chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HIBV
Symptoms: Device connection issue, Device defective, Product complaint, Product preparation issue
Clinical narrative: extracted and reconstituted diluent using different syringe and needle; needle was not able to be attached at all in syringe; Product Complaint; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate reconstitution technique in a patient who received Hib (Hiberix) (batch number ED9P2, expiry date 30-SEP-2025) for prophylaxis. This case was associated with a product complaint.   On an unknown date, the patient received Hiberix. On an unknown date, an unknown time after receiving Hiberix, the patient experienced inappropriate reconstitution technique (Verbatim: extracted and reconstituted diluent using different syringe and needle), syringe connection issue (Verbatim: needle was not able to be attached at all in syringe) and pharmaceutical product complaint (Verbatim: Product Complaint). The outcome of the inappropriate reconstitution technique, syringe connection issue and pharmaceutical product complaint were unknown.   Additional Information: GSK Receipt Date: 09-APR-2024 Healthcare professional office was closed for 2 doses of Hiberix. The patient did review the Product information for use step by step. The patient did confirm there was no damage due to shipping. The nurse stated that when the administrator took a Hiberix syringe out of a new box that had just been opened, and went to attach the Luer Lock needle to the Luer Lock Adaptor, as soon as the administrator touched the Luer Lock Adaptor, it fell off the syringe. This happened the same way with a second Hiberix syringe from the same box. The needle was not able to be attached at all in either suspect syringe. It was confirmed that all operations were performed appropriately before defect was discovered.  The defect was discovered during preparation and the 2 doses were in a brand new box that was just opened. The mixing/shaking is performed gently. One suspect dose of Hiberix was administered and one suspect dose of Hiberix was not administered. The HCP preparing the 2 doses of Hiberix was an experienced user. The component impacted was the Leur Lock adaptor on both suspect syringes. A picture of the defect will be sent via the email provided from content. Cannot attach needle to syringe or Luer Lock defect. 25G 5/8 Luer Lock needle. The cap was Screwed off. The needles were not able to be connected as the Luer Lock adaptor fell off when contact was made.  The reporter is a Nurse for a Pediatric Office and reported that because the Luer Lock Adaptor fell off of the Hiberix syringe, the experienced administrator in the practice held the Luer Lock Adaptor in place and extracted the diluent component using a different syringe and needle that was not provided with the Hiberix, and used it to reconstitute the vaccine and administer one dose of Hiberix.
Sex: U
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: a pediatric dose of Engerix-B given to adult; a pediatric dose of Engerix-B given to adult; This non-serious case was reported by a nurse via call center representative and described the occurrence of underdose in a adult patient who received HBV (Engerix B pediatric) (batch number f5l5e, expiry date 04-NOV-2025) for prophylaxis.   On an unknown date, the patient received Engerix B pediatric. On an unknown date, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: a pediatric dose of Engerix-B given to adult) and adult use of a child product (Verbatim: a pediatric dose of Engerix-B given to adult). The outcome of the underdose and adult use of a child product 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: 10-APR-2024 The nurse from vaccine service center reported that, when she was checking on lot and realized that a pediatric dose of Engerix-B was given to 20 and 21 year old patient, which led to an underdose and adult use of a child product. The reporter did not consent to follow up. This case was linked with US2024046338 reported by same reporter.; Sender's Comments:  US-GSK-US2024046338:Same reporter / different patient
Age: 0.33
Sex: F
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 4 month old baby accidentally received a dose of flulaval; This non-serious case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2023-2024 season) (batch number B2L4G, expiry date 30-JUN-2024) for prophylaxis.   On 25-MAR-2024, the patient received FluLaval Quadrivalent 2023-2024 season. On 25-MAR-2024, an unknown time after receiving FluLaval Quadrivalent 2023-2024 season, the patient experienced inappropriate age at vaccine administration (Verbatim: 4 month old baby accidentally received a dose of flulaval). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 11-APR-2024 The doctor reported that a 4 month old baby accidentally received a dose of Flulaval, he/she knew its early and before 6 month recommendation, which led to inappropriate age at vaccine administration. The reporter asked was there any recommendations or side effects, was it okay to give a second dose at six months or restart the series. The vaccine administration facility was the same as primary reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Swelling face
Clinical narrative: swollen face; itching; redness on the face; This non-serious case was reported by a consumer via call center representative and described the occurrence of facial swelling in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced facial swelling (Verbatim: swollen face), pruritus (Verbatim: itching) and red face (Verbatim: redness on the face). The outcome of the facial swelling, pruritus and red face were unknown.   It was unknown if the reporter considered the facial swelling, pruritus and red face to be related to Shingrix.     It was unknown if the company considered the facial swelling, pruritus and red face to be related to Shingrix.   Additional Information: GSK Receipt Date: 11-APR-2024 The reporter was patient's friend. The patient developed symptoms after receiving the Shingrix vaccine. The patient developed a swollen face, redness on the face, and itching.
Sex: U
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: administration of antigen without reconstitution with adjuvant; administration of antigen without reconstitution with adjuvant; 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 Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: administration of antigen without reconstitution with adjuvant) and inappropriate dose of vaccine administered (Verbatim: administration of antigen without reconstitution with adjuvant). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 11-APR-2024  The health care provider reported that one of the medical assistants administered Shingrix without the adjuvant.  The patient received the antigen only. The reporter asked, what would be advised next steps. The patient received only antigen of Shingrix without reconstitution with adjuvant, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The vaccine administration facility was the same as primary reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Skin warm
Clinical narrative: arm has been sore; Warm arm/arm was warm; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number YN592, expiry date 10-FEB-2026) for prophylaxis.   On 19-FEB-2024, the patient received the 1st dose of Shingrix. On 19-FEB-2024, less than a day after receiving Shingrix, the patient experienced pain in arm (Verbatim: arm has been sore) and skin warm (Verbatim: Warm arm/arm was warm). The outcome of the pain in arm was not resolved and the outcome of the skin warm was resolved.   It was unknown if the reporter considered the pain in arm and skin warm to be related to Shingrix.     It was unknown if the company considered the pain in arm and skin warm to be related to Shingrix.   Additional Information: GSK Receipt Date: 12-APR-2024 The pharmacist explained that the patient received first dose of Shingrix and first couple of days her arm was warm and her arm had been sore ever since and almost 2 months later (53 days so far).  The reporter clarified they were not worried the shot was administered too high and it was in the right place but still hurted and that was unusual. The vaccine administration facility was the same as primary reporter. The reporter consent to follow up.
Age: 0.83
Sex: U
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: DTaP, IPV, Hib vaccine so they should administer Pediarix but, accidentally administered Kinrix; patient who is less than 1 year recived Kinrix 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 10-month-old patient who received DTPa-IPV (Kinrix) (batch number 7D2Y4, expiry date 22-AUG-2025) for prophylaxis.   On 11-APR-2024, the patient received the 1st dose of Kinrix. On 11-APR-2024, an unknown time after receiving Kinrix, the patient experienced wrong vaccine administered (Verbatim: DTaP, IPV, Hib vaccine so they should administer Pediarix but, accidentally administered Kinrix) and inappropriate age at vaccine administration (Verbatim: patient who is less than 1 year recived Kinrix vaccine). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration 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: 12-APR-2024 The healthcare professional reported that  the patient who was less than 1 year, needed the DTaP, IPV, Hib vaccine, so they should administer Pediarix but accidentally administered Kinrix which led to, wrong vaccine administered and inappropriate age at vaccine administration. The vaccine administration facility was the same as primary reporter. The reporter consent the follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Anaphylactic shock, Chest discomfort, Dyspnoea
Clinical narrative: Customer was diagnosed with anaphylactic shock in the emergency department; night had chest pressure; shortness of breath; This serious case was reported by a pharmacist via sales rep and described the occurrence of anaphylactic shock in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   In APR-2024, the patient received Shingrix .5 ml. In APR-2024, less than a week after receiving Shingrix, the patient experienced anaphylactic shock (Verbatim: Customer was diagnosed with anaphylactic shock in the emergency department) (serious criteria hospitalization and GSK medically significant), chest pressure (Verbatim: night had chest pressure) (serious criteria hospitalization) and shortness of breath (Verbatim: shortness of breath) (serious criteria hospitalization). The outcome of the anaphylactic shock, chest pressure and shortness of breath were resolved.   