chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, COVID-19, Drug ineffective, Neuropathy peripheral
Clinical narrative: Tested positive for Covid. Symptoms included fever of 102, severe joint pain, dry mouth, 3 and neuropathy.; Tested positive for Covid. Symptoms included fever of 102, severe joint pain, dry mouth, 3 and neuropathy.; severe joint pain; neuropathy; This is a spontaneous report received from a contactable reporter (Consumer or other non-HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2, on 29Dec2020 as dose 1, single (Batch/Lot number: unknown), in right arm, on 26Feb2021 as dose 2, single (Batch/Lot number: unknown), in right arm and on 21Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 66 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Systemic scleroderma" (unspecified if ongoing); "osteoarthritis" (unspecified if ongoing); "thyroiditis" (unspecified if ongoing). Concomitant medications included: CENTRIM; VITAMIN D [COLECALCIFEROL]; VITAMIN C [ASCORBIC ACID]; B-COMPLEX [VITAMIN B COMPLEX]; VITAMIN E [TOCOPHEROL]; CALCIUM VITAMIN C [ASCORBIC ACID; CALCIUM]; PROBIOTICS; HEMP SEED OIL. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Tested positive for Covid. Symptoms included fever of 102, severe joint pain, dry mouth, 3 and neuropathy."; ARTHRALGIA (medically significant), outcome "unknown", described as "severe joint pain"; NEUROPATHY PERIPHERAL (medically significant), outcome "unknown", described as "neuropathy". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (30May2022) Negative; (31May2022) Negative; (01Jun2022) Negative; (02Jun2022) Negative; (03Jun2022) Negative; (04Jun2022) Positive; Body temperature: (unspecified date) 102. Therapeutic measures were taken as a result of drug ineffective, covid-19 included: full course of Paxlovid from 26May2022 to 30May2022. Clinical course: patient was tested positive for COVID-19 on unknown date. Symptoms included fever of 102, severe joint pain, dry mouth, 3 and neuropathy. Patient took full course of Paxlovid ending on a Monday (30May2022), tested negative. Felt great Mon (30May2022). and Tues (31May2022). Wed (01Jun2022), woke up feeling very fatigued, congested (head stuffed and chest congestion), experiencing neuropathy and joint pain, headache and stomach pain. Same on Thurs (02Jun2022), but also developed sore throat. Felt jittery and anxious and couldn't sleep. Tested negative Mon (30May2022)-Fri (03Jun2022) and Positive on Saturday (04Jun2022). No fever but had chills as well on Saturday (04Jun2022).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Tested positive for Covid. Symptoms included fever of 102, severe joint pain, dry mouth, 3 and neuropathy.; Tested positive for Covid. Symptoms included fever of 102, severe joint pain, dry mouth, 3 and neuropathy.; severe joint pain; neuropathy; This is a spontaneous report received from a contactable reporter (Consumer or other non-HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2, on 29Dec2020 as dose 1, single (Batch/Lot number: unknown), in right arm, on 26Feb2021 as dose 2, single (Batch/Lot number: unknown), in right arm and on 21Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 66 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Systemic scleroderma" (unspecified if ongoing); "osteoarthritis" (unspecified if ongoing); "thyroiditis" (unspecified if ongoing). Concomitant medications included: CENTRIM; VITAMIN D [COLECALCIFEROL]; VITAMIN C [ASCORBIC ACID]; B-COMPLEX [VITAMIN B COMPLEX]; VITAMIN E [TOCOPHEROL]; CALCIUM VITAMIN C [ASCORBIC ACID; CALCIUM]; PROBIOTICS; HEMP SEED OIL. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Tested positive for Covid. Symptoms included fever of 102, severe joint pain, dry mouth, 3 and neuropathy."; ARTHRALGIA (medically significant), outcome "unknown", described as "severe joint pain"; NEUROPATHY PERIPHERAL (medically significant), outcome "unknown", described as "neuropathy". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (30May2022) Negative; (31May2022) Negative; (01Jun2022) Negative; (02Jun2022) Negative; (03Jun2022) Negative; (04Jun2022) Positive; Body temperature: (unspecified date) 102. Therapeutic measures were taken as a result of drug ineffective, covid-19 included: full course of Paxlovid from 26May2022 to 30May2022. Clinical course: patient was tested positive for COVID-19 on unknown date. Symptoms included fever of 102, severe joint pain, dry mouth, 3 and neuropathy. Patient took full course of Paxlovid ending on a Monday (30May2022), tested negative. Felt great Mon (30May2022). and Tues (31May2022). Wed (01Jun2022), woke up feeling very fatigued, congested (head stuffed and chest congestion), experiencing neuropathy and joint pain, headache and stomach pain. Same on Thurs (02Jun2022), but also developed sore throat. Felt jittery and anxious and couldn't sleep. Tested negative Mon (30May2022)-Fri (03Jun2022) and Positive on Saturday (04Jun2022). No fever but had chills as well on Saturday (04Jun2022).  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
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 06Feb2021 at 14:00 as dose number unknown, 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: "Heart disease" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received Paxlovid as treatment of COVID-19 from 01Jun2022 to 03Jun2022.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 75.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Mar2022 as dose 4 (booster), single (Lot number: FM0698) at the age of 75 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 28Jan2021 as dose 1, single (Lot number: 044L20N), in right arm, on 02Mar2021 as dose 2, single (Lot number: 011A21A), in right arm and on 02Nov2021 as dose 3 (booster), single (Lot number: 033F21A), in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: No Other medication in 2 weeks. Anti-viral details: product-COVID 19 Treatment, brand-Pfizer, treatment start date-10May2022, treatment stop date-14May2022, lot number-unknown, indication-Treatment of COVID-19.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Mar2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 22Apr2021 as dose 2, single (Batch/Lot number: unknown), in right arm, on 20Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and on 29Apr2022 at 15:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 49 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's" (unspecified if ongoing); "Subglottic stenosis" (unspecified if ongoing); "Know allergies: Sulfa" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Azithromycin, reaction(s): "Know allergies: Azythromacin". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31May2022) Negative; (04Jun2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: Other medication in 2weeks was Yes. The patient was taking any other medications products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine. vaccine received was Yes.  The lot number for the vaccine BNT162b2 (COMIRNATY), was not provided and will be requested during follow up.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID Infection; COVID Infection; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  An 8-year-old male patient received BNT162b2 (BNT162B2), on 13Nov2021 as dose 1, single (Lot number: FK5127) and on 04Dec2021 as dose 2, single (Lot number: FK5127) at the age of 8 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 16Apr2022, outcome "recovered" and all described as "COVID Infection". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Dec2021) Negative, notes: Nasal Swab; (16Apr2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  The patient was not received other vaccine in four weeks and covid prior vaccination. She was covid tested post-vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
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 58-year-old male patient received BNT162b2 (BNT162B2), on 10Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 57 years, 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 had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. Anti-viral details includes COVID 19 Treatment. Treatment start date was on 24May2022 and Treatment start date was on 29May2022. Adverse event reported as COVID symptoms returned 5 days after Treatment. Patient had no known allergies. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient. A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Dec2020 at 18:00 as dose 1, single (Lot number: EK5730), in left arm, on 08Jan2021 at 20:30 as dose 2, single (Lot number: EL3246), in left arm, on 25Aug2021 at 09:00 as dose 3 (booster), single (Lot number: EW0182), in left arm and on 30Mar2022 at 14:00 as dose 4 (booster), single (Lot number: FL3198) at the age of 70 years, in left arm for Covid-19 immunisation. The patient's relevant medical history included: "GERD" (unspecified if ongoing); "allergic rhinitis" (unspecified if ongoing); "dyslipidemia" (unspecified if ongoing); "LBP" (unspecified if ongoing), notes: LBP; "insomnia" (unspecified if ongoing). Concomitant medication(s) included: Trazodone; Famotidine; Montelukast; Atorvastatin; Cyclobenzaprine; APAP; Vitamin D [Colecalciferol]; Calcium Antacid; B12 [Cyanocobalamin]. Past drug history included: Nickel, reaction(s): "Known allergies: Nickel". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, Covid-19. Clinical course: Patient took Paxlovid from May2022 to May2022 for Treatment of COVID-19. Other Medication In 2 weeks Product included: Trazodone 150 Mg, Famotidine 40 Mg, Montelukast10 Mg, Atorvastatin 10 Mg, Cyclobenzaprine 10 Mg, Acetaminophen(APAP) 1000 Mg, Vitamin D 2000 unit (IU), Calcium Chew 600 Mg, B12 1000 MCGM. 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 vaccination failure/COVID-19 cannot be ruled out
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old male patient received BNT162b2 (BNT162B2), on 23Mar2021 as dose 1, single (Lot number: EP6955), in left arm, on 14Apr2021 as dose 2, single (Lot number: EW0158), in left arm, on 12Nov2021 as dose 3 (booster), single (Lot number: FH2808), in left arm and on 30Apr2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 60 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: SIMVASTATIN, stop date: 22May2022; LEVOTHYROXINE; VITAMIN D [COLECALCIFEROL]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: PNC13
Symptoms: Death, Dyspnoea, Mechanical ventilation, Oxygen saturation decreased, Pneumonia bacterial
Clinical narrative: He was struggling with breathing; His O2 saturation was in the 80s; pneumonia bacteria from his lung; At some point he passed away; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A 9-month-old male patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SYMBICORT. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "At some point he passed away"; DYSPNOEA (hospitalization), outcome "unknown", described as "He was struggling with breathing"; OXYGEN SATURATION DECREASED (hospitalization), outcome "unknown", described as "His O2 saturation was in the 80s"; PNEUMONIA BACTERIAL (medically significant), outcome "unknown", described as "pneumonia bacteria from his lung". The patient underwent the following laboratory tests and procedures: Oxygen saturation: in the 80s. Therapeutic measures were taken as a result of dyspnoea, oxygen saturation decreased. The patient date of death was unknown. Reported cause of death: "At some point he passed away". It was not reported if an autopsy was performed.  Clinical course: He was given nevulizer treatment and place on oxygen. He was placed on a ventilator in 2 hours after arriving at hospital.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available limited information and a possible contributory role of the suspect product PREVNAR 13 to the reported events cannot be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: At some point he passed away
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "recovered" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of suspected covid-19.  Clinical course: Patient received treatment for COVID-19, Route of administration: Oral.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Feb2021 at 18:00 as dose 1, single (Lot number: EM9810), in left arm, on 26Feb2021 at 10:45 as dose 2, single (Lot number: EN6202), in left arm and on 13Dec2021 at 18:30 as dose 3 (booster), single (Lot number: 33030BD) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin. Concomitant medication(s) included: LEXAPRO, start date: 14Jun2010, stop date: 03Jun2022; IBUPROFEN, start date: 21May2022, stop date: 23May2022. The following information was reported: VACCINATION FAILURE (medically significant) with onset 21May2022, outcome "unknown", COVID-19 (medically significant) with onset 21May2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21May2022) Positive, notes: Recent COVID test @ (institute name-withheld) on Sat 21May was Positive; (28May2022) Negative, notes: On 28May I tested and was Negative for COVID; (02Jun2022) Positive, notes: On Thursday, 02Jun while at work I felt the COVID symptoms again. Went home and tested positive for COVID; (03Jun2022) Positive, notes: Also had a test at booth Ive gone to many times today 03Jun and tested positive for COVID. Therapeutic measures were taken as a result of covid-19. Clinical course: The patient received treatment for COVID-19 included Paxlovid.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: product=COVID 19 Treatment, brand=Paxlovid/vaccine brand=Pfizer / BioNTech.; product=COVID 19 Treatment, brand=Paxlovid/vaccine brand=Pfizer / BioNTech.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old male patient received BNT162b2 (BNT162B2), on 20Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 45 years for covid-19 immunization; 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 immunization. The patient's relevant medical history included: "IBS" (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 02Jun2022 at 08:00, outcome "recovering" and all described as "product=COVID 19 Treatment, brand=Paxlovid/vaccine brand=Pfizer / BioNTech.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Jun2022) Negative, notes: testing negative day 8; (02Jun2022) Positive, notes: Testing positive on day 9; (05Jun2022) Positive, notes: Now on day 12 and still testing positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (PFIZER/BIONTECH COVID-19 VACCINE), on 13Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 38 years, in right arm for covid-19 immunisation; 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 was not reported. Concomitant medication included: PROZAC. 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: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19 and included treatment with Paxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Mar2021 as dose 1, single (Lot number: En6198), in left arm, on 22Mar2021 as dose 2, single (Lot number: En6208), in left arm and on 22Oct2021 as dose 3 (booster), single (Lot number: PF1ZCCFF2528) at the age of 65 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 11Apr2022 as dose 4 (booster), single (Lot number: 001M21A) for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "migraines" (unspecified if ongoing); "Known allergies: Shellfish" (unspecified if ongoing); "Thyroid" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID taken for thyroid disorder; AIMOVIG taken for migraine. Past drug history included: Neosporin, reaction(s): "Known allergies: Neosporin". 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 antibody test: Positive, notes: Took paxlovid one day into testing positive. 3 days later symptoms reoccur with positive test again; Negative, notes: tested negative 2x within 3 days. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient had Covid rebound. Took paxlovid one day into testing positive. 7days after positive, tested negative 2x within 3 days. 3 days later symptoms reoccur with positive test again. Adverse event start date was 30May2022 at 11: 30 am. No treatment was taken for Adverse event. The patient was recovering from the event.  No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Mar2021 as dose 1, single (Lot number: ER8732), in left arm, on 17Apr2021 as dose 2, single (Lot number: EW0169), in left arm and on 14Nov2021 as dose 3 (booster), single (Lot number: FG3527) at the age of 36 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "IBS" (unspecified if ongoing); "known allergies: Lactose" (unspecified if ongoing); "known allergies: scallops" (unspecified if ongoing); "known allergies: cats" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: Positive, notes: COVID 19 Treatment/ testing positive again as well; Negative, notes: I started testing negative again after 5; Positive, notes: I started testing positive again as well. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Addition information: Treatment start date was 16May2022. Treatment stop date was 21May2022. Adverse event- 5 days after completing my Paxlovid I fully relapsed. Symptoms were a little different this time and I was more tired than my first round of COVID symptoms. I started testing positive again as well. Symptoms subsided after 3 days. I started testing negative again after 5.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 52-year-old female patient received BNT162b2 (BNT162B2), on 22May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 52 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 was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results. Therapeutic measures were taken as a result of drug ineffective, covid-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; 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.
Age: 62.0
Sex: F
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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Feb2021 as dose 1, single (Batch/Lot number: unknown), on 08Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 01Sep2021 at 14:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Sulfa drugs" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Covid rebound mild symptoms and positive test. Therapeutic measures were taken as a result of drug ineffective, covid-19. Therapeutic measures included PAXLOVID.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
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).  A 69-year-old male patient received BNT162b2 (BNT162B2), 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: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 23May2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23May2022) Positive; (04Jun2022) positive, notes: after symptoms recurred, tested positive. Therapeutic measures were taken as a result of covid-19, drug ineffective.  Clinical information: Antiviral details: product- COVID 19 treatment, treatment start date: 23May2022, treatment stop date: 27May2022. Adverse event: Possible case of rebound. Symptoms subsided but then recurred approximately one week after completing full dosing regimen. First home/rapid antigen test on 23May was positive. Retest on 04Jun, after symptoms recurred, tested positive. No known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID Positive on 30May2022; COVID Positive on 30May2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Feb2021 as dose 1, single (Lot number: EL9264), in left arm, on 22Feb2021 as dose 2, single (Lot number: EN6200), in left arm, on 19Aug2021 as dose 3 (booster), single (Lot number: EW0186), in left arm and on 21Jan2022 as dose 4 (booster), single (Lot number: 330368D) at the age of 50 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Autoimmune Hepatitis" (unspecified if ongoing); "Primary Billiary Cirrosis" (unspecified if ongoing). The patient took concomitant medications. Patient had not received any other vaccine in four weeks. Patient did not had covid prior to vaccination nor been tested post vaccination. Patient had no known allergies.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 30May2022 at 15:30, outcome "recovering" and all described as "COVID Positive on 30May2022". The event "covid positive on 30may2022" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30May2022) Positive, notes: COVID Positive on 30May2022; (20Sep2021) Negative, notes: Nasal Swab. Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: PNC20
Symptoms: Loss of personal independence in daily activities, Malaise, Mobility decreased
Clinical narrative: she did not feel well 24 hours after her Prevnar 20 vaccine and she had to stay in bed for the whole day; she did not feel well 24 hours after her Prevnar 20 vaccine and she had to stay in bed for the whole day; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), in 2022 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Autoimmune issue" (ongoing), notes: The pharmacist also mentioned that she has an, autoimmune issue which probably led to her reaction. The patient's concomitant medications were not reported. The following information was reported: MALAISE (non-serious), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) all with onset 2022, outcome "recovering" and all described as "she did not feel well 24 hours after her Prevnar 20 vaccine and she had to stay in bed for the whole day".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 52-year-old male patient received BNT162b2 (BNT162B2), on 05Jun2021 as dose 1, single (Lot number: EW0H6), in left arm, on 26Jun2021 as dose 2, single (Lot number: EW0180), in left arm and on 13Dec2021 as dose 3 (booster), single (Lot number: 330308D) at the age of 51 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "HBP" (unspecified if ongoing); "Known allergies: Shea butter" (unspecified if ongoing). Concomitant medication(s) included: DEXAMETHASONE; ALVOGEN ALMAGATE oral, start date: 31May2022, stop date: 04Jun2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. Anti-viral details: Product: Covid 19 Treatment, Brand: Paxlovid, Treatment start date: 31May2022, Treatment stop date: 04Jun2022, Lot number: Fw4118, Indication: Treatment of Covid-19, Administrator route: Oral.  No follow-up attempts are possible. 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 vaccination failure / COVID-19 cannot be ruled out
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Lot number: EN6199), in left arm, on 08Apr2021 as dose 2, single (Lot number: ER8737), in left arm and on 03Dec2021 as dose 3 (booster), single (Lot number: 330308D) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: penicillin" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE. 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: Unknown results. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinial course: Patient received other medication in 2weeks(product- Levothroxine).  Antiviral details: Product- COVID 19 Treatment with Brand- Pfizer Treatment of COVID-19 start date on 26May2022 and treatment stop date on 30May2022 with Lot number-Not sure. - rx # 923861 After 5 days of taking Paxlovid patient symptoms returned  No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Mar2021 as dose 1, single (Lot number: ER8732), in left arm and on 21Apr2021 as dose 2, single (Lot number: EW0775) at the age of 41 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 04Nov2021 as dose 3 (booster), single (Lot number: 039F21A) for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Sulfa" (unspecified if ongoing), notes: known allergies: Sulfa. Concomitant medication(s) included: MIRENA L; TOPIRAMATE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient received treatment Paxlovid for the events. other medication in 2weeks product: IUD
Age: 23.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: exposed on vacation for a week ending 30May2022, then sx ST congestion HA fatigue and positive test 02Jun2022 Ag; exposed on vacation for a week ending 30May2022, then sx ST congestion HA fatigue and positive test 02Jun2022 Ag; This is a spontaneous report received from a non-contactable reporter(s) (Nurse). The reporter is the parent.  A 24-year-old patient received BNT162b2 (BNT162B2), on 24Dec2021 as dose 1, single (Lot number: FF2589) at the age of 23 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 02Jun2022, outcome "unknown" and all described as "exposed on vacation for a week ending 30May2022, then sx ST congestion HA fatigue and positive test 02Jun2022 Ag". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Jun2022) Positive, notes: Nasal Swab; (01Jun2022) Pending, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19. Patient exposed on vacation for a week ending 30May2022, then sx ST congestion HA fatigue and positive test 02Jun2022 Ag.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the event covid 19 and Drug ineffective and the role of suspect drug cannot be ruled out. The case will be reassessed once new information is available.
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 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (Dose Number: 1, Manufacturer: Unknown), for Covid-19 Immunization; Covid-19 vaccine (Dose Number: 2, Manufacturer: Unknown), for Covid-19 Immunization; Covid-19 vaccine (Dose Number: 3 (Booster), Manufacturer: Unknown), for Covid-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19.  Clinical course: COVID 19 Treatment (brand: Paxlovid), Treatment start date: 26May2022 and stop date: 31May2022. The patient received other medication in 2weeks. The patient had no known allergies. The patient experienced on 03Jun2022. She tested negative for two days after completing paxlovid treatment. However, on day 3 She had sore throat, tiredness and headache and sob with cough. She tested positive again on home rapid antigen test. She had paxlovid rebound infection. The outcome of event was not recovered. The patient was not received treatment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Nurse). The reporter is the patient.  A 35-year-old female patient (not pregnant) 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 included: "Allergy: Shellfish" (unspecified if ongoing). There were no concomitant medications or other medications in 2 weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 02Jun2022 to 03Jun2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the event covid 19 and Drug ineffective and the role of suspect drug cannot be ruled out. The case will be reassessed once new information is available.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 47 years, in left arm, as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SPIRONOLACTONE; BUPROPION; LEVOTHYROXINE. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 29May2022, outcome "recovered" (03Jun2022) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29May2022) positive. Therapeutic measures were not taken as a result of covid-19, drug ineffective.  Clinical course: Patient did not had known allergies. Rebound of Covid positive home testing and sx on 29May2022.  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 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.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood cholesterol, 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 50-year-old male patient received BNT162b2 (BNT162B2), on 06Nov2021 at 15:00 as dose 3 (booster), single (Lot number: 30155BA) at the age of 50 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing), notes: High cholesterol (treated); "Cancer" (unspecified if ongoing), notes: Cancer, (surgery and radiation treatments from, Jan2022-May2022). Concomitant medication(s) included: ATORVASTATIN, start date: 01Jan2022, stop date: 26May2022. Past drug history included: Keflex, reaction(s): "Known allergies: Keflex". The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: Blood cholesterol: high; SARS-CoV-2 test unknown. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received vaccine was yes. Antiviral details-Product- COVID 19 Treatment, Brand- Paxlovid, Treatment start date- 27May2022, Treatment stop date- 31May2022, Indication-Treatment of COVID-19. Adverse event- Rebound COVID-19 infection, with symptoms starting to become apparent during the late evening (after 10 PM) on 3Jun2022. The symptoms include fatigue, a mild headache, runny nose, sore throat, and feeling of constriction in the airway plus cough. If patient recovered was recovering, The patient did not receive treatment for AE.  No follow-up attempts are needed. No further information is expected.