chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Product=COVID 19 Treatment; Product=COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Oct2022 as dose 5 (booster), single (Lot number: GH9702) at the age of 60 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 30Apr2021 as dose 1, single (Lot number: EW0171), in left arm, on 21May2021 as dose 2, single (Lot number: EW0186), in left arm, on 04Dec2021 as dose 3 (booster), single (Lot number: FG3527), in left arm and on 18May2022 as dose 4 (booster), single (Lot number: FK9894), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 07Apr2023, outcome "unknown" and all described as "Product=COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Apr2023) Positive; (Apr2023) Positive, notes: tested positive again. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient took Paxlovid for COVID-19 treatment from 07Apr2023 to 12Apr2023.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Drug ineffective; COVID-19; 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 female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Oct2022 at 15:30 as dose 5 (booster), single (Lot number: 9H9697) at the age of 72 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "Dilaudid allergy" (unspecified if ongoing); "Cephalexin allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received treatment of Paxlovid for COVID-19 from 14Apr2023 to 19Apr2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300166748 Same patient, different drug/AE.;
Sex: M
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) (Physician). The reporter is the patient.  A 53-year-old male patient received BNT162b2 (BNT162B2), in May2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Mild intermittent asthma" (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 Apr2023, outcome "recovered" (Apr2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2023) Positive, notes: COVID 19 Treatment; (Apr2023) Negative, notes: testing negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient had received the treatment of COVID-19 as Paxlovid on 12Apr2023 to 17Apr2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the drug ineffective (LOE) , covid-19 cannot be ruled out.,Linked Report(s) : US-PFIZER INC-202300168488 same reporter/patient, different product/event;
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Drug ineffective / COVID 19 Treatment; COVID-19/ COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 63-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). The patient had no known allergies. There were no concomitant medications. The following information was reported: COVID-19 (medically significant) with onset Apr2023, outcome "unknown", described as "COVID-19/ COVID 19 Treatment"; DRUG INEFFECTIVE (medically significant) with onset Apr2023, outcome "unknown", described as "Drug ineffective / COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid (Treatment start date: 14Apr2023, Treatment stop date: 18Apr2023).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162b2 to the reported drug ineffective / COVID-19 cannot be ruled out.,Linked Report(s) : US-PFIZER INC-202300168532 Same reporter/patient, different product/AE.;
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive for Covid 24Apr2023; tested positive for Covid 24Apr2023; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 63-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Nov2022 as dose 5 (booster), single (Lot number: GJ5342) at the age of 62 years intramuscular for covid-19 immunisation; BNT162b2 (BNT162B2), on 23Dec2020 as dose 1, single (Lot number: EH9899), on 13Jan2021 as dose 2, single (Lot number: EL1283), on 29Oct2021 as dose 3 (booster), single (Lot number: EW0169) and on 10Aug2022 as dose 4 (booster), single (Lot number: FP7137), all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "High Cholesterol" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "Known allergies: Crab" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 24Apr2023 at 09:30, outcome "recovering" and all described as "tested positive for Covid 24Apr2023". The event "tested positive for covid 24apr2023" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24Apr2023) Positive, notes: at 9:30 am. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300171842 same patient, different drug, different events;
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstrual disorder
Clinical narrative: increased menstrual bleeding; Abnormal menstrual period; This is a spontaneous report received from non-contactable reporter(s) (Pharmacist).  A female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in 2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 Immunisation. The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious), outcome "unknown", described as "increased menstrual bleeding"; MENSTRUAL DISORDER (non-serious), outcome "unknown", described as "Abnormal menstrual period".  Additional information: The patient reported abnormal menstrual period (increased bleeding) for a couple of months following the bivalent booster last year.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing in ears; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 22Mar2021 as dose 2, single (Lot number: EN6198) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing), notes: arthritis; "high blood pressure" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: BNT162b2 (Dose 1, Batch/lot number: EN6198, left arm), administration date: 01Mar2021, when the patient was 68-year-old, for COVID-19 immunization. The following information was reported: TINNITUS (non-serious) with onset Sep2021, outcome "not recovered", described as "Ringing in ears". The event "ringing in ears" required physician office visit. Therapeutic measures were taken as a result of tinnitus.  Additional information: No prior vaccinations. Everything good except the arthritis. Has high blood pressure, which he takes medicine for. No relevant family medical history. Patient has had 4 total doses Covid shots. Third shot (LOT: FF8839) on 29Oct2021 and fourth shot (Moderna) on 24May2022. Ringing in ears was reported as worsened. Started about 6 months after getting Covid shot. Reported this to his arthritis doctor. Heard Covid shot causes that ringing in ears. At time of report, was still ringing, has gotten louder. Bought over the counter stuff, that ain't helping him. Told rheumatologist about it, was asking him about it, the ringing in the ears. Doctor told him, at his age, would probably get it. Then, caller heard the vaccine was causing it. Figured, while he was on the phone with Pfizer, would talk about it. Patient just talked to his rheumatologist about it, probably a year ago. It has gotten worse, since it started. For the treatment, other than the over counter stuff, has had no other treatments.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300169105 same reporter/patient, similar event, different dose;
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Tinnitus
Clinical narrative: Ringing in ears; Still ringing, has gotten louder; This is a spontaneous report received from contactable reporter (Consumer), Program ID: The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 29Oct2021 as dose 3 (booster), single (Lot number: FF8839) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing), notes: which he takes medicine for; "Ringing in ears", start date: 22Mar2021 (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/lot number: EN6198, Dosage text: First shot, left arm), administration date: 01Mar2021, when the patient was 68-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE, LOT: EN6198, NDC, EXP: Unknown), administration date: 22Mar2021, when the patient was 68-year-old, for COVID-19 immunization, reaction(s): "Ringing in ears". The following information was reported: TINNITUS (non-serious), outcome "not recovered", described as "Ringing in ears"; CONDITION AGGRAVATED (non-serious), outcome "not recovered", described as "Still ringing, has gotten louder". Therapeutic measures were taken as a result of tinnitus, condition aggravated.  Additional information: Ringing in ears: Started about 6 months after getting first Covid shot. Ringing in ears: Right after he took first shot, about 6 months after, started ringing in ears. Still ringing, has gotten louder. Bought over the counter stuff, that isn't helping him. Fourth Shot Covid shot, Moderna: 24May2022. Sender's Comments: Linked Report(s): US-PFIZER INC-202300168958 same reporter/patient/event, different dose number;
Sex: U
Vaccine: COVID19
Symptoms: Headache, Interchange of vaccine products, Vomiting
Clinical narrative: got the initial series in 2021 and I got Moderna/  I was told to Pfizer has a lower dose so I tried that; I get the terrible like extremally headache like, worse than anything; I was not able to keep anything down and then I spent whole day like vomiting; 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 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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: Moderna (DOSE 1, SINGLE), administration date: 2021, for COVID-19 immunization; Moderna (DOSE 2, SINGLE), administration date: 2021, for COVID-19 immunization, reaction(s): " have the absolutely terrible time with the second Moderna shot". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown", described as "got the initial series in 2021 and I got Moderna/  I was told to Pfizer has a lower dose so I tried that"; HEADACHE (non-serious), outcome "unknown", described as "I get the terrible like extremally headache like, worse then anything"; VOMITING (non-serious), outcome "unknown", described as "I was not able to keep anything down and then I spent whole day like vomiting".  Additional Information: The patient was calling about the Pfizer Covid vaccine Bivalent. The patient had the initial series in 2021, got Moderna and had the absolutely terrible time with the second Moderna shot and so, patient didn't get booster until now. The patient was told that Pfizer has a lower dose so patient tried that. Patient had really exactly the same of course that patient had with Moderna but was slightly milder but still really awful. Unlike most people the patient know who have got no symptoms and discomfort for about a day and they were okay, patient had three days of "hell". The patient meant that for about 36 hours of "what is being to give really bad for me", patient get the "terrible extremally headache like, worse then anything I know I used to have it" and at about 36 hours, patient was not able "to keep anything down and then I spent whole day like vomiting."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Vomiting
Clinical narrative: throwing up; awful; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) intramuscular, in arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization, reaction(s): "throwing up"; Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization, reaction(s): "awful", "terrible headache". The following information was reported: VOMITING (non-serious), outcome "unknown", described as "throwing up"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "awful"; HEADACHE (non-serious), outcome "unknown". Therapeutic measures were taken as a result of vomiting, headache.  Additional information: Patient had a number of problems, the worst problem for the patient and this was the second time patient got a really similar cores, about 36 hours into it or after getting the vaccines, patient started throwing up, and cannot keep anything down. Patient got a terrible headache like no other headache patient. Patient tried to have treatment, but it was hard to take anything. The first day patient was able to take ibuprofen alternated with Tylenol and took some Zofran to try to not, end up throwing up the whole day again but that did not prevent it and the second day, patient could not keep anything down. The patient took things but could not keep up.  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: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Dysgeusia, Saliva altered, X-ray
Clinical narrative: saliva was getting thicker; file (bad) tasting; burning; 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 74-year-old female patient received BNT162b2 (BNT162B2), on 22Sep2021 as dose 3 (booster), single (Lot number: EW0168) at the age of 73 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, lot: ER8733, NDC: Unknown , expiration: Unknown), administration date: 27Mar2021, when the patient was 73-year-old, for Covid-19 immunization; BNT162b2 (DOSE 2, SINGLE, lot: EW0162, NDC: Unknown , expiration: Unknown), administration date: 17Apr2021, when the patient was 73-year-old, for Covid-19 immunization. The following information was reported: BURNING SENSATION (non-serious) with onset 01Mar2022, outcome "unknown", described as "burning"; DYSGEUSIA (non-serious) with onset 01Mar2022, outcome "unknown", described as "file (bad) tasting"; SALIVA ALTERED (non-serious) with onset 01Mar2022, outcome "unknown", described as "saliva was getting thicker". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of saliva altered. Additional information: On 1Mar2022, I started noticing saliva was getting thicker, file (bad) tasting, burning and stringy. I thought I had an abscess in my teeth so went to dentist since I was constantly sucking out from the gums. All x-rays show nothing wrong, no abscess. Dentist said to just to drink more water and take Xylo melt so saliva will thin out.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: Half inch diameter redness; non healing sore at the inoculation site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 82-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Jul2022 as dose 3 (booster), single (Lot number: 30/4s8a) at the age of 82 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing); "High Blood Pressure" (unspecified if ongoing); "Gout" (unspecified if ongoing); "Anemia" (unspecified if ongoing). Concomitant medication(s) included: IRON; CALCIUM; LOSARTAN; B-12; SIMVASTATIN; ALLOPUR. 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.  The following information was reported: VACCINATION SITE ERYTHEMA (non-serious) with onset 14Jul2022, outcome "not recovered", described as "Half inch diameter redness"; VACCINATION SITE PAIN (non-serious) with onset 14Jul2022, outcome "not recovered", described as "non healing sore at the inoculation site". Therapeutic measures were not taken as a result of vaccination site erythema, vaccination site pain. Additional information: No other vaccine in four wees. No COVID prior vaccination. The patient had no known allergy. The patient didn't have COVID tested post vaccination.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300163630 same reporter/patient/product/AE, different dose;
Sex: U
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: heart palpitations; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: The reporter is the patient.  A 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: PALPITATIONS (non-serious), outcome "unknown", described as "heart palpitations". Additional information: Three COVID-19 vaccines have caused patient heart palpitations in the last year and a half. Patient was hoping they would pass, however they still came and went. mRNA marker had been affecting patient heart. Palpitations was significantly impacting patient life.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Drug ineffective; COVID-19; Disease Recurrence/tested positive for covid twice; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "longstanding heart condition" (unspecified if ongoing), notes: husband has a longstanding heart condition that he takes many drugs to control. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown"; DISEASE RECURRENCE (medically significant), outcome "unknown", described as "Disease Recurrence/tested positive for covid twice". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: tested positive for covid twice. Clinical course: Reporter's husband had a longstanding heart condition that he takes many drugs to control. Had both tested positive for covid twice even though they had taken precautions and had taken shots as they become available. Both times her husband ended up with symptoms much less than her. she believe that it was possible that one or more of the heart medicines he takes may had lessened his response as compared to her.  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-PV202300074310 same reporter/drug, different patient;
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus; 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 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. The following information was reported: TINNITUS (non-serious), outcome "unknown". Additional information: Patient had two Pfizer vaccine Covid shots. Patient had been diagnosed with tinitus and would like to know if there is a class action suit for this.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Pre-existing condition improved, Therapeutic response unexpected