It was unknown if the reporter considered the anaphylactic shock, chest pressure and shortness of breath to be related to Shingrix.     It was unknown if the company considered the anaphylactic shock, chest pressure and shortness of breath to be related to Shingrix.   Additional Information: GSK Receipt Date: 16-APR-2024 Sales representative called on behalf of an healthcare professional (HCP). HCP identified herself as a pharmacist to the Sales Representative. Sales representative attempted to get more information to identify healthcare professional HCP.  However, pharmacy staff was uncomfortable giving HCP's full name and title. Limited information was available for adverse events. Reporter stated that the adverse event has been previously reported but she does not know where it was reported. Reporter stated that a customer received vaccine last week. Customer stayed in pharmacy and was monitored after administration of vaccine and had no adverse reaction. Customer went home and that night had chest pressure and shortness of breath. Customer then went to the emergency department. Customer was diagnosed with anaphylactic shock in the emergency department. It was unknown if the customer was admitted to the hospital.  Reporter stated that the customer called the pharmacy at some point after the hospital event and said that they were ok. Initials and date of birth of customer were not available. No further information available at time of call. The reporter consented to follow up. Emergency department (ER) Visit Required.
Age: 1.0
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Seizure
Clinical narrative: got a seizure; This serious case was reported by a other health professional via call center representative and described the occurrence of seizure in a 1-year-old male patient who received DTPa (Infanrix) (batch number TX77L, expiry date 21-FEB-2025) for prophylaxis.   Co-suspect products included Pneumococcal vaccine conj 7v (CRM197) (Prevenar) for prophylaxis and HIB vaccine for prophylaxis.   On 16-APR-2024, the patient received Infanrix, Prevenar and HIB vaccine. In APR-2024, an unknown time after receiving Infanrix, the patient experienced seizure (Verbatim: got a seizure) (serious criteria GSK medically significant). The outcome of the seizure was unknown.   It was unknown if the reporter considered the seizure to be related to Infanrix and Infanrix Pre-Filled Syringe Device.     It was unknown if the company considered the seizure to be related to Infanrix and Infanrix 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: 17-APR-2024 Medical assistant reported that a patient receive Infanrix and then got a seizure. The reporter consented to follow up. The Vaccine Administration Facility was the same as Primary Reporter. The same day received Prevenar and Hib (non-GSK vaccines). It was unknown if the reporter considered the seizure to be related to Prevenar and HIB vaccine. This case had been linked with US2024049460, reported by the same reporter.; Sender's Comments:  US-GSK-US2024049460:2ND PATIENT
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Death; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Death) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Suspect product dosage text was reported as unknown. No treatment medication was reported. This case is reported for patient 37 out of 68 patients.  Company Comment This spontaneous case concerns a patient of an unknown age and gender, with no reported medical history, who experienced the unexpected, (due to medically significant), fatal event of death, which occurred on an unknown date and with unknown latency after a dose of mRNA-1273 vaccine. Death occurred on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. No further information was disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2024-761576 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-761576:Patient 37 out of 68; Reported Cause(s) of Death: unknown cause of death
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune disorder
Clinical narrative: I have autoimmune; This spontaneous case was reported by a patient and describes the occurrence of AUTOIMMUNE DISORDER (I have autoimmune) 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 AUTOIMMUNE DISORDER (I have autoimmune) (seriousness criterion medically significant). At the time of the report, AUTOIMMUNE DISORDER (I have autoimmune) outcome was unknown.            The concomitant medication was not reported by reporter.  It was reported that patient had a Moderna first shot wayback March or April 2020, and she had it every 6 months having the last shot on October 2023 confirming that it was the 2023-2024 formula. Patient stated as per her verbatim "she was autoimmune. Well, they think it's autoimmune and her symptoms had increased very, very much so in the last couple of years and she just wanted to see if there was any relationship between the vaccine and this type of symptom, ground glass X, CT scans, that kind of thing.   The treatment medication was not reported by reporter.  Company comment-This is a spontaneous case concerning a female patient of an unknown age with no reported medical history, who experienced the serious (medically significant) unexpected event autoimmune disorder on an unknown date after a dose of SPIKEVAX NOS vaccine was administered. Temporal association cannot be assessed due to lack of information on onset date of the event and vaccination date. It was reported patient was autoimmune, they think it's autoimmune and her symptoms had increased very, very much so in the last couple of years. No further details were provided for medical review. The benefit-risk relationship of SPIKEVAX NOS vaccine is not affected by this report. Event´s seriousness assessed as reported.   This case was linked to MOD-2024-765848 (Patient Link).
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Brain fog, Chills, Contusion, Dizziness, Dyspnoea
Clinical narrative: brain fog; shortness of breath; sore left arm, and top arm above the elbow became hard and slightly bruised; sore left arm, and top arm above the elbow became hard and slightly bruised; shivers with a sensitivity to light; sore left arm, and top arm above the elbow became hard and slightly bruised; dizzy; shivers with a sensitivity to light; This spontaneous case was reported by an other health care professional and describes the occurrence of BRAIN FOG (brain fog), DYSPNOEA (shortness of breath), CONTUSION (sore left arm, and top arm above the elbow became hard and slightly bruised), MUSCULOSKELETAL STIFFNESS (sore left arm, and top arm above the elbow became hard and slightly bruised) and PHOTOPHOBIA (shivers with a sensitivity to light) in a 34-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 208H23A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) 1 dosage form. On 17-Apr-2024, the patient experienced BRAIN FOG (brain fog), DYSPNOEA (shortness of breath), CONTUSION (sore left arm, and top arm above the elbow became hard and slightly bruised), MUSCULOSKELETAL STIFFNESS (sore left arm, and top arm above the elbow became hard and slightly bruised), PHOTOPHOBIA (shivers with a sensitivity to light), PAIN IN EXTREMITY (sore left arm, and top arm above the elbow became hard and slightly bruised), DIZZINESS (dizzy) and CHILLS (shivers with a sensitivity to light). At the time of the report, BRAIN FOG (brain fog), DYSPNOEA (shortness of breath), CONTUSION (sore left arm, and top arm above the elbow became hard and slightly bruised), MUSCULOSKELETAL STIFFNESS (sore left arm, and top arm above the elbow became hard and slightly bruised), PHOTOPHOBIA (shivers with a sensitivity to light), PAIN IN EXTREMITY (sore left arm, and top arm above the elbow became hard and slightly bruised), DIZZINESS (dizzy) and CHILLS (shivers with a sensitivity to light) was resolving.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant drugs were reported. The patient did not experience any additional symptoms/events.  Treatment drugs were not provided.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Pain in extremity, Photophobia
Clinical narrative: brain fog; shortness of breath; sore left arm, and top arm above the elbow became hard and slightly bruised; sore left arm, and top arm above the elbow became hard and slightly bruised; shivers with a sensitivity to light; sore left arm, and top arm above the elbow became hard and slightly bruised; dizzy; shivers with a sensitivity to light; This spontaneous case was reported by an other health care professional and describes the occurrence of BRAIN FOG (brain fog), DYSPNOEA (shortness of breath), CONTUSION (sore left arm, and top arm above the elbow became hard and slightly bruised), MUSCULOSKELETAL STIFFNESS (sore left arm, and top arm above the elbow became hard and slightly bruised) and PHOTOPHOBIA (shivers with a sensitivity to light) in a 34-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 208H23A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) 1 dosage form. On 