chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort
Clinical narrative: Had to use bathroom a couple hours after shot; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Had to use bathroom a couple hours after shot) in a female 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (Had to use bathroom a couple hours after shot). At the time of the report, ABDOMINAL DISCOMFORT (Had to use bathroom a couple hours after shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment medication were provided.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Arm was sore; fever; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Arm was sore) and PYREXIA (fever) in a 73-year-old male 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm was sore) and PYREXIA (fever). At the time of the report, PAIN IN EXTREMITY (Arm was sore) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment medication were provided.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling hot, Pain, Pain in extremity, Pyrexia
Clinical narrative: hot to touch; painful; Fever; Terrible chills; Pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm), FEELING HOT (hot to touch), PAIN (painful), PYREXIA (Fever) and CHILLS (Terrible chills) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     Concomitant products included PREDNISONE for an unknown indication.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm). On 03-Mar-2021, the patient experienced CHILLS (Terrible chills). On 27-Mar-2021, the patient experienced PYREXIA (Fever). On 30-Mar-2021, the patient experienced FEELING HOT (hot to touch) and PAIN (painful). On 28-Feb-2021, PAIN IN EXTREMITY (Pain in arm) had resolved. On 07-Mar-2021, CHILLS (Terrible chills) outcome was unknown. On 29-Mar-2021, PYREXIA (Fever) had resolved. At the time of the report, FEELING HOT (hot to touch) and PAIN (painful) outcome was unknown.            This case was linked to MOD-2021-064184 (Patient Link).
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph nodes n her collar bones and neck; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen lymph nodes n her collar bones and neck) in a 25-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 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced LYMPHADENOPATHY (Swollen lymph nodes n her collar bones and neck). At the time of the report, LYMPHADENOPATHY (Swollen lymph nodes n her collar bones and neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Products known to have been used by the patient, within two weeks prior to the event were not provided.  No laboratory investigations were provided. The Treatment information included Ibuprofen, and acetaminophen.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Muscle spasms
Clinical narrative: Leg cramps in both legs; Feels like a rubber band, like tightening; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Leg cramps in both legs) and FEELING ABNORMAL (Feels like a rubber band, like tightening) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 10-Apr-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 MUSCLE SPASMS (Leg cramps in both legs) and FEELING ABNORMAL (Feels like a rubber band, like tightening). At the time of the report, MUSCLE SPASMS (Leg cramps in both legs) and FEELING ABNORMAL (Feels like a rubber band, like tightening) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medications and treatment details were not provided.  The patient  started with the leg cramps in both legs. It was terrible for 3-4 days. Se still have it when she first wake up and get out of bed. It feels like a rubber band, like tightening.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Myalgia, SARS-CoV-2 test
Clinical narrative: sore arm; tested positive for Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for Covid-19) and MYALGIA (sore arm) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced COVID-19 (tested positive for Covid-19). On an unknown date, the patient experienced MYALGIA (sore arm). At the time of the report, COVID-19 (tested positive for Covid-19) and MYALGIA (sore arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Apr-2021, SARS-CoV-2 test: positive (Positive) COVID-19 Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Agitation, Fatigue, Feeling abnormal
Clinical narrative: Agitated; Very edgy/snappy; Tired; This spontaneous case was reported by a consumer and describes the occurrence of AGITATION (Agitated), FEELING ABNORMAL (Very edgy/snappy) and FATIGUE (Tired) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     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 AGITATION (Agitated), FEELING ABNORMAL (Very edgy/snappy) and FATIGUE (Tired). At the time of the report, AGITATION (Agitated), FEELING ABNORMAL (Very edgy/snappy) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medications and treatment details were not provided.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: tested positive for COVID19; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for COVID19) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concurrent medical conditions included COVID-19.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for COVID19). At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive for COVID19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant information was reported. Treatment information was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, COVID-19, Chills, Headache
Clinical narrative: COVID-19; Lower back pain; Inflammation around entire body; Joint pain; Headache; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), BACK PAIN (Lower back pain), INFLAMMATION (Inflammation around entire body), ARTHRALGIA (Joint pain) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 45B21A and 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Apr-2021, the patient experienced BACK PAIN (Lower back pain), INFLAMMATION (Inflammation around entire body), ARTHRALGIA (Joint pain), HEADACHE (Headache), CHILLS (Chills) and PYREXIA (Fever). On 05-May-2021, the patient experienced COVID-19 (COVID-19). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19), BACK PAIN (Lower back pain), INFLAMMATION (Inflammation around entire body), ARTHRALGIA (Joint pain), HEADACHE (Headache), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-May-2021, SARS-CoV-2 test: (Positive) No other results are reported..         No concomitant medications were provided.  The action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Follow-up information received on 17-May-2021 contains information regarding additional event COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Pyrexia, SARS-CoV-2 test
Clinical narrative: COVID-19; Lower back pain; Inflammation around entire body; Joint pain; Headache; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), BACK PAIN (Lower back pain), INFLAMMATION (Inflammation around entire body), ARTHRALGIA (Joint pain) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 45B21A and 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Apr-2021, the patient experienced BACK PAIN (Lower back pain), INFLAMMATION (Inflammation around entire body), ARTHRALGIA (Joint pain), HEADACHE (Headache), CHILLS (Chills) and PYREXIA (Fever). On 05-May-2021, the patient experienced COVID-19 (COVID-19). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19), BACK PAIN (Lower back pain), INFLAMMATION (Inflammation around entire body), ARTHRALGIA (Joint pain), HEADACHE (Headache), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-May-2021, SARS-CoV-2 test: (Positive) No other results are reported..         No concomitant medications were provided.  The action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Follow-up information received on 17-May-2021 contains information regarding additional event COVID-19.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle swelling, Pain in extremity
Clinical narrative: arm is still sore; muscle on inside of the left arm is swollen and puffy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm is still sore) and MUSCLE SWELLING (muscle on inside of the left arm is swollen and puffy) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm is still sore) and MUSCLE SWELLING (muscle on inside of the left arm is swollen and puffy). At the time of the report, PAIN IN EXTREMITY (arm is still sore) and MUSCLE SWELLING (muscle on inside of the left arm is swollen and puffy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Products known to have been used by the patient, within two weeks prior to the event were not provided.  No laboratory investigations were provided. The Treatment information was not provided.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Sinusitis
Clinical narrative: Sinus infection; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (Sinus infection) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038a21a) for COVID-19 vaccination.     Concurrent medical conditions included BP.    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, the patient experienced SINUSITIS (Sinus infection). The patient was treated with AMOXICILLIN TRIHYDRATE, CLAVULANATE POTASSIUM (AMOXICLAV) at an unspecified dose and frequency. At the time of the report, SINUSITIS (Sinus infection) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication include three different BP medications.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Headache, Myalgia, Product dose omission issue
Clinical narrative: Not be taking 2nd shot; Body aches; Headache; Light headed; Weak; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Light headed), ASTHENIA (Weak), PRODUCT DOSE OMISSION ISSUE (Not be taking 2nd shot), MYALGIA (Body aches) and HEADACHE (Headache) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced DIZZINESS (Light headed), ASTHENIA (Weak), MYALGIA (Body aches) and HEADACHE (Headache). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Not be taking 2nd shot). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, DIZZINESS (Light headed), ASTHENIA (Weak), MYALGIA (Body aches) and HEADACHE (Headache) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Not be taking 2nd shot) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       Concomitant medication list was not provided.  Action taken with mRNA-1273 in response to the event was withdrawn.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Feeling abnormal, Headache, Myalgia
Clinical narrative: fatigue; Slept all night untill saturday; nausea; felt bad; body aches; joint pain; headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt bad), MYALGIA (body aches), ARTHRALGIA (joint pain), HEADACHE (headache) and FATIGUE (fatigue) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced FEELING ABNORMAL (felt bad), MYALGIA (body aches), ARTHRALGIA (joint pain) and HEADACHE (headache). On 17-Apr-2021, the patient experienced FATIGUE (fatigue) and SOMNOLENCE (Slept all night untill saturday). 17-Apr-2021, the patient experienced NAUSEA (nausea). On 18-Apr-2021, FEELING ABNORMAL (felt bad), FATIGUE (fatigue), SOMNOLENCE (Slept all night untill saturday) and NAUSEA (nausea) outcome was unknown. On 19-Apr-2021, MYALGIA (body aches) and ARTHRALGIA (joint pain) outcome was unknown. At the time of the report, HEADACHE (headache) outcome was unknown.            Treatment information were not provided. List of concomitant medication were not given.   This case was linked to US-MODERNATX, INC.-MOD-2021-080344 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-080344:
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Somnolence
Clinical narrative: fatigue; Slept all night untill saturday; nausea; felt bad; body aches; joint pain; headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt bad), MYALGIA (body aches), ARTHRALGIA (joint pain), HEADACHE (headache) and FATIGUE (fatigue) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced FEELING ABNORMAL (felt bad), MYALGIA (body aches), ARTHRALGIA (joint pain) and HEADACHE (headache). On 17-Apr-2021, the patient experienced FATIGUE (fatigue) and SOMNOLENCE (Slept all night untill saturday). 17-Apr-2021, the patient experienced NAUSEA (nausea). On 18-Apr-2021, FEELING ABNORMAL (felt bad), FATIGUE (fatigue), SOMNOLENCE (Slept all night untill saturday) and NAUSEA (nausea) outcome was unknown. On 19-Apr-2021, MYALGIA (body aches) and ARTHRALGIA (joint pain) outcome was unknown. At the time of the report, HEADACHE (headache) outcome was unknown.            Treatment information were not provided. List of concomitant medication were not given.   This case was linked to US-MODERNATX, INC.-MOD-2021-080344 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-080344:
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Bedridden, Bone pain, Chills, Discomfort
Clinical narrative: "still sick today"; couldn't get out of bed; left arm swelling; joint pain; muscle pain; chills; nausea; vomiting; fever; fatigue; headache; felt a "sharp pain" during the vaccination; Painful arm; felt like they "stuck it in the bone"; felt like the vaccine "went to her heart; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (felt like they "stuck it in the bone"), DISCOMFORT (felt like the vaccine "went to her heart), ILLNESS ("still sick today"), BEDRIDDEN (couldn't get out of bed) and VACCINATION SITE PAIN (felt a "sharp pain" during the vaccination) in a 64-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.    Co-suspect product included non-company product IBUPROFEN (MOTRIN [IBUPROFEN]) for an unknown indication.    The patient's past medical history included COVID-19 in October 2020. Concurrent medical conditions included Osteoarthritis and Seafood allergy (Shellfish). Concomitant products included PARACETAMOL (TYLENOL) for Fever, IBUPROFEN and NAPROXEN for an unknown indication.   On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started IBUPROFEN (MOTRIN [IBUPROFEN]) (unknown route) dosage form. On 17-Apr-2021, the patient experienced BONE PAIN (felt like they "stuck it in the bone"), DISCOMFORT (felt like the vaccine "went to her heart), VACCINATION SITE PAIN (felt a "sharp pain" during the vaccination) and VACCINATION SITE PAIN (Painful arm). On 18-Apr-2021, the patient experienced BEDRIDDEN (couldn't get out of bed), VACCINATION SITE SWELLING (left arm swelling), ARTHRALGIA (joint pain), MYALGIA (muscle pain), CHILLS (chills), NAUSEA (nausea), VOMITING (vomiting), PYREXIA (fever), FATIGUE (fatigue) and HEADACHE (headache). On 19-Apr-2021, the patient experienced ILLNESS ("still sick today"). At the time of the report, BONE PAIN (felt like they "stuck it in the bone"), DISCOMFORT (felt like the vaccine "went to her heart), ILLNESS ("still sick today"), BEDRIDDEN (couldn't get out of bed), VACCINATION SITE PAIN (felt a "sharp pain" during the vaccination), VACCINATION SITE PAIN (Painful arm), VACCINATION SITE SWELLING (left arm swelling), ARTHRALGIA (joint pain), MYALGIA (muscle pain), CHILLS (chills), NAUSEA (nausea), VOMITING (vomiting), PYREXIA (fever), FATIGUE (fatigue) and HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient had recovered, recently had a physical examination which went well, and reported adverse events had subsided. Patient had nothing further to report.  No treatment drug information are reported   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Significant follow up received. TCR attached, updated outcome of all events as recovered.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Illness, Myalgia, Nausea
Clinical narrative: "still sick today"; couldn't get out of bed; left arm swelling; joint pain; muscle pain; chills; nausea; vomiting; fever; fatigue; headache; felt a "sharp pain" during the vaccination; Painful arm; felt like they "stuck it in the bone"; felt like the vaccine "went to her heart; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (felt like they "stuck it in the bone"), DISCOMFORT (felt like the vaccine "went to her heart), ILLNESS ("still sick today"), BEDRIDDEN (couldn't get out of bed) and VACCINATION SITE PAIN (felt a "sharp pain" during the vaccination) in a 64-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.    Co-suspect product included non-company product IBUPROFEN (MOTRIN [IBUPROFEN]) for an unknown indication.    The patient's past medical history included COVID-19 in October 2020. Concurrent medical conditions included Osteoarthritis and Seafood allergy (Shellfish). Concomitant products included PARACETAMOL (TYLENOL) for Fever, IBUPROFEN and NAPROXEN for an unknown indication.   On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started IBUPROFEN (MOTRIN [IBUPROFEN]) (unknown route) dosage form. On 17-Apr-2021, the patient experienced BONE PAIN (felt like they "stuck it in the bone"), DISCOMFORT (felt like the vaccine "went to her heart), VACCINATION SITE PAIN (felt a "sharp pain" during the vaccination) and VACCINATION SITE PAIN (Painful arm). On 18-Apr-2021, the patient experienced BEDRIDDEN (couldn't get out of bed), VACCINATION SITE SWELLING (left arm swelling), ARTHRALGIA (joint pain), MYALGIA (muscle pain), CHILLS (chills), NAUSEA (nausea), VOMITING (vomiting), PYREXIA (fever), FATIGUE (fatigue) and HEADACHE (headache). On 19-Apr-2021, the patient experienced ILLNESS ("still sick today"). At the time of the report, BONE PAIN (felt like they "stuck it in the bone"), DISCOMFORT (felt like the vaccine "went to her heart), ILLNESS ("still sick today"), BEDRIDDEN (couldn't get out of bed), VACCINATION SITE PAIN (felt a "sharp pain" during the vaccination), VACCINATION SITE PAIN (Painful arm), VACCINATION SITE SWELLING (left arm swelling), ARTHRALGIA (joint pain), MYALGIA (muscle pain), CHILLS (chills), NAUSEA (nausea), VOMITING (vomiting), PYREXIA (fever), FATIGUE (fatigue) and HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient had recovered, recently had a physical examination which went well, and reported adverse events had subsided. Patient had nothing further to report.  No treatment drug information are reported   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Significant follow up received. TCR attached, updated outcome of all events as recovered.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain, Vaccination site swelling, Vomiting
Clinical narrative: "still sick today"; couldn't get out of bed; left arm swelling; joint pain; muscle pain; chills; nausea; vomiting; fever; fatigue; headache; felt a "sharp pain" during the vaccination; Painful arm; felt like they "stuck it in the bone"; felt like the vaccine "went to her heart; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (felt like they "stuck it in the bone"), DISCOMFORT (felt like the vaccine "went to her heart), ILLNESS ("still sick today"), BEDRIDDEN (couldn't get out of bed) and VACCINATION SITE PAIN (felt a "sharp pain" during the vaccination) in a 64-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.    Co-suspect product included non-company product IBUPROFEN (MOTRIN [IBUPROFEN]) for an unknown indication.    The patient's past medical history included COVID-19 in October 2020. Concurrent medical conditions included Osteoarthritis and Seafood allergy (Shellfish). Concomitant products included PARACETAMOL (TYLENOL) for Fever, IBUPROFEN and NAPROXEN for an unknown indication.   On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started IBUPROFEN (MOTRIN [IBUPROFEN]) (unknown route) dosage form. On 17-Apr-2021, the patient experienced BONE PAIN (felt like they "stuck it in the bone"), DISCOMFORT (felt like the vaccine "went to her heart), VACCINATION SITE PAIN (felt a "sharp pain" during the vaccination) and VACCINATION SITE PAIN (Painful arm). On 18-Apr-2021, the patient experienced BEDRIDDEN (couldn't get out of bed), VACCINATION SITE SWELLING (left arm swelling), ARTHRALGIA (joint pain), MYALGIA (muscle pain), CHILLS (chills), NAUSEA (nausea), VOMITING (vomiting), PYREXIA (fever), FATIGUE (fatigue) and HEADACHE (headache). On 19-Apr-2021, the patient experienced ILLNESS ("still sick today"). At the time of the report, BONE PAIN (felt like they "stuck it in the bone"), DISCOMFORT (felt like the vaccine "went to her heart), ILLNESS ("still sick today"), BEDRIDDEN (couldn't get out of bed), VACCINATION SITE PAIN (felt a "sharp pain" during the vaccination), VACCINATION SITE PAIN (Painful arm), VACCINATION SITE SWELLING (left arm swelling), ARTHRALGIA (joint pain), MYALGIA (muscle pain), CHILLS (chills), NAUSEA (nausea), VOMITING (vomiting), PYREXIA (fever), FATIGUE (fatigue) and HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient had recovered, recently had a physical examination which went well, and reported adverse events had subsided. Patient had nothing further to report.  No treatment drug information are reported   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Significant follow up received. TCR attached, updated outcome of all events as recovered.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: administer the vaccine to patient under 18 years old patient; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administer the vaccine to patient under 18 years old patient) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0047A21A 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 19-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administer the vaccine to patient under 18 years old patient). On 16-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administer the vaccine to patient under 18 years old patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information not provided.   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Follow up received on 14-MAY-2021, contains no new information.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Missed dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed dose). On 02-Mar-2021, PRODUCT DOSE OMISSION ISSUE (Missed dose) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information not provided. List of concomitant medication were not given
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Injection site pain
Clinical narrative: tenderness at site of injection; This spontaneous case was reported by a physician and describes the occurrence of INJECTION SITE PAIN (tenderness at site of injection) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032120A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-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 INJECTION SITE PAIN (tenderness at site of injection). At the time of the report, INJECTION SITE PAIN (tenderness at site of injection) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information not provided. List of concomitant medication were not given.   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Follow up received on 21-MAY-2021: event details was updated.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Knee joint pain; Elbow joint pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Knee joint pain) and ARTHRALGIA (Elbow joint pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 724- 627-8874) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced ARTHRALGIA (Knee joint pain) and ARTHRALGIA (Elbow joint pain). At the time of the report, ARTHRALGIA (Knee joint pain) and ARTHRALGIA (Elbow joint pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information not provided. List of concomitant medication were not given.   This case was linked to US-MODERNATX, INC.-MOD-2021-079951 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-079951:Dose 2
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Chills, Dyspnoea, Epstein-Barr virus test
Clinical narrative: shortness of breath; hot flashes; body aches; uncontrollable shakes; low blood pressure; fever of 104.4 degrees Farenheight; vomiting; chills; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath), HOT FLUSH (hot flashes), MYALGIA (body aches), TREMOR (uncontrollable shakes) and HYPOTENSION (low blood pressure) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00813212A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced DYSPNOEA (shortness of breath), HOT FLUSH (hot flashes), MYALGIA (body aches), TREMOR (uncontrollable shakes), HYPOTENSION (low blood pressure), PYREXIA (fever of 104.4 degrees Farenheight), VOMITING (vomiting) and CHILLS (chills). The patient was treated with POTASSIUM for Adverse event, at an unspecified dose and frequency and MAGNESIUM for Adverse event, at an unspecified dose and frequency. On 31-Mar-2021, DYSPNOEA (shortness of breath), HOT FLUSH (hot flashes), MYALGIA (body aches), TREMOR (uncontrollable shakes), HYPOTENSION (low blood pressure), PYREXIA (fever of 104.4 degrees Farenheight), VOMITING (vomiting) and CHILLS (chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Mar-2021, Body temperature: 104.4 degree farhanite (High) High. On 30-Mar-2021, COVID-19: negative (Negative) negative. On 30-Mar-2021, Epstein-Barr virus test: negative for mononucleosis (Negative) negative for Mononucleosis.         No concomitant medications were reported. The patient had no adverse events after dose 2.   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Vaccine dose 2 details added. Event outcome updated.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Hot flush, Hypotension, Myalgia, Pyrexia, Tremor
Clinical narrative: shortness of breath; hot flashes; body aches; uncontrollable shakes; low blood pressure; fever of 104.4 degrees Farenheight; vomiting; chills; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath), HOT FLUSH (hot flashes), MYALGIA (body aches), TREMOR (uncontrollable shakes) and HYPOTENSION (low blood pressure) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00813212A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced DYSPNOEA (shortness of breath), HOT FLUSH (hot flashes), MYALGIA (body aches), TREMOR (uncontrollable shakes), HYPOTENSION (low blood pressure), PYREXIA (fever of 104.4 degrees Farenheight), VOMITING (vomiting) and CHILLS (chills). The patient was treated with POTASSIUM for Adverse event, at an unspecified dose and frequency and MAGNESIUM for Adverse event, at an unspecified dose and frequency. On 31-Mar-2021, DYSPNOEA (shortness of breath), HOT FLUSH (hot flashes), MYALGIA (body aches), TREMOR (uncontrollable shakes), HYPOTENSION (low blood pressure), PYREXIA (fever of 104.4 degrees Farenheight), VOMITING (vomiting) and CHILLS (chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Mar-2021, Body temperature: 104.4 degree farhanite (High) High. On 30-Mar-2021, COVID-19: negative (Negative) negative. On 30-Mar-2021, Epstein-Barr virus test: negative for mononucleosis (Negative) negative for Mononucleosis.         No concomitant medications were reported. The patient had no adverse events after dose 2.   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Vaccine dose 2 details added. Event outcome updated.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: shortness of breath; hot flashes; body aches; uncontrollable shakes; low blood pressure; fever of 104.4 degrees Farenheight; vomiting; chills; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath), HOT FLUSH (hot flashes), MYALGIA (body aches), TREMOR (uncontrollable shakes) and HYPOTENSION (low blood pressure) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00813212A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced DYSPNOEA (shortness of breath), HOT FLUSH (hot flashes), MYALGIA (body aches), TREMOR (uncontrollable shakes), HYPOTENSION (low blood pressure), PYREXIA (fever of 104.4 degrees Farenheight), VOMITING (vomiting) and CHILLS (chills). The patient was treated with POTASSIUM for Adverse event, at an unspecified dose and frequency and MAGNESIUM for Adverse event, at an unspecified dose and frequency. On 31-Mar-2021, DYSPNOEA (shortness of breath), HOT FLUSH (hot flashes), MYALGIA (body aches), TREMOR (uncontrollable shakes), HYPOTENSION (low blood pressure), PYREXIA (fever of 104.4 degrees Farenheight), VOMITING (vomiting) and CHILLS (chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Mar-2021, Body temperature: 104.4 degree farhanite (High) High. On 30-Mar-2021, COVID-19: negative (Negative) negative. On 30-Mar-2021, Epstein-Barr virus test: negative for mononucleosis (Negative) negative for Mononucleosis.         No concomitant medications were reported. The patient had no adverse events after dose 2.   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Vaccine dose 2 details added. Event outcome updated.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Decreased appetite, Pyrexia, Vomiting
Clinical narrative: Can´t stand; Does not want to eat; Is vomiting; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Can´t stand), DECREASED APPETITE (Does not want to eat), VOMITING (Is vomiting), PYREXIA (Fever) and CHILLS (Chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 18-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (Can´t stand), DECREASED APPETITE (Does not want to eat), VOMITING (Is vomiting), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, ASTHENIA (Can´t stand), DECREASED APPETITE (Does not want to eat), VOMITING (Is vomiting), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.            Concomitant medications were not provided. Treatment information was not reported.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, COVID-19, Chills, Cough, Diarrhoea
Clinical narrative: Tested positive for Covid; Dry cough and then flem cough; diarhea; Sore arm; Headache; Joint pain; fever and chills; fever and chills; nausea taste; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 (Tested positive for Covid), COUGH (Dry cough and then flem cough), DIARRHEA (diarrhea), PAIN IN EXTREMITY (Sore arm) and HEADACHE (Headache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported).    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced COUGH (Dry cough and then flem cough), DIARRHEA (diarhea), PAIN IN EXTREMITY (Sore arm), HEADACHE (Headache), ARTHRALGIA (Joint pain), PYREXIA (fever and chills), CHILLS (fever and chills) and NAUSEA (nausea taste). On 06-Apr-2021, the patient experienced COVID-19 (Tested positive for Covid). At the time of the report, COVID-19 (Tested positive for Covid), COUGH (Dry cough and then flem cough), DIARRHEA (diarhea), PAIN IN EXTREMITY (Sore arm), HEADACHE (Headache), ARTHRALGIA (Joint pain), PYREXIA (fever and chills), CHILLS (fever and chills) and NAUSEA (nausea taste) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Tested positive for Covid; Dry cough and then flem cough; diarhea; Sore arm; Headache; Joint pain; fever and chills; fever and chills; nausea taste; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 (Tested positive for Covid), COUGH (Dry cough and then flem cough), DIARRHEA (diarrhea), PAIN IN EXTREMITY (Sore arm) and HEADACHE (Headache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported).    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced COUGH (Dry cough and then flem cough), DIARRHEA (diarhea), PAIN IN EXTREMITY (Sore arm), HEADACHE (Headache), ARTHRALGIA (Joint pain), PYREXIA (fever and chills), CHILLS (fever and chills) and NAUSEA (nausea taste). On 06-Apr-2021, the patient experienced COVID-19 (Tested positive for Covid). At the time of the report, COVID-19 (Tested positive for Covid), COUGH (Dry cough and then flem cough), DIARRHEA (diarhea), PAIN IN EXTREMITY (Sore arm), HEADACHE (Headache), ARTHRALGIA (Joint pain), PYREXIA (fever and chills), CHILLS (fever and chills) and NAUSEA (nausea taste) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling
Clinical narrative: Swelling in her throat; This spontaneous case was reported by a consumer and describes the occurrence of PHARYNGEAL SWELLING (Swelling in her throat) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) 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) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced PHARYNGEAL SWELLING (Swelling in her throat). On 19-Mar-2021, PHARYNGEAL SWELLING (Swelling in her throat) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information was provided.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Tinnitus
Clinical narrative: ringing in his ears; more of a brain thing, excruciating at night, feels like a slow death; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (ringing in his ears) and FEELING ABNORMAL (more of a brain thing, excruciating at night, feels like a slow death) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030a21a) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Mar-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TINNITUS (ringing in his ears) and FEELING ABNORMAL (more of a brain thing, excruciating at night, feels like a slow death). At the time of the report, TINNITUS (ringing in his ears) and FEELING ABNORMAL (more of a brain thing, excruciating at night, feels like a slow death) outcome was unknown.            No Concomitant Medicines were provided.  No treatment information were reported.   This case was linked to MOD21-078161, MOD21-078175, MOD21-078177 (E2B Linked Report).; Sender's Comments:  MOD21-078161: MOD21-078175: MOD21-078177: