chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: M
Vaccine: PNC20
Symptoms: Pain in extremity, Pyrexia, Vaccination site pain
Clinical narrative: I started getting paralysis in the arm; My arm got really sore; Pain is excruciating, on 1-10 its 9.5, its from the injection site up a little and all way down to my arm; Fever; cannot move it/ can barely move; I was moving it very slowly and its very painful; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 25Aug2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 66 years for immunisation. The patient's relevant medical history included: "Pulmonary fibrosis" (unspecified if ongoing). Concomitant medication(s) included: OFEV taken for pulmonary fibrosis. The following information was reported: PYREXIA (non-serious) with onset 25Aug2023, outcome "unknown", described as "Fever"; MONOPLEGIA (medically significant) with onset 25Aug2023, outcome "unknown", described as "I started getting paralysis in the arm"; PAIN (non-serious) with onset 25Aug2023, outcome "unknown", described as "I was moving it very slowly and its very painful"; PAIN IN EXTREMITY (non-serious) with onset 25Aug2023, outcome "unknown", described as "My arm got really sore"; VACCINATION SITE PAIN (non-serious) with onset 25Aug2023, outcome "unknown", described as "Pain is excruciating, on 1-10 its 9.5, its from the injection site up a little and all way down to my arm"; MOBILITY DECREASED (non-serious) with onset 25Aug2023, outcome "unknown", described as "cannot move it/ can barely move". Therapeutic measures were taken as a result of monoplegia, pain in extremity, vaccination site pain, pyrexia, mobility decreased, pain. The patient got a shot of that Prevnar 20 the day before 26Aug2023 and it was in 3 hours his arm got really sore. He had excruciating pain up to like a number 10. He had this shot around 4 O'clock, 5 O'clock, pain started about 7 O'clock and then around 9 O'clock he started getting paralysis in the arm, he cannot move it and I was moving it very slowly and its very painful and he got a slight fever he thought from that. The pain was excruciating, on 1-10 its 9.5, it was from the injection site up a little and all way down to his arm and he can barely move. He had a lab test when prescribed the medication, it was physical. The treatment included Excedrin.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
Age: 68.0
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 contactable reporter(s) (Consumer or other non HCP) from product quality group. 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 06Oct2022 as dose 5 (booster), single (Lot number: GH9693) at the age of 68 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "chronic atrial fibrillation" (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 2023, outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.
Sex: U
Vaccine: COVID19-2
Symptoms: Immunodeficiency
Clinical narrative: immunocompromised; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunisation. The following information was reported: IMMUNODEFICIENCY (hospitalization, medically significant), outcome "unknown", described as "immunocompromised". The event "immunocompromised" required physician office visit. Clinical course: Patient had an adverse reaction to the first Pfizer booster that landed the patient in the hospital x 2 and resulted in physicians telling to never, ever get any type of Covid vaccine. Therefore, patient was very immunocompromised.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Balance disorder, Crohn's disease, Fatigue, SARS-CoV-2 test
Clinical narrative: Hand tremors; weakness in hands; Chronic fatigue; unbalanced; Crohn's disease came out of remission; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old male patient received BNT162b2 (BNT162B2), on 04Apr2021 as dose 2, single (Lot number: EW0153) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Type two diabetes" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "Crohn's disease" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "Known allergies: Black pepper" (unspecified if ongoing); "Known allergies: lactose" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Cephalexin, reaction(s): "Known allergies: Cephalexin". Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: Unknown. EP7534, Location of injection: Arm Left), administration date: 23Mar2021, when the patient was 56-year-old, for COVID-19 Immunization; Humira, reaction(s): "Known allergies: Humira". The following information was reported: FATIGUE (hospitalization, disability) with onset 25Apr2021, outcome "not recovered", described as "Chronic fatigue"; CROHN'S DISEASE (hospitalization, disability) with onset 25Apr2021, outcome "not recovered", described as "Crohn's disease came out of remission"; TREMOR (hospitalization, disability) with onset 25Apr2021, outcome "not recovered", described as "Hand tremors"; BALANCE DISORDER (hospitalization, disability) with onset 25Apr2021, outcome "not recovered", described as "unbalanced"; ASTHENIA (hospitalization, disability) with onset 25Apr2021, outcome "not recovered", described as "weakness in hands". The patient was hospitalized for tremor, asthenia, fatigue, balance disorder, crohn's disease (hospitalization duration: 4 day(s)). The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Nasal Swab. Therapeutic measures were taken as a result of tremor, asthenia, fatigue, balance disorder, crohn's disease. Clinical course: No other vaccine in four weeks, no vaccination before. AE treatment: IV fluids, antibiotics, colonoscopy, blood tests.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Hand tremors; weakness in hands; Chronic fatigue; unbalanced; Crohn's disease came out of remission; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old male patient received BNT162b2 (BNT162B2), on 04Apr2021 as dose 2, single (Lot number: EW0153) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Type two diabetes" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "Crohn's disease" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "Known allergies: Black pepper" (unspecified if ongoing); "Known allergies: lactose" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Cephalexin, reaction(s): "Known allergies: Cephalexin". Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: Unknown. EP7534, Location of injection: Arm Left), administration date: 23Mar2021, when the patient was 56-year-old, for COVID-19 Immunization; Humira, reaction(s): "Known allergies: Humira". The following information was reported: FATIGUE (hospitalization, disability) with onset 25Apr2021, outcome "not recovered", described as "Chronic fatigue"; CROHN'S DISEASE (hospitalization, disability) with onset 25Apr2021, outcome "not recovered", described as "Crohn's disease came out of remission"; TREMOR (hospitalization, disability) with onset 25Apr2021, outcome "not recovered", described as "Hand tremors"; BALANCE DISORDER (hospitalization, disability) with onset 25Apr2021, outcome "not recovered", described as "unbalanced"; ASTHENIA (hospitalization, disability) with onset 25Apr2021, outcome "not recovered", described as "weakness in hands". The patient was hospitalized for tremor, asthenia, fatigue, balance disorder, crohn's disease (hospitalization duration: 4 day(s)). The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Nasal Swab. Therapeutic measures were taken as a result of tremor, asthenia, fatigue, balance disorder, crohn's disease. Clinical course: No other vaccine in four weeks, no vaccination before. AE treatment: IV fluids, antibiotics, colonoscopy, blood tests.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2022 as dose 5 (booster), single (Lot number: AS7165B) at the age of 27 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 16Jun2022 as dose 4 (booster), single (Lot number: FJ4989) for covid-19 immunisation; BNT162b2 (BNT162B2), on 17Mar2021 as dose 1, single (Lot number: EN6208), on 07Apr2021 as dose 2, single (Lot number: EW0151) and on 23Oct2021 as dose 3 (booster), single (Lot number: FE3590) for covid-19 immunisation. The patient's relevant medical history included: "MCAS" (unspecified if ongoing); "POTS" (unspecified if ongoing); "EDS" (unspecified if ongoing). The patient's concomitant medications were not reported. The patient had no known allergy.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 including Paxlovid form 18Aug2023 to 22Aug2023.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Caller started Paxlovid 14Aug2023 and completed the treatment; Caller started Paxlovid 14Aug2023 and completed the treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster),single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "unknown" and all described as "Caller started Paxlovid 14Aug2023 and completed the treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Aug2023) positive, notes: Treatment of Covid-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient had started Paxlovid treatment on 14Aug2023. She has had all her shots and boosters for Covid 19 from Pfizer.  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: Linked Report(s) : US-PFIZER INC-202300287028 same patient, different drug/events;
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Name of Drug as Reported: Pfizer / BioNTech; Patient Drug Start date: 20Sep2022; 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 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Sep2022 as dose 5 (booster), single (Lot number: GH9730), in left arm and on 01May2023 at 13:00 as dose 6 (booster), single (Lot number: GK1337) at the age of 68 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 18Jan2021 as dose 1, single (Lot number: 042l20A), in left arm, on 13Feb2021 as dose 2, single (Lot number: 024m20a), in left arm, on 22Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 18Apr2022 as dose 4 (booster), single (Lot number: 0021m21a), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Small bowel obstruction", start date: 2021 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 20Sep2022, outcome "unknown", described as "Name of Drug as Reported: Pfizer / BioNTech; Patient Drug Start date: 20Sep2022"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 17Aug2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Aug2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from 17Aug2023 to 21Aug2023.
