chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: COVID19-2
Symptoms: Brain fog, Cataract, Retinal detachment, Tinnitus
Clinical narrative: cataracts; detached retina; brain fog; tinnitus; This spontaneous case was reported by a consumer and describes the occurrence of CATARACT (cataracts) and RETINAL DETACHMENT (detached retina) in a 59-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. 042L20A and 023M20A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CATARACT (cataracts) (seriousness criterion medically significant), RETINAL DETACHMENT (detached retina) (seriousness criterion medically significant), BRAIN FOG (brain fog) and TINNITUS (tinnitus). At the time of the report, CATARACT (cataracts), RETINAL DETACHMENT (detached retina), BRAIN FOG (brain fog) and TINNITUS (tinnitus) outcome was unknown.            No relevant concomitant medications were reported. No treatment medication reported.  Company comment.  This spontaneous case concerns a 59  year  old female patient, with no medical history reported, who experienced the unexpected, serious (medically significant) events of cataract and retinal detachment. Latency cannot be properly assessed since exact onset date and vaccination date were not provided. It was reported that after 2 shots of mRNA  1273 vaccine the patient experienced brain fog, tinnitus, detached retina, and cataracts. No further clinical details were provided for medical reviewing. The benefit-risk relationship of mRNA  1273.222 (Original/Omicron BA.4/5) vaccine is not affected by this report.
Age: 67.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 02-MAR-2023 and administered to patient on 27-APR-2023; No adverse event; Accidentally administered dose of Moderna COVID-19 Vaccine Bivalent after more than 30 days stored in the fridge; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Accidentally administered dose of Moderna COVID-19 Vaccine Bivalent after more than 30 days stored in the fridge), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 02-MAR-2023 and administered to patient on 27-APR-2023) and NO ADVERSE EVENT (No adverse event) in a 67-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 066H22A) for COVID-19 prophylaxis.     Concurrent medical conditions included Hyperlipidemia.    On 27-Apr-2023, the patient received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 27-Apr-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Accidentally administered dose of Moderna COVID-19 Vaccine Bivalent after more than 30 days stored in the fridge). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 02-MAR-2023 and administered to patient on 27-APR-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Accidentally administered dose of Moderna COVID-19 Vaccine Bivalent after more than 30 days stored in the fridge), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 02-MAR-2023 and administered to patient on 27-APR-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Accidentally administered dose of Moderna COVID-19 Vaccine Bivalent after more than 30 days stored in the fridge) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 02-MAR-2023 and administered to patient on 27-APR-2023).    It was unknown patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No concomitant medications were provided. The dosage text was reported as unknown. The vial size was 2.5 ml. The vial was initially stored in the refrigerator on 02-Mar-2023. The vial did not undergo any temperature excursions. No Adverse events were reported.  No treatment medication was provided. This case was reported for patient number 3.
Sex: M
Vaccine: COVID19-2
Symptoms: Respiratory failure
Clinical narrative: once given the experimental vaccine he began to have a health problem called respiratory failure; This spontaneous case was reported by a non-health professional and describes the occurrence of RESPIRATORY FAILURE (once given the experimental vaccine he began to have a health problem called respiratory failure) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced RESPIRATORY FAILURE (once given the experimental vaccine he began to have a health problem called respiratory failure) (seriousness criterion medically significant). At the time of the report, RESPIRATORY FAILURE (once given the experimental vaccine he began to have a health problem called respiratory failure) outcome was unknown.            Before the vaccine, patient did not had any signs of respiratory problems. No information provided if he was a clinical trial participant or not. Concomitant medications were not reported.  No treatment information was provided by the reporter.  Company comment.  This spontaneous case concerns a male patient (unknown age), with no medical history reported, who received a dose of mRNA  1273.222 (Original/Omicron BA.4/5) vaccine and experienced the unexpected, serious (medically significant) event of respiratory failure. Latency cannot be properly assessed since exact onset date and vaccination date were not reported. No information about previous immunisation schedule was disclosed. No further clinical details were provided for medical reviewing. The benefit-risk relationship of mRNA  1273.222 (Original/Omicron BA.4/5) vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; First dose on 21-Jan-2021 and second dose on 04-Mar-2021; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 21-Jan-2021 and second dose on 04-Mar-2021) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 043L20A) for COVID-19 prophylaxis.     The patient's past medical history included Esophageal dilation procedure. Concurrent medical conditions included GERD (Esophageal dilation), Anxiety, Allergic rhinitis and Schatzki's ring (Esophageal dilation). Concomitant products included LEVOCETIRIZINE DIHYDROCHLORIDE (ALLEGRA [LEVOCETIRIZINE DIHYDROCHLORIDE]) for Allergy, SERTRALINE for Anxiety, OMEPRAZOLE for GERD.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 21-Jan-2021 and second dose on 04-Mar-2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 21-Jan-2021 and second dose on 04-Mar-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            On 22-Dec-2021, patient took 3rd dose of Pfizer vaccine (lot no.: FF2590) in arm.  On 14-Jul-2022, patient took 4th dose of Pfizer vaccine (lot no.: FP4554) in arm.  On 15-Nov-2022, patient took 5th dose of Pfizer vaccine (lot no.: GJJ6665) in arm.  On an unknown date in Mar-2023, patient was tested positive for COVID-19.  A day after being tested COVID-19 positive, patient started Paxlovid. Patient followed package instructions and took the entire course. By day 7, the patient was symptom free. On day 10, the symptoms of COVID appeared again and was tested positive for COVID until day 18.  No treatment medications were reported.
Age: 78.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 02-MAR-2023 and administered to patient on 27-APR-2023; No adverse event; HCP explained they accidentally administered dose of Moderna COVID-19 Vaccine Bivalent after more than 30 days stored in the fridge; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP explained they accidentally administered dose of Moderna COVID-19 Vaccine Bivalent after more than 30 days stored in the fridge), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 02-MAR-2023 and administered to patient on 27-APR-2023) and NO ADVERSE EVENT (No adverse event) in a 78-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 066H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Apr-2023, the patient received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 27-Apr-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP explained they accidentally administered dose of Moderna COVID-19 Vaccine Bivalent after more than 30 days stored in the fridge). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 02-MAR-2023 and administered to patient on 27-APR-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP explained they accidentally administered dose of Moderna COVID-19 Vaccine Bivalent after more than 30 days stored in the fridge), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 02-MAR-2023 and administered to patient on 27-APR-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (HCP explained they accidentally administered dose of Moderna COVID-19 Vaccine Bivalent after more than 30 days stored in the fridge) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 02-MAR-2023 and administered to patient on 27-APR-2023).    It was unknown patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No concomitant medication was reported.  The vial was initially stored in the refrigerator on 02-MAR-2023. The vial did not undergo any temperature excursions. No treatment information was reported.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction, Impaired quality of life
Clinical narrative: she knows of a woman whose entire life is ruined by the COVID shot; she knows of a woman whose entire life is ruined by the COVID shot/she's on a respirator for life; This spontaneous case was reported by a consumer and describes the occurrence of IMPAIRED QUALITY OF LIFE (she knows of a woman whose entire life is ruined by the COVID shot) and IMMUNISATION REACTION (she knows of a woman whose entire life is ruined by the COVID shot/she's on a respirator for life) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMPAIRED QUALITY OF LIFE (she knows of a woman whose entire life is ruined by the COVID shot) and IMMUNISATION REACTION (she knows of a woman whose entire life is ruined by the COVID shot/she's on a respirator for life). At the time of the report, IMPAIRED QUALITY OF LIFE (she knows of a woman whose entire life is ruined by the COVID shot) had not resolved and IMMUNISATION REACTION (she knows of a woman whose entire life is ruined by the COVID shot/she's on a respirator for life) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication details not reported by the reporter. The caller stated that she knew a woman whose entire life was ruined by the COVID shot. The caller doesn't know what kind she got. This was after 2020. It was the woman's second shot, and she's on a respirator for life. The caller was trying to understand what is being done about such a thing. She was not asking for treatment information.   Reporter did not allow further contact
Age: 57.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 25-Apr-2023; No adverse event; Patient came in yesterday that they gave a Moderna Bivalent to and it expired on 23May2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient came in yesterday that they gave a Moderna Bivalent to and it expired on 23May2023), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 25-Apr-2023 ) and NO ADVERSE EVENT (No adverse event) in a 57-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 011H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 30-May-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 30-May-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient came in yesterday that they gave a Moderna Bivalent to and it expired on 23May2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 25-Apr-2023 ) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient came in yesterday that they gave a Moderna Bivalent to and it expired on 23May2023), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 25-Apr-2023 ) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient came in yesterday that they gave a Moderna Bivalent to and it expired on 23May2023) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 25-Apr-2023 ).    No concomitant medications were reported.  The vial was initially stored in the refrigerator on 25-Apr-2023.  The vial did not  undergo any temperature excursions.  No treatment medications were reported.
Sex: U
Vaccine: COVID19-2
Symptoms: Cardiac discomfort, Illness
Clinical narrative: My heart has been messing with me; I've been sick ever since I taken that COVID shot; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISCOMFORT (My heart has been messing with me) and ILLNESS (I've been sick ever since I taken that COVID shot) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced CARDIAC DISCOMFORT (My heart has been messing with me) and ILLNESS (I've been sick ever since I taken that COVID shot). At the time of the report, CARDIAC DISCOMFORT (My heart has been messing with me) and ILLNESS (I've been sick ever since I taken that COVID shot) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that patient kept going to emergency room. Treatment medications were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 31-May-2023: Live follow-up received: Narrative updated
Age: 80.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 02-Mar-2023; No adverse event; Patient administered the vaccine after 30-day Use By Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 02-Mar-2023 ) and NO ADVERSE EVENT (No adverse event ) in an 80-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 066H22A) for COVID-19 prophylaxis.     Concurrent medical conditions included Hypertension.    On 10-May-2023, the patient received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 10-May-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 02-Mar-2023 ) and NO ADVERSE EVENT (No adverse event ). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 02-Mar-2023 ) and NO ADVERSE EVENT (No adverse event ) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event ) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after 30-day Use By Date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 02-Mar-2023 ).    No concomitant medications were reported.  It was unknown if the patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  The vial was initially stored in the refrigerator on 02-Mar-2023.  The vial did not undergo any temperature excursions.   No AEs were reported.  No treatment medications were reported.  This case contains information for the 5th patient.
Age: 0.58
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Underdose, Wrong product administered
Clinical narrative: No adverse event; 7 month child recvd monovalent 5/03/23 (4 weeks ago)has bivalent 0.2ml dose; 7 month child recvd monovalent 5/03/23 (4 weeks ago)has bivalent 0.2ml dose; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (7 month child recvd monovalent 5/03/23 (4 weeks ago)has bivalent 0.2ml dose), UNDERDOSE (7 month child recvd monovalent 5/03/23 (4 weeks ago)has bivalent 0.2ml dose) and NO ADVERSE EVENT (No adverse event) in a 7-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 03-May-2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .2 milliliter. On 03-May-2023, the patient experienced WRONG PRODUCT ADMINISTERED (7 month child recvd monovalent 5/03/23 (4 weeks ago)has bivalent 0.2ml dose) and UNDERDOSE (7 month child recvd monovalent 5/03/23 (4 weeks ago)has bivalent 0.2ml dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (7 month child recvd monovalent 5/03/23 (4 weeks ago)has bivalent 0.2ml dose), UNDERDOSE (7 month child recvd monovalent 5/03/23 (4 weeks ago)has bivalent 0.2ml dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (7 month child recvd monovalent 5/03/23 (4 weeks ago)has bivalent 0.2ml dose) and UNDERDOSE (7 month child recvd monovalent 5/03/23 (4 weeks ago)has bivalent 0.2ml dose).    No concomitant medications were provided. No side effects were reported. No treatment medication was provided.
Age: 82.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 02-Mar-2023 and was administered on 10-May-2023; No adverse event; Accidentally administered dose of Moderna COVID-19 Vaccine Bivalent after more than 30 days stored in the fridge; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Accidentally administered dose of Moderna COVID-19 Vaccine Bivalent after more than 30 days stored in the fridge), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 02-Mar-2023 and was administered on 10-May-2023) and NO ADVERSE EVENT (No adverse event) in an 82-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 066H22A) for COVID-19 prophylaxis.     It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 10-May-2023, the patient received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 10-May-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Accidentally administered dose of Moderna COVID-19 Vaccine Bivalent after more than 30 days stored in the fridge). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 02-Mar-2023 and was administered on 10-May-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Accidentally administered dose of Moderna COVID-19 Vaccine Bivalent after more than 30 days stored in the fridge), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 02-Mar-2023 and was administered on 10-May-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Accidentally administered dose of Moderna COVID-19 Vaccine Bivalent after more than 30 days stored in the fridge) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 02-Mar-2023 and was administered on 10-May-2023).    No concomitant medications were provided. The vial size was 2.5 ml. The vial was initially stored in the refrigerator on 02-Mar-2023. The vial did not undergo any temperature excursions. No Adverse events were reported.  No treatment medication was provided. This case is for patient number 4.
Age: 85.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: the vial was initially stored in the refrigerator on 02-MAR-2023 and administered on 27-Apr-2023; No adverse event; HCP explained they accidentally administered 6 doses of Moderna COVID-19 Vaccine Bivalent after more than 30 days; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP explained they accidentally administered 6 doses of Moderna COVID-19 Vaccine Bivalent after more than 30 days), PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 02-MAR-2023 and administered on 27-Apr-2023) and NO ADVERSE EVENT (No adverse event) in an 85-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 066H22A) for COVID-19 prophylaxis.     Patient had no relevant medical history and allergy.  It was unknown that patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 27-Apr-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 27-Apr-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP explained they accidentally administered 6 doses of Moderna COVID-19 Vaccine Bivalent after more than 30 days). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 02-MAR-2023 and administered on 27-Apr-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP explained they accidentally administered 6 doses of Moderna COVID-19 Vaccine Bivalent after more than 30 days), PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 02-MAR-2023 and administered on 27-Apr-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (HCP explained they accidentally administered 6 doses of Moderna COVID-19 Vaccine Bivalent after more than 30 days) and PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 02-MAR-2023 and administered on 27-Apr-2023).    No concomitant medications were provided. The vial size was 2.5 ml. The vial was initially stored in the refrigerator on 02-Mar-2023. The vial did not undergo any temperature excursions. No Adverse events were reported.  No treatment medication was provided.
Age: 38.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vaccine which expired on 28-May-2023 was initially stored in refrigerator on 31-May-2023; No adverse event; An expired dose of Moderna bivalent vaccine was given. It expired 28-May-2023.; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (An expired dose of Moderna bivalent vaccine was given. It expired 28-May-2023.), PRODUCT STORAGE ERROR (The vaccine which expired on 28-May-2023 was initially stored in refrigerator on 31-May-2023) and NO ADVERSE EVENT (No adverse event) in a 38-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 016H22A) for COVID-19 prophylaxis.     It was reported that patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccines.  Previously administered products included for COVID-19 prophylaxis: Spikevax (Dose 1) and Spikevax (Dose 2). Past adverse reactions to the above products included No adverse event with Spikevax and Spikevax.    On 31-May-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 31-May-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (An expired dose of Moderna bivalent vaccine was given. It expired 28-May-2023.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vaccine which expired on 28-May-2023 was initially stored in refrigerator on 31-May-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (An expired dose of Moderna bivalent vaccine was given. It expired 28-May-2023.), PRODUCT STORAGE ERROR (The vaccine which expired on 28-May-2023 was initially stored in refrigerator on 31-May-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (An expired dose of Moderna bivalent vaccine was given. It expired 28-May-2023.) and PRODUCT STORAGE ERROR (The vaccine which expired on 28-May-2023 was initially stored in refrigerator on 31-May-2023).    Dosage text for suspect product was reported as unknown.  Concomitant drugs were not reported.  It was reported that the bivalent vial of 2.5 ml size was not exposed to temperature excursion.   Treatment medications were not provided.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: caught covid of December of 2021, sneezed all day; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (caught covid of December of 2021, sneezed all day) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS7642B) for COVID-19 prophylaxis.     No Medical History information was reported.   In 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced COVID-19 (caught covid of December of 2021, sneezed all day). At the time of the report, COVID-19 (caught covid of December of 2021, sneezed all day) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Dosage text for suspect product was reported as unknown.  Concomitant drugs were not reported. It was reported that patient sneezed all day. It was also reported that patient just got a Moderna bivalent booster and wanted to know if it will do any good since he received the bivalent. Treatment medications were not provided.
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose
Clinical narrative: Patient received a 0.25ml dose instead of a 0.5ml dose of the Moderna Covid-19 bivalent vaccine; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (Patient received a 0.25ml dose instead of a 0.5ml dose of the Moderna Covid-19 bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 022H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (Patient received a 0.25ml dose instead of a 0.5ml dose of the Moderna Covid-19 bivalent vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Patient received a 0.25ml dose instead of a 0.5ml dose of the Moderna Covid-19 bivalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (Patient received a 0.25ml dose instead of a 0.5ml dose of the Moderna Covid-19 bivalent vaccine).    No concomitant medications were reported.  No other adverse events were reported.  No treatment medications were reported.    This case was linked to US-MODERNATX, INC.-MOD-2023-727280, US-MODERNATX, INC.-MOD-2023-727281.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-727280:Master Case US-MODERNATX, INC.-MOD-2023-727281:Master Case
Age: 56.0
Sex: M
Vaccine: TDAP
Symptoms: Blister, Erythema, Pain in extremity
Clinical narrative: Patient states that on 5/22/2023 he was at medical facility for an evaluation and was due for a Tdap vaccine, patient received the Tdap vaccine on that date. Patient reports he initially had soreness in the left arm and several days later noticed a blister had developed and "popped". Patient self treated blister with Neosporin ointment. Patient noticed area was reddened at worsening on 5/28/2023 and called medical facility on 5/30/2023 to report issue. Patient was seen on 5/30/2023 and was started on oral antibiotics.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Third/unnecessary vaccination administered to patient.
Age: 20.0
Sex: M
Vaccine: HPV9
Symptoms: Disorientation, Feeling abnormal, Nausea
Clinical narrative: Shortly after vaccine was administrated I became disoriented and nauseated. Felt off, wasn't severe, no injection site reactions
Age: 50.0
Sex: M
Vaccine: COVID19-2
Symptoms: Arthralgia, Bedridden, Blood creatinine increased, Blood pressure increased, Blood test
Clinical narrative: On 12/8/2022 at about 7-8 PM, I began to have a scratchy, sore throat. At around 6:30 AM on 12/9/2022, I woke up with a fever, chills, muscle aches, joint pain, headache, and nasal congestion. I then took a home antigen test and got a positive result. At 11:25 AM the same day, I also underwent a PCR test, and I got a positive result back on 12/10/2022. At this time, I began taking PAXLOVID. Later in the evening on 12/9/2022, I developed chest congestion and cough. On 12/10/2022, my symptoms continued to worsen, and I had some difficulty breathing. It was around this time that I began the PAXLOVID therapy. I was bedridden on 12/10/2022 and 12/11/2022. On 12/12/2022, my symptoms began to lessen. On 12/14/2022, I finished taking the PAXLOVID. By 12/15/2022, my symptoms had resolved. I was out of work between 12/9/2022 and 12/15/2022. On 12/16/2022, I did remote work. On 12/19/2022, I was able to return to the office. Sometime in January 2023, I began to develop mild hypertension. My blood pressure reading was around 130/80; before then, it was usually 120/70. By April 2023, it had increased to 150/90. On 4/19/2023, it was 170/100. At that time, my PCP did bloodwork. Everything was within range, except my serum creatinine had risen to 1.34, with a GFR of 64.5. My PCP then prescribed me losartan/HCT (50-12.5). In March-April 2023, I began to experience chronic fatigue and vascular headache. Despite having normalized blood pressure after beginning the losartan/HCT, I have continued to have chronic fatigue and vascular headache. As a result, on 5/25/2023, my PCP repeated bloodwork. My serum creatinine had risen to 1.41, and my GFR had dropped to 60.3. Because of that, I underwent a renal ultrasound on 5/31/2023, with additional testing. My PTH was notably elevated at 154.2. This means that I have now have chronic kidney disease, stage 2. I have a nephrology appointment in a few days.
Age: 50.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Chills, Chronic kidney disease, Cough, Dyspnoea
Clinical narrative: On 12/8/2022 at about 7-8 PM, I began to have a scratchy, sore throat. At around 6:30 AM on 12/9/2022, I woke up with a fever, chills, muscle aches, joint pain, headache, and nasal congestion. I then took a home antigen test and got a positive result. At 11:25 AM the same day, I also underwent a PCR test, and I got a positive result back on 12/10/2022. At this time, I began taking PAXLOVID. Later in the evening on 12/9/2022, I developed chest congestion and cough. On 12/10/2022, my symptoms continued to worsen, and I had some difficulty breathing. It was around this time that I began the PAXLOVID therapy. I was bedridden on 12/10/2022 and 12/11/2022. On 12/12/2022, my symptoms began to lessen. On 12/14/2022, I finished taking the PAXLOVID. By 12/15/2022, my symptoms had resolved. I was out of work between 12/9/2022 and 12/15/2022. On 12/16/2022, I did remote work. On 12/19/2022, I was able to return to the office. Sometime in January 2023, I began to develop mild hypertension. My blood pressure reading was around 130/80; before then, it was usually 120/70. By April 2023, it had increased to 150/90. On 4/19/2023, it was 170/100. At that time, my PCP did bloodwork. Everything was within range, except my serum creatinine had risen to 1.34, with a GFR of 64.5. My PCP then prescribed me losartan/HCT (50-12.5). In March-April 2023, I began to experience chronic fatigue and vascular headache. Despite having normalized blood pressure after beginning the losartan/HCT, I have continued to have chronic fatigue and vascular headache. As a result, on 5/25/2023, my PCP repeated bloodwork. My serum creatinine had risen to 1.41, and my GFR had dropped to 60.3. Because of that, I underwent a renal ultrasound on 5/31/2023, with additional testing. My PTH was notably elevated at 154.2. This means that I have now have chronic kidney disease, stage 2. I have a nephrology appointment in a few days.
Age: 50.0
Sex: M
Vaccine: COVID19-2
Symptoms: Fatigue, Glomerular filtration rate, Headache, Hypertension, Impaired work ability
Clinical narrative: On 12/8/2022 at about 7-8 PM, I began to have a scratchy, sore throat. At around 6:30 AM on 12/9/2022, I woke up with a fever, chills, muscle aches, joint pain, headache, and nasal congestion. I then took a home antigen test and got a positive result. At 11:25 AM the same day, I also underwent a PCR test, and I got a positive result back on 12/10/2022. At this time, I began taking PAXLOVID. Later in the evening on 12/9/2022, I developed chest congestion and cough. On 12/10/2022, my symptoms continued to worsen, and I had some difficulty breathing. It was around this time that I began the PAXLOVID therapy. I was bedridden on 12/10/2022 and 12/11/2022. On 12/12/2022, my symptoms began to lessen. On 12/14/2022, I finished taking the PAXLOVID. By 12/15/2022, my symptoms had resolved. I was out of work between 12/9/2022 and 12/15/2022. On 12/16/2022, I did remote work. On 12/19/2022, I was able to return to the office. Sometime in January 2023, I began to develop mild hypertension. My blood pressure reading was around 130/80; before then, it was usually 120/70. By April 2023, it had increased to 150/90. On 4/19/2023, it was 170/100. At that time, my PCP did bloodwork. Everything was within range, except my serum creatinine had risen to 1.34, with a GFR of 64.5. My PCP then prescribed me losartan/HCT (50-12.5). In March-April 2023, I began to experience chronic fatigue and vascular headache. Despite having normalized blood pressure after beginning the losartan/HCT, I have continued to have chronic fatigue and vascular headache. As a result, on 5/25/2023, my PCP repeated bloodwork. My serum creatinine had risen to 1.41, and my GFR had dropped to 60.3. Because of that, I underwent a renal ultrasound on 5/31/2023, with additional testing. My PTH was notably elevated at 154.2. This means that I have now have chronic kidney disease, stage 2. I have a nephrology appointment in a few days.
Age: 50.0
Sex: M
Vaccine: COVID19-2
Symptoms: Myalgia, Nasal congestion, Oropharyngeal pain, Pyrexia, Respiratory tract congestion
Clinical narrative: On 12/8/2022 at about 7-8 PM, I began to have a scratchy, sore throat. At around 6:30 AM on 12/9/2022, I woke up with a fever, chills, muscle aches, joint pain, headache, and nasal congestion. I then took a home antigen test and got a positive result. At 11:25 AM the same day, I also underwent a PCR test, and I got a positive result back on 12/10/2022. At this time, I began taking PAXLOVID. Later in the evening on 12/9/2022, I developed chest congestion and cough. On 12/10/2022, my symptoms continued to worsen, and I had some difficulty breathing. It was around this time that I began the PAXLOVID therapy. I was bedridden on 12/10/2022 and 12/11/2022. On 12/12/2022, my symptoms began to lessen. On 12/14/2022, I finished taking the PAXLOVID. By 12/15/2022, my symptoms had resolved. I was out of work between 12/9/2022 and 12/15/2022. On 12/16/2022, I did remote work. On 12/19/2022, I was able to return to the office. Sometime in January 2023, I began to develop mild hypertension. My blood pressure reading was around 130/80; before then, it was usually 120/70. By April 2023, it had increased to 150/90. On 4/19/2023, it was 170/100. At that time, my PCP did bloodwork. Everything was within range, except my serum creatinine had risen to 1.34, with a GFR of 64.5. My PCP then prescribed me losartan/HCT (50-12.5). In March-April 2023, I began to experience chronic fatigue and vascular headache. Despite having normalized blood pressure after beginning the losartan/HCT, I have continued to have chronic fatigue and vascular headache. As a result, on 5/25/2023, my PCP repeated bloodwork. My serum creatinine had risen to 1.41, and my GFR had dropped to 60.3. Because of that, I underwent a renal ultrasound on 5/31/2023, with additional testing. My PTH was notably elevated at 154.2. This means that I have now have chronic kidney disease, stage 2. I have a nephrology appointment in a few days.
Age: 50.0
Sex: M
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test positive, Throat irritation, Ultrasound kidney, Vascular headache
Clinical narrative: On 12/8/2022 at about 7-8 PM, I began to have a scratchy, sore throat. At around 6:30 AM on 12/9/2022, I woke up with a fever, chills, muscle aches, joint pain, headache, and nasal congestion. I then took a home antigen test and got a positive result. At 11:25 AM the same day, I also underwent a PCR test, and I got a positive result back on 12/10/2022. At this time, I began taking PAXLOVID. Later in the evening on 12/9/2022, I developed chest congestion and cough. On 12/10/2022, my symptoms continued to worsen, and I had some difficulty breathing. It was around this time that I began the PAXLOVID therapy. I was bedridden on 12/10/2022 and 12/11/2022. On 12/12/2022, my symptoms began to lessen. On 12/14/2022, I finished taking the PAXLOVID. By 12/15/2022, my symptoms had resolved. I was out of work between 12/9/2022 and 12/15/2022. On 12/16/2022, I did remote work. On 12/19/2022, I was able to return to the office. Sometime in January 2023, I began to develop mild hypertension. My blood pressure reading was around 130/80; before then, it was usually 120/70. By April 2023, it had increased to 150/90. On 4/19/2023, it was 170/100. At that time, my PCP did bloodwork. Everything was within range, except my serum creatinine had risen to 1.34, with a GFR of 64.5. My PCP then prescribed me losartan/HCT (50-12.5). In March-April 2023, I began to experience chronic fatigue and vascular headache. Despite having normalized blood pressure after beginning the losartan/HCT, I have continued to have chronic fatigue and vascular headache. As a result, on 5/25/2023, my PCP repeated bloodwork. My serum creatinine had risen to 1.41, and my GFR had dropped to 60.3. Because of that, I underwent a renal ultrasound on 5/31/2023, with additional testing. My PTH was notably elevated at 154.2. This means that I have now have chronic kidney disease, stage 2. I have a nephrology appointment in a few days.
Age: 4.0
Sex: M
Vaccine: UNK
Symptoms: Expired product administered
Clinical narrative: Pt was given an expired vaccine, Proquad.  Mother of child was notified and informed that she needed to bring the child at least 30 days after the incident to be revaccinated.  Provider was advised of the error.   MA was counseled.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Crying, Erythema, Hypoaesthesia, Initial insomnia, Injection site erythema
Clinical narrative: Reported BLE swelling after B thigh injections, with deeply red maroon color BLE and child crying for ~15 minutes post shot, and in pain following day. Child with persistent pain, unable to go to sleep easily evening of shots. Day following had improved. Pt provided by parents APAP only. Persistent redness of skin and swelling and skin hypesthesia (appeared painful). No central necrosis/duskiness reported. No localized scale/desquamation. Denied history of sx c/w anaphylaxis (no urticaria, respiratory sx, GI sx, hypotensive sx). Child subsequently able to tolerate dose #3 of above vaccines excepting HiB (not scheduled for 6month appointment. Clinical evaluation by allergist suggesting a mild Arthus reaction given prior sensitization, however pt had no pathognomonic features so diagnosis uncertain.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Injection site swelling, Pain, Sensitisation, Swelling, Type III immune complex mediated reaction
Clinical narrative: Reported BLE swelling after B thigh injections, with deeply red maroon color BLE and child crying for ~15 minutes post shot, and in pain following day. Child with persistent pain, unable to go to sleep easily evening of shots. Day following had improved. Pt provided by parents APAP only. Persistent redness of skin and swelling and skin hypesthesia (appeared painful). No central necrosis/duskiness reported. No localized scale/desquamation. Denied history of sx c/w anaphylaxis (no urticaria, respiratory sx, GI sx, hypotensive sx). Child subsequently able to tolerate dose #3 of above vaccines excepting HiB (not scheduled for 6month appointment. Clinical evaluation by allergist suggesting a mild Arthus reaction given prior sensitization, however pt had no pathognomonic features so diagnosis uncertain.