chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Colitis ulcerative, Diarrhoea, Haematochezia, Pruritus, Rash
Clinical narrative: Ulcerative colitis; Itching / Pruritus; Diarrhea; Rash on arm; Bloody stool; This spontaneous case was reported by a consumer and describes the occurrence of HAEMATOCHEZIA (Bloody stool) and COLITIS ULCERATIVE (Ulcerative colitis) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hives (Hives/urticaria), Hypersensitivity reaction, Colonoscopy (Dr. confirmed ulcerative colitis, and that the vaccine caused immune system to attack on colon.) and Diverticulitis in 2018. Concurrent medical conditions included Asthma, Hypothyroidism, Sulfonamide allergy (sulfa - Rash), Penicillin allergy (Rash), Drug allergy (Cefdinir - wekts) and Allergy to antibiotic (Moxifloxacin - Rash). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism, MULTIVITAMIN ACTIVE WOMAN 55+ for an unknown indication.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced HAEMATOCHEZIA (Bloody stool) (seriousness criterion medically significant). On an unknown date, the patient experienced COLITIS ULCERATIVE (Ulcerative colitis) (seriousness criterion medically significant), PRURITUS (Itching / Pruritus), DIARRHOEA (Diarrhea) and RASH (Rash on arm). The patient was treated with MESALAZINE (PENTASA) at a dose of Pentasa. At the time of the report, HAEMATOCHEZIA (Bloody stool), COLITIS ULCERATIVE (Ulcerative colitis), PRURITUS (Itching / Pruritus) and DIARRHOEA (Diarrhea) outcome was unknown and RASH (Rash on arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       patient were taken as treatment medication that includes antibiotic for the rash.   This case was linked to MOD-2021-244731 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Additional information received On 30-Jun-2021: Upon internal review on 08-DEC-2022 non-significant corrections performed to update "case received from field" to blank.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  Further information has been requested.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration
Clinical narrative: Humira did not work as good as pre covid; First dose on 01Feb2021 and second dose on 20Mar2021; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Humira did not work as good as pre covid) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 01Feb2021 and second dose on 20Mar2021) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis and Rheumatoid arthritis.    Family history included COVID-19 (Family covid). Concurrent medical conditions included Plaque psoriasis and Rheumatoid arthritis.   In 2020, the patient ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 20-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 01Feb2021 and second dose on 20Mar2021). On an unknown date, the patient experienced COVID-19 (Humira did not work as good as pre covid). At the time of the report, COVID-19 (Humira did not work as good as pre covid) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 01Feb2021 and second dose on 20Mar2021) outcome was unknown.            Concomitant medications were not reported.  It was reported that Humira did not work as good as pre covid (Drug effect decreased). The reporter's causality for the events of Humira did not work as good as pre covid with Adalimumab Solution for Injection was Not Provided. Treatment medications were not reported.
