chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Occupational exposure to product
Clinical narrative: Occupational Exposure to Adjuvant/Vaccine content in the eye/face (skin); This non-serious case was reported by a pharmacist via call center representative and described the occurrence of occupational exposure via skin contact with product in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13-NOV-2024, the patient received Shingrix. On 13-NOV-2024, an unknown time after receiving Shingrix, the patient experienced occupational exposure via skin contact with product (Verbatim: Occupational Exposure to Adjuvant/Vaccine content in the eye/face (skin)). The outcome of the occupational exposure via skin contact with product was unknown.   Additional Information: GSK Receipt Date: 13-NOV-2024 The pharmacist called asking about how they should proceed in the event that a female employee got Shingrix vaccine or adjuvant in the eye or face skin which led to occupational exposure via skin contact with product. The reporter did not know whether it was the Shingrix vaccine or the adjuvant that caused the incident.  The reporter did not provided any detail about the Shingrix vaccine lot number and expiration date. The reporter provided only first name's initial and gender of the employee, incident date was provided too, no age/date of birth was provided during this call.  No further information was provided from the reporter's end during this call.
Sex: M
Vaccine: DTAPIPV
Symptoms: Intercepted product selection error
Clinical narrative: Nurse Practitioner that ordered the Kinrix instead of the Boostrix and patient does not have any vaccine; This non-serious case was reported by a nurse via call center representative and described the occurrence of intercepted product selection error in a 9-year-old male patient who received DTPa-IPV (Kinrix) (batch number Y49BZ, expiry date 31-AUG-2026) for prophylaxis.   On an unknown date, the patient did not receive the 1st dose of Kinrix (intramuscular, right deltoid). On an unknown date, an unknown time after receiving Kinrix, the patient experienced intercepted product selection error (Verbatim: Nurse Practitioner that ordered the Kinrix instead of the Boostrix and patient does not have any vaccine). The outcome of the intercepted product selection error 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: 14-NOV-2024 and 15-NOV-2024 The nurse practitioner reported that they ordered the Kinrix instead of the Boostrix in the patient.  The patient did not showed any signs of symptoms. It was reported as the wrong vaccine was ordered for patient and healthcare professional stated that the patient had just arrived to the country and did not had any vaccine, which led to intercepted product selection error.
Sex: F
Vaccine: FLU3
Symptoms: Device connection issue, Occupational exposure to product
Clinical narrative: Medication got on the preparer's hand; Medication got on the preparer's hand; medication leaked out the plunger end/ defect related to the plunger rod and plunger stopper; Pharmaceutical product complaint; This non-serious case was reported by a nurse via call center representative and described the occurrence of occupational exposure via skin contact with product in a adult female patient who received Flu Seasonal TIV Quebec (FluLaval 2024-2025 season) (batch number 9h5j5, expiry date 30-JUN-2025) for prophylaxis. This case was associated with a product complaint.   On an unknown date, the patient received FluLaval 2024-2025 season. On an unknown date, an unknown time after receiving FluLaval 2024-2025 season, the patient experienced occupational exposure via skin contact with product (Verbatim: Medication got on the preparer's hand), inadvertent exposure to vaccine (Verbatim: Medication got on the preparer's hand), syringe connection issue (Verbatim: medication leaked out the plunger end/ defect related to the plunger rod and plunger stopper) and pharmaceutical product complaint (Verbatim: Pharmaceutical product complaint). The outcome of the occupational exposure via skin contact with product, inadvertent exposure to vaccine, syringe connection issue and pharmaceutical product complaint 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: 15-NOV-2024 The nurse stated that plunger from Flulaval syringe became detached when a nurse picked it up from the box and medication leaked out the plunger end. Medication got on the preparer's hand which led to occupational exposure via skin contact with product and inadvertent exposure to vaccine. Defect was noticed during preparation and after partial use of the pack. Product was not administered or partially administered to a patient. The defect was related to the plunger rod and plunger stopper both. The plunger fell out completely when the nurse picked up the syringe from the box. The detachment had happened during use and there was liquid in the box which was leaked at the back through the stopper. The syringe was not pre-assembled with needle some time before administration, leaking occurred before needle attachment. The tray and/or carton were not damaged. It was unknown if leaking was from plunger stopper, were there any liquid traces observed on the plunger stopper rings. Luer Lok was not damaged and the defect was not related to Luer Lok. There was no damage/breakage on the syringe barrel. Reporter did not consent to follow-up.
