chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 66-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 26Oct2023 at 10:00 as dose 1, single (Batch/Lot number: unknown) at the age of 65 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Cancer/radiation within last 12 months" (unspecified if ongoing), notes: Cancer/radiation within last 12 months; "Cancer/radiation within last 12 months" (unspecified if ongoing), notes: Cancer/radiation within last 12 months; "Known allergies: Aromatase inhibitor" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose number: 1& 2, Primary immunization completed, UNKNOWN MANUFACTURER), for Covid-19 immunization; Covid-19 vaccine (Dose number: 3, UNKNOWN MANUFACTURER), for Covid-19 immunization; Covid-19 vaccine (Dose number: 4, UNKNOWN MANUFACTURER), for Covid-19 immunization.  The following information was reported: VACCINATION FAILURE (medically significant), outcome "not recovered", COVID-19 (medically significant), 2 months 2 days 14 hrs after the suspect product(s) administration, 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: Positive covid test/symptoms after four days of negative testing; Negative, notes: Positive covid test/symptoms after four days of negative testing. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid taken from 19Dec2023 to 24Dec2023.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 41-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 23Sep2023 as dose 1, single at the age of 41 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Flax seed" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE, UNKNOWN MANUFACTURER), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, UNKNOWN MANUFACTURER), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE, UNKNOWN MANUFACTURER), for COVID-19 immunization; Covid-19 vaccine (DOSE 1, SINGLE, UNKNOWN MANUFACTURER), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "COVID 19 Treatment".  Therapeutic measures, Paxlovid from 19Dec2023 to 23Dec2023, were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for [Comirnaty (2023-2024 Formula)] has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Rebound covid; Rebound covid; This is a spontaneous report received from a Consumer or other non HCP.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Depression" (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 "Rebound covid". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included PAXLOVID taken from 23Dec2023 to 27Dec2023.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Contracted COVID on 01Jan2024; Contracted COVID on 01Jan2024; This is a spontaneous report received from a Consumer or other non HCP.  A 40-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Sep2023 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 39 years intramuscular, in left arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single), as dose 2, single), as dose 3 (booster), single), as dose 4 (booster), single) and as dose 5 (booster), single) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 01Jan2024, outcome "recovering" and all described as "Contracted COVID on 01Jan2024". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Jan2024) Positive, notes: Nasal Swab.  Clinical course: No other vaccine in 4 weeks. No other medication in 2 weeks. No covid prior vaccination.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400001689 same patient, different product/event;
Age: 58.0
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 Consumer or other non HCP.  A 58-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 23Oct2023 at 12:00 as dose 1, single (Batch/Lot number: unknown) at the age of 58 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "COPD (Chronic obstructive pulmonary disease)" (unspecified if ongoing); "Known allergies: sulfa drugs" (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 Dec2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures, Paxlovid from 21Dec2023 to 25Dec2023, were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 69-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Athsma" (unspecified if ongoing); "seasonal alergies" (unspecified if ongoing); "afib" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed, Manufacturer unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose 3, Manufacturer unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose 4, Manufacturer unknown), for COVID-19 Immunization.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: neg, notes: After testing neg twice in 48 hours; neg, notes: After testing neg twice in 48 hours; +, notes: Tested again and+ for covid. Therapeutic measures were taken as a result of vaccination failure, covid-19 Paxlovid taken from 17Dec2023 to 21Dec2023.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Seizure
Clinical narrative: Seizure; heart issue; This is a spontaneous report received from a Consumer or other non HCP.  A 56-year-old female patient received BNT162b2 (BNT162B2), on 07Feb2022 as dose 3 (booster), single (Lot number: FK?729) at the age of 55 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (ongoing), notes: For many years before the vaccine. It is controlled. The patient's family history included: "heart issues" (unspecified if ongoing), notes: history of heart issues in her family. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1, single (Lot number: ER8733), in left arm), administration date: 31Mar2021, for covid-19 immunisation; BNT162b2 (Dose 2, single (Lot number: EP7533), in left arm), administration date: 21Apr2021, for covid-19 immunisation. The following information was reported: CARDIAC DISORDER (medically significant) with onset May2022, outcome "recovering", described as "heart issue"; SEIZURE (hospitalization) with onset 09Aug2023, outcome "unknown". The patient was hospitalized for seizure (start date: 09Aug2023, hospitalization duration: 7 day(s)). The event "heart issue" required emergency room visit. Therapeutic measures were taken as a result of seizure, cardiac disorder.  Additional information: The patient wanted to do to protect herself and avoid more serious complications, she received COVID-19 vaccines. She got the shot she had developed heart issue and seizure. She was hospitalized since 09Aug2023 and hospitalized for a week. As treatment she received pacemaker and a stent and some medication (unknown). No other vaccinations within four weeks prior to the first administration date of BNT162b2. No relevant tests.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Nurse.  A 73-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 05Oct2023 at 12:30 as dose 1, single (Batch/Lot number: unknown) at the age of 72 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Osteoporosis" (unspecified if ongoing). The patient has no known allergies. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 5 BOOSTER, SINGLE, MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 4 BOOSTER, SINGLE, MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 3 BOOSTER, SINGLE, MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 1 and DOSE 2, SINGLE, Primary immunisation completed, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "recovered" (17Dec2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2023) Positive; (17Dec2023) Negative. Therapeutic measures, Paxlovid from 12Dec2023 to 16Dec2023, were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162b2 omi xbb.1.5  in this patient cannot be completely excluded.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 40-year-old male patient received BNT162b2 (BNT162B2), in Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 38 years for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single) and as dose 2, single) 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 Jan2024, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 02Jan2024 to 02Jan2024. Clinical course: Patient reported that this was regarding complaint and enquiry about Paxlovid tablet sold at (PRIVACY) pharmacy at (PRIVACY). Pharmacist sold that medication with 3 different expiry date on it. 1. Tablet stip has Sep2023 2. Box has stricker where manually written as Feb2024 3. Printed label at the box has Feb2025. When he asked them why this had 3 different date and which one was correct and they told Feb2024 was one used as Pfizer called them written manually. Not sure if Pfizer would did that practice and would there any side effect using this medication with 3 different date on it. He asked to please help him on that.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID 19; COVID 19; Interchange of vaccine products; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A 68-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 at 14:00 as dose 5 (booster), single (Lot number: CTJ2524) at the age of 66 years, in right arm for covid-19 immunisation; elasomeran (COVID-19 VACCINE MODERNA), on 19Jan2021 at 14:00 as dose 1, single (Lot number: 025L20A), in right arm, as dose 2, single (Lot number: 073M20A), in right arm, on 17Aug2021 at 14:00 as dose 3 (booster), single (Lot number: 049E21A), in right arm, on 11Feb2022 at 14:00 as dose 4 (booster), single (Lot number: 083J21A), in right arm, on 25Apr2023 at 14:00 as dose 6 (booster), single (Lot number: A57170B), in right arm and on 28Sep2023 at 12:00 as dose 7 (booster), single (Lot number: 203F23A-1), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Sero-negative Rheumatoid Arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Cephalosporins, reaction(s): "known allergies Cephalosporins". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 16Sep2022 at 14:00, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19 and included treatment with Paxlovid from 12Dec2023 to 17Dec2023.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 71-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01May2023 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 70 years, in left arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single), as dose 2, single), as dose 3 (booster), single) and as dose 4 (booster), single) 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), outcome "unknown", 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.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 will be requested and submitted if and when received.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 61-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Jan2023 as dose 5 (booster), single (Lot number: GL0446) at the age of 60 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 21Jun2022 as dose 4 (booster), single (Lot number: FN2908), in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 01May2021 as dose 1, single (Lot number: EW0171), in right arm, on 25May2021 as dose 2, single (Lot number: EW0186), in right arm and on 21Dec2021 as dose 3 (booster), single (Lot number: F63527), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Heart attack", start date: May2022 (unspecified if ongoing); "OSA (Obstructive sleep apnea)/Sleep Apnea" (unspecified if ongoing), notes: OSA (Obstructive sleep apnea)/Sleep Apnea; "OSA (Obstructive sleep apnea)/Sleep Apnea" (unspecified if ongoing), notes: OSA (Obstructive sleep apnea)/Sleep Apnea. Concomitant medication(s) included: DIOVAN, start date: 29May2022; METOPROLOL, start date: 29May2022; PRASUGREL, start date: 29May2022; CRESTOR, start date: 29May2022; BAYER ASPIRIN, start date: 29May2022. Past drug history included: Lisinopril, reaction(s): "known allergies: Lisinopril"; Losartan, reaction(s): "known allergies: losartan". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, latency 9 days after the suspect product(s) administration, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures, Paxlovid from 21Dec2023 to 26Dec2023, were taken as a result of vaccination failure, covid-19.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: Heart attack; This is a spontaneous report received from a consumer.  A 59-year-old male patient received BNT162b2 (BNT162B2), on 21Dec2021 as dose 3 (booster), single (Lot number: F63527) at the age of 59 years, in right arm for COVID-19 immunisation. The patient's relevant medical history included: "OSA; sleep apnea" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Lisinopril, reaction(s): "Drug allergies"; Losartan, reaction(s): "Drug allergies". Vaccination history included: BNT162b2 (DOSE 1; Lot Number: EW0171; right arm), administration date: 01May2021, when the patient was 58-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2; Lot Number: EW0186; right arm), administration date: 25May2021, when the patient was 58-year-old, for COVID-19 immunization. The following information was reported: MYOCARDIAL INFARCTION (medically significant) with onset May2022, outcome "unknown", described as "Heart attack".
Sex: U
Vaccine: COVID19
Symptoms: Angina pectoris, Interchange of vaccine products, Neurological symptom, Spinal pain
Clinical narrative: Moderna shot; sharp pains near the area above my heart; neurological symptoms; pain running down the left side of my spine; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not 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: Pfizer shots (Dose 1, single), for COVID-19 immunization, reaction(s): "sharp pains near the area above my heart", "neurological symptoms", "pain running down the left side of my spine"; Moderna shot (Dose number unknown, single), for COVID-19 immunization, reaction(s): "worse but different". The following information was reported: ANGINA PECTORIS (medically significant), outcome "unknown", described as "sharp pains near the area above my heart"; NEUROLOGICAL SYMPTOM (non-serious), outcome "unknown", described as "neurological symptoms"; SPINAL PAIN (non-serious), outcome "unknown", described as "pain running down the left side of my spine"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Moderna shot". Clinical course: Patient's first, second, and third Pfizer shots gave him/her some odd neurological symptoms including pain running down the left side of his/her spine and sharp pains near the area above his/her heart. They came on within a half hour of his/her shot and tapered to nothing over months. The patient not getting any of these with the new shot for Covid. The Moderna shot was worse but different.   The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400001841 Same Reporter/Patient/Drug/AE, Different Vaccine Dose;US-PFIZER INC-PV202400000955 Same Reporter/Patient/Drug/AE, Different Vaccine Dose;
Sex: U
Vaccine: COVID19
Symptoms: Angina pectoris, Neurological symptom, Spinal pain
Clinical narrative: sharp pains near the area above my heart; neurological symptoms; pain running down the left side of my spine; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "sharp pains near the area above my heart", "neurological symptoms", "pain running down the left side of my spine"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization, reaction(s): "sharp pains near the area above my heart", "neurological symptoms", "pain running down the left side of my spine". The following information was reported: ANGINA PECTORIS (medically significant), outcome "recovered", described as "sharp pains near the area above my heart"; NEUROLOGICAL SYMPTOM (non-serious), outcome "recovered", described as "neurological symptoms"; SPINAL PAIN (non-serious), outcome "recovered", described as "pain running down the left side of my spine".  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400001840 Same Reporter/Patient/Drug/AE, Different Vaccine Dose;US-PFIZER INC-PV202400000955 Same Reporter/Patient/Drug/AE, Different Vaccine Dose;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 45-year-old female patient received BNT162b2 (BNT162B2), on 02Jan2022 as dose 3 (booster), single (Lot number: FJ8762) for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, and dose 2, single 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". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. The patient received Paxlovid from 18Dec2023 to 22Dec2023 as treatment for event covid-19.  No follow-up attempts are possible.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Dose 5/Dose 4/Dose 3/Dose 2/Dose 1:Pfizer; Dose 6 :Spikevax; Dose 7: Moderna; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A 70-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 at 12:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 69 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 06Feb2021 at 13:15 as dose 1, single (Lot number: EL9261), in left arm, on 21Feb2021 at 13:15 as dose 2, single (Lot number: EN6203), in left arm, as dose 3 (booster), single (Lot number: FF8841), in left arm and on 16May2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; elasomeran (SPIKEVAX), on 23Sep2023 at 13:00 as dose 7 (booster), single), in left arm for covid-19 immunisation; davesomeran, elasomeran (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 16Jan2023 at 13:00 as dose 6 (booster), single (Lot number: AS71728B), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Heart disease" (unspecified if ongoing). The patient has no known allergies. There were no concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 16Jan2023 at 13:00, outcome "unknown", described as "Dose 5/Dose 4/Dose 3/Dose 2/Dose 1:Pfizer; Dose 6 :Spikevax; Dose 7: Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures, Paxlovid from 22Dec2023 to 26Dec2023, were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 will be requested and submitted if and when received.
Age: 40.0
Sex: M
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 Consumer or other non HCP.  A 42-year-old male patient received BNT162b2 (BNT162B2 NOS), on 19Sep2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 40 years, in right arm 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 Dec2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received treatment with Paxlovid from 23Dec2023 to 28Dec2023 for COVID-19.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Interchange of vaccine product (Dose 1,2,3: Pfizer vaccine, Dose 4: Moderna, Dose 5,6: Pfizer vaccine); Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A 79-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 as dose 5 (booster), single (Lot number: GH9694) and on 21Aug2023 as dose 6 (booster), single (Lot number: GK0923) at the age of 78 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 27Jan2021 as dose 1, single (Lot number: EL9263), on 17Feb2021 as dose 2, single (Lot number: EL9267) and on 25Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 09Mar2022 as dose 4 (booster), single (Lot number: FC3183) for covid-19 immunisation; BNT162b2 (COVID-19 VACCINE NOS MANUFACTURER UNKNOWN), in Nov2023 as dose 7 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN, start date: Dec2014; MYRBETRIQ, start date: Jun2023, stop date: Dec2023; METHOTREXATE, start date: Jan2020, stop date: Dec2023; LEUCOVORINE, start date: Jan2021, stop date: Dec2023; RHEUMATE, start date: Jan2020, stop date: Dec2023. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "recovered" and all described as "Treatment of COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "recovered", described as "Interchange of vaccine product (Dose 1,2,3: Pfizer vaccine, Dose 4: Moderna, Dose 5,6: Pfizer vaccine)". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Patient was treated with Paxlovid from 24Dec2023 to 28Dec2023. Patient had no Known allergies.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; vaccine brand=Pfizer/BioNTech; vaccine dose number=4;vaccine brand other=Moderna; vaccine dose number=3; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A 74-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 as dose 4 (booster), single (Lot number: GH9694) at the age of 73 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 15Feb2021 as dose 1, single (Lot number: 011M20A), on 15Mar2021 as dose 2, single (Lot number: 002B21A) and on 03Nov2021 as dose 3 (booster), single (Lot number: 033F21A) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "Hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 12Sep2022, outcome "unknown", described as "vaccine brand=Pfizer/BioNTech; vaccine dose number=4;vaccine brand other=Moderna; vaccine dose number=3"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 25Dec2023 to 29Dec2023.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A 67-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2023 at 12:00 as dose 5 (booster), single (Lot number: GH9694) at the age of 66 years, in left arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single), as dose 2, single), as dose 3 (booster), single) and as dose 4 (booster), single) for covid-19 immunisation. The patient's relevant medical history included: "Asplenia" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Bactrim, reaction(s): "Known allergies: Bactrim". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "Treatment of COVID-19".  The patient received Paxlovid as Treatment of COVID-19 from 28Dec2023 to 02Jan2024.
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A 79-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Dec2023 as dose number unknown (booster), single (Lot number: GJ6742) at the age of 79 years, in left arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose number unknown, single) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (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 Dec2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Interchange of vaccine products, Lethargy, Pain, Pyrexia
Clinical narrative: Interchange of vaccine products; fever; body aches for a day; tiredness; lethargy and extra effort needed to do my normal routine; disruption of sleep; This is a spontaneous report received from a Consumer or other non HCP.  A 75-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Sep2022 as dose 4 (booster), single (Lot number: GJ2524) at the age of 74 years, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "Breast CA", start date: 26Aug2014, stop date: 19Nov2022; "Lumpectomy Right Breast", start date: 06May2015 (unspecified if ongoing). The patient's family history included: "Breast CA" (unspecified if ongoing), notes: Mother at age 42; "Breast CA" (unspecified if ongoing), notes: Sister; "Lupus" (unspecified if ongoing), notes: Sister; "Follicular Lymphoma" (unspecified if ongoing), notes: Son. Concomitant medication(s) included: LEVOTHYROXINE oral taken for hypothyroidism, start date: 11Jan2017 (ongoing). Vaccination history included: spikevax (DOSE 1, SINGLE, Lot number: 029L20A, Anatomical Site of injection: Right Deltoid, Route of administration: Intramuscular), administration date: 20Jan2021, when the patient was 72-year-old, for COVID-19 immunization, reaction(s): "tired"; spikevax (DOSE 2, SINGLE, Lot number: 022M204, Anatomical Site of injection: Right Deltoid, Route of administration: Intramuscular), administration date: 17Feb2021, when the patient was 72-year-old, for COVID-19 immunization, reaction(s): "tired"; spikevax (DOSE 3 (BOOSTER), SINGLE, Lot number: 037F21A, Anatomical Site of injection: Left Deltoid, Route of administration: Intramuscular), administration date: 03Nov2021, when the patient was 73-year-old, for COVID-19 immunization, reaction(s): "tired". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 13Sep2022, outcome "recovered"; PYREXIA (non-serious), outcome "recovered", described as "fever"; PAIN (non-serious), outcome "recovered", described as "body aches for a day"; FATIGUE (non-serious), outcome "recovered", described as "tiredness"; LETHARGY (non-serious), outcome "recovered", described as "lethargy and extra effort needed to do my normal routine"; SLEEP DISORDER (non-serious), outcome "recovered", described as "disruption of sleep".  Additional information: This is about her concern about the vaccines. With the first three doses (all Moderna), she felt tired for a day or two but no fever or arm soreness ever. But she noticed a lower energy level for about a month after. With the fourth dose (Pfizer), she had a fever & body aches for a day and tiredness for a week. But there was an ongoing lethargy and extra effort needed to do her normal routine and disruption of sleep. This lasted for about six months. After having COVID and recovering, she felt so much better and noticed her energy level is back to normal for her.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300405443 same patient; different suspect drug and events;
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder
Clinical narrative: Interchange of vaccine products; fever; body aches for a day; tiredness; lethargy and extra effort needed to do my normal routine; disruption of sleep; This is a spontaneous report received from a Consumer or other non HCP.  