chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Periarthritis
Clinical narrative: sore/frozen shoulder; sore/frozen shoulder; This spontaneous case was reported by a patient and describes the occurrence of PERIARTHRITIS (sore/frozen shoulder) and ARTHRALGIA (sore/frozen shoulder) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: moderna (dose 2) and moderna (dose 1). Past adverse reactions to the above products included No adverse effect with moderna and moderna.    On an unknown date, the patient received third dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIARTHRITIS (sore/frozen shoulder) and ARTHRALGIA (sore/frozen shoulder). At the time of the report, PERIARTHRITIS (sore/frozen shoulder) and ARTHRALGIA (sore/frozen shoulder) had not resolved.       Company Comments: This spontaneous case concerns in a male patient of an unknown age, with no medical history information reported, who experienced the unexpected  non serious event of Periarthritis  and expected non serious event of Arthralgia. The events occurred on unknown date after third dose of SPIKEVAX NOS (SPIKEVAX NOS). Considering fact that the events occurred after the vaccination and knowing safety profile of the vaccine both events are assessed as related. The benefit-risk relationship of SPIKEVAX NOS (SPIKEVAX NOS) is not affected by this report.     Concomitant product use was not provided by the reporter. Suspect vaccine dosage text was reported as unknown. The patient had received 3 vaccines including the covid vaccine in the shoulder last fall. It created a sore/frozen shoulder that had not yet healed. Reporter causality was not reported. Treatment information was not provided.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: vertigo; This spontaneous case was reported by a patient family member or friend and describes the occurrence of VERTIGO (vertigo) in a 55-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Sep-2024 at 2:00 PM, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. On 23-Sep-2024,  after starting mRNA-1273.712 (SPIKEVAX 2024-2025 PFS), the patient experienced VERTIGO (vertigo). At the time of the report, VERTIGO (vertigo) had not resolved.            Concomitant product use was not provided by the reporter.  Suspect vaccine dosage text was reported as unknown.  It was reported that in the morning of 23-Sep-2024, patient experienced that her room was spinning as soon as she opened up her eyes. She had a vertigo and then when she got up later on for the rest of the morning, she felt dizzy, but the room was not spinning but she still feels lightheaded.  Treatment information was not provided.  Reporter causality was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-109896 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-109896:patient Husband case (different product)
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: moderate aches; chills; This spontaneous case was reported by a patient and describes the occurrence of PAIN (moderate aches) and CHILLS (chills) in an adult patient of an unknown gender who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. In 2024, the patient experienced PAIN (moderate aches) and CHILLS (chills). In 2024, PAIN (moderate aches) and CHILLS (chills) had resolved.        The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Suspect vaccine dosage text was reported as unknown. The patient had same mild symptoms, chills, moderate aches, that go away in a day. Patient thought that there's a possibility of enlarged lymph nodes and lymph glands, and to not have a mammogram right away because it may give false results.  Reporter causality was not reported. Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive with COVID-19/ current symptoms are sore throat, fever and headache when getting up; tested positive with COVID-19/ current symptoms are sore throat, fever and headache when getting up; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 76-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "blood pressure" (unspecified if ongoing), notes: taking Losartan; "supposed to have surgery for prostate" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN taken for blood pressure abnormal; TRAZODONE; LACTOSE; ATIVAN; MELATONIN. Vaccination history included: Pfizer covid-19 vaccine (DOSE 1, SINGLE), for COVID-19 Immunisation; Pfizer covid-19 vaccine (DOSE 2, SINGLE), for COVID-19 Immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2024, outcome "unknown" and all described as "tested positive with COVID-19/ current symptoms are sore throat, fever and headache when getting up". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2024) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: A patient who had been administered with Pfizer COVID-19 vaccine tested positive with COVID-19. He tested positive in Sep2024 (reported as 4 days ago) and the doctor only sent the prescription for Paxlovid last night. His current symptoms are sore throat, fever and takes Tylenol for it every 6 hours, and headache when getting up. The patient already had 2-3 shots of Pfizer COVID-19 vaccine and is scheduled for the booster on Oct2024. The patient was asking regarding Paxlovid drug interactions.  The information on the batch/lot number for [BNT162B2] will be requested and submitted if and when received.
Age: 65.0
Sex: F
Vaccine: COVID19, FLUX, PPV
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Patient tested positive for covid on Sunday, 22Sep2024.  have cold and sore throat symptoms.; This is a spontaneous report received from an Other HCP.  A 65-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 17Sep2024 at 16:00 as dose 1, single (Batch/Lot number: unknown) at the age of 65 years, in left arm for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 17Sep2024 as dose number unknown, single); pneumococcal vaccine (PNEUMOCOCCAL VACCINE), on 17Sep2024 as dose number, single); amlodipine besilate (AMLODIPINE BESYLATE), since 17Sep2024 (Lot number: 220607). The patient's relevant medical history included: "have only one kidney" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (non-serious) with onset 21Sep2024 at 16:00, outcome "recovering", described as "Patient tested positive for covid on Sunday, 22Sep2024. have cold and sore throat symptoms.". Relevant laboratory tests and procedures are available in the appropriate section. The action taken for amlodipine besilate was unknown. Therapeutic measures were not taken as a result of covid-19.
Age: 40.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Dizziness, Dyspnoea, Heart rate, Heart rate increased
Clinical narrative: After climbing a flight of stairs my heart rate was 170; out of breath; lightheaded; This is a spontaneous report received from a Consumer or other non HCP.  A 40-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 20Sep2024 at 17:30 as dose 1, single (Batch/Lot number: unknown) at the age of 40 years, in right arm for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), on 20Sep2024 as dose number unknown, single), in right arm for immunisation. The patient's relevant medical history included: "Fish allergy" (unspecified if ongoing); "Neurally mediated hypotension" (unspecified if ongoing); "migraines" (unspecified if ongoing); "IBS" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "OCD" (unspecified if ongoing). Concomitant medication(s) included: CETIRIZINE, start date: 25Aug2024; VITAMIN D NOS, start date: 01Jun2021. The following information was reported: HEART RATE INCREASED (non-serious) with onset 22Sep2024 at 16:15, outcome "recovering", described as "After climbing a flight of stairs my heart rate was 170"; DIZZINESS (non-serious) with onset 22Sep2024 at 16:15, outcome "recovering", described as "lightheaded"; DYSPNOEA (non-serious) with onset 22Sep2024 at 16:15, outcome "recovering", described as "out of breath". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: after climbing a flight of stairs, the patient's heart rate was 170, she was out of breath and lightheaded. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Skin disorder
Clinical narrative: side effect of skin; This is a spontaneous report received from a Consumer or other non HCP.  An 86-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: SKIN DISORDER (non-serious), outcome "unknown", described as "side effect of skin". Additional information: The patient has called about the Pfizer Covid vaccination and was sent some documents. Would like to know what date it was, he went to read it again and wants to show it to his dermatologist for skin problem. Doesn't remember when he reported, it was sent about side effects it was 2-3 years ago. States he needs something about side effects around the skin and wants to provide to his dermatologist to educate the doctor also. Whatever she has asked him to do is not working. maybe if she reads it, it will help.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Biopsy, Investigation, Lymphoproliferative disorder, Physical examination
Clinical narrative: PC-SMPTCL; This is a literature report, Program ID for the following literature source(s).  