Sex: U
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Pediatric dose administered to adult; Underdose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of adult use of a child product in a adult patient who received HBV (Engerix B pediatric) for prophylaxis.   On 14-NOV-2024, the patient received Engerix B pediatric. On 14-NOV-2024, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: Pediatric dose administered to adult) and underdose (Verbatim: Underdose). The outcome of the adult use of a child product and underdose were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 15-NOV-2024 The reporter reported that administration of a pediatric dose of Engerix-B to an adult but did not know any data about the vaccine nor patient which leads to Adult use of a child product and underdose.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Maladministration of Bexsero After the Expiration Date; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 18-year-old male patient who received Men B NVS (Bexsero) (batch number TP294, expiry date 31-OCT-2024) for prophylaxis.   On 11-NOV-2024, the patient received Bexsero. On 11-NOV-2024, an unknown time after receiving Bexsero, the patient experienced expired vaccine used (Verbatim: Maladministration of Bexsero After the Expiration Date). 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: 15-NOV-2024 Healthcare Professional asked about an expired dose that was administered to a male patient last 11th November 2024.  The patient received an expire dose of Bexsero, which led to expired vaccine used.
Sex: F
Vaccine: UNK
Symptoms: Exposure via skin contact, Syringe issue, Underdose
Clinical narrative: vaccine ran down the patient's arm; the vaccine ran down the patient's arm; Underdose/unsure if a complete dose was received; Pharmaceutical product complaint; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of exposure via skin contact in a female patient who received Flu Seasonal TIV Dresden (Fluarix 2024-2025 season) (batch number 7554T, 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, an unknown time after receiving Fluarix 2024-2025 season, the patient experienced exposure via skin contact (Verbatim: vaccine ran down the patient's arm), inadvertent exposure to vaccine (Verbatim: the vaccine ran down the patient's arm), underdose (Verbatim: Underdose/unsure if a complete dose was received) and pharmaceutical product complaint (Verbatim: Pharmaceutical product complaint). The outcome of the exposure via skin contact, inadvertent exposure to vaccine, underdose and pharmaceutical product complaint 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: 15-NOV-2024 and 16-NOV-2024 The pharmacist stated that while a nurse was injected an adult female with Fluarix, the vaccine ran down the patient's arm which led to exposure via skin contact and inadvertent exposure to vaccine. Because of this, the nurse and reporter were unsure if a complete dose was received (related underdose), which led to underdose. The reporter was unable to provide the initials or date of birth of the patient. Their employee health nurse was vaccinating an employee and when she took the syringe out and attached the needle, she has given hundreds of these already this season, but she said that something just not felt quite right, that it did clicked and it felt secure but it seemed not to belong as well as the other ones but it was secure and she proceed to the vaccination.  The needle went into the employee's arm and however, as she was pushing down on the plunger, there was liquid running down in the arm of the employee onto the floor and she was not sure if any of the vaccine got onto the arm. This agent made an outbound call to the pharmacist / reporter to gather further details.  The reporter was unable to speak with this agent at the time of the call due to an emergency on the reporters end.  As per request of the reporter, this agent would follow up on Monday. It was unknown in the suspect product was available to return product quality complaint was filed with limited information.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: the mixed the powder portion of the Shingrix vaccine with the Menveo 1 vial; the mixed the powder portion of the Shingrix vaccine with the Menveo 1 vial; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 51-year-old female patient who received Herpes zoster (Shingrix) (batch number 9L5P2) for prophylaxis.   On 15-NOV-2024, the patient received the 1st dose of Shingrix. On 15-NOV-2024, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: the mixed the powder portion of the Shingrix vaccine with the Menveo 1 vial) and inappropriate dose of vaccine administered (Verbatim: the mixed the powder portion of the Shingrix vaccine with the Menveo 1 vial). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 15-NOV-2024 A medical assistant reported that they mixed the powder portion of the Shingrix vaccine with the Menveo (1 vial) with batch number X4T99 because she thought it was the diluent, she did not check, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. Also, she escalated this to 2nd line agent, her colleague informed her that this was also an incomplete dose, it was not something that they directly mentioned to him, but it was recorded. The vaccine administration facility was the same as primary reporter.
Sex: U
Vaccine: HIBV
Symptoms: Product preparation issue
Clinical narrative: only administered the diluent; only administered the diluent; 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 Hib (Hiberix) for prophylaxis.   On 06-JUN-2024, the patient received Hiberix. On 06-JUN-2024, an unknown time after receiving Hiberix, the patient experienced inappropriate preparation of medication (Verbatim: only administered the diluent) and inappropriate dose of vaccine administered (Verbatim: only administered the diluent ). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 18-NOV-2024 Reporter stated that a nurse was administering HIBERIX to a patient but only administered the diluent and did not reconstitute with product. Nurse/office did not realize that until later in the week when recounting inventory and realized they had the wrong amount of product.  Office was able to narrow down who the patient was, but they could not provide any patient information to GSK. The patient received only diluent of Hiberix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: U
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: patient was administered a dose of Shingrix, was exposed to temperature below freezing; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a patient who received Herpes zoster (Shingrix) (batch number JS3S4, expiry date 26-OCT-2026) for prophylaxis.   On 19-NOV-2024, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incorrect storage of drug (Verbatim: patient was administered a dose of Shingrix, was exposed to temperature below freezing). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 20-NOV-2024 The pharmacist reported that a patient was administered a dose of Shingrix and this vaccine was exposed to temperature below freezing, which led to incorrect storage of drug.  The reporter wanted to knew any advise in this case. The Vaccine Administration Facility was the same as Primary Reporter.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration
Clinical narrative: received a dose of Shingrix as a subcutaneous injection instead of intramuscularly; This non-serious case was reported by a nurse via call center representative and described the occurrence of intramuscular formulation administered by other route in a 50-year-old female patient who received Herpes zoster (Shingrix) (batch number 9R397, expiry date 27-OCT-2026) for prophylaxis.   On 19-NOV-2024, the patient received Shingrix (subcutaneous, left arm). On 19-NOV-2024, an unknown time after receiving Shingrix, the patient experienced intramuscular formulation administered by other route (Verbatim: received a dose of Shingrix as a subcutaneous injection instead of intramuscularly). The outcome of the intramuscular formulation administered by other route was unknown.   Additional Information: GSK Receipt Date: 20-NOV-2024 The registered nurse reported that yesterday (prior to the reporting day) the patient received a dose of Shingrix as a subcutaneous injection instead of intramuscularly (wrong route of administration), which led to intramuscular formulation administered by other route.
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product use issue
Clinical narrative: pregnant women are getting RSV vaccine; patients who already got RSV vaccine during pregnancy; This non-serious prospective pregnancy case was reported by a physician via sales rep and described the occurrence of vaccine exposure during pregnancy in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced vaccine exposure during pregnancy (Verbatim: pregnant women are getting RSV vaccine) and drug use in unapproved population (Verbatim: patients who already got RSV vaccine during pregnancy). The outcome of the vaccine exposure during pregnancy and drug use in unapproved population were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 03-DEC-2024 The physician reported that a pregnant women are getting Arexvy vaccine, which led to vaccine exposure during pregnancy and drug use in unapproved population. If delivering between March-September she would like to know if patients who already got RSV vaccine during pregnancy would get it again when they turn 60 yrs or older.
