chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Haemoptysis, Pulmonary cavitation, Syncope
Clinical narrative: syncope; hemoptysis; cavitary pulmonary disease; This is a spontaneous report received from a Physician.  A male patient in his 30's received BNT162b2 (COMIRNATY), 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: Comirnaty (DOSE 1), for Covid-19 immunization, reaction(s): "syncope". The patient was treated and went back to the baseline. The following information was reported: SYNCOPE (hospitalization, medically significant), outcome "unknown"; HAEMOPTYSIS (hospitalization), outcome "unknown", described as "hemoptysis"; PULMONARY CAVITATION (medically significant), outcome "unknown", described as "cavitary pulmonary disease". After the second dose, the patient had another episode of syncope and hemoptysis. After that, he was diagnosed with cavitary pulmonary disease and received a treatment and follow up with the specialist. The events "syncope" and "hemoptysis" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of syncope, haemoptysis, pulmonary cavitation.   The lot number for BNT162b2, was not provided and will be requested during follow up.; Sender's Comments: Limited information precludes a comprehensive causality assessment, however the contributory role of suspect drug BNT162b2 (COMIRNATY) cannot be totally excluded for the reported events. Information on details surrounding patient complete medical history and concomitant medications would aid in comprehensive medical assessment. Case will be reassessed should 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.,Linked Report(s) : US-PFIZER INC-202400013049 Same reporter and patient, different dose and event;US-PFIZER INC-202400013875 Same reporter and patient, different dose and event;
Sex: U
Vaccine: COVID19
Symptoms: Ageusia, Anosmia
Clinical narrative: neighbor's lost both sense of smell and taste and has not gotten it back yet; neighbor's lost both sense of smell and taste and has not gotten it back yet; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose 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: ANOSMIA (non-serious), AGEUSIA (non-serious), outcome "not recovered" and all described as "neighbor's lost both sense of smell and taste and has not gotten it back yet".  Additional information: The reporter stated that one of his neighbor's lost both sense of smell and taste and has not gotten it back yet. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Abnormal behaviour, Amnesia, Illness, Sensory disturbance
Clinical narrative: was sick for 2 weeks; had memory loss for 3 days; she is mean to people on the phone for no reason; had insects crawling in her skin; This is a spontaneous report received from a Consumer or other non HCP.  A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Lot number: Not Provided) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "was sick for 2 weeks"; AMNESIA (non-serious), outcome "unknown", described as "had memory loss for 3 days"; ABNORMAL BEHAVIOUR (non-serious), outcome "unknown", described as "she is mean to people on the phone for no reason"; SENSORY DISTURBANCE (non-serious), outcome "unknown", described as "had insects crawling in her skin".  Additional Context: Patient on the line calling about the Pfizer Covid-19 Vaccine and said that she was sick for 2 weeks, had memory loss for 3 days. She reported she is mean to people on the phone for no reason and claimed that she had insects crawling in her skin.  No follow-up attempts are possible.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 56-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Oct2022 as dose 5 (booster), single (Lot number: GH9693) at the age of 54 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 18Jul2022 as dose 4 (booster), single (Lot number: FN2908), in left arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single), as dose 2, single) and as dose 3 (booster), single) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Major depressive disorder" (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 Jan2024, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Jan2024) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19, patient took Paxlovid from 06Jan2024 to 12Jan2024.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Laboratory test
Clinical narrative: My hair is falling out like crazy; This is a spontaneous report received from a Consumer or other non HCP.  A 79-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Nov2023 as dose number unknown (booster), single (Lot number: Unknown) at the age of 79 years, in arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: ALOPECIA (non-serious) with onset 2023, outcome "not recovered", described as "My hair is falling out like crazy". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of alopecia.  Additional information: The patient had no other conditions. The patient stated that she got the Pfizer Booster shot (clarified as Pfizer COVID-19 Booster Vaccine) and her hair was falling out as result of it. It was the last one that she got. She had the other two (further not clarified; unspecified shots) and then this one was her first Pfizer, so she thinks it was called the Pfizer Booster shot. When probed to clarify the name of the previous vaccine if Pfizer COVID-19 Vaccine, consumer stated that the two she had before was not Pfizer. Stated that it begins with M but she cannot remember. Further stated that she gets all the vaccines and she has never had COVID and did not want COVID. The event occurred like right after she got the shot, so may be a couple months ago. She was still experiencing it and stated that her hair was falling out like crazy. It was worsening. She got her calendar and looked up the date she got the shot and she thinks it was in November of last year. She also got her flu shot but she got it separately (no other vaccine prior 4 week of vaccination). She does not remember what time she got the Pfizer vaccine but stated that it was sometime in the afternoon and then experienced the event that week. She has been trying things like a rice solution as treatment, a homemade stuff but nothing professional.  Batch/lot number is not provided, and it cannot be obtained.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Arm pain; redness; Arm pain, redness, swelling; fever; This is a spontaneous report received from a Consumer or other non HCP.  A 65-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 12Jan2024 at 09:30 as dose 1,single (Lot number: 10265) at the age of 65 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto disease" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN; LEVOTHYROXINE; BUPROPION; VITAMIN B12 [VITAMIN B12 NOS]; BIOTIN. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 12Jan2024 at 20:30, outcome "not recovered", described as "Arm pain"; PERIPHERAL SWELLING (non-serious) with onset 12Jan2024 at 20:30, outcome "not recovered", described as "Arm pain, redness, swelling"; PYREXIA (non-serious) with onset 12Jan2024 at 20:30, outcome "not recovered", described as "fever"; ERYTHEMA (non-serious) with onset 12Jan2024 at 20:30, outcome "not recovered", described as "redness". Therapeutic measures were not taken as a result of pain in extremity, erythema, peripheral swelling, pyrexia.  Additional information:  Arm pain, redness, swelling, fever starting 11 hours after shot and last at least 36 hours.
Sex: M
Vaccine: COVID19
Symptoms: Anosmia
Clinical narrative: Since hereceived covid vaccince he has no sense of smell; This is a spontaneous report received from a Consumer or other non HCP.  A male patient received BNT162b2 (BNT162B2), on 20Jan2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (dose 1, Lot number: unknown), administration date: 29Dec2020, for COVID-19 immunisation, reaction(s): "Since he received covid vaccince he has no sense of smell". The following information was reported: ANOSMIA (non-serious), outcome "unknown", described as "Since hereceived covid vaccince he has no sense of smell". Additional information: Patient stated that since he received COVID vaccine he had no sense of smell. What concerned him was that he had friends that underwent the same situation but their sense of smell has returned. One of his neighbor's lost both sense of smell and taste and has not gotten it back yet. Patient mentioned that if this could be straightened out, he did not have to do the route of getting a lawyer.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400006284 same patient/suspect drug/event, different dose number;US-PFIZER INC-202400016294 same patient/suspect drug/event, different dose number;
Sex: M
Vaccine: COVID19
Symptoms: Anosmia
Clinical narrative: Since hereceived covid vaccince he has no sense of smell; This is a spontaneous report received from a Consumer or other non HCP.  A male patient received BNT162b2 (BNT162B2), on 29Dec2020 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: ANOSMIA (non-serious), outcome "unknown", described as "Since hereceived covid vaccince he has no sense of smell". Additional information: Patient stated that since he received COVID vaccine he had no sense of smell. What concerned him was that he had friends that underwent the same situation but their sense of smell has returned. One of his neighbor's lost both sense of smell and taste and has not gotten it back yet. Patient mentioned that if this could be straightened out, he did not have to do the route of getting a lawyer.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400006284 same patient/suspect drug/event, different dose number;US-PFIZER INC-202400016293 same patient/suspect drug/event, different dose number;
Age: 74.0
Sex: F
Vaccine: UNK
Symptoms: Balance disorder, Chest X-ray, Electrocardiogram, Full blood count, Gait inability
Clinical narrative: lost balance, couldn't walk, equilibrium issues.
