chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: COVID-19, Drug ineffective, Immunodeficiency, SARS-CoV-2 test
Clinical narrative: Immunodeficiency; COVID-19 recurrent; COVID-19 recurrent; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4491669-00 (AbbVie).  A 45-year-old female patient received BNT162b2 (BNT162B2), on 15Aug2021 as dose 1, single (Batch/Lot number: unknown), on 07Sep2021 as dose 2, single (Batch/Lot number: unknown) and on 04May2022 as dose 3 (booster), single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), as dose number unknown (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown), subcutaneous. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNODEFICIENCY (medically significant), outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID-19 recurrent". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: On unknown dates, the patient experienced COVID TWICE. The action taken for adalimumab was dosage permanently withdrawn.  Additional information: There was no reported medical history. It was unknown if patient was enrolled in a covid-19 vaccine trial. The reporter's assessment of the causal relationship of "immunodeficiency" and "covid-19 recurrent" with the suspect product(s) BNT162b2 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. The reporter's causality for the event(s) of covid twice and lower in immune system with adalimumab (HUMIRA) was not provided.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the lack of efficacy  cannot be ruled out. The reported events of   "immunodeficiency" is assessed as not related to suspect product Comirnaty and more likely due to the ongoing immunosuppressants  co med adalimumab., given the known mechanism of the drug.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac disorder, Cardiac stress test, Echocardiogram, Myocarditis
Clinical narrative: myocarditis; heart problems; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from legal division, Program ID:. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (COMIRNATY), in 2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDIAC DISORDER (non-serious) with onset 2021, outcome "unknown", described as "heart problems"; MYOCARDITIS (medically significant) with onset 2021, outcome "unknown". The patient underwent the following laboratory tests and procedures: Cardiac stress test: Unknown; Echocardiogram: Unknown. Clinical course: Per reporter, "You people gave me myocarditis when I got the vaccine April/May2021. I have been having heart problems for the past 2 or 3 months. I don't know how you coded the nucleotides, which most people don't know about, but I understand ribonucleic acid, and how uracil and thime and adenine and guanine work, and how permutations of those compose amino acids, the building block of proteins. I'd love to know exactly how you coded it. I will sue you. I am having an echocardiogram and a stress test done."  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Haemorrhage subcutaneous
Clinical narrative: received the second Covid vaccination and developed immediately blood in their hands and fingers underneath the skin; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1, manufacturer unknown), for Covid-19 Immunization. The following information was reported: HAEMORRHAGE SUBCUTANEOUS (medically significant), outcome "unknown", described as "received the second Covid vaccination and developed immediately blood in their hands and fingers underneath the skin". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201046298 Same reporter/product/event, different patient;
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: testing positive on antigen test; testing positive on antigen test; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 71 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), in Feb2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (unspecified if ongoing), notes: Is the patient a smoker/former smoker? No; "Is the patient a smoker/former smoker? No" (unspecified if ongoing); "Colitis" (unspecified if ongoing); "Pouchitis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 18Jun2022, outcome "recovered" (2022) and all described as "testing positive on antigen test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The efficacy of a vaccine varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine product BNT162B2 to the reported events drug ineffective and COVID-19 cannot be ruled out.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain, Pain in extremity
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 54-year-old male patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 (DOSE 3; MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm"; HEADACHE (non-serious), outcome "unknown"; PAIN (non-serious), outcome "unknown", described as "body aches". Additional information: It was reported that the patient's weight was 150. The event took place after use of product. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Vaccines work, dam it! It's the omicron break thru got us". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive for omicron, notes: Wife got BA4/5 from (name-withheld) Duty. Clinical course: Patient got BA4/5 from (name-withheld) Duty. It was reported that "Vaccines work, Dam it, Its the omicron break through got patient". Pfizer not the problem! Evolution is the culprit. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Computerised tomogram, Magnetic resonance imaging head, SARS-CoV-2 test, Tinnitus
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 64-year-old male patient received BNT162b2 (BNT162B2), on 30Sep2021 as dose 3 (booster),single (Lot number: FF2587) at the age of 64 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Thyroid Disease", start date: 01Jan2005, stop date: 17May2017, notes: Pertinent Details: Radiation Therapy; "Pre Diabetes", start date: 01Jun2018 (ongoing), notes: Stop date: ongoing, Pertinent Details: Metformin pills- diet/Exercise; "Diabetes" (unspecified if ongoing); "Blood pressure" (unspecified if ongoing). Concomitant medication(s) included: TYLENOL, start date: 21Jun2022. Vaccination history included: BNT162b2 (DOSE:2, Anatomical location: Left arm, Batch/lot number: ER8737), administration date: 08Apr2021, when the patient was 63-year-old, for Covid-19 Immunization; BNT162b2 (DOSE;1, Anatomical location: Left arm, Batch/lot number: EN6208), administration date: 11Mar2021, when the patient was 63-year-old, for Covid-19 Immunization. The following information was reported: TINNITUS (non-serious), outcome "not recovered". The event "tinnitus" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Therapeutic measures were taken as a result of tinnitus. Follow up has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Neuropathy peripheral
Clinical narrative: neuropathy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2022NVX-US-000002741 (Novavax).  A male patient received BNT162b2 (BNT162B2), 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 patient experienced symptoms of neuropathy on an unspecified date. The outcome of the event was unknown. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Patient got COVID; Patient got COVID; This is a spontaneous report received from contactable reporter (consumer). Other Case identifier: 2022NVX-US-000002649.  A patient in their 70's received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Patient got COVID".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 85.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Pemphigoid, Pruritus
Clinical narrative: broke out in a bad flare of BP; broke out in a bad flare of BP; Bad itch; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 86-year-old female patient received BNT162b2 (BNT162B2), in Aug2021 as dose 2, single (Batch/Lot number: unknown) at the age of 85 years for covid-19 immunisation. The patient's relevant medical history included: "Bullous pemphigoid" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, single, lot number: EY0584, intramuscularly administered in the left arm (upper) at 12:00), administration date: 03Aug2021, when the patient was 85-year-old, for covid-19 immunisation, reaction(s): "Bullous pemphigoid flare", "Condition aggravated", "Rash". The following information was reported: CONDITION AGGRAVATED (medically significant), PEMPHIGOID (medically significant) all with onset 18Jul2022, outcome "unknown" and all described as "broke out in a bad flare of BP"; PRURITUS (non-serious) with onset 2022, outcome "unknown", described as "Bad itch". Therapeutic measures were taken as a result of pruritus. Course of events: The patient has been communicating over the past year regarding COVID and her autoimmune disease "Bullous Pemphigoid". This is the 8th year she had this auto immune disease. She had her 2 vaccines, the last Aug2021. After 2 weeks from 04Jul2022, she broke out in a bad flare of BP (above). She had bad itch and need Doxycycline every day. She was trying to avoid prednisone. She think that vaccines for COVID should not be given to people with BP.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 85.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: broke out in a bad flare of BP; broke out in a bad flare of BP; Bad itch; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 86-year-old female patient received BNT162b2 (BNT162B2), in Aug2021 as dose 2, single (Batch/Lot number: unknown) at the age of 85 years for covid-19 immunisation. The patient's relevant medical history included: "Bullous pemphigoid" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, single, lot number: EY0584, intramuscularly administered in the left arm (upper) at 12:00), administration date: 03Aug2021, when the patient was 85-year-old, for covid-19 immunisation, reaction(s): "Bullous pemphigoid flare", "Condition aggravated", "Rash". The following information was reported: CONDITION AGGRAVATED (medically significant), PEMPHIGOID (medically significant) all with onset 18Jul2022, outcome "unknown" and all described as "broke out in a bad flare of BP"; PRURITUS (non-serious) with onset 2022, outcome "unknown", described as "Bad itch". Therapeutic measures were taken as a result of pruritus. Course of events: The patient has been communicating over the past year regarding COVID and her autoimmune disease "Bullous Pemphigoid". This is the 8th year she had this auto immune disease. She had her 2 vaccines, the last Aug2021. After 2 weeks from 04Jul2022, she broke out in a bad flare of BP (above). She had bad itch and need Doxycycline every day. She was trying to avoid prednisone. She think that vaccines for COVID should not be given to people with BP.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lymphadenopathy
Clinical narrative: This is a spontaneous report received from a contactable reporter (Nurse). The reporter is the patient. A 71-year-old female patient received BNT162b2 (BNT162B2), 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 (DOSE 1; Lot number: en6203; Route of administration: intramuscular), administration date: 20Feb2021, for COVID-19 immunization, reactions: "a raised red and itchy rash on chest and torso lasting for 3-4 days", "fatigue for 1-2 days. Was still able to work", "a raised red on chest and torso lasting for 3-4 days/ rash on my abdomen for about 4-5 days", "a raised red on chest and torso lasting for 3-4 days"; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: FATIGUE (non-serious), outcome "unknown"; LYMPHADENOPATHY (non-serious), outcome "recovered", described as "enlarged (minor) lymph node above left clavicle. Painless - was gone in 3 days.". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : PFIZER INC-2021438587 same reporter/patient, different dose/event;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Vaccinated and boosted. And then I got COVID; Vaccinated and boosted. And then I got COVID; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A 42-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2022, outcome "unknown" and all described as "Vaccinated and boosted. And then I got COVID".  Additional information: I have attached the AE report forms for the above referenced project. The information regarding the patients and physicians in the reports are very limited due to the de-identified nature of our data. However, if you have any questions regarding the reports please don't hesitate to reach out. It was reported that the patient got COVID despite being vaccinated. The course of conversation were as follows: DR: Now, over the last, um, couple of months, we've seen more and more people get exposed and, and come down with, uh, COVID but you've been -, PT: Hm., DR: Doing okay?, PT: Yeah., DR: As far as that's concerned?, PT: Yeah. Totally fine., DR: Okay. And were you vaccinated?, PT: Yes., DR: Okay., PT: Vaccinated and boosted. And then I got COVID in, um, Jan., DR: Okay. And which vaccine did you get?, PT: Uh, Pfizer., DR: Okay. [DEIDENTIFIED]. And a lot of people have been asking if they need to get their second booster., PT: Um-hum. The outcome was unknown and causality was not reported.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Conjunctivitis, Eye swelling, Lip exfoliation
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Physician). Other Case identifier(s): 2022NVX-000002718 (NOVAVAX). A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 21Jul2022 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: EYE SWELLING (non-serious), CONJUNCTIVITIS (non-serious) all with onset 2022, outcome "unknown" and all described as "eyes swelled shut and got all "pinky""; LIP EXFOLIATION (non-serious) with onset 2022, outcome "unknown", described as "lips were crusted and peeling". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Cough, Influenza like illness, Pain in extremity, Rheumatoid arthritis, Weight
Clinical narrative: Coughing; Pain in arm; Flu-like symptoms; Lost weight; Rheumatoid arthritis flare up; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4493973-00 (AbbVie).  A 54-year-old female patient received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown) and in 2021 as dose 2, single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 22Apr2022 as dose 3 (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Lot number: 1162590), subcutaneous 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 23Apr2022, outcome "unknown", described as "Rheumatoid arthritis flare up"; COUGH (non-serious), outcome "unknown", described as "Coughing"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Pain in arm"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "Flu-like symptoms"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "Lost weight". The patient underwent the following laboratory tests and procedures: Weight: Lost. The action taken for adalimumab was unknown.  The reporter considered "rheumatoid arthritis flare up", "coughing", "pain in arm", "flu-like symptoms" and "lost weight" 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 available information, the event rheumatoid arthritis flare up is related to the natural course of RA, possibly associated with MODERNA COVID-19 VACCINE based on close temporal relationship (event onset 1 day after booster dose), and is assessed as unrelated to BNT162b2. The causal relationship between BNT162b2 and the events cough, pain in extremity, influenza like illness and weight decreased cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes 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, UNK
Symptoms: Weight decreased
Clinical narrative: Coughing; Pain in arm; Flu-like symptoms; Lost weight; Rheumatoid arthritis flare up; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4493973-00 (AbbVie).  A 54-year-old female patient received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown) and in 2021 as dose 2, single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 22Apr2022 as dose 3 (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Lot number: 1162590), subcutaneous 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 23Apr2022, outcome "unknown", described as "Rheumatoid arthritis flare up"; COUGH (non-serious), outcome "unknown", described as "Coughing"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Pain in arm"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "Flu-like symptoms"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "Lost weight". The patient underwent the following laboratory tests and procedures: Weight: Lost. The action taken for adalimumab was unknown.  The reporter considered "rheumatoid arthritis flare up", "coughing", "pain in arm", "flu-like symptoms" and "lost weight" 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 available information, the event rheumatoid arthritis flare up is related to the natural course of RA, possibly associated with MODERNA COVID-19 VACCINE based on close temporal relationship (event onset 1 day after booster dose), and is assessed as unrelated to BNT162b2. The causal relationship between BNT162b2 and the events cough, pain in extremity, influenza like illness and weight decreased cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes 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: Back disorder, Balance disorder, Blindness, Cardiovascular disorder, Dizziness
Clinical narrative: loss of vision; leg felt funny; felt off-balance/ loss of equilibrium; eyes pinpoint; left leg asleep, couldn't move leg; slurred speech; dizzy; golf ball to softball sized pressure on lower back/kidney area; couldn't straighten back; cardiovascular incident; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  2022NVX-US-000002730   A female patient received BNT162b2 (BNT162B2), on 15Apr2021 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: BLINDNESS (medically significant), outcome "unknown", described as "loss of vision"; LIMB DISCOMFORT (non-serious), outcome "unknown", described as "leg felt funny"; BALANCE DISORDER (non-serious), outcome "unknown", described as "felt off-balance/ loss of equilibrium"; MIOSIS (non-serious), outcome "unknown", described as "eyes pinpoint"; MOVEMENT DISORDER (non-serious), outcome "unknown", described as "left leg asleep, couldn't move leg"; DYSARTHRIA (non-serious), outcome "unknown", described as "slurred speech"; DIZZINESS (non-serious), outcome "unknown", described as "dizzy"; MUSCULOSKELETAL DISCOMFORT (non-serious), outcome "unknown", described as "golf ball to softball sized pressure on lower back/kidney area"; BACK DISORDER (non-serious), outcome "unknown", described as "couldn't straighten back"; CARDIOVASCULAR DISORDER (non-serious), outcome "unknown", described as "cardiovascular incident". The patient experienced symptoms of loss of vision, leg felt funny, felt off-balance, eyes pinpoint, left leg asleep, couldn't move leg, slurred speech, dizzy, loss of equilibrium, golf ball to softball sized pressure on lower back/kidney area, couldn't straighten back, was suddenly craving meat after being vegetarian, and a cardiovascular incident.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Dysarthria, Limb discomfort, Miosis, Movement disorder, Musculoskeletal discomfort
Clinical narrative: loss of vision; leg felt funny; felt off-balance/ loss of equilibrium; eyes pinpoint; left leg asleep, couldn't move leg; slurred speech; dizzy; golf ball to softball sized pressure on lower back/kidney area; couldn't straighten back; cardiovascular incident; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  2022NVX-US-000002730   A female patient received BNT162b2 (BNT162B2), on 15Apr2021 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: BLINDNESS (medically significant), outcome "unknown", described as "loss of vision"; LIMB DISCOMFORT (non-serious), outcome "unknown", described as "leg felt funny"; BALANCE DISORDER (non-serious), outcome "unknown", described as "felt off-balance/ loss of equilibrium"; MIOSIS (non-serious), outcome "unknown", described as "eyes pinpoint"; MOVEMENT DISORDER (non-serious), outcome "unknown", described as "left leg asleep, couldn't move leg"; DYSARTHRIA (non-serious), outcome "unknown", described as "slurred speech"; DIZZINESS (non-serious), outcome "unknown", described as "dizzy"; MUSCULOSKELETAL DISCOMFORT (non-serious), outcome "unknown", described as "golf ball to softball sized pressure on lower back/kidney area"; BACK DISORDER (non-serious), outcome "unknown", described as "couldn't straighten back"; CARDIOVASCULAR DISORDER (non-serious), outcome "unknown", described as "cardiovascular incident". The patient experienced symptoms of loss of vision, leg felt funny, felt off-balance, eyes pinpoint, left leg asleep, couldn't move leg, slurred speech, dizzy, loss of equilibrium, golf ball to softball sized pressure on lower back/kidney area, couldn't straighten back, was suddenly craving meat after being vegetarian, and a cardiovascular incident.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Immunosuppression
Clinical narrative: immune-suppressed; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2022NVX-US-000002689 (Novavax).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), 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: IMMUNOSUPPRESSION (medically significant), outcome "unknown", described as "immune-suppressed". Additional information: On 20Jul2022, it was reported that the patient started treatment on an unspecified date with Pfizer Biontech Covid-19 Vaccine. It was reported that the patient experienced immune-suppressed.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 75.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Atrial fibrillation, Cardiac disorder
Clinical narrative: Atrial fibrillation; Heart Condition; This is a solicited report received from contactable reporter(s) (Consumer). The reporter is the patient. Other Case identifier(s): 22K-163-4458666-00 (AbbVie). Solicited report from the USA by a consumer of an elderly male with an event of non-serious In and out of Atrial fibrillation with Heart Condition with HUMIRA (ADALIMUMAB). There was no reported medical history.  On unknown dates, the patient experienced In and out of Atrial fibrillation with Heart Condition and In and out of Atrial fibrillation with Heart Condition. In 2022, the In and out of Atrial fibrillation with Heart Condition resolved. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   Clinical information: A 76-year-old male patient received BNT162b2 (BNT162B2), on 04Jan2021 as dose 1, single (Lot number: EK9241), on 25Jan2021 as dose 2, single (Lot number: EK9231) and on 02Nov2021 as dose 3 (booster), single (Lot number: FE3590), all intramuscular for COVID-19 immunization; adalimumab (HUMIRA), (Lot number: 1162590) till 17Jun2022, subcutaneous for Crohn's disease. The patient's relevant medical history and concomitant medications were not reported. The action taken for adalimumab was dosage permanently withdrawn on 17Jun2022.  The reporter considered "atrial fibrillation" and "heart condition " related to BNT162b2. The reporter's causality for the event(s) of Heart Condition with HUMIRA (ADALIMUMAB) was not provided while for the event of In and out of Atrial fibrillation was a reasonable possibility.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on provided information and temporal association reported events atrial fibrillation and heart disorder causal relationship with the suspect drugBNT162B2 cannot be excluded. However there is very limited information provided in this report. Additional information is needed to better assess the case, including complete medical history and diagnostics workup. This case will be reassessed upon receipt of follow-up information.    The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: DTAP
Symptoms: Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: patient experienced swelling, warmth to the touch, and hardness at the injection site; patient experienced swelling, warmth to the touch, and hardness at the injection site; patient experienced swelling, warmth to the touch, and hardness at the injection site; Initial information received on 08-Aug-2022 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 5 years old and unknown gender patient who experienced swelling, warmth to the touch, and hardness at the injection site, after receiving vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.    On an unknown date, the patient received a 0.5ml total dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (strength, formulation was unknown, lot C5816AA and expiry date was unknown) via unknown route in unknown administration site for Immunization. Information regarding batch and expiry date was requested.   On an unknown date the patient developed a non-serious event of patient experienced swelling, warmth to the touch, and hardness at the injection site (vaccination site warmth, vaccination site induration, vaccination site swelling) (unknown latency) following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE. PTC (product technical complaint) assessment medical/Physical : Medical   Action taken : not applicable.  It was not reported if the patient received a corrective treatment for the events   Outcome: Unknown
Sex: U
Vaccine: IPV
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: 24 minutes the IPOL was in the excursion with no reported adverse event; vaccine was administered to patient post excursion with no reported adverse event; Initial information received on 03-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves Child of an unknown gender patient who was administered vaccine post excursion with no reported adverse event  and vaccine had temperature excursion for 24 minutes the ipol was in the excursion with no reported adverse event  vaccine , while receiving vaccine IPV (VERO) [IPOL].  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 IPV (VERO) lot number not reported at an unknow dose via unknown route at an unknown administrative site for immunization.  On an unknown date, the reporter stated that her colleague called yesterday about IPOL stability and they realized it was given to a patient (poor quality product administered)(latency: same day)so they want to know what they need to do. it was reported that if it was over 10 minutes they could not use it and they have left the vial out of the refrigerator but they want to know if they need to revaccinate the child. due to nurse doing inventory with a new nurse the door was left open and the vaccine for 24 minutes was in the excursion should they revaccinate the child(product storage error)    Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events.   Outcome: unknown for both events   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: HIBV
Symptoms: Expired product administered
Clinical narrative: expired ACT-HIB was inadvertently given  with no reported adverse event; Initial information received on 04-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 12 years old female patient to whom expired HIB (PRP/T) VACCINE [ACT-HIB] was inadvertently given  with no reported adverse event.  The patient's past medical treatment(s), vaccination(s) and family history were not provided. The patient had some other health issues (ill-defined disorders)   On 04-Aug-2022, the patient received 0.25 ml dose of suspect HIB (PRP/T) VACCINE, with an unknown formulation and strength, (frequency: once) ( lot:  UJ661AAA ; expiry date: 06-May-2022)  via intramuscular route in the right arm for immunization.  It was reported that an expired Act-hib was inadvertently given  with no reported adverse event (expired product administered) (onset date: 04-Aug-2022) (latency: same day). No other vaccines were given  Action taken: not applicable.  Outcome: unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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: U
Vaccine: IPV
Symptoms: Expired product administered
Clinical narrative: expired ipol was accidentally administered to a patient, with no reported adverse event; Initial information received on 05-Aug-2022 regarding an unsolicited valid  non-serious case received from a Nurse.  This case involves an unknown age and unknown gender patient to whom expired IPV (VERO) [IPOL]was accidentally administered to a patient, with no reported adverse event.   The patient's past medical history, medical treatment(s),concomitant medication, vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect IPV (VERO) (strength, formulation, lot number and expiry date was unknown) via unknown route in unknown administration site for Immunization. Information for batch and expiry date was requested.  On an unknown date the patient developed a non-serious event of expired ipol was accidentally administered to a patient, with no reported adverse event (expired product administered) (latency: unknown) following the administration of IPV (VERO).Reporter would like some guidance on next steps.  Action taken with POLIOMYELITIS VACCINE (INACTIVATED) (IPOL) was not applicable.  Outcome: Unknown  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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: 4.0
Sex: F
Vaccine: IPV
Symptoms: Incorrect dose administered
Clinical narrative: patient prematurely pulled away while receiving IPOL injection with no reported adverse event; Initial information received  on 08-Aug-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 4 years old female patient prematurely pulled away while receiving injection with no reported adverse event ,while receiving vaccine IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was reported that the IPOL was given with 4 other vaccines, however he did not know which ones.    On 28-Jul-2022, the patient received a  dose of suspect IPV (VERO) lot number not reported via subcutaneous route in the arm nos for immunization.   On 28-Jul-2022 (latency: same day), the patient prematurely pulled away while receiving ipol injection with no reported adverse event  (incorrect dose administered) following the administration of IPV (VERO).  Action taken : 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.
Age: 64.0
Sex: U
Vaccine: DTAP
Symptoms: Wrong product administered
Clinical narrative: inadvertently administered DAPTACEL to a 64 year old patient instead of Tdap  with no adverse event.; Initial information received on 08-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 64 years old and unknown gender patient to whom inadvertently administered diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] instead of tdap with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient was inadvertently administered  a  dose of suspect diphtheria-15/tetanus/5 AC pertussis vaccine, suspension for injection (dose, frequency, batch lot number, expiry date: not reported) via unknown route in unknown administration site for Immunization instead of tdap (wrong product administered) (unknown latency).  Action taken : not applicable.   At time of reporting, the outcome was Unknown for the event inadvertently administered daptacel to a 64 year old patient instead of tdap.   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: 4.0
Sex: M
Vaccine: IPV
Symptoms: Expired product administered
Clinical narrative: Ipol was administered to a patient after the expiration date with no reported adverse event; Initial information received on 08-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 years old male patient to whom IPV (VERO) [IPOL] was administered to a patient after the expiration date with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation; VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (VARIVAX [VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK)]) for Immunisation; and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) for Immunisation.  On 28-Jul-2022, the patient received a 0.5ml once dose of suspect IPV (VERO) (strength, formulation was unknown, lot T1D48214 and expiry date: 25-Jul-2022) via intramuscular route in the right deltoid for Immunization.  On 28-Jul-2022 the patient developed a non-serious ipol was administered to a patient after the expiration date with no reported adverse event (expired product administered)(Latency: same day) following the administration of IPV (VERO).First time product used : No Still using product : Yes  Action taken with POLIOMYELITIS VACCINE (INACTIVATED) (IPOL) was not applicable.  Outcome: Unknown  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: expired dose of ADACEL was administered with no adverse event; Initial information received on 08-Aug-2022 regarding an unsolicited valid non-serious case received from health professional. (GMI number: 01226493).  This case involves a 11-year-old female patient to whom expired dose of Diphtheria-2/Tetanus/5 AC Pertussis Vaccine [Adacel] was administered with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Meningococcal Vaccine A/C/Y/W CONJ (DIP TOX) (Menactra) for Immunization, and HPV vaccine for Immunization.  On 08-Aug-2022, the patient received a 1st dose of suspect Adacel vaccine at dose 0.5ml once via intramuscular route in the left deltoid (Lot: U6767AA, expiry date: 31-JUL-2022) with Immunization (expired product administered, same day latency). No adverse event was reported.  Action taken: Not applicable.  At time of reporting, the outcome was 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.