chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Bone pain, Cough, Feeling abnormal
Clinical narrative: Felt like an allergy; little cough; Bone pain; Tasteless as if he was not eating anything; Can't smell anything and he has not got back the sense of smell yet; Phlegm; Felt bad; Headache; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Felt like an allergy), COUGH (little cough), BONE PAIN (Bone pain), AGEUSIA (Tasteless as if he was not eating anything) and ANOSMIA (Can't smell anything and he has not got back the sense of smell yet) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-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 HYPERSENSITIVITY (Felt like an allergy), COUGH (little cough), BONE PAIN (Bone pain), AGEUSIA (Tasteless as if he was not eating anything), ANOSMIA (Can't smell anything and he has not got back the sense of smell yet), PRODUCTIVE COUGH (Phlegm), FEELING ABNORMAL (Felt bad) and HEADACHE (Headache). At the time of the report, HYPERSENSITIVITY (Felt like an allergy), COUGH (little cough), BONE PAIN (Bone pain), AGEUSIA (Tasteless as if he was not eating anything), ANOSMIA (Can't smell anything and he has not got back the sense of smell yet), PRODUCTIVE COUGH (Phlegm), FEELING ABNORMAL (Felt bad) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Lab test: SARS-CoV-2 test: positive (Positive) Positive after first dose of vaccine  Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Hypersensitivity, Productive cough
Clinical narrative: Felt like an allergy; little cough; Bone pain; Tasteless as if he was not eating anything; Can't smell anything and he has not got back the sense of smell yet; Phlegm; Felt bad; Headache; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Felt like an allergy), COUGH (little cough), BONE PAIN (Bone pain), AGEUSIA (Tasteless as if he was not eating anything) and ANOSMIA (Can't smell anything and he has not got back the sense of smell yet) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-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 HYPERSENSITIVITY (Felt like an allergy), COUGH (little cough), BONE PAIN (Bone pain), AGEUSIA (Tasteless as if he was not eating anything), ANOSMIA (Can't smell anything and he has not got back the sense of smell yet), PRODUCTIVE COUGH (Phlegm), FEELING ABNORMAL (Felt bad) and HEADACHE (Headache). At the time of the report, HYPERSENSITIVITY (Felt like an allergy), COUGH (little cough), BONE PAIN (Bone pain), AGEUSIA (Tasteless as if he was not eating anything), ANOSMIA (Can't smell anything and he has not got back the sense of smell yet), PRODUCTIVE COUGH (Phlegm), FEELING ABNORMAL (Felt bad) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Lab test: SARS-CoV-2 test: positive (Positive) Positive after first dose of vaccine  Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Feeling of body temperature change, Nausea, Paraesthesia
Clinical narrative: Dizzy; Hot and cold flashes; Tingling and buzzing in finger tips of both hands; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), FEELING OF BODY TEMPERATURE CHANGE (Hot and cold flashes), PARAESTHESIA (Tingling and buzzing in finger tips of both hands) and NAUSEA (Nausea) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-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 DIZZINESS (Dizzy), FEELING OF BODY TEMPERATURE CHANGE (Hot and cold flashes), PARAESTHESIA (Tingling and buzzing in finger tips of both hands) and NAUSEA (Nausea). At the time of the report, DIZZINESS (Dizzy), FEELING OF BODY TEMPERATURE CHANGE (Hot and cold flashes), PARAESTHESIA (Tingling and buzzing in finger tips of both hands) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Body ache; Elevated temp; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body ache), PYREXIA (Elevated temp) and HEADACHE (Headache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Body ache), PYREXIA (Elevated temp) and HEADACHE (Headache). At the time of the report, PAIN (Body ache), PYREXIA (Elevated temp) and HEADACHE (Headache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) dosing remained unchanged.       Concomitant product use was not reported.  Treatment information was not provided.    Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: NNI
Age: 74.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Diarrhoea, Fatigue, Feeling abnormal, Illness
Clinical narrative: broke out with a rash; muscle aches; joint ache; severe diarrhea with no stomach cramps; extremely tired; feeling horribly sick for 5 days; feeling lousy; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (feeling horribly sick for 5 days), FEELING ABNORMAL (feeling lousy), DIARRHOEA (severe diarrhea with no stomach cramps), FATIGUE (extremely tired) and MYALGIA (muscle aches) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product TRIAMCINOLONE ACETONIDE cream for Rash.    Concurrent medical conditions included Dystonia (has limited use on her right arm.).   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started TRIAMCINOLONE ACETONIDE (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced ILLNESS (feeling horribly sick for 5 days), FEELING ABNORMAL (feeling lousy) and FATIGUE (extremely tired). On 07-Feb-2021, the patient experienced DIARRHOEA (severe diarrhea with no stomach cramps), MYALGIA (muscle aches) and ARTHRALGIA (joint ache). On 08-Feb-2021, the patient experienced RASH (broke out with a rash). At the time of the report, ILLNESS (feeling horribly sick for 5 days), FEELING ABNORMAL (feeling lousy), FATIGUE (extremely tired), MYALGIA (muscle aches), ARTHRALGIA (joint ache) and RASH (broke out with a rash) outcome was unknown and DIARRHOEA (severe diarrhea with no stomach cramps) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.    Treatment included 2 Imodium (reported as Immodiums) (loperamide hydrochloride) to treat severe diarrhea.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Follow-up received on 22-Jun-2021 contains No new Information- TCR is attached
Age: 74.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Myalgia, Rash
Clinical narrative: broke out with a rash; muscle aches; joint ache; severe diarrhea with no stomach cramps; extremely tired; feeling horribly sick for 5 days; feeling lousy; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (feeling horribly sick for 5 days), FEELING ABNORMAL (feeling lousy), DIARRHOEA (severe diarrhea with no stomach cramps), FATIGUE (extremely tired) and MYALGIA (muscle aches) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product TRIAMCINOLONE ACETONIDE cream for Rash.    Concurrent medical conditions included Dystonia (has limited use on her right arm.).   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started TRIAMCINOLONE ACETONIDE (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced ILLNESS (feeling horribly sick for 5 days), FEELING ABNORMAL (feeling lousy) and FATIGUE (extremely tired). On 07-Feb-2021, the patient experienced DIARRHOEA (severe diarrhea with no stomach cramps), MYALGIA (muscle aches) and ARTHRALGIA (joint ache). On 08-Feb-2021, the patient experienced RASH (broke out with a rash). At the time of the report, ILLNESS (feeling horribly sick for 5 days), FEELING ABNORMAL (feeling lousy), FATIGUE (extremely tired), MYALGIA (muscle aches), ARTHRALGIA (joint ache) and RASH (broke out with a rash) outcome was unknown and DIARRHOEA (severe diarrhea with no stomach cramps) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.    Treatment included 2 Imodium (reported as Immodiums) (loperamide hydrochloride) to treat severe diarrhea.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Follow-up received on 22-Jun-2021 contains No new Information- TCR is attached
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Swelling (Hardness) - Near Injection Site; Itchy Sensation - Near Injection Site; Redness - Near Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swelling (Hardness) - Near Injection Site), VACCINATION SITE PRURITUS (Itchy Sensation - Near Injection Site) and VACCINATION SITE ERYTHEMA (Redness - Near Injection Site) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced VACCINATION SITE SWELLING (Swelling (Hardness) - Near Injection Site), VACCINATION SITE PRURITUS (Itchy Sensation - Near Injection Site) and VACCINATION SITE ERYTHEMA (Redness - Near Injection Site). At the time of the report, VACCINATION SITE SWELLING (Swelling (Hardness) - Near Injection Site), VACCINATION SITE PRURITUS (Itchy Sensation - Near Injection Site) and VACCINATION SITE ERYTHEMA (Redness - Near Injection Site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: ADR - NNI
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: she was in so much pain; Arm was sore, not the rest of her body; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore, not the rest of her body) and PAIN (she was in so much pain) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 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 PAIN IN EXTREMITY (Arm was sore, not the rest of her body). On an unknown date, the patient experienced PAIN (she was in so much pain). On 05-Mar-2021, PAIN IN EXTREMITY (Arm was sore, not the rest of her body) had resolved. At the time of the report, PAIN (she was in so much pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.   This case was linked to MOD-2021-062625 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Aug-2021: Follow up received and it does not contain any new information.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: Fever; Felt nauseous; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and NAUSEA (Felt nauseous) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-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 PYREXIA (Fever) and NAUSEA (Felt nauseous). At the time of the report, PYREXIA (Fever) and NAUSEA (Felt nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.    Concomitant information use was not reported.  Treatment information was not provided.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate increased, Influenza like illness, Terminal insomnia, Tremor
Clinical narrative: Flu-like symptoms; Headache; shaking; Woken up at least six times due to the shaking; Pulse elevated after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms ), HEADACHE (Headache), TREMOR (shaking), TERMINAL INSOMNIA (Woken up at least six times due to the shaking) and HEART RATE INCREASED (Pulse elevated after 2nd dose) in a 57-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 08-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced HEART RATE INCREASED (Pulse elevated after 2nd dose). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms ), HEADACHE (Headache), TREMOR (shaking) and TERMINAL INSOMNIA (Woken up at least six times due to the shaking). At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms ), HEADACHE (Headache), TREMOR (shaking), TERMINAL INSOMNIA (Woken up at least six times due to the shaking) and HEART RATE INCREASED (Pulse elevated after 2nd dose) outcome was unknown. Not Provided      Concomitant information use was not reported.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Body temperature, Eye pain, Headache
Clinical narrative: stomach hurt; nasal drip; eyes hurt; arm is hot - injection site; headache; 101 fever; joint hurt; aches/Pains; huge red circle - injection site; sore arm - left arm; arm is tender - injection site; arm is hot - injection site; arm is burning - injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of ABDOMINAL PAIN UPPER (stomach hurt), RHINORRHOEA (nasal drip), EYE PAIN (eyes hurt), the first episode of VACCINATION SITE WARMTH (arm is hot - injection site) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included PARACETAMOL (TYLENOL) for Fever.   On 08-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) at an unspecified dose. On 09-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach hurt), RHINORRHOEA (nasal drip), EYE PAIN (eyes hurt), the first episode of VACCINATION SITE WARMTH (arm is hot - injection site), HEADACHE (headache), PYREXIA (101 fever), ARTHRALGIA (joint hurt), MYALGIA (aches/Pains), VACCINATION SITE ERYTHEMA (huge red circle - injection site), PAIN IN EXTREMITY (sore arm - left arm), TENDERNESS (arm is tender - injection site), the second episode of VACCINATION SITE WARMTH (arm is hot - injection site) and SKIN BURNING SENSATION (arm is burning - injection site). At the time of the report, ABDOMINAL PAIN UPPER (stomach hurt), RHINORRHOEA (nasal drip), EYE PAIN (eyes hurt), HEADACHE (headache), PYREXIA (101 fever), ARTHRALGIA (joint hurt), MYALGIA (aches/Pains), VACCINATION SITE ERYTHEMA (huge red circle - injection site), PAIN IN EXTREMITY (sore arm - left arm), TENDERNESS (arm is tender - injection site), the last episode of VACCINATION SITE WARMTH (arm is hot - injection site) and SKIN BURNING SENSATION (arm is burning - injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Mar-2021, Body temperature: 101 (High) fever.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment for the events included acetaminophen (Tylenol) and ice pack.   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: NNI
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Pyrexia, Rhinorrhoea, Skin burning sensation
Clinical narrative: stomach hurt; nasal drip; eyes hurt; arm is hot - injection site; headache; 101 fever; joint hurt; aches/Pains; huge red circle - injection site; sore arm - left arm; arm is tender - injection site; arm is hot - injection site; arm is burning - injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of ABDOMINAL PAIN UPPER (stomach hurt), RHINORRHOEA (nasal drip), EYE PAIN (eyes hurt), the first episode of VACCINATION SITE WARMTH (arm is hot - injection site) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included PARACETAMOL (TYLENOL) for Fever.   On 08-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) at an unspecified dose. On 09-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach hurt), RHINORRHOEA (nasal drip), EYE PAIN (eyes hurt), the first episode of VACCINATION SITE WARMTH (arm is hot - injection site), HEADACHE (headache), PYREXIA (101 fever), ARTHRALGIA (joint hurt), MYALGIA (aches/Pains), VACCINATION SITE ERYTHEMA (huge red circle - injection site), PAIN IN EXTREMITY (sore arm - left arm), TENDERNESS (arm is tender - injection site), the second episode of VACCINATION SITE WARMTH (arm is hot - injection site) and SKIN BURNING SENSATION (arm is burning - injection site). At the time of the report, ABDOMINAL PAIN UPPER (stomach hurt), RHINORRHOEA (nasal drip), EYE PAIN (eyes hurt), HEADACHE (headache), PYREXIA (101 fever), ARTHRALGIA (joint hurt), MYALGIA (aches/Pains), VACCINATION SITE ERYTHEMA (huge red circle - injection site), PAIN IN EXTREMITY (sore arm - left arm), TENDERNESS (arm is tender - injection site), the last episode of VACCINATION SITE WARMTH (arm is hot - injection site) and SKIN BURNING SENSATION (arm is burning - injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Mar-2021, Body temperature: 101 (High) fever.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment for the events included acetaminophen (Tylenol) and ice pack.   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: NNI
Sex: F
Vaccine: COVID19
Symptoms: Tenderness, Vaccination site erythema, Vaccination site warmth
Clinical narrative: stomach hurt; nasal drip; eyes hurt; arm is hot - injection site; headache; 101 fever; joint hurt; aches/Pains; huge red circle - injection site; sore arm - left arm; arm is tender - injection site; arm is hot - injection site; arm is burning - injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of ABDOMINAL PAIN UPPER (stomach hurt), RHINORRHOEA (nasal drip), EYE PAIN (eyes hurt), the first episode of VACCINATION SITE WARMTH (arm is hot - injection site) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included PARACETAMOL (TYLENOL) for Fever.   On 08-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) at an unspecified dose. On 09-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach hurt), RHINORRHOEA (nasal drip), EYE PAIN (eyes hurt), the first episode of VACCINATION SITE WARMTH (arm is hot - injection site), HEADACHE (headache), PYREXIA (101 fever), ARTHRALGIA (joint hurt), MYALGIA (aches/Pains), VACCINATION SITE ERYTHEMA (huge red circle - injection site), PAIN IN EXTREMITY (sore arm - left arm), TENDERNESS (arm is tender - injection site), the second episode of VACCINATION SITE WARMTH (arm is hot - injection site) and SKIN BURNING SENSATION (arm is burning - injection site). At the time of the report, ABDOMINAL PAIN UPPER (stomach hurt), RHINORRHOEA (nasal drip), EYE PAIN (eyes hurt), HEADACHE (headache), PYREXIA (101 fever), ARTHRALGIA (joint hurt), MYALGIA (aches/Pains), VACCINATION SITE ERYTHEMA (huge red circle - injection site), PAIN IN EXTREMITY (sore arm - left arm), TENDERNESS (arm is tender - injection site), the last episode of VACCINATION SITE WARMTH (arm is hot - injection site) and SKIN BURNING SENSATION (arm is burning - injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Mar-2021, Body temperature: 101 (High) fever.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment for the events included acetaminophen (Tylenol) and ice pack.   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: NNI
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site rash
Clinical narrative: Red rash on site of injection; Red rash on site of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Red rash on site of injection) and VACCINATION SITE RASH (Red rash on site of injection) in a 66-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 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red rash on site of injection) and VACCINATION SITE RASH (Red rash on site of injection). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE ERYTHEMA (Red rash on site of injection) and VACCINATION SITE RASH (Red rash on site of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant information use was not reported.  Treatment : Cold compress   Most recent FOLLOW-UP information incorporated above includes: On 15-Mar-2021: No specific follow-up information recorded.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Itchy; Hives on both of her arms; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of URTICARIA (Hives on both of her arms) and PRURITUS (Itchy) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced URTICARIA (Hives on both of her arms). On an unknown date, the patient experienced PRURITUS (Itchy). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) ongoing since an unknown date for Itchy, at an unspecified dose and frequency. At the time of the report, URTICARIA (Hives on both of her arms) and PRURITUS (Itchy) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. The patient developed hives on both of her arms somewhere around 23-Feb-2021. The physician reported that the patient has no history of prior hives. The patient responded to Benadryl (diphenhydramine hydrochloride), due to the event became itchy and looked like hives.  Treatment medications included unspecified antihistamines which the patient responded well to and diphenhydramine hydrochloride.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: My arm was a little sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (My arm was a little sore at the injection site) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced VACCINATION SITE PAIN (My arm was a little sore at the injection site). At the time of the report, VACCINATION SITE PAIN (My arm was a little sore at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant information use was not reported.  Treatment information was not provided.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Chest discomfort, Chills, Cough, Myalgia
Clinical narrative: dry cough; Fever; Chills; aching muscle; bones ached; Blurry vision; Chest is tight; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (dry cough), PYREXIA (Fever), CHILLS (Chills), MYALGIA (aching muscle) and BONE PAIN (bones ached) in a 53-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.     No Medical History information was reported.    On 06-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 07-Mar-2021, the patient experienced COUGH (dry cough), PYREXIA (Fever), CHILLS (Chills), MYALGIA (aching muscle), BONE PAIN (bones ached), VISION BLURRED (Blurry vision) and CHEST DISCOMFORT (Chest is tight). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, COUGH (dry cough), PYREXIA (Fever), CHILLS (Chills), MYALGIA (aching muscle), BONE PAIN (bones ached), VISION BLURRED (Blurry vision) and CHEST DISCOMFORT (Chest is tight) outcome was unknown. Not Provided          Concomitant information use was not reported.    Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: non-significant follow-up appended
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vision blurred
Clinical narrative: dry cough; Fever; Chills; aching muscle; bones ached; Blurry vision; Chest is tight; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (dry cough), PYREXIA (Fever), CHILLS (Chills), MYALGIA (aching muscle) and BONE PAIN (bones ached) in a 53-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.     No Medical History information was reported.    On 06-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 07-Mar-2021, the patient experienced COUGH (dry cough), PYREXIA (Fever), CHILLS (Chills), MYALGIA (aching muscle), BONE PAIN (bones ached), VISION BLURRED (Blurry vision) and CHEST DISCOMFORT (Chest is tight). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, COUGH (dry cough), PYREXIA (Fever), CHILLS (Chills), MYALGIA (aching muscle), BONE PAIN (bones ached), VISION BLURRED (Blurry vision) and CHEST DISCOMFORT (Chest is tight) outcome was unknown. Not Provided          Concomitant information use was not reported.    Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: non-significant follow-up appended
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Off label use in pregnant patient; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Off label use in pregnant patient) in a 32-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 09-Sep-2021. On 09-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Off label use in pregnant patient). On 09-Mar-2021, EXPOSURE DURING PREGNANCY (Off label use in pregnant patient) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Patient received 1st dose and got some adverse side effects, called EMS; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Patient received 1st dose and got some adverse side effects, called EMS) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced VACCINATION COMPLICATION (Patient received 1st dose and got some adverse side effects, called EMS). At the time of the report, VACCINATION COMPLICATION (Patient received 1st dose and got some adverse side effects, called EMS) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant and treatment information were not provided.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Body temperature, Headache, Illness
Clinical narrative: nausea; Terrible headache; Joint pain is unreal; Had a fever of 101; So sick she thought she was going to die; Sick as ever been; Set off her degenerative arthritis in back and neck; Threw up twice; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (So sick she thought she was going to die), MALAISE (Sick as ever been), ARTHRITIS (Set off her degenerative arthritis in back and neck), VOMITING (Threw up twice) and HEADACHE (Terrible headache) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in August 2020 and COVID-19 in December 2020. Concurrent medical conditions included Joint pain, Cholesterol, Immunodeficiency and Ulcer. Concomitant products included LEFLUNOMIDE (ARAVA) for Arthritis, ROSUVASTATIN CALCIUM (ROVASTAT) for Cholesterol, AMOXICILLIN TRIHYDRATE, CLARITHROMYCIN, ESOMEPRAZOLE MAGNESIUM (NEXIUM 1-2-3) for Upset stomach.    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 ILLNESS (So sick she thought she was going to die), MALAISE (Sick as ever been), ARTHRITIS (Set off her degenerative arthritis in back and neck), VOMITING (Threw up twice), ARTHRALGIA (Joint pain is unreal) and PYREXIA (Had a fever of 101). On 06-Mar-2021, the patient experienced HEADACHE (Terrible headache). On an unknown date, the patient experienced NAUSEA (nausea). The patient was treated with HYDROCODONE for Pain, at a dose of 6 a day and ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (VANQUISH [ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL]) for Headache, at an unspecified dose and frequency. On 06-Mar-2021, VOMITING (Threw up twice) and PYREXIA (Had a fever of 101) had resolved. At the time of the report, ILLNESS (So sick she thought she was going to die), MALAISE (Sick as ever been), ARTHRITIS (Set off her degenerative arthritis in back and neck), HEADACHE (Terrible headache) and ARTHRALGIA (Joint pain is unreal) outcome was unknown and NAUSEA (nausea) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Body temperature: 101 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient had a low immune system.  The patient also mentioned that she will not take the second dose of vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: No specific follow-up information recorded.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nausea, Pyrexia, Vomiting
Clinical narrative: nausea; Terrible headache; Joint pain is unreal; Had a fever of 101; So sick she thought she was going to die; Sick as ever been; Set off her degenerative arthritis in back and neck; Threw up twice; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (So sick she thought she was going to die), MALAISE (Sick as ever been), ARTHRITIS (Set off her degenerative arthritis in back and neck), VOMITING (Threw up twice) and HEADACHE (Terrible headache) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in August 2020 and COVID-19 in December 2020. Concurrent medical conditions included Joint pain, Cholesterol, Immunodeficiency and Ulcer. Concomitant products included LEFLUNOMIDE (ARAVA) for Arthritis, ROSUVASTATIN CALCIUM (ROVASTAT) for Cholesterol, AMOXICILLIN TRIHYDRATE, CLARITHROMYCIN, ESOMEPRAZOLE MAGNESIUM (NEXIUM 1-2-3) for Upset stomach.    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 ILLNESS (So sick she thought she was going to die), MALAISE (Sick as ever been), ARTHRITIS (Set off her degenerative arthritis in back and neck), VOMITING (Threw up twice), ARTHRALGIA (Joint pain is unreal) and PYREXIA (Had a fever of 101). On 06-Mar-2021, the patient experienced HEADACHE (Terrible headache). On an unknown date, the patient experienced NAUSEA (nausea). The patient was treated with HYDROCODONE for Pain, at a dose of 6 a day and ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (VANQUISH [ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL]) for Headache, at an unspecified dose and frequency. On 06-Mar-2021, VOMITING (Threw up twice) and PYREXIA (Had a fever of 101) had resolved. At the time of the report, ILLNESS (So sick she thought she was going to die), MALAISE (Sick as ever been), ARTHRITIS (Set off her degenerative arthritis in back and neck), HEADACHE (Terrible headache) and ARTHRALGIA (Joint pain is unreal) outcome was unknown and NAUSEA (nausea) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Body temperature: 101 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient had a low immune system.  The patient also mentioned that she will not take the second dose of vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: No specific follow-up information recorded.