chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L21A and 017F21A) for COVID-19 vaccination.     Concurrent medical conditions included Gluten sensitivity.   On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2022, the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 18-May-2022 to 22-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, SARS-CoV-2 test: negative (Negative) Negative and positive (Positive) Positive. On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medications were reported.  The patient previously received a COVID-19 Vaccine.  It was reported that patient experienced return of symptoms and tested positive on day 9 after testing negative on day 7. Device Date was reported as 27 May 2022  Company comment: This is a spontaneous case reported by a consumer. A 55-year-old male patient, with no relevant medical history, experienced non serious event of COVID-19 after receiving mRNA-1273 vaccine, reported as the fourth dose of the COVID-19 vaccination schedule. Exact onset date of the event was not provided. Patient was treated with Paxlovid; symptoms returned and test was positive on day 9 after testing negative on day 7. No further details were disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case reported by a consumer. A 55-year-old male patient, with no relevant medical history, experienced non serious event of COVID-19 after receiving mRNA-1273 vaccine, reported as the fourth dose of the COVID-19 vaccination schedule. Exact onset date of the event was not provided. Patient was treated with Paxlovid; symptoms returned and test was positive on day 9 after testing negative on day 7. No further details were disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pain
Clinical narrative: Pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    The patient's past medical history included Clinical trial participant (patient number : 89452). Concurrent medical conditions included Rheumatoid arthritis.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose once a week. On an unknown date, the patient experienced PAIN (Pain). At the time of the report, PAIN (Pain) outcome was unknown.            No information on concomitant medications was reported.  The patient took Humira 40 mg/0.4 mL once in 7 days (form : solution for injection in prefilled pen).  On an unknown date, the treatment with Humira was discontinued.  No information on treatment medications was reported.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: some arm soreness; normal fatigue; This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN IN EXTREMITY (some arm soreness) and FATIGUE (normal fatigue) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     Concurrent medical conditions included Chiari malformation.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form, third dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form and fourth dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (some arm soreness) and FATIGUE (normal fatigue). At the time of the report, PAIN IN EXTREMITY (some arm soreness) and FATIGUE (normal fatigue) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported.  It was reported that patient received all 4 shots with Moderna and did not pass out or had panic attacks with needles or immunizations.  Treatment medications were not provided.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthralgia
Clinical narrative: Increased joint pain after getting Second Covid booster; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Increased joint pain after getting Second Covid booster) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced ARTHRALGIA (Increased joint pain after getting Second Covid booster). At the time of the report, ARTHRALGIA (Increased joint pain after getting Second Covid booster) had resolved.            No concomitant medication were reported.  No treatment drug were reported. Causality for RINVOQ drug was reported as no reasonable possibility.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Pruritus
Clinical narrative: itchy; red patch on left arm; sore arm; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (itchy), ERYTHEMA (red patch on left arm) and PAIN IN EXTREMITY (sore arm) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039D21A, 024M20A and 027L20A) for COVID-19 vaccination.     No medical history was provided by the reporter. The patient had never been diagnosed with/ tested positive for COVID-19.  Concurrent medical conditions included Penicillin allergy (Penicillin). Concomitant products included SIMVASTATIN, HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN HCTZ), AMLODIPINE BESYLATE, LEVOTHYROXINE SODIUM (SYNTHROID), FISH OIL, UBIDECARENONE (COQ-10) and HYDROXYCHLOROQUINE SULFATE (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]) for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2022, the patient experienced PAIN IN EXTREMITY (sore arm). On 29-May-2022, the patient experienced ERYTHEMA (red patch on left arm). On 30-May-2022, the patient experienced PRURITUS (itchy). At the time of the report, PRURITUS (itchy), ERYTHEMA (red patch on left arm) and PAIN IN EXTREMITY (sore arm) was resolving.            Patient height was reported as 5 inch. The patient had received First booster dose of Moderna vaccine on 12-Oct-2021. The patient had received second booster dose of Moderna vaccine on 27-May-2022. Concomitant medications also included Multivitamin and Vitamin D. No treatment medications were provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired doses administered to multiple patients) and PRODUCT STORAGE ERROR (Total amount of time the vial was exposed to room temperature range (8 degree to 25 degree Centigrate equals to 46 degree to 77 degree Fahrenheit) was about 27 hours) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049L21A) for COVID-19 vaccination. No Medical History information was reported.    In May 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In May 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired doses administered to multiple patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Total amount of time the vial was exposed to room temperature range (8 degree to 25 degree Centigrate equals to 46 degree to 77 degree Fahrenheit) was about 27 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired doses administered to multiple patients) and PRODUCT STORAGE ERROR (Total amount of time the vial was exposed to room temperature range (8 degree to 25 degree Centigrate equals to 46 degree to 77 degree Fahrenheit) was about 27 hours) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  Patient received the booster dose.  The vial was punctured for more than 12 hours. The vial was initially stored in the refrigerator on 09-May-2022. The vial was first punctured on 23-May-2022 at 8:30 AM. The vial was stored post puncture at room temperature. The vial did not undergo any temperature excursions. The room is about 74F where the vaccine was stored in room temperature range.  No treatment information was reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial was punctured on 23-May-2022 at 08:30 AM and administered on 24-May-2022 at 10 AM, after more than 12 hours of puncture.; The vial was punctured on 23-May-2022 at 08:30 AM and administered on 24-May-2022 at 10 AM, after more than 12 hours of puncture.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The vial was punctured on 23-May-2022 at 08:30 AM and administered on 24-May-2022 at 10 AM, after more than 12 hours of puncture.) and PRODUCT STORAGE ERROR (The vial was punctured on 23-May-2022 at 08:30 AM and administered on 24-May-2022 at 10 AM, after more than 12 hours of puncture.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-May-2022 at 10:00 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 24-May-2022 at 10:00 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (The vial was punctured on 23-May-2022 at 08:30 AM and administered on 24-May-2022 at 10 AM, after more than 12 hours of puncture.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was punctured on 23-May-2022 at 08:30 AM and administered on 24-May-2022 at 10 AM, after more than 12 hours of puncture.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The vial was punctured on 23-May-2022 at 08:30 AM and administered on 24-May-2022 at 10 AM, after more than 12 hours of puncture.) and PRODUCT STORAGE ERROR (The vial was punctured on 23-May-2022 at 08:30 AM and administered on 24-May-2022 at 10 AM, after more than 12 hours of puncture.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  Patient received vaccine from the vial that was punctured for more than 12 hours. Vial was first punctured on 23-May-2022 at 8:30 AM. Vial was initially stored in the refrigerator on 09-May-2022. Vial was stored at Room temperature post puncture. Vial did not undergo any temperature excursions.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Psoriasis
Clinical narrative: psoriasis flare-up,chronic plaque psoriasis flare up patches on legs and knees; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (psoriasis flare-up,chronic plaque psoriasis flare up patches on legs and knees) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Plaque psoriasis.    No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free (Solution for injection in pre-filled pen). On an unknown date, the patient experienced PSORIASIS (psoriasis flare-up,chronic plaque psoriasis flare up patches on legs and knees). At the time of the report, PSORIASIS (psoriasis flare-up,chronic plaque psoriasis flare up patches on legs and knees) had not resolved.            It was unknown if patient was enrolled in a COVID-19 vaccine trial. No concomitant medications were reported. No treatment information was reported.   The reporter's causality of Humira for the event chronic plaque psoriasis flare up patches on legs and knees was not provided.
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Back disorder, Grip strength decreased, Nasopharyngitis, Pain in extremity, Vaccination site pain
Clinical narrative: Back problem; PROBLEMS GRIPPING THINGS; Cold symptoms; Hand pain; SORE ARM FOLLOWING SHINGLES/COVID VACCINATION; This spontaneous case was reported by a consumer and describes the occurrence of BACK DISORDER (Back problem), GRIP STRENGTH DECREASED (PROBLEMS GRIPPING THINGS), NASOPHARYNGITIS (Cold symptoms), PAIN IN EXTREMITY (Hand pain) and VACCINATION SITE PAIN (SORE ARM FOLLOWING SHINGLES/COVID VACCINATION) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products UPADACITINIB (RINVOQ) for Rheumatoid arthritis and VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) for an unknown indication.    No Medical History information was reported.   In 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose and dose of VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) (unknown route) 1 dosage form. On an unknown date, the patient experienced BACK DISORDER (Back problem), GRIP STRENGTH DECREASED (PROBLEMS GRIPPING THINGS), NASOPHARYNGITIS (Cold symptoms), PAIN IN EXTREMITY (Hand pain) and VACCINATION SITE PAIN (SORE ARM FOLLOWING SHINGLES/COVID VACCINATION). At the time of the report, BACK DISORDER (Back problem), GRIP STRENGTH DECREASED (PROBLEMS GRIPPING THINGS), NASOPHARYNGITIS (Cold symptoms), PAIN IN EXTREMITY (Hand pain) and VACCINATION SITE PAIN (SORE ARM FOLLOWING SHINGLES/COVID VACCINATION) outcome was unknown.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for co-suspect (SHINGRIX and RINVOQ) for the event(s) of back problems, sore arm following shingles/covid vaccination, hand pain, problems gripping things and cold symptoms was not reported.  No concomitant and treatment medication were reported.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Anger, Anxiety, Blood test, Disturbance in attention, Executive dysfunction
Clinical narrative: Executive dysfunction; symptoms were back; Scatter brain; Mood swings; Inflammation; Angry; Anxiety; Pain; Shaking; This spontaneous case was reported by a consumer and describes the occurrence of EXECUTIVE DYSFUNCTION (Executive dysfunction), GENERAL SYMPTOM (symptoms were back), DISTURBANCE IN ATTENTION (Scatter brain), MOOD SWINGS (Mood swings) and INFLAMMATION (Inflammation) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Drug allergy (Manifested to hives and lip swelling.), Fibromyalgia, GERD, Tobacco user (VAPE) since 2007, Alcohol use (One Wine once a month.) since 2009, Neuropathy and Rheumatoid arthritis.   In March 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Oct-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On an unknown date, the patient experienced EXECUTIVE DYSFUNCTION (Executive dysfunction), GENERAL SYMPTOM (symptoms were back), DISTURBANCE IN ATTENTION (Scatter brain), MOOD SWINGS (Mood swings), INFLAMMATION (Inflammation), ANGER (Angry), ANXIETY (Anxiety), PAIN (Pain) and TREMOR (Shaking). At the time of the report, EXECUTIVE DYSFUNCTION (Executive dysfunction) had resolved and GENERAL SYMPTOM (symptoms were back), DISTURBANCE IN ATTENTION (Scatter brain), MOOD SWINGS (Mood swings), INFLAMMATION (Inflammation), ANGER (Angry), ANXIETY (Anxiety), PAIN (Pain) and TREMOR (Shaking) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: results not reported Results not reported. On an unknown date, Laboratory test: results not reported Results not reported. On an unknown date, X-ray: inflammed Inflammed.         Concomitant medication information was not provided by the reporter.  The de-challenge results for event Executive dysfunction (Humira) was reported as Yes. The reporter's causality for the events of executive dysfunction, scatter brain, mood swings, angry, anxiety and shaking with Humira 40mg/0.4 mL (ADALIMUMAB) was a reasonable possibility. The reporter's causality for the events of symptoms were back was not provided. The reporter's causality for the events of inflammation and pain with Humira 40mg/0.4 mL (ADALIMUMAB) was a no reasonable possibility. It was reported that it was unknown if patient was enrolled in a COVID-19 vaccine trial.  Treatment information was not provided by the reporter.
Sex: F
Vaccine: COVID19, UNK
Symptoms: General symptom, Inflammation, Laboratory test, Mood swings, Pain
Clinical narrative: Executive dysfunction; symptoms were back; Scatter brain; Mood swings; Inflammation; Angry; Anxiety; Pain; Shaking; This spontaneous case was reported by a consumer and describes the occurrence of EXECUTIVE DYSFUNCTION (Executive dysfunction), GENERAL SYMPTOM (symptoms were back), DISTURBANCE IN ATTENTION (Scatter brain), MOOD SWINGS (Mood swings) and INFLAMMATION (Inflammation) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Drug allergy (Manifested to hives and lip swelling.), Fibromyalgia, GERD, Tobacco user (VAPE) since 2007, Alcohol use (One Wine once a month.) since 2009, Neuropathy and Rheumatoid arthritis.   In March 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Oct-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On an unknown date, the patient experienced EXECUTIVE DYSFUNCTION (Executive dysfunction), GENERAL SYMPTOM (symptoms were back), DISTURBANCE IN ATTENTION (Scatter brain), MOOD SWINGS (Mood swings), INFLAMMATION (Inflammation), ANGER (Angry), ANXIETY (Anxiety), PAIN (Pain) and TREMOR (Shaking). At the time of the report, EXECUTIVE DYSFUNCTION (Executive dysfunction) had resolved and GENERAL SYMPTOM (symptoms were back), DISTURBANCE IN ATTENTION (Scatter brain), MOOD SWINGS (Mood swings), INFLAMMATION (Inflammation), ANGER (Angry), ANXIETY (Anxiety), PAIN (Pain) and TREMOR (Shaking) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: results not reported Results not reported. On an unknown date, Laboratory test: results not reported Results not reported. On an unknown date, X-ray: inflammed Inflammed.         Concomitant medication information was not provided by the reporter.  The de-challenge results for event Executive dysfunction (Humira) was reported as Yes. The reporter's causality for the events of executive dysfunction, scatter brain, mood swings, angry, anxiety and shaking with Humira 40mg/0.4 mL (ADALIMUMAB) was a reasonable possibility. The reporter's causality for the events of symptoms were back was not provided. The reporter's causality for the events of inflammation and pain with Humira 40mg/0.4 mL (ADALIMUMAB) was a no reasonable possibility. It was reported that it was unknown if patient was enrolled in a COVID-19 vaccine trial.  Treatment information was not provided by the reporter.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Tremor, X-ray
Clinical narrative: Executive dysfunction; symptoms were back; Scatter brain; Mood swings; Inflammation; Angry; Anxiety; Pain; Shaking; This spontaneous case was reported by a consumer and describes the occurrence of EXECUTIVE DYSFUNCTION (Executive dysfunction), GENERAL SYMPTOM (symptoms were back), DISTURBANCE IN ATTENTION (Scatter brain), MOOD SWINGS (Mood swings) and INFLAMMATION (Inflammation) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Drug allergy (Manifested to hives and lip swelling.), Fibromyalgia, GERD, Tobacco user (VAPE) since 2007, Alcohol use (One Wine once a month.) since 2009, Neuropathy and Rheumatoid arthritis.   In March 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Oct-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On an unknown date, the patient experienced EXECUTIVE DYSFUNCTION (Executive dysfunction), GENERAL SYMPTOM (symptoms were back), DISTURBANCE IN ATTENTION (Scatter brain), MOOD SWINGS (Mood swings), INFLAMMATION (Inflammation), ANGER (Angry), ANXIETY (Anxiety), PAIN (Pain) and TREMOR (Shaking). At the time of the report, EXECUTIVE DYSFUNCTION (Executive dysfunction) had resolved and GENERAL SYMPTOM (symptoms were back), DISTURBANCE IN ATTENTION (Scatter brain), MOOD SWINGS (Mood swings), INFLAMMATION (Inflammation), ANGER (Angry), ANXIETY (Anxiety), PAIN (Pain) and TREMOR (Shaking) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: results not reported Results not reported. On an unknown date, Laboratory test: results not reported Results not reported. On an unknown date, X-ray: inflammed Inflammed.         Concomitant medication information was not provided by the reporter.  The de-challenge results for event Executive dysfunction (Humira) was reported as Yes. The reporter's causality for the events of executive dysfunction, scatter brain, mood swings, angry, anxiety and shaking with Humira 40mg/0.4 mL (ADALIMUMAB) was a reasonable possibility. The reporter's causality for the events of symptoms were back was not provided. The reporter's causality for the events of inflammation and pain with Humira 40mg/0.4 mL (ADALIMUMAB) was a no reasonable possibility. It was reported that it was unknown if patient was enrolled in a COVID-19 vaccine trial.  Treatment information was not provided by the reporter.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Psoriasis
Clinical narrative: Psoriasis aggravated/skin was cracked all over and he had blood spots on it; This spontaneous case was reported by a patient and describes the occurrence of PSORIASIS (Psoriasis aggravated/skin was cracked all over and he had blood spots on it) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) injection for Psoriasis vulgaris.    No known allergies were reported.  Concurrent medical conditions included Psoriasis vulgaris. Concomitant products included IBUPROFEN for an unknown indication.   On 24-Jun-2021, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) 150 milligram. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PSORIASIS (Psoriasis aggravated/skin was cracked all over and he had blood spots on it). At the time of the report, PSORIASIS (Psoriasis aggravated/skin was cracked all over and he had blood spots on it) outcome was unknown.     It was reported that patient's psoriasis vulgaris got worsened two weeks after he received the moderna vaccination. When he had taken off his shirt the skin was skin was cracked all over and he had blood spots on it. Patient stated that it was getting embarrassing when had to go out. It was unknown if the patient was enrolled in a covid-19 vaccine trial.  The reporter's causality for Skyrizi(risankizumab) for the event of psoriasis vulgaris worsened was not provided.  No treatment medication was reported.
