chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Patient had hard, red tender area at injection site
Age: 45.0
Sex: M
Vaccine: COVID19, FLU3, HEP, HEPAB, MMR, TDAP, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient did not have any adverse events. He received duplicate vaccines Heplisav B and Twinrx. Patient did not get any reaction, did not get sick and was not hospitalized.
Age: 33.0
Sex: M
Vaccine: HPV9
Symptoms: Extra dose administered
Clinical narrative: Vaccination error: patient received 4th dose due to incomplete information in state database.
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Received a second unneeded dose
Age: 51.0
Sex: F
Vaccine: PNC21
Symptoms: Asthenia, Dizziness, Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: After the injection within a 24-hour period, I started to feel very weak, dizzy and my left arm was in severe pain and became red and swollen.  I noticed the swollen area seemed to have fluid and was itching. I took Tylenol every 4 hours, and the pain never subsided.  On Saturday (12/21/2024), The red swollen area started itching so I applied hydrocortisone cream on the itching, but it seemed like the itching was internal.  I took an Epsom  salt bath in an attempt to bring down the swelling of my arm that help a little.  Then, Sunday (12/22/2024) I took a Benadryl for the itching and applied hydrocortisone cream but the itching still continue. By Monday (12/23/2024) the red patch on my left are has small hives on top.
Age: 51.0
Sex: F
Vaccine: PNC21
Symptoms: Pruritus, Urticaria
Clinical narrative: After the injection within a 24-hour period, I started to feel very weak, dizzy and my left arm was in severe pain and became red and swollen.  I noticed the swollen area seemed to have fluid and was itching. I took Tylenol every 4 hours, and the pain never subsided.  On Saturday (12/21/2024), The red swollen area started itching so I applied hydrocortisone cream on the itching, but it seemed like the itching was internal.  I took an Epsom  salt bath in an attempt to bring down the swelling of my arm that help a little.  Then, Sunday (12/22/2024) I took a Benadryl for the itching and applied hydrocortisone cream but the itching still continue. By Monday (12/23/2024) the red patch on my left are has small hives on top.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Asthenia
Clinical narrative: Patient complains of left shoulder pain with some weakness. There is no swelling or redness. No reported fever or swelling
Age: 80.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Only one dose of Arexvy is recommended for this patient. They forgot that they had a dose a year prior on 10/4/23, and we did not catch it ourselves either. Patient was given a second dose of Arexvy that was not needed on 12/17/24
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Peripheral swelling
Clinical narrative: Patient had Pneumovax yesterday his has severe swollen tender left arm since.  She denies any shortness of breath or fever and really has had full range of motion of her elbow and her shoulder better whole biceps area is quite tender swollen and erythematous.  She sent a photograph.  Otherwise her exam today is benign of the local reaction.  Reassurance was given she will continue ibuprofen 600 mg 3 times a day and warm compresses recommended.  I reviewed the literature with her.
Age: 87.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Patient was given a 2nd dose of Arexvy when she only needed. Patient forgot that they had a dose a year prior on 10/4/23. We also failed to catch the duplicate vaccination.
Age: 85.0
Sex: M
Vaccine: RSV
Symptoms: Dyspnoea
Clinical narrative: Dyspnea
Age: 24.0
Sex: F
Vaccine: UNK
Symptoms: Visual impairment
Clinical narrative: Patient presents with:  Possible reaction to the covid or flu vaccine given on 12/12/24.  Now is having a vision concern because she see's a white line of light at times and also seeing a circle of blue/purple in one part of her eye on the left side.  More intense when starting to wake up. Denies pain overall. Just vision.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Neck pain
Clinical narrative: Patient called and reported issue on 12/16/2024 of pain not getting better in shoulder and neck.  Stated that it started 3 days after immunization.
Age: 72.0
Sex: F
Vaccine: COVID19, FLU3, VARZOS
Symptoms: Balance disorder, Electrocardiogram normal, Fatigue, Gait disturbance, Magnetic resonance imaging normal
Clinical narrative: Patient states immunization on 12/11/2024, on 12/16/24 she had weakness in legs, felt exhausted, her balance was off and right leg was dragging.  She went to the emergency room on 12/18/2024.  Patient states they ran multiple tests including MRI and EKG and "everything was normal".  She said the doctor referred her to physical therapy to help her balance and leg drag.  She starts therapy on 12/30/24
Age: 72.0
Sex: F
Vaccine: COVID19, FLU3, VARZOS
Symptoms: Muscular weakness
Clinical narrative: Patient states immunization on 12/11/2024, on 12/16/24 she had weakness in legs, felt exhausted, her balance was off and right leg was dragging.  She went to the emergency room on 12/18/2024.  Patient states they ran multiple tests including MRI and EKG and "everything was normal".  She said the doctor referred her to physical therapy to help her balance and leg drag.  She starts therapy on 12/30/24
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Rash erythematous
Clinical narrative: reddish rash at the site of injection with small dots  inside
Age: 69.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient received a second dose of Arexvy. First dose was administered on 3/8/24. Second dose is not indicated at this time. Followed up with patient today and he has not experienced any side effects, injection site reactions, fever, or malaise
Age: 84.0
Sex: F
Vaccine: RSV
Symptoms: Periorbital swelling, Rash
Clinical narrative: A rash and swelling around the eyes and eyelids
Age: 33.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Extra dose administered
Clinical narrative: The error I am reporting is a second dose of RSV (Abrysvo) was administered on this date, 10/2/24. Pt had previously received a dose of RSV (Abrysvo) on 9/23/24. This is a vaccine that is to be administered one time during a pregnancy episode. This vaccine was ordered and administered twice in error. Due to this error, I am working with an EMR clinical specialist to create a hard stop to prevent this from occurring in the future.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Rash, Skin warm
Clinical narrative: patient reported a rash that is warm to the touch and a dull headache. patient stated that this was not her first covid vaccine. patient has not experienced any anaphylaxis or other serious adverse event to the vaccine. patient was instructed to use a warm compress on the area affected and take tylenol as needed and contact her provider if symptoms do not resolve or if they get any worse
Age: 0.5
Sex: F
Vaccine: RV1
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Pt was given an extraneous dose of Rotarix. No adverse symptoms occured.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Hypoaesthesia, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Nausea, chills, numbness from deltoid to face (below earlove and jaw)   Two dime sized red dots appeared 24 hours after injection. One at injection site the other 1 inch below. Very painful. Warm. Pain radiates down arm to elbow. 12/23/2024 in am those dots grew larger and closer together. Clinic stated a possible arthus reaction.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea, Pain, Type III immune complex mediated reaction
Clinical narrative: Nausea, chills, numbness from deltoid to face (below earlove and jaw)   Two dime sized red dots appeared 24 hours after injection. One at injection site the other 1 inch below. Very painful. Warm. Pain radiates down arm to elbow. 12/23/2024 in am those dots grew larger and closer together. Clinic stated a possible arthus reaction.
Age: 0.58
Sex: M
Vaccine: FLU3
Symptoms: Underdose
Clinical narrative: Patient's last recorded weight on 11/18 was 10.05kg, patient received RSV(Beyfortus) on 12/2 and was given 50 mg dose instead of 100 mg dose based off of weight. Noticed error on 12/23. Spoke to parents in person, parents stated patient had no symptoms, rashes, or adverse outcomes from receiving the vaccines. Spoke to Sanofi medical employee, notified there is no data to suggest giving an additional dose to a patient who was underdosed and there is no statistical efficacy to say how well supported the baby will be for being underdosed.
Age: 67.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Patient received two RSV vaccines. 1 in 12-13-2023 and 1 in 10-8-2024
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Mother calling regarding Covid Moderna vaccine she received from our office on 11/25/2024. She reports she spoke to her PCP her advised her to contact our office regarding the urticaria she developed 12 days post administration. Her urticaria still persists as of today, 12/23/2024. Informed that per my supervisor we will likely be filing a VAERS report form and that she may or may not get a follow up phone call from the VAERS team.
Age: 1.25
Sex: F
Vaccine: FLUN3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Pt given flumist to soon. No actual reaction or adverse event.