Age: 74.0
Sex: F
Vaccine: UNK
Symptoms: Laboratory test, Metabolic function test, Polymerase chain reaction
Clinical narrative: lost balance, couldn't walk, equilibrium issues.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: VACCINE FROZEN IN STEAD OF REFRIGERATED
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: VACCINE FROZEN ISTEAD OF REFRIGERATED
Age: 46.0
Sex: M
Vaccine: FLUC4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received his Flucelvax Quadrivalent by Seqirus Inc at 08:30 and then went to his physician clinic who gave him the vaccine again 2 hours later.  There was no adverse reaction.  Clinic documented they gave a flu vaccine after given by our clinic but patient says he never got an additional vaccine
Age: 42.0
Sex: F
Vaccine: COVID19-2
Symptoms: Condition aggravated, Urticaria
Clinical narrative: Retriggering of chronic hives that broke through the Xolair
Age: 24.0
Sex: U
Vaccine: FLUC4
Symptoms: No adverse event, Pathogen resistance
Clinical narrative: He was given the vaccine again while visiting the clinic physician 2 hours later with no adverse reaction.  Clinic documented they gave a flu vaccine after given by our clinic but patient says he did not receive a second flu vaccine.  AGAIN THERE WAS NO ADVERSE REACTION he received 2 doses.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral herpes, Rash
Clinical narrative: THE PATIENT CAME IN TODAY AND REPORTED THAT SHE GOT A RASH ON HER ARMS AND LEGS, AS WELL AS A COLD SORE AFTER GETTING HER 2ND DOSE OF SHINGRIX VACCINE.
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: patient given vaccine 17 hours after expiration
Age: 87.0
Sex: F
Vaccine: RSV
Symptoms: Erythema, Inflammation, Pain
Clinical narrative: local redness, pain and inflammation
Age: 62.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Rash, Urticaria
Clinical narrative: Hives/rash on torso continuing for several weeks
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received Pfizer covid vaccine administration after beyond use date.
Sex: U
Vaccine: COVID19
Symptoms: Malaise, Myalgia, Nausea, Vaccination site pain, Vaccination site swelling
Clinical narrative: Mild injection site tenderness (tender to touch); Mild injection site swelling; Mild malaise/feeling sick and no interference with activity; Mild muscle pain and no interference with activity; Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting; Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Dec2023 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: VACCINATION SITE SWELLING (non-serious) with onset Dec2023, outcome "unknown", described as "Mild injection site swelling"; VACCINATION SITE PAIN (non-serious) with onset Dec2023, outcome "unknown", described as "Mild injection site tenderness (tender to touch)"; MALAISE (non-serious) with onset Dec2023, outcome "unknown", described as "Mild malaise/feeling sick and no interference with activity"; MYALGIA (non-serious) with onset Dec2023, outcome "unknown", described as "Mild muscle pain and no interference with activity"; NAUSEA (non-serious), VOMITING (non-serious) all with onset Dec2023, outcome "unknown" and all described as "Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting".  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Mild injection site tenderness (tender to touch); Mild injection site swelling; Mild malaise/feeling sick and no interference with activity; Mild muscle pain and no interference with activity; Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting; Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Dec2023 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: VACCINATION SITE SWELLING (non-serious) with onset Dec2023, outcome "unknown", described as "Mild injection site swelling"; VACCINATION SITE PAIN (non-serious) with onset Dec2023, outcome "unknown", described as "Mild injection site tenderness (tender to touch)"; MALAISE (non-serious) with onset Dec2023, outcome "unknown", described as "Mild malaise/feeling sick and no interference with activity"; MYALGIA (non-serious) with onset Dec2023, outcome "unknown", described as "Mild muscle pain and no interference with activity"; NAUSEA (non-serious), VOMITING (non-serious) all with onset Dec2023, outcome "unknown" and all described as "Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting".  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Myalgia, Vaccination site pain
Clinical narrative: Mild injection site pain and no interference with activity/Moderate injection site tenderness (tenderness with movement); Headache and no interference with activity; Moderate muscle pain with some interference with activity; Joint pain with significant interference with activity; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 22Dec2023, outcome "unknown", described as "Headache and no interference with activity"; ARTHRALGIA (non-serious) with onset 22Dec2023, outcome "unknown", described as "Joint pain with significant interference with activity"; VACCINATION SITE PAIN (non-serious) with onset 22Dec2023, outcome "unknown", described as "Mild injection site pain and no interference with activity/Moderate injection site tenderness (tenderness with movement)"; MYALGIA (non-serious) with onset 22Dec2023, outcome "unknown", described as "Moderate muscle pain with some interference with activity". Additional information: No injection site redness, no injection site swelling, no fever (less than 100.4 °F), fatigue not present, malaise/feeling sick not present, no nausea/vomiting present.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: bells palsy; This is a spontaneous report received from a Consumer or other non HCP from License Party. Other Case identifier(s): AE-012306 (BioNTech).  A female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BELL'S PALSY (medically significant), outcome "unknown", described as "bells palsy".  The lot number for BNT162b2 omi xbb.1.5, was not provided and will be requested during follow up.  BNT162b2 omi xbb.1.5 is under agreement with BIONTECH.
Sex: M
Vaccine: RSV
Symptoms: Asthma, Immunodeficiency
Clinical narrative: have asthma; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A male patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ASTHMA (non-serious), outcome "unknown", described as "have asthma". Additional information: The reporter called in seeking assistance with the Abrysvo vaccine. During the call caller stated, "The cost for my husband and I is just shy of (amount redacted) to go to the pharmacy and get those prescriptions, we both have asthma, I have advanced airway disease and I'm immunocompromised in another way and I'm about to have oral surgeries."  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: She would like to know if it is safe for her daughter to take Paxlovid; She would like to know if it is safe for her daughter to take Paxlovid; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A female patient received BNT162b2 omi xbb.1.5 (PFIZER-BIONTECH COVID-19 VACCINE (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "does not have a spleen" (unspecified if ongoing), notes: she mentioned that the patient does not have a spleen.; "Autoimmune disorder" (unspecified if ongoing), notes: her daughter has an Autoimmune disorder. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "She would like to know if it is safe for her daughter to take Paxlovid". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400006279 Same patient and product, different event;
Sex: U
Vaccine: COVID19
Symptoms: Mental disorder
Clinical narrative: mind control; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MENTAL DISORDER (non-serious), outcome "unknown", described as "mind control". Additional information: Patient wants to know what's in the covid shot, states vaccine is causing mind control.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: nose bleeds; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A female patient (unknown if pregnant) 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: EPISTAXIS (non-serious), outcome "unknown", described as "nose bleeds".  Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: mentioned she has an underlying condition and has both Pfizer shots but she still got COVID.; mentioned she has an underlying condition and has both Pfizer shots but she still got COVID.; This is a spontaneous report received from a Consumer or other non HCP from product quality group, Program ID.  A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) and 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 "mentioned she has an underlying condition and has both Pfizer shots but she still got COVID.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: she tested for COVID and she needs to get approval for Paxlovid and mentioned she has an underlying condition and has both Pfizer shots but she still got COVID.  Clinical information: The caller said she called this morning for her daughter to get approval for Paxlovid because she has COVID and now she tested for COVID and she needs to get approval for Paxlovid and mentioned she has an underlying condition and has both Pfizer shots but she still got COVID.   The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: She developed blood clots within 24 hrs of receiving your Covid vaccination.; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 90-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Jan2024 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: THROMBOSIS (death) with onset Jan2024, outcome "fatal", described as "She developed blood clots within 24 hrs of receiving your Covid vaccination.". The patient date of death was Jan2024. Reported cause of death: "She developed blood clots within 24 hrs of receiving your Covid vaccination". It was not reported if an autopsy was performed. Clinical course: It was reported that patient had never a blood clot history. She never had been hospitalized for any problem her whole life. She developed blood clots within 24 hrs of receiving your Covid vaccination.   The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Reported Cause(s) of Death: She developed blood clots within 24 hrs of receiving your Covid vaccination