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: Left injection site arm was sore after the first  dose of the Moderna Covid-19 vaccine; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Left injection site arm was sore after the first  dose of the Moderna Covid-19 vaccine) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.  On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jan-2021, the patient experienced VACCINATION SITE PAIN (Left injection site arm was sore after the first  dose of the Moderna Covid-19 vaccine). At the time of the report, VACCINATION SITE PAIN (Left injection site arm was sore after the first  dose of the Moderna Covid-19 vaccine) outcome was unknown.      No concomitant medication reported. No treatment medication details reported.   This case was linked to MOD-2022-580197, MOD-2022-580196 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain, Vitamin D
Clinical narrative: Tiredness; Vaccination site pain/Sore arm from covid booster vaccination; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tiredness) and VACCINATION SITE PAIN (Vaccination site pain/Sore arm from covid booster vaccination) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease.    Concurrent medical conditions included Crohn's disease (Moderate to severe adult).   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen, Citrate free. On an unknown date, the patient experienced FATIGUE (Tiredness) and VACCINATION SITE PAIN (Vaccination site pain/Sore arm from covid booster vaccination). At the time of the report, FATIGUE (Tiredness) and VACCINATION SITE PAIN (Vaccination site pain/Sore arm from covid booster vaccination) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Vitamin D: low (Low) Low.         Concomitant medications were not reported. Reporter causality for HUMIRA(ADALIMUMAB) for the events Vitamin D low, Tiredness and Vaccination site pain was not reported. Dose 2 information was not reported. Treatment medications were not reported.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17 years old was given their first dose of the Moderna COVID-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years old was given their first dose of the Moderna COVID-19 vaccine) in a 17-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 049L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-May-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 24-May-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years old was given their first dose of the Moderna COVID-19 vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years old was given their first dose of the Moderna COVID-19 vaccine) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications details were not reported. Reporter states patient had not reported any symptoms to the contact. No additional doses, medications, or treatments have been administered in response. Treatment reported as none.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthralgia
Clinical narrative: Pain in hip; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Pain in hip) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and dose of ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced ARTHRALGIA (Pain in hip). At the time of the report, ARTHRALGIA (Pain in hip) was resolving. Not Provided. No Concomitant medication reported. Moderna Vaccine therapy started year reported 2022. No Treatment medication reported.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Rotator cuff syndrome, Vaccination site pain, Vaccination site swelling
Clinical narrative: pain in both rotator cuffs for about a month prior to the 2nd full dose due to rotator cuff tendonitis; experienced arm soreness and swelling in the injected arm after the 1st full dose; experienced arm soreness and swelling in the injected arm after the 1st full dose; This spontaneous case was reported by a patient and describes the occurrence of ROTATOR CUFF SYNDROME (pain in both rotator cuffs for about a month prior to the 2nd full dose due to rotator cuff tendonitis), VACCINATION SITE PAIN (experienced arm soreness and swelling in the injected arm after the 1st full dose) and VACCINATION SITE SWELLING (experienced arm soreness and swelling in the injected arm after the 1st full dose) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ROTATOR CUFF SYNDROME (pain in both rotator cuffs for about a month prior to the 2nd full dose due to rotator cuff tendonitis), VACCINATION SITE PAIN (experienced arm soreness and swelling in the injected arm after the 1st full dose) and VACCINATION SITE SWELLING (experienced arm soreness and swelling in the injected arm after the 1st full dose). At the time of the report, ROTATOR CUFF SYNDROME (pain in both rotator cuffs for about a month prior to the 2nd full dose due to rotator cuff tendonitis) and VACCINATION SITE SWELLING (experienced arm soreness and swelling in the injected arm after the 1st full dose) outcome was unknown and VACCINATION SITE PAIN (experienced arm soreness and swelling in the injected arm after the 1st full dose) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported.  