chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Positive covid test after getting 1st dose; Arm was so sore couldn't lift; Muscle ache; Low grade fever; Nausea; Chills; Fatigue; Joint pain; Headache; A spontaneous report was received from a consumer concerning a 48 year old, female patient who had positive COVID test after getting 1st dose and experienced muscle ache, low grade fever, nausea, chills, fatigue, joint pain, headache and arm was so sore couldn't lift.   The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter.     The patient received their first of two planned doses of mRNA-1273 (Batch number: 025J202A in the left arm for prophylaxis of COVID-19 infection.    The patient received her first dose of Moderna vaccine 29-DEC-2020 in the left arm at vaccination center. She confirmed on 30-DEC-2020 that she was exposed to COVID. The patient tested at work on 31-DEC-2020 and results came back positive. Patient stated after receiving the vaccine the following day she experienced arm was so sore couldn't lift, muscle ache, low-grade fever, nausea, chills, fatigue, body aches, joint pain, headache. After that day she felt she was fine, but continues to feel lethargic and nauseous. Treatment information was not provided/unknown.    Action taken with mRNA-1273 in response to the event(s) was not provided/unknown.  The outcome of the events  was/were unknown/not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events of myalgia, arthralgia, pyrexia, chills, nausea, headache, fatigue,pain in extremity,  a causal relationship cannot be excluded. Based on the current available information and the mechanism of action of mRNA-1237 vaccine, the event of Covid-19 is assessed as unlikely related.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy
Clinical narrative: felt a lump above her collar bone; headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) and LYMPHADENOPATHY (felt a lump above her collar bone) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No medical history was reported by the reporter.     On 19-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced HEADACHE (headache). On 24-Jan-2021, the patient experienced LYMPHADENOPATHY (felt a lump above her collar bone). At the time of the report, HEADACHE (headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Pyrexia, Rash, SARS-CoV-2 test
Clinical narrative: could not stop shaking; weakness; rash behind knees and in groin area; feverish; had chills; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (could not stop shaking), ASTHENIA (weakness), RASH (rash behind knees and in groin area), PYREXIA (feverish) and CHILLS (had chills) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included METFORMIN for an unknown indication.    On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jan-2021, the patient experienced TREMOR (could not stop shaking), ASTHENIA (weakness), RASH (rash behind knees and in groin area), PYREXIA (feverish), CHILLS (had chills) and VACCINATION SITE PAIN (sore arm). On 25-Jan-2021, VACCINATION SITE PAIN (sore arm) outcome was unknown. At the time of the report, TREMOR (could not stop shaking), ASTHENIA (weakness), RASH (rash behind knees and in groin area), PYREXIA (feverish) and CHILLS (had chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2020, COVID-19:.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Tremor, Vaccination site pain
Clinical narrative: could not stop shaking; weakness; rash behind knees and in groin area; feverish; had chills; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (could not stop shaking), ASTHENIA (weakness), RASH (rash behind knees and in groin area), PYREXIA (feverish) and CHILLS (had chills) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included METFORMIN for an unknown indication.    On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jan-2021, the patient experienced TREMOR (could not stop shaking), ASTHENIA (weakness), RASH (rash behind knees and in groin area), PYREXIA (feverish), CHILLS (had chills) and VACCINATION SITE PAIN (sore arm). On 25-Jan-2021, VACCINATION SITE PAIN (sore arm) outcome was unknown. At the time of the report, TREMOR (could not stop shaking), ASTHENIA (weakness), RASH (rash behind knees and in groin area), PYREXIA (feverish) and CHILLS (had chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2020, COVID-19:.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chronic obstructive pulmonary disease, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: COPD; Hot to Touch Sensation - Near Injection Site; Swelling - Near Injection Site; Pain - Near Injection Site; Fever (102F); A spontaneous report was received from a consumer concerning a 78-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events COPD, hot to touch sensation - near injection site, swelling - near injection site, pain - near injection site, fever (102f).  The patient's medical history, as provided by the reporter COPD . Concomitant medications reported were Advair, Albuterol for drug use for unknown indication.  On 30 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: N A (Card Not Available)) intramuscularly for prophylaxis of COVID-19 infection.  On 30 Jan 2021, the patient experienced the events hot to touch sensation - near injection site, swelling - near injection site, pain - near injection site, fever (102f).  Treatment details included Advil - Self medicating to try to alleviate symptoms.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, COPD, hot to touch sensation - near injection site, swelling - near injection site, pain - near injection site, fever (102f) was unknown.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: COPD; Hot to Touch Sensation - Near Injection Site; Swelling - Near Injection Site; Pain - Near Injection Site; Fever (102F); A spontaneous report was received from a consumer concerning a 78-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events COPD, hot to touch sensation - near injection site, swelling - near injection site, pain - near injection site, fever (102f).  The patient's medical history, as provided by the reporter COPD . Concomitant medications reported were Advair, Albuterol for drug use for unknown indication.  On 30 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: N A (Card Not Available)) intramuscularly for prophylaxis of COVID-19 infection.  On 30 Jan 2021, the patient experienced the events hot to touch sensation - near injection site, swelling - near injection site, pain - near injection site, fever (102f).  Treatment details included Advil - Self medicating to try to alleviate symptoms.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, COPD, hot to touch sensation - near injection site, swelling - near injection site, pain - near injection site, fever (102f) was unknown.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: kind of shingles; This spontaneous case was reported by a consumer and describes the occurrence of   in a 59-year-old female adult exposed to mRNA-1273 (Moderna COVID-19 Vaccine) , while the parent received the product for COVID-19 vaccination.     No Medical History information was reported.    On 29-Dec-2020, the parent received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. Last menstrual period and estimated date of delivery were not provided. The Adult was exposed to mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.         The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: a lot of heat; a pretty significant site reaction that's just getting worse; it is very raised; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (a lot of heat), VACCINATION SITE ERYTHEMA (a pretty significant site reaction that's just getting worse) and VACCINATION SITE SWELLING (it is very raised) 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 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (a lot of heat), VACCINATION SITE ERYTHEMA (a pretty significant site reaction that's just getting worse) and VACCINATION SITE SWELLING (it is very raised). At the time of the report, VACCINATION SITE WARMTH (a lot of heat), VACCINATION SITE ERYTHEMA (a pretty significant site reaction that's just getting worse) and VACCINATION SITE SWELLING (it is very raised) 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.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Really bad rash on her arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Really bad rash on her arm) in a 94-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced RASH (Really bad rash on her arm). The patient was treated with HYDROCORTISONE (CORTISONE [HYDROCORTISONE]) at an unspecified dose and frequency. At the time of the report, RASH (Really bad rash on her arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Influenza like illness, SARS-CoV-2 antibody test positive
Clinical narrative: Still feeling tired; Tested positive for COVID; Flu-like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms), SARS-COV-2 ANTIBODY TEST POSITIVE (Tested positive for COVID) and FATIGUE (Still feeling tired) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms). On 23-Jan-2021, the patient experienced SARS-COV-2 ANTIBODY TEST POSITIVE (Tested positive for COVID). On an unknown date, the patient experienced FATIGUE (Still feeling tired). The patient was treated with ASCORBIC ACID (VIT C) at an unspecified dose and frequency; COLECALCIFEROL, MENAQUINONE-7, PHYTOMENADIONE, RETINOL PALMITATE, TOCOPHEROL, TOCOTRIENOLS NOS (VITAMIN D COMPLEX) at an unspecified dose and frequency and ZINC at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms), SARS-COV-2 ANTIBODY TEST POSITIVE (Tested positive for COVID) and FATIGUE (Still feeling tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Jan-2021, COVID-19: Test positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other treatment medications include Lots of Fluids. No relevant concomitant medications were reported.; Sender's Comments: Based on the natural history of COVID-19, and the established information about the mRNA-1273 vaccine, a causal association between the event of tested positive for COVID and the product use is assessed as unlikely,  The other events are assessed as symptoms of the COVID-19 and not due to the vaccine  Hence, also assessed as unlikely related with mRNA-1273 vaccination
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Breast feeding
Clinical narrative: received the vaccine and she's a nursing mother; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BREAST FEEDING (received the vaccine and she's a nursing mother) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 01-Feb-2021, the patient experienced BREAST FEEDING (received the vaccine and she's a nursing mother). At the time of the report, BREAST FEEDING (received the vaccine and she's a nursing mother) outcome was unknown.        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.   No relevant concomitant medications were reported. No treatment information was provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Fatigue, Headache, Illness, Vomiting
Clinical narrative: got horrible vomiting; got horrible headache; tired; illness with the headache and upset stomach; upset stomach; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (illness with the headache and upset stomach), ABDOMINAL DISCOMFORT (felt like I had high altitude illness with the headache and upset stomach), VOMITING (got horrible headache and was vomiting), HEADACHE (got horrible headache and was vomiting) and FATIGUE (I was tired) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A and 015M20A) for COVID-19 vaccination.     The patient's past medical history included Altitude sickness.   On 13-Jan-2021 at 12:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced ILLNESS (illness with the headache and upset stomach). 13-Jan-2021, the patient experienced ABDOMINAL DISCOMFORT (felt like I had high altitude illness with the headache and upset stomach). 13-Jan-2021, the patient experienced FATIGUE (I was tired). On 13-Jan-2021 at 2:00 AM, the patient experienced HEADACHE (got horrible headache and was vomiting). On 13-Jan-2021 at 4:30 AM, the patient experienced VOMITING (got horrible headache and was vomiting). On 15-Jan-2021, ILLNESS (illness with the headache and upset stomach), ABDOMINAL DISCOMFORT (felt like I had high altitude illness with the headache and upset stomach), VOMITING (got horrible headache and was vomiting), HEADACHE (got horrible headache and was vomiting) and FATIGUE (I was tired) had resolved.            No concomitant medication were provided by the reporter.   Patient took one Advil and Sinus tablet for the symptoms.   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: first dose details, patient demographics  and events were updated and second dose details were added.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dermatitis, Pruritus, Sleep disorder, Vaccination site mass
Clinical narrative: couldn't sleep / Can Not Sleep after Second dose; ump on her left shoulder Injection Site (Tennis ball size) after Second dose; Inflammation on skin all over back after Second dose / Diagnosed as Allergy via biopsy after Second dose; Itchy all over back after Second dose; Pain in shoulder / Can Not Work after Second dose; This spontaneous case was reported by a patient and describes the occurrence of SLEEP DISORDER (couldn't sleep / Can Not Sleep after Second dose), VACCINATION SITE MASS (ump on her left shoulder Injection Site (Tennis ball size) after Second dose), DERMATITIS (Inflammation on skin all over back after Second dose / Diagnosed as Allergy via biopsy after Second dose), PRURITUS (Itchy all over back after Second dose) and ARTHRALGIA (Pain in shoulder / Can Not Work after Second dose) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K2OA) for COVID-19 vaccination.     The patient's past medical history included Broken wrist and Wrist surgery (Surgery on Dec 2-2020 on a broken wrist.) on 02-Dec-2020. Concurrent medical conditions included Inflammation (Wrist inflammation.).   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Feb-2021, the patient experienced SLEEP DISORDER (couldn't sleep / Can Not Sleep after Second dose), VACCINATION SITE MASS (ump on her left shoulder Injection Site (Tennis ball size) after Second dose), DERMATITIS (Inflammation on skin all over back after Second dose / Diagnosed as Allergy via biopsy after Second dose), PRURITUS (Itchy all over back after Second dose) and ARTHRALGIA (Pain in shoulder / Can Not Work after Second dose). At the time of the report, SLEEP DISORDER (couldn't sleep / Can Not Sleep after Second dose), VACCINATION SITE MASS (ump on her left shoulder Injection Site (Tennis ball size) after Second dose), DERMATITIS (Inflammation on skin all over back after Second dose / Diagnosed as Allergy via biopsy after Second dose), PRURITUS (Itchy all over back after Second dose) and ARTHRALGIA (Pain in shoulder / Can Not Work after Second dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Treatment details included as Ice Pack.   This case was linked to MOD-2021-246758 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Jul-2021: Significant follow up appended
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site pain, Lethargy, Pain in extremity, Pyrexia
Clinical narrative: lethargic; redness expanded; sore to touch; low-grade fever; pain in the arm; tender and sore to touch; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (pain in the arm), TENDERNESS (tender and sore to touch), LETHARGY (lethargic), ERYTHEMA (redness expanded) and INJECTION SITE PAIN (sore to touch) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event and Reaction to previous exposure to any vaccine (mild reaction to flu shot). Concurrent medical conditions included Drug allergy (Codein). Concomitant products included ZOLPIDEM TARTRATE (AMBIEN) from 01-Jan-2015 to an unknown date for Insomnia, IBUPROFEN (ADVIL [IBUPROFEN]) and VITAMINS NOS for an unknown indication.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Jan-2021, the patient experienced PAIN IN EXTREMITY (pain in the arm), TENDERNESS (tender and sore to touch), ERYTHEMA (redness expanded), INJECTION SITE PAIN (sore to touch) and PYREXIA (low-grade fever). On 01-Feb-2021, the patient experienced LETHARGY (lethargic). On 06-Feb-2021, PAIN IN EXTREMITY (pain in the arm), TENDERNESS (tender and sore to touch), LETHARGY (lethargic), ERYTHEMA (redness expanded), INJECTION SITE PAIN (sore to touch) and PYREXIA (low-grade fever) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information included Benadryl, ibuprofen for fever reducer, applied topical cortisone and Benadryl cream, hydroxyzine on prescription.   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Added patient demographics, concomitant drug information added, updated event(s) onset date and stop date and updated outcome rom unknown to recovered, added 2nd dose information
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: lethargic; redness expanded; sore to touch; low-grade fever; pain in the arm; tender and sore to touch; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (pain in the arm), TENDERNESS (tender and sore to touch), LETHARGY (lethargic), ERYTHEMA (redness expanded) and INJECTION SITE PAIN (sore to touch) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event and Reaction to previous exposure to any vaccine (mild reaction to flu shot). Concurrent medical conditions included Drug allergy (Codein). Concomitant products included ZOLPIDEM TARTRATE (AMBIEN) from 01-Jan-2015 to an unknown date for Insomnia, IBUPROFEN (ADVIL [IBUPROFEN]) and VITAMINS NOS for an unknown indication.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Jan-2021, the patient experienced PAIN IN EXTREMITY (pain in the arm), TENDERNESS (tender and sore to touch), ERYTHEMA (redness expanded), INJECTION SITE PAIN (sore to touch) and PYREXIA (low-grade fever). On 01-Feb-2021, the patient experienced LETHARGY (lethargic). On 06-Feb-2021, PAIN IN EXTREMITY (pain in the arm), TENDERNESS (tender and sore to touch), LETHARGY (lethargic), ERYTHEMA (redness expanded), INJECTION SITE PAIN (sore to touch) and PYREXIA (low-grade fever) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information included Benadryl, ibuprofen for fever reducer, applied topical cortisone and Benadryl cream, hydroxyzine on prescription.   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Added patient demographics, concomitant drug information added, updated event(s) onset date and stop date and updated outcome rom unknown to recovered, added 2nd dose information
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: slight soreness of the arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (slight soreness of the arm) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE PAIN (slight soreness of the arm). At the time of the report, VACCINATION SITE PAIN (slight soreness of the arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  Treatment medications were not provided.   Reporter did not allow further contact
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Nasty metal taste in mouth; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Nasty metal taste in mouth) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced DYSGEUSIA (Nasty metal taste in mouth). At the time of the report, DYSGEUSIA (Nasty metal taste in mouth) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Swelling at injection site; itchiness at injection site; injection site hot to the touch; red rash at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swelling at injection site), VACCINATION SITE PRURITUS (itchiness at injection site), VACCINATION SITE WARMTH (injection site hot to the touch) and VACCINATION SITE RASH (red rash at injection site) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) and METOPROLOL for an unknown indication.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced VACCINATION SITE SWELLING (Swelling at injection site), VACCINATION SITE PRURITUS (itchiness at injection site), VACCINATION SITE WARMTH (injection site hot to the touch) and VACCINATION SITE RASH (red rash at injection site). On 31-Jan-2021, VACCINATION SITE SWELLING (Swelling at injection site), VACCINATION SITE PRURITUS (itchiness at injection site) and VACCINATION SITE WARMTH (injection site hot to the touch) had resolved. At the time of the report, VACCINATION SITE RASH (red rash at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications Lipitor, metoprolol No treatment medications were reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Vaccination site pain
