chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Fatigue, Insomnia, Vaccination site pain
Clinical narrative: She could barely sleep her arm  hurts and she woke up screaming; After the second dose she was hurting so bad; Dizzy; After each shot her arm was very sore/After the second dose she was hurting so bad; Tired; This spontaneous case was reported by a patient and describes the occurrence of INSOMNIA (She could barely sleep her arm  hurts and she woke up screaming), PAIN (After the second dose she was hurting so bad), DIZZINESS (Dizzy), PAIN IN EXTREMITY (After each shot her arm was very sore/After the second dose she was hurting so bad) and FATIGUE (Tired) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     The patient's past medical history included Accident automobile (She was a passenger in a car accident.) and Fusion of vertebra (Currently she had six screws and fusion in her back). Concurrent medical conditions included Blood pressure high (She was taking high blood pressure medication.), Back disorder (She was  taking back problem medication.), Degenerative disc disease, Sciatica and COPD (She was taking oxygen for COPD). Concomitant products included OXYGEN for COPD.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced DIZZINESS (Dizzy), PAIN IN EXTREMITY (After each shot her arm was very sore/After the second dose she was hurting so bad) and FATIGUE (Tired). On an unknown date, the patient experienced INSOMNIA (She could barely sleep her arm  hurts and she woke up screaming) and PAIN (After the second dose she was hurting so bad). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, INSOMNIA (She could barely sleep her arm  hurts and she woke up screaming), PAIN (After the second dose she was hurting so bad), DIZZINESS (Dizzy), PAIN IN EXTREMITY (After each shot her arm was very sore/After the second dose she was hurting so bad) and FATIGUE (Tired) outcome was unknown.            The patient had no allergies with medications, food and other products.  There was no medical history related to mentioned AE and there was no acute and chronic illnesses at the time of vaccination.  There was no other vaccines given within 1 month prior to Moderna COVID-19 vaccine.   The patient mentioned that her left arm  was hurting for 3 months since she got the shot last year. When she went to the hospital, they just prescribe her ibuprofen and did not do much to help. She was putting cream  in the area to help with the pain. She could barely sleep her arm hurts and she woke up screaming. She felt very dizzy and tired every time she got a shot. After each shot her arm  was very sore. After the second dose she was hurting so bad that she decided she had to go to her doctor to get the next shot.   This case was linked to MOD-2022-667455, MOD-2022-667545 (Patient Link).
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Fatigue, Pain in extremity
Clinical narrative: She could barely sleep her arm  hurts and she woke up screaming; After the second dose she was hurting so bad; Dizzy; After each shot her arm was very sore/After the second dose she was hurting so bad; Tired; This spontaneous case was reported by a patient and describes the occurrence of INSOMNIA (She could barely sleep her arm  hurts and she woke up screaming), PAIN (After the second dose she was hurting so bad), DIZZINESS (Dizzy), PAIN IN EXTREMITY (After each shot her arm was very sore/After the second dose she was hurting so bad) and FATIGUE (Tired) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     The patient's past medical history included Accident automobile (She was a passenger in a car accident.) and Fusion of vertebra (Currently she had six screws and fusion in her back). Concurrent medical conditions included Blood pressure high (She was taking high blood pressure medication.), Back disorder (She was  taking back problem medication.), Degenerative disc disease, Sciatica and COPD (She was taking oxygen for COPD). Concomitant products included OXYGEN for COPD.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced DIZZINESS (Dizzy), PAIN IN EXTREMITY (After each shot her arm was very sore/After the second dose she was hurting so bad) and FATIGUE (Tired). On an unknown date, the patient experienced INSOMNIA (She could barely sleep her arm  hurts and she woke up screaming) and PAIN (After the second dose she was hurting so bad). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, INSOMNIA (She could barely sleep her arm  hurts and she woke up screaming), PAIN (After the second dose she was hurting so bad), DIZZINESS (Dizzy), PAIN IN EXTREMITY (After each shot her arm was very sore/After the second dose she was hurting so bad) and FATIGUE (Tired) outcome was unknown.            The patient had no allergies with medications, food and other products.  There was no medical history related to mentioned AE and there was no acute and chronic illnesses at the time of vaccination.  There was no other vaccines given within 1 month prior to Moderna COVID-19 vaccine.   The patient mentioned that her left arm  was hurting for 3 months since she got the shot last year. When she went to the hospital, they just prescribe her ibuprofen and did not do much to help. She was putting cream  in the area to help with the pain. She could barely sleep her arm hurts and she woke up screaming. She felt very dizzy and tired every time she got a shot. After each shot her arm  was very sore. After the second dose she was hurting so bad that she decided she had to go to her doctor to get the next shot.   This case was linked to MOD-2022-667455, MOD-2022-667545 (Patient Link).
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Fatigue, Insomnia, Pain, Pain in extremity
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of INSOMNIA (can barely sleep arm hurts and wakes up screaming), FATIGUE (Patient feels very dizzy and tired), DIZZINESS (Patient feels very dizzy and tired) and VACCINATION SITE PAIN (patient arm was very sore/left arm hurting) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     The patient's past medical history included Road traffic accident (Patient was a passenger in a car accident) and Fusion of vertebra (Patient had six screws and fusion in back). Concurrent medical conditions included Blood pressure high (Patient was taking high blood pressure medication.), Back disorder (Patient was taking back problem medication), Degenerative disc disease, Sciatica and Chronic obstructive pulmonary disease. Concomitant products included OXYGEN for Chronic obstructive pulmonary disease.    On 30-Mar-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 INSOMNIA (can barely sleep arm hurts and wakes up screaming), FATIGUE (Patient feels very dizzy and tired), DIZZINESS (Patient feels very dizzy and tired) and VACCINATION SITE PAIN (patient arm was very sore/left arm hurting). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, INSOMNIA (can barely sleep arm hurts and wakes up screaming), FATIGUE (Patient feels very dizzy and tired), DIZZINESS (Patient feels very dizzy and tired) and VACCINATION SITE PAIN (patient arm was very sore/left arm hurting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient had no allergies with medications, food, and other products.     There were no other vaccines given within 1 month prior to Moderna COVID-19 vaccine.    The patient mentioned that her left arm was hurting for 3 months since patient got the shot last year. When patient went to the hospital, they just prescribe her ibuprofen and did not do much to help. Patient was putting cream in the area to help with the pain. Patient could barely sleep her arm hurts and woke up screaming. Patient felt very dizzy and tired every time patient got a shot. After each shot arm was very sore. .
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Fatigue, Insomnia, Vaccination site pain
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of INSOMNIA (can barely sleep arm hurts and wakes up screaming), FATIGUE (Patient feels very dizzy and tired), DIZZINESS (Patient feels very dizzy and tired) and VACCINATION SITE PAIN (patient arm was very sore/left arm hurting) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     The patient's past medical history included Road traffic accident (Patient was a passenger in a car accident) and Fusion of vertebra (Patient had six screws and fusion in back). Concurrent medical conditions included Blood pressure high (Patient was taking high blood pressure medication.), Back disorder (Patient was taking back problem medication), Degenerative disc disease, Sciatica and Chronic obstructive pulmonary disease. Concomitant products included OXYGEN for Chronic obstructive pulmonary disease.    On 30-Mar-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 INSOMNIA (can barely sleep arm hurts and wakes up screaming), FATIGUE (Patient feels very dizzy and tired), DIZZINESS (Patient feels very dizzy and tired) and VACCINATION SITE PAIN (patient arm was very sore/left arm hurting). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, INSOMNIA (can barely sleep arm hurts and wakes up screaming), FATIGUE (Patient feels very dizzy and tired), DIZZINESS (Patient feels very dizzy and tired) and VACCINATION SITE PAIN (patient arm was very sore/left arm hurting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient had no allergies with medications, food, and other products.     There were no other vaccines given within 1 month prior to Moderna COVID-19 vaccine.    The patient mentioned that her left arm was hurting for 3 months since patient got the shot last year. When patient went to the hospital, they just prescribe her ibuprofen and did not do much to help. Patient was putting cream in the area to help with the pain. Patient could barely sleep her arm hurts and woke up screaming. Patient felt very dizzy and tired every time patient got a shot. After each shot arm was very sore. .
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Fatigue, Pain in extremity
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of INSOMNIA (can barely sleep arm hurts and wakes up screaming), FATIGUE (Patient feels very dizzy and tired), DIZZINESS (Patient feels very dizzy and tired) and VACCINATION SITE PAIN (patient arm was very sore/left arm hurting) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     The patient's past medical history included Road traffic accident (Patient was a passenger in a car accident) and Fusion of vertebra (Patient had six screws and fusion in back). Concurrent medical conditions included Blood pressure high (Patient was taking high blood pressure medication.), Back disorder (Patient was taking back problem medication), Degenerative disc disease, Sciatica and Chronic obstructive pulmonary disease. Concomitant products included OXYGEN for Chronic obstructive pulmonary disease.    On 30-Mar-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 INSOMNIA (can barely sleep arm hurts and wakes up screaming), FATIGUE (Patient feels very dizzy and tired), DIZZINESS (Patient feels very dizzy and tired) and VACCINATION SITE PAIN (patient arm was very sore/left arm hurting). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, INSOMNIA (can barely sleep arm hurts and wakes up screaming), FATIGUE (Patient feels very dizzy and tired), DIZZINESS (Patient feels very dizzy and tired) and VACCINATION SITE PAIN (patient arm was very sore/left arm hurting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient had no allergies with medications, food, and other products.     There were no other vaccines given within 1 month prior to Moderna COVID-19 vaccine.    The patient mentioned that her left arm was hurting for 3 months since patient got the shot last year. When patient went to the hospital, they just prescribe her ibuprofen and did not do much to help. Patient was putting cream in the area to help with the pain. Patient could barely sleep her arm hurts and woke up screaming. Patient felt very dizzy and tired every time patient got a shot. After each shot arm was very sore. .
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Fatigue, Insomnia, Pain, Pain in extremity
Clinical narrative: Dizzy; Arm was very sore; Tired; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (Dizzy), PAIN IN EXTREMITY (Arm was very sore) and FATIGUE (Tired) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 10121A and 018B21A) for COVID-19 vaccination.     Patient had no Allergies.  The patient's past medical history included Accident (Patient was a passenger in a car accident and now she had six screws and fusion in her back.). Concurrent medical conditions included Blood pressure high (Patient stated she was taking high blood pressure medication.), Back disorder (Patient had back problem medication), Degenerative disc disease (Degenerative disease), Sciatica and COPD (She was taking oxygen for COPD.). Concomitant products included OXYGEN for COPD.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Feb-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 DIZZINESS (Dizzy), PAIN IN EXTREMITY (Arm was very sore) and FATIGUE (Tired). At the time of the report, DIZZINESS (Dizzy), PAIN IN EXTREMITY (Arm was very sore) and FATIGUE (Tired) outcome was unknown.     There was no medical history relating to mentioned AE and both Acute and Chronic illnesses at the time of vaccination. The patient never had COVID positive test or diagnosis. No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine. No treatment medication was provided.   This case was linked to MOD-2022-667455, MOD-2022-667530 (Patient Link).
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Fatigue, Insomnia, Vaccination site pain
Clinical narrative: Dizzy; Arm was very sore; Tired; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (Dizzy), PAIN IN EXTREMITY (Arm was very sore) and FATIGUE (Tired) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 10121A and 018B21A) for COVID-19 vaccination.     Patient had no Allergies.  The patient's past medical history included Accident (Patient was a passenger in a car accident and now she had six screws and fusion in her back.). Concurrent medical conditions included Blood pressure high (Patient stated she was taking high blood pressure medication.), Back disorder (Patient had back problem medication), Degenerative disc disease (Degenerative disease), Sciatica and COPD (She was taking oxygen for COPD.). Concomitant products included OXYGEN for COPD.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Feb-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 DIZZINESS (Dizzy), PAIN IN EXTREMITY (Arm was very sore) and FATIGUE (Tired). At the time of the report, DIZZINESS (Dizzy), PAIN IN EXTREMITY (Arm was very sore) and FATIGUE (Tired) outcome was unknown.     There was no medical history relating to mentioned AE and both Acute and Chronic illnesses at the time of vaccination. The patient never had COVID positive test or diagnosis. No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine. No treatment medication was provided.   This case was linked to MOD-2022-667455, MOD-2022-667530 (Patient Link).
