chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: M
Vaccine: SMALLMNK
Symptoms: No adverse event
Clinical narrative: The treatment is the first of a two-series vaccination; the outcome was uneventful, with no symptoms or signs of reactions reported.
Age: 62.0
Sex: M
Vaccine: SMALLMNK
Symptoms: No adverse event
Clinical narrative: The treatment was the first of a two-series vaccination; the outcome was uneventful, with no symptoms or signs of reactions reported.
Age: 16.0
Sex: F
Vaccine: UNK
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event, patient was given incorrect vaccine, Vaxellis, instead of Meningitis. Spoke to Doctors about if any risks. Patients parent was contacted and informed. Asked to watch out if patient was having any reaction. Patients parent said no, and they are coming in to get the correct shot
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blindness, Headache, Inflammation, Nausea
Clinical narrative: Headache, joint pain, nausea within 20 hours of administration. Acute loss of vision, inflammation after 1 day
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Hypogeusia, Hyposmia, Palpitations, Tinnitus
Clinical narrative: Tinnitus severe, diminished smell and taste, heart palpitations
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired dose of Covid vaccine administered. Dose expired on 4/30/25, administered on 5/13/25.I viewed the vaccine and expiration date and told the employee what I was giving him and that it was not an expired vaccine. I administered a Covid 19 Vaccine Comirnaty Pfizer 2024-2025 formulation to an employee.  The employee is a physician, and he is aware of the incident. Lot # LR6262, Expiration 2025/04/30. This information  is on clear glass prefilled syringe. I realized that I misread the expiration date, after administration, when the gray plunger was pulled nearly out of the syringe revealing the full date clearly.  I misinterpreted the month as 06, not 04.  This was obscured by the gray plunger making it difficult to read.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: patient received a third shingrix dose 12/12/2024.  first 2 doses received in 2022, 2 months apart
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: me too I received the shindrix however u spell it I got sick; 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 (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced sickness (Verbatim: me too I received the shindrix however u spell it I got sick). The outcome of the sickness was not reported.   It was unknown if the reporter considered the sickness to be related to Shingrix.     It was unknown if the company considered the sickness to be related to Shingrix.   Additional Information: GSK Receipt Date: 03-MAY-2025 This case was reported by a patient via interactive digital media. The patient received the Shingrix however spell it he/she got sick.
Age: 86.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: patient received third shingrix dose in 2024. first 2 doses were in 2022, 2 months apart
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: Pt was given  0.25ml twice to make 0.5ml (1 dose). Patient did not call us to report any adverse events following administration.  We only knew about this event after we received the email from DPH on 12/312024.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Cold sweat, Feeling abnormal, Pallor
Clinical narrative: Pt was given Tdap and MCV4, in this order, in Left deltoid, greater than 1" apart. After MCV4 was given pt leaned forward and was asked if he felt ok, he voiced "no, I feel funny". Had pt lay down on exam table. Did not feel clammy at this time and his skin tone was still normal appearance. Call bell placed next to pt/father and advised to ring if needing assistance while this nurse went to get a cup of water. Water was given to pt, when entering room father voiced he did feel clammy at that time, and pt was pale skin tone. Ice pack was then placed on back of pt neck, and he was sitting up. Noted to have felt better. Had pt wait in exam room for 15mins post adminstration, consulted a provider in the office, it was agreed upon to not give the HPV9 d/t the rxn from other vaccines. Pt left office stating he felt fine, color was back to his normal and not feeling clammy any longer.
Age: 37.0
Sex: M
Vaccine: SMALLMNK
Symptoms: No adverse event
Clinical narrative: The treatment was the first of a two-series vaccination; the outcome was uneventful, with no symptoms or signs of reaction reported.
Age: 39.0
Sex: M
Vaccine: SMALLMNK
Symptoms: No adverse event
Clinical narrative: The treatment was the first of a two-series vaccination; the outcome was uneventful, with no symptoms or signs of reactions reported.
Age: 23.0
Sex: M
Vaccine: IPV
Symptoms: Blood pressure decreased, Heart rate decreased, Nausea, Presyncope
Clinical narrative: Patient vasovagal upon receiving inactivated polio.. Symptoms included decrease in heart rate and blood pressure as well as feeling the need to vomit. Pt was given ice pack to place on back of neck and laid supine to be given ammonia to smell. Vitals were taken and doctor observed and made to wait 15 minutes before rechecking for vitals again.
Age: 30.0
Sex: M
Vaccine: SMALLMNK
Symptoms: No adverse event
Clinical narrative: The treatment was the first of a two-series vaccination; the outcome was uneventful, with no symptoms or sign of reaction reported.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: Patient had no symptoms
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Wrong product administered
Clinical narrative: My provider asked I could give the patient a vaccine around 10:40 a.m. I grabbed the vaccine from the Hep B box and gave the patient the vaccine. When I realized I inject the patient with the wrong vaccine, I informed her right away and put her back in the room. I told the nurse about what happened, and she immediately told the provider. After the nurse told the provider what happened, she told me it was okay to give the correct vaccine.
Age: 0.92
Sex: F
Vaccine: MMR
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Given too soon at incorrect recommendation by medical assistant in triage position
Age: 29.0
Sex: M
Vaccine: SMALLMNK
Symptoms: No adverse event
Clinical narrative: The treatment was the first of a two-series vaccination; the outcome was uneventful, with no symptoms or signs of reaction reported.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood test, Erythema, Gait disturbance, Joint swelling
Clinical narrative: Just a couple of days after I got the Pfizer covid booster vaccine, I noticed a lot of swelling and redness in my left ankle. I had no prior injury or anything that stands out that would cause this issue. It has now been over 4 years and the pain in my left ankle is unbearable. It is majorly swollen on most days and I am in pain / discomfort every day. My foot does not fit in shoes normally and it hurts all the time. There is significant swelling around my ankle, foot, and toes. I can barely walk.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal discomfort, Pain in extremity, Peripheral swelling, Ultrasound Doppler, Venogram
Clinical narrative: Just a couple of days after I got the Pfizer covid booster vaccine, I noticed a lot of swelling and redness in my left ankle. I had no prior injury or anything that stands out that would cause this issue. It has now been over 4 years and the pain in my left ankle is unbearable. It is majorly swollen on most days and I am in pain / discomfort every day. My foot does not fit in shoes normally and it hurts all the time. There is significant swelling around my ankle, foot, and toes. I can barely walk.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: Just a couple of days after I got the Pfizer covid booster vaccine, I noticed a lot of swelling and redness in my left ankle. I had no prior injury or anything that stands out that would cause this issue. It has now been over 4 years and the pain in my left ankle is unbearable. It is majorly swollen on most days and I am in pain / discomfort every day. My foot does not fit in shoes normally and it hurts all the time. There is significant swelling around my ankle, foot, and toes. I can barely walk.
Age: 60.0
Sex: M
Vaccine: SMALLMNK
Symptoms: No adverse event
Clinical narrative: The treatment was the first of a two-series vaccination; the outcome was uneventful, with no symptoms or signs of reaction reported.
Age: 38.0
Sex: M
Vaccine: SMALLMNK
Symptoms: No adverse event
Clinical narrative: The treatment was the firs of a two-series vaccination; the outcome was uneventful, with no symptoms or signs of reaction reported.
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: arm was really sore; whole body hurts; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 02-MAY-2025, the patient received the 1st dose of Shingles vaccine. In MAY-2025, less than a week after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: arm was really sore) and general body pain (Verbatim: whole body hurts). The outcome of the pain in arm and general body pain were not reported.   It was unknown if the reporter considered the pain in arm and general body pain to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm and general body pain to be related to Shingles vaccine.   Additional Information: GSK receipt date: 03-MAY-2025 This case was reported by a patient via interactive digital media The reporter guessed that everybody reacts differently, the patient got first shot yesterday and arm was really sore and whole body was hurting.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Abdominal discomfort, Chest discomfort, Dyspnoea, Enterovirus test negative, Facial discomfort
Clinical narrative: Around 50 minutes after getting vaccines stomach started feeling uncomfortable,  continued through the night with  feeling of "brick in stomach" increased bowel movements and attempts of emesis with dry heaving, dyspnea with "chest having heavy feeling and gasping for breaths", "Headache with facial pressure" "Felt heart beating in throat". Difficulty moving left arm d/t pain.  Feeling felt a little better this morning, then at school had similar feelings of difficulty taking deep breath, dyspnea.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Frequent bowel movements, Headache, Human rhinovirus test, Influenza A virus test negative, Influenza B virus test negative
