chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. An elderly female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Mar2022 as dose 4 (booster), single (Lot number: FM0698), in left arm for covid-19 immunisation; coviD-19 vaccine mRNA (mRNA 1273) (COVID-19 VACCINE MODERNA), on 05Jan2021 as dose 1, single (Lot number: 011L20A), in left arm, on 02Feb2021 as dose 2, single (Lot number: 012M20A), in left arm and on 21Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: sulfa" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Ampicillin, reaction(s): "Known allergies: Ampicillin". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Rebound Covid after Paxlovid course of treatment; Unknown results. Therapeutic measures were taken as a result of vaccination failure, covid-19. Treatment was given of Paxlovid from 15Jul2022 till 20Jul2022. No follow-up attempts are possible. No further information is expected. Sender's Comments: Linked Report(s): US-PFIZER INC-202201046264 Same patient, different product and event.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 79-year-old female patient received BNT162b2 (BNT162B2), on 21Jan2020 as dose 1, single (Batch/Lot number: unknown) at the age of 76 years, on 02Feb2021 as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Lot number: EL3302) for 1 day, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: AMNESIA (non-serious), outcome "unknown", described as "I have memory loss consistent". Therapeutic measures were not taken as a result of amnesia. Additional information: It was reported that the patient had three Pfizer vaccines and have memory loss consistent. The reporter reported that it was impossible to reach the company and tried to email Pfizer nothing happened. The patient had dropped five messages but not received any response. The patient would like to know if any information about memory loss for someone who has taken three different, what you call vaccine information available. The reporter reported the date and time of vaccination on 21Jan2020 then she had another one.  The reporter asked if she has to report for all three. She reported next one 02Feb2021 next one. She notified whoever wrote that go back to learn how to write properly it was awful, 12Feb1921. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 47-year-old male patient received BNT162b2 (BNT162B2), on 01Oct2021 at 13:30 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 46 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: "Diabetes T2" (unspecified if ongoing); "asthma" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN, start date: 01Jan2010. Past drug history included: Erythromycin, reaction(s): "Known allergies: Erythromycin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 08Aug2022 at 13:00, outcome "recovering" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Aug2022) Negative, notes: Tested negative 04Aug am; (05Aug2022) Negative, notes: Negative tests 05Aug, 06Aug and 08Aug am; (06Aug2022) Negative, notes: Negative tests 05Aug, 06Aug and 08Aug am; (06Aug2022) Negative, notes: Negative tests 05Aug, 06Aug and 08Aug am; (08Aug2022) Negative, notes: Negative tests 05Aug, 06Aug and 08Aug am; (08Aug2022) Positive, notes: Felt congested 08Aug afternoon, tested positive 08Aug at 1 pm. 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: 50.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive for Covid; tested positive for Covid; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old patient received BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Lot number: EL3247), on 17Mar2021 as dose 2, single (Lot number: EN6203), on 15Dec2021 as dose 3 (booster), single (Lot number: FF8839) and on 14Jun2022 as dose 4 (booster), single (Lot number: FL3197) at the age of 50 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ATENOLOL; HYDROCHLOROTHIAZIDE; ATORVASTATIN. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 06Aug2022, outcome "unknown" and all described as "tested positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Aug2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: Patient experienced congestion, cough, headaches, sore throat, and overall achiness on 06Aug2022 then tested positive for COVID on 09Aug2022. No other vaccine in 4 weeks. No COVID prior vaccination.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient (not pregnant) received BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), on 16Feb2021 as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL, start date: 04Dec2019, stop date: 04Dec2019. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team. An adult female patient received BNT162b2 (BNT162B2), as dose 4 (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 (First Booster dose, UNKNOWN MANUFACTURER), for COVID-19 immunization; Covid-19 vaccine (Primary Immunization series complete; UNKNOWN MANUFACTURER), for COVID-19 immunization. The following information was reported: RASH PRURITIC (non-serious), 3 days after the suspect product(s) administration, outcome "unknown", described as "Diffused, systemic, itchy rash". Additional information: Reporter asked if there is any reports for Pfizer covid-19 vaccine of a diffused itchy rash in patient over 55 years of age. Patient's developed a systemic rash potentially within 3 days of getting the Pfizer COVID-19 Vaccine.  It is not at the injection site, but all over.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 59 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing); "Type 2 diabetes" (unspecified if ongoing), notes: Type 2 diabetes (well controlled). Concomitant medication(s) included: CARVEDILOL; L-THYROXINE [LEVOTHYROXINE]; METFORMIN HCL. Vaccination history included: Moderna coviD-19 vaccine (Dose 1), administration date: 09Jan2021, for COVID-19 immunisation; Moderna coviD-19 vaccine (Dose 2), administration date: 06Feb2021, for COVID-19 immunisation; Moderna coviD-19 vaccine (Dose 3), administration date: 23Oct2021, for COVID-19 immunisation. 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". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19/Covid symptoms on day 11. Persistent low-grade symptoms headache sore throat and cough; Treatment of COVID-19/Covid symptoms on day 11. Persistent low-grade symptoms headache sore throat and cough; This is a spontaneous report received from a non-contactable consumer. The reporter is the patient.  A 71-year-old female patient received BNT162b2 (BNT162B2), on 16Apr2022 as dose 4 (booster), single (Lot number: FK9895), in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 23Jan2021 as dose 1, single (Lot number: 037K20A), in right arm, on 27Feb2021 as dose 2, single (Lot number: 026A21A), in right arm and on 15Nov2021 as dose 3 (booster), single (Lot number: 065F21A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: statins" (unspecified if ongoing). Concomitant medication(s) included: LEXAPRO; AMLODIPINE. Past drug history included: Lusinopril, reaction(s): "known allergies: Lusinopril". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19/Covid symptoms on day 11. Persistent low-grade symptoms headache sore throat and cough". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Return of Covid symptoms on day 11. Therapeutic measures were taken such as Paxlovid as a result of drug ineffective and covid-19. Additional information: The patient had return of Covid symptoms on day 11. Persistent low-grade symptoms headache sore throat and cough that have lasted one week (unspecified date).  No follow-up attempts are possible. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. An 80-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Lot number: EL9263), in left arm, on 22Feb2021 as dose 2, single (Lot number: EL9265), in left arm, on 29Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 05May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 80 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Mitral valve replacement" (unspecified if ongoing); "Osteoporosis" (unspecified if ongoing); "Glaucoma" (unspecified if ongoing). The patient had no known allergies. Concomitant medication(s) included: WARFARIN; VITAMIN D; ASPIRIN 81. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient was a little tired the first shot. No reaction after the other three. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: This is a spontaneous report received from a contactable reporter (consumer). The reporter is the patient. A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Feb2021 at 13:00 as dose 1, single (Lot number: Unknown), in right arm and on 27Oct2021 at 13:00 as dose 2, single (Lot number: Unknown) at the age of 65 years, in right arm for COVID-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa drugs" (unspecified if ongoing); "Depression" (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 "Did you/the patient previously receive a COVID-19 Vaccine?: Yes/ Paxlovid for COVID-19 treatment". Therapeutic measures were taken as a result of drug ineffective, COVID-19. Clinical course: The patient received Paxlovid as COVID-19 treatment from 29Jul2022 to 03Aug2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Jan2021 at 10:00 as dose 1, single (Lot number: El9264), in left arm, on 23Feb2021 at 10:00 as dose 2, single (Lot number: En6200), in left arm and on 21Dec2021 at 16:00 as dose 3 (booster), single (Lot number: 6076165) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "diabetic" (unspecified if ongoing), notes: Other medical history: Mono 3x, diabetic. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; tested positive again; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 41 years 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: "Multiple sclerosis" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing); "known allergies: sulfa" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Erythromycin, reaction(s): "known allergies: Erythromycin"; Clindamycin, reaction(s): "known allergies: Clindamycin". The following information was reported: DISEASE RECURRENCE (medically significant) with onset 09Aug2022, outcome "not recovered", described as "tested positive again"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (02Aug2022) Negative; (03Aug2022) Negative; (04Aug2022) Negative; (05Aug2022) Negative; (06Aug2022) Negative; (07Aug2022) Negative; (08Aug2022) Negative; (09Aug2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Pfizer/BioNTech/Treatment of COVID-19; Pfizer/BioNTech/Treatment of COVID-19; This is a spontaneous report received from contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 60-year-old male patient received BNT162b2 (BNT162B2), on 09Oct2020 at 13:30 as DOSE 1, SINGLE (lot number: P220395-0053L), in the left arm; on 30Oct2020 at 12:30 as DOSE 2, SINGLE (lot number: P220395-0024L), in the left arm and on 22Oct2021 at 13:00 as DOSE 3 (BOOSTER), SINGLE (lot number: P220395-0090L), in the left arm for COVID-19 immunization. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication included: OLMESARTAN/HYDROCHLOROTHIAZIDE, start date: 01Feb2017, stop date: 09Aug2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "Pfizer/BioNTech/Treatment of COVID-19." Therapeutic measures were taken as a result of Vaccination failure, Covid-19.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Pharmacist). A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 58 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, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Replacement aortic valve (congenital)" (unspecified if ongoing); "Ascending aortic aneurysm" (unspecified if ongoing); "Aortic stenosis" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Depression" (unspecified if ongoing); "vasomotor symptoms related to menopause" (unspecified if ongoing); "Osteoarthritis" (unspecified if ongoing). No known allergies. Concomitant medication(s) included: ATORVASTATIN oral, start date: Oct2005; CYMBALTA oral, start date: Apr2019; ASPIRIN [ACETYLSALICYLIC ACID] oral, start date: Oct2005. Past drug history included: Lipitor 5 mg; Premarin vaginal cream. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "started taking Paxlovid for COVID 19 Treatment/ coming back positive". The patient received COVID 19 Treatment, Paxlovid from 30Jul2022 (evening) to 04Aug2022. On 07Aug2022, the patient had noticeable increase of sneezing, congestion, aches, and feeling tired/malaise. On 08Aug2022, the patient took two home test (one I watched her do properly) with coming back positive. Currently the patient has been taking acetaminophen and naproxen for aches & pain with no appreciable relief. The patient also took a cetirizine (ZYRTEC) 10 mg to help with sneezing and congestion to some effect. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the events Drug ineffective, COVID-19 cannot be completely excluded.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: felt especially fatigued the last 4 days. I tested positive on 30Jul; felt especially fatigued the last 4 days. I tested positive on 30Jul; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Mar2021 as dose 1, single (Lot number: EN6208), in left arm, on 07Apr2021 as dose 2, single (Lot number: ER8734), in left arm and on 27Aug2021 as dose 3 (booster), single (Lot number: FC3180) at the age of 26 years, in left arm for COVID-19 immunization; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 03Feb2022 as dose 4 (booster), single (Lot number: 022J21A), in left arm for COVID-19 immunization. The patient's relevant medical history included: "Selective IgA deficiency" (unspecified if ongoing); "IgG subclass deficiency" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 30Jul2022, outcome "not recovered" and all described as "felt especially fatigued the last 4 days. I tested positive on 30Jul". The patient underwent the following laboratory tests and procedures: Covid test: (unspecified date) Positive, notes: I took a COVID test and it was positive; (30Jul2022) Positive, notes: I have felt especially fatigued the last 4 days. I tested positive on 30Jul; (09Aug2022) Positive, notes: then I just retested positive today 09Aug; PCR test (06Aug2022) Negative, notes: after testing negative on a PCR on 06Aug; rapid test (04Aug2022) Negative, notes: my rapid tests were negative starting 04Aug; (08Aug2022) Negative, notes: and on a rapid test on 08Aug. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information:: The patient woke up this morning feeling a bit of a sore throat and her nose was pretty stuffy. She took her allergy medicine and the stuffiness went away, but she was still feeling pretty low energy so she took a Covid test and it was positive. She have felt especially fatigued the last 4 days. She tested positive on 30Jul, my rapid tests were negative starting 4Aug, and then she just retested positive today (09Aug) after testing negative on a PCR on 06Aug and on a rapid test on 08Aug.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Apr2021 as dose 1, single (Lot number: EW0151), in right arm, on 26Apr2021 as dose 2, single (Lot number: Ew0170), in right arm and on 29Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 64 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 10Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Aug2022) Negative, notes: I tested negative on two home tests, 04Aug2022 and 06Aug2022; (06Aug2022) Negative, notes: I tested negative on two home tests, 04Aug2022 and 06Aug2022; (08Aug2022) Positive, notes: I tested positive on a home test on 08Aug2022. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: The patient has not had other medications in 2 weeks. The patient has no known allergies. It was reported that after a five-day course of Paxlovid, patient tested negative on two home tests, 04Aug22 and 06Aug22. I tested positive on a home test on 08Aug2022 and have very mild cold symptoms.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
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 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 41 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: Other medical history: asthma. The patient took 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: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient. A 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Sep2021 at 14:30 as dose 3 (booster), single (Lot number: FF2587), in left arm and on 28Jul2022 at 11:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 73 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: "Ankylosing spondylitis" (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: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of covid-19 which included Paxlovid administration from 04Aug2022 to 09Aug2022. Additional information: Patient has no known allergies. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 67-year-old male patient received BNT162b2 (BNT162B2), on 12Feb2021 as dose 1, single (Lot number: Em9808) at the age of 65 years, in right arm, on 05Mar2021 as dose 2, single (Lot number: En6198) at the age of 65 years, in left arm, on 01Oct2021 as dose 3 (booster), single (Lot number: 301358A) at the age of 66 years, in right arm and on 11Apr2022 as dose 4 (booster), single (Lot number: Fk9893) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Keflex, reaction(s): "allergies", notes: known allergies: Yes - Keflex. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 23Jul2022, outcome "unknown" and all described as "Contracted Covid 19". The patient contracted Covid 19 on 23Jul2022. The patient took Paxlovid for 5 days then tested negative on 30Jul2022. The patient retested on 03Aug2022 and tested positive again. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Jul2022) Negative; (03Aug2022) Positive, notes: Retested positive again. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid.
Age: 31.0
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 contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 31-year-old male patient received BNT162b2 (BNT162B2), on 18Nov2021 at 16:15 as dose 3 (booster), single (Lot number: FH8028) at the age of 31 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: "Other medical history: Bipolar Disorder" (unspecified if ongoing), notes: Other medical history: Bipolar Disorder; "Known allergies: Sulfa based antibiotics" (unspecified if ongoing), notes: Known allergies: Sulfa based antibiotics. Concomitant medication(s) included: LAMOTRIGINE, start date: Jan2018. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID 19 Treatment; Positive, notes: positive antigen test. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for Covid-19; Tested positive for 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), on 26Jan2021 as dose 1, single (Lot number: EL8982), in left arm, on 19Feb2021 as dose 2, single (Lot number: EL9266), in left arm, on 29Sep2021 as dose 3 (booster), single (Lot number: 301458A), in left arm and on 18Apr2022 at 12:00 as dose 4 (booster), single (Lot number: FK9895) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Sleep apnea" (unspecified if ongoing); "dystonia" (unspecified if ongoing); "Known allergies: Sulfas" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 15Jun2022, outcome "unknown" and all described as "Tested positive for Covid-19 ". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Jun2022) Positive; (21Jun2022) Negative; (26Jun2022) Positive; (03Jul2022) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: Rebound Covid-19. Tested positive for Covid-19 on Wed 15Jun and started Paxlovid same day. Tested negative on 21Jun. Tested positive on 26Jun after bronchitis-like cough. 03Jul tested negative (still had cough). No treatment received for rebound Covid-19.
Sex: M
Vaccine: COVID19
Symptoms: Bone disorder
Clinical narrative: developed a bump on his left clavicle between his shoulder and neck; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: The reporter is the patient.  A male patient received BNT162b2 (COMIRNATY), on 05Aug2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "aorta vein was cut ", start date: 2002 (unspecified if ongoing), notes: had to be repaired and patched with Teflon. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete, unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (First booster dose, unknown manufacturer), for COVID-19 Immunization. The following information was reported: BONE DISORDER (non-serious), outcome "unknown", described as "developed a bump on his left clavicle between his shoulder and neck".  Additional information: Seriousness was reported as No. Caller in regards to the Pfizer BIONTECH COVID 19 vaccine. Reports he got his 4th shot last Friday the 5th 05AUG2022 and has developed a bump on his left clavicle between his shoulder and neck. Caller states he got the shot in his left arm. He concerned because he has history back in 2002 in a accident his aorta vein was cut and had to be repaired and patched with teflon, concerned about the bump and seeking information. Is there any information about the bump, has this been reported before?  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: Drug ineffective, Suspected COVID-19
Clinical narrative: had four doses of the Pfizer COVID-19 vaccine, she still got COVID-19 and has now long Covid for two months now; had four doses of the Pfizer COVID-19 vaccine, she still got COVID-19 and has now long Covid for two months now; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 75-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", SUSPECTED COVID-19 (medically significant), outcome "not recovered" and all described as "had four doses of the Pfizer COVID-19 vaccine, she still got COVID-19 and has now long Covid for two months now".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201018374 same reporter/drug/event for different patients;
Age: 18.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: On 31Jan2022, she had fever and covid-19; On 31Jan2022, she had fever and covid-19; The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received. This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2K-163-4265157-00.  A 19-year-old female patient received BNT162b2 (BNT162B2), on 09Mar2021 as dose 1, single (Batch/Lot number: unknown) and on 01Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 18 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at unk (citrate free), subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 31Jan2022, outcome "recovering" and all described as "On 31Jan2022, she had fever and covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31Jan2022) Positive, notes: On 31Jan2022, the patient experienced COVID-19. The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of "on 31jan2022, she had fever and covid-19" 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.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The event indicating a lack of effect is assessed as related to the suspect drug bnt162b2 by the company, as the efficacy of a drug varies individually and may be affected by different factors including drug potency.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pain in extremity, Pyrexia
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Pharmacist). A 5-year-old male patient received BNT162b2 (BNT162B2), on 08Aug2022 at 15:00 as dose 2, single (Lot number: FL8095) at the age of 5 years intramuscular, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (lot number=FL8095, route=Intramuscular, administration time=03:30 PM, vaccine location=Left arm), administration date: 13Jul2022, when the patient was 5-year-old, for COVID-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 09Aug2022 at 05:00, outcome "recovering", described as "Fever (101.5 F)"; PAIN IN EXTREMITY (non-serious) with onset 09Aug2022 at 05:00, outcome "recovering", described as "sore arm". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, pain in extremity. Additional information: no other vaccine in four weeks. No COVID prior vaccination and no COVID tested post vaccination. The patient had no known allergies. The patient received Tylenol as treatment.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient. A 63-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on 16Dec2020 as dose 1, single (Batch/Lot number: unknown), in left arm, on 08Jan2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 31Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 62 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Obstructive sleep apnea" (unspecified if ongoing); "MALT lymphoma", start date: 2009 (unspecified if ongoing), notes: MALT lymphoma; "known allergies Sulfa" (unspecified if ongoing), notes: known allergies Sulfa. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 and included Paxlovid. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Sender's Comments: The contributory role of the suspect product, BNT162B2 vaccine to the reported vaccination failure, Covid-19 cannot be excluded as the efficacy of a vaccine varies individually and may be affected by various patient-related and vaccine-related factors.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old male patient received BNT162b2 (BNT162B2), on 04Mar2021 at 12:00 as dose 1, single (Lot number: EN6199), in left arm, on 01Apr2021 at 12:00 as dose 2, single (Lot number: ER8734), in left arm, on 29Sep2021 at 16:00 as dose 3 (booster), single (Lot number: FE3992), in right arm and on 17May2022 at 12:15 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 47 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received Paxlovid as COVID-19 treatment from afternoon 27Jul2022 to 01Aug2022. 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, COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; COVID -19 rebound; 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 male patient received BNT162b2 (BNT162B2), on 02Dec2021 at 14:00 as dose 3 (booster), single (Lot number: EW0217) at the age of 51 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Colitis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DISEASE RECURRENCE (medically significant) with onset 09Aug2022, outcome "not recovered", described as "COVID -19 rebound"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "Treatment of COVID-19". The patient took Paxlovid from 31Jul2022 to 05Aug2022 for Treatment of COVID-19. Patient reported he tested COVID positive today (09Aug2022) and he was experiencing a COVID -19 rebound case today after previously testing negative on 06Aug2022 after taking Paxlovid for 5 days. His COVID symptoms today include runny nose, congestion, sneezing, headache, slight sore throat.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 57-year-old male patient received BNT162b2, on 25Apr2022 at 14:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 57 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 and concomitant medications were not reported. Past drug history included: Known allergies: Lasix, reaction(s): "Drug allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". Paxlovid was taken to treat Covid-19 from 28Jul2022 to 01Aug2022. 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: Lymphadenopathy, Oropharyngeal discomfort, Pain in extremity
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "Swollen lymph nodes"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Arm pain"; OROPHARYNGEAL DISCOMFORT (non-serious), outcome "unknown", described as "barely talk right now/woke up like this/it's in the throat". Additional information: Consumer stated "I got a stack of papers that was giving the free shot. I can barely talk right now. I took the COVID-19 shot (Suspect Captured as per verbatim; Manufacture not clarified, hence tab left unchecked) and that I had at free shot place at Walmart's, they gave me a stack of papers. I am not understanding this. When I went in this say what should I do about side effects, it maybe a side effect. I have a paper here, reports vaccine side effects to FDA, vaccine adverse event. I understand that's why I am calling, I woke up like this, I wasn't like this when I went over there.". When paraphrased, consumer stated "I was fine but right now, its in my throat.". When probed to clarify if consumer has any questions regarding the side effect, consumer stated "That's why I am calling you. I can breathe, no chest pain. I can look at the paper real good, I got them, I have these swollen lymph nodes, no diarrhea, no vomiting but I do have the arm pain. I am not paining but I don't know why I took this shot. I have been having, I have to test that COVID-19 in one hospital and then I got over it and it was months ago. I just want to know, I don't want to go through these issues, I want to call with held  but I should see someone now because I don't have this before.". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.