17-Apr-2024, the patient experienced BRAIN FOG (brain fog), DYSPNOEA (shortness of breath), CONTUSION (sore left arm, and top arm above the elbow became hard and slightly bruised), MUSCULOSKELETAL STIFFNESS (sore left arm, and top arm above the elbow became hard and slightly bruised), PHOTOPHOBIA (shivers with a sensitivity to light), PAIN IN EXTREMITY (sore left arm, and top arm above the elbow became hard and slightly bruised), DIZZINESS (dizzy) and CHILLS (shivers with a sensitivity to light). At the time of the report, BRAIN FOG (brain fog), DYSPNOEA (shortness of breath), CONTUSION (sore left arm, and top arm above the elbow became hard and slightly bruised), MUSCULOSKELETAL STIFFNESS (sore left arm, and top arm above the elbow became hard and slightly bruised), PHOTOPHOBIA (shivers with a sensitivity to light), PAIN IN EXTREMITY (sore left arm, and top arm above the elbow became hard and slightly bruised), DIZZINESS (dizzy) and CHILLS (shivers with a sensitivity to light) was resolving.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant drugs were reported. The patient did not experience any additional symptoms/events.  Treatment drugs were not provided.
Sex: F
Vaccine: COVID19
Symptoms: Gastrointestinal disorder
Clinical narrative: she stated that "they're examining what the problem is with my small intestine; This spontaneous case was reported by a consumer and describes the occurrence of GASTROINTESTINAL DISORDER (she stated that "they're examining what the problem is with my small intestine) in a female patient of an unknown age 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 GASTROINTESTINAL DISORDER (she stated that "they're examining what the problem is with my small intestine). At the time of the report, GASTROINTESTINAL DISORDER (she stated that "they're examining what the problem is with my small intestine) outcome was unknown.        For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was unknown if the patient had received any other vaccines in the 4 weeks prior to COVID-19 vaccine. At the time of reporting patient stated that she had received moderna vaccine over 5 months ago and was going to have MRI-E "the one with barium" in about 3 weeks. Patient stated that needed an MRI-E test with Barium drink and a contrast dye and that she needed to know whether or not the Moderna vaccine's efficacy would be altered. Patient mentioned that she had already received moderna vaccine many times. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2024: Live non-significant follow-up received and updated narrative.
Sex: U
Vaccine: RSV
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain Barre; This is a spontaneous report received from a physician from medical information team.  A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), 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: GUILLAIN-BARRE SYNDROME (medically significant), outcome "unknown", described as "Guillain Barre". The reporting physician was asking someone from the medical team to set up an appointment to speak to another physician immediately regarding Abrysvo and serious side effects such as Guillain Barre (also reported as non-serious).  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the event Guillain-Barre syndrome and the suspect drug RSV VACCINE PROT.SUBUNIT PREF 2V cannot be excluded. The case will be reassessed once new information is available. 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: M
Vaccine: COVID19
Symptoms: Malignant melanoma
Clinical narrative: Melanoma; This is a spontaneous report received from a Physician.  An adult male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (DOSE 1, SINGLE), for COVID-19 immunization. The following information was reported: MALIGNANT MELANOMA (medically significant) with onset Apr2024, outcome "not recovered", described as "Melanoma". The event "melanoma" required physician office visit. It was unknown if therapeutic measures were taken as a result of malignant melanoma. Clinical course: It was unknown if patient had tested COVID positive post vaccination and patient was not COVID positive before vaccination. It was unknown if patient received any other vaccine in 4 weeks.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the event malignant melanoma and the suspect drug BNT162B2 OMI XBB.1.5 cannot be excluded. The case will be reassessed once new information is available. 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: COVID-19, Drug ineffective
Clinical narrative: Drug ineffective; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 44-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 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: COVID-19 (medically significant) with onset Apr2024, outcome "unknown"; DRUG INEFFECTIVE (medically significant) with onset Apr2024, outcome "unknown". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 11Apr2024 to 15Apr2024.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Dry skin
Clinical narrative: a hard layer of dry skin under my feet; This is a spontaneous report received from a Consumer or other non HCP.  A 24-year-old male patient received BNT162b2 (BNT162B2), on 24Mar2021 as dose 1, single (Lot number: EN 6204) at the age of 24 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Dog Allergy" (unspecified if ongoing), notes: Dog Allergy. The patient's concomitant medications were not reported. The following information was reported: DRY SKIN (non-serious), outcome "recovered", described as "a hard layer of dry skin under my feet".  Additional Information: The reporter stated that after the 1st dose developed a hard layer of dry skin under my feet, and  slid on hardwood floor from it. It went away in a few weeks. The patient was not tested for COVID prior to and post vaccination
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Rheumatoid arthritis
Clinical narrative: Developed rheumatoid arthritis; This is a spontaneous report received from a Consumer or other non HCP.  A 65-year-old female patient received BNT162b2 (BNT162B2), on 21Feb2021 as dose 1, single (Lot number: EZ9266) at the age of 65 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "heart disease" (ongoing). The patient's concomitant medications were not reported. The following information was reported: RHEUMATOID ARTHRITIS (medically significant) with onset 2021, outcome "unknown", described as "Developed rheumatoid arthritis". Therapeutic measures were taken as a result of rheumatoid arthritis with Leflunomide and Hydroxychloroquine (Plaquenil), tablets of Methotrexate.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400092061 Same Patient/reporter/drug/AE, different dose;US-PFIZER INC-202400092062 Same Patient/reporter/drug/AE, different dose;US-PFIZER INC-202400092060 Same Patient/reporter/drug/AE, different dose;
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Investigation, Rheumatoid arthritis
Clinical narrative: In between each one when I have a flare, I take a Prednisolone/still have flares in between; This is a spontaneous report received from a Consumer or other non HCP.  A 68-year-old female patient received BNT162b2 (BNT162B2), on 14Mar2021 as dose 2, single (Lot number: EN6207) at the age of 65 years for covid-19 immunisation. The patient's relevant medical history included: "heart disease" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE , Lot number: EZ9266, Route of administration: Intramuscular, Anatomical location: Consumer stated, I think I got it the left arm.), administration date: 21Feb2021, when the patient was 65-year-old, for COVID-19 Immunization, reaction(s): "Developed rheumatoid arthritis". The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "not recovered", described as "In between each one when I have a flare, I take a Prednisolone/still have flares in between". The patient underwent the following laboratory tests and procedures: Investigations: Unknown results. Therapeutic measures were taken as a result of rheumatoid arthritis. Clinical course: Consumer stated, she developed rheumatoid arthritis. Consumer stated, There were years from now, so she be at 65. Consumer stated, Yes, she was believing that's the one. There wasn't too far after that, that she developed it. There was no time on here. Not on the first one but on the second one there was a time. Vaccination facility details: It was a hospital. It was at the same place. (Institution name withheld) Hospital. They had 4 vaccines. When probed to clarify the vaccine details after which she experienced rheumatoid arthritis: Consumer stated, she thought it was the very first one. She had been on treatment ever since. This (Unclear voice) she started out with taking Hydroxychloroquine (Plaquenil) and that didn't do much good, so they started her on tablets of Methotrexate and Injections didn't do her much good. In between each one when she had a flare, she took a Prednisolone. Now she was taking Leflunomide and Plaquenil, Hydroxychloroquine. They helped her a bit, she still had flares in between. Most recent Hydroxychloroquine. She had been on it for 3 years. She had an RX. She had another one for the RA that was taking along with the Plaquenil for the rheumatoid arthritis and it was Leflunomide. Hydroxychloroquine and Methotrexate handy: She hadn't been taking the Methotrexate since Oct of last year. She had one vial of, a partial vial left that she need to take.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400091998 Same patient/product, different dose/events;
