chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive in May and started Paxlovid.; Tested positive in May and started Paxlovid.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old male patient received BNT162b2 (BNT162B2), on 25Mar2021 as dose 1, single (Lot number: ER8727) and on 15Apr2021 as dose 2, single (Lot number: Ew0169) at the age of 35 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 11Dec2021 as dose 3 (booster), single (Lot number: 018F21A) for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE, start date: Jan2022; DOXYCYCLIN [DOXYCYCLINE MONOHYDRATE], start date: 10May2022, stop date: 20May2022; SERTRALINE HCL, start date: Feb2022; EMTRICITABIN TENOFOVIR, start date: Feb2016. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "not recovered" and all described as "Tested positive in May and started Paxlovid.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) positive, notes: Tested positive in May and started Paxlovid; (23May2022) Negative, notes: Tested negative at the end of treatment; (14Jun2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Other medication in 2weeks reported as yes. Anti-viral details reported as COVID 19 Treatment, brand name was paxlovid, treatment start date reported as 18May2022, treatment stop date was 23May2022 and indication as treatment of COVID-19. Other medication in 2weeks product was Dextroamp-amphetamin, other medication in 2weeks start date was Jan2022. Tested positive in May and started Paxlovid. Tested negative at the end of treatment. Then today (14Jun2022) tested positive again after feeling brain fog, body aches and running nose. Adverse events start date was 14Jun2022. Patient was recovering and treatment ae was reported as no.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Developed COVID-19 while on vacation in Ireland after receiving 3 doses of Pfizer Covid-19 Vaccine; Developed COVID-19 while on vacation after receiving 3 doses of Pfizer Covid-19 Vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 29-year-old male patient received BNT162b2 (BNT162B2), in Dec2020 as dose 1, single (Batch/Lot number: unknown), in Jan2021 as dose 2, single (Batch/Lot number: unknown) and in Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 28 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "recovering" and all described as "Developed COVID-19 while on vacation after receiving 3 doses of Pfizer Covid-19 Vaccine". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2021) Negative; (Jun2022) Positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Feb2021 as dose 1, single (Lot number: ENG6200), in left arm, on 22Mar2021 as dose 2, single (Lot number: ER8732), in left arm, on 30Nov2021 as dose 3 (booster), single (Lot number: 30130BA), in left arm and on 22Apr2022 as dose 4 (booster), single (Lot number: FJ4989) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: Kiwi" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Additional information: patient received BNT162b2 for COVID 19 Treatment.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Skin disorder
Clinical narrative: The skin on on my arms has been destroyed since my vaccination; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Feb2021 as dose 1, single (Batch/Lot number: unknown) and in Mar2021 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: SKIN DISORDER (non-serious) with onset 2021, outcome "unknown", described as "The skin on on my arms has been destroyed since my vaccination".  Additional information: I was harmed by your Covid vaccine which received in Feb and Mar of 2021. The skin on my arms has been destroyed since my vaccination. It was suggested by a friend that I contact you about this. This supposedly save vaccine was not safe for me and thus far I have no remedy.  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: 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 62-year-old female patient received BNT162b2 (BNT162B2), on 25Mar2021 as dose 1, single (Lot number: ER2613), in left arm, on 15Apr2021 as dose 2, single (Lot number: ER8729), in left arm, on 22Nov2021 as dose 3 (booster), single (Lot number: FJ8762), in left arm and on 01May2022 as dose 4 (booster), single (Lot number: FJ4991), in left arm for covid-19 immunisation. The patient's relevant medical history included: "chronic fatigue syndrome" (unspecified if ongoing); "migraines" (unspecified if ongoing), notes: migraines. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19".  Clinical information: Adverse event Had positive test results for 9 days. Days 5-8 was feeling better. Day 9 redeveloped bad headache that she had on days 1-2. Day 10 first negative test but headache bad and legs achy or just not feeling well. Felt lousy day 11-12. Awoke day 13 yesterday (from initial day she felt symptoms and initial positive test) feeling like she did on day 1. Bad headache, sinus drainage which was causing sore throat, nasal passage burning and nose running. Felt wiped out all over again. Did home test and tested positive after negative a few days ago. Today headache improved. Just mild off and on, sneezing and runny nose and just feel lousy in general. Adverse event country: Adverse event start date: 09Jun2022 Ae resulted in. No Known allergies. Other medical history of chronic fatigue syndrome, migraines. Were you/Was the patient taking any other medications/products within 2 weeks of starting COVID-19 treatment: Yes. Did you/the patient previously receive a COVID-19 Vaccine: Yes. Patient considered event as non serious.  No follow-up attempts are possible. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient. A 78-year-old female patient received BNT162b2 (BNT162B2), on 10Feb2021 as dose 1, single (Lot number: EN5318), on 03Mar2021 as dose 2, single (Lot number: EN6202) and on 03Sep2021 as dose 3 (booster), single (Lot number: FD0809) at the age of 77 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "Ascending aorta replaced", start date: 2019, stop date: 2019, notes: three years ago, her ascending aorta was replaced; "giant cell arthritis" (unspecified if ongoing), notes: The illness she has is giant cell arthritis; "lumpectomy in both breasts" (unspecified if ongoing), notes: Had lumpectomy in both breasts; "breast cancer" (unspecified if ongoing), notes: Has a history of breast cancer. Concomitant medication(s) included: PROLIA, start date: 23May2022, stop date: 23May2022. Past drug history included: Prednisone for giant cell arthritis, notes: Takes prednisone because of the giant cell arthritis.; Anastrozole for breast cancer, notes: Anastrozole because of the breast cancer. The following information was reported: VACCINATION FAILURE (medically significant) with onset May2022, outcome "unknown", COVID-19 (medically significant) with onset May2022, outcome "not recovered" and all described as "Covid-19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (14Jun2022) Awaiting Results; (13Jun2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Positive for Covid one month after taking Paxlovid start date 13Jun2022. Clinical course: Two days before she tested positive in May2022, she was at the doctors office for three hours for a stress test. She thinks that was where she got it. That was on 05May2022. She was also in another doctors office on 03May2022.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID-19 (10Jun2021-20Jun2021); COVID-19 (10Jun2021-20Jun2021); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4431061-00.  A 67-year-old female patient received BNT162b2 (BNT162B2), on 08May2021 as dose 1, single (Batch/Lot number: unknown) and on 25May2021 as dose 2, single (Batch/Lot number: unknown) at the age of 67 years, all intramuscular 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) all with onset 10Jun2021, outcome "recovered" (20Jun2021) and all described as "COVID-19 (10Jun2021-20Jun2021)". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm was a little sore; A 78-year-old female patient received BNT162b2 (BNT162B2), on 10Feb2021 as dose 1, single (Lot number: EN5318) at the age of 76 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "Ascending aorta replaced" (unspecified if ongoing), notes: three years ago, her ascending aorta was replaced; "giant cell arthritis" (unspecified if ongoing), notes: The illness she has is giant cell arteritis; "lumpectomy in both breasts" (unspecified if ongoing), notes: Had lumpectomy in both breasts; "Breast cancer" (unspecified if ongoing). Concomitant medication(s) included: PREDNISONE taken for giant cell arteritis; ANASTROZOLE taken for breast cancer; METHOTREXATE taken for breast cancer. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Feb2021, outcome "unknown", described as "arm was a little sore".  Additional information: Does not want her physician contacted. Declines. Takes a thyroid medication daily and a bunch of vitamins. On 23May2022, she had the Prolia injection. Something she gets twice yearly. no Prior Vaccinations within 4 weeks to the first administration date of the suspect vaccine This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID:  The reporter is the patient.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm was a little sore; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  A 76-year-old female patient received BNT162b2 (BNT162B2), on 03Mar2021 as dose 2, single (Lot number: EN6202) at the age of 76 years for covid-19 immunization. The patient's relevant medical history included: "Breast cancer" (unspecified if ongoing); "Gaint cell arthritis" (unspecified if ongoing); "Lumpectomy" (unspecified if ongoing); "ascending aorta replacement" (unspecified if ongoing), notes: Three years ago, her ascending aorta was replaced. Concomitant medication(s) included: ANASTROZOLE taken for breast cancer; METHOTREXATE taken for breast cancer; PREDNISONE [PREDNISONE ACETATE]. Vaccination history included: BNT162b2 (Dose 01, Lot: EN5318), administration date: 10Feb2021, when the patient was 76-year-old, for COVID-19 Immunization, reaction(s): "her arm was little sore". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "Arm was a little sore".  Additional information: Takes a thyroid medication daily and a bunch of vitamins. She has some serious conditions. Three years ago, her ascending aorta was replaced. The illness she has is giant cell arthritis. Had lumpectomy in both breasts. Takes prednisone because of the giant cell arthritis. Anastrozole because of the breast cancer. Methotrexate to work with the steroids. Has a history of breast cancer and giant cell arthritis. On 23May2022, she had the Prolia injection. Something she gets twice yearly. No additional vaccine were administered on the same day of the Pfizer vaccine administered. No prior vaccinations within 4 weeks of first administration. No adverse event prior vaccination. Patient's arm was a little sore after the COVID vaccines, that was it. No Antipyretic use around the date of vaccination.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 42-year-old male 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 was not reported. There were no concomitant medications. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 2022, 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, notes: Rebound of symptoms and confirmed with antigen testing. Therapeutic measures were taken as a result of covid-19, drug ineffective.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The reported Covid 19 positive after both the doses of  COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
Age: 71.0
Sex: F
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 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Feb2021 at 12:00 as dose 1, single (Lot number: En6198), in right arm, on 21Mar2021 at 12:00 as dose 2, single (Lot number: Er8727), in right arm, on 24Sep2021 at 12:00 as dose 3 (booster), single (Lot number: Ff8834), in right arm and on 06May2022 at 11:00 as dose 4 (booster), single (Lot number: Fj4989) at the age of 71 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Mild copd" (unspecified if ongoing); "known allergies: Sausage" (unspecified if ongoing). Concomitant medication(s) included: SPIRIVA RESPIMAT, start date: 02Jun2021, stop date: 14Jun2022. 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 Treatment". Therapeutic measures were taken as a result of covid-19. Clinical course: The patient was treated with Paxlovid from 03Jun2022 to 08Jun2022.  No follow-up attempts are possible. No further information is expected.
Age: 63.0
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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old male patient received BNT162b2 (BNT162B2), in Jan2021 as dose 1, single (Batch/Lot number: unknown), in Feb2021 as dose 2, single (Batch/Lot number: unknown) and in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 63 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), in Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "DM" (unspecified if ongoing), notes: other medical history: DM; "HTN" (unspecified if ongoing), notes: other medical history: HTN; "hyperlipidemia" (unspecified if ongoing). Concomitant medication(s) included: ALLOPURINOL; ATORVASTATIN; METFORMIN; LOSARTAN; JARDIANCE; TRAZODONE. Past drug history included: Known allergies: prednisone, reaction(s): "Known allergies: Prednisone", notes: Known allergies: Prednisone. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Negative, notes: Negative at day 9 and 10; (2022) Positive, notes: Positive at day 11. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Course: Antiviral details: Product: COVID 19 Treatment, brand=Pfizer, Treatment start date: 03Jun2022, Treatment stop date: 09Jun2022, Indication: 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: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Clarified that the caller had 4 shots before she got Covid the first time; Clarified that the caller had 4 shots before she got Covid the first time; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A 65-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), in Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "immunocompromised" (unspecified if ongoing), notes: She is also immunocompromised. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Clarified that the caller had 4 shots before she got Covid the first time".  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, Pain in extremity
Clinical narrative: Clarified that the caller had 4 shots before she got Covid the first time; Clarified that the caller had 4 shots before she got Covid the first time; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A 65-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), in Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "immunocompromised" (unspecified if ongoing), notes: She is also immunocompromised. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Clarified that the caller had 4 shots before she got Covid the first time".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old male patient received BNT162b2 (BNT162B2), on 30Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 33 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 and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset May2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19, drug ineffective with paxlovid from 31May2022 to 04Jun2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), in left arm 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 had no relevant medical history. 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 "COVID 19 Treatment". 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 drug ineffective, suspected covid-19. No other medication in 2weeks. COVID 19 Treatment, Paxlovid, from 30May2022 to 03Jun2022.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure management, Drug ineffective, Suspected COVID-19
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 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Oct2021 as dose 3 (booster), single (Lot number: 320308d) and in Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), in Feb2021 as dose 1, single (Batch/Lot number: unknown) and in Mar2021 as dose 2, single (Lot number: 0294214) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure controlled" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: Blood pressure management: controlled. Therapeutic measures were taken as a result of suspected covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Feb2022 as dose 4 (booster), single (Lot number: FJ5602) at the age of 72 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 18Sep2021 as dose 3 (booster), single (Lot number: 035c21a), 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: "Ulcerative Colitis" (unspecified if ongoing); "Afib" (unspecified if ongoing); "high BP" (unspecified if ongoing), notes: high BP. Concomitant medication(s) included: VALSARTAN; TAMOXIFEN; ROSUVASTATIN; FLECAINIDE; PSYLLIUM [PLANTAGO PSYLLIUM]; VITAMIN D3. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "recovering" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Tested positive again; (07Jun2022) Positive, notes: Tested positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Anti-viral details: Product: COVID 19 Treatment, Brand: Pfizer, treatment start date: 27May2022, treatment stop date: 01Jun2022, indication: treatment of COVID-19. Tested positive again on 07Jun22 with similar Covid symptoms of congestion. No known allergies.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, 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 29-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 09Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 06Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 29 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Attention deficit hyperactivity disorder" (unspecified if ongoing), notes: ADHD. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of covid-19, vaccination failure. It was reported that patient received treatment of paxlovid for Covid 19 (29May2022).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 51.0
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 52-year-old male patient received BNT162b2 (BNT162B2), on 01Feb2021 as dose 1, single (Lot number: EN5318), in left arm, on 22Feb2021 as dose 2, single (Lot number: EN6200), in left arm, on 08Nov2021 as dose 3 (booster, single) (Lot number: FF2593), in left arm and on 23May2022 at 11:00 as dose 4 (booster, single) (Lot number: FJ4989) at the age of 51 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "High Blood pressure" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Aripiprazole, reaction(s): "Allergy". 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: (05Jun2022) Positive; (10Jun2022) Negative, notes: completed 5 day course of paxlovid; symptoms had resolved; covid antigen home test negative; (14Jun2022) Positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 79-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 79 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: "parkinson" (unspecified if ongoing), notes: Parkinsons; "chronic pain" (unspecified if ongoing); "Bronchiectasis" (unspecified if ongoing), notes: bronchiactisis. Concomitant medication(s) included: SINEMET, start date: Mar2022; MYRBETRIQ, start date: Jan2020; CELECOXIB, start date: Jan2019; WIXELA INHUB nasal, start date: Aug2020; MONTELUKAST, start date: Jan2020; DULOXETINE, start date: Oct2018. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) positive, notes: (since day 1 of diagnosis & paxlovid start) She tested positive on rapid test. 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: 62.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Arrhythmia, Product use issue, SARS-CoV-2 test, Ventricular extrasystoles
Clinical narrative: Developed Heart Rhythm issues and PVC beats; Developed Heart Rhythm issues and PVC beats; other vaccine same date as vaccine date; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 27Oct2021 at 09:30 as dose 3 (booster), single (Lot number: PF2080) at the age of 62 years, in right arm for covid-19 immunisation; influenza vaccine (INFLUENZA), on 27Oct2021 as dose 1, single (Batch/Lot number: unknown), in left arm for immunisation. The patient's relevant medical history included: "A-Fib" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Atorvastatin, reaction(s): "Known allergies: Atorvastatin". Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: LR 8727, Location of injection: Arm Right, Vaccine Administration Time: 09:00 AM), administration date: 27Mar2021, when the patient was 62-year-old, for Covid-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Right, Vaccine Administration Time: 01:00 PM), administration date: 06Mar2021, when the patient was 62-year-old, for Covid-19 immunization. The following information was reported: ARRHYTHMIA (disability, medically significant, life threatening), VENTRICULAR EXTRASYSTOLES (disability, life threatening) all with onset 27Oct2021 at 09:30, outcome "not recovered" and all described as "Developed Heart Rhythm issues and PVC beats"; PRODUCT USE ISSUE (non-serious) with onset 27Oct2021 at 09:30, outcome "unknown", described as "other vaccine same date as vaccine date". The events "developed heart rhythm issues and pvc beats" and "other vaccine same date as vaccine date" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of arrhythmia, ventricular extrasystoles, product use issue.  Clinical information: ae treatment Cardioversion and medication. Patient was not covid prior vaccination.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Oropharyngeal pain, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive for covid-19; tested positive for covid-19; sore throat; fatigue; 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 34-year-old male patient received BNT162b2 (COMIRNATY), on 13Apr2021 as dose 1, single (Batch/Lot number: unknown), on 04May2021 as dose 2, single (Lot number: EW0153) and on 21Dec2021 as dose 3 (booster), single (Lot number: FD8448) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive for covid-19"; OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "sore throat"; FATIGUE (non-serious), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Jun2022) Positive, notes: via 2 at-home rapid tests; (13Jun2022) Positive, notes: today via 2 at-home rapid tests. Clinical course: It was reported that, having been fully vaccinated (2 doses) and boosted (1 dose), I tested positive for covid-19 today via 2 at-home rapid tests. So far, my symptoms are relatively minor, and include sore throat and fatigue.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Inappropriate schedule of product administration, Inflammatory bowel disease, Off label use
Clinical narrative: First Dose: 02Mar2021; Second dose: 20May2021; First Dose: 02Mar2021; Second dose: 20May2021; Inflammatory bowel disease; Urgent diarrhea; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4426825-00 (Company).  A 45-year-old female patient received BNT162b2 (BNT162B2), on 02Mar2021 as dose 1, single (Batch/Lot number: unknown) and on 20May2021 as dose 2, single (Batch/Lot number: unknown) at the age of 43 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at unk (citrate free), subcutaneous for crohn's disease. The patient's relevant medical history was not reported. Concomitant medication(s) included: AMITRIPTYLINE. The following information was reported: OFF LABEL USE (medically significant), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (medically significant), outcome "unknown" and all described as "First Dose: 02Mar2021; Second dose: 20May2021"; INFLAMMATORY BOWEL DISEASE (medically significant), outcome "not recovered"; DIARRHOEA (non-serious), outcome "not recovered", described as "Urgent diarrhea". The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of "inflammatory bowel disease" and "urgent diarrhea" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  Causality for HUMIRA (ADALIMUMAB): The reporter's causality for the event (s) of URGENT diarrhea and inflammation in digestive tract and bowels was not provided.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information and known profile of the Comirnaty vaccine  ,the reported events of  diarrhoea  were assessed as related to the  Comirnaty vaccine . Based on the information provided by the reporter, it appears unlikely that suspect drug contributed to the reported events inflamamatory bowel disease.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: tested positive for COVID; tested positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 10-year-old 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), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive for COVID". Clinical course: 10 year old 6 months after COVID second vaccine dose tested positive for COVID. Event took place after use of product.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Hallucination, Memory impairment
Clinical narrative: bunch of issues suddenly with memory and hallucinations; bunch of issues suddenly with memory and hallucinations; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 02161374.  An elderly patient received BNT162b2 (BNT162B2), in Jun2022 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 series complete, Unknown Manufacturer), for COVID-19 Immunization. The following information was reported: HALLUCINATION (medically significant), MEMORY IMPAIRMENT (non-serious) all with onset Jun2022, outcome "unknown" and all described as "bunch of issues suddenly with memory and hallucinations".   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Bradycardia, Condition aggravated, Dyspnoea, Jaundice
Clinical narrative: Cardiovascular/ Arrthythmia/ bradycardia; pre-existing diseases worsened: just weakness, joint pain; jaundice; dyspnea; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 67-year-old male patient received BNT162b2 (BNT162B2), in Feb2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 67 years intramuscular for covid-19 immunisation. The patient's relevant medical history included: "ckd" (unspecified if ongoing); "Colon polyps" (unspecified if ongoing); "prior pneumonia" (unspecified if ongoing); "egg allergy" (unspecified if ongoing); "shell fish allergy" (unspecified if ongoing); "pre-existing diseases: just weakness, joint pain" (unspecified if ongoing); "pre-existing diseases: just weakness, joint pain" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, intramuscular), administration date: Jan2020, for COVID-19 IMMUNIZATION; Bnt162b2 (DOSE 2, intramuscular), administration date: Jan2020, for COVID-19 IMMUNIZATION. The following information was reported: BRADYCARDIA (medically significant), outcome "unknown", described as "Cardiovascular/ Arrthythmia/ bradycardia"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "pre-existing diseases worsened: just weakness, joint pain"; JAUNDICE (non-serious), outcome "unknown"; DYSPNOEA (non-serious), outcome "unknown", described as "dyspnea".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Considering the nature of the reported events and product profile, a causal role of the suspect BNT162B2 cannot be denied for the reported events.   The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. ,Linked Report(s) : US-PFIZER INC-202200762322 same patient/vaccine, different dose/event;
Sex: F
Vaccine: COVID19
Symptoms: Ear infection, Ear pain, Nasopharyngitis, Pain in extremity, Pyrexia
Clinical narrative: cold; which progressed to a middle ear infection; rhinitis; ear pain; Fever; pain in limbs; Rash on both legs of unclear origin; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): MDEM22-02170 (Moderna).  A female patient received BNT162b2 (COMIRNATY), on 07Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (SPIKEVAX), on 11Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "RRMS" (ongoing). Concomitant medication(s) included: OCREVUS intravenous taken for relapsing-remitting multiple sclerosis, start date: 16Mar2018; TENOFOVIR. Vaccination history included: comirnaty (2ND DOSE), administration date: 30Jun2021, for COVID-19 immunization; comirnaty (1ST DOSE), administration date: 09Jun2021, for COVID-19 immunization. The following information was reported: RASH (non-serious) with onset Jan2022, outcome "recovered" (Apr2022), described as "Rash on both legs of unclear origin"; PYREXIA (non-serious) with onset 11Apr2022, outcome "recovered" (15Apr2022), described as "Fever"; PAIN IN EXTREMITY (non-serious) with onset 11Apr2022, outcome "recovered" (15Apr2022), described as "pain in limbs"; NASOPHARYNGITIS (non-serious) with onset May2022, outcome "recovered" (May2022), described as "cold"; EAR PAIN (non-serious) with onset May2022, outcome "recovered" (May2022); RHINITIS (non-serious) with onset May2022, outcome "recovered" (May2022); EAR INFECTION (non-serious) with onset May2022, outcome "recovered" (May2022), described as "which progressed to a middle ear infection". Therapeutic measures were taken as a result of rash, pyrexia, pain in extremity, nasopharyngitis, ear infection, rhinitis, ear pain.  Additional information: the patient was missing Sars-CoV-2- antibodies after the four dose of vaccination. The patient had Rash on both legs of unclear origin from early Jan2022 to Mid-Apr2022. Treatment included various creams (names cannot be remembered on request). The patient had Fever (felt; patient did not measure this) and pain in limbs from 11Apr2022 with a duration of 4 days. Treatment included ibuprofen 400 mg as needed. Patient sees relationship to fourth vaccination with Spikevax (11Apr2022). The patient had a cold (rhinitis, ear pain) from early May2022 with a duration of 2 weeks, which progressed to a middle ear infection. Treatment included antibiotic for 6 days (1-0-1; name not remembered on request). The events were not life threatening, disabling/Incapacitating or Medically Important. Hospitalization is not required.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rhinitis
Clinical narrative: cold; which progressed to a middle ear infection; rhinitis; ear pain; Fever; pain in limbs; Rash on both legs of unclear origin; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): MDEM22-02170 (Moderna).  A female patient received BNT162b2 (COMIRNATY), on 07Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (SPIKEVAX), on 11Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "RRMS" (ongoing). Concomitant medication(s) included: OCREVUS intravenous taken for relapsing-remitting multiple sclerosis, start date: 16Mar2018; TENOFOVIR. Vaccination history included: comirnaty (2ND DOSE), administration date: 30Jun2021, for COVID-19 immunization; comirnaty (1ST DOSE), administration date: 09Jun2021, for COVID-19 immunization. The following information was reported: RASH (non-serious) with onset Jan2022, outcome "recovered" (Apr2022), described as "Rash on both legs of unclear origin"; PYREXIA (non-serious) with onset 11Apr2022, outcome "recovered" (15Apr2022), described as "Fever"; PAIN IN EXTREMITY (non-serious) with onset 11Apr2022, outcome "recovered" (15Apr2022), described as "pain in limbs"; NASOPHARYNGITIS (non-serious) with onset May2022, outcome "recovered" (May2022), described as "cold"; EAR PAIN (non-serious) with onset May2022, outcome "recovered" (May2022); RHINITIS (non-serious) with onset May2022, outcome "recovered" (May2022); EAR INFECTION (non-serious) with onset May2022, outcome "recovered" (May2022), described as "which progressed to a middle ear infection". Therapeutic measures were taken as a result of rash, pyrexia, pain in extremity, nasopharyngitis, ear infection, rhinitis, ear pain.  Additional information: the patient was missing Sars-CoV-2- antibodies after the four dose of vaccination. The patient had Rash on both legs of unclear origin from early Jan2022 to Mid-Apr2022. Treatment included various creams (names cannot be remembered on request). The patient had Fever (felt; patient did not measure this) and pain in limbs from 11Apr2022 with a duration of 4 days. Treatment included ibuprofen 400 mg as needed. Patient sees relationship to fourth vaccination with Spikevax (11Apr2022). The patient had a cold (rhinitis, ear pain) from early May2022 with a duration of 2 weeks, which progressed to a middle ear infection. Treatment included antibiotic for 6 days (1-0-1; name not remembered on request). The events were not life threatening, disabling/Incapacitating or Medically Important. Hospitalization is not required.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.