chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Leukocytosis, White blood cell count
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of LEUKOCYTOSIS (my white blood cell count was slightly elevated) in a  patient of an unknown age and gender 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 fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form, 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. On an unknown date, the patient experienced LEUKOCYTOSIS (my white blood cell count was slightly elevated). At the time of the report, LEUKOCYTOSIS (my white blood cell count was slightly elevated) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, White blood cell count: slightly elevated. No concomitant medication was reported. It was reported that after patient had second Moderna booster shot, patient's white blood cell count was slightly elevated. The event had caused patient to seek medical care.
Sex: U
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Intense reaction to the second COVID vaccine received) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. No Medical History information was reported. In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Intense reaction to the second COVID vaccine received). At the time of the report, IMMUNISATION REACTION (Intense reaction to the second COVID vaccine received) outcome was unknown. No concomitant medication was reported. It was reported that patient was sensitive to lot many medication. No treatment medication was reported.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Headache, Pyrexia, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injection site hot), VACCINATION SITE PRURITUS (Injection site itches), VACCINATION SITE ERYTHEMA (Injection site red spot), HEADACHE (Headache) and PYREXIA (Mild fever) in an adult female patient who received mRNA-1273 (Spikevax) 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 Crohn's disease. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free, pre-filled pen. On an unknown date, the patient experienced VACCINATION SITE WARMTH (Injection site hot), VACCINATION SITE PRURITUS (Injection site itches), VACCINATION SITE ERYTHEMA (Injection site red spot), HEADACHE (Headache), PYREXIA (Mild fever) and VACCINATION SITE SWELLING (Injection site swollen). At the time of the report, VACCINATION SITE WARMTH (Injection site hot), VACCINATION SITE PRURITUS (Injection site itches), VACCINATION SITE ERYTHEMA (Injection site red spot), HEADACHE (Headache), PYREXIA (Mild fever) and VACCINATION SITE SWELLING (Injection site swollen) had resolved. Concomitant medication list was not provided. Treatment information was not provided. The reporter's causality with respect to Humira for the events, injection site redness, fever, headache, injection site warmth, injection site itching and injection site swelling were not related. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Vaccination site warmth
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injection site hot), VACCINATION SITE PRURITUS (Injection site itches), VACCINATION SITE ERYTHEMA (Injection site red spot), HEADACHE (Headache) and PYREXIA (Mild fever) in an adult female patient who received mRNA-1273 (Spikevax) 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 Crohn's disease. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free, pre-filled pen. On an unknown date, the patient experienced VACCINATION SITE WARMTH (Injection site hot), VACCINATION SITE PRURITUS (Injection site itches), VACCINATION SITE ERYTHEMA (Injection site red spot), HEADACHE (Headache), PYREXIA (Mild fever) and VACCINATION SITE SWELLING (Injection site swollen). At the time of the report, VACCINATION SITE WARMTH (Injection site hot), VACCINATION SITE PRURITUS (Injection site itches), VACCINATION SITE ERYTHEMA (Injection site red spot), HEADACHE (Headache), PYREXIA (Mild fever) and VACCINATION SITE SWELLING (Injection site swollen) had resolved. Concomitant medication list was not provided. Treatment information was not provided. The reporter's causality with respect to Humira for the events, injection site redness, fever, headache, injection site warmth, injection site itching and injection site swelling were not related. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (No adverse reaction other than mild reaction) in a 60-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. Concurrent medical conditions included Hypertension, Arterial calcification (arterial calcium buildup) and Drug allergy (unspecified drug). Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) from 01-Aug-2021 to an unknown date and AMLODIPINE from 01-Sep-2021 to an unknown date for an unknown indication. On 22-Apr-2022 at 12:00 PM, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 23-Apr-2022, the patient experienced IMMUNISATION REACTION (No adverse reaction other than mild reaction). At the time of the report, IMMUNISATION REACTION (No adverse reaction other than mild reaction) outcome was unknown. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. Pfizer was reported with indication of Treatment of COVID-19 used from 8-AUG-2022 to 12-AUG-2022. No treatment information was reported . Device Date was reported as 22-Aug-2022.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: vial that was left at room temperature since yesterday; no adverse event; vaccine administered to patient more than 12 hours post puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine administered to patient more than 12 hours post puncture), PRODUCT STORAGE ERROR (vial that was left at room temperature since yesterday) and NO ADVERSE EVENT (no adverse event) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011B22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 24-Aug-2022 at 2:00 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 24-Aug-2022 at 2:00 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine administered to patient more than 12 hours post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial that was left at room temperature since yesterday) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccine administered to patient more than 12 hours post puncture), PRODUCT STORAGE ERROR (vial that was left at room temperature since yesterday) 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 EXPIRED PRODUCT ADMINISTERED (vaccine administered to patient more than 12 hours post puncture) and PRODUCT STORAGE ERROR (vial that was left at room temperature since yesterday).    No concomitant drug was reported. It was stated that a patient received 2nd booster dose of the vaccine from a vial that was left at room temperature since 23AUG2022. The vial was first punctured on 23AUG2022 at 2:14 PM and the dose was administered on 24AUG2022 at 2:00 PM (Lot 011B22A). The patient had not reported any adverse reactions at this time. No Treatment medications were reported.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Illness, Tearfulness
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (gotten sick for about a day and a half starting about 5 hours after the dose), FEELING ABNORMAL (felt spacy & was wondering where her water bottle was even though it was in her hand.) and TEARFULNESS (went to another destination to drop something off & busted out in tears) in a 52-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 051B22A) for COVID-19 vaccination. Concurrent medical conditions included Depression. Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT) for Depression. On 26-Jul-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 26-Jul-2022, the patient experienced ILLNESS (gotten sick for about a day and a half starting about 5 hours after the dose). 26-Jul-2022, the patient experienced FEELING ABNORMAL (felt spacy & was wondering where her water bottle was even though it was in her hand.) and TEARFULNESS (went to another destination to drop something off & busted out in tears). In July 2022, ILLNESS (gotten sick for about a day and a half starting about 5 hours after the dose) had resolved. At the time of the report, FEELING ABNORMAL (felt spacy & was wondering where her water bottle was even though it was in her hand.) and TEARFULNESS (went to another destination to drop something off & busted out in tears) outcome was unknown.    It was reported that patient had never been in a psyche ward. No treatment information was reported. This case was linked to MOD-2022-633798 (Patient Link).
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Depression suicidal, Feeling abnormal, Hangover, Tearfulness
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (gotten sick for about a day and a half starting about 5 hours after the dose), FEELING ABNORMAL (felt spacy & was wondering where her water bottle was even though it was in her hand.) and TEARFULNESS (went to another destination to drop something off & busted out in tears) in a 52-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 051B22A) for COVID-19 vaccination. Concurrent medical conditions included Depression. Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT) for Depression. On 26-Jul-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 26-Jul-2022, the patient experienced ILLNESS (gotten sick for about a day and a half starting about 5 hours after the dose). 26-Jul-2022, the patient experienced FEELING ABNORMAL (felt spacy & was wondering where her water bottle was even though it was in her hand.) and TEARFULNESS (went to another destination to drop something off & busted out in tears). In July 2022, ILLNESS (gotten sick for about a day and a half starting about 5 hours after the dose) had resolved. At the time of the report, FEELING ABNORMAL (felt spacy & was wondering where her water bottle was even though it was in her hand.) and TEARFULNESS (went to another destination to drop something off & busted out in tears) outcome was unknown.    It was reported that patient had never been in a psyche ward. No treatment information was reported. This case was linked to MOD-2022-633798 (Patient Link).
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Oropharyngeal pain
Clinical narrative: Sore throat; Fatigue; This spontaneous case was reported by a patient and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat) and FATIGUE (Fatigue) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form and dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (Sore throat) and FATIGUE (Fatigue). At the time of the report, OROPHARYNGEAL PAIN (Sore throat) and FATIGUE (Fatigue) had resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported.  It was reported that twice for the patient too, six months apart. Sore throat and fatigue for a couple of days was all.  No treatment information was reported.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Abnormal behaviour, Chills, Feeling abnormal, Headache, Influenza like illness
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (got a pretty bad dose of flu), NASOPHARYNGITIS (cold), FEELING ABNORMAL (miserable/felt really crummy/with one of the boosters I felt crummy for a month), MALAISE (I've been feeling lousy the last couple of days too) and ABNORMAL BEHAVIOUR (I didn't know if I was sleeping or hallucinating/unsavory dreams so he thinks he may have been hallucinating/very vivid, unsavory dreams/didn't know if I was dreaming or hallucinating/you pass through these different stages) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002M21A, 014F21A, 041B21A and 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Gluten intolerance, Lactose intolerance, Food allergy, Babesia, Arrhythmia and Lyme disease. Concomitant products included NEBIVOLOL HYDROCHLORIDE (BYSTOLIC) and FLECAINIDE ACETATE for Arrhythmia, ARTEMISININ for Babesia, MAGNESIUM, FINASTERIDE, COLECALCIFEROL (VITAMIN D3), CRYPTOLEPIS DUBIA and CAT'S CLAW [UNCARIA TOMENTOSA] for an unknown indication. On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 01-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (got a pretty bad dose of flu), NASOPHARYNGITIS (cold), FEELING ABNORMAL (miserable/felt really crummy/with one of the boosters I felt crummy for a month), MALAISE (I've been feeling lousy the last couple of days too), ABNORMAL BEHAVIOUR (I didn't know if I was sleeping or hallucinating/unsavory dreams so he thinks he may have been hallucinating/very vivid, unsavory dreams/didn't know if I was dreaming or hallucinating/you pass through these different stages), HEADACHE (headache) and CHILLS (chills). At the time of the report, INFLUENZA LIKE ILLNESS (got a pretty bad dose of flu), NASOPHARYNGITIS (cold), FEELING ABNORMAL (miserable/felt really crummy/with one of the boosters I felt crummy for a month), MALAISE (I've been feeling lousy the last couple of days too), ABNORMAL BEHAVIOUR (I didn't know if I was sleeping or hallucinating/unsavory dreams so he thinks he may have been hallucinating/very vivid, unsavory dreams/didn't know if I was dreaming or hallucinating/you pass through these different stages), HEADACHE (headache) and CHILLS (chills) had resolved. No treatment medication was reported. This case was linked to MOD-2022-633815, MOD-2022-633816 (Patient Link).
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Nasopharyngitis
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (got a pretty bad dose of flu), NASOPHARYNGITIS (cold), FEELING ABNORMAL (miserable/felt really crummy/with one of the boosters I felt crummy for a month), MALAISE (I've been feeling lousy the last couple of days too) and ABNORMAL BEHAVIOUR (I didn't know if I was sleeping or hallucinating/unsavory dreams so he thinks he may have been hallucinating/very vivid, unsavory dreams/didn't know if I was dreaming or hallucinating/you pass through these different stages) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002M21A, 014F21A, 041B21A and 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Gluten intolerance, Lactose intolerance, Food allergy, Babesia, Arrhythmia and Lyme disease. Concomitant products included NEBIVOLOL HYDROCHLORIDE (BYSTOLIC) and FLECAINIDE ACETATE for Arrhythmia, ARTEMISININ for Babesia, MAGNESIUM, FINASTERIDE, COLECALCIFEROL (VITAMIN D3), CRYPTOLEPIS DUBIA and CAT'S CLAW [UNCARIA TOMENTOSA] for an unknown indication. On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 01-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (got a pretty bad dose of flu), NASOPHARYNGITIS (cold), FEELING ABNORMAL (miserable/felt really crummy/with one of the boosters I felt crummy for a month), MALAISE (I've been feeling lousy the last couple of days too), ABNORMAL BEHAVIOUR (I didn't know if I was sleeping or hallucinating/unsavory dreams so he thinks he may have been hallucinating/very vivid, unsavory dreams/didn't know if I was dreaming or hallucinating/you pass through these different stages), HEADACHE (headache) and CHILLS (chills). At the time of the report, INFLUENZA LIKE ILLNESS (got a pretty bad dose of flu), NASOPHARYNGITIS (cold), FEELING ABNORMAL (miserable/felt really crummy/with one of the boosters I felt crummy for a month), MALAISE (I've been feeling lousy the last couple of days too), ABNORMAL BEHAVIOUR (I didn't know if I was sleeping or hallucinating/unsavory dreams so he thinks he may have been hallucinating/very vivid, unsavory dreams/didn't know if I was dreaming or hallucinating/you pass through these different stages), HEADACHE (headache) and CHILLS (chills) had resolved. No treatment medication was reported. This case was linked to MOD-2022-633815, MOD-2022-633816 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No Adverse Event; 1st dose - 05Mar2021, 2nd dose - 19Mar2022; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose - 05Mar2021, 2nd dose - 19Mar2022) and NO ADVERSE EVENT (No Adverse Event) in a 64-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 016F21A and 001A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 19-Mar-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 19-Mar-2022,  after starting mRNA-1273 (Spikevax), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose - 05Mar2021, 2nd dose - 19Mar2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose - 05Mar2021, 2nd dose - 19Mar2022) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.  Concomitant drugs were not reported. It was reported that patient wants to verify the expiration date of a Moderna COVID-19 vaccine lot number which was administered to them for second dose and was told as was working for that this had already expired. Treatment medications were not provided.
Age: 47.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Back pain, Intervertebral disc protrusion, Vaccination site pain
Clinical narrative: Back pain; BULGING DISC IN NECK; COVID VACCINE ISSUE/SORE ARM; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back pain), INTERVERTEBRAL DISC PROTRUSION (BULGING DISC IN NECK) and VACCINATION SITE PAIN (COVID VACCINE ISSUE/SORE ARM) in a 47-year-old 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 (Moderate to severe Rheumatoid arthritis.).   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-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 UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced BACK PAIN (Back pain), INTERVERTEBRAL DISC PROTRUSION (BULGING DISC IN NECK) and VACCINATION SITE PAIN (COVID VACCINE ISSUE/SORE ARM). At the time of the report, BACK PAIN (Back pain) had not resolved and INTERVERTEBRAL DISC PROTRUSION (BULGING DISC IN NECK) and VACCINATION SITE PAIN (COVID VACCINE ISSUE/SORE ARM) outcome was unknown.            Concomitant medications were not provided by the reporter. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Patient's back pain had worsened. Treatment information was not provided.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Myalgia, Pruritus, Sleep apnoea syndrome
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy skin), SLEEP APNOEA SYNDROME (INCREASED SLEEP APNEA) and MYALGIA (MUSCLE ACHES with HUMIRA) 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) solution for injection for Rheumatoid arthritis. NO KNOWN ALLERGIES.  Concurrent medical conditions included Rheumatoid arthritis. In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Jul-2022, 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. On an unknown date, the patient experienced PRURITUS (Itchy skin), SLEEP APNOEA SYNDROME (INCREASED SLEEP APNEA) and MYALGIA (MUSCLE ACHES with HUMIRA). At the time of the report, PRURITUS (Itchy skin), SLEEP APNOEA SYNDROME (INCREASED SLEEP APNEA) and MYALGIA (MUSCLE ACHES with HUMIRA) had not resolved.    The patient did not receive any concomitant drugs. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter causality for the events of ITCHY SKIN, INCREASED SLEEP APNEA and MUSCLE ACHES with HUMIRA was not provided. No treatment drug details was reported.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Fatigue, Oral herpes, Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ORAL HERPES (rinvoq seems to aggravate Cold sores), PAIN IN EXTREMITY (Pain in arm) and FATIGUE (Fatigue) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. Co-suspect product included non-company product UPADACITINIB (RINVOQ) for an unknown indication. Concurrent medical conditions included Cold sores (taken medication for cold sores for 15 years). In 2021, the patient received first 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. In 2022, 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 UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced ORAL HERPES (rinvoq seems to aggravate Cold sores), PAIN IN EXTREMITY (Pain in arm) and FATIGUE (Fatigue). At the time of the report, ORAL HERPES (rinvoq seems to aggravate Cold sores), PAIN IN EXTREMITY (Pain in arm) and FATIGUE (Fatigue) outcome was unknown. No concomitant medication was reported. It was reported that the patient was taken medication for cold sores for 15 years but rinvoq seemed to aggravate them. Her covid vaccine cause sore arm and fatigue. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medication was provided.
Age: 44.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Plaque psoriasis, Ulcerative colitis and Rheumatoid arthritis. Concurrent medical conditions included Plaque psoriasis (MODERATE TO SEVERE CHRONIC), Rheumatoid arthritis (MODERATE TO SEVERE) and Ulcerative colitis (MODERATE TO SEVERE). 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form, second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. and UPADACITINIB (RINVOQ) (Oral) dosage was changed to at an unspecified dose. In June 2022, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown. No concomitant medications were reported. It was reported that, in June 2022, the patient experienced COVID 19. In 2022, the COVID was resolved. The patient had COVID back. It was unknown if patient was enrolled in a COVID-19 vaccine trial. No treatment drugs were reported. Company Comment: This spontaneous case concerns a 44-year-old female patient, with concurrent medical conditions plaque psoriasis, rheumatoid arthritis, and ulcerative colitis, for which she is taking upadacitinib, who experienced unexpected, non-serious Covid19 after receiving 3 doses of mRNA-1273 on unspecified dates.  It was reported that she had Covid19 which resolved, then had Covid19 back.  Onset latency of the event from time of vaccination could not be determined due to limited information.  Further clinical course, diagnostic evaluation and treatment details were not reported.  The outcome was unknown.  Concomitant use of upadacitinib could be a confounding factor.  The ongoing Covid19 pandemic could also be a contributory factor.  The benefit risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This spontaneous case concerns a 44-year-old female patient, with concurrent medical conditions plaque psoriasis, rheumatoid arthritis, and ulcerative colitis, for which she is taking upadacitinib, who experienced unexpected, non-serious AESI Covid19 after receiving 3 doses of mRNA-1273 on unspecified dates.  It was reported that she had Covid19 which resolved, then had Covid19 back.  Onset latency of the event from time of vaccination could not be determined due to limited information.  Further clinical course, diagnostic evaluation and treatment details were not reported.  The outcome was unknown.  Concomitant use of upadacitinib could be a confounding factor.  The ongoing Covid19 pandemic could also be a contributory factor.  The benefit risk relationship of mRNA-1273 is not affected by this report.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; Received half dose instead of a full dose for 2nd primary shot; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (Received half dose instead of a full dose for 2nd primary shot) and NO ADVERSE EVENT (No adverse event) in a 31-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 037A22B and 037A22B) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jul-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 24-Aug-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 24-Aug-2022, the patient experienced ACCIDENTAL UNDERDOSE (Received half dose instead of a full dose for 2nd primary shot). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Received half dose instead of a full dose for 2nd primary shot) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Received half dose instead of a full dose for 2nd primary shot).    No concomitant medications were reported.  31-year-old patient received 2 doses of Moderna COVID-19 vaccine. The 2nd shot was given as a half dose instead of a full dose from a red cap vial of Moderna COVID-19 vaccine.  No treatment medications were reported.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Postural orthostatic tachycardia syndrome
Clinical narrative: Postural orthostatic tachycardia syndrome, 1 week after receiving the first dose of Moderna vaccine.; This literature-non-study case was reported in a literature article and describes the occurrence of POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (Postural orthostatic tachycardia syndrome, 1 week after receiving the first dose of Moderna vaccine.) in a 37-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.   LITERATURE REFERENCE:    No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Spikevax), the patient experienced POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (Postural orthostatic tachycardia syndrome, 1 week after receiving the first dose of Moderna vaccine.) (seriousness criterion medically significant). At the time of the report, POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (Postural orthostatic tachycardia syndrome, 1 week after receiving the first dose of Moderna vaccine.) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter considered POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (Postural orthostatic tachycardia syndrome, 1 week after receiving the first dose of Moderna vaccine.) to be related.    No concomitant and treatment medications were reported. Company comment: This literature-non-study case concerns a 37-year-old female patient, with no medical history reported, who experienced the serious (due to medically significant) AESI of Postural orthostatic tachycardia syndrome, a week after receiving the first dose of mRNA-1273 vaccine. No further clinical information was provided for medical reviewing. The benefit-risk relationship of the mRNA-1273 is not affected by this report.; Sender's Comments: This literature-non-study case concerns a 37-year-old female patient, with no medical history reported, who experienced the serious (due to medically significant) AESI of Postural orthostatic tachycardia syndrome, a week after receiving the first dose of mRNA-1273 vaccine. No further clinical information was provided for medical reviewing. The benefit-risk relationship of the mRNA-1273 is not affected by this report.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Dyspepsia, Fatigue, Illness, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Got sick/ ill for 7 weeks), DYSPEPSIA (sour stomach), DECREASED APPETITE (no appetite), FATIGUE (extreme fatigue) and PYREXIA (temperature that bounced all over the place) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Got sick/ ill for 7 weeks), DYSPEPSIA (sour stomach), DECREASED APPETITE (no appetite), FATIGUE (extreme fatigue) and PYREXIA (temperature that bounced all over the place). At the time of the report, ILLNESS (Got sick/ ill for 7 weeks), DYSPEPSIA (sour stomach), DECREASED APPETITE (no appetite), FATIGUE (extreme fatigue) and PYREXIA (temperature that bounced all over the place) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a dose of expired Moderna Covid-19 vaccine), PRODUCT STORAGE ERROR (initially stored in the refrigerator on 13JUL2022 and administration of vaccine on 24AUG2022) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. AR4504B) for COVID-19 prophylaxis. No Medical History information was reported. On 24-Aug-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 24-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (received a dose of expired Moderna Covid-19 vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (initially stored in the refrigerator on 13JUL2022 and administration of vaccine on 24AUG2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received a dose of expired Moderna Covid-19 vaccine), PRODUCT STORAGE ERROR (initially stored in the refrigerator on 13JUL2022 and administration of vaccine on 24AUG2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (received a dose of expired Moderna Covid-19 vaccine) and PRODUCT STORAGE ERROR (initially stored in the refrigerator on 13JUL2022 and administration of vaccine on 24AUG2022). Concomitant medications were not reported. The vaccine was past the 30 day use by date. Number of dose was 1. The vial did not undergo any temperature excursions. No other adverse reactions were reported.  Treatment medications were not reported.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with the 2nd dose of the Moderna Covid-19 vaccine which has expired.) and NO ADVERSE EVENT (No adverse events were reported by the patient.) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 038A21A) for COVID-19 vaccination. No Medical History information was reported. On 01-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 06-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 06-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with the 2nd dose of the Moderna Covid-19 vaccine which has expired.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse events were reported by the patient.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered with the 2nd dose of the Moderna Covid-19 vaccine which has expired.) and NO ADVERSE EVENT (No adverse events were reported by the patient.) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse events were reported by the patient.) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Administered with the 2nd dose of the Moderna Covid-19 vaccine which has expired.). No concomitant product use was reported.  No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received first dose in 2021 more than 35 days ago) and NO ADVERSE EVENT (No adverse event) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The patient was not immunocompromised. In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received first dose in 2021 more than 35 days ago) and NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received first dose in 2021 more than 35 days ago) 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 assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received first dose in 2021 more than 35 days ago). No concomitant medication information was reported. It was reported that the patient was in prison at that time of vaccination. The patient got out of prison but did not receive the second dose till now. The reporter tried to call the prison but could not get any accurate information regarding whether the patient received first dose of Moderna or Pfizer vaccine. The reporter could not find the vaccination record of the patient. The patient thinks that the patient received Moderna vaccine as first dose. The reporter asked that if the patient was wrong and had received the Pfizer vaccine as first dose, would not the patient be able to get a second Moderna dose or restart the series then. No treatment information was reported.
