chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Induration, Pruritus, Swelling
Clinical narrative: large red area 2 inch round; area is hardened; her arm starting itching really bad; area is swollen; This spontaneous case was reported by a health care professional and describes the occurrence of ERYTHEMA (large red area 2 inch round), INDURATION (area is hardened), PRURITUS (her arm starting itching really bad) and SWELLING (area is swollen) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced ERYTHEMA (large red area 2 inch round), INDURATION (area is hardened), PRURITUS (her arm starting itching really bad) and SWELLING (area is swollen). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, ERYTHEMA (large red area 2 inch round), INDURATION (area is hardened), PRURITUS (her arm starting itching really bad) and SWELLING (area is swollen) 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 was not provided by the reporter. Treatment for the events included Benadryl and ice on area.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pyrexia
Clinical narrative: Fever 102; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever 102) and HEADACHE (Headache) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high. Concomitant products included DIAZEPAM (VALIUM) for an unknown indication.   On 21-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, the patient experienced PYREXIA (Fever 102) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) for Fever and Headache, at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever 102) and HEADACHE (Headache) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Mar-2021, Body temperature: 102 (High) Fever 102.         Concomitant products included blood pressure medications.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) for Headache, at a dose of 400. At the time of the report, HEADACHE (headache) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient already received the second dose and had  been very well, without any problem. No concomitant medication were provided. ?   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: event outcome added
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: arm was itchy; redness on arm inside arm to elbow; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (arm was itchy) and ERYTHEMA (redness on arm inside arm to elbow) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (arm was itchy) and ERYTHEMA (redness on arm inside arm to elbow). At the time of the report, PRURITUS (arm was itchy) and ERYTHEMA (redness on arm inside arm to elbow) outcome was unknown.      Action taken with mRNA-1273 in response to the events was not applicable     The concomitant product and treatment were not provided.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Muscle rigidity, Pain, Peripheral swelling, Vaccination site pain
Clinical narrative: left swollen arm; hard left arm; pain in arm at injection site; body aches; just didn't feel great; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), FEELING ABNORMAL (just didn't feel great), PERIPHERAL SWELLING (left swollen arm), MUSCLE RIGIDITY (hard left arm) and VACCINATION SITE PAIN (pain in arm at injection site) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced PAIN (body aches) and FEELING ABNORMAL (just didn't feel great). On 22-Mar-2021, the patient experienced VACCINATION SITE PAIN (pain in arm at injection site). On 23-Mar-2021, the patient experienced PERIPHERAL SWELLING (left swollen arm) and MUSCLE RIGIDITY (hard left arm). On 18-Mar-2021, PAIN (body aches) and FEELING ABNORMAL (just didn't feel great) had resolved. At the time of the report, PERIPHERAL SWELLING (left swollen arm), MUSCLE RIGIDITY (hard left arm) and VACCINATION SITE PAIN (pain in arm at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication use was unknown Treatment information was unknown
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Itchy red spot on injection site; Itchy red spot on injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchy red spot on injection site) and VACCINATION SITE ERYTHEMA (Itchy red spot on injection site) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy red spot on injection site). 22-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (Itchy red spot on injection site). The patient was treated with HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (Itchy red spot on injection site) and VACCINATION SITE ERYTHEMA (Itchy red spot on injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant medicines was not reported by reporter   treatment information was not provide  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Diarrhoea, Flatulence, Headache, Myalgia
Clinical narrative: headache; body pain; extreme nausea/nausea; dry heaving; diarrhea/5 liquid stools that have a metal smell; severe abdominal pain and gas with a metal smell; gas; gas as well the same night with a metal smell; This spontaneous case was reported by a consumer and describes the occurrence of RETCHING (dry heaving), DIARRHOEA (diarrhea/5 liquid stools that have a metal smell), ABDOMINAL PAIN (severe abdominal pain and gas with a metal smell), FLATULENCE (gas) and PAROSMIA (gas as well the same night with a metal smell) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Fibromyalgia.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced RETCHING (dry heaving), DIARRHOEA (diarrhea/5 liquid stools that have a metal smell), ABDOMINAL PAIN (severe abdominal pain and gas with a metal smell), FLATULENCE (gas), PAROSMIA (gas as well the same night with a metal smell) and NAUSEA (extreme nausea/nausea). On 22-Mar-2021, the patient experienced HEADACHE (headache) and MYALGIA (body pain). On 05-Mar-2021, RETCHING (dry heaving), DIARRHOEA (diarrhea/5 liquid stools that have a metal smell) and ABDOMINAL PAIN (severe abdominal pain and gas with a metal smell) had resolved. On 22-Mar-2021, HEADACHE (headache), NAUSEA (extreme nausea/nausea) and MYALGIA (body pain) had resolved. At the time of the report, FLATULENCE (gas) and PAROSMIA (gas as well the same night with a metal smell) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medication information was reported.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Parosmia, Retching
Clinical narrative: headache; body pain; extreme nausea/nausea; dry heaving; diarrhea/5 liquid stools that have a metal smell; severe abdominal pain and gas with a metal smell; gas; gas as well the same night with a metal smell; This spontaneous case was reported by a consumer and describes the occurrence of RETCHING (dry heaving), DIARRHOEA (diarrhea/5 liquid stools that have a metal smell), ABDOMINAL PAIN (severe abdominal pain and gas with a metal smell), FLATULENCE (gas) and PAROSMIA (gas as well the same night with a metal smell) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Fibromyalgia.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced RETCHING (dry heaving), DIARRHOEA (diarrhea/5 liquid stools that have a metal smell), ABDOMINAL PAIN (severe abdominal pain and gas with a metal smell), FLATULENCE (gas), PAROSMIA (gas as well the same night with a metal smell) and NAUSEA (extreme nausea/nausea). On 22-Mar-2021, the patient experienced HEADACHE (headache) and MYALGIA (body pain). On 05-Mar-2021, RETCHING (dry heaving), DIARRHOEA (diarrhea/5 liquid stools that have a metal smell) and ABDOMINAL PAIN (severe abdominal pain and gas with a metal smell) had resolved. On 22-Mar-2021, HEADACHE (headache), NAUSEA (extreme nausea/nausea) and MYALGIA (body pain) had resolved. At the time of the report, FLATULENCE (gas) and PAROSMIA (gas as well the same night with a metal smell) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medication information was reported.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: fever all day; tired; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever all day) and FATIGUE (tired) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, the patient experienced PYREXIA (fever all day) and FATIGUE (tired). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PYREXIA (fever all day) and FATIGUE (tired) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication included blood pressure medications and antidepressant.  Action taken with mRNA-1273 in response to the event was not applicable.  Patient took second dose on 20 Mar 2021 and lot number was 048A21A.   This case was linked to MOD-2021-054344 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: Cheeks became red; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Cheeks became red) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Neck pain. Concomitant products included PARACETAMOL (TYLENOL) for Neck pain.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced ERYTHEMA (Cheeks became red). On 24-Feb-2021, ERYTHEMA (Cheeks became red) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication was reported.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash erythematous, Rash macular, Tinea infection
Clinical narrative: Still having issues regarding red rash; Ring worm; Blotches that look like reddish brownish dry scaly skin patches on patient's stomach; Blotches are itchy; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH MACULAR (Blotches that look like reddish brownish dry scaly skin patches on patient's stomach), PRURITUS (Blotches are itchy), RASH ERYTHEMATOUS (Still having issues regarding red rash) and TINEA INFECTION (Ring worm) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced RASH MACULAR (Blotches that look like reddish brownish dry scaly skin patches on patient's stomach) and PRURITUS (Blotches are itchy). On an unknown date, the patient experienced RASH ERYTHEMATOUS (Still having issues regarding red rash) and TINEA INFECTION (Ring worm). At the time of the report, RASH MACULAR (Blotches that look like reddish brownish dry scaly skin patches on patient's stomach) and RASH ERYTHEMATOUS (Still having issues regarding red rash) had not resolved and PRURITUS (Blotches are itchy) and TINEA INFECTION (Ring worm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications and treatment information were reported.    Most recent FOLLOW-UP information incorporated above includes: On 31-Mar-2021: Additional information received on 31-Mar-2021 was updated with additional event of red rash, ring worm, treatment received and outcome of the events.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Neuralgia, Pain in jaw
Clinical narrative: sharp pain in her right ear especially when she swallows; nerve pain in the left side of her body; sharp pain in the left side of her jaw /couldn't eat on her left side because of this pressure and pain; sharp pain in the left side of her jaw and ear; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN JAW (sharp pain in the left side of her jaw /couldn't eat on her left side because of this pressure and pain), EAR PAIN (sharp pain in the left side of her jaw and ear), NEURALGIA (nerve pain in the left side of her body) and EAR PAIN (sharp pain in her right ear especially when she swallows) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced PAIN IN JAW (sharp pain in the left side of her jaw /couldn't eat on her left side because of this pressure and pain) and EAR PAIN (sharp pain in the left side of her jaw and ear). On 20-Mar-2021, the patient experienced NEURALGIA (nerve pain in the left side of her body). On 22-Mar-2021, the patient experienced EAR PAIN (sharp pain in her right ear especially when she swallows). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form. On 22-Mar-2021, PAIN IN JAW (sharp pain in the left side of her jaw /couldn't eat on her left side because of this pressure and pain), EAR PAIN (sharp pain in the left side of her jaw and ear) and NEURALGIA (nerve pain in the left side of her body) had resolved. At the time of the report, EAR PAIN (sharp pain in her right ear especially when she swallows) had not 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.   There was no concomitant list.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Urinary incontinence
Clinical narrative: WHENEVER STANDING WOULD LOSE CONTROL OF BLADDER; EXTREMELY BAD HEADACHE; GENERAL MUSCLE ACHES AND PAIN/MUSCLES WASN'T DOING GOOD; VERY TIRED; This spontaneous case was reported by a consumer and describes the occurrence of URINARY INCONTINENCE (WHENEVER STANDING WOULD LOSE CONTROL OF BLADDER), HEADACHE (EXTREMELY BAD HEADACHE), MYALGIA (GENERAL MUSCLE ACHES AND PAIN/MUSCLES WASN'T DOING GOOD) and FATIGUE (VERY TIRED) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URINARY INCONTINENCE (WHENEVER STANDING WOULD LOSE CONTROL OF BLADDER), HEADACHE (EXTREMELY BAD HEADACHE), MYALGIA (GENERAL MUSCLE ACHES AND PAIN/MUSCLES WASN'T DOING GOOD) and FATIGUE (VERY TIRED). At the time of the report, URINARY INCONTINENCE (WHENEVER STANDING WOULD LOSE CONTROL OF BLADDER), HEADACHE (EXTREMELY BAD HEADACHE), MYALGIA (GENERAL MUSCLE ACHES AND PAIN/MUSCLES WASN'T DOING GOOD) and FATIGUE (VERY TIRED) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment details were reported.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Influenza like illness, Oropharyngeal pain, Pain in extremity
Clinical narrative: warm at the injection site; mild sore throat; "flu-like" symptoms; pain in the arm; redness , a red circle; chills; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm at the injection site), OROPHARYNGEAL PAIN (mild sore throat), INFLUENZA LIKE ILLNESS ("flu-like" symptoms), PAIN IN EXTREMITY (pain in the arm) and VACCINATION SITE ERYTHEMA (redness , a red circle) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No significant historical event reported.).    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 22-Mar-2021, the patient experienced VACCINATION SITE WARMTH (warm at the injection site), OROPHARYNGEAL PAIN (mild sore throat), INFLUENZA LIKE ILLNESS ("flu-like" symptoms), PAIN IN EXTREMITY (pain in the arm), VACCINATION SITE ERYTHEMA (redness , a red circle), CHILLS (chills) and FATIGUE (tiredness). At the time of the report, VACCINATION SITE WARMTH (warm at the injection site), OROPHARYNGEAL PAIN (mild sore throat), INFLUENZA LIKE ILLNESS ("flu-like" symptoms), PAIN IN EXTREMITY (pain in the arm), VACCINATION SITE ERYTHEMA (redness , a red circle), CHILLS (chills) and FATIGUE (tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       There was no concomitant list.  Treatment was not provided.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site warmth
Clinical narrative: warm at the injection site; mild sore throat; "flu-like" symptoms; pain in the arm; redness , a red circle; chills; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm at the injection site), OROPHARYNGEAL PAIN (mild sore throat), INFLUENZA LIKE ILLNESS ("flu-like" symptoms), PAIN IN EXTREMITY (pain in the arm) and VACCINATION SITE ERYTHEMA (redness , a red circle) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No significant historical event reported.).    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 22-Mar-2021, the patient experienced VACCINATION SITE WARMTH (warm at the injection site), OROPHARYNGEAL PAIN (mild sore throat), INFLUENZA LIKE ILLNESS ("flu-like" symptoms), PAIN IN EXTREMITY (pain in the arm), VACCINATION SITE ERYTHEMA (redness , a red circle), CHILLS (chills) and FATIGUE (tiredness). At the time of the report, VACCINATION SITE WARMTH (warm at the injection site), OROPHARYNGEAL PAIN (mild sore throat), INFLUENZA LIKE ILLNESS ("flu-like" symptoms), PAIN IN EXTREMITY (pain in the arm), VACCINATION SITE ERYTHEMA (redness , a red circle), CHILLS (chills) and FATIGUE (tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       There was no concomitant list.  Treatment was not provided.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Breast discharge, Breast mass, Breast swelling, Pain in extremity, Skin irritation
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in the arm), BREAST SWELLING (their left breast was swollen), BREAST MASS, BREAST DISCHARGE and SKIN IRRITATION in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045LA2LLA) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, the patient experienced BREAST SWELLING (their left breast was swollen). On 23-Mar-2021, the patient experienced BREAST MASS, BREAST DISCHARGE and SKIN IRRITATION. On an unknown date, the patient experienced PAIN IN EXTREMITY (pain in the arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (pain in the arm), BREAST SWELLING (their left breast was swollen), BREAST MASS, BREAST DISCHARGE and SKIN IRRITATION outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was reported.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea
Clinical narrative: stomach aches and diarrhea; stomach aches and diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach aches and diarrhea) and DIARRHOEA (stomach aches and diarrhea) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history reported by the reporter.  Concomitant products included RIVAROXABAN (XARELTO) for an unknown indication.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach aches and diarrhea) and DIARRHOEA (stomach aches and diarrhea). At the time of the report, ABDOMINAL PAIN UPPER (stomach aches and diarrhea) and DIARRHOEA (stomach aches and diarrhea) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.   Reporter did not allow further contact
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Depressed mood, Headache, Pain
Clinical narrative: Achy after 2nd dose; Feels run down after 2nd dose; Headache after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achy after 2nd dose), DEPRESSED MOOD (Feels run down after 2nd dose) and HEADACHE (Headache after 2nd dose) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Achy after 2nd dose), DEPRESSED MOOD (Feels run down after 2nd dose) and HEADACHE (Headache after 2nd dose). At the time of the report, PAIN (Achy after 2nd dose), DEPRESSED MOOD (Feels run down after 2nd dose) and HEADACHE (Headache after 2nd dose) outcome was unknown.            no treatment information provided. Concomitant medications were not reported
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: nausea; headaches; injection site is so sore feels like it has a fever; feels like a knot but the redness is gone and now more pink; body aches; another full 24 hours of fever; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body aches), PYREXIA (another full 24 hours of fever), NAUSEA (nausea), HEADACHE (headaches) and VACCINATION SITE PAIN (injection site is so sore feels like it has a fever) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (another full 24 hours of fever). On 21-Mar-2021, the patient experienced MYALGIA (body aches), NAUSEA (nausea), HEADACHE (headaches), VACCINATION SITE PAIN (injection site is so sore feels like it has a fever) and VACCINATION SITE ERYTHEMA (feels like a knot but the redness is gone and now more pink). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MYALGIA (body aches), PYREXIA (another full 24 hours of fever), NAUSEA (nausea), HEADACHE (headaches), VACCINATION SITE PAIN (injection site is so sore feels like it has a fever) and VACCINATION SITE ERYTHEMA (feels like a knot but the redness is gone and now more pink) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Mar-2021, Body temperature: 99 (High) fever of 99.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: nausea; headaches; injection site is so sore feels like it has a fever; feels like a knot but the redness is gone and now more pink; body aches; another full 24 hours of fever; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body aches), PYREXIA (another full 24 hours of fever), NAUSEA (nausea), HEADACHE (headaches) and VACCINATION SITE PAIN (injection site is so sore feels like it has a fever) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (another full 24 hours of fever). On 21-Mar-2021, the patient experienced MYALGIA (body aches), NAUSEA (nausea), HEADACHE (headaches), VACCINATION SITE PAIN (injection site is so sore feels like it has a fever) and VACCINATION SITE ERYTHEMA (feels like a knot but the redness is gone and now more pink). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MYALGIA (body aches), PYREXIA (another full 24 hours of fever), NAUSEA (nausea), HEADACHE (headaches), VACCINATION SITE PAIN (injection site is so sore feels like it has a fever) and VACCINATION SITE ERYTHEMA (feels like a knot but the redness is gone and now more pink) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Mar-2021, Body temperature: 99 (High) fever of 99.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Atrial flutter, Ocular hyperaemia, Vision blurred
Clinical narrative: Flutter atrial; Feeling anxious; Blurred vision; Eyes red; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (Blurred vision), OCULAR HYPERAEMIA (Eyes red), ATRIAL FLUTTER (Flutter atrial) and ANXIETY (Feeling anxious) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B219) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced VISION BLURRED (Blurred vision) and OCULAR HYPERAEMIA (Eyes red). On an unknown date, the patient experienced ATRIAL FLUTTER (Flutter atrial) and ANXIETY (Feeling anxious). The patient was treated with OXYMETAZOLINE HYDROCHLORIDE (DECONGESTANT [OXYMETAZOLINE HYDROCHLORIDE]) at a dose of 1 dosage form and ACETYLSALICYLIC ACID (ALKA SELTZER [ACETYLSALICYLIC ACID]) at a dose of 1 dosage form. At the time of the report, VISION BLURRED (Blurred vision), OCULAR HYPERAEMIA (Eyes red), ATRIAL FLUTTER (Flutter atrial) and ANXIETY (Feeling anxious) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: New events added
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Erythema, Headache, Injection site pain, Peripheral swelling
Clinical narrative: swelling (left) arm; stomach ache; itching; Warm; redness; pain at injection site reemerged; pain in injection site; headache; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (pain in injection site), HEADACHE (headache), ERYTHEMA (redness), PERIPHERAL SWELLING (swelling (left) arm) and ABDOMINAL PAIN UPPER (stomach ache) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-Mar-2021, 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 16-Mar-2021, the patient experienced INJECTION SITE PAIN (pain in injection site) and HEADACHE (headache). On 20-Mar-2021, the patient experienced VACCINATION SITE PAIN (pain at injection site reemerged). On 21-Mar-2021, the patient experienced ERYTHEMA (redness), ABDOMINAL PAIN UPPER (stomach ache), PRURITUS (itching) and VACCINATION SITE WARMTH (Warm). On 23-Mar-2021, the patient experienced PERIPHERAL SWELLING (swelling (left) arm). On 19-Mar-2021, INJECTION SITE PAIN (pain in injection site) and HEADACHE (headache) had resolved. On 23-Mar-2021, ERYTHEMA (redness), PERIPHERAL SWELLING (swelling (left) arm), ABDOMINAL PAIN UPPER (stomach ache) and PRURITUS (itching) had resolved. At the time of the report, VACCINATION SITE WARMTH (Warm) and VACCINATION SITE PAIN (pain at injection site reemerged) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       For treatment patient consulted HCP nurse campus care
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site pain, Vaccination site warmth
Clinical narrative: swelling (left) arm; stomach ache; itching; Warm; redness; pain at injection site reemerged; pain in injection site; headache; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (pain in injection site), HEADACHE (headache), ERYTHEMA (redness), PERIPHERAL SWELLING (swelling (left) arm) and ABDOMINAL PAIN UPPER (stomach ache) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-Mar-2021, 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 16-Mar-2021, the patient experienced INJECTION SITE PAIN (pain in injection site) and HEADACHE (headache). On 20-Mar-2021, the patient experienced VACCINATION SITE PAIN (pain at injection site reemerged). On 21-Mar-2021, the patient experienced ERYTHEMA (redness), ABDOMINAL PAIN UPPER (stomach ache), PRURITUS (itching) and VACCINATION SITE WARMTH (Warm). On 23-Mar-2021, the patient experienced PERIPHERAL SWELLING (swelling (left) arm). On 19-Mar-2021, INJECTION SITE PAIN (pain in injection site) and HEADACHE (headache) had resolved. On 23-Mar-2021, ERYTHEMA (redness), PERIPHERAL SWELLING (swelling (left) arm), ABDOMINAL PAIN UPPER (stomach ache) and PRURITUS (itching) had resolved. At the time of the report, VACCINATION SITE WARMTH (Warm) and VACCINATION SITE PAIN (pain at injection site reemerged) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       For treatment patient consulted HCP nurse campus care
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Nasal congestion, Nasopharyngitis, Oropharyngeal pain
Clinical narrative: Some viral type thing or bad cold; sore throat; congested; cough; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Some viral type thing or bad cold), OROPHARYNGEAL PAIN (sore throat), NASAL CONGESTION (congested) and COUGH (cough) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Lung cancer (had lung cancer and only has one lung).    On 19-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 NASOPHARYNGITIS (Some viral type thing or bad cold), OROPHARYNGEAL PAIN (sore throat), NASAL CONGESTION (congested) and COUGH (cough). At the time of the report, NASOPHARYNGITIS (Some viral type thing or bad cold), OROPHARYNGEAL PAIN (sore throat), NASAL CONGESTION (congested) and COUGH (cough) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        The patient was appointment for the second shot on Friday 26Mar2021.  No concomitant medication details were provided. The patient has been taking antihistamines.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site reaction
Clinical narrative: Covid arm; horrible rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Covid arm) and RASH (horrible rash) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (Covid arm) and RASH (horrible rash). At the time of the report, VACCINATION SITE REACTION (Covid arm) and RASH (horrible rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment medication was reported.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Pain, Vaccination complication
Clinical narrative: body aches; other symptoms; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), PAIN (body aches) and VACCINATION COMPLICATION (other symptoms) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. O36A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced DIARRHOEA (Diarrhea). On an unknown date, the patient experienced PAIN (body aches) and VACCINATION COMPLICATION (other symptoms). At the time of the report, DIARRHOEA (Diarrhea), PAIN (body aches) and VACCINATION COMPLICATION (other symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Discomfort, Disorganised speech, Fatigue, Feeling hot
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN (sore), DISCOMFORT (uncomfortable), BACK PAIN (pain in the back especially when I stretch), FEELING HOT (felt really hot) and DISORGANISED SPEECH (I was mixing up my words and saying the wrong things) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included SERTRALINE and CARBAMAZEPINE for an unknown indication.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced PAIN (sore) and DISCOMFORT (uncomfortable). On 19-Mar-2021, the patient experienced BACK PAIN (pain in the back especially when I stretch) and FATIGUE (fatigue). On 21-Mar-2021, the patient experienced DISORGANISED SPEECH (I was mixing up my words and saying the wrong things). On 22-Mar-2021, the patient experienced FEELING HOT (felt really hot). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 19-Mar-2021, PAIN (sore) and DISCOMFORT (uncomfortable) had resolved. At the time of the report, BACK PAIN (pain in the back especially when I stretch), FEELING HOT (felt really hot), DISORGANISED SPEECH (I was mixing up my words and saying the wrong things) and FATIGUE (fatigue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN (sore), DISCOMFORT (uncomfortable), BACK PAIN (pain in the back especially when I stretch), FEELING HOT (felt really hot) and DISORGANISED SPEECH (I was mixing up my words and saying the wrong things) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included SERTRALINE and CARBAMAZEPINE for an unknown indication.