A 75-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Sep2022 as dose 4 (booster), single (Lot number: GJ2524) at the age of 74 years, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "Breast CA", start date: 26Aug2014, stop date: 19Nov2022; "Lumpectomy Right Breast", start date: 06May2015 (unspecified if ongoing). The patient's family history included: "Breast CA" (unspecified if ongoing), notes: Mother at age 42; "Breast CA" (unspecified if ongoing), notes: Sister; "Lupus" (unspecified if ongoing), notes: Sister; "Follicular Lymphoma" (unspecified if ongoing), notes: Son. Concomitant medication(s) included: LEVOTHYROXINE oral taken for hypothyroidism, start date: 11Jan2017 (ongoing). Vaccination history included: spikevax (DOSE 1, SINGLE, Lot number: 029L20A, Anatomical Site of injection: Right Deltoid, Route of administration: Intramuscular), administration date: 20Jan2021, when the patient was 72-year-old, for COVID-19 immunization, reaction(s): "tired"; spikevax (DOSE 2, SINGLE, Lot number: 022M204, Anatomical Site of injection: Right Deltoid, Route of administration: Intramuscular), administration date: 17Feb2021, when the patient was 72-year-old, for COVID-19 immunization, reaction(s): "tired"; spikevax (DOSE 3 (BOOSTER), SINGLE, Lot number: 037F21A, Anatomical Site of injection: Left Deltoid, Route of administration: Intramuscular), administration date: 03Nov2021, when the patient was 73-year-old, for COVID-19 immunization, reaction(s): "tired". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 13Sep2022, outcome "recovered"; PYREXIA (non-serious), outcome "recovered", described as "fever"; PAIN (non-serious), outcome "recovered", described as "body aches for a day"; FATIGUE (non-serious), outcome "recovered", described as "tiredness"; LETHARGY (non-serious), outcome "recovered", described as "lethargy and extra effort needed to do my normal routine"; SLEEP DISORDER (non-serious), outcome "recovered", described as "disruption of sleep".  Additional information: This is about her concern about the vaccines. With the first three doses (all Moderna), she felt tired for a day or two but no fever or arm soreness ever. But she noticed a lower energy level for about a month after. With the fourth dose (Pfizer), she had a fever & body aches for a day and tiredness for a week. But there was an ongoing lethargy and extra effort needed to do her normal routine and disruption of sleep. This lasted for about six months. After having COVID and recovering, she felt so much better and noticed her energy level is back to normal for her.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300405443 same patient; different suspect drug and events;
Sex: U
Vaccine: RSV
Symptoms: Asthma, Back pain, COVID-19, Dyspepsia, Gait disturbance
Clinical narrative: rheumatoid arthritis; moderate asthma; Back pain; I had COVID; Osteopenia; I can't go walking; digestion issue; losing 5 pounds in a week; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "over weight" (unspecified if ongoing); "leg neuropathy" (unspecified if ongoing); "sedentary" (unspecified if ongoing); "does not help my lung capacity " (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "unknown"; ASTHMA (non-serious), outcome "unknown", described as "moderate asthma"; BACK PAIN (non-serious), outcome "unknown"; COVID-19 (non-serious), outcome "unknown", described as "I had COVID"; OSTEOPENIA (non-serious), outcome "unknown", described as "Osteopenia "; GAIT INABILITY (non-serious), outcome "unknown", described as "I can't go walking"; DYSPEPSIA (non-serious), outcome "unknown", described as "digestion issue"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "losing 5 pounds in a week". The patient underwent the following laboratory tests and procedures: Weight: over weight; Weight: 5 lbs, notes: losing 5 pounds in a week. Therapeutic measures were taken as a result of rheumatoid arthritis, back pain.  Clinical course: Caller called in seeking assistance with the Abrysvo vaccine. During the call caller stated "I have moderate asthma, I have a billion comorbidities including me being over weight, leg neuropathy which makes me sedentary which does not help my lung capacity or ability to fight off diseases. I take Tylenol everyday to help with my back pain because I'm not allowed to take opioids... I have rheumatoid arthritis and I take a medication called Xeljanz which greatly reduces my immune system... I had COVID... I'm got Osteopenia I can't go walking. I now have a digestion issue where I'm losing 5 pounds in a week."   The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.
Sex: U
Vaccine: RSV
Symptoms: Osteopenia, Rheumatoid arthritis, Weight decreased
Clinical narrative: rheumatoid arthritis; moderate asthma; Back pain; I had COVID; Osteopenia; I can't go walking; digestion issue; losing 5 pounds in a week; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "over weight" (unspecified if ongoing); "leg neuropathy" (unspecified if ongoing); "sedentary" (unspecified if ongoing); "does not help my lung capacity " (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "unknown"; ASTHMA (non-serious), outcome "unknown", described as "moderate asthma"; BACK PAIN (non-serious), outcome "unknown"; COVID-19 (non-serious), outcome "unknown", described as "I had COVID"; OSTEOPENIA (non-serious), outcome "unknown", described as "Osteopenia "; GAIT INABILITY (non-serious), outcome "unknown", described as "I can't go walking"; DYSPEPSIA (non-serious), outcome "unknown", described as "digestion issue"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "losing 5 pounds in a week". The patient underwent the following laboratory tests and procedures: Weight: over weight; Weight: 5 lbs, notes: losing 5 pounds in a week. Therapeutic measures were taken as a result of rheumatoid arthritis, back pain.  Clinical course: Caller called in seeking assistance with the Abrysvo vaccine. During the call caller stated "I have moderate asthma, I have a billion comorbidities including me being over weight, leg neuropathy which makes me sedentary which does not help my lung capacity or ability to fight off diseases. I take Tylenol everyday to help with my back pain because I'm not allowed to take opioids... I have rheumatoid arthritis and I take a medication called Xeljanz which greatly reduces my immune system... I had COVID... I'm got Osteopenia I can't go walking. I now have a digestion issue where I'm losing 5 pounds in a week."   The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Angina pectoris, Neurological symptom, Spinal pain
Clinical narrative: sharp pains near the area above my heart; neurological symptoms; pain running down the left side of my spine; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) 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: ANGINA PECTORIS (medically significant), outcome "recovered", described as "sharp pains near the area above my heart"; NEUROLOGICAL SYMPTOM (non-serious), outcome "recovered", described as "neurological symptoms"; SPINAL PAIN (non-serious), outcome "recovered", described as "pain running down the left side of my spine". Clinical course: The reporter mentioned that the first, second, and third Pfizer shots gave some odd neurological symptoms including pain running down the left side of spine and sharp pains near the area above the heart. They came on within a half hour of shot and tapered to nothing over months. The patient is not getting any of these with the new shot for Covid. The reporter mentioned that the Moderna shot was worse but different.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400001840 Same reporter/patient/drug/event; different dose;US-PFIZER INC-202400001841 Same reporter/patient/drug/event; different dose;
Age: 1.17
Sex: M
Vaccine: IPV, UNK
Symptoms: Medication error, Wrong product administered
Clinical narrative: patient was administered with TUBERSOL instead of IPOL with no reported adverse event; Initial information received on 06-Dec-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 14 months old male patient who was administered with Tuberculin Test [Tubersol] instead of Poliomyelitis Vaccine (Inactivated) (IPOL) with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included varicella zoster vaccine (varicella vaccine) for prophylactic vaccination; measles vaccine, mumps vaccine, rubella vaccine (mmr) for prophylactic vaccination; pneumococcal vaccine conj 20v (crm197) (prevnar 20) for prophylactic vaccination; and influenza vaccine (influenza vaccine) for Prophylactic vaccination.  On 05-Dec-2023, the patient started taking Tuberculin Test Solution for injection 0.1 mL via intramuscular route in quadriceps (Strength: standard) (Frequency: once) (lot - 3CA04C1, 31-Dec-2026) for Immunisation.  On 05-Dec-2023, the patient was administered with Tuberculin Test [Tubersol] instead of Poliomyelitis Vaccine (Inactivated) (IPOL) with no reported adverse event (wrong product administered) (latency: same day).  It was reported, Caller reported that patient was administered with TUBERSOL instead of IPOL. Caller asked for contraindications, what they should watch out for, and what to worry about. offered to call back to prevent making a long hold. called back at 9:45 AM (6DEC2023) to relay the information and ask for the details of the patient and about the administered TUBERSOL. This situation is pre-assessed as a medication error/an inappropriate use due to the incorrect vaccine that was administered to a patient.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.