chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Vaccination site pain
Clinical narrative: Did not sleep very well overnight; Achy; Headache; Nausea; Fatigue; Chills; Soreness at injection site; Flu-like symptoms; This spontaneous case was reported by an other health care professional and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms), MIDDLE INSOMNIA (Did not sleep very well overnight), PAIN (Achy), HEADACHE (Headache) and NAUSEA (Nausea) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.  The patient's past medical history included No adverse event.   On 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms), PAIN (Achy), HEADACHE (Headache), NAUSEA (Nausea), FATIGUE (Fatigue), CHILLS (Chills) and VACCINATION SITE PAIN (Soreness at injection site). On 05-Feb-2021, the patient experienced MIDDLE INSOMNIA (Did not sleep very well overnight). At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms), MIDDLE INSOMNIA (Did not sleep very well overnight), PAIN (Achy), NAUSEA (Nausea), FATIGUE (Fatigue) and CHILLS (Chills) outcome was unknown and HEADACHE (Headache) and VACCINATION SITE PAIN (Soreness at injection site) had not resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant product use was reported.  No treatment details were provided.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperaesthesia, Injection site pain, Injection site swelling, Pyrexia, Vaccination site erythema
Clinical narrative: Right arm sensitive to the touch; Injection site is hot to the touch; Fever; hard 1.5 inch diameter around the injection site; redness in right arm; Pain in right arm; Right arm swollen; slight pain on the left arm after the vaccination; This spontaneous case was reported by a consumer and describes the occurrence of HYPERAESTHESIA (Right arm sensitive to the touch), VACCINATION SITE WARMTH (Injection site is hot to the touch), PYREXIA (Fever), VACCINATION SITE INDURATION (hard 1.5 inch diameter around the injection site) and VACCINATION SITE ERYTHEMA (redness in right arm) in a 55-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 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERAESTHESIA (Right arm sensitive to the touch), VACCINATION SITE WARMTH (Injection site is hot to the touch), PYREXIA (Fever), VACCINATION SITE INDURATION (hard 1.5 inch diameter around the injection site), VACCINATION SITE ERYTHEMA (redness in right arm), VACCINATION SITE PAIN (Pain in right arm), INJECTION SITE SWELLING (Right arm swollen) and INJECTION SITE PAIN (slight pain on the left arm after the vaccination). At the time of the report, HYPERAESTHESIA (Right arm sensitive to the touch), VACCINATION SITE WARMTH (Injection site is hot to the touch), PYREXIA (Fever), VACCINATION SITE INDURATION (hard 1.5 inch diameter around the injection site), VACCINATION SITE ERYTHEMA (redness in right arm), VACCINATION SITE PAIN (Pain in right arm), INJECTION SITE SWELLING (Right arm swollen) and INJECTION SITE PAIN (slight pain on the left arm after the vaccination) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided. No treatment medication were provided.   This case was linked to MOD-2021-079539, MOD-2021-079539.   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Live follow up received on 16-Apr-2021: Event related information added. On 11-Jul-2021: Updated event outcome from unknown to recovered resolved
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site induration, Vaccination site pain, Vaccination site warmth
Clinical narrative: Right arm sensitive to the touch; Injection site is hot to the touch; Fever; hard 1.5 inch diameter around the injection site; redness in right arm; Pain in right arm; Right arm swollen; slight pain on the left arm after the vaccination; This spontaneous case was reported by a consumer and describes the occurrence of HYPERAESTHESIA (Right arm sensitive to the touch), VACCINATION SITE WARMTH (Injection site is hot to the touch), PYREXIA (Fever), VACCINATION SITE INDURATION (hard 1.5 inch diameter around the injection site) and VACCINATION SITE ERYTHEMA (redness in right arm) in a 55-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 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERAESTHESIA (Right arm sensitive to the touch), VACCINATION SITE WARMTH (Injection site is hot to the touch), PYREXIA (Fever), VACCINATION SITE INDURATION (hard 1.5 inch diameter around the injection site), VACCINATION SITE ERYTHEMA (redness in right arm), VACCINATION SITE PAIN (Pain in right arm), INJECTION SITE SWELLING (Right arm swollen) and INJECTION SITE PAIN (slight pain on the left arm after the vaccination). At the time of the report, HYPERAESTHESIA (Right arm sensitive to the touch), VACCINATION SITE WARMTH (Injection site is hot to the touch), PYREXIA (Fever), VACCINATION SITE INDURATION (hard 1.5 inch diameter around the injection site), VACCINATION SITE ERYTHEMA (redness in right arm), VACCINATION SITE PAIN (Pain in right arm), