chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Meibomian gland dysfunction, Ocular discomfort, SARS-CoV-2 test
Clinical narrative: Burning eyes; hurting my quality of life; Itching eyes; Meibomian gland is swollen; Feels like I have sand in my eyes; Diagnosed with Dry eye on February 2022; This spontaneous case was reported by a patient and describes the occurrence of OCULAR DISCOMFORT (Feels like I have sand in my eyes), DRY EYE (Diagnosed with Dry eye on February 2022), EYE IRRITATION (Burning eyes), IMPAIRED QUALITY OF LIFE (hurting my quality of life) and EYE PRURITUS (Itching eyes) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013F21A, 031B21A and 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Dry eye (Mild case of dry eye such as Itchiness before the pandemic, became worse during pandemic) and Attention deficit hyperactivity disorder (+). Concomitant products included ATOMOXETINE HYDROCHLORIDE (STRATTERA) for Attention deficit hyperactivity disorder.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 14-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. In February 2022, the patient experienced DRY EYE (Diagnosed with Dry eye on February 2022). On an unknown date, the patient experienced OCULAR DISCOMFORT (Feels like I have sand in my eyes), EYE IRRITATION (Burning eyes), IMPAIRED QUALITY OF LIFE (hurting my quality of life), EYE PRURITUS (Itching eyes) and MEIBOMIAN GLAND DYSFUNCTION (Meibomian gland is swollen). The patient was treated with LIFITEGRAST (XIIDRA) at an unspecified dose and frequency. At the time of the report, OCULAR DISCOMFORT (Feels like I have sand in my eyes), DRY EYE (Diagnosed with Dry eye on February 2022), EYE IRRITATION (Burning eyes), IMPAIRED QUALITY OF LIFE (hurting my quality of life), EYE PRURITUS (Itching eyes) and MEIBOMIAN GLAND DYSFUNCTION (Meibomian gland is swollen) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Allergy test: Had no allergies, but reacted much later. On an unknown date, SARS-CoV-2 test: (Negative) Always tested Negative for COVID-19.         Patient's height was reported as 5'2  Patient was asking if she could take 2nd Booster dose. Patient had mild case of dry eye such as itchiness before the pandemic, but symptoms became worse during the pandemic. Patient was not sure if the event was related to Moderna vaccine.  Patient seek medical care from Opthalmologist. It was reported that the symptoms got worse.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Fatigue, Feeling hot, Muscular weakness
Clinical narrative: Felt too hot after first  booster; Sore on & off for a long time after first; Weak Legs for 1-2 weeks post activity after first  booster; Feels weak for a while after a little house work after first  booster; Whiplash pain got worst after first  booster; Shoulders hurt just to walk after first  booster; Felt too tired after first  booster; This spontaneous case was reported by a patient and describes the occurrence of FEELING HOT (Felt too hot after first  booster), PAIN (Sore on & off for a long time after first ), MUSCULAR WEAKNESS (Weak Legs for 1-2 weeks post activity after first  booster), ASTHENIA (Feels weak for a while after a little house work after first  booster) and NECK PAIN (Whiplash pain got worst after first  booster) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005C21A, 030A21A and 025B21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Whiplash injury in 1987. Concurrent medical conditions included Blood pressure high (controlled with medications).   On 10-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 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, the patient experienced FEELING HOT (Felt too hot after first  booster), PAIN (Sore on & off for a long time after first ), MUSCULAR WEAKNESS (Weak Legs for 1-2 weeks post activity after first  booster), ASTHENIA (Feels weak for a while after a little house work after first  booster), NECK PAIN (Whiplash pain got worst after first  booster), ARTHRALGIA (Shoulders hurt just to walk after first  booster) and FATIGUE (Felt too tired after first  booster). The patient was treated with KETOROLAC TROMETHAMINE (TORADOL) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FEELING HOT (Felt too hot after first  booster), PAIN (Sore on & off for a long time after first ), MUSCULAR WEAKNESS (Weak Legs for 1-2 weeks post activity after first  booster), ASTHENIA (Feels weak for a while after a little house work after first  booster), NECK PAIN (Whiplash pain got worst after first  booster), ARTHRALGIA (Shoulders hurt just to walk after first  booster) and FATIGUE (Felt too tired after first  booster) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   One time the patient used the weed grabber.  The patient had high blood pressure which was controlled with medications but did not remember the name of BP medications.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain
Clinical narrative: Felt too hot after first  booster; Sore on & off for a long time after first; Weak Legs for 1-2 weeks post activity after first  booster; Feels weak for a while after a little house work after first  booster; Whiplash pain got worst after first  booster; Shoulders hurt just to walk after first  booster; Felt too tired after first  booster; This spontaneous case was reported by a patient and describes the occurrence of FEELING HOT (Felt too hot after first  booster), PAIN (Sore on & off for a long time after first ), MUSCULAR WEAKNESS (Weak Legs for 1-2 weeks post activity after first  booster), ASTHENIA (Feels weak for a while after a little house work after first  booster) and NECK PAIN (Whiplash pain got worst after first  booster) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005C21A, 030A21A and 025B21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Whiplash injury in 1987. Concurrent medical conditions included Blood pressure high (controlled with medications).   On 10-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 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, the patient experienced FEELING HOT (Felt too hot after first  booster), PAIN (Sore on & off for a long time after first ), MUSCULAR WEAKNESS (Weak Legs for 1-2 weeks post activity after first  booster), ASTHENIA (Feels weak for a while after a little house work after first  booster), NECK PAIN (Whiplash pain got worst after first  booster), ARTHRALGIA (Shoulders hurt just to walk after first  booster) and FATIGUE (Felt too tired after first  booster). The patient was treated with KETOROLAC TROMETHAMINE (TORADOL) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FEELING HOT (Felt too hot after first  booster), PAIN (Sore on & off for a long time after first ), MUSCULAR WEAKNESS (Weak Legs for 1-2 weeks post activity after first  booster), ASTHENIA (Feels weak for a while after a little house work after first  booster), NECK PAIN (Whiplash pain got worst after first  booster), ARTHRALGIA (Shoulders hurt just to walk after first  booster) and FATIGUE (Felt too tired after first  booster) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   One time the patient used the weed grabber.  The patient had high blood pressure which was controlled with medications but did not remember the name of BP medications.
Sex: U
Vaccine: COVID19
Symptoms: Illness, Nausea
Clinical narrative: I was very ill after both injections and needed anti nausea medcine to get through it.; I was very ill after both injections and needed anti nausea medcine to get through it.; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (I was very ill after both injections and needed anti nausea medcine to get through it.) and NAUSEA (I was very ill after both injections and needed anti nausea medcine to get through it.) 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 27-Jun-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 (I was very ill after both injections and needed anti nausea medicine to get through it.) and NAUSEA (I was very ill after both injections and needed anti nausea medicine to get through it.). At the time of the report, ILLNESS (I was very ill after both injections and needed anti nausea medicine to get through it.) and NAUSEA (I was very ill after both injections and needed anti nausea medicine to get through it.) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No Concomitant medication reported. The patient had received the second dose of Moderna COVID-19 Vaccine on 29-Jul-2021.  The patient received anti nausea medicine as treatment.   This case was linked to MOD-2022-612486 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylaxis; This literature-non-study case was reported in a literature article and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylaxis) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANAPHYLACTIC REACTION (Anaphylaxis) (seriousness criterion medically significant). At the time of the report, ANAPHYLACTIC REACTION (Anaphylaxis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered ANAPHYLACTIC REACTION (Anaphylaxis) to be related.    This case contains information for the 1 of 21 patients described by the reporter. Vital signs were taken and physical examinations were performed before vaccine administration; however, results were not provided. No concomitant and treatment medications were reported. Patient had a first dose of vaccine between 17-Dec-2020 and 28-Feb-2021.  Company comment. This is a literature non  study case concerning a patient of an unknown age and gender with no medical history reported, who experienced the expected serious medically significant event of anaphylaxis reaction. The patient received a dose of mRNA-1273, reported as first dose of patient´s COVID  19 immunization schedule. Temporal association cannot be assessed due to lack of information on onset date of the event and vaccination date. The patient fulfilled the Criteria of level 1 for the highest level of diagnostic certainty for anaphylaxis and the grade 3 severity. The patient was recommended to defer the second dose. No further clinical information was provided for medical reviewing. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2022-610603, US-MODERNATX, INC.-MOD-2022-612775 (Linked Report).; Sender's Comments: This is a literature non  study case concerning a patient of an unknown age and gender with no medical history reported, who experienced the expected serious medically significant event of anaphylaxis reaction. The patient received a dose of mRNA-1273, reported as first dose of patient´s COVID  19 immunization schedule. Temporal association cannot be assessed due to lack of information on onset date of the event and vaccination date. The patient fulfilled the Criteria of level 1 for the highest level of diagnostic certainty for anaphylaxis and the grade 3 severity. The patient was recommended to defer the second dose. No further clinical information was provided for medical reviewing. The benefit-risk relationship of mRNA-1273 is not affected by this report. US-MODERNATX, INC.-MOD-2022-612775:1 patient developed Uncontrolled urticaria US-MODERNATX, INC.-MOD-2022-610603:19 Patients with presumed allergic reactions
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Gingival ulceration, Immunisation reaction, Mucosal inflammation, Noninfective gingivitis
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (she has lingering symptoms), MUCOSAL INFLAMMATION (Mucositis), TOOTH DISORDER (block on teeth), NONINFECTIVE GINGIVITIS (Inflammation on her front gum) and GINGIVAL ULCERATION (Ulcer on her right lower gum) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A and 010A21A) for COVID-19 vaccination. Concomitant products included PANTOPRAZOLE for an unknown indication. On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced NONINFECTIVE GINGIVITIS (Inflammation on her front gum). In September 2021, the patient experienced MUCOSAL INFLAMMATION (Mucositis). In December 2021, the patient experienced GINGIVAL ULCERATION (Ulcer on her right lower gum). On an unknown date, the patient experienced IMMUNISATION REACTION (she has lingering symptoms) and TOOTH DISORDER (block on teeth). The patient was treated with DEXAMETHASONE at an unspecified dose and frequency; CLOBETASOL at a dose of tropical; DOXYCYCLINE at an unspecified dose and frequency and METRONIDAZOLE (FLAGYL [METRONIDAZOLE]) at an unspecified dose and frequency. At the time of the report, IMMUNISATION REACTION (she has lingering symptoms), MUCOSAL INFLAMMATION (Mucositis) and TOOTH DISORDER (block on teeth) outcome was unknown, NONINFECTIVE GINGIVITIS (Inflammation on her front gum) had not resolved and GINGIVAL ULCERATION (Ulcer on her right lower gum) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, Biopsy: (Negative) It was just mucositis. It was reported that patient after receiving the second primary dose had inflammation on front gum where she had crowns, dentist prescribed mouth wash to treat it but did not work. Patient was referred to periodontist who gave her dexamethasone which did not work and for this they gave Clobetasol(topical ointment) which too did not work. After biopsy patient was recommended to maintain oral hygiene and dental cleaning. On Dec-2021 she had ulcer on right lower gum and the doctor prescribed doxycycline and Flagyl, the ulcer got better but the inflammation was still the same. This case was linked to MOD-2022-612792 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Tooth disorder
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (she has lingering symptoms), MUCOSAL INFLAMMATION (Mucositis), TOOTH DISORDER (block on teeth), NONINFECTIVE GINGIVITIS (Inflammation on her front gum) and GINGIVAL ULCERATION (Ulcer on her right lower gum) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A and 010A21A) for COVID-19 vaccination. Concomitant products included PANTOPRAZOLE for an unknown indication. On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced NONINFECTIVE GINGIVITIS (Inflammation on her front gum). In September 2021, the patient experienced MUCOSAL INFLAMMATION (Mucositis). In December 2021, the patient experienced GINGIVAL ULCERATION (Ulcer on her right lower gum). On an unknown date, the patient experienced IMMUNISATION REACTION (she has lingering symptoms) and TOOTH DISORDER (block on teeth). The patient was treated with DEXAMETHASONE at an unspecified dose and frequency; CLOBETASOL at a dose of tropical; DOXYCYCLINE at an unspecified dose and frequency and METRONIDAZOLE (FLAGYL [METRONIDAZOLE]) at an unspecified dose and frequency. At the time of the report, IMMUNISATION REACTION (she has lingering symptoms), MUCOSAL INFLAMMATION (Mucositis) and TOOTH DISORDER (block on teeth) outcome was unknown, NONINFECTIVE GINGIVITIS (Inflammation on her front gum) had not resolved and GINGIVAL ULCERATION (Ulcer on her right lower gum) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, Biopsy: (Negative) It was just mucositis. It was reported that patient after receiving the second primary dose had inflammation on front gum where she had crowns, dentist prescribed mouth wash to treat it but did not work. Patient was referred to periodontist who gave her dexamethasone which did not work and for this they gave Clobetasol(topical ointment) which too did not work. After biopsy patient was recommended to maintain oral hygiene and dental cleaning. On Dec-2021 she had ulcer on right lower gum and the doctor prescribed doxycycline and Flagyl, the ulcer got better but the inflammation was still the same. This case was linked to MOD-2022-612792 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator was on 15-Jun-2022 and the vaccine was administered on 21-Jul-2022; The patient received COVID-19 vaccine past its Use by date of 16-Jul-2022 in her left arm on 21-Jul-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received COVID-19 vaccine past its Use by date of 16-Jul-2022 in her left arm on 21-Jul-2022) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator was on 15-Jun-2022 and the vaccine was administered on 21-Jul-2022) in a 75-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 014B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Jul-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 21-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received COVID-19 vaccine past its Use by date of 16-Jul-2022 in her left arm on 21-Jul-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator was on 15-Jun-2022 and the vaccine was administered on 21-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patient received COVID-19 vaccine past its Use by date of 16-Jul-2022 in her left arm on 21-Jul-2022) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator was on 15-Jun-2022 and the vaccine was administered on 21-Jul-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  The vial did not undergo any temperature excursions.  The reporter reported that the patient was administered with Moderna COVID-19 vaccine past the 30 day use by date.  No treatment information was provided by the reporter.
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face, Urticaria
Clinical narrative: face was puffy/she went to bed with the face still puffy/woke up and it was fine; face was covered in hives/spots started to disappear/woke up and it was fine; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (face was puffy/she went to bed with the face still puffy/woke up and it was fine) and URTICARIA (face was covered in hives/spots started to disappear/woke up and it was fine) in a 3-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. FT9142) for COVID-19 prophylaxis.     Concurrent medical conditions included Milk allergy (not anaphylaxis but when she drank cows milk, she breaks out in hives). Concomitant products included CYPROHEPTADINE HYDROCHLORIDE (PERIACTIN) and FAMOTIDINE for an unknown indication.    On 22-Jul-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2022, the patient experienced SWELLING FACE (face was puffy/she went to bed with the face still puffy/woke up and it was fine) and URTICARIA (face was covered in hives/spots started to disappear/woke up and it was fine). The patient was treated with CETIRIZINE HYDROCHLORIDE (EQUATE ALLERGY RELIEF [CETIRIZINE HYDROCHLORIDE]) for Allergy, at a dose of 2.5 milliliter. At the time of the report, SWELLING FACE (face was puffy/she went to bed with the face still puffy/woke up and it was fine) and URTICARIA (face was covered in hives/spots started to disappear/woke up and it was fine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Past medical history included J2 dependent.  It was reported that paitent received  the vaccine yesterday last night and did not see anything, but 40 minutes later after they drive home, her face was covered in hives and face was puffy. Caller reported the primary care doctor told her to gave an allergy medicine and all she had was Equate brand cetirizine hydrochloride 2.5 ml. Caller told it helped, the spots started to disappear an hour after and then she went to bed with the face still puffy and then woke up and it was fine.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Antinuclear antibody, Blood test, Cough
Clinical narrative: Chronic coughing got worse; This spontaneous case was reported by a patient and describes the occurrence of COUGH (Chronic coughing got worse) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 056M21A, 020B21A and 010A21A) for COVID-19 vaccination.     Concurrent medical conditions included Chronic cough. Concomitant products included PANTOPRAZOLE for an unknown indication.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Apr-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2022, the patient experienced COUGH (Chronic coughing got worse). The patient was treated with BENZONATATE (TESSALON PERLE) in 2022 for Cough aggravated, at an unspecified dose and frequency and HYDROXYCHLOROQUINE in 2022 at an unspecified dose and frequency. At the time of the report, COUGH (Chronic coughing got worse) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, Antinuclear antibody: (Positive) Positive. In 2022, Blood test: (Negative) negative.         It was reported that after receiving the first booster dose on 06-Apr-2022, the patients chronic coughing got worse. For this reason the patient visited patients primary HCP, who prescribed the medicine, Tessalon Perles. This medication had not helped the patient. The patient then visited physicians office and was prescribed with oral steroids and this made the patient feel better. They did a specific antibody test and could find any positive.The HCP referred the patient to a rheumatologist and an immunologist. The doctor did another blood work test and it came back negative, after which they put the patient on an experimental drug, Hydroxychloroquine. The patient had already been 10 days with this treatment and saw no changes.   This case was linked to MOD-2022-612788 (Patient Link).
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Immunodeficiency
Clinical narrative: Diagnosed with a condition that made him immunocompromised; This spontaneous case was reported by a pharmacist and describes the occurrence of IMMUNODEFICIENCY (Diagnosed with a condition that made him immunocompromised) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033h21a, 024m20a and 042l20a) for COVID-19 prophylaxis.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. In February 2022, the patient experienced IMMUNODEFICIENCY (Diagnosed with a condition that made him immunocompromised). At the time of the report, IMMUNODEFICIENCY (Diagnosed with a condition that made him immunocompromised) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details were reported.  No treatment medication details were reported.
Age: 1.58
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Pain in extremity, Sleep disorder
Clinical narrative: Woke up 5 hours after the 2nd shot; Limping 6 hours after the 2nd shot; Leg is hurting 6 hours after the 2nd shot; This spontaneous case was reported by a patient family member or friend and describes the occurrence of SLEEP DISORDER (Woke up 5 hours after the 2nd shot), GAIT DISTURBANCE (Limping 6 hours after the 2nd shot) and PAIN IN EXTREMITY (Leg is hurting 6 hours after the 2nd shot) in a 21-month-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AS1416B and AS1416B) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Jun-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jul-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Jul-2022, the patient experienced SLEEP DISORDER (Woke up 5 hours after the 2nd shot), GAIT DISTURBANCE (Limping 6 hours after the 2nd shot) and PAIN IN EXTREMITY (Leg is hurting 6 hours after the 2nd shot). At the time of the report, SLEEP DISORDER (Woke up 5 hours after the 2nd shot), GAIT DISTURBANCE (Limping 6 hours after the 2nd shot) and PAIN IN EXTREMITY (Leg is hurting 6 hours after the 2nd shot) outcome was unknown.            No concomitant drug information was provided.  Patient had the second dose in the upper left leg and 6 hours after vaccination, it appeared patient's leg was hurting and she was crying. Patient didn't experience any events after the first vaccine.  No treatment drug information was provided.