chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Investigation, Menstrual disorder, SARS-CoV-2 test
Clinical narrative: have not been having regular periods anymore; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Mar2021 as dose 2, single (Lot number: ER8737) at the age of 38 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "epilepsy" (unspecified if ongoing); "childhood asthma" (unspecified if ongoing); "seasonal allergies" (unspecified if ongoing). Concomitant medication(s) included: DEPAKOTE; FOLIC ACID; VITAMIN D [COLECALCIFEROL]; MULTIVITAMIN [VITAMINS NOS]. Past drug history included: Cephalexin, reaction(s): "known allergies: cephalexin"; Bactrim, reaction(s): "known allergies: bactrim". Vaccination history included: BNT162b2 (Dose 1, single, Batch/Lot No: EN6208, Location of injection: Arm Left), administration date: 09Mar2021, when the patient was 38-year-old, for COVID-19 immunization, reaction(s): "have not been having regular periods anymore". The following information was reported: MENSTRUAL DISORDER (non-serious) with onset Mar2021, outcome "not recovered", described as "have not been having regular periods anymore". The event "have not been having regular periods anymore" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Ever since receiving the Covid vaccines patient had not been having regular periods anymore. After her initial covid vaccine she thought it could just be a coincidence but after she received her subsequent doses it was apparent that it was related. she still has not had a period after receiving her last dose and her husband and she were hoping to have another child. Her PCP has done lab work & found no abnormal hormone levels or other factors that would indicate any other issues or early menopause etc. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered at inappropriate site, Vomiting
Clinical narrative: Vomiting starting at 36 hours after vaccine administration, for around 6 hours off and on through the night. No fever, and otherwise healthy/happy.; vaccine Location=Left leg; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 2-year-old female patient received BNT162b2 (BNT162B2), on 24Jun2022 at 09:15 as dose 1, single (Lot number: FT9142) at the age of 2 years, in left leg for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious) with onset 24Jun2022 at 09:15, outcome "unknown", described as "vaccine Location=Left leg"; VOMITING (non-serious) with onset 25Jun2022 at 22:00, outcome "recovered", described as "Vomiting starting at 36 hours after vaccine administration, for around 6 hours off and on through the night. No fever, and otherwise healthy/happy.". Therapeutic measures were not taken as a result of product administered at inappropriate site, vomiting.  Additional information:Facility type vaccine: Doctor's office/urgent care, The patient did not receive other vaccine in fourweeks or any other medication in two weeks. The patient reported vomiting starting at 36 hours after vaccine administration, for around 6 hours off and on through the night. No fever, and otherwise healthy/happy. The patient did not receive covid prior vaccination or covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Herpes zoster
Clinical narrative: I have been vaccinated (unspecified vaccine) and I am on Xeljanz; I got shingles; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (002591). The reporter is the patient.  A 68-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; tofacitinib citrate (XELJANZ), (Lot number: FH6267, Expiration Date: May2025) at 5 mg 2x/day (one tablet in the morning and one tablet in the evening) for rheumatoid arthritis, osteoarthritis. The patient's relevant medical history included: "Depression" (ongoing); "Blood pressure high" (unspecified if ongoing); "Sleep and Depression" (ongoing), notes: Sleep and Depression; "Sleep and Depression" (ongoing), notes: Sleep and Depression; "to maintain cellular integrity" (ongoing), notes: to maintain cellular integrity; "I take it for my bones" (ongoing), notes: I take it for my bones. Concomitant medication(s) included: VITAMIN D3 taken for bone disorder; FOLIC ACID taken for plasma cell disorder; PAMELOR taken for sleep disorder, depression. The following information was reported: HERPES ZOSTER (non-serious) with onset 10Jun2022, outcome "unknown", described as "I have been vaccinated (unspecified vaccine) and I am on Xeljanz; I got shingles". The action taken for tofacitinib citrate was unknown. Therapeutic measures were not taken as a result of herpes zoster.  Additional information: It was reported that a patient on the back line, needs to report about reporting earlier a case of shingles after receiving the vaccine, so she said it was the Pfizer vaccine, she got shingles. And consumer stated, "No, that's not what I am calling about, I am on Xeljanz 5mg B.I.D and I have been vaccinated all the vaccine that are available, and I have taken the vaccination had disasters shingles, vaccine (unspecified vaccine) which would be two (doses) and of the Jun I started developing up Shingles. I am calling to report having the shingles and after I have been vaccinated.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 62.0
Sex: M
Vaccine: COVID19, 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 62-year-old male patient received BNT162b2 (BNT162B2), on 19Apr2022 at 14:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 62 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 had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Negative; (Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: No other medication in 2weeks. anti viral COVID 19 Treatment Plaxovid, treatment start date 18Jun2022, treatment stop date 23Jun2022, adverse event Tested negative then after day 10 got sick again and tested positive. if patient recovered Not recovered, known allergies No and no other medical history.  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 contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: positive at home test; Negative, notes: after I had recovered and had negative test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 44-year-old male patient received BNT162b2 (BNT162B2), on 18Dec2020 at 05:30 as dose 1, single (Lot number: Ej1685), in left arm, on 08Jan2021 at 06:00 as dose 2, single (Lot number: El1283), in left arm and on 27Sep2021 at 17:00 as dose 3 (booster), single (Lot number: Fe3592) at the age of 42 years, in left arm 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 "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: Rebound Covid positive after taking paxlovid; Unknown results, notes: Indication: Covid-19 treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: The patient did not receive any other medication in 2weeks. Other medical history: None.  No follow-up attempts are possible. No further information is expected. OR  No follow-up attempts are needed. No further information is expected.
