chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 05Oct2021 as dose 2, single (Batch/Lot number: unknown) at the age of 48 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Small fibre neuropathy" (unspecified if ongoing); "Known allergies:Cat scan dye" (unspecified if ongoing). The patient had received other medications in in 2 weeks. Concomitant medication(s) included: LYRICA, start date: 24Dec2020; KLONOPIN, start date: 03Feb2010; PEPCID [FAMOTIDINE], start date: 06Jan2021; ZOLOFT, start date: 03Dec2020. 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: Patient received anti-viral medication Paxlovid from 30Sep2022 to 05Oct2022 for the treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old male patient received BNT162b2 (BNT162B2), in Apr2022 as dose 4 (booster), single (Lot number: fp4554) 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" (unspecified if ongoing), notes: prostate cancer (4 years ago); "allergy" (unspecified if ongoing). Concomitant medication(s) included: DOXAZOSIN.  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: (unspecified date) Unknown results, notes: Indication: COVID 19 Treatment; (04Oct2022) Negative, notes: Tested negative 04Oct; (06Oct2022) Negative, notes: Tested negative 06Oct; (08Oct2022) Positive, notes: Tested positive 08Oct. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Interchange of vaccine products; COVID 19; COVID 19; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). 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 12Sep2022 as dose 4 (booster), single (Lot number: GH9702) at the age of 61 years, in left arm for COVID-19 immunization; elasomeran (MODERNA COVID-19 VACCINE), on 11Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 11Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 20Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for COVID-19 immunization. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Sjogrens'" (unspecified if ongoing); "Hashimoto's" (unspecified if ongoing); "NHL", stop date: 2007, notes: in remission since 2007; "Primary Immune Deficiency", start date: 2015 (unspecified if ongoing), notes: on IVIG. Concomitant medications included: ESTRADIOL, start date: 01Jan2008; PROGESTERONE, start date: 01Jan2008; ADVAIR, start date: 01Jan2015; MONTELUKAST, start date: 01Jan2015; BLOOD PLASMA, start date: 01Jan2016. Past drug history included: Vicodin, reaction(s): "known allergies: Vicodin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 12Sep2022, outcome "unknown". The patient underwent the following laboratory tests and procedures: COVID-19 Test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. As COVID 19 Treatment, patient received Paxlovid from 26Sep2022 to 01Oct2022.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Mar2022 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. 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: Negative, notes: After testing negative for 3 days; Negative, notes: After testing negative for 3 days; Negative, notes: After testing negative for 3 days. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient did not had other medication in 2 weeks. No known allergies. The patient had treated for COVID-19 with anti-viral drug from 12Sep2022 to 16Sep2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 43 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: "Depression" (unspecified if ongoing). Concomitant medication(s) included: ZOLOFT, start date: 01Jan2022, stop date: 09Oct2022 received in 2 weeks. 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, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Anti-viral details for COVID 19 Treatment included paxlovid, Treatment start date: 01Oct2022, Treatment stop date: 06Oct2022. The patient had no known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test, Thyroid hormones 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 76-year-old female patient received BNT162b2 (BNT162B2), on 27Jul2022 as dose 4 (booster), single (Lot number: FP7137) at the age of 75 years, in right 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: "pernicious anemia" (unspecified if ongoing); "low thyroid" (unspecified if ongoing), notes: low thyroid; "known allergies: sulfa" (unspecified if ongoing), notes: known allergies: sulfa; "known allergies: fusarium mold" (unspecified if ongoing), notes: known allergies: fusarium mold. The patient's concomitant medications were not reported. Past drug history included: Known allergies: cipro, reaction(s): "Allergy", notes: known allergies: cipro.   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: I took five full days of Paxlovid after testing positive for COVID; (08Oct2022) negative, notes: A COVID test on 08Oct was negative; Thyroid hormones test: (unspecified date) low, notes: low thyroid. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received treatment with Paxlovid from 28Sep2022 to 02Oct2022 for covid-19. It was reported that patient took five full days of Paxlovid after testing positive for COVID. Last does was 02Oct. On 08Oct symptoms returned: congestion, feeling tired and achey. A COVID test on 08Oct was negative.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: he was positive for Covid; he was positive for Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 75-year-old male patient received BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Lot number: EN6203), on 18Mar2021 as dose 2, single (Lot number: ER2613) and on 30Aug2021 as dose 3 (booster), single (Lot number: FF2587, Expiration Date: 31Dec2021) at the age of 74 years for covid-19 immunisation. The patient's relevant medical history included: "Atrial fibrillation" (unspecified if ongoing), notes: Atrial fibrillation diagnosed over 10 years ago; "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: OXAZEPAM oral (1 capsule by mouth 4 times a day 15mg on that over 20 years) taken for anxiety. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "not recovered" and all described as "he was positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Aug2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 and treatment included Paxlovid form 08Aug2022 to 11Aug2022. Clinical course: Caller reported that her husband had went into the hospital 08Aug2022 because he fell and broke his ribs. While he was there, he was found to have Covid. He was then sent home. He had history of A-fib and was 75 years old, so he was placed on Paxlovid. Stated he only took the medicine for 3 days. When attempted for clarification on hospitalization dates and caller stated he first went in 08Aug2022. Went in around midnight and sent him home the next morning with 3 broken ribs. He was to be discharged to a nursing home, but the nursing homes required covid test and when they did it, they found out that he was positive for Covid and sent him home instead (as reported).
