chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Immunodeficiency
Clinical narrative: newly immunocompromised patient; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNODEFICIENCY (medically significant), outcome "unknown", described as "newly immunocompromised patient".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Musculoskeletal stiffness, Off label use, Product use issue, Scan
Clinical narrative: his right fingers were not able to move; right arm numb from time to time; had 3 PFE-BNT shots from Mar-May2021; had 3 PFE-BNT shots from Mar-May2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 64 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, administration date Apr2021 (Batch/Lot number: unknown) as dose 2, single and administration date Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 2021, outcome "unknown" and all described as "had 3 PFE-BNT shots from Mar-May2021"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset Jan2022, outcome "not recovered", described as "his right fingers were not able to move"; HYPOAESTHESIA (non-serious) with onset Jan2022, outcome "not recovered", described as "right arm numb from time to time". The events "his right fingers were not able to move" and "right arm numb from time to time" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of musculoskeletal stiffness, hypoaesthesia.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy, Thyroid mass, Thyroid pain
Clinical narrative: my lymph node on the right side; is swollen and little bit ''laid up''; something is like growing for my thyroid, it is like a ''penny'' and its very painful; I can''t touch it; pain is not going; my thyroid is very painful, I can't touch it, you know.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 07Mar2022 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE: 1), administration date: 2021, for COVID-19 Immunization, reaction(s): "Dizzy"; Bnt162b2 (DOSE: 2), administration date: 2021, for Covid-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "my lymph node on the right side; is swollen and little bit ''laid up''"; THYROID MASS (non-serious), outcome "unknown", described as "something is like growing for my thyroid, it is like a ''penny'' and its very painful; I can''t touch it; pain is not going"; THYROID PAIN (non-serious), outcome "unknown", described as "my thyroid is very painful, I can't touch it, you know.".  The lot number for bnt162b2 was not provided and will be requested during follow up. Sender's Comments: Linked Report(s) : US-PFIZER INC-202200411099 same patient and drug, different event separated in time
Sex: U
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: I feel one day dizzy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious), outcome "recovered", described as "I feel one day dizzy".  Additional information: The patient received both vaccinations last year. The patient had the first vaccination with Pfizer it was like after one, not even one week the patient felt one day dizzy but it goes away and that's it.  The lot number for bnt162b2 was not provided and will be requested during follow up. Sender's Comments: Linked Report(s) : US-PFIZER INC-202200410067 same patient and drug, different event separated in time
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Blood thyroid stimulating hormone, Cerebrovascular accident, Feeling abnormal, Magnetic resonance imaging
Clinical narrative: stroke; I would be feel foggy headed; This is a spontaneous report received from contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program (003110). The reporter is the patient.  A 63 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 29Sep2021 11:00 (Lot number: FF2588) at the age of 63 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "MS", start date: 1992 (unspecified if ongoing); "Thyroid", start date: 1975 (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Lot number: EW0172, Expiration date: 30Nov2021, intramuscularly in left arm at 11:00 as dose 1, single), administration date: 03Sep2021, when the patient was 63 years old, for COVID-19 Immunisation, reaction(s): "could barely move / felt like I was paralyzed", "Very painful throughout of my body", "Aggravated my MS". The patient did not receive any other vaccine within 4 weeks prior to COVID-19 vaccine. The following information was reported: CEREBROVASCULAR ACCIDENT (hospitalization, medically significant) with onset 20Dec2021, outcome "not recovered", described as "stroke"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "I would be feel foggy headed". It was further reported that the patient has not experienced any effects from 2nd dose. The next few months after receiving the vaccine she would felt "foggy" headed, at times she would say to herself that she hope this was not stroke. It would subsided until December and it increased. On 20Dec2021, patient had stroke. It was reported that the patient has no history of high blood pressure and has no indication to have stroke. The event "stroke" was evaluated at the emergency room visit twice. The patient underwent the following laboratory tests and procedures: blood thyroid stimulating hormone (0.350-4.840): (22Dec2021) 1.300, notes: Normal; magnetic resonance imaging: (20Dec2021) unknown results; (22Dec2021) unknown results. Therapeutic measures were taken as a result of cerebrovascular accident.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200192886 same reporter, drug and patient; similar event, different dose
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Discomfort, Fear, Heart rate, Heart rate increased
Clinical narrative: fast heart beatings; feels uncomfortable and scared; feels uncomfortable and scared; 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 66 year-old female patient received bnt162b2 (BNT162B2), administration date 28Sep2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, single, Manufacturer Unknown), for COVID-19 immunization. The following information was reported: HEART RATE INCREASED (non-serious), outcome "unknown", described as "fast heart beatings"; DISCOMFORT (non-serious), FEAR (non-serious), outcome "unknown" and all described as "feels uncomfortable and scared". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient received second dose on 28Sep2021, after that she started to feel fast heart beatings, occasional in the beginning but now it happens every day, even more than one time a day. She reported that she never felt this before the vaccine, that she is a healthy person who usually exercises; she practices swimming and walking. Her doctor find the heartbeat abnormal, Patient describes this as a very fast heartbeat like her heart is getting out of the chest or like getting out of the mouth, she feels uncomfortable and scared. Her doctor recommended to visit a cardiologist. Patient asked for the frequency that this adverse reaction is reported, if this will be a long term or short term lasting effect and if she would be vaccinated with booster.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ageusia, Amnesia, Anosmia, Arthralgia, COVID-19
Clinical narrative: fast heart beatings; feels uncomfortable and scared; feels uncomfortable and scared; 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 66 year-old female patient received bnt162b2 (BNT162B2), administration date 28Sep2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, single, Manufacturer Unknown), for COVID-19 immunization. The following information was reported: HEART RATE INCREASED (non-serious), outcome "unknown", described as "fast heart beatings"; DISCOMFORT (non-serious), FEAR (non-serious), outcome "unknown" and all described as "feels uncomfortable and scared". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient received second dose on 28Sep2021, after that she started to feel fast heart beatings, occasional in the beginning but now it happens every day, even more than one time a day. She reported that she never felt this before the vaccine, that she is a healthy person who usually exercises; she practices swimming and walking. Her doctor find the heartbeat abnormal, Patient describes this as a very fast heartbeat like her heart is getting out of the chest or like getting out of the mouth, she feels uncomfortable and scared. Her doctor recommended to visit a cardiologist. Patient asked for the frequency that this adverse reaction is reported, if this will be a long term or short term lasting effect and if she would be vaccinated with booster.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiac disorder, Pain, Physical examination, Pruritus, Pyrexia
Clinical narrative: fast heart beatings; feels uncomfortable and scared; feels uncomfortable and scared; 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 66 year-old female patient received bnt162b2 (BNT162B2), administration date 28Sep2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, single, Manufacturer Unknown), for COVID-19 immunization. The following information was reported: HEART RATE INCREASED (non-serious), outcome "unknown", described as "fast heart beatings"; DISCOMFORT (non-serious), FEAR (non-serious), outcome "unknown" and all described as "feels uncomfortable and scared". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient received second dose on 28Sep2021, after that she started to feel fast heart beatings, occasional in the beginning but now it happens every day, even more than one time a day. She reported that she never felt this before the vaccine, that she is a healthy person who usually exercises; she practices swimming and walking. Her doctor find the heartbeat abnormal, Patient describes this as a very fast heartbeat like her heart is getting out of the chest or like getting out of the mouth, she feels uncomfortable and scared. Her doctor recommended to visit a cardiologist. Patient asked for the frequency that this adverse reaction is reported, if this will be a long term or short term lasting effect and if she would be vaccinated with booster.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, Vaccination failure
Clinical narrative: fast heart beatings; feels uncomfortable and scared; feels uncomfortable and scared; 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 66 year-old female patient received bnt162b2 (BNT162B2), administration date 28Sep2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, single, Manufacturer Unknown), for COVID-19 immunization. The following information was reported: HEART RATE INCREASED (non-serious), outcome "unknown", described as "fast heart beatings"; DISCOMFORT (non-serious), FEAR (non-serious), outcome "unknown" and all described as "feels uncomfortable and scared". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient received second dose on 28Sep2021, after that she started to feel fast heart beatings, occasional in the beginning but now it happens every day, even more than one time a day. She reported that she never felt this before the vaccine, that she is a healthy person who usually exercises; she practices swimming and walking. Her doctor find the heartbeat abnormal, Patient describes this as a very fast heartbeat like her heart is getting out of the chest or like getting out of the mouth, she feels uncomfortable and scared. Her doctor recommended to visit a cardiologist. Patient asked for the frequency that this adverse reaction is reported, if this will be a long term or short term lasting effect and if she would be vaccinated with booster.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 57.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Blood test, Pain in extremity, Peripheral swelling, Rheumatoid arthritis, Vitamin D decreased
Clinical narrative: Vitamin D low; feet started hurting very bad; fingers started swelling; Might triggered rheumatoid arthritis; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4308882-00 (AbbVie).  A 57 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 02Apr2021 (Batch/Lot number: unknown) at the age of 57 years as dose 1, single for covid-19 immunisation; upadacitinib (RINVOQ), oral (Lot number: 1155129) for rheumatoid arthritis. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: RHEUMATOID ARTHRITIS (medically significant) with onset 2021, outcome "unknown", described as "Might triggered rheumatoid arthritis"; VITAMIN D DECREASED (non-serious), outcome "unknown", described as "Vitamin D low"; PAIN IN EXTREMITY (non-serious) with onset 11Apr2021, outcome "recovering", described as "feet started hurting very bad"; PERIPHERAL SWELLING (non-serious) with onset 2021, outcome "unknown", described as "fingers started swelling". The patient underwent the following laboratory tests and procedures: blood test: vitamin d low. The action taken for upadacitinib was unknown. Therapeutic measures were taken as a result of vitamin d decreased.  The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information currently available and known safety profile the events rheumatoid arthritis flare up, vitamin D decreased, pain in extremity and peripheral swelling are most likely due to an inter current or underlying condition hence assessed as unrelated to the suspect drug bnt162b2.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Peripheral swelling, Rheumatoid arthritis, Vitamin D decreased
Clinical narrative: Vitamin D decreased; Swelling of fingers; Rheumatoid arthritis flare up; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4308882-00.  A 57 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 23Apr2021 (Batch/Lot number: unknown) at the age of 57 years as dose 2, single and intramuscular, administration date 02Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; upadacitinib (RINVOQ), oral (Lot number: 1155129) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RHEUMATOID ARTHRITIS (medically significant) with onset 2021, outcome "unknown", described as "Rheumatoid arthritis flare up"; VITAMIN D DECREASED (non-serious), outcome "unknown", described as "Vitamin D decreased"; PERIPHERAL SWELLING (non-serious) with onset 2021, outcome "unknown", described as "Swelling of fingers". The patient underwent the following laboratory tests and procedures: blood test: vitamin d low. The action taken for upadacitinib was unknown. Therapeutic measures were taken as a result of vitamin d decreased.  Clinical course:  She had blood work and vitamin D was low, so she was put on vitamin D3 2000 daily.It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The patient was treated with VITAMIN D 3. The reporter's causality for the event(s) of Pfizer covid-19 vaccine might triggered rheumatoid arthritis, vitamin d low and fingers started swelling was not provided. the reporter's causality for the event(s) of feet started hurting very bad with RInvoq(Upadacitinib) was no reasonable possibility.  The reporter considered "rheumatoid arthritis flare up", "vitamin d decreased" and "swelling of fingers" related to bnt162b2.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the currently available information the possibility of causal association between the events reported and the suspect drug BNT162B2  cannot be ruled out. 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.
