chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: LITTLE BIT SLEEPY; This spontaneous report received from a patient concerned a male of unspecified age, ethnic origin and race. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, administered on an unspecified date for covid-19 prophylaxis.  On an unspecified date, the patient experienced little bit sleepy and fatigue (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, administered on an unspecified date for covid-19 prophylaxis. The batch number was not reported and has been requested.  No concomitant medications were reported.  On an unspecified date, the patient was a little bit sleepy (dose number in series 2), the patient was feeling this way for 1 day.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from little bit sleepy. This report was non-serious. This case, involving the same patient is linked to 20221012790.
Age: 45.0
Sex: F
Vaccine: COVID19-2
Symptoms: Heavy menstrual bleeding, Influenza
Clinical narrative: Flu; Bleeding; This spontaneous case was reported by a pharmacist and describes the occurrence of INFLUENZA (Flu) and HEAVY MENSTRUAL BLEEDING (Bleeding) in a 45-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 060f22a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 06-Oct-2022, the patient experienced HEAVY MENSTRUAL BLEEDING (Bleeding). On an unknown date, the patient experienced INFLUENZA (Flu). At the time of the report, INFLUENZA (Flu) and HEAVY MENSTRUAL BLEEDING (Bleeding) was resolving.        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 medicine were reported. No treatment medicine were reported.
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product dose omission issue
Clinical narrative: Patient has not received the 2nd primary dose of the Moderna Covid19 vaccine in more than a year; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient has not received the 2nd primary dose of the Moderna Covid19 vaccine in more than a year) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In 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 PRODUCT DOSE OMISSION ISSUE (Patient has not received the 2nd primary dose of the Moderna Covid19 vaccine in more than a year) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient has not received the 2nd primary dose of the Moderna Covid19 vaccine in more than a year) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT DOSE OMISSION ISSUE (Patient has not received the 2nd primary dose of the Moderna Covid19 vaccine in more than a year).    No concomitant medication reported.  Reporter was asking about a second dose of a Moderna COVID-19 vaccine. She stated that a woman that was not pregnant received the Moderna COVID-19 vaccine first primary series last year and now would like to receive a second dose, but she was currently pregnant and would like to receive the second dose. Pregnant patient was not vaccinated yet. No treatment medication reported.
Age: 56.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Aphasia, Bedridden, Thinking abnormal
Clinical narrative: Neurological symptoms such as disorganized thinking; trouble finding words; Bedridden for three days; This spontaneous case was reported by a patient family member or friend and describes the occurrence of BEDRIDDEN (Bedridden for three days), THINKING ABNORMAL (Neurological symptoms such as disorganized thinking) and APHASIA (trouble finding words) in a 56-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7163B) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.    No Medical History information was reported.   On 29-Sep-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 and dose of INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) (unknown route) 1 dosage form. On 04-Oct-2022, the patient experienced THINKING ABNORMAL (Neurological symptoms such as disorganized thinking) and APHASIA (trouble finding words). On an unknown date, the patient experienced BEDRIDDEN (Bedridden for three days). At the time of the report, BEDRIDDEN (Bedridden for three days) had resolved and THINKING ABNORMAL (Neurological symptoms such as disorganized thinking) and APHASIA (trouble finding words) outcome was unknown.            No concomitant medications were reported. The patient was in mid-50s.  The patient's previous Moderna vaccinations included dose 1 received on 02-Apr-2021 (lot number: 021B21A), dose 2 received on 30-Apr-2021 (lot number: 005C21A), dose 3 (first booster) received on 10-Dec-2021 (lot number: 069F21A) and dose 4 (second booster) received on 05-May-2021 (lot number: 0571421A). The patient usually only experienced the normal headache/fever reactions 48 hours after receiving previous doses.  It was reported that, the patient had several symptoms after bivalent booster dose. The patient was bedridden for 3 days after receiving the booster. On day 5 after receiving the booster, the patient felt fine starting off the day but started work with neurological symptoms such as disorganized thinking and trouble finding words. The patient found the neurological reaction weird and concerning.   No treatment details were reported.   This case was linked to MOD-2022-656156 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Oct-2022: Live follow-up information included patient's details (initials, date of birth and age), vaccine information (vaccination date, batch lot number, dose number) updated, event onset date as per vaccination date updated and previous vaccination and reaction details updated in narrative supplement.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: headache; Fever; This spontaneous case was reported by a patient family member or friend and describes the occurrence of HEADACHE (headache) and PYREXIA (Fever) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 057M21A, 069F21A, 005C21A and 021B21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache) and PYREXIA (Fever). At the time of the report, HEADACHE (headache) and PYREXIA (Fever) outcome was unknown.            No concomitant medications were reported.   It was reported that,the patient was in her mid 50s, patient usually experienced the normal headache or fever reaction 48 hours after she receive previous shots.  No treatment details were reported.   This case was linked to MOD-2022-656151 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Oct-2022: Live significant follow up received contains vaccination details and patient name were reported.
Age: 70.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Body temperature, COVID-19, Chest discomfort, Decreased appetite, SARS-CoV-2 test
Clinical narrative: COVID-19 / Tested positive three days after his son tested positive.; tightness in his chest; Appetite dropped; This spontaneous case was reported by a patient and describes the occurrence of CHEST DISCOMFORT (tightness in his chest), DECREASED APPETITE (Appetite dropped) and COVID-19 (COVID-19 / Tested positive three days after his son tested positive.) in a 70-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE for an unknown indication.    Concurrent medical conditions included Prostate cancer (Treatment with radiation.), Blood pressure high, Diabetes and Hypercholesteremia. Concomitant products included SIMVASTATIN for Hypercholesteremia.   On 09-Sep-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 and dose of INFLUENZA VACCINE (unknown route) 1 dosage form. In September 2022, the patient experienced CHEST DISCOMFORT (tightness in his chest) and DECREASED APPETITE (Appetite dropped). On 27-Sep-2022, the patient experienced COVID-19 (COVID-19 / Tested positive three days after his son tested positive.). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) (oral) from 28-Sep-2022 to 02-Oct-2022 for COVID-19 treatment, at a dose of 3 in morning and 3 at night for 5 days. On 03-Oct-2022, COVID-19 (COVID-19 / Tested positive three days after his son tested positive.) had resolved. At the time of the report, CHEST DISCOMFORT (tightness in his chest) and DECREASED APPETITE (Appetite dropped) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2022, Weight: Weight has dropped from 160 bs. On 27-Sep-2022, SARS-CoV-2 test: (Positive) Positive. On 28-Sep-2022, Body temperature: 101.7 and 102. On 03-Oct-2022, SARS-CoV-2 test: (Negative) Negative. In October 2022, Body temperature: 69.9. On an unknown date, Body temperature: 97.8, 97.0, 97.7 and 97.1.         Concomitant products were not reported.    It was reported that patient was more susceptible to colds and the Flu.  It was reported that patient received dose 1 on 25-Feb-2021, dose 2 on 25-Mar-2021, dose 3 on 04-Nov-2021, dose 4 on 28-May-2022. Also received the flu shot the same day as the Moderna Covid-19 Booster Vaccine in Sep2022. Patient had ill effects. patient had raw throat and tightness in chest. Fever went on, scratchy throat came within a day. Sore throat started up one or two days after being diagnosed. All subsided after that.   Did the self home test for Covid-19 on Tuesday, 27Sep2022 at midnight and following day got Paxlovid and started it that evening on the 28Sep2022. Patient had to track his blood pressure and blood sugar too.
Age: 70.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Weight
Clinical narrative: COVID-19 / Tested positive three days after his son tested positive.; tightness in his chest; Appetite dropped; This spontaneous case was reported by a patient and describes the occurrence of CHEST DISCOMFORT (tightness in his chest), DECREASED APPETITE (Appetite dropped) and COVID-19 (COVID-19 / Tested positive three days after his son tested positive.) in a 70-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE for an unknown indication.    Concurrent medical conditions included Prostate cancer (Treatment with radiation.), Blood pressure high, Diabetes and Hypercholesteremia. Concomitant products included SIMVASTATIN for Hypercholesteremia.   On 09-Sep-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 and dose of INFLUENZA VACCINE (unknown route) 1 dosage form. In September 2022, the patient experienced CHEST DISCOMFORT (tightness in his chest) and DECREASED APPETITE (Appetite dropped). On 27-Sep-2022, the patient experienced COVID-19 (COVID-19 / Tested positive three days after his son tested positive.). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) (oral) from 28-Sep-2022 to 02-Oct-2022 for COVID-19 treatment, at a dose of 3 in morning and 3 at night for 5 days. On 03-Oct-2022, COVID-19 (COVID-19 / Tested positive three days after his son tested positive.) had resolved. At the time of the report, CHEST DISCOMFORT (tightness in his chest) and DECREASED APPETITE (Appetite dropped) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2022, Weight: Weight has dropped from 160 bs. On 27-Sep-2022, SARS-CoV-2 test: (Positive) Positive. On 28-Sep-2022, Body temperature: 101.7 and 102. On 03-Oct-2022, SARS-CoV-2 test: (Negative) Negative. In October 2022, Body temperature: 69.9. On an unknown date, Body temperature: 97.8, 97.0, 97.7 and 97.1.         Concomitant products were not reported.    It was reported that patient was more susceptible to colds and the Flu.  It was reported that patient received dose 1 on 25-Feb-2021, dose 2 on 25-Mar-2021, dose 3 on 04-Nov-2021, dose 4 on 28-May-2022. Also received the flu shot the same day as the Moderna Covid-19 Booster Vaccine in Sep2022. Patient had ill effects. patient had raw throat and tightness in chest. Fever went on, scratchy throat came within a day. Sore throat started up one or two days after being diagnosed. All subsided after that.   Did the self home test for Covid-19 on Tuesday, 27Sep2022 at midnight and following day got Paxlovid and started it that evening on the 28Sep2022. Patient had to track his blood pressure and blood sugar too.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, No adverse event
Clinical narrative: Patient received booster during pregnancy; No adverse event; This spontaneous retrospective pregnancy case was reported by a patient and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Patient received booster during pregnancy) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Patient received booster during pregnancy) and NO ADVERSE EVENT (No adverse event). The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Delivered NOS. At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Patient received booster during pregnancy) had resolved and NO ADVERSE EVENT (No adverse event) outcome was unknown.    No concomitant and treatment medications were reported.  Patient received a booster while being pregnant. Patient received 4 doses of the Moderna COVID-19 vaccine.  Company comment: This spontaneous case concerns a pregnant patient of unknown age with no reported medical history who received the third dose of mRNA1273 at an unspecified stage of her pregnancy (maternal exposure during pregnancy). Latency of the event maternal exposure during pregnancy cannot be fully established since the exact onset date was not reported. The last menstrual period and gestational age of the patient was not provided in the case. Information regarding other COVID-19 vaccine were not mentioned. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2022-656363 (Patient Link).; Sender's Comments: This spontaneous case concerns a pregnant patient of unknown age with no reported medical history who received the third dose of mRNA1273 at an unspecified stage of her pregnancy (maternal exposure during pregnancy). Latency of the event maternal exposure during pregnancy cannot be fully established since the exact onset date was not reported. The last menstrual period and gestational age of the patient was not provided in the case. Information regarding other COVID-19 vaccine were not mentioned. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: fever; chills; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (fever) and CHILLS (chills) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A, 015M20A and 011D21A) for COVID-19 vaccination.     The patient had no allergy.  The patient had no mentioned AE and both acute and chronic illness at the time of vaccination.  Concomitant products included DOXYCYCLINE for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jan-2021, the patient experienced PYREXIA (fever) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. On 28-Jan-2021, PYREXIA (fever) and CHILLS (chills) had resolved.            The height was 175.25 cm (5 feet9 inch).  The patient had episodes of fever and chills after each administered dose. The episodes of fever and chills occurred 36 hours of the first dose .On 23-Feb-2021, during 24 hours of the second dose, the patient had fever and chills and the events recovered on 24-Feb-2021. On 10-Dec-2021, during 24 hours of the first booster dose, the patient  had fever and chills and the events recovered on 11-Dec-2021.  Patient had not received other vaccines within one month prior to moderna covid-19 vaccine. The patient had not seek any medical care because of adverse event. Also patient had no similar events in the past.   This case was linked to MOD-2022-656373 (Patient Link).
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Feeling abnormal, Irritability
Clinical narrative: morning he felt sleepy; lost appetite; felt a little funny before going to bed/ brain was foggy, not working with the usual ability,he had trouble sorting things out; little irritability; overnight fever; chills; nausea; fatigue; This spontaneous case was reported by a patient and describes the occurrence of SOMNOLENCE (morning he felt sleepy), DECREASED APPETITE (lost appetite), FEELING ABNORMAL (felt a little funny before going to bed/ brain was foggy, not working with the usual ability,he had trouble sorting things out), IRRITABILITY (little irritability) and PYREXIA (overnight fever) in an 80-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     It was reported that patient had no allergies. Patient never had COVID positive test or diagnosis.  Concurrent medical conditions included Hypothyroidism, Blood pressure abnormal, Heart disease, unspecified, Cardiac fibrillation (heart rate), Hemochromatosis and Heart rate abnormal. Concomitant products included RIVAROXABAN (XARELTO) for Anticoagulant therapy, METOPROLOL SUCCINATE (TOPROL) for Blood pressure management and Heart rate abnormal, VITAMINS NOS, ASPIRIN [ACETYLSALICYLIC ACID] and DOXYCYCLINE for an unknown indication.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (morning he felt sleepy), DECREASED APPETITE (lost appetite), FEELING ABNORMAL (felt a little funny before going to bed/ brain was foggy, not working with the usual ability,he had trouble sorting things out), IRRITABILITY (little irritability), PYREXIA (overnight fever), CHILLS (chills), NAUSEA (nausea) and FATIGUE (fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, SOMNOLENCE (morning he felt sleepy), DECREASED APPETITE (lost appetite), FEELING ABNORMAL (felt a little funny before going to bed/ brain was foggy, not working with the usual ability,he had trouble sorting things out), IRRITABILITY (little irritability), PYREXIA (overnight fever), CHILLS (chills), NAUSEA (nausea) and FATIGUE (fatigue) was resolving.            Concomitant medication included Thyroid medication for Hypothyroidism. It was reported that patient did not any seek medical care.   This case was linked to MOD-2022-656368 (Patient Link).
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Somnolence
Clinical narrative: morning he felt sleepy; lost appetite; felt a little funny before going to bed/ brain was foggy, not working with the usual ability,he had trouble sorting things out; little irritability; overnight fever; chills; nausea; fatigue; This spontaneous case was reported by a patient and describes the occurrence of SOMNOLENCE (morning he felt sleepy), DECREASED APPETITE (lost appetite), FEELING ABNORMAL (felt a little funny before going to bed/ brain was foggy, not working with the usual ability,he had trouble sorting things out), IRRITABILITY (little irritability) and PYREXIA (overnight fever) in an 80-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     It was reported that patient had no allergies. Patient never had COVID positive test or diagnosis.  Concurrent medical conditions included Hypothyroidism, Blood pressure abnormal, Heart disease, unspecified, Cardiac fibrillation (heart rate), Hemochromatosis and Heart rate abnormal. Concomitant products included RIVAROXABAN (XARELTO) for Anticoagulant therapy, METOPROLOL SUCCINATE (TOPROL) for Blood pressure management and Heart rate abnormal, VITAMINS NOS, ASPIRIN [ACETYLSALICYLIC ACID] and DOXYCYCLINE for an unknown indication.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (morning he felt sleepy), DECREASED APPETITE (lost appetite), FEELING ABNORMAL (felt a little funny before going to bed/ brain was foggy, not working with the usual ability,he had trouble sorting things out), IRRITABILITY (little irritability), PYREXIA (overnight fever), CHILLS (chills), NAUSEA (nausea) and FATIGUE (fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, SOMNOLENCE (morning he felt sleepy), DECREASED APPETITE (lost appetite), FEELING ABNORMAL (felt a little funny before going to bed/ brain was foggy, not working with the usual ability,he had trouble sorting things out), IRRITABILITY (little irritability), PYREXIA (overnight fever), CHILLS (chills), NAUSEA (nausea) and FATIGUE (fatigue) was resolving.            Concomitant medication included Thyroid medication for Hypothyroidism. It was reported that patient did not any seek medical care.   This case was linked to MOD-2022-656368 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Pyrexia, SARS-CoV-2 test
Clinical narrative: mild symptoms of COVID-19; fever; chills; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (mild symptoms of COVID-19), PYREXIA (fever) and CHILLS (chills) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L21A, 011D21A, 015M20A and 013L20A) for COVID-19 vaccination.     Patient had no allergies to medications, food and other products. Patient had no medical history related to mentioned adverse event and both Acute and Chronic illnesses at the time of vaccination. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  Concomitant products included DOXYCYCLINE for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Apr-2022, the patient experienced PYREXIA (fever) and CHILLS (chills). In July 2022, the patient experienced COVID-19 (mild symptoms of COVID-19). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. On 11-Apr-2022, PYREXIA (fever) and CHILLS (chills) had resolved. In July 2022, COVID-19 (mild symptoms of COVID-19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2022, SARS-CoV-2 test: (Positive) Positive.         The adverse event did not cause patient to seek medical care. The patient did not experience a similar event in the past.   This case was linked to MOD-2022-656370 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Energy increased
Clinical narrative: She felt like if she had received a steroid shot. She was going 100 miles an hour. She felt very energized, she had excess of energy. She kept going and going and going.; This spontaneous case was reported by a patient and describes the occurrence of ENERGY INCREASED (She felt like if she had received a steroid shot. She was going 100 miles an hour. She felt very energized, she had excess of energy. She kept going and going and going.) in a 72-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.    Co-suspect product included non-company product INFLUENZA VACCINE for an unknown indication.    Previously administered products included for Product used for unknown indication: Pfizer (Dose 1, Lot number: EN9581.) on 14-Jan-2021, Pfizer (Dose 2, Lot number: EL3246.) on 03-Feb-2021, Pfizer (Dose 3, Lot number: EW0175.) on 23-Aug-2021, Pfizer (Dose 4 and Lot number: FL3197.) on 27-Jan-2022. Past adverse reactions to the above products included No adverse event with Pfizer, Pfizer, Pfizer and Pfizer. Concurrent medical conditions included Drug allergy (gluten). Concomitant products included ROSUVASTATIN for an unknown indication.   On 04-Sep-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 and dose of INFLUENZA VACCINE (unknown route) 1 dosage form. On an unknown date, the patient experienced ENERGY INCREASED (She felt like if she had received a steroid shot. She was going 100 miles an hour. She felt very energized, she had excess of energy. She kept going and going and going.). At the time of the report, ENERGY INCREASED (She felt like if she had received a steroid shot. She was going 100 miles an hour. She felt very energized, she had excess of energy. She kept going and going and going.) had resolved.            No treatment medications was reported.
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Myalgia
Clinical narrative: Aches and Pains all over the body a few hours after bivalent booster; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (Aches and Pains all over the body a few hours after bivalent booster) 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)) (batch no. 055F22B) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Oct-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 06-Oct-2022, the patient experienced MYALGIA (Aches and Pains all over the body a few hours after bivalent booster). At the time of the report, MYALGIA (Aches and Pains all over the body a few hours after bivalent booster) had not resolved.            No concomitant information provided. Reported that patient received 5 doses of Moderna COVID-19 vaccine so far, 2 primary, 2 Monovalent boosters and 1 Bivalent Booster. After Bivalent Booster patient started with Aches and Pains all over the body last night and she had them. This time she was not sure if it will go away after 24 hours. She stated that she went away for work and has not exercised for 5 weeks. Yesterday she decided to exercise again. She was not sure if the pain was from the exercise or the vaccine or both. No treatment information provided   This case was linked to MOD-2021-076249, MOD-2021-109926, MOD-2022-656445 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: aches and pain all over the body lasted for 24 hours for first booster dose and 2nd booster dose; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (aches and pain all over the body lasted for 24 hours for first booster dose and 2nd booster dose) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (aches and pain all over the body lasted for 24 hours for first booster dose and 2nd booster dose). At the time of the report, MYALGIA (aches and pain all over the body lasted for 24 hours for first booster dose and 2nd booster dose) had resolved.            No Concomitant medications were provided. Patient received 2 Monovalent boosters. No treatment medications were provided.   This case was linked to MOD-2021-076249, MOD-2021-109926, MOD-2022-656439 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Administration error: bivalent vaccine administered instead of 1st dose of the primary series; No adverse event; This spontaneous case was reported by a patient family member or friend and describes the occurrence of WRONG PRODUCT ADMINISTERED (Administration error: bivalent vaccine administered instead of 1st dose of the primary series) and NO ADVERSE EVENT (No adverse event) 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)) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Administration error: bivalent vaccine administered instead of 1st dose of the primary series) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Administration error: bivalent vaccine administered instead of 1st dose of the primary series) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant medications were provided.  It was unknown if patient experienced any AEs or if any treatment was given.   Reporter did not allow further contact
Age: 67.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; expired dose given/Dose administered after 30-day Use By Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose given/Dose administered after 30-day Use By Date) and NO ADVERSE EVENT (No adverse event) in a 67-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 03-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 03-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose given/Dose administered after 30-day Use By Date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired dose given/Dose administered after 30-day Use By Date) 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 EXPIRED PRODUCT ADMINISTERED (expired dose given/Dose administered after 30-day Use By Date).    Concomitant medications details were not reported by the reporter. Vial did not undergo any temperature excursion.  Date the vial was initially stored in refrigerator was Unknown. Treatment details was not reported by the reporter.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Received pediatric vaccine instead of Bivalent Booster; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Received pediatric vaccine instead of Bivalent Booster) and NO ADVERSE EVENT (No adverse event) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Received pediatric vaccine instead of Bivalent Booster) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Received pediatric vaccine instead of Bivalent Booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Received pediatric vaccine instead of Bivalent Booster).    No concomitant medications were reported.  Reporter stated that in Oct-2022 they accidentally administered 2 patients, the Moderna Covid-19 vaccines for children 6 months to 5 years old instead of administering the Moderna Covid19 Bivalent booster. Reporter stated that on 07-Oct-2022 patient were mad because they were travelling.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 07-Oct-2022: Live follow up received contains I narrative were updated.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Received pediatric vaccine instead of Bivalent Booster; no adverse event; This spontaneous case was reported by a nurse and describes the occurrence of INCORRECT DOSE ADMINISTERED (Received pediatric vaccine instead of Bivalent Booster) and NO ADVERSE EVENT (no adverse event) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INCORRECT DOSE ADMINISTERED (Received pediatric vaccine instead of Bivalent Booster) and NO ADVERSE EVENT (no adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (Received pediatric vaccine instead of Bivalent Booster) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for INCORRECT DOSE ADMINISTERED (Received pediatric vaccine instead of Bivalent Booster).    No concomitant medications were reported. Reporter stated that in Oct-2022 they accidentally administered 2 patients, the Moderna Covid-19 vaccines for children 6 months to 5 years old instead of administering the Moderna Covid19 Bivalent booster. Reporter stated that on 07-Oct-2022 patient were mad because they were travelling. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 07-Oct-2022: Live follow up received includes: Narrative updated.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia
Clinical narrative: had a body ache for 24 hours; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (had a body ache for 24 hours) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011F21A, 028L20A and 001J20A) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Sep-2022, the patient received fourth dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. In 2021, the patient experienced MYALGIA (had a body ache for 24 hours). At the time of the report, MYALGIA (had a body ache for 24 hours) had resolved.            No concomitant product was provided.  It was reported that after the patient received the Pfizer COVID-19 vaccine she had very bad side effects and her blood pressure went so high. It was reported that the patient  was taking medication in regards with her blood pressure. It was reported that the patients blood pressure went so high happened last week, after she got the Pfizer COVID-19 vaccine booster. On 27-Sep-2022, the nurse took her blood pressure and it was normal, then she gave her the shot and she came home and her blood pressure had shot up to 189/100 she believes. Her doctor put her to more medication to bring it down. She was very, very not feeling well, she was very dizzy and her blood pressure had not gotten better even with extra medication. Her blood vessel popped in her left eye when her blood pressure goes up, this happened the day before yesterday. For the popped blood vessel in her left eye she had done no treatment, there is nothing she can do. She asked the doctor and there was nothing she can do, just wait until it goes away. It was reported that the body ache for 24 hour, It happened for each dose and then she was fine after that for Moderna. she was on two medications for high blood pressure but when took it was normal before received the shot. No treatment medication was reported.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Incorrect dose administered, No adverse event
Clinical narrative: booster doses given at a higher dose; immunocompromised patient not given a 3rd dose; no adverse event; This spontaneous case was reported by a patient family member or friend and describes the occurrence of INCORRECT DOSE ADMINISTERED (booster doses given at a higher dose), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (immunocompromised patient not given a 3rd dose) and NO ADVERSE EVENT (no adverse event) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cancer, Immunocompromised and Multiple myeloma.   On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form, second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INCORRECT DOSE ADMINISTERED (booster doses given at a higher dose), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (immunocompromised patient not given a 3rd dose) and NO ADVERSE EVENT (no adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (booster doses given at a higher dose), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (immunocompromised patient not given a 3rd dose) and NO ADVERSE EVENT (no adverse event) outcome was unknown.            No concomitant drug were reported.   It was also reported that, patient had the 1st 2 doses followed by the 2 booster doses.   The patient was not on chemotherapy  No treatment drug were reported.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse event; inadvertently gave the monovalent vaccine instead of the bivalent booster dose for their 3rd booster dose at 0.5ml to a patient; This spontaneous case was reported by a medical assistant and describes the occurrence of INCORRECT DOSE ADMINISTERED (inadvertently gave the monovalent vaccine instead of the bivalent booster dose for their 3rd booster dose at 0.5ml to a patient) and NO ADVERSE EVENT (No adverse event) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 083B22A, 004M21A and 013F21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Oct-2022, received fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 05-Oct-2022, the patient experienced INCORRECT DOSE ADMINISTERED (inadvertently gave the monovalent vaccine instead of the bivalent booster dose for their 3rd booster dose at 0.5ml to a patient). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (inadvertently gave the monovalent vaccine instead of the bivalent booster dose for their 3rd booster dose at 0.5ml to a patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INCORRECT DOSE ADMINISTERED (inadvertently gave the monovalent vaccine instead of the bivalent booster dose for their 3rd booster dose at 0.5ml to a patient).    No concomitant medications were reported.  It was reported that the patient was inadvertently gave the monovalent vaccine instead of the bivalent booster dose for their 3rd booster dose at 0.5ml and They want to know if they can still give the bivalent booster dose to the patient. If so, when and what is the dose.   Patient has not reported any adverse reactions.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills
Clinical narrative: chills from her upper thigh near her hip all they way down her legs for 4-6 months following each dose; This spontaneous case was reported by a patient and describes the occurrence of CHILLS (chills from her upper thigh near her hip all they way down her legs for 4-6 months following each dose) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013F21A, 013M20A and 030L20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHILLS (chills from her upper thigh near her hip all they way down her legs for 4-6 months following each dose). At the time of the report, CHILLS (chills from her upper thigh near her hip all they way down her legs for 4-6 months following each dose) had resolved.            No relevant concomitant medications were reported. Treatment medication was not provided by the reporter. It was reported that patient had chills from her upper thigh near her hip all they way down her legs for 4-6 months following each dose.   This case was linked to MOD-2022-656706 (Patient Link).