chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Biopsy lung, Bronchoalveolar lavage, COVID-19 pneumonia, Computerised tomogram thorax, Drug ineffective
Clinical narrative: COVID-19 pneumonia; COVID-19 pneumonia; This is a literature report.  INTRODUCTION: Organizing pneumonia secondary to COVID-19 usually has a subacute presentation with a prolonged clinical course. Risk factors leading to progression remain uncertain. The authors present a 56-year-old male who developed organizing pneumonia due to COVID-19 on chronic immunosuppression with rituximab therapy (anti CD20) with a rapid deterioration of clinical course and poor outcome. DESCRIPTION: A 56-year-old male presented to the ED with acute onset of dyspnea. Medical history was significant for refractory polymyositis on chronic rituximab therapy. He had received COVID-19 (mRNA) vaccination. Initial testing revealed he was SARS- CoV-2 positive and was managed as an outpatient with Bebtelovimab infusion without significant clinical improvement. On hospital admission, CT Chest showed bilateral lower lobe atelectasis. He was treated empirically for pneumonia along with dexamethasone. Remdesivir was not given due to patient preference. Two weeks later, he was readmitted for persistent fevers. Infectious work up for typical and atypical respiratory pathogens were negative. CT Chest showed interval worsening with bilateral peripheral sub pleural ground glass opacities. Bronchoalveolar lavage showed mixed inflammatory infiltrates with lung biopsy showing foamy macrophages and focal fibrosis suggestive of organizing pneumonia. He was started on prednisone 1 mg/kg and then escalated to intravenous methylprednisolone along with azathioprine for worsening respiratory failure. Subsequently he was put on mechanical ventilation and started on venovenous Extracorporeal Membrane Oxygenation along with lung rest strategy. Despite continued treatment for two weeks, he succumbed to his illness. DISCUSSION: Organizing pneumonia in COVID -19 usually has a subacute to chronic presentation. Rapid progression leading to acute fibrinous organizing pneumonia with poor prognosis has been described. This case highlights the fact that organizing pneumonia needs to be considered in the differential of COVID-19 pneumonia with chronic immunosuppression. The authors postulate that immunosuppression with rituximab in addition to COVID-19 pneumonia may have led to rapid progression to fibrinous stage. Corticosteroids remain the cornerstone of treatment. The benefit of anti-viral treatment remains to be determined.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162B2 in this patient cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate; Reported Cause(s) of Death: COVID-19 pneumonia
Sex: M
Vaccine: COVID19
Symptoms: Investigation, SARS-CoV-2 test
Clinical narrative: COVID-19 pneumonia; COVID-19 pneumonia; This is a literature report.  INTRODUCTION: Organizing pneumonia secondary to COVID-19 usually has a subacute presentation with a prolonged clinical course. Risk factors leading to progression remain uncertain. The authors present a 56-year-old male who developed organizing pneumonia due to COVID-19 on chronic immunosuppression with rituximab therapy (anti CD20) with a rapid deterioration of clinical course and poor outcome. DESCRIPTION: A 56-year-old male presented to the ED with acute onset of dyspnea. Medical history was significant for refractory polymyositis on chronic rituximab therapy. He had received COVID-19 (mRNA) vaccination. Initial testing revealed he was SARS- CoV-2 positive and was managed as an outpatient with Bebtelovimab infusion without significant clinical improvement. On hospital admission, CT Chest showed bilateral lower lobe atelectasis. He was treated empirically for pneumonia along with dexamethasone. Remdesivir was not given due to patient preference. Two weeks later, he was readmitted for persistent fevers. Infectious work up for typical and atypical respiratory pathogens were negative. CT Chest showed interval worsening with bilateral peripheral sub pleural ground glass opacities. Bronchoalveolar lavage showed mixed inflammatory infiltrates with lung biopsy showing foamy macrophages and focal fibrosis suggestive of organizing pneumonia. He was started on prednisone 1 mg/kg and then escalated to intravenous methylprednisolone along with azathioprine for worsening respiratory failure. Subsequently he was put on mechanical ventilation and started on venovenous Extracorporeal Membrane Oxygenation along with lung rest strategy. Despite continued treatment for two weeks, he succumbed to his illness. DISCUSSION: Organizing pneumonia in COVID -19 usually has a subacute to chronic presentation. Rapid progression leading to acute fibrinous organizing pneumonia with poor prognosis has been described. This case highlights the fact that organizing pneumonia needs to be considered in the differential of COVID-19 pneumonia with chronic immunosuppression. The authors postulate that immunosuppression with rituximab in addition to COVID-19 pneumonia may have led to rapid progression to fibrinous stage. Corticosteroids remain the cornerstone of treatment. The benefit of anti-viral treatment remains to be determined.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162B2 in this patient cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate; Reported Cause(s) of Death: COVID-19 pneumonia
