chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; vaccine dose number: 1; manufacturer: janssen; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old male patient received BNT162b2 (BNT162B2), on 28Oct2021 as dose 2,  single (Batch/Lot number: unknown), in left arm and on 20Jul2022 at 18:30 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 58 years, in left arm for covid-19 immunisation; coviD-19 vaccine nrvv ad26 (jnj 78436735) (JANSSEN COVID-19 VACCINE), on 07Mar2021 at 10:00 as dose 1, single (Lot number: 1805020), in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 28Oct2021, outcome "unknown", described as "vaccine dose number: 1; manufacturer: janssen"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19: Plaxlovid from 07Apr2023 to 12Apr2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 48.0
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; Interchange of vaccine products; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Mar2021 at 15:00 as dose 1, single (Lot number: ER8732), in left arm, on 23Apr2021 at 14:00 as dose 2, single (Lot number: EW0172), in left arm and on 26Nov2021 at 10:00 as dose 3 (booster), single (Lot number: FH8030) at the age of 48 years, in left arm for covid-19 immunisation; elasomeran (COVID-19 VACCINE MODERNA), on 04Feb2023 at 11:00 as dose 4 (booster), single (Lot number: 049d22a), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroid" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 04Feb2023 at 11:00, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 10Apr2023 to 14Apr2023.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Calling regarding PAXLOVID. Caller states she picked up the prescription/has taken both Pfizer Covid vaccines; Calling regarding PAXLOVID. Caller states she picked up the prescription/has taken both Pfizer Covid vaccines; 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 female patient received 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), outcome "unknown" and all described as "Calling regarding PAXLOVID. Caller states she picked up the prescription/has taken both Pfizer Covid vaccines". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Caller stated she was already feeling better and had taken both Pfizer Covid vaccines.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 at 12:00 as dose 5 (booster), single (Lot number: GJ2524) at the age of 54 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) and as dose 4 (booster), 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) with onset 2023, outcome "unknown", COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: The patient treated with Paxlovid from 10Apr2023 to 15Apr2023. Known allergies and other medical history was not reported. Other medication in 2weeks: No.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Loss of personal independence in daily activities, Palpitations
Clinical narrative: heart palpitations; palpitations are significantly impacting my life; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP), Program ID: The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Manufacturer: Pfizer), for COVID-19 immunization, reaction(s): "palpitations are significantly impacting my life", "Heart palpitations". The following information was reported: PALPITATIONS (non-serious), outcome "unknown", described as "heart palpitations"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "unknown", described as "palpitations are significantly impacting my life".  Additional information: The patient reported that three COVID-19 vaccines had caused the heart palpitations in the last year and a half. The patient had hoped that the palpitations would pass, however, they still came and went. The mRNA marker had been affecting patients heart. Pfizer was running research on the long-term impacts of the vaccine, and the patient had expressed interest in being part of that research. The patient had requested a response to message, as the palpitations were significantly impacting life and patient wanted to know how to resolve them. The patient believed that Pfizer should be (and likely is) the best source to find a resolution.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Sender's Comments: Linked Report(s): US-PFIZER INC-202300168647 same reporter/patient/product/event, different dose.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest pain, Dyspnoea, Heart rate increased, Palpitations
Clinical narrative: heart palpitations; palpitations are significantly impacting my life; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP), Program ID: The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Manufacturer: Pfizer), for COVID-19 immunization, reaction(s): "palpitations are significantly impacting my life", "Heart palpitations". The following information was reported: PALPITATIONS (non-serious), outcome "unknown", described as "heart palpitations"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "unknown", described as "palpitations are significantly impacting my life".  Additional information: The patient reported that three COVID-19 vaccines had caused the heart palpitations in the last year and a half. The patient had hoped that the palpitations would pass, however, they still came and went. The mRNA marker had been affecting patients heart. Pfizer was running research on the long-term impacts of the vaccine, and the patient had expressed interest in being part of that research. The patient had requested a response to message, as the palpitations were significantly impacting life and patient wanted to know how to resolve them. The patient believed that Pfizer should be (and likely is) the best source to find a resolution.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Sender's Comments: Linked Report(s): US-PFIZER INC-202300168647 same reporter/patient/product/event, different dose.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team, Program ID: The reporter is the patient.  A 71-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Dec2022 as dose 5 (booster), single (Lot number: GJ3275) at the age of 71 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot: EL9262), administration date: 23Jan2021, when the patient was 69-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE, Lot: EL9266), administration date: 13Feb2021, when the patient was 69-year-old, for COVID-19 immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Lot: EW0217), administration date: 15Sep2021, when the patient was 70-year-old, for COVID-19 immunization; BNT162b2 (DOSE 4 (BOOSTER), SINGLE, Lot: FK9894), administration date: 16Apr2022, when the patient was 70-year-old, for COVID-19 immunization. The following information was reported: TINNITUS (non-serious), outcome "not recovered". The event "tinnitus" required physician office visit. Therapeutic measures were not taken as a result of tinnitus.  Additional information: The patient did not receive any other vaccines within 4 weeks prior vaccination.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: she is up to date all of the shots, all of the boosters and she had the Corona four times; she is up to date all of the shots, all of the boosters and she had the Corona four times; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female 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), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "she is up to date all of the shots, all of the boosters and she had the Corona four times".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: severe headache; muscle aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP), Program ID: The reporter is the patient.  A 51-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Apr2023 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE), for COVID-19 immunization. The following information was reported: MYALGIA (non-serious) with onset 19Apr2023, outcome "unknown", described as "muscle aches"; HEADACHE (non-serious) with onset 19Apr2023, outcome "unknown", described as "severe headache".  Additional Information: Patient had not experienced anything with the previous Pfizer boosters. The headache was really bad. Patient never had COVID.  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
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Covid-19; Covid-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): LRN4890780.  A 67-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "frequent urination" (ongoing); "High blood pressure" (ongoing). Concomitant medication(s) included: AMANTADINE; GABAPENTIN; AMPYRA; GEMTESA; AMLODIPINE; SOLIFENACIN.  The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Jan2022, outcome "unknown" and all described as "Covid-19".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300165822 same patient/ product, different event;
Sex: F
Vaccine: COVID19
Symptoms: Multiple sclerosis
Clinical narrative: episodes of electrical, burning and stabbing pains now diagnosed with MS; 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 female patient received BNT162b2 (BNT162B2), in Mar2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for Covid-19 Immunisation. The following information was reported: MULTIPLE SCLEROSIS (medically significant), outcome "unknown", described as "episodes of electrical, burning and stabbing pains now diagnosed with MS". The events "episodes of electrical, burning and stabbing pains now diagnosed with ms" required physician office visit. Therapeutic measures were taken as a result of multiple sclerosis. Clinical course: Inquiry: Patient received Pfizer booster in Mar2022 with no history of medical issues until 2-3 weeks after started having episodes of electrical, burning and stabbing pains now diagnosed with MS after a long painful year of suffering. Patient believe the shot that was mandated turned his life for the worse and Patient would like to know whom patient can speak with. Patient have been in and out of the hospital seen numerous doctors with no relief. Patient need help and would kindly ask for someone to get back as to what patient can do.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: elevated resting heart rate; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  An adult female 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. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series completed; unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE ; Unknown manufacturer, First booster), for COVID-19 immunization. The following information was reported: HEART RATE INCREASED (non-serious), outcome "unknown", described as "elevated resting heart rate". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: "Mother of adult daughter shared with my wife that her daughter had experienced elevated resting heart rate since taking the second Covid Pfizer vaccine booster. The condition was reportedly checked BU (name withheld) cardiologist already, with conclusion that there was no evidence to support vaccine and elevated heart rate". Event took place after use of product.  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: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for covid twice; tested positive for covid twice; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive for covid twice". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Positive. The patient (wife) stated she and husband both tested positive for covid twice even though they have taken precautions and have taken shots as they become available. Both times husband ended up with symptoms much less than the patient. She believe that it is possible that one or more of the heart meds he takes may have lessened his response as compared to her.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300074311 same reporter/drug, different patient;
Sex: F
Vaccine: COVID19
Symptoms: Arterial occlusive disease, Cerebral venous thrombosis, Ophthalmic artery occlusion
Clinical narrative: Progressive Central Artery Occlusion, Ophthalmic Artery Occlusion, and Hemispheric Intracranial Thrombosis after COVID-19 mRNA Vaccine; Progressive Central Artery Occlusion, Ophthalmic Artery Occlusion, and Hemispheric Intracranial Thrombosis after COVID-19 mRNA Vaccine; Progressive Central Artery Occlusion, Ophthalmic Artery Occlusion, and Hemispheric Intracranial Thrombosis after COVID-19 mRNA Vaccine; This is a literature report.  A patient (no qualifiers provided) received BNT162b2 (COVID-19 VACCINE NOS MANUFACTURER UNKNOWN), 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: ARTERIAL OCCLUSIVE DISEASE (medically significant), OPHTHALMIC ARTERY OCCLUSION (medically significant), CEREBRAL VENOUS THROMBOSIS (medically significant), outcome "unknown" and all described as "Progressive Central Artery Occlusion, Ophthalmic Artery Occlusion, and Hemispheric Intracranial Thrombosis after COVID-19 mRNA Vaccine".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: A causal relationship between the reported events ARTERIAL OCCLUSIVE DISEASE ,OPHTHALMIC ARTERY OCCLUSION and CEREBRAL VENOUS THROMBOSIS  cannot be excluded based on temporal association.  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 RAs, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Depression, Post-acute COVID-19 syndrome
Clinical narrative: Long Haul Syndrome; Depressing/turned off; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 63-year-old female 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. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete, Manufacturer Unknown), for COVID-19 immunization. The following information was reported: POST-ACUTE COVID-19 SYNDROME (non-serious), outcome "unknown", described as "Long Haul Syndrome"; DEPRESSION (non-serious), outcome "unknown", described as "Depressing/turned off".  Additional information: The reporter stated depressing turned off, it immediately reminded what the patient went through after booster shot and the patient is still suffering and struggling with Long Haul Syndrome. The reporter stated that it immediately became obvious to her the first teenager she saw already seemingly looked depressed; which in turn brought memories to her about when she took the vaccination and all that she had endured from that.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: allowed me to have a mild case; allowed me to have a mild case; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "allowed me to have a mild case".  Clinical course: Patients age was reported as 72. Patient thought the visuals were interesting. Music For her was difficult to understand the words kind of like when you sing the wrong lyrics and don't find it out for ages or until someone tells you. As for Pfizer she was grateful and feel positive towards it for if nothing else being the developer of the Covid vaccine [Comirnaty] which she used and allowed me to have a mild case.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: I also had covid 3 times despite being vaccinated; I also had covid 3 times despite being vaccinated; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP.. The reporter is the patient.  A 46-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "I also had covid 3 times despite being vaccinated".  Additional Information: Patient was reported that he also had covid 3 times despite being vaccinated so not sure how well it really works and he was know that if he was in decent health, he should be ok so he was not terribly worried about it right  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Full blood count, HIV test, Hepatitis B, Hepatitis C
Clinical narrative: Pityriasis rubra pilaris; This is a literature report.   A 54-year-old woman with a history of melanoma on her small finger presented with a 4-month history of a widespread, pruritic rash. The rash was initially localized to her trunk but gradually expanded to cover the majority of her body. It first appeared 2 weeks after she received the Pfizer-BioNTech COVID-19 booster vaccine. She had previously received the Janssen COVID-19 vaccine 6 months prior, with no rash eruption. Examination showed multiple large, orange-red plaques covering 70% to 80% of the body surface area, including the back chest, abdomen, and extremities, with multiple islands of sparing. Additionally, she had hyperlinear palms with waxy, orange hyperkeratosis on her hands and feet. She had previously been treated with topical triamcinolone and clobetasol, oral prednisone, and dupilumab with no significant improvement. A punch biopsy was performed on one of the lesions bn the upper back prior to her referral to our clinic. The biopsy revealed hyperkeratosis, including broad areas of parakeratosis, overlying the epidermis showing patchy hypogranulosis, moderate acanthosis, and mild spongiosis. Focal exocytosis of small cytologically bland, mature-appearing lymphocytes was also noted. No interface vacuolar changes were identified. The dermal portion of the biopsy contained a perivascular lymphocytic infiltrate; however, no atypical lymphocytes were identified. Overall the biopsy was consistent with psoriasiform spongiotic dermatitis. The initial differential diagnosis included psoriasis and PRP. Atopic dermatitis was less likely given the lack of improvement with oral steroids and dupilumab. At the time of her initial presentation, the physical examination appeared most consistent with type PRP. Given her history of melanoma, the plan was to treat her with a more targeted biologic medication to minimize her risk of immunosuppression. As such, she was initially treated with ixekizumab injections at an initial dose of 160 mg and 80 mg every 2 weeks thereafter. Complete blood count, complete metabolic panel, and quantiferon gold were unremarkable. Additionally, HIV, hepatitis B, and hepatitis C serologies were negative. After 2 months of treatment with ixekizumab there was near-complete resolution of her rash. Only mild, thin erythematous plaques remained On small areas of the bilateral flanks buttocks, and lateral aspect of the thighs.; Sender's Comments: Based on the temporal relationship, the reasonable possibility of an association between "Pityriasis rubra pilaris" and BNT162B2 cannot be ruled out.  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: Investigation, Physical examination, Pityriasis rubra pilaris
Clinical narrative: Pityriasis rubra pilaris; This is a literature report.   A 54-year-old woman with a history of melanoma on her small finger presented with a 4-month history of a widespread, pruritic rash. The rash was initially localized to her trunk but gradually expanded to cover the majority of her body. It first appeared 2 weeks after she received the Pfizer-BioNTech COVID-19 booster vaccine. She had previously received the Janssen COVID-19 vaccine 6 months prior, with no rash eruption. Examination showed multiple large, orange-red plaques covering 70% to 80% of the body surface area, including the back chest, abdomen, and extremities, with multiple islands of sparing. Additionally, she had hyperlinear palms with waxy, orange hyperkeratosis on her hands and feet. She had previously been treated with topical triamcinolone and clobetasol, oral prednisone, and dupilumab with no significant improvement. A punch biopsy was performed on one of the lesions bn the upper back prior to her referral to our clinic. The biopsy revealed hyperkeratosis, including broad areas of parakeratosis, overlying the epidermis showing patchy hypogranulosis, moderate acanthosis, and mild spongiosis. Focal exocytosis of small cytologically bland, mature-appearing lymphocytes was also noted. No interface vacuolar changes were identified. The dermal portion of the biopsy contained a perivascular lymphocytic infiltrate; however, no atypical lymphocytes were identified. Overall the biopsy was consistent with psoriasiform spongiotic dermatitis. The initial differential diagnosis included psoriasis and PRP. Atopic dermatitis was less likely given the lack of improvement with oral steroids and dupilumab. At the time of her initial presentation, the physical examination appeared most consistent with type PRP. Given her history of melanoma, the plan was to treat her with a more targeted biologic medication to minimize her risk of immunosuppression. As such, she was initially treated with ixekizumab injections at an initial dose of 160 mg and 80 mg every 2 weeks thereafter. Complete blood count, complete metabolic panel, and quantiferon gold were unremarkable. Additionally, HIV, hepatitis B, and hepatitis C serologies were negative. After 2 months of treatment with ixekizumab there was near-complete resolution of her rash. Only mild, thin erythematous plaques remained On small areas of the bilateral flanks buttocks, and lateral aspect of the thighs.; Sender's Comments: Based on the temporal relationship, the reasonable possibility of an association between "Pityriasis rubra pilaris" and BNT162B2 cannot be ruled out.  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.
Age: 1.0
Sex: M
Vaccine: HIBV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: they both administered ACTHIB & VAXELIS to a patient with no reported adverse event; Initial information received on 19-Apr-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 1 years old male patient and is reported they both administered HIB (PRP/T) vaccine [ACT-HIB] & vaxelis 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 diphtheria vaccine toxoid, hepatitis B vaccine RHBSAG (YEAST), HIB vaccine CONJ (menigococcal protein), pertussis vaccine acellular 5-component, polio VACCINE INACT 3V (VERO), tetanus vaccine toxoid (Vaxelis) for Prophylactic vaccination.  On 22-Mar-2023, the patient received a dose 0.5 ml of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection lot UJ796AA via intramuscular route in the left thigh for immunization.  On an unknown date the patient developed a non-serious event "they both administered acthib & vaxelis to a patient with no reported adverse event" (Extra dose administered) latency unknown following the administration of HIB (PRP/T) Vaccine.  Action taken was not applicable.  At time of reporting, the outcome was Recovered / Resolved on an unknown date for the event they both administered acthib & vaxelis 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 guidelines. 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: 15.0
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired dose of the daptacel single-dose vial was inadvertently administered with no reported adverse event; Initial information received on 20-Apr-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 15 months old male patient who experienced had dose of the daptacel single-dose vial was inadvertently administered with no reported adverse event after receiving vaccine diphtheria-15/tetanus/5 ac pertussis vaccine [daptacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included hib vaccine conj (tet tox) (hiberix) for Prophylactic vaccination.  On 20-Apr-2023, the patient received a dose 4  0.5 ml of suspect diphtheria-15/tetanus/5 ac pertussis vaccine Suspension for injection, lot C5828AA via intramuscular route in the left thigh for Prophylactic vaccination (Immunisation).  On 20-APR-2023 the patient developed a non-serious event expired dose of the daptacel single-dose vial was inadvertently administered with no reported adverse event (expired product administered) (latency: same day).  Lab data was not reported.  Action taken was not applicable.  Outcome: Unknown for the event expired dose of the daptacel single-dose vial was inadvertently administered 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 guidelines. 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: 11.0
Sex: U
Vaccine: MEN
Symptoms: Loss of consciousness, Syncope
Clinical narrative: passed out or fainted; Initial information received on 21-Apr-2023 regarding an unsolicited valid  serious case received from a other health professional.  This case involves a 11 years old and unknown gender patient who experienced passed out or fainted while receiving vaccine meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi].  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 meningococcal A-C-Y-W135 (T CONJ) vaccine Solution for injection strength, dose, expiry date not reported lot number unknown via unknown route in unknown administration site for prophylactic vaccination (immunization).  On an unknown date the patient developed a serious passed out or fainted (loss of consciousness) (unknown latency) following the administration of meningococcal A-C-Y-W135 (T CONJ) vaccine. This event was assessed as medically significant.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event passed out or fainted.  At time of reporting, the outcome was Unknown for the event passed out or fainted.  Seriousness criteria: This event was assessed as medically significant.; Sender's Comments: Sanofi company comment dated 25-Apr-2023: This case involves a 11 years old and unknown gender patient who experienced passed out or fainted while receiving vaccine A-C-Y-W135 (T CONJ) vaccine [Menquadfi]. Based on information provided, the causal role of company suspect cannot be excluded. Case will be re-evaluated post further update on information regarding underlying disease, risk precipitating factor, concomitant medication, past medical history and patient lifestyle which will preclude a comprehensive assessment of this case.
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: administered ACTHIB with an expired diluent with no reported adverse event; Initial information was received on 21-Apr-2023 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves an unknown age/gender patient who involved in administered haemophilus type b (HIB) (PRP/T) vaccine [ACT-HIB] with an expired diluent with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received 0.5 ml total dose of suspect haemophilus type b (HIB) (PRP/T) vaccine Powder and solvent for solution for injection (lot number: UJ667ABA, expiry date: 15-May-2023) with an expired diluent (Lot Number:U7261AA, expiration date: 07-Apr-2023) (strength, route, administration site: Unknown) for Immunization (immunization) with no reported adverse event (expired product administered) (latency: same day).  No lab data reported.  Action taken: not applicable.  Outcome: Unknown for the event administered acthib with an expired diluent 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 guidelines. 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: 49.0
Sex: F
Vaccine: YF
Symptoms: Erythema, Limb discomfort, Pruritus
Clinical narrative: the next day worsen itchy redder cream; condition worsened; arms have rxns; Initial information was received on 21-Apr-2023 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 49 years old female patient who experienced arms have rxns and the next day worsen itchy redder cream  after being vaccinated with yellow fever vaccine [YF-vax].  The patient's past medical history, medical treatment(s), concomitants, vaccination(s) and family history were not provided.  On 14-Apr-2023, the patient received a dose of 0.5 ml total suspect yellow fever vaccine Solution for injection (strength: standard) (lot number: UJ782AA, expiration date: 17-Feb-2024) via subcutaneous route in unknown administration site for Immunization (immunization).  On 14-Apr-2023 the patient developed a non-serious event of "arms have rxns" (limb discomfort) same day following the administration of yellow fever vaccine.  On 15-Apr-2023 the patient developed a non-serious the next day "worsen itchy redder cream" (pruritus) and condition worsened (condition aggravated) 1 day following the administration of yellow fever vaccine.  No lab data reported.  Action taken: not applicable.  A redder cream as corrective treatment was received for the events (condition worsened, the next day worsen itchy redder cream). It was not reported if the patient received a corrective treatment for the event (arms have rxns).  Outcome: Recovered / Resolved on an unknown date for the event arms have rxns and was Recovering / Resolving for the event the next day worsen itchy redder cream.
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pruritus, Urticaria, Vaccine positive rechallenge
Clinical narrative: I have received 2 booster shots, both the Moderna brand. While I had no significant reaction to either of my initial doses, I think I may be allergic to the booster. My first booster was on 12/27/21 and starting 1/7/22, exactly 2 weeks after, I began having a reaction that consisted of painful and itchy hives all over my body that didn't respond to anything and lasted consistently for about a month following. My second dose of the booster was on 4/11/23 and starting 4/25/23, also exactly 2 weeks later, I developed painful and itchy hives that have not responded to anything. With still being in the presumable month if this follows the first time, I don't know how long it will last.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Dry throat, Inflammation, Lymphadenopathy, Malaise
Clinical narrative: Pain, inflammation, bruising, swelling, dry throat, swollen lymph glands, general malaise
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Pain
Clinical narrative: Pain, inflammation, bruising, swelling, dry throat, swollen lymph glands, general malaise
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Shingles / Suspected Vaccination Failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Shingles / Suspected Vaccination Failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 22-Apr-2023 This case was reported by a patient via interactive digital media. The patient received the Shingles vaccine but still had a shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Sex: M
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: ACUTE ONSET OF MULTIPLE SEIZURES; This spontaneous report received from a consumer via a company representative concerned a 31 year old male of an unspecified race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on MAR-2023 for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On MAR-2023 (six weeks earlier), the patient experienced acute onset of multiple seizures that required intubation and ICU (Intensive Care Unit) admission, and was hospitalized (date unspecified). The patient was hospitalized six weeks earlier from that of reporting. The number of days of hospitalization was not reported and it was unsure if the patient was discharged from the hospital. The latency for acute onset of multiple seizures was reported as 24 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of acute onset of multiple seizures was not reported. This report was serious (Hospitalization Caused / Prolonged, and Life Threatening).; Sender's Comments: V0-20230456890-Acute onset of multiple seizures- The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: arrival of the shipment outside the acceptable 2-day window with no reported adverse event; children received doses of ActHIB that was deemed unusable later due to arrival of the shipment outside the acceptable 2-day window with no reported adverse event; Initial information received on 19-Apr-2023 regarding an unsolicited valid non-serious case received from a physician.  This case is linked to cases 2023SA124713, 2023SA129826, 2023SA130667, 2023SA130874, 2023SA130917, 2023SA130922, 2023SA130029 and 2023SA129826.  This case involves Infant patient of unknown age and demographics who received dose of HIB (PRP/T) vaccine [ACT-HIB] that was deemed unusable later due to arrival of the shipment outside the acceptable 2-day window 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 HIB (PRP/T) vaccine Powder and solvent for solution for injection (strength, lot number and expiry date: not reported) via unknown route in unknown administration site as prophylactic vaccination (Immunisation). Information on the batch number was requested.  On an unknown date, a non-serious event arrival of the shipment outside the acceptable 2-day window with no reported adverse event (product storage error) (unknown latency), was reported.  On an unknown date, the patient developed a non-serious event children received doses of HIB (PRP/T) vaccine that was deemed unusable later due to arrival of the shipment outside the acceptable 2-day window with no reported adverse event (poor quality product administered) (latency: same day).  No lab data was reported.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event arrival of the shipment outside the acceptable 2-day window with no reported adverse event and was Unknown for the event children received doses of acthib that was deemed unusable later due to arrival of the shipment outside the acceptable 2-day window 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 guidelines. 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.; Sender's Comments:  US-SA-2023SA130415:
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site pain, Pain
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Joint Pain-Medium
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Fatigue, Headache, Hyperhidrosis, Influenza virus test negative
Clinical narrative: one hour post administer patient reported chills, myalgia, headache, and returned next day with a fever f 100.4 F , fatigue, light sensitivity, chills, sweats, full body myalgia and marked tendernes on site of administeration though no noticeable erythama or swelling on site.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injection site pain, Myalgia, Photophobia, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: one hour post administer patient reported chills, myalgia, headache, and returned next day with a fever f 100.4 F , fatigue, light sensitivity, chills, sweats, full body myalgia and marked tendernes on site of administeration though no noticeable erythama or swelling on site.