chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: two shots 8 weeks apart; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (two shots 8 weeks apart) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 047A21A)) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (two shots 8 weeks apart). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (two shots 8 weeks apart) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information not provided. Concomitant medications were not provided. Vaccine information in narrative included Patient states his wife got two doses of Moderna COVID19 Vaccine 8 weeks apart: 28Jan2021 and 26Mar2021 (lot #047A21A). No further information provided. Consent for safety to contact was not obtained.   Reporter did not allow further contact
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Lymphadenopathy, Nausea
Clinical narrative: swollen lymph nodes; headache; nausea; chills; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (swollen lymph nodes), HEADACHE (headache), NAUSEA (nausea) and CHILLS (chills) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced LYMPHADENOPATHY (swollen lymph nodes), HEADACHE (headache), NAUSEA (nausea) and CHILLS (chills). At the time of the report, LYMPHADENOPATHY (swollen lymph nodes), HEADACHE (headache), NAUSEA (nausea) and CHILLS (chills) outcome was unknown.            Concomitant medication use was not reported.   Treatment information was not reported.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Gait inability, Pain, Pyrexia, Vaccination site warmth
Clinical narrative: Injection site is hot to the touch; Can barely walk because his entire body hurts; Body aches that progressively worsened; Has no appetite; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injection site is hot to the touch), GAIT INABILITY (Can barely walk because his entire body hurts), PAIN (Body aches that progressively worsened) and DECREASED APPETITE (Has no appetite) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included AMLODIPINE for Hypertension.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced VACCINATION SITE WARMTH (Injection site is hot to the touch), GAIT INABILITY (Can barely walk because his entire body hurts), PAIN (Body aches that progressively worsened) and DECREASED APPETITE (Has no appetite). At the time of the report, VACCINATION SITE WARMTH (Injection site is hot to the touch), GAIT INABILITY (Can barely walk because his entire body hurts), PAIN (Body aches that progressively worsened) and DECREASED APPETITE (Has no appetite) outcome was unknown. Unknown    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: 100.1 (High) 100.1.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information includes Ibuprofen, Acetaminophen.
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Very sick from the shot; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Very sick from the shot) in a male patient of an unknown age 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 ILLNESS (Very sick from the shot). At the time of the report, ILLNESS (Very sick from the shot) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was reported. Concomitant product use was not provided by the reporte
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Vaccination site movement impairment
Clinical narrative: sore arm; can not lift up; hurts so bad; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PAIN IN EXTREMITY (sore arm), VACCINATION SITE MOVEMENT IMPAIRMENT (can not lift up) and PAIN (hurts so bad) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm), VACCINATION SITE MOVEMENT IMPAIRMENT (can not lift up) and PAIN (hurts so bad). At the time of the report, PAIN IN EXTREMITY (sore arm), VACCINATION SITE MOVEMENT IMPAIRMENT (can not lift up) and PAIN (hurts so bad) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant and treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Updated event outcome.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Nausea
Clinical narrative: lack of appetite; intermittent nausea; extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (lack of appetite), NAUSEA (intermittent nausea) and FATIGUE (extreme fatigue) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M02A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced DECREASED APPETITE (lack of appetite), NAUSEA (intermittent nausea) and FATIGUE (extreme fatigue). At the time of the report, DECREASED APPETITE (lack of appetite), NAUSEA (intermittent nausea) and FATIGUE (extreme fatigue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site induration, Vaccination site pruritus
Clinical narrative: lumpy "patches" and itchiness; lumpy "patches" and itchiness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (lumpy "patches" and itchiness) and VACCINATION SITE PRURITUS (lumpy "patches" and itchiness) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN), CARVEDILOL, APIXABAN (ELIQUIS), LEVOTHYROXINE, MONTELUKAST, ESOMEPRAZOLE, SERTRALINE and SIMVASTATIN for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced VACCINATION SITE INDURATION (lumpy "patches" and itchiness) and VACCINATION SITE PRURITUS (lumpy "patches" and itchiness). At the time of the report, VACCINATION SITE INDURATION (lumpy "patches" and itchiness) had not resolved and VACCINATION SITE PRURITUS (lumpy "patches" and itchiness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was scheduled to receive the second dose on 09-Apr-2021. Treatment drug included diphenhydramine"the little pink ones".
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: the arm is swollen and painful; the arm is swollen and painful; stomach pain; chills; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (the arm is swollen and painful), PAIN IN EXTREMITY (the arm is swollen and painful), ABDOMINAL PAIN UPPER (stomach pain) and CHILLS (chills) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced PERIPHERAL SWELLING (the arm is swollen and painful), PAIN IN EXTREMITY (the arm is swollen and painful), ABDOMINAL PAIN UPPER (stomach pain) and CHILLS (chills). At the time of the report, PERIPHERAL SWELLING (the arm is swollen and painful), PAIN IN EXTREMITY (the arm is swollen and painful), ABDOMINAL PAIN UPPER (stomach pain) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: 100.1f (High) 100.1F.         No concomitant medications or treatment reported. Patient denied to give any other information regarding events or first dose.
Sex: F
Vaccine: COVID19
Symptoms: Illness, SARS-CoV-2 test positive
Clinical narrative: COVID19 postitive; she was sick for 3 weeks; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SARS-COV-2 TEST POSITIVE (COVID19 postitive) and ILLNESS (she was sick for 3 weeks) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced SARS-COV-2 TEST POSITIVE (COVID19 postitive) and ILLNESS (she was sick for 3 weeks). At the time of the report, SARS-COV-2 TEST POSITIVE (COVID19 postitive) and ILLNESS (she was sick for 3 weeks) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant or treatment medications listed. Patient reports she had been exposed to COVID-19 prior to receiving the vaccination but did not have symptoms or test positive until a few days after she received the vaccine.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: Subcutaneous Route of Administration; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Subcutaneous Route of Administration) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) 1 dosage form. On 08-Apr-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Subcutaneous Route of Administration). At the time of the report, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Subcutaneous Route of Administration) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Hyperhidrosis, Myalgia
Clinical narrative: r. Sweating; Joint pain from head to toe; nausea; chills; body aches; Fever; Headache; Vomiting; This spontaneous case was reported by a nurse and describes the occurrence of HYPERHIDROSIS (Sweating), ARTHRALGIA (Joint pain from head to toe), NAUSEA (nausea), CHILLS (chills) and MYALGIA (body aches) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Latex allergy, Allergic reaction to analgesics (Naproxen) and Drug allergy (Ditropan). Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for Allergy, SERTRALINE HYDROCHLORIDE (ZOLOFT) for Anxiety, LEVOTHYROXINE for Hypothyroidism, HYDROXYZINE for Itching.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Jan-2021, the patient experienced HYPERHIDROSIS (Sweating), ARTHRALGIA (Joint pain from head to toe), NAUSEA (nausea), CHILLS (chills), MYALGIA (body aches), PYREXIA (Fever), HEADACHE (Headache) and VOMITING (Vomiting). At the time of the report, HYPERHIDROSIS (Sweating), ARTHRALGIA (Joint pain from head to toe), NAUSEA (nausea), CHILLS (chills), MYALGIA (body aches), PYREXIA (Fever), HEADACHE (Headache) and VOMITING (Vomiting) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered HYPERHIDROSIS (Sweating), ARTHRALGIA (Joint pain from head to toe), NAUSEA (nausea), CHILLS (chills) and VOMITING (Vomiting) to be possibly related. No further causality assessments were provided for MYALGIA (body aches), PYREXIA (Fever) and HEADACHE (Headache).    Treatment medications were not provided by reporter.    This case was linked to MOD-2021-071072, MOD-2021-071082 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Patient's initials, details, medical history, concomitant drugs were updated. Patient's second and first dose of vaccine were updated. Vomiting added as event. Causality for chills, sweating, joint pain, nausea and vomiting was updated.; Sender's Comments:  MOD-2021-071072:Mother First dose of vaccine case MOD-2021-071082:Mother Second dose of vaccine case
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: r. Sweating; Joint pain from head to toe; nausea; chills; body aches; Fever; Headache; Vomiting; This spontaneous case was reported by a nurse and describes the occurrence of HYPERHIDROSIS (Sweating), ARTHRALGIA (Joint pain from head to toe), NAUSEA (nausea), CHILLS (chills) and MYALGIA (body aches) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Latex allergy, Allergic reaction to analgesics (Naproxen) and Drug allergy (Ditropan). Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for Allergy, SERTRALINE HYDROCHLORIDE (ZOLOFT) for Anxiety, LEVOTHYROXINE for Hypothyroidism, HYDROXYZINE for Itching.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Jan-2021, the patient experienced HYPERHIDROSIS (Sweating), ARTHRALGIA (Joint pain from head to toe), NAUSEA (nausea), CHILLS (chills), MYALGIA (body aches), PYREXIA (Fever), HEADACHE (Headache) and VOMITING (Vomiting). At the time of the report, HYPERHIDROSIS (Sweating), ARTHRALGIA (Joint pain from head to toe), NAUSEA (nausea), CHILLS (chills), MYALGIA (body aches), PYREXIA (Fever), HEADACHE (Headache) and VOMITING (Vomiting) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered HYPERHIDROSIS (Sweating), ARTHRALGIA (Joint pain from head to toe), NAUSEA (nausea), CHILLS (chills) and VOMITING (Vomiting) to be possibly related. No further causality assessments were provided for MYALGIA (body aches), PYREXIA (Fever) and HEADACHE (Headache).    Treatment medications were not provided by reporter.    This case was linked to MOD-2021-071072, MOD-2021-071082 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Patient's initials, details, medical history, concomitant drugs were updated. Patient's second and first dose of vaccine were updated. Vomiting added as event. Causality for chills, sweating, joint pain, nausea and vomiting was updated.; Sender's Comments:  MOD-2021-071072:Mother First dose of vaccine case MOD-2021-071082:Mother Second dose of vaccine case
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Chills, Dizziness, Dyskinesia, Epistaxis
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of the second episode of DIZZINESS, the second episode of INFLAMMATION, the second episode of BLOOD PRESSURE INCREASED, HEART RATE INCREASED, and the second episode of MYALGIA (January 2021) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 038B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included SARS-CoV-2 infection in January 2021.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2. On 04-Mar-2021, the patient experienced CHILLS, the first episode of DIZZINESS, the first episode of INFLAMMATION, the first episode of BLOOD PRESSURE INCREASED, HEART RATE ABNORMAL, and the first episode of MYALGIA. On 06-Apr-2021, the patient experienced the second episode of DIZZINESS, the second episode of INFLAMMATION, the second episode of BLOOD PRESSURE INCREASED, HEART RATE INCREASED, the second episode of MYALGIA, HEADACHE, VAGINAL HAEMORRHAGE, EPISTAXIS, and DYSKINESIA. At the time of the report, last episode of DIZZINESS, the last episode of INFLAMMATION, the last episode of BLOOD PRESSURE INCREASED, HEART RATE INCREASED, the last episode of MYALGIA, HEADACHE, VAGINAL HAEMORRHAGE, EPISTAXIS, DYSKINESIA, CHILLS, and HEART RATE ABNORMAL outcome was unknown. Not Provided.          The patient received the 1st dose of the vaccine on 04-Mar-2021 in her right arm and she had dizziness, her whole body, hand, and feet inflammation, chills, elevated blood pressure, elevated heartrate to 110, general head and body pain like when she had Covid in January 2021. The patient received the 2nd dose of the vaccine on 06-Apr-2021 in her left arm. That same night she started to have dizziness, her whole body, hand, and feet inflammation, elevated blood pressure, elevated heartrate to 110, general head and body pain like when she had Covid in January 2021. On Wed 07-Apr-2021 she had vaginal and nose bleeding and also involuntary movements on her left thumb.   This case was linked to US-MODERNATX, INC.-MOD-2021-071186. Sender's Comments:  US-MODERNATX, INC-MOD-2021-071186. Case for first dose.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate abnormal, Heart rate increased, Inflammation, Myalgia
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of the second episode of DIZZINESS, the second episode of INFLAMMATION, the second episode of BLOOD PRESSURE INCREASED, HEART RATE INCREASED, and the second episode of MYALGIA (January 2021) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 038B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included SARS-CoV-2 infection in January 2021.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2. On 04-Mar-2021, the patient experienced CHILLS, the first episode of DIZZINESS, the first episode of INFLAMMATION, the first episode of BLOOD PRESSURE INCREASED, HEART RATE ABNORMAL, and the first episode of MYALGIA. On 06-Apr-2021, the patient experienced the second episode of DIZZINESS, the second episode of INFLAMMATION, the second episode of BLOOD PRESSURE INCREASED, HEART RATE INCREASED, the second episode of MYALGIA, HEADACHE, VAGINAL HAEMORRHAGE, EPISTAXIS, and DYSKINESIA. At the time of the report, last episode of DIZZINESS, the last episode of INFLAMMATION, the last episode of BLOOD PRESSURE INCREASED, HEART RATE INCREASED, the last episode of MYALGIA, HEADACHE, VAGINAL HAEMORRHAGE, EPISTAXIS, DYSKINESIA, CHILLS, and HEART RATE ABNORMAL outcome was unknown. Not Provided.          The patient received the 1st dose of the vaccine on 04-Mar-2021 in her right arm and she had dizziness, her whole body, hand, and feet inflammation, chills, elevated blood pressure, elevated heartrate to 110, general head and body pain like when she had Covid in January 2021. The patient received the 2nd dose of the vaccine on 06-Apr-2021 in her left arm. That same night she started to have dizziness, her whole body, hand, and feet inflammation, elevated blood pressure, elevated heartrate to 110, general head and body pain like when she had Covid in January 2021. On Wed 07-Apr-2021 she had vaginal and nose bleeding and also involuntary movements on her left thumb.   This case was linked to US-MODERNATX, INC.-MOD-2021-071186. Sender's Comments:  US-MODERNATX, INC-MOD-2021-071186. Case for first dose.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Vaginal haemorrhage
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of the second episode of DIZZINESS, the second episode of INFLAMMATION, the second episode of BLOOD PRESSURE INCREASED, HEART RATE INCREASED, and the second episode of MYALGIA (January 2021) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 038B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included SARS-CoV-2 infection in January 2021.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2. On 04-Mar-2021, the patient experienced CHILLS, the first episode of DIZZINESS, the first episode of INFLAMMATION, the first episode of BLOOD PRESSURE INCREASED, HEART RATE ABNORMAL, and the first episode of MYALGIA. On 06-Apr-2021, the patient experienced the second episode of DIZZINESS, the second episode of INFLAMMATION, the second episode of BLOOD PRESSURE INCREASED, HEART RATE INCREASED, the second episode of MYALGIA, HEADACHE, VAGINAL HAEMORRHAGE, EPISTAXIS, and DYSKINESIA. At the time of the report, last episode of DIZZINESS, the last episode of INFLAMMATION, the last episode of BLOOD PRESSURE INCREASED, HEART RATE INCREASED, the last episode of MYALGIA, HEADACHE, VAGINAL HAEMORRHAGE, EPISTAXIS, DYSKINESIA, CHILLS, and HEART RATE ABNORMAL outcome was unknown. Not Provided.          The patient received the 1st dose of the vaccine on 04-Mar-2021 in her right arm and she had dizziness, her whole body, hand, and feet inflammation, chills, elevated blood pressure, elevated heartrate to 110, general head and body pain like when she had Covid in January 2021. The patient received the 2nd dose of the vaccine on 06-Apr-2021 in her left arm. That same night she started to have dizziness, her whole body, hand, and feet inflammation, elevated blood pressure, elevated heartrate to 110, general head and body pain like when she had Covid in January 2021. On Wed 07-Apr-2021 she had vaginal and nose bleeding and also involuntary movements on her left thumb.   This case was linked to US-MODERNATX, INC.-MOD-2021-071186. Sender's Comments:  US-MODERNATX, INC-MOD-2021-071186. Case for first dose.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Insomnia, Muscle spasticity, Pain in extremity
Clinical narrative: The right arm pain is overwhelming and even worse; Could not even sleep last; Cannot lift her right arm and cannot extend her right arm outward without using her other arm to assist; Anxiety; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (The right arm pain is overwhelming and even worse), MUSCLE SPASTICITY (Cannot lift her right arm and cannot extend her right arm outward without using her other arm to assist), ANXIETY (Anxiety) and INSOMNIA (Could not even sleep last) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 044A21A) for COVID-19 vaccination.     The patient's past medical history included Anxiety and Anticoagulant therapy since 1994. Concurrent medical conditions included Heart valve disorders since 1994. Concomitant products included WARFARIN SODIUM (JANTOVEN) for an unknown indication.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021 at 1:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced PAIN IN EXTREMITY (The right arm pain is overwhelming and even worse) and INSOMNIA (Could not even sleep last). In April 2021, the patient experienced MUSCLE SPASTICITY (Cannot lift her right arm and cannot extend her right arm outward without using her other arm to assist) and ANXIETY (Anxiety). At the time of the report, PAIN IN EXTREMITY (The right arm pain is overwhelming and even worse) had not resolved and MUSCLE SPASTICITY (Cannot lift her right arm and cannot extend her right arm outward without using her other arm to assist), ANXIETY (Anxiety) and INSOMNIA (Could not even sleep last) outcome was unknown. Not Provided          Treatment for the events included acetaminopehen and a wet compress on her right arm. Patient reported that the band-aid placed after the second dose is quite high and more toward the back of the arm and wonders if the second dose may have been incorrectly administered into her shoulder. Action taken with mRNA-1273 in response to the events were not applicable.   This case was linked to MOD21-071731, MOD21-071816, US-MODERNATX, INC.-MOD-2021-071441 (E2B Linked Report).; Sender's Comments:  MOD21-071731:MOD-2021-071191  1st dose case MOD21-071816: US-MODERNATX, INC.-MOD-2021-071441:crosslinked
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: two shots 8 weeks apart; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (two shots 8 weeks apart) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 047A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-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 2. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (two shots 8 weeks apart). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (two shots 8 weeks apart) outcome was unknown. Not Provided          Patient stated he received two shots 8 weeks apart: 28-Jan-2021 and 25-Mar-2021 (lot #047A21A). His wife also received her Moderna COVID-19 Vaccine more than 8 weeks apart (crosslinked MOD21-072052).
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Erythema, Fatigue, Feeling cold, Feeling hot
Clinical narrative: very hot; feeling cold; bump on her arm and developed size of cantaloupe; pain in her arm; arm redness; Hardness; fatigue; muscle pain; joint pain; nausea; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (very hot), FEELING COLD (feeling cold), PERIPHERAL SWELLING (bump on her arm and developed size of cantaloupe), PAIN IN EXTREMITY (pain in her arm) and ERYTHEMA (arm redness) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced FEELING HOT (very hot), FEELING COLD (feeling cold), PERIPHERAL SWELLING (bump on her arm and developed size of cantaloupe), PAIN IN EXTREMITY (pain in her arm), ERYTHEMA (arm redness), INDURATION (Hardness), FATIGUE (fatigue), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and NAUSEA (nausea). At the time of the report, FEELING HOT (very hot), FEELING COLD (feeling cold), PERIPHERAL SWELLING (bump on her arm and developed size of cantaloupe), PAIN IN EXTREMITY (pain in her arm), ERYTHEMA (arm redness), INDURATION (Hardness), FATIGUE (fatigue), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication provided was allergy medicine. Treatment information provided was two antibiotics.   This case was linked to -MODERNATX, INC.-MOD-2021-071541 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Follow-up information received on 10-May-2021 contains non-significant information.; Sender's Comments:  -MODERNATX, INC.-MOD-2021-071541:Daughter AE's
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Induration, Myalgia, Nausea, Pain in extremity, Peripheral swelling
Clinical narrative: very hot; feeling cold; bump on her arm and developed size of cantaloupe; pain in her arm; arm redness; Hardness; fatigue; muscle pain; joint pain; nausea; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (very hot), FEELING COLD (feeling cold), PERIPHERAL SWELLING (bump on her arm and developed size of cantaloupe), PAIN IN EXTREMITY (pain in her arm) and ERYTHEMA (arm redness) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced FEELING HOT (very hot), FEELING COLD (feeling cold), PERIPHERAL SWELLING (bump on her arm and developed size of cantaloupe), PAIN IN EXTREMITY (pain in her arm), ERYTHEMA (arm redness), INDURATION (Hardness), FATIGUE (fatigue), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and NAUSEA (nausea). At the time of the report, FEELING HOT (very hot), FEELING COLD (feeling cold), PERIPHERAL SWELLING (bump on her arm and developed size of cantaloupe), PAIN IN EXTREMITY (pain in her arm), ERYTHEMA (arm redness), INDURATION (Hardness), FATIGUE (fatigue), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication provided was allergy medicine. Treatment information provided was two antibiotics.   This case was linked to -MODERNATX, INC.-MOD-2021-071541 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Follow-up information received on 10-May-2021 contains non-significant information.; Sender's Comments:  -MODERNATX, INC.-MOD-2021-071541:Daughter AE's
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pain in extremity, Suspected COVID-19, Vaccination site induration, Vaccination site pain
Clinical narrative: feels she had COVID-19; like a bee sting at the injection site; swelling in arm at the injection site; Dizziness; arm like a hard boiled egg, at the injection site; vertigo only when standing to lay down; warmness at the injection site; arm was a little sore; This spontaneous case was reported by a consumer and describes the occurrence of SUSPECTED COVID-19 (feels she had COVID-19), VERTIGO (vertigo only when standing to lay down), VACCINATION SITE WARMTH (warmness at the injection site), PAIN IN EXTREMITY (arm was a little sore) and DIZZINESS (Dizziness) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M208 and 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure, Autoimmune disorder, Thyroid disorder and Neuropathy. Concomitant products included PREDNISONE for Autoimmune disorder, ATENOLOL for Blood pressure, GABAPENTIN (NEURONTIN) for Neuropathy, LIOTHYRONINE SODIUM (CYTOMEL) for Thyroid disorder.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm was a little sore). On 16-Mar-2021, the patient experienced VERTIGO (vertigo only when standing to lay down), VACCINATION SITE WARMTH (warmness at the injection site), DIZZINESS (Dizziness), VACCINATION SITE INDURATION (arm like a hard boiled egg, at the injection site) and VACCINATION SITE SWELLING (swelling in arm at the injection site). On an unknown date, the patient experienced SUSPECTED COVID-19 (feels she had COVID-19) and VACCINATION SITE PAIN (like a bee sting at the injection site). The patient was treated with MECLIZINE [MECLOZINE] for Vertigo and Dizziness, at an unspecified dose and frequency. At the time of the report, SUSPECTED COVID-19 (feels she had COVID-19), VERTIGO (vertigo only when standing to lay down), VACCINATION SITE WARMTH (warmness at the injection site), PAIN IN EXTREMITY (arm was a little sore), DIZZINESS (Dizziness), VACCINATION SITE INDURATION (arm like a hard boiled egg, at the injection site), VACCINATION SITE PAIN (like a bee sting at the injection site) and VACCINATION SITE SWELLING (swelling in arm at the injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment included meclezine for dizziness and vertigo   This case was linked to MOD-2021-103706 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Reporter details, concomitant medications, second dose vaccine details and new events were added.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site warmth, Vertigo
Clinical narrative: feels she had COVID-19; like a bee sting at the injection site; swelling in arm at the injection site; Dizziness; arm like a hard boiled egg, at the injection site; vertigo only when standing to lay down; warmness at the injection site; arm was a little sore; This spontaneous case was reported by a consumer and describes the occurrence of SUSPECTED COVID-19 (feels she had COVID-19), VERTIGO (vertigo only when standing to lay down), VACCINATION SITE WARMTH (warmness at the injection site), PAIN IN EXTREMITY (arm was a little sore) and DIZZINESS (Dizziness) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M208 and 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure, Autoimmune disorder, Thyroid disorder and Neuropathy. Concomitant products included PREDNISONE for Autoimmune disorder, ATENOLOL for Blood pressure, GABAPENTIN (NEURONTIN) for Neuropathy, LIOTHYRONINE SODIUM (CYTOMEL) for Thyroid disorder.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm was a little sore). On 16-Mar-2021, the patient experienced VERTIGO (vertigo only when standing to lay down), VACCINATION SITE WARMTH (warmness at the injection site), DIZZINESS (Dizziness), VACCINATION SITE INDURATION (arm like a hard boiled egg, at the injection site) and VACCINATION SITE SWELLING (swelling in arm at the injection site). On an unknown date, the patient experienced SUSPECTED COVID-19 (feels she had COVID-19) and VACCINATION SITE PAIN (like a bee sting at the injection site). The patient was treated with MECLIZINE [MECLOZINE] for Vertigo and Dizziness, at an unspecified dose and frequency. At the time of the report, SUSPECTED COVID-19 (feels she had COVID-19), VERTIGO (vertigo only when standing to lay down), VACCINATION SITE WARMTH (warmness at the injection site), PAIN IN EXTREMITY (arm was a little sore), DIZZINESS (Dizziness), VACCINATION SITE INDURATION (arm like a hard boiled egg, at the injection site), VACCINATION SITE PAIN (like a bee sting at the injection site) and VACCINATION SITE SWELLING (swelling in arm at the injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment included meclezine for dizziness and vertigo   This case was linked to MOD-2021-103706 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Reporter details, concomitant medications, second dose vaccine details and new events were added.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Lethargy
Clinical narrative: Diarrhea for two weeks; Chills for a week; Felt lethargic for one week; This spontaneous case was reported by a pharmacist and describes the occurrence of DIARRHOEA (Diarrhea for two weeks), CHILLS (Chills for a week) and LETHARGY (Felt lethargic for one week) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea for two weeks), CHILLS (Chills for a week) and LETHARGY (Felt lethargic for one week). At the time of the report, DIARRHOEA (Diarrhea for two weeks), CHILLS (Chills for a week) and LETHARGY (Felt lethargic for one week) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Body temperature, Fatigue, Gait disturbance
Clinical narrative: She can barely sleep; Feeling very tired; Muscles and body aches; Lack of energy/pretty intense; Massive back pain; Tinnitus; Could barely walk; Shacking all over; Felt very ill; 100.2 temperature; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of GAIT DISTURBANCE (Could barely walk), TREMOR (Shacking all over), MALAISE (Felt very ill), ASTHENIA (Lack of energy/pretty intense) and BACK PAIN (Massive back pain) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced GAIT DISTURBANCE (Could barely walk), TREMOR (Shacking all over), MALAISE (Felt very ill) and PYREXIA (100.2 temperature). In March 2021, the patient experienced ASTHENIA (Lack of energy/pretty intense), BACK PAIN (Massive back pain), TINNITUS (Tinnitus) and MYALGIA (Muscles and body aches). On an unknown date, the patient experienced INSOMNIA (She can barely sleep) and FATIGUE (Feeling very tired). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. On 01-Mar-2021, GAIT DISTURBANCE (Could barely walk), TREMOR (Shacking all over), MALAISE (Felt very ill) and PYREXIA (100.2 temperature) had resolved. At the time of the report, ASTHENIA (Lack of energy/pretty intense), BACK PAIN (Massive back pain), TINNITUS (Tinnitus), INSOMNIA (She can barely sleep), MYALGIA (Muscles and body aches) and FATIGUE (Feeling very tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Feb-2021, Body temperature: 100.2 (High) 100.2 temperature.         The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  Concomitant medications was not provided by the reporter.  Treatment information included Advil and other OTC medication for the pain.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Malaise, Myalgia, Pyrexia, Tinnitus
Clinical narrative: She can barely sleep; Feeling very tired; Muscles and body aches; Lack of energy/pretty intense; Massive back pain; Tinnitus; Could barely walk; Shacking all over; Felt very ill; 100.2 temperature; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of GAIT DISTURBANCE (Could barely walk), TREMOR (Shacking all over), MALAISE (Felt very ill), ASTHENIA (Lack of energy/pretty intense) and BACK PAIN (Massive back pain) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced GAIT DISTURBANCE (Could barely walk), TREMOR (Shacking all over), MALAISE (Felt very ill) and PYREXIA (100.2 temperature). In March 2021, the patient experienced ASTHENIA (Lack of energy/pretty intense), BACK PAIN (Massive back pain), TINNITUS (Tinnitus) and MYALGIA (Muscles and body aches). On an unknown date, the patient experienced INSOMNIA (She can barely sleep) and FATIGUE (Feeling very tired). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. On 01-Mar-2021, GAIT DISTURBANCE (Could barely walk), TREMOR (Shacking all over), MALAISE (Felt very ill) and PYREXIA (100.2 temperature) had resolved. At the time of the report, ASTHENIA (Lack of energy/pretty intense), BACK PAIN (Massive back pain), TINNITUS (Tinnitus), INSOMNIA (She can barely sleep), MYALGIA (Muscles and body aches) and FATIGUE (Feeling very tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Feb-2021, Body temperature: 100.2 (High) 100.2 temperature.         The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  Concomitant medications was not provided by the reporter.  Treatment information included Advil and other OTC medication for the pain.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: She can barely sleep; Feeling very tired; Muscles and body aches; Lack of energy/pretty intense; Massive back pain; Tinnitus; Could barely walk; Shacking all over; Felt very ill; 100.2 temperature; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of GAIT DISTURBANCE (Could barely walk), TREMOR (Shacking all over), MALAISE (Felt very ill), ASTHENIA (Lack of energy/pretty intense) and BACK PAIN (Massive back pain) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced GAIT DISTURBANCE (Could barely walk), TREMOR (Shacking all over), MALAISE (Felt very ill) and PYREXIA (100.2 temperature). In March 2021, the patient experienced ASTHENIA (Lack of energy/pretty intense), BACK PAIN (Massive back pain), TINNITUS (Tinnitus) and MYALGIA (Muscles and body aches). On an unknown date, the patient experienced INSOMNIA (She can barely sleep) and FATIGUE (Feeling very tired). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. On 01-Mar-2021, GAIT DISTURBANCE (Could barely walk), TREMOR (Shacking all over), MALAISE (Felt very ill) and PYREXIA (100.2 temperature) had resolved. At the time of the report, ASTHENIA (Lack of energy/pretty intense), BACK PAIN (Massive back pain), TINNITUS (Tinnitus), INSOMNIA (She can barely sleep), MYALGIA (Muscles and body aches) and FATIGUE (Feeling very tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Feb-2021, Body temperature: 100.2 (High) 100.2 temperature.         The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  Concomitant medications was not provided by the reporter.  Treatment information included Advil and other OTC medication for the pain.