A 35-year-old male patient received BNT162b2 (COMIRNATY), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LYMPHOPROLIFERATIVE DISORDER (medically significant), 1 week after the suspect product(s) administration, outcome "unknown", described as "PC-SMPTCL". The patient underwent the following laboratory tests and procedures: Biopsy: superficial and deep multinodular lymphocytic, notes: infiltrate accentuated around vessels and adnexal structures without epidermotropism; Phenotypic studies: predominance of CD4+ T-cells, notes: His lymphocytes expressed BCL6 and PD1 and thus, confirmed follicular helper T-cell phenotype; physical exam: an erythematous non-tender, notes: non-ulcerated, nodule on the mid-forhead. Clinical course: Patient received first dose of the tozinameran [Pfizer-BioNTech vaccine]. After 1 week, he developed a nodule on his forehead. After 2 months, his nodule persisted. A punch biopsy revealed superficial and deep multinodular lymphocytic infiltrate accentuated around vessels and adnexal structures without epidermotropism. Phenotypic studies revealed predominance of CD4+ T-cells. His lymphocytes expressed BCL6 and PD1 and thus, confirmed follicular helper T-cell phenotype. Hence, PC-SMPTCL was diagnosed. Upon presentation, the nodule had been present which were asymptomatic. His physical exam revealed an erythematous non-tender, non-ulcerated, nodule on the mid-forehead. At follow-up, he showed spontaneous complete resolution. Further, he received another dose of tozinameran [Pfizer-BioNTech vaccine] and elasomeran [moderna booster] without relapse.Thus, PC-SMPTCL secondary to tozinameran was considered. Author Comment: We also describe unreported cases of lymphomatoid papulosis (LyP) and primary cutaneous CD4+ small/medium sized pleomorphic T-cell lymphoproliferative disorder (PC-SMPTCL) following [tozinameran]." "While a causal relationship cannot be definitively established, the reactive nature of [lymphoproliferative disorders] infiltrates suggests possible antigenic stimulation from [ tozinameran]."  No follow-up attempts are possible.; Sender's Comments: Based on the temporal relationship, the association between the event lymphoproliferative disorder with COMIRNATY can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Insomnia, Pain, Polyuria, Tremor
Clinical narrative: chills; shakes; body ache; Excessive urination; can't sleep; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), 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 nos (DOSE 1), for COVID-19 immunization, reaction(s): "chills", "can't sleep", "body ache", "Excessive urination", "shakes". The following information was reported: CHILLS (non-serious), outcome "recovered"; TREMOR (non-serious), outcome "recovered", described as "shakes"; PAIN (non-serious), outcome "recovered", described as "body ache"; POLYURIA (non-serious), outcome "recovered", described as "Excessive urination"; INSOMNIA (non-serious), outcome "recovered", described as "can't sleep".  Additional information: The patient has been receiving Pfizer's COVID shots. Have had 6 of them. On the day of and next day. The patient gets chills, shakes, body ache, Excessive urination, can't sleep. Only lasts through the next day.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400122214 same patient/event, different vaccine dose;
Sex: F
Vaccine: FLUX, RSV
Symptoms: Exposure during pregnancy, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: The injection site is warm to the touch; The injection site is ... swollen; injection site is ...  painful; injection site ... itchy; This is a spontaneous report received from a Consumer or other non HCP from medical information team and a sales representative.  A female patient (pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 18Sep2024 as dose number unknown, single (Batch/Lot number: unknown) for maternal immunisation; influenza vaccine (INFLUENZA), on 18Sep2024). The patient's relevant medical history included: "allergy" (unspecified if ongoing). The patient was 32 weeks pregnant at the event onset. The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE SWELLING (non-serious) with onset 18Sep2024, outcome "recovering", described as "The injection site is ... swollen"; VACCINATION SITE WARMTH (non-serious) with onset 18Sep2024, outcome "recovering", described as "The injection site is warm to the touch"; VACCINATION SITE PRURITUS (non-serious) with onset 18Sep2024, outcome "recovering", described as "injection site ... itchy"; VACCINATION SITE PAIN (non-serious) with onset 18Sep2024, outcome "recovering", described as "injection site is ...  painful". It was unknown if therapeutic measures were taken as a result of vaccination site warmth, vaccination site swelling, vaccination site pain, vaccination site pruritus.  Additional information: Per patient, "I just wanted to report that my reaction/response to the RSV shot wa getting worse. The injection site is warm to the touch, swollen, painful, and itchy. The reaction itself has continued spreading/getting larger over the last few days."
Sex: F
Vaccine: RSV
Symptoms: Cough
Clinical narrative: Dry Cough; This is a spontaneous report received from a Physician from a sales representative.  A female patient (pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for maternal immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COUGH (non-serious), outcome "unknown", described as "Dry Cough". It was unknown if therapeutic measures were taken as a result of cough.
Sex: F
Vaccine: RSV
Symptoms: Cough
Clinical narrative: Dry Cough; This is a spontaneous report received from a Physician from a sales representative.  A female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. It was unknown if the patient received any vaccines on the same date as the vaccine(s). It was unknown if the patient received any vaccines within 4 weeks prior to the vaccine(s). It was unknown if the patient was taking any medications within 2 weeks of the event starting. The following information was reported: COUGH (non-serious), outcome "unknown", described as "Dry Cough". It was unknown if therapeutic measures were taken as a result of cough.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: why if i kept up with my covid vaccines why i still got covid; why if i kept up with my covid vaccines why i still got covid; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "why if i kept up with my covid vaccines why i still got covid".  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Parkinson's disease
Clinical narrative: Parkinson's syndrome symptoms / full blown Parkinson; This is a spontaneous report received from a Physician.  A 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: PARKINSON'S DISEASE (medically significant), outcome "unknown", described as "Parkinson's syndrome symptoms / full blown Parkinson".  Clinical course: A doctor told a pharmaceutical rep for Pfizer that a patient had got Parkinson's from the Pfizer Vaccine. The patient a couple of years ago had a Pfizer vaccine for Covid. The exact timeline was unknown but two- or three-weeks post Pfizer Vaccine, he started developing Parkinson's syndrome symptoms and now, he basically had full blown Parkinson. He was blaming the vaccine. The doctor did called it an adverse event.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the event Parkinson's disease and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: feeling "crummy" after dose; This is a spontaneous report received from a Nurse from a sales representative.  An adult female patient (unknown if pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in 2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious) with onset 2024, outcome "unknown", described as "feeling "crummy" after dose". It was unknown if therapeutic measures were taken as a result of malaise. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Covid-19; Covid-19; This is a spontaneous report received from a Consumer or other non HCP.  A 71-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 04Apr2024 as dose 1, single (Batch/Lot number: unknown) at the age of 71 years for COVID-19 immunisation. The patient's relevant medical history included: "occasional acid reflux" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing); "Known allergies: sulfa" (unspecified if ongoing); "Known allergies: walnuts" (unspecified if ongoing); "Known allergies: eggplant" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2024, outcome "not recovered" and all described as "Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Sep2024) Negative, notes: Home test; (21Sep2024) Positive, notes: then felt symptoms returning 17Sep2024 or 18Sep2024, confirmed by positive home test. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient had home test negative for COVID on 09Sep2024; then felt symptoms returning 17Sep2024 or 18Sep2024, confirmed by positive home test 21Sep2024.  The information on the batch/lot number for BNT162B2 OMI XBB.1.5 will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Chills, Pyrexia
Clinical narrative: Fever; Chills; This is a spontaneous report received from a consumer.  A 53-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose 3 (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation; influenza vaccine (INFLUENZA VACCINE), as dose number unknown, single) for immunisation. The patient's relevant medical history included: "Reactive arthritis" (unspecified if ongoing); "Bee stings allergy" (unspecified if ongoing); "Coconut allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Bupropion, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 immunization, reaction(s): "Chills", "Fever"; Bnt162b2 (DOSE 2), for COVID-19 immunization, reaction(s): "Chills", "Fever". The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Fever"; CHILLS (non-serious), outcome "unknown".  Additional information: The patient had received Pfizer vaccine since start of COVID-19. Prior to the patient's sixth shot, the patient had gotten flu and COVID-19 shot at the same time since COVID-19 began. Other than fever and chills, the patient had not had any other side effects until now. This resulted in a trip to immediate care.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400261257 Same patient and product; different events and dose;
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Abdominal pain upper
Clinical narrative: Bad stomach ache; This is a spontaneous report and received from Consumer or other non HCPs.  An adult female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Sep2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), in Sep2024 as dose number unknown, single) for immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Past drug history included: Drug, unspecified, reaction(s): "Hypersensitivity". The following information was reported: ABDOMINAL PAIN UPPER (non-serious) with onset Sep2024, outcome "recovered" (Sep2024), described as "Bad stomach ache". Therapeutic measures were not taken as a result of abdominal pain upper.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Near death experience, Pulmonary thrombosis, Thrombosis
Clinical narrative: multiple blood clots on each leg; one in each lungs; Almost died because of that shot; This is a spontaneous report received from a Consumer or other non HCP.  A 59-year-old male patient received BNT162b2 (BNT162B2), on 08May2021 as dose 1, single (Lot number: EWO183) at the age of 59 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "blood pressure" (unspecified if ongoing). Concomitant medication(s) included: BENICAR HCT taken for blood pressure abnormal. The following information was reported: NEAR DEATH EXPERIENCE (life-threatening, hospitalization, medically significant) with onset 04Jun2021, outcome "unknown", described as "Almost died because of that shot"; THROMBOSIS (life-threatening, hospitalization, medically significant) with onset 04Jun2021, outcome "unknown", described as "multiple blood clots on each leg"; PULMONARY THROMBOSIS (life-threatening, hospitalization, medically significant) with onset 04Jun2021, outcome "unknown", described as "one in each lungs". The patient was hospitalized for thrombosis, pulmonary thrombosis, near death experience (start date: 04Jun2021). The patient underwent the following laboratory tests and procedures: Blood test: Unknown results. Therapeutic measures were taken as a result of thrombosis, pulmonary thrombosis, near death experience.  Clinical course: When the patient had the covid vaccine, he got the Pfizer shot and so his body had reaction to it and he only had one shot and he was in ICU with multiple blood clots in each leg and one in each lung and so he was in ICU for 3 days, he was given Heparin, which dissolves the blood clots,  and now he has been told that he need to be on Eliquis the rest of his life and so, he is just wondering if there is any reparation or anything. His oncologist said that he got it from the shot because his body, the proteins or whatever was in the shot did not agree with his body. He was checked for cancer, and confirmed that he did not have, and was told to not get shot any more. Almost died because of that shot. So, now he is paying dollars a month, for the rest of his life for Pfizer vaccine. He does not want to pay. He is retired and just think it is not right. So, is there anything that Pfizer can do to help him get some kind of a discount on this blood thinner that he has to take the rest of his life.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Psoriasis
Clinical narrative: major psoriasis flare (bloody fingertips, etc. awful flare); This is a spontaneous report received from a Consumer or other non HCP.  A 75-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 18Sep2024 as dose 1, single (Batch/Lot number: unknown) at the age of 75 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Otezla for Psoriasis, notes: she was on Otezla for almost a year and psoriasis went into remission. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization; Bnt162b2, bnt162b2 omi ba.4-5 (Dose number unknown (booster). About 2 weeks later she developed psoriasis), administration date: 2022, for COVID-19 immunization, reaction(s): "Psoriasis". The following information was reported: PSORIASIS (medically significant) with onset 22Sep2024, outcome "not recovered", described as "major psoriasis flare (bloody fingertips, etc. awful flare)". After previous occurrence, the patient did not give psoriasis a thought until now. She did not think it was a coincidence and considered the event may be related to the suspect product.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400125046 same patient/event, different vaccine dose;
Sex: U
Vaccine: COVID19
Symptoms: Chills, Insomnia, Pain, Polyuria, Tremor
Clinical narrative: chills; shakes; body ache; Excessive urination; can't sleep; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose 3 (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 nos (DOSE 1), for COVID-19 immunization, reaction(s): "chills", "can't sleep", "body ache", "Excessive urination", "shakes"; Bnt162b2 nos (DOSE 2), for COVID-19 immunization, reaction(s): "chills", "can't sleep", "body ache", "Excessive urination", "shakes". The following information was reported: CHILLS (non-serious), outcome "recovered"; TREMOR (non-serious), outcome "recovered", described as "shakes"; PAIN (non-serious), outcome "recovered", described as "body ache"; POLYURIA (non-serious), outcome "recovered", described as "Excessive urination"; INSOMNIA (non-serious), outcome "recovered", described as "can't sleep".  Additional information: The patient has been receiving Pfizer's COVID shots. Have had 6 of them. On the day of and next day. The patient gets chills, shakes, body ache, Excessive urination, can't sleep. Only lasts through the next day.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400122214 same patient/event, different vaccine dose;
Sex: U
Vaccine: COVID19
Symptoms: Chills, Insomnia, Pain, Polyuria, Tremor
Clinical narrative: chills; shakes; body ache; Excessive urination; can't sleep; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose 4 (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 nos (DOSE 1), for COVID-19 immunization, reaction(s): "chills", "can't sleep", "body ache", "Excessive urination", "shakes"; Bnt162b2 nos (DOSE 2), for COVID-19 immunization, reaction(s): "chills", "can't sleep", "body ache", "Excessive urination", "shakes"; Bnt162b2 nos (DOSE 3), for COVID-19 immunization, reaction(s): "chills", "can't sleep", "body ache", "Excessive urination", "shakes". The following information was reported: CHILLS (non-serious), outcome "recovered"; TREMOR (non-serious), outcome "recovered", described as "shakes"; PAIN (non-serious), outcome "recovered", described as "body ache"; POLYURIA (non-serious), outcome "recovered", described as "Excessive urination"; INSOMNIA (non-serious), outcome "recovered", described as "can't sleep".  Additional information: The patient has been receiving Pfizer's COVID shots. Have had 6 of them. On the day of and next day. The patient gets chills, shakes, body ache, Excessive urination, can't sleep. Only lasts through the next day.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400122214 same patient/event, different vaccine dose;
Sex: U
Vaccine: COVID19
Symptoms: Chills, Insomnia, Pain, Polyuria, Tremor
Clinical narrative: chills; shakes; body ache; Excessive urination; can't sleep; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 nos (DOSE 1), for COVID-19 immunization, reaction(s): "chills", "can't sleep", "body ache", "Excessive urination", "shakes"; Bnt162b2 nos (DOSE 2), for COVID-19 immunization, reaction(s): "chills", "can't sleep", "body ache", "Excessive urination", "shakes"; Bnt162b2 nos (DOSE 3), for COVID-19 immunization, reaction(s): "chills", "can't sleep", "body ache", "Excessive urination", "shakes"; Bnt162b2 nos (DOSE 4), for COVID-19 immunization, reaction(s): "chills", "can't sleep", "body ache", "Excessive urination", "shakes". The following information was reported: CHILLS (non-serious), outcome "recovered"; TREMOR (non-serious), outcome "recovered", described as "shakes"; PAIN (non-serious), outcome "recovered", described as "body ache"; POLYURIA (non-serious), outcome "recovered", described as "Excessive urination"; INSOMNIA (non-serious), outcome "recovered", described as "can't sleep".  Additional information: The patient has been receiving Pfizer's COVID shots. Have had 6 of them. On the day of and next day. The patient gets chills, shakes, body ache, Excessive urination, can't sleep. Only lasts through the next day.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400122214 same patient/event, different vaccine dose;
Sex: U
Vaccine: COVID19
Symptoms: Chills, Insomnia, Pain, Polyuria, Tremor
Clinical narrative: chills; shakes; body ache; Excessive urination; can't sleep; This is a spontaneous report received from a Consumer or other non HCP, Program ID:.  A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose 6 (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 nos (DOSE 1), for COVID-19 immunization, reaction(s): "chills", "can't sleep", "body ache", "Excessive urination", "shakes"; Bnt162b2 nos (DOSE 2), for COVID-19 immunization, reaction(s): "chills", "can't sleep", "body ache", "Excessive urination", "shakes"; Bnt162b2 nos (DOSE 3), for COVID-19 immunization, reaction(s): "chills", "can't sleep", "body ache", "Excessive urination", "shakes"; Bnt162b2 nos (DOSE 4), for COVID-19 immunization, reaction(s): "chills", "can't sleep", "body ache", "Excessive urination", "shakes"; Bnt162b2 nos (DOSE 5), for COVID-19 immunization, reaction(s): "chills", "can't sleep", "body ache", "Excessive urination", "shakes". The following information was reported: CHILLS (non-serious), outcome "recovered"; TREMOR (non-serious), outcome "recovered", described as "shakes"; PAIN (non-serious), outcome "recovered", described as "body ache"; POLYURIA (non-serious), outcome "recovered", described as "Excessive urination"; INSOMNIA (non-serious), outcome "recovered", described as "can't sleep".  Additional information: The patient has been receiving Pfizer's COVID shots. Have had 6 of them. On the day of and next day. The patient gets chills, shakes, body ache, Excessive urination, can't sleep. Only lasts through the next day.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400122214 same patient/event, different vaccine dose;
Sex: U
Vaccine: COVID19
Symptoms: Chills, Insomnia, Pain, Polyuria, Tremor
Clinical narrative: chills; shakes; body ache; Excessive urination; can't sleep; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious), outcome "recovered"; TREMOR (non-serious), outcome "recovered", described as "shakes"; PAIN (non-serious), outcome "recovered", described as "body ache"; POLYURIA (non-serious), outcome "recovered", described as "Excessive urination"; INSOMNIA (non-serious), outcome "recovered", described as "can't sleep".  Additional information: The patient has been receiving Pfizer's COVID shots. Have had 6 of them. On the day of and next day. The patient gets chills, shakes, body ache, Excessive urination, can't sleep. Only lasts trough the next day.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400263272 same patient/event, different vaccine dose;US-PFIZER INC-202400263270 same patient/event, different vaccine dose;US-PFIZER INC-202400263273 same patient/event, different vaccine dose;US-PFIZER INC-202400263271 same patient/event, different vaccine dose;US-PFIZER INC-202400261694 same patient/event, different vaccine dose;
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Poor quality product administered, Product contamination microbial
Clinical narrative: took the covid vaccine that contained yeast; took the covid vaccine that contained yeast; took the covid vaccine that contained yeast anyhow and had an allergic reaction; This is a spontaneous report received from a Consumer or other non HCP.  A female patient received BNT162b2 omicron (kp.2) (BNT162B2 OMICRON (KP.2)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (medically significant), PRODUCT CONTAMINATION MICROBIAL (medically significant), outcome "unknown" and all described as "took the covid vaccine that contained yeast"; ALLERGY TO VACCINE (medically significant), outcome "unknown", described as "took the covid vaccine that contained yeast anyhow and had an allergic reaction".  Clinical course: The reporter stated that her sister was advised by a pharmacy that she should not take the covid 19 vaccine due to it having yeast. She took the covid vaccine that contained yeast anyhow and had an allergic reaction.  Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Biopsy, Investigation, Lymphomatoid papulosis, Physical examination, Positron emission tomogram
Clinical narrative: Lymphomatoid papulosis; This is a literature report, Program ID for the following literature source(s).  An 18-year-old male patient developed LyP following treatment with tozinameran for COVID-19 immunisation. The man presented with papulonodular and ulcerative lesions suggestive of LyP. However, he did not respond to unspecified steroids. His lesion appeared after 1 month of second dose of tozinameran [Pfizer-BioNTech vaccine]. His physical examination revealed over 30 erythematous papules, nodules, and ulcerated tumors on the face, back, extremities, and groin. A PET-CT scan demonstrated numerous hypermetabolic cutaneous lesions. A biopsy revealed extensive atypical lymphocytic infiltrate. His epidermal response ranged from psoriasiform hyperplasia to frank ulceration as well as polymorphous inflammatory background included eosinophils, occasional neutrophils and histiocytes. Additionally, predominance of CD4 over CD8 T-cells with atypical cells of the CD4 subset and extensive CD30 positivity was noted with significant B-cell hyperplasia characterized by CD21 and CD23 positivity. Thus, his presentation was consistaent with borderline type C LyP. Hence, he received treatment with methotrexate. Subsequently, he showed remission. He did not received another dose of tozinameran. However, he developed recurrence and thus, received another course of methotrexate which led to complete remission. Thus, LyP secondary to tozinameran was considered.  No follow-up attempts are possible.; Sender's Comments: A possibly contributory role of BNT162B2 in triggering the onset of lymphomatoid papulosis / Cutaneous lymphoproliferative disorders might not be fully excluded, considering the temporal relationship.  More immunological and biomolecular evidence would be needed to explore the plausible physiopathologic mechanism between the vaccination and the occurrence.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: Bronchitis
Clinical narrative: I'm know to get Bronchitis; This is a spontaneous report received from a Consumer or other non HCP, Program ID:.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BRONCHITIS (non-serious), outcome "unknown", described as "I'm know to get Bronchitis".  Additional information: The patient was seeking assistance with the Abrysvo vaccine. The patient stated, " Through Pfizer I got my Booster shot and a Covid shot. My doctor wants me to get a RSV shot cause in the winter time I'm know to get Bronchitis.".  Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Blood test abnormal, Chest pain, Dyspnoea, Fatigue
Clinical narrative: spike count in blood test still showing over 5000 years later/Spike protein in blood still over 5,000 years later; dealing with resting heart rate of 100 minimum and whenever I stand up. It jumps up to 140 bpm; chest pain/debilitating chest pain; trouble breathing/shortness of breath; bad fatigue/horrible fatigue on top of everything; chronic health issues; This is a spontaneous report received from a Consumer or other non HCP.  A 31-year-old male patient received BNT162b2 (BNT162B2), in 2021 as dose number unknown, single (Lot number: FC3181) intramuscular, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: BLOOD TEST ABNORMAL (medically significant), outcome "not recovered", described as "spike count in blood test still showing over 5000 years later/Spike protein in blood still over 5,000 years later"; HEART RATE INCREASED (medically significant), outcome "unknown", described as "dealing with resting heart rate of 100 minimum and whenever I stand up. It jumps up to 140 bpm"; CHEST PAIN (non-serious), outcome "not recovered", described as "chest pain/debilitating chest pain"; DYSPNOEA (non-serious), outcome "not recovered", described as "trouble breathing/shortness of breath"; FATIGUE (non-serious), outcome "not recovered", described as "bad fatigue/horrible fatigue on top of everything"; GENERAL PHYSICAL HEALTH DETERIORATION (non-serious), outcome "unknown", described as "chronic health issues". The patient underwent the following laboratory tests and procedures: Blood test: still over 5,000, notes: years later; still showing over 5,000, notes: years later; Heart rate: 100, notes: resting heart rate of 100 minimum; 140, notes: bpm; and whenever I stand up. It jumps up to 140 bpm. Clinical course: Patient did not receive any other vaccines on the same date as the Pfizer vaccine, was not taking any other medications within 2 weeks prior to the event onset and did not receive any other vaccines within 4 weeks prior to the first administration of the suspect vaccine. The patient was not allergic to any previous vaccination, medication, food or other products and there were no other diagnosed illnesses/medical history/chronic health conditions to report. Patient was completely healthy prior to the vaccines after taking then he had chronic health issues. Also dealing with resting heart rate of 100 minimum and whenever he stand up. It jumps up to 140 bpm.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400262099 same patient/product, different dose/event;US-PFIZER INC-PV202400108765 same patient/product, different dose/event;