chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Vaccination site swelling
Clinical narrative: redness that is spreading and getting bigger; itching; when she touches the site of injection she feels a slight bump under the skin; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness that is spreading and getting bigger), PRURITUS (itching) and VACCINATION SITE SWELLING (when she touches the site of injection she feels a slight bump under the skin) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     Concurrent medical conditions included Tendon injury (Torn tendon in left arm.).    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced ERYTHEMA (redness that is spreading and getting bigger), PRURITUS (itching) and VACCINATION SITE SWELLING (when she touches the site of injection she feels a slight bump under the skin). At the time of the report, ERYTHEMA (redness that is spreading and getting bigger), PRURITUS (itching) and VACCINATION SITE SWELLING (when she touches the site of injection she feels a slight bump under the skin) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported No treatment medications were reported
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue, Pyrexia
Clinical narrative: First dose 68 days ago; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (First dose 68 days ago) and PYREXIA (Fever) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (First dose 68 days ago) and PYREXIA (Fever). On 07-Feb-2021, PRODUCT DOSE OMISSION ISSUE (First dose 68 days ago) and PYREXIA (Fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 07 Feb 2021, the patient had fever due to which patient could not get second dose of vaccine. the patient also stated that fever is not related to first dose of vaccination  No concomitant medications was reported by the reporter No treatment medications was  provided by the reporter.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Myalgia, Paraesthesia
Clinical narrative: Tingly around injection site; Redness around injection site; Tenderness around injection site; Itchiness around injection site; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingly around injection site), MYALGIA (Sore arm), INJECTION SITE ERYTHEMA (Redness around injection site), INJECTION SITE PAIN (Tenderness around injection site) and INJECTION SITE PRURITUS (Itchiness around injection site) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) 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) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced MYALGIA (Sore arm). On 15-Mar-2021, the patient experienced PARAESTHESIA (Tingly around injection site), INJECTION SITE ERYTHEMA (Redness around injection site), INJECTION SITE PAIN (Tenderness around injection site) and INJECTION SITE PRURITUS (Itchiness around injection site). At the time of the report, PARAESTHESIA (Tingly around injection site), MYALGIA (Sore arm), INJECTION SITE ERYTHEMA (Redness around injection site), INJECTION SITE PAIN (Tenderness around injection site) and INJECTION SITE PRURITUS (Itchiness around injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       treatment medication: cortisone cream, anti histamines.   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: patient contact information was updated
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Nausea
Clinical narrative: Fatigue; headache; Aches; Nausea; Fever; Chills; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aches), NAUSEA (Nausea), PYREXIA (Fever), CHILLS (Chills) and the first episode of FATIGUE (Fatigue) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032m2ua) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT), THYROID, VALACICLOVIR HYDROCHLORIDE (VALTREX) and NALTREXONE for an unknown indication.   On 09-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced PAIN (Aches), NAUSEA (Nausea), PYREXIA (Fever), CHILLS (Chills), the first episode of FATIGUE (Fatigue) and HEADACHE (headache). In April 2021, the patient experienced the second episode of FATIGUE (Fatigue). In March 2021, PAIN (Aches), NAUSEA (Nausea), PYREXIA (Fever) and CHILLS (Chills) had resolved. At the time of the report, last episode of FATIGUE (Fatigue) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.2 (High) Mild fever.         No treatment medications were reported.   This case was linked to MOD21-077286, US-MODERNATX, INC.-MOD-2021-079767 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Follow up was received on 17-MAR-2021. Additional events- chills, headache and pain were added.; Sender's Comments:  MOD21-077286:follow up US-MODERNATX, INC.-MOD-2021-079767:2nd dose