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune disorder, Immune thrombocytopenia
Clinical narrative: brought back her disorder; immune thrombocytopenia; This is a spontaneous report received from a Consumer or other non HCP.  A female patient received BNT162b2 omi xbb.1.5 (PFIZER-BIONTECH COVID-19 VACCINE (2023-2024 FORMULA)), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "autoimmune disorder" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid vaccines (DOSE NUMBER UNKNOWN; MANUFACTURER UNKNOWN), for Covid-19 immunisation. The following information was reported: AUTOIMMUNE DISORDER (medically significant), outcome "unknown", described as "brought back her disorder"; IMMUNE THROMBOCYTOPENIA (medically significant), outcome "unknown". The reporter called on behalf of her daughter and stated that the patient had COVID vaccines before and now she got the immune thrombocytopenia, her condition came back with a vengeance.  The lot number for BNT162b2 omi xbb.1.5, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400005719 Same patient and product, different event;
Sex: M
Vaccine: COVID19
Symptoms: Anosmia
Clinical narrative: Since hereceived covid vaccince he has no sense of smell; This is a spontaneous report received from a Consumer or other non HCP.  A male patient received BNT162b2 (BNT162B2), on 03Sep2021 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: unknown), administration date: 29Dec2020, for COVID-19 immunisation, reaction(s): "Since he received covid vaccince he has no sense of smell"; BNT162b2 (dose 2, Lot number: unknown), administration date: 20Jan2021, for COVID-19 immunisation, reaction(s): "Since he received covid vaccince he has no sense of smell". The following information was reported: ANOSMIA (non-serious), outcome "unknown", described as "Since hereceived covid vaccince he has no sense of smell". Additional information: Patient stated that since he received COVID vaccine he had no sense of smell. What concerned him was that he had friends that underwent the same situation but their sense of smell has returned. One of his neighbor's lost both sense of smell and taste and has not gotten it back yet. Patient mentioned that if this could be straightened out, he did not have to do the route of getting a lawyer.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400016293 same patient/suspect drug/event, different dose number;US-PFIZER INC-202400016294 same patient/suspect drug/event, different dose number;
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose decreased, Dehydration, Dizziness, Hypotension, Off label use
Clinical narrative: dizzy; The patent's representative took her blood pressure, and it was low / low blood pressure; low blood sugar; dehydration; patent got their Covid and Influenza vaccine on 20Dec2023; patent got their Covid and Influenza vaccine on 20Dec2023; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): NUS2024US005505_NC.  A 31-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 20Dec2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (INFLUENZA), from 20Dec2023) to 20Dec2023 at single (dose number unknown, single). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "dizzy"; HYPOTENSION (non-serious), outcome "unknown", described as "The patent's representative took her blood pressure, and it was low / low blood pressure"; BLOOD GLUCOSE DECREASED (non-serious), outcome "unknown", described as "low blood sugar"; DEHYDRATION (non-serious), outcome "unknown"; OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious), outcome "unknown" and all described as "patent got their Covid and Influenza vaccine on 20Dec2023". Additional information: The patient's was taken to the ER last evening. She was dizzy. The patient's representative took her blood pressure, and it was low. The ER diagnosed her with low blood sugar, low blood pressure, and dehydration. The patient's representative does not think it was related to Acthar, but it could be the vaccine.  Batch/lot number is not provided, and it cannot be obtained.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Product use issue
Clinical narrative: dizzy; The patent's representative took her blood pressure, and it was low / low blood pressure; low blood sugar; dehydration; patent got their Covid and Influenza vaccine on 20Dec2023; patent got their Covid and Influenza vaccine on 20Dec2023; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): NUS2024US005505_NC.  A 31-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 20Dec2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (INFLUENZA), from 20Dec2023) to 20Dec2023 at single (dose number unknown, single). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "dizzy"; HYPOTENSION (non-serious), outcome "unknown", described as "The patent's representative took her blood pressure, and it was low / low blood pressure"; BLOOD GLUCOSE DECREASED (non-serious), outcome "unknown", described as "low blood sugar"; DEHYDRATION (non-serious), outcome "unknown"; OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious), outcome "unknown" and all described as "patent got their Covid and Influenza vaccine on 20Dec2023". Additional information: The patient's was taken to the ER last evening. She was dizzy. The patient's representative took her blood pressure, and it was low. The ER diagnosed her with low blood sugar, low blood pressure, and dehydration. The patient's representative does not think it was related to Acthar, but it could be the vaccine.  Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Fatigue, Headache, Malaise
Clinical narrative: Mild injection site pain and no interference with activity/Moderate injection site tenderness (tenderness with movement); Mild fever (100.4 to 101.2 F); Moderate fatigue with some interference with activity; Moderate malaise/feeling sick present with some interference with activity; Mild muscle pain and no interference with activity; Joint pain and no interference with activity; Headache and no interference with activity; This is a spontaneous report received from a Consumer or other non HCP. A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 03Jan2024 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: HEADACHE (non-serious) with onset 05Jan2024, outcome "unknown", described as "Headache and no interference with activity"; ARTHRALGIA (non-serious) with onset 05Jan2024, outcome "unknown", described as "Joint pain and no interference with activity"; PYREXIA (non-serious) with onset 05Jan2024, outcome "unknown", described as "Mild fever (100.4 to 101.2 F)"; VACCINATION SITE PAIN (non-serious) with onset 05Jan2024, outcome "unknown", described as "Mild injection site pain and no interference with activity/Moderate injection site tenderness (tenderness with movement)"; MYALGIA (non-serious) with onset 05Jan2024, outcome "unknown", described as "Mild muscle pain and no interference with activity"; FATIGUE (non-serious) with onset 05Jan2024, outcome "unknown", described as "Moderate fatigue with some interference with activity"; MALAISE (non-serious) with onset 05Jan2024, outcome "unknown", described as "Moderate malaise/feeling sick present with some interference with activity". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The events "mild injection site pain, moderate injection site tenderness, mild fever, moderate fatigue, moderate malaise/feeling sick, mild muscle pain, joint pain, and headache" were reported to have also occurred on 06Jan2024. No injection site tenderness, no injection site swelling, and no nausea/vomiting.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, Vaccination site pain
Clinical narrative: Mild injection site pain and no interference with activity/Moderate injection site tenderness (tenderness with movement); Mild fever (100.4 to 101.2 F); Moderate fatigue with some interference with activity; Moderate malaise/feeling sick present with some interference with activity; Mild muscle pain and no interference with activity; Joint pain and no interference with activity; Headache and no interference with activity; This is a spontaneous report received from a Consumer or other non HCP. A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 03Jan2024 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: HEADACHE (non-serious) with onset 05Jan2024, outcome "unknown", described as "Headache and no interference with activity"; ARTHRALGIA (non-serious) with onset 05Jan2024, outcome "unknown", described as "Joint pain and no interference with activity"; PYREXIA (non-serious) with onset 05Jan2024, outcome "unknown", described as "Mild fever (100.4 to 101.2 F)"; VACCINATION SITE PAIN (non-serious) with onset 05Jan2024, outcome "unknown", described as "Mild injection site pain and no interference with activity/Moderate injection site tenderness (tenderness with movement)"; MYALGIA (non-serious) with onset 05Jan2024, outcome "unknown", described as "Mild muscle pain and no interference with activity"; FATIGUE (non-serious) with onset 05Jan2024, outcome "unknown", described as "Moderate fatigue with some interference with activity"; MALAISE (non-serious) with onset 05Jan2024, outcome "unknown", described as "Moderate malaise/feeling sick present with some interference with activity". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The events "mild injection site pain, moderate injection site tenderness, mild fever, moderate fatigue, moderate malaise/feeling sick, mild muscle pain, joint pain, and headache" were reported to have also occurred on 06Jan2024. No injection site tenderness, no injection site swelling, and no nausea/vomiting.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: pain; This is a spontaneous report received from a Consumer or other non HCP.  A female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), 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: PAIN (non-serious), outcome "unknown".  Additional information: Caller is a consumer calling in regards to Pfizer covid19 vaccine and mentioned that she did get the vaccine yesterday. She wants to know if she can take any type of pain relievers such as Tylenol or Motrin. She didn't want to take anything without checking first.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Neoplasm malignant
Clinical narrative: dying from three rare cancers triggered by your vaccine; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose 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: NEOPLASM MALIGNANT (medically significant), outcome "unknown", described as "dying from three rare cancers triggered by your vaccine".  The lot number for BNT162b2, was not provided and will be requested during follow up.
Age: 14.0
Sex: M
Vaccine: IPV
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: refrigerator door being accidentally left open/high of 8.9C out of range for 40 minutes with no adverse event; two doses administered post excursion with no reported adverse event; Initial information was received on 09-Jan-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to case 2024SA014573 (CLUSTER).  This case involves a 14 years old male patient to whom IPV (VERO) [Ipol] was administered when refrigerator door being accidentally left open/high of 8.9c out of range for 40 minutes with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HPV VACCINE (HPV VACCINE) for Prophylactic vaccination.  On 22-Nov-2023, the patient received a 0.5 ml, once of suspect IPV (VERO) (Suspension for injection) (lot V1B902M, expiry date: 02-Jun-2024) via intramuscular route in left deltoid for Prophylactic vaccination (Immunisation) (poor quality product administered) (Latency: same day).  On an unknown date the patient developed a non-serious refrigerator door being accidentally left open/high of 8.9c out of range for 40 minutes with no adverse event (product storage error).  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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: FLUX
Symptoms: Exposure to communicable disease, Influenza, Malaise, Pyrexia, Respiratory disorder
Clinical narrative: Flu; Respiratory illness; High fever; This spontaneous case was received on 09-Jan-2024 from other healthcare professional (reference number SEQW24-00108) and concerned a patient of unreported age and gender.  The patient's medical history and concomitant medications were not reported.  On an unspecified date (reported as 'in October'), the patient was vaccinated with influenza vaccine (brand not specified; dose, route of administration, anatomical location and indication: not reported). The batch number was not reported.  On an unspecified date (reported as 'over Christmas'), unknown amount of time after receiving influenza vaccine, the patient experienced what was believed to be the flu, but the patient was never actually tested because of the holiday and having a quick recovery. It was considered to be flu due to quick onset and high fever as well as several people around the patient had tested positive in days prior to the patient getting sick. As reported, there were also other illnesses going around and since the patient didn't get tested it doesn't know if actually had the flu. The reporter stated all they could say was that they had a respiratory illness.  On an unspecified day, the patient recovered from the event of flu.  The outcome of the event of fever was not reported.  The reporter did not provide a causality assessment.  The event of flu was considered to be medically significant by a Physician within Department.  This case is linked with cases 202400029, 202400201 and 202400031 (the same reporter).  Company comment: A patient of unreported age experienced respiratory illness consistent with influenza infection an unknown amount of time after receiving the suspect product influenza vaccine. The patient's illness was not lab-confirmed, but it was suspected to be flu due to rapid onset, high fever, and exposure to others who tested positive. However, the patient couldn't confirm it as they were not tested during the holiday season, categorizing it simply as a respiratory illness. Due to lack of information and unclear temporal relationship, causality for the above-mentioned reported events is unassessable.; Sender's Comments: A patient of unreported age experienced respiratory illness consistent with influenza infection an unknown amount of time after receiving the suspect product influenza vaccine. The patient's illness was not lab-confirmed, but it was suspected to be flu due to rapid onset, high fever, and exposure to others who tested positive. However, the patient couldn't confirm it as they were not tested during the holiday season, categorizing it simply as a respiratory illness. Due to lack of information and unclear temporal relationship, causality for the above-mentioned reported events is unassessable.
Sex: U
Vaccine: FLUX
Symptoms: Exposure to communicable disease, Influenza, Malaise, Pyrexia, Respiratory disorder
Clinical narrative: Flu; Respiratory illness; High fever; This spontaneous case was received on 09-Jan-2024, from other healthcare professional via agency (reference number: SEQW24-00108) and concerned a patient of unreported age and gender.  The patient's medical history and concomitant medications were not reported.  On an unspecified date, reported as 'in October', the patient was vaccinated with influenza vaccine (brand not specified; dose, route of administration, and anatomical location: not reported) for active immunization against influenza disease. The batch number was not reported.   On an unspecified date, reported as 'over Christmas', an unknown amount of time after receiving influenza vaccine, the patient got what was believed to be the flu, but the patient was never actually tested because of the holiday. The patient believed it was the flu due to quick onset and high fever for a few of them. The patient had several people around who tested positive days prior to the patient getting sick. There were also other illnesses going around and since the patient did not get tested, the patient did not know if they actually had the flu. All the patient could really say was that the patient had a respiratory illness.  On an unspecified date, the patient recovered from all events. As reported, the patient had a quick recovery.  The reporter did not provide a causality assessment.  The event of flu was considered to be medically significant by a Physician within Seqirus's Pharmacovigilance Department.  This case is linked with the cases 202400031, 202400200, and 202400029 (the same reporter).  Company comment: A patient of unreported age experienced respiratory illness consistent with influenza infection an unknown amount of time after receiving the suspect product influenza vaccine. The patient's illness was not lab-confirmed, but it was suspected to be flu due to rapid onset, high fever, and exposure to others who tested positive. However, the patient couldn't confirm it as they were not tested during the holiday season, categorizing it simply as a respiratory illness. Due to lack of information and unclear temporal relationship, causality for the above-mentioned reported events is unassessable.; Sender's Comments: A patient of unreported age experienced respiratory illness consistent with influenza infection an unknown amount of time after receiving the suspect product influenza vaccine. The patient's illness was not lab-confirmed, but it was suspected to be flu due to rapid onset, high fever, and exposure to others who tested positive. However, the patient couldn't confirm it as they were not tested during the holiday season, categorizing it simply as a respiratory illness. Due to lack of information and unclear temporal relationship, causality for the above-mentioned reported events is unassessable.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Decreased appetite, Feeling of body temperature change, Hyperhidrosis, Neurological symptom
Clinical narrative: Hot/cold sweats. Severe chest pains, loss of appetite, stroke and or heart attack symptoms.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Pneumonia, X-ray
Clinical narrative: Hot/cold sweats. Severe chest pains, loss of appetite, stroke and or heart attack symptoms.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Mobility decreased
Clinical narrative: back pain; started day after shot..3-4 days could not get out of bed
Age: 65.0
Sex: M
Vaccine: PNC20
Symptoms: Extra dose administered
Clinical narrative: The patient received an additional dose of Prevnar today on this date, 1/17/24. According to the Immunization System, the patient was previously administered Prevnar 20 on 11/15/22.