chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Polymyalgia rheumatica
Clinical narrative: polymyalgia rheumatica; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 77-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Dec2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 77 years intramuscular for covid-19 immunisation. The patient's relevant medical history included: "afib" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing). The patient did not have COVID prior to vaccinations. The patient had no known allergies. Concomitant medication(s) included: CRESTOR; ELIQUIS; FLECAINIDE; LISINOPRIL; ZINC. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: POLYMYALGIA RHEUMATICA (medically significant) with onset 30Dec2022, outcome "recovered with sequelae". The event "polymyalgia rheumatica" required physician office visit. The patient developed symptoms of polymyalgia rheumatica confirmed by rheumatologist. Symptoms started 3 days after the vaccination was received. Therapeutic measures were taken as a result of polymyalgia rheumatica which included prednisone.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events Polymyalgia rheumatica  and the use of suspect product Comirnaty  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, 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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-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; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history 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". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Stroke; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient received BNT162b2 (BNT162B2), on 13Dec2021 as dose 3 (booster), single (Lot number: FE3594) at the age of 60 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Enlarged prostate" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. Concomitant medication(s) included: TAMSULOSIN; LATANOPROST; DORZOLAMIDE. Vaccination history included: BNT162b2 (DOSE 2, SINGLE, Batch/Lot number: ER8732, Anatomical location: Left Arm), administration date: 30Mar2021, for Covid-19 immunization; BNT162b2 (DOSE 1, SINGLE, Batch/Lot number: EN1699, Anatomical location: Left Arm), administration date: 03Mar2021, for Covid-19 Immunization. The following information was reported: CEREBROVASCULAR ACCIDENT (hospitalization) with onset 23Sep2022 at 15:30, outcome "recovered with sequelae", described as "Stroke". The patient was hospitalized for cerebrovascular accident (hospitalization duration: 2 day(s)). The event "stroke" required emergency room visit. Therapeutic measures were taken as a result of cerebrovascular accident. Clinical course included: AE treatment: Stroke treatment & clot buster.
Age: 66.0
Sex: M
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 contactable reporter(s) (Physician). The reporter is the patient.  A 67-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Oct2022 as dose 5 (booster), single (Lot number: GJ5342) at the age of 66 years, in left arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (unspecified if ongoing); "coronary artery disease" (unspecified if ongoing); "gastroesophageal reflux" (unspecified if ongoing); "BPH" (unspecified if ongoing). The patient's concomitant medications were not reported. Patient had no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included treatment with paxlovid from 17May2023 to 21May2023.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the drug ineffective (LOE) and COVID-19 cannot be ruled out.,Linked Report(s) : US-PFIZER INC-202300206865 same patient, different drug, different event.;
Sex: M
Vaccine: COVID19
Symptoms: Cardiomyopathy
Clinical narrative: he does have 3 spots on his heart muscle; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 17-year-old male patient received BNT162b2 (BNT162B2), on 18Jun2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. An unspecified medication was also considered as suspect by the reporter. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN ), for COVID-19 IMMUNIZATION. The following information was reported: CARDIOMYOPATHY (medically significant), outcome "unknown", described as "he does have 3 spots on his heart muscle". The patient had a reaction after the second dose of the Pfizer COVID-19 vaccine that was administered on 18Jun2021. He wound up taking steroids (corticosteroids) and recovered but he does have 3 spots on his heart muscle.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Arthralgia, Ear pain, Heart rate increased, Musculoskeletal stiffness
Clinical narrative: I had pain from the left shoulder to my right shoulder; pain up to my ear for 2 weeks; it was stiffness with the pain before; My heart beats very fast sometimes and it would last 6 to 10 seconds; My anxiety seems to be agitated; I started getting more pain throughout my whole body; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), in 2021 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: Covid-19 vaccine (DOSE 1; Unknown Manufacturer), for COVID-19 immunization. The following information was reported: ARTHRALGIA (non-serious), outcome "unknown", described as "I had pain from the left shoulder to my right shoulder"; EAR PAIN (non-serious), outcome "unknown", described as "pain up to my ear for 2 weeks"; MUSCULOSKELETAL STIFFNESS (non-serious), outcome "unknown", described as "it was stiffness with the pain before"; HEART RATE INCREASED (non-serious), outcome "unknown", described as "My heart beats very fast sometimes and it would last 6 to 10 seconds"; ANXIETY (non-serious), outcome "unknown", described as "My anxiety seems to be agitated"; PAIN (non-serious), outcome "unknown", described as "I started getting more pain throughout my whole body".  Additional information: The patient had pain from the left shoulder to my right shoulder and pain up to my ear for 2 weeks and it sort of went away. And it was stiffness with the pain before. My heart beats very fast sometimes and it would last 6 to 10 seconds. My anxiety seems to be agitated. In 2021 when I got my 2nd shot, I started getting more pain throughout my whole body.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: I had pain from the left shoulder to my right shoulder; pain up to my ear for 2 weeks; it was stiffness with the pain before; My heart beats very fast sometimes and it would last 6 to 10 seconds; My anxiety seems to be agitated; I started getting more pain throughout my whole body; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), in 2021 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: Covid-19 vaccine (DOSE 1; Unknown Manufacturer), for COVID-19 immunization. The following information was reported: ARTHRALGIA (non-serious), outcome "unknown", described as "I had pain from the left shoulder to my right shoulder"; EAR PAIN (non-serious), outcome "unknown", described as "pain up to my ear for 2 weeks"; MUSCULOSKELETAL STIFFNESS (non-serious), outcome "unknown", described as "it was stiffness with the pain before"; HEART RATE INCREASED (non-serious), outcome "unknown", described as "My heart beats very fast sometimes and it would last 6 to 10 seconds"; ANXIETY (non-serious), outcome "unknown", described as "My anxiety seems to be agitated"; PAIN (non-serious), outcome "unknown", described as "I started getting more pain throughout my whole body".  Additional information: The patient had pain from the left shoulder to my right shoulder and pain up to my ear for 2 weeks and it sort of went away. And it was stiffness with the pain before. My heart beats very fast sometimes and it would last 6 to 10 seconds. My anxiety seems to be agitated. In 2021 when I got my 2nd shot, I started getting more pain throughout my whole body.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID-19; COVID-19; Moderna: dose number 5/dose number: 4; 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), on 11Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 01Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 02Oct2021 as dose 3 (booster), single (Lot number: 30145BA) at the age of 63 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 04May2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm and on 14Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Osteopenia" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN B-12, start date: 01May2023; CETRIZINE, start date: 01May2023, Vitamins and eye vitamins taken on 01May2023. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 04May2022, outcome "unknown", described as "Moderna: dose number 5/dose number: 4"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2023, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient took Paxlovid from 17May2023 to 22May2023 for COVID-19 treatment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300206999 same patient, different drug/AE.;
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Drug ineffective; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2022 as dose 4 (booster), single (Lot number: GH9703) at the age of 58 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: COVID-19 (medically significant) with onset 2023, outcome "not recovered"; DRUG INEFFECTIVE (medically significant) with onset 2023, outcome "not recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included: Anti viral from 18May2023 to 23May2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300206998 same patient, different drug/AE.;
Sex: M
Vaccine: COVID19
Symptoms: Hypoacusis, Tinnitus
Clinical narrative: I have bad hearing; Ears are always ringing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPOACUSIS (non-serious), outcome "unknown", described as "I have bad hearing"; TINNITUS (non-serious), outcome "unknown", described as "Ears are always ringing".  Additional information: The patient reported that he has hard hearing.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID-19 Treatment; COVID 19 Treatment; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient received BNT162b2 (BNT162B2), on 26Feb2021 as dose 1, single (Batch/Lot number: unknown) and on 19Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 36 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 04Nov2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: latex" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 04Nov2022, outcome "not recovered"; DRUG INEFFECTIVE (medically significant), outcome "not recovered", described as "COVID-19 Treatment"; COVID-19 (medically significant), outcome "not recovered", described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300207471 same reporter/patient, different drug/event;
Age: 43.0
Sex: M
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 43-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Nov2022 as dose 4 (booster), single (Lot number: GJ6665) at the age of 43 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 was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: 4 days of testing negative followed by positive test on day 5; Positive, notes: 4 days of testing negative followed by positive test on day 5. Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300207327 Same reporter/patient,different drug/AE.;
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Bone disorder, Nervous system disorder, Neuropathy peripheral, Osteonecrosis
Clinical narrative: Neuropathy; neuropathy in his left foot; first shot: both of his hips died (polymyalgia rheumatica or osteonecrosis); first shot: both of his hips died (polymyalgia rheumatica or osteonecrosis); first shot: pain in both hips; numerous nerve and bone issues; numerous nerve and bone issues; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old male patient received BNT162b2 (BNT162B2), on 02Apr2021 as dose 1, single (Lot number: ER8734) at the age of 47 years for covid-19 immunisation. The patient's relevant medical history included: "Had three spinal surgeries" (not ongoing), notes: Had three spinal surgeries on unknown dates; "brain surgery", start date: 26Jul2012 (not ongoing). There were no concomitant medications. The following information was reported: BONE DISORDER (non-serious), NERVOUS SYSTEM DISORDER (non-serious) all with onset 2021, outcome "not recovered" and all described as "numerous nerve and bone issues"; NEUROPATHY PERIPHERAL (medically significant), outcome "unknown", described as "Neuropathy; neuropathy in his left foot"; POLYMYALGIA RHEUMATICA (medically significant), OSTEONECROSIS (medically significant), outcome "recovered with sequelae" and all described as "first shot: both of his hips died (polymyalgia rheumatica or osteonecrosis)"; ARTHRALGIA (medically significant), outcome "not recovered", described as "first shot: pain in both hips". The events "first shot: both of his hips died (polymyalgia rheumatica or osteonecrosis)", "first shot: pain in both hips" and "numerous nerve and bone issues" required physician office visit. Therapeutic measures were taken as a result of polymyalgia rheumatica, osteonecrosis, arthralgia.  Clinical course: Report was not related to study. No investigations and no other products. As he was doing his research he eventually a year after or so both hips were dead and believed it was called polymyalgia rheumatica or osteonecrosis. Had no idea if that was related. Neuropathy was the worst one. Had left hip replaced 29Dec2022. Pain in both hips was after his first shot. Experienced for a while before he saw a doctor. Even the one that was replaced was still actively bugging him and was ongoing. Right was worsened left had some relief after surgery but for some reason has still been bothering him. Treatment was Vicodin and Baclofen, muscle relaxer. Both of his hips died: First time he saw the doctor in regards to that was last summer (2022) maybe around June, July or August. Recovered with lasting effects still in a lot of left hip pain, one he had replaced and right hip pain and needed that one replaced. Was worried that the necrosis might have traveled. After surgery care was physical therapy on the left hip.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300207982 same patient, different dose/event;
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Polymyalgia rheumatica
Clinical narrative: Neuropathy; neuropathy in his left foot; first shot: both of his hips died (polymyalgia rheumatica or osteonecrosis); first shot: both of his hips died (polymyalgia rheumatica or osteonecrosis); first shot: pain in both hips; numerous nerve and bone issues; numerous nerve and bone issues; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old male patient received BNT162b2 (BNT162B2), on 02Apr2021 as dose 1, single (Lot number: ER8734) at the age of 47 years for covid-19 immunisation. The patient's relevant medical history included: "Had three spinal surgeries" (not ongoing), notes: Had three spinal surgeries on unknown dates; "brain surgery", start date: 26Jul2012 (not ongoing). There were no concomitant medications. The following information was reported: BONE DISORDER (non-serious), NERVOUS SYSTEM DISORDER (non-serious) all with onset 2021, outcome "not recovered" and all described as "numerous nerve and bone issues"; NEUROPATHY PERIPHERAL (medically significant), outcome "unknown", described as "Neuropathy; neuropathy in his left foot"; POLYMYALGIA RHEUMATICA (medically significant), OSTEONECROSIS (medically significant), outcome "recovered with sequelae" and all described as "first shot: both of his hips died (polymyalgia rheumatica or osteonecrosis)"; ARTHRALGIA (medically significant), outcome "not recovered", described as "first shot: pain in both hips". The events "first shot: both of his hips died (polymyalgia rheumatica or osteonecrosis)", "first shot: pain in both hips" and "numerous nerve and bone issues" required physician office visit. Therapeutic measures were taken as a result of polymyalgia rheumatica, osteonecrosis, arthralgia.  Clinical course: Report was not related to study. No investigations and no other products. As he was doing his research he eventually a year after or so both hips were dead and believed it was called polymyalgia rheumatica or osteonecrosis. Had no idea if that was related. Neuropathy was the worst one. Had left hip replaced 29Dec2022. Pain in both hips was after his first shot. Experienced for a while before he saw a doctor. Even the one that was replaced was still actively bugging him and was ongoing. Right was worsened left had some relief after surgery but for some reason has still been bothering him. Treatment was Vicodin and Baclofen, muscle relaxer. Both of his hips died: First time he saw the doctor in regards to that was last summer (2022) maybe around June, July or August. Recovered with lasting effects still in a lot of left hip pain, one he had replaced and right hip pain and needed that one replaced. Was worried that the necrosis might have traveled. After surgery care was physical therapy on the left hip.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300207982 same patient, different dose/event;
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Hip arthroplasty, Pain
Clinical narrative: pain; Had left hip replaced 29Dec2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 4 (booster), single (Lot number: GH9694) at the age of 48 years for covid-19 immunisation. The patient's relevant medical history included: "spinal surgeries" (unspecified if ongoing), notes: Had three spinal surgeries on unknown dates; "brain surgery", start date: 26Jul2012 (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot Number: ER8734), administration date: 02Apr2021, when the patient was 47-year-old, for COVID-19 immunization, reaction(s): "getting small fiber neuropathy in his left foot", "first shot: both of his hips died (polymyalgia rheumatica or osteonecrosis)", "first shot: both of his hips died (polymyalgia rheumatica or osteonecrosis)", "Necrosis", "first shot: pain in both hips", "numerous nerve and bone issues", "numerous nerve and bone issues"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization. The following information was reported: HIP ARTHROPLASTY (non-serious) with onset 29Dec2022, outcome "not recovered", described as "Had left hip replaced 29Dec2022"; PAIN (non-serious), outcome "not recovered".  Additional information: the patient after fourth shot had Left hip replaced happened on 29Dec2022 and has not recovered 100% it still hurts.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300207966 same patient/drug, different dose/event;
Age: 50.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine was administered past the vial's Beyond Use Date of 05/16/2023 @ 11AM. Per manufacturer recommendations, clinic medical director to reach out to patient to schedule visit for re-administration of new dose.
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine was administered past the vial's Beyond Use Date of 05/16/2023 @ 11AM. Per manufacturer recommendations, clinic medical director to reach out to patient to schedule visit for re-administration of new dose.
Sex: M
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: Staff used wrong dilutant for vaccine preparation. no reports of adverse reactions at this time.
Age: 40.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Chest X-ray normal, Full blood count normal, Human chorionic gonadotropin negative, Lymphadenopathy
Clinical narrative: No reaction to vaccine while in clinic ER visit 2/14/22 with complaint of axillary lymphadenopathy, fever diffuse rash and joint pain starting the day after the vaccination
Age: 40.0
Sex: F
Vaccine: MMR
Symptoms: Metabolic function test normal, Pyrexia, Rash, Urine analysis normal
Clinical narrative: No reaction to vaccine while in clinic ER visit 2/14/22 with complaint of axillary lymphadenopathy, fever diffuse rash and joint pain starting the day after the vaccination
Age: 59.0
Sex: M
Vaccine: PNC20
Symptoms: Injection site rash, Skin warm
Clinical narrative: Patient asked about a rash on arm a few inches below injection site that extended to bend in arm. Rash appeared to be slightly larger than a dollar bill. They stated it was warm to touch but did not itch. They  were recommended to apply cold compress and follow up at scheduled visit with primary care next day 6/2/23.
Age: 51.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Chest discomfort, Cough, Fatigue, Influenza virus test negative
Clinical narrative: 2/22/2023 woke up with a scratchy throat. The throat felt different and I got an odd feeling in my chest as well.  By 3 PM I got a tickle in my throat and developed a cough.  By 5 PM when I coughed I felt my airways closed off.  This got worse as the night went by.  I went to the ER early in the morning of 2/23/2023.  In ER the PCR COVID-19 test was positive.  I received a steroid injection, Prednisone, Zinc, Paxlovid, and a Zpak.  I went home and slept the rest of the day and woke up the next day and took the medications.  Symptoms gradually got better over the next 6 days.  The cough lingered for a few days and fatigue lingered about a month.
Age: 51.0
Sex: F
Vaccine: COVID19-2
Symptoms: Oropharyngeal discomfort, Respiratory syncytial virus test negative, SARS-CoV-2 test positive, Throat irritation
Clinical narrative: 2/22/2023 woke up with a scratchy throat. The throat felt different and I got an odd feeling in my chest as well.  By 3 PM I got a tickle in my throat and developed a cough.  By 5 PM when I coughed I felt my airways closed off.  This got worse as the night went by.  I went to the ER early in the morning of 2/23/2023.  In ER the PCR COVID-19 test was positive.  I received a steroid injection, Prednisone, Zinc, Paxlovid, and a Zpak.  I went home and slept the rest of the day and woke up the next day and took the medications.  Symptoms gradually got better over the next 6 days.  The cough lingered for a few days and fatigue lingered about a month.
Age: 93.0
Sex: F
Vaccine: VARZOS
Symptoms: Death, Dyspnoea, Dysstasia, Fatigue, Retching
Clinical narrative: Pt received Shingrx on Saturday, May 27 2023 at 3 pm.  Patient started having dry heaves at 4 am on 5-28-23.  Difficult breathing, fatigue and had difficult standing on her own. Family then attended the patient with assistance on getting oxygen and laying with her to calm her down.  She did get calmed but passed away at approximately 8:30 am on that same day.  No ambulance or dr's were  involved.   Not sure if Shingrix was involved, but we are reporting at this time.
Age: 1.0
Sex: M
Vaccine: COVID19-2, COVID19-2, COVID19-2
Symptoms: Death
Clinical narrative: Death
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV, PNC15
Symptoms: Urticaria
Clinical narrative: Patient broke out in generalized urticarial rash the day after receiving these three vaccines.  Photographs viewed were consistent with generalized urticarial eruption.  Parents report Benadryl would improve the rash within about 30 minutes, but the hives kept reappearing until complete resolution within 2-3 days of onset.
Age: 56.0
Sex: F
Vaccine: PNC20, TDAP, VARZOS
Symptoms: Cellulitis, Peripheral swelling
Clinical narrative: PATIENT RECEIVED VACCINES ON 5/28. ON 5/29 SHE WOKE UP AND HER LEFT ARM WAS SWOLLEN IT KEPT GETTING WORSE THROUGHOUT THE DAY. ON 5/30 SHE CAME TO PHARMACY AND WAS ADVISED TO TAKE IBUPROFEN AND BENADRYL AND ICE HER ARM AND GO TO DR IF IT KEPT GETTING WORSE  OR DID NOT RESOLVE. PATIENT WENT TO DR 6/1 AND WAS DIAGNOSED WITH CELLULITIS AND PRESCRIBED DOXYCYCLINE AND PREDNISONE
Age: 0.17
Sex: F
Vaccine: HIBV
Symptoms: Circumstance or information capable of leading to medication error, Vaccination complication
Clinical narrative: Administration complication- Mother of child's hand was near the patient's thigh and the needle grazed the mother of child's finger. I stopped, capped the needle, and applied gauze and a bandaid since the needle broke skin. None of the vaccine was released at any time of the grazing. I told the mother that I would need to change the needle before administering the vaccine since it grazed her.  I left the room and returned with the new needle. I changed the needle and discarded the original in the sharps container. I communicated to keep hands further away and positioned the thigh with more room then continued to administer without complication.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination site pruritus, Vaccination site rash
Clinical narrative: Patient developed a localized rash and itching just below the vaccine site on her left deltoid.  Symptoms started yesterday (5/31/23). Denied any fever, nausea/vomiting, SOB, chest pain, swelling or any other generalized symptoms.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Acoustic stimulation tests, Cerumen removal, Tinnitus
Clinical narrative: tinnitus in left ear
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Blister, Culture wound, Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: started with fever and hives per mom night of shot, blistered 5/31 and fever, 6/1 no fever just blisters and crusting, redness and pain around site, well appearring otherwise seen in office given benadryl, bactroban and triamcinalone with f/u scheduled for next AM by photograph
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Scab, Urticaria
Clinical narrative: started with fever and hives per mom night of shot, blistered 5/31 and fever, 6/1 no fever just blisters and crusting, redness and pain around site, well appearring otherwise seen in office given benadryl, bactroban and triamcinalone with f/u scheduled for next AM by photograph
Age: 4.0
Sex: M
Vaccine: COVID19-2
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: 2nd Bivalent vaccine was given 6 days early No adverse reaction noted Pediatrician informed
Age: 33.0
Sex: F
Vaccine: TD
Symptoms: No adverse event
Clinical narrative: no adverse reaction noted at the time
Age: 0.08
Sex: M
Vaccine: HEP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Received extra dose of Hep B vac on 3/13/23. No adverse effects reported
Age: 6.0
Sex: F
Vaccine: UNK
Symptoms: Immunisation reaction
Clinical narrative: Adverse effect of other vaccines and biological substances, initial encounter on 2022-12-16.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Ear pain, Ear swelling, Erythema, Eye pain, Magnetic resonance imaging head abnormal
Clinical narrative: A few days after 2nd Pfizer Covid 19 vaccine, developed left ear pain, redness, swelling. Treated in June and July with IV steroids/antibiotics. Then 8/21, developed left  > right eye redness/ pain, dx uveitis. ENT felt patient had relapsing-polychondritis.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Ocular hyperaemia, Polychondritis, Uveitis
Clinical narrative: A few days after 2nd Pfizer Covid 19 vaccine, developed left ear pain, redness, swelling. Treated in June and July with IV steroids/antibiotics. Then 8/21, developed left  > right eye redness/ pain, dx uveitis. ENT felt patient had relapsing-polychondritis.
Sex: U
Vaccine: VARCEL, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: Did not experience any other adverse event; the patient received an expired dose of VARIVAX on 4/26/2023.; This spontaneous report was received from a licensed vocational nurse concerning a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 26-APR-2023, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #U012222, expiration date: 16-APR-2023, administered as prophylaxis (strength, and route of administration were not provided) (Expired product administered). The patient did no experience any other adverse events.
Age: 18.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no additional AE's; an 18 year old patient who was administered a dose of PROQUAD.; This spontaneous report was received from a registered nurse and refers to an 18-year-old patient of unknown gender.  The patient's pertinent medical history, current conditions, drug reactions or allergies and concomitant medications were not reported.  On 04-MAY-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, 0.5 milliliter, lot #W012729, expiration date: 16-OCT-2023, administered subcutaneously for prophylaxis (strength was not provided) while being 18 years old (Product administered to patient of inappropriate age). No additional adverse events details or product quality complaints were reported (no adverse event).
Age: 25.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product preparation issue
Clinical narrative: No additional AE reported; pharmacist diluted the VARIVAX with 0.9% sodium chloride multidose vial rather than the diluent provided; This spontaneous report was received from a pharmacist and refers to a 25-year-old male patient.  The patient's pertinent medical history, current conditions, drug reactions or allergies were not reported. Concomitant medications included sodium chloride.   On 20-APR-2023, the patient was vaccinated with the first dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). On 05-MAY-2023, the patient was vaccinated with the second dose of varicella virus vaccine live (oka/merck) (VARIVAX). Before the administration, the pharmacist diluted the varicella virus vaccine live (oka/merck) (VARIVAX) with 0.9% sodium chloride multidose vial rather than the diluent provided (Product preparation issue). The patient was not having any problems at the time of the report. No additional adverse events details or product quality complaints were reported (no adverse event).
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; A HCP called and reported that an expired dose of MMR II was administered to a patient. The caller refused to provide a first and last name. No adverse effects were noted. No additional AE reported. No PQC; This spontaneous report was received from a Registered Nurse (RN)and refers to a 58-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 11-MAY-2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, 0.5 milliliter, once, lot #U011995, expiration date: 15-APR-2023, administered for prophylaxis (strength, and route of administration were not provided) (Expired product administered). No additional adverse event reported.
Sex: M
Vaccine: HPV9, HPV9, HPV9, HPV9, HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: Product storage error; No adverse event on patient; This spontaneous report was received from Other and refers to a 13-year-old male.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient started therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot #1775811, expiration date: 07-DEC-2023, administered for prophylaxis (strength, and route of administration were not provided); hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot #1775827, expiration date: 27-JUN-2024, administered for prophylaxis (strength, and route of administration were not provided); hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot #U032681, expiration date: 26-OCT-2023, administered for prophylaxis (strength, and route of administration were not provided); hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot #1780876, expiration date: 09-NOV-2023, administered for prophylaxis (strength, and route of administration were not provided); and  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot #W009829, expiration date: 19-OCT-2024, administered for prophylaxis (strength, and route of administration were not provided).  On an unknown date, the patient experienced Product storage error, the patient experienced No adverse event on patient. ; Sender's Comments:  US-009507513-2304USA002221:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs; GARDASIL 9 was administered following temperature excursion; This spontaneous report was received from a nurse and referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.   On an unknown date, hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (1 dosage form, lot #W014513, expiration date: 26-JAN-2025) was underwent a temperature excursion of 52.86 degree Fahrenheit (F) for 96 hours (worst case scenario as reported). No previous temperature excursion.    On 12-MAY-2023, the improperly stored vaccine was administered to the patient for prophylaxis (strength and route of administration were not provided) (product storage error). No additional adverse events (AEs).  This is one of 5 reports received from the same reporter. ; Sender's Comments:  US-009507513-2305USA005519: US-009507513-2305USA005550: US-009507513-2305USA005725: US-009507513-2305USA005554:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: patient received improperly stored vaccine; no adverse event; This spontaneous report was received from another health professional and referred to a patient of unspecified age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 03-MAY-2023, the patient was vaccinated with a dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 0.5ml/once, with a reported an validated: lot number of x004813, and an expiration date of 28-JUL-2024, administered for prophylaxis (strength, and route of administration were not provided). The vaccine was improperly stored and the medical assistant was reporting that a patient received improperly stored vaccine. The vaccine presented a temperature excursion with a temperature above 46.74Fahrenheit (F) for 2 minutes. No previous temperature excursion were reported. And no adverse events were reported. No further information provided.
Age: 1.08
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No additional AE; patient was scheduled to receive MMR II and received a dose of VARIVAX instead; This spontaneous report was received from a medical assistant and referred to a 16-month-old patient of unknown gender. The patient's medical history and concurrent conditions were not reported. Concomitant medications included sterile diluent (manufacturer unknown).   On 23-SEP-2022, the patient was vaccinated with the first dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided).  On 27-DEC-2022 (when the patient was 16 months old), the patient was scheduled to receive measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and received a dose of varicella virus vaccine live (oka/merck) (VARIVAX) instead (indication: prophylaxis; strength, dose, lot #, expiry date, and route of administration were not provided) (wrong product administered). The reporter stated the second dose of varicella virus vaccine live (oka/merck) (VARIVAX) was administered too early. No additional adverse events (AEs).
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs reported; Caller reported VARIVAX administered after temperature excursion.; This spontaneous report was received from a Registered Nurse regarding a female patient of an unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 19-MAY-2023, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 ml, administered intramuscularly (IM), lot #W034708, expiration date: 01-NOV-2024 (lot # and expiration date were incorrectly documented as "W031810" and "05-OCT-2023"), administered as prophylaxis (Product storage error).  The improperly stored vaccine underwent a temperature excursion of 6.4 degrees Fahrenheit (F) for 42 minutes without previous excursions. No adverse events were reported.  This is one of three cases received from the same reporter.; Sender's Comments:  US-009507513-2305USA007944: US-009507513-2305USA008104:
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product dose omission issue
Clinical narrative: Caller reporting a missed dose for GARDASIL 9. Caller stated a customer received her first dose in December 2022 and was back in the pharmacy today to get the second dose. Caller provided no additional information. No additional AE. No PQC.; No additional AE; This spontaneous report was received from pharmacist technician, concerning to female patient of unknown age.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unspecified date in December 2022, the patient was vaccinated with first dose  of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter (strength, lot #, expiration date, and route of administration were unprovided) for prophylaxis.   On unreported date, the patient missed dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). On 23-MAY-2023 (also reported as today), the patient was back in the pharmacist to get the second dose. No additional adverse event was reported.
Age: 16.0
Sex: M
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: no additional AEs; expired dose of VARIVAX was administered; This spontaneous report was received from a medical assistant, referring to a 16-year-old male patient. The patient's concomitant therapy, concurrent condition, medical history and drug reactions/allergies were not reported.  On 25-MAY-2023, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) (dose was 0.5 milliliter (ml), lot number was reported as U016063, expiration date was reported as 20-MAY-2023, route and anatomical location were not provided) for prophylaxis (expired product administered), 5 days past expiration date of 20-MAY-2023. No additional adverse event (AE) reported (no adverse event).