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: skin rashes; This spontaneous case was reported by a patient and describes the occurrence of RASH (skin rashes) in a male patient of an unknown age 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 third 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 and 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 RASH (skin rashes). At the time of the report, RASH (skin rashes) was resolving.            No concomitant medication was reported. After 4 weeks the skin doctor did a biopsy for which they are still awaiting results. The patient was prescribed 2 weeks of an antibiotic & a non steroid cream.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; first dose of the Moderna covid19 vaccine on 1March2021 the lot number 025A21a, second dose 8Apr2021 with lot number 038A21A; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose of the Moderna covid19 vaccine on 1March2021 the lot number 025A21a, second dose 8Apr2021 with lot number 038A21A) and NO ADVERSE EVENT (No adverse event) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 025A21a) for COVID-19 prophylaxis.     Patient had no allergy to food and other products It was unknown if the patient ever had COVID-19 test or diagnosis.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose of the Moderna covid19 vaccine on 1March2021 the lot number 025A21a, second dose 8Apr2021 with lot number 038A21A). 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 of the Moderna covid19 vaccine on 1March2021 the lot number 025A21a, second dose 8Apr2021 with lot number 038A21A) 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 assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose of the Moderna covid19 vaccine on 1March2021 the lot number 025A21a, second dose 8Apr2021 with lot number 038A21A).    No concomitant medications were reported. No treatment medications were reported. It was reported patient has not received any other vaccines within 1 month prior to Moderna COVID-19 vaccine   This case was linked to MOD-2022-633828 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 antibody test, Suspected COVID-19
Clinical narrative: I got COVID in mid-May 2022/The biggest things I dealt with during that time were fatigue, brain fog, and muscle soreness.; I got COVID in mid-May 2022/The biggest things I dealt with during that time were fatigue, brain fog, and muscle soreness.; The initial case was missing the following minimum criteria: No Adverse Event. Upon receipt of follow-up information on (22Aug2022), this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (003110). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 26Apr2021 as dose 1, single (Batch/Lot number: unknown), on 10May2021 as dose 2, single (Batch/Lot number: unknown) and on 04Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "I got COVID in mid-May 2022/The biggest things I dealt with during that time were fatigue, brain fog, and muscle soreness.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (May2022) Unknown results, notes: I got COVID in mid-May2022.  Clinical course: it wa reported that 1st injection on 26Apr2021 At a nursing home in RI. 2nd injection on 10May2021 at a pharmacy in RI. Both were Pfizer injections. 3rd dose of a booster was on 04Dec2021 at a doctor's office in NYC. This was also a Pfizer injection. I got COVID in mid May2022. The biggest things I dealt with during that time were fatigue, brain fog, and muscle soreness. I was in bed for a few days. Since then, I still experience fatigue and brain fog and my anti-depressants stopped working. I've gained weight. It isn't fun and I've been struggling with my mental health and feeling motivated. What I'm saying is, I'm not taking any more boosters from anyone until y'all figure this out. I see how pharma is making more money by requiring more injections. But I'm not taking any additional injections from Pfizer or any other company until we know that they are both safe for humans long term and effective long term effective as in preventing getting COVID completely and suffering from it's symptoms. If you still have questions, feel free to send me an online form via your website.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.  Follow-up (22Jun2022): Follow-up attempts are completed. No further information is expected.