Patient reported his experiences after receiving 2 primary doses (2nd dose lot # unknown).  Patient experienced arm soreness and swelling in the injected arm after the 1st full dose and patient wasn't sure if he experienced any injection arm soreness after the 2nd full dose because he had been experiencing pain in both rotator cuffs for about a month prior to the 2nd full dose due to rotator cuff tendonitis and thinks it may have masked any injection arm soreness they may have had. Patient has not experienced any injection arm soreness today and is now worried whether or not he received any vaccine.  No treatment details were reported.   This case was linked to MOD-2022-580217 (Patient Link).   Reporter did not allow further contact
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: pain in both rotator cuffs for about a month prior to the 2nd full dose due to rotator cuff tendonitis; experienced arm soreness and swelling in the injected arm after the 1st full dose; experienced arm soreness and swelling in the injected arm after the 1st full dose; This spontaneous case was reported by a patient and describes the occurrence of ROTATOR CUFF SYNDROME (pain in both rotator cuffs for about a month prior to the 2nd full dose due to rotator cuff tendonitis), VACCINATION SITE PAIN (experienced arm soreness and swelling in the injected arm after the 1st full dose) and VACCINATION SITE SWELLING (experienced arm soreness and swelling in the injected arm after the 1st full dose) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ROTATOR CUFF SYNDROME (pain in both rotator cuffs for about a month prior to the 2nd full dose due to rotator cuff tendonitis), VACCINATION SITE PAIN (experienced arm soreness and swelling in the injected arm after the 1st full dose) and VACCINATION SITE SWELLING (experienced arm soreness and swelling in the injected arm after the 1st full dose). At the time of the report, ROTATOR CUFF SYNDROME (pain in both rotator cuffs for about a month prior to the 2nd full dose due to rotator cuff tendonitis) and VACCINATION SITE SWELLING (experienced arm soreness and swelling in the injected arm after the 1st full dose) outcome was unknown and VACCINATION SITE PAIN (experienced arm soreness and swelling in the injected arm after the 1st full dose) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported.  Patient reported his experiences after receiving 2 primary doses (2nd dose lot # unknown).  Patient experienced arm soreness and swelling in the injected arm after the 1st full dose and patient wasn't sure if he experienced any injection arm soreness after the 2nd full dose because he had been experiencing pain in both rotator cuffs for about a month prior to the 2nd full dose due to rotator cuff tendonitis and thinks it may have masked any injection arm soreness they may have had. Patient has not experienced any injection arm soreness today and is now worried whether or not he received any vaccine.  No treatment details were reported.   This case was linked to MOD-2022-580217 (Patient Link).   Reporter did not allow further contact
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Rotator cuff syndrome, Vaccination site pain, Vaccination site swelling
Clinical narrative: Arm soreness and swelling in the injected arm after the 1st booster dose; Arm soreness and swelling in the injected arm after the 1st booster dose; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Arm soreness and swelling in the injected arm after the 1st booster dose) and VACCINATION SITE SWELLING (Arm soreness and swelling in the injected arm after the 1st booster dose) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Arm soreness and swelling in the injected arm after the 1st booster dose) and VACCINATION SITE SWELLING (Arm soreness and swelling in the injected arm after the 1st booster dose). At the time of the report, VACCINATION SITE PAIN (Arm soreness and swelling in the injected arm after the 1st booster dose) and VACCINATION SITE SWELLING (Arm soreness and swelling in the injected arm after the 1st booster dose) outcome was unknown.            Patient received second booster dose on 31-May-2022. No concomitant medication details was reported. No treatment medication details was reported. It was reported that patient has not experienced any injection arm soreness on 31-May-2022.   This case was linked to MOD-2022-580198 (Patient Link).   Reporter did not allow further contact