Clinical narrative: The Pfizer covid vaccine improved my hearing and lessened my tinnitus; The Pfizer covid vaccine improved my hearing and lessened my tinnitus; 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 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "The Pfizer COVID vaccine IMPROVED my hearing and LESSENED my tinnitus" (unspecified if ongoing); "The Pfizer COVID vaccine IMPROVED my hearing and LESSENED my tinnitus" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), PRE-EXISTING CONDITION IMPROVED (non-serious), outcome "unknown" and all described as "The pfizer covid vaccine improved my hearing and lessened my tinnitus".  Additional information: The Pfizer COVID vaccine IMPROVED my hearing and LESSENED my tinnitus. I know there is research happening regarding an alleged cause of tinnitus from the vaccine because of perceived prevalence, but my experience was the exact opposite. I have tinnitus because of a TBI, and the initial research seems to connect the neurological effects of COVID with the vaccine's alleged effect on tinnitus. It had the opposite effect on me. I'm not sure how to get that information to the right researchers.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: I have had COVID over 8 times; I have had COVID over 8 times; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I have had COVID over 8 times". Clinical course: Reporter stated she will not give her children any medicine for COVID. She was given every vaccine and every booster she could have. She is a high school teacher and was in the middle of the COVID crockpot with all the students. It was not a vaccine, a vaccine stops it from occurring. She had COVID over 8 times all with conditions. Her kids (4 of them) have no vaccine has not had any symptoms or problems. They were around her every time she was sick with COVID.  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: M
Vaccine: COVID19
Symptoms: Amnesia
Clinical narrative: short term memory loss; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID:   An 82-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; tofacitinib citrate (XELJANZ XR), at 11 mg daily. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: AMNESIA (non-serious) with onset Aug2022, outcome "unknown", described as "short term memory loss". The action taken for tofacitinib citrate was unknown.  Additional information: The patient wanted to know if Xeljanz and Pfizer Covid vaccine could potentially cause short term memory loss, whether individually or together. Patient has been suffering short term memory loss since Aug2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: they do not work; they do not work; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "they do not work".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Poor quality product administered
Clinical narrative: poor quality vaccine administered (with no reported adverse event); Initial information received on 19-Apr-2023 regarding an unsolicited valid  non-serious case received via physician.  This case involves Infant and unknown gender to whom poor quality vaccine hib (prp/t) vaccine [Act-Hib] administered (with no reported adverse event)  The patient's past medical history, medical treatment(s), concomitant(s) and family history were not provided.   On an unknown date, the patient received  suspect hib (prp/t) vaccine Powder and solvent for solution for injectionat dose of 0.5 ml (strength, batch number, expiry date: unknown) via unknown route in unknown administration site for prophylactic vaccination (immunization)  On an unknown date, vaccine act-hib  poor quality was administered (poor quality product administered) (same day latency) with no reported adverse event  Action taken was not applicable.  At time of reporting, the outcome was Unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  01582774: 01576636:
Age: 17.0
Sex: U
Vaccine: YF
Symptoms: Injection site pain, Injection site pruritus, Injection site reaction, Skin reaction, Vaccination site pain
Clinical narrative: pruritic skin reactions at the site of Yellow Fever vaccine injection; at the site, were somewhat tender; Initial information received on 21-Apr-2023 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 17 years old and unknown gender patient who experienced "pruritic skin reactions at the site of yellow fever vaccine injection and at the site, were somewhat tender," after receiving vaccine Yellow Fever Vaccine [Yf-Vax].  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 Yellow Fever Vaccine (lot number, expiry date: not reported) via subcutaneous route in unknown administration site (form strength: unknown) for prophylactic vaccination.  On an unknown date the patient developed a non-serious events of "pruritic skin reactions at the site of yellow fever vaccine injection" (vaccination site pruritus) and "at the site, were somewhat tender" (vaccination site pain) (unknown latency) following the administration of YELLOW FEVER VACCINE.  It was reported, "We have a moderate size travel clinic, and over the past 3-4 days have received 3 reports of localized, pruritic skin reactions at the site of SQ Yellow Fever vaccine injection. The 3 individuals were 17,18, and 49 years old. They began 2-3 days post vaccination, at the site, were somewhat tender and indurated initially, but quickly became intensely pruritic while expanding."  Action taken with YELLOW FEVER VACCINE was not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Recovering / Resolving for both the events.
