently received an extra dose (the 6th) after she was 7 year old; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 7-year-old female patient who received DTPa (Infanrix) for prophylaxis.   Previously administered products included Infanrix (received 5 doses of Infanrix vaccine on an unknown date).   On an unknown date, the patient received the 6th dose of Infanrix. On an unknown date, an unknown time after receiving Infanrix, the patient experienced extra dose administered (Verbatim: inadvertently received an extra dose (the 6th) after she was 7 year old). The outcome of the extra dose administered was unknown.   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: 08-OCT-2024 The reporter had a questioned at this point, was there was any guidance like if a patient had an inadvertently 6th dose of the Infanrix. The reporter asked questioned was there any data when they should get the T dap vaccine and that changes anything. During the call, the HCP (Healthcare professional) mentioned that the patient completes the Infanrix series, based on normal schedule and the 5th dose was administer when the patient was between 4- to 6-year-old which led to, extra dose administered. And inadvertently received an extra dose (the 6th) after she was 7-year-old.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: inappropriate schedule of vaccine; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Varicella zoster vaccine rgE (CHO) (Shingrix).   On 03-DEC-2023, the patient received the 2nd dose of Shingrix. On 03-DEC-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: inappropriate schedule of vaccine). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 11-OCT-2024 The pharmacist requested data on whether patient needed to did a 3rd dose of Shingrix due to early (less than 2 months after initial dose). The patient received 1st Shingrix vaccine on 22nd October 2023 and 2nd dose on 03rd December 2023. The reporter asked that did the patient needed a 3rd dose since the 2nd dose was administered less than 2 months interval, was the 2nd dose considered a valid dose. the patient received the 2nd dose of Shingrix later than the recommended interval, which led to lengthening of vaccine schedule.
Sex: M
Vaccine: RSV
Symptoms: Product preparation issue
Clinical narrative: Arexvy possibly adjuvant only; Arexvy possibly adjuvant only; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 73-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 4LJ4T, expiry date 12-OCT-2025) for prophylaxis.   On 11-OCT-2024, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: Arexvy possibly adjuvant only) and inappropriate dose of vaccine administered (Verbatim: Arexvy possibly adjuvant only). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 11-OCT-2024 The pharmacist reported that Arexvy was administered to two patients and after vaccination it was discover that one of them only received the adjuvant but did not know who received a complete dose and who received the adjuvant only which led to Inappropriate preparation of medication and Inappropriate dose of vaccine administered. The vaccine administration facility was the same as primary reporter.; Sender's Comments:  US-GSK-US2024125626:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Immune system disorder
Clinical narrative: immune condition that affects her nerves; exacerbation of this condition; This non-serious case was reported by a nurse via call center representative and described the occurrence of nervous system disorder in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included nervous system disorder.   In JUL-2024, the patient received the 1st dose of Shingrix. On an unknown date, several days after receiving Shingrix, the patient experienced nervous system disorder (Verbatim: immune condition that affects her nerves) and condition aggravated (Verbatim: exacerbation of this condition). The outcome of the nervous system disorder was not resolved and the outcome of the condition aggravated was not reported.   The reporter considered the nervous system disorder and condition aggravated to be possibly related to Shingrix.     The company considered the nervous system disorder and condition aggravated to be possibly related to Shingrix.   Additional Information: GSK Receipt Date: 11-OCT-2024 This case was reported by patient itself. The reporter reported few days after vaccination the patient experienced a bad reaction.  The patient mentioned she had an immune condition that affects her nerves but it has been controlled for the last 7 years.  After vaccination patient reported the exacerbation of this condition and at the time of reporting she feels like she has no control of her body. Since zoster virus affects nerves she thinks that vaccination could triggered the reaction reported. Moreover, the patient mentioned it was likely that she will not receive the second dose due to this event. The reporter consented to follow up.
Sex: U
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: given Arexvy to a patient and then found out that she had already had the vaccine given; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Previously administered products included Arexvy (received Arexvy in January 2024).   On 11-OCT-2024, the patient received the 2nd dose of Arexvy. On 11-OCT-2024, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: given Arexvy to a patient and then found out that she had already had the vaccine given). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 12-OCT-2024 and 14-OCT-2024 The other health professional reported that they had given Arexvy to a patient and then found out that she had already had the vaccine given which led to extra dose administered.  The other health professional asked was there anything they need to do. No other information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Infertility female
Clinical narrative: unable to get pregnant, requiring in-vitro fertilization; This spontaneous case was reported by a patient family member or friend and describes the occurrence of INFERTILITY FEMALE (unable to get pregnant, requiring in-vitro fertilization) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.  On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFERTILITY FEMALE (unable to get pregnant, requiring in-vitro fertilization). At the time of the report, INFERTILITY FEMALE (unable to get pregnant, requiring in-vitro fertilization) outcome was unknown.     The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   No concomitant medications were reported. Treatment medications were not provided.   This case was linked to US-MODERNATX, INC.-MOD-2024-775284 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-775284:Master Case (AE#1)
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: sore arm at injection site; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm at injection site) and FATIGUE (fatigue) in a male patient of an unknown age who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.    Co-suspect product included non-company product Influenza vaccine (Flu) for an unknown indication.    No Medical History information was reported.   On 16-Oct-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form and dose of Influenza vaccine (Flu) (unknown route) 1 dosage form. On 17-Oct-2024, the patient experienced VACCINATION SITE PAIN (sore arm at injection site) and FATIGUE (fatigue). At the time of the report, VACCINATION SITE PAIN (sore arm at injection site) and FATIGUE (fatigue) was resolving.        The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) was unknown.       No concomitant medication was reported.  It was reported that also administered flu vaccine at same time (other arm) to patient. It was unknown if the patient experienced any additional symptoms/events.   No treatment information was reported.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: her arm hurt a little where the injection was/slightest pain in the arm; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (her arm hurt a little where the injection was/slightest pain in the arm) in a 79-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. ASKU) for COVID-19 prophylaxis.     Concurrent medical conditions included Multiple myeloma (she has cancer having multiple myeloma).    In October 2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (her arm hurt a little where the injection was/slightest pain in the arm). At the time of the report, VACCINATION SITE PAIN (her arm hurt a little where the injection was/slightest pain in the arm) had resolved.        The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown) was unknown.   For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  She got the Spikevax two weeks ago, but it did not state it was Moderna and now she was a little mixed up. Patient added her arm hurt a little where the injection was but said it was not a big deal. she was fine and that she did not even remember if she had it.   She said her arm hurt a little, she refused to give further details by saying, "She did not know. she just, I did not have anything now. It was very slight. no, just where they just, where they gave her the shot.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 17-Oct-2024: Live non-significant follow up added. Reference number added.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: He added that he had no other symptom aside from sore arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (He added that he had no other symptom aside from sore arm) in a male patient of an unknown age who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Oct-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (He added that he had no other symptom aside from sore arm). At the time of the report, PAIN IN EXTREMITY (He added that he had no other symptom aside from sore arm) had not resolved.        The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown) was unknown.   For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. Dosage text for suspect product was reported as unknown. No treatment medication was provided.   This case was linked to US-MODERNATX, INC.-MOD-2024-775467 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-775467:Wife case