chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.25
Sex: F
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: 3 month old infant was inadvertently administered a dose of Kinrix; This was the patient's first dose of DTaP and IPV; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 3-month-old female patient who received DTPa-IPV (Kinrix) (batch number C472T, expiry date 22-MAR-2024) for prophylaxis.   On 17-AUG-2023, the patient received Kinrix. On 17-AUG-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 3 month old infant was inadvertently administered a dose of Kinrix) and inappropriate schedule of vaccine administered (Verbatim: This was the patient's first dose of DTaP and IPV).  The outcome of the inappropriate age at vaccine administration and inappropriate schedule of vaccine administered 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 24 August 2023: The pharmacist reported that 3 month old patient was inadvertently administered a dose of Kinrix. This was the patient's first dose of DTaP and IPV.  Pharmacist was unsure which vaccine the patient was supposed to have received.   The reporter consented to follow up. The Vaccine Administration Facility was the same as Primary Reporter. The 3 month old patient was inadvertently administered a dose of Kinrix as first dose of DTaP and IPV which led to inappropriate age at vaccine administration and inappropriate schedule of vaccine administered.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Inappropriate schedule of product administration
Clinical narrative: a male received an initial dose of Menveo on 14Aug2023 and an early 2nd dose on 24Aug2023; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 17-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMAMVA950A, expiry date 31-JUL-2024) for prophylaxis.   Concomitant products included MENVEO.   On 24-AUG-2023, the patient received the 2nd dose of Menveo. On 24-AUG-2023, an unknown time after receiving Menveo, the patient experienced drug dose administration interval too short (Verbatim: a male received an initial dose of Menveo on 14Aug2023 and an early 2nd dose on 24Aug2023).  The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK receipt date 24 August 2023: A nurse reported that the patient received an initial dose of Menveo on 14th Aug 2023 and an early 2nd dose on 24th August 2023. No symptoms reported. The reporter consented to follow up via email. The patient received early 2nd dose of Menveo which led to shortening of vaccination schedule.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: A patient received a dose of Engerix-B that had expired on 11 Aug 2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 22-year-old female patient who received HBV (Engerix B) (batch number 4345R, expiry date 11-AUG-2023) for prophylaxis.   On 23-AUG-2023, the patient received Engerix B. On 23-AUG-2023, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: A patient received a dose of Engerix-B that had expired on 11 Aug 2023).  The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 24-AUG-2023. On 24-Aug-2023, a pharmacist called to inform that, a patient received a dose of Engerix-B which was expired, which led to expired vaccine used. The reporter consented to follow-up. The Vaccine Administration Facility was the same as Primary Reporter.
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram, Inflammation, Pericarditis
Clinical narrative: Pericarditis; had a multi-inflammatory thing going; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 43-year-old male patient received BNT162b2 (BNT162B2), in 2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PERICARDITIS (medically significant) with onset 2021, outcome "not recovered"; INFLAMMATION (medically significant) with onset 2021, outcome "not recovered", described as "had a multi-inflammatory thing going". The events "pericarditis" and "had a multi-inflammatory thing going" required physician office visit. The patient underwent the following laboratory tests and procedures: Electrocardiogram: Unknown Results. Clinical course: The patient stated he filed an adverse event report in Feb2021 or Mar2021 and was wondering why there was no follow-up from Pfizer about this. He had spoken with the drug safety department and they referred him to medical information. The patient explained that he experienced Pericarditis after receiving the Pfizer Covid vaccine. He received the vaccine and had a multi-inflammatory thing going and felt he still had effects. He stated he went into his cardiologist to get an EKGs because he had symptoms and was unsure if they were related to the vaccine. He had Pericarditis inflammatory issues after he received the vaccine in 2021. He went to the hospital (further not clarified). He had Pericarditis inflammation of the heart.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Petit mal epilepsy
Clinical narrative: petit mal seizures; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID.  A 72-year-old male patient received BNT162b2 (BNT162B2), on 26Feb2021 as dose 2, single (Lot number: EN6205) at the age of 72 years, in arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Batch/Lot number: EM9809, Anatomical location: Arm left, Time the vaccination: Morning), for COVID-19 Immunisation, reaction(s): "Petite mal seizures starting sometime shortly after 1st COVID". The following information was reported: PETIT MAL EPILEPSY (medically significant) with onset 2021, outcome "unknown", described as "petit mal seizures". The event "petit mal seizures" required physician office visit. Therapeutic measures were taken as a result of petit mal epilepsy. Clinical course: Patient started having petit mal seizures after his initial shot series. His doctor finally got them under control with Xcopri. Since then each time he had gotten a booster he had had 1 or 2 seizures within a week. He never had seizures until the COVID shot. He was fine until he took a booster and then he had one the next day, then this year they got another booster since they were leaving the country, he had 2 seizures the next day. Called doctor and she said to let her know if any more occurred. He did not have any past the two. The reason reporter believed it was the vaccine was because each time he had gotten a booster, he would have at least 1 episode even though he had been taking Xcopri 200's daily. Boosters caused one seizure shortly after even when taking XCOPRI. Adverse event did not require visit to Emergency Room. Called with last booster because he had 2 seizures.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300127998 Same patient/product, different dose (dose 1)/events.;US-PFIZER INC-202300288376 Same patient/product, different dose (dose 3)/events.;US-PFIZER INC-202300288377 Same patient/product, different dose (dose 4)/events.;
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Petit mal epilepsy
Clinical narrative: petit mal seizures; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID.  A 74-year-old male patient received BNT162b2 (BNT162B2), on 11Nov2021 as dose 3 (booster), single (Lot number: FH8028) at the age of 73 years, in arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 2, single, Lot Number: EN6205, Anatomical location: arm), administration date: 26Feb2021, for COVID-19 immunisation, reaction(s): "petit mal seizures"; Bnt162b2 (Dose 1, single, Lot Number: EM9809, Anatomical location: arm left, Time the vaccination was given: Morning), for COVID-19 immunisation, reaction(s): "Petite mal seizures starting sometime shortly after 1st COVID". The following information was reported: PETIT MAL EPILEPSY (medically significant), outcome "unknown", described as "petit mal seizures". The event "petit mal seizures" required physician office visit. Therapeutic measures were taken as a result of petit mal epilepsy. Clinical course: Patient started having petit mal seizures after his initial shot series. His doctor finally got them under control with Xcopri. Since then each time he had gotten a booster he had had 1 or 2 seizures within a week. He never had seizures until the COVID shot. He was fine until he took a booster and then he had one the next day, then this year they got another booster since they were leaving the country, he had 2seizures the next day. Called doctor and she said to let her know if any more occurred. He did not had any past the two. The reason reporter believed it was the vaccine was because each time he had gotten a booster, he would have at least 1 episode even though he had been taking Xcopri 200's daily. Boosters caused one seizure shortly after even when taking XCOPRI. Adverse event did not require visit to Emergency Room, Physician Office. Called with last booster because he had 2 seizures.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300288375 same patient/drug/AE, different dose number (Dose 2);US-PFIZER INC-PV202300127998 same patient/drug/AE, different dose number (Dose 1);US-PFIZER INC-202300288377 same patient/drug/AE, different dose number (Dose 4);
Sex: M
Vaccine: COVID19
Symptoms: Petit mal epilepsy
Clinical narrative: petit mal seizures; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID.  A 74-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in 2023 as dose 4 (booster), single (Lot number: GL2092), in arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose: 2, single, Lot Number: EN6205, Anatomical location: Arm), administration date: 26Feb2021, when the patient was 72-year-old, for COVID-19 immunization, reaction(s): "petit mal seizures"; BNT162b2 (DOSE 3 (BOOSTER), SINGLE , Lot Number: FH8028, Anatomical location: Arm), administration date: 11Nov2021, when the patient was 73-year-old, for COVID-19 immunization, reaction(s): "petit mal seizures"; Bnt162b2 (Dose:1, single, Lot Number: EM9809, Anatomical location: arm left, Time the vaccination was given: Morning), for COVID-19 immunization, reaction(s): "Petite mal seizures starting sometime shortly after 1st COVID". The following information was reported: PETIT MAL EPILEPSY (medically significant) with onset 2023, outcome "recovered" (2023), described as "petit mal seizures". The event "petit mal seizures" required physician office visit. Therapeutic measures were taken as a result of petit mal epilepsy.  Clinical course: Patient started having petit mal seizures after his initial shot series. His doctor finally got them under control with Xcopri. Since then each time he had gotten a booster he had had 1 or 2 seizures within a week. He never had seizures until the COVID shot. He was fine until he took a booster and then he had one the next day, then this year they got another booster since they were leaving the country, he had 2 seizures the next day. Called doctor and she said to let her know if any more occurred. He did not have any past the two. The reason reporter believed it was the vaccine was because each time he had gotten a booster, he would have at least 1 episode even though he had been taking Xcopri 200's daily. Boosters caused one seizure shortly after even when taking XCOPRI. Adverse event did not require visit to Emergency Room. Called with last booster because he had 2 seizures.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300288375 same patient/product/adverse event, different dose number;US-PFIZER INC-202300288376 same patient/product/adverse event, different dose number;US-PFIZER INC-PV202300127998 same patient/product/adverse event, different dose number;
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Vaccine brand other: Moderna; Vaccine brand: Pfizer/BioNTech; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old male patient received BNT162b2 (BNT162B2), on 16May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 61 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 09Sep2022 at 16:30 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Positive lupus anticoagulant" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 09Sep2022 at 16:30, outcome "unknown", described as "Vaccine brand other: Moderna; Vaccine brand: Pfizer/BioNTech"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12May2023 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 56 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: Thyroid cancer and hypothyroidism due to thyroidectomy. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Paxlovid was given from 21Aug2023 to 25Aug2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for Covid; tested positive for Covid; This is a spontaneous report received from contactable reporter(s) (Pharmacist). The reporter is the patient.  A 79-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in 2022 as dose number unknown (booster), single for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 27Aug2023, outcome "unknown" and all described as "tested positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Aug2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 28Aug2023 and still ongoing.  Clinical course: Patient tested positive for Covid for the first time ever. He had all the vaccines but not this year, his last one was last year. He had all the Pfizer vaccines (Unspecified Vaccines). He tested positive for Covid on Sunday and he was having all the symptoms pretty bad and he started Paxlovid on Monday and so far he was not noticing any improvement, that almost immediately with Paxlovid he had so much stomach ache, intestinal cramping and diarrhea with Paxlovid. He also stated that he was a very healthy 79 years old retired Pharmacist and Ihe had a very strong stomach and nothing  the he ate or drink before that bothered him but the Paxlovid or the Covid had been very harsh on his system.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Anxiety, Aphasia, Brain fog, Depression
Clinical narrative: Brain fog; headaches; memory loss; changes in mood; partial disability; aphasia; severe anxiety; depression; body aches; tinitus; can't focus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20May2021 as dose 2, single (Lot number: EN0173) at the age of 41 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot Number: EN0162, Location of injection: Arm Left; Administration time: 03:30 PM), administration date: 20Apr2021, when the patient was 41-year-old, for COVID-19 Immunization. The following information was reported: BRAIN FOG (disability) with onset 10Jun2021, outcome "not recovered"; APHASIA (disability) with onset 10Jun2021, outcome "not recovered"; PAIN (disability) with onset 10Jun2021, outcome "not recovered", described as "body aches"; DISTURBANCE IN ATTENTION (disability) with onset 10Jun2021, outcome "not recovered", described as "can't focus"; MOOD ALTERED (disability) with onset 10Jun2021, outcome "not recovered", described as "changes in mood"; DEPRESSION (disability) with onset 10Jun2021, outcome "not recovered"; HEADACHE (disability) with onset 10Jun2021, outcome "not recovered", described as "headaches"; AMNESIA (disability) with onset 10Jun2021, outcome "not recovered", described as "memory loss"; DISABILITY (disability) with onset 10Jun2021, outcome "not recovered", described as "partial disability"; ANXIETY (disability) with onset 10Jun2021, outcome "not recovered", described as "severe anxiety"; TINNITUS (disability) with onset 10Jun2021, outcome "not recovered", described as "tinitus". The events "brain fog", "headaches", "memory loss", "changes in mood", "partial disability", "aphasia", "severe anxiety", "depression", "body aches", "tinitus" and "can't focus" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of brain fog, headache, amnesia, mood altered, disability, aphasia, anxiety, depression, pain, tinnitus, disturbance in attention.  Clinical course: Patient had severe Brain fog, headaches, memory loss, changes in mood, partial disability as a result, aphasia, and severe anxiety beginning about 2 weeks month after the 2nd dose. Over the next year the brain fog improved slightly but the other issues remained and depression and body aches were added to the symptoms. Patient is now permanently disabled and have frequent headaches, anxiety, memory loss, brain fog, aphasia, mood issues, and can't focus. She also developed tinnitus.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Disability, Disturbance in attention, Headache, Mood altered, Pain
