chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Dose 3: Moderna: Dose 2 Pfizer/Dose 1 Pfizer; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 54-year-old male patient received BNT162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Lot number: en6204), in left arm and on 01Apr2021 as dose 2, single (Lot number: er8737) at the age of 53 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 12Dec2021 as dose 3 (booster), single (Lot number: 067HZ1A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Chronic bronchitis" (unspecified if ongoing); "Depression" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 12Dec2021, outcome "unknown", described as "Dose 3: Moderna: Dose 2 Pfizer/Dose 1 Pfizer"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Nov2022) Positive, notes: Tested positive covid 13Nov PM; (15Nov2022) Negative, notes: Tested negative 15Nov AM and asymptomatic at that time; (19Nov2022) Positive, notes: 19Nov similar, tested positive COVID later that morning. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course included, vaccine received was noted as yes. Other medical history was noted as chronic bronchitis and depression. Known allergies was not reported. The anti-viral details included product COVID 19 Treatment with brand Paxlovid. The treatment started on 08Nov2022 and stopped on 13Nov2022, Lot number was GD5282. Indication was treatment of COVID-19. It was reported that patient took Paxlovid ending 13Nov2022 AM dose. All doses taken on time. Symptoms were down to very mild by 3rd dose. Tested positive covid 13Nov2022 PM. Tested negative 15Nov2022 AM and asymptomatic at that time. 18Nov2022 AM, patient woke up to heavy sinus drainage and slight (99) fever, some tiredness during day. 19Nov2022 similar, tested positive COVID later that morning.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Feb2021 as dose 1, single (Lot number: EM9810), in left arm, on 26Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 18Oct2021 as dose 3 (booster), single (Lot number: 30155BA) at the age of 74 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "controlled hypertension" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL; VALSARTAN; HYDROCHLOROTHIAZIDE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative; (unspecified date) Positive, notes: I tested positive for covid after testing negative; (unspecified date) Positive, notes: Tested positive when feeling tired and Achy again approx 5 days after neg test; (18Nov2022) Negative, notes: Tested negative couple 3 days after completing Paxlovid. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Elderly (65 plus years). The patient received anti viral covid-19 treatment from 09Nov2022 to 15Nov2022. The patient had received other medication in 2 weeks. The patient have no known allergies.  The lot number for [BNT162b2], was not provided and will be requested during follow up.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 82-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 as dose 5 (booster), single (Lot number: Gj5342) at the age of 82 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Lot number: Em6062), on 18Mar2021 as dose 2, single (Lot number: Ep7534), on 30Sep2021 as dose 3 (booster), single (Lot number: 301358A) and on 01May2022 as dose 4 (booster), single (Lot number: Fk9893) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 18Nov2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Nov2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 46-year-old male patient 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 46 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "high cholesterol" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin, amoxicillin. Concomitant medication(s) included: LISINOPRIL; LEXAPRO; PANTOPRAZOL [PANTOPRAZOLE]; METOPROLOL; LORAZEPAM. Past drug history included: Known allergies: amoxicillin, reaction(s): "Known allergies: Amoxicillin", notes: known allergies: Penicillin, amoxicillin. 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. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: patient had known allergies of Penicillin, amoxicillin.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Jan2021 as dose 1, single (Lot number: EZ9263), in left arm, on 16Feb2021 as dose 2, single (Lot number: FL9267), in left arm, on 13Oct2021 as dose 3 (booster), single (Lot number: 30155BA), in left arm and on 14Apr2022 at 10:00 as dose 4 (booster), single (Lot number: FJ4991) at the age of 68 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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of covid-19.  Clinical course: Paxlovid, Treatment start date 12Aug2022, Treatment stop date=16Aug2022, Treatment of COVID -19.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Sep2022 at 11:00 as dose 5 (booster), single (Lot number: GH9693) at the age of 72 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's relevant medical history included: "High blood pressure" (unspecified if ongoing); "Arthritis" (unspecified if ongoing). There were no concomitant medications. The patient did not receive any other medications in two weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: positive at-home test. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid.
Sex: F
Vaccine: COVID19
Symptoms: General physical health deterioration
Clinical narrative: drastically declined in health/eventually died last year; This is a spontaneous report received from contactable reporter(s) (Nurse) from a sales representative.  An adult female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Grandmother of nurse had a heart condition" (unspecified if ongoing). The patient's concomitant medications were not reported. No other vaccine in four weeks. Vaccination history included: Covid19 vaccine (DOSE 1, SINGLE, Manufacturer Unknown), for COVID-19 immunization; Covid19 vaccine (DOSE 2, SINGLE, Manufacturer Unknown), for COVID-19 immunization. The following information was reported: GENERAL PHYSICAL HEALTH DETERIORATION (death) with onset Sep2021, outcome "fatal", described as "drastically declined in health/eventually died last year". Nurse talked about her grandmother having heart issues and did not do well from a Covid shot and wasn't going to receive another one and a pharmacy talked her getting one. The nurse felt her grandmother drastically declined in health after her vaccine and eventually died last year. Neither nurse mentioned the brand of Covid vaccine but thought I should report and neither wanted to be contacted. Not sure of the month her grandmother died.It was unknown if therapeutic measures were taken as a result of general physical health deterioration. The patient date of death was Sep2021. Reported cause of death: "drastically declined in health/eventually died last year". It was not reported if an autopsy was performed. 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 vaccine cannot be excluded for the reported event due to temporal relationship. However, the reported event may likely represent intercurrent medical condition in this patient with history of underlying cardiac conditions. There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including autopsy results, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available.  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.; Reported Cause(s) of Death: drastically declined in health/eventually died last year
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; Dose 1: Janssen (J&J), dose 2 and dose 3: Pfizer; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Nov2021 at 15:00 as dose 2 (booster), single (Lot number: FG3527), in right arm and on 18May2022 at 14:30 as dose 3 (booster), single (Lot number: FM9992) at the age of 56 years, in right arm for covid-19 immunisation; coviD-19 vaccine nrvv ad26 (jnj 78436735) (COVID-19 VACCINE JANSSEN), on 25Mar2021 at 15:00 as dose 1, single (Lot number: 1808978), in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The patient had no known allergies. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 12Nov2021, outcome "unknown", described as "Dose 1: Janssen (J&J), dose 2 and dose 3: Pfizer"; 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 with antiviral drug Paxlovid from 09Nov2022. Clinical course: Treatment of COVID-19 with Paxlovid. Relapse 4 days after last Paxlovid pill on 14Nov2022. Stuffy nose, running nose, no energy, slight headache.
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: having an allergic reaction; This is a spontaneous report received from contactable reporter(s) (Nurse) from a sales representative.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: One nurse is to latex" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "having an allergic reaction". Therapeutic measures were taken as a result of hypersensitivity.  Additional information: Nurse 1 (patient) was allergic to latex and when administered the Covid vaccine started having an allergic reaction which is believed to have come from the "stopper" in the vial and this was reported in VERS at the time. This nurse was given a double dose of Benadryl and no other action was needed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 02Nov2022 at 17:15 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 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: (Nov2022) Positive, notes: Covid rebound. I test positive and felt covid symptoms 4 days; (unspecified date) Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: No other medication in 2 weeks. Known allergies was none. The patient received antiviral treatment from 13Nov2022 to 17Nov2022 for COVID 19.  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: COVID19, 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 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in right arm and as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypo thyroidism" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "type 2 diabetes" (unspecified if ongoing); "reflux" (unspecified if ongoing); "depression" (unspecified if ongoing); "restless leg" (unspecified if ongoing); "vitamin d deficiency" (unspecified if ongoing); "high cholesterol but quit taking for ten days" (unspecified if ongoing); "Known allergies: Sulfa drugs" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL, start date: 01Sep2009; LEVOTHYROXINE, start date: 01Mar2009; NEXIUM [ESOMEPRAZOLE MAGNESIUM], start date: 01Mar2019; PRAMIPEXOLE, start date: 01Mar2015; SERTRALINE, start date: 01Aug2018; VITAMIN D [VITAMIN D NOS], start date: 01Jun2018. Past drug history included: Bactrim, reaction(s): "Known allergies: Bactrim"; Erythromycin, reaction(s): "Known allergies: erythromycin". 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. Therapeutic measures included Antiviral details: Product: COVID 19 Treatment, Brand: Paxlovid, Treatment started on 09Nov2022 and stopped on 14Nov2022, Indication: Treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Lymph node was very swollen underneath left armpit. Significant bump remained for two weeks after the second dose; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Lot number: EN6206), in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: TESTOSTERONE. Vaccination history included: Bnt162b2 (Prev dose product=COVID 19, Prev dose brand=Pfizer,, Prev dose brand unknown=False,, Is bivalent=False,, Prev dose lot number=EL3249,, Prev dose lot unknown=False,, Prev dose dose number=1,, Prev dose vaccine location=Left arm), for COVID-19 Immunization. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "recovered", described as "Lymph node was very swollen underneath left armpit. Significant bump remained for two weeks after the second dose".  Additional information: Lymph node was very swollen underneath left armpit. Significant bump remained for two weeks after the second dose and patient currently had the same after the third dose. Patient did not receive other vaccines within 4 weeks. Patient had no covid prior vaccination and was not tested for covid post vaccination. Patient had no known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Headache, Lethargy, Lymphadenopathy
Clinical narrative: Lymph node was very swollen underneath left armpit. Significant bump remained for two weeks after the second dose; tightness in the chest; Headaches; lethargic behavior; Chills; extreme shaking; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Nov2022 at 12:00 as dose 3 (booster), single (Lot number: GJ5342) at the age of 44 years for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: TESTOSTERONE. Vaccination history included: Bnt162b2 (Prev dose product=COVID 19,, Prev dose brand=Pfizer,, Prev dose brand unknown=False,, Is bivalent=False,, Prev dose lot number=EN6206,, Prev dose lot unknown=False,, Prev dos dose number=2,, Prev dose vaccine location=Left arm,), for Covid-19 immunization, reaction(s): "Lymph node was very swollen underneath left armpit. Significant bump remained for two weeks after the second dose"; Bnt162b2 (Prev dose product=COVID 19, Prev dose brand=Pfizer,, Prev dose brand unknown=False,, Is bivalent=False,, Prev dose lot number=EL3249,, Prev dose lot unknown=False,, Prev dose dose number=1,, Prev dose vaccine location=Left arm), for Covid-19 immunization. The following information was reported: CHILLS (non-serious) with onset 15Nov2022 at 22:00, outcome "not recovered"; HEADACHE (non-serious) with onset 15Nov2022 at 22:00, outcome "not recovered", described as "Headaches"; LYMPHADENOPATHY (non-serious) with onset 15Nov2022 at 22:00, outcome "not recovered", described as "Lymph node was very swollen underneath left armpit. Significant bump remained for two weeks after the second dose"; TREMOR (non-serious) with onset 15Nov2022 at 22:00, outcome "not recovered", described as "extreme shaking"; LETHARGY (non-serious) with onset 15Nov2022 at 22:00, outcome "not recovered", described as "lethargic behavior"; CHEST DISCOMFORT (non-serious) with onset 15Nov2022 at 22:00, outcome "not recovered", described as "tightness in the chest". Therapeutic measures were not taken as a result of lymphadenopathy, chest discomfort, headache, lethargy, chills, tremor.  Additional information: The patient did not receive other vaccine in four weeks. He was not diagnosed with covid-19 prior to vaccination and not positive for Covid-19 after vaccination. The patient had no known allergy. Other medical history: None. It was reported that Lymph node was very swollen underneath left armpit. Significant bump remained for two weeks after the second dose and I'm currently have the same after the third dose. Great deal of tightness in the chest. Headaches and lethargic behavior. Chills with extreme shaking approximately 12 hours after the third dose.  No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Lymph node was very swollen underneath left armpit. Significant bump remained for two weeks after the second dose; tightness in the chest; Headaches; lethargic behavior; Chills; extreme shaking; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Nov2022 at 12:00 as dose 3 (booster), single (Lot number: GJ5342) at the age of 44 years for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: TESTOSTERONE. Vaccination history included: Bnt162b2 (Prev dose product=COVID 19,, Prev dose brand=Pfizer,, Prev dose brand unknown=False,, Is bivalent=False,, Prev dose lot number=EN6206,, Prev dose lot unknown=False,, Prev dos dose number=2,, Prev dose vaccine location=Left arm,), for Covid-19 immunization, reaction(s): "Lymph node was very swollen underneath left armpit. Significant bump remained for two weeks after the second dose"; Bnt162b2 (Prev dose product=COVID 19, Prev dose brand=Pfizer,, Prev dose brand unknown=False,, Is bivalent=False,, Prev dose lot number=EL3249,, Prev dose lot unknown=False,, Prev dose dose number=1,, Prev dose vaccine location=Left arm), for Covid-19 immunization. The following information was reported: CHILLS (non-serious) with onset 15Nov2022 at 22:00, outcome "not recovered"; HEADACHE (non-serious) with onset 15Nov2022 at 22:00, outcome "not recovered", described as "Headaches"; LYMPHADENOPATHY (non-serious) with onset 15Nov2022 at 22:00, outcome "not recovered", described as "Lymph node was very swollen underneath left armpit. Significant bump remained for two weeks after the second dose"; TREMOR (non-serious) with onset 15Nov2022 at 22:00, outcome "not recovered", described as "extreme shaking"; LETHARGY (non-serious) with onset 15Nov2022 at 22:00, outcome "not recovered", described as "lethargic behavior"; CHEST DISCOMFORT (non-serious) with onset 15Nov2022 at 22:00, outcome "not recovered", described as "tightness in the chest". Therapeutic measures were not taken as a result of lymphadenopathy, chest discomfort, headache, lethargy, chills, tremor.  Additional information: The patient did not receive other vaccine in four weeks. He was not diagnosed with covid-19 prior to vaccination and not positive for Covid-19 after vaccination. The patient had no known allergy. Other medical history: None. It was reported that Lymph node was very swollen underneath left armpit. Significant bump remained for two weeks after the second dose and I'm currently have the same after the third dose. Great deal of tightness in the chest. Headaches and lethargic behavior. Chills with extreme shaking approximately 12 hours after the third dose.  No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from product quality group. The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Oct2022 as dose 5 (booster), single at the age of 52 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 11Jan2021 as dose 1, single (Lot number: EK5730), on 02Feb2021 as dose 2, single (Lot number: EN5315), in left arm, on 01Dec2021 as dose 3 (booster), single (Lot number: 3303050), in left arm and on 22Jul2022 as dose 4 (booster), single (Lot number: FP7135), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimotos disease" (unspecified if ongoing); "Granuloma Annulare" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2022) Positive, notes: Rebound of COVID infection. Positive test and symptoms. Therapeutic measures were taken as a result of vaccination failure, covid-19 (treatment with PAXLOVID).; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drugs BNT162B2 and BNT162b2, BNT162b2 omi ba.4-5 cannot be excluded. The case will be reassessed once new information is available.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 69-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 at 11:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 68 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 21Feb2021 at 11:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 22Mar2021 at 11:00 as dose 2, single (Batch/Lot number: unknown), in left arm and on 05Oct2021 at 11:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Sleep apnea" (unspecified if ongoing); "Osteoarthritis" (unspecified if ongoing); "pre- diabetes" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL SUCCINATE, start date: 11Nov2016; TERAZOSIN. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccines in this patient cannot be completely excluded.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Interchange of vaccine product.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old male patient received BNT162b2 (BNT162B2), on 18Jan2021 as dose 1, single (Lot number: EL3247), in left arm, on 13Feb2021 as dose 2, single (Lot number: EL9267), in left arm and on 22Aug2021 as dose 3 (booster), single (Lot number: FA7485), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 01Apr2022 as dose 4 (booster), single (Lot number: 002M21A) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing), notes: Other medical history: hypertension. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 01Apr2022, outcome "unknown", described as "Interchange of vaccine product."; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 12Nov2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Nov2022) negative, notes: took rapid antigen tests every morning and night since then and tested negative on the night of 16Nov; (19Nov2022) Positive, notes: I have continued to tests morning and night. I am now positive on two antigen tests on the morning of 19Nov. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Apr2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 25Apr2021 as dose 2, single (Batch/Lot number: unknown), in right arm and on 01Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 45 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Repaired atrial septal defect", start date: 2001 (unspecified if ongoing); "Birth control pills" (unspecified if ongoing), notes: Birth control pills. The patient took concomitant medications. Past drug history included: Demerol, reaction(s): "known allergies: Demerol". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 28Dec2021, outcome "unknown" and all described as "Covid test date=28Dec2021, covid test result=Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Dec2021) Positive, notes: Nasal Swab.  Additional information: No other vaccine in four weeks. Other medications in two weeks included birth control pills.  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): PFIZER INC-202201313468 Same reporter/patient/vaccine, different dose/event.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acute myocardial infarction, Myocarditis, Nasopharyngeal swab, Pericarditis
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Apr2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 25Apr2021 as dose 2, single (Batch/Lot number: unknown), in right arm and on 01Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 45 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Repaired atrial septal defect", start date: 2001 (unspecified if ongoing); "Birth control pills" (unspecified if ongoing), notes: Birth control pills. The patient took concomitant medications. Past drug history included: Demerol, reaction(s): "known allergies: Demerol". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 28Dec2021, outcome "unknown" and all described as "Covid test date=28Dec2021, covid test result=Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Dec2021) Positive, notes: Nasal Swab.  Additional information: No other vaccine in four weeks. Other medications in two weeks included birth control pills.  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): PFIZER INC-202201313468 Same reporter/patient/vaccine, different dose/event.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Myalgia
Clinical narrative: Fever; headache; nausea; chills; muscle soreness; fatigue; soreness at injection site; sore throat; lightheadedness; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 12-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Nov2022 at 11:30 as dose 4 (booster), single (Lot number: GJ6796) at the age of 12 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Augmentin, reaction(s): "known allergies: Augmentin", notes: known allergies Augmentin; Amoxicillin, reaction(s): "known allergies: amoxicillin", notes: known allergies amoxicillin. Vaccination history included: Covid-19 vaccine (Dose: 1, Manufacturer unknow, Lot batch number unknown), for COVID-19 immunization; Covid-19 vaccine (Dose: 2, Manufacturer unknow, Lot batch number unknown), for COVID-19 immunization; Covid-19 vaccine (Dose: 3, Manufacturer unknow, Lot batch number unknown), for COVID-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 19Nov2022 at 21:15, outcome "recovering", described as "Fever"; CHILLS (non-serious) with onset 19Nov2022 at 21:15, outcome "recovering"; FATIGUE (non-serious) with onset 19Nov2022 at 21:15, outcome "recovering"; HEADACHE (non-serious) with onset 19Nov2022 at 21:15, outcome "recovering"; DIZZINESS (non-serious) with onset 19Nov2022 at 21:15, outcome "recovering", described as "lightheadedness"; MYALGIA (non-serious) with onset 19Nov2022 at 21:15, outcome "recovering", described as "muscle soreness"; NAUSEA (non-serious) with onset 19Nov2022 at 21:15, outcome "recovering"; OROPHARYNGEAL PAIN (non-serious) with onset 19Nov2022 at 21:15, outcome "recovering", described as "sore throat"; VACCINATION SITE PAIN (non-serious) with onset 19Nov2022 at 21:15, outcome "recovering", described as "soreness at injection site". Therapeutic measures were not taken as a result of pyrexia, headache, nausea, chills, myalgia, fatigue, vaccination site pain, oropharyngeal pain, dizziness.  Additional information: If other vaccine in four weeks: no. Other medications in two weeks: no, If covid prior vaccination: no, If covid tested post vaccination: no.  No follow-up attempts are possible. No further information is expected.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Oropharyngeal pain, Pyrexia, Vaccination site pain
Clinical narrative: Fever; headache; nausea; chills; muscle soreness; fatigue; soreness at injection site; sore throat; lightheadedness; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 12-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Nov2022 at 11:30 as dose 4 (booster), single (Lot number: GJ6796) at the age of 12 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Augmentin, reaction(s): "known allergies: Augmentin", notes: known allergies Augmentin; Amoxicillin, reaction(s): "known allergies: amoxicillin", notes: known allergies amoxicillin. Vaccination history included: Covid-19 vaccine (Dose: 1, Manufacturer unknow, Lot batch number unknown), for COVID-19 immunization; Covid-19 vaccine (Dose: 2, Manufacturer unknow, Lot batch number unknown), for COVID-19 immunization; Covid-19 vaccine (Dose: 3, Manufacturer unknow, Lot batch number unknown), for COVID-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 19Nov2022 at 21:15, outcome "recovering", described as "Fever"; CHILLS (non-serious) with onset 19Nov2022 at 21:15, outcome "recovering"; FATIGUE (non-serious) with onset 19Nov2022 at 21:15, outcome "recovering"; HEADACHE (non-serious) with onset 19Nov2022 at 21:15, outcome "recovering"; DIZZINESS (non-serious) with onset 19Nov2022 at 21:15, outcome "recovering", described as "lightheadedness"; MYALGIA (non-serious) with onset 19Nov2022 at 21:15, outcome "recovering", described as "muscle soreness"; NAUSEA (non-serious) with onset 19Nov2022 at 21:15, outcome "recovering"; OROPHARYNGEAL PAIN (non-serious) with onset 19Nov2022 at 21:15, outcome "recovering", described as "sore throat"; VACCINATION SITE PAIN (non-serious) with onset 19Nov2022 at 21:15, outcome "recovering", described as "soreness at injection site". Therapeutic measures were not taken as a result of pyrexia, headache, nausea, chills, myalgia, fatigue, vaccination site pain, oropharyngeal pain, dizziness.  Additional information: If other vaccine in four weeks: no. Other medications in two weeks: no, If covid prior vaccination: no, If covid tested post vaccination: no.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, FLUX, PPV
Symptoms: Vaccination site bruising
Clinical narrative: has bruising on the area especially on pneumonia shot; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP), Program ID: (051529).  A 62-year-old female patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN)), in 2022 as dose number unknown, single (Batch/Lot number: unknown) for immunisation; influenza vaccine (INFLUENZA VACCINE), (Batch/Lot number: unknown) for immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PLAVIX. The following information was reported: VACCINATION SITE BRUISING (non-serious) with onset 2022, outcome "unknown", described as "has bruising on the area especially on pneumonia shot".  Additional information: Patient reports that she recently received pneumonia, influenza and COVID-19 booster and has bruising on the area especially on pneumonia shot. Also gets bruising on insulin injection sites. Takes Plavix and doctors are aware.  The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.  Amendment: This follow-up report is being submitted to amend previous information: Product was recoded to reflect appropriate drug device combination license.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia areata, SARS-CoV-2 test
Clinical narrative: front scalp small patch; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 56-year-old female patient received BNT162b2 (BNT162B2), on 06Jan2021 as dose 2, single (Lot number: EL3249) at the age of 55 years intramuscular for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: EH9899;Route of administration: Intramuscular; Anatomical site of injection: Left shoulder), administration date: 17Dec2020, when the patient was 55-year-old, for Covid-19 immunization. The following information was reported: ALOPECIA AREATA (non-serious) with onset 2021, outcome "not recovered", described as "front scalp small patch". The event "front scalp small patch" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient had no any prior vaccinations.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201265242 Same patient, different dose and event.;
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension
Clinical narrative: He also mentioned that the patient was recently diagnosed with hypertension, possibly uncontrolled. The patient has been in and out of the Hospital with uncontrolled elevated Hypertension.; This is a spontaneous report received from a contactable reporter(s) (Pharmacist), Program ID:.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPERTENSION (hospitalization), outcome "unknown", described as "He also mentioned that the patient was recently diagnosed with hypertension, possibly uncontrolled. The patient has been in and out of the Hospital with uncontrolled elevated Hypertension.". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: elevated.  Clinical course: pharmacist has a drug question about the Pfizer bivalent vaccine. They have a patient who would like to get a vaccination for the Pfizer bivalent vaccine. They are concerned about the inactive ingredients of the Pfizer bivalent vaccine. They are concerned about raising possible blood pressure with the inactive ingredient, because the patient received the previous vaccine with no concern, but theres a concern about the new bivalent vaccine. He was wondering if theres any information about the inactive ingredients that we can send to him and see if anything would possibly cause any increase in blood pressure for the patient. He also mentioned that the patient was recently diagnosed with hypertension, possibly uncontrolled. The patient has been in and out of the Hospital with uncontrolled elevated Hypertension. Medical information included Customer and/or medical inquiry forwarded or referred.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information in the case, an association between the reported events and The suspected drug cannot be ruled out.  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.
Sex: F
Vaccine: COVID19
Symptoms: Blister, Cellulitis
Clinical narrative: 10" x 10" blistering site on skin with cellulitis; 10" x 10" blistering site on skin with cellulitis; This is a spontaneous report received from contactable reporter(s) (Nurse) from a sales representative.  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, manufacturer unknown), for COVID-19 immunization. The following information was reported: CELLULITIS (medically significant), BLISTER (non-serious), outcome "unknown" and all described as "10" x 10" blistering site on skin with cellulitis".  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 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.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Fall, Hypertension, Pneumonia
Clinical narrative: Pneumonia; High BP; Fall; 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 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1; Manufacturer Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose 2; Manufacturer Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose 3 (Booster); Manufacturer Unknown), for COVID-19 Immunization. The following information was reported: PNEUMONIA (medically significant), outcome "unknown"; HYPERTENSION (non-serious), outcome "recovered", described as "High BP"; FALL (non-serious), outcome "unknown". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: High. Therapeutic measures were taken as a result of hypertension.  Clinical course: Patient was in good to excellent health, high BP controlled with Lisinopril, plus oral HRT. Patient had pneumonia in second grade, patient not had flu shot since last fall, and had both COVID Shots and two boosters.  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.