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced PAIN (sore) and DISCOMFORT (uncomfortable). On 19-Mar-2021, the patient experienced BACK PAIN (pain in the back especially when I stretch) and FATIGUE (fatigue). On 21-Mar-2021, the patient experienced DISORGANISED SPEECH (I was mixing up my words and saying the wrong things). On 22-Mar-2021, the patient experienced FEELING HOT (felt really hot). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 19-Mar-2021, PAIN (sore) and DISCOMFORT (uncomfortable) had resolved. At the time of the report, BACK PAIN (pain in the back especially when I stretch), FEELING HOT (felt really hot), DISORGANISED SPEECH (I was mixing up my words and saying the wrong things) and FATIGUE (fatigue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Bone cancer.   On 18-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On an unknown date, the patient experienced DIZZINESS (dizzy). At the time of the report, DIZZINESS (dizzy) outcome was unknown. Patient experienced dizziness after the first dose of the two scheduled doses of mRNA-1273.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant products included Bone cancer medication and Blood pressure medication for an unknown indication.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site rash, Vaccination site swelling, Vaccination site warmth
Clinical narrative: it's hot like it's infected - injection site - right arm - from shoulder to almost to the elbow; a little hard injection site - right arm - from shoulder to almost to the elbow; rash at the injection site - right arm - from shoulder to almost to the elbow; red spot at the injection site - right arm - from shoulder to almost to the elbow; a little swollen injection site - right arm - from shoulder to almost to the elbow; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (it's hot like it's infected - injection site - right arm - from shoulder to almost to the elbow), VACCINATION SITE INDURATION (a little hard injection site - right arm - from shoulder to almost to the elbow), VACCINATION SITE RASH (rash at the injection site - right arm - from shoulder to almost to the elbow), VACCINATION SITE ERYTHEMA (red spot at the injection site - right arm - from shoulder to almost to the elbow) and VACCINATION SITE SWELLING (a little swollen injection site - right arm - from shoulder to almost to the elbow) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     Concurrent medical conditions included Alzheimer's disease, Diabetes and Dementia.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced VACCINATION SITE WARMTH (it's hot like it's infected - injection site - right arm - from shoulder to almost to the elbow), VACCINATION SITE INDURATION (a little hard injection site - right arm - from shoulder to almost to the elbow), VACCINATION SITE RASH (rash at the injection site - right arm - from shoulder to almost to the elbow), VACCINATION SITE ERYTHEMA (red spot at the injection site - right arm - from shoulder to almost to the elbow) and VACCINATION SITE SWELLING (a little swollen injection site - right arm - from shoulder to almost to the elbow). At the time of the report, VACCINATION SITE WARMTH (it's hot like it's infected - injection site - right arm - from shoulder to almost to the elbow), VACCINATION SITE INDURATION (a little hard injection site - right arm - from shoulder to almost to the elbow), VACCINATION SITE RASH (rash at the injection site - right arm - from shoulder to almost to the elbow), VACCINATION SITE ERYTHEMA (red spot at the injection site - right arm - from shoulder to almost to the elbow) and VACCINATION SITE SWELLING (a little swollen injection site - right arm - from shoulder to almost to the elbow) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Vaccination site pain
Clinical narrative: Diarrhoea; Soreness of the right arm around injection site; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhoea) and VACCINATION SITE PAIN (Soreness of the right arm around injection site) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     Concomitant products included METFORMIN, LEVOTHYROXINE, DILTIAZEM, APIXABAN (ELIQUIS), FAMOTIDINE (PEPCID AC), VITAMIN B3, CYANOCOBALAMIN (B12 [CYANOCOBALAMIN]) and FISH OIL for an unknown indication.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced VACCINATION SITE PAIN (Soreness of the right arm around injection site). On 21-Mar-2021, the patient experienced DIARRHOEA (Diarrhoea). On 21-Mar-2021, DIARRHOEA (Diarrhoea) was resolving. At the time of the report, VACCINATION SITE PAIN (Soreness of the right arm around injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient's diarrhea got better eventually without any medication. On 21-Mar-2021, the patient had soreness of the arm around the injection site.