chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Can not get the 2nd shot; difficulty breathing upon minimal exertion; pain everywhere; fatigue (slept for 5 days); chills; fatigue (slept for 5 days); This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Can not get the 2nd shot), DYSPNOEA (difficulty breathing upon minimal exertion), PAIN (pain everywhere), HYPERSOMNIA (fatigue (slept for 5 days)) and CHILLS (chills) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced DYSPNOEA (difficulty breathing upon minimal exertion), PAIN (pain everywhere), HYPERSOMNIA (fatigue (slept for 5 days)), CHILLS (chills) and FATIGUE (fatigue (slept for 5 days)). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Can not get the 2nd shot). The patient was treated with IBUPROFEN at a dose of 1 dosage form. At the time of the report, PRODUCT DOSE OMISSION ISSUE (Can not get the 2nd shot) had resolved and DYSPNOEA (difficulty breathing upon minimal exertion), PAIN (pain everywhere), HYPERSOMNIA (fatigue (slept for 5 days)), CHILLS (chills) and FATIGUE (fatigue (slept for 5 days)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.   This case was linked to MOD-2021-079973 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Jul-2021: Event added. On 31-Jul-2021: Follow-up information included no new information. On 04-Aug-2021: Follow-up information included no new information.
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Body temperature increased, Chills, Headache, Influenza like illness
Clinical narrative: headache midday Saturday 17Apr2021; "couldn't get back to sleep"; "flu like symptoms."; "Could feel aches coming on"; temperature was 98.8, which is higher than normal. Caller states her normal temperature runs around 97.4. Caller states "by the end of the day on 14Apr2021 temperature was 99.5."; "stayed in bed all day."; "waking up at 3am with a headache"; "Could feel chills coming on"; This spontaneous case was reported by a consumer and describes the occurrence of MIDDLE INSOMNIA ("couldn't get back to sleep"), INFLUENZA LIKE ILLNESS ("flu like symptoms."), PAIN ("Could feel aches coming on"), BODY TEMPERATURE INCREASED (temperature was 98.8, which is higher than normal. Caller states her normal temperature runs around 97.4. Caller states "by the end of the day on 14Apr2021 temperature was 99.5.") and BEDRIDDEN ("stayed in bed all day.") in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 14-Apr-2021, the patient experienced MIDDLE INSOMNIA ("couldn't get back to sleep"), INFLUENZA LIKE ILLNESS ("flu like symptoms."), PAIN ("Could feel aches coming on"), BODY TEMPERATURE INCREASED (temperature was 98.8, which is higher than normal. Caller states her normal temperature runs around 97.4. Caller states "by the end of the day on 14Apr2021 temperature was 99.5."), BEDRIDDEN ("stayed in bed all day."), HEADACHE ("waking up at 3am with a headache") and CHILLS ("Could feel chills coming on"). On 17-Apr-2021, the patient experienced HEADACHE (headache midday Saturday 17Apr2021). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN USA) at an unspecified dose and frequency. On 15-Apr-2021, MIDDLE INSOMNIA ("couldn't get back to sleep"), INFLUENZA LIKE ILLNESS ("flu like symptoms."), PAIN ("Could feel aches coming on"), BODY TEMPERATURE INCREASED (temperature was 98.8, which is higher than normal. Caller states her normal temperature runs around 97.4. Caller states "by the end of the day on 14Apr2021 temperature was 99.5."), BEDRIDDEN ("stayed in bed all day."), HEADACHE ("waking up at 3am with a headache") and CHILLS ("Could feel chills coming on") had resolved. On 18-Apr-2021, HEADACHE (headache midday Saturday 17Apr2021) had resolved.            There is no relevant treatment and concomitant medication provided.
Sex: F
Vaccine: COVID19
Symptoms: Middle insomnia, Pain
Clinical narrative: headache midday Saturday 17Apr2021; "couldn't get back to sleep"; "flu like symptoms."; "Could feel aches coming on"; temperature was 98.8, which is higher than normal. Caller states her normal temperature runs around 97.4. Caller states "by the end of the day on 14Apr2021 temperature was 99.5."; "stayed in bed all day."; "waking up at 3am with a headache"; "Could feel chills coming on"; This spontaneous case was reported by a consumer and describes the occurrence of MIDDLE INSOMNIA ("couldn't get back to sleep"), INFLUENZA LIKE ILLNESS ("flu like symptoms."), PAIN ("Could feel aches coming on"), BODY TEMPERATURE INCREASED (temperature was 98.8, which is higher than normal. Caller states her normal temperature runs around 97.4. Caller states "by the end of the day on 14Apr2021 temperature was 99.5.") and BEDRIDDEN ("stayed in bed all day.") in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 14-Apr-2021, the patient experienced MIDDLE INSOMNIA ("couldn't get back to sleep"), INFLUENZA LIKE ILLNESS ("flu like symptoms."), PAIN ("Could feel aches coming on"), BODY TEMPERATURE INCREASED (temperature was 98.8, which is higher than normal. Caller states her normal temperature runs around 97.4. Caller states "by the end of the day on 14Apr2021 temperature was 99.5."), BEDRIDDEN ("stayed in bed all day."), HEADACHE ("waking up at 3am with a headache") and CHILLS ("Could feel chills coming on"). On 17-Apr-2021, the patient experienced HEADACHE (headache midday Saturday 17Apr2021). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN USA) at an unspecified dose and frequency. On 15-Apr-2021, MIDDLE INSOMNIA ("couldn't get back to sleep"), INFLUENZA LIKE ILLNESS ("flu like symptoms."), PAIN ("Could feel aches coming on"), BODY TEMPERATURE INCREASED (temperature was 98.8, which is higher than normal. Caller states her normal temperature runs around 97.4. Caller states "by the end of the day on 14Apr2021 temperature was 99.5."), BEDRIDDEN ("stayed in bed all day."), HEADACHE ("waking up at 3am with a headache") and CHILLS ("Could feel chills coming on") had resolved. On 18-Apr-2021, HEADACHE (headache midday Saturday 17Apr2021) had resolved.            There is no relevant treatment and concomitant medication provided.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Herpes zoster, Rash
Clinical narrative: developed shingles; develop a rash that started on her back, went up her side, and onto her chest; Multiple sores are silver dollar size, sores scabbed over, pretty big, rest of sores are dot size; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HERPES ZOSTER (developed shingles), RASH (develop a rash that started on her back, went up her side, and onto her chest) and BLISTER (Multiple sores are silver dollar size, sores scabbed over, pretty big, rest of sores are dot size) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 12-Apr-2021, the patient experienced RASH (develop a rash that started on her back, went up her side, and onto her chest) and BLISTER (Multiple sores are silver dollar size, sores scabbed over, pretty big, rest of sores are dot size). On 14-Apr-2021, the patient experienced HERPES ZOSTER (developed shingles). At the time of the report, HERPES ZOSTER (developed shingles), RASH (develop a rash that started on her back, went up her side, and onto her chest) and BLISTER (Multiple sores are silver dollar size, sores scabbed over, pretty big, rest of sores are dot size) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Paraesthesia, Vaccination site bruising, Vaccination site induration, Vaccination site swelling
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (injection site is swollen, very hard, and hot to the touch), VACCINATION SITE BRUISING (dark purple), MOBILITY DECREASED (can't move it), PARAESTHESIA (warm, tingling sensation) and VACCINATION SITE INDURATION (injection site is swollen, very hard, and hot to the touch) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, the patient experienced VACCINATION SITE WARMTH (injection site is swollen, very hard, and hot to the touch), VACCINATION SITE BRUISING (dark purple), MOBILITY DECREASED (can't move it), PARAESTHESIA (warm, tingling sensation), VACCINATION SITE INDURATION (injection site is swollen, very hard, and hot to the touch) and VACCINATION SITE SWELLING (injection site is swollen, very hard, and hot to the touch). At the time of the report, VACCINATION SITE WARMTH (injection site is swollen, very hard, and hot to the touch), VACCINATION SITE BRUISING (dark purple), MOBILITY DECREASED (can't move it), PARAESTHESIA (warm, tingling sensation), VACCINATION SITE INDURATION (injection site is swollen, very hard, and hot to the touch) and VACCINATION SITE SWELLING (injection site is swollen, very hard, and hot to the touch) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications provided. No treatment information provided.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (injection site is swollen, very hard, and hot to the touch), VACCINATION SITE BRUISING (dark purple), MOBILITY DECREASED (can't move it), PARAESTHESIA (warm, tingling sensation) and VACCINATION SITE INDURATION (injection site is swollen, very hard, and hot to the touch) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, the patient experienced VACCINATION SITE WARMTH (injection site is swollen, very hard, and hot to the touch), VACCINATION SITE BRUISING (dark purple), MOBILITY DECREASED (can't move it), PARAESTHESIA (warm, tingling sensation), VACCINATION SITE INDURATION (injection site is swollen, very hard, and hot to the touch) and VACCINATION SITE SWELLING (injection site is swollen, very hard, and hot to the touch). At the time of the report, VACCINATION SITE WARMTH (injection site is swollen, very hard, and hot to the touch), VACCINATION SITE BRUISING (dark purple), MOBILITY DECREASED (can't move it), PARAESTHESIA (warm, tingling sensation), VACCINATION SITE INDURATION (injection site is swollen, very hard, and hot to the touch) and VACCINATION SITE SWELLING (injection site is swollen, very hard, and hot to the touch) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications provided. No treatment information provided.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Hypersomnia, Influenza, Injection site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Flu symptoms), HYPERSOMNIA (slept for up to 23 hours), PAIN IN EXTREMITY (Pressure in the legs and hips), PYREXIA (Fever (101F)) and NAUSEA (Nausea) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included HYDROCHLOROTHIAZIDE, TRIAMTERENE (TRIAMTERENE/HCTZ), AMLODIPINE, CLOPIDOGREL BISULFATE (PLAVIX) and EZETIMIBE for an unknown indication. On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Apr-2021, the patient experienced INFLUENZA (Flu symptoms), HYPERSOMNIA (slept for up to 23 hours), PAIN IN EXTREMITY (Pressure in the legs and hips), PYREXIA (Fever (101F)), NAUSEA (Nausea), ARTHRALGIA (Generalized sore and achy joints), HEADACHE (Severe Headaches) and INJECTION SITE PAIN (Tenderness at injection site). On 19-Apr-2021, INFLUENZA (Flu symptoms), PAIN IN EXTREMITY (Pressure in the legs and hips), PYREXIA (Fever (101F)), NAUSEA (Nausea), ARTHRALGIA (Generalized sore and achy joints) and HEADACHE (Severe Headaches) had resolved. At the time of the report, HYPERSOMNIA (slept for up to 23 hours) and INJECTION SITE PAIN (Tenderness at injection site) outcome was unknown.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Flu symptoms), HYPERSOMNIA (slept for up to 23 hours), PAIN IN EXTREMITY (Pressure in the legs and hips), PYREXIA (Fever (101F)) and NAUSEA (Nausea) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included HYDROCHLOROTHIAZIDE, TRIAMTERENE (TRIAMTERENE/HCTZ), AMLODIPINE, CLOPIDOGREL BISULFATE (PLAVIX) and EZETIMIBE for an unknown indication. On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Apr-2021, the patient experienced INFLUENZA (Flu symptoms), HYPERSOMNIA (slept for up to 23 hours), PAIN IN EXTREMITY (Pressure in the legs and hips), PYREXIA (Fever (101F)), NAUSEA (Nausea), ARTHRALGIA (Generalized sore and achy joints), HEADACHE (Severe Headaches) and INJECTION SITE PAIN (Tenderness at injection site). On 19-Apr-2021, INFLUENZA (Flu symptoms), PAIN IN EXTREMITY (Pressure in the legs and hips), PYREXIA (Fever (101F)), NAUSEA (Nausea), ARTHRALGIA (Generalized sore and achy joints) and HEADACHE (Severe Headaches) had resolved. At the time of the report, HYPERSOMNIA (slept for up to 23 hours) and INJECTION SITE PAIN (Tenderness at injection site) outcome was unknown.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Soreness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN (Soreness) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 006B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced PAIN (Soreness). The patient was treated with MELOXICAM for Pain, at an unspecified dose and frequency and IBUPROFEN for Pain, at an unspecified dose and frequency. At the time of the report, PAIN (Soreness) had not resolved.            Concomitant product use was not provider by the reporter.  Action taken with mRNA-1273 in response to the events was not Applicable.    This case was linked to MOD-2021-080326, MOD-2021-080291, MOD-2021-080302 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus, Vaccination site rash, Vaccination site warmth
Clinical narrative: Delayed rash at the injection site; Arm is warm at injection site area; Itching near the injection site; Tender arm  after injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Arm is warm at injection site area), VACCINATION SITE PRURITUS (Itching near the injection site), VACCINATION SITE PAIN (Tender arm  after injection) and VACCINATION SITE RASH (Delayed rash at the injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) 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) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced VACCINATION SITE PAIN (Tender arm  after injection). On 15-Apr-2021, the patient experienced VACCINATION SITE WARMTH (Arm is warm at injection site area) and VACCINATION SITE PRURITUS (Itching near the injection site). On an unknown date, the patient experienced VACCINATION SITE RASH (Delayed rash at the injection site). The patient was treated with HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Arm is warm at injection site area), VACCINATION SITE PAIN (Tender arm  after injection) and VACCINATION SITE RASH (Delayed rash at the injection site) outcome was unknown and VACCINATION SITE PRURITUS (Itching near the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient received their first dose of the vaccine and after the injection, their arm was a little tender. On 15-Apr-2021, the patient's arm began to itch near the injection site. The patient reported that the area was warm and was still itching as of 19-Apr-2021. The patient has applied hydrocortisone cream which has helped with the itching. The patient also reported that they read about delayed rash at the injection site in an article.  No Concomitant product use was reported.  Treatment medication included hydrocortisone cream which has helped with the itching.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HERPES ZOSTER (Shingles) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced HERPES ZOSTER (Shingles). The patient was treated with ACYCLOVIR [ACICLOVIR] for Shingles, at an unspecified dose and frequency. At the time of the report, HERPES ZOSTER (Shingles) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.    Reporter did not allow further contact
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling, Vaccination site swelling
Clinical narrative: Swelling in left side and neck; Swelling in left side and neck; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swelling in left side and neck) and VACCINATION SITE SWELLING (Swelling in left side and neck) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (Medical history was not reported).    On 09-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 SWELLING (Swelling in left side and neck) and VACCINATION SITE SWELLING (Swelling in left side and neck). At the time of the report, SWELLING (Swelling in left side and neck) and VACCINATION SITE SWELLING (Swelling in left side and neck) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       This case was linked to US-MODERNATX, INC.-MOD-2021-080378 (E2B Linked Report). This case was linked to MOD-2021-080364 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-080378:
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) 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 PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.  Treatment medications was not given.   This case was linked to MOD21-078063, MOD21-078106, MOD21-078105 (E2B Linked Report).; Sender's Comments:  MOD21-078063:MOD-2021-080080 MOD21-078106:MOD-2021-080080 MOD21-078105:MOD-2021-080336
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle tightness, Musculoskeletal discomfort, Musculoskeletal stiffness, Neck pain
Clinical narrative: tightness in left side of neck; Discomfort in left side of neck; Stiffness in left side of neck; Very hard and painful to turn neck to the right or left; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MUSCLE TIGHTNESS (tightness in left side of neck), MUSCULOSKELETAL DISCOMFORT (Discomfort in left side of neck), MUSCULOSKELETAL STIFFNESS (Stiffness in left side of neck) and NECK PAIN (Very hard and painful to turn neck to the right or left) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MUSCLE TIGHTNESS (tightness in left side of neck), MUSCULOSKELETAL STIFFNESS (Stiffness in left side of neck) and NECK PAIN (Very hard and painful to turn neck to the right or left). 17-Apr-2021, the patient experienced MUSCULOSKELETAL DISCOMFORT (Discomfort in left side of neck). At the time of the report, MUSCLE TIGHTNESS (tightness in left side of neck), MUSCULOSKELETAL DISCOMFORT (Discomfort in left side of neck), MUSCULOSKELETAL STIFFNESS (Stiffness in left side of neck) and NECK PAIN (Very hard and painful to turn neck to the right or left) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Treatment information not provided
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Cough, Dizziness, Dyspnoea
Clinical narrative: arm swelled so big; fast heart beat; dizziness; shaking really bad; weakness; Itching welts all over it; foggy head; runny nose; sore throat; shortness of breath; cough; chills; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm swelled so big), PALPITATIONS (fast heart beat), DIZZINESS (dizziness), TREMOR (shaking really bad) and ASTHENIA (weakness) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced PERIPHERAL SWELLING (arm swelled so big), PALPITATIONS (fast heart beat), DIZZINESS (dizziness), TREMOR (shaking really bad), ASTHENIA (weakness), URTICARIA (Itching welts all over it), FEELING ABNORMAL (foggy head), RHINORRHOEA (runny nose), OROPHARYNGEAL PAIN (sore throat), DYSPNOEA (shortness of breath), COUGH (cough), CHILLS (chills) and FATIGUE (fatigue). At the time of the report, PERIPHERAL SWELLING (arm swelled so big), PALPITATIONS (fast heart beat), DIZZINESS (dizziness), TREMOR (shaking really bad), ASTHENIA (weakness), URTICARIA (Itching welts all over it), FEELING ABNORMAL (foggy head), RHINORRHOEA (runny nose), OROPHARYNGEAL PAIN (sore throat), DYSPNOEA (shortness of breath), COUGH (cough), CHILLS (chills) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided. No treatment medication information was provided.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Oropharyngeal pain, Palpitations, Peripheral swelling
Clinical narrative: arm swelled so big; fast heart beat; dizziness; shaking really bad; weakness; Itching welts all over it; foggy head; runny nose; sore throat; shortness of breath; cough; chills; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm swelled so big), PALPITATIONS (fast heart beat), DIZZINESS (dizziness), TREMOR (shaking really bad) and ASTHENIA (weakness) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced PERIPHERAL SWELLING (arm swelled so big), PALPITATIONS (fast heart beat), DIZZINESS (dizziness), TREMOR (shaking really bad), ASTHENIA (weakness), URTICARIA (Itching welts all over it), FEELING ABNORMAL (foggy head), RHINORRHOEA (runny nose), OROPHARYNGEAL PAIN (sore throat), DYSPNOEA (shortness of breath), COUGH (cough), CHILLS (chills) and FATIGUE (fatigue). At the time of the report, PERIPHERAL SWELLING (arm swelled so big), PALPITATIONS (fast heart beat), DIZZINESS (dizziness), TREMOR (shaking really bad), ASTHENIA (weakness), URTICARIA (Itching welts all over it), FEELING ABNORMAL (foggy head), RHINORRHOEA (runny nose), OROPHARYNGEAL PAIN (sore throat), DYSPNOEA (shortness of breath), COUGH (cough), CHILLS (chills) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided. No treatment medication information was provided.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, Tremor, Urticaria
Clinical narrative: arm swelled so big; fast heart beat; dizziness; shaking really bad; weakness; Itching welts all over it; foggy head; runny nose; sore throat; shortness of breath; cough; chills; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm swelled so big), PALPITATIONS (fast heart beat), DIZZINESS (dizziness), TREMOR (shaking really bad) and ASTHENIA (weakness) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced PERIPHERAL SWELLING (arm swelled so big), PALPITATIONS (fast heart beat), DIZZINESS (dizziness), TREMOR (shaking really bad), ASTHENIA (weakness), URTICARIA (Itching welts all over it), FEELING ABNORMAL (foggy head), RHINORRHOEA (runny nose), OROPHARYNGEAL PAIN (sore throat), DYSPNOEA (shortness of breath), COUGH (cough), CHILLS (chills) and FATIGUE (fatigue). At the time of the report, PERIPHERAL SWELLING (arm swelled so big), PALPITATIONS (fast heart beat), DIZZINESS (dizziness), TREMOR (shaking really bad), ASTHENIA (weakness), URTICARIA (Itching welts all over it), FEELING ABNORMAL (foggy head), RHINORRHOEA (runny nose), OROPHARYNGEAL PAIN (sore throat), DYSPNOEA (shortness of breath), COUGH (cough), CHILLS (chills) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided. No treatment medication information was provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dyspnoea, Headache, Influenza virus test
Clinical narrative: Chills; Fever; shortness of breath; shortness of breath; not feeling great; Headache; Fever; joint pain; Muscle pain; shortness of breath; not feeling great; Headache; Fever; joint pain; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of DYSPNOEA (shortness of breath), the first episode of MALAISE (not feeling great), the first episode of HEADACHE (Headache), the first episode of PYREXIA (Fever) and the first episode of ARTHRALGIA (joint pain) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypothyroidism. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism.    On 15-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced the first episode of DYSPNOEA (shortness of breath), the first episode of MALAISE (not feeling great), the first episode of HEADACHE (Headache), the first episode of PYREXIA (Fever), the first episode of ARTHRALGIA (joint pain) and the first episode of MYALGIA (Muscle pain). On 27-Mar-2021, the patient experienced the second episode of DYSPNOEA (shortness of breath), the second episode of MALAISE (not feeling great), the second episode of HEADACHE (Headache), the second episode of PYREXIA (Fever), the second episode of ARTHRALGIA (joint pain) and the second episode of MYALGIA (Muscle pain). On 19-Apr-2021, the patient experienced CHILLS (Chills). 19-Apr-2021, the patient experienced the third episode of PYREXIA (Fever) and the third episode of DYSPNOEA (shortness of breath). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 28-Mar-2021, last episode of MALAISE (not feeling great), the last episode of HEADACHE (Headache), the last episode of ARTHRALGIA (joint pain) and the last episode of MYALGIA (Muscle pain) had resolved. At the time of the report, CHILLS (Chills), the last episode of PYREXIA (Fever) and the last episode of DYSPNOEA (shortness of breath) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Mar-2021, Influenza virus test: negative Negative. On 28-Mar-2021, SARS-CoV-2 test: negative Negative. On 31-Mar-2021, SARS-CoV-2 test: negative Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-080376 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: no new information
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Myalgia, Pyrexia, SARS-CoV-2 test
Clinical narrative: Chills; Fever; shortness of breath; shortness of breath; not feeling great; Headache; Fever; joint pain; Muscle pain; shortness of breath; not feeling great; Headache; Fever; joint pain; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of DYSPNOEA (shortness of breath), the first episode of MALAISE (not feeling great), the first episode of HEADACHE (Headache), the first episode of PYREXIA (Fever) and the first episode of ARTHRALGIA (joint pain) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypothyroidism. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism.    On 15-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced the first episode of DYSPNOEA (shortness of breath), the first episode of MALAISE (not feeling great), the first episode of HEADACHE (Headache), the first episode of PYREXIA (Fever), the first episode of ARTHRALGIA (joint pain) and the first episode of MYALGIA (Muscle pain). On 27-Mar-2021, the patient experienced the second episode of DYSPNOEA (shortness of breath), the second episode of MALAISE (not feeling great), the second episode of HEADACHE (Headache), the second episode of PYREXIA (Fever), the second episode of ARTHRALGIA (joint pain) and the second episode of MYALGIA (Muscle pain). On 19-Apr-2021, the patient experienced CHILLS (Chills). 19-Apr-2021, the patient experienced the third episode of PYREXIA (Fever) and the third episode of DYSPNOEA (shortness of breath). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 28-Mar-2021, last episode of MALAISE (not feeling great), the last episode of HEADACHE (Headache), the last episode of ARTHRALGIA (joint pain) and the last episode of MYALGIA (Muscle pain) had resolved. At the time of the report, CHILLS (Chills), the last episode of PYREXIA (Fever) and the last episode of DYSPNOEA (shortness of breath) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Mar-2021, Influenza virus test: negative Negative. On 28-Mar-2021, SARS-CoV-2 test: negative Negative. On 31-Mar-2021, SARS-CoV-2 test: negative Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-080376 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: no new information
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Fatigue, Feeding disorder
Clinical narrative: Cold; Dizziness; Head spinning; Unable to eat; Unwell; Weakness; Vomiting; Chills; Fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NASOPHARYNGITIS (Cold), DIZZINESS (Dizziness), VERTIGO (Head spinning), FEEDING DISORDER (Unable to eat) and MALAISE (Unwell) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Colon cancer and Vertigo.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (Cold), DIZZINESS (Dizziness), VERTIGO (Head spinning), FEEDING DISORDER (Unable to eat), MALAISE (Unwell), ASTHENIA (Weakness), VOMITING (Vomiting), CHILLS (Chills) and FATIGUE (Fatigue). At the time of the report, NASOPHARYNGITIS (Cold), VERTIGO (Head spinning), FEEDING DISORDER (Unable to eat), MALAISE (Unwell), ASTHENIA (Weakness), CHILLS (Chills) and FATIGUE (Fatigue) had resolved and DIZZINESS (Dizziness) and VOMITING (Vomiting) had not resolved.            Patient was prescribed medication for dizziness. No concomitant medication were provided. Action taken for Moderna COVID-19 Vaccine was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Event outcomes were updated.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Nasopharyngitis, Vertigo, Vomiting
Clinical narrative: Cold; Dizziness; Head spinning; Unable to eat; Unwell; Weakness; Vomiting; Chills; Fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NASOPHARYNGITIS (Cold), DIZZINESS (Dizziness), VERTIGO (Head spinning), FEEDING DISORDER (Unable to eat) and MALAISE (Unwell) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Colon cancer and Vertigo.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (Cold), DIZZINESS (Dizziness), VERTIGO (Head spinning), FEEDING DISORDER (Unable to eat), MALAISE (Unwell), ASTHENIA (Weakness), VOMITING (Vomiting), CHILLS (Chills) and FATIGUE (Fatigue). At the time of the report, NASOPHARYNGITIS (Cold), VERTIGO (Head spinning), FEEDING DISORDER (Unable to eat), MALAISE (Unwell), ASTHENIA (Weakness), CHILLS (Chills) and FATIGUE (Fatigue) had resolved and DIZZINESS (Dizziness) and VOMITING (Vomiting) had not resolved.            Patient was prescribed medication for dizziness. No concomitant medication were provided. Action taken for Moderna COVID-19 Vaccine was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Event outcomes were updated.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Vomiting
Clinical narrative: legs cramp; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (legs cramp) and VOMITING (Vomiting) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, the patient experienced MUSCLE SPASMS (legs cramp) and VOMITING (Vomiting). On 19-Apr-2021, MUSCLE SPASMS (legs cramp) had resolved. At the time of the report, VOMITING (Vomiting) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Follow received and contains No new information On 02-Aug-2021: TCR received. Contact address updated. Data correction; outcome of Vomiting changed to Not recovered.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN (Soreness) and HEADACHE (Headache) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031721A and 046A21A) 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. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced PAIN (Soreness) and HEADACHE (Headache). The patient was treated with ACETAMINOPHEN at a dose of 1 dosage form. At the time of the report, PAIN (Soreness) and HEADACHE (Headache) had resolved.    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Relevant concomitant medications were not reported. Treatment information was included acetaminophen. This case was linked to US-MODERNATX, INC.-MOD-2021-080370 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-080370:2nd dose case.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dizziness, Erythema, Feeling abnormal
Clinical narrative: Patient did not get second dose; tinnitus; arm swollen/rock hard; arm was red; it feels as though you're about to have a stroke or anaphylactic reaction; dizziness,felt as if she got thrown on the high way and hit by the truck,; lymph nodes; fever,; vomiting; joint pain; chills,; all the symptoms on the FAQ sheet given to her: nausea; muscle aches,; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient did not get second dose), TINNITUS (tinnitus), PERIPHERAL SWELLING (arm swollen/rock hard), ERYTHEMA (arm was red) and FEELING ABNORMAL (it feels as though you're about to have a stroke or anaphylactic reaction) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Feb-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 did not get second dose), TINNITUS (tinnitus), PERIPHERAL SWELLING (arm swollen/rock hard), ERYTHEMA (arm was red), FEELING ABNORMAL (it feels as though you're about to have a stroke or anaphylactic reaction), DIZZINESS (dizziness,felt as if she got thrown on the high way and hit by the truck,), LYMPHADENOPATHY (lymph nodes), PYREXIA (fever,), VOMITING (vomiting), ARTHRALGIA (joint pain), CHILLS (chills,), NAUSEA (all the symptoms on the FAQ sheet given to her: nausea) and MYALGIA (muscle aches,). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient did not get second dose), TINNITUS (tinnitus), PERIPHERAL SWELLING (arm swollen/rock hard), ERYTHEMA (arm was red), DIZZINESS (dizziness,felt as if she got thrown on the high way and hit by the truck,), LYMPHADENOPATHY (lymph nodes), PYREXIA (fever,), VOMITING (vomiting), ARTHRALGIA (joint pain), CHILLS (chills,), NAUSEA (all the symptoms on the FAQ sheet given to her: nausea) and MYALGIA (muscle aches,) outcome was unknown. Not Provided          Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Email:  in response to ADR forms. She is in the middle of filling out. Will send later.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Myalgia, Nausea, Peripheral swelling, Product dose omission issue
Clinical narrative: Patient did not get second dose; tinnitus; arm swollen/rock hard; arm was red; it feels as though you're about to have a stroke or anaphylactic reaction; dizziness,felt as if she got thrown on the high way and hit by the truck,; lymph nodes; fever,; vomiting; joint pain; chills,; all the symptoms on the FAQ sheet given to her: nausea; muscle aches,; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient did not get second dose), TINNITUS (tinnitus), PERIPHERAL SWELLING (arm swollen/rock hard), ERYTHEMA (arm was red) and FEELING ABNORMAL (it feels as though you're about to have a stroke or anaphylactic reaction) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Feb-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 did not get second dose), TINNITUS (tinnitus), PERIPHERAL SWELLING (arm swollen/rock hard), ERYTHEMA (arm was red), FEELING ABNORMAL (it feels as though you're about to have a stroke or anaphylactic reaction), DIZZINESS (dizziness,felt as if she got thrown on the high way and hit by the truck,), LYMPHADENOPATHY (lymph nodes), PYREXIA (fever,), VOMITING (vomiting), ARTHRALGIA (joint pain), CHILLS (chills,), NAUSEA (all the symptoms on the FAQ sheet given to her: nausea) and MYALGIA (muscle aches,). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient did not get second dose), TINNITUS (tinnitus), PERIPHERAL SWELLING (arm swollen/rock hard), ERYTHEMA (arm was red), DIZZINESS (dizziness,felt as if she got thrown on the high way and hit by the truck,), LYMPHADENOPATHY (lymph nodes), PYREXIA (fever,), VOMITING (vomiting), ARTHRALGIA (joint pain), CHILLS (chills,), NAUSEA (all the symptoms on the FAQ sheet given to her: nausea) and MYALGIA (muscle aches,) outcome was unknown. Not Provided          Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Email:  in response to ADR forms. She is in the middle of filling out. Will send later.