Clinical narrative: Flu like symptoms/body aches/fever; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms/body aches/fever) and VACCINATION SITE PAIN (Sore arm) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms/body aches/fever) and VACCINATION SITE PAIN (Sore arm). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms/body aches/fever) and VACCINATION SITE PAIN (Sore arm) had not resolved.            No concomitant drug were reported. No treatment information was reported. Action taken with mRNA-1273 in response to the events was not applicable.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, vaccination site pain and Influenza like illness, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: tested positive; This spontaneous case was reported by a physician and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 26-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive). At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Jan-2021, SARS-CoV-2 test: (Positive) Positive.     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.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to MOD-2021-017822 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema
Clinical narrative: A big round red spot at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (A big round red spot at the injection site) 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.    On 09-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 INJECTION SITE ERYTHEMA (A big round red spot at the injection site). At the time of the report, INJECTION SITE ERYTHEMA (A big round red spot at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-018108 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-018108:
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Contracted Shingles Virus; This spontaneous case was reported by a physician and describes the occurrence of HERPES ZOSTER (Contracted Shingles Virus) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced HERPES ZOSTER (Contracted Shingles Virus). The patient was treated with VALACICLOVIR HYDROCHLORIDE (VALTREX) ongoing since an unknown date for Herpes virus infection, at an unspecified dose and frequency. At the time of the report, HERPES ZOSTER (Contracted Shingles Virus) outcome was unknown.        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.   No concomitant medications were reported.  Patient was scheduled for the second done on 05 Feb 2021
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Sore arm; Fever of 104.9F; Body aches; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever of 104.9F), MYALGIA (Body aches), CHILLS (Chills) and HEADACHE (Headache) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) 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 01-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever of 104.9F), MYALGIA (Body aches), CHILLS (Chills) and HEADACHE (Headache). The patient was treated with ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL, SALICYLAMIDE (EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL;SALICYLAMIDE]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever of 104.9F), MYALGIA (Body aches), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site erythema
Clinical narrative: itching; redness 2 inches around like a square shape around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching) and VACCINATION SITE ERYTHEMA (redness 2 inches around like a square shape around the injection site) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported by the reporter.     On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced PRURITUS (itching) and VACCINATION SITE ERYTHEMA (redness 2 inches around like a square shape around the injection site). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PRURITUS (itching) and VACCINATION SITE ERYTHEMA (redness 2 inches around like a square shape around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included blood pressure medication.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, Chills, Headache, Pyrexia
Clinical narrative: a case of the runs; Mild headache; Raging fever during the night; Chills; This spontaneous case was reported by a physician and describes the occurrence of ADVERSE EVENT (a case of the runs), PYREXIA (Raging fever during the night), CHILLS (Chills) and HEADACHE (Mild headache) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-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 27-Jan-2021, the patient experienced PYREXIA (Raging fever during the night) and CHILLS (Chills). On 28-Jan-2021, the patient experienced ADVERSE EVENT (a case of the runs) and HEADACHE (Mild headache). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. On 29-Jan-2021, ADVERSE EVENT (a case of the runs), PYREXIA (Raging fever during the night), CHILLS (Chills) and HEADACHE (Mild headache) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported by the reporter.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Headache, Injection site pain
Clinical narrative: Difficulty Breathing; Fatigue; Headache; Injection Site Pain; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Difficulty Breathing), FATIGUE (Fatigue), HEADACHE (Headache) and INJECTION SITE PAIN (Injection Site Pain) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included OMEPRAZOLE for an unknown indication.    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced DYSPNOEA (Difficulty Breathing), FATIGUE (Fatigue), HEADACHE (Headache) and INJECTION SITE PAIN (Injection Site Pain). At the time of the report, DYSPNOEA (Difficulty Breathing), FATIGUE (Fatigue), HEADACHE (Headache) and INJECTION SITE PAIN (Injection Site Pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details were not reported by the reporter.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Severe itching all over body; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of PRURITUS (Severe itching all over body) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (Medical history not provided). Concomitant products included EMERGEN C, CENTRUM FOR WOMEN and PROBIOTICS NOS for an unknown indication.    On 25-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced PRURITUS (Severe itching all over body). On 29-Jan-2021, PRURITUS (Severe itching all over body) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash
Clinical narrative: Itchy arm; Rash at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchy arm) and VACCINATION SITE RASH (Rash at injection site) 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 24-Jan-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 VACCINATION SITE PRURITUS (Itchy arm) and VACCINATION SITE RASH (Rash at injection site). At the time of the report, VACCINATION SITE PRURITUS (Itchy arm) and VACCINATION SITE RASH (Rash at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-018092 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Warm patch; Soreness; swelling; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm patch), VACCINATION SITE PAIN (Soreness) and VACCINATION SITE SWELLING (swelling) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-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 VACCINATION SITE WARMTH (Warm patch), VACCINATION SITE PAIN (Soreness) and VACCINATION SITE SWELLING (swelling). At the time of the report, VACCINATION SITE WARMTH (Warm patch), VACCINATION SITE PAIN (Soreness) and VACCINATION SITE SWELLING (swelling) outcome was unknown.        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.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Soreness in arm; Pain throughout elbow; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness in arm) and ARTHRALGIA (Pain throughout elbow) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) 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 01-Feb-2021, the patient experienced PAIN IN EXTREMITY (Soreness in arm) and ARTHRALGIA (Pain throughout elbow). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Soreness in arm) and ARTHRALGIA (Pain throughout elbow) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia, Vaccination site pain
Clinical narrative: Soreness in the arm; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness in the arm), CHILLS (chills) and PYREXIA (fever) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE PAIN (Soreness in the arm), CHILLS (chills) and PYREXIA (fever). At the time of the report, VACCINATION SITE PAIN (Soreness in the arm), CHILLS (chills) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Herpes virus infection, Skin lesion
Clinical narrative: lesion on hip; Herpes; This spontaneous case was reported by a physician and describes the occurrence of HERPES VIRUS INFECTION (Herpes) and SKIN LESION (lesion on hip) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was not reported by the reporter.  Concomitant products included APIXABAN (ELIQUIS) for an unknown indication.    On 08-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 HERPES VIRUS INFECTION (Herpes) and SKIN LESION (lesion on hip). At the time of the report, HERPES VIRUS INFECTION (Herpes) and SKIN LESION (lesion on hip) outcome was unknown.        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.   Treatment details were not reported by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: 3 adverse events that happened at our clinic; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of ADVERSE EVENT (3 adverse events that happened at our clinic) in a  patient of an unknown age and gender 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 provided).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced ADVERSE EVENT (3 adverse events that happened at our clinic). At the time of the report, ADVERSE EVENT (3 adverse events that happened at our clinic) outcome was unknown.        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.   No relevant concomitant medications were reported.  No treatment information was provided.; Reporter's Comments: Very limited information regarding the events has been provided at this time and is insufficient for causality assessment. Further information has been requested.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Redness on the injection arm; hardnes on the injecton arm; A spontaneous report was received from a Consumer concerning a 71-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events redness on the injection arm , and hardness on the injection arm.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 22 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch: 013L20) intramuscularly for prophylaxis of COVID-19 infection.  On 1 Feb 2021, the patient experienced the events redness on the injection arm . which returned on January 31st, 2021, hardness on the injection arm..  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date the outcome of events include, redness on the injection arm , was not resolved, and outcome of hardness on the injection arm was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.