chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HEPAB
Symptoms: Antibody test, Blood test, Full blood count normal, Metabolic function test normal, Therapeutic response decreased
Clinical narrative: some blood tests and surface ab blood and core ab total were non reactive and surface ab quantitative was less than 5. CDC and CMP were normal.; This non-serious case was reported by a consumer via call center representative and described the occurrence of therapeutic response decreased in a female patient who received HAB (Twinrix adult) for prophylaxis.   Concurrent medical conditions included crohn's disease. Concomitant products included risankizumab (Skyrizi).   On 03-JAN-2014, the patient received Twinrix adult. On an unknown date, an unknown time after receiving Twinrix adult, the patient experienced therapeutic response decreased (Verbatim: some blood tests and surface ab blood and core ab total were non reactive and surface ab quantitative was less than 5. CDC and CMP were normal.). The outcome of the therapeutic response decreased was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 20-OCT-2023 Reporter is the patient, who received a series of Twinrix on 3rd January 2014. She states that she went to a new gastroenterologist who did some blood tests and surface ab blood and core ab total were non-reactive and surface ab quantitative was less than 5. CDC and CMP were normal. Her doctor told her she is not immune to the virus and wanted her to get the vaccine series again. The patient has Crohns disease and is on a biologic (Skyrizi). The patient already received 1 dose of the new series and is waiting to get the next 2 doses. The reporter did not consent to follow up.
Age: 35.0
Sex: F
Vaccine: RSV
Symptoms: Delivery, Exposure during pregnancy, Live birth, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: her third trimester of pregnancy.; delivered a healthy baby; administration to patient less than 60 years of age; patient was given a dose of Arexvy, instead of Pfizer's RSV vaccine; This non-serious retrospective pregnancy case was reported by a physician via call center representative and described the occurrence of vaccine exposure during pregnancy in a 35-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 05-SEP-2023, the patient received Arexvy. On 05-SEP-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: administration to patient less than 60 years of age) and wrong vaccine administered (Verbatim: patient was given a dose of Arexvy, instead of Pfizer's RSV vaccine). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: her third trimester of pregnancy.) and live birth (Verbatim: delivered a healthy baby). The outcome of the vaccine exposure during pregnancy, inappropriate age at vaccine administration, wrong vaccine administered and live birth were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): To mother in third trimester  Pregnancy Details (Neonate 1):  Delivery Type: vaginal Pregnancy Outcome: Live neonate with no apparent congenital anomaly   Additional Information: GSK Receipt Date: 20-OCT-2023 Physician reports her 35 year old patient was given a dose of Arexvy, instead of Pfizer's RSV vaccine, while she was in her third trimester of pregnancy which led to inappropriate age at vaccine administration, wrong vaccine administered. Physician confirms the patient has since delivered a healthy baby and did not require a C-section. Physician could not provide lot number or expiration date of product. No additional information provided. The reporter consented to follow up.
Age: 59.0
Sex: M
Vaccine: RSV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 59 year old not immunocompromised male patient received Arexvy today, Oct 20th 2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 59-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number A4945, expiry date 05-MAR-2025) for prophylaxis.   On 20-OCT-2023, the patient received Arexvy. On 20-OCT-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: 59 year old not immunocompromised male patient received Arexvy today, Oct 20th 2023). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK receipt date: 20-Oct-2023 Pharmacist reported that the patient was turning 60 years in December. The reporter consented to follow-up. The patient received a dose of Arexvy at an inappropriate age, which led to inappropriate age at vaccine administration.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: has not received the second vaccination; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 83-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose in January 2020).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: has not received the second vaccination). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 20-Oct-2023 Consumer called on the day of reporting and reported he had not received the second vaccination. The reporter consented to follow-up. Till the time of reporting, the patient did not receive second dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: Pharmacist stated that an expired dose of Twinrix was administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received HAB (Twinrix) (batch number 2KE55, expiry date 22-SEP-2023) for prophylaxis.   On 20-OCT-2023, the patient received Twinrix. On 20-OCT-2023, an unknown time after receiving Twinrix, the patient experienced expired vaccine used (Verbatim: Pharmacist stated that an expired dose of Twinrix was administered). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 20-Oct-2023 The vaccine administration facility was the same as primary reporter. The caller declined to provide more information. The reporter did not consent to follow-up. The patient received an expired dose of Twinrix, which led to expired vaccine used.
Age: 0.58
Sex: U
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 7 month old was inadvertently administered a dose of Kinrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 7-month-old patient who received DTPa-IPV (Kinrix) for prophylaxis.   On 20-OCT-2023, the patient received Kinrix. On 20-OCT-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 7 month old was inadvertently administered a dose of Kinrix). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 23-OCT-2023 It was reported that a 7 month old was inadvertently administered a dose of Kinrix which led to inappropriate age at vaccine administration. The reporter was unable to provide any vaccine or patient details. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Product preparation error
Clinical narrative: administered the diluent only; administered the diluent only; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23-OCT-2023, the patient received Shingrix. On 23-OCT-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: administered the diluent only) and inappropriate dose of vaccine administered (Verbatim: administered the diluent only). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 23-OCT-2023 The pharmacist reported that she administered the diluent only to an elderly female patient which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: given a Shingrix expired dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 56-year-old male patient who received Herpes zoster (Shingrix) (batch number 252JX, expiry date 14-SEP-2023) for prophylaxis.   On 24-OCT-2023, the patient received the 1st dose of Shingrix (intramuscular). On 24-OCT-2023, an unknown time after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: given a Shingrix expired dose). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 24-OCT-2023 It was reporter that patient was given Shingrix expired dose which led to expired vaccine used. The reporter consented to follow up.
Sex: F
Vaccine: RSV
Symptoms: Incorrect dose administered
Clinical narrative: patient received an incomplete dose of Arexvy; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 77-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 9994M, expiry date 21-MAR-2025) for prophylaxis.   On 24-OCT-2023, the patient received Arexvy. On 24-OCT-2023, an unknown time after receiving Arexvy, the patient experienced incomplete dose administered (Verbatim: patient received an incomplete dose of Arexvy). The outcome of the incomplete dose administered was unknown.   Additional Information: GSK Receipt Date: 24-OCT-2023 A pharmacist reported that a patient received an incomplete dose of Arexvy which led to incomplete dose administered. The patient was still in the clinic. The reporter asked for guidance on this situation. The reporter did not consent to follow up.
Age: 16.0
Sex: F
Vaccine: UNK
Symptoms: Extra dose administered
Clinical narrative: accidentally received another dose of Flulaval; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 16-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2023-2024 season) (batch number A2L45, expiry date 30-JUN-2024) for prophylaxis.   Concomitant products included INFLUENZA VACCINE INACT SPLIT 4V (FLULAVAL QUADRIVALENT).   On 20-OCT-2023, the patient received the 2nd dose of FluLaval Quadrivalent 2023-2024 season. On 20-OCT-2023, an unknown time after receiving FluLaval Quadrivalent 2023-2024 season, the patient experienced extra dose administered (Verbatim: accidentally received another dose of Flulaval). The outcome of the extra dose administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 24-OCT-2023 The reporter informed that a 16-year-old  received a dose of FluLaval on 21 September 2023 accidentally received another dose of this vaccine on 20 October 2023 which led to extra dose administered. The reporter consented to follow up.  The vaccine administration facility is the same as primary reporter.
Sex: M
Vaccine: MEN
Symptoms: Extra dose administered, Medication error, No adverse event
Clinical narrative: consumer received an extra dose of menquadfi in error with no reported adverse event; Initial information received from on 19-Oct-2023 regarding an unsolicited valid non-serious case received via other health professional.  This case involves an unknown age male patient, and reporter stated consumer received an extra dose of meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] in error with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.  On 25-Oct-2022, the patient received an unknown dose of suspect meningococcal A-C-Y-W135 (T CONJ) vaccine, solution for injection (lot number, strength, expiry date: unknown) not reported via unknown route in unknown administration site for immunization. On 18-Oct-2023 he also received 0.5 ml total dose of the same vaccine (lot number, strength, expiry date: unknown) via unknown route in unknown administration site for immunization and consumer received an extra dose of menquadfi in error with no reported adverse event (extra dose administered) (latency: 11 months 24 days) following the first administration and (latency: same day) following the last administration of meningococcal A-C-Y-W135 (T CONJ) vaccine.  It was reported that a patient received the vaccine sooner that they should have. Patient received vaccine a little under 3 years and The clinic reported that the consumer received an extra dose of MENQUADFI in error described as getting a dose on 18Oct2023 that was not needed due to having their dose last year on 25Oct2022.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 12.0
Sex: M
Vaccine: TYP, YF
Symptoms: Incorrect route of product administration, No adverse event, Wrong product administered
Clinical narrative: came in for a typhoid fever vaccine but was given YF-VAX with no reported adverse event; given YF-VAX intramuscularly instead of subcutaneously with no reported adverse event; Initial information received on 20-Oct-2023 regarding an unsolicited valid  non-serious case received via Nurse.  This case is linked to cases 2023SA326768(CLUSTER) and 2023SA326868(CLUSTER).  This case involves a 12-year-old male patient and reporter reported came in for a typhoid fever vaccine but was given yellow fever vaccine - [YF-VAX] with no reported adverse event and given yf-vax intramuscularly instead of subcutaneously with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On 20-Oct-2023, the patient received 0.5 ml total dose of suspect yellow fever vaccine, Solution for injection (lot: UJ819AA, expiry date: 18-Apr-2024) (strength: unknown) via intramuscular route in the arm nos for immunization and came in for a typhoid fever vaccine but was given yf-vax with no reported adverse event (wrong product administered) and yf-vax intramuscularly instead of subcutaneously with no reported adverse event (incorrect route of product administration) (latency: same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 61.0
Sex: M
Vaccine: COVID19-2
Symptoms: Arthralgia, Joint range of motion decreased, Walking aid user
Clinical narrative: Intense pain at the medial portion of the right knee joint, as if someone took a hammer to it.  No pain in this location prior to getting the vaccine.   Unable to bend knee, and only walking to the bathroom with crutches.   No treatment, other than OTC anti-inflammatories which are not doing any good.   So far, this has lasted for two  and a half days, since getting the vaccine, with no signs of subsiding, yet.
Age: 70.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: The following symptoms started in the evening, peaked during the night and gradually diminished over the following 24 to 48 hours: Pain, redness, and swelling at the injection site Muscle pain Fatigue Headache Chills Fever Gastrointestinal symptoms (nausea)
Age: 70.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Injection site swelling, Myalgia, Nausea, Pyrexia
Clinical narrative: The following symptoms started in the evening, peaked during the night and gradually diminished over the following 24 to 48 hours: Pain, redness, and swelling at the injection site Muscle pain Fatigue Headache Chills Fever Gastrointestinal symptoms (nausea)
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Autoimmune disorder, Erythema
Clinical narrative: Autoimmune issues that now cause red marks all over my legs
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Discomfort, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: red, swollen, itchy, warm area of 5cm x 4.7 cm at injection site. Discomfort began the day after the vaccine and the skin changes noticed the morning after (2 days after vaccine administration) It is unclear which vaccine site it is
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Skin disorder
Clinical narrative: red, swollen, itchy, warm area of 5cm x 4.7 cm at injection site. Discomfort began the day after the vaccine and the skin changes noticed the morning after (2 days after vaccine administration) It is unclear which vaccine site it is
Age: 58.0
Sex: F
Vaccine: UNK
Symptoms: Rash, Rash erythematous
Clinical narrative: a veiny rash on their leg/ leg turned bright red in a veiny pattern; This spontaneous case was reported by a patient and describes the occurrence of RASH (a veiny rash on their leg/ leg turned bright red in a veiny pattern) in a 58-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     The patient had no relevant medical history/conditions, allergy, concomitant diseases and risk factor.  Previously administered products included for Product used for unknown indication: INFLUENZA VACCINE (got the flu vaccine a week before.) in 2023. Past adverse reactions to the above products included No adverse event with INFLUENZA VACCINE.    On 25-Oct-2023, the patient received second dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 25-Oct-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced RASH (a veiny rash on their leg/ leg turned bright red in a veiny pattern). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) in 2023 at an unspecified dose and frequency. At the time of the report, RASH (a veiny rash on their leg/ leg turned bright red in a veiny pattern) was resolving.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported.  The had a Moderna covid Spikevax shot and developed a veiny rash on their leg. This morning on 25-Oct2-023 leg turned bright red in a veiny pattern as if only the veins had the allergic reaction with white areas in between. It was reported that the reaction is quieting down but there were still some remnants. The patient took a Zyrtec but it is on it year-round (as reported).
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Fever 99 degrees
Age: 64.0
Sex: F
Vaccine: UNK
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19 ) in a 64-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 on 24-Dec-2022.    On 16-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) .5 milliliter. On 25-Oct-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced COVID-19 (COVID-19 ). At the time of the report, COVID-19 (COVID-19 ) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Oct-2023, SARS-CoV-2 test: Positive.         Concomitant medication was not reported.  It was reported that 9 days following vaccination the symptoms and positive test for COVID-19 had begun. It was unknown if the patient experienced any additional symptoms/events. There were no lab data/results available.  Treatment medication was not reported.
Sex: F
Vaccine: UNK
Symptoms: Headache, Neck pain
Clinical narrative: her neck is hurting; headache; This spontaneous case was reported by a patient and describes the occurrence of NECK PAIN (her neck is hurting) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced NECK PAIN (her neck is hurting) and HEADACHE (headache). At the time of the report, NECK PAIN (her neck is hurting) and HEADACHE (headache) had not resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       No concomitant medication was reported.  No treatment information was reported.   Reporter did not allow further contact
Age: 42.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dizziness, Heart rate abnormal, Nausea, Pain in extremity
Clinical narrative: Severe pain in arm, nausea, elevated heart rate, dizziness
Age: 65.0
Sex: F
Vaccine: COVID19, FLUA4
Symptoms: Blood pressure increased, Chills, Pyrexia
Clinical narrative: About 0800 the next morning my blood pressure shot up to 188/108 and I had the chills and a low grade fever.  I took an Availde blood pressure pill to assist with bringing my blood pressure down.  I was down in 1 hour of taking this drug.
Age: 28.0
Sex: F
Vaccine: UNK
Symptoms: Ear pruritus, Pruritus, Rash, Urticaria
Clinical narrative: A few hours after getting my flu shot, I started to break out in a hive-like rash on my arms, chest, on my ears/head/face. Over the next few days, the rash went down but I still have itchiness on and around my ears and chest. I called my primary's office and the people on the phone said it was nothing to worry about, but I still have remnants of the rash almost 2 weeks later.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Blood culture positive, COVID-19, Cough, Diarrhoea
Clinical narrative: Discharge summary "Hospital Course: Patient is a 64 year old male with a past medical history of quadriplegia, being cared for at home by family, blindness, HTN, DM, epilepsy who presented to the ED with 3-4 day hx of cough, SOB, fever and diarrhea.    The following issues were addressed during his hospital stay:   Sepsis Acute respiratory insufficiency Likely due to COVID 19 infection SIRS: tachycardia 129, tachypnea 36, temp 103.8 on admission, hypoxic down to 88% -vitals are within normal limits, greatly improved from admission -continue ceftriaxone -discontinued decadron and remdesivir due to improvement and nonsevere disease -scheduled mucomyst, mucinex, mucomyst nebs -PRN chest physiotherapy, albuterol nebs -blood cultures x2 - 1/2 staph epidermidis, likely contaminant   Abnormal urinalysis -on ceftriaxone -urine culture, E.coli 10,000 CFU/mL   T2DM - SSI, accuchecks HTN - continue home atorvastatin and lisinopril Epilepsy - continue home levetiracetam Quadriplegia   Patient was discharged in stable condition. Physical exam on discharge"
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Escherichia test positive, Hypoxia, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: Discharge summary "Hospital Course: Patient is a 64 year old male with a past medical history of quadriplegia, being cared for at home by family, blindness, HTN, DM, epilepsy who presented to the ED with 3-4 day hx of cough, SOB, fever and diarrhea.    The following issues were addressed during his hospital stay:   Sepsis Acute respiratory insufficiency Likely due to COVID 19 infection SIRS: tachycardia 129, tachypnea 36, temp 103.8 on admission, hypoxic down to 88% -vitals are within normal limits, greatly improved from admission -continue ceftriaxone -discontinued decadron and remdesivir due to improvement and nonsevere disease -scheduled mucomyst, mucinex, mucomyst nebs -PRN chest physiotherapy, albuterol nebs -blood cultures x2 - 1/2 staph epidermidis, likely contaminant   Abnormal urinalysis -on ceftriaxone -urine culture, E.coli 10,000 CFU/mL   T2DM - SSI, accuchecks HTN - continue home atorvastatin and lisinopril Epilepsy - continue home levetiracetam Quadriplegia   Patient was discharged in stable condition. Physical exam on discharge"
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Sepsis, Staphylococcus test positive, Tachycardia, Tachypnoea, Urine analysis abnormal
Clinical narrative: Discharge summary "Hospital Course: Patient is a 64 year old male with a past medical history of quadriplegia, being cared for at home by family, blindness, HTN, DM, epilepsy who presented to the ED with 3-4 day hx of cough, SOB, fever and diarrhea.    The following issues were addressed during his hospital stay:   Sepsis Acute respiratory insufficiency Likely due to COVID 19 infection SIRS: tachycardia 129, tachypnea 36, temp 103.8 on admission, hypoxic down to 88% -vitals are within normal limits, greatly improved from admission -continue ceftriaxone -discontinued decadron and remdesivir due to improvement and nonsevere disease -scheduled mucomyst, mucinex, mucomyst nebs -PRN chest physiotherapy, albuterol nebs -blood cultures x2 - 1/2 staph epidermidis, likely contaminant   Abnormal urinalysis -on ceftriaxone -urine culture, E.coli 10,000 CFU/mL   T2DM - SSI, accuchecks HTN - continue home atorvastatin and lisinopril Epilepsy - continue home levetiracetam Quadriplegia   Patient was discharged in stable condition. Physical exam on discharge"
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Imaging procedure abnormal, Noninfective gingivitis, Oral disorder, Oral mucosal erythema, Stomatitis
Clinical narrative: After getting the Vaccination of Covid-19 Booster - Comirnaty) along side of Flu shot at the same time from medical center. There was a mouth sore started on the upper right gum just close to the No. 1 tooth in formation of 1/2 of an inch square shaped formation. red at the center and slight white at the edges. Health care provider reviewed the case and referred to head and Neck Surgery/ENT for further evaluation and treatment options on 24th October, 2023. We are still awaiting a call from the ENT.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Aphasia, Cerebrovascular accident, Dysstasia, Erythema, Memory impairment
Clinical narrative: I had the first Shingles vaccine on 06/14/2023 at the hospital here. I got a terrible reaction in my arm and it swelled up to about double size and was red, hot and very painful. Almost exactly 72 hours after receiving the vaccine I had a stroke. I lost speech and was unable to stand up and my wife called the ambulance. I have a Watchman device and am not supposed to get blood clots and they did not find any clots on 2 scans at the hospital, one without contrast and one with contrast. They did give me the TNK after a video conference with a neurologist. My speech started to return in about an hour and by the next day I was normal with speech. My wife feels I may have some residual memory issues. I have heard that inflammation can cause a stroke and I feel the inflammation from the vaccine caused mine. I saw a neurologist at the Hospital where I go for my cardiology and he calls it an "event" as I am unable to have an MRI due to my pacemaker. I will not be getting the second shot for the shingles vaccine.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling, Scan normal, Scan with contrast normal, Skin warm
Clinical narrative: I had the first Shingles vaccine on 06/14/2023 at the hospital here. I got a terrible reaction in my arm and it swelled up to about double size and was red, hot and very painful. Almost exactly 72 hours after receiving the vaccine I had a stroke. I lost speech and was unable to stand up and my wife called the ambulance. I have a Watchman device and am not supposed to get blood clots and they did not find any clots on 2 scans at the hospital, one without contrast and one with contrast. They did give me the TNK after a video conference with a neurologist. My speech started to return in about an hour and by the next day I was normal with speech. My wife feels I may have some residual memory issues. I have heard that inflammation can cause a stroke and I feel the inflammation from the vaccine caused mine. I saw a neurologist at the Hospital where I go for my cardiology and he calls it an "event" as I am unable to have an MRI due to my pacemaker. I will not be getting the second shot for the shingles vaccine.
Sex: M
Vaccine: FLU4
Symptoms: Chest discomfort, Discomfort, Echocardiogram normal, Electrocardiogram abnormal, Hypotension
Clinical narrative: 10/22/2023 new onset severe sinus bradycardia with PVCs and hypotension not related to MI, CAD or new heart block or conduction delay. History of RBBB only, mild HTN and HLD. Patient received Fluzone HD 23-24 PFS Sano, Lot U8984AB on 10/21/2023
Sex: M
Vaccine: FLU4
Symptoms: Laboratory test normal, Myocardial ischaemia, Scan myocardial perfusion abnormal, Sinus bradycardia, Ventricular extrasystoles
Clinical narrative: 10/22/2023 new onset severe sinus bradycardia with PVCs and hypotension not related to MI, CAD or new heart block or conduction delay. History of RBBB only, mild HTN and HLD. Patient received Fluzone HD 23-24 PFS Sano, Lot U8984AB on 10/21/2023
Age: 65.0
Sex: F
Vaccine: COVID19, FLUA4, RSV
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Received flu shot, covid and RSV in (L) deltoid. Reach to Employee health c/o itching, soreness swelling to (L) deltoid area. She states having all 3 vaccines in (L) deltoid. Influenza vaccine is the only provided by agency.
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Immunisation reaction
Clinical narrative: frequency: 21 days on then 7 days off. patient was hospitalized on 10/11/2023 due to reaction to either flu and/or covid vaccination shot that was administered on 10/09/2023. patient was released from hospital on 10/17; his last dose of lenalidomde was taken approximately 10/01/2023. unknown if pt has resumed taking lenalidomide. oncologist is aware of hospitalization. no other information provided.
Sex: U
Vaccine: COVID19
Symptoms: Syringe issue
Clinical narrative: 3 Spikevax syringes cracked during today's clinic while nurse was removing the cap. All belonged to Lot: 3031279. All 3 were recognized and discarded, not administered.
Sex: F
Vaccine: FLUR4
Symptoms: Device breakage, Exposure via skin contact
Clinical narrative: I was getting a flu vaccine ready for administration. As I was attaching the needle there was a clicking sound which at the time I thought nothing of, as the needle I had attached are not the ones we normally have ordered to our office, and so I thought it was just the needle clicking into place. I believe this was the moment that the hub of the needle I was using cracked. As I was unaware of the crack, and did not see any deformities or issues with any part of the needle, I went along with administering the flu shot to the patient. Upon pushing the plunger to deliver the flu shot, instead of going through the needle, came through the crack in the hub of the needle. I gave the patient some paper towels, as he now had most if not all of a Flublock vaccine dripping down his left upper arm. MD aware and instructed me, so long as the patient was okay with it, to give the flu shot again as it was unlikely he got any of the previous one. I got the new flu shot ready using the needles we regularly have ordered to the office, and administered as usual.
Age: 92.0
Sex: F
Vaccine: RSV
Symptoms: Pruritus, Urticaria
Clinical narrative: I received the RSV shot and 24 hours later developed very itchy hives
Sex: F
Vaccine: FLUC4
Symptoms: Injection site swelling, Lip swelling
Clinical narrative: Pt had a flu shot at the pharmacy on Monday 10/6/2023. She called on Tuesday saying that she slept on her injection site all night long and when she woke up she noticed that she has a swelling at her lower upper shoulder close to the injection site. When she called up, she said that the swelling has been reduced some since the previous day. I asked her to go to the ER or doctor, she said that she would rather show it to us first. She came on Thursday 10/12/2023. 2 pharmacists evaluated the swelling. Pt said that it has been reducing from Monday. She had no warmth skin, no fever, no N/V. She decided to continue to keep an eye on the swelling and will update us if any changes. I called her on Saturday, she said that the swelling has been down and diminished. She said that she will follow up with her doctor. I confirmed that it will be the best to do. and Let us know it we can be in any way to help. Pt said that she had a burger on Saturday, and she noticed that her lips swelled after eating. Informed her to go the ER if it is an allergic reaction of some sort.
Age: 62.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Constipation, Discomfort, Dizziness, Fatigue, Headache
Clinical narrative: Flu and moderna injection: 1. Headache and light sensitivity 2. Nausea and constipation, but unable to vomit or move bowels resulting in extreme discomfort. 3. Dizziness 4. Exhaustion Severe symptoms lasted 20 hours, then leftover exhaustion.
Age: 62.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Nausea, Photophobia
Clinical narrative: Flu and moderna injection: 1. Headache and light sensitivity 2. Nausea and constipation, but unable to vomit or move bowels resulting in extreme discomfort. 3. Dizziness 4. Exhaustion Severe symptoms lasted 20 hours, then leftover exhaustion.
Age: 43.0
Sex: F
Vaccine: TYP
Symptoms: Loss of personal independence in daily activities, Muscular weakness, Musculoskeletal disorder, Sleep disorder
Clinical narrative: For several days could not move right arm normally after receiving typhoid vaccine. Within 2 hours, my arm got really weak. I could not move it, from my shoulder to my wrist. I could not use the computer, could not dress/undress, could not shower, could not wipe after using the restroom. I could not sleep on my side. It took about a week to regain normal function.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Recurrent urticaria beginning 3 days after receiving Pfizer monovalent Comirnaty 12+ 23-24SDV. NDC 00069-2362-10 on 10/8/23 Urticaria distributed over trunk, limbs and face. Last episode 10/29/23 Treated PRN with Allegra and NSAIDs which relieved symptoms
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Injected limb mobility decreased, Injection site pain, Limb discomfort, Pain in extremity
Clinical narrative: on the date mentioned was injected with Spikevax 12+ BPK 23-24 in the early afternoon. after a few hours, the arm injected became increasingly sore and had the feeling of weightedness and immobility. was awoken in the night with deep chills and visible trembling . side affects abated in the late afternoon the next day. a lite soreness persists at the injection site, but the worst of tie, the chills and trembling are now nonexistent
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Sleep disorder, Tremor
Clinical narrative: on the date mentioned was injected with Spikevax 12+ BPK 23-24 in the early afternoon. after a few hours, the arm injected became increasingly sore and had the feeling of weightedness and immobility. was awoken in the night with deep chills and visible trembling . side affects abated in the late afternoon the next day. a lite soreness persists at the injection site, but the worst of tie, the chills and trembling are now nonexistent
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: Sustained tachycardia. Heart rate was consistently over 110 for two days. On Saturday 10/28/2023 heart rate climbed to 189 while cleaning and stayed between 120-150 while resting for a 3 hour period. I have had mild tachycardia with the previous COVID 19 vaccines and while having COVID 19 but not to this degree or for this sustained period of time.
Age: 54.0
Sex: F
Vaccine: FLU4, RSV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient was given Arexvy and Fluzone HD. She is under 60 years old. No adverse events have been reported.
Age: 66.0
Sex: F
Vaccine: UNK
Symptoms: Abdominal pain upper, Fatigue, Headache, Pyrexia
Clinical narrative: Head Ache, stomach pain, fever, exhaustion
Age: 61.0
Sex: M
Vaccine: UNK
Symptoms: Erythema, Eye irritation, Pruritus, Rash
Clinical narrative: Flu vaccine on 10/20/23, left arm.   Itching started about 40 minutes after vaccine. Pt thought it was her asthma.  But then saw rash, redness.  Taking Benadryl after work.  Did that for few days, then eyes started to be irritated.  Went to MD on 10/23/23.  Script for Prednisone called in to Pharmacy, had to leave work to get meds.  Pt states Prednisone worked, and rash and itching cleared up. Pt states about 16 years ago had similar reaction. Had bad reaction to COVID vaccine, in bed for 7 days after vaccine. No vaccines or illness 1 month prior to flu vaccine this year.
Age: 79.0
Sex: M
Vaccine: RSV
Symptoms: Arthralgia, Blood test normal, Chest X-ray normal, Chills, Computerised tomogram normal
Clinical narrative: four hours after vaccination severe pain in left shoulder and elbow joints , shivering and trembling, fainting then taken to ER for treatment
Age: 79.0
Sex: M
Vaccine: RSV
Symptoms: Electrocardiogram normal, Fall, Injection site joint pain, Loss of consciousness, Syncope
Clinical narrative: four hours after vaccination severe pain in left shoulder and elbow joints , shivering and trembling, fainting then taken to ER for treatment
Age: 79.0
Sex: M
Vaccine: RSV
Symptoms: Tremor, Urine analysis normal, X-ray limb normal
Clinical narrative: four hours after vaccination severe pain in left shoulder and elbow joints , shivering and trembling, fainting then taken to ER for treatment
Age: 58.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site vesicles, Injection site warmth
Clinical narrative: PATIENT DEVELOPED BLISTERS ON THE POINT OF INJECTION AND THE AREA WAS WARM
Age: 1.83
Sex: M
Vaccine: FLUC4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received two flu shots previous season (2022-2023 season). Received 2023 flu shot on 10/4/23. Erroneously received a second flu shot this season on 10/28/23. No adverse effects reported.
Age: 2.0
Sex: M
Vaccine: COVID19, DTAP, FLU4, HEP, MMR
Symptoms: Rash
Clinical narrative: Patient developed rash post vaccination.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: Patient had no adverse event. He was given the wrong dosage of COVID vaccine, he was given the 6mons-11 year old and he is 13.5 years old. Pt returned the next week and got another of the same to make up for the full dose he should have been given from the start.
Age: 14.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Dizziness, Fall, Head injury
Clinical narrative: Patient got dizzy right after I gave the shots, he might have lost consciousness for a second. He fell down from the chair and hit his forehead on the floor.
Age: 69.0
Sex: M
Vaccine: RSV
Symptoms: Rash
Clinical narrative: Skin rash on arms, hands, and fingers that has not yet completely faded.  Rash is below elbow. No itching or burning noted. Rash does not respond to hydrocortisone.
Age: 42.0
Sex: M
Vaccine: COVID19-2, COVID19-2
Symptoms: Hallucination
Clinical narrative: Pt. presents today stating " someone is following him and is out to get him." He has a history of mental health hospitalizations. He is hallucinating but asking for another COVID vaccine and flu shot. He is not able to give consent. In checking database, he got 2- Bivalent COVID vaccines, one 4/2023 and 5/2023. Evidently, when he came in May, he stated it was his first COVID vaccine. Pt. is also stating " the COVID vaccine grew my breast and caused me to sweat." Gynecomastia. Nurse Manager, spoke and assessed patient and he is referred to  Health Center.  Homeless reps at health dept. gave him some personal care items and food. 3- at home COVID test were given.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Blood bilirubin, Fatigue
Clinical narrative: Severe fatigue 20 hours after injection.  Lasted 8 hours.  Possible high bilirubin level (179)   in blood test 30 hours after injection/.