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: Rash near the injection site after 10 days; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash near the injection site after 10 days) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Concomitant products included LISINOPRIL, ACETYLSALICYLIC ACID (ASPRIN), PRAVASTATIN, METOPROLOL SUCCINATE (TOPROL XL) and CETIRIZINE for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced VACCINATION SITE RASH (Rash near the injection site after 10 days). At the time of the report, VACCINATION SITE RASH (Rash near the injection site after 10 days) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Vomited for several hours; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Vomited for several hours) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VOMITING (Vomited for several hours). At the time of the report, VOMITING (Vomited for several hours) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant information use was not reported.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (Shingles). The patient was treated with VALACYCLOVIR [VALACICLOVIR] for Shingles, at an unspecified dose and frequency. At the time of the report, HERPES ZOSTER (Shingles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia, Vaccination site pain
Clinical narrative: sore left upper arm (injection site); Chills; fever 103F; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore left upper arm (injection site)), CHILLS (Chills) and PYREXIA (fever 103F) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included INTERFERON BETA-1B (BETASERON), VALSARTAN and LEVOTHYROXINE for an unknown indication.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced VACCINATION SITE PAIN (sore left upper arm (injection site)), CHILLS (Chills) and PYREXIA (fever 103F). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 08-Mar-2021, CHILLS (Chills) and PYREXIA (fever 103F) had resolved. At the time of the report, VACCINATION SITE PAIN (sore left upper arm (injection site)) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Mar-2021, Body temperature: 103f (High) 103F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Inflammation, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: arm was bad red; arm was inflamed; arm was swelled; Red spot large as a softball; arm was itching; Injection site arm was tender; Arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (arm was bad red), INFLAMMATION (arm was inflamed), PERIPHERAL SWELLING (arm was swelled), RASH ERYTHEMATOUS (Red spot large as a softball) and PAIN IN EXTREMITY (Arm was sore) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm was sore) and VACCINATION SITE PAIN (Injection site arm was tender). On 19-Feb-2021, the patient experienced ERYTHEMA (arm was bad red), INFLAMMATION (arm was inflamed), PERIPHERAL SWELLING (arm was swelled), RASH ERYTHEMATOUS (Red spot large as a softball) and PRURITUS (arm was itching). At the time of the report, ERYTHEMA (arm was bad red), INFLAMMATION (arm was inflamed), PERIPHERAL SWELLING (arm was swelled), RASH ERYTHEMATOUS (Red spot large as a softball), PAIN IN EXTREMITY (Arm was sore), PRURITUS (arm was itching) and VACCINATION SITE PAIN (Injection site arm was tender) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Vaccination site pain
Clinical narrative: arm was bad red; arm was inflamed; arm was swelled; Red spot large as a softball; arm was itching; Injection site arm was tender; Arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (arm was bad red), INFLAMMATION (arm was inflamed), PERIPHERAL SWELLING (arm was swelled), RASH ERYTHEMATOUS (Red spot large as a softball) and PAIN IN EXTREMITY (Arm was sore) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm was sore) and VACCINATION SITE PAIN (Injection site arm was tender). On 19-Feb-2021, the patient experienced ERYTHEMA (arm was bad red), INFLAMMATION (arm was inflamed), PERIPHERAL SWELLING (arm was swelled), RASH ERYTHEMATOUS (Red spot large as a softball) and PRURITUS (arm was itching). At the time of the report, ERYTHEMA (arm was bad red), INFLAMMATION (arm was inflamed), PERIPHERAL SWELLING (arm was swelled), RASH ERYTHEMATOUS (Red spot large as a softball), PAIN IN EXTREMITY (Arm was sore), PRURITUS (arm was itching) and VACCINATION SITE PAIN (Injection site arm was tender) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Hypoaesthesia oral, Oral pain
Clinical narrative: Numb tongue; Tongue , cheeks and forehead are "on fire"; Sore mouth; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA ORAL (Numb tongue), BURNING SENSATION (Tongue , cheeks and forehead are "on fire") and ORAL PAIN (Sore mouth) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced HYPOAESTHESIA ORAL (Numb tongue), BURNING SENSATION (Tongue , cheeks and forehead are "on fire") and ORAL PAIN (Sore mouth). At the time of the report, HYPOAESTHESIA ORAL (Numb tongue), BURNING SENSATION (Tongue , cheeks and forehead are "on fire") and ORAL PAIN (Sore mouth) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.