chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 30-jun-2022 And was administered on 05-aug-2022; No adverse event; dose was administered from a vial that was more than 30 days after the initial thaw date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose was administered from a vial that was more than 30 days after the initial thaw date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 30-jun-2022 And was administered on 05-aug-2022) and NO ADVERSE EVENT (No adverse event) in a 10-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 064A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Aug-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 05-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose was administered from a vial that was more than 30 days after the initial thaw date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 30-jun-2022 And was administered on 05-aug-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose was administered from a vial that was more than 30 days after the initial thaw date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 30-jun-2022 And was administered on 05-aug-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (dose was administered from a vial that was more than 30 days after the initial thaw date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 30-jun-2022 And was administered on 05-aug-2022).    No concomitant medication reported. They have not experienced any symptoms. No treatment information reported.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature abnormal, Feeling abnormal, Overdose, Product preparation error, Product preparation issue
Clinical narrative: had slight temp; fussy/cranky; Administered an undiluted dose; Administered an undiluted dose; Administered an undiluted dose; This is a spontaneous report received from contactable reporter(s) (Other HCP and Physician) from medical information team, Program ID:.  A 5-year-old female patient received BNT162b2 (BNT162B2), on 17Jun2022 as dose 2, single (Lot number: FL8695) at the age of 5 years intramuscular, in left deltoid for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, At 09:00, Anatomical Site of injection: Left Deltoid, Route of administration: Intramuscular, Batch/Lot Number: FL2757), administration date: 25May2022, for COVID-19 immunization. The following information was reported: OVERDOSE (non-serious), PRODUCT PREPARATION ERROR (non-serious), PRODUCT PREPARATION ISSUE (non-serious) all with onset 17Jun2022, outcome "unknown" and all described as "Administered an undiluted dose"; FEELING ABNORMAL (non-serious) with onset 17Jun2022 at 17:06, outcome "recovering", described as "fussy/cranky"; BODY TEMPERATURE ABNORMAL (non-serious) with onset 17Jun2022 at 17:06, outcome "recovering", described as "had slight temp". Therapeutic measures were not taken as a result of body temperature abnormal, feeling abnormal.  Additional information: The patient was administered with Pfizer Covid-19 vaccine, orange cap which was not diluted. The patient's mom was on site hanging out and before they leave, the reporter needed to know what kind of side effects to look out for this patient and if she will need the booster of Pfizer Covid-19 vaccine. An undiluted vaccine given (0.2 mL of undiluted 5 -11 year Pfizer preparation). The medication error affected the patient with clinical consequences slight temp and fussy/cranky that night but was not hospitalized. Prior vaccinations (within 4 weeks), relevant tests and specific relevant test for thromboembolic events with thrombocytopenia was none. The Pfizer product had a casual effect to the reported adverse events.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.  Follow-up (17Jun2022): new information received from a contactable Other HCP includes: adverse event and reporter details.  Follow-up (03Aug2022): This is a spontaneous follow-up report from a contactable Other HCP. This Other HCP reported in response to HCP letter sent which included that: Updated information included: reporter physician information, patient information details, relevant medical history and historical vaccine details, suspect drug details, vaccination facility information, new events body temperature abnormal and feeling abnormal, onset date updated for at risk events and additional information were updated. No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: M
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 contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 01Feb2022 as dose 4 (booster), single (Lot number: fd0809) at the age of 67 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 16Feb2021 as dose 2, single (Lot number: 024M20A), in left arm and on 27Aug2021 as dose 3 (booster), single (Lot number: 004F21A), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PREGABALIN, stop date: 12Jun2022. Past drug history included: Tetanus, reaction(s): "Known allergies: Tetanus". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Jun2022) Negative, notes: Tested negative on June 20; (22Jun2022) Positive, notes: Tested positive on Jun 22. Clinical course: Patient received Other Medication in 2weeks. Finished the course of treatment on on 17Jun. Felt better. Tested negative on 20Jun. Started to fill sick the next day. Tested positive on 22Jun. Was sick until testing negative again on 01Jul.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Influenza like illness
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 24-year-old male patient received BNT162b2 (BNT162B2), on 20May2021 as dose 1, single (Lot number: EW0171) at the age of 22 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: FATIGUE (non-serious), outcome "recovered"; INFLUENZA LIKE ILLNESS (non-serious), outcome "recovered", described as "Flu like symptoms". Additional information: It was reported that, the patient did not receive any other vaccinations within four weeks prior to the first administration date of the suspect vaccines. The family medical history relevant to AE was not provided. Relevant tests were reported as none.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy test, Blood test, Rash, SARS-CoV-2 test
Clinical narrative: After my second dose, a red patch started showing up under my left eye; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 23-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Mar2021 as dose 2, single (Lot number: EN6202) at the age of 22 years for covid-19 immunisation. The patient's relevant medical history included: "If covid prior vaccination: Yes" (unspecified if ongoing), notes: If covid prior vaccination: Yes; "Known allergies: Eggs" (unspecified if ongoing), notes: Known allergies: Eggs; "Known allergies: Hazelnuts" (unspecified if ongoing), notes: Known allergies: Hazelnuts; "Ibs" (unspecified if ongoing), notes: Other medical history: Ibs; "Eczema since little" (unspecified if ongoing), notes: Other medical history: eczema since little. There were no concomitant medications. Vaccination history included: BNT162b2 (Prev dose product: COVID 19,, Prev dose brand: Pfizer,, Prev dose brand unknown: False,, Prev dose lot number: EM9810,, Prev dose lot unknown: False,, Prev dose administration date: 09Feb2022,, Prev dose dose number: 1), administration date: 09Feb2021, when the patient was 22-year-old, for COVID-19 immunization. The following information was reported: RASH (non-serious) with onset 2021, outcome "unknown", described as "After my second dose, a red patch started showing up under my left eye". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of rash.  Additional information: The patient did not received any other vaccine in four weeks and did not received any other medications in two weeks. After her second dose, a red patch started showing up under her left eye. It would come and go. Treatment included allergy tests, blood tests, and antihistamines. Covid test type post vaccination included nasal Swab, covid test result: Negative.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201033362 Same patient and drug, different event separated in time;
Age: 46.0
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) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Mar2021 as dose 1, single (Lot number: Er8735), in right arm and on 20Apr2021 as dose 2, single (Lot number: Ew0161) at the age of 46 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 13Nov2021 as dose 3 (booster), single (Lot number: 051f21a), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "type 2 diabetes" (unspecified if ongoing); "Known allergies: penicillin" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; VYVANSE; ADVAIR, stop date: 26Jul2022; PROAIR RESPICLICK; ROSUVASTATIN, stop date: 26Jul2022; FLONASE [MOMETASONE FUROATE], stop date: 26Jul2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". Paxlovid was started as therapeutic measures for vaccination failure, covid-19 from 27Jul2022 to 01Aug2022.  Clinical course: Symptoms of covid reappeared 2 days after completing Paxlovid, with the addition of respiratory and lung congestion on 02Aug2022 10:00 PM  No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 26Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 10Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 27Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "Sinus problems from allergies" (unspecified if ongoing); "Sinus problems from allergies" (unspecified if ongoing); "Known allergies: Sulfa antibiotics" (unspecified if ongoing). Concomitant medication(s) included: AMOXICILIN, start date: 11Jul2022, stop date: 20Jul2022; MONTELUKAST, stop date: Aug2022; SYMBICORT, start date: Mar2014, stop date: Aug2022. Past drug history included: Codeine, reaction(s): "Drug allergy".  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 25Jul2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Jul2022) Positive; (30Jul2022) Negative; (02Aug2022) Negative; (03Aug2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient tested positive for COVID on 25Jul2022 and started Paxlovid that day. Took it for 5 days, had two negative tests on 30Jul2022 and 02Aug2022. Symptoms recurred and stronger on 03Aug2022 and tested positive-rebound case. The patient received no other medication in 2 weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Lot number: fn6204), in left arm, on 31Mar2021 as dose 2, single (Lot number: ep7533), in left arm, on 18Oct2021 as dose 3 (booster), single (Lot number: fe359), in left arm and on 20Apr2022 as dose 4 (booster), single (Lot number: ps4989) at the age of 59 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LEVOTHYROXINE; LOSARTAN HCTZ; VALACYCLOVIR HCL. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 23Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Jul2022) Positive; (28Jul2022) Negative; (01Aug2022) Positive. Therapeutic measures were taken as a result of covid-19.  Clinical information: Patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment, also patient had previously received a COVID-19 Vaccine. Patient tested positive for covid on 23Jul2022 and Patient took paxlovid for covid-19 treatment started on 23Jul2022 to 27Jul2022 and Tested negative on 28Jul2022. Started sneezing a lot the evening of 31Jul2022, tested positive again 01Aug2022.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: felt sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient received BNT162b2 (BNT162B2), on 18Feb2021 as dose 2, single (Lot number: EL3247) at the age of 38 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Major depressive disorder", start date: Jun2013 (ongoing); "Graves' disease", start date: Mar2022 (ongoing); "Appendectomy", start date: 1987 (unspecified if ongoing); "Depression" (unspecified if ongoing); "gallbladder removal", start date: 1993 (unspecified if ongoing). The patient's family history included: "Type 2 diabetes", start date: Nov2012 (ongoing), notes: Type 2 diabetes, Mother has asthma, diabetes, bipolar disorder (age 76 years old). Concomitant medication(s) included: METFORMIN oral taken for diabetes mellitus (ongoing); GLIMEPIRIDE oral taken for diabetes mellitus (ongoing); LANTUS taken for diabetes mellitus (ongoing); PROZAC taken for depression (ongoing); METHIMAZOLE oral taken for basedow's disease (ongoing); PROPRANOLOL oral taken for basedow's disease (ongoing). Vaccination history included: BNT162b2 (Dose: 1, Time: unknown, Anatomical site of injection: upper right arm, Route of administration: Intramuscular, Batch/Lot number: EL3247), administration date: 29Jan2021, when the patient was 38-year-old, for COVID-19 immunization, reaction(s): "very sore arm", "felt sick". The following information was reported: ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "felt sick".  Additional information: 1st dose of vaccine on 29Jan2021, felt sick 2 days+ very sore arm; 2nd dose of vaccine on 18Feb2021, felt sick 2 days; 3rd dose of vaccine 11Oct2021, felt sick 2 days; On 18Jun2022-flu like symptoms( malaise, sore throat, congestion, headache); on 19Jun2022- positive for COVID, started paxlovid, felt horrible (sore throat, cough, aches, fatigue, bitter taste in throat); On 23Jun2022-finshed paxlovid; on 25Jun-01Jul2022 negative for COVID but still felt tired; On 02Jul2022-positive for COVID again( sore throat, tired, cough, congestion, headache, fatigue, no bitter taste); on 06Jul2022-begged my doctor for antibody test denied. On 10Jul2022-finally felt better and tested negative on rapid test. The patient did not take any vaccination prior to 4 weeks.  No follow-up attempts are possible, no information is necessary.
Age: 65.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 65 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 21May2022 as dose 4 (booster), single (Batch/Lot number: unknown), in right 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: "Asthma" (unspecified if ongoing), notes: Other medical history: asthma; "known allergies: Sulfa drugs" (unspecified if ongoing), notes: known allergies: Sulfa drugs. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.The patient received Paxlovid, from 08Jul2022 to 12Jul2022 for treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, UNK
Symptoms: Rhinitis
Clinical narrative: This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient. A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; varenicline tartrate (CHANTIX), for smoking cessation therapy. The patient's relevant medical history included: "smoker" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: RHINITIS (non-serious), outcome "unknown". The action taken for varenicline tartrate was unknown. Additional information: "The problem that I am having is with rhinitis and it's recurring and may have something to do with your not using fluorine. So, one product is, for person name is (PRIVACY) and (PRIVACY) is the one who has taken the Chantix. (further details unknown) I am smoker. I don't smoke THC. I smoke cigarettes. I smoke methamphetamine but I am having problems with rhinitis and I believe that it's because of the use of Chantix that is facilitated with your Pfizer Vaccine for COVID (clarified as COVID-19 Vaccine). Comparing that to the monkey pox treatment. I use tamarind with the fluorine. It's a kind of like Chantix however it doesn't, you don't have the fluorine, you are not using fluorine. I believe that your product is not safe and could be spreading some disease and there are non smokers that are presently, other use THC and CBD. I don't use THC and CBD. However, you know some of these people that are allowed to do that and others they are allowed to smoke cigarettes and one person got Chantix and that was enough to have a problems with the CF Virus." No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Pyrexia, 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 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Feb2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 58 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: Pyrexia: (unspecified date) 98.5, notes: My fever on first day was 98.5 or something menial like that and then never had another one; SARS-CoV-2 test: (unspecified date) Positive, notes: after day ten after i tested positive and had completed paxlovid on day twelve my symptoms came back worse; (28Jul2022) Unknown Results. Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid from 20Jul2022 to 25Jul2022.  Clinical course: It was reported that after day ten she tested positive and had completed paxlovid on day twelve her symptoms came back worse. She had not yet even tested negative but had completed her ten day isolation and was testing regular. There was never a negative test but symptoms came back. She also never had a fever and still have not. Her fever on first day was 98.5 or something menial like that and then never had another one.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
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 25-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in right arm for COVID-19 immunization. The patient's relevant medical history was not reported. Concomitant medication(s) included: DAYQUIL; NYQUIL; CELEXA [CELECOXIB]; QSYMIA; OMEPRAZOLE; IBUPROFEN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient's antiviral medication included Paxlovid received for COVID-19 Treatment. Treatment started on 25Jul2022 and stopped on 29Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 66.0
Sex: M
Vaccine: 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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), on 26Mar2021 as dose 1, single (Lot number: En6199), in left arm, on 20Apr2021 as dose 2, single (Lot number: En6207), in left arm, on 26Oct2021 as dose 3 (booster), single (Lot number: Fe3590), in left arm and on 12Apr2022 as dose 4 (booster), single (Lot number: Fk9895) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Penicillin" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "herpes simplex2" (unspecified if ongoing); "aneurysm" (unspecified if ongoing); "ascending aorta" (unspecified if ongoing). Concomitant medication(s) included: ACYCLOVIR-MISR, start date: 01Jan2022; METOPROLOL SUCCINATE, start date: 01Jan2022; VYVANSE, start date: 01Jan2022; LOVASTATIN, start date: 01Jan2022, stop date: 24Jul2022; FLUTICASONE, start date: 01Jan2022; AZELASTINE, start date: 01Jan2022; FLOVENT, start date: 01Jan2022; RESTASIS, start date: 22Apr2022; TURMERIC [CURCUMA LONGA], start date: 01Jan2022. Past drug history included: Bactrim, reaction(s): "Drug Allergy"; Lexapro, reaction(s): "Drug Allergy"; Demerol, reaction(s): "Drug Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 36-year-old male patient received BNT162b2 (BNT162B2), on 05Apr2021 as dose 1, single (Lot number: ER8735), in left arm, on 26Apr2021 as dose 2, single (Lot number: EW0169), in left arm and on 09Dec2021 as dose 3 (booster), single (Lot number: FJ8757) at the age of 35 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Bipolar Disorder" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "lactose intolerant" (unspecified if ongoing). Concomitant medication(s) included: LAMOTRIGINE, start date: 01Aug2020; HYDROCHLOROTHIAZIDE;LISINOPRIL, start date: 01Feb2022; BENZONATATE, start date: 31Jul2022; ALBUTEROL SULFATE, start date: 31Jul2022. Past drug history included: Cozart, reaction(s): "Known allergies: Cozart". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical information: The patient has received other medication in 2 weeks include Congestion & Cough Tablets started on 31Jul2022. Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot ER8735 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. Analytical release test results were also reviewed. The final scope included the reported finished goods lot ER8735, fill lot EP8687, and the formulated drug product lot EP8574. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There was no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Jul2021 as dose 1, single (Lot number: EW0191), in left arm and on 20Aug2021 as dose 2, single (Lot number: EW0186) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Kidney transplant patient" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Gentamycin, reaction(s): "Known allergies: Gentamycin"; Cefazolin, reaction(s): "Known allergies: Cefazolin".  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown result, notes: Product: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid started on 20Jul2022 and stop date 24Jul2022.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded.
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Aug2022 at 14:30 as dose 4 (booster), single (Lot number: Fn2908), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing). There were no concomitant medications. Past drug history included: No. Vaccination history included: Moderna (DOSE 3, ;Lot No: Os4e4a; Anatomical location: Arm Left, Vaccine Administration Time: 02:30 PM), administration date: 24Nov2021, for Covid-19 Immunization; Covid 19 (Initial immunization completed: MANUFRACTURER UNKNOWN ), for COVID-19 immunization. The following information was reported: OROPHARYNGEAL PAIN (non-serious) with onset 03Aug2022 at 06:00, outcome "recovering", described as "Sore throat". Therapeutic measures were not taken as a result of oropharyngeal pain. No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Cerebral haemorrhage, Subdural haematoma
Clinical narrative: subdural hematoma; brain bleed; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received BNT162b2 (COMIRNATY), as dose number known, 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: SUBDURAL HAEMATOMA (medically significant), outcome "unknown", described as "subdural hematoma"; CEREBRAL HAEMORRHAGE (medically significant), outcome "unknown", described as "brain bleed".  Clinical course : Caller (48 years old when he had subdural hematoma), 49 years old now) calling for Pfizer covid vaccine wanted to know if  subdural hematoma has been reported with the vaccine. He was worried as he has subdural hematoma but he did not hit his head. He stated the doctor told him its not the vaccine what caused it, he might have hit his head and he forget about it. He stated it happened 6 months after taking the covid vaccine. He rides bike 30-40 km and nothing happened to him before. But now 6 month later of getting the vaccine he has brain bleed. He stated he was very suspicious of the vaccine and will not be taking any other dose. He need to have the blood grained from the head. He stated his childhood friend, same age and received the Pfizer covid Vaccine experienced the same subdural haematoma / brain bleed. He also did not hit his head. Reporter stated, "So last year in April reporter took the Pfizer vaccine and after like three week reporter did the second shot and then in October reporter had something called subdural hematoma in my head which was like bleed in the brain, the doctor told me you hit your head or something like that but reporter could not remember reporter hit my head. reporter have been thinking the vaccine (Pfizer COVID-19 Vaccine) could be the problem but nine months after, reporter did surgery they believe reporter have in my head to take the blood and things like that and that had risk to die basically and reporter did not hear that somebody had this situation right but like a month ago my close friend had the same issue and he had the Pfizer vaccine (Pfizer COVID-19 Vaccine) as well. So my call was here to ask you do you heard some situation like this? Can you confirm this was a Pfizer because now reporter am worried can reporter have again something like that because me and my friend, the guys was my childhood friend and he was very close to my age. reporter am like 49 he was like 48 may be and he had the same problem, both of us and we both get the Pfizer and we both do not remember we hit our head and subdural hematoma usually come when you hit your head or make car accident or something like that."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201037906 Same product and event, different patient;
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-1 test positive, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Jun2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 65 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hyperlipidaemia" (unspecified if ongoing). Concomitant medication(s) included: PRAVASTATIN oral, start date: 01Jun2021, stop date: 21Jul2022; DOXYCLINE [DOXYCYCLINE] oral, start date: 01Jun2022, stop date: 04Aug2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-1 test positive: Positive, notes: positive antigen test after about a week of being symptoms free; SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Course: It was reported that patient had not received other medication in 2weeks. Patient received COVID 19 Treatment from 21Jul2022 to 25Jul2022 via oral route. Known allergies: no. Return of symptoms (head congestion, chills, headache) and positive antigen test after about a week of being symptoms free.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported vents.
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) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) 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 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-19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received treatment of Paxlovid tablets and for COVID-19.  Clinical information: The patient mentioned that she had the vaccination, 2 of them. Patient had one booster and had hearing loss from the booster, so patient cannot get vaccinated anymore to get a second booster.   The lot number for [BNT162b2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Died; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  An 83-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "Died". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: Died
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician) from product quality group. The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Lot number: EL9266), on 24Mar2021 as dose 2, single (Lot number: ER8733) and on 27Sep2021 as dose 3 (booster), single (Lot number: 301308A) at the age of 66 years for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "OA" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "CA Prostate (no sign of recurrence)" (unspecified if ongoing), notes: CA Prostate (no sign of recurrence). Concomitant medication(s) included: METFORMIN; LANTUS; PRINIVIL; HCTZ; NAPROXEN; JANUVIA; GLIMEPIRIDE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Positive; Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Patient treated with Covid 19- treatment (Brand: Pfizer) from 24Jul2022 to 04Aug2022. Clinical course: Known allergies: none known. Other medication in 2weeks: Yes. Patient had rebound infection (2 positive tests after a negative test).  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and vaccination failure, Covid 19 cannot be completely excluded.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test, Vaccination failure
Clinical narrative: Following Paxlovid I tested negative; Following Paxlovid I tested negative; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 13Feb2021 as dose 1, single (Lot number: EL9266), in left arm, on 08Mar2021 as dose 2, single (Lot number: EN6204), in left arm, on 30Aug2021 as dose 3 (booster), single (Lot number: 301308A), in left arm and on 14Apr2022 as dose 4 (booster), single (Lot number: FP4554) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Gluten intolerance" (unspecified if ongoing); "Known allergies: Almonds" (unspecified if ongoing); "Known allergies: Maple products" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 22Jul2022, outcome "not recovered" and all described as "Following Paxlovid I tested negative". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (unspecified date) Unknown results, notes: COVID 19 Treatment; (unspecified date) Negative, notes: Following Paxlovid I tested negative; (04Aug2022) Positive, notes: Covid rebound. Asymptomatic. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: Antiviral details: Paxlovid indicated for COVID 19 Treatment. Treatment start date was 22Jul2022 and treatment stop date was 27Jul2022. Following paxlovid, I tested negative, but 5 days later on 04Aug I tested positive again-Covid rebound. Asymptomatic. No other medication in 2 weeks.
Sex: M
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 contactable reporter(s) (Physician). The reporter is the patient.  A 75-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Osteoarthritis" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 29Jul2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: negative, notes: Tested negative after the tablets were taken; positive, notes: Got sick again and tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient stated that he was heavily exposed to covid so took Paxlovid and it quickly controlled the disease. Tested negative after the tablets were taken. Got sick again and tested positive. Then sick for several days. Anti-viral details for COVID 19 Treatment included PAXLOVID (lot number: unknown), treatment start date was on 19Jul2022 and treatment stop date was on 23Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported events.
Age: 72.0
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 contactable reporter(s) (Physician). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Mar2022 at 10:00 as dose 4 (booster), single (Lot number: fk7894) at the age of 72 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for 1 day, as dose 2, single (Batch/Lot number: unknown) for 1 day and as dose 3 (booster), single (Batch/Lot number: unknown) for 1 day for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications/Other medication in 2weeks.No known allergies 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: Positive, notes: still present on day 15 with positive covid antigen test; Negative, notes: testing negative on days 6,7,8,9 and 10. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: COVID 19 Treatment with pfizer product Paxlovid started on 21Jul2022 and stop on 26Jul2022. Paxlovid rebound on day 11 - new sore throat, cold symptoms still present on day 15 with positive covid antigen test after being asymptomatic and testing negative on days 6,7,8,9 and 10.; Sender's Comments: Based on the available reported information, the causal association between the events and the suspect drug BNT162B2 cannot be excluded.
Sex: F
Vaccine: 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) (Other HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Apr2021 as dose number unknown, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes mellitus" (unspecified if ongoing). No other medication in 2 weeks. There were no concomitant medications. Past drug history included: Morphine, reaction(s): "Allergy:morphine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "recovered" (2022) and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive. Therapeutic measures were taken as a result of covid-19 included treatment of COVID-19with Paxlovid from 27Jul2022 till unspecified date in Jul2022.  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 drug ineffectiveness and COVID-19 cannot be ruled out.