Age: 75.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: 12 hours after shot: chills, headache, queasiness, muscle pain, joint pain  started at 4 AM and continued for 16 hours, moderate to severe in nature Tylenol mildly helpful  2X 48 hours later symptoms dissipated but fatigued, 72 hours later fatigued
Age: 75.0
Sex: F
Vaccine: RSV
Symptoms: Nausea
Clinical narrative: 12 hours after shot: chills, headache, queasiness, muscle pain, joint pain  started at 4 AM and continued for 16 hours, moderate to severe in nature Tylenol mildly helpful  2X 48 hours later symptoms dissipated but fatigued, 72 hours later fatigued
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Brain fog, Flank pain, Malaise
Clinical narrative: Continued muscle pain, right flank/low back/hip pain, low grade temperature elevation, malaise, fogginess. Also arm soreness but worse symptom in the pain. Said symptoms were severe on day 1 and 2, some improvement on day 3.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Continued muscle pain, right flank/low back/hip pain, low grade temperature elevation, malaise, fogginess. Also arm soreness but worse symptom in the pain. Said symptoms were severe on day 1 and 2, some improvement on day 3.
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient was given a 12+ Moderna 0.5ml vaccine instead of the 6mo-11year Moderna 0.25ml vaccine. Patient was monitored 15 minutes after, Mom was informed.  No reaction noted, mom states patient doing okay. Explained to call with any changes.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Erythema
Clinical narrative: localized erythematous reaction with blistering
Age: 81.0
Sex: F
Vaccine: RSV
Symptoms: Allergy to vaccine, C-reactive protein increased, Headache, Heart rate increased, Hyperacusis
Clinical narrative: High temp, rapid pulse.  Admitted to hospital with c-reactive  protein level of 891.  Head ache extreme especially activated with sound or light.  For five days they ran every test they could think of to find cause of my symptoms?..even though I told them I had just had an RSV injection.  After five days and no positive results for any disease or condition it was divided it must have been an allergic reaction to shot.  As soon as I was given steroids intravenously, I started to improve.  After 5 days in bed I also picked up pneumonia so antibiotics were also prescribed.  A day and a half later, I was discharged from the hospital.
Age: 81.0
Sex: F
Vaccine: RSV
Symptoms: Hypersensitivity, Laboratory test normal, Photophobia, Pneumonia, Pyrexia
Clinical narrative: High temp, rapid pulse.  Admitted to hospital with c-reactive  protein level of 891.  Head ache extreme especially activated with sound or light.  For five days they ran every test they could think of to find cause of my symptoms?..even though I told them I had just had an RSV injection.  After five days and no positive results for any disease or condition it was divided it must have been an allergic reaction to shot.  As soon as I was given steroids intravenously, I started to improve.  After 5 days in bed I also picked up pneumonia so antibiotics were also prescribed.  A day and a half later, I was discharged from the hospital.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Pt received 6month-11 year version of vaccine, .25 rather than .5
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Chills, Headache, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: She got her vaccine, the injection site was OK, nothing new about it.  Later that day in the afternoon she started to get the feeling of malaise and the arm was a little bit sore, and slightly red and warm around the injection site.  The bad reactions actually started the next day and that's when she ended up with a headache, had fever, had chills, slight nausea, and around the injection site she had a lot of redness, spread to about the size of 5" in diameter.  There was swelling around the injection site as well as pain.  She took Aleve for her reaction and used ice packs on the arm throughout the day.  This did not relieve her symptoms, the ice did for a little bit, the pain of the area.  The next morning she site swelling and fever, as well as redness, swelling pain and then itchiness wanting to scratch that area.  She took Benadryl for that reaction.  On 10/28/23 the headache and fever had left.  She still had redness, some pain and itchiness which continued to this morning.  There is still some slight redness and some soreness to the area today, but it is diminishing and looks so much better this morning.    She did contact her doctor on 10/26/23 and she was the one who told her to put ice on her and to call back if she got any worse.
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Injection site swelling, Injection site warmth, Malaise, Nausea, Pain in extremity
Clinical narrative: She got her vaccine, the injection site was OK, nothing new about it.  Later that day in the afternoon she started to get the feeling of malaise and the arm was a little bit sore, and slightly red and warm around the injection site.  The bad reactions actually started the next day and that's when she ended up with a headache, had fever, had chills, slight nausea, and around the injection site she had a lot of redness, spread to about the size of 5" in diameter.  There was swelling around the injection site as well as pain.  She took Aleve for her reaction and used ice packs on the arm throughout the day.  This did not relieve her symptoms, the ice did for a little bit, the pain of the area.  The next morning she site swelling and fever, as well as redness, swelling pain and then itchiness wanting to scratch that area.  She took Benadryl for that reaction.  On 10/28/23 the headache and fever had left.  She still had redness, some pain and itchiness which continued to this morning.  There is still some slight redness and some soreness to the area today, but it is diminishing and looks so much better this morning.    She did contact her doctor on 10/26/23 and she was the one who told her to put ice on her and to call back if she got any worse.