Clinical narrative: Brain fog; headaches; memory loss; changes in mood; partial disability; aphasia; severe anxiety; depression; body aches; tinitus; can't focus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20May2021 as dose 2, single (Lot number: EN0173) at the age of 41 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot Number: EN0162, Location of injection: Arm Left; Administration time: 03:30 PM), administration date: 20Apr2021, when the patient was 41-year-old, for COVID-19 Immunization. The following information was reported: BRAIN FOG (disability) with onset 10Jun2021, outcome "not recovered"; APHASIA (disability) with onset 10Jun2021, outcome "not recovered"; PAIN (disability) with onset 10Jun2021, outcome "not recovered", described as "body aches"; DISTURBANCE IN ATTENTION (disability) with onset 10Jun2021, outcome "not recovered", described as "can't focus"; MOOD ALTERED (disability) with onset 10Jun2021, outcome "not recovered", described as "changes in mood"; DEPRESSION (disability) with onset 10Jun2021, outcome "not recovered"; HEADACHE (disability) with onset 10Jun2021, outcome "not recovered", described as "headaches"; AMNESIA (disability) with onset 10Jun2021, outcome "not recovered", described as "memory loss"; DISABILITY (disability) with onset 10Jun2021, outcome "not recovered", described as "partial disability"; ANXIETY (disability) with onset 10Jun2021, outcome "not recovered", described as "severe anxiety"; TINNITUS (disability) with onset 10Jun2021, outcome "not recovered", described as "tinitus". The events "brain fog", "headaches", "memory loss", "changes in mood", "partial disability", "aphasia", "severe anxiety", "depression", "body aches", "tinitus" and "can't focus" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of brain fog, headache, amnesia, mood altered, disability, aphasia, anxiety, depression, pain, tinnitus, disturbance in attention.  Clinical course: Patient had severe Brain fog, headaches, memory loss, changes in mood, partial disability as a result, aphasia, and severe anxiety beginning about 2 weeks month after the 2nd dose. Over the next year the brain fog improved slightly but the other issues remained and depression and body aches were added to the symptoms. Patient is now permanently disabled and have frequent headaches, anxiety, memory loss, brain fog, aphasia, mood issues, and can't focus. She also developed tinnitus.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Brain fog; headaches; memory loss; changes in mood; partial disability; aphasia; severe anxiety; depression; body aches; tinitus; can't focus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20May2021 as dose 2, single (Lot number: EN0173) at the age of 41 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot Number: EN0162, Location of injection: Arm Left; Administration time: 03:30 PM), administration date: 20Apr2021, when the patient was 41-year-old, for COVID-19 Immunization. The following information was reported: BRAIN FOG (disability) with onset 10Jun2021, outcome "not recovered"; APHASIA (disability) with onset 10Jun2021, outcome "not recovered"; PAIN (disability) with onset 10Jun2021, outcome "not recovered", described as "body aches"; DISTURBANCE IN ATTENTION (disability) with onset 10Jun2021, outcome "not recovered", described as "can't focus"; MOOD ALTERED (disability) with onset 10Jun2021, outcome "not recovered", described as "changes in mood"; DEPRESSION (disability) with onset 10Jun2021, outcome "not recovered"; HEADACHE (disability) with onset 10Jun2021, outcome "not recovered", described as "headaches"; AMNESIA (disability) with onset 10Jun2021, outcome "not recovered", described as "memory loss"; DISABILITY (disability) with onset 10Jun2021, outcome "not recovered", described as "partial disability"; ANXIETY (disability) with onset 10Jun2021, outcome "not recovered", described as "severe anxiety"; TINNITUS (disability) with onset 10Jun2021, outcome "not recovered", described as "tinitus". The events "brain fog", "headaches", "memory loss", "changes in mood", "partial disability", "aphasia", "severe anxiety", "depression", "body aches", "tinitus" and "can't focus" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of brain fog, headache, amnesia, mood altered, disability, aphasia, anxiety, depression, pain, tinnitus, disturbance in attention.  Clinical course: Patient had severe Brain fog, headaches, memory loss, changes in mood, partial disability as a result, aphasia, and severe anxiety beginning about 2 weeks month after the 2nd dose. Over the next year the brain fog improved slightly but the other issues remained and depression and body aches were added to the symptoms. Patient is now permanently disabled and have frequent headaches, anxiety, memory loss, brain fog, aphasia, mood issues, and can't focus. She also developed tinnitus.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Dose 1, 2, 3: Moderna; Dose 4, 5, 6: Pfizer / BioNTech; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 as dose 5 (booster), single (Lot number: GJ2524), in left arm and on 07Jun2023 as dose 6 (booster), single (Lot number: 6J6743) at the age of 71 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 04Jun2022 as dose 4 (booster), single (Lot number: 045A22A), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 22Jan2021 as dose 1, single (Lot number: 032L20A), in left arm, on 19Feb2021 as dose 2, single (Lot number: 006M29A), in left arm and on 23Oct2021 as dose 3 (booster), single (Lot number: 045C21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing). The patient had no known allergies. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 04Jun2022, outcome "not recovered", described as "Dose 1, 2, 3: Moderna; Dose 4, 5, 6: Pfizer / BioNTech"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Aug2023) Negative, notes: Had negative antigen tests x3; (Aug2023) Negative, notes: Had negative antigen tests x3; (Aug2023) Negative, notes: Had negative antigen tests x3; (31Aug2023) Positive, notes: tested positive on Covid antigen test. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid.
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Dec2022 at 14:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 46 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension/high blood pressure" (unspecified if ongoing); "non insulin dependent type 2 diabetes" (unspecified if ongoing). The patient has no known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Antibody test, Breakthrough COVID-19, Drug ineffective
Clinical narrative: breakthrough infection; breakthrough infection; This is a literature report for the following literature source(s).  A 59-year-old patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Kidney transplant" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), BREAKTHROUGH COVID-19 (medically significant), all with latency 13 days after the suspect product(s) administration, outcome "unknown" and all described as "breakthrough infection". Breakthrough infection noted 13 days post-vaccination of dose 3. The patient underwent the following laboratory tests and procedures: Antibody test: 30.5 IU/ml, notes: Pre-exposure; 227 IU/ml, notes: Original post-exposure; 163120 IU/ml, notes: Retested post-exposure.; Sender's Comments: Based on the information currently available, a lack of efficacy with bnt162b2 vaccine in this patient cannot be completely excluded.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: received all doses before but he was tested positive recently/ tested positive for COVID; received all doses before but he was tested positive recently/ tested positive for COVID; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "received all doses before but he was tested positive recently/ tested positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: he was tested positive recently/One of his friends tested positive for COVID. Clinical course: The reporter, wanted to ask about COVID-19 Bivalent availability, as his friend received all doses before, but he was tested positive recently. The reporter wanted to know when the new Pfizer COVID-19 vaccine will be available. He also mentioned that one of his friends tested positive for COVID after getting all the doses of the Pfizer Bivalent COVID vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Immunisation reaction, Pyrexia, Vaccination site erythema, Vaccination site swelling
Clinical narrative: diffuse swelling of the entire upper arm; reported vaccine reaction that there was redness; fever; Initial information was received on 25-Aug-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves 5 years old male patient who reported that diffuse swelling of the entire upper arm, reported vaccine reaction that there was redness and fever after receiving diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine [Quadracel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 23-Aug-2023, the patient received a dose 5 of 0.5 ml of suspect diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine (Suspension for injection) (Frequency : Once, lot U7564AA, Expiry date : 08-Nov-2024, strength was unknown) via intramuscular route in the right arm for Immunization.  On 23-Aug-2023 the patient developed diffuse swelling of the entire upper arm (peripheral swelling), reported vaccine reaction that there was redness (erythema) and fever (pyrexia) (latency : same day) following the administration of diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events (reported vaccine reaction that there was redness, diffuse swelling of the entire upper arm, fever).  At time of reporting, the outcome was Unknown for all the events.
Age: 5.0
Sex: U
Vaccine: DTAP, DTAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: vaccines got switched, received tdap instead of dtap with no reported adverse event; Initial information received on 28-Aug-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 5 years old and unknown gender patient whose vaccines got switched, received Diphtheria, Tetanus, AC Pertussis and IPV Vaccine instead of Diphtheria, Tetanus and Acellular Pertussis Vaccine with no reported 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, Tetanus, AC Pertussis and IPV Vaccine produced by unknown manufacturer formulation, strength, dose, expiry date, lot number not reported via unknown route in unknown administration site for prophylactic vaccination (immunization) instead of Diphtheria, Tetanus and Acellular Pertussis Vaccine and vaccines got switched, received tdap instead of dtap with no reported adverse event (wrong product administered) (latency: on the same day).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event vaccines got switched, received tdap instead of dtap with no reported adverse event.  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: HIBV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: administered an expired ACT-HIB dose to a patient with no reported adverse event; Initial information received on 29-Aug-2023 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 15 month old male patient who was administered an expired HIB (PRP/T) VACCINE [ACT-HIB] dose to a patient 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 (Pneumococcal Conjugate Vaccine) for Prophylactic vaccination (immunization).  On 28-Aug-2023, the patient received a dose 0.5 ml of suspect HIB (PRP/T) Vaccine Powder and solvent for solution for injection lot UJ802AA expiry date: 14-Aug-2023 via intramuscular route in the left thigh for immunization and was administered an expired act-hib dose to a patient with no reported adverse event (expired product administered) on the same day following the administration of HIB (PRP/T) Vaccine.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event administered an expired act-hib dose to a patient with no reported adverse event.  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: 18.0
Sex: M
Vaccine: MEN
Symptoms: Inappropriate schedule of product administration, Medication error, No adverse event
Clinical narrative: administration of Menquadfi today, as per past immunization record patient had his initial dose when he was 12 years old and booster dose when he was 16 years old with no reported adverse event; Initial information on 29-Aug-2023 regarding an unsolicited valid non-serious case received from a Nurse.  This case involves a 18 years old male patient who got administration of meningococcal A-C-Y-W135 (T conj) vaccine [Menquadfi] today, as per past immunization record patient had his initial dose when he was 12 years old and booster dose when he was 16 years old 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 meningococcal vaccine B for Prophylactic vaccination.  On 29-Aug-2023, the patient received 0.5 ml (TOTAL) dose 3 of suspect meningococcal a-c-y-w135 (t conj) vaccine Solution for injection (lot U7675CA and expiration date- 01-Oct-2025) via intramuscular route in the right deltoid (strength: not provided) for Immunization (inappropriate schedule of product administration) (latency- same day).  Action taken- not applicable.  At time of reporting, the outcome was Unknown for the event.  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: 76.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: inadvertently received 2 doses of Fluzone high dose QIV instead of a dose of FLUZONE HIGH DOSE QIV and an RSV vaccination (with no reported adverse event); Initial information received on 29-Aug-2023 regarding an unsolicited valid non-serious case received via physician.  This case involves a 76-year-old female patient who had inadvertently received 2 doses of influenza quadrival A-B high dose HV vaccine [fluzone high-dose quadrivalent] instead of a dose of fluzone high dose QIV and an RSV vaccination (with no reported adverse event).  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.  On 29-Aug-2023, the patient received 0.7 ml dose of suspect influenza quadrival A-B high dose HV vaccine (strength, form: unknown) (lot: UT8043AA, expiry date: 01-Jun-2024) via intramuscular route in the left and right deltoid for immunization and patient inadvertently received 2 doses of fluzone high dose qiv instead of a dose of fluzone high dose QIV and an RSV vaccination (with no reported adverse event) (incorrect dose administered) (latency: same day)  Action taken with quadrivalent influenza vaccine (Fluzone High-Dose Quadrivalent) was not applicable.  Outcome: unknown   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: F
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: patient was given the 1st injection on 25Jul2023. The next injection that the patient received was on 18Aug2023, a three week gap with no reported adverse event; Initial information was received on 29-Aug-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown age female patient to whom the 1st injection of rabies (HDC) vaccine [Imovax rabies] on 25jul2023, the next injection was given on 18aug2023, a three week gap with no reported 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 1 ml, twice dose of suspect rabies (HDC) vaccine (Powder and solvent for suspension for injection) (lot number, expiry date, strength, was unknown) via unknown route in unknown administration site for Immunization and patient was given the 1st injection on 25jul2023, the next injection that the patient received was on 18aug2023, a three week gap with no reported adverse event (inappropriate schedule of product administration) (unknown latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  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: IPV
Symptoms: Medication error, No adverse event, Poor quality product administered
Clinical narrative: temp. excursion occured, product was administered to patient with no reported adverse event; Initial information was received on 29-Aug-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-healthcare professional.  This case involves 20 patients of unknown age and gender to whom IPV (VERO) [IPOL] was administered post excursion with no reported 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 an unknown dose of suspect IPV (VERO) (Suspension for injection) (lot V1A011M, expiry date, strength: unknown) via unknown route in unknown administration site for prophylactic vaccination (Immunisation) and temp. excursion occured, product was administered to patient with no reported adverse event (poor quality product administered) (Latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  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.