Sex: F
Vaccine: FLU3
Symptoms: Blood glucose decreased
Clinical narrative: patient that experienced low sugar levels after the administration of a GlaxoSmithKline flu vaccine; This non-serious case was reported by a consumer via call center representative and described the occurrence of blood sugar decreased in a female patient who received Flu Seasonal TIV Quebec (FluLaval 2024-2025 season) (batch number 5RE93, expiry date 30-JUN-2025) for prophylaxis.   Concurrent medical conditions included diabetes.   On 03-OCT-2024, the patient received FluLaval 2024-2025 season. On an unknown date, an unknown time after receiving FluLaval 2024-2025 season, the patient experienced blood sugar decreased (Verbatim: patient that experienced low sugar levels after the administration of a GlaxoSmithKline flu vaccine). The outcome of the blood sugar decreased was unknown.   It was unknown if the reporter considered the blood sugar decreased to be related to FluLaval 2024-2025 season and Flulaval Pre-Filled Syringe Device.     It was unknown if the company considered the blood sugar decreased to be related to FluLaval 2024-2025 season and Flulaval 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: 06-DEC-2024 The reporter reported that a patient experienced low sugar levels, after the administration of flu vaccine, that was Flulaval vaccine. The patient suffers from Diabetes (type non specified), the patient  wants to know more information about this
Sex: F
Vaccine: COVID19
Symptoms: Gastrointestinal inflammation
Clinical narrative: intestinal inflammation; This spontaneous case was reported by an other health care professional and describes the occurrence of GASTROINTESTINAL INFLAMMATION (intestinal inflammation) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced GASTROINTESTINAL INFLAMMATION (intestinal inflammation). At the time of the report, GASTROINTESTINAL INFLAMMATION (intestinal inflammation) 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.   The concomitant medication was not reported by reporter. The treatment medication was not reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2024-779018 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-779018:Master case
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity, Peripheral swelling
Clinical narrative: Got pain shooting from the top of my arm all the way through my hand; Hand swelled; Pain went from the top of her shoulder to arm; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (Got pain shooting from the top of my arm all the way through my hand), PERIPHERAL SWELLING (Hand swelled) and ARTHRALGIA (Pain went from the top of her shoulder to arm) in a 55-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 8080799) for COVID-19 prophylaxis.     No Medical History information was reported.    On 04-Dec-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On 04-Dec-2024, the patient experienced PAIN IN EXTREMITY (Got pain shooting from the top of my arm all the way through my hand), PERIPHERAL SWELLING (Hand swelled) and ARTHRALGIA (Pain went from the top of her shoulder to arm). At the time of the report, PAIN IN EXTREMITY (Got pain shooting from the top of my arm all the way through my hand), PERIPHERAL SWELLING (Hand swelled) and ARTHRALGIA (Pain went from the top of her shoulder to arm) had not resolved.        For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   Concomitant medication use information was not provided by reporter.  Patient got a Moderna Spikevax in the evening of 4-Dec-2024 and in first two hours, everything was fine and then all of a sudden, patient got pain shooting from the top of arm all the way through hand.   It was reported that patient thought, the shot was actually put in joint, at the top of her shoulder instead of down further.   It was reported that patient received the vaccine in her right-side arm and after 2-2 1/2 hours pain went from the top of her shoulder to arm and the hand swelled. Pain was ongoing.   The patient did not experience any additional symptoms/events.   Treatment medication use information was not provided by reporter.
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Sinus headache
Clinical narrative: heavy congestion like getting a cold. Head congestion, like heavy sinus problems, head cold symptoms; heavy congestion like getting a cold. Head congestion, like heavy sinus problems, head cold symptoms; This spontaneous case was reported by a patient and describes the occurrence of NASOPHARYNGITIS (heavy congestion like getting a cold. Head congestion, like heavy sinus problems, head cold symptoms) and SINUS HEADACHE (heavy congestion like getting a cold. Head congestion, like heavy sinus problems, head cold symptoms) in a female patient of an unknown age who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (heavy congestion like getting a cold. Head congestion, like heavy sinus problems, head cold symptoms) and SINUS HEADACHE (heavy congestion like getting a cold. Head congestion, like heavy sinus problems, head cold symptoms). At the time of the report, NASOPHARYNGITIS (heavy congestion like getting a cold. Head congestion, like heavy sinus problems, head cold symptoms) and SINUS HEADACHE (heavy congestion like getting a cold. Head congestion, like heavy sinus problems, head cold symptoms) outcome was unknown.            No concomitant medications were reported. The patient did not experience any additional symptoms/events.  Treatment medications were not provided.   This case was linked to US-MODERNATX, INC.-MOD-2024-779100 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-779100:Wife's case
