chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Blood urine present
Clinical narrative: Blood in urine; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD URINE PRESENT (Blood in urine) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for an unknown indication.     The patient's past medical history included Kidney cancer stage IV since an unknown date. Concomitant products included ATORVASTATIN, FINASTERIDE, METOPROLOL, CALCITRIOL and TAMSULOSIN for an unknown indication, FENOFIBRATE (FENOFIBRATE S).   On 25-Feb-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 25-Feb-2021, the patient experienced BLOOD URINE PRESENT (Blood in urine). At the time of the report, BLOOD URINE PRESENT (Blood in urine) outcome was unknown.            No Treatment information provided   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: NNI
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Muscle spasms, Nausea, Pain in extremity
Clinical narrative: vertigo; Charley horse(cramps); fever; chills; nausea; fatigue; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), VERTIGO (vertigo), MUSCLE SPASMS (Charley horse(cramps)), PYREXIA (fever) and CHILLS (chills) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history was not reported .  Concomitant products included LANSOPRAZOLE (PREVACID), LEVOTHYROXINE SODIUM (THYROXIN), DIAZEPAM (VALIUM), VITAMIN D NOS, VITAMIN B COMPLEX (COMPLEX B [VITAMIN B COMPLEX]), MAGNESIUM and POTASSIUM for an unknown indication.   On 21-Feb-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 21-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm), PYREXIA (fever), CHILLS (chills), NAUSEA (nausea) and FATIGUE (fatigue). On 26-Feb-2021, the patient experienced VERTIGO (vertigo) and MUSCLE SPASMS (Charley horse(cramps)). On 24-Feb-2021, PAIN IN EXTREMITY (sore arm), PYREXIA (fever), CHILLS (chills), NAUSEA (nausea) and FATIGUE (fatigue) had resolved. At the time of the report, VERTIGO (vertigo) and MUSCLE SPASMS (Charley horse(cramps)) outcome was unknown.            No Treatment information provided
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vertigo
Clinical narrative: vertigo; Charley horse(cramps); fever; chills; nausea; fatigue; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), VERTIGO (vertigo), MUSCLE SPASMS (Charley horse(cramps)), PYREXIA (fever) and CHILLS (chills) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history was not reported .  Concomitant products included LANSOPRAZOLE (PREVACID), LEVOTHYROXINE SODIUM (THYROXIN), DIAZEPAM (VALIUM), VITAMIN D NOS, VITAMIN B COMPLEX (COMPLEX B [VITAMIN B COMPLEX]), MAGNESIUM and POTASSIUM for an unknown indication.   On 21-Feb-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 21-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm), PYREXIA (fever), CHILLS (chills), NAUSEA (nausea) and FATIGUE (fatigue). On 26-Feb-2021, the patient experienced VERTIGO (vertigo) and MUSCLE SPASMS (Charley horse(cramps)). On 24-Feb-2021, PAIN IN EXTREMITY (sore arm), PYREXIA (fever), CHILLS (chills), NAUSEA (nausea) and FATIGUE (fatigue) had resolved. At the time of the report, VERTIGO (vertigo) and MUSCLE SPASMS (Charley horse(cramps)) outcome was unknown.            No Treatment information provided
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Balance disorder, Fatigue, Headache, Impaired driving ability
Clinical narrative: headache on and off; her equilibrium was completely off, she felt like she was going to trip over; She could not drive; sore shoulder; extremely tired; This spontaneous case was reported by a consumer and describes the occurrence of BALANCE DISORDER (her equilibrium was completely off, she felt like she was going to trip over), IMPAIRED DRIVING ABILITY (She could not drive), ARTHRALGIA (sore shoulder), FATIGUE (extremely tired) and HEADACHE (headache on and off) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No relevant medical history was reported.  Concomitant products included VITAMINS NOS and ALPRAZOLAM for an unknown indication.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Feb-2021, the patient experienced ARTHRALGIA (sore shoulder) and FATIGUE (extremely tired). On 20-Feb-2021, the patient experienced BALANCE DISORDER (her equilibrium was completely off, she felt like she was going to trip over) and IMPAIRED DRIVING ABILITY (She could not drive). On an unknown date, the patient experienced HEADACHE (headache on and off). On 19-Feb-2021, ARTHRALGIA (sore shoulder) had resolved. On 20-Feb-2021, FATIGUE (extremely tired) had resolved. At the time of the report, BALANCE DISORDER (her equilibrium was completely off, she felt like she was going to trip over) was resolving and IMPAIRED DRIVING ABILITY (She could not drive) and HEADACHE (headache on and off) outcome was unknown.            No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Reporter provided details about 2nd shot: received 19MAR2021 with "no bad reactions."
Sex: M
Vaccine: COVID19
Symptoms: Adverse event, Arthralgia, Body temperature decreased, Chills, Fatigue
Clinical narrative: No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced ADVERSE EVENT (standard side effects), PAIN (achy), BODY TEMPERATURE DECREASED (low temperature), FATIGUE (tired), CHILLS (chills that shook his body), PYREXIA (feverish feeling) and ARTHRALGIA (achy joints). On 02-Mar-2021, ADVERSE EVENT (standard side effects), PAIN (achy), BODY TEMPERATURE DECREASED (low temperature), FATIGUE (tired), CHILLS (chills that shook his body), PYREXIA (feverish feeling) and ARTHRALGIA (achy joints) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided. No relevant concomitant medications reported.    Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced ADVERSE EVENT (standard side effects), PAIN (achy), BODY TEMPERATURE DECREASED (low temperature), FATIGUE (tired), CHILLS (chills that shook his body), PYREXIA (feverish feeling) and ARTHRALGIA (achy joints). On 02-Mar-2021, ADVERSE EVENT (standard side effects), PAIN (achy), BODY TEMPERATURE DECREASED (low temperature), FATIGUE (tired), CHILLS (chills that shook his body), PYREXIA (feverish feeling) and ARTHRALGIA (achy joints) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided. No relevant concomitant medications reported.    Reporter did not allow further contact
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Skin reaction, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Concomitant products included HYDROCORTISONE (CORTAID INTENSIVE THERAPY) and LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) for an unknown indication.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced VACCINATION SITE RASH (red dots like rash). On an unknown date, the patient experienced SKIN REACTION (localized and measures 3 cm wide and 5 cm tall), VACCINATION SITE PRURITUS (some itchiness), VACCINATION SITE PAIN (burning/soreness) and VACCINATION SITE ERYTHEMA (more red). At the time of the report, SKIN REACTION (localized and measures 3 cm wide and 5 cm tall), VACCINATION SITE RASH (red dots like rash), VACCINATION SITE PRURITUS (some itchiness), VACCINATION SITE PAIN (burning/soreness) and VACCINATION SITE ERYTHEMA (more red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       treatment product included HYDROCORTISONE (CORTAID INTENSIVE THERAPY) and LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) for an unknown indication For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Tenderness at reaction site; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (Tenderness at reaction site) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Tenderness at reaction site). At the time of the report, VACCINATION SITE PAIN (Tenderness at reaction site) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable  No concomitant medications reported. No treatment reported.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Chromaturia, Faeces soft
Clinical narrative: Urine turned very yellow; Stool became very soft; This spontaneous case was reported by a consumer and describes the occurrence of CHROMATURIA (Urine turned very yellow) and FAECES SOFT (Stool became very soft) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No medical history provided by reporter.  Concomitant products included ATORVASTATIN for Hyperlipaemia, METFORMIN and CENTRUM MEN for an unknown indication.    On 11-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 CHROMATURIA (Urine turned very yellow) and FAECES SOFT (Stool became very soft). At the time of the report, CHROMATURIA (Urine turned very yellow) and FAECES SOFT (Stool became very soft) 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 Treatment information provided   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Follow-up information received on 12-MAY-2021 contains significant information - Concomitant medications added.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Neuralgic amyotrophy, Pain in extremity
Clinical narrative: Parsonage turners syndrome; extreme weakness in her shoulder and arm.; extreme pain in her shoulder and arm.; A spontaneous report was received from a consumer concerning a 69-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events parsonage turners syndrome/neuralgic amyotrophy, extreme weakness in her shoulder and arm/muscular weakness, extreme pain in her shoulder and arm/pain in extremity.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 013L20A)  for prophylaxis of COVID-19 infection. No adverse event reported with the first dose of the vaccine.  On unknown date, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 039K20A) for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the events developed Parsonage turners syndrome, extreme weakness in her shoulder and arm, extreme pain in her shoulder and arm.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events parsonage turners syndrome, extreme weakness in her shoulder and arm, extreme pain in her shoulder and arm was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash, Swelling
Clinical narrative: Itchy; Swollen; Red; 2 rash bites on her neck like mosquito bite; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy), SWELLING (Swollen), ERYTHEMA (Red) and RASH (2 rash bites on her neck like mosquito bite) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Itchy), SWELLING (Swollen), ERYTHEMA (Red) and RASH (2 rash bites on her neck like mosquito bite). At the time of the report, PRURITUS (Itchy), SWELLING (Swollen), ERYTHEMA (Red) and RASH (2 rash bites on her neck like mosquito bite) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitants were not reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: TCR received on 26-APR-2021 contains no new information.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain, Headache, Nausea, SARS-CoV-2 test negative
Clinical narrative: stomach issue; pain in the lower abdomen near the colon area/ it seems like they are getting worse/ it seems to get worse right after she eats lunch; extremely sore arm as she couldn't even use her arm for 2 days; nausea; headaches; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (stomach issue), ABDOMINAL PAIN (pain in the lower abdomen near the colon area/ it seems like they are getting worse/ it seems to get worse right after she eats lunch), VACCINATION SITE PAIN (extremely sore arm as she couldn't even use her arm for 2 days), NAUSEA (nausea) and HEADACHE (headaches) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-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 ABDOMINAL DISCOMFORT (stomach issue), ABDOMINAL PAIN (pain in the lower abdomen near the colon area/ it seems like they are getting worse/ it seems to get worse right after she eats lunch), VACCINATION SITE PAIN (extremely sore arm as she couldn't even use her arm for 2 days), NAUSEA (nausea) and HEADACHE (headaches). At the time of the report, ABDOMINAL DISCOMFORT (stomach issue), ABDOMINAL PAIN (pain in the lower abdomen near the colon area/ it seems like they are getting worse/ it seems to get worse right after she eats lunch), VACCINATION SITE PAIN (extremely sore arm as she couldn't even use her arm for 2 days), NAUSEA (nausea) and HEADACHE (headaches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test negative: negative negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Non significant follow-up: TCR received, email address, consent to follow-up doctor added
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: stomach issue; pain in the lower abdomen near the colon area/ it seems like they are getting worse/ it seems to get worse right after she eats lunch; extremely sore arm as she couldn't even use her arm for 2 days; nausea; headaches; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (stomach issue), ABDOMINAL PAIN (pain in the lower abdomen near the colon area/ it seems like they are getting worse/ it seems to get worse right after she eats lunch), VACCINATION SITE PAIN (extremely sore arm as she couldn't even use her arm for 2 days), NAUSEA (nausea) and HEADACHE (headaches) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-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 ABDOMINAL DISCOMFORT (stomach issue), ABDOMINAL PAIN (pain in the lower abdomen near the colon area/ it seems like they are getting worse/ it seems to get worse right after she eats lunch), VACCINATION SITE PAIN (extremely sore arm as she couldn't even use her arm for 2 days), NAUSEA (nausea) and HEADACHE (headaches). At the time of the report, ABDOMINAL DISCOMFORT (stomach issue), ABDOMINAL PAIN (pain in the lower abdomen near the colon area/ it seems like they are getting worse/ it seems to get worse right after she eats lunch), VACCINATION SITE PAIN (extremely sore arm as she couldn't even use her arm for 2 days), NAUSEA (nausea) and HEADACHE (headaches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test negative: negative negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Non significant follow-up: TCR received, email address, consent to follow-up doctor added
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Dysphonia, Feeling abnormal, Pharyngeal swelling, Rhinorrhoea
Clinical narrative: It looked like I was about to lose my voice; voice and sound of voice was affected; Running nose; Throat swelling; Burning sensation on the left side of the Body; Left side of the body bigger than the right side; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPHONIA (It looked like I was about to lose my voice; voice and sound of voice was affected), FEELING ABNORMAL (Left side of the body bigger than the right side), BURNING SENSATION (Burning sensation on the left side of the Body), RHINORRHOEA (Running nose) and PHARYNGEAL SWELLING (Throat swelling) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced FEELING ABNORMAL (Left side of the body bigger than the right side). On 01-Mar-2021, the patient experienced BURNING SENSATION (Burning sensation on the left side of the Body). On an unknown date, the patient experienced DYSPHONIA (It looked like I was about to lose my voice; voice and sound of voice was affected), RHINORRHOEA (Running nose) and PHARYNGEAL SWELLING (Throat swelling). At the time of the report, DYSPHONIA (It looked like I was about to lose my voice; voice and sound of voice was affected) and PHARYNGEAL SWELLING (Throat swelling) had not resolved and FEELING ABNORMAL (Left side of the body bigger than the right side), BURNING SENSATION (Burning sensation on the left side of the Body) and RHINORRHOEA (Running nose) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient reported drinking warm tea with honey and lemon that makes the event feel better.  He had X-rays taken and scans done on an unknown date which showed that "lungs are clear." The patient reported the same reactions occurred after both doses of the vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: TCR was received on 11-MAY-2021 included Anatomical Location of 1st dose and additional event details. On 31-May-2021: Follow-up was received on 21-MAY-2021. It contains no new information.
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17 year old male got the 1st dose of the moderna vaccine; A spontaneous report was received from a Health care professional concerning a 17-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) before 18 years of age.  The patient's medical history was not provided by the reporter. No concomitant medications was reported.  On an unknown date, the patient received their first of two planned doses of mRNA-1273 (Lot number: 026L20A) intramuscularly in left deltoid for prophylaxis of COVID-19 infection.   On an unknown date, the HCP reported that the patient was vaccinated at 17 years of age (Product administered to patient of inappropriate age).  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event is resolved.; Reporter's Comments: This case concerns a 17-year-old male patient who received their first of two planned doses of mRNA-1273 (Lot 026L20A), reporting Product administered to patient of inappropriate age without any associated adverse events.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain in extremity, Vaccination site swelling, Vaccination site warmth
Clinical narrative: underarm is sore; hot; lymph nodes under my arm are swollen; red swelling around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (underarm is sore), VACCINATION SITE WARMTH (hot), LYMPHADENOPATHY (lymph nodes under my arm are swollen) and VACCINATION SITE SWELLING (red swelling around the injection site) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included PAROXETINE, BUMETANIDE, POTASSIUM, RIVAROXABAN (XARELTO), AMLODIPINE, LEVOTHYROXINE, ASCORBIC ACID, TOCOPHERYL ACETATE, XANTOFYL, ZEAXANTHIN, ZINC (AREDS) and MELATONIN for an unknown indication.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced PAIN IN EXTREMITY (underarm is sore), VACCINATION SITE WARMTH (hot), LYMPHADENOPATHY (lymph nodes under my arm are swollen) and VACCINATION SITE SWELLING (red swelling around the injection site). At the time of the report, PAIN IN EXTREMITY (underarm is sore), VACCINATION SITE WARMTH (hot), LYMPHADENOPATHY (lymph nodes under my arm are swollen) and VACCINATION SITE SWELLING (red swelling around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: hot to the touch injection site; Itching around injection site; Redness from injection site to elbow; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itching around injection site), VACCINATION SITE ERYTHEMA (Redness from injection site to elbow) and VACCINATION SITE WARMTH (hot to the touch injection site) in a 71-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 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itching around injection site) and VACCINATION SITE ERYTHEMA (Redness from injection site to elbow). On an unknown date, the patient experienced VACCINATION SITE WARMTH (hot to the touch injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, VACCINATION SITE PRURITUS (Itching around injection site), VACCINATION SITE ERYTHEMA (Redness from injection site to elbow) and VACCINATION SITE WARMTH (hot to the touch injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment details was included ice.; 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.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: mild side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (mild side effects) 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 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced VACCINATION COMPLICATION (mild side effects). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (mild side effects) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling of body temperature change, Flushing, Lethargy, Myalgia
Clinical narrative: felt pretty bad; just woke up with a facial rash; Rash on arm; achy; the arm got red , a slight redness; nauseas; very fatigue; cold,hot; felt lousy for 2 days; got a whole flush, cold, hot, nausea and it happened ten minutes later; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (felt lousy for 2 days), FLUSHING (got a whole flush, cold, hot, nausea and it happened ten minutes later), VACCINATION COMPLICATION (felt pretty bad), FEELING OF BODY TEMPERATURE CHANGE (cold,hot) and RASH (just woke up with a facial rash) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (Mo medical history reported). Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR), LISINOPRIL and OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced LETHARGY (felt lousy for 2 days), FLUSHING (got a whole flush, cold, hot, nausea and it happened ten minutes later), FEELING OF BODY TEMPERATURE CHANGE (cold,hot), MYALGIA (achy), VACCINATION SITE ERYTHEMA (the arm got red , a slight redness), NAUSEA (nauseas) and FATIGUE (very fatigue). On an unknown date, the patient experienced VACCINATION COMPLICATION (felt pretty bad), RASH (just woke up with a facial rash) and VACCINATION SITE RASH (Rash on arm). At the time of the report, LETHARGY (felt lousy for 2 days), FLUSHING (got a whole flush, cold, hot, nausea and it happened ten minutes later), VACCINATION COMPLICATION (felt pretty bad), FEELING OF BODY TEMPERATURE CHANGE (cold,hot), MYALGIA (achy), NAUSEA (nauseas) and FATIGUE (very fatigue) was resolving and RASH (just woke up with a facial rash), VACCINATION SITE ERYTHEMA (the arm got red , a slight redness) and VACCINATION SITE RASH (Rash on arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included diphenhydramine, ibuprofen, paracetamol.; 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: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Rash, Vaccination complication, Vaccination site erythema, Vaccination site rash
Clinical narrative: felt pretty bad; just woke up with a facial rash; Rash on arm; achy; the arm got red , a slight redness; nauseas; very fatigue; cold,hot; felt lousy for 2 days; got a whole flush, cold, hot, nausea and it happened ten minutes later; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (felt lousy for 2 days), FLUSHING (got a whole flush, cold, hot, nausea and it happened ten minutes later), VACCINATION COMPLICATION (felt pretty bad), FEELING OF BODY TEMPERATURE CHANGE (cold,hot) and RASH (just woke up with a facial rash) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (Mo medical history reported). Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR), LISINOPRIL and OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced LETHARGY (felt lousy for 2 days), FLUSHING (got a whole flush, cold, hot, nausea and it happened ten minutes later), FEELING OF BODY TEMPERATURE CHANGE (cold,hot), MYALGIA (achy), VACCINATION SITE ERYTHEMA (the arm got red , a slight redness), NAUSEA (nauseas) and FATIGUE (very fatigue). On an unknown date, the patient experienced VACCINATION COMPLICATION (felt pretty bad), RASH (just woke up with a facial rash) and VACCINATION SITE RASH (Rash on arm). At the time of the report, LETHARGY (felt lousy for 2 days), FLUSHING (got a whole flush, cold, hot, nausea and it happened ten minutes later), VACCINATION COMPLICATION (felt pretty bad), FEELING OF BODY TEMPERATURE CHANGE (cold,hot), MYALGIA (achy), NAUSEA (nauseas) and FATIGUE (very fatigue) was resolving and RASH (just woke up with a facial rash), VACCINATION SITE ERYTHEMA (the arm got red , a slight redness) and VACCINATION SITE RASH (Rash on arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included diphenhydramine, ibuprofen, paracetamol.; 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: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Cough, Fatigue, Pyrexia
Clinical narrative: Tested positive for Covid; Cough; Extremely weak; Tired; Low fever; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for Covid), COUGH (Cough), ASTHENIA (Extremely weak), FATIGUE (Tired) and PYREXIA (Low fever) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 21-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 COUGH (Cough), ASTHENIA (Extremely weak), FATIGUE (Tired) and PYREXIA (Low fever). On 05-Feb-2021, the patient experienced COVID-19 (Tested positive for Covid). At the time of the report, COVID-19 (Tested positive for Covid), COUGH (Cough), ASTHENIA (Extremely weak), FATIGUE (Tired) and PYREXIA (Low fever) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Feb-2021, SARS-CoV-2 test: unknown (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were  provided by the reporter. Treatment included Infusion of bam was noted.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Contains no new information.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Tested positive for Covid; Cough; Extremely weak; Tired; Low fever; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for Covid), COUGH (Cough), ASTHENIA (Extremely weak), FATIGUE (Tired) and PYREXIA (Low fever) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 21-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 COUGH (Cough), ASTHENIA (Extremely weak), FATIGUE (Tired) and PYREXIA (Low fever). On 05-Feb-2021, the patient experienced COVID-19 (Tested positive for Covid). At the time of the report, COVID-19 (Tested positive for Covid), COUGH (Cough), ASTHENIA (Extremely weak), FATIGUE (Tired) and PYREXIA (Low fever) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Feb-2021, SARS-CoV-2 test: unknown (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were  provided by the reporter. Treatment included Infusion of bam was noted.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Contains no new information.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: "wasn't feeling well after the vaccination"; A spontaneous report was received from a consumer concerning a 79-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced 'wasn't feeling well after the vaccination'/feeling abnormal.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 9 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced 'wasn't feeling well after the vaccination'/feeling abnormal.  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 'wasn't feeling well after the vaccination'/feeling abnormal was unknown.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).   On 09-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 10-Feb-2021, the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) outcome was unknown.             No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-031245 (Patient Link).
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Influenza like illness, Myalgia
Clinical narrative: The back and shoulders were hurting; I felt like I had the flu; I had such a body ache that I had to get up; The back and shoulders were hurting; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (The back and shoulders were hurting), INFLUENZA LIKE ILLNESS (I felt like I had the flu), MYALGIA (I had such a body ache that I had to get up) and ARTHRALGIA (The back and shoulders were hurting) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No Medical History.  Concomitant products included METFORMIN, FINASTERIDE, PRAVASTATIN, CARVEDILOL, ISOSORBIDE, FENOFIBRATE, RAMIPRIL and INSULIN for an unknown indication.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced BACK PAIN (The back and shoulders were hurting), INFLUENZA LIKE ILLNESS (I felt like I had the flu), MYALGIA (I had such a body ache that I had to get up) and ARTHRALGIA (The back and shoulders were hurting). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 01-Mar-2021, INFLUENZA LIKE ILLNESS (I felt like I had the flu) had resolved. At the time of the report, BACK PAIN (The back and shoulders were hurting), MYALGIA (I had such a body ache that I had to get up) and ARTHRALGIA (The back and shoulders were hurting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication included Tylenol. 2-3 minutes after taking it, the pain was gone. He says this was coincidental, and not due to the Tylenol (can't act that quick, he said).   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow up received on 25-May-2021 contains no new information-patient denied further follow up.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: very sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (very sick) 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.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced ILLNESS (very sick). At the time of the report, ILLNESS (very sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Fall, Joint dislocation
Clinical narrative: Fell and separated her shoulder; Fell and separated her shoulder; This spontaneous case was reported by a consumer and describes the occurrence of FALL (Fell and separated her shoulder) and JOINT DISLOCATION (Fell and separated her shoulder) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced FALL (Fell and separated her shoulder) and JOINT DISLOCATION (Fell and separated her shoulder). At the time of the report, FALL (Fell and separated her shoulder) and JOINT DISLOCATION (Fell and separated her shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  No concomitant medications were reported. No treatment related information has been reported.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Depressed mood, Emotional disorder, Fatigue
Clinical narrative: psychotropic effects, emotional changes, sadness and depressed; psychotropic effects, emotional changes, sadness and depressed; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of EMOTIONAL DISORDER (psychotropic effects, emotional changes (sadness and depressed)), DEPRESSED MOOD (psychotropic effects, emotional changes (sadness and depressed)) and FATIGUE (Fatigue) 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 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced EMOTIONAL DISORDER (psychotropic effects, emotional changes (sadness and depressed)), DEPRESSED MOOD (psychotropic effects, emotional changes (sadness and depressed)) and FATIGUE (Fatigue). On 27-Feb-2021, EMOTIONAL DISORDER (psychotropic effects, emotional changes (sadness and depressed)), DEPRESSED MOOD (psychotropic effects, emotional changes (sadness and depressed)) and FATIGUE (Fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment related information has been reported.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Had a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Had a sore arm) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced PAIN IN EXTREMITY (Had a sore arm). At the time of the report, PAIN IN EXTREMITY (Had a sore arm) outcome was unknown. Not Provided          Treatment details included ice.  No concomitant medications were provided.  Action taken with mRNA-1273 in response to the events was not applicable.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Oropharyngeal pain, Pruritus, Rash, SARS-CoV-2 test
Clinical narrative: Pretty severe itch; Developed a rash all over his back; Had a sore throat; Had mild COVID-19 symptoms; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Had a sore throat), PRURITUS (Pretty severe itch), COVID-19 (Had mild COVID-19 symptoms) and RASH (Developed a rash all over his back) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concomitant products included IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDE (ADVIL COLD) 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 01-Feb-2021, the patient experienced OROPHARYNGEAL PAIN (Had a sore throat) and COVID-19 (Had mild COVID-19 symptoms). On 08-Feb-2021, the patient experienced PRURITUS (Pretty severe itch) and RASH (Developed a rash all over his back). The patient was treated with TRIAMCINOLONE at an unspecified dose and frequency. On 06-Feb-2021, OROPHARYNGEAL PAIN (Had a sore throat) and COVID-19 (Had mild COVID-19 symptoms) had resolved. At the time of the report, PRURITUS (Pretty severe itch) and RASH (Developed a rash all over his back) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Feb-2021, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant- sinus.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Erythema, Fatigue, Pain, Rash
Clinical narrative: Rash; Started to get tired/ severe exhaustion; Redness/ Small red patch/getting bigger now; Dried cough; Soreness; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of COUGH (Dried cough), PAIN (Soreness), ERYTHEMA (Redness/ Small red patch/getting bigger now), RASH (Rash) and FATIGUE (Started to get tired/ severe exhaustion) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), DULOXETINE HYDROCHLORIDE (CYMBALTA), LOSARTAN, APIXABAN (ELIQUIS) and VITAMINS NOS for an unknown indication.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN (Soreness). On 06-Feb-2021, the patient experienced COUGH (Dried cough). On 08-Feb-2021, the patient experienced ERYTHEMA (Redness/ Small red patch/getting bigger now). On 09-Feb-2021, the patient experienced FATIGUE (Started to get tired/ severe exhaustion). On an unknown date, the patient experienced RASH (Rash). At the time of the report, COUGH (Dried cough), PAIN (Soreness), ERYTHEMA (Redness/ Small red patch/getting bigger now) and FATIGUE (Started to get tired/ severe exhaustion) had not resolved and RASH (Rash) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-008779 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: New event added
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash vagina up to the neck; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash vagina up to the neck) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-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 RASH (Rash vagina up to the neck). At the time of the report, RASH (Rash vagina up to the neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and treatment medications were not reported.