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Skin papilloma
Clinical narrative: warts; This spontaneous report was received from a consumer and refers to a female patient of unknown age. Information regarding the patient's concurrent conditions, medical history, or concomitant medications was not provided.  On 31-MAR-2015, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (dose, route of administration, vaccination scheme frequency, and anatomical location were not provided; invalid lot number K009811, with expiration date not provided). On 30-JUL-2015, the patient received the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (dose, route of administration, vaccination scheme frequency, and anatomical location were not provided; invalid lot number U5058AB, with expiration date not provided). On 19-JAN-2016, the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (dose, route of administration, vaccination scheme frequency, and anatomical location were not provided; valid lot number L019287, with expiration date not provided but upon internal validations established as 14-SEP-2017). All the vaccine doses were administered as prophylaxis.  On an unknown date, the patient experienced warts. It was not reported if the patient sought medical attention, received any treatment, or if she had laboratory diagnostics or studies performed for this adverse event.  At the reporting time, the patient had not recovered from the adverse event. The causal relationship between the adverse event and the suspect vaccine was not provided.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional AE; patient was inadvertently administered a dose of PROQUAD and VARIVAX during a routine vaccination appointment today; This spontaneous report was received from medical assistantand refers to a patient of an unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 12-DEC-2024, the patient was inadventently vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 0.5 milliliter, valid lot # Y014439, expiration date: 22-FEB-2026, administered for prophylaxis (strength and route of administration were not provided); and  varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 milliliter, valid lot # Y013346, expiration date: 02-AUG-2026, administered for prophylaxis (strength and route of administration were not provided) (accidental overdose).  It was confirmed that the patient has not experienced any medical concerns or symptoms after the inadvertent administration of the vaccines. No additional information provided. No additional adverse event (AE) was reported.
Age: 1.0
Sex: U
Vaccine: MMR, MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: she administered a dose of PROQUAD to a 12 month old patient, instead of administering MMR II.; the patient ended up receiving a dose of MMRII, PROQUAD, and VARIVAX i; no adverse event; This spontaneous report was received from a Licensed Practical Nurse referring to a 12 month old patient. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies, and concomitant therapies were not reported.  On an unknown date, the licensed practical nurse administered a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD), instead of administering Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live(M-M-R II) (Wrong product administered).   The patient ended up receiving a dose ofMeasles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live(M-M-R II), measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD), and varicella virus vaccine live (Oka/Merck)(VARIVAX) in the same visit (overdose).   Other suspect therapies included sterile diluent (MERCK STERILE DILUENT) (strength, dose,dose number, route, lot number, expiration date and anatomical location were not provided for all suspect therapies) for prophylazis.  No adverse event reported.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site mass, Injection site pain
Clinical narrative: painful lump at injection site that developed 5 weeks after injection; painful lump at injection site that developed 5 weeks after injection; This spontaneous report was received from a nurse and refers to a 13-year-old female patient.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 19-NOV-2024, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (exact dose, lot #, expiration date, route of administration and anatomical location were not provided) for prophylaxis.  On an unknown date in December 2024 (also reported as 5 weeks after injection- discrepancy), the patient experienced painful lump at injection site. At the time of reporting, the outcome of the events was not known. The action taken with suspect vaccine was not applicable.  The causal relationship between events and suspect vaccine was not provided.  Lot # is being requested and will be submitted if received.; Sender's Comments:  US-009507513-2412USA007413
Age: 0.25
Sex: U
Vaccine: HEPA, MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE/No PQC; HCP calling to a report a patient born was administered a VAQTA and PROQUAD dose on 12/18/2024 prior to the age of 1. Consent to contact is yes. No adverse side effects were reported. MIR cases were also submitted 02724681 & 02724685. No; This spontaneous report was received from a medical assistant and refers to a 3-month-old patient. No information on patient's medical history, current conditions and concomitant medications was provided.  On 18-DEC-2024 the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) lot # Y008285 and expiration date 24-NOV-2025 for prophylaxis (exact dose, dose number, route and site of administration was provided) and with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (albumin status: rHA) lot # Y008284 and expiration date 21-OCT-2025 for prophylaxis (exact dose, dose number, route and site of administration was provided). Patient received those vaccines before age of one (product administered to patient of inappropriate age). No adverse side effects were reported (no adverse event).
Age: 0.17
Sex: F
Vaccine: MMR
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No additional AE/PQC.; Consumer called and reported that her 2-month-old daughter inadvertently received a dose of MMR-II on 20DEC2024. No additional information was provided. Limited demographics provided; therefore, no AEFU could be sent. No additional AE/PQC.; This spontaneous report was received from a consumer and refers to a 2-month-old female patient. No information on patient's medical history, current conditions and concomitant medications was provided.  On 20-DEC-2024 the patient inadvertently received a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) for prophylaxis (exact dose, dose number, route and site of administration, lot number and expiration date were not provided) (wrong product administered). No additional adverse event and product Quality complaint was reported (no adverse event).
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No symptoms reported. No additional AE; patient who was administered improperly stored VAQTA on 12/19/2024; This spontaneous report was received from a physician and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 19-DEC-2024, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 0.5 milliliter, lot #Y011731, expiration date: 25-OCT-2025, administered for prophylaxis (anatomical location, strength, and route of administration were not provided), after being improperly stored on the same day; temperature of 33.4 F, for 1 hour 6 minutes 0 seconds (Product storage error). None of previous temperature excursion. No symptoms reported. No additional AE details reported.
Sex: M
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: My Husband Received First Dose, and Will Not Get Second Dose Until December, Will He Have to Repeat Series; Initial report received on 20-Nov-2024.~   A consumer reported a male (age, race, ethnicity not provided) received the first dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization on 16-Oct-2024 and the patient will not be able to receive the second dose until 03-Dec-2024 according to the provider.   No medical history or concomitant medications were reported.   On 16-Oct-2024, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot number, expiration date, NDC number, site not specified)].  The patient would not be able to receive the second dose until 03-Dec-2024.   No additional information was reported.   Reporter did not give consent to contact her.     Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: after his second dose of Shingrix, he experienced fatigue; This non-serious case was reported by a nurse via sales rep and described the occurrence of fatigue in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (Patient received 1st dose of Shingrix on an unknown date,about when Shingrix was first available).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced fatigue (Verbatim: after his second dose of Shingrix, he experienced fatigue). The outcome of the fatigue was resolved.   It was unknown if the reporter considered the fatigue to be related to Shingrix.     It was unknown if the company considered the fatigue to be related to Shingrix.   Additional Information: GSK Receipt Date: 25-NOV-2024 The nurse reported that her father, age unknown, started Shingrix, dose unknown, on an unknown date, "about when Shingrix was first available".  On an unknown date, he received a second dose of Shingrix.  On an unknown date, after his second dose of Shingrix, he experienced fatigue. On an unknown date, after a few days, explained as after the weekend, the fatigue resolved. All other information is unknown. He usually does not have any  adverse reactions to vaccines.  He has not had any reactions to any dose of COVID vaccines. The case had been linked to US2024AMR148347 and US2024AMR148495 reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2024AMR148347:same reporter different patient US-GSK-US2024AMR148495:same reporter different patient US-GSK-US2024AMR148347:same reporter different patient
Sex: U
Vaccine: MNQ
Symptoms: Product preparation issue
Clinical narrative: administered only the liquid portion to a patient; administered only the liquid portion to a patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: administered only the liquid portion to a patient) and inappropriate dose of vaccine administered (Verbatim: administered only the liquid portion to a patient). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 27-NOV-2024 The reporter reported that they had two dose vials of Meningococcal conjugate vaccine (Menveo), the one with liquid and with the lyophilized and they had 2nd of the lyophilized conjugated component but not the diluent portion They had a patient that received just the liquid diluent, but it was not combined, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter was asking if it was possible to use the powder portion with another diluent. After asking her if any patient received this, then reporter mentioned that they administered only the liquid portion to a patient, that's why they had only the powder portion. The Vaccine Administration Facility was the same as Primary Reporter
Age: 70.0
Sex: F
Vaccine: RSV
Symptoms: Overdose
Clinical narrative: A patient received a double dose of Arexvy on 26/November/2024; This non-serious case was reported by a other health professional via call center representative and described the occurrence of overdose in a 70-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 7A999, expiry date 02-MAR-2025) for prophylaxis.   Concomitant products included RSV vaccine prot. subunit PreF3 (Arexvy).   On 26-NOV-2024, the patient received Arexvy. On 26-NOV-2024, an unknown time after receiving Arexvy, the patient experienced overdose (Verbatim: A patient received a double dose of Arexvy on 26/November/2024). The outcome of the overdose was unknown.   Additional Information: GSK Receipt Date: 27-NOV-2024 The nurse reported that a patient received a double dose of Arexvy, which led to overdose. The reporter was ask what was the protocol to follow, was there anything else that need to do.
Age: 76.0
Sex: M
Vaccine: RSV
Symptoms: Single component of a two-component product administered
Clinical narrative: adjuvant only when seeking an AREXVY vaccine; adjuvant only when seeking an AREXVY vaccine; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 76-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 27-NOV-2024, the patient received Arexvy. On 27-NOV-2024, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: adjuvant only when seeking an AREXVY vaccine) and inappropriate dose of vaccine administered (Verbatim: adjuvant only when seeking an AREXVY vaccine). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 02-DEC-2024 The health care professional reported that the patient was given only adjuvant only when seeking an Arexvy vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. They discovered the error and administered the correct dose.
Age: 78.0
Sex: F
Vaccine: RSV
Symptoms: Single component of a two-component product administered
Clinical narrative: Administration of liquid only; Administration of liquid 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 78-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number ae435, expiry date 30-OCT-2025) for prophylaxis.   On 02-DEC-2024, the patient received Arexvy. On 02-DEC-2024, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: Administration of liquid only) and inappropriate dose of vaccine administered (Verbatim: Administration of liquid only). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 02-DEC-2024 The pharmacist reported that a patient received a dose of Arexvy but it was not reconstituted and the liquid portion only was administered, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The vaccine administration facility was the same as primary reporter.
Age: 48.0
Sex: M
Vaccine: RSV
Symptoms: Expired product administered, Product administered to patient of inappropriate age
Clinical narrative: Expired drug administered; received at 48 year of age; 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 48-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number T3H32, expiry date 01-DEC-2024) for prophylaxis.   On 02-DEC-2024, the patient received Arexvy. On 02-DEC-2024, an unknown time after receiving Arexvy, the patient experienced expired vaccine used (Verbatim: Expired drug administered) and inappropriate age at vaccine administration (Verbatim: received at 48 year of age). The outcome of the expired vaccine used and inappropriate age at vaccine administration were unknown.   Additional Information: GSK Receipt Date: 02-DEC-2024 The health care professional reported that a patient received Arexvy vaccine which was already expired, which led to expired vaccine used. The patient received dose of Arexvy at an inappropriate age, which led to inappropriate age at vaccine administration. The vaccine administration facility was the same as primary reporter.
Age: 0.08
Sex: F
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Flulaval Trivalent vaccine was administered in the left thigh of a 38 days old female infant.; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 38-day-old female patient who received Flu Seasonal TIV Quebec (FluLaval 2024-2025 season) (batch number 2B3YJ, expiry date 06-JUN-2025) for prophylaxis.   On 13-DEC-2024, the patient received FluLaval 2024-2025 season (intramuscular, left thigh). On 13-DEC-2024, an unknown time after receiving FluLaval 2024-2025 season, the patient experienced inappropriate age at vaccine administration (Verbatim: Flulaval Trivalent vaccine was administered in the left thigh of a 38 days old female infant.). The outcome of the inappropriate age at vaccine administration 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: 13-DEC-2024 The reporter was a healthcare professional. The healthcare professional reported an adverse event for Flulaval Trivalent 2024-2025 vaccine on 13th December 2024. The healthcare professional reported that on the day of reporting a Flulaval Trivalent vaccine was administered in the left thigh of a 38 days old female infant. The healthcare professional reported patient was not of the age of 6 months and should had not been given the vaccine which led to inappropriate age at vaccine administered. Per PI, Flulaval dosing was 6 months through 8 years. Per content documentation, the prescription was administered by accident.
Age: 67.0
Sex: M
Vaccine: RSV
Symptoms: Abdominal discomfort, Death, Malaise, Nausea, Vomiting
Clinical narrative: 2nd day after vaccine, patient started vomiting, then patient passed away; next day, patient was not feeling well-upset stomach; Nausea; This serious case was reported by a consumer via call center representative and described the occurrence of upset stomach in a 67-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 16-DEC-2023, the patient received Arexvy (intramuscular, right arm). On 17-DEC-2023, 1 days after receiving Arexvy, the patient experienced upset stomach (Verbatim: next day, patient was not feeling well-upset stomach) (serious criteria death, life threatening and other: Serious as per reporter) and nausea (Verbatim: Nausea) (serious criteria death, life threatening and other: Serious as per reporter). On 18-DEC-2023, the patient experienced vomiting (Verbatim: 2nd day after vaccine, patient started vomiting, then patient passed away) (serious criteria death, life threatening and other: Serious as per reporter). The patient died on 18-DEC-2023. The reported cause of death was upset stomach, nausea and vomiting.   The reporter considered the upset stomach, nausea and vomiting to be related to Arexvy.     The company considered the upset stomach, nausea and vomiting to be unrelated to Arexvy.   Additional Information: GSK Receipt Date: 16-DEC-2024 and 17-DEC-2024 This case was reported by the wife of the patient to report patient's death after Arexvy vaccine. She reported that, patient had no initial reaction after vaccine. Next day after vaccination, patient was not feeling well (upset stomach). Symptoms started (nausea). 2nd day after vaccine, patient started vomiting and then subsequently died the same day (patient passed away). The vaccine administration facility was the same as primary reporter.; Sender's Comments: Abdominal discomfort and Vomiting are unlisted events which are considered unrelated to GSK vaccine Arexvy.  Nausea is a listed event which is considered related to GSK vaccine Arexvy.; Reported Cause(s) of Death: Upset stomach; Nausea; Vomiting
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Breast cancer, COVID-19, SARS-CoV-2 test
Clinical narrative: Ive been tested positive for covid; I was diagnosed with breast cancer in July of this year; This spontaneous case was reported by a patient and describes the occurrence of BREAST CANCER (I was diagnosed with breast cancer in July of this year) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In July 2024, the patient experienced BREAST CANCER (I was diagnosed with breast cancer in July of this year) (seriousness criterion medically significant). On an unknown date, the patient experienced COVID-19 (Ive been tested positive for covid). The patient was treated with Surgery (Had extensive breast surgery and underwent 20 rounds of radiation) for Breast cancer. At the time of the report, BREAST CANCER (I was diagnosed with breast cancer in July of this year) had not resolved and COVID-19 (Ive been tested positive for covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Positive.         Concomitant medication was not provided.  Patient received Moderna vaccine on 03-Mar-2021 and ??-Nov-2021. She was diagnosed with breast cancer in JUL-2024 and had extensive breast surgery and recently underwent radiation. All of that were very painful and she will be suffering for months, possibly years.   There was no cancer in any of her family for generations. She took care of her health and had mammograms every year.  She wanted to get the shot, but she was also scared.   Most recent FOLLOW-UP information incorporated above includes: On 17-Dec-2024: Updated reporter details, updated case from Invalid to valid, added medical history, added Laboratory data, added suspect date of administration, added new event of breast cancer, removed event of fear and updated narrative.; Reporter's Comments: Company comment: The event of breast cancer is assessed as not related considering lack of biological plausibility for causality and patient's advanced age as risk factor. The benefit-risk relationship of product is not affected by this report.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Hypokinesia
Clinical narrative: discomfort; restricted movement of his arm; This spontaneous case was reported by a pharmacist and describes the occurrence of DISCOMFORT (discomfort) and HYPOKINESIA (restricted movement of his arm) in a 69-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3043822) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Oct-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) .5 milliliter. In 2024, the patient experienced DISCOMFORT (discomfort) and HYPOKINESIA (restricted movement of his arm). At the time of the report, DISCOMFORT (discomfort) and HYPOKINESIA (restricted movement of his arm) had not resolved.        The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) was unknown.   For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   Patient had no previous vaccine in the past 4 weeks.  Concomitant product use was not provided by the reporter.  Expiry date was reported was reported as 12-Jun-2025. Patient had taken the flu shot almost 3 weeks later and in the same arm.  He had a discomfort since then that had gotten better with time but not in the rate that he would had imagined. HCP mentions that the patient currently has restricted movement of his arm. It was unknown if the patient experienced any additional symptoms or events.  Treatment information was not provided.  Reporter causality was not reported.
Sex: U
Vaccine: RSV
Symptoms: Device leakage
Clinical narrative: While mixing, pushing liquid in, everything spilled out; The initial case was missing the following minimum criteria: product complaint only. Upon receipt of follow-up information on 09Dec2024, this case now contains all required information to be considered valid.  This is a spontaneous report received from a Pharmacist from product quality group.  A patient should have received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose 1, single (Lot number: KC7884, Expiration Date: Oct2025) for immunisation, Device Lot Number: HM8389; 8764H, Device Expiration Date: Mar2025.  The following information was reported: SYRINGE ISSUE (non-serious), outcome "unknown", described as "While mixing, pushing liquid in, everything spilled out". Additional information: reporter was trying to administered this vaccine to a patient. While mixing it, something was wrong, reporter though with the screw on the diluent. So, the reporter screwed it on, and lost all the fluid, the dilute, could not mixed it and he had to use a different product.  Dilute details: NDC# 00069025001 UPC#: Reporter stated, "I do not have the UPC# but I have the LOT#." LOT#: HM8389 Expiration date: 9/2025 (Clarified as September/2025) When probed for the Vial NDC#, UPC#, LOT# and expiration date: NDC#: 00069020701 LOT#: KC7884 Expiration date: 10/2025 (Clarified as October/2025) When probed for the Adaptor NDC#, UPC#, LOT# and expiration date: Reporter stated, "The adaptor do not have NDC but I have a LOT#." LOT#: H764 Expiration date: June/1/2028.  The reporter considered "while mixing, pushing liquid in, everything spilled out" not related to rsv vaccine prot.subunit pref 2v. Causality for "while mixing, pushing liquid in, everything spilled out" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).  Product Quality Group provided investigational results on 09Dec2024 for rsv vaccine prot.subunit pref 2v (ABRYSVO): The complaint for "While mixing, pushing liquid in, everything spilled out." of Abrysvo was investigated. The investigation included reviewing the involved batch records, deviation investigation, the returned complaint sample, an analysis of the complaint history for the involved scope and Annual Product Review. Quantity of returned complaint sample(s): one carton,one WFI syringe, one Abrysvo vial and one adapter. The reported defect was not present on the returned complaint sample. The complaint is not confirmed. No root cause or CAPA were identified as the complaint was not confirmed.No related quality issues were identified during the investigation.There is no impact on product quality, regulatory, validation, stability and patient safety. The Issue Escalation (NTM) process determined that no regulatory notification was required. The final scope was determined to be the associated lot(s) of the reported lot KC7884. The reported defect is not representative of the quality of the batch, and reported lot remains acceptable for further distribution.
Sex: U
Vaccine: RSV
Symptoms: Device connection issue
Clinical narrative: glass was broken when attempting to transfer the medication into a syringe; This is a spontaneous report received from an Other HCP from product quality group.  Nurse reported about rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Lot number: LG9827, Expiration Date: 31Oct2025) for immunisation.  The following information was reported: DEVICE BREAKAGE (non-serious), outcome "unknown", described as "glass was broken when attempting to transfer the medication into a syringe". The action taken for rsv vaccine prot.subunit pref 2v was unknown.   Additional information: Nurse reported a product complaint for Abrysvo, that when they tried to draw up a dose of Abrysvo, however, the vial bursted and could not be used. No patient received the vaccine. Glass was broken when attempting to transfer the medication into a syringe. Packaging was sealed and intact upon arrival. Product was not available to be returned. The vial bursted and  was only able to recover the sticker that was on it.  Causality for "glass was broken when attempting to transfer the medication into a syringe" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).
Sex: F
Vaccine: COVID19, FLUX
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19 test positive; COVID-19 test positive; 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 24Nov2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 24Nov2024 as dose number unknown, single) 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 17Dec2024, outcome "not recovered" and all described as "COVID-19 test positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Dec2024) positive. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical details: No other vaccine in four weeks. Unknown if patient received other medications in two weeks. The event did not result in emergency room visit or physician office visit.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: she need the medication for Paxlovid; she need the medication for Paxlovid; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A female 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. Vaccination history included: Bnt162b2 (DOSE 1, lot number unknown), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2024, outcome "unknown" and all described as "she need the medication for Paxlovid". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Said that she need the medication for Paxlovid. Said that she need help because she is very sick.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: FLUX
Symptoms: Impaired work ability, Malaise
Clinical narrative: sick; Initial information received on 08-Dec-2024 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health care professional (Patient).  This case involves Adult male patient who experienced sick after receiving Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s),concomitant medications and family history were not provided.   On an unknown date in October 2024, the patient received a unknown dose of suspect Influenza Vaccine produced by unknown manufacturer formulation, strength, expiry date, lot number not reported via unknown route in unknown administration site for Prophylactic vaccination (Immunization). There will be no information on batch number and expiration date corresponding to the one at time of event occurrence.  On an unknown date in 2024 the patient developed sick (illness) (unknown latency) following the administration of Influenza Vaccine.  Reportedly "Had to take off work for two days and was still not feeling any better for a week."  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (sick).  At time of reporting, the outcome was Not Recovered / Not Resolved for the event sick.
Sex: F
Vaccine: FLUX
Symptoms: Dizziness
Clinical narrative: dizziness; Initial information received on 13-Dec-2024 regarding an unsolicited valid Social Media non-serious case received from a Non health care professional.  This case involves, an unknown age female patient who had Dizziness after receiving vaccine Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect Influenza Vaccine produced by unknown manufacturer (unknown strength, dosage, expiry date, formulation, batch number and route) via unknown administration site for prophylactic vaccination.  On an unknown date in 2023, the patient developed dizziness (unknown latency) following the administration of Influenza Vaccine.  Information on the batch number was requested corresponding to the one at time of event occurrence.  Reportedly, As reported the patient got it last year and experienced dizziness in 15 months. To this day the dizziness side effect had not left her.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Not Recovered / Not Resolved for the event.
Age: 71.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Chills, Musculoskeletal chest pain, Myalgia, Pain in extremity, Paraesthesia
Clinical narrative: paraesthesia; tremor; pain in extremity; chills; musculoskeletal chest pain; myalgia; Initial information received on 10-Dec-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 71-year-old female patient who experienced paraesthesia, tremor, pain in extremity, chills, musculoskeletal chest pain and myalgia after receiving COVID-19 vaccine prot. subunit (NVX CoV 2373) [Novavax COVID-19 Vaccine] and influenza USP trival A-B high dose subvirion vaccine [Fluzone High Dose].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  At the time of the event, the patient had ongoing Drug hypersensitivity.  Concomitant medications included Hydrochlorothiazide, Losartan; Montelukast sodium (Singulair); Amlodipine, Raloxifene hydrochloride (Evista); Fluticasone Furoate, Vilanterol trifenatate (Breo ellipta); Calcium, Vitamin d ; Cetirizine ; and Aspirin.  On 04-Oct-2024, the patient received a  dose of suspect Influenza USP Trival A-B High Dose Subvirion Vaccine Suspension for injection in pre-filled syringe of lot U8527CA (strength, expiry date: not reported) via intramuscular route in the right arm and suspect Novavax COVID-19 Vaccine not produced by Sanofi Pasteur of lot 3042388 (formulation, strength, expiry date: not reported) via intramuscular route in the right arm for prophylactic vaccination.  On 08-OCT-2024 the patient developed paraesthesia, tremor, pain in extremity, chills, musculoskeletal chest pain, myalgia (latency: 4 days).   Reportedly, four days after injection of both COVID and FLU HD ,chills, shaking later pain left arm, left trapezious muscle, left chest wall, continued increasing pain with tingling of left 4th and 5th fingers forearm pain, continues with increasing level of pain in that area to filling date 11/5/2024.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for all the events.  At time of reporting, the outcome was Not Recovered / Not Resolved for all the events.