chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: SECOND DOSE OF MODERNA CAUSED FEVER, CHILLS, AND BODY ACHES.; SECOND DOSE OF MODERNA CAUSED FEVER, CHILLS, AND BODY ACHES.; SECOND DOSE OF MODERNA CAUSED FEVER, CHILLS, AND BODY ACHES.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (SECOND DOSE OF MODERNA CAUSED FEVER, CHILLS, AND BODY ACHES.), PYREXIA (SECOND DOSE OF MODERNA CAUSED FEVER, CHILLS, AND BODY ACHES.) and CHILLS (SECOND DOSE OF MODERNA CAUSED FEVER, CHILLS, AND BODY ACHES.) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced PAIN (SECOND DOSE OF MODERNA CAUSED FEVER, CHILLS, AND BODY ACHES.), PYREXIA (SECOND DOSE OF MODERNA CAUSED FEVER, CHILLS, AND BODY ACHES.) and CHILLS (SECOND DOSE OF MODERNA CAUSED FEVER, CHILLS, AND BODY ACHES.). At the time of the report, PAIN (SECOND DOSE OF MODERNA CAUSED FEVER, CHILLS, AND BODY ACHES.), PYREXIA (SECOND DOSE OF MODERNA CAUSED FEVER, CHILLS, AND BODY ACHES.) and CHILLS (SECOND DOSE OF MODERNA CAUSED FEVER, CHILLS, AND BODY ACHES.) outcome was unknown.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant product use was reported.   All the doses of vaccine administered one in once.  No treatment information was provided.  The reporter's causality for the events of second dose of moderna caused fever, chills with Humira (Adalimumab) was no reasonable possibility.   This case was linked to MOD-2022-640765 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, Vomiting
Clinical narrative: excessive vomiting/extreme vomiting; lowgrade fever; muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (excessive vomiting/extreme vomiting), PYREXIA (lowgrade fever) and MYALGIA (muscle aches) in an elderly female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Concurrent medical conditions included Blood cholesterol abnormal (Cholesterol). Concomitant products included SERTRALINE for an unknown indication.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VOMITING (excessive vomiting/extreme vomiting), PYREXIA (lowgrade fever) and MYALGIA (muscle aches). The patient was treated with BISMUTH SUBSALICYLATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE]) for Adverse event, at an unspecified dose and frequency and ACETYLSALICYLIC ACID (ALKA SELTZER [ACETYLSALICYLIC ACID]) for Adverse event, at an unspecified dose and frequency. At the time of the report, VOMITING (excessive vomiting/extreme vomiting), PYREXIA (lowgrade fever) and MYALGIA (muscle aches) outcome was unknown.            Patient was over 65 years old and wants to go get the Covid19 vaccine booster.  Reporter said his wife got excessive vomiting, extreme vomiting, low grade fever, muscle aches from the second primary Moderna Covid.  The patient took Pepto Bismol or Alka Seltzer for the side effects.   This case was linked to MOD-2022-640744 (Patient Link).   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: got .25mL of the bivalent booster instead of 0.5mL; no adverse event; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (got .25mL of the bivalent booster instead of 0.5mL) and NO ADVERSE EVENT (no adverse event) in a female patient of an unknown age who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (got .25mL of the bivalent booster instead of 0.5mL) and NO ADVERSE EVENT (no adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (got .25mL of the bivalent booster instead of 0.5mL) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (got .25mL of the bivalent booster instead of 0.5mL).    No concomitant medication were reported.             No treatment information was provided by the reporter.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: extreme nausea; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (extreme nausea) in an elderly female patient who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No medical history was provided by the reporter.  Concomitant products included SERTRALINE for an unknown indication.    In April 2022, the patient received fourth dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced NAUSEA (extreme nausea). The patient was treated with BISMUTH SUBSALICYLATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE]) at an unspecified dose and frequency and ACETYLSALICYLIC ACID (ALKA SELTZER [ACETYLSALICYLIC ACID]) at an unspecified dose and frequency. At the time of the report, NAUSEA (extreme nausea) outcome was unknown.            The patient was over 65 years old. The patient received the second booster dose in Apr2022 and experienced extreme nausea but no vomiting. The patient took Pepto Bismol or Alka Seltzer for the side effects.   This case was linked to MOD-2022-640742 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: Arm hurt at injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Arm hurt at injection site) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019F21A) for COVID-19 vaccination.     Patient had no allergies (medications, food and other products), Patient never had COVID positive test or diagnosis. Patient not received other vaccines within 1 month prior to Moderna COVID-19 vaccine.  Previously administered products included for Product used for unknown indication: JANSSEN COVID-19 VACCINE (received the Johnson and Johnson vaccine 1st dose and it almost kill her, she was down for 6 weeks, Lot number: 1805075 /1805025 and Route: IM) on 25-Mar-2021. Past adverse reactions to the above products included Vaccination adverse reaction with JANSSEN COVID-19 VACCINE. Concurrent medical conditions included Thyroid disorder (Thyroid problem) and Autoimmune disorder (Autoimmune system).    On 24-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Arm hurt at injection site). At the time of the report, VACCINATION SITE PAIN (Arm hurt at injection site) had resolved.            No concomitant medications were reported.  She stated she had received the Moderna vaccine 6 months later, two doses of Moderna vaccine. Reported that her arm hurts for a day after receiving the first booster dose.  No treatment medications were reported.   This case was linked to MOD-2022-640754 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, Injection site pain, Vaccination site pain
Clinical narrative: Arm hurt at injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Arm hurt at injection site) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019F21A) for COVID-19 vaccination.     Patient had no allergies (medications, food and other products), Patient never had COVID positive test or diagnosis. Patient not received other vaccines within 1 month prior to Moderna COVID-19 vaccine.  Previously administered products included for Product used for unknown indication: JANSSEN COVID-19 VACCINE (received the Johnson and Johnson vaccine 1st dose and it almost kill her, she was down for 6 weeks, Lot number: 1805075 /1805025 and Route: IM) on 25-Mar-2021. Past adverse reactions to the above products included Vaccination adverse reaction with JANSSEN COVID-19 VACCINE. Concurrent medical conditions included Thyroid disorder (Thyroid problem) and Autoimmune disorder (Autoimmune system).    On 24-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Arm hurt at injection site). At the time of the report, VACCINATION SITE PAIN (Arm hurt at injection site) had resolved.            No concomitant medications were reported.  She stated she had received the Moderna vaccine 6 months later, two doses of Moderna vaccine. Reported that her arm hurts for a day after receiving the first booster dose.  No treatment medications were reported.   This case was linked to MOD-2022-640754 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: Arm hurt at injection site; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Arm hurt at injection site) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017F21A and 019F21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Johnson and Johnson vaccine (dose 1 and lot number 1805075 /1805025 in intramuscular route) on 25-Mar-2021. Past adverse reactions to the above products included Vaccination adverse reaction with Johnson and Johnson vaccine. Concurrent medical conditions included Thyroid disorder and Autoimmune disorder.   On 24-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On an unknown date, the patient experienced VACCINATION SITE PAIN (Arm hurt at injection site). At the time of the report, VACCINATION SITE PAIN (Arm hurt at injection site) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown.            Patient reported to the doctor that the 1st vaccination Johnson and Johnson almost killed and was down for 6 weeks. Patient had no allergy. No other vaccine was taken prior 1 month to Moderna.  No concomitant medication was reported by reporter.  Patient received Moderna vaccine 6 month later the Johnson and Johnson.  No treatment medication was reported by reporter.   This case was linked to MOD-2022-640749 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, Injection site pain, Vaccination site pain
Clinical narrative: Arm hurt at injection site; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Arm hurt at injection site) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017F21A and 019F21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Johnson and Johnson vaccine (dose 1 and lot number 1805075 /1805025 in intramuscular route) on 25-Mar-2021. Past adverse reactions to the above products included Vaccination adverse reaction with Johnson and Johnson vaccine. Concurrent medical conditions included Thyroid disorder and Autoimmune disorder.   On 24-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On an unknown date, the patient experienced VACCINATION SITE PAIN (Arm hurt at injection site). At the time of the report, VACCINATION SITE PAIN (Arm hurt at injection site) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown.            Patient reported to the doctor that the 1st vaccination Johnson and Johnson almost killed and was down for 6 weeks. Patient had no allergy. No other vaccine was taken prior 1 month to Moderna.  No concomitant medication was reported by reporter.  Patient received Moderna vaccine 6 month later the Johnson and Johnson.  No treatment medication was reported by reporter.   This case was linked to MOD-2022-640749 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse event; I was supposed to get the bivalent newupdated booster but instead I got the the original strength vaccine, the 0.5 mL, the 100mcg.; This spontaneous case was reported by a patient and describes the occurrence of INCORRECT DOSE ADMINISTERED (I was supposed to get the bivalent newupdated booster but instead I got the the original strength vaccine, the 0.5 mL, the 100mcg.) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Sep-2022, the patient experienced INCORRECT DOSE ADMINISTERED (I was supposed to get the bivalent newupdated booster but instead I got the the original strength vaccine, the 0.5 mL, the 100mcg.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (I was supposed to get the bivalent newupdated booster but instead I got the the original strength vaccine, the 0.5 mL, the 100mcg.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product administration interrupted, White blood cell count
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (Patient is immunocompromised and only received two primary care series doses of the Moderna Covid-19 vaccine.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination. Concurrent medical conditions included Leukemia and Immunocompromised. On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (Patient is immunocompromised and only received two primary care series doses of the Moderna Covid-19 vaccine.) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (Patient is immunocompromised and only received two primary care series doses of the Moderna Covid-19 vaccine.) and NO ADVERSE EVENT (No adverse event) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, White blood cell count: Leukemia with low counts of white blood cells. No concomitant drug information was provided. The patient was immunocompromised and only received two doses of primary series of the Moderna vaccine. The patient had leukemia with low counts of white blood cells. The patient never received a third primary series dose. No treatment drug information was provided.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Psoriasis, Psoriatic arthropathy
Clinical narrative: Psoriatic arthritis; Psoriasis; This spontaneous case was reported by a consumer and describes the occurrence of PSORIATIC ARTHROPATHY (Psoriatic arthritis) in an adult male 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) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced PSORIATIC ARTHROPATHY (Psoriatic arthritis) (seriousness criterion medically significant) and PSORIASIS (Psoriasis). At the time of the report, PSORIATIC ARTHROPATHY (Psoriatic arthritis) and PSORIASIS (Psoriasis) outcome was unknown.      The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.   It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the event Psoriatic arthritis and Psoriasis with  HUMIRA(ADALIMUMAB) was no reasonable possibility. The formulation of Humira was reported as Solution for injection in pre-filled pen  No concomitant medication information was reported.  No treatment medication information was reported.  Company comment: This spontaneous case concerns an adult male patient of an unspecified age, with no reported medical history, who experienced the unexpected serious (medically significant) event of Psoriatic arthropathy on an unknown date in the context of receiving 1st dose of mRNA-1273 vaccine, along with the non-serious event of psoriasis. Onset latency could not be determined as date of vaccination and onset date of event were not provided. Clinical course and treatment details were not reported. On an unknown date, the patient had received Adalimumab (indication unknown) which could be considered as a confounder. The outcome of event was reported as unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns an adult male patient of an unspecified age, with no reported medical history, who experienced the unexpected serious (medically significant) event of Psoriatic arthropathy on an unknown date in the context of receiving 1st dose of mRNA-1273 vaccine, along with the non-serious event of psoriasis. Onset latency could not be determined as date of vaccination and onset date of event were not provided. Clinical course and treatment details were not reported. On an unknown date, the patient had received Adalimumab (indication unknown) which could be considered as a confounder. The outcome of event was reported as unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Felt a little tired the next day after receiving the vaccine; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (Felt a little tired the next day after receiving the vaccine) in a 47-year-old female patient who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 vaccination: Pfizer (All previous doses for them were the Pfizer COVID-19 vaccine.). Past adverse reactions to the above products included No adverse event with Pfizer.  On 03-Sep-2022, the patient received dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 04-Sep-2022, the patient experienced FATIGUE (Felt a little tired the next day after receiving the vaccine). At the time of the report, FATIGUE (Felt a little tired the next day after receiving the vaccine) had resolved.     Concomitant product use was not provided by the reporter.  It was reported that patient felt a little tired the next day after receiving the vaccine but felt fine after.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-640773, US-MODERNATX, INC.-MOD-2022-640772 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-640773:Husband case US-MODERNATX, INC.-MOD-2022-640772:same reporter as  ( Case for husband and wife )
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Product administered to patient of inappropriate age
Clinical narrative: slightly sore arm; Moderna bivalent vaccine given to patient less than 18 years old; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PAIN IN EXTREMITY (slightly sore arm) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna bivalent vaccine given to patient less than 18 years old) in a 14-year-old female patient who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS714K) for COVID-19 prophylaxis.     Concomitant products included INFLUENZA VACCINE for an unknown indication.    On 03-Sep-2022, the patient received dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 03-Sep-2022, the patient experienced PAIN IN EXTREMITY (slightly sore arm) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna bivalent vaccine given to patient less than 18 years old). On 04-Sep-2022, PAIN IN EXTREMITY (slightly sore arm) had resolved. At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna bivalent vaccine given to patient less than 18 years old) outcome was unknown.            No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-640766, US-MODERNATX, INC.-MOD-2022-640773 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-640766:same reporter as  ( Case for husband and wife ) US-MODERNATX, INC.-MOD-2022-640773:same reporter as  ( Case for husband and wife )
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: felt a little tired the next day after receiving the vaccine; This spontaneous case was reported by a patient family member or friend and describes the occurrence of FATIGUE (felt a little tired the next day after receiving the vaccine) in a 44-year-old male patient who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 vaccination: Pfizer COVID-19 vaccine (All previous doses were Pfizer COVID-19 vaccine.). Past adverse reactions to the above products included No adverse event with Pfizer COVID-19 vaccine.    On 03-Sep-2022, the patient received dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 04-Sep-2022,  after starting mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced FATIGUE (felt a little tired the next day after receiving the vaccine). The patient was treated with PARACETAMOL (TYLENOL) for Tiredness, at an unspecified dose and frequency. At the time of the report, FATIGUE (felt a little tired the next day after receiving the vaccine) had resolved.            No concomitant drug was reported. It was reported that patient felt a little tired the next day after receiving the vaccine but felt fine after. Patient received Tylenol for symptoms.   This case was linked to US-MODERNATX, INC.-MOD-2022-640766, US-MODERNATX, INC.-MOD-2022-640772 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-640766:Wife case US-MODERNATX, INC.-MOD-2022-640772:daugter's case
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of TINNITUS (tinnitus after an hour or two) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058S21A, 022M20A and 025A21A) for COVID-19 prophylaxis. The patient's past medical history included Suspected COVID-19 without laboratory confirmation (might have had COVID in September/August 2021) in 2021. Concomitant products included COLECALCIFEROL (VITAMIN D3) and MAGNESIUM for an unknown indication. On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced TINNITUS (tinnitus after an hour or two). At the time of the report, TINNITUS (tinnitus after an hour or two) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient had inflammatory symptoms and was sick but didn't get tested. Patient was administered with first booster and she were debating on getting a second booster. No treatment information was reported. This case was linked to MOD-2022-640779 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Inflammation
Clinical narrative: inflammatory symptoms; was sick but didn't get tested; This spontaneous case was reported by a nurse and describes the occurrence of INFLAMMATION (inflammatory symptoms) and ILLNESS (was sick but didn't get tested) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 022M20A) for COVID-19 prophylaxis. No medical history was provided by the reporter. Concomitant products included COLECALCIFEROL (VITAMIN D3) and MAGNESIUM for an unknown indication. On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLAMMATION (inflammatory symptoms) and ILLNESS (was sick but didn't get tested). At the time of the report, INFLAMMATION (inflammatory symptoms) and ILLNESS (was sick but didn't get tested) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient might had COVID in September/August 2021 but did not get tested. No treatment information was provided by the reporter. Concomitant product vitamin D3 was administered in winter.   This case was linked to MOD-2022-640775 (Patient Link).
Age: 55.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Chills
Clinical narrative: Chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis (Moderate to Severe).   In June 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In July 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On an unknown date, the patient experienced CHILLS (Chills). At the time of the report, CHILLS (Chills) outcome was unknown.            Concomitant medications details were not reported by the reporter.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Reporter also reported that HUMIRA was no longer effective. Moderna Vaccine all doses were administered one in once, Humira was citrate free.  The reporters causality for the events of CHILLS and HUMIRA WAS NO LONGER EFFECTIVE was not provided for HUMIRA.  Treatment details were not reported by the reporter.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngitis, Psoriasis, Pyrexia, Wrong technique in product usage process
Clinical narrative: Psoriasis came back/psoriasis started coming out on hips, bellybutton, buttocks, legs, hands, wrists/started coming out on elbows/one single plaque on scalp/plaques getting bigger; FEVER; USE ERROR- PLUM BUTTON WAS ACCIDENTALLY PRESSED; THROAT INFECTION; This spontaneous case was reported by a consumer and describes the occurrence of PHARYNGITIS (THROAT INFECTION), PSORIASIS (Psoriasis came back/psoriasis started coming out on hips, bellybutton, buttocks, legs, hands, wrists/started coming out on elbows/one single plaque on scalp/plaques getting bigger), PYREXIA (FEVER) and WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (USE ERROR- PLUM BUTTON WAS ACCIDENTALLY PRESSED) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis (Moderate to severe).   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 01-Mar-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PHARYNGITIS (THROAT INFECTION). On an unknown date, the patient experienced PSORIASIS (Psoriasis came back/psoriasis started coming out on hips, bellybutton, buttocks, legs, hands, wrists/started coming out on elbows/one single plaque on scalp/plaques getting bigger), PYREXIA (FEVER) and WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (USE ERROR- PLUM BUTTON WAS ACCIDENTALLY PRESSED). At the time of the report, PHARYNGITIS (THROAT INFECTION) was resolving, PSORIASIS (Psoriasis came back/psoriasis started coming out on hips, bellybutton, buttocks, legs, hands, wrists/started coming out on elbows/one single plaque on scalp/plaques getting bigger) had resolved with sequelae, PYREXIA (FEVER) outcome was unknown and WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (USE ERROR- PLUM BUTTON WAS ACCIDENTALLY PRESSED) had not resolved.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant product use was reported.   Both the doses of vaccine administered one in once.  No treatment information was provided.  The reporter's causality with Humira (Adalimumab) for the events of use error- plum button was accidentally pressed and fever was not provided. The reporter's causality for the events of throat infection and psoriasis came back/psoriasis started coming out on hips, bellybutton, buttocks, legs, hands, wrists/started coming out on elbows/one single plaque on scalp/plaques getting bigger with Humira (Adalimumab) was no reasonable possibility.  The reporter's causality for the event of humira not working with Humira (Adalimumab) was a reasonable possibility.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Gait disturbance, Headache
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness, no energy), PAIN (Everything was hurting), GAIT DISTURBANCE (Couldn't walk), CHILLS (Body chills) and FATIGUE (Tired) in a 48-year-old female patient who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. A57144B, 012421A, 028A21A and 032821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 26-Feb-2021, the patient received first dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) dosage was changed to 1 dosage form. On 03-Sep-2022 at 11:00 AM, received fourth dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) dosage was changed to 1 dosage form. On 03-Sep-2022, the patient experienced NAUSEA (Little bit of nausea). On 03-Sep-2022 at 4:00 PM, the patient experienced ASTHENIA (Weakness, no energy) and FATIGUE (Tired). On 03-Sep-2022 at 6:00 PM, the patient experienced PAIN (Everything was hurting), GAIT DISTURBANCE (Couldn't walk), CHILLS (Body chills), HEADACHE (Headaches) and PAIN IN EXTREMITY (Arm hurt when lifting it up). At the time of the report, ASTHENIA (Weakness, no energy), PAIN (Everything was hurting), GAIT DISTURBANCE (Couldn't walk), CHILLS (Body chills), FATIGUE (Tired), HEADACHE (Headaches), PAIN IN EXTREMITY (Arm hurt when lifting it up) and NAUSEA (Little bit of nausea) had resolved. No concomitant medications was reported. The patient not had a fever and not received any medications or treatments.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness, no energy), PAIN (Everything was hurting), GAIT DISTURBANCE (Couldn't walk), CHILLS (Body chills) and FATIGUE (Tired) in a 48-year-old female patient who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. A57144B, 012421A, 028A21A and 032821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 26-Feb-2021, the patient received first dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) dosage was changed to 1 dosage form. On 03-Sep-2022 at 11:00 AM, received fourth dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) dosage was changed to 1 dosage form. On 03-Sep-2022, the patient experienced NAUSEA (Little bit of nausea). On 03-Sep-2022 at 4:00 PM, the patient experienced ASTHENIA (Weakness, no energy) and FATIGUE (Tired). On 03-Sep-2022 at 6:00 PM, the patient experienced PAIN (Everything was hurting), GAIT DISTURBANCE (Couldn't walk), CHILLS (Body chills), HEADACHE (Headaches) and PAIN IN EXTREMITY (Arm hurt when lifting it up). At the time of the report, ASTHENIA (Weakness, no energy), PAIN (Everything was hurting), GAIT DISTURBANCE (Couldn't walk), CHILLS (Body chills), FATIGUE (Tired), HEADACHE (Headaches), PAIN IN EXTREMITY (Arm hurt when lifting it up) and NAUSEA (Little bit of nausea) had resolved. No concomitant medications was reported. The patient not had a fever and not received any medications or treatments.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: experienced side effects after receiving the first two doses; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (experienced side effects after receiving the first two doses) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (experienced side effects after receiving the first two doses). At the time of the report, IMMUNISATION REACTION (experienced side effects after receiving the first two doses) outcome was unknown. Not Provided          No concomitant medications were reported.   No treatment details were reported.
Age: 69.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Headache, Hyperhidrosis, Pain in extremity, Pruritus, Sleep deficit
Clinical narrative: SWEATING CAUSED ITCHING; Lack of sleep; HEADACHES FROM LACK OF SLEEP; itching; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching), HYPERHIDROSIS (SWEATING CAUSED ITCHING), SLEEP DEFICIT (Lack of sleep), PAIN IN EXTREMITY (sore arm) and HEADACHE (HEADACHES FROM LACK OF SLEEP) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis.   On 02-Oct-2020, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On 13-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced PRURITUS (itching) and PAIN IN EXTREMITY (sore arm). On an unknown date, the patient experienced HYPERHIDROSIS (SWEATING CAUSED ITCHING), SLEEP DEFICIT (Lack of sleep) and HEADACHE (HEADACHES FROM LACK OF SLEEP). At the time of the report, PRURITUS (itching) and PAIN IN EXTREMITY (sore arm) outcome was unknown and HYPERHIDROSIS (SWEATING CAUSED ITCHING), SLEEP DEFICIT (Lack of sleep) and HEADACHE (HEADACHES FROM LACK OF SLEEP) had not resolved.            No concomitant medications were provided by the reporter. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the event(s) of Pain in arm, Sweating, Sleep deficit, Headache, Itchiness with SKYRIZI(RISANKIZUMAB) was no reasonable possibility. Treatment information was not provided.   This case was linked to MOD-2022-617331 (Patient Link).   Reporter did not allow further contact
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pemphigus
Clinical narrative: Pemphigus foliaceus; This literature-non-study case was reported in a literature article and describes the occurrence of PEMPHIGUS (Pemphigus foliaceus) in a 67-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.    No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PEMPHIGUS (Pemphigus foliaceus) (seriousness criterion medically significant). At the time of the report, PEMPHIGUS (Pemphigus foliaceus) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter considered PEMPHIGUS (Pemphigus foliaceus) to be related.    Relevant concomitant and treatment medications were not reported.  Patient had Pemphigus Foliaceus after mRNA-1273 vaccine. Company comment- This literature-non-study case, concerns a 67-year-old female patient, with no medical history reported, who experienced the unexpected serious (medically significant) event of Pemphigus (reported as Pemphigus foliaceus) that occurred in the context of mRNA-1273 vaccination (dose number not specified). Latency cannot be assessed since vaccination date nor event onset date was disclosed. No further information on risk factors, concurrent illness, detailed clinical course, investigations, treatment of the event was available in the report. Outcome of the event was not known at the time of report. Elderly age could be a risk factor to the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This literature-non-study case, concerns a 67-year-old female patient, with no medical history reported, who experienced the unexpected serious (medically significant) event of Pemphigus (reported as Pemphigus foliaceus) that occurred in the context of mRNA-1273 vaccination (dose number not specified). Latency cannot be assessed since vaccination date nor event onset date was disclosed. No further information on risk factors, concurrent illness, detailed clinical course, investigations, treatment of the event was available in the report. Outcome of the event was not known at the time of report. Elderly age could be a risk factor to the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: experienced painful joints after the 1st dose and it was even worse with the 2nd one; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (experienced painful joints after the 1st dose and it was even worse with the 2nd one) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced ARTHRALGIA (experienced painful joints after the 1st dose and it was even worse with the 2nd one). At the time of the report, ARTHRALGIA (experienced painful joints after the 1st dose and it was even worse with the 2nd one) had not resolved.            No concomitant medications were reported. It was reported that the painful joints was so bad that the patient looked like a crippled person and was not like that before. The patient went to the doctor, and they felt that it was the vaccine. The doctor also said that was the Moderna vaccine. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: the vial was initially stored in the refrigerator on 04Aug2022 and administered on 06Sep2022; No adverse Event; Dose administered after 30-day Use By Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 04Aug2022 and administered on 06Sep2022) and NO ADVERSE EVENT (No adverse Event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. AS1412B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Sep-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 06-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 04Aug2022 and administered on 06Sep2022) and NO ADVERSE EVENT (No adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 04Aug2022 and administered on 06Sep2022) 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 (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 04Aug2022 and administered on 06Sep2022).    No concomitant medications were reported. The vial was initially stored in the refrigerator on 04-Aug-2022. The facility administered the vaccination after the 30 day BUD. The vial did not  undergo any temperature excursions. No treatment medications were reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Influenza like illness, Malaise
Clinical narrative: flu like symptoms; feeling like sick/malaise; lack of energy; felt dizzy; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), MALAISE (feeling like sick/malaise), ASTHENIA (lack of energy) and DIZZINESS (felt dizzy) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 056A22A, 048F21A, 043B21A and 007B21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: shingrix (Dose 1) on 24-Oct-2019, shingrix (Dose 2) on 20-Jan-2020, pneumococcal on 12-Oct-2021 and flu vaccine (at 65 years). Past adverse reactions to the above products included No adverse event with flu vaccine, pneumococcal, shingrix and shingrix. Concurrent medical conditions included Seasonal allergy and Allergy to antibiotic (Augmentin).   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Apr-2022, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), MALAISE (feeling like sick/malaise), ASTHENIA (lack of energy) and DIZZINESS (felt dizzy). On 27-Apr-2022, INFLUENZA LIKE ILLNESS (flu like symptoms), MALAISE (feeling like sick/malaise), ASTHENIA (lack of energy) and DIZZINESS (felt dizzy) had resolved.            No concomitant medication information reported Patient reports that patient had had flu like symptoms, felling like sick, malaise, lack of energy, felt dizzy a day after (23Apr2022) getting the 2nd booster dose of the Moderna Covid- 19 vaccine. Patient never had COVID positive test or diagnosis. Patient not had experienced a similar events in the past. Outcome of all events reported as recovered after 4 days No treatment information reported.