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Fatigue; headache; Aches; Nausea; Fever; Chills; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aches), NAUSEA (Nausea), PYREXIA (Fever), CHILLS (Chills) and the first episode of FATIGUE (Fatigue) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032m2ua) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT), THYROID, VALACICLOVIR HYDROCHLORIDE (VALTREX) and NALTREXONE for an unknown indication.   On 09-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced PAIN (Aches), NAUSEA (Nausea), PYREXIA (Fever), CHILLS (Chills), the first episode of FATIGUE (Fatigue) and HEADACHE (headache). In April 2021, the patient experienced the second episode of FATIGUE (Fatigue). In March 2021, PAIN (Aches), NAUSEA (Nausea), PYREXIA (Fever) and CHILLS (Chills) had resolved. At the time of the report, last episode of FATIGUE (Fatigue) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.2 (High) Mild fever.         No treatment medications were reported.   This case was linked to MOD21-077286, US-MODERNATX, INC.-MOD-2021-079767 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Follow up was received on 17-MAR-2021. Additional events- chills, headache and pain were added.; Sender's Comments:  MOD21-077286:follow up US-MODERNATX, INC.-MOD-2021-079767:2nd dose
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 17-Mar-2021 and was forwarded to Moderna on 17-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M70A and 031L20A) for COVID-19 vaccination.     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 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Sore arm). On 17-Mar-2021, PAIN IN EXTREMITY (Sore arm) had resolved. Not Provided          Patient reported concomitant medications included all kinds of medicines and were too many to say.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Follow up received on 06-MAY-2021 contains no new information.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Illness, SARS-CoV-2 test
Clinical narrative: Tested COVID positive; Fell sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Fell sick) and COVID-19 (Tested COVID positive) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Dialysis since an unknown date. Concurrent medical conditions included Hypertension, COPD, Lung disorder and Kidney disorder. Concomitant products included OMEPRAZOLE for Acid reflux (esophageal), VALPROATE SEMISODIUM (DIVALPROEX) and VALPROATE SEMISODIUM (DEPAKOTE) for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced ILLNESS (Fell sick). On 25-Jan-2021, the patient experienced COVID-19 (Tested COVID positive). At the time of the report, ILLNESS (Fell sick) and COVID-19 (Tested COVID positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jan-2021, SARS-CoV-2 test: positive (Inconclusive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications also included blood pressure medication. Patient was reported to be enrolled in program where he received iv infusion of monoclonal antibodies.   This case was linked to MOD21-028165 (E2B Linked Report).; Sender's Comments:  MOD21-028165:
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Vaccination site erythema, Vaccination site rash, Vaccination site warmth
Clinical narrative: injection site warmness; injection site rash; injection site redness; itching; another rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (injection site warmness), PRURITUS (itching), RASH (another rash), VACCINATION SITE RASH (injection site rash) and VACCINATION SITE ERYTHEMA (injection site redness) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced PRURITUS (itching) and RASH (another rash). On an unknown date, the patient experienced VACCINATION SITE WARMTH (injection site warmness), VACCINATION SITE RASH (injection site rash) and VACCINATION SITE ERYTHEMA (injection site redness). On 16-Mar-2021, PRURITUS (itching) had resolved. At the time of the report, VACCINATION SITE WARMTH (injection site warmness), VACCINATION SITE RASH (injection site rash) and VACCINATION SITE ERYTHEMA (injection site redness) had not resolved and RASH (another rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were reported
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site rash
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash all around injection site) and RASH (Rash down arm to elbow) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026a21a) for COVID-19 vaccination.     Concomitant products included TOPIRAMATE (TOPAMAX) and SIMVASTATIN (ZOCOR) for an unknown indication.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced VACCINATION SITE RASH (Rash all around injection site) and RASH (Rash down arm to elbow). At the time of the report, VACCINATION SITE RASH (Rash all around injection site) and RASH (Rash down arm to elbow) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant Product: Antidepressant.  Patient stated she received the first Moderna vaccine on 2-2-2021. Patient stated after first Moderna vaccine she had a rash on day 9,all around the injection site down arm above elbow.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain, Skin discolouration