Sex: F
Vaccine: COVID19
Symptoms: Cardiac operation
Clinical narrative: she had open heart surgery; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Lot number: EN6203), on 18Mar2021 as dose 2, single (Lot number: ER2613) and on 30Aug2021 as dose 3 (booster), single (Lot number: FF2587, Expiration Date: 31Dec2021) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDIAC OPERATION (medically significant), outcome "unknown", described as "she had open heart surgery". Therapeutic measures were taken as a result of cardiac operation.  Clinical course: The patient stated that she had open heart surgery and was trying to get better while all this was going on. The patient stated that she and her husband both had all the vaccines and she was thankful that Pfizer came out with something because she was scared she would have got sick or Covid would kill them.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Mar2021 as dose 1, single (Lot number: ER 8734), in right arm, on 21Apr2021 as dose 2, single (Lot number: Ew 0153), in right arm and on 30Dec2021 at 14:00 as dose 3 (booster), single (Lot number: 7J8757) at the age of 67 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "High BP" (unspecified if ongoing), notes: Other medical history :High BP, former breast cancer pt,; "former breast cancer pt" (unspecified if ongoing), notes: Other medical history :High BP, former breast cancer pt,. Concomitant medication(s) included: AMLODIPINE BESYLATE, start date: 04Aug2022, stop date: 26Sep2022; MUCINEX DM, start date: 26Sep2022, stop date: 29Sep2022; TYLENOL, start date: 25Sep2022, stop date: 30Sep2022. Patient known allergies reported as none.   The following information was reported: VACCINATION FAILURE (medically significant), 1 year 6 months 8 days 7 hrs after the suspect product(s) administration, outcome "not recovered", COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient received treatment with paxlovid from 26Sep2022 to 30Sep2022 for COVID-19.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Feb2021 as dose 1, single (Lot number: EL3247), in right arm, on 14Apr2021 as dose 2, single (Lot number: FK9895), in right arm, on 05Oct2021 as dose 3 (booster), single (Lot number: FF2587), in left leg and on 12Jan2022 as dose 4 (booster), single (Lot number: EL9264) at the age of 65 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin; "High cholesterol" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (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: COVID 19 Treatment; Positive, notes: Covid-19 rebound after takin Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19.   Clinical course: Patient received COVID 19 treatment as Paxlovid from 25Sep2022 to 29Sep2022. Patient did not received other medication in 2weeks.