Sex: F
Vaccine: COVID19
Symptoms: Investigation, Rheumatoid arthritis
Clinical narrative: In between each one when I have a flare, I take a Prednisolone/ still have flares in between; This is a spontaneous report received from a Consumer or other non HCP.  A 68-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Lot number: GH9694) for covid-19 immunisation. The patient's relevant medical history included: "Heart Disease" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/Lot number: EZ9266, Route of Administration : Intramuscular, Anatomical Location: Arm left), administration date: 21Feb2021, when the patient was 65-year-old, for COVID-19 immunisation, reaction(s): "Developed rheumatoid arthritis"; BNT162b2 (DOSE 2, SINGLE, Batch/Lot number: EN6207), administration date: 14Mar2021, when the patient was 65-year-old, for COVID-19 immunisation, reaction(s): "In between each one when I have a flare, I take a Prednisolone/still have flares in between"; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Batch/Lot number: FC3182), administration date: 26Aug2021, when the patient was 65-year-old, for COVID-19 immunisation, reaction(s): "In between each one when I have a flare, I take a Prednisolone/ still have flares in between". The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "not recovered", described as "In between each one when I have a flare, I take a Prednisolone/ still have flares in between". The patient underwent the following laboratory tests and procedures: Investigations: (unspecified date) Unknown Results; (19Apr2024) Unknown Results. Therapeutic measures were taken as a result of rheumatoid arthritis. Clinical course:Patient had been on treatment ever since. She started out with taking Hydroxychloroquine (Plaquenil)and that didn't do much good, so started tablets of Methotrexate, they didn't do much good and Injections didn't do much good. In between each one when patient had a flare, she taken a Prednisolone. Now she was taking Leflunomide and Plaquenil, Hydroxychloroquine. Upon clarification patient stated Hydroxychloroquine, Methotrexate and Injections helped a bit, but still had flares in between." Consumer stated she had not been taking the Methotrexate since October of last year and not takes Methotrexate anymore. she had one vial of a partial vial left that need to take. Consumer stated the most recent Hydroxychloroquine she had been on it for 3 years. Consumer takes one time a day and 20 milligrams of Leflunomide along with the Hydroxychloroquine (Plaquenil) for the rheumatoid arthritis. Yes, Patient just had some lab drawn yesterday. But patient did it, only got two labs (Hence, investigations tab checked as Yes but haven't got the results yet.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400091998 Same patient/ Vaccine, different dose/events (Dose 1);
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  An 80-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 06Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 80 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer: Unknown, Dose number: 6), for COVID-19 immunization; Covid-19 vaccine (Manufacturer: Unknown, Dose number: 5), for COVID-19 immunization; Covid-19 vaccine (Manufacturer: Unknown, Dose number: 4), for COVID-19 immunization; Covid-19 vaccine (Manufacturer: Unknown, Dose number: 3), for COVID-19 immunization; Covid-19 vaccine (Manufacturer: Unknown, Dose number: 2), for COVID-19 immunization; Covid-19 vaccine (Manufacturer: Unknown, Dose number: 1), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Apr2024, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2024) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient took Paxlovid from 08Apr2024 to 13Apr2024. Four days after completing Paxlovid, patient began to have symptoms of headache, head cold, stuffy nose and had to go to bed. Next morning patient tested positive (Apr2024). Treatment: use nasal spray, Tylenol and Zrytec to tx (treat) symptoms. Patient has no allergies.