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Glomerular filtration rate, SARS-CoV-2 test
Clinical narrative: covid; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (covid) in an elderly female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Concurrent medical conditions included Type 1 diabetes mellitus (over 65 years of age) and Kidney disorder. Concomitant products included NIRMATRELVIR, RITONAVIR (PAXLOVID) for Kidney disorder, INSULIN for Type 1 diabetes mellitus.    On an unknown date, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 07-Dec-2022, the patient experienced COVID-19 (covid). At the time of the report, COVID-19 (covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Dec-2022, SARS-CoV-2 test: Positive. On an unknown date, Glomerular filtration rate: between 50 and 60.         Patient age was over 65 years. Patient received two regular Moderna Covid-19 vaccines. Treatment medication was not reported.   This case was linked to MOD-2021-048086 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; First dose on 23-JAN-2020 and second dose on 23-APR-2020; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 23-JAN-2020 and second dose on 23-APR-2020) and NO ADVERSE EVENT (No adverse event) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Penicillin allergy.   On 23-Jan-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2020, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Apr-2020, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 23-JAN-2020 and second dose on 23-APR-2020). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 23-JAN-2020 and second dose on 23-APR-2020) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     No concomitant medications were reported. Patient received Pfizer vaccine from 17-Nov-2022 to 21-Nov-2022 for treatment of COVID-19. On 03-Dec-2022 at 09:00, patient had difficulty breathing upon exertion of activity, Cough, Sore Throat, Muscle aches, Hoarseness, Fatigue, Not sleeping well and Chills. All events were recovering. It was reported that the patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. It was reported that the patient previously received a COVID-19 Vaccine. Device Date was given as 08-Dec-2022. No treatment information was provided.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; First dose on 18-Oct-2022 and second dose on 30-Nov-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 18-Oct-2022 and second dose on 30-Nov-2022) and NO ADVERSE EVENT (No adverse event) in a 44-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 044C22A) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: Flulaval (Dose 1) on 15-Nov-2022. Past adverse reactions to the above products included No adverse event with Flulaval.    On 30-Nov-2022 at 11:48 AM, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 30-Nov-2022 at 11:48 AM, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 18-Oct-2022 and second dose on 30-Nov-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 18-Oct-2022 and second dose on 30-Nov-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 18-Oct-2022 and second dose on 30-Nov-2022).    No concomitant medication was reported. No treatment medication was reported. On 18-Oct-2022, the patient received first dose of Moderna Bivalent Vaccine.   This case was linked to MOD-2022-672840 (Patient Link).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: Cough; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced COUGH (Cough). At the time of the report, COUGH (Cough) was resolving.            No concomitant medications were reported.  The reporter's causality for the event of cough with Adalimumab solution for injection was reported as reasonable possibility.  No treatment medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: He developed a rash on his body/ It's on his legs, back, arms and it itches horribly; This spontaneous case was reported by a patient family member or friend and describes the occurrence of RASH PRURITIC (He developed a rash on his body/ It's on his legs, back, arms and it itches horribly) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: COVID-19 vaccine (Received first two vaccines for COVID). Past adverse reactions to the above products included No adverse reaction with COVID-19 vaccine.    On 27-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH PRURITIC (He developed a rash on his body/ It's on his legs, back, arms and it itches horribly). At the time of the report, RASH PRURITIC (He developed a rash on his body/ It's on his legs, back, arms and it itches horribly) had not resolved.            No concomitant medication information was reported.  On 27-Dec-2021, the patient received the Moderna booster shot.   The patient developed a rash on the body that was still present for an entire year later. The patient was still suffering from this rash.  The patient had consulted with physicians and nobody knew how to treat this condition. It cost the patient a lot of money.  No treatment medications were reported.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Dose 1 received on 8-Mar-2021 and Dose 2 received on 16-Apr-2021; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 received on 8-Mar-2021 and Dose 2 received on 16-Apr-2021) and NO ADVERSE EVENT (No adverse event) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 received on 8-Mar-2021 and Dose 2 received on 16-Apr-2021) and NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 received on 8-Mar-2021 and Dose 2 received on 16-Apr-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 received on 8-Mar-2021 and Dose 2 received on 16-Apr-2021).    Concomitant medications were not reported.  Treatment information was not provided.   This case was linked to MOD-2022-675268 (Patient Link).
Age: 46.0
Sex: F
Vaccine: COVID19, 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) (Physician). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Sep2022 at 17:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 46 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. The patient had no known allergies. Patient received other vaccine and no other medication in 2weeks. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 Paxlovid started on 26Nov2022 and stopped on 30Nov2022. Clinical course was reported as, Covid rebound on 04Dec2022 at 06:00. No treatment received for symptoms and patient was not recovered from symptoms. No other medication in 2 weeks. No known allergies.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to its Lack of efficacy cannot be ruled out.