Age: 57.0
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 57-year-old male patient received BNT162b2 (BNT162B2), on 18Mar2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 57 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 had no relevant medical history. Patient had no Known allergies. There were no concomitant medications (Other medication in 2 weeks reported as no). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19 and treatment included Paxlovid from 23Sep2022 to 28Sep2022.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
Age: 66.0
Sex: F
Vaccine: COVID19, 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 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29May2022 as dose 4 (booster), single (Lot number: fm7553) at the age of 66 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: "PVC's" (unspecified if ongoing); "anxiety" (unspecified if ongoing). Known allergies: not to patient's knowledge. The medication in 2weeks product/Concomitant medication(s) included: XANAX. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received Anti-viral treatment details: Product: COVID 19 treatment, Treatment start date=07Oct2022, Lot number: 2815236, Indication: Treatment of COVID-19.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Vaccine dose number: 4, vaccine brand other: Moderna;; 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 27Mar2021 as dose 1, single (Lot number: CVS07462), in left arm, on 17Apr2021 as dose 2, single (Lot number: CVS07462), in left arm and on 05Nov2021 as dose 3 (booster), single (Lot number: CVS7475) at the age of 57 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 14Apr2022 as dose 4 (booster), single (Lot number: CVS3708), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Had Gillian Barre as a child" (unspecified if ongoing), notes: Other medical history: Had Gillian Barre as a child. The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment"; INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown", described as "Vaccine dose number: 4, vaccine brand other: Moderna;". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (08Oct2022) Negative, notes: Day 8 and 9 after starting Paxlovid I was feeling better and tested negative; (09Oct2022) Negative, notes: Day 8 and 9 after starting Paxlovid I was feeling better and tested negative; (10Oct2022) Positive, notes: Day 10 I was sneezing and felt "head cold" symptoms and tested positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pyrexia
Clinical narrative: fever; chills; headache; tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Oct2022 at 13:15 as dose 3 (booster), single (Batch/Lot number: unknown), 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: janssen (Dose Number: 1, Batch/Lot No: 042A21A, Vaccine Administration Time: 04:00 PM), administration date: 08Apr2021, when the patient was 57-year-old, for Covid-19 immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: FE3590, Location of injection: Arm Left, Vaccine Administration Time: 03:00 PM), administration date: 21Nov2021, when the patient was 57-year-old, for COVID-19 Immunization. The following information was reported: CHILLS (non-serious) with onset 07Oct2022 at 00:30, outcome "not recovered"; PYREXIA (non-serious) with onset 07Oct2022 at 00:30, outcome "not recovered", described as "fever"; HEADACHE (non-serious) with onset 07Oct2022 at 00:30, outcome "not recovered"; FATIGUE (non-serious) with onset 07Oct2022 at 00:30, outcome "not recovered", described as "tired". Therapeutic measures were not taken as a result of pyrexia, chills, headache, fatigue. Additional information: Lot unknown for dose 3 (The number the nurse put down G56739 is not showing valid). Vaccine administered at Public Health Clinic/Administration facility. No known allergies. No other vaccine in fourweeks. Patient did not suffer from covid prior vaccination. Covid was not tested post vaccination. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Blister, Eye swelling
Clinical narrative: bottom eyelid similar to fever blister and bump/blister underneath eye; Swelling in left eye, Swelling was about 3-4 mm in length.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Oct2022 at 14:30 as dose 3 (booster), single (Lot number: GH9702) at the age of 38 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Covid-19" (unspecified if ongoing), notes: if covid prior vaccination: Yes. Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE]. Vaccination history included: BNT162b2 (Dose 1, Single. Batch/Lot No: EW0164), administration date: 16Apr2021, for COVID-19 immunization; BNT162b2 (Dose 2, Single. Batch/Lot No: EW0170), administration date: 07May2021, for COVID-19 immunization. The following information was reported: EYE SWELLING (non-serious) with onset 08Oct2022 at 20:00, outcome "not recovered", described as "Swelling in left eye, Swelling was about 3-4 mm in length."; BLISTER (non-serious) with onset 08Oct2022 at 20:00, outcome "not recovered", described as "bottom eyelid similar to fever blister and bump/blister underneath eye". Therapeutic measures were not taken as a result of blister, eye swelling.  Additional information: The patient had no known allergies. Facility type vaccine was pharmacy or drug store. No other vaccine was received in four weeks. Other medication in two weeks included Zyrtec. The patient was not tested for covid post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 39.0
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 39-year-old male patient received BNT162b2 (BNT162B2), on 19Sep2022 at 20:45 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 39 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: HYDROXYCHLOROQUINE, start date: 30Sep2022, stop date: 09Oct2022. The following information was reported: DRUG INEFFECTIVE (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: Positive, notes: indication=Treatment of COVID-19; Positive, notes: Rebound COVID 19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It was reported that anti-viral details for product=COVID 19 Treatment, start date was on 30Sep2022, stop date was on 05Oct2022.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 68.0
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 contactable reporter(s) (Physician). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Jan2021 at 09:00 as dose 1, single (Lot number: EL3249), on 08Feb2021 at 13:00 as dose  2, single (Lot number: EL3249) and on 22Nov2021 at 14:00 as dose 3 (booster), single (Lot number: FF8841) at the age of 68 years for covid-19 immunisation. The patient's relevant medical history included: "Psoriatic arthritis" (unspecified if ongoing); "DM type2" (unspecified if ongoing); "Hypothyroid" (unspecified if ongoing); "Hypercholesterolemia" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: OTEZLA, start date: 24Sep2021. 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: Positive; Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 including Paxlovid.; Sender's Comments: A contributory role of BNT162B2 to event COVID-19 cannot be excluded based on temporal association and available information.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Headache, Pain, SARS-CoV-2 test
Clinical narrative: tested positive for Covid; tested positive for Covid; severe headache; chills; slept poorly; body aches; 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 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Lot number: EL9266), in left arm, on 24Mar2021 as dose 2, single (Lot number: FN6205), in left arm, on 19Nov2021 as dose 3 (booster), single (Lot number: FL8030), in left arm and on 20Aug2022 as dose 4 (booster), single (Lot number: FP7150), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. The following information was reported: PAIN (non-serious) with onset 20Sep2022, outcome "unknown", described as "body aches"; CHILLS (non-serious) with onset 20Sep2022, outcome "unknown"; HEADACHE (non-serious) with onset 20Sep2022, outcome "unknown", described as "severe headache"; SLEEP DISORDER (non-serious) with onset 20Sep2022, outcome "unknown", described as "slept poorly"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 21Sep2022, outcome "unknown" and all described as "tested positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Sep2022) Positive, notes: I tested positive for Covid at home on the morning of 21Sep2022; (29Sep2022) Negative, notes: On 29Sep2022 I tested negative at home and felt fine; (04Oct2022) Positive, notes: On 04Oct2022 I started coughing and had a faint positive test at home; (05Oct2022) Positive, notes: On 05Oct2022 I woke up with a headache, body aches and head and chest cold and tested positive. Therapeutic measures were taken as a result of vaccination failure, covid-19, headache, chills, sleep disorder, pain.  Clinical course: Product=COVID 19 Treatment, brand=Paxlovid, treatment start date=21Sep2022, treatment stop date=25Sep2022. Patient received other medication in 2 weeks include multivitamin. Patient had a severe headache and chills on the evening of 20Sep2022. Patient slept poorly and had body aches. Patient tested positive for Covid at home on the morning of 21Sep2022 and went to her FNP who confirmed the positive and prescribed Paxlovid. Patient stayed home and completed taking Paxlovid. On 29Sep2022 patient tested negative at home and felt fine. On 04Oct2022 patient started coughing and had a faint positive test at home. On 05Oct2022 patient woke up with a headache, body aches and head and chest cold and tested positive. Chest cold and cough were worse than when I first tested positive for Covid on 21Sep2022 before having Paxlovid treatment. Patient took Tylenol, Claritin-D, Promethazine. Patient had no known allergies.
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder, Vaccination failure
Clinical narrative: tested positive for Covid; tested positive for Covid; severe headache; chills; slept poorly; body aches; 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 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Lot number: EL9266), in left arm, on 24Mar2021 as dose 2, single (Lot number: FN6205), in left arm, on 19Nov2021 as dose 3 (booster), single (Lot number: FL8030), in left arm and on 20Aug2022 as dose 4 (booster), single (Lot number: FP7150), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. The following information was reported: PAIN (non-serious) with onset 20Sep2022, outcome "unknown", described as "body aches"; CHILLS (non-serious) with onset 20Sep2022, outcome "unknown"; HEADACHE (non-serious) with onset 20Sep2022, outcome "unknown", described as "severe headache"; SLEEP DISORDER (non-serious) with onset 20Sep2022, outcome "unknown", described as "slept poorly"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 21Sep2022, outcome "unknown" and all described as "tested positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Sep2022) Positive, notes: I tested positive for Covid at home on the morning of 21Sep2022; (29Sep2022) Negative, notes: On 29Sep2022 I tested negative at home and felt fine; (04Oct2022) Positive, notes: On 04Oct2022 I started coughing and had a faint positive test at home; (05Oct2022) Positive, notes: On 05Oct2022 I woke up with a headache, body aches and head and chest cold and tested positive. Therapeutic measures were taken as a result of vaccination failure, covid-19, headache, chills, sleep disorder, pain.  Clinical course: Product=COVID 19 Treatment, brand=Paxlovid, treatment start date=21Sep2022, treatment stop date=25Sep2022. Patient received other medication in 2 weeks include multivitamin. Patient had a severe headache and chills on the evening of 20Sep2022. Patient slept poorly and had body aches. Patient tested positive for Covid at home on the morning of 21Sep2022 and went to her FNP who confirmed the positive and prescribed Paxlovid. Patient stayed home and completed taking Paxlovid. On 29Sep2022 patient tested negative at home and felt fine. On 04Oct2022 patient started coughing and had a faint positive test at home. On 05Oct2022 patient woke up with a headache, body aches and head and chest cold and tested positive. Chest cold and cough were worse than when I first tested positive for Covid on 21Sep2022 before having Paxlovid treatment. Patient took Tylenol, Claritin-D, Promethazine. Patient had no known allergies.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Made her throw up; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 80-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown, Expiration Date: 02Dec2022) at the age of 80 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose: 1, LOT: EL9262), administration date: 29Jan2021, when the patient was 78-year-old, for COVID-19 Immunization; BNT162b2 (Dose: 2, LOT: EN6202), administration date: 25Feb2021, when the patient was 78-year-old, for COVID-19 Immunization; BNT162b2 (Dose: 3, LOT: EW0165), administration date: 28Sep2021, when the patient was 79-year-old, for COVID-19 Immunization; BNT162b2 (Dose: 4, LOT: 320308D), administration date: 15Apr2022, when the patient was 79-year-old, for COVID-19 Immunization.  The following information was reported: VOMITING (non-serious) with onset 05Oct2022, outcome "recovered" (05Oct2022), described as "Made her throw up".  Additional information: Called regarding the Covid-19 booster vaccine. Patient got her third shot on Wednesday and 30 minutes after that, she had to pull over because it made her throw up. Called the people who gave her the shot and they gave her the number and asked her to report it. Caller clarified that she had actually received 5 Covid-19 vaccines. She doesn't have any medical history or medications that she feels like would be relevant. The throwing up didn't happen with any of the other vaccines, and she hasn't changed anything since then. No other vaccines. she was due to have her Covid booster and flu shot. Wouldn't advise her to do both at the same time. Didn't had any flu vaccine.  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: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Diarrhoea, Fatigue, Myalgia
Clinical narrative: Diarrhea; muscle & joint aches; muscle & joint aches; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 82-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Oct2022 at 16:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 82 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Arthritis" (unspecified if ongoing). Concomitant medication(s) included: MELOXICAM; PRILOSEC [OMEPRAZOLE MAGNESIUM]. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: DIARRHOEA (non-serious) with onset 08Oct2022 at 12:00, outcome "recovered" (Oct2022), described as "Diarrhea"; FATIGUE (non-serious) with onset 08Oct2022 at 12:00, outcome "recovered" (Oct2022); MYALGIA (non-serious), ARTHRALGIA (non-serious) all with onset 08Oct2022 at 12:00, outcome "recovered" (Oct2022) and all described as "muscle & joint aches". Therapeutic measures were not taken as a result of diarrhoea, myalgia, arthralgia, fatigue. Additional information: The patient did not have covid prior vaccination and has not been tested for COVID-19 post vaccination.  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.
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Nasal congestion, Rhinorrhoea
Clinical narrative: shortness of breath; Runny nose; Decongestion; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A male patient 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: DYSPNOEA (non-serious), outcome "unknown", described as "shortness of breath"; RHINORRHOEA (non-serious), outcome "unknown", described as "Runny nose"; NASAL CONGESTION (non-serious), outcome "unknown", described as "Decongestion"; FATIGUE (non-serious), outcome "unknown".  Additional information: Received the Pfizer Covid 19 Vaccine the last two years and was now (as per report) had runny nose and decongestion. Caller clarified that caller had been in the Covid 19 Vaccine setting for two years. Had an e-diary and whenever had symptoms of runny nose, fatigue, shortness of breath or anything like that reports in the diary weekly. That day or the next day a doctor from the facility calls. On Monday (unspecified), caller had a runny nose and decongestion and put that in the e-diary. The doctor called the next day, or before day (06Oct2022) or whenever it was and caller explained what was happening. Was told to come into the office that day (07Oct2022), and get nose swab. Was told that Pfizer cancelled the study and won't see the caller at the office and that the caller was sent a text and called on the phone to be advised of that. Clarified, that doctor called before day afternoon, on 06Oct2022. Nobody called or sent a message informing cancelled study and won't see caller at the office. In addition, had a clin card and the clin card puts compensation for time and travel. Caller's clin card was damaged, meaning can't get compensation which already had on the clin card. There were no new clin cards at the caller's doctor's office. Can't get a new card. Money on the clin card can't be for office today to compensate time and travel. Pfizer did not call and advise caller to not come to the office or that the study was cancelled.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
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 65-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 at 20:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 64 years, in right 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hyperthyroid" (unspecified if ongoing). There were no concomitant medications. 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: (unspecified date) Positive, notes: COVID 19 Treatment; (07Oct2022) Negative, notes: tested negative 2 days after completing Paxlovid on 07Oct2022; (10Oct2022) Positive, notes: tested positive this morning 10Oct2022. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course- Patient received vaccine. Patient did not received any other medication in 2weeks. Patient received Paxlovid from 30sep2022 to 04Oct2022 for Covid-19 treatment. Patient tested negative 2 days after completing Paxlovid on 07Oct22. She started to feel like I was getting a head cold on 09Oct22 and tested positive this morning 10Oct22.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 47.0
Sex: M
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 48-year-old male patient received BNT162b2 (BNT162B2), on 26Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 47 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. 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". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Indication: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Patient did not have other medication in 2 weeks. Anti viral details product: COVID 19 Treatment, Brand: paxlovid, Treatment start date: 08Oct2022, Treatment stop date: 09Oct2022, Lot number: GF3187, Indication: Treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 57 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Glaucoma" (unspecified if ongoing); "Known allergies: Adhesive" (unspecified if ongoing); "Known allergies: wakame (seaweed)" (unspecified if ongoing). Concomitant medication(s) included: ZIOPTAN, start date: 01Jan2020, stop date: 10Oct2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: The patient received other medication (ZIOPTAN) in 2 weeks of vaccination. Anti-viral details included COVID 19 Treatment, (Paxlovid from 03Oct2022 to 08Oct2022).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune disorder
Clinical narrative: autoimmune disease that they cannot pinpoint; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the parent.  A female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 Immunization. The following information was reported: AUTOIMMUNE DISORDER (hospitalization, medically significant), outcome "unknown", described as "autoimmune disease that they cannot pinpoint".  Clinical course: The reporter stated that last year she was vaccinated at the medical center with her second dose she and she had shingles. Mentioned that ever since she has experienced tremendous pain in her arm after she was vaccinated. Stated that she has a 33 year old grandson who got vaccinated and had erratic blood pressure. Also, she has a daughter who held her sister's hand when she came off the ventilator who now has autoimmune disease that they cannot pinpoint. The patient was in the hospital for 4.5 months. Has had two doses of the vaccine. Clarified that she had the Pfizer vaccine. Her conditions did not happen until 5-6 months then she came down with it. Later clarified she is unsure if it was the Pfizer or Moderna vaccine that she had because she worked with the school system. Unable to determine which vaccine she had.  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: Blood pressure abnormal, Blood pressure measurement, Myocarditis
Clinical narrative: Myocarditis; erratic blood pressure; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  A 32-year-old male patient 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: MYOCARDITIS (medically significant), outcome "unknown"; BLOOD PRESSURE ABNORMAL (non-serious), outcome "unknown", described as "erratic blood pressure". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: Abnormal.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 65-year-old male patient received BNT162b2 (BNT162B2), on 04Mar2021 as dose 1, single (Lot number: en6198), in right arm, on 01Apr2021 as dose 2, single (Lot number: en6199), in right arm, on 12Nov2021 as dose 3 (booster), single (Lot number: fh8027), in left arm and on 05May2022 as dose 4 (booster), single (Lot number: fm9992) at the age of 65 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Paxlovid treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Reportedly the patient received anti-viral COVID 19 treatment with Paxlovid from 27Sep2022 to 01Oct2022 for treatment of COVID-19.