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: Pediatric Patient received 50mcg or 0.25ml of Moderna Covid-19 vaccine from an Adult vaccine with a Red Cap; child received a 50mcg dose instead of the 25 mcg dose for his second dose of the Moderna Covid-19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Pediatric Patient received 50mcg or 0.25ml of Moderna Covid-19 vaccine from an Adult vaccine with a Red Cap) and INCORRECT DOSE ADMINISTERED (child received a 50mcg dose instead of the 25 mcg dose for his second dose of the Moderna Covid-19 vaccine) in a 5-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 21-Jul-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Pediatric Patient received 50mcg or 0.25ml of Moderna Covid-19 vaccine from an Adult vaccine with a Red Cap) and INCORRECT DOSE ADMINISTERED (child received a 50mcg dose instead of the 25 mcg dose for his second dose of the Moderna Covid-19 vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Pediatric Patient received 50mcg or 0.25ml of Moderna Covid-19 vaccine from an Adult vaccine with a Red Cap) and INCORRECT DOSE ADMINISTERED (child received a 50mcg dose instead of the 25 mcg dose for his second dose of the Moderna Covid-19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment information was provided.  The Medical Assistant had a situation where for a pediatric patient received 50mcg or 0.25ml of Moderna Covid-19 vaccine from an Adult vaccine with a Red Cap the child was 5 years of age. The child received a 50mcg dose instead of the 25 mcg dose for the second dose of the Moderna Covid-19 vaccine.   Reporter did not allow further contact
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Eczema
Clinical narrative: Ezcema/Skin on left leg has become hardened/Dry skin/get newareas of skin rashes on body everyday/spot on the leg leaking/spot on the leg has moisture/areas between fingers are also red/Newred/dark purple spot at at the bottom of her leg; This spontaneous case was reported by a patient and describes the occurrence of ECZEMA (Ezcema/Skin on left leg has become hardened/Dry skin/get newareas of skin rashes on body everyday/spot on the leg leaking/spot on the leg has moisture/areas between fingers are also red/Newred/dark purple spot at at the bottom of her leg) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy (allergic to sulfa) and Trachyonychia (Fast heart rate). Concomitant products included ANASTROZOLE for Hormone therapy, METOPROLOL for Tachycardia.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2022, the patient experienced ECZEMA (Ezcema/Skin on left leg has become hardened/Dry skin/get newareas of skin rashes on body everyday/spot on the leg leaking/spot on the leg has moisture/areas between fingers are also red/Newred/dark purple spot at at the bottom of her leg). The patient was treated with CLOBETASOL PROPIONATE (CLOBETASOL PROPRIONATE) at an unspecified dose and frequency and COD LIVER OIL [COD-LIVER OIL] at an unspecified dose and frequency. At the time of the report, ECZEMA (Ezcema/Skin on left leg has become hardened/Dry skin/get newareas of skin rashes on body everyday/spot on the leg leaking/spot on the leg has moisture/areas between fingers are also red/Newred/dark purple spot at at the bottom of her leg) had not resolved.            Patient was taking concomitant medication anastrozole to block a hormone that creates a tumor.  Patient had first dose in mid Apr 2021 and 2nd dose in early May2021  Patient reported that starting in May2022, the skin on left leg hasbecome hardened and there was now a newred/dark purple spot at the bottom of leg and it had moisture and it was leaking at time of reporting. The areas between her fingers are also red and leaking fluid. Patient stated that she was starting to get new areas of purple and skin rashes on body everyday and doesnot want them to get onto face. Patient had consulted with dermatologist who prescribed with Clobetasol proprionate Ointment which did not do any good. Patient  was told that it was eczema or dry skin. Patient used Cod Liver Oil to nourish the skin but it did not do any good as well.   This case was linked to MOD-2021-095308 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Epistaxis, Fatigue, Headache, Pain in extremity
Clinical narrative: nose has been bleeding profusely, some blood when they blow their nose,blow their nose there is a small amount of blood; fatigue,tiredess; sore arm; mild headache,somewhat of a headache; a bit of chills; This spontaneous case was reported by a patient and describes the occurrence of EPISTAXIS (nose has been bleeding profusely, some blood when they blow their nose,blow their nose there is a small amount of blood), FATIGUE (fatigue,tiredess), PAIN IN EXTREMITY (sore arm), HEADACHE (mild headache,somewhat of a headache) and CHILLS (a bit of chills) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No medical history was provided by the reporter.  Concomitant products included LANSOPRAZOLE (PREVACID), VITAMINS NOS and PROBIOTICS NOS for an unknown indication.    On 20-Jul-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2022, the patient experienced FATIGUE (fatigue,tiredess), PAIN IN EXTREMITY (sore arm), HEADACHE (mild headache,somewhat of a headache) and CHILLS (a bit of chills). On 22-Jul-2022, the patient experienced EPISTAXIS (nose has been bleeding profusely, some blood when they blow their nose,blow their nose there is a small amount of blood). At the time of the report, EPISTAXIS (nose has been bleeding profusely, some blood when they blow their nose,blow their nose there is a small amount of blood), FATIGUE (fatigue,tiredess), PAIN IN EXTREMITY (sore arm), HEADACHE (mild headache,somewhat of a headache) and CHILLS (a bit of chills) outcome was unknown.            Patient received Moderna vaccine for all 4 doses she received. Patient did not have vaccination card available to provide details on those vaccinations.  The patient did not had fever, and, body aches,  No treatment medications was reported.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for Covid 19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Tested positive for Covid 19) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 05AR21A and 032M20A) for COVID-19 prophylaxis.     Allergies: No No medical history was reported by the reporter.  Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID], LISINOPRIL, SIMVASTATIN and ALENDRONATE SODIUM (ALENDRONATE) for an unknown indication.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jan-2022, the patient experienced COVID-19 (Tested positive for Covid 19). At the time of the report, COVID-19 (Tested positive for Covid 19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jan-2022, SARS-CoV-2 test: (Positive) Positive for COVID-19 Omicron variant.         The patient had symptoms of burning feeling in her throat, chills, A little headache and body ache. Patient reported that she did not take any medication for these symptoms.  Company Comment: This spontaneous case reported by a patient concerns a 64-year-old female patient, obese with a body mass index of 30.8, and with concomitant intake of aspirin, lisinopril and simvastatin, who experienced unexpected, non-serious AESI Covid19, after vaccination with 2 doses of mRNA-1273.  She received her first dose of mRNA-1273 around 10 months prior; the date of vaccination of the second dose was unknown.  The patient had symptoms of chills, body ache, headache and burning feeling in the throat.  She did not take any medications for these symptoms.  The ongoing Covid19 pandemic could be a contributory factor.  Obesity and intake of aspirin, lisinopril and simvastatin indicative of possible heart disease, hypertension and dyslipidemia could also be confounding factors.  The benefit risk relationship of mRNA-1273 is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This spontaneous case reported by a patient concerns a 64-year-old female patient, obese with a body mass index of 30.8, and with concomitant intake of aspirin, lisinopril and simvastatin, who experienced unexpected, non-serious AESI Covid19, after vaccination with 2 doses of mRNA-1273.  She received her first dose of mRNA-1273 around 10 months prior; the date of vaccination of the second dose was unknown.  The patient had symptoms of chills, body ache, headache and burning feeling in the throat.  She did not take any medications for these symptoms.  The ongoing Covid19 pandemic could be a contributory factor.  Obesity and intake of aspirin, lisinopril and simvastatin indicative of possible heart disease, hypertension and dyslipidemia could also be confounding factors.  The benefit risk relationship of mRNA-1273 is not affected by this report.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Less than 18 years old received Moderna booster; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Less than 18 years old received Moderna booster) in a 14-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Patient had no allergies or medical history reported. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine. Patient never had COVID test or diagnosis.  Previously administered products included for Product used for unknown indication: Pfizer (Dose number 1 and lot number and dose was unknown) on 01-Jul-2021 and Pfizer (Three weeks after first dose. Dose number 2 and lot number and dose was unknown). Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.    On 22-Jul-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jul-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Less than 18 years old received Moderna booster). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Less than 18 years old received Moderna booster) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported.  It was reported that patient received booster dose of Moderna COVID-19 Vaccine.  Treatments were not provided.
Age: 0.67
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Second dose administered on day 21 after the first dose; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered on day 21 after the first dose) in a 9-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AS1414B and AS1414B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 30-Jun-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jul-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered on day 21 after the first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered on day 21 after the first dose) outcome was unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication reported.  No Treatment medication reported.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: mixed series which patient had received 1st dose Pfizer COVID19 vaccine and 2nd dose Moderna; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (mixed series which patient had received 1st dose Pfizer COVID19 vaccine and 2nd dose Moderna) in an 11-year-old male patient who received mRNA-1273 (Spikevax) (batch no. AR4504B) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (1st dose). Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE.    On 22-Jul-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 22-Jul-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (mixed series which patient had received 1st dose Pfizer COVID19 vaccine and 2nd dose Moderna). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (mixed series which patient had received 1st dose Pfizer COVID19 vaccine and 2nd dose Moderna) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  It was reported that HCP was looking for further information regarding mixing and matching COVID19 vaccines in pediatric patients. HCP refused to provide further information as they did not agree on seeing the event as a deviation as they did not have availability of Pfizer COVID19 vaccines.  Treatment medication was not provided by the reporter.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient of age under 18 years old received Moderna booster; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient of age under 18 years old received Moderna booster) in a 13-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Patient had no Allergies.  Previously administered products included for Product used for unknown indication: Pfizer vaccine (Dose 1) on 01-Jul-2021 and Pfizer vaccine (Dose 2 administered three weeks after first dose) in July 2021. Past adverse reactions to the above products included No adverse event with Pfizer vaccine and Pfizer vaccine.    On 22-Jul-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jul-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient of age under 18 years old received Moderna booster). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient of age under 18 years old received Moderna booster) outcome was unknown.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient had never tested positive for COVID-19. No other vaccines were given to patient within 1 month prior to Moderna COVID-19 vaccine. No concomitant medications were reported. No treatment details were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-612803 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2022-612803:patient 1
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Carbohydrate antigen 125, Carbohydrate antigen 19-9, Carcinoembryonic antigen, Computerised tomogram, Tinnitus
Clinical narrative: Tinnitus after each dose; This spontaneous case was reported by a patient and describes the occurrence of TINNITUS (Tinnitus after each dose) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy (breaks into pinkish rash). Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced TINNITUS (Tinnitus after each dose). At the time of the report, TINNITUS (Tinnitus after each dose) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2020, Carbohydrate antigen 125: Normal. In November 2020, Carbohydrate antigen 19-9: normal. In November 2020, Carcinoembryonic antigen: normal. In November 2020, Computerised tomogram: normal.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient did not had any COVID-19 test or diagnosis previously. Tinnitus after each dose, it was so loud, took 3-4 months. Reporter reported that patient had went to the acupuncturist for Tinnitus.   This case was linked to MOD-2022-613185 (Patient Link).
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Carbohydrate antigen 125, Carbohydrate antigen 19-9, Carcinoembryonic antigen, Computerised tomogram, Inappropriate schedule of product administration
Clinical narrative: Tinnitus after each dose; This spontaneous case was reported by a patient and describes the occurrence of TINNITUS (Tinnitus after each dose) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy (breaks into pinkish rash). Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced TINNITUS (Tinnitus after each dose). At the time of the report, TINNITUS (Tinnitus after each dose) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2020, Carbohydrate antigen 125: Normal. In November 2020, Carbohydrate antigen 19-9: normal. In November 2020, Carcinoembryonic antigen: normal. In November 2020, Computerised tomogram: normal.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient did not had any COVID-19 test or diagnosis previously. Tinnitus after each dose, it was so loud, took 3-4 months. Reporter reported that patient had went to the acupuncturist for Tinnitus.   This case was linked to MOD-2022-613185 (Patient Link).