Clinical narrative: Around 50 minutes after getting vaccines stomach started feeling uncomfortable,  continued through the night with  feeling of "brick in stomach" increased bowel movements and attempts of emesis with dry heaving, dyspnea with "chest having heavy feeling and gasping for breaths", "Headache with facial pressure" "Felt heart beating in throat". Difficulty moving left arm d/t pain.  Feeling felt a little better this morning, then at school had similar feelings of difficulty taking deep breath, dyspnea.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Injected limb mobility decreased, Pain in extremity, Pulse abnormal, Respiratory syncytial virus test negative, Retching
Clinical narrative: Around 50 minutes after getting vaccines stomach started feeling uncomfortable,  continued through the night with  feeling of "brick in stomach" increased bowel movements and attempts of emesis with dry heaving, dyspnea with "chest having heavy feeling and gasping for breaths", "Headache with facial pressure" "Felt heart beating in throat". Difficulty moving left arm d/t pain.  Feeling felt a little better this morning, then at school had similar feelings of difficulty taking deep breath, dyspnea.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Streptococcus test negative
Clinical narrative: Around 50 minutes after getting vaccines stomach started feeling uncomfortable,  continued through the night with  feeling of "brick in stomach" increased bowel movements and attempts of emesis with dry heaving, dyspnea with "chest having heavy feeling and gasping for breaths", "Headache with facial pressure" "Felt heart beating in throat". Difficulty moving left arm d/t pain.  Feeling felt a little better this morning, then at school had similar feelings of difficulty taking deep breath, dyspnea.
Age: 29.0
Sex: M
Vaccine: SMALLMNK
Symptoms: No adverse event
Clinical narrative: The treatment was the first of a two-series vaccination; the outcome was uneventful, with no symptoms or signs of reactions reported.
Age: 30.0
Sex: M
Vaccine: SMALLMNK
Symptoms: No adverse event
Clinical narrative: The treatment was the second of a two-series vaccination; the outcome was uneventful, with no symptoms or signs of reaction reported.
Sex: M
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: Erythema, Infant irritability, Swelling
Clinical narrative: Redness, swelling, fussiness. Provider reccommended cold compresses, mark the area to see if redness or swelling spreads in the next hours, take appropriate dose of Tylenol and rtc if symptoms dont improve or new symptoms arise
Age: 13.0
Sex: M
Vaccine: HEP
Symptoms: Incorrect dose administered
Clinical narrative: Dr. sent in Engerix B pediatric dose, pharmacy entered adult dose and administered adult dose to pediatric pt
Age: 28.0
Sex: M
Vaccine: SMALLMNK
Symptoms: No adverse event
Clinical narrative: The treatment was the first of a two-series vaccination; the outcome was uneventful, with no symptoms or signs of reactions reported.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Injected limb mobility decreased, Pain in extremity
Clinical narrative: Patient reported having limitation in range of movement in his left arm and shoulder. He said that the pain moves periodically from his arm to shoulder and  back but it is mostly in his shoulder. He said the the severity of the pain remains the same as when he started to experience it 30 minutes after the vaccine was administered. He said all these symptoms are still experienced today.
Vaccine: VARZOS, VARZOS
Symptoms: Feeling abnormal, Incomplete course of vaccination
Clinical narrative: That dang 1st shot was awful; never got a second shot of shingles vaccine; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of feels awful 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 did not receive the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, not applicable after receiving Shingles vaccine and an unknown time after receiving Shingles vaccine, the patient experienced feels awful (Verbatim: That dang 1st shot was awful) and incomplete course of vaccination (Verbatim: never got a second shot of shingles vaccine). The outcome of the feels awful was not reported and the outcome of the incomplete course of vaccination was not applicable.   It was unknown if the reporter considered the feels awful to be related to Shingles vaccine.     It was unknown if the company considered the feels awful to be related to Shingles vaccine.   Additional Information: GSK receipt date: 03-MAY-2025 This case was reported by a patient via interactive digital media The patient reported that dang 1st shot was awful, and the patient never got a second one which led to incomplete course of vaccination. But the patient also had the original one and he/ she was done.
Vaccine: VARZOS
Symptoms: Malaise, Pyrexia
Clinical narrative: got really sick; high fever; 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.   Previously administered products included Shingles vaccine (Received 1st dose of Shingrix vaccine on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: got really sick) and fever (Verbatim: high fever). The outcome of the sickness and fever were not reported.   It was unknown if the reporter considered the sickness and fever to be related to Shingles vaccine.     It was unknown if the company considered the sickness and fever to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2025AMR056754   Additional Information: GSK Receipt Date: 05-MAY-2025 This case was reported by a patient via interactive digital media. It was reported that due to the second one, the patient got really sick, high fever. For tolerance to first dose refer case US2025AMR056754.; Sender's Comments:  US-GSK-US2025AMR056754:
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; have 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: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: have shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 06-MAY-2025 This case was reported by a patient via interactive digital media. The patient had the 2 part shingle vaccinations last year (2024) and at the time of reporting have shingles. The patient hoping the anti-viral and steroid has been prescribed will decrease the possible long lasting effect. 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.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, time to onset  and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine (dose 1 and 2)
Vaccine: VARZOS
Symptoms: Burning sensation, Localised infection, Pain, Vaccination failure, Zoster sine herpete
Clinical narrative: Suspected vaccination failure; Internal shingles; Foot infection; 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.   The patient's past medical history included shingles (had 20 years ago) and rash.   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: Suspected vaccination failure) (serious criteria GSK medically significant), zoster sine herpete (Verbatim: Internal shingles) and foot infection (Verbatim: Foot infection). The patient was treated with gabapentin. The outcome of the vaccination failure and foot infection were not reported and the outcome of the zoster sine herpete was not resolved.   It was unknown if the reporter considered the vaccination failure, zoster sine herpete and foot infection to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the zoster sine herpete and foot infection to be related to Shingles vaccine.   Additional Information: GSK receipt date: 06-MAY-2025 This case was reported by a patient via interactive digital media. The patient got the shingles vaccine a couple years ago. And just had to be on several antibiotics for a foot infection, which wiped out the immune system and now had internal shingles. The patient did not have rash because he/she had vaccine but had the pain and burning sensation. He/she was on gabapentin. It sounded like everyone got on that. The patient asked if anyone had the internal shingles. 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.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: did not receive second dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of vaccine on 19th June 2018).   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: did not receive second dose). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 06-MAY-2025 The reporter reported that a he received first dose of the Shingrix vaccine on 19th June 2018.  The reporter understand the next dose is recommended to be 2 to 6 months apart.  For some reason that it might have been availability and then forgetfulness, did not receive our second dose until 11th December 2021.  The reporter was ask the effectiveness of the timing of these two doses. This case is linked with US2025AMR057413, reported by same reporter.  Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.; Sender's Comments:  US-GSK-US2025AMR057413:same reporter different patient
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Vomiting
Clinical narrative: patient developed nausea; vomiting; This non-serious case was reported by a consumer via sales rep and described the occurrence of nausea in a 55-year-old 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, several hours after receiving Shingrix, the patient experienced nausea (Verbatim: patient developed nausea) and vomiting (Verbatim: vomiting). Shingrix was discontinued. The outcome of the nausea and vomiting were not reported.   It was unknown if the reporter considered the nausea and vomiting to be related to Shingrix.     It was unknown if the company considered the nausea and vomiting to be related to Shingrix.   Additional Information: GSK Receipt Date: 09-MAY-2025 The reporter reported that the patient took the 1 dose of the Shingrix. Within a few hours the patient developed nausea and vomiting. Her side effects were so severe that her doctor decided not to give her dose 2 of the series.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose of Shingrix on 18Dec2023 and the second dose in February 2025; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 81-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (a patient received the first dose of Shingrix on 18-Dec-2023).   In FEB-2025, the patient received the 2nd dose of Shingrix. In FEB-2025, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: first dose of Shingrix on 18Dec2023 and the second dose in February 2025). The outcome of the drug dose administration interval too long was not applicable.   Additional Information: GSK Receipt Date: 05-MAY-2025 Pharmacist reported that a patient received the first dose of Shingrix on 18 December 2023 and the second dose in February of 2025 which led to drug dose administration interval too long. Consented to follow up.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Maladministration of Menveo One-vial Presentation After the Expiration Date; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 17-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number 3553D, expiry date 28-FEB-2025) for prophylaxis.   On 05-MAY-2025, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: Maladministration of Menveo One-vial Presentation After the Expiration Date). The outcome of the expired vaccine used was not applicable.   Additional Information: GSK Receipt Date: 05-MAY-2025 Nurse reported that on a pediatric male patient received Menveo one vial presentation after the expiration date, which led to expired vaccine used.
Age: 96.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Site of injection sore; Site of injection warm to the touch; Site of injection red; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) (batch number 9L5P2, expiry date 27-OCT-2026) for prophylaxis.   On 02-MAY-2025, the patient received the 1st dose of Shingrix. In MAY-2025, less than a week after receiving Shingrix, the patient experienced injection site pain (Verbatim: Site of injection sore), injection site warmth (Verbatim: Site of injection warm to the touch) and injection site erythema (Verbatim: Site of injection red). The outcome of the injection site pain, injection site warmth and injection site erythema were not resolved.   It was unknown if the reporter considered the injection site pain, injection site warmth and injection site erythema to be related to Shingrix.     It was unknown if the company considered the injection site pain, injection site warmth and injection site erythema to be related to Shingrix.   Additional Information: GSK receipt date: 06-MAY-2025 Other HCP reported that a patient got first dose of Shingrix on May 2nd 2025, but at the time of reporting the area of injection was red and warm to the touch, and when she presses on it was sore, and it had been like that for 4 days already, was still ongoing till the time of reporting. Consented to follow up.
Age: 63.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: administered an expire Priorix vaccine; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 63-year-old female patient who received MMR (Priorix) (batch number X011430) for prophylaxis.   On 06-MAY-2025, the patient received Priorix. On 06-MAY-2025, an unknown time after receiving Priorix, the patient experienced expired vaccine used (Verbatim: administered an expire Priorix vaccine). The outcome of the expired vaccine used was not applicable.   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: 06-MAY-2025 Other HCP reported that they administered an expire Priorix vaccine, the vaccine was expired since 5 days ago, which led to expired vaccine used.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles; This serious case was reported by a physician via sales rep and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 06-MAY-2025 The patient had developed a shingles rash reaction after receiving the Shingrix 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.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix
Age: 80.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: Extra dose; Late second dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 80-year-old male patient who received Herpes zoster (Shingrix) (batch number E7335, expiry date 15-JUN-2026) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number FA95N/4Z4JG, expiry date 28-JUL-2023) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 28-APR-2021 expiry date 30-OCT-2022).   On 24-OCT-2024, the patient received the 3rd dose of Shingrix. On 16-AUG-2022, the patient received the 2nd dose of Shingrix. On 16-AUG-2022, not applicable after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Late second dose). On 24-OCT-2024, the patient experienced extra dose administered (Verbatim: Extra dose). The outcome of the extra dose administered and drug dose administration interval too long were not applicable.   Additional Information: GSK Receipt Date: 07-MAY-2025 The registered Nurse who requested to remain anonymous and declined consent to follow up with Safety, explained that a patient received a late second dose and a third extra dose of Shingrix which led to extra dose administered. The patient received the 2nd dose of Shingrix later than the recommended interval, which led to lengthening of vaccine schedule.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: patient received just 1 vaccine; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (patient that received her first Shingrix shot in sept 2021, just 1 vaccine).   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 received just 1 vaccine). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK receipt date: 07-MAY-2025 Other HCP reported that a female patient received her first Shingrix shot in sept 2021, just 1 vaccine. Did not consent to follow-up. Till the time of reporting patient did not receive 2nd dose of vaccine, which led to incomplete course of vaccination.
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: Wrong vaccine administered; This non-serious case was reported by a consumer via call center representative and described the occurrence of wrong vaccine administered in a 11-year-old patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included Men ACWY-CRM NVS (Menveo) for prophylaxis and Meningococcal vaccine A/C/Y/W conj (tet tox) (Menquadfi) for prophylaxis.   On an unknown date, the patient received Bexsero, did not receive Menveo and Menquadfi. On an unknown date, an unknown time after receiving Bexsero and not applicable after receiving Menveo, the patient experienced wrong vaccine administered (Verbatim: Wrong vaccine administered). The outcome of the wrong vaccine administered was not applicable.   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: 07-MAY-2025 The GSK Representative explained that a Pediatrician mentioned that an 11 year old patient received a Bexsero vaccine instead of MenQuadfi or Menveo, but GSK Representative did not have further details for the adverse event report which led to wrong vaccine administered. Outbound call placed to get further adverse event details, no answer, agent left a voicemail with case number. They would send a follow up email to safety team in case that they were able to contact the physician later.
Age: 68.0
Sex: M
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: administered an expired dose of priorix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 68-year-old male patient who received MMR (Priorix) (batch number 342RC, expiry date 01-MAY-2025) for prophylaxis.   On 07-MAY-2025, the patient received Priorix. On 07-MAY-2025, an unknown time after receiving Priorix, the patient experienced expired vaccine used (Verbatim: administered an expired dose of priorix). The outcome of the expired vaccine used was not applicable.   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-MAY-2025 The Vaccine Administration Facility is the same as Primary Reporter. The Health Center Manager called to ask about guidance on revaccination for an adult male patient that was administered an expired dose of Priorix vaccine which led to expired vaccine used.
Vaccine: JEV1
Symptoms: Ear infection
Clinical narrative: The patient is due today (13 May 2024) for his 2nd dose of Japanese encephalitis vaccine (IXIARO). The patient got an ear infection 2 days ago (11 May 2024), and started antibiotics. The patient received his first dose of IXIARO on 08 Apr 2024.; The patient is due for his 2nd IXIARO dose, but he got an ear infection 2 days ago and started antibiotics yesterday; The following information was received from a Healthcare Professional via service provider on 13 May 2024.  A 40-year-old male received his first dose of IXIARO (Japanese encephalitis vaccine, batch number JEV22H63E) i.m. on 08 Apr 2024.  Concomitant medication included Allopurinol (allopurinol) and his medical history was stated as gout.  On 11 May 2024 he experienced an ear infection and was treated with Amox/Kclav 875/125 mg (amoxicillin, clavulanic acid) since 12 May 2024.  On 13 May 2024 he was due for his second dose of IXIARO. The outcome of the event ear infection was not reported.; Sender's Comments: Causality assessed as not related, as inactivated vaccines do not cause infections. Causality assessment is not applicable for the event Incomplete course of vaccination, as this is no adverse event.
Sex: M
Vaccine: COVID19
Symptoms: Agitation, Mental disorder, Pyrexia, Slow response to stimuli, Speech disorder
Clinical narrative: altered mental status; increased agitation; slow response; limited speech; fever; This spontaneous case was reported by an other health care professional and describes the occurrence of MENTAL DISORDER (altered mental status), AGITATION (increased agitation), SLOW RESPONSE TO STIMULI (slow response), SPEECH DISORDER (limited speech) and PYREXIA (fever) in an elderly male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3046731) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Apr-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) .5 milliliter. On an unknown date, the patient experienced MENTAL DISORDER (altered mental status), AGITATION (increased agitation), SLOW RESPONSE TO STIMULI (slow response), SPEECH DISORDER (limited speech) and PYREXIA (fever). At the time of the report, MENTAL DISORDER (altered mental status), AGITATION (increased agitation), SLOW RESPONSE TO STIMULI (slow response), SPEECH DISORDER (limited speech) and PYREXIA (fever) outcome was unknown.        For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   This case contains information about 2nd patient out of 2 patients as reported by reporter.  No concomitant medications were reported.  HCP stated that patient received a Spikevax dose in October 2024, but no other vaccines in the last four weeks and was unable to provide medical history.  HCP stated that patient was changed from the regular baseline and ended up going to the emergency room.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2025-785850 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2025-785850:Patient 02
Sex: M
Vaccine: COVID19
Symptoms: Agitation, Mental disorder, Pyrexia, Slow response to stimuli, Speech disorder
Clinical narrative: altered mental status; increased agitation; slow response; limited speech; fever; This spontaneous case was reported by an other health care professional and describes the occurrence of MENTAL DISORDER (altered mental status), AGITATION (increased agitation), SLOW RESPONSE TO STIMULI (slow response), SPEECH DISORDER (limited speech) and PYREXIA (fever) in an elderly male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3046731) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Apr-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) .5 milliliter. On an unknown date, the patient experienced MENTAL DISORDER (altered mental status), AGITATION (increased agitation), SLOW RESPONSE TO STIMULI (slow response), SPEECH DISORDER (limited speech) and PYREXIA (fever). At the time of the report, MENTAL DISORDER (altered mental status), AGITATION (increased agitation), SLOW RESPONSE TO STIMULI (slow response), SPEECH DISORDER (limited speech) and PYREXIA (fever) outcome was unknown.        For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   This case contains information about 1st patient out of 2 patients as reported by reporter.  No concomitant medications were reported.  HCP stated that patient received a Spikevax dose in October 2024, but no other vaccines in the last four weeks and was unable to provide medical history.  HCP stated that patient changed from the regular baseline and ended up going to the emergency room.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2025-785851 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2025-785851:Patient 02
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Neoplasm malignant, Weight, Weight decreased
Clinical narrative: unexplained weight-loss; This spontaneous case was reported by a patient and describes the occurrence of WEIGHT DECREASED (unexplained weight-loss) in a 66-year-old male patient 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) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced WEIGHT DECREASED (unexplained weight-loss). At the time of the report, WEIGHT DECREASED (unexplained weight-loss) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Neoplasm malignant: but it's coming up negative. On an unknown date, Weight: unexplained weight-loss.   The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown.   No concomitant medications were reported.  It was reported that the patient had experienced unexplained weight loss and had undergone every possible test for cancer and other conditions that his doctor had conducted, but all the results had come back negative. He stated that the only possible explanation he could think of was that it might be due to the vaccine he had taken two to three years ago.  It was unknown if the patient experienced any additional symptoms or events  No treatment medications were reported.
Vaccine: COVID19
Symptoms: Pulmonary mass
Clinical narrative: getting a biopsy on a nodule in my lung; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE NUMBER UNKNOWN, SINGLE), for COVID-19 immunization. The following information was reported: PULMONARY MASS (non-serious), outcome "unknown", described as "getting a biopsy on a nodule in my lung".  Additional information: The patient was getting a biopsy on a nodule in lung that patient want to have the pathologist to check for the  mRNA from the 2 covid vaccines received. The patient was asking what tests to tell the doctor and pathologist to get check and what test to run. The patient non symptomatic and these nodule's came out of nowhere.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram, Ventricular tachycardia
Clinical narrative: super-ventricular tachycardia, so two of the pathways to his heart were shot; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A 40-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VENTRICULAR TACHYCARDIA (life threatening, medically significant), outcome "unknown", described as "super-ventricular tachycardia, so two of the pathways to his heart were shot". The patient underwent the following laboratory tests and procedures: Electrocardiogram: (06May2025) Unknown results. Clinical course: The patient received the vaccine, and has super-ventricular tachycardia, so two of the pathways to his heart were shot. But he mentioned he has incredibly good health otherwise. The patient inquired on if Pfizer had been sued because of this, because if he hadn't request an EKG in his check up on Tuesday, he might have dropped dead. He mentioned he wanted to know the lawsuit information, because he wanted to know what Pfizer was doing to make this better.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: PNC20
Symptoms: Pain
Clinical narrative: it being to painful for the child; This is a spontaneous report received from a Physician from a sales representative.  A 22-month-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), in Nov2024 as dose 1, single (Batch/Lot number: unknown) for immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset Nov2024, outcome "recovered" (Dec2024), described as "it being to painful for the child". It was unknown if therapeutic measures were taken as a result of pain.  Additional information: Vaccine administration time was 02:00 PM.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 49.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for Covid. Experiencing mild symptoms.; Tested positive for Covid. Experiencing mild symptoms.; This is a spontaneous report received from a Consumer or other non HCP.  A 50-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 03Oct2024 as dose 1, single (Lot number: LM2210) at the age of 49 years, in right deltoid for covid-19 immunisation; influenza vaccine inact sag 3v (FLUCELVAX), on 03Oct2024 as dose number unknown, single (Lot number: 388527), in left arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 02May2025, outcome "recovering" and all described as "Tested positive for Covid. Experiencing mild symptoms.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02May2025) Positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19.
Sex: F
Vaccine: COVID19, FLUX
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: As of 10May2025 I contracted Covid-19 based on the Lucira test taken; As of 10May2025 I contracted Covid-19 based on the Lucira test taken; This is a spontaneous report received from a Consumer or other non HCP.  An adult female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 02Oct2024 at 10:15 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 02Oct2024 as dose number unknown, single), in left arm for immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 09May2025 at 14:00, outcome "not recovered" and all described as "As of 10May2025 I contracted Covid-19 based on the Lucira test taken". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10May2025) contracted Covid-19. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Clinical course: The reporter informed that the vaccine location was at the upper left arm and the facility type was workplace clinic. The patient has no other vaccine in four weeks and has no other medications in two weeks.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.