chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Psoriasis
Clinical narrative: her whole body was covered with spots/ spots did not truly went away but lightened/Her doctor states that the Moderna shot caused what she has which is psoriasis; This spontaneous case was reported by a patient and describes the occurrence of PSORIASIS (her whole body was covered with spots/ spots did not truly went away but lightened/Her doctor states that the Moderna shot caused what she has which is psoriasis) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A, 011A21A and 017F21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Blood pressure high, Penicillin allergy, Sulfonamide allergy and Drug allergy.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced PSORIASIS (her whole body was covered with spots/ spots did not truly went away but lightened/Her doctor states that the Moderna shot caused what she has which is psoriasis). The patient was treated with RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Psoriasis, at an unspecified dose and frequency. At the time of the report, PSORIASIS (her whole body was covered with spots/ spots did not truly went away but lightened/Her doctor states that the Moderna shot caused what she has which is psoriasis) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient did not had other vaccines in the 4 weeks prior to COVID-19 vaccine. Reporter stated that patient was okay after first dose. The next day after the 2nd dose patient whole body was covered with spots. Patient went to her dermatologis, primary care and was treated with all stuff. The spots did not went away but lightened. Patient was given anti-biotics and steroids. After the 3rd shot in Oct2021, she again got covered with spots and they have not gone away since. Patient doctor states that the Moderna shot caused psoriasis. Patient had gone to 5 doctors and used 15 creams. No concomitant medication were reported.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19 3 weeks ago; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19 3 weeks ago) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis.     Concurrent medical conditions included Immunocompromised.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19 3 weeks ago). At the time of the report, COVID-19 (COVID-19 3 weeks ago) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products reported.  It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19. Patient stated he was immunocompromised and already received 3 Moderna full shots. Patient came down with COVID-19 3 weeks ago, but currently he was negative. Patient stated he was running out of time and decided not to provide additional information on the case. It was unknown if patient experienced any adverse events after any of the vaccines.  No treatement products reported.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product dose omission issue
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Contact had received 1st dose of the Moderna COVID-19 vaccines in July. He has not received a second dose at this point in December.) and NO ADVERSE EVENT (No adverse event) in a 12-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In July 2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Contact had received 1st dose of the Moderna COVID-19 vaccines in July. He has not received a second dose at this point in December.) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Contact had received 1st dose of the Moderna COVID-19 vaccines in July. He has not received a second dose at this point in December.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.           No concomitant product reported by reporter. No treatment medication reported by reporter.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dizziness, Dyspnoea, Dysstasia, Gait disturbance
Clinical narrative: the area where the rash was is itchy; congestion; breathing issues; could not stand; had to crawl on the floor to get to the bathroom.; had ringing in her left ear; Pin Point Rash on her neck and torso; headache; fever; dizzy; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), PYREXIA (fever), DIZZINESS (dizzy), RASH (Pin Point Rash on her neck and torso) and RASH PRURITIC (the area where the rash was is itchy) in a 62-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 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE. Concurrent medical conditions included Asthma.    On 04-Dec-2022, 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 04-Dec-2022, the patient experienced HEADACHE (headache), PYREXIA (fever) and DIZZINESS (dizzy). On 05-Dec-2022, the patient experienced RASH (Pin Point Rash on her neck and torso). On an unknown date, the patient experienced RASH PRURITIC (the area where the rash was is itchy), NASAL CONGESTION (congestion), DYSPNOEA (breathing issues), DYSSTASIA (could not stand), GAIT DISTURBANCE (had to crawl on the floor to get to the bathroom.) and TINNITUS (had ringing in her left ear). At the time of the report, HEADACHE (headache), PYREXIA (fever), DIZZINESS (dizzy), RASH (Pin Point Rash on her neck and torso) and RASH PRURITIC (the area where the rash was is itchy) was resolving and NASAL CONGESTION (congestion), DYSPNOEA (breathing issues), DYSSTASIA (could not stand), GAIT DISTURBANCE (had to crawl on the floor to get to the bathroom.) and TINNITUS (had ringing in her left ear) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103 degrees Farenheight.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19. It was reported that patient received Pfizer vaccine for primary series. No treatment medication was provided.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nasal congestion, Pyrexia, Rash, Rash pruritic
Clinical narrative: the area where the rash was is itchy; congestion; breathing issues; could not stand; had to crawl on the floor to get to the bathroom.; had ringing in her left ear; Pin Point Rash on her neck and torso; headache; fever; dizzy; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), PYREXIA (fever), DIZZINESS (dizzy), RASH (Pin Point Rash on her neck and torso) and RASH PRURITIC (the area where the rash was is itchy) in a 62-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 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE. Concurrent medical conditions included Asthma.    On 04-Dec-2022, 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 04-Dec-2022, the patient experienced HEADACHE (headache), PYREXIA (fever) and DIZZINESS (dizzy). On 05-Dec-2022, the patient experienced RASH (Pin Point Rash on her neck and torso). On an unknown date, the patient experienced RASH PRURITIC (the area where the rash was is itchy), NASAL CONGESTION (congestion), DYSPNOEA (breathing issues), DYSSTASIA (could not stand), GAIT DISTURBANCE (had to crawl on the floor to get to the bathroom.) and TINNITUS (had ringing in her left ear). At the time of the report, HEADACHE (headache), PYREXIA (fever), DIZZINESS (dizzy), RASH (Pin Point Rash on her neck and torso) and RASH PRURITIC (the area where the rash was is itchy) was resolving and NASAL CONGESTION (congestion), DYSPNOEA (breathing issues), DYSSTASIA (could not stand), GAIT DISTURBANCE (had to crawl on the floor to get to the bathroom.) and TINNITUS (had ringing in her left ear) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103 degrees Farenheight.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19. It was reported that patient received Pfizer vaccine for primary series. No treatment medication was provided.
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: the area where the rash was is itchy; congestion; breathing issues; could not stand; had to crawl on the floor to get to the bathroom.; had ringing in her left ear; Pin Point Rash on her neck and torso; headache; fever; dizzy; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), PYREXIA (fever), DIZZINESS (dizzy), RASH (Pin Point Rash on her neck and torso) and RASH PRURITIC (the area where the rash was is itchy) in a 62-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 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE. Concurrent medical conditions included Asthma.    On 04-Dec-2022, 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 04-Dec-2022, the patient experienced HEADACHE (headache), PYREXIA (fever) and DIZZINESS (dizzy). On 05-Dec-2022, the patient experienced RASH (Pin Point Rash on her neck and torso). On an unknown date, the patient experienced RASH PRURITIC (the area where the rash was is itchy), NASAL CONGESTION (congestion), DYSPNOEA (breathing issues), DYSSTASIA (could not stand), GAIT DISTURBANCE (had to crawl on the floor to get to the bathroom.) and TINNITUS (had ringing in her left ear). At the time of the report, HEADACHE (headache), PYREXIA (fever), DIZZINESS (dizzy), RASH (Pin Point Rash on her neck and torso) and RASH PRURITIC (the area where the rash was is itchy) was resolving and NASAL CONGESTION (congestion), DYSPNOEA (breathing issues), DYSSTASIA (could not stand), GAIT DISTURBANCE (had to crawl on the floor to get to the bathroom.) and TINNITUS (had ringing in her left ear) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103 degrees Farenheight.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19. It was reported that patient received Pfizer vaccine for primary series. No treatment medication was provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache
Clinical narrative: headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) and CHILLS (chills) in a 71-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 120109714402) for COVID-19 prophylaxis.     The patient's past medical history included Disorder thyroid. Previously administered products included for Product used for unknown indication: Influenza vaccine two weeks before; for COVID-19 prophylaxis: MODERNA COVID-19 VACCINE. Past adverse reactions to the above products included No adverse event with Influenza vaccine two weeks before and MODERNA COVID-19 VACCINE.    On 09-Dec-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 an unknown date, the patient experienced HEADACHE (headache) and CHILLS (chills). At the time of the report, HEADACHE (headache) and CHILLS (chills) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 97.     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 medication was not provided.  Treatment medication information was not provided by the reporter.  There was no parental vaccine exposure.  Patient received other vaccines in the 4 weeks prior to COVID-19 vaccine.  Information about previous COVID-19 vaccination doses was provided.
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: such as passing out; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (such as passing out) in an adult male patient 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 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. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (such as passing out) (seriousness criterion medically significant). At the time of the report, LOSS OF CONSCIOUSNESS (such as passing out) outcome was unknown.        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.   No concomitant medications were reported. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Treatment information was not provided.  Company comment: This spontaneous case concerns an adult male patient with no reported medical history, who experienced the unexpected serious (medically significant) event of Loss of consciousness, with an unknown time to onset, after receiving a dose of mRNA-1273.222 bivalent vaccine. No information on risk factors, detailed clinical course, investigations, treatment of the event and outcome was available in the report. The benefit-risk relationship of mRNA-1273.222 bivalent vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns an adult male patient with no reported medical history, who experienced the unexpected serious (medically significant) event of Loss of consciousness, with an unknown time to onset, after receiving a dose of mRNA-1273.222 bivalent vaccine. No information on risk factors, detailed clinical course, investigations, treatment of the event and outcome was available in the report. The benefit-risk relationship of mRNA-1273.222 bivalent vaccine is not affected by this report.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Neoplasm malignant
Clinical narrative: cancer; illness; This spontaneous case was reported by a consumer and describes the occurrence of NEOPLASM MALIGNANT (cancer) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054A22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NEOPLASM MALIGNANT (cancer) (seriousness criterion medically significant) and ILLNESS (illness). At the time of the report, NEOPLASM MALIGNANT (cancer) and ILLNESS (illness) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. On 9-DEC-2022, Patient was scheduled to get the 3rd booster, but had to cancel it twice because of an illness. This illness was a recurrence of her cancer. Contact is a cancer patient and is wondering if this variant booster or previous boosters alter any CA-125 factors. One of doctors she has spoken to had mentioned that he had read an article that breast cancer patients who got the vaccine had elevated blood markers. She was now received  chemotherapy.   Treatment information was not provided.  Company Comment This spontaneous case concerns a 69-years-old female patient, with no medical history reported who experienced the unexpected events of neoplasm malignant (seriousness criterion medically significant) and illness unknown days after 4th.  dose of  mRNA- 1273 vaccine. This illness was a recurrence of her cancer; the patient is wondering if this dose or previous boosters alter any CA-125 factors. The benefit-risk relationship of mrna-1273 vaccine is not affected by this report. Events seriousness was assessed based on medical judgement.; Sender's Comments: Company Comment This spontaneous case concerns a 69-years-old female patient, with no medical history reported who experienced the unexpected events of neoplasm malignant (seriousness criterion medically significant) and illness unknown days after 4th.  dose of  mRNA- 1273 vaccine. This illness was a recurrence of her cancer; the patient is wondering if this dose or previous boosters alter any CA-125 factors. The benefit-risk relationship of mrna-1273 vaccine is not affected by this report. Events seriousness was assessed based on medical judgement.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, COVID-19 immunisation, Chills, Fatigue, Headache
Clinical narrative: fatigue; headache; joint pains; chills; nausea; fever; Muscle pain; Revaccination with different Covid-19 vaccine; Interchange of vaccine products; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 IMMUNISATION (Revaccination with different Covid-19 vaccine), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products), FATIGUE (fatigue), HEADACHE (headache) and ARTHRALGIA (joint pains) in a 52-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7167B) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     There was no parental vaccine exposure.  The patient's past medical history included Ovarian cancer, Endometrial cancer and Skin cancer. Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (First dose. Lot number: ER8732) on 29-Mar-2021, PFIZER BIONTECH COVID-19 VACCINE (Second dose. Lot number: ER8736) on 24-Apr-2021, PFIZER BIONTECH COVID-19 VACCINE (First booster. Lot number: FH8028) on 05-Nov-2021 and INFLUENZA. Past adverse reactions to the above products included No adverse event with INFLUENZA, PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE. Concurrent medical conditions included Type 2 diabetes mellitus, Lynch syndrome and Colorectal cancer.    On 30-Nov-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 30-Nov-2022, the patient experienced COVID-19 IMMUNISATION (Revaccination with different Covid-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). On 01-Dec-2022, the patient experienced FATIGUE (fatigue), HEADACHE (headache), ARTHRALGIA (joint pains), CHILLS (chills), NAUSEA (nausea), PYREXIA (fever) and MYALGIA (Muscle pain). On 04-Dec-2022, FATIGUE (fatigue), HEADACHE (headache), ARTHRALGIA (joint pains), CHILLS (chills), NAUSEA (nausea), PYREXIA (fever) and MYALGIA (Muscle pain) had resolved. At the time of the report, COVID-19 IMMUNISATION (Revaccination with different Covid-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) outcome was unknown.        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 medication was not reported.  Patient had side effects the day after getting the Moderna bivalent booster dose (2nd booster but 1st Moderna vaccine). She experienced the following fatigue, headache, muscle and joint pains chills nausea and fever, the day after 30-Nov-2022 and these resolved on 04-Dec-2022. Treatment details were not reported.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products, Myalgia, Nausea, Pyrexia
Clinical narrative: fatigue; headache; joint pains; chills; nausea; fever; Muscle pain; Revaccination with different Covid-19 vaccine; Interchange of vaccine products; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 IMMUNISATION (Revaccination with different Covid-19 vaccine), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products), FATIGUE (fatigue), HEADACHE (headache) and ARTHRALGIA (joint pains) in a 52-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7167B) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     There was no parental vaccine exposure.  The patient's past medical history included Ovarian cancer, Endometrial cancer and Skin cancer. Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (First dose. Lot number: ER8732) on 29-Mar-2021, PFIZER BIONTECH COVID-19 VACCINE (Second dose. Lot number: ER8736) on 24-Apr-2021, PFIZER BIONTECH COVID-19 VACCINE (First booster. Lot number: FH8028) on 05-Nov-2021 and INFLUENZA. Past adverse reactions to the above products included No adverse event with INFLUENZA, PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE. Concurrent medical conditions included Type 2 diabetes mellitus, Lynch syndrome and Colorectal cancer.    On 30-Nov-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 30-Nov-2022, the patient experienced COVID-19 IMMUNISATION (Revaccination with different Covid-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). On 01-Dec-2022, the patient experienced FATIGUE (fatigue), HEADACHE (headache), ARTHRALGIA (joint pains), CHILLS (chills), NAUSEA (nausea), PYREXIA (fever) and MYALGIA (Muscle pain). On 04-Dec-2022, FATIGUE (fatigue), HEADACHE (headache), ARTHRALGIA (joint pains), CHILLS (chills), NAUSEA (nausea), PYREXIA (fever) and MYALGIA (Muscle pain) had resolved. At the time of the report, COVID-19 IMMUNISATION (Revaccination with different Covid-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) outcome was unknown.        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 medication was not reported.  Patient had side effects the day after getting the Moderna bivalent booster dose (2nd booster but 1st Moderna vaccine). She experienced the following fatigue, headache, muscle and joint pains chills nausea and fever, the day after 30-Nov-2022 and these resolved on 04-Dec-2022. Treatment details were not reported.
Age: 78.0
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Gait disturbance, Illness
Clinical narrative: I could barely talk. My voice sounded awful & terrible. It gets worse if I talk longer.; I couldn't go 2 steps without my walker. I was losing my ability to walk/I feel like I'm paralyzed; I feel like the door shut in my head; The muscles in my arms & legs & my back. It was like my arms & legs were frozen; fever; ill; cold; shivering; was very tired; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), ILLNESS (ill), NASOPHARYNGITIS (cold), CHILLS (shivering) and FATIGUE (was very tired) in a 78-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Patient had gate unsteady at times & uses walker at times.  The patient's past medical history included Breast cancer. Concurrent medical conditions included Blood pressure high and Unsteady gait (gate unsteady at times & uses walker at times).    On 02-Nov-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 03-Nov-2022, the patient experienced PYREXIA (fever), ILLNESS (ill), NASOPHARYNGITIS (cold), CHILLS (shivering), FATIGUE (was very tired) and MUSCLE SPASMS (The muscles in my arms & legs & my back. It was like my arms & legs were frozen). On an unknown date, the patient experienced SPEECH DISORDER (I could barely talk. My voice sounded awful & terrible. It gets worse if I talk longer.), GAIT DISTURBANCE (I couldn't go 2 steps without my walker. I was losing my ability to walk/I feel like I'm paralyzed) and FEELING ABNORMAL (I feel like the door shut in my head). At the time of the report, PYREXIA (fever), ILLNESS (ill), NASOPHARYNGITIS (cold) and CHILLS (shivering) was resolving and FATIGUE (was very tired), SPEECH DISORDER (I could barely talk. My voice sounded awful & terrible. It gets worse if I talk longer.), GAIT DISTURBANCE (I couldn't go 2 steps without my walker. I was losing my ability to walk/I feel like I'm paralyzed), MUSCLE SPASMS (The muscles in my arms & legs & my back. It was like my arms & legs were frozen) and FEELING ABNORMAL (I feel like the door shut in my head) outcome was unknown.        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.   No concomitant medication was reported. Patient felt like paralyzed. Physical Therapy done. On 10-Nov-2022 patient went to urgent care. They said it was a severe reaction & that it would go away.
Age: 78.0
Sex: U
Vaccine: COVID19
Symptoms: Muscle spasms, Nasopharyngitis, Pyrexia, Speech disorder
Clinical narrative: I could barely talk. My voice sounded awful & terrible. It gets worse if I talk longer.; I couldn't go 2 steps without my walker. I was losing my ability to walk/I feel like I'm paralyzed; I feel like the door shut in my head; The muscles in my arms & legs & my back. It was like my arms & legs were frozen; fever; ill; cold; shivering; was very tired; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), ILLNESS (ill), NASOPHARYNGITIS (cold), CHILLS (shivering) and FATIGUE (was very tired) in a 78-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Patient had gate unsteady at times & uses walker at times.  The patient's past medical history included Breast cancer. Concurrent medical conditions included Blood pressure high and Unsteady gait (gate unsteady at times & uses walker at times).    On 02-Nov-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 03-Nov-2022, the patient experienced PYREXIA (fever), ILLNESS (ill), NASOPHARYNGITIS (cold), CHILLS (shivering), FATIGUE (was very tired) and MUSCLE SPASMS (The muscles in my arms & legs & my back. It was like my arms & legs were frozen). On an unknown date, the patient experienced SPEECH DISORDER (I could barely talk. My voice sounded awful & terrible. It gets worse if I talk longer.), GAIT DISTURBANCE (I couldn't go 2 steps without my walker. I was losing my ability to walk/I feel like I'm paralyzed) and FEELING ABNORMAL (I feel like the door shut in my head). At the time of the report, PYREXIA (fever), ILLNESS (ill), NASOPHARYNGITIS (cold) and CHILLS (shivering) was resolving and FATIGUE (was very tired), SPEECH DISORDER (I could barely talk. My voice sounded awful & terrible. It gets worse if I talk longer.), GAIT DISTURBANCE (I couldn't go 2 steps without my walker. I was losing my ability to walk/I feel like I'm paralyzed), MUSCLE SPASMS (The muscles in my arms & legs & my back. It was like my arms & legs were frozen) and FEELING ABNORMAL (I feel like the door shut in my head) outcome was unknown.        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.   No concomitant medication was reported. Patient felt like paralyzed. Physical Therapy done. On 10-Nov-2022 patient went to urgent care. They said it was a severe reaction & that it would go away.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: Allergy; This spontaneous case was reported by an other health care professional and describes the occurrence of HYPERSENSITIVITY (Allergy) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (Allergy). At the time of the report, HYPERSENSITIVITY (Allergy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided. No treatment information provided.       Reporter did not allow further contact
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: feeling a little tired / Patient laid in bed all day/ Patient went to bed; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (feeling a little tired / Patient laid in bed all day/ Patient went to bed) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 054A22A, 012L20A and 031L20A) for COVID-19 prophylaxis.     Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included ADALIMUMAB (HUMIRA) and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) from 21-Nov-2021 to an unknown date for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Jun-2022, received 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 02-Jun-2022, the patient experienced FATIGUE (feeling a little tired / Patient laid in bed all day/ Patient went to bed). At the time of the report, FATIGUE (feeling a little tired / Patient laid in bed all day/ Patient went to bed) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Some adult patients received Bivalent as first dose and some received Bivalent as 2nd primary dose; No Adverse Event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Some adult patients received Bivalent as first dose and some received Bivalent as 2nd primary dose) and NO ADVERSE EVENT (No Adverse Event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 061F22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Some adult patients received Bivalent as first dose and some received Bivalent as 2nd primary dose) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, WRONG PRODUCT ADMINISTERED (Some adult patients received Bivalent as first dose and some received Bivalent as 2nd primary dose) 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 (Some adult patients received Bivalent as first dose and some received Bivalent as 2nd primary dose).    No concomitant medications were reported.  Reporter stated that patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine as Unknown.  It was reported Some of the patients came from another country and they do not had any way of identifying what the original series were. Date of administrations were several different days.  No treatment medications were reported.
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Diarrhoea
Clinical narrative: covid 19; diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (covid 19) and DIARRHOEA (diarrhea) in a 76-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7167B) for COVID-19 prophylaxis.    Co-suspect product included mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (1st dose) in January 2021, Moderna COVID-19 Vaccine (2nd Dose, Lot#022M20A) on 25-Feb-2021, Moderna COVID-19 Vaccine (1st booster (Dose 3)Lot number- 939903 ) on 10-Nov-2021 and Moderna COVID-19 Vaccine (2nd booster dose(Dose 4) : 09Apr2022 004M21A) on 09-Apr-2022; for Product used for unknown indication: Flu Shot. Past adverse reactions to the above products included No adverse event with Flu Shot, Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine. Concurrent medical conditions included Lung cancer.   On 08-Dec-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Dec-2022, the patient experienced COVID-19 (covid 19) and DIARRHOEA (diarrhea). The patient was treated with TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (covid 19) and DIARRHOEA (diarrhea) had not resolved.        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. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient took  daily thyroid pills THYROID THERAPY as a concomitant drug. Patient had a feeling it was a mild reaction to the booster. Patient reported that they got a mild case of Covid back in March or April2022 and the warning sign was diarrhea.  Patient  took the Pfizer drug that took care of covid in 4 days.
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: heart razing; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PALPITATIONS (heart razing) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     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. On an unknown date, the patient experienced PALPITATIONS (heart razing). At the time of the report, PALPITATIONS (heart razing) outcome was unknown.            Age of patient was reported as 58 or 59 years old.  No concomitant product use was reported.  It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Reporter stated that her sister had heart razing with the booster.  No treatment information was provided.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Given dose of bivalent vaccine as first dose of COVID-19 vaccines; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Given dose of bivalent vaccine as first dose of COVID-19 vaccines) and NO ADVERSE EVENT (No adverse event) in a 64-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 015H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Dec-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 09-Dec-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (Given dose of bivalent vaccine as first dose of COVID-19 vaccines). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Given dose of bivalent vaccine as first dose of COVID-19 vaccines) 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 (Given dose of bivalent vaccine as first dose of COVID-19 vaccines).    Concomitant product use was not provided by the reporter. Patient did not received any other vaccines in the four weeks prior to COVID-19 vaccine. Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Bed rest, Fatigue
Clinical narrative: Very tired; stayed in bed for a day; This spontaneous case was reported by a consumer and describes the occurrence of BED REST (stayed in bed for a day) and FATIGUE (Very tired) in an adult female patient who received mRNA-1273 (Spikevax) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced BED REST (stayed in bed for a day) and FATIGUE (Very tired). At the time of the report, BED REST (stayed in bed for a day) had resolved and FATIGUE (Very tired) 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.   Concomitant medication list was not provided. It was reported that when the reporters supervisor at work received the first dose of primary series vaccine that patient became very tired and stayed in bed for a day. Treatment information was not provided.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement
Clinical narrative: elevated blood pressure/reading was 142 over something /reading that said 134/68; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (elevated blood pressure/reading was 142 over something /reading that said 134/68) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     The patient's past medical history included Meniere's disease. Concurrent medical conditions included Blood pressure. Concomitant products included HYDROCHLOROTHIAZIDE, TRIAMTERENE (TRIAMTERENE/HYDROCHLOROTHIAZIDE) and CLOPIDOGREL BISULFATE (PLAVIX) for an unknown indication.    On 11-Nov-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 16-Nov-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced BLOOD PRESSURE INCREASED (elevated blood pressure/reading was 142 over something /reading that said 134/68). At the time of the report, BLOOD PRESSURE INCREASED (elevated blood pressure/reading was 142 over something /reading that said 134/68) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Oct-2022, Blood pressure measurement: 104/70. On an unknown date, Blood pressure measurement: 134/68.     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.   It was reported that patient got all 5 Moderna shots: 2 initial and 3 booster. Patient received Moderna COVID-19 Vaccine and Spikevax. All of a sudden, for the first time, he was walking with elevated blood pressure. He had been working with his doctor, who doubled the dosage of his triamterene/hydrochlorothiazide. However, he had not much impact on reducing his blood pressure. His arm was not even sore. Around 21 Oct 2022, the patient stopped taking Plavix. On 26 Oct 2022, he went for the annual physical with his PCP, and his blood pressure was 104/70. On 11 Nov 2022, he took the COVID booster shot. On 16 Nov 2022, he saw his gastroenterologist, who told him he had elevated blood pressure, but might be he was nervous about talking about his next colonoscopy. His blood pressure reading was 142 over something (unknown). The doctor thought he heard something in his heart and took a second manual reading that said 134/68. His blood pressure had been between 135-150 ever since. He stated it was a heart attack risk. There was no diagnosis of myocarditis or pericarditis.
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: patient was supposed to sign up for his first dose of the Moderna COVID-19 vaccine but accidentally signed up for the booster dose instead; No Adverse Event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (patient was supposed to sign up for his first dose of the Moderna COVID-19 vaccine but accidentally signed up for the booster dose instead) and NO ADVERSE EVENT (No Adverse Event) in an adult male patient 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 an unknown date, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (patient was supposed to sign up for his first dose of the Moderna COVID-19 vaccine but accidentally signed up for the booster dose instead) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, WRONG PRODUCT ADMINISTERED (patient was supposed to sign up for his first dose of the Moderna COVID-19 vaccine but accidentally signed up for the booster dose instead) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) 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 (patient was supposed to sign up for his first dose of the Moderna COVID-19 vaccine but accidentally signed up for the booster dose instead).    No concomitant medications were reported.   Healthcare professional reported that, there was an incident at the store where a patient was supposed to sign up for his first dose of the Moderna COVID-19 vaccine but accidentally signed up for the booster dose instead. When he came to the pharmacy, per his paperwork he was administered a dose of the Moderna COVID-19 bivalent booster shot instead of his 1st dose. The patient did not report any adverse reactions.  No treatment details were reported.   Reporter did not allow further contact