Age: 57.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Blood test, Pain in extremity, Peripheral swelling, Rheumatoid arthritis, Therapeutic product effect incomplete
Clinical narrative: Drug effect incomplete; Vitamin D decreased; Painful feet; Rheumatoid arthritis aggravated; Swelling of fingers; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4314581-00.  A 58 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 02Apr2021 (Batch/Lot number: unknown) at the age of 57 years as dose 1, single and intramuscular, administration date 23Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for rheumatoid arthritis. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: RHEUMATOID ARTHRITIS (medically significant) with onset 2021, outcome "unknown", described as "Rheumatoid arthritis aggravated"; THERAPEUTIC PRODUCT EFFECT INCOMPLETE (non-serious), outcome "unknown", described as "Drug effect incomplete"; VITAMIN D DECREASED (non-serious), outcome "unknown", described as "Vitamin D decreased"; PERIPHERAL SWELLING (non-serious) with onset 2021, outcome "unknown", described as "Swelling of fingers"; PAIN IN EXTREMITY (non-serious) with onset 11Apr2021, outcome "unknown", described as "Painful feet". The patient underwent the following laboratory tests and procedures: blood test: unknown results; vitamin d: low. The action taken for adalimumab was unknown.  Clinical Course: On unknown dates, the patient experienced humira worked for a month and a half only and vitamin d low. In 2021, the patient experienced covid vaccine might trigger rheumatoid arthritis and swelling fingers. On 11Apr2021, the patient experienced feet started hurting very bad. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) Was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Report source reported as study. Report type was initial. The event abates after stopping drug reported as not applicable.   Drug: HUMIRA (Solution for injection in pre-filled pen) (ADALIMUMAB). Causality: Causality as per reporter (Drug/Vaccine) for Painful feet (Pain in extremity): No reasonable possibility. For other events it was Not Reported.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Reported events of rheumatoid arthritis aggravated, vitamin D decreased, pain in extremity and peripheral swelling can be more plausibly explained by considering the natural course of the underlying disease, unrelated to the suspect drug. The efficacy of a drug varies from patient to patient and may be influenced by multiple factors, including the severity of the inherent disease condition, concurrent medical conditions, and concomitant medications, thus unrelated to the suspect product.
Age: 57.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Vitamin D, Vitamin D decreased
Clinical narrative: Drug effect incomplete; Vitamin D decreased; Painful feet; Rheumatoid arthritis aggravated; Swelling of fingers; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4314581-00.  A 58 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 02Apr2021 (Batch/Lot number: unknown) at the age of 57 years as dose 1, single and intramuscular, administration date 23Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for rheumatoid arthritis. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: RHEUMATOID ARTHRITIS (medically significant) with onset 2021, outcome "unknown", described as "Rheumatoid arthritis aggravated"; THERAPEUTIC PRODUCT EFFECT INCOMPLETE (non-serious), outcome "unknown", described as "Drug effect incomplete"; VITAMIN D DECREASED (non-serious), outcome "unknown", described as "Vitamin D decreased"; PERIPHERAL SWELLING (non-serious) with onset 2021, outcome "unknown", described as "Swelling of fingers"; PAIN IN EXTREMITY (non-serious) with onset 11Apr2021, outcome "unknown", described as "Painful feet". The patient underwent the following laboratory tests and procedures: blood test: unknown results; vitamin d: low. The action taken for adalimumab was unknown.  Clinical Course: On unknown dates, the patient experienced humira worked for a month and a half only and vitamin d low. In 2021, the patient experienced covid vaccine might trigger rheumatoid arthritis and swelling fingers. On 11Apr2021, the patient experienced feet started hurting very bad. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) Was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Report source reported as study. Report type was initial. The event abates after stopping drug reported as not applicable.   Drug: HUMIRA (Solution for injection in pre-filled pen) (ADALIMUMAB). Causality: Causality as per reporter (Drug/Vaccine) for Painful feet (Pain in extremity): No reasonable possibility. For other events it was Not Reported.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Reported events of rheumatoid arthritis aggravated, vitamin D decreased, pain in extremity and peripheral swelling can be more plausibly explained by considering the natural course of the underlying disease, unrelated to the suspect drug. The efficacy of a drug varies from patient to patient and may be influenced by multiple factors, including the severity of the inherent disease condition, concurrent medical conditions, and concomitant medications, thus unrelated to the suspect product.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Colitis ulcerative, Mineral supplementation
Clinical narrative: iron infusion; ulcerative colitis flare ups; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient.  A 33 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 2021 (Batch/Lot number: unknown) as dose 3 (booster), single, intramuscular (Batch/Lot number: unknown) as dose 2, single and intramuscular (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), first regimen subcutaneous from 23Nov2021 (Lot number: 1155994) to 23Nov2021 at 160 mg (160 mg citrate free (1 in 1 once)), second regimen subcutaneous from 07Dec2021 (Batch/Lot number: unknown) to 07Dec2021 at 80 mg (80 mg citrate free (1 in 1 once)) and third regimen subcutaneous since Dec2021 (ongoing) (Batch/Lot number: unknown) at 40 mg (40 mg citrate free (1 in 7d)) for colitis ulcerative. Relevant medical history included: "ulcerative colitis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COLITIS ULCERATIVE (medically significant) with onset 2021, outcome "recovering", described as "ulcerative colitis flare ups"; MINERAL SUPPLEMENTATION (non-serious), outcome "unknown", described as "iron infusion". The action taken for adalimumab was dosage not changed.  The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The events Colitis ulcerative aggravated and Iron supplementation are assessed as unrelated to the suspect product BNT162B2 administration.
Sex: U
Vaccine: COVID19
Symptoms: Transient acantholytic dermatosis
Clinical narrative: each time I break out Grovers Disease; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202200426198 (Pfizer).  A 78 year-old patient received bnt162b2 (BNT162B2), administration date Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single, administration date Mar2021 (Batch/Lot number: unknown) as dose 2, single and administration date Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "heart bypass" (unspecified if ongoing), notes: I am 78 with heart bypass 17 years ago. The patient's concomitant medications were not reported. The following information was reported: TRANSIENT ACANTHOLYTIC DERMATOSIS (non-serious), outcome "recovered", described as "each time I break out Grovers Disease". The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Hair growth abnormal, Rheumatoid arthritis
Clinical narrative: has been experiencing rheumatoid arthritis lately/ had the rheumatoid arthritis flare up; hair is not growing/ hair is not coming in the way it used to; 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 84 year-old female patient received bnt162b2 (BNT162B2), administration date 10Feb2021 (Lot number: EM9809) as dose 1, single and administration date 03Mar2021 (Lot number: EN6205) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "unknown", described as "has been experiencing rheumatoid arthritis lately/ had the rheumatoid arthritis flare up"; HAIR GROWTH ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "hair is not growing/ hair is not coming in the way it used to". Therapeutic measures were taken as a result of rheumatoid arthritis. Clinical Course: Caller having vaccine had it last year and as soon as she had the vaccine she had a question about her hair. This has been going on about a year and she didn't lose her hair, but its not coming in the way it used to or always was and it's not the same hair.Caller stated that she has been experiencing rheumatoid arthritis lately. She had the rheumatoid arthritis flare up then.Her doctor changed her infusion medication for her rheumatoid arthritis and that was helpful.   No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Cerebrovascular accident, Incoherent, Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis flare; episode of being incoherent; stroke like symptoms; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4313804-00 (Agency).  A 60 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date Oct2021 (Batch/Lot number: unknown) at the age of 59 years as dose 3 (booster), single, intramuscular, administration date 2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date Jan2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at citrate free for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CEREBROVASCULAR ACCIDENT (hospitalization, medically significant), outcome "unknown", described as "stroke like symptoms"; RHEUMATOID ARTHRITIS (hospitalization, medically significant), outcome "unknown", described as "Rheumatoid arthritis flare"; INCOHERENT (hospitalization), outcome "unknown", described as "episode of being incoherent". The patient was hospitalized for cerebrovascular accident (hospitalization duration: 1 day(s)). The action taken for adalimumab was unknown.  The reporter considered "episode of being incoherent" related to bnt162b2. The reporter's and manufacturer causality for the events of stroke like symptoms was not reported and rheumatoid arthritis flare was not reported for PFIZER BioNTech Covid-19 Vaccine. The reporter's causality for the events of stroke like symptoms, episode of being incoherent following covid vaccine and rheumatoid arthritis flare was not provided for Humira (Adalimumab). Agency's opinion is that the event of stroke like symptoms is not assessable for Humira (Adalimumab). Agency's opinion is that there is no reasonable possibility that the events of episode of being incoherent following covid vaccine and rheumatoid arthritis flare are related to Humira (Adalimumab).   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of the reported events Cannot be 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: Myocarditis
Clinical narrative: Myocarditis after COVID-19 vaccine (with only a single fatal case); This is a literature report.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDITIS (death, medically significant), outcome "fatal", described as "Myocarditis after COVID-19 vaccine (with only a single fatal case)". The patient date of death was unknown. The reported cause of death was myocarditis. It was not reported if an autopsy was performed.  Meta-analysis of studies reports on the occurrence of myocarditis after a full vaccination course with RNAbased SARS-CoV2 vaccines; pooled incidence of myocarditis after vaccine was 0.0035% over ~2 years of reporting, with only a single fatal case. Conclusion: Myocarditis after COVID-19 vaccine occurs, but occurrence is rare, which is often associated with complete recovery. Although rare, serious cases may persist.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the temporal relationship, the association between the event fatal myocarditis with BNT162b2 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.; Reported Cause(s) of Death: Myocarditis after COVID-19 vaccine (with only a single fatal case)
Sex: F
Vaccine: COVID19
Symptoms: Near death experience
Clinical narrative: Grandmother took the vaccine and had complications and was on her death bed.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unkown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEAR DEATH EXPERIENCE (medically significant), outcome "unknown", described as "Grandmother took the vaccine and had complications and was on her death bed.".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Syphilis, Systemic lupus erythematosus, Treponema test false positive
Clinical narrative: lupus; tested positive for syphilis, but tested negative during the confirmatory test/ false positive may have been due to lupus; 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 48 year-old female patient received bnt162b2 (COMIRNATY), administration date 01Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 Immunization; Bnt162b2 (Dose 2), for COVID-19 Immunization. The following information was reported: SYSTEMIC LUPUS ERYTHEMATOSUS (medically significant), outcome "unknown", described as "lupus"; TREPONEMA TEST FALSE POSITIVE (non-serious), outcome "unknown", described as "tested positive for syphilis, but tested negative during the confirmatory test/ false positive may have been due to lupus". The patient underwent the following laboratory tests and procedures: blood test: unknown result; syphilis: positive; negative, notes: tested negative during the confirmatory test. Clinical course: Patient recently had her yearly gynecology appointment where she did a blood test panel for STI. Patient tested positive for syphilis, but tested negative during the confirmatory test. Patient stated that the same sample was used for the blood test and the confirmatory test. Patient was told that the false positive may have been due to lupus and other things. Patient did her research and found the letter from the FDA and CDC online in Dec2021 about false positive results with patients who received the Pfizer COVID-19 Vaccine within 5 months. Patient wanted to know if Pfizer had more information about it. Patient stated that it's possible that she may have been the first to report this since it's not a common test.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 1.42
Sex: U
Vaccine: TDAP
Symptoms: Accidental exposure to product, Medication error
Clinical narrative: inadvertently administered ADACEL to a 17 month old patient instead of DTaP, with no reported adverse event; Initial information received on 15-Mar-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 17 months old and unknown gender patient who experienced inadvertently administered adacel to a 17 month old patient instead of dtap, with no reported adverse event while receiving diphtheria-2/tetanus/5 ac pertussis vaccine [Adacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect diphtheria-2/tetanus/5 ac pertussis vaccine (with an unknown strength, dosage, frequency, batch number and expiry date) via unknown route in unknown administration site for immunization  On an unknown date(latency : same day) the patient developed a non-serious inadvertently administered adacel to a 17 month old patient instead of dtap, with no reported adverse event (accidental exposure to product) following the administration of diphtheria-2/tetanus/5 ac pertussis vaccine.  Action taken : not applicable.  It was not reported if the patient received a corrective treatment for the event (inadvertently administered ADACEL to a 17 month old patient instead of DTaP, with no reported adverse event).  At time of reporting, the outcome was Unknown for the event (inadvertently administered ADACEL to a 17 month old patient instead of DTaP, with no reported adverse event).   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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: 2.0
Sex: U
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: QUADRACEL was inadvertently given to a patient under the age of 4, and is inquiring if the dose is still valid; Initial information received on 16-Mar-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 2 years old and unknown gender patient who was inadvertently given Diphtheria-15/Tetanus/5 hybrid AC Pertussis/IPV (MRC5) vaccine [Quadracel] under the age of 4.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Measles vaccine, Mumps vaccine, Rubella vaccine (MMR) and Varicella Zoster vaccine (Varicella vaccine), both for Prophylactic vaccination.  On 16-Mar-2022, the patient received a dose of suspect Diphtheria-15/Tetanus/5 hybrid AC Pertussis/IPV (MRC5) vaccine (with an unknown strength and formulation) (lot number: C5851AA, expiry date: 23-Mar-2023) at a dose of 0.5 mL via intramuscular route in the right thigh for prophylactic immunization.  On 16-MAR-2022 the patient was inadvertently given Diphtheria-15/Tetanus/5 hybrid AC Pertussis/IPV (MRC5) vaccine, under the age of 4 (product use issue) (latency: same day).   Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  Outcome: Unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.
Sex: F
Vaccine: FLUX
Symptoms: Hypersensitivity
Clinical narrative: Allergy; This spontaneous case was received on 09-Mar-2022 from other non-health care professional (consumer) via Agency (reference number: NVSC2022US051254_NS) and concerned a female patient. At the time of this report, the patient was 67-year-old.   The patient's medical history and concomitant medications were not reported.  On an unspecified date, the patient was vaccinated with influenza virus vaccine polyvalent (brand not specified; dose, route of administration, anatomical location and indication: not reported). The batch number was not reported.  On an unspecified date, an unknown amount of time after receiving influenza virus vaccine polyvalent, the patient experienced allergy.   The outcome of the event was not reported.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: The event of 'allergy' is assessed as unassessable to influenza virus vaccine polyvalent due to insufficient information provided.; Sender's Comments: The event of 'allergy' is assessed as unassessable to influenza virus vaccine polyvalent due to insufficient information provided.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Nightmare, Sleep disorder
Clinical narrative: Very vivid short nightmares  Will fall asleep for 10 to 15 minutes then I can't get back to sleep.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: injection site sore; This case was reported by a consumer and described the occurrence of injection site pain in a 57-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th March 2022, the patient received the 1st dose of Shingrix. In March 2022, less than a week after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The case was self-reported by the patient. The age at vaccination was unknown. The patient received first dose of Shingrix vaccine on 14th March 2022 which was administered by the physician. After 2 days, the patient contacted doctor and asked how long the injection site would be sore. The patient's physician told there might be pain for 1-2 weeks. This case was linked with US2022AMR048529, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR048529:Same reporter. Hearsay case
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Rash, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles; severe pain; rash; This case was reported by a physician via sales rep and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain and rash. On an unknown date, the outcome of the vaccination failure, shingles, pain and rash were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, pain and rash to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 2 doses of Shingrix vaccine and had shingles. The reporter stated that, the vaccine was working and doing its job, however, when the patient developed shingles in rare instance after vaccination, it took a very long time and many different tests to determine that the issue was shingles because there was no rash that occurred right away like it typically did for shingles diagnosis. The patient had severe pain and many tests for months before the rash finally occurred and then was diagnosed with Shingles, at this point it was too late to treat. The reporter sated that, Shingles vaccine in cases where there was an outbreak in a patient after vaccination, prolonged diagnosis of actual Shingles. This case was considered as suspected vaccination failure, since the details regarding time to onset for event was not provided.    The reporter did not consent to follow-up. This case has been linked to US2022AMR049400, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR049400:Same reporter