chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RSV
Symptoms: Headache, Malaise
Clinical narrative: terrific headache; feeling of malease; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of headache in a 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 headache (Verbatim: terrific headache) and malaise (Verbatim: feeling of malease). The outcome of the headache and malaise were not reported.   It was unknown if the reporter considered the headache and malaise to be related to Arexvy.     It was unknown if the company considered the headache and malaise to be related to Arexvy.   Additional Information: GSK Receipt Date: 22-MAR-2024 This case was reported by a patient via interactive digital media. The patient had terrific headache & feeling of malaise after receiving the Arexvy vaccine. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: RSV
Symptoms: Injection site erythema, Pain in extremity
Clinical narrative: arm was also sore; a baseball size reddened area around my injection site; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site erythema in a 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 injection site erythema (Verbatim: a baseball size reddened area around my injection site) and pain in arm (Verbatim: arm was also sore). The outcome of the injection site erythema was resolved (duration 5 days) and the outcome of the pain in arm was not reported.   It was unknown if the reporter considered the injection site erythema and pain in arm to be related to Arexvy.     It was unknown if the company considered the injection site erythema and pain in arm to be related to Arexvy.   Additional Information: GSK Receipt Date: 22-MAR-2024 This case was reported by a patient via (Open field AE monitoring) interactive digital media. The reporter reported that he/she had baseball size reddened area around his/her injection site for 5 days, arm was also sore. The patient never had a reaction to any other vaccines.
Sex: U
Vaccine: RSV
Symptoms: Fatigue, Headache, Pain, Performance status decreased
Clinical narrative: splitting headache; hurt all over; so tired; cannot function; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of headache in a 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 headache (Verbatim: splitting headache), pain (Verbatim: hurt all over), tiredness (Verbatim: so tired) and performance status decreased (Verbatim: cannot function). The outcome of the headache, pain, tiredness and performance status decreased were not reported.   It was unknown if the reporter considered the headache, pain, tiredness and performance status decreased to be related to Arexvy.     It was unknown if the company considered the headache, pain, tiredness and performance status decreased to be related to Arexvy.   Additional Information: GSK Receipt Date: 22-MAR-2024 The case was received from the patient via (Open field AE monitoring) interactive digital media. The patient reported that had all of them, had a splitting headache and hurt all over and so tired that could not function.
Sex: U
Vaccine: RSV
Symptoms: Arthralgia, Myalgia
Clinical narrative: joint pain; muscle pain; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of joint pain in a 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 joint pain (Verbatim: joint pain) and muscle pain (Verbatim: muscle pain). The outcome of the joint pain and muscle pain were not reported.   It was unknown if the reporter considered the joint pain and muscle pain to be related to Arexvy.     It was unknown if the company considered the joint pain and muscle pain to be related to Arexvy.   Additional Information: GSK Receipt Date: 22-MAR-2024 The case was received from the patient via Interactive digital media. The patient was reporter The reporter reported that the patient received Arexvy vaccine. The patient asked the how long might muscle or joint pain last.
Sex: U
Vaccine: RSV
Symptoms: Pruritus, Rash
Clinical narrative: itching; rash; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pruritus in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, 2 days after receiving Arexvy, the patient experienced pruritus (Verbatim: itching) and rash (Verbatim: rash). The outcome of the pruritus and rash were not reported.   It was unknown if the reporter considered the pruritus and rash to be related to Arexvy.     It was unknown if the company considered the pruritus and rash to be related to Arexvy.   Additional Information: GSK receipt date: 22-MAR-2024 The patient was asked what about itching and rash which was experienced 2 days after injection. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: RSV
Symptoms: Influenza
Clinical narrative: flu; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of influenza in a 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 influenza (Verbatim: flu). The outcome of the influenza was not reported.   It was unknown if the reporter considered the influenza to be related to Arexvy.     It was unknown if the company considered the influenza to be related to Arexvy.   Additional Information: GSK Receipt Date: 22-MAR-2024 The case was received from the patient via interactive digital media.   The patient had a flu and asked to seek ll of the symptoms he/she felt last.
Sex: U
Vaccine: RSV
Symptoms: Bronchitis, Respiratory symptom
Clinical narrative: respiratory symptoms; Bronchitis; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of respiratory symptom in a 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 respiratory symptom (Verbatim: respiratory symptoms) and bronchitis (Verbatim: Bronchitis). The outcome of the respiratory symptom and bronchitis were not reported.   It was unknown if the reporter considered the respiratory symptom and bronchitis to be related to Arexvy.     It was unknown if the company considered the respiratory symptom and bronchitis to be related to Arexvy.   Additional Information: GSK Receipt date: 22-MAR-2024 This case was reported by patient via (Open field AE monitoring)  interactive digital media. The reporter reported that he or she gets respiratory symptoms similar to bronchitis after receiving the Arexvy vaccine.
Sex: U
Vaccine: RSV
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: large swollen about the size of a baseball, about 2 inches below the injection site; very itchy area about the size of a baseball, about 2 inches below the injection site; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of swelling in a 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 swelling (Verbatim: large swollen about the size of a baseball, about 2 inches below the injection site) and pruritus (Verbatim: very itchy area about the size of a baseball, about 2 inches below the injection site). The outcome of the swelling and pruritus were not resolved.   It was unknown if the reporter considered the swelling and pruritus to be related to Arexvy.     It was unknown if the company considered the swelling and pruritus to be related to Arexvy.   Additional Information: GSK Receipt Date: 22-MAR-2024 This case was reported by a patient via (Open field AE monitoring) interactive digital media. The patient had an reaction which was a large swollen, very (illegible text) and very itchy area about the size of a baseball and about 2 inches below the injection site. It had been there for 3 days and was not getting any better and was not going away.
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site bruising, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Administration in left leg (instead of upper arm); Swollen in leg/swelling in the area; red in the area (injection site); was bruising (injection site); it was itchy (injection site); hot in the area (injection site); This non-serious case was reported by a nurse via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 4-year-old male patient who received DTPa-IPV (Kinrix) (batch number 5H958, expiry date 16-FEB-2026) for prophylaxis.   On 18-MAR-2024, the patient received Kinrix (left thigh). In MAR-2024, an unknown time after receiving Kinrix, the patient experienced extensive swelling of vaccinated limb (Verbatim: Swollen in leg/swelling in the area), injection site erythema (Verbatim: red in the area (injection site)), injection site bruising (Verbatim: was bruising (injection site)), injection site itching (Verbatim: it was itchy (injection site)) and injection site warmth (Verbatim: hot in the area (injection site)). On 18-MAR-2024, the patient experienced vaccine administered at inappropriate site (Verbatim: Administration in left leg (instead of upper arm)). The outcome of the extensive swelling of vaccinated limb, injection site erythema, injection site bruising, injection site itching, injection site warmth and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site erythema, injection site bruising, injection site itching and injection site warmth to be related to Kinrix and Kinrix Pre-Filled Syringe Device.     It was unknown if the company considered the extensive swelling of vaccinated limb, injection site erythema, injection site bruising, injection site itching and injection site warmth to be related to Kinrix and Kinrix 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-MAR-2024 The reporter reported that they run to a physician assistant day before reporting (yesterday) that had patient with a reaction to the Kinrix.  The patient was swollen, red, hot in the area, it was itchy it was in the left leg, it was about 4 inches in the longer diameter and it was bruising.  The vaccine was administration in left leg instead of upper arm which led to vaccine administered at inappropriate site. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up. This case was linked with US2024036941, reported by the same reporter.; Sender's Comments:  US-GSK-US2024036941:Same reporter,2nd patient
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered at inappropriate site
Clinical narrative: Administration in left leg (instead of upper arm); Swollen in leg/swelling in the area; red in the area (injection site); was bruising (injection site); it was itchy (injection site); hot in the area (injection site); This non-serious case was reported by a nurse via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 4-year-old male patient who received DTPa-IPV (Kinrix) (batch number 5H958, expiry date 16-FEB-2026) for prophylaxis.   On 18-MAR-2024, the patient received Kinrix (left thigh). In MAR-2024, an unknown time after receiving Kinrix, the patient experienced extensive swelling of vaccinated limb (Verbatim: Swollen in leg/swelling in the area), injection site erythema (Verbatim: red in the area (injection site)), injection site bruising (Verbatim: was bruising (injection site)), injection site itching (Verbatim: it was itchy (injection site)) and injection site warmth (Verbatim: hot in the area (injection site)). On 18-MAR-2024, the patient experienced vaccine administered at inappropriate site (Verbatim: Administration in left leg (instead of upper arm)). The outcome of the extensive swelling of vaccinated limb, injection site erythema, injection site bruising, injection site itching, injection site warmth and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site erythema, injection site bruising, injection site itching and injection site warmth to be related to Kinrix and Kinrix Pre-Filled Syringe Device.     It was unknown if the company considered the extensive swelling of vaccinated limb, injection site erythema, injection site bruising, injection site itching and injection site warmth to be related to Kinrix and Kinrix 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-MAR-2024 The reporter reported that they run to a physician assistant day before reporting (yesterday) that had patient with a reaction to the Kinrix.  The patient was swollen, red, hot in the area, it was itchy it was in the left leg, it was about 4 inches in the longer diameter and it was bruising.  The vaccine was administration in left leg instead of upper arm which led to vaccine administered at inappropriate site. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up. This case was linked with US2024036941, reported by the same reporter.; Sender's Comments:  US-GSK-US2024036941:Same reporter,2nd patient
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, Product administered at inappropriate site
Clinical narrative: Swollen (injection site)/ swollen, warm to the touch, 4 inches in the longer diameter; Itchy (injection site); Warm to the touch (injection site); Erythema (injection site); Administration in left leg (instead of upper arm); This non-serious case was reported by a nurse via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 4-year-old male patient who received DTPa-IPV (Kinrix) (batch number 5H958, expiry date 16-FEB-2026) for prophylaxis.   On 18-MAR-2024, the patient received Kinrix. On 18-MAR-2024, an unknown time after receiving Kinrix, the patient experienced intramuscular formulation administered by other route (Verbatim: Administration in left leg (instead of upper arm)). On an unknown date, the patient experienced extensive swelling of vaccinated limb (Verbatim: Swollen (injection site)/ swollen, warm to the touch, 4 inches in the longer diameter), injection site itching (Verbatim: Itchy (injection site)), injection site warmth (Verbatim: Warm to the touch (injection site)) and injection site erythema (Verbatim: Erythema (injection site)). The outcome of the extensive swelling of vaccinated limb, injection site itching, injection site warmth, injection site erythema and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site itching, injection site warmth and injection site erythema to be related to Kinrix and Kinrix Pre-Filled Syringe Device.     It was unknown if the company considered the extensive swelling of vaccinated limb, injection site itching, injection site warmth and injection site erythema to be related to Kinrix and Kinrix 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-MAR-2024 The reporter reported that they run to a physician assistant that they had patient with a reaction to the Kinrix. The patient got the vaccination on 18th March 2024. The patient were experienced reactions that it was on the left side again, erythema, swollen, warm to the touch, 4 inches in the longer diameter, erythema on the skin, swollen, warm to the touch, 4 inches in the longer diameter, looks like it was itchy but hot at the injection site. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. This case had been linked with the case US2024036936, reported by same reporter.; Sender's Comments:  US-GSK-US2024036936:Same reporter,2nd patient
Age: 0.5
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Pyrexia
Clinical narrative: Patient is back at the clinic today due to high temperature; Patient received Kinrix instead of Infanrix yesterday by mistake; 6 month old patient received Kinrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of high temperature in a 6-month-old male patient who received DTPa-IPV (Kinrix) for prophylaxis.   On 21-MAR-2024, the patient received Kinrix. On 21-MAR-2024, an unknown time after receiving Kinrix, the patient experienced wrong vaccine administered (Verbatim: Patient received Kinrix instead of Infanrix yesterday by mistake) and inappropriate age at vaccine administration (Verbatim: 6 month old patient received Kinrix). On 22-MAR-2024, the patient experienced high temperature (Verbatim: Patient is back at the clinic today due to high temperature). The outcome of the high temperature was not resolved and the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   It was unknown if the reporter considered the high temperature to be related to Kinrix and Kinrix Pre-Filled Syringe Device.     It was unknown if the company considered the high temperature to be related to Kinrix and Kinrix 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: 22-MAR-2024 The reporter was from a family medical center who stated a 6 month old male patient received Kinrix instead of Infanrix a day before reporting by mistake, which led to wrong vaccine administered and inappropriate age at vaccine administration. According to the reporter the patient was back at the clinic on the day of reporting due to high temperature and refused Tylenol.  The patient was being seen by the doctor at the time of the call. The reporter consented to follow up.
Age: 40.0
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: Boostrix that expired on 11/18/2023 was administered to a patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 40-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 4547C, expiry date 18-NOV-2023) for prophylaxis.   On 19-MAR-2024, the patient received Boostrix. On 19-MAR-2024, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: Boostrix that expired on 11/18/2023 was administered to a patient). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 25-MAR-2024 The reporter stated that expired Boostrix was administered to a patient, which led to expired vaccine used. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up via postal.
Sex: U
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: patient received an expired dose of Menveo (2-vial).; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMAA859A, expiry date 31-JAN-2024) and (batch number AMXA859A, expiry date FEB-2025) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: patient received an expired dose of Menveo (2-vial).). The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 25-MAR-2024 Pharmacist called to report that a patient received an expired dose of Menveo (2-vial).  The powder expiration date was January 2024, and the diluent was February 2025. Lot number in the box was AMVA859A Pharmacist did not have any patient demographics. The patient received expired powder, which led to expired vaccine used.
Age: 71.0
Sex: F
Vaccine: TDAP
Symptoms: Wrong product administered
Clinical narrative: patient received Boostrix instead of Td vaccine.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 71-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number ET475, expiry date 08-MAY-2026) for prophylaxis.   On 28-MAR-2024, the patient received Boostrix. On 28-MAR-2024, an unknown time after receiving Boostrix, the patient experienced wrong vaccine administered (Verbatim: patient received Boostrix instead of Td vaccine.). The outcome of the wrong vaccine administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 28-MAR-2024 A medical assistant reported that a patient received Boostrix instead of Td vaccine which led to wrong vaccine administered. The HCP wanted to know if there was any risk for the patient.
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Severe chattering of teeth lasting approximately 30 minutes, 2 hours  after having received a Moderna Spikevax dose; This spontaneous case was reported by a pharmacist and describes the occurrence of CHILLS (Severe chattering of teeth lasting approximately 30 minutes, 2 hours  after having received a Moderna Spikevax dose) 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,  after starting SPIKEVAX NOS (SPIKEVAX NOS), the patient experienced CHILLS (Severe chattering of teeth lasting approximately 30 minutes, 2 hours  after having received a Moderna Spikevax dose). At the time of the report, CHILLS (Severe chattering of teeth lasting approximately 30 minutes, 2 hours  after having received a Moderna Spikevax dose) had resolved.        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.   Concomitant medication was not provided.  Patient received the vaccine over a year ago. She had severe chattering of teeth after 2 hours of vaccination, it lasted for approximately for 30 minutes. She was unable to assess whether she was febrile at that time.  Treatment information was not reported.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Got sick; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ILLNESS (Got sick) in an 86-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Got sick). At the time of the report, ILLNESS (Got sick) had resolved.        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.   Concomitant medication was not provided. Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2024-764497, US-MODERNATX, INC.-MOD-2024-764704 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 02-Apr-2024: Live follow-up received and added no new information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-764497:Same reporter, Daughter Case US-MODERNATX, INC.-MOD-2024-764704:Same reporter, Father Case
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: got sick; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ILLNESS (got sick) in a 90-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) (batch no. ASKU) 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 ILLNESS (got sick). At the time of the report, ILLNESS (got sick) had resolved.        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.   Concomitant product use was not provided by the reporter. Treatment information was not provided.   Patient was in the hospital because he had a quadruple bypass and he was in there for two months.   This case was linked to US-MODERNATX, INC.-MOD-2024-764658 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 02-Apr-2024: LIve significant follow-up received- added; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-764658:Same reporter different patient
Sex: U
Vaccine: PNC20
Symptoms: No adverse event, Syringe issue
Clinical narrative: After the vaccine was administered, the luer lock part of the syringe broke off from the phalange from the head of the syringe; After the vaccine was administered, the luer lock part of the syringe broke off from the phalange from the head of the syringe; This is a spontaneous report received from a Nurse.  A patient (age and gender not provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 27Mar2024 as dose number unknown, 0.5 ml single (Lot number: HH9323, Expiration Date: May2025) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: POOR QUALITY DEVICE USED (non-serious), SYRINGE ISSUE (non-serious) all with onset 27Mar2024 and all described as "After the vaccine was administered, the luer lock part of the syringe broke off from the phalange from the head of the syringe".  Additional information: The reporter stated that after the nurse administered the vaccine, she went to go put on the safety on the attached needle and the luer lock part of the syringe broke off from the phalange from the head of the syringe. States no harm reached the patient and the patient did not get hurt but she does not know the patient specific details for the patient to provide and that nurse is not here today to ask for patient specific information. She thinks the Prevnar 20 was administered yesterday 27Mar2024 to the patient. The lot number of the Prevnar 20 is HH9323, expiry date May2025 and NDC 0005-2000-01 and the needles are manufactured by (withheld) safety needles. The patient did not require treatment for the reported event.  Causality for "after the vaccine was administered, the luer lock part of the syringe broke off from the phalange from the head of the syringe" was determined associated to device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein).
Sex: U
Vaccine: RSV
Symptoms: Device breakage
Clinical narrative: Vial adapter would not puncture vial; This is a spontaneous report received from a Pharmacist.  A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Lot number: HN3801, Expiration Date: Mar2025) and as dose number unknown, single (Lot number: HC3598, Expiration Date: Mar2025) for immunisation, Device Lot Number: H758, Device Expiration Date: 01May2028. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE ISSUE (non-serious), outcome "unknown", described as "Vial adapter would not puncture vial".  Additional information: There was no patient involvement. When clarifying details of broken piece and dose, caller stated, when they went to diluted it, vial adapter would not puncture the vial. Noticed, the piece inside the vial, the little plastic piece that is supposed to be sharp, was not sharp, would not puncture through the vial.  The reporter considered "vial adapter would not puncture vial" not related to rsv vaccine prot.subunit pref 2v. Causality for "vial adapter would not puncture vial" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).
Sex: M
Vaccine: FLUX
Symptoms: Acute myocardial infarction, C-reactive protein increased, Chest pain, Electrocardiogram PR segment depression, Electrocardiogram ST segment elevation
Clinical narrative: Myopericarditis; mild cold symptoms; chest pain; diaphoresis; nausea; emesis; pericardial rub; Initial information received on 27-Mar-2024 via Other Health care professional regarding an unsolicited valid serious case issued from a literature article:  This case involves a 27-year-old male patient who experienced myopericarditis while receiving vaccine Influenza Vaccine (Latency: approximately few days).  The patient's past medical treatment(s), vaccination(s) were not provided.   On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.  Patient with no medical history presented to the emergency room with chest pain accompanied by diaphoresis (Hyperhidrosis), nausea, and emesis. In the emergency department, he was found to have an elevated troponin level. He was loaded with aspirin, started on a heparin drip, and transferred to our facility for possible catheterization for suspected non-St elevation myocardial infarction. Decision-making On further questioning, he reported receiving an influenza vaccination a few days prior to onset of chest pain and had experienced mild cold symptoms (Nasopharyngitis). He denied any history of chest pain in the past and endorsed an active lifestyle. Exam revealed a pericardial rub. Electrocardiogram was suspicious for pericarditis with diffuse ST elevations and PR depressions. Labs showed elevated erythrocyte sedimentation rate and c-reactive protein (CRP). Given patient's young age, no family history of early cardiac disease, and high suspicion for pericarditis, he was started on colchicine and high dose aspirin. A cardiac magnetic resonance imaging was also obtained and revealed findings consistent with myocarditis. His symptoms improved over the following two days with a decrease in CRP.   Action taken: not applicable. Corrective treatment: aspirin, heparin drip, colchicine for the event Outcome: recovering for the event Seriousness criteria: Medically significant and hospitalization  Reporter causality: related for all events; Sender's Comments: Sanofi company comment dated 02-Apr-2024: This case involves a 27-year-old male patient who experienced myopericarditis while receiving vaccine Influenza Vaccine. Based on the limited information received the causal role of VACCINE cannot be excluded due to compatible temporal relationship of ADR to the VACCINE. Further information regarding concurrent condition during vaccination, previous vaccination, tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of vaccine cannot be assessed completely.
Sex: M
Vaccine: FLUX
Symptoms: Hyperhidrosis, Magnetic resonance imaging heart abnormal, Myopericarditis, Nasopharyngitis, Nausea
Clinical narrative: Myopericarditis; mild cold symptoms; chest pain; diaphoresis; nausea; emesis; pericardial rub; Initial information received on 27-Mar-2024 via Other Health care professional regarding an unsolicited valid serious case issued from a literature article:  This case involves a 27-year-old male patient who experienced myopericarditis while receiving vaccine Influenza Vaccine (Latency: approximately few days).  The patient's past medical treatment(s), vaccination(s) were not provided.   On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.  Patient with no medical history presented to the emergency room with chest pain accompanied by diaphoresis (Hyperhidrosis), nausea, and emesis. In the emergency department, he was found to have an elevated troponin level. He was loaded with aspirin, started on a heparin drip, and transferred to our facility for possible catheterization for suspected non-St elevation myocardial infarction. Decision-making On further questioning, he reported receiving an influenza vaccination a few days prior to onset of chest pain and had experienced mild cold symptoms (Nasopharyngitis). He denied any history of chest pain in the past and endorsed an active lifestyle. Exam revealed a pericardial rub. Electrocardiogram was suspicious for pericarditis with diffuse ST elevations and PR depressions. Labs showed elevated erythrocyte sedimentation rate and c-reactive protein (CRP). Given patient's young age, no family history of early cardiac disease, and high suspicion for pericarditis, he was started on colchicine and high dose aspirin. A cardiac magnetic resonance imaging was also obtained and revealed findings consistent with myocarditis. His symptoms improved over the following two days with a decrease in CRP.   Action taken: not applicable. Corrective treatment: aspirin, heparin drip, colchicine for the event Outcome: recovering for the event Seriousness criteria: Medically significant and hospitalization  Reporter causality: related for all events; Sender's Comments: Sanofi company comment dated 02-Apr-2024: This case involves a 27-year-old male patient who experienced myopericarditis while receiving vaccine Influenza Vaccine. Based on the limited information received the causal role of VACCINE cannot be excluded due to compatible temporal relationship of ADR to the VACCINE. Further information regarding concurrent condition during vaccination, previous vaccination, tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of vaccine cannot be assessed completely.
Sex: M
Vaccine: FLUX
Symptoms: Pericardial rub, Red blood cell sedimentation rate increased, Troponin increased, Vomiting
Clinical narrative: Myopericarditis; mild cold symptoms; chest pain; diaphoresis; nausea; emesis; pericardial rub; Initial information received on 27-Mar-2024 via Other Health care professional regarding an unsolicited valid serious case issued from a literature article:  This case involves a 27-year-old male patient who experienced myopericarditis while receiving vaccine Influenza Vaccine (Latency: approximately few days).  The patient's past medical treatment(s), vaccination(s) were not provided.   On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.  Patient with no medical history presented to the emergency room with chest pain accompanied by diaphoresis (Hyperhidrosis), nausea, and emesis. In the emergency department, he was found to have an elevated troponin level. He was loaded with aspirin, started on a heparin drip, and transferred to our facility for possible catheterization for suspected non-St elevation myocardial infarction. Decision-making On further questioning, he reported receiving an influenza vaccination a few days prior to onset of chest pain and had experienced mild cold symptoms (Nasopharyngitis). He denied any history of chest pain in the past and endorsed an active lifestyle. Exam revealed a pericardial rub. Electrocardiogram was suspicious for pericarditis with diffuse ST elevations and PR depressions. Labs showed elevated erythrocyte sedimentation rate and c-reactive protein (CRP). Given patient's young age, no family history of early cardiac disease, and high suspicion for pericarditis, he was started on colchicine and high dose aspirin. A cardiac magnetic resonance imaging was also obtained and revealed findings consistent with myocarditis. His symptoms improved over the following two days with a decrease in CRP.   Action taken: not applicable. Corrective treatment: aspirin, heparin drip, colchicine for the event Outcome: recovering for the event Seriousness criteria: Medically significant and hospitalization  Reporter causality: related for all events; Sender's Comments: Sanofi company comment dated 02-Apr-2024: This case involves a 27-year-old male patient who experienced myopericarditis while receiving vaccine Influenza Vaccine. Based on the limited information received the causal role of VACCINE cannot be excluded due to compatible temporal relationship of ADR to the VACCINE. Further information regarding concurrent condition during vaccination, previous vaccination, tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of vaccine cannot be assessed completely.
Age: 0.75
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered
Clinical narrative: expired pentacel was given to a patient/it was just 4 days since the vaccine expired with no reported adverse event; Initial information received on 28-Mar-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 9 months and 21 days old female patient who was administered expired Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine [Pentacel (Vero)] it was just 4 days since the vaccine expired with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Pneumococcal Vaccine CONJ 15V (CRM197) (Vaxneuvance) for Immunisation.  On 28-Mar-2024, the patient received 0.5 ml  dose of expired suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine (Suspension for injection) it was just 4 days since the vaccine expired with no reported adverse event (expired product administered) (Latency: same day) (lot UJ870AA, expiry: 24-Mar-2024) (Strength: standard) via intramuscular route in the right thigh for Immunization.  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.
Age: 1.25
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired acthib was administered to one patient with no reported adverse event; Initial information received on 28-Mar-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 15 months old female patient who administered expired HIB (PRP/T) Vaccine [ACT-HIB] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular 3-Component, Tetanus Vaccine Toxoid (Infanrix) and Pneumococcal Vaccine CONJ 15V (CRM197) (Vaxneuvance) for prophylactic vaccination (Immunisation).  On 27-Mar-2024, the patient received 0.5 ml dose of expired suspect HIB (PRP/T) Vaccine (Powder and solvent for solution for injection) with no reported adverse event (expired product administered) (Latency: same day) (lot UJ855AA, expiry: 22-Mar-2024) (Frequency: once) (strength: standard) via intramuscular route in the right thigh for Immunisation.  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.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient was administered with the expired PENTACEL with no reported adverse event; Initial information received on 28-Mar-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 4 months old female patient who was administered expired Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine [Pentacel (Vero)] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Rotavirus Vaccine Live Reassort Oral 5V (Rotateq) and Pneumococcal Vaccine Conj 20V (CRM197) (Prevnar 20) for Prophylactic vaccination.  On 28-Mar-2024, the patient received 0.5 ml (dose 1) of expired suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine (Suspension for injection) with no reported adverse event (expired product administered) (Latency: Same day) (lot UJ869AA) (expiry: 23-Mar-2024) (Strength: standard) via intramuscular route in left vastus lateralis for Immunization.  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.
Age: 37.0
Sex: M
Vaccine: YF
Symptoms: No adverse event, Product preparation error
Clinical narrative: administering YF-VAX to a patient that was diluted with sterile water instead of the supplied diluent with no reported adverse event; Initial information received on 01-Apr-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 37 years old male patient who administering Yellow Fever Vaccine - [YF-VAX] that was diluted with sterile water instead of the supplied diluent with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 29-Feb-2024, the patient received Unknown dose of suspect Yellow Fever Vaccine- (Solution for injection) that was diluted with sterile water instead of the supplied diluent with no reported adverse event (product preparation error) (Latency: same day) (lot number, expiry not reported) (strength: standard, Frequency: once) via intramuscular route in unknown administration site for Immunization. Information regarding batch number will be requested in this case.  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.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: administered an expired dose of PENTACEL with no reported adverse event; Initial information received on 01-Apr-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 15 months old male patient who was administered an expired dose of Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine [Pentacel (Vero)] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Hepatitis A Vaccine (Hepatitis A) for Prophylactic vaccination.  On 28-Mar-2024, the patient received 0.5 ml dose of expired suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine (Suspension for injection) with no reported adverse event (expired product administered) (Latency: same day) (lot UJ877AA) (expiry: 22-Mar-2024) (Frequency: once) (strength: Standard) via unknown route in Thigh NOS (not otherwise specified) (Left Vastus Lateralis)  for Immunization.  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.