Age: 17.0
Sex: U
Vaccine: YF
Symptoms: Vaccination site pruritus
Clinical narrative: pruritic skin reactions at the site of Yellow Fever vaccine injection; at the site, were somewhat tender; Initial information received on 21-Apr-2023 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 17 years old and unknown gender patient who experienced "pruritic skin reactions at the site of yellow fever vaccine injection and at the site, were somewhat tender," after receiving vaccine Yellow Fever Vaccine [Yf-Vax].  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 Yellow Fever Vaccine (lot number, expiry date: not reported) via subcutaneous route in unknown administration site (form strength: unknown) for prophylactic vaccination.  On an unknown date the patient developed a non-serious events of "pruritic skin reactions at the site of yellow fever vaccine injection" (vaccination site pruritus) and "at the site, were somewhat tender" (vaccination site pain) (unknown latency) following the administration of YELLOW FEVER VACCINE.  It was reported, "We have a moderate size travel clinic, and over the past 3-4 days have received 3 reports of localized, pruritic skin reactions at the site of SQ Yellow Fever vaccine injection. The 3 individuals were 17,18, and 49 years old. They began 2-3 days post vaccination, at the site, were somewhat tender and indurated initially, but quickly became intensely pruritic while expanding."  Action taken with YELLOW FEVER VACCINE was not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Recovering / Resolving for both the events.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: broken cold chain until two weeks after the shipment arrived with no reported adverse event; after excursion, vaccine was administered with no reported adverse event; Initial information received on 19-Apr-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves Infant and unknown gender patient and reporter reported broken cold chain for haemophilus type B (HIB) (PRP/T) vaccine [ACT-HIB] until two weeks after the shipment arrived with no reported adverse event and after excursion, vaccine was administered with no reported adverse event   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect haemophilus type B (HIB) (PRP/T) vaccine Powder and solvent for solution for injection (lot number, strength, dosage, expiry date- not reported) via unknown route in unknown administration site for prophylactic vaccination. Information on the batch number was requested  Caller reported broken cold chain for haemophilus type B (HIB) (PRP/T) vaccine [ACT-HIB] until two weeks after the shipment arrived with no reported adverse event (product storage error) (unknown latency) and after excursion, vaccine was administered with no reported adverse event (poor quality product administered) (latency- same day).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for both the events.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.; Sender's Comments:  US-SA-2023SA124713:Master case
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: broken cold chain until two weeks after the shipment arrived with no reported adverse event; After excursion, vaccine was administered with no reported adverse event; Initial information received on 19-Apr-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves Infant and unknown gender patient and reporter reported broken cold chain for haemophilus type B (HIB) (PRP/T) vaccine [ACT-HIB] until two weeks after the shipment arrived with no reported adverse event and after excursion, vaccine was administered with no reported adverse event   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect haemophilus type B (HIB) (PRP/T) vaccine Powder and solvent for solution for injection (lot number, strength, dosage, expiry date- not reported) via unknown route in unknown administration site for prophylactic vaccination. Information on the batch number was requested  Caller reported broken cold chain for haemophilus type B (HIB) (PRP/T) vaccine [ACT-HIB] until two weeks after the shipment arrived with no reported adverse event (product storage error) (unknown latency) and after excursion, vaccine was administered with no reported adverse event (poor quality product administered) (latency- same day).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for both the events.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.; Sender's Comments:  US-SA-2023SA124713:Master case
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: vaccine Act-HIB for which cold chain break is reported with no reported adverse event; excursion vaccine was administered with no reported AE; Initial information received on 19-Apr-2022 regarding an unsolicited valid non-serious case received from a physician.  This case involves Infant and unknown gender patient who was administered HIB (PRP/T) vaccine [ACT-HIB] for which cold chain break and and excursion is reported with no reported adverse event.  The patient's past medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.  On an unknown date, the patient received an unknown dose of suspect HIB (PRP/T) vaccine, powder and solvent for solution for injection (expiry date and batch number unknown) via unknown route in unknown administration site for prophylactic vaccination (immunization) for which cold chain break and and excursion is reported with no reported adverse event (product storage error) (poor quality product administered) (same day latency). Information on the batch number was requested.  It was reported that children received doses of ActHIB that was deemed unusable later due to arrival of the shipment outside the acceptable 2-day window.  It is unknown if there were lab data/results available.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event excursion vaccine was administered with no reported adverse and was Unknown for the event act-hib for which cold chain break is reported with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2023SA124713:Master Case
Sex: U
Vaccine: HIBV
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: Products were not good and needed to be returned with no reported; Poor quality vaccine administered with no reported adverse event; Initial information was received on 19-Apr-2023 regarding an unsolicited valid  non-serious case received from a physician.  This case is linked to case 2023SA129826.  This case involves Infant and unknown gender patient who involved in the products HIB (PRP/T) VACCINE [ACT-HIB] were not good and needed to be returned and poor quality vaccine administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient received 0.5 ml dose of suspect products HIB (PRP/T) vaccine Powder and solvent for solution for injection (lot UJ756AAA, expiry date: 12-Aug-2023, strength, route administrative site: Unknown) for prophylactic vaccination (immunization).  On an unknown date the patient developed a non-serious products were not good and needed to be returned with no reported (product storage error) and poor quality vaccine administered with no reported adverse event (poor quality product administered) (latency: same day) following the administration of HIB (PRP/T) VACCINE.  No lab data reported.  Action taken: not applicable.  Outcome: Unknown for both the event products.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: vaccine Act-HIB for which cold chain break is reported and excursion vaccine was administered with no reported adverse event; Initial information received on 19-Apr-2023 regarding an unsolicited valid  non-serious case received via physician.  This case is linked to case 2023SA129826.  This case involves Infant and unknown gender patient who was administered vaccine act-hib for which cold chain break is reported and excursion  happened with no reported adverse event   The patient's past medical history, medical treatment(s), concomitant(s) and family history were not provided.  On an unknown date, the patient received  suspect hib (prp/t) vaccine Powder and solvent for solution for injectionat dose of 0.5 ml (strength, batch number, expiry date: unknown) via unknown route in unknown administration site for prophylactic vaccination (immunization)  On an unknown date, vaccine act-hib for which cold chain break is reported and excursion vaccine was administered (poor quality product administered) (same day latency) with no reported adverse event  Action taken was not applicable.  At time of reporting, the outcome was Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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. ; Sender's Comments:  2023SA124713:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Poor quality product administered
Clinical narrative: poor quality vaccine administered/Products were not good and needed to be returned with no reported adverse event; Initial information was received on 19-Apr-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves Infant and unknown gender patient who reported that poor quality vaccine administered/products were not good and needed to be returned with no reported adverse event after receiving hib (prp/t) vaccine [ACT-HIB].  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 unknown dose of suspect hib (prp/t) vaccine(Powder and solvent for solution for injection) (strength, expiry date, lot number not reported) via unknown route in unknown administration site for prophylactic vaccination(Immunization).  On an unknown date the patient developed a non-serious event of poor quality vaccine administered/products were not good and needed to be returned with no reported adverse event (poor quality product administered) (unknown latency) following the administration of hib (prp/t) vaccine.  Action taken with haemophilus type b (hib) vaccine (ACT-HIB) was not applicable.  At time of reporting, the outcome was Unknown for the event poor quality vaccine administered/products were not good and needed to be returned with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.