Age: 46.0
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 non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) 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: "Asthma" (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 "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 21Aug2023 to 25Aug2023.  Clinical course: On day 3 after completing paxlovid, I feel worse. Headache, nausea, and fatigue.  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 lack of efficacy with the suspect vaccine BNT162b2, BNT162b2 omi ba.4-5 in this patient cannot be completely excluded.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Oct2022 as dose 5 (booster), single (Lot number: GH9702) at the age of 67 years, in left arm for COVID-19 immunisation; BNT162b2 (BNT162B2), on 13Apr2022 as dose 4 (booster), single (Lot number: FK9895), in left arm for COVID-19 immunisation; BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Lot number: EN6201), in left arm, on 25Mar2021 as dose 2, single (Lot number: EN6205), in left arm and on 14Oct2021 as dose 3 (booster), single (Lot number: FH8027), in left arm for COVID-19 immunisation. The patient's relevant medical history included: "ITP" (unspecified if ongoing); "Osteoperosis" (unspecified if ongoing); "Erythrocytosis" (unspecified if ongoing); "Known allergies: Sulpha drugs" (unspecified if ongoing); "Known allergies: sulfites in wine" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, COVID-19.
Age: 55.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 as dose 4 (booster), single (Lot number: gn-9693) at the age of 55 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 26Mar2021 as dose 1, single (Lot number: FR8783), in left arm, on 16Apr2021 as dose 2, single (Lot number: EW0164), in left arm and on 05Nov2021 as dose 3 (booster), single (Lot number: 301308-A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "restless leg syndrome" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing); "depression/anxiety" (unspecified if ongoing); "2 colon cancer (2021)", start date: 2021 (unspecified if ongoing); "Known allergies: Z-pack antibiotics" (unspecified if ongoing), notes: Known allergies: Z-pack antibiotics; "Known allergies: ginger" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "known allergies: codeine"; Iodine, reaction(s): "Known allergies: iodine"; Betadine, reaction(s): "known allergies: betadine". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received Paxlovid as treatment on 18Aug2023 to 23Aug2023.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in May2021 as dose 2, single (Batch/Lot number: unknown), in left arm and in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 35 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing), notes: other medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient took Paxlovid (start date and stop date: May2022) the day patient received a positive COVID test in May2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Paxlovid was received from 15Aug2023 to 20Aug2023.  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
Symptoms: COVID-19, Drug ineffective
Clinical narrative: I got vaxed two times and boostered once and I still just got COVID/Doctor gave me Paxlovid; I got vaxed two times and boostered once and I still just got COVID/Doctor gave me Paxlovid; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 2, 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) for covid-19 immunisation. The patient's relevant medical history included: "Chronic Bronchitis" (unspecified if ongoing), notes: Other medical history: Asthma, Chronic Bronchitis; "Asthma" (unspecified if ongoing), notes: Other medical history: Asthma, Chronic Bronchitis. The patient's concomitant medications were not reported. Past drug history included: Keflex, reaction(s): "Known allergies: Keflex", notes: Known allergies: Keflex. The following information was reported: DRUG INEFFECTIVE (medically significant, life threatening), COVID-19 (medically significant, life threatening) all with onset 21Aug2023 at 02:00, outcome "not recovered" and all described as "I got vaxed two times and boostered once and I still just got COVID/Doctor gave me Paxlovid". Therapeutic measures were taken as a result of drug ineffective, covid-19.(Paxlovid on 28Aug2023).  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 the current available limited information in the case provided, the causal association between the events Drug ineffective, Covid-19 and the use of suspect product cannot be fully excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: bee venom allergy" (unspecified if ongoing), notes: Known allergies: Penicillin keflex bee venom allergy; "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin keflex bee venom allergy. The patient's concomitant medications were not reported. Past drug history included: Keflex, reaction(s): "Known allergies: keflex". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Aug2023) Positive, notes: Rebound positive for covid. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received Paxlovid as treatment from 17Aug2023 to 21Aug2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Dose #1: Moderna/ Dose #2: Moderna/ Dose #3: Pfizer/ Dose #4: Pfizer/ Dose #5: Pfizer.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Nov2022 as dose 5 (booster), single (Lot number: GH9693) at the age of 63 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 21Dec2021 as dose 3 (booster), single (Lot number: FJ8762), in left arm and on 25May2022 as dose 4 (booster), single (Lot number: FM0173), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 22Apr2021 as dose 1, single (Lot number: 007C21A), in left arm and on 20May2021 as dose 2, single (Lot number: 024C21A), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 21Dec2021, outcome "unknown", described as "Dose #1: Moderna/ Dose #2: Moderna/ Dose #3: Pfizer/ Dose #4: Pfizer/ Dose #5: 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 included Paxlovid from 20Aug2023 to 25Aug2023.  Clinical course: Rebound 4 days after 5-day paxlovid course Symptoms: heavy chesty cough, runny nose, nasal congestion.
Sex: U
Vaccine: COVID19
Symptoms: Renal failure, Thrombosis
Clinical narrative: kidney failure; They diagnosed and treated me for dozens of blood clots in my left leg and abdomen which they removed; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  An elderly patient received BNT162b2 (PFIZER-BIONTECH COVID- 19 VACCINE), on 26Feb2021 as dose 2, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (on 05Feb2021 I got my Pfizer-BioNTech COVID- 19 injection (Dose 1)), administration date: 05Feb2021, for COVID-19 immunization. The following information was reported: THROMBOSIS (hospitalization, medically significant) with onset 2021, outcome "unknown", described as "They diagnosed and treated me for dozens of blood clots in my left leg and abdomen which they removed"; RENAL FAILURE (hospitalization, medically significant) with onset 2021, outcome "unknown", described as "kidney failure". The patient was hospitalized for renal failure, thrombosis (start date: 29Jul2021). Therapeutic measures were taken as a result of renal failure, thrombosis. Additional information: So, like a good soldier on 05Feb2021 the patient got Pfizer-BioNTech COVID- 19 injection then followed up with a booster on 26Feb2021. On 29Jul2021, the patient was taken by ambulance to (Hospital name withheld) arriving in total kidney failure. They diagnosed and treated the patient for dozens of blood clots in left leg and abdomen which was removed. The patient was in ICU for 4 days. The patient was now on Eliquis for the rest of the patient's life. The patient was asking for assistance in paying for this drug for the rest of the patient's life, the patient was 77.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 1.0
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: ACTHIB was given past the expiration date with no reported adverse event; Initial information received on 24-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 1-year-old female patient for whom HIB (PRP/T) vaccine [ACT-HIB] was given past the expiration date 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 Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular, Tetanus Vaccine Toxoid (Daptacel), Varicella Zoster Vaccine (Varicella Vaccine) And Measles Vaccine, Mumps Vaccine, Rubella Vaccine (MMR), all for Immunisation.  On 24-Aug-2023, the patient received an expired dose of 0.5 ml (Frequency = once) of standard strength suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection (lot: UJ796AA, Expiry date: 12-Aug-2023) via intramuscular route in the left thigh for Immunization no reported adverse event (expired product administered) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown.  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 guidelines. 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.
Age: 53.0
Sex: F
Vaccine: TYP, YF
Symptoms: Anxiety, Feeling hot, Hypoaesthesia oral, Paraesthesia oral
Clinical narrative: Patient states of numbness and tingling of both lips and warmth in abdominal area. Patient states she is anxious. Vital signs checked multiple times initial was 15 minutes after vaccine administrations BP150/83 P 85 O298 R20  vitals about  20 min later BP 151/82 P82 r 20. Patient observed for 60minutes  and all symptoms disappeared denies blurred vision , and shortness of breath.and all other symptoms.
Age: 57.0
Sex: M
Vaccine: HEP
Symptoms: Extra dose administered
Clinical narrative: Pt. reported having HIV/HepC and was told to get hepA and hepB vaccine. HepB was given as a 3rd dose because of pt. reported disease state. We learned later from the HIV clinic provider he does not have HIV.
Age: 48.0
Sex: F
Vaccine: COVID19-2
Symptoms: Erythema, Myalgia, Swelling
Clinical narrative: Muscle soreness, redness and swelling.
Age: 43.0
Sex: M
Vaccine: TD
Symptoms: Chills, Discomfort, Nausea, Pain, Pyrexia
Clinical narrative: Within 1hr following vaccination:  Fevers, Chills, Rigors, Body Aches, Nausea, Vomiting.   Taking Tylenol for fever and discomfort
Age: 43.0
Sex: M
Vaccine: TD
Symptoms: Vomiting
Clinical narrative: Within 1hr following vaccination:  Fevers, Chills, Rigors, Body Aches, Nausea, Vomiting.   Taking Tylenol for fever and discomfort
Age: 16.0
Sex: M
Vaccine: HEPA, HEPA, TDAP, TDAP
Symptoms: Blood glucose normal, Disorientation, Dizziness, Electrocardiogram normal, Eye movement disorder
Clinical narrative: Patient appears to have had seizure activity about 15 minutes after vaccine administration. Pt had history of fainting after shots. Patient first experienced feeling faint before vaccines while RN was taking BP. Vaccines were given while patient was supine. When RN sat patient up with legs dangling at bedside, he stated he was fine.  But when nurse took his BP again, he felt faint, and RN laid patient back down. At this point, patient stopped talking, became stiff and stared with open eyes at the ceiling, unresponsive but maintaining respirations. RN instructed Mom to call for help while RN remained with patient, protecting hoim from injury and monitoring respirations. Pt's eyes rolled back in his head, body convulsed for about 15 seconds, and left arm was raised and still above his head.. RN and CMA arrived promptly and called 911.  Seizure like activity lasted approximately 3-5 minutes including recovery. Patient was momentarily disoriented but recovered quickly. He sat up  again, with legs dangling over side of bed. CMA applied ice to the back of his upper back. Medics arrived within 5 minutes and evaluated patient. He was hooked up to EKG monitor and vitals except BP were taken. All vitals stable, monitor showed normal sinus rhythm.  Blood glucose was check with result of 107. He had not eaten breakfast. BP was 118/98 just before event occured. Pt had indicated no history of seizures with vaccines, but stated it was normal for him to have the "eye thing" WHen RN ask patient if he had any history of head injury, he had a "mild" head injury in March during Rugby.  At that time he had a CT and saw a "brain" doctor who appears to have conducted a neurological exam. He was released to cntinue normal activities. Patient was discharged home in care of Mom. RN advised he call his mother and update her on todday's event's to determine if she wants additional evaluation.
Age: 16.0
Sex: M
Vaccine: HEPA, HEPA, TDAP, TDAP
Symptoms: Musculoskeletal stiffness, Seizure, Seizure like phenomena, Sinus rhythm, Staring
Clinical narrative: Patient appears to have had seizure activity about 15 minutes after vaccine administration. Pt had history of fainting after shots. Patient first experienced feeling faint before vaccines while RN was taking BP. Vaccines were given while patient was supine. When RN sat patient up with legs dangling at bedside, he stated he was fine.  But when nurse took his BP again, he felt faint, and RN laid patient back down. At this point, patient stopped talking, became stiff and stared with open eyes at the ceiling, unresponsive but maintaining respirations. RN instructed Mom to call for help while RN remained with patient, protecting hoim from injury and monitoring respirations. Pt's eyes rolled back in his head, body convulsed for about 15 seconds, and left arm was raised and still above his head.. RN and CMA arrived promptly and called 911.  Seizure like activity lasted approximately 3-5 minutes including recovery. Patient was momentarily disoriented but recovered quickly. He sat up  again, with legs dangling over side of bed. CMA applied ice to the back of his upper back. Medics arrived within 5 minutes and evaluated patient. He was hooked up to EKG monitor and vitals except BP were taken. All vitals stable, monitor showed normal sinus rhythm.  Blood glucose was check with result of 107. He had not eaten breakfast. BP was 118/98 just before event occured. Pt had indicated no history of seizures with vaccines, but stated it was normal for him to have the "eye thing" WHen RN ask patient if he had any history of head injury, he had a "mild" head injury in March during Rugby.  At that time he had a CT and saw a "brain" doctor who appears to have conducted a neurological exam. He was released to cntinue normal activities. Patient was discharged home in care of Mom. RN advised he call his mother and update her on todday's event's to determine if she wants additional evaluation.
Age: 16.0
Sex: M
Vaccine: HEPA, HEPA, TDAP, TDAP
Symptoms: Unresponsive to stimuli
Clinical narrative: Patient appears to have had seizure activity about 15 minutes after vaccine administration. Pt had history of fainting after shots. Patient first experienced feeling faint before vaccines while RN was taking BP. Vaccines were given while patient was supine. When RN sat patient up with legs dangling at bedside, he stated he was fine.  But when nurse took his BP again, he felt faint, and RN laid patient back down. At this point, patient stopped talking, became stiff and stared with open eyes at the ceiling, unresponsive but maintaining respirations. RN instructed Mom to call for help while RN remained with patient, protecting hoim from injury and monitoring respirations. Pt's eyes rolled back in his head, body convulsed for about 15 seconds, and left arm was raised and still above his head.. RN and CMA arrived promptly and called 911.  Seizure like activity lasted approximately 3-5 minutes including recovery. Patient was momentarily disoriented but recovered quickly. He sat up  again, with legs dangling over side of bed. CMA applied ice to the back of his upper back. Medics arrived within 5 minutes and evaluated patient. He was hooked up to EKG monitor and vitals except BP were taken. All vitals stable, monitor showed normal sinus rhythm.  Blood glucose was check with result of 107. He had not eaten breakfast. BP was 118/98 just before event occured. Pt had indicated no history of seizures with vaccines, but stated it was normal for him to have the "eye thing" WHen RN ask patient if he had any history of head injury, he had a "mild" head injury in March during Rugby.  At that time he had a CT and saw a "brain" doctor who appears to have conducted a neurological exam. He was released to cntinue normal activities. Patient was discharged home in care of Mom. RN advised he call his mother and update her on todday's event's to determine if she wants additional evaluation.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal cavity drainage
Clinical narrative: Patient receives the appropriate medication(s), safely administered during the pre-procedure period. The patient participates in the decisions related to their procedure plan of care. The patient demonstrates knowledge of the expected responses to the operative or invasive procedure.   Corona virus screening: Patient denies  any contact with a person who is under investigation for corona virus. Patient denies fever and  respiratory symptoms.   Belongings:  Pt belongings bag including clothes, shoes, , cell phone, are stored in designated area.  Pt was instructed not to bring any valuables.Patient was encouraged to give valuables to family at time of admission.  Patient denies any other valuables in bag.    Medications:none   Antibiotics to be administered during surgery were spiked, primed and labeled (with date and time spiked per anesthesia directive).  They were hung on the gurney IV pole, unattached to the primary line, and handed off to the circulator RN.    LAB:      Note Details  Author (R.N.) File Time 8/24/2023 11:41 AM Author Type REGISTERED NURSE Status Signed Last Editor (R.N.) Specialty GENERAL, OTHER Admit Date 8/24/2023  Admission (Discharged) on 8/24/2023  Admission (Discharged) on 8/24/2023   Detailed Report  Note shared with patient Care Timeline  08/24   PARACENTESIS ABDOMINAL, THERAPEUTIC    Discharged 1503
Age: 63.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Abdominal pain, Autoimmune pancreatitis, Biopsy pancreas abnormal, Blood sodium decreased, Blood test abnormal
Clinical narrative: August 1, 2022: Initially, diarrhea, moderate-sever intermittent abdominal pain, some nausea and dizziness, and moderate weight loss that persisted for 4 weeks. Visited doctors and urgent care multiple times and did blood & stool tests and scheduled a CT.  September 4, 2022: Rushed to ER. Sodium level was 126. Admitted/ospitalized for over a week. CT+contrast, MRCP, EUS Pancreas & Biopsy, Colonoscopy & many other tests confirmed elevated IgG4 (250), IgG4 cells in pancreas; SO: Type-1 Autoimmune Pancreatitis. October 2022 - Present (August 2023): Treated with high dose prednisone (40 mg) for 2 months, then tapering down very gradually (currently 5 mg).  Current IgG4 260, have symptoms, Planning Retuximab.
Age: 63.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Carbohydrate antigen 19-9, Cholangitis sclerosing, Colonoscopy abnormal, Computerised tomogram pancreas abnormal, Diarrhoea
Clinical narrative: August 1, 2022: Initially, diarrhea, moderate-sever intermittent abdominal pain, some nausea and dizziness, and moderate weight loss that persisted for 4 weeks. Visited doctors and urgent care multiple times and did blood & stool tests and scheduled a CT.  September 4, 2022: Rushed to ER. Sodium level was 126. Admitted/ospitalized for over a week. CT+contrast, MRCP, EUS Pancreas & Biopsy, Colonoscopy & many other tests confirmed elevated IgG4 (250), IgG4 cells in pancreas; SO: Type-1 Autoimmune Pancreatitis. October 2022 - Present (August 2023): Treated with high dose prednisone (40 mg) for 2 months, then tapering down very gradually (currently 5 mg).  Current IgG4 260, have symptoms, Planning Retuximab.
Age: 63.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Dizziness, Lipase, Magnetic resonance cholangiopancreatography, Nausea, Scan with contrast abnormal
Clinical narrative: August 1, 2022: Initially, diarrhea, moderate-sever intermittent abdominal pain, some nausea and dizziness, and moderate weight loss that persisted for 4 weeks. Visited doctors and urgent care multiple times and did blood & stool tests and scheduled a CT.  September 4, 2022: Rushed to ER. Sodium level was 126. Admitted/ospitalized for over a week. CT+contrast, MRCP, EUS Pancreas & Biopsy, Colonoscopy & many other tests confirmed elevated IgG4 (250), IgG4 cells in pancreas; SO: Type-1 Autoimmune Pancreatitis. October 2022 - Present (August 2023): Treated with high dose prednisone (40 mg) for 2 months, then tapering down very gradually (currently 5 mg).  Current IgG4 260, have symptoms, Planning Retuximab.
Age: 63.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Stool analysis, Ultrasound pancreas abnormal, Weight decreased
Clinical narrative: August 1, 2022: Initially, diarrhea, moderate-sever intermittent abdominal pain, some nausea and dizziness, and moderate weight loss that persisted for 4 weeks. Visited doctors and urgent care multiple times and did blood & stool tests and scheduled a CT.  September 4, 2022: Rushed to ER. Sodium level was 126. Admitted/ospitalized for over a week. CT+contrast, MRCP, EUS Pancreas & Biopsy, Colonoscopy & many other tests confirmed elevated IgG4 (250), IgG4 cells in pancreas; SO: Type-1 Autoimmune Pancreatitis. October 2022 - Present (August 2023): Treated with high dose prednisone (40 mg) for 2 months, then tapering down very gradually (currently 5 mg).  Current IgG4 260, have symptoms, Planning Retuximab.