Age: 41.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: patient who received her first GARDASIL 9 on 11Dec2023. She didn't come back for her second dose until today. When should she get her third dose; No additional AE; This spontaneous report was received from a pharmacist and refers to a 41-year-old female. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 11-DEC-2023, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot number X019863, expiration date: 14-FEB-2025, administered for prophylaxis (strength, specific dosage, route of administration and anatomical site of application date were not provided). On an unspecified date in February 2024, did not returned to the pharmacy for her second dose and on 11-MAY-2024, received the second dose (strength, specific dosage, dose number, route of administration, anatomical site of application, lot number and expiration date were not provided) also for prophylaxis (inappropriate schedule of product administration). No additional AE/no PQC.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pallor, Rash maculo-papular
Clinical narrative: Generalized rash that is macular papular and blanching, Started on abdomen 5/14/24 and spread to all body. Nothing in mouth. No fever. May have been warm on 5/12/24.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Expired product administered
Clinical narrative: The event happened on 4-29-24 at 11:00am at Health Center on the first floor room 104. I gave the Pfzier12+ Covid vaccine that was past the used by date. The vaccine should be used by 4-26-24 and I gave the covid vaccine on 4-29-24. I was rooming a patient before the incident occurred and did not catch the CDC covid paper that was in the fridge.
Age: 56.0
Sex: M
Vaccine: HEPAB, MMR, PNC20, TBE
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt experienced erythema and tenderness at the injection site, swelling and redness still occurring 2 weeks later at TBE booster appointment today, although improving. No other symptoms of systemic allergic reaction present. Gave booster in the other arm.
Age: 41.0
Sex: F
Vaccine: COVID19-2, FLU4, TDAP
Symptoms: Hypoaesthesia, Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: Patient says she has pain and numbness in both arms. She says  she has called here (pharmacy) and her doctor multiple times and was told it should improve. I'm not sure if patient has ever been examined by a physician, but does claim the pain and numbness interferes with her life. I'm not sure if the pain was immediate or delayed (she did say the pharmacist who gave her the vaccine was dismissive so I am assuming it was immediate).
Age: 26.0
Sex: M
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Pt presented to clinic for Hep B booster after having a negative titer (pt had 3 of 3 doses previously during childhood) and was required to get a booster for clinicals.  I accidentally gave the patient a pediatric dose of Engerix-B (Glaxo Smith Kline) instead of the adult dose.  I realized it later in the day when entering all the data in the chart.  Notified management immediately to establish protocol.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at injection site.  2 days post vaccine.
Age: 67.0
Sex: M
Vaccine: COVID19, RSV, TDAP
Symptoms: Expired product administered
Clinical narrative: Vaccination expired
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Fear, Impaired work ability, Injected limb mobility decreased, Injection site pain, Magnetic resonance imaging
Clinical narrative: The injection was very painful. I was surprised at the pain. The first one didn't hurt as much. At 5 days, I couldn't raise my arm. I was afraid. The arm swelled, I had a slight fever. It started to hurt more and more. I went to the emergency room. They gave me an injection of morphine and sent me home saying it would get better. It never got better. I went to the pharmacy where they gave me the shot. They ignored me. I have been suffering. Today, 3 yrs later, I still have a throbbing pain. I can only raise my arm a little bit. I have been unable to work.  I have received injections in the arm. The relief lasts 3 days, no more.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Peripheral swelling, Pyrexia, X-ray limb
Clinical narrative: The injection was very painful. I was surprised at the pain. The first one didn't hurt as much. At 5 days, I couldn't raise my arm. I was afraid. The arm swelled, I had a slight fever. It started to hurt more and more. I went to the emergency room. They gave me an injection of morphine and sent me home saying it would get better. It never got better. I went to the pharmacy where they gave me the shot. They ignored me. I have been suffering. Today, 3 yrs later, I still have a throbbing pain. I can only raise my arm a little bit. I have been unable to work.  I have received injections in the arm. The relief lasts 3 days, no more.
Age: 18.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient had no adverse reaction to the adult dose of Hep A vaccine.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Hypersensitivity, Lymphadenopathy, Pain, Pain in extremity
Clinical narrative: Patient stated that at about 8:00 pm on the vaccination date her arm was red, swollen, and egg shaped.  it continued to get worse into the next day and by 4:00 pm on the following day she also had a fever of 102.7. swollen neck glands, shooting pain into her fingers, and vomiting.  She was seen at urgent care and they diagnosed it as an allergy and treated her with cephalexin & a steroid dose pack.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Pyrexia, Vomiting
Clinical narrative: Patient stated that at about 8:00 pm on the vaccination date her arm was red, swollen, and egg shaped.  it continued to get worse into the next day and by 4:00 pm on the following day she also had a fever of 102.7. swollen neck glands, shooting pain into her fingers, and vomiting.  She was seen at urgent care and they diagnosed it as an allergy and treated her with cephalexin & a steroid dose pack.
Age: 64.0
Sex: F
Vaccine: RSV
Symptoms: Erythema, Pain, Peripheral swelling
Clinical narrative: Patient called on 5/16/24 at 5:30pm stating she just noticed her upper arm is swollen and red. Patient stated her has been a little sore since the vaccination, but didn't pay much attention to until today. Patient denied having any fever or shortness of breath, or any other symptom.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Administration site pain, Administration site swelling, Injection site erythema
Clinical narrative: large redness, swelling and pain at site of vaccine administration (L) arm started the day after vaccination
Sex: U
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Pt. was given the wrong vaccine of Hep B adolescent/peds up to 19 yrs of age.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: Caller reporting temperature excursion and a dose was administered. No additional AE, no PQC. No additional information.          ?    Names of vaccines involved (including lot/exp): GARDASIL 9 2014790 4/22/2026        ?    Temperature :10.76 F F; No additional AE; This spontaneous report was received from a medical assistant and refers to a patient of unknown age or gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported.  On an unspecified date, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # 2014790, expiration date: 22-APR-2026 (strength, route of administration, anatomical location not provided) as prophylaxis; which underwent a temperature excursion with a temperature of 10.76 Fahrenheit (F) for 13 hours and 50 minutes; and a temperature of 10.69 F for 8 hours and 21 minutes.  There were No previous temperature excursions, no additional adverse events were reported.
Age: 0.92
Sex: M
Vaccine: MMR
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE; Received first dose of MMRII one day before their 1st birthday (11 months of age) on 4/30/2007 and received their second dose on 3/18/2011; This spontaneous report has been received from a licensed practical nurse (LPN), concerning a 4-year-old male patient.  The patient's medical history, concurrent conditions, historical drugs, and concomitant therapies were not reported.  On 30-APR-2007, at 11-month-old, the patient was vaccinated with the 1st dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, and on 18-MAR-2011, he received the 2nd dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection (Inappropriate schedule of product administration). Both vaccines were administered as prophylaxis (exact doses, lot numbers, expiration dates, routes of administration, and anatomical locations were not provided). The reporter inquired if the patient would required another dose/revaccination.  No additional adverse event (AE) was reported.  Lot # is being requested and will be submitted if received.
Age: 0.33
Sex: U
Vaccine: HEPA, MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: The patient did not experience any symptoms; Medical Assistant calling to report adverse event regarding a 4 month old patient that was inadvertently administered a dose of PROQUAD and VAQTA; This spontaneous report was received from a medical assistant concerning a 4-months-old patient of unknown gender. Patient's concurrent conditions, pertinent medical history and concomitant therapies were not provided.  On 13-MAY-2024, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 0.5 milliliter, lot #X025908, expiration date: 24-APR-2025, administered for prophylaxis (strength, frequency, route of administration, and anatomical location were not provided); and measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) injection, 0.5 milliliter, lot #: Y000134 with expiration date not provided but upon internal validation confirmed as 01-JUL-2025, administered for prophylaxis (strength, frequency, expiry date, route of administration, and anatomical location were not provided)(inappropriate age at vaccine administration).  The patient did not experienced any symptoms or medical concern after being vaccinated.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Vaccine administered after temperature excursion; This spontaneous report has been received from other health professional (nurse) referring to a 4-year-old female patient. The patients' concurrent conditions, medical history and concomitant medications were not provided.    On 15-APR-2024, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) subcutaneous injection, administered subcutaneously, lot number X025823 that was verified to be a valid lot number (expiration date reported as 24-APR-2025, but upon internal validation established as 29-APR-2025) as prophylaxis (strengths, specific dosage, vaccination scheme, and anatomical site of application were not provided) (product storage error). Review of the data logger printout showed that the dose was exposed to a temperature excursion (TE) of -9.0C, for a time range between of 2 hours 46 minutes 0 seconds. The TE was not noted by employee checking thermometer reading (occurred after hours on weekend) due to power outage for a couple of hours. No previous excursion was reported. No additional adverse events.
Sex: U
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: HAVE 2.5 YEARS TO LIVE AND DIDN'T HAVE THESE DISEASES BEFORE THE SHOT; This spontaneous report received from a patient concerned a patient of unspecified age and sex. Initial information was processed with additional information received on 10-MAY-2024. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (dose series 1) (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. We are unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient reported they had 2.5 years to live and didn't have these diseases before that shot (dose series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of have 2.5 years to live and didn't have these diseases before the shot was not reported. This report was serious (Other Medically Important Condition). The suspected product quality complaint has been confirmed to be 90000324618 - this customer preference case has been assessed and does not represent a product quality complaint. the disposition and root cause determination were documented properly. based on the PQC evaluation/investigation performed.; Sender's Comments: V0:  Unevaluable event. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Got COVID; Got COVID; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 67-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 immunization; Bnt162b2 (DOSE 2), for COVID-19 immunization; Bnt162b2 (DOSE NUMBER UNKNOWN (BOOSTER)), for COVID-19 immunization. The patient reported he got all Pfizer COVID vaccines in the past. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2024, outcome "unknown" and all described as "Got COVID". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient was given nirmatrelvir, ritonavir (PAXLOVID) as treatment of COVID-19.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400108418 same reporter/product/event, different patient;
Sex: U
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: injection sites were swollen, red, and warm to the touch; injection sites were swollen, red, and warm to the touch; injection sites were swollen, red, and warm to the touch; Initial information received on 13-May-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patients who experienced injection sites were swollen, red, and warm to the touch after receiving Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel].  The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patients received  0.5 ml total of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine Suspension for injection (lot number: U7953AA) (with an unknown strength, expiry date) via unknown route in unknown administration site for immunization.  On an unknown date, the patients developed events of injection sites were swollen, red, and warm to the touch (vaccination site erythema) (vaccination site swelling) (vaccination site warmth) (unknown latency).  Reportedly, The email reports that two patients reported an abnormal local reaction to their Tdap vaccine. There was no distinguishing information between the two patients. They are therefore both reported in this same case.   Action taken: not applicable.  It was not reported if the patients received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for the events
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Hypersensitivity, Immediate post-injection reaction, Injection site erythema, Injection site pruritus
Clinical narrative: immediate hives, redness and itchiness" at the injection site; immediate hives, redness and itchiness" at the injection site; patient is "allergic" to DTaP vaccine; immediate hives, redness and itchiness" at the injection site; received the fourth dose, during her fourth pregnancy; Initial information received on 13-May-2024 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 28 years old female patient who experienced immediate hives, redness and itchiness" at the injection site and received the fourth dose, during her fourth pregnancy while receiving vaccine diphtheria-2/tetanus/5 ac pertussis vaccine [Adacel]. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known and occurred at unknown gestation period.  The date of last menstrual period was not reported.  The estimated due date was not reported.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose 4 of suspect diphtheria-2/tetanus/5 ac pertussis vaccine Suspension for injection lot number not reported via unknown route in unknown administration site (strength and expiration date: not provided) for Immunisation (exposure during pregnancy).  On an unknown date the patient developed immediate hives, redness and itchiness" at the injection site (vaccination site urticaria), (vaccination site pruritus), (hypersensitivity), vaccination site erythema) (unknown latency).  Action taken- not applicable.  It was not reported if the patient received a corrective treatment for the events (immediate hives, redness and itchiness" at the injection site, patient is "allergic" to DTaP vaccine).  At time of reporting, the outcome was Unknown for all the events. Additionally, at time of reporting, the outcome of the pregnancy is unknown.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site urticaria
Clinical narrative: immediate hives, redness and itchiness" at the injection site; immediate hives, redness and itchiness" at the injection site; patient is "allergic" to DTaP vaccine; immediate hives, redness and itchiness" at the injection site; received the fourth dose, during her fourth pregnancy; Initial information received on 13-May-2024 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 28 years old female patient who experienced immediate hives, redness and itchiness" at the injection site and received the fourth dose, during her fourth pregnancy while receiving vaccine diphtheria-2/tetanus/5 ac pertussis vaccine [Adacel]. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known and occurred at unknown gestation period.  The date of last menstrual period was not reported.  The estimated due date was not reported.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose 4 of suspect diphtheria-2/tetanus/5 ac pertussis vaccine Suspension for injection lot number not reported via unknown route in unknown administration site (strength and expiration date: not provided) for Immunisation (exposure during pregnancy).  On an unknown date the patient developed immediate hives, redness and itchiness" at the injection site (vaccination site urticaria), (vaccination site pruritus), (hypersensitivity), vaccination site erythema) (unknown latency).  Action taken- not applicable.  It was not reported if the patient received a corrective treatment for the events (immediate hives, redness and itchiness" at the injection site, patient is "allergic" to DTaP vaccine).  At time of reporting, the outcome was Unknown for all the events. Additionally, at time of reporting, the outcome of the pregnancy is unknown.
Sex: U
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: she misinterpreted the expiration date on the vial and a patient received an expired dose with no reported adverse event; Initial information received on 14-May-2024 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient who received  Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult [Tenivac] she misinterpreted the expiration date on the vial and a patient received an expired dose with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) ,concomitant medications and family history were not provided.   On 14-Apr-2024, the patient received a unknown dose of suspect Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult (Suspension for injection) (strength, lot number not reported) (Expiry date: 24-Sep-2023) via unknown route in unknown administration site for Prophylactic vaccination (Immunization) and she misinterpreted the expiration date on the vial and a patient received an expired dose with no reported adverse event (expired product administered) (latency : same day). The information on batch number was requested.   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: 16.0
Sex: M
Vaccine: MENB
Symptoms: No adverse event
Clinical narrative: no signs and symptoms
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site urticaria
Clinical narrative: Pt developed localized wheal approx 1 inch laterally from MMR on left thigh and 1 inch medially from varicella on right thigh
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood creatinine increased, Chromaturia, Chronic kidney disease, Creatinine urine increased, Discomfort
Clinical narrative: I started to develop foamy dark pigmented urine I went for an annual checkup at Medical Services in 11/21/ 2023 for a physical and again for a follow up on 12/12/2023 my PCP said there was something alarming going with my kidneys and my serum creatinine was 1.3 dl on April 16, 2024 I went to see a nephrologist at the same office she diagnosed me with stage II CKD Chronic Kidney disease I have lost approximately 28% of my kidney function I've experienced pain and discomfort I believe it was due to the Moderna COVID 19 vaccine and booster shot which I was vehemently opposed to take.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain, Renal impairment, Urine abnormality
Clinical narrative: I started to develop foamy dark pigmented urine I went for an annual checkup at Medical Services in 11/21/ 2023 for a physical and again for a follow up on 12/12/2023 my PCP said there was something alarming going with my kidneys and my serum creatinine was 1.3 dl on April 16, 2024 I went to see a nephrologist at the same office she diagnosed me with stage II CKD Chronic Kidney disease I have lost approximately 28% of my kidney function I've experienced pain and discomfort I believe it was due to the Moderna COVID 19 vaccine and booster shot which I was vehemently opposed to take.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Accidental exposure to product, Syringe issue, Underdose
Clinical narrative: AFTER GIVING PROQUAD VACCINE MOM STATED "SHE WAS SPRAYED WITH SOMETHING"  WE NOTICED LIQUID IN THE PATIENT'S HAIR, ON HER SHIRT, & ON THE MOM'S SHIRT.  I LOOKED AT MY SYRINGE & REALIZED THERE WAS A CRACK, CAUSING THE LIQUID TO NOT GET INJECTED, BUT WAS SPRAYED OUT OF THE SYRINGE BEFORE REACHING THE NEEDLE/BEVEL.
Age: 4.0
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse effect. A Tdap was given versus a Dtap.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Erythema, Pain, Skin warm
Clinical narrative: Patient had redness that spread overnight to the area, it was warm to touch and painful
Age: 69.0
Sex: M
Vaccine: FLU4
Symptoms: Dyspnoea, Exercise tolerance decreased, FEV1/FVC ratio decreased, Fatigue, Malaise
Clinical narrative: Loud inspiratory wheezing all fields, dyspnea, malaise, fatigue; treated with dexamethasone 7 mg po qd X 1 wk, then tapered over 1 wk.  Recurrent milder wheezing episodes over next 4 months, treated with rescue albuterol and fluticasone 44ug inhalers; in April FEV1 and peak flow mildly decreased, normalized with albuterol.   Persistent fatigue, exercise intolerance.  Worse than usual seasonal spring pollen allergy symptoms, requiring triamcinolone suspension 80 mg IM.
Age: 69.0
Sex: M
Vaccine: FLU4
Symptoms: Peak expiratory flow rate decreased, Seasonal allergy, Wheezing
Clinical narrative: Loud inspiratory wheezing all fields, dyspnea, malaise, fatigue; treated with dexamethasone 7 mg po qd X 1 wk, then tapered over 1 wk.  Recurrent milder wheezing episodes over next 4 months, treated with rescue albuterol and fluticasone 44ug inhalers; in April FEV1 and peak flow mildly decreased, normalized with albuterol.   Persistent fatigue, exercise intolerance.  Worse than usual seasonal spring pollen allergy symptoms, requiring triamcinolone suspension 80 mg IM.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: 2nd HPV dose was given too early.  1st dose was given 2/12/24, second dose was given 5/16/24, but should have been on or after 8/12/24.  Patient suffered no adverse reactions and will return for another HPV dose later this year.
Age: 78.0
Sex: F
Vaccine: RSV
Symptoms: Injection site bruising, Injection site erythema, Injection site pruritus
Clinical narrative: Patient came to the pharmacy.  Area on arm near injection site was red and she said it was itchy at times (started a few days after the injection).  I told her she could put some ice on the area and also try some over the counter hydrocortisone cream if needed.  She also states she had a big black bruise that appeared 2 days after below the injection site on the back of the arm, but it disappeared quickly.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Decreased appetite, Gait disturbance, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Received 4 year vaccines (MMR/Varicella subcutaneous to left thigh and DTaP/IPV IM to right thigh) yesterday. Within 24 hours from vaccination, Patient complained of pain and started limping. Within 34 hours of vaccination, Patient developed large red, hard, raised spot at DTaP/IPV right thigh vaccine site; photo uploaded to chart. No reaction to MMR/Varicella left thigh vaccine site. She also developed fever Tmax 102F around 34 hour mark.   Mother noted some lethargy, paleness, and decreased appetite. Denies coughing, shortness of breath, wheezing, difficulty swallowing, chest tightness, nausea, vomiting, diarrhea, dizziness or fainting.   No history of vaccine reactions. No allergies to gelatin, eggs, milk.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Lethargy, Pain, Pallor, Pyrexia
Clinical narrative: Received 4 year vaccines (MMR/Varicella subcutaneous to left thigh and DTaP/IPV IM to right thigh) yesterday. Within 24 hours from vaccination, Patient complained of pain and started limping. Within 34 hours of vaccination, Patient developed large red, hard, raised spot at DTaP/IPV right thigh vaccine site; photo uploaded to chart. No reaction to MMR/Varicella left thigh vaccine site. She also developed fever Tmax 102F around 34 hour mark.   Mother noted some lethargy, paleness, and decreased appetite. Denies coughing, shortness of breath, wheezing, difficulty swallowing, chest tightness, nausea, vomiting, diarrhea, dizziness or fainting.   No history of vaccine reactions. No allergies to gelatin, eggs, milk.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Small fibre neuropathy, Therapy non-responder
Clinical narrative: She got her vaccine, then after a couple of days she noticed her hand was swelling, her lips were swelling, was tired and thought it was her back.  She went to surgeon and did MRI of her back and it was normal  Went to pain doctor did not know why her arm was swelling and why she was tired.  She did PT and after that she went for an EMG, which was fibromyalgia.  They told her they did not know, pushed medicine, Lyrica and whatever for pain and it did not work.  Sent her to neurologist, they do not know what is going on with her, why her lips are swelling, why she has arm pain.  In March of 2022 they did blood work and found out that she has small fiber neuropathy.  After this her neurologist decided that she had to have infusions.  She left her job, she applied for disability as she cannot stand, cannot take care of her kids and cannot step on stairs.  They did PT, water therapy, floor therapy.  Now she takes an infusion every month.  She goes to the place and then they give it to her 2 days, and now the nurse comes to her house.  They do not know if she is going to be good or not.  They found that she has high protein in her blood.   She cannot cook for her kids, cannot take for her kids.  Now with the IV therapy it is helping her some, but it makes her system sick and she cannot be by somebody who is sick as her immune system is not good.  Yesterday she had the IV therapy and every-time she gets the IV therapy she gets a reaction and has to take Steroids, which she states is too much.  The nurse stayed with her yesterday and she took care of her.  She feels this is not fair that she has these symptoms as she had taken the shots for her kids and she has a 20 year old and is informed that she has lupus.  She pushed her kids to take the vaccine, and now she feels this is from the vaccine.   The infusion takes many hours to finish and she is a caregiver and at 49 now she has to be taken care of.  She took 2 vaccines and did not get the 3rd one.  She was 100% in favor the vaccines, and took the Pfizer and is now against the vaccines 100% due to her reaction.  The problem even when she talks to her doctor after 1 month she got the COVID then she got the vaccine, which put move of the virus in her body and was informed that she could get the vaccine within 2 weeks of getting over COVID.  She went to many hospitals to seek treatment and many different specialists and had therapy in 2021.  She has had problems with her back and they felt that she may have had herniation in her back.  She had to take the infusions as the small fiber neuropathy was going to attack all her joints.  She was also found to have sleep apnea.  She goes every 3 months to see neurologist, her pain doctor and other doctors.  Her condition has not improved, and she continues to see her doctors at Hospital.  She is improving, but still not her normal.    She sees a psychiatrist as now she has depresion and anxiety and takes Cymbalta as this is too much what she has been through.  She was a very active person and now a nurse has to come to her house to help her.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Biopsy breast, Breast mass, Fibroadenoma of breast, Imaging procedure abnormal
Clinical narrative: Developed two fibroadenomas in left breast within 3 months of vaccination. Biopsy confirmed benign. No existing history of fibroadenomas or breast cancer prior to vaccination, and no immediate family history of fibroadenomas or breast cancer. One of the masses developed large enough to require excision.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Mammogram abnormal, Mass excision, Pain, Ultrasound breast abnormal
Clinical narrative: Developed two fibroadenomas in left breast within 3 months of vaccination. Biopsy confirmed benign. No existing history of fibroadenomas or breast cancer prior to vaccination, and no immediate family history of fibroadenomas or breast cancer. One of the masses developed large enough to require excision.