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Fatigue, Pain in extremity
Clinical narrative: Dizzy; Arm was very sore; Tired; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (Dizzy), PAIN IN EXTREMITY (Arm was very sore) and FATIGUE (Tired) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 10121A and 018B21A) for COVID-19 vaccination.     Patient had no Allergies.  The patient's past medical history included Accident (Patient was a passenger in a car accident and now she had six screws and fusion in her back.). Concurrent medical conditions included Blood pressure high (Patient stated she was taking high blood pressure medication.), Back disorder (Patient had back problem medication), Degenerative disc disease (Degenerative disease), Sciatica and COPD (She was taking oxygen for COPD.). Concomitant products included OXYGEN for COPD.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Feb-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 DIZZINESS (Dizzy), PAIN IN EXTREMITY (Arm was very sore) and FATIGUE (Tired). At the time of the report, DIZZINESS (Dizzy), PAIN IN EXTREMITY (Arm was very sore) and FATIGUE (Tired) outcome was unknown.     There was no medical history relating to mentioned AE and both Acute and Chronic illnesses at the time of vaccination. The patient never had COVID positive test or diagnosis. No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine. No treatment medication was provided.   This case was linked to MOD-2022-667455, MOD-2022-667530 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental exposure to product, Eczema, Injection site pain
Clinical narrative: Eczema get out of hand; gave injection and it hurt very bad; Lot of medication ran down hand; This spontaneous case was reported by a patient and describes the occurrence of ECZEMA (Eczema get out of hand), INJECTION SITE PAIN (gave injection and it hurt very bad) and ACCIDENTAL EXPOSURE TO PRODUCT (Lot of medication ran down hand) in a 74-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for Prophylactic vaccination.    Co-suspect product included non-company product DUPILUMAB (DUPIXENT) for Atopic dermatitis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form and DUPILUMAB (DUPIXENT) (Subcutaneous) 300 milligram. On 14-Oct-2022, the patient experienced INJECTION SITE PAIN (gave injection and it hurt very bad) and ACCIDENTAL EXPOSURE TO PRODUCT (Lot of medication ran down hand). On an unknown date, the patient experienced ECZEMA (Eczema get out of hand). At the time of the report, ECZEMA (Eczema get out of hand) was resolving, INJECTION SITE PAIN (gave injection and it hurt very bad) had resolved and ACCIDENTAL EXPOSURE TO PRODUCT (Lot of medication ran down hand) outcome was unknown. Not Provided    For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  It was not reported if the patient received a corrective treatment for the events.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19 immunisation, Interchange of vaccine products, Pain in extremity
Clinical narrative: sore arm; Revaccination with different COVID-19 vaccine; Interchange of vaccine products; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arm), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (COVID-19 VACCINE JANSSEN) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and first dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (COVID-19 VACCINE JANSSEN) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at a dose of Every four hour. At the time of the report, PAIN IN EXTREMITY (sore arm), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) outcome was unknown.            Patient received antidepressant and sleeping pill.  It was reported that patient received Johnson and Johnson vaccine and then the second dose of Moderna. Caller did not have their vaccination card at the time of call. patient said they had a sore arm with the first two.   This case was linked to MOD-2022-667601 (Patient Link).
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Tinnitus
Clinical narrative: COVID Positive test/Late August 2022; I have noticed that I have been having a problem with ringing in my ear/Tinnitus is constant; This spontaneous case was reported by a patient and describes the occurrence of TINNITUS (I have noticed that I have been having a problem with ringing in my ear/Tinnitus is constant) and COVID-19 (COVID Positive test/Late August 2022) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050E21A, 002B21A and 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol high, Blood pressure high and Ulcerative colitis. Concomitant products included LISINOPRIL for Blood cholesterol abnormal, ATORVASTATIN for Blood pressure high, BALSALAZIDE for Ulcerative colitis.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 19-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. In June 2022, the patient experienced TINNITUS (I have noticed that I have been having a problem with ringing in my ear/Tinnitus is constant). In August 2022, the patient experienced COVID-19 (COVID Positive test/Late August 2022). At the time of the report, TINNITUS (I have noticed that I have been having a problem with ringing in my ear/Tinnitus is constant) had not resolved and COVID-19 (COVID Positive test/Late August 2022) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2022, SARS-CoV-2 test: Positive.         No other vaccines were received by the patient within 1 month prior to Moderna COVID-19 vaccine.   Reported that patient had problem with ringing in ear. HCP said it was probably a sign of hearing loss. It was reported that patient seek medical care and went to ENT. Patient did not experience a similar event in the past.   No treatment medication was provided.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, Wheezing
Clinical narrative: I began wheezing as if I had athsma; All Four doses of vaccine administered on 28 Oct 2022; This spontaneous case was reported by a patient and describes the occurrence of WHEEZING (I began wheezing as if I had athsma) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (All Four doses of vaccine administered on 28 Oct 2022) in a 25-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 031H21H) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    The patient's past medical history included COVID-19. Concurrent medical conditions included Penicillin allergy.   On 28-Oct-2022, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form and fourth dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 28-Oct-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (All Four doses of vaccine administered on 28 Oct 2022). On 30-Oct-2022, the patient experienced WHEEZING (I began wheezing as if I had athsma). At the time of the report, WHEEZING (I began wheezing as if I had athsma) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (All Four doses of vaccine administered on 28 Oct 2022) outcome was unknown.            Concomitant medication not reported.  Co-suspect product also included Moderna Dose 1 (Batch number 031C20H) and Dose 2 (Batch number 003B21A) administered on same date 28 Oct 2022. Location of injection for vaccine was Arm. Since the vaccination, the patient was not  tested positive for COVID-19.  Patient went on a run two days after receiving the vaccine, and began wheezing as if she had asthma. Patient never wheezed during a run before, and this type of run was a regular part of her routine. Treatment medication not reported.
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Patient been having a problem with ringing in ear; This spontaneous case was reported by a patient and describes the occurrence of TINNITUS (Patient been having a problem with ringing in ear) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TINNITUS (Patient been having a problem with ringing in ear). At the time of the report, TINNITUS (Patient been having a problem with ringing in ear) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) was unknown.       No concomitant medications was reported.  Patient reported that having a problem with ringing in ear. HCP said it was probably a sign of hearing loss. However, she read on line that some of the Moderna vaccines were related to Tinnitus.   No treatment medications was reported.  Patient went to a Health related website where several people reported ringing in their ears and some mentioned tinnitus after receiving the Moderna booster.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19 immunisation, Fatigue, Immunisation reaction, Interchange of vaccine products, Pyrexia
Clinical narrative: Revaccination with different COVID-19 vaccine; Interchange of vaccine products; ALMOST KILLED/A LONG LIST OF SIDE EFFECT; LITTLE HEAT AT THE SITE OF INJECTION; LOW GRADE FEVER; FATIGUE REOCCURENCE; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (ALMOST KILLED/A LONG LIST OF SIDE EFFECT), VACCINATION SITE WARMTH (LITTLE HEAT AT THE SITE OF INJECTION), PYREXIA (LOW GRADE FEVER), FATIGUE (FATIGUE REOCCURENCE) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for COVID-19 prophylaxis.    Previously administered products included for Prophylactic vaccination: INFLUENZA VACCINE and INFLUENZA VACCINE. Past adverse reactions to the above products included Fatigue with INFLUENZA VACCINE; and Injection site warmth with INFLUENZA VACCINE. Concurrent medical conditions included Abstains from alcohol, Non-smoker, Fibromyalgia, Anxiety disorder, Heartburn (Occasional), Difficulty sleeping, Chronic fatigue syndrome and Drug allergy. Concomitant products included ALPRAZOLAM (XANAX) and NAPROXEN (MOTRIN [NAPROXEN]) for Anxiety disorder.   On 19-Mar-2021, the patient received first dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (unknown route) 1 dosage form. On 29-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced IMMUNISATION REACTION (ALMOST KILLED/A LONG LIST OF SIDE EFFECT), VACCINATION SITE WARMTH (LITTLE HEAT AT THE SITE OF INJECTION), PYREXIA (LOW GRADE FEVER) and FATIGUE (FATIGUE REOCCURENCE). On 29-Oct-2021, the patient experienced COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). In 2021, PYREXIA (LOW GRADE FEVER) had resolved. At the time of the report, IMMUNISATION REACTION (ALMOST KILLED/A LONG LIST OF SIDE EFFECT), VACCINATION SITE WARMTH (LITTLE HEAT AT THE SITE OF INJECTION), FATIGUE (FATIGUE REOCCURENCE), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) outcome was unknown.            The patient had no COVID infections after vaccination. Patient reported that adverse events were minor with no diarrhea and no vomiting.  Treatment medications were not reported.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Revaccination with different COVID-19 vaccine; Interchange of vaccine products; ALMOST KILLED/A LONG LIST OF SIDE EFFECT; LITTLE HEAT AT THE SITE OF INJECTION; LOW GRADE FEVER; FATIGUE REOCCURENCE; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (ALMOST KILLED/A LONG LIST OF SIDE EFFECT), VACCINATION SITE WARMTH (LITTLE HEAT AT THE SITE OF INJECTION), PYREXIA (LOW GRADE FEVER), FATIGUE (FATIGUE REOCCURENCE) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for COVID-19 prophylaxis.    Previously administered products included for Prophylactic vaccination: INFLUENZA VACCINE and INFLUENZA VACCINE. Past adverse reactions to the above products included Fatigue with INFLUENZA VACCINE; and Injection site warmth with INFLUENZA VACCINE. Concurrent medical conditions included Abstains from alcohol, Non-smoker, Fibromyalgia, Anxiety disorder, Heartburn (Occasional), Difficulty sleeping, Chronic fatigue syndrome and Drug allergy. Concomitant products included ALPRAZOLAM (XANAX) and NAPROXEN (MOTRIN [NAPROXEN]) for Anxiety disorder.   On 19-Mar-2021, the patient received first dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (unknown route) 1 dosage form. On 29-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced IMMUNISATION REACTION (ALMOST KILLED/A LONG LIST OF SIDE EFFECT), VACCINATION SITE WARMTH (LITTLE HEAT AT THE SITE OF INJECTION), PYREXIA (LOW GRADE FEVER) and FATIGUE (FATIGUE REOCCURENCE). On 29-Oct-2021, the patient experienced COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). In 2021, PYREXIA (LOW GRADE FEVER) had resolved. At the time of the report, IMMUNISATION REACTION (ALMOST KILLED/A LONG LIST OF SIDE EFFECT), VACCINATION SITE WARMTH (LITTLE HEAT AT THE SITE OF INJECTION), FATIGUE (FATIGUE REOCCURENCE), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) outcome was unknown.            The patient had no COVID infections after vaccination. Patient reported that adverse events were minor with no diarrhea and no vomiting.  Treatment medications were not reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pyrexia, Vertigo
Clinical narrative: Vertigo; Dizziness; Low grade fever; This spontaneous case was reported by a patient and describes the occurrence of VERTIGO (Vertigo), DIZZINESS (Dizziness) and PYREXIA (Low grade fever) in a 66-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy and Allergy to antibiotic (Macrolide). Concomitant products included ATENOLOL, IBUPROFEN (ADVIL [IBUPROFEN]) and OXYCODONE HYDROCHLORIDE, OXYCODONE TEREPHTHALATE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]) for an unknown indication.    On 01-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 01-Nov-2022, the patient experienced VERTIGO (Vertigo), DIZZINESS (Dizziness) and PYREXIA (Low grade fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VERTIGO (Vertigo), DIZZINESS (Dizziness) and PYREXIA (Low grade fever) outcome was unknown.            Patient did not have COVID-19 Positive test. Concomitant product included protonic for an unknown indication.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Adverse event; Received expired 2nd primary dose, 1.5 months after manufacturer expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired 2nd primary dose, 1.5 months after manufacturer expiration date) and NO ADVERSE EVENT (No Adverse event) in a 73-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 006M21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Nov-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 01-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired 2nd primary dose, 1.5 months after manufacturer expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired 2nd primary dose, 1.5 months after manufacturer expiration date) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Received expired 2nd primary dose, 1.5 months after manufacturer expiration date).    No concomitant medications were provided. Caller did not had information on first dose of patient. No treatment medication was provided.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered at inappropriate site
Clinical narrative: No adverse event; was given to her a few inches towards the back of the arm; This spontaneous case was reported by a patient and describes the occurrence of PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (was given to her a few inches towards the back of the arm) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 02-Nov-2022, the patient experienced PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (was given to her a few inches towards the back of the arm). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (was given to her a few inches towards the back of the arm) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant medication were reported. Patient received the booster. However, patient did not believe it was given in the deltoid muscle. It was given a few inches towards the back of the arm.  No treatment information was provided by the reporter.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Cyst, Pain
Clinical narrative: painful bump; cysts; This spontaneous case was reported by a patient and describes the occurrence of PAIN (painful bump) and CYST (cysts) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Blood pressure high and Diabetes.   In September 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 experienced PAIN (painful bump) and CYST (cysts). The patient was treated with IBUPROFEN for Pain, at an unspecified dose and frequency. At the time of the report, PAIN (painful bump) and CYST (cysts) outcome was unknown.            No concomitant medications were reported.  The patient went to the doctor and they want to get cysts removed.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product administration interrupted
Clinical narrative: patient had only one of the 1st 3 doses of the Covid-19 vaccines which was given "quite a few months ago; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (patient had only one of the 1st 3 doses of the Covid-19 vaccines which was given "quite a few months ago) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     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 PRODUCT ADMINISTRATION INTERRUPTED (patient had only one of the 1st 3 doses of the Covid-19 vaccines which was given "quite a few months ago) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (patient had only one of the 1st 3 doses of the Covid-19 vaccines which was given "quite a few months ago) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant information provided. No treatment information provided.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; received Moderna bivalent booster instead of primary series; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (received Moderna bivalent booster instead of primary series) and NO ADVERSE EVENT (No adverse event) in a 29-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 014H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 02-Nov-2022, the patient experienced WRONG PRODUCT ADMINISTERED (received Moderna bivalent booster instead of primary series). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (received Moderna bivalent booster instead of primary series) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (received Moderna bivalent booster instead of primary series).    Concomitant medication was not provided.  Treatment information was not provided.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Joint effusion, Mass, Pain in extremity, Pruritus
Clinical narrative: Big sacks underneath armpit, like fluid in the sack, it's skin but a sack underneath; Like you got fluid on the knee; Itches; Armpit was sore; Arms were sore; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Arms were sore), MASS (Big sacks underneath armpit, like fluid in the sack, it's skin but a sack underneath), JOINT EFFUSION (Like you got fluid on the knee), PRURITUS (Itches) and AXILLARY PAIN (Armpit was sore) in a 57-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 013H22A) for COVID-19 prophylaxis.     Concurrent medical conditions included Cholesterol. Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) for Cholesterol.    On 31-Oct-2022, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 01-Nov-2022, the patient experienced PAIN IN EXTREMITY (Arms were sore). On 02-Nov-2022, the patient experienced MASS (Big sacks underneath armpit, like fluid in the sack, it's skin but a sack underneath), JOINT EFFUSION (Like you got fluid on the knee), PRURITUS (Itches) and AXILLARY PAIN (Armpit was sore). At the time of the report, PAIN IN EXTREMITY (Arms were sore), MASS (Big sacks underneath armpit, like fluid in the sack, it's skin but a sack underneath), JOINT EFFUSION (Like you got fluid on the knee), PRURITUS (Itches) and AXILLARY PAIN (Armpit was sore) outcome was unknown.            Patient received first dose of Moderna COVID-19 Vaccine on 16-Apr-2021 (Batch number: 040B21A) and second dose of Moderna COVID-19 Vaccine on 14-May-2021 (Batch number: 022C21A).  Patient had not taken any medications following the vaccine.   This case was linked to US-MODERNATX, INC.-MOD-2022-668181 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-668181:Wife case :MOD22-028423
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Incorrect dose administered, No adverse event
Clinical narrative: No adverse event; accidentally given a bivalent booster dose; first dose more than 35 days ago; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (accidentally given a bivalent booster dose), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose more than 35 days ago) and NO ADVERSE EVENT (No adverse event) in a 31-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 017H22A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Nov-2022, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 02-Nov-2022, the patient experienced INCORRECT DOSE ADMINISTERED (accidentally given a bivalent booster dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose more than 35 days ago). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (accidentally given a bivalent booster dose), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose more than 35 days ago) and NO ADVERSE EVENT (No adverse event) outcome was unknown.    For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for INCORRECT DOSE ADMINISTERED (accidentally given a bivalent booster dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose more than 35 days ago).    Concomitant drugs were not reported. It was reported that patient received dose 1 of Moderna on 09-Feb-2022 and wanted to receive second dose but instead was administered bivalent booster dose. Treatment medications were not provided.