chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Sep2022 at 10:00 as dose 5 (booster), single (Lot number: GH9702) at the age of 61 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 20Feb2021 as dose 1, single (Lot number: EL9266), in left arm, on 03Mar2021 as dose 2, single (Lot number: EN6205), in left arm, on 28Oct2021 as dose 3 (booster), single (Lot number: FF2593), in left arm and on 06May2022 as dose 4 (booster), single (Lot number: FK9894), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Past drug history included: Doxycycline, reaction(s): "known allergies: Doxycycline".  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown), 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), 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: "Coronary artery disease" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "cauda equina syndrome" (unspecified if ongoing); "arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Jan2023) Positive, notes: Tested positive for Covid on Saturday 07Jan with two tests; (07Jan2023) Positive, notes: Tested positive for Covid on Saturday 07Jan with two tests; (10Jan2023) Positive, notes: Tested positive again today, 10Jan. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical information: Patient received BNT162B2 OMI BA.4-5 on an unknown date in Sep2022 at 11:00. Patient received paxlovid on 29Dec2022 as treatment for Covid-19. On Friday night, 06Jan, patient began experiencing symptoms of a bad cold, cough, massive congestion. Tested positive for Covid on Saturday 07Jan with two tests. No fever. Tested positive again today, 10Jan, symptoms (cough, congestion) continue.  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: F
Vaccine: PNC20
Symptoms: Vaccination site erythema, Vaccination site inflammation
Clinical narrative: redness below the site of injection/A lot of redness/below the injection site; Some inflammation in the area below the injection sites; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 66-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Lot number: GA5915, Expiration Date: Jan2024) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), 8 days after the suspect product(s) administration, outcome "unknown", described as "redness below the site of injection/A lot of redness/below the injection site"; VACCINATION SITE INFLAMMATION (non-serious), 8 days after the suspect product(s) administration, outcome "unknown", described as "Some inflammation in the area below the injection sites". Additional information: There was a patient, he's received a Prevnar 20 vaccination and 8 days later they are reporting that they have like a lot of redness and some inflammation in the area below the injection site. He just wanted to ask if that's considered normal, that's something need to advice them, to advice the patient to seek some medical attention.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An adult male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300012926 same patient, events after different doses of the vaccine;
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An adult male 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, single, lot number unknown), for COVID-19 immunization, reaction(s): "sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300012926 same patient, events after different doses of the vaccine.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 28-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), for COVID-19 IMMUNIZATION, reaction(s): "sore arm"; Bnt162b2 (Dose 2, single), for COVID-19 IMMUNIZATION, reaction(s): "sore arm"; Bnt162b2 (Dose 3, single), for COVID-19 IMMUNIZATION, reaction(s): "sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  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: 66.0
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) from product quality group. The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 as dose 3 (booster), single (Lot number: 882589) at the age of 66 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 24Feb2021 as dose 1, single (Lot number: EN 6200) and on 27Apr2022 as dose 2, single (Batch/Lot number: unknown), 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: 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: COVID symptoms with a positive test; Negative, notes: 2 days following negative COVID test. Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300013169 Same reporter/patient, same drug/different dose, different AE.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Caller refers having a home test and testing positive. Her last Pfizer COVID-19 booster vaccine was administered on Dec 2021; Caller refers having a home test and testing positive. Her last Pfizer COVID-19 booster vaccine was administered on Dec 2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (Unknown). The reporter is the patient.  A 65-year-old female patient received BNT162b2 (BNT162B2), in Dec2021 as dose number unknown (booster), single for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: NEBIVOLOL; HYDROCHLOROTHIAZIDE;TRIAMTERENE; ROSUVASTATIN; SYNTHROID; ASPIRIN [ACETYLSALICYLIC ACID]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Caller refers having a home test and testing positive. Her last Pfizer COVID-19 booster vaccine was administered on Dec 2021". 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 with Paxlovid.  Clinical information: The patient referred being on nebivolol, triamterene hydrochlorothiazide, rosuvastatin, Synthroid and Aspirin and was asking if these medications would interfere with Paxlovid.
Age: 61.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Oct2022 as dose 5 (booster), single (Lot number: gj6739) at the age of 61 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), 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 had no relevant medical history. There were no concomitant medications, also reported as no other medication in 2 weeks. Patient had no known allergies. 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; (Jan2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received COVID-19 Treatment with Paxlovid (Lot number: gf6426) from 01Jan2023 to 02Jan2023. The noxious taste that the Paxlovid created in mouth was untenable and unbearable for patient. After three doses patient had to stop. However it was now day 14 and she was still testing positive and still have symptoms and wonder if that's because she only took three doses of Paxlovid.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive; Tested positive; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 32-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Sep2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 32 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: "Asthma" (unspecified if ongoing); "Depression" (unspecified if ongoing); "ADHD" (unspecified if ongoing). The patient had no known allergies. Concomitant medication(s) included: ADDERALL, start date: 03Jan2016; ADVAIR, start date: 06Feb2000; ALBUTEROL [SALBUTAMOL], start date: 04May2003; SERTRALINE, start date: 15Aug2021. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31Dec2022) Positive; (05Jan2023) Negative; (09Jan2023) Positive, notes: Tested positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 31Dec2022 to 05Jan2023 (Lot number: GG3517). The patient initially tested positive on 31Dec2022 and began taking Paxlovid. Finished Paxlovid on 05Jan2023 and tested negative.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information and the temporal association, a possible contributory role of Comirnaty vaccine cannot be excluded for the reported events of "DRUG INEFFECTIVE " and "COVID-19 ".
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Oct2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 34 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19, drug ineffective.  Clinical information: Strong chemical taste in mouth that will not go away with food, drink or gum. Other medication in 2 weeks: No. Product: COVID 19 Treatment, Brand: Paxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Moderna/Dose number: 2; 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 60-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose 2, single (Batch/Lot number: unknown), in right 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's relevant medical history included: "Some kidney issues" (unspecified if ongoing), notes: Some kidney issues. Took renal dose of Paxlovid. Concomitant medication(s) included: LEXAPRO. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Moderna/Dose number: 2"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Other medication in 2 weeks was Statin. No known allergies. Took renal dose of Paxlovid. The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid infection; Covid infection; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A 66-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) 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), 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 was not reported. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 06Jan2023, outcome "recovering" and all described as "Covid infection". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Jan2023) Positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  Clinical Information: Patient received other vaccine in 4 weeks. Facility where the most recent COVID-19 vaccine was administered was workplace clinic. Prior to vaccination, was the patient diagnosed with COVID-19 was unknown. Since the vaccination, the patient has been tested for COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The reported COVID-19 positive after BNT162b2, BNT162b2 omi ba.4-5 immunization is considered ineffective of BNT162b2, BNT162b2 omi ba.4-5, and the Company cannot completely exclude the possible causality between the reported events and suspect product.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: covid infection; covid infection; This is a spontaneous report received from a contactable reporter(s) (Nurse).  An adult patient received BNT162b2 (BNT162B2), on 19Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 06Jan2023, outcome "recovering" and all described as "covid infection". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Jan2023) Positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  Clinical course: If other vaccine in four weeks: Unknown. if treatment ae: No. If covid prior vaccination: Unknown. If covid tested post vaccination: Yes.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Dec2020 as dose 2, single (Batch/Lot number: unknown) at the age of 37 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's relevant medical history included: "Pcn Allergy" (unspecified if ongoing); "sulfa Allergy" (unspecified if ongoing). 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". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received anti-viral product Paxlovid from 01Jan2023 till 06Jan2023 for covid-19 treatment. Vaccine lot unknown reason stated as not available/ provided to reporter at the time of report completion. No adverse events. Reporting paxlovid rebound.  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 BNT162B2 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Sep2022 at 15:00 as dose 1, single (Batch/Lot number: unknown) at the age of 42 years, in left arm 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 "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 (Paxlovid, 02Jan2023 to 06Jan2023).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood cholesterol, Body temperature, Extra dose administered, Gait disturbance
Clinical narrative: By 18Dec2022 she could hardly walk on her left leg; Pain in hip; administered in hip, left; administered in hip, left; Dose 5 / Third booster administered; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 71-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Nov2022 as dose 5 (booster), single (Lot number: GJ327, Expiration Date: 31Jul2023) at the age of 71 years for COVID-19 immunisation. The patient's relevant medical history included: "Cancer" (ongoing); "Lymph nodes removed", start date: Nov2019 (unspecified if ongoing), notes: Other Conditions: Reporter later clarified details. She had cancer that had spread to the lymph nodes in both arms. Both of those lymph nodes were removed. The lymph nodes were removed Nov 2019.; "COVID", start date: 01Jan2021 (unspecified if ongoing), notes: She initially provided she had Covid 01Jan2020, but clarified it was 01 Jan 2021.; "Heartburn" (ongoing). Concomitant medication(s) included: LETROZOLE taken for neoplasm malignant (ongoing); ESOMEPRAZOLE MAGNESIUM taken for dyspepsia (ongoing). Vaccination history included: BNT162b2 (First COVID Booster (Dose: 3 Booster), Batch/lot number: EW0187   , Dosage text: 0.3ml administered in arm; unknown which one, Time Administered: It was given late afternoon; evening. Exact time unknown), administration date: 11Oct2021, when the patient was 70-year-old, for COVID-19 immunization, reaction(s): "Hives", "Pain"; BNT162b2 (Second  COVID Booster  (Dose: 4 Booster) , Batch/lot number: FK9894 , Dosage text: 0.3ml administered in left arm , Second COVID Booster manufacturer: unspecified, NDC number of Second COVID Booster: Unknown, Expiry Date of Second COVID Booster: Unknown  , Time Administered: In the evening), administration date: 21Apr2022, when the patient was 71-year-old, for COVID-19 immunization, reaction(s): "Hives", "Arm swelled even more with enormous hives", "Pain"; Covid-19 vaccine (Dose 1, Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Unknown manufacturer), for COVID-19 immunization. The following information was reported: EXTRA DOSE ADMINISTERED (non-serious) with onset 17Nov2022, outcome "unknown", described as "Dose 5 / Third booster administered"; OFF LABEL USE (non-serious), PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious) all with onset 17Nov2022, outcome "unknown" and all described as "administered in hip, left"; ARTHRALGIA (non-serious) with onset 18Nov2022, outcome "recovering", described as "Pain in hip"; GAIT DISTURBANCE (non-serious) with onset 18Dec2022, outcome "unknown", described as "By 18Dec2022 she could hardly walk on her left leg". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of arthralgia, gait disturbance. Additional information: The patient started physical therapy and it was helping.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Product administered at inappropriate site
Clinical narrative: By 18Dec2022 she could hardly walk on her left leg; Pain in hip; administered in hip, left; administered in hip, left; Dose 5 / Third booster administered; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 71-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Nov2022 as dose 5 (booster), single (Lot number: GJ327, Expiration Date: 31Jul2023) at the age of 71 years for COVID-19 immunisation. The patient's relevant medical history included: "Cancer" (ongoing); "Lymph nodes removed", start date: Nov2019 (unspecified if ongoing), notes: Other Conditions: Reporter later clarified details. She had cancer that had spread to the lymph nodes in both arms. Both of those lymph nodes were removed. The lymph nodes were removed Nov 2019.; "COVID", start date: 01Jan2021 (unspecified if ongoing), notes: She initially provided she had Covid 01Jan2020, but clarified it was 01 Jan 2021.; "Heartburn" (ongoing). Concomitant medication(s) included: LETROZOLE taken for neoplasm malignant (ongoing); ESOMEPRAZOLE MAGNESIUM taken for dyspepsia (ongoing). Vaccination history included: BNT162b2 (First COVID Booster (Dose: 3 Booster), Batch/lot number: EW0187   , Dosage text: 0.3ml administered in arm; unknown which one, Time Administered: It was given late afternoon; evening. Exact time unknown), administration date: 11Oct2021, when the patient was 70-year-old, for COVID-19 immunization, reaction(s): "Hives", "Pain"; BNT162b2 (Second  COVID Booster  (Dose: 4 Booster) , Batch/lot number: FK9894 , Dosage text: 0.3ml administered in left arm , Second COVID Booster manufacturer: unspecified, NDC number of Second COVID Booster: Unknown, Expiry Date of Second COVID Booster: Unknown  , Time Administered: In the evening), administration date: 21Apr2022, when the patient was 71-year-old, for COVID-19 immunization, reaction(s): "Hives", "Arm swelled even more with enormous hives", "Pain"; Covid-19 vaccine (Dose 1, Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Unknown manufacturer), for COVID-19 immunization. The following information was reported: EXTRA DOSE ADMINISTERED (non-serious) with onset 17Nov2022, outcome "unknown", described as "Dose 5 / Third booster administered"; OFF LABEL USE (non-serious), PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious) all with onset 17Nov2022, outcome "unknown" and all described as "administered in hip, left"; ARTHRALGIA (non-serious) with onset 18Nov2022, outcome "recovering", described as "Pain in hip"; GAIT DISTURBANCE (non-serious) with onset 18Dec2022, outcome "unknown", described as "By 18Dec2022 she could hardly walk on her left leg". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of arthralgia, gait disturbance. Additional information: The patient started physical therapy and it was helping.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Rheumatoid arthritis
Clinical narrative: Suffered from the RA; Has a hard time sleeping at night; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 68-year-old male patient received BNT162b2 (BNT162B2), on 20Sep2021 as dose 1, single (Batch/Lot number: unknown) at the age of 68 years for covid-19 immunisation. The patient's relevant medical history included: "Guillain-Barre syndrome" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INSOMNIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "Has a hard time sleeping at night"; RHEUMATOID ARTHRITIS (medically significant) with onset 2021, outcome "recovered" (2021), described as "Suffered from the RA". Therapeutic measures were taken as a result of rheumatoid arthritis. Therapeutic measures were not taken as a result of insomnia. Clinical course: His arthritis was really bad due to having to temporarily stop the medication to get a COVID vaccine and he also has a hard time sleeping at night. As per directed by Pfizer, Patient was told to not to take med for 1 (one) week before Pfizer each injection. Because of my earlier Guillain-Barre syndrome. My first injection was on 20Sep2021 and the second on 17Oct2021. Not taking the med but for 1 week I suffered from the RA. Till nearly the end of year. The Xeljanz XR did its job and the patient feels great again.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101655837 same patient/event, different vaccine dose;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient received BNT162b2 (BNT162B2), on 02Jun2022 as dose 2, single (Lot number: 17804), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 08Sep2021 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine nrvv MVa (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 17Nov2022 at 13:00 as dose 3 (booster), single (Lot number: 010H22A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Lymphoma" (unspecified if ongoing); "known allergies: Sulfa" (unspecified if ongoing), notes: known allergies: Sulfa. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received the treatment for event COVID-19 included Paxlovid, treatment started on 02Jan2023 and stopped on 07Jan2023.
Age: 53.0
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 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Aug2022 as dose 4 (booster), single (Lot number: FPu55u) at the age of 53 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: "High Blood Pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. 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. Therapeutic measures were taken as a result of drug ineffective, covid-19. Anti viral details: COVID 19 Treatment with Paxlovid (Lot number: 2707499), Treatment start date was 29Dec2022, Treatment stop date=03Jan2023.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Metamorphopsia, Mood swings, Thinking abnormal
Clinical narrative: Memory loss; mood swings; disorted vision and thoughts; disorted vision and thoughts; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Aug2021 as dose 1, single (Lot number: fc3182) at the age of 39 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications.  The following information was reported: AMNESIA (non-serious), outcome "not recovered", described as "Memory loss"; MOOD SWINGS (non-serious), outcome "not recovered"; METAMORPHOPSIA (non-serious), THINKING ABNORMAL (non-serious), outcome "not recovered" and all described as "disorted vision and thoughts". The events "memory loss", "mood swings" and "disorted vision and thoughts" required physician office visit. Therapeutic measures were taken as a result of metamorphopsia.  Patient did not develop Covid prior to vaccination. Covid was not tested post vaccination.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Nov2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 35 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 had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID positive infection; COVID positive infection; This is a spontaneous report received from a contactable reporter (Nurse).  A 32-year-old female patient received BNT162b2 (BNT162B2), in Jan2021 as dose 1, single (batch/lot number: unknown), in Feb2021 as dose 2, single (batch/lot number: unknown) and in Mar2022 as dose 3 (booster), single (batch/lot number: unknown) at the age of 31 years for covid-19 immunization. It was reported that the vaccine facility was at a workplace clinic. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 09Jan2023, outcome "recovering" and all described as "COVID positive infection". The patient underwent the following laboratory tests and procedures: covid test/home AG test: (09Jan2023) positive, notes: nasal swab. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of the subject product BNT162b2 vaccine,  cannot be excluded for suspected LOE. There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid home test positive 28Dec2022 with symptoms; Covid home test positive 28Dec2022 with symptoms; 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 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Oct2022 at 12:00 as dose 6 (booster), single (Lot number: GH9693) at the age of 57 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: CETIRIZINE HCL, start date: 01Jan2021; DUPIXENT, start date: 07May2021; FAMOTIDINE, start date: 01Jan2021. Past drug history included: Bacitracin, reaction(s): "Known allergies: Bacitracin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 28Dec2022, outcome "not recovered" and all described as "Covid home test positive 28Dec2022 with symptoms". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Dec2022) Positive, notes: Covid home test positive 28Dec2022 with symptoms; (06Jan2023) Negative, notes: improvement of symptoms by 06Jan2023 and Covid home tested negative; (08Jan2023) Positive, notes: Covid home tested positive 08Jan2023. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Covid home test positive 28Dec2022 with symptoms. Started Paxlovid 30Dec2022 to 04Jan2023 (lot number: GE3014) with improvement of symptoms by 06Jan2023 and Covid home tested negative. Symptoms returned 07Jan2023 and Covid home tested positive 08Jan2023.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; vaccine brand other=Moderna/vaccine administration date=24Oct2021,; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Mar2021 as dose 1, single (Lot number: EN6202), in left arm and on 22Mar2021 as dose 2, single (Lot number: ER8730) at the age of 37 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 24Oct2021 as dose 3 (booster), single (Lot number: 011F21A), in left arm and on 07Sep2022 as dose 4 (booster), single (Lot number: AS7144B), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: MUCINEX, start date: 01Jan2023, stop date: 05Jan2023. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "vaccine brand other=Moderna/vaccine administration date=24Oct2021,". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: testing every day and tests were very faintly positive,; positive, notes: but have progressively gotten darker again the last two days (days 10-11); positive, notes: but have progressively gotten darker again the last two days (days 10-11). Therapeutic measures were taken as a result of vaccination failure, covid-19, PAXLOVID as treatment.
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: she had a stroke after her last Pfizer booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "she had a stroke after her last Pfizer booster".  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: U
Vaccine: COVID19
Symptoms: Neurological symptom
Clinical narrative: serious neurological symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 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, I had ever single one), for Covid-19 immunization. The following information was reported: NEUROLOGICAL SYMPTOM (medically significant), outcome "unknown", described as "serious neurological symptoms".  Clinical course: After being extremely thankful for the amazingly quick development of the Pfizer COVID-19 vaccine, I had ever single one, including the omicron booster. After the second shot, I had some significant side effects, insignificant ones for two boosters, then the worst symptoms from the Omicron booster. I told my doctor shortly after and to my surprise, she said they were serious neurological symptoms and getting another would be dangerous. I'm very concerned about COVID.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300012028 same patient and event, different dose;US-PFIZER INC-202300012027 same reporter/pt/event, different dose;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: she has already got all the shots for the Pfizer Covid 19 vaccine and she stated that she tested positive for covid; she has already got all the shots for the Pfizer Covid 19 vaccine and she stated that she tested positive for covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "she has already got all the shots for the Pfizer Covid 19 vaccine and she stated that she tested positive for covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: she tested positive for covid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient mentioned that she has already got all the shots for the Pfizer Covid 19 vaccine and she stated that she tested positive for covid and now she is taking the medication Paxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Illness, Mental impairment
Clinical narrative: Feels awful and brain not working; Feels awful and brain not working; COVID vaccine/gotten sick; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-ABBVIE-4229502.  A 73-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; upadacitinib (RINVOQ), (Batch/Lot number: unknown) oral. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MENTAL IMPAIRMENT (medically significant), FEELING ABNORMAL (non-serious), outcome "unknown" and all described as "Feels awful and brain not working"; ILLNESS (non-serious), outcome "unknown", described as "COVID vaccine/gotten sick".  The reporter's assessment of the causal relationship of "feels awful and brain not working" 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 "covid vaccine/gotten sick" related to BNT162b2.  Clinical course: The reporter's causality for the event(s) of Covid vaccine/gotten sick, Feels awful and brain not working with Upadacitinib was Reasonable Possibility. The reporter's causality for the event(s) of Covid vaccine/gotten sick with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Reasonable Possibility .   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; 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. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.