Age: 32.0
Sex: F
Vaccine: VARCEL
Symptoms: Contusion, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: patient stated the next day her arm was  warm to touch, swollen, bruised with pain. She went to her PCP on 5/15/2024  and was prescribed Benadryl and Cephalexin, and was told to apply a ice pack.
Age: 0.58
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Single component of a two-component product administered
Clinical narrative: Pentacel vaccine ordered (2 vials).  DTap-IPV dose drawn up and administered to patient; however, ActHIB dose was missed/not given.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Anaemia, Atrial fibrillation, Candida infection, Condition aggravated
Clinical narrative: Hospitalized 1/4/23-1/10/23 abdominal pain, difficulty swallowing, vomiting, kidney stones, malnutrition, anemia, pruritus, UTI, candida, a-fib with RVR
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Malnutrition, Nephrolithiasis, Pruritus, Urinary tract infection
Clinical narrative: Hospitalized 1/4/23-1/10/23 abdominal pain, difficulty swallowing, vomiting, kidney stones, malnutrition, anemia, pruritus, UTI, candida, a-fib with RVR
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Hospitalized 1/4/23-1/10/23 abdominal pain, difficulty swallowing, vomiting, kidney stones, malnutrition, anemia, pruritus, UTI, candida, a-fib with RVR
Age: 5.0
Sex: F
Vaccine: DTAP, UNK
Symptoms: Anaphylaxis treatment, Crying, Decreased appetite, Fatigue, Laboratory test
Clinical narrative: She got her shots on Monday, and a little after 1pm she got tired and didnt want to eat. We just let her sleep and she slept the rest of the day. We didnt check her temp, but we could tell she was getting fevers on and off, we could tell she was hot. When she woke up that next morning around 7 am, I noticed her body covered in hives all over her body. I did take progress photos throughout that whole day. By 10am, her body was even more covered with bigger patches on her stomach, the side of her face and neck. They were about 5 in in diameter, they were all in small patches. I called her pediatrician after 10am on Tuesday and I told them everything. The person I spoke to stated that "it was normal" and they would see us the next day for the TB follow up. I told the nurse about the crying, fever, and itching, and he still said it was normal. Less than an hour later, I took photos again and she was covered even more. The ones on her back was also getting larger 25%-50% larger. We brought cortizone and tylenol for her fever, and calamine lotion, but nothing was helping her spots. By 4:00 I was taking more photos. They look like hives, but different. Looked as they was moving and getting larger, coming and going. They weer starting to come on her face and her lip was swelling. I gave her an aveno oat bath. By 4:30pm she was having hives even on her toes, her feet and ankles. More spots were popping up. We just kept monitoring her. By 6pm her right eye started to swell, and the under side of her thighs were covered in patches as well. By 6:45 her right eBye was completely swollen, she could not open it any longer. By 8:30 her whole face was swollen, she was unreconizable as the same kid. We went to the er, she did not seem like her self at all. 10pm, we went to ER. By 10:15, they had given her Benedryl and 1min later Epinephren, and at 10:32 they gave her ibprophen, at 10:34 they gave her tylenol, at 12:21 they gave her decadron, then at 1:13am, more benedryl. We were there until 5am. I continued to take pictures, as she continued to get worse.
Age: 5.0
Sex: F
Vaccine: DTAP, UNK
Symptoms: Lip swelling, Pruritus, Pyrexia, Skin warm, Somnolence
Clinical narrative: She got her shots on Monday, and a little after 1pm she got tired and didnt want to eat. We just let her sleep and she slept the rest of the day. We didnt check her temp, but we could tell she was getting fevers on and off, we could tell she was hot. When she woke up that next morning around 7 am, I noticed her body covered in hives all over her body. I did take progress photos throughout that whole day. By 10am, her body was even more covered with bigger patches on her stomach, the side of her face and neck. They were about 5 in in diameter, they were all in small patches. I called her pediatrician after 10am on Tuesday and I told them everything. The person I spoke to stated that "it was normal" and they would see us the next day for the TB follow up. I told the nurse about the crying, fever, and itching, and he still said it was normal. Less than an hour later, I took photos again and she was covered even more. The ones on her back was also getting larger 25%-50% larger. We brought cortizone and tylenol for her fever, and calamine lotion, but nothing was helping her spots. By 4:00 I was taking more photos. They look like hives, but different. Looked as they was moving and getting larger, coming and going. They weer starting to come on her face and her lip was swelling. I gave her an aveno oat bath. By 4:30pm she was having hives even on her toes, her feet and ankles. More spots were popping up. We just kept monitoring her. By 6pm her right eye started to swell, and the under side of her thighs were covered in patches as well. By 6:45 her right eBye was completely swollen, she could not open it any longer. By 8:30 her whole face was swollen, she was unreconizable as the same kid. We went to the er, she did not seem like her self at all. 10pm, we went to ER. By 10:15, they had given her Benedryl and 1min later Epinephren, and at 10:32 they gave her ibprophen, at 10:34 they gave her tylenol, at 12:21 they gave her decadron, then at 1:13am, more benedryl. We were there until 5am. I continued to take pictures, as she continued to get worse.
Age: 5.0
Sex: F
Vaccine: DTAP, UNK
Symptoms: Swelling face, Swelling of eyelid, Urticaria
Clinical narrative: She got her shots on Monday, and a little after 1pm she got tired and didnt want to eat. We just let her sleep and she slept the rest of the day. We didnt check her temp, but we could tell she was getting fevers on and off, we could tell she was hot. When she woke up that next morning around 7 am, I noticed her body covered in hives all over her body. I did take progress photos throughout that whole day. By 10am, her body was even more covered with bigger patches on her stomach, the side of her face and neck. They were about 5 in in diameter, they were all in small patches. I called her pediatrician after 10am on Tuesday and I told them everything. The person I spoke to stated that "it was normal" and they would see us the next day for the TB follow up. I told the nurse about the crying, fever, and itching, and he still said it was normal. Less than an hour later, I took photos again and she was covered even more. The ones on her back was also getting larger 25%-50% larger. We brought cortizone and tylenol for her fever, and calamine lotion, but nothing was helping her spots. By 4:00 I was taking more photos. They look like hives, but different. Looked as they was moving and getting larger, coming and going. They weer starting to come on her face and her lip was swelling. I gave her an aveno oat bath. By 4:30pm she was having hives even on her toes, her feet and ankles. More spots were popping up. We just kept monitoring her. By 6pm her right eye started to swell, and the under side of her thighs were covered in patches as well. By 6:45 her right eBye was completely swollen, she could not open it any longer. By 8:30 her whole face was swollen, she was unreconizable as the same kid. We went to the er, she did not seem like her self at all. 10pm, we went to ER. By 10:15, they had given her Benedryl and 1min later Epinephren, and at 10:32 they gave her ibprophen, at 10:34 they gave her tylenol, at 12:21 they gave her decadron, then at 1:13am, more benedryl. We were there until 5am. I continued to take pictures, as she continued to get worse.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Pruritus, Rash
Clinical narrative: patient developed rash and itching and burning sensation.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Acute kidney injury, Anaemia, Cough, Hyperglycaemia, Hypoxia
Clinical narrative: Hospitalized 12/25/22-1/9/23 Hypoxia, cough, hyperglycemia, O2 supplementation, leukocytosis, anemia, AKI, UTI, PNA, malnutrition,
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Leukocytosis, Malnutrition, Pneumonia, Urinary tract infection
Clinical narrative: Hospitalized 12/25/22-1/9/23 Hypoxia, cough, hyperglycemia, O2 supplementation, leukocytosis, anemia, AKI, UTI, PNA, malnutrition,
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV, PNC20
Symptoms: Anaphylactic reaction, Angioedema, Cough, Pruritus, Urticaria
Clinical narrative: anaphylaxis - Hives (diffuse to head, trunk, extremities), pruritis, wheezing, angioedema, more persistent cough w/in 30 minutes after vaccine administration. Returned to pediatricians and recieved zyrtec 10 ml and Epi-pen JR.  Refered to Emergency Department for further evaluation x 4 hours. discharged home with improved symptoms.