chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: M
Vaccine: DTAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event noted. Patient incorrectly received Infanrix vaccine, instead of ordered Tdap vaccine.
Age: 8.0
Sex: F
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: On 11/4/2024 the patient came in for immunizations.  Patient was needing a Polio vaccine.  At 3:30PM the client was given the SQ injection of IPOL.  On 11/12/2024, this nurse became aware the vaccine  wasn't received within 2 days from shipment date.  Per the manufacturer's instructions, the vaccine is to be received within 2 days of shipping.  If it is not received within 2 days, the manufacturer cannot guarantee the vaccine was kept at the proper temperature.  Therefore, we cannot guarantee long-term immunity for the person vaccinated.  When we called the patient to report the possible temperature excursion during the shipment process, the patient's mother was able to reschedule the vaccine.  Patient's mother made no mention of any adverse reactions while on the phone.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity, X-ray limb normal
Clinical narrative: Continued pain in left arm and decreased mobility 2 weeks following vaccine adminsitration
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary embolism, Pyrexia, Vomiting
Clinical narrative: Patient reported that she had a fever of 103 for 6 plus days, even with aspirin, Vomiting, and eventually a pulmonary emboli
Age: 8.0
Sex: M
Vaccine: HEPA, MMRV, TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: On 10/29/2024 the patient came in for immunizations.  Patient was needing a Polio vaccine along with MMRV, Hep A, and Tdap.  At 3:01PM the client was given the SQ injection of IPOL.  On 11/12/2024, this nurse became aware the vaccine  wasn't received within 2 days from shipment date.  Per the manufacturer's instructions, the vaccine is to be received within 2 days of shipping.  If it is not received within 2 days, the manufacturer cannot guarantee the vaccine was kept at the proper temperature.  Therefore, we cannot guarantee long-term immunity for the person vaccinated.  When we called the patient to report the possible temperature excursion during the shipment process, the patient's mother was able to schedule an appointment for re vaccination.  No adverse reaction was reported at the time of the phone call for reschedule.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Lingering sore arm six days after administration; improving each day.  No redness, swelling, present on upper left arm.  Patient reports good range of motion.
Age: 2.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Rash
Clinical narrative: rash on body
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram ambulatory abnormal, Heart rate increased
Clinical narrative: My smart device indicated that while I was sleeping my heart was beating at a moderately active level (104-121 bpm) for half an hour and at a vigorous (122-143 bpm) or peak (144+ bpm) level for three hours. This resolved on its own with me taking it easy for the day.
Age: 76.0
Sex: F
Vaccine: RSV
Symptoms: Chest X-ray normal, Upper respiratory tract congestion
Clinical narrative: Several days after getting RSV vaccine, I developed upper respiratory congestion. More than 30 days later, I still have it.
Age: 0.33
Sex: M
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was given influenza vaccine at his 4 month WCC even though he was not 6 months. This was discovered last week when the shot schedule was being combed and it was noticed that patient was scheduled for #2. Once this was discovered, provider was informed, mom was informed (reached today),  and understands will have to restart series once 6 months old. No reported concerns from parents.
Age: 81.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event
Clinical narrative: No adverse events reported
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong patient
Clinical narrative: Patient came into the clinic with 5 other family members. Originally thought all of the family members came in for just the flu vaccine and they all ended up wanting COVID vaccine too. The dad did not need the flu vaccine. After having all of the flu shots prepared, went back to the shot room and grabbed 6 of the same COVID vaccines instead of 4 of the 12+ and 2 of the under than 12. Administered the wrong COVID vaccine to the patient.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Wrong patient
Clinical narrative: Patient came into the clinic with 5 other family members. Originally thought all of the family members came in for just the flu vaccine and they all ended up wanting COVID vaccine too. The dad did not need the flu vaccine. After having all of the flu shots prepared, went back to the shot room and grabbed 6 of the same COVID vaccines instead of 4 of the 12+ and 2 of the under than 12. Administered the wrong COVID vaccine to the patient.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site mass, Injection site warmth
Clinical narrative: Injection area red next day after removing band aid. Last evening the redness is worsening, the area is warm to touch and significant bump according to patients representative
Age: 0.83
Sex: F
Vaccine: PPV
Symptoms: Gaze palsy, Pyrexia, Seizure, Tremor, Vomiting
Clinical narrative: Started with a high fever 12 hours after vaccine was administered, by the next morning around 24 hours after vaccine was administered she started convulsing with a seizure and vomiting, her eyes were rolling back and she wouldn?t stop shaking or puking.
Age: 75.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Arthralgia, Asthenia, Headache, Neck pain, Pain
Clinical narrative: severe weakness, body aches (bilateral shoulder and neck pain) and severe headache.  Went to ED, admitted to hospital for 1 night.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Brain fog, Chills, Headache, Influenza like illness
Clinical narrative: Experienced shivering the night of the injection.  The next morning felt extremely weak and nauseous with a headache and sinus pressure.  Could not sit up for an hour at a time, continually napped during the day and could not stay awake.  Drank plenty of fluids but stumbled around each time I got up to either get more fluids or go to the bathroom.  I also could not think clearly. Felt like I had the flu but without body aches.  The second day after the injection I felt better but still could not think clearly.  The third day after the brain fogginess seemed to lift later in the day and I felt physically better.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Mental impairment, Nausea, Pain, Paranasal sinus discomfort
Clinical narrative: Experienced shivering the night of the injection.  The next morning felt extremely weak and nauseous with a headache and sinus pressure.  Could not sit up for an hour at a time, continually napped during the day and could not stay awake.  Drank plenty of fluids but stumbled around each time I got up to either get more fluids or go to the bathroom.  I also could not think clearly. Felt like I had the flu but without body aches.  The second day after the injection I felt better but still could not think clearly.  The third day after the brain fogginess seemed to lift later in the day and I felt physically better.
Age: 77.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site infection, Injection site pruritus, Injection site reaction, Injection site scab
Clinical narrative: After 12 hours pt developed red puffy itchy scab at site, 2 weeks later it started weeping and developed into a deep infection for which Dr is treating with doxycycline 100mg and mupirocin.  Pt describes wound as a deep ulcer.
Age: 77.0
Sex: F
Vaccine: RSV
Symptoms: Injection site swelling, Skin weeping
Clinical narrative: After 12 hours pt developed red puffy itchy scab at site, 2 weeks later it started weeping and developed into a deep infection for which Dr is treating with doxycycline 100mg and mupirocin.  Pt describes wound as a deep ulcer.
Age: 44.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Pediatric dose given instead of adult dose.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Patient received a flu vaccine today after she had just had one given on 10/30/2024.
Age: 76.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received 2 flu shots- first shot given on 8/26/24 and second shot given on 11/18/2024. Patient called and no SE experienced.
Age: 76.0
Sex: F
Vaccine: PNC20
Symptoms: Feeling abnormal
Clinical narrative: Pt reports left arm "hasn't felt the same since receiving vaccine"
Age: 71.0
Sex: F
Vaccine: RSV
Symptoms: Pruritus, Urticaria
Clinical narrative: started with itching on hand, went bed woke up with hives on forearms and arms and started spreading.Went to urgent care that day. They instructed her to take Zyrtec 10mg bid, and gave rx for triamcinolone.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Flushing, Paraesthesia, Tachycardia
Clinical narrative: Tingling 2 hours after injection, tachycardia, flush in the face, felt like calling 911.
Age: 0.08
Sex: F
Vaccine: RSV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: pt was administered Abrysvo adult RSV vaccine  instead of Beyfortus
Age: 17.0
Sex: F
Vaccine: COVID19, UNK, UNK
Symptoms: Musculoskeletal stiffness, Pain, Pain in extremity
Clinical narrative: Often arms sore for a few days after vaccines but  this time only the right side improved after the 2 days. The Left arm sore and tight/stiff till at least 11/13/24.  That day had begun to improve with more movement before triggering pain. No edema, no parasthesia, no radiation of pain elsewhere.
Age: 39.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Injection site bruising, Injection site mass, Injection site pain
Clinical narrative: Patient came in to the clinic for a Hep B vaccine on 11/19/2024 when bruising and a small bump was noticed on the patient's left arm. Per the patient, she began having swelling the day after the COVID and Flu Vaccines were given on 11/13/2024, the day when she felt the swelling was on 11/14/2024. Per patient, it was only pain at the injection site and bruising. She states that today the bruising and bump have improved, she still has some soreness when touching the site of injection. Both COVID and flu vaccines were given on her left deltoid.  I consulted with a provider, only treatment right now is warm compress.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: No adverse event, Underdose
Clinical narrative: Patient was 19 years of age when she received the adult Hep B of 20 micrograms of 20 years of age and older.  Provider contacted patient to notify. Patient was doing ok. No side effects per patient.
Sex: F
Vaccine: RSV
Symptoms: Product use issue
Clinical narrative: Drug exposure during pregnancy; Product use in unapproved population; This non-serious prospective pregnancy case was reported by a nurse via sales rep and described the occurrence of vaccine exposure during pregnancy in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 06-NOV-2024, the patient received Arexvy (unknown arm). On 06-NOV-2024, an unknown time after receiving Arexvy, the patient experienced product use in unapproved population (Verbatim: Product use in unapproved population). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: Drug exposure during pregnancy). The outcome of the vaccine exposure during pregnancy and product use in unapproved population were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 06-NOV-2024 Nurse reported that the patient took Arexvy vaccine during pregnancy, which led to vaccine exposure during pregnancy and product use in unapproved population.
Sex: U
Vaccine: UNK
Symptoms: Erythema, Musculoskeletal stiffness, Pain, Peripheral swelling, Pruritus
Clinical narrative: significant swelling; itchiness; hives; erythema to their right arm which radiated up to the neck; arm was very tight; had burning pain; product complaint; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of swelling in a patient who received Flu Seasonal TIV Dresden (Fluarix 2024-2025 season) (batch number 72RF2, expiry date 30-JUN-2025) for prophylaxis. This case was associated with a product complaint.   On an unknown date, the patient received Fluarix 2024-2025 season. On an unknown date, 2 hrs after receiving Fluarix 2024-2025 season, the patient experienced swelling (Verbatim: significant swelling), pruritus (Verbatim: itchiness), hives (Verbatim: hives), erythema (Verbatim: erythema to their right arm which radiated up to the neck), muscle tightness (Verbatim: arm was very tight), pain burning (Verbatim: had burning pain) and pharmaceutical product complaint (Verbatim: product complaint). The patient was treated with diphenhydramine. The outcome of the swelling, pruritus, hives, erythema, muscle tightness and pain burning were not reported and the outcome of the pharmaceutical product complaint was unknown.   It was unknown if the reporter considered the swelling, pruritus, hives, erythema, muscle tightness and pain burning to be related to Fluarix 2024-2025 season and Fluarix Pre-Filled Syringe Device.     It was unknown if the company considered the swelling, pruritus, hives, erythema, muscle tightness and pain burning to be related to Fluarix 2024-2025 season and Fluarix Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 21-OCT-2024 and 28-OCT-2024 The health care professional reported that a patient received Fluarix, and less than two hours developed significant swelling, itchiness, hives, and erythema to their right arm which radiated up to the neck, the arm was very tight and had burning pain they went to the emergency department, the provider had concerns about the tight arm. The patient was administered diphenhydramine. This was 1 of 4 linked report, reported by same reporter. .; Sender's Comments:  US-GSK-US2024AMR131525:Same Reporter US-GSK-US2024129463:Same Reporter US-GSK-US2024AMR131527:Same Reporter US-GSK-US2024133757:Same reporter
Sex: U
Vaccine: UNK
Symptoms: Urticaria
Clinical narrative: significant swelling; itchiness; hives; erythema to their right arm which radiated up to the neck; arm was very tight; had burning pain; product complaint; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of swelling in a patient who received Flu Seasonal TIV Dresden (Fluarix 2024-2025 season) (batch number 72RF2, expiry date 30-JUN-2025) for prophylaxis. This case was associated with a product complaint.   On an unknown date, the patient received Fluarix 2024-2025 season. On an unknown date, 2 hrs after receiving Fluarix 2024-2025 season, the patient experienced swelling (Verbatim: significant swelling), pruritus (Verbatim: itchiness), hives (Verbatim: hives), erythema (Verbatim: erythema to their right arm which radiated up to the neck), muscle tightness (Verbatim: arm was very tight), pain burning (Verbatim: had burning pain) and pharmaceutical product complaint (Verbatim: product complaint). The patient was treated with diphenhydramine. The outcome of the swelling, pruritus, hives, erythema, muscle tightness and pain burning were not reported and the outcome of the pharmaceutical product complaint was unknown.   It was unknown if the reporter considered the swelling, pruritus, hives, erythema, muscle tightness and pain burning to be related to Fluarix 2024-2025 season and Fluarix Pre-Filled Syringe Device.     It was unknown if the company considered the swelling, pruritus, hives, erythema, muscle tightness and pain burning to be related to Fluarix 2024-2025 season and Fluarix Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 21-OCT-2024 and 28-OCT-2024 The health care professional reported that a patient received Fluarix, and less than two hours developed significant swelling, itchiness, hives, and erythema to their right arm which radiated up to the neck, the arm was very tight and had burning pain they went to the emergency department, the provider had concerns about the tight arm. The patient was administered diphenhydramine. This was 1 of 4 linked report, reported by same reporter. .; Sender's Comments:  US-GSK-US2024AMR131525:Same Reporter US-GSK-US2024129463:Same Reporter US-GSK-US2024AMR131527:Same Reporter US-GSK-US2024133757:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Mobility decreased, Pain
Clinical narrative: They had chills; and aching that kept them in bed for 24 hours.; aching that kept them in bed for 24 hours; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of chills in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included COVID-19 with an associated reaction of no adverse event (The patient had never experienced side effects with prior immunizations, such as influenza or COVID-1) and Influenza vaccine with an associated reaction of no adverse event (The patient had never experienced side effects with prior immunizations, such as influenza or COVID-1).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced chills (Verbatim: They had chills), pain (Verbatim: and aching that kept them in bed for 24 hours.) and bedridden (Verbatim: aching that kept them in bed for 24 hours). The outcome of the chills and pain were not reported and the outcome of the bedridden was resolved (duration 24 hrs).   The reporter considered the chills, pain and bedridden to be possibly related to Shingrix.     The company considered the chills, pain and bedridden to be possibly related to Shingrix.   Additional Information: GSK Receipt Date: 22-OCT-2024 The case was received from the patient via interactive digital media. The patient was reporter. The reporter reported that patient received their first dose of Shingrix vaccine and was informed of possible side effects. The reported that she had chills and aching that kept them in bed for 24 hours. The reported that they are now due for the second dose but is debating getting it because the reaction was so severe the first time. The patient reported that she never experienced side effects with prior to immunizations, such as Influenza or Covid-19 vaccine. The reporter asked are the side effects normally that bad for everyone or were mine an exception? also, they due for the second vaccine, should get it or not, and will the reaction be the same or worse since it was so bad the first time?".
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Left arm was a little sore; 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.   Previously administered products included RSV vaccine, Shingles Vaccine (1st dose received on unknown date) and Covid vaccine.   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 pain in arm (Verbatim: Left arm was a little sore). The outcome of the pain in arm was not reported.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm to be related to Shingles vaccine.   Additional Information: GSK receipt date 30 Oct 2024: The patient received last injection of Shingles and had little soreness in left arm. No other sides affects.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; got another case of Shingles and it was my worst outbreak; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 52-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had suffered from Shingles outbreak on unknown date).   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: got another case of Shingles and it was my worst outbreak). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix.   Additional Information: GSK receipt date: 06-NOV-2024 Reporter reported that he was immunized with Shingrix almost 7 years ago.  He just got another case of Shingles and it was his worst outbreak.  He asked that was it ok to had another shot of Shingrix.  Also patient chat with the chatbot of GSK and also with the pharmacist. This case was considered as suspected vaccination failure as details regarding completion of 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 details regarding  completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles) is considered unrelated to GSK vaccine Shingrix.  Herpes zoster  is an unlisted event which is considered unrelated to GSK vaccine Shingrix.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure; I had it even after having the shingles shot.; It was so painful; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: I had it even after having the shingles shot.) and pain (Verbatim: It was so painful). The outcome of the vaccination failure, shingles and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain 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 shingles and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 09-NOV-2024 This case was reported by a patient via interactive digital media.  The patient had it (shingles) even after having the shingles shot and it was so painful.  Also stated that it was worse than childbirth.  She had 4 children but never had that much pain.  The patient asked to get the shot but pray not to get 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 details regarding  completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles) is considered unrelated to GSK vaccine Shingles vaccine.
Age: 5.0
Sex: M
Vaccine: MNQ
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Inappropriate age; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 5-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number X4T99, expiry date 30-SEP-2025) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced inappropriate age at vaccine administration (Verbatim: Inappropriate age). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 22-OCT-2024 The health care professional reported that a patient received Menveo (1 vial) at an inappropriate age, which led to inappropriate age at vaccine administration. The vaccine administration facility was the same as primary reporter.; Sender's Comments:  US-GSK-US2024131278:ANOTHER PATIENT
Sex: F
Vaccine: MENB, MENB
Symptoms: Incomplete course of vaccination, Product administered to patient of inappropriate age
Clinical narrative: did not complete the series.; Pharmacist reports 36 year old female patient received first dose of Bexsero; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 36-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included Men B NVS (Bexsero) for prophylaxis.   On 06-FEB-2020, the patient received the 1st dose of Bexsero. On an unknown date, the patient did not receive the 2nd dose of Bexsero. On 06-FEB-2020, an unknown time after receiving Bexsero and not applicable after receiving Bexsero, the patient experienced inappropriate age at vaccine administration (Verbatim: Pharmacist reports 36 year old female patient received first dose of Bexsero). On an unknown date, the patient experienced incomplete course of vaccination (Verbatim: did not complete the series.). The outcome of the inappropriate age at vaccine administration and incomplete course of vaccination were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 22-OCT-2024  The pharmacist reported that 36 year old female patient received first dose of Bexsero which led to inappropriate age at vaccine administration. The patient did not complete the series.  The pharmacist was seeking advice on completing the series for this patient, but at the time of reporting the patient has not received any additional doses.  Till the time of reporting the patient did not receive the second dose of Becsero which led to incomplete course of vaccination.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: doctor's office gave her the shingles vaccine but they mistakenly gave adjuvant substance component only; the doctor's office gave her the shingles vaccine but they mistakenly gave adjuvant substance component only; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate dose of vaccine administered in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21-OCT-2024, the patient received the 1st dose of Shingrix. On 21-OCT-2024, an unknown time after receiving Shingrix, the patient experienced inappropriate dose of vaccine administered (Verbatim: doctor's office gave her the shingles vaccine but they mistakenly gave adjuvant substance component only) and inappropriate preparation of medication (Verbatim: the doctor's office gave her the shingles vaccine but they mistakenly gave adjuvant substance component only). The outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were unknown.   Additional Information: GSK Receipt Date: 22-OCT-2024 The pharmacist reported that a patient got shingles vaccine to a doctor's office, but the doctor's office gave her the shingles vaccine but they mistakenly gave adjuvant substance component only, which led inappropriate preparation of medication and inappropriate dose of vaccine administered. Patient's information was not provided. The lot number was not known.
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Engerix B +  administration of expired dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 44-year-old female patient who received HBV (Engerix B) (batch number ZY7D9, expiry date 12-AUG-2024) for prophylaxis.   On 22-OCT-2024, the patient received Engerix B. On 22-OCT-2024, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Engerix B +  administration of expired dose). The outcome of the expired vaccine used 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: 22-OCT-2024 Licensed vocational nurse reported that a medical assistant administered a dose of Engerix B to patient on the day reporting which was expired, which led to expired vaccine used. The reporter consented to follow up. The Vaccine Administration Facility is the same as Primary Reporter.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Device connection issue, Product complaint, Underdose
Clinical narrative: received less than recommended dose of Menveo; needle was not properly adhered to the hub of the syringe; Pharmaceutical product complaint; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 11-year-old female 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 incomplete dose administered (Verbatim: received less than recommended dose of Menveo), device connection issue (Verbatim: needle was not properly adhered to the hub of the syringe) and pharmaceutical product complaint (Verbatim: Pharmaceutical product complaint). The outcome of the incomplete dose administered, device connection issue and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the device connection issue to be related to Menveo.     It was unknown if the company considered the device connection issue to be related to Menveo.   Additional Information: GSK Receipt Date: 22-OCT-2024 The pharmacist reported that a patient received less than the recommended dose because the needle was not properly adhered to the hub of the syringe and the majority of the dose did not go into the deltoid, which led to incomplete dose administered. The reporter was ask how soon could we revaccinate or schedule the revaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Early dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 89-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 21-OCT-2024, the patient received the 2nd dose of Shingrix. On 21-OCT-2024, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: Early dose). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 22-OCT-2024 Pharmacy technician called to report he was calling in regards to the administration of the second dose of the shingles vaccine, the Shingrix vaccine that was done before the allowed time of period.  First dose of Shingrix was given on 25-SEP-2024. The patient received 2nd dose of Shingrix, earlier than the recommended interval, which led to shortening of vaccination schedule. Lot number was not asked by agent. Patient date of birth was unknown only age was given. The reporter consented to follow up.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration
Clinical narrative: received a dose of Shingrix via the subcutaneous route; This non-serious case was reported by a other health professional via call center representative and described the occurrence of intramuscular formulation administered by other route in a 72-year-old female patient who received Herpes zoster (Shingrix) (batch number 94SE2, expiry date 09-AUG-2026) for prophylaxis.   On 21-OCT-2024, the patient received the 1st dose of Shingrix (subcutaneous). On 21-OCT-2024, an unknown time after receiving Shingrix, the patient experienced intramuscular formulation administered by other route (Verbatim: received a dose of Shingrix via the subcutaneous route). The outcome of the intramuscular formulation administered by other route was unknown.   Additional Information: GSK Receipt Date: 22-OCT-2024  The other health professional (pharmacy technician) reported that the patient accidentally received a dose of Shingrix via the subcutaneous route which led to intramuscular formulation administered by other route The other health professional wished to know if there was any information that could be provided.  The Vaccine Administration Facility was the same as Primary Reporter.
Age: 65.0
Sex: F
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: Havrix pediatric dose administered to an adult; Havrix pediatric dose administered to an adult; This non-serious case was reported by a nurse via call center representative and described the occurrence of adult use of a child product in a 65-year-old female patient who received HAV (Havrix pediatric) (batch number BM4R5, expiry date 24-APR-2026) for prophylaxis.   On 22-OCT-2024, the patient received the 2nd dose of Havrix pediatric. On 22-OCT-2024, an unknown time after receiving Havrix pediatric, the patient experienced adult use of a child product (Verbatim: Havrix pediatric dose administered to an adult) and underdose (Verbatim: Havrix pediatric dose administered to an adult). The outcome of the adult use of a child product and underdose were unknown.   Additional Information: GSK Receipt Date: 22-OCT-2024 The nurse reported that an adult patient received Havrix pediatric formulation, which led to underdose and adult use of a child product. The vaccine administration facility was the same as primary reporter.
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Malaise, Nausea, Overdose, Pyrexia
Clinical narrative: Malaise; Low-grade fever; Chills; Nausea; wrong vaccine administered/pediatric patient receiving an adult dose; vaccine Overdose/pediatric patient receiving an adult dose/ Moderna vaccine overdose in 6 ys old/Recieved adult (0.5 mL dose) instead of pediatric (0.25 mL dose); This spontaneous case was reported by a pharmacist and describes the occurrence of MALAISE (Malaise), PYREXIA (Low-grade fever), CHILLS (Chills), NAUSEA (Nausea) and WRONG PRODUCT ADMINISTERED (wrong vaccine administered/pediatric patient receiving an adult dose) in a 6-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3043501) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Nov-2024 at 5:00 PM, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) .5 milliliter. On 02-Nov-2024 at 5:00 PM, the patient experienced WRONG PRODUCT ADMINISTERED (wrong vaccine administered/pediatric patient receiving an adult dose) and OVERDOSE (vaccine Overdose/pediatric patient receiving an adult dose/ Moderna vaccine overdose in 6 ys old/Recieved adult (0.5 mL dose) instead of pediatric (0.25 mL dose)). On 03-Nov-2024, the patient experienced MALAISE (Malaise), PYREXIA (Low-grade fever), CHILLS (Chills) and NAUSEA (Nausea). On 02-Nov-2024 at 5:00 PM, WRONG PRODUCT ADMINISTERED (wrong vaccine administered/pediatric patient receiving an adult dose) and OVERDOSE (vaccine Overdose/pediatric patient receiving an adult dose/ Moderna vaccine overdose in 6 ys old/Recieved adult (0.5 mL dose) instead of pediatric (0.25 mL dose)) had resolved. On 04-Nov-2024, MALAISE (Malaise), PYREXIA (Low-grade fever), CHILLS (Chills) and NAUSEA (Nausea) had resolved.        For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown), the reporter did not provide any causality assessments.   Co-suspect product included non-company product Afluria (route: intramuscular, site: right deltoid, batch number: AW1671A) for an unknown indication received on 02-Nov-20224.  No concomitant medication was reported.   Patient's parent's reported low-grade fever, chills, malaise, and nausea the day after vaccine was administered. Adverse effect subsided by Monday 04-Nov-2024 and patient was able to return to school that same day.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 12-Nov-2024: Follow-up information received included significant information added reporter details and reporter added, patient details (gender and race), suspect vaccine details (route of administration), added new events (pyrexia, chills, malaise and nausea) and event details (onset dates, stop dates and outcome). Narrative was amended accordingly. On 13-Nov-2024: Follow-up information received included no new information.
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Malaise; Low-grade fever; Chills; Nausea; wrong vaccine administered/pediatric patient receiving an adult dose; vaccine Overdose/pediatric patient receiving an adult dose/ Moderna vaccine overdose in 6 ys old/Recieved adult (0.5 mL dose) instead of pediatric (0.25 mL dose); This spontaneous case was reported by a pharmacist and describes the occurrence of MALAISE (Malaise), PYREXIA (Low-grade fever), CHILLS (Chills), NAUSEA (Nausea) and WRONG PRODUCT ADMINISTERED (wrong vaccine administered/pediatric patient receiving an adult dose) in a 6-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3043501) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Nov-2024 at 5:00 PM, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) .5 milliliter. On 02-Nov-2024 at 5:00 PM, the patient experienced WRONG PRODUCT ADMINISTERED (wrong vaccine administered/pediatric patient receiving an adult dose) and OVERDOSE (vaccine Overdose/pediatric patient receiving an adult dose/ Moderna vaccine overdose in 6 ys old/Recieved adult (0.5 mL dose) instead of pediatric (0.25 mL dose)). On 03-Nov-2024, the patient experienced MALAISE (Malaise), PYREXIA (Low-grade fever), CHILLS (Chills) and NAUSEA (Nausea). On 02-Nov-2024 at 5:00 PM, WRONG PRODUCT ADMINISTERED (wrong vaccine administered/pediatric patient receiving an adult dose) and OVERDOSE (vaccine Overdose/pediatric patient receiving an adult dose/ Moderna vaccine overdose in 6 ys old/Recieved adult (0.5 mL dose) instead of pediatric (0.25 mL dose)) had resolved. On 04-Nov-2024, MALAISE (Malaise), PYREXIA (Low-grade fever), CHILLS (Chills) and NAUSEA (Nausea) had resolved.        For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown), the reporter did not provide any causality assessments.   Co-suspect product included non-company product Afluria (route: intramuscular, site: right deltoid, batch number: AW1671A) for an unknown indication received on 02-Nov-20224.  No concomitant medication was reported.   Patient's parent's reported low-grade fever, chills, malaise, and nausea the day after vaccine was administered. Adverse effect subsided by Monday 04-Nov-2024 and patient was able to return to school that same day.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 12-Nov-2024: Follow-up information received included significant information added reporter details and reporter added, patient details (gender and race), suspect vaccine details (route of administration), added new events (pyrexia, chills, malaise and nausea) and event details (onset dates, stop dates and outcome). Narrative was amended accordingly. On 13-Nov-2024: Follow-up information received included no new information.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Covid-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Covid-19) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. In July 2024, the patient experienced COVID-19 (Covid-19). At the time of the report, COVID-19 (Covid-19) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Suspect product dosage text was reported as unknown. Caller stated she went to get her Moderna COVID shot as she has been getting Moderna shots. Caller added she had just got COVID 4 months ago. And then she stated that it was Spikevax that was available and not Moderna. No treatment information was provided.   Reporter did not allow further contact
Age: 42.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Illness, Pneumonia
Clinical narrative: pneumonia; sick; This is a spontaneous report received from a Consumer or other non HCP.  A 42-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 02Nov2024 at 11:00 as dose 1, single (Batch/Lot number: unknown) at the age of 42 years, in arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 02Nov2024 as dose 1, single), in left arm for immunisation. The patient had no relevant medical history. The patient had no known allergy. There were no concomitant medications. The following information was reported: ILLNESS (non-serious) with onset 05Nov2024 at 17:00, outcome "not recovered", described as "sick"; PNEUMONIA (medically significant) with onset 13Nov2024, outcome "not recovered". The patient was diagnosed with pneumonia on 13Nov2024 after being sick starting 3 days after 02Nov2024 vaccine was received. Therapeutic measures were taken as a result of pneumonia, illness including Doxycycline HYC, benzonatate, methylprednisolone.  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: Thrombosis
Clinical narrative: Blood clotted to death; This is a spontaneous report received from a Consumer or other non HCP.  A female patient received BNT162b2 (BNT162B2 NOS), 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. The following information was reported: THROMBOSIS (death), outcome "fatal", described as "Blood clotted to death". The patient date of death was unknown. Reported cause of death: "Blood clotted to death". It was not reported if an autopsy was performed. Clinical course: Report was received from patient's brother. His sister died 4 days after the shot and said that her blood clotted to death.  Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400303131 Same reporter/drug, different patient/event;US-PFIZER INC-202400303132 Same reporter/drug, different patient/event;US-PFIZER INC-202400303146 Same reporter/drug, different patient/event;US-PFIZER INC-202400303150 Same reporter/drug, different patient/event;; Reported Cause(s) of Death: Blood clotted to death
Sex: U
Vaccine: UNK
Symptoms: Headache, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: Throat was hot and soar; Throat was hot and soar; Had a runny nose; headaches; This spontaneous case, initially received on 30-Oct-2024, was reported by a non-health professional and concerns an patient of unknown age/gender.  No relevant medical history and concomitant medications were reported.  Administration of company suspect drug(s): On an unknown date, the patient received Flucelvax Quadrivalent for Indication not reported, Dose regimen: not reported, Administration route: not reported, Anatomical location: left deltoid, Lot number: 946624.  No additional suspect drugs.  Adverse reactions/events and outcomes: On an unknown date, the patient experienced Throat was hot and soar (outcome: Unknown), Throat was hot and soar (outcome: Unknown), Had a runny nose (outcome: Unknown), headaches (outcome: Unknown).  Patient was not sure what caused the illness, it occurred within days of having the flu shot at work. Throat was hot and soar for a couple days, had a runny nose with mild headaches. Tested negative for strep and COVID.  Non-drug treatment/Other action taken:  Flucelvax Quadrivalent action taken: Not Applicable  Reporter's assessment: The reporter did not provide a serious and causality assessment.; Reporter's Comments: The events were considered related.
Age: 35.0
Sex: M
Vaccine: UNK
Symptoms: Brain fog, Fatigue, Memory impairment
Clinical narrative: forgetfulness by patient in to the hospital and clearly stated why they were there; foggy brain; he was so exhausted; This spontaneous case, initially received on 30-Oct-2024, was reported by a non health professional and concerns an adult male patient.  Administration of company suspect drug: On 15-Oct-2024, the patient received Flucelvax (TIV) for Influenza vaccination, Dose regimen: 0.5 ml, Lot number: 391315.  No additional suspect drugs.  Adverse reactions/events and outcomes: On 15-Oct-2024, the patient experienced forgetfulness by patient in to the hospital and clearly stated why they were there (outcome: Unknown, stop date: 15-Oct-2024), foggy brain (outcome: Unknown, stop date: 15-Oct-2024), he was so exhausted (outcome: Unknown, stop date: 15-Oct-2024).  It was reported from pharmacist that patient had some odd things happen to him after he was vaccinated Flucelvax. He reports the onset occurred 15 minutes after vaccine administration and that had never happened to him after any other flu shot in the past and he reports patient received a flu shot annually.   Flucelvax (TIV) action taken: Not Applicable  Reporter's assessment: The reporter considered the events as non serious and causality assessment was not provided.; Reporter's Comments: Causality: related