Clinical narrative: Dark blue purple spot on the right hand about the size; Pain in the left Shoulder blade; Soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Soreness), SKIN DISCOLOURATION (Dark blue purple spot on the right hand about the size) and ARTHRALGIA (Pain in the left Shoulder blade) in a 72-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-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced PAIN (Soreness) and ARTHRALGIA (Pain in the left Shoulder blade). On 16-Mar-2021, the patient experienced SKIN DISCOLOURATION (Dark blue purple spot on the right hand about the size). At the time of the report, PAIN (Soreness), SKIN DISCOLOURATION (Dark blue purple spot on the right hand about the size) and ARTHRALGIA (Pain in the left Shoulder blade) outcome was unknown.            No treatment information was provided.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     Concomitant products included METFORMIN, VITAMIN D3, VITAMIN B12 NOS (VITAMIN B 12 [VITAMIN B12 NOS]), AMLODIPINE and OMEPRAZOLE for an unknown indication.   On 14-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 15-Mar-2021, the patient experienced DIARRHOEA (Diarrhea). The patient was treated with BISMUTH SUBSALICYLATE (PEPTO-BISMOL) for Diarrhea, at a dose of UNK dosage form. At the time of the report, DIARRHOEA (Diarrhea) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Hypersensitivity, Paraesthesia oral, Vision blurred
Clinical narrative: Slight allergic reaction; Tongue tingled; Pulse went up to 118 within seconds; Blurred vision; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Slight allergic reaction), PARAESTHESIA ORAL (Tongue tingled), HEART RATE INCREASED (Pulse went up to 118 within seconds) and VISION BLURRED (Blurred vision) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced HYPERSENSITIVITY (Slight allergic reaction), PARAESTHESIA ORAL (Tongue tingled), HEART RATE INCREASED (Pulse went up to 118 within seconds) and VISION BLURRED (Blurred vision). On 13-Mar-2021, PARAESTHESIA ORAL (Tongue tingled) had resolved. At the time of the report, HYPERSENSITIVITY (Slight allergic reaction), HEART RATE INCREASED (Pulse went up to 118 within seconds) and VISION BLURRED (Blurred vision) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Mar-2021, Heart rate: 118 (High) pulse went up to 118 within seconds.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported. No Treatments were reported.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: 3-4 days later he had diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (3-4 days later he had diarrhea) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DIARRHOEA (3-4 days later he had diarrhea). The patient was treated with ELECTROLYTES NOS for Diarrhoea, at a dose of UNK dosage form and LOPERAMIDE HYDROCHLORIDE (IMODIUM) for Diarrhoea, at a dose of UNK dosage form. At the time of the report, DIARRHOEA (3-4 days later he had diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  No Concomitant medications were reported.  Treatment medications also Included yogurt and lots of water.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Headache, Influenza like illness, Lymphadenopathy, Muscular weakness
Clinical narrative: Legs Rubbery; Weak; Feels like Flu; Swollen Lymph Gland the size of a baseball; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Legs Rubbery), ASTHENIA (Weak), INFLUENZA LIKE ILLNESS (Feels like Flu), LYMPHADENOPATHY (Swollen Lymph Gland the size of a baseball) and HEADACHE (Headache) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced MUSCULAR WEAKNESS (Legs Rubbery), ASTHENIA (Weak), INFLUENZA LIKE ILLNESS (Feels like Flu), LYMPHADENOPATHY (Swollen Lymph Gland the size of a baseball) and HEADACHE (Headache). At the time of the report, MUSCULAR WEAKNESS (Legs Rubbery), ASTHENIA (Weak), INFLUENZA LIKE ILLNESS (Feels like Flu), LYMPHADENOPATHY (Swollen Lymph Gland the size of a baseball) and HEADACHE (Headache) outcome was unknown.            Concomitant product information, if any, was not provided by the reporter. Treatment information, if any, was not provided.  Action taken with mRNA-1273 in response to the event was not applicable.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: shortness of breath; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (shortness of breath) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     The patient's past medical history included Heart disorder (shortness of breath reported was found to be due to something with the heart).   On 10-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced DYSPNOEA (shortness of breath). At the time of the report, DYSPNOEA (shortness of breath) outcome was unknown.            No concomitant medication were provided Treatment information provided as "Doctors treated the problem"   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Additional information received
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: vomiting; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (vomiting) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     Concomitant products included VALACYCLOVIR [VALACICLOVIR] and PREDNISONE for Eye disorder NOS, APIXABAN (ELIQUIS), METOPROLOL, LATANOPROST, CALCIUM, COLECALCIFEROL (CALCIUM & VITAMIN D [CALCIUM;COLECALCIFEROL]), MAGNESIUM and SHARK CARTILAGE for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-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 VOMITING (vomiting). At the time of the report, VOMITING (vomiting) had resolved.            Treatment information was not provided   This case was linked to MOD-2021-047824 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Musculoskeletal discomfort, Nausea
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (knee unstable), FATIGUE (fatigue), HEADACHE (headache), ARTHRALGIA (joint pain) and NAUSEA (nausea) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B2117) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Ulcerative colitis.    On 14-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 FATIGUE (fatigue). On 15-Mar-2021, the patient experienced MUSCULOSKELETAL DISCOMFORT (knee unstable), HEADACHE (headache), ARTHRALGIA (joint pain), NAUSEA (nausea) and VOMITING (vomiting). At the time of the report, MUSCULOSKELETAL DISCOMFORT (knee unstable), FATIGUE (fatigue), HEADACHE (headache), ARTHRALGIA (joint pain), NAUSEA (nausea) and VOMITING (vomiting) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported  No treatment information were  reported  It was reported that Patient consulted HCP on 18 march 2021     Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Event outcome was updated as recovered/resolved.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (knee unstable), FATIGUE (fatigue), HEADACHE (headache), ARTHRALGIA (joint pain) and NAUSEA (nausea) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B2117) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Ulcerative colitis.    On 14-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 FATIGUE (fatigue). On 15-Mar-2021, the patient experienced MUSCULOSKELETAL DISCOMFORT (knee unstable), HEADACHE (headache), ARTHRALGIA (joint pain), NAUSEA (nausea) and VOMITING (vomiting). At the time of the report, MUSCULOSKELETAL DISCOMFORT (knee unstable), FATIGUE (fatigue), HEADACHE (headache), ARTHRALGIA (joint pain), NAUSEA (nausea) and VOMITING (vomiting) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported  No treatment information were  reported  It was reported that Patient consulted HCP on 18 march 2021     Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Event outcome was updated as recovered/resolved.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Confusional state, Fatigue, Illness, Joint swelling
Clinical narrative: two to three days of being sick in bed; sinus pressure in face because of swelling of lymph nodes; blowing his nose a lot; knocked out; fever; throat hurting only on injection side (left side); glands of the left side of neck, collar bone, and jaw were swollen; swelling in the TMJ area; pain in the TMJ area; felt really tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (felt really tired), ARTHRALGIA (pain in the TMJ area), CONFUSIONAL STATE (knocked out), PYREXIA (fever) and OROPHARYNGEAL PAIN (throat hurting only on injection side (left side)) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced FATIGUE (felt really tired). On 10-Mar-2021, the patient experienced ARTHRALGIA (pain in the TMJ area) and JOINT SWELLING (swelling in the TMJ area). On 12-Mar-2021, the patient experienced CONFUSIONAL STATE (knocked out), PYREXIA (fever), OROPHARYNGEAL PAIN (throat hurting only on injection side (left side)) and LYMPHADENOPATHY (glands of the left side of neck, collar bone, and jaw were swollen). On an unknown date, the patient experienced ILLNESS (two to three days of being sick in bed), PARANASAL SINUS DISCOMFORT (sinus pressure in face because of swelling of lymph nodes) and NASAL CONGESTION (blowing his nose a lot). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) for Pain, at a dose of UNK dosage form. At the time of the report, FATIGUE (felt really tired), ARTHRALGIA (pain in the TMJ area), CONFUSIONAL STATE (knocked out), PYREXIA (fever), OROPHARYNGEAL PAIN (throat hurting only on injection side (left side)), LYMPHADENOPATHY (glands of the left side of neck, collar bone, and jaw were swollen), PARANASAL SINUS DISCOMFORT (sinus pressure in face because of swelling of lymph nodes), NASAL CONGESTION (blowing his nose a lot) and JOINT SWELLING (swelling in the TMJ area) outcome was unknown and ILLNESS (two to three days of being sick in bed) was resolving. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were reported.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Nasal congestion, Oropharyngeal pain, Paranasal sinus discomfort, Pyrexia
Clinical narrative: two to three days of being sick in bed; sinus pressure in face because of swelling of lymph nodes; blowing his nose a lot; knocked out; fever; throat hurting only on injection side (left side); glands of the left side of neck, collar bone, and jaw were swollen; swelling in the TMJ area; pain in the TMJ area; felt really tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (felt really tired), ARTHRALGIA (pain in the TMJ area), CONFUSIONAL STATE (knocked out), PYREXIA (fever) and OROPHARYNGEAL PAIN (throat hurting only on injection side (left side)) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced FATIGUE (felt really tired). On 10-Mar-2021, the patient experienced ARTHRALGIA (pain in the TMJ area) and JOINT SWELLING (swelling in the TMJ area). On 12-Mar-2021, the patient experienced CONFUSIONAL STATE (knocked out), PYREXIA (fever), OROPHARYNGEAL PAIN (throat hurting only on injection side (left side)) and LYMPHADENOPATHY (glands of the left side of neck, collar bone, and jaw were swollen). On an unknown date, the patient experienced ILLNESS (two to three days of being sick in bed), PARANASAL SINUS DISCOMFORT (sinus pressure in face because of swelling of lymph nodes) and NASAL CONGESTION (blowing his nose a lot). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) for Pain, at a dose of UNK dosage form. At the time of the report, FATIGUE (felt really tired), ARTHRALGIA (pain in the TMJ area), CONFUSIONAL STATE (knocked out), PYREXIA (fever), OROPHARYNGEAL PAIN (throat hurting only on injection side (left side)), LYMPHADENOPATHY (glands of the left side of neck, collar bone, and jaw were swollen), PARANASAL SINUS DISCOMFORT (sinus pressure in face because of swelling of lymph nodes), NASAL CONGESTION (blowing his nose a lot) and JOINT SWELLING (swelling in the TMJ area) outcome was unknown and ILLNESS (two to three days of being sick in bed) was resolving. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were reported.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Vaccination site pain
Clinical narrative: swelling in the injection site; pain in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE SWELLING (swelling in the injection site) and VACCINATION SITE PAIN (pain in the injection site) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Bee sting hypersensitivity and Ant bite.    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 INJECTION SITE SWELLING (swelling in the injection site) and VACCINATION SITE PAIN (pain in the injection site). At the time of the report, INJECTION SITE SWELLING (swelling in the injection site) and VACCINATION SITE PAIN (pain in the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported. No Treatments were reported.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Wicked Headache) 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 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced HEADACHE (Wicked Headache). At the time of the report, HEADACHE (Wicked Headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported.  Treatment information not provided.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Bone pain, Fatigue, Pyrexia
Clinical narrative: Feverish; Bone aches; Tired; Small movable lump under my armpit; This spontaneous case was reported by a nurse and describes the occurrence of AXILLARY MASS (Small movable lump under my armpit), PYREXIA (Feverish), BONE PAIN (Bone aches) and FATIGUE (Tired) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 031M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Mar-2021, the patient experienced AXILLARY MASS (Small movable lump under my armpit). On 15-Mar-2021, the patient experienced PYREXIA (Feverish), BONE PAIN (Bone aches) and FATIGUE (Tired). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, AXILLARY MASS (Small movable lump under my armpit), PYREXIA (Feverish), BONE PAIN (Bone aches) and FATIGUE (Tired) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were reported.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Missed the second dose; A spontaneous report was received from a consumer concerning for himself, a 70-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced event missed the second dose/product dose omission issue,  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 31Jan2021, prior to the onset of the event the patient received first of two planned doses of mRNA-1273 (lot/batch: 030L20A or 630L20A) via unknown route on Left Arm for prophylaxis of COVID-19 infection.  On 28Feb2021, patient missed the second dose because his appointment was cancelled. He was now just getting back from out of town and wants to schedule his second dose.  Action taken with mRNA-1273 in response to the event was Unknown.   The outcome of event Missed the second dose was recovered on 28Feb2021, at the time of this report.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: tested positive for Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for Covid-19) 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 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for Covid-19). At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive for Covid-19) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, SARS-CoV-2 test positive: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided. No Treatments were provided.   Reporter did not allow further contact
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Pruritus, Urticaria
Clinical narrative: Hives all over the body; Itches like crazy; Affecting the breathing; This spontaneous case was reported by a health care professional and describes the occurrence of URTICARIA (Hives all over the body), PRURITUS (Itches like crazy) and DYSPNOEA (Affecting the breathing) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     The patient's past medical history included Diabetes (Reported diagnosed with Diabetes 2 years ago) in 2019. Concomitant products included MAGNESIUM, VITAMIN E NOS (VITAMIN E + MAGNESIUM), MULTI VIT and COLECALCIFEROL (VIT D [COLECALCIFEROL]) for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced URTICARIA (Hives all over the body), PRURITUS (Itches like crazy) and DYSPNOEA (Affecting the breathing). The patient was treated with CORTISONE for Hives, at a dose of UNK dosage form. At the time of the report, URTICARIA (Hives all over the body), PRURITUS (Itches like crazy) and DYSPNOEA (Affecting the breathing) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Dyspnoea, Fatigue, Feeling abnormal
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), RASH (a five inch circle), FATIGUE (extreme fatigue/unusually tired), CHILLS (almost felt was going to get the chills) and FEELING ABNORMAL (something isn't quite right) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02SA21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Breast cancer and Acid reflux (esophageal). Concomitant products included OMEPRAZOLE and COLECALCIFEROL (VIT D [COLECALCIFEROL]) for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and RASH (a five inch circle). On 05-Mar-2021, the patient experienced FATIGUE (extreme fatigue/unusually tired). On an unknown date, the patient experienced CHILLS (almost felt was going to get the chills), FEELING ABNORMAL (something isn't quite right), DYSPNOEA (felt was a little short of breath), PYREXIA (felt like I had a slight fever in my body) and COUGH (felt was about to get a cough). On 15-Mar-2021, PAIN IN EXTREMITY (sore arm), RASH (a five inch circle), FATIGUE (extreme fatigue/unusually tired), CHILLS (almost felt was going to get the chills), FEELING ABNORMAL (something isn't quite right), DYSPNOEA (felt was a little short of breath), PYREXIA (felt like I had a slight fever in my body) and COUGH (felt was about to get a cough) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatments were reported.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Rash
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), RASH (a five inch circle), FATIGUE (extreme fatigue/unusually tired), CHILLS (almost felt was going to get the chills) and FEELING ABNORMAL (something isn't quite right) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02SA21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Breast cancer and Acid reflux (esophageal). Concomitant products included OMEPRAZOLE and COLECALCIFEROL (VIT D [COLECALCIFEROL]) for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and RASH (a five inch circle). On 05-Mar-2021, the patient experienced FATIGUE (extreme fatigue/unusually tired). On an unknown date, the patient experienced CHILLS (almost felt was going to get the chills), FEELING ABNORMAL (something isn't quite right), DYSPNOEA (felt was a little short of breath), PYREXIA (felt like I had a slight fever in my body) and COUGH (felt was about to get a cough). On 15-Mar-2021, PAIN IN EXTREMITY (sore arm), RASH (a five inch circle), FATIGUE (extreme fatigue/unusually tired), CHILLS (almost felt was going to get the chills), FEELING ABNORMAL (something isn't quite right), DYSPNOEA (felt was a little short of breath), PYREXIA (felt like I had a slight fever in my body) and COUGH (felt was about to get a cough) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatments were reported.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Pruritus, Rash