Age: 22.0
Sex: F
Vaccine: TD
Symptoms: Cyanosis, Dizziness, Immediate post-injection reaction, Pallor
Clinical narrative: Immediately after receiving immunization, Donor became pale, lips cyanotic.  Assisted to lie down, ice packs applied, and legs held up until Donor was turned in bed an foot of bed was raised.  Donor stated was feeling better and was assisted to chair with help of two.  After eating snack, Donor stated was dizzy again so was returned to bed with bilateral ice packs placed front and back again.  Donor again stated felt better and was assisted to sitting position and additional snacks provided.  Donor had eaten well just before noon, stating had tator tots, turkey sandwich, and chicken quesadilla.
Age: 37.0
Sex: F
Vaccine: TD
Symptoms: Discomfort, Hyperhidrosis
Clinical narrative: Donor reported to Center staff after returning from the rest room that she felt sweaty.  Snacks provided and assisted into Booth to monitor vital signs.  At her worst discomfort level on a scale of 0 to10, ten feeling the worst, her discomfort was a 9/10.  At 1555 Donor stated her discomfort was 2/10.  At 1608, Donor reported discomfort level as 0/10.  Donor released alert and orientated times three, steady gait and balance, and self ambulatory.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Hyperhidrosis, Injection site erythema
Clinical narrative: Body aches, muscle spasms, headache, fever 99F, chills, sweats, red rash on the torso but not painful or itchy, major fatigue (stayed in bed ),  painful and red injection site.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Muscle spasms, Pain, Rash, Rash erythematous
Clinical narrative: Body aches, muscle spasms, headache, fever 99F, chills, sweats, red rash on the torso but not painful or itchy, major fatigue (stayed in bed ),  painful and red injection site.
Age: 30.0
Sex: F
Vaccine: COVID19-2
Symptoms: Unevaluable event
Clinical narrative: NONE
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Apnoea, Dyspnoea, Laboratory test, Respiration abnormal, X-ray
Clinical narrative: Episodes of gasping for air (apnea). Pt. was born prematurely.
Sex: U
Vaccine: RAB
Symptoms: Incorrect disposal of product, Injury associated with device, Wrong technique in product usage process
Clinical narrative: A nurse pulled a Rabavert vaccine kit to administer to a patient. The Rabavert kit only contains two needles in the package for usage. One needle is for reconstitution and the second one is for administration. The needle in the Rabavert vaccine kit for administration is not a safety needle. The nurse used the contained administration needle to give the vaccine to the patient. After administration of the vaccine the nurse tried to to recap the needle using the "scoop" method, and the needlestick occurred thereafter.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Unevaluable event
Clinical narrative: I got the Moderna vaccine, lot#060H21A, at Pharmacy. It was the winter of 2021 I think. This vaccine put my brain into severe pain. No medicine would help with this pain for 3 days. This vaccine is magnetic.
Sex: U
Vaccine: HPV9
Symptoms: Device malfunction, Syringe issue, Underdose
Clinical narrative: Patient was to receive an HPV vaccination. The syringe was prepared and seemed to be normal and in working order. All the air was expressed from the vaccine and there were no signs of leakage. When the needle was inserted into the patients arm and the plunger pressed down upon by the nurse, most if not all the vaccine shot out from under the hub where the needle would fit together with the syringe. The vaccine sprayed onto the nurse and the patient and some on the table. Supervisor was made aware immediately and so was the provider. I apologized to the parents for the malfunction, and they were very understanding. My supervisor informed me that I should do this report and also consult the provider on whether to do the vaccine again or wait until another appointment.
Sex: F
Vaccine: RSV
Symptoms: Hallucination, Migraine, Pyrexia, Seizure
Clinical narrative: Patient had a migraine for 4 days and a fever for 4 days. Patient states they were hallucinating. Patient states they had a seizure but the hospital advised them not to come in.