Sex: F
Vaccine: COVID19
Symptoms: Amyotrophic lateral sclerosis
Clinical narrative: quick moving ALS; This spontaneous case was reported by a patient family member or friend and describes the occurrence of AMYOTROPHIC LATERAL SCLEROSIS (quick moving ALS) 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) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced AMYOTROPHIC LATERAL SCLEROSIS (quick moving ALS) (seriousness criteria death and medically significant). The reported cause of death was quick moving als. It is unknown if an autopsy was performed.            No concomitant medication was reported. No treatment information was provided. It was unknown if the patient experienced any additional symptoms/events.   This case was linked to US-MODERNATX, INC.-MOD-2024-779142 (E2B Linked Report).; Reporter's Comments: Company comment: The benefit-risk relationship of product is not affected by this report.; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-779142:Reporter's case with different moderna product; Reported Cause(s) of Death: quick moving ALS
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Flushing
Clinical narrative: extreme facial flushing; redness; This spontaneous case was reported by a patient and describes the occurrence of FLUSHING (extreme facial flushing) and ERYTHEMA (redness) in a 54-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Concurrent medical conditions included Rosacea (neurogenic rosacea).    On 07-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 07-Oct-2023, the patient experienced FLUSHING (extreme facial flushing) and ERYTHEMA (redness). The patient was treated with Diphenhydramine hydrochloride (Benadryl) at an unspecified dose and frequency. At the time of the report, FLUSHING (extreme facial flushing) and ERYTHEMA (redness) had resolved with sequelae.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant medication was reported. It was reported that patient required use of antihistamine and was unknown if patient experienced any additional symptoms/events. The patient did not have any additional medical history, concomitant disease or risk factor. There was no lab data and results available. Patient took Benadryl for immediate reaction.
Sex: F
Vaccine: RSV
Symptoms: Feeling abnormal
Clinical narrative: feeling really really bad; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (feeling really really bad) in a female patient of an unknown age who received mRNA-1345 (mRESVIA) for Lower respiratory tract infection.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1345 (mRESVIA) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (feeling really really bad). At the time of the report, FEELING ABNORMAL (feeling really really bad) outcome was unknown.        The action taken with mRNA-1345 (mRESVIA) (Unknown) was unknown.       The concomitant medication was not reported by reporter. The treatment medication was not reported by reporter.
Sex: M
Vaccine: RSV, RSV
Symptoms: Crying, Product administered to patient of inappropriate age
Clinical narrative: Male infant received RSV Abrysvo Vaccine X 2 (total of 0.5 mL x 2 doses for a total of 240 mcg pr 1 mL); crying a lot; This is a spontaneous report received from a Physician from a sales representative.  A 2-month-old male patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, 240 ug single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CRYING (non-serious) with onset 18Oct2024, outcome "unknown", described as "crying a lot"; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious), outcome "unknown", described as "Male infant received RSV Abrysvo Vaccine X 2 (total of 0.5 mL x 2 doses for a total of 240 mcg pr 1 mL)". Therapeutic measures were not taken as a result of crying. Additional information: Male infant received rsv vaccine prot.subunit pref 2v  X 2 (total of 0.5 mL x 2 doses for a total of 240 mcg pr 1 mL). At this point the physician stated there were currently no known adverse drug events (ADE) that have occurred since vaccination. Reporter was continuing to follow up with the parents. The medication error occurred when the product was administered to/taken by the patient. The error was not noticed and intercepted before the product was supplied to the patient. Favorable outcome for event "crying a lot" and no treatment received as the patient is easily consoled when carried in parents arms'. The parents are not certain the side/adverse event is a result of the vaccine but do state that it is the only event since the vaccination.  Follow-up (05Dec2024): This is a spontaneous follow-up report received from a Physician from a sales representative. Updated information: event (added crying) and narrative.
Sex: M
Vaccine: RSV, RSV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Male infant received RSV Abrysvo Vaccine X 2 (total of 0.5 mL x 2 doses for a total of 240 mcg pr 1 mL); crying a lot; This is a spontaneous report received from a Physician from a sales representative.  A 2-month-old male patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, 240 ug single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CRYING (non-serious) with onset 18Oct2024, outcome "unknown", described as "crying a lot"; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious), outcome "unknown", described as "Male infant received RSV Abrysvo Vaccine X 2 (total of 0.5 mL x 2 doses for a total of 240 mcg pr 1 mL)". Therapeutic measures were not taken as a result of crying. Additional information: Male infant received rsv vaccine prot.subunit pref 2v  X 2 (total of 0.5 mL x 2 doses for a total of 240 mcg pr 1 mL). At this point the physician stated there were currently no known adverse drug events (ADE) that have occurred since vaccination. Reporter was continuing to follow up with the parents. The medication error occurred when the product was administered to/taken by the patient. The error was not noticed and intercepted before the product was supplied to the patient. Favorable outcome for event "crying a lot" and no treatment received as the patient is easily consoled when carried in parents arms'. The parents are not certain the side/adverse event is a result of the vaccine but do state that it is the only event since the vaccination.  Follow-up (05Dec2024): This is a spontaneous follow-up report received from a Physician from a sales representative. Updated information: event (added crying) and narrative.
Sex: F
Vaccine: PNC20
Symptoms: Occupational exposure to product
Clinical narrative: Before administering the vaccine, the pharmacist removed the air from the syringe and took off the cover. During the process, some droplets from the vaccine sprayed into her eyes; Occupational exposure while preparing product for administration; This is a spontaneous report received from a Pharmacist from medical information team.  A female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OCCUPATIONAL EXPOSURE TO PRODUCT (non-serious), described as "Before administering the vaccine, the pharmacist removed the air from the syringe and took off the cover. During the process, some droplets from the vaccine sprayed into her eyes"; EXPOSURE VIA EYE CONTACT (non-serious), described as "Occupational exposure while preparing product for administration".  Causality for "before administering the vaccine, the pharmacist removed the air from the syringe and took off the cover. during the process, some droplets from the vaccine sprayed into her eyes" and "occupational exposure while preparing product for administration" was determined associated to device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein) (malfunction).  Additional information: Before administering the vaccine, the pharmacist removed the air from the syringe and took off the cover. During the process, some droplets from the vaccine sprayed into her eyes. She immediately rinsed her eyes with water. Asking if there are any recommended steps to take following this incident?
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Incorrect route of product administration, Vaccination site erythema
Clinical narrative: one red mark on her arm where the dose was administered; administered subcutaneously; This is a spontaneous report received from an Other HCP.  A 60-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) subcutaneous, in left arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), as dose number unknown, single) subcutaneous, in left arm for immunisation. The patient's relevant medical history included: "Blood pressure abnormal" (unspecified if ongoing); "fungal infection" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN taken for blood pressure abnormal. The patient also took other concomitant therapy. Vaccination history included: Covid-19 vaccine (primary immunization series complete; manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (dose number unknown (booster); manufacturer unknown), for COVID-19 immunisation. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), described as "one red mark on her arm where the dose was administered "; INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious), described as "administered subcutaneously". Additional information: The patient takes a lot of medication. She takes medication for blood pressure and medication for fungal infections. The patient got the Pfizer Covid-19 Vaccine along with flu vaccine at the same injection site. It was two separate syringes, two punctures, one red mark on her arm where the dose was administered and it was on the back of the left arm. It was administered subcutaneously and not intramuscularly and it was administered a couple month ago. Red mark was normal reaction to injection. It was nothing like a side effects. It was exactly what you are expected to see, when you get injection.
Sex: F
Vaccine: COVID19
Symptoms: Gait inability, Myocarditis
Clinical narrative: myocarditis; no longer even walk to the restroom; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A female patient received BNT162b2 (BNT162B2 NOS), as dose 5 (booster), 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, SINGLE), for COVID-19 immunization, reaction(s): "After each and every shot my mother wound up in the hospital for at least 2-3 weeks"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization, reaction(s): "After each and every shot my mother wound up in the hospital for at least 2-3 weeks"; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization, reaction(s): "After each and every shot my mother wound up in the hospital for at least 2-3 weeks"; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE), for COVID-19 immunization, reaction(s): "After each and every shot my mother wound up in the hospital for at least 2-3 weeks". The following information was reported: MYOCARDITIS (death, hospitalization), outcome "fatal"; GAIT INABILITY (non-serious), outcome "unknown", described as "no longer even walk to the restroom". The patient date of death was 2022. Reported cause of death: "Myocarditis". Clinical course: Patient received all 5 of the Covid-19 shots (Name withheld) they first came out even though her children begged her not to, 2-3 days after each and every shot she wound up in the hospital for at least 2-3 weeks. After her 5th and final shot she could no longer even walk to the restroom. The doctor (Name withheld) if she took so many as 3 steps she would die. Patient passed away in a nursing home 2 1/2 years ago from myocarditis. Nothing was ever wrong with her heart before this.   The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400161742 Same patient/product, different dose/event;; Reported Cause(s) of Death: Myocarditis
Sex: M
Vaccine: COVID19
Symptoms: Immune system disorder
Clinical narrative: caused irreparable damage to my father's immune system; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNE SYSTEM DISORDER (non-serious), outcome "unknown", described as "caused irreparable damage to my father's immune system". 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: Anti-thyroid antibody, Blood thyroid stimulating hormone, Graves' disease, Iodine uptake, Thyroid stimulating immunoglobulin
Clinical narrative: Graves disease; This is a literature report for the following literature source(s):  A 60-year-old 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 included: "hypertension" (unspecified if ongoing); "asthma" (unspecified if ongoing); "T2NxM0 low grade gastrointestinal stromal tumor (GIST)" (unspecified if ongoing); "hyperaldosteronism" (unspecified if ongoing); "thyroid disorders" (unspecified if ongoing); "weight gain" (unspecified if ongoing); "palpitations" (unspecified if ongoing); "Hashimoto thyrotoxicosis" (unspecified if ongoing); "Hashimoto thyrotoxicosis" (unspecified if ongoing); "GIST tumor resected" (unspecified if ongoing). Concomitant medication(s) included: METHIMAZOLE taken for hyperthyroidism, autoimmune thyroiditis. Past drug history included: Atenolol for Hashimoto thyrotoxicosis, notes: 50mg; Atenolol for Hashimoto thyrotoxicosis, notes: 50mg. The following information was reported: GRAVES' DISEASE (medically significant), outcome "recovered", described as "Graves disease". The patient underwent the following laboratory tests and procedures: Anti-thyroid antibody: less than 1; less than 1, notes: Repeat testing; Anti-thyroid antibody: Positive, notes: Repeat testing; 46 IU/ml; 41 IU/ml, notes: Repeat testing; Blood thyroid stimulating hormone: less than 0.01; Iodine uptake: normal; Positive, notes: Repeat testing; Iodine uptake: 15 %, notes: uptake at 6 hours; 25 %, notes: uptake at 24 hours; 47 %, notes: uptake at 6 hours Repeat testing; 61 %, notes: uptake at 24 hours Repeat testing; Thyroid stimulating immunoglobulin: Negative; Positive, notes: Repeat testing; Thyroid stimulating immunoglobulin: 102 %; 294 %, notes: Repeat testing; Thyroxine free: 1.6 ng/dL; Tri-iodothyronine free: 6.5 ng/ml; Ultrasound scan: A slightly enlarged thyroid was noted. Therapeutic measures were taken as a result of graves' disease.; Sender's Comments: The event Graves' disease is conservatively assessed as related to the suspect drug BNT162B2 based on plausible temporal association but consider also possible contributory effects from medical history of the patient and/or concomitant medications. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Thyroxine free, Tri-iodothyronine free, Ultrasound scan
Clinical narrative: Graves disease; This is a literature report for the following literature source(s):  A 60-year-old 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 included: "hypertension" (unspecified if ongoing); "asthma" (unspecified if ongoing); "T2NxM0 low grade gastrointestinal stromal tumor (GIST)" (unspecified if ongoing); "hyperaldosteronism" (unspecified if ongoing); "thyroid disorders" (unspecified if ongoing); "weight gain" (unspecified if ongoing); "palpitations" (unspecified if ongoing); "Hashimoto thyrotoxicosis" (unspecified if ongoing); "Hashimoto thyrotoxicosis" (unspecified if ongoing); "GIST tumor resected" (unspecified if ongoing). Concomitant medication(s) included: METHIMAZOLE taken for hyperthyroidism, autoimmune thyroiditis. Past drug history included: Atenolol for Hashimoto thyrotoxicosis, notes: 50mg; Atenolol for Hashimoto thyrotoxicosis, notes: 50mg. The following information was reported: GRAVES' DISEASE (medically significant), outcome "recovered", described as "Graves disease". The patient underwent the following laboratory tests and procedures: Anti-thyroid antibody: less than 1; less than 1, notes: Repeat testing; Anti-thyroid antibody: Positive, notes: Repeat testing; 46 IU/ml; 41 IU/ml, notes: Repeat testing; Blood thyroid stimulating hormone: less than 0.01; Iodine uptake: normal; Positive, notes: Repeat testing; Iodine uptake: 15 %, notes: uptake at 6 hours; 25 %, notes: uptake at 24 hours; 47 %, notes: uptake at 6 hours Repeat testing; 61 %, notes: uptake at 24 hours Repeat testing; Thyroid stimulating immunoglobulin: Negative; Positive, notes: Repeat testing; Thyroid stimulating immunoglobulin: 102 %; 294 %, notes: Repeat testing; Thyroxine free: 1.6 ng/dL; Tri-iodothyronine free: 6.5 ng/ml; Ultrasound scan: A slightly enlarged thyroid was noted. Therapeutic measures were taken as a result of graves' disease.; Sender's Comments: The event Graves' disease is conservatively assessed as related to the suspect drug BNT162B2 based on plausible temporal association but consider also possible contributory effects from medical history of the patient and/or concomitant medications. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: seizures; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  An adult patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SEIZURE (medically significant), outcome "unknown", described as "seizures". Therapeutic measures were taken as a result of seizure. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: M
Vaccine: FLUX
Symptoms: Cerebrovascular accident, Guillain-Barre syndrome, Paralysis
Clinical narrative: Guillain Barre Syndrome; stroke; paralyzed; Initial information received on 08-Dec-2024 regarding an unsolicited valid Social Media serious case received from a Non health care professional.  This case involves Adult male patient who had guillain barre syndrome, stroke and paralyzed after receiving  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 the patient developed guillain barre syndrome (guillain-barre syndrome), stroke (cerebrovascular accident) and paralyzed (paralysis) (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, the patient said he got a flu shot and got Guillain Barre Syndrome, he then had a stroke and was paralyzed. They taught him to talk, use my hands, walk, feed my self, he now try to write right handed when he was left handed before that flu shot. They told me do not get the COVID SHOT.  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 unknown for all the events.  Seriousness criteria: All the events were assessed as medically significant.; Sender's Comments: Sanofi company comment dated 13-Dec-2024: This case involves Adult male patient who had guillain barre syndrome, stroke and paralyzed after receiving  INFLUENZA VACCINE. The time to onset was compatible with the role of vaccine. The clinical course of the event was not provided. Furthermore, information regarding condition at the time of vaccination, role of medical history, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: staff accidentally gave a patient 2 flu vaccine, one is fluzone hd and one is gsk fluarix with no ae; Initial information received on 04-Dec-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves, a 71 years old male patient who experienced staff accidentally gave a patient 2  flu vaccine, one is INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HD] with no adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included INFLUENZA VACCINE INACT SPLIT 3V (FLUARIX) for Immunisation  On 03-Dec-2024 the patient was accidentally given a patient 2 Flu vaccine, one High dose of suspect (1X once) INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE Suspension for injection in pre-filled syringe (lot UT8463AA) (unknown strength) via intramuscular route in unknown administration site for prophylactic had (Accidental overdose) (latency-same day)  Reportedly, this situation is pre-assessed as a medication error/an inappropriate use due to 2 doses of flu shot given to a patient. Caller stated that one of their staff accidentally gave a patient 2 flu vaccine, one is FLUZONE HD and one is GSK Fluarix.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.