chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received bnt162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown), in right 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) all with onset Sep2023, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included paxlovid from 10Sep2023 to 14Sep2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 33.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Nov2022 as dose 4 (booster), single (Lot number: GJ3Z76) at the age of 33 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 07Sep2023 to 11Sep2023.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), 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: "Heart disease" (unspecified if ongoing); "diabetes" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 included paxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300303873 same patient, different drug/AE;
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Nov2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 64 years for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The patient had no known allergy.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from 02Sep2023 to 06Sep2023.  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: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Moderna: and Pfizer / BioNTech; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 at 12:00 as dose 4 (booster), single (Lot number: GM9694), in left arm and on 23Jan2023 as dose 5 (booster), single (Lot number: GL0446) at the age of 69 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 09Jan2021 at 12:00 as dose 1, single (Lot number: 025L20A), in left arm, on 06Feb2021 at 12:00 as dose 2, single (Lot number: 042L20A), in right arm and on 23Oct2021 at 12:00 as dose 3 (booster), single (Lot number: 037C21A). The patient had no relevant medical history. The patient's concomitant medications were not reported. The patient had no known allergy.  The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 23Oct2021 at 12:00, outcome "unknown", described as "Moderna: and Pfizer / BioNTech"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. including Paxlovid from 05Sep2023 to 19Sep2023.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood immunoglobulin G, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 at 01:00 as dose number unknown (booster), single (Lot number: OH9694), in left arm and on 25Apr2023 at 11:00 as dose number unknown (booster), single (Lot number: GJ3268) at the age of 72 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Chronic Lymphocetic Leukemia" (ongoing), notes: dormant - no treatment at this time; "Penicillin allergy" (unspecified if ongoing); "Sulpha allergy" (unspecified if ongoing); "Immunocomprised" (unspecified if ongoing), notes: Immunocomprised - low IgG. Infusions of IV/IG taken every 5 weeks. IgG in normal range at this time.; "low IgG" (unspecified if ongoing), notes: Immunocomprised - low IgG. Infusions of IV/IG taken every 5 weeks. IgG in normal range at this time. 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: Blood immunoglobulin G: (unspecified date) Low, notes: low IgG. Infusions of IV/IG taken every 5 weeks. IgG in normal range at this time; (unspecified date) Normal, notes: low IgG. Infusions of IV/IG taken every 5 weeks. IgG in normal range at this time; SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (15Sep2023) Negative, notes: Tested negative on 15Sep2023; (19Sep2023) Positive, notes: Tested positive on 19Sep2023. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Oct2022 at 15:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 04Feb2021 at 11:00 as dose 1, single (Lot number: EM9810), in left arm, on 25Sep2021 at 13:00 as dose 2, single (Lot number: EM9810), in left arm, on 04Oct2021 at 15:00 as dose 3 (booster), single (Lot number: FF8841), in right arm and on 12Apr2022 at 12:00 as dose 4 (booster), single (Lot number: FP4554), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Hashimoto's thyroiditis" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Positive, notes: positive antigen test; (2023) Negative, notes: negative test. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 08Sep2023 to 12Sep2023. 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: Linked Report(s) : US-PFIZER INC-202300304630 same reporter/patient/product, different dose/AE;US-PFIZER INC-202300304631 same reporter/patient/product, different dose/AE;
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Dose 1: Moderna/ Dose 2: Moderna/ Dose 3: Moderna/ Dose 4: Pfizer; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 as dose 4 (booster), single (Lot number: GH9694) at the age of 35 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 21Mar2021 as dose 1, single (Lot number: 047A21A), in left arm, on 18Apr2021 as dose 2, single (Lot number: 046B), in left arm and on 27Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Migraines" (unspecified if ongoing). Concomitant medication(s) included: WELLBUTRIN, start date: Aug2020; QULIPTA, start date: Jun2022. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 08Sep2022, outcome "not recovered", described as "Dose 1: Moderna/ Dose 2: Moderna/ Dose 3: Moderna/ Dose 4: Pfizer"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 06Sep2023, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Sep2023) Positive; (11Sep2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included received Paxlovid from 06Sep2023 to 10Sep2023. Clinical courses: Covid symptoms and first positive covid test developed 6 days after known covid exposure. The patient's only symptom was still loss of voice with NO sore throat.   No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Dose Number 3, Pfizer / BioNTech; Dose Number 4, Moderna; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Oct2022 as dose 5 (booster), single (Lot number: Ofi6739) and on 01Aug2023 as dose 6 (booster), single (Lot number: As7642b) at the age of 68 years for covid-19 immunisation; bnt162b2 (BNT162B2), on 26Jan2021 as dose 1, single (Lot number: EL9261), on 22Feb2021 as dose 2, single (Lot number: En6201) and on 24Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (COVID-19 VACCINE MODERNA), on 19Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing). No known allergies. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 19Apr2022, outcome "unknown", described as "Dose Number 3, Pfizer / BioNTech; Dose Number 4, Moderna"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 including Paxlovid from 09Sep2023 to 14Sep2023.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Age: 45.0
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) (Consumer or other non 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 21Nov2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 45 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 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: "Endometriosis" (unspecified if ongoing); "known allergies: Penecillan" (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. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: had covid; had covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 80-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Nov2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; bnt162b2 (BNT162B2), 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "had covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Sep2023) Negative, notes: she recently had Covid and tested negative on 16Sep2023; (18Sep2023) Negative, notes: yesterday tested negative.  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.
Sex: U
Vaccine: RSV
Symptoms: Respiratory disorder
Clinical narrative: respiratory issues; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A patient in their 60's received pf-06928316 (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation; for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RESPIRATORY DISORDER (non-serious), outcome "unknown", described as "respiratory issues".  The information on the batch/lot number for pf-06928316, pf-06928316  has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I tested positive for Covid on 28Aug2023; I tested positive for Covid on 28Aug2023; 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 69-year-old patient 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 28Aug2023, outcome "unknown" and all described as "I tested positive for Covid on 28Aug2023". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Aug2023) Positive.   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: Bell's palsy
Clinical narrative: Bell's palsy; 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 NOS), as unknown dose, single dose (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: BELL'S PALSY (medically significant), outcome "unknown". The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Age: 39.0
Sex: M
Vaccine: FLUC3
Symptoms: Exercise tolerance decreased, Injected limb mobility decreased, Injection site pain, Joint range of motion decreased, Muscular weakness
Clinical narrative: Can barely move his arm / can't even exercise or lift things / can't barely lift thing, workout, no range of motion; Lots of pain onsite of the injection; Started feeling muscle pain, pain intensified and continued to get worse; This spontaneous case was received on 15-Sep-2023 from other non-healthcare professional (the patient's spouse) (reference number: SEQW23-02325) and concerned a 39-year-old, male patient.  The patient's concurrent conditions included blood clotting disorder. The patient's concomitant medication included Coumadin (warfarin sodium), used for an unreported indication.  On 09-Sep-2023, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml, route of administration and anatomical location: not reported) as the patient had a little baby daughter and wanted to be the most protected as he could be, and that was the patient's first time with flu vaccine. The batch number reported was 372395.   On the same date, after receiving Flucelvax Quadrivalent, the patient started feeling lots of pain onsite of the injection. Could not barely move the arm. It was becoming worse each day.  On an unspecified date in Sep-2023, the patient started taking ibuprofen, one pill of 800 mg, morning and night. The patient got preoccupied because ibuprofen was not dealing with the problem and the patient could not even exercise or lift things.  On an unspecified date in Sep-2023, at day three, as reported, the patient started feeling muscle pain. The pain intensified and continued to get worse each day until day six. No symptoms were visualized, only felt inside (mostly pain).  At the time of initial reporting, on 15-Sep-2023, the patient was recovering from the events. As reported, ibuprofen helped a little bit, however, the patient was still having the pain. The patient could not barely lift thing, workout, and had no range of motion.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: A 39-year-old patient was vaccinated with Flucelvax Quadrivalent. On the same date, after receiving Flucelvax Quadrivalent, the patient developed vaccination site pain. Three days later, the patient started feeling muscle pain. Could not barely move the arm and it was worsening every day. Due to plausible time relationship, causal role of the suspect vaccine is assessed as possibly related for all events (vaccination site pain, myalgia and mobility decreased).; Sender's Comments: A 39-year-old patient was vaccinated with Flucelvax Quadrivalent. On the same date, after receiving Flucelvax Quadrivalent, the patient developed vaccination site pain. Three days later, the patient started feeling muscle pain. Could not barely move the arm and it was worsening every day. Due to plausible time relationship, causal role of the suspect vaccine is assessed as possibly related for all events (vaccination site pain, myalgia and mobility decreased).
Age: 39.0
Sex: M
Vaccine: FLUC3
Symptoms: Myalgia
Clinical narrative: Can barely move his arm / can't even exercise or lift things / can't barely lift thing, workout, no range of motion; Lots of pain onsite of the injection; Started feeling muscle pain, pain intensified and continued to get worse; This spontaneous case was received on 15-Sep-2023 from other non-healthcare professional (the patient's spouse) (reference number: SEQW23-02325) and concerned a 39-year-old, male patient.  The patient's concurrent conditions included blood clotting disorder. The patient's concomitant medication included Coumadin (warfarin sodium), used for an unreported indication.  On 09-Sep-2023, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml, route of administration and anatomical location: not reported) as the patient had a little baby daughter and wanted to be the most protected as he could be, and that was the patient's first time with flu vaccine. The batch number reported was 372395.   On the same date, after receiving Flucelvax Quadrivalent, the patient started feeling lots of pain onsite of the injection. Could not barely move the arm. It was becoming worse each day.  On an unspecified date in Sep-2023, the patient started taking ibuprofen, one pill of 800 mg, morning and night. The patient got preoccupied because ibuprofen was not dealing with the problem and the patient could not even exercise or lift things.  On an unspecified date in Sep-2023, at day three, as reported, the patient started feeling muscle pain. The pain intensified and continued to get worse each day until day six. No symptoms were visualized, only felt inside (mostly pain).  At the time of initial reporting, on 15-Sep-2023, the patient was recovering from the events. As reported, ibuprofen helped a little bit, however, the patient was still having the pain. The patient could not barely lift thing, workout, and had no range of motion.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: A 39-year-old patient was vaccinated with Flucelvax Quadrivalent. On the same date, after receiving Flucelvax Quadrivalent, the patient developed vaccination site pain. Three days later, the patient started feeling muscle pain. Could not barely move the arm and it was worsening every day. Due to plausible time relationship, causal role of the suspect vaccine is assessed as possibly related for all events (vaccination site pain, myalgia and mobility decreased).; Sender's Comments: A 39-year-old patient was vaccinated with Flucelvax Quadrivalent. On the same date, after receiving Flucelvax Quadrivalent, the patient developed vaccination site pain. Three days later, the patient started feeling muscle pain. Could not barely move the arm and it was worsening every day. Due to plausible time relationship, causal role of the suspect vaccine is assessed as possibly related for all events (vaccination site pain, myalgia and mobility decreased).
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in unapproved storage unit.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 87.0
Sex: M
Vaccine: COVID19-2
Symptoms: Erythema, Injection site erythema, Injection site warmth, Joint swelling
Clinical narrative: Nurse reported on 7/28 at 8:35am that patient is experiencing swelling redness, warm to touch at the injection site and redness on the upper abdomen (V/S BP 145/87 , P 78 , RR 16 Temp 97.8 F). Monitored patients symptoms. No further action required.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in unapproved storage unit,
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in unapproved storage unit
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Coordination abnormal, Eye movement disorder, Fall, Neurological symptom, Shock
Clinical narrative: Patient received 1st dose of shingrix. Within a few minutes, the patient was sitting down and appeared to be in shock (eyes rolling back, initially unresponsive, symptoms relating to stroke- speech delay/trouble forming words/slow, uncoordinated movement). I had the customer at pick up call 911 as I announced code white (I was alone in the pharmacy). I then quickly wheeled the IMZ cart to her. She was breathing, but I was concerned she would enter cardiac arrest and felt for her pulse, which felt normal. After a minute or two, she was able to respond. She denied any itching, closing of throat, or trouble breathing. No visible hives or rash. Patient began to fall backwards, but her husband and I kept her upright. She vomited. I gave her an ice pack, water, felt for her pulse (felt normal), and attempted to check her blood pressure while waiting for EMT. Patient started to feel better after vomiting and drinking a bottle of water. EMT checked vitals when they arrived and determined she was okay to go home
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Slow speech, Speech disorder developmental, Unresponsive to stimuli, Vomiting
Clinical narrative: Patient received 1st dose of shingrix. Within a few minutes, the patient was sitting down and appeared to be in shock (eyes rolling back, initially unresponsive, symptoms relating to stroke- speech delay/trouble forming words/slow, uncoordinated movement). I had the customer at pick up call 911 as I announced code white (I was alone in the pharmacy). I then quickly wheeled the IMZ cart to her. She was breathing, but I was concerned she would enter cardiac arrest and felt for her pulse, which felt normal. After a minute or two, she was able to respond. She denied any itching, closing of throat, or trouble breathing. No visible hives or rash. Patient began to fall backwards, but her husband and I kept her upright. She vomited. I gave her an ice pack, water, felt for her pulse (felt normal), and attempted to check her blood pressure while waiting for EMT. Patient started to feel better after vomiting and drinking a bottle of water. EMT checked vitals when they arrived and determined she was okay to go home
Age: 41.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Immediate post-injection reaction, Loss of consciousness, Respiratory arrest
Clinical narrative: Patient immediately passed out after administration of second vaccine which was Moderna's monovalent vaccine, after Flu administration. Patient stopped breathing and was provided epinephrine 0.3 LOT G230106 EXP Date 8/31/2024 NDC 00115-1694-49 .Patient came to and was completely coherent within 2 minutes of passing out.
Age: 60.0
Sex: M
Vaccine: FLUR4
Symptoms: Chest pain, Dyspnoea, Heart rate increased
Clinical narrative: The patient received his flu vaccine and left the pharmacy to do some shopping. The patient returned to the pharmacy 10-15 minutes later having shortness of breath, chest pain, and elevated heart rate. The patient said he had a heart stent placed on 9/14/2023. An ambulance was called and the patient was taken to the hospital by EMS.
Age: 81.0
Sex: F
Vaccine: FLUA4
Symptoms: Injected limb mobility decreased, Pyrexia
Clinical narrative: FLUAD: PATIENT EXPERIENCED LOW GRADE FEVER, 100.4, AND UNABLE TO RAISE LEFT ARM
Age: 63.0
Sex: F
Vaccine: HEP
Symptoms: Chills, Cold sweat, Headache, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: Headache, fever, body chills, cold sweats. Headache is main concern lasting longer than 2 weeks, losing sleep. Other symptoms have also remained for 2 weeks. Tested negative for covid.
Age: 65.0
Sex: F
Vaccine: FLUA4
Symptoms: Rash, Rash pruritic
Clinical narrative: PATIENT REPORTED RASH ON CHEST AND AROUND NECK THAT ITCHES, NO OTHER SYMPTOMS.
Age: 39.0
Sex: F
Vaccine: COVID19-2, FLU4, PPV
Symptoms: Chills, Fatigue, Hyperhidrosis, Oropharyngeal pain
Clinical narrative: Sore throat, chills, sweats, tiredness
Age: 7.0
Sex: M
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Quadracel, an immunization licensed for ages 4-6, was given to this 7 year old patient. I confirmed with family he did not have any side effects they noted.
Age: 83.0
Sex: F
Vaccine: FLUA4, RSV
Symptoms: Balance disorder, Dizziness
Clinical narrative: PATIENT COMPLAINED OF FEELING WOBBLY/LIGHT HEADED POST VACCINATION.
Age: 6.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMR, MMR
Symptoms: Extra dose administered, No adverse event
Clinical narrative: I was orienting alongside second nurse. We drew up vaccines for two children, ages 6 years old and 9 years old, who are sisters. We verified the correct vaccines for each child, and placed the vaccines that each nurse was to administer in separate trays. When administering the vaccines, I accidentally gave the client an additional MMR (the other nurse had given an MMR in the other arm). There was a last minute change on what vaccines the nurse orienting me wished to give. However, I should have been more diligent in verifying that I had the correct vaccine for the correct patient. We immediately reported the event to our supervisor, and informed the parent that a mistake was made. At the time of discharge, the patient did not have any adverse effects.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray, Echocardiogram, Electrocardiogram, Pericarditis
Clinical narrative: Patient diagnosed with pericarditis at the ER 2d after receiving his booster (4th dose) of the Pfizer COVID-19 immunization. He has not had any prior reactions to this vaccine or any others.
Age: 64.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Rash erythematous
Clinical narrative: A RED, ITCHY RAISED BUMP WITH THE SIZE OF THE PINKY FINGERNAIL , NOT PAINFUL  HAS DEVELOPED  AT THE INJECTION SITE ON THE FIFTH DAY AFTER GETTING THE VACCINE. SHE NOTICED IT WAS THERE AT 1:00PM, AND NO MORE ITCHY AT 4:53PM TODAY 9/20/23.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Patient fainted.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Headache, chills and slight fever. Treated with Tylenol
Age: 57.0
Sex: M
Vaccine: UNK
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Red itchy patches of skin, one area of inside of the elbow was swollen
Age: 0.58
Sex: F
Vaccine: PNC13
Symptoms: Cough, Dysphonia, Pyrexia, Rhinorrhoea, Sneezing
Clinical narrative: On dose #2 of prevnar 13 she also has RotaTeq vaccine and she developed a full body rash with her face being the worst. She also developed a fever.   This dose of prevnar 13 (3rd dose) she received this vaccine only. She has had a fever as high as 101.8, developed a runny nose and cough. The fever was at 99.0 6am the following morning of her vaccine. The runny nose/sneezing/cough/hoarseness continued to develop throughout the day. She was in good health leading up to the vaccine
Age: 31.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Red raised rash around injection site (approx quarter sized), painful to touch
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Back pain, Dizziness, Fatigue, Gait disturbance
Clinical narrative: Starting at 6 pm on 09/18/23, pain began in my left arm, headache, muscle pain in my back and a feeling of tiredness. On 09/19/23 the symptoms were more intense. After a light lunch at around 3 pm I tried to take a nap and when I lay down in bed I felt intense dizziness that I have never had before, I got up and as I walked the dizziness went away. After an hour I tried to take a nap and the intense dizziness occurred again, when I got up it was difficult for me to walk due to the intensity of the dizziness. At 6 pm I felt nauseous and after a few minutes I vomited, a situation that was repeated between 8 pm and 9 pm. Today, 09/20/23, I had mild dizziness, a mild headache, and an upset stomach that prevented me from eating.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Hypophagia, Nausea, Pain in extremity, Vomiting
Clinical narrative: Starting at 6 pm on 09/18/23, pain began in my left arm, headache, muscle pain in my back and a feeling of tiredness. On 09/19/23 the symptoms were more intense. After a light lunch at around 3 pm I tried to take a nap and when I lay down in bed I felt intense dizziness that I have never had before, I got up and as I walked the dizziness went away. After an hour I tried to take a nap and the intense dizziness occurred again, when I got up it was difficult for me to walk due to the intensity of the dizziness. At 6 pm I felt nauseous and after a few minutes I vomited, a situation that was repeated between 8 pm and 9 pm. Today, 09/20/23, I had mild dizziness, a mild headache, and an upset stomach that prevented me from eating.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Illness, Influenza, Nasopharyngitis
Clinical narrative: After receiving this vaccine, every time I have gotten covid or any other sickness from the common cold, to the flu it has been severely worse than ever before in my life making no sense because I am healthier in every area in my life than ever before with the only difference being the covid 19 shot.
Age: 51.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Discontinued product administered, No adverse event
Clinical narrative: Vaccine administered after 09/11/2023 No adverse effects reported.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Burning sensation, Peripheral swelling, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Bilateral hand rash - swelling, burning sensation, red, itchy.
Age: 65.0
Sex: F
Vaccine: COVID19, FLU4, PNC20, RSV
Symptoms: Erythema, Induration, Peripheral swelling, Pruritus
Clinical narrative: (R) arm is swollen, red, hard, itchy and continues to spread
Age: 40.0
Sex: F
Vaccine: COVID19-2
Symptoms: Brain fog, Burning sensation, Culture urine negative, Dizziness, Eye pain
Clinical narrative: Symptoms started at night the day off vaccination and include:  burning to bilateral soles of feet excluding toes, right calf cramping at rest and while walking, burning of the tip of tongue, burning sensation after urination, tingling and loss of sensation to clitoral area during sexual intercourse. All these symptoms lasted for 3-4months. I also developed dizziness, brain fog and intermittent blurry and painful vision. Blurry vision was noted when looking at near objects, e.g. while reading, these symptoms resolved weeks later. The morning after vaccination I developed increased heart rate at rest ranging at 100-110s bpm which is normally in the 60s and elevated heart rate while walking or standing at 130-140s bpm. Tachycardia resolved 2 days later. Edema to right axilla resolved several days later.    11/25/2022 I was seen in Hospital ED for ongoing symptoms. Snellen eyes test was applied and normal, vital signs, CBC, urinalysis and Covid19/flu/rsv rapid test were normal. Received 1 dose of Ketorolac for eye pain, no change after intervention noted. Was told I probably had some viral illness and was told to take Ibuprofen around the clock for 2 weeks which I did and no improvement noted.   12/23/2022 I was seen by PA at Medical Center as a follow up. Urinalysis and urine culture test and neurological exam were normal. I was prescribed Gabapentin which I didn?t take.
Age: 40.0
Sex: F
Vaccine: COVID19-2
Symptoms: Full blood count normal, Heart rate increased, Hypoaesthesia, Influenza virus test negative, Muscle spasms
Clinical narrative: Symptoms started at night the day off vaccination and include:  burning to bilateral soles of feet excluding toes, right calf cramping at rest and while walking, burning of the tip of tongue, burning sensation after urination, tingling and loss of sensation to clitoral area during sexual intercourse. All these symptoms lasted for 3-4months. I also developed dizziness, brain fog and intermittent blurry and painful vision. Blurry vision was noted when looking at near objects, e.g. while reading, these symptoms resolved weeks later. The morning after vaccination I developed increased heart rate at rest ranging at 100-110s bpm which is normally in the 60s and elevated heart rate while walking or standing at 130-140s bpm. Tachycardia resolved 2 days later. Edema to right axilla resolved several days later.    11/25/2022 I was seen in Hospital ED for ongoing symptoms. Snellen eyes test was applied and normal, vital signs, CBC, urinalysis and Covid19/flu/rsv rapid test were normal. Received 1 dose of Ketorolac for eye pain, no change after intervention noted. Was told I probably had some viral illness and was told to take Ibuprofen around the clock for 2 weeks which I did and no improvement noted.   12/23/2022 I was seen by PA at Medical Center as a follow up. Urinalysis and urine culture test and neurological exam were normal. I was prescribed Gabapentin which I didn?t take.
Age: 40.0
Sex: F
Vaccine: COVID19-2
Symptoms: Oedema peripheral, Paraesthesia, Respiratory syncytial virus test negative, SARS-CoV-2 test negative, Tachycardia
Clinical narrative: Symptoms started at night the day off vaccination and include:  burning to bilateral soles of feet excluding toes, right calf cramping at rest and while walking, burning of the tip of tongue, burning sensation after urination, tingling and loss of sensation to clitoral area during sexual intercourse. All these symptoms lasted for 3-4months. I also developed dizziness, brain fog and intermittent blurry and painful vision. Blurry vision was noted when looking at near objects, e.g. while reading, these symptoms resolved weeks later. The morning after vaccination I developed increased heart rate at rest ranging at 100-110s bpm which is normally in the 60s and elevated heart rate while walking or standing at 130-140s bpm. Tachycardia resolved 2 days later. Edema to right axilla resolved several days later.    11/25/2022 I was seen in Hospital ED for ongoing symptoms. Snellen eyes test was applied and normal, vital signs, CBC, urinalysis and Covid19/flu/rsv rapid test were normal. Received 1 dose of Ketorolac for eye pain, no change after intervention noted. Was told I probably had some viral illness and was told to take Ibuprofen around the clock for 2 weeks which I did and no improvement noted.   12/23/2022 I was seen by PA at Medical Center as a follow up. Urinalysis and urine culture test and neurological exam were normal. I was prescribed Gabapentin which I didn?t take.
Age: 40.0
Sex: F
Vaccine: COVID19-2
Symptoms: Tongue discomfort, Urine analysis, Vision blurred, Visual acuity tests
Clinical narrative: Symptoms started at night the day off vaccination and include:  burning to bilateral soles of feet excluding toes, right calf cramping at rest and while walking, burning of the tip of tongue, burning sensation after urination, tingling and loss of sensation to clitoral area during sexual intercourse. All these symptoms lasted for 3-4months. I also developed dizziness, brain fog and intermittent blurry and painful vision. Blurry vision was noted when looking at near objects, e.g. while reading, these symptoms resolved weeks later. The morning after vaccination I developed increased heart rate at rest ranging at 100-110s bpm which is normally in the 60s and elevated heart rate while walking or standing at 130-140s bpm. Tachycardia resolved 2 days later. Edema to right axilla resolved several days later.    11/25/2022 I was seen in Hospital ED for ongoing symptoms. Snellen eyes test was applied and normal, vital signs, CBC, urinalysis and Covid19/flu/rsv rapid test were normal. Received 1 dose of Ketorolac for eye pain, no change after intervention noted. Was told I probably had some viral illness and was told to take Ibuprofen around the clock for 2 weeks which I did and no improvement noted.   12/23/2022 I was seen by PA at Medical Center as a follow up. Urinalysis and urine culture test and neurological exam were normal. I was prescribed Gabapentin which I didn?t take.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Eye disorder, Investigation
Clinical narrative: seen in f/u in Nov2021: Covid infection; seen in f/u in Nov2021: Covid infection; This is a spontaneous report received from contactable reporter(s) (Physician).  A 56-year-old female patient received bnt162b2 (BNT162B2), on 19Apr2021 as dose 1, single (Batch/Lot number: unknown) and on 11May2021 as dose 2, single (Lot number: EW0164) at the age of 55 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "Alcohol use: Not currently" (unspecified if ongoing); "Smokeless tobacco: Never" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Lortab, reaction(s): "allergies"; Morphine, reaction(s): "allergies". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2021, outcome "unknown" and all described as "seen in f/u in Nov2021: Covid infection". 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 and the known product safety profile, a causal relationship between the reported events vaccination failure, COVID-19 and suspect product cannot be excluded.,Linked Report(s) : US-PFIZER INC-202300288490 same patient/reporter; different vaccine dose/AE;US-PFIZER INC-202300288509 same patient/reporter; different vaccine dose/AE;
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: seen in f/u in Nov2021: Covid infection; seen in f/u in Nov2021: Covid infection; This is a spontaneous report received from contactable reporter(s) (Physician).  A 56-year-old female patient received bnt162b2 (BNT162B2), on 19Apr2021 as dose 1, single (Batch/Lot number: unknown) and on 11May2021 as dose 2, single (Lot number: EW0164) at the age of 55 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "Alcohol use: Not currently" (unspecified if ongoing); "Smokeless tobacco: Never" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Lortab, reaction(s): "allergies"; Morphine, reaction(s): "allergies". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2021, outcome "unknown" and all described as "seen in f/u in Nov2021: Covid infection". 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 and the known product safety profile, a causal relationship between the reported events vaccination failure, COVID-19 and suspect product cannot be excluded.,Linked Report(s) : US-PFIZER INC-202300288490 same patient/reporter; different vaccine dose/AE;US-PFIZER INC-202300288509 same patient/reporter; different vaccine dose/AE;
Sex: U
Vaccine: PPV, PPV
Symptoms: Expired product administered
Clinical narrative: No other AE and no PQC; expired dose of a PNEUMOVAX 23 SYRINGE to a patient on 09/01/2023; This spontaneous report was report was received from a health business professional (HBP) concerning a patient of unknown age and gender. Their concurrent conditions, medical history, drug reactions/allergies, and concomitant medications were not provided.   On 01-SEP-2023, the patient was vaccinated with an expired dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) injection, lot number U032086 with expiration date 29-AUG-2023, administered as prophylaxis (dosage regimen and route of administration were not provided) (Expired product administered). No additional adverse event was reported (No adverse event).