Sex: F
Vaccine: RSV
Symptoms: Asthenia, Exposure during pregnancy, Inappropriate schedule of product administration, Vomiting
Clinical narrative: Receiving the vaccine at 23 weeks; Feeling weak; Vomiting; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  An adult female patient (pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), (Batch/Lot number: unknown) for immunisation. The patient was 23 weeks pregnant at the event onset. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT USE ISSUE (non-serious), outcome "unknown", described as "Receiving the vaccine at 23 weeks"; ASTHENIA (non-serious), outcome "unknown", described as "Feeling weak"; VOMITING (non-serious), outcome "unknown". Additional information: The reporter stated that the patient was feeling weak and vomiting for about 24 hours after receiving the vaccine at 23 weeks (though the timing cannot be confirmed).  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: RSV
Symptoms: Eructation, Exposure during pregnancy, Flatulence
Clinical narrative: Constant burping and gas; Constant burping and gas; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  An adult female patient (pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for maternal exposure timing unspecified. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FLATULENCE (non-serious), ERUCTATION (non-serious), outcome "unknown" and all described as "Constant burping and gas". Additional information: patient experienced constant burping and gas after receiving the RSV vaccine when pregnant.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: my arm got sore for a couple days from getting the shot; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 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: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "my arm got sore for a couple days from getting the shot".  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 0.17
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired vaccine given with no reported adverse event; Initial information received on 16-Apr-2024 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 2 months old female patient who was administered expired HIB (PRP/T) VACCINE [ACT-HIB] vaccine with no reported adverse event.  The patient had no medical history, concomitant disease or risk factor. The patient's past medical treatment(s), vaccination(s) and family history were not provided.   On 26-Mar-2024, the patient received expired suspect HIB (PRP/T) VACCINE, Powder and solvent for solution for injection lot UJ863AA via intramuscular route in unknown administration site for immunization (strength, dose, expiry date- unknown) with no reported adverse event (expired product administered) (latency same day).  There were no lab data/results available.   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.
Sex: U
Vaccine: TDAP
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: administered an ADACEL vaccine after excursion with no adverse event; Initial information received on 15-Apr-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who was administered an diphtheria-2/tetanus/5 AC pertussis vaccine [adacel] vaccine after excursion with no adverse event.  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 diphtheria-2/tetanus/5 AC pertussis vaccine (lot number, strength, dose and expiry not reported) via unknown route in unknown administration site as prophylactic vaccination after excursion with no adverse event (poor quality product administered) (unknown latency).  It was reported "a refrigerator thermometer had fallen and disconnected so the temperature in the refrigerator was not recorded over the weekend. There is no proof that the refrigerator didn't go out of range with an excursion over the weekend. Reason: Refrigerator malfunction (refrigerator thermometer has fallen) Max/Low Temperature reached: Unknown/unsure if there is an excursion (no temperature provided as the thermometer fell out) Duration out of labelled range: 50-60 hours Human Error: No"   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: 1.58
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: an expired dose of DAPTACEL was administered to a patient with no adverse event; Initial information received on 15-Apr-2024 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 1 years old female patient who was administered an expired dose of diphtheria-15/tetanus/5 ac pertussis vaccine [daptacel] with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included hib vaccine (hib vaccine) for prophylactic vaccination; and hepatitis a vaccine (hepatitis a) for Prophylactic vaccination.  On 15-Apr-2024, the patient received 0.5 ml total dose of suspect Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine Suspension for injection (lot number: C5980AB) (Expiry date: 06-Apr-2024) (strength: standard) (Frequency: once) via intramuscular route in the left thigh for immunization.  On 15-Apr-2024, the patient was administered an expired dose of diphtheria-15/tetanus/5 ac pertussis vaccine [daptacel] with no adverse event (expired product administered) (latency: same day).  It was reported, The caller was not aware of any adverse reactions post administration. This situation is reported to PV (pharmacovigilance) due to the inappropriate administration of an expired product to a patient  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.