chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 27.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 27 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, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Oct2023) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient used Paxlovid from 15Oct2023 to 19Oct2023 for COVID-19 treatment. Patient reported, "I have paxlovid rebound. I tested positive for COVID 18Oct and never tested negative but my tests were very faint lines, and today they are dark lines indicating I am more infectious."  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.
Age: 33.0
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 a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 08Nov2021 as dose number unknown, single (Lot number: 320308D) at the age of 33 years 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 15Oct2023, outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 30Sep2023 at 11:00 as dose 1, single (Lot number: HD9835) at the age of 53 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Interstitial lung disease" (unspecified if ongoing); "myositis" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). Concomitant medication(s) included: CELLCEPT [MYCOPHENOLATE MOFETIL HYDROCHLORIDE], start date: 01Oct2012. Past drug history included: Amoxicillin, reaction(s): "known allergies: amoxicillin". 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; Covid-19 vaccine (DOSE 4, MANUFACTURER UNKNOWN), for COVID-19 Immunization. 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 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 69-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 02Oct2023 at 11:00 as dose 1, single (Lot number: HD9874) at the age of 69 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Stroke" (unspecified if ongoing); "PFO closure" (unspecified if ongoing); "sleeve gastrectomy" (unspecified if ongoing); "kidney stones" (unspecified if ongoing); "knee replacement" (unspecified if ongoing); "hip tendon repairs" (unspecified if ongoing); "knee revision" (unspecified if ongoing); "arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Macrodantin, reaction(s): "Known allergies: Macrodantin"; Rosuvastatin, reaction(s): "Known allergies: Rosuvastatin". Vaccination history included: Covid-19 vaccine (Dose 4), for COVID-19 immunization; Covid-19 vaccine (Dose 3), for COVID-19 immunization; Covid-19 vaccine (Dose 2), for COVID-19 immunization; Covid-19 vaccine (Dose 1), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events Vaccination failure , Covid-19 and the use of suspect product cannot be fully excluded.
Age: 63.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Mar2023 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 63 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: "lupus-like auto immune disorder" (unspecified if ongoing).  No known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Oct2023) Negative, notes: tested covid negative 3 days after completing  Paxlovid, Covid rebound symptoms 5 days after finishing Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19. 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.
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Condition aggravated, Dizziness, Fatigue, Pain in extremity
Clinical narrative: Dizzy; Fatigued; worsened; Arm was still aching; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) intramuscular, in right arm for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), as dose 1, single (Batch/Lot number: unknown), in right deltoid for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 19Oct2023, outcome "recovered", described as "Arm was still aching"; DIZZINESS (non-serious) with onset 19Oct2023, outcome "recovered", described as "Dizzy"; FATIGUE (non-serious) with onset 19Oct2023, outcome "recovered", described as "Fatigued"; CONDITION AGGRAVATED (non-serious) with onset 19Oct2023, outcome "recovered", described as "worsened". Therapeutic measures were taken as a result of dizziness, fatigue, condition aggravated, pain in extremity.  Additional information: patient started feeling very dizzy and fatigued after a 3 mile walk which worsened. Took Tylenol went to bed and woke up after sleeping 5 hours. She took more Tylenol since her arm was still aching. 48 hours after she woke up feeling better. By Sunday she was back to normal. Covid prior vaccination: no. Covid tested post vaccination: no.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Blood pressure measurement, Dyspnoea, Heart rate, Heart rate increased, Hypertension
Clinical narrative: Shortness of breath; elevated pulse rate of 90 to 120 for over 4 hours,; elevated blood pressure as high as 152/83; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 23Oct2023 at 13:45 as dose 1, single (Lot number: HD9876), in left arm for covid-19 immunisation; influenza vaccine (FLUZONE [INFLUENZA VACCINE]), on 23Oct2023 as dose 1, single (Batch/Lot number: unknown), in left arm for immunisation. The patient's relevant medical history included: "Elevated cholesterol" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN. Vaccination history included: Covid-19 vaccine (DOSE 5, SINGLE, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 4, SINGLE, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3, SINGLE, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2, SINGLE, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 1, SINGLE, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: DYSPNOEA (non-serious) with onset 24Oct2023 at 01:30, outcome "recovering", described as "Shortness of breath"; HYPERTENSION (non-serious) with onset 24Oct2023 at 01:30, outcome "recovering", described as "elevated blood pressure as high as 152/83"; HEART RATE INCREASED (non-serious) with onset 24Oct2023 at 01:30, outcome "recovering", described as "elevated pulse rate of 90 to 120 for over 4 hours,". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dyspnoea, heart rate increased, hypertension.  Additional information: other medications in two weeks included multivitamin, D, glucosamine, calcium. The patient reported shortness of breath, elevated pulse rate of 90 to 120 for over 4 hours, elevated blood pressure as high as 152/83. His normal resting bp is typically 125/80 with a pulse rate in the low 70s or high 60s. His resting pulse remains high at 83 bpm, 24 hours after receipt of vaccine. The patient had no known allergies.
Sex: M
Vaccine: COVID19, FLU3
Symptoms: SARS-CoV-2 test
Clinical narrative: Shortness of breath; elevated pulse rate of 90 to 120 for over 4 hours,; elevated blood pressure as high as 152/83; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 23Oct2023 at 13:45 as dose 1, single (Lot number: HD9876), in left arm for covid-19 immunisation; influenza vaccine (FLUZONE [INFLUENZA VACCINE]), on 23Oct2023 as dose 1, single (Batch/Lot number: unknown), in left arm for immunisation. The patient's relevant medical history included: "Elevated cholesterol" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN. Vaccination history included: Covid-19 vaccine (DOSE 5, SINGLE, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 4, SINGLE, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3, SINGLE, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2, SINGLE, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 1, SINGLE, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: DYSPNOEA (non-serious) with onset 24Oct2023 at 01:30, outcome "recovering", described as "Shortness of breath"; HYPERTENSION (non-serious) with onset 24Oct2023 at 01:30, outcome "recovering", described as "elevated blood pressure as high as 152/83"; HEART RATE INCREASED (non-serious) with onset 24Oct2023 at 01:30, outcome "recovering", described as "elevated pulse rate of 90 to 120 for over 4 hours,". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dyspnoea, heart rate increased, hypertension.  Additional information: other medications in two weeks included multivitamin, D, glucosamine, calcium. The patient reported shortness of breath, elevated pulse rate of 90 to 120 for over 4 hours, elevated blood pressure as high as 152/83. His normal resting bp is typically 125/80 with a pulse rate in the low 70s or high 60s. His resting pulse remains high at 83 bpm, 24 hours after receipt of vaccine. The patient had no known allergies.
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Headache, Nausea, Oropharyngeal pain
Clinical narrative: I am very nauseous; Very sore throat; Very sort of a terrible headache; Could not eat; not been able to eat anything; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 81-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NAUSEA (non-serious), outcome "unknown", described as "I am very nauseous"; OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "Very sore throat"; HEADACHE (non-serious), outcome "unknown", described as "Very sort of a terrible headache"; DECREASED APPETITE (non-serious), outcome "unknown", described as "Could not eat; not been able to eat anything". Therapeutic measures were not taken as a result of nausea, oropharyngeal pain, headache, decreased appetite. Additional ifnormation: The patient reported she was very nauseous, she had been very sore throat. She had been very sort of a terrible headache and she got up to get dressed to go teach this morning and she just lost, she could not do it, she just could not get her clothes on. She could not eat, she had not been able to eat anything and she didn't know what to do for it, she should try to eat or just drink water or any of that. 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: 68.0
Sex: F
Vaccine: UNK
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), on 05Oct2023 at 13:00 as dose 1, single at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Advil, reaction(s): "known allergies: Advil". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.
Sex: M
Vaccine: COVID19, COVID19-2
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Vaccine dose =3, brand=Pfizer / BioNTech/ vaccine dose =4, vaccine brand =Moderna; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 46-year-old male patient received bnt162b2 (BNT162B2 NOS), as dose 1, single, as dose 2, single and as dose 3 (booster), single for covid-19 immunisation; davesomeran, elasomeran (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), as dose 4 (booster), single (Batch/Lot number: unknown) and on 29Sep2023 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm 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 Oct2023, outcome "unknown" and all described as "Treatment of COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Vaccine dose =3, brand=Pfizer / BioNTech/ vaccine dose =4, vaccine brand =Moderna". Therapeutic measures were taken as a result of drug ineffective, covid-19, Paxlovid administered from 23Oct2023.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Syncope
Clinical narrative: blacked out for a number of seconds; fainted; 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 90-year-old female patient received bnt162b2 (BNT162B2), on 12Nov2021 as dose 3 (booster), single (Lot number: FF2593) at the age of 90 years for covid-19 immunisation. The patient's relevant medical history included: "Arthritis" (unspecified if ongoing); "Glaucoma" (unspecified if ongoing); "Just to my thyroid gets little slow" (unspecified if ongoing); "my cholesterol just a little high" (unspecified if ongoing); "glaucoma" (unspecified if ongoing). Concomitant medication(s) included: ASPIRIN [ACETYLSALICYLIC ACID]; LEVOTHYROXINE taken for thyroid disorder; LATANOPROST ophthalmic taken for glaucoma; TYLENOL. Vaccination history included: bnt162b2 (Dose 2, 6208), administration date: 12Mar2021, when the patient was 90-year-old, for COVID-19 Immunization; Bnt162b2 (Dose 1, EM9809), administration date: Feb2021, when the patient was 90 years old, for COVID-19 Immunization. Concomitant medication also included unspecified Vitamins. The following information was reported: LOSS OF CONSCIOUSNESS (medically significant) with onset 12Nov2021, outcome "unknown", described as "blacked out for a number of seconds"; SYNCOPE (medically significant) with onset 12Nov2021, outcome "unknown", described as "fainted".  Clinical course: The patient took the COVID-19 vaccine booster shot yesterday and she forgot to sit down and rest for 15 minutes. Caller was wondering if that would cause a problem. Caller also stated that she had a usual bit of a sore arm. She also had the flu shot on the other arm. Last time she had the Pfizer COVID vaccine booster she did have a blackout about 35 minutes after. She received that shot on Nov2021. The shot she had yesterday was the 4th Pfizer COVID vaccine that she had had. The patient had the shot and waited for 15 minutes then she had to go, she headed to (Name: Withheld) and then she had to (Name: Withheld) and then had to go to the checkout one, so that was another 15-20 minutes getting home, so she was trying it occurred maybe about an hour and a half after she had shot, she had never fainted in her life like this and lived in a retirement village her husband and her at that time and she was not on a city street she was inside of retirement complex then all of a sudden she was driving on the wrong side of the road she had just blacked out for a number of seconds, she did not know 10, 15, 20 and that was all, that was a little frightening so she decided that she would not drive alone to have an injection again she would have to have somebody just for safety sake. That was all happened.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300342163 same patient, different dose number/event;
Age: 55.0
Sex: F
Vaccine: 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 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 05Oct2023 at 16:15 as dose 1, single (Batch/Lot number: unknown) at the age of 55 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "mild asthma" (unspecified if ongoing); "Known allergies: penicillin" (unspecified if ongoing); "Known allergies: sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Cephalasporin, reaction(s): "Known allergies: cephalasporin"; Cipro, reaction(s): "Known allergies: cipro". Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, Unknown manufacture), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE, Unknown manufacture), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, Unknown manufacture), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Oct2023) Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test, Thyroid function test
Clinical narrative: COVID; COVID; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 79-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Sep2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (ongoing); "Hypopituitarism" (ongoing); "Hypocalcemia" (ongoing); "Pituitary adenoma" (unspecified if ongoing); "total Thyroidectomy" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE oral taken for hypothyroidism, start date: Aug2019 (ongoing); TESTOSTERONE taken for hypopituitarism, start date: Aug2019; VITAMIN D [COLECALCIFEROL] oral taken for hypopituitarism, hypocalcaemia, start date: Oct2021; ROSUVASTATIN, stop date: 15Oct2023. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID". The patient received Pfizer booster exactly 3 weeks before he got sick with COVID. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Did another COVID test of myself today; it becomes positive again; rebound COVID; Thyroid function test: (2023) Normal, notes: 3 or 4 weeks before to ensure my thyroid function was normal. The patient was treated with Paxlovid.; Sender's Comments: Based on the known the information available the Causal relation between the events Drug ineffective, Covid 19 and suspect drug cannot be excluded completely
Age: 46.0
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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Apr2023 at 13:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 46 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Anti-synthetase Syndrome" (unspecified if ongoing). Patient had no known allergies. 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 "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Oct2023) Negative; (23Oct2023) Possitive. Therapeutic measures were taken as a result of drug ineffective, covid-19, which included Paxlovid from 09Oct2023 to 13Oct2023.  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.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), 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, SINGLE), for Covid-19 Immunization, reaction(s): "Headache", "Also developed tinnitus on right after 1st vaccine which has been constant". The following information was reported: HEADACHE (non-serious), outcome "unknown".  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300176335 Same patient, different dose number/event;
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28-year-old male patient received bnt162b2 (BNT162B2), on 29Jan2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 25 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Ibs" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Clexa, reaction(s): "Drug Allergy: Clexa", notes: Known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received treatment Paxlovid from 23Oct2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: RSV
Symptoms: Injection site erythema, Myalgia
Clinical narrative: muscle soreness; redness near the injection site; 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 patient (no qualifiers provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation; for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYALGIA (non-serious), outcome "unknown", described as "muscle soreness"; INJECTION SITE ERYTHEMA (non-serious), outcome "unknown", described as "redness near the injection site".  Additional information: It was reported that patient experienced muscle soreness and redness near the injection site and would like to know if it is normal.   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
Symptoms: Blood pressure decreased, Blood pressure measurement, Paraesthesia
Clinical narrative: tingling sensation in fingers or toes; lowered blood pressure; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "disclosed high blood pressure, otherwise unknonwn" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: PARAESTHESIA (non-serious), outcome "recovered", described as "tingling sensation in fingers or toes"; BLOOD PRESSURE DECREASED (non-serious), outcome "unknown", described as "lowered blood pressure". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: patient said she experienced lowered blood pressure. She no longer experienced tingling sensation in fingers or toes that she had been experiencing over the past two weeks. She did say that she had some concurrent medications increased within the past two weeks.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Immune system disorder, Inflammation, Vasculitis
Clinical narrative: Vasculitis; his immune system saw this more as an attack, and the response; was major inflammation; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient in his 40's 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: VASCULITIS (non-serious), outcome "recovering"; IMMUNE SYSTEM DISORDER (non-serious), outcome "unknown", described as "his immune system saw this more as an attack, and the response"; INFLAMMATION (non-serious), outcome "unknown", described as "was major inflammation". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported that testing his Anti-Body level (Body's immune response), he discovered that his Anti- Body level was extremely high, which meant, receiving the vaccine created more unnecessary Anti- Bodies and his immune system saw this more as an attack, and the response, was major inflammation.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200820941 same reporter and drug, different patient and event;
Sex: U
Vaccine: COVID19
Symptoms: Nasal odour, Olfactory test
Clinical narrative: olfactory results of covid vaccine post injection have heightened acrid odors; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 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: NASAL ODOUR (non-serious), outcome "unknown", described as "olfactory results of covid vaccine post injection have heightened acrid odors". Relevant laboratory tests and procedures are available in the appropriate section. The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Persistent headache; This is a spontaneous report received from contactable reporter(s) (Physician).  A male 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: HEADACHE (non-serious), outcome "unknown", described as "Persistent headache".' Additional information: Patient was upset about experiencing new daily persistent headache after a COVID19 vaccination from Pfizer.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: achy; fever; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2023NVX-US-000001270 (Novavax).  A 69-year-old female patient received bnt162b2 (BNT162B2), 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: PAIN (non-serious), outcome "unknown", described as "achy"; PYREXIA (non-serious), outcome "unknown", described as "fever".  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300347497 Same patient, different AE/vaccine dose;
Sex: U
Vaccine: COVID19
Symptoms: Blood disorder, Blood test
Clinical narrative: wrong with my blood work; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers 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: BLOOD DISORDER (non-serious), outcome "unknown", described as "wrong with my blood work". The patient underwent the following laboratory tests and procedures: Blood test: Unknown results. Additional information: the patient received an injection for the COVID-19 virus and afterwards there was a "thing wrong with my blood work."  The information on the batch/lot number for bnt162b2 omi xbb.1.5, has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Headache, Tinnitus
Clinical narrative: tinnitus; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), 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: TINNITUS (non-serious), outcome "unknown"; HEADACHE (non-serious), outcome "recovered".  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300347676 Same patient, different dose number/event;
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID; COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  An adult 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID". The reporter intended to sue "you" for damages and lost wages that was cause by COVID> The reporter had to quit job to care for wife and raise kids.      The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain-Barré syndrome; Initial information received on 19-Oct-2023 regarding an unsolicited valid Social Media serious case received from non-healthcare professional.  This case involves an unknown age male patient who experienced guillain-barré syndrome after receiving vaccine Influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of suspect Influenza Vaccine produced by unknown manufacturer (strength, formulation, lot number and expiry: not reported) via unknown route in unknown administration site as prophylactic vaccination (immunization). Information on the batch number was requested.  On an unknown date, the patient developed guillain-barré syndrome (guillain-barre syndrome) (unknown latency) following the administration of Influenza vaccine. This event was assessed as medically significant.  No lab data was reported.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (Guillain-Barré syndrome).  At time of reporting, the outcome was Unknown for the event guillain-barré syndrome.; Sender's Comments: Sanofi company comment dated 25-Oct-2023: This case involves an unknown age male patient who experienced guillain-barré syndrome after receiving vaccine Influenza vaccine. The time to onset was compatible with the role of vaccine. The clinical course of the event was not provided. Furthermore, information regarding condition at the time of vaccination, role of medical history, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Drug ineffective, Illness, Vaccination failure
Clinical narrative: shots are not effective; sick; Initial information received on 18-Oct-2023 regarding an unsolicited valid Social Media serious case received via Patient.  This case involves an unknown age and unknown gender patient who stated shots are not effective and sick after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (strength, form, lot number, expiry date: unknown) via unknown route in unknown administration site for prophylactic vaccination (immunization). Information on batch number was requested.  On an unknown date the patient had events of shots are not effective (vaccination failure) and sick (illness) (unknown latency) following the administration of influenza vaccine.   It was reported, shots are not effective in my opinion. Talk to a real nurse or a doctor and do your research. I got sick every year I was forced to get those shots by my employer.  It was unknown if any lab data/test results available.  Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the event.  Outcome: unknown.  Seriousness criteria:  shots are not effective (vaccination failure) was assessed as medically significant.
Sex: U
Vaccine: FLUX
Symptoms: Dyspnoea, Urticaria
Clinical narrative: broke out in hives all night; had trouble breathing; Initial information received on 18-Oct-2023 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-healthcare professional.  This case involves an unknown age and unknown gender patient who broke out in hives all night and had trouble breathing after receiving vaccine Influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), risk factor and family history were not provided.   On an unknown date, the patient received a dose of suspect Influenza vaccine produced by unknown manufacturer (lot number, strength, dose, form, expiry date not reported) via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date the patient broke out in hives all night (urticaria) and had trouble breathing (dyspnoea) (unknown latency) following the administration of Influenza vaccine.  No lab data reported.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for the events.
Sex: U
Vaccine: FLUX
Symptoms: Bedridden
Clinical narrative: I was in bed for 31 day; Initial information was received on 18-Oct-2023 regarding an unsolicited valid Social Media serious case received from a consumer/non-healthcare professional.  This case involves Adult and unknown gender patient who was in bed for 31 day after receiving influenza vaccine.  It is unknown if the patient had any medical history, concomitant disease or risk factor. The patient's past medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (unknown formulation) (lot number, expiry date, strength, was unknown) via unknown route in unknown administration site for prophylactic vaccination (Immunization). The information on the batch number was requested.  On an unknown date the patient was in bed for 31 day (bedridden) (unknown latency).  It is unknown if there were lab data/results available.  Action taken: not applicable.  It is unknown if the patient experienced any additional symptoms/events.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.  Seriousness Criteria: Disability for event Bedridden.; Sender's Comments: Sanofi Company Comment dated 25-Oct-2023: This case involves Adult and unknown gender patient who was in bed for 31 day after receiving influenza vaccine. Further information on medical history, allergy history, family history, past or concomitant medication, laboratory investigation, previous laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the limited reported information, the role of the individual suspect vaccine cannot be assessed.
Sex: M
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: got sick; Initial information received on 19-Oct-2023 regarding an unsolicited valid Social Media non-serious case received from non-healthcare professional.  This case involves an unknown age male patient who got sick after receiving vaccine Influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of suspect Influenza vaccine produced by unknown manufacturer (strength, formulation, lot number and expiry: not reported) via unknown route in unknown administration site as prophylactic vaccination (immunization). Information on the batch number was requested.  On an unknown date, the patient got sick (illness) (unknown latency) following the administration of Influenza vaccine.  No lab data was reported.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (got sick).  At time of reporting, the outcome was Unknown for the event got sick.; Sender's Comments:  US-SA-2023SA327986:
Sex: F
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: became sick from a flu vaccine, almost died on two different occasions from flu shots, ended up in hospital; Initial information received on 18-Oct-2023 regarding an unsolicited valid Social Media serious case received via consumer.  This case involves an unknown age female patient who became sick from a flu vaccine, almost died on two different occasions from flu shots, ended up in hospital after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (strength, lot number, form, expiry date: unknown) via unknown route in unknown administration site for prophylactic vaccination (immunization).  On an unknown date the patient developed a serious became sick from a flu vaccine, almost died on two different occasions from flu shots, ended up in hospital (illness) (unknown latency) following the administration of influenza vaccine.   It was unknown if any lab data/test results available.  Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the event.  Outcome: Unknown for the event  Seriousness criteria: The patient was hospitalized for this event.; Sender's Comments: Sanofi company comment dated 27-OCT-2023: This case involves an unknown age female patient who became sick from a flu vaccine, almost died on two different occasions from flu shots, ended up in hospital after receiving influenza vaccine.The time to onset was compatible with the role of vaccine. The clinical course of the event was not provided. Furthermore, information regarding condition at the time of vaccination, role of medical history, concomitants, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of an individual vaccine cannot be assessed. SanofiPVPortal20231020000606:PORTAL ID
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: last time I got the flu was when I got the flu shot; Initial information received on 19-Oct-2023 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who last time  got the flu was when he got the flu shot (Influenza vaccine).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect Influenza vaccine by unknown manufacturer (strength, dose, formulation, frequency, lot number and expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination (Immunisation). Information on the batch number was requested  On an unknown date the patient last time got the flu was when he got the flu shot (influenza) (unknown latency).  Reporter Commented: Atleast they aren't hiding the fact that they're getting paid. The last time I got the flu was when I got the flu shot,  And I've worked in childcare with kids sneezing in my face for years. It's a no from me  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (last time I got the flu was when I got the flu shot).  At time of reporting, the outcome was Unknown for the event last time i got the flu was when i got the flu shot.