Age: 54.0
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 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Feb2021 as dose 1, single (Lot number: EN6200), in left arm, on 14Mar2021 as dose 2, single (Lot number: EP7534), in left arm and on 02Oct2021 as dose 3 (booster), single (Lot number: PFRERFE3F90) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High Blood Pressure" (unspecified if ongoing), notes: High Blood Pressure. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Jun2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Follow-up attempts are completed. No further information is expected.
Age: 60.0
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 a contactable reporter(s) (Physician). The reporter is the patient.  A 60-year-old male patient received BNT162b2 (BNT162B2), on 26Sep2021 at 10:00 as dose 3 (booster), single (Lot number: FF2587) at the age of 60 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: "food allergies" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Jun2022) Negative; (29Jun2022) Positive, notes: home test x 2; (29Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Apr2022 as dose 4 (booster), single (Lot number: FMO698) at the age of 70 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 11Jan2021 as dose 1, single (Lot number: 013L20A), in left arm, on 08Feb2021 as dose 2, single (Lot number: 013M20A), in left arm and on 03Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ATORVASTATIN, stop date: 16Jun2022; LISINOPRIL; METOPROLOL; LANSOPRAZOLE; CLOPIDOGREL; FAMOTIDINE. Past drug history included: Benadryl, reaction(s): "Allergy: Benadryl", notes: known allergies: Benadryl; Omnicef, reaction(s): "Allergy: Omnicef", notes: known allergies: Omnicef; Z-pak, reaction(s): "Allergy: Z-Pak", notes: known allergies: Z-Pak; Amoxicillin, reaction(s): "Allergy: amoxicillin", notes: known allergies: amoxicillin; Cefdinir, reaction(s): "Allergy: cefdinir", notes: known allergies: cefdinir; Sulfadiazine, reaction(s): "Allergy: sulfadiazine", notes: known allergies: sulfadiazine. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Positive; (24Jun2022) Negative; (26Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient took other medication in 2 weeks. The patient was treated with Paxlovid for COVID-19 from 16Jun2022 to 20Jun2022. Rebound COVID-originally tested positive for COVID and started Paxlovid 17Jun2022 then tested negative on 24Jun2022. Symptoms hit again 26Jun2022 and tested positive on 26Jun2022.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: covid; covid; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 14Feb2022 at 12:00 as dose 4 (booster), single (Lot number: CV59749) at the age of 69 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Coronary artery disease" (unspecified if ongoing); "Lung cancer" (unspecified if ongoing); "HTN" (unspecified if ongoing), notes: Other medical history: HTN; "Hypothyroid" (unspecified if ongoing), notes: Other medical history: hypothyroid; "Osteoarthritis" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTIN, start date: 30Apr2010, stop date: 16Jun2022; PLAVIX, start date: 30Apr2020, stop date: 16Jun2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: indication=Treatment of COVID-19; (23Jun2022) Negative, notes: Tested negative one day after completing Paxlovid course; (26Jun2022) Positive, notes: Positive test 4 days after completing course. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Tested negative one day after completing Paxlovid course. Recurring nasal congestion and positive test 4 days after completing course. Having nasal congestion, mild cough, no fever, no body aches. Mild headache.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The reported COVID-19 positive after COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Did not feel very good after her first booster; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient received BNT162b2 (BNT162B2), 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. Vaccination history included: Covid-19 vaccine (Verbatim: two doses of the Covid Vaccine, Primary Immunization series complete; unknown manufacturer), for Covid-19 immunization; Flu vaccine (Verbatim: Sick as a dog after flu vaccine States that she had one flu shot), for Flu, reaction(s): "Sick". The following information was reported: MALAISE (non-serious), outcome "unknown", described as "Did not feel very good after her first booster".  Additional information: Caller states that she is 70 years old and sometimes weighs 100 pounds, but is usually a few pounds under that. States she does not understand why she would take the same dose of the Covid Vaccine that a 500 pound man takes. Caller states that she has had two doses of the Covid Vaccine and then the booster. She wants to get the second booster and talked to her doctor about getting the child's dose. Caller states that her doctor prescribed it for her, but her vaccination provider would not give it to her, that provider gave her the phone number for Pfizer. Caller states that she did not feel very good after her first booster. Caller mentions that she has been a vegetarian for about 50 years. States that she had one flu shot in her life when they first came out when she was in high school and it made her sick as a dog. Caller states that she is not an anti-vaxxer, but she is cautious. States that the flu vaccine might have been a live vaccine back then, or egg based, and she doesn't eat eggs. Caller declines to complete safety report, states she does not think it matters. Caller also declines to provide last name and phone number, states it is not relevant.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: 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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult patient received BNT162b2 (BNT162B2), on 02Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 26Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 06Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes type 2" (unspecified if ongoing), notes: Other medical history: Diabetes type 2; "asthma" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing); "Known allergies: Peanuts" (unspecified if ongoing), notes: Known allergies: Peanuts. 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: 79.0
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.  An 80-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Feb2021 as dose 1, single (Lot number: EL9262), in left arm, on 27Feb2021 as dose 2, single (Lot number: EN6205), in left arm and on 07Oct2021 as dose 3 (booster), single (Lot number: WAG09477) at the age of 79 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 25Apr2022 at 10:00 as dose 4 (booster), single (Lot number: 059M21A), in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Cipro, reaction(s): "known allergies: Cipro", notes: Known allergies: Cipro Keflex; Keflex, reaction(s): "known allergies: Keflex", notes: Known allergies: Cipro Keflex. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Three days after testing negative; negative, notes: Three days after testing negative; positive, notes: I tested positive for Covid again. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: If vaccine received reported as Yes. Other medication in 2weeks reported as No. Anti-viral details: Product: Covid 19 Treatment, brand: Paxlovid, treatment start date: 03Jun2022, treatment stop date: 07Jun2022, Adverse event reported as Three days after testing negative I started to have symptoms. Two days later I tested positive for Covid again.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Positive COVID test; Positive COVID test; The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received. This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old male patient received BNT162b2 (BNT162B2), on 09Aug2021 as dose 2 (booster), single (Batch/Lot number: unknown), in left arm and on 09Feb2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 31 years, in right arm for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 04Apr2021 as dose 1, single, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Ulcerative colitis" (unspecified if ongoing). Concomitant medication(s) included: STELARA, start date: 14Oct2021. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Positive COVID test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: Positive COVID test 5 days after completion of Paxlovid after having tested negative; (unspecified date) Unknown results, notes: COVID 19 Treatment; (27Jun2022) Positive, notes: Positive COVID test. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: COVID symptoms returned 5 days after completion of Paxlovid. Positive, COVID test 5 days after completion of Paxlovid after having tested negative immediately following Paxlovid course. Adverse event start date 27Jun2022.  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; 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 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Cll/sll" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing), notes: Penicillin sulfates. Concomitant medication(s) included: CALQUENCE, start date: 31Dec2020. 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. Therapeutic measures were taken as a result of drug ineffective, covid-19.   Clinical Course: The patient took other medication in 2 weeks. The patient received COVID 19 Treatment with start date reported as 16Jun2022 and stop date as 21Jun2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. An 89-year-old female patient received BNT162b2 (BNT162B2), in Dec2020 as dose 1, single (Batch/Lot number: unknown), in left arm and in Feb2022 as dose 2, single (Batch/Lot number: unknown) at the age of 88 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing), notes: high blood pressure; "hypothyroidism" (unspecified if ongoing); "GERD" (unspecified if ongoing); "hypertensive chronic kidney" (unspecified if ongoing), notes: hypertensive chronic kidney, disease. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of suspected covid-19.  Clinical course: Adverse event: After taking first dosage at 2pm, immediately had bitter taste in my mouth. At 4pm, experienced explosive diarrhea that lasted 15 minutes. Green in color, and then black in color next two times.  The information on the batch/lot number for (BNT162B2), has been requested and will be submitted if and when received.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 16Mar2021 as dose 2, single (Batch/Lot number: unknown), in right arm and on 21Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 32 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing), notes: Other medical history: Anxiety; "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa, augmenten, erythramycen. Concomitant medication(s) included: ESCITALOPRAM, start date: 31May2022, stop date: 29Jun2022 was also other medication in 2 weeks. Past drug history included: Augmentin, reaction(s): "Known allergies: augmentin", notes: Known allergies: Sulfa, augmenten, erythramycen; Erythromycin, reaction(s): "Known allergies: erythromycin", notes: Known allergies: Sulfa, augmenten, erythramycen. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Rebound of symptoms after a negative test after completing full course of paxlovid; Unknown results, notes: Rebound of symptoms after a negative test after completing full course of paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid.  Clinical course: Other medication in 2weeks product was Plan B emergency contraceptive; start date: 09Jun2022; stop date: 09Jun2022. Rebound of symptoms after a negative test after completing full course of paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Positive for Covid-19; Positive for Covid-19; This is a solicited report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4443121-00 (Agency). A 16-year-old female patient received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown), in 2021 as dose 2, single (Batch/Lot number: unknown) and in 2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 16 years for covid-19 immunisation. The patient's relevant medical history included: "Nontobacco user" (unspecified if ongoing), notes: Nontobacco user; "Abstains from alcohol" (unspecified if ongoing), notes: Abstains from alcohol. The patient's concomitant medications were not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 13Jun2022, outcome "unknown", COVID-19 (medically significant) with onset 13Jun2022, outcome "recovered" (17Jun2022) and all described as "Positive for Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Jun2022) Positive, notes: Positive for Covid-19. Therapeutic measures were taken as a result of covid-19. The patient was treated with Tylenol and Mucinex.   The reporter's assessment of the causal relationship of "positive for 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 reporter considered "positive for covid-19" related to BNT162b2.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded.
Age: 48.0
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) (Nurse). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Dec2020 at 09:00 as dose 1, single (Lot number: FL1284), in right arm, on 13Jan2021 at 09:15 as dose 2, single (Lot number: FT1686), in right arm, on 20Aug2021 at 13:00 as dose 3 (booster), single (Lot number: FD8448), in right arm and on 02Jun2022 at 15:15 as dose 4 (booster), single (Lot number: FM9992) at the age of 48 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Crohn's Disease" (unspecified if ongoing), notes: Crohn's Disease; "Arrhythmia (PVC)" (unspecified if ongoing), notes: Arrhythmia (PVC),; "Previous COVID infection", start date: Jun2020 (unspecified if ongoing). 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 "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: tested positive for COVID again; (26Jun2022) Positive, notes: Symptoms returned on 26Jun and I tested positive for COVID again at that time. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Symptoms returned on 26Jun and I tested positive for COVID again at that time.  No follow-up attempts are possible. No further information is expected.; Sender's Comments:  The reported Covid 19 positive after both the doses of  COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31May2021 as dose number unknown, single (Batch/Lot number: unknown), in left arm and on 14Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 45 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Graves Disease" (unspecified if ongoing); "known allergies: Yes" (unspecified if ongoing), notes: known allergies: Yes. Concomitant medication(s) included: LEVOTHYROXINE. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Tested positive again with symptoms; Unknown Results. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 62.0
Sex: 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 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Nov2021 as dose 3 (booster), single (Lot number: 330308D) at the age of 62 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: "Obesity" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional Information: Yes the patient received vaccine. No other medication received in 2 weeks.  No follow up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Ultrasound kidney
Clinical narrative: Flu like symptoms; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 21K-163-3977168-00.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFLUENZA LIKE ILLNESS (hospitalization), outcome "unknown", described as "Flu like symptoms". The patient underwent the following laboratory tests and procedures: Ultrasound kidney: Unknown Results, notes: For Kidney stones.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Ultrasound kidney
Clinical narrative: Flu like symptoms; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 21K-163-3977168-00.  A female 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: INFLUENZA LIKE ILLNESS (hospitalization), outcome "unknown", described as "Flu like symptoms". The patient underwent the following laboratory tests and procedures: Ultrasound kidney: Unknown results, notes: For Kidney stones.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Jan2021 at 08:45 as dose 1, single (Lot number: EL1284), in left arm, on 23Feb2021 at 09:30 as dose 2, single (Lot number: EL9261), in left arm, on 24Sep2021 at 11:00 as dose 3 (booster), single (Lot number: 301308a), in left arm and on 30Mar2022 at 10:00 as dose 4 (booster), single (Lot number: Fk9896) at the age of 77 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hyperfactor VIII" (unspecified if ongoing); "spinal stenosis" (unspecified if ongoing); "rectal incontinence" (unspecified if ongoing); "glaucoma" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "hyper cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Known allergies: wellbutrin, reaction(s): "Allergy to Wellbutrin", notes: Known allergies: Wellbutrin; Known allergies: thiomersol, reaction(s): "Allergy to Thiomersol", notes: Known allergies: thiomersol; Known allergies: lisinopril, reaction(s): "Allergy to Lisinopril", notes: Known allergies: lisinopril. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. Clinical information: Other medication was given in 2 weeks.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: she then would develop this immune reaction after every covid-19 vaccine and it would get less severe with each one; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): LRN4625954 (Agency).  A 31-year-old female patient received BNT162b2 (BNT162B2), on 03Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 30 years for covid-19 immunisation. The patient's relevant medical history included: "Flare up" (unspecified if ongoing); "Swollen lymph node" (unspecified if ongoing); "Marijuana usage" (unspecified if ongoing); "Relapsing remitting multiple sclerosis" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Fatigue" (unspecified if ongoing); "Complex ptsd" (unspecified if ongoing); "Lactose intolerant" (unspecified if ongoing); "Vitamin D deficiency" (unspecified if ongoing); "Disk bulging" (unspecified if ongoing); "Disk degeneration" (unspecified if ongoing); "Dysphagia" (unspecified if ongoing); "Covid" (unspecified if ongoing). Concomitant medication(s) included: WELLBUTRIN XL; PAXLOVID; VITAMIN B COMPLEX; VITAMIN D3; CALCIUM MAGNESIUM WITH VITAMIN D3; TYLENOL; IBUPROFEN; CBD OIL. Vaccination history included: BNT162b2 (Dose: 1), administration date: 21Apr2021, when the patient was 30-year-old, for Covid-19 Immunization, reaction(s): "swollen lymph node/Recurring swollen lymph node", "swollen lymph node/Recurring swollen lymph node", "big lump under armpit"; BNT162b2 (Dose: 2), administration date: 14May2021, when the patient was 30-year-old, for Covid-19 Immunization, reaction(s): "where she would receive the vaccine she would develop a swollen lymph node". The following information was reported: LYMPHADENOPATHY (non-serious) with onset 05Nov2021, outcome "recovered" (Nov2021), described as "she then would develop this immune reaction after every covid-19 vaccine and it would get less severe with each one". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19 infection; COVID-19 infection; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Mar2021 as dose 1, single (Lot number: el3247), in left arm, on 22Mar2021 as dose 2, single (Lot number: el3247), in left arm and on 18Nov2021 as dose 3 (booster), single (Lot number: ff2587) at the age of 44 years, in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 26Jun2022, outcome "recovering" and all described as "COVID-19 infection". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Jun2022) Negative, notes: Nasal Swab; (26Jun2022) Positive, notes: Nasal Swab; (27Jun2022) Positive, notes: Nasal Swab; (28Jun2022) Positive, notes: Nasal Swab; (29Jun2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.
Age: 71.0
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Mar2021 at 11:00 as dose 1, single (Lot number: EN6203), in left arm, on 22Mar2021 at 11:00 as dose 2, single (Lot number: ER8727), in left arm and on 08Dec2021 at 13:00 as dose 3 (booster), single (Lot number: 33038D) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Psoriasis" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN oral, start date: 28Feb2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown result, notes: COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19. Patient received drug Paxlovid oral from May2022 as COVID 19 treatment.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID-19; COVID-19; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4407176-00.  A 63-year-old female patient (unknown if pregnant) received BNT162b2 (BNT162B2), on 01Feb2021 as dose 1, single (Batch/Lot number: unknown) and on 22Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 62 years, all intramuscular for covid-19 immunization; adalimumab (HUMIRA), (Batch/Lot number: unknown) subcutaneous for hidradenitis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Nov2021, outcome "unknown" and all described as "COVID-19".  Clinical information: It was unknown if patient was enrolled in COVID-19 Vaccine trial.   The reporter's assessment of the causal relationship of "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. Causality for Humira (Adalimumab). The reporters causality for the event(s) of little sluggish after second COVID-19 Vaccination, Psoriasis in groin area, and under breast, COVID and Hidradenitis suppurativa flare ups with Humira (Adalimumab) was not provided.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded.