chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Chest pain, Heart rate increased
Clinical narrative: fast heart beat; chest pain; 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 79-year-old female patient received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), on 02Oct2023 as dose 1, single (Lot number: HG4628) at the age of 79 years, in left arm for covid-19 immunisation; for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "Blood pressure high" (unspecified if ongoing); "heart attack" (unspecified if ongoing); "breathing problems" (unspecified if ongoing). Concomitant medication(s) included: OLMESARTAN; METOPROLOL; HYDROCHLOROTHIAZIDE; AMLODIPINE BESYLATE; ATORVASTATIN; VITAMIN D3; VITAMIN B12 [CYANOCOBALAMIN]; PROAIR [SALBUTAMOL SULFATE]. Vaccination history included: Moderna covid-19 vaccine (DOSE 5 (BOOSTER), SINGLE), for Covid-19 immunization; Moderna covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE), for Covid-19 immunization; Moderna covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE), for Covid-19 immunization; Moderna covid-19 vaccine (DOSE 2, SINGLE), for Covid-19 immunization; Moderna covid-19 vaccine (DOSE 1, SINGLE), for Covid-19 immunization. The following information was reported: CHEST PAIN (non-serious) with onset Oct2023, outcome "unknown"; HEART RATE INCREASED (non-serious) with onset Oct2023, outcome "unknown", described as "fast heart beat". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of heart rate increased, chest pain. Additional information: Patient received Comirnaty 2023-2024 vaccine yesterday (02Oct2023) in which she was experiencing a "fast heart beat and chest pain." Patient also provided that she had previously received a Moderna vaccine, however they were not on the same day. Patient stated she had the shot yesterday (02Oct2023) at the (withheld) and was reading that if she had a fast heart beat and chest pain, she should go to the emergency room. She was now asking what should happen to her and what to do.   The information on the batch/lot number for bnt162b2 omi xbb.1.5  has been requested and will be submitted if and when received.
Age: 63.0
Sex: M
Vaccine: RSV
Symptoms: Gait disturbance, Hypoaesthesia, Inflammation, Pain, Spinal X-ray normal
Clinical narrative: He got the RSV together with Flu shot; Inflamed the right side of his body and he needs to crawl as he mentioned just to get out of his room; Numbness; Pain; had to crawl from room to room; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old male patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 31Aug2023 as single (Batch/Lot number: unknown) at the age of 63 years for immunisation; for immunisation; influenza vaccine (INFLUENZA VACCINE), on 31Aug2023 as dose number unknown,single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFLAMMATION (hospitalization), outcome "unknown", described as "He got the RSV together with Flu shot; Inflamed the right side of his body and he needs to crawl as he mentioned just to get out of his room"; HYPOAESTHESIA (hospitalization), outcome "unknown", described as "Numbness"; PAIN (hospitalization), outcome "unknown"; GAIT DISTURBANCE (hospitalization), outcome "unknown", described as "had to crawl from room to room". The events "he got the rsv together with flu shot; inflamed the right side of his body and he needs to crawl as he mentioned just to get out of his room", "numbness", "pain" and "had to crawl from room to room" required emergency room visit. The patient underwent the following laboratory tests and procedures: X-ray: Unknown Results, notes: they also did a spinal x-ray and nothing really showed up. Therapeutic measures were taken as a result of inflammation, hypoaesthesia, pain, gait disturbance.  Clinical course details:  He got the RSV together with Flu shot and caller mentioned that he has been in and out of the hospital, inflamed the right side of his body and he needs to crawl as he mentioned just to get out of his room. The patient ended up with inflammation in the lower back and down the leg all the way to the foot and have got numbness, had too much pain, had to crawl from room to room and leads to the emergency room to make sure I did not have a blood clot, they also did a spinal x-ray and nothing really showed up much there but I have been on physical therapy for 3 weeks so this happened before holiday so it was the months last Thursday when he got the vaccines and so just been in incredible pain. The doctor put him on Steroids and different meds (Intent: Treatment) to try to relief the pain.   The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.
Age: 63.0
Sex: M
Vaccine: RSV
Symptoms: X-ray
Clinical narrative: He got the RSV together with Flu shot; Inflamed the right side of his body and he needs to crawl as he mentioned just to get out of his room; Numbness; Pain; had to crawl from room to room; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old male patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 31Aug2023 as single (Batch/Lot number: unknown) at the age of 63 years for immunisation; for immunisation; influenza vaccine (INFLUENZA VACCINE), on 31Aug2023 as dose number unknown,single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFLAMMATION (hospitalization), outcome "unknown", described as "He got the RSV together with Flu shot; Inflamed the right side of his body and he needs to crawl as he mentioned just to get out of his room"; HYPOAESTHESIA (hospitalization), outcome "unknown", described as "Numbness"; PAIN (hospitalization), outcome "unknown"; GAIT DISTURBANCE (hospitalization), outcome "unknown", described as "had to crawl from room to room". The events "he got the rsv together with flu shot; inflamed the right side of his body and he needs to crawl as he mentioned just to get out of his room", "numbness", "pain" and "had to crawl from room to room" required emergency room visit. The patient underwent the following laboratory tests and procedures: X-ray: Unknown Results, notes: they also did a spinal x-ray and nothing really showed up. Therapeutic measures were taken as a result of inflammation, hypoaesthesia, pain, gait disturbance.  Clinical course details:  He got the RSV together with Flu shot and caller mentioned that he has been in and out of the hospital, inflamed the right side of his body and he needs to crawl as he mentioned just to get out of his room. The patient ended up with inflammation in the lower back and down the leg all the way to the foot and have got numbness, had too much pain, had to crawl from room to room and leads to the emergency room to make sure I did not have a blood clot, they also did a spinal x-ray and nothing really showed up much there but I have been on physical therapy for 3 weeks so this happened before holiday so it was the months last Thursday when he got the vaccines and so just been in incredible pain. The doctor put him on Steroids and different meds (Intent: Treatment) to try to relief the pain.   The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Colonoscopy, Drug ineffective
Clinical narrative: got Covid had it pretty bad.; got Covid had it pretty bad.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  A 72-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in 2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "stage 3 kidney disease" (unspecified if ongoing), notes: She only has one kidney and stage 3 kidney disease.; "heart attack" (unspecified if ongoing); "Lung Problems" (unspecified if ongoing), notes: lung problems; "CONTRAST MEDIA ALLERGY" (unspecified if ongoing), notes: can't get a heart cat because she has an allergy to the dye. Concomitant medication(s) included: ASPIRIN [ACETYLSALICYLIC ACID]. Past drug history included: Plavix, reaction(s): "bleeding". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "got Covid had it pretty bad.". The patient underwent the following laboratory tests and procedures: Colonoscopy: Unknown results. Clinical course: the patient has had 5 previous Pfizer Covid vaccines and had last Pfizer Covid shot in Nov2022 or Dec2022. Then in Mar2023, got Covid and had it pretty bad.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5, bnt162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: received his COVID vaccine yesterday but got COVID today; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team and product quality group. The reporter is the patient.  A male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 02Oct2023 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: COVID-19 (non-serious) with onset 03Oct2023, outcome "unknown", described as "received his COVID vaccine yesterday but got COVID today". Therapeutic measures were taken as a result of covid-19.  Additional information: Reporter was a Doctor but he was also a patient. He took the vaccine yesterday and he got sick. He thought he had a COVID but he sure he did. Now he is taking Paxlovid, but he also has a COVID virus and he starts taking Paxlovid, he would like to know if the vaccine he took yesterday will negate the Paxlovid, he would like to know some recommendations about it. Suspect Product(s): Pfizer vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: fatigue; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 03Oct2023 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: pollen" (unspecified if ongoing). Concomitant medication(s) included: FLU VACCINE VII. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 3, Manufacturer unknown), for COVID-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 03Oct2023 at 15:00, outcome "recovering". Therapeutic measures were not taken as a result of fatigue. Additional information: The patient received flu vaccine within 2 weeks of vaccination. The event was reported as non-serious.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 70-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Jul2023 at 12:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 70 years, in right arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Slight kidney decrease in function" (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 Sep2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 22Sep2023 till 27Sep2023.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided in the narrative, a causal association between the events and the suspect drug cannot be completely excluded.,Linked Report(s) : US-PFIZER INC-202300317295 same reporter/patient, different drug/AE;
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 64-year-old female patient (not pregnant) received bnt162b2 (BNT162B2 NOS), on 01Oct2022 as dose number unknown, single at the age of 63 years for covid-19 immunisation. The patient's relevant medical history included: "sleep apnea" (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 Sep2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient took Paxlovid as treatment from 24Sep2023 to 28Sep2023.; 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 drug ineffectiveness and COVID-19 cannot be ruled out. Events are considered related conservatively. Case will be reassessed upon receipt of additional information.,Linked Report(s) : US-PFIZER INC-202300317356 same reporter/patient, different drug/event;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Sep2022 as dose 4 (booster), single (Lot number: GH9693), in right arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: The patient recovered from coronavirus test positive; Positive, notes: tested positive again 10 days later. Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid from 22Sep2023 to 26Sep2023. Clinical course: The patient recovered from coronavirus test positive but began to feel ill again around 8 days later and tested positive again 10 days later.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300317215 same patient, different drug, different event;
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: a week of not feeling good every single time I receive the Pfizer COVID vaccine; 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 61-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE NMBER UNKNOWN, SINGLE; Lot number: unknown), for Covid-19 Immunization, reaction(s): "a week of not feeling good every single time I receive the Pfizer COVID vaccine". The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "a week of not feeling good every single time I receive the Pfizer COVID vaccine".  Additional information: Reporter did not want warm-transfer to DSU as caller stated she had already reported her side effects when she first got the Pfizer COVID shots and did not want to report again. Caller stated that it was a week of not feeling good every single time she received the Pfizer COVID vaccine. Caller was asking if the new shot will not have a side effect. Caller mentioned that when she took the last booster shot a couple of years ago, it gave a terrible side effect. She stated that she went to the website and couldn't find side effects to the new Pfizer COVID vaccine for 12 years of age and older as it was still talking about the old shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: chills; headache/ head hurts; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 71-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 03Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious) with onset 04Oct2023, outcome "unknown"; HEADACHE (non-serious) with onset 04Oct2023, outcome "unknown", described as "headache/ head hurts". Additional information: Patient could not remember if she was advised to take paracetamol (TYLENOL). She was asking if it's okay to take paracetamol after receiving the vaccine as she did not want to minimize the effect of the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 as dose 5 (booster), single (Lot number: GH9702) at the age of 65 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 13Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 03Apr2021 as dose 2, single (Lot number: EW0151), in left arm, on 05Oct2021 as dose 3 (booster), single (Lot number: 30155BA), in left arm and on 08Apr2022 as dose 4 (booster), single (Lot number: FK9894), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Known allergies: penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 20Sep2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Sep2023) Positive, notes: Covid-19 infection treated with Paxlovid on Days 2 - 6 of initial Covid-19 infection (confirmed on Day 0 by rapid test); (30Sep2023) Negative, notes: Day 10: negative COVID-19 infection based on rapid test; (04Oct2023) Positive, notes: Day 14: experienced total loss of taste and smell; rapid test for COVID-19 was very positive (dark red line). Therapeutic measures were taken as a result of vaccination failure, covid-19; patient was treated with PAXLOVID.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Dec2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 49 years for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "CAD (Coronary artery disease)" (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 Sep2023, outcome "unknown" and all described as "COVID 19 Treatment". Paxlovid was taken as a result of therapeutic measures of drug ineffective, covid-19 from 20Sep2023 to 24Sep2023. Clinical course: Patient denied for any known allergies.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300318143 Same patient, different drug;
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, COVID-19, Drug ineffective, Major depression, SARS-CoV-2 test
Clinical narrative: Major depression and feelings of doom.; Major depression and feelings of doom.; Since the vaccination, has the patient been tested for COVID-19?:Yes; Since the vaccination, has the patient been tested for COVID-19?:Yes; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 29Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 38 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing), notes: if covid prior vaccination: Yes. Concomitant medication(s) included: INFLUENZA VACCINE taken for immunisation as dose number unknown, single. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "Since the vaccination, has the patient been tested for COVID-19?:Yes"; MAJOR DEPRESSION (Medically significant), ANXIETY (non-serious) all with onset 30Sep2023, outcome "unknown" and all described as "Major depression and feelings of doom.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Positive. Therapeutic measures were not taken as a result of major depression, anxiety. Clinical course: Patient experienced major depression and feelings of doom. Something patient have never experienced before.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Acute COVID-19 signs and symptoms and had a strong positive on a home antigent test; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 03Oct2023 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: COVID-19 (medically significant) with onset 04Oct2023, outcome "unknown", described as "Acute COVID-19 signs and symptoms and had a strong positive on a home antigent test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Oct2023) positive, notes: This morning patient awoke with acute COVID-19 signs and symptoms and had a strong positive on a home antigent test.  Clinical course: The patient received the latest COVID-19 (the 2023-2024 formula) vaccine yesterday (03Oct2023). The reporter was not sure if it was the Pfizer or Moderna vaccine. This morning (04Oct2023) patient awoke with acute COVID-19 signs and symptoms and had a strong positive on a home antigen test. The patient is at increased risk of hospitalization and death and the reporter would like to start Paxlovid as soon as possible. The reporter asked if there's a contraindication/drug interaction for treatment with Paxlovid following COVID-19 administration.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information, the event COVID-19 was not considered related to the suspect vaccine bnt162b2 omi xbb.1.5 as the vaccine may have not provided protection yet. 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: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Immune thrombocytopenia, SARS-CoV-2 test
Clinical narrative: Immune mediated thrombocytopenia; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 68-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 30Sep2023 as dose 4 (booster), single (Lot number: HF9275) at the age of 68 years intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "GERD" (unspecified if ongoing); "hiatal hernia" (unspecified if ongoing); "Nickel allergy" (unspecified if ongoing); "Known Allergies: Bee/Wasp Venom" (unspecified if ongoing); "Known Allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: INFLUENZA taken for immunisation, start date: 16Sep2023, stop date: 16Sep2023; BENADRYL; PRILOSEC [OMEPRAZOLE MAGNESIUM]; VITAMIN D [COLECALCIFEROL] and Mens multi vitamin. Vaccination history included: Covid-19 vaccine (Primary series of immunization completed, Manufacturer Unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 3, Manufacturer Unknown), for COVID-19 Immunization. The following information was reported: IMMUNE THROMBOCYTOPENIA (hospitalization, life threatening) with onset 01Oct2023, outcome "recovering", described as "Immune mediated thrombocytopenia". The event "immune mediated thrombocytopenia" required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Oct2023) Negative, notes: Nasal Swab. Therapeutic measures were taken as a result of immune thrombocytopenia, patient was administered with steroids, IVIG, platelet transfusions.; Sender's Comments: Based on the available information, a possible contributory role of the suspect product cannot be completely excluded for the reported 'Immune mediated thrombocytopenia'' due to a plausible temporal association.The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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: Fatigue, Headache, Ophthalmic migraine
Clinical narrative: optical migraine; Tiredness; headaches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient in her 50's received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Optical migraine" (unspecified if ongoing), notes: Optical migraine: , Has experienced them before. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed, Manufacturer: Unknown), for COVID-19 Immunization. The following information was reported: OPHTHALMIC MIGRAINE (non-serious), 3 days after the suspect product(s) administration, outcome "unknown", described as "optical migraine"; FATIGUE (non-serious), outcome "unknown", described as "Tiredness"; HEADACHE (non-serious), outcome "unknown", described as "headaches". Additional information: Patient was approximately around 54 years-old. After reporters last COVID-19 booster, she experienced tiredness, headaches and, a 3 days later, optical migraine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from product quality group. The reporter is the patient.  A 63-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 22Apr2022 as dose 4 (booster), single (Lot number: Fp4554) at the age of 62 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Sulfa allergy" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Ht/ Hypertension" (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 Jun2023, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient took Paxlovid for treatment of COVID-19 from 26Jun2023 to 30Jun2023.; Sender's Comments: Based on the information provided in the narrative, a causal association between the events and the suspect drug cannot be completely excluded.,Linked Report(s) : US-PFIZER INC-202300318350 Same reporter/patient, different drug/event.;
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 at 12:30 as dose 5 (booster), single (Lot number: GH9694) at the age of 59 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Avocado, reaction(s): "Known allergies: Avocado", notes: Known allergies: Avocado. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, latency 1 year 9 days 11 hrs 30 min after the suspect product(s) administration, outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Sep2023) Negative; (02Oct2023) Positive; (04Oct2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 22Apr2021 as dose 1, single (Lot number: EW0170), on 13May2021 as dose 2, single (Lot number: EV0179) and on 26Nov2021 as dose 3 (booster), single (Lot number: PH8020), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypohidrotic epidermal dysplasia" (unspecified if ongoing); "frequent bronchitis or pneumonia" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Ciprofloxacin, reaction(s): "Allergy: Ciprofloxacin". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: Seizure; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A 72-year-old male patient received bnt162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SEIZURE (medically significant), outcome "unknown". The patient mentioned that he got Pfizer COVID-19 vaccine and his last dose was in Feb (unknown year).  He mentioned that after he took the last vaccine, he got seizure and he was afraid to get the new shot.   The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: shivering; achy; feverish; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 03Oct2023 at 12:30 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 55 years intramuscular, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU VACCINE VII, start date: 12Sep2023, stop date: 12Sep2023. Vaccination history included: Covid-19 vaccine (DOSE 5 (BOOSTER), SINGLE; Unknown Manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE; Unknown Manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE; Unknown Manufacturer), for COVID-19 immunization; Covid-19 vaccine (Primary immunization complete, Unknown Manufacturer), for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset 04Oct2023 at 01:00, outcome "not recovered", described as "achy"; PYREXIA (non-serious) with onset 04Oct2023 at 01:00, outcome "not recovered", described as "feverish"; CHILLS (non-serious) with onset 04Oct2023 at 01:00, outcome "not recovered", described as "shivering". Therapeutic measures were not taken as a result of chills, pain, pyrexia.  Additional information: Patient awoke at 1:00 a.m. shivering, achy and feverish. Patient had no known allergy, no covid prior to vaccination and not covid tested post vaccination.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Decreased appetite, Fatigue, Headache
Clinical narrative: Extremally exhausted; like even I go up the steps, it takes me a lot time/very tired/very fatigued; a very bad headache; very weak; loss of appetite; still very sickly; have chills as well; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on 03Oct2023, this case now contains all required information to be considered valid.  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 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 02Oct2023 at 13:00 as dose 1, single (Batch/Lot number: unknown) at the age of 66 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "multiple sclerosis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete; Manufacturer unknown), for COVID-19 immunisation. The following information was reported: FATIGUE (non-serious) with onset 04Oct2023, outcome "not recovered", described as "Extremally exhausted; like even I go up the steps, it takes me a lot time/very tired/very fatigued"; HEADACHE (non-serious) with onset 04Oct2023, outcome "not recovered", described as "a very bad headache"; CHILLS (non-serious) with onset 04Oct2023, outcome "unknown", described as "have chills as well"; DECREASED APPETITE (non-serious) with onset 04Oct2023, outcome "unknown", described as "loss of appetite"; ILLNESS (non-serious) with onset 04Oct2023, outcome "not recovered", described as "still very sickly"; ASTHENIA (non-serious) with onset 04Oct2023, outcome "unknown", described as "very weak". Additional information: Patient was fully vaccinated from before. The patient got extremally exhausted, a very bad headache, very weak, loss of appetite. She left work and came home and slept for 6 hours and today, was still very sickly, very tired, loss of appetite and headache is very slight today. She was extremally exhausted like even the patient go up the steps, it takes her a lot time. Patient did have chills as well. Patient stated "I guess we could it still persisting today because I still have the fatigue and slight headache".  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Extremally exhausted; like even I go up the steps, it takes me a lot time/very tired/very fatigued; a very bad headache; very weak; loss of appetite; still very sickly; have chills as well; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on 03Oct2023, this case now contains all required information to be considered valid.  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 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 02Oct2023 at 13:00 as dose 1, single (Batch/Lot number: unknown) at the age of 66 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "multiple sclerosis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete; Manufacturer unknown), for COVID-19 immunisation. The following information was reported: FATIGUE (non-serious) with onset 04Oct2023, outcome "not recovered", described as "Extremally exhausted; like even I go up the steps, it takes me a lot time/very tired/very fatigued"; HEADACHE (non-serious) with onset 04Oct2023, outcome "not recovered", described as "a very bad headache"; CHILLS (non-serious) with onset 04Oct2023, outcome "unknown", described as "have chills as well"; DECREASED APPETITE (non-serious) with onset 04Oct2023, outcome "unknown", described as "loss of appetite"; ILLNESS (non-serious) with onset 04Oct2023, outcome "not recovered", described as "still very sickly"; ASTHENIA (non-serious) with onset 04Oct2023, outcome "unknown", described as "very weak". Additional information: Patient was fully vaccinated from before. The patient got extremally exhausted, a very bad headache, very weak, loss of appetite. She left work and came home and slept for 6 hours and today, was still very sickly, very tired, loss of appetite and headache is very slight today. She was extremally exhausted like even the patient go up the steps, it takes her a lot time. Patient did have chills as well. Patient stated "I guess we could it still persisting today because I still have the fatigue and slight headache".  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 39.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Headache, Pyrexia
Clinical narrative: headache; fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old male patient received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), on 04Oct2023 at 08:00 as dose 1, single (Batch/Lot number: unknown) at the age of 39 years, in left arm for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 04Oct2023 as dose number unknown, single (Batch/Lot number: unknown), in right arm. The patient's relevant medical history included: "Currently have a herniated spinal disc between L5-S1" (unspecified if ongoing). Concomitant medication(s) included: GABAPENTIN. The following information was reported: PYREXIA (non-serious) with onset 04Oct2023 at 21:00, outcome "recovering", described as "fever"; HEADACHE (non-serious) with onset 04Oct2023 at 21:00, outcome "recovering". Therapeutic measures were taken as a result of headache, pyrexia.  Additional information: The patient developed a headache and fever overnight (day of the vaccine into the next day). He took OTC ibuprofen. Known allergies: Kaflex causes a skin rash.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Dizziness, Influenza like illness
Clinical narrative: Extreme nausea for 2 1/2 hours but could not vomit; Fever of 101 degrees for hours; Chills; Joint and Muscle pain; Joint and Muscle pain; Ache all over; some dizziness; felt like a bad flu; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 02Oct2023 at 11:00 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 76 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Non-Hodgkin's Lymphoma - in remission" (unspecified if ongoing). Concomitant medication(s) included: RSV VACCINE taken for immunisation, on 13Sep2023 as dose 1, single; TRAMADOL; GABAPENTIN; NORCO; ATORVASTATIN. Past drug history included: Epinephrine, reaction(s): "Known allergies: Epinephrine"; Lyrica, reaction(s): "Known allergies: Lyrica"; Prozac, reaction(s): "Known allergies: Prozac". Vaccination history included: Covid-19 vaccine (Dose 1; Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2; Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 3 (BOOSTER); Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 4 (BOOSTER); Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 5 (BOOSTER); Manufacturer Unknown), for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset 03Oct2023 at 02:00, outcome "recovering", described as "Ache all over"; CHILLS (non-serious) with onset 03Oct2023 at 02:00, outcome "recovering"; NAUSEA (non-serious) with onset 03Oct2023 at 02:00, outcome "recovering", described as "Extreme nausea for 2 1/2 hours but could not vomit"; PYREXIA (non-serious) with onset 03Oct2023 at 02:00, outcome "recovering", described as "Fever of 101 degrees for hours"; ARTHRALGIA (non-serious), MYALGIA (non-serious) all with onset 03Oct2023 at 02:00, outcome "recovering" and all described as "Joint and Muscle pain"; INFLUENZA LIKE ILLNESS (non-serious) with onset 03Oct2023 at 02:00, outcome "recovering", described as "felt like a bad flu"; DIZZINESS (non-serious) with onset 03Oct2023 at 02:00, outcome "recovering", described as "some dizziness". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of nausea, pyrexia, chills, arthralgia, myalgia, pain, dizziness, influenza like illness. Additional information: 15 hours after receiving vaccine: Extreme nausea for 2 1/2 hours but could not vomit. This was the worst nausea she had ever had since she was a kid, fever of 101 degrees for hours, chills, joint and muscle pain, ache all over, some dizziness; all of this felt like a bad flu. The patient did not have covid prior vaccination. No covid tested post vaccination.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.