Age: 42.0
Sex: F
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 42 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); "Pre-ventricular contractions" (unspecified if ongoing). Concomitant medication(s) included: CRESTOR, start date: 01Jun2022, stop date: 27Nov2022; MYRBETRIQ taken for incontinence, start date: 01Jan2022, stop date: 06Dec2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Anti-viral Product Paxlovid from 27Nov2022 till 01Dec2022 for Covid-19 Treatment. Patient received antibiotic Azithromycin from 27Nov2022 till 01Dec2022. Had rebound of congestion from 05Dec2022 and recovered on unspecified, with no treatment. Vaccine lot unknown reason was Not available/provided to reporter at the time of report completion.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Nov2022 at 15:45 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 51 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: METOPROLOL. 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". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient had no known allergies. Anti-viral details: COVID 19 Treatment; Paxlovid  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 64.0
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) from product quality group. The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 as dose 5 (booster), single (Lot number: GJ2524) at the age of 64 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 27Feb2021 as dose 1, single (Lot number: EN6201), on 24Mar2021 as dose 2, single (Lot number: EN6205), on 07Oct2021 as dose 3 (booster), single (Lot number: Ff2589) and on 01Apr2022 as dose 4 (booster), single (Lot number: Fk9895), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes, on insulin pump" (unspecified if ongoing) and no known allergies. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 26Nov2022 to 01Dec2022.  Clinical course: No known allergies
Age: 82.0
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 contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  An 83-year-old male patient received BNT162b2 (BNT162B2), on 19May2022 at 13:30 as dose 4 (booster), single (Lot number: FK9893) at the age of 82 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Prostate Cancer Radiation + Hormone Therapy 2014" (unspecified if ongoing), notes: Prostate Cancer Radiation + Hormone Therapy 2014; "Pollen Allergy" (unspecified if ongoing); "Radiation" (unspecified if ongoing), notes: Radiation + Hormone Therapy 2014; "Hormone Therapy", start date: 2014 (unspecified if ongoing), notes: Hormone Therapy 2014. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (2022) Negative, notes: had aleady tested negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Treatment included Pfizer covid-19 treatment from 26Aug2022 to 30Aug2022. The patient had no known allergies. Other medical history included Prostate Cancer Radiation + Hormone Therapy 2014; Pollen Allergy.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunization; BNT162b2 (BNT162B2), on 19Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 09Feb2021 as dose 2, single (Lot number: EM9809), in left arm, on 21Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 04Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunization. The patient's relevant medical history included: "hypertension" (unspecified if ongoing); "isolated case of afib" (unspecified if ongoing); "penicillin allergy" (unspecified if ongoing). Concomitant medication(s) included: CARTIA XT; ETODOLAC; VALSARTAN; PRILOSEC [OMEPRAZOLE]; CITRACAL + D [CALCIUM CITRATE;COLECALCIFEROL]; CENTRUM B. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: positive tests. Therapeutic measures were taken as a result of vaccination failure, covid-19. Adverse event included Heavy cold symptoms: coughing, sneezing, chills, fever, positive tests, rebound. Ae treatment: Paxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from product quality group. The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Sep2022 as dose 5 (booster), single (Lot number: 6149693), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 25Jan2021 as dose 1, single (Lot number: P220395-0074L), in left arm, on 23Feb2021 as dose 2, single (Lot number: P220395-0077L), in left arm, on 27Oct2021 as dose 3 (booster), single (Lot number: P220395-0089L), in left arm and on 13May2022 as dose 4 (booster), single (Lot number: FM999Z), in left arm for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing). Concomitant medication(s) included: LIPITOR, start date: Jan2019 (ongoing); AMLODIPIN [AMLODIPINE BESILATE], start date: Jun2022; OLMESARTAN, start date: Jan2019 (ongoing); PRILOSEC [OMEPRAZOLE MAGNESIUM], start date: Jan2012 (ongoing); ZYRTEC [CETIRIZINE HYDROCHLORIDE], start date: Feb1996 (ongoing).  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Test for Covid-19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.; 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: 52.0
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). The reporter is the patient.  A 52-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 52 years, in left arm for covid-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "anxiety" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: No Known allergies: No, No other medication in 2 weeks. COVID 19 Treatment with Paxlovid from 27Nov2022 to 01Dec2022.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 59.0
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) from product quality group. The reporter is the patient.  A 59-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Sep2022 as dose 4 (booster), single (Lot number: GH9694) at the age of 59 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: "MS" (unspecified if ongoing); "cholesterol" (unspecified if ongoing). Concomitant medication(s) included: TECFIDERA; ROSUVASTATIN; BACLOFEN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Covid positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 27Nov2022 to 01Dec2022.  Clinical course: No known allergies. Covid positive & started Paxlovid on 27Nov2022. Symptom-free until 04Dec2022.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse) from product quality group.  A 40-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Oct2022 as dose 4 (booster), single (Lot number: gj6739) at the age of 40 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "depression" (unspecified if ongoing); "GERD" (unspecified if ongoing); "migraines" (unspecified if ongoing); "Known allergies: latex" (unspecified if ongoing); "Known allergies: adhesives" (unspecified if ongoing); "Known allergies: nickel" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Clindamycin, reaction(s): "known allergies"; Doxycycline, reaction(s): "known allergies".  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Other medication in 2 weeks was unknown. Paxlovid orally from 05Dec2022 to 07Dec2022 for COVID 19 Treatment.; Sender's Comments: Based on available information and the temporal association, a possible contributory role of Comirnaty vaccine cannot be excluded for the reported events of "DRUG INEFFECTIVE " and "COVID-19 ".
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Investigation, Nasopharyngeal swab, SARS-CoV-2 test
Clinical narrative: Covid positive after vaccines and boosters; Covid positive after vaccines and boosters; 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.  An 80-year-old female patient received BNT162b2 (BNT162B2), on 22Jan2021 as dose 1, single (Lot number: EL9262), on 02Feb2021 as dose 2, single (Lot number: EL9269), on 18Oct2021 as dose 3 (booster) , single (Lot number: FE3590) and on 20Aug2022 as dose 4 (booster), single (Lot number: FP7137) at the age of 79 years for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing), notes: COVID-19 Caller has had Covid 19 a total of three times. States that she cannot remember the dates or time frames for the first two times she had Covid 19. Concomitant medication(s) included: ARICEPT. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05Dec2022, outcome "not recovered" and all described as "Covid positive after vaccines and boosters". The patient underwent the following laboratory tests and procedures: Flu test: (unspecified date) Negative, notes: Doctor also tested her for the flu and another test that they swab for, but both of those were negative; Nasopharyngeal swab: (unspecified date) Negative, notes: Doctor also tested her for the flu and another test that they swab for, but both of those were negative; SARS-CoV-2 test: (05Dec2022) Positive; Scan brain: (05Dec2022) Unknown results, notes: The doctor did a brain scan. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: COVID-19 Caller has had Covid 19 a total of three times. States that she cannot remember the dates or time frames for the first two times she had Covid 19. Her most recent positive Covid 19 test, for her third time having it, was on 05Dec2022. Patient was received Paxlovid as treatment (Start: 05Dec2022 Stop: Ongoing). Paxlovid, the medication they gave her for Covid.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Scan brain
Clinical narrative: Covid positive after vaccines and boosters; Covid positive after vaccines and boosters; 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.  An 80-year-old female patient received BNT162b2 (BNT162B2), on 22Jan2021 as dose 1, single (Lot number: EL9262), on 02Feb2021 as dose 2, single (Lot number: EL9269), on 18Oct2021 as dose 3 (booster) , single (Lot number: FE3590) and on 20Aug2022 as dose 4 (booster), single (Lot number: FP7137) at the age of 79 years for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing), notes: COVID-19 Caller has had Covid 19 a total of three times. States that she cannot remember the dates or time frames for the first two times she had Covid 19. Concomitant medication(s) included: ARICEPT. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05Dec2022, outcome "not recovered" and all described as "Covid positive after vaccines and boosters". The patient underwent the following laboratory tests and procedures: Flu test: (unspecified date) Negative, notes: Doctor also tested her for the flu and another test that they swab for, but both of those were negative; Nasopharyngeal swab: (unspecified date) Negative, notes: Doctor also tested her for the flu and another test that they swab for, but both of those were negative; SARS-CoV-2 test: (05Dec2022) Positive; Scan brain: (05Dec2022) Unknown results, notes: The doctor did a brain scan. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: COVID-19 Caller has had Covid 19 a total of three times. States that she cannot remember the dates or time frames for the first two times she had Covid 19. Her most recent positive Covid 19 test, for her third time having it, was on 05Dec2022. Patient was received Paxlovid as treatment (Start: 05Dec2022 Stop: Ongoing). Paxlovid, the medication they gave her for Covid.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Lymphadenopathy, Vulval ulceration
Clinical narrative: vulvar aphthous ulcer in adolescent; swollen lymph nodes in left armpit; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 13-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Dec2022 at 16:00 as dose 4 (booster), single (Lot number: GJ6738) at the age of 13 years intramuscular, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: SLOW FE; ALLEGRA 24 HOUR. Vaccination history included: BNT162b2 (dose 3 (booster), administered intramuscularly in the left arm at 18:15, Batch/Lot no: unknown), administration date: 06Jan2022, when the patient was 12-year-old, for COVID-19 immunization; Covid-19 vaccine (primary immunization series complete, manufacturer unknown), for COVID-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 05Dec2022 at 18:00, outcome "recovering", described as "swollen lymph nodes in left armpit"; VULVAL ULCERATION (non-serious) with onset 05Dec2022 at 18:00, outcome "recovering", described as "vulvar aphthous ulcer in adolescent". The events "vulvar aphthous ulcer in adolescent" and "swollen lymph nodes in left armpit" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of vulval ulceration, lymphadenopathy.  Additional information: Patient had no other vaccine in four weeks. Doctor confirmed the events on 07Dec2022. Bloodwork was ordered and it was confirmed that no other virus present such as mono, flu, or pneumonia. Therapeutic measures were taken as a result of vulval ulceration, lymphadenopathy which included topical cortisone, topical lidocaine, and ibuprofen.
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Pain, Pain in extremity, Vaccination site pain, X-ray
Clinical narrative: Experiencing pain in the left arm/from the injection site down to the fingers; Experiencing pain in the left arm/from the injection site down to the fingers/Throbbing pain/painful, pain down to fingers; The problem is going extremely worse; She would stay awake at night; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), in 2021 as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "not recovered", described as "Experiencing pain in the left arm/from the injection site down to the fingers"; PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "Experiencing pain in the left arm/from the injection site down to the fingers/Throbbing pain/painful, pain down to fingers"; PAIN (non-serious), outcome "not recovered", described as "The problem is going extremely worse"; INSOMNIA (non-serious), outcome "unknown", described as "She would stay awake at night". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller reported the Pfizer-BioNTech COVID-19 Vaccine which she received in 2021. She was still experiencing pain in the left arm, from the injection site down to the fingers. She describes it as a throbbing pain. She wanted to know if this side effect has been reported before. She said that nobody seems to be able to help her and the problem was going extremely worse. Stated she had the vaccine in left arm and her arm throbbed for months after. She had an X-ray. Throbbing was so bad, she would stay awake at night, painful, pain down to fingers. She doesn't know what to do. The throbbing hasn't gone away. Throbbing gets worse on a daily basis; never goes away. Caller felt that the report will just get sweeped under a rug. She was trying to fix this issue and wanted to speak to someone.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Coccidioidomycosis, Pneumonia, Sepsis
Clinical narrative: Pneumonia; sepsis; Valley Fever in Apr2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient received BNT162b2 (BNT162B2), on 01Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 69 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "HBP", start date: 1990 (ongoing), notes: HBP; "increase cholesterol", start date: 1990 (ongoing), notes: increase cholesterol; "Gastric Ulcer", start date: 2017 (unspecified if ongoing); "Pre diabetic" (ongoing), notes: Pre diabetic; "Ulcer" (ongoing). Concomitant medication(s) included: LISINOPRIL oral taken for hypertension (ongoing); METFORMIN oral taken for glucose tolerance impaired (ongoing); TOPROL XL oral taken for hypertension (ongoing); PANTOPRAZOLE oral taken for ulcer (ongoing); ATORVASTATIN oral taken for blood cholesterol increased (ongoing); HTZ oral taken for hypertension (ongoing). Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Time: 01:30 pm, Anatomical site of injection: Right Arm, Route of administration: Intramuscular, Batch/Lot number: EL9262), administration date: 09Feb2021, when the patient was 68-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE, Time: 01:00 pm, Anatomical site of injection: Left Arm, Route of administration: Intramuscular, Batch/Lot number: EN0202: Unable to locate or Read the details), administration date: 03Mar2021, when the patient was 68-year-old, for COVID-19 immunization. The following information was reported: PNEUMONIA (hospitalization, medically significant) with onset Apr2022, outcome "unknown"; COCCIDIOIDOMYCOSIS (medically significant) with onset Apr2022, outcome "unknown", described as "Valley Fever in Apr2022"; SEPSIS (hospitalization, medically significant) with onset Apr2022, outcome "unknown". The patient was hospitalized for pneumonia, sepsis (start date: Apr2022, discharge date: Aug2022). Therapeutic measures were taken as a result of pneumonia, sepsis. Clinical information: No Specific Relevant tests for thromboembolic events with thrombocytopenia. Hospitalized for sepsis and Pneumonia, T4 with Fluconazole 40 mg from Apr to Aug2022.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nasal congestion, Oropharyngeal pain, Pain, Pain in extremity
Clinical narrative: Body aches; sore throat; congestion; fatigue; sore arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Dec2022 at 14:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 42 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Shellfish" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN D [COLECALCIFEROL]; VITAMIN B COMPLEX. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: Unknown), administration date: Mar2021, for COVID-19 Immunization; Bnt162b2 (DOSE 2, SINGLE; Lot number: Unknown; Anatomical location: Arm Right), administration date: Oct2021, when the patient was 41 years old, for COVID-19 Immunization, reaction(s): "Inappropriate schedule of vaccine administered". The following information was reported: PAIN (non-serious) with onset 07Dec2022, outcome "recovering", described as "Body aches"; NASAL CONGESTION (non-serious) with onset 07Dec2022, outcome "recovering", described as "congestion"; FATIGUE (non-serious) with onset 07Dec2022, outcome "recovering"; PAIN IN EXTREMITY (non-serious) with onset 07Dec2022, outcome "recovering", described as "sore arm"; OROPHARYNGEAL PAIN (non-serious) with onset 07Dec2022, outcome "recovering", described as "sore throat". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain, oropharyngeal pain, nasal congestion, fatigue, pain in extremity.  Additional information: The reporter assessed the event as non-serious. The patient did not receive any other vaccination in 4 weeks. The patient did not had COVID prior to vaccination and was tested for COVID post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201362476 Same patient/Vaccine,different event,different vaccine dose;
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Body aches; sore throat; congestion; fatigue; sore arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Dec2022 at 14:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 42 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Shellfish" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN D [COLECALCIFEROL]; VITAMIN B COMPLEX. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: Unknown), administration date: Mar2021, for COVID-19 Immunization; Bnt162b2 (DOSE 2, SINGLE; Lot number: Unknown; Anatomical location: Arm Right), administration date: Oct2021, when the patient was 41 years old, for COVID-19 Immunization, reaction(s): "Inappropriate schedule of vaccine administered". The following information was reported: PAIN (non-serious) with onset 07Dec2022, outcome "recovering", described as "Body aches"; NASAL CONGESTION (non-serious) with onset 07Dec2022, outcome "recovering", described as "congestion"; FATIGUE (non-serious) with onset 07Dec2022, outcome "recovering"; PAIN IN EXTREMITY (non-serious) with onset 07Dec2022, outcome "recovering", described as "sore arm"; OROPHARYNGEAL PAIN (non-serious) with onset 07Dec2022, outcome "recovering", described as "sore throat". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain, oropharyngeal pain, nasal congestion, fatigue, pain in extremity.  Additional information: The reporter assessed the event as non-serious. The patient did not receive any other vaccination in 4 weeks. The patient did not had COVID prior to vaccination and was tested for COVID post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201362476 Same patient/Vaccine,different event,different vaccine dose;