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: Arm soreness and swelling in the injected arm after the 1st booster dose; Arm soreness and swelling in the injected arm after the 1st booster dose; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Arm soreness and swelling in the injected arm after the 1st booster dose) and VACCINATION SITE SWELLING (Arm soreness and swelling in the injected arm after the 1st booster dose) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Arm soreness and swelling in the injected arm after the 1st booster dose) and VACCINATION SITE SWELLING (Arm soreness and swelling in the injected arm after the 1st booster dose). At the time of the report, VACCINATION SITE PAIN (Arm soreness and swelling in the injected arm after the 1st booster dose) and VACCINATION SITE SWELLING (Arm soreness and swelling in the injected arm after the 1st booster dose) outcome was unknown.            Patient received second booster dose on 31-May-2022. No concomitant medication details was reported. No treatment medication details was reported. It was reported that patient has not experienced any injection arm soreness on 31-May-2022.   This case was linked to MOD-2022-580198 (Patient Link).   Reporter did not allow further contact
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Anaemia, Asthenia, Inappropriate schedule of product administration, Musculoskeletal stiffness
Clinical narrative: Energy decreased/Lowenergy; Stiffness; Anemic; Stomach pain; First Dose on 21-Apr-2021 and Second Dose 05-May-2021; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Energy decreased/Lowenergy), MUSCULOSKELETAL STIFFNESS (Stiffness), ANAEMIA (Anemic), ABDOMINAL PAIN UPPER (Stomach pain) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Dose on 21-Apr-2021 and Second Dose 05-May-2021) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    Concurrent medical conditions included Crohn's disease.   On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 05-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Dose on 21-Apr-2021 and Second Dose 05-May-2021). On an unknown date, the patient experienced ASTHENIA (Energy decreased/Lowenergy), MUSCULOSKELETAL STIFFNESS (Stiffness), ANAEMIA (Anemic) and ABDOMINAL PAIN UPPER (Stomach pain). The patient was treated with CYANOCOBALAMIN (VITAMIN B 12 [CYANOCOBALAMIN]) at an unspecified dose and frequency and IRON at an unspecified dose and frequency. At the time of the report, ASTHENIA (Energy decreased/Lowenergy), MUSCULOSKELETAL STIFFNESS (Stiffness), ANAEMIA (Anemic) and ABDOMINAL PAIN UPPER (Stomach pain) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Dose on 21-Apr-2021 and Second Dose 05-May-2021) outcome was unknown.            No concomitant medication was provided. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Eczema, SARS-CoV-2 antibody test
Clinical narrative: Eczema/Eczema on legs; This spontaneous case was reported by a consumer and describes the occurrence of ECZEMA (Eczema/Eczema on legs) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Rheumatoid arthritis: RINVOQ (Route -Oral.). Past adverse reactions to the above products included No adverse event with RINVOQ.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In November 2021, the patient experienced ECZEMA (Eczema/Eczema on legs). At the time of the report, ECZEMA (Eczema/Eczema on legs) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2021, SARS-CoV-2 antibody test: negative (Negative) Negative. On an unknown date, Blood test: no antibodies No antibodies to the covid 19 vaccination.         It was unknown whether patient was enrolled in covid-19 vaccine trial.  The reporters causality for the event Eczema/Eczema on legs with RINVOQ was reported has no reasonable possibility.  Concomitant drugs were not reported.  Treatment details were not given
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: vaccine received on 12-Mar-2021 and 17-Apr-2021 (36 days apart); This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (vaccine received on 12-Mar-2021 and 17-Apr-2021 (36 days apart)) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (vaccine received on 12-Mar-2021 and 17-Apr-2021 (36 days apart)). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (vaccine received on 12-Mar-2021 and 17-Apr-2021 (36 days apart)) outcome was unknown.            No concomitant medications were reported No treatment drugs were reported   This case was linked to MOD-2022-580190 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired dose administered to a patient; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered to a patient) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033K21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-May-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered to a patient). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose administered to a patient) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Patient received 1st booster dose. Reporter stated no adverse events were reported by the patient after getting the vaccine.  Date the vial was initially stored in the refrigerator was reported as 27 Apr 2022. The vial not underwent any temperature excursions.  No treatment medication was reported.