Clinical narrative: itchy; red; hot; Rash; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH (Rash), PRURITUS (itchy), ERYTHEMA (red) and FEELING HOT (hot) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No medical information history was reported.  Concomitant products included MERCAPTOPURINE for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced RASH (Rash). On 13-Mar-2021, the patient experienced PRURITUS (itchy), ERYTHEMA (red) and FEELING HOT (hot). The patient was treated with CLINDAMYCIN at an unspecified dose and frequency and CLOBETASOL PROPIONATE at an unspecified dose and frequency. At the time of the report, RASH (Rash) was resolving and PRURITUS (itchy), ERYTHEMA (red) and FEELING HOT (hot) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Rash pruritic, Vaccination complication
Clinical narrative: complete bad reaction; rash itches and burns; rash all over the body; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION COMPLICATION (complete bad reaction), RASH PRURITIC (rash itches and burns) and RASH (rash all over the body) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced VACCINATION COMPLICATION (complete bad reaction), RASH PRURITIC (rash itches and burns) and RASH (rash all over the body). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (complete bad reaction), RASH PRURITIC (rash itches and burns) and RASH (rash all over the body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: lymph nodes on both arms are swollen; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (lymph nodes on both arms are swollen) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     Concurrent medical conditions included Chronic leukemia.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (lymph nodes on both arms are swollen). At the time of the report, LYMPHADENOPATHY (lymph nodes on both arms are swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient's concomitant medication included an unspecified infusion for chronic leukemia.  Patient's lymph nodes on both arms were swollen about a week after vaccination. She did not took any treatment for the event.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Pain in jaw
Clinical narrative: moderate focal jaw pain on the side where she got the vaccine; flushing of the face; dizziness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN JAW (moderate focal jaw pain on the side where she got the vaccine), FLUSHING (flushing of the face) and DIZZINESS (dizziness) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced PAIN IN JAW (moderate focal jaw pain on the side where she got the vaccine), FLUSHING (flushing of the face) and DIZZINESS (dizziness). At the time of the report, PAIN IN JAW (moderate focal jaw pain on the side where she got the vaccine), FLUSHING (flushing of the face) and DIZZINESS (dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.   Treatment information was not provided.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Speech disorder, Thinking abnormal
Clinical narrative: Trouble thinking; Trouble talking; Whole body rash; A spontaneous report was received from a consumer concerning a 68 year-old, female patient, COVID-19 vaccine (mRNA-1273) received the first Moderna COVID-19 vaccine (mRNA-1273) on 02 Feb 2021. Patient stated after first Moderna vaccine she had a rash on day 9, Patient stated she received her second Moderna vaccine on 01 Mar 2021 and on day 12 she had a whole body rash.  The patient's medical history, as provided by the reporter, immunocompromised . Concomitant medications reported included Antidepressant, Topamax, Zocor. Treatment received include Acterma Prednisone  on 02 Feb 2021. Patient stated after first Moderna vaccine she had a rash on day 9, all around the injection site down arm above elbow. Patient stated she received her second Moderna vaccine on 01 Mar 2021 and on day 12 she had a whole body rash. Patient stated she visited her doctor on 15 Mar 2021. Patient stated healthcare professional (HCP) prescribed acterma and prednisone.  Patient stated she is immunocompromised. Patient stated the only clear part on her body is the sole of her feet and eyes and arm at the injection site.  Action taken with mRNA-1273 in response to the events was not applicable.  The events, trouble thinking, trouble talking, rash all around injection site, immunocompromised were not resolved.; Reporter's Comments: Based on the current available information which includes a temporal association between the use of the product onset of the event including evidence of re-challenge and excluding any other etiology, a causal relationship with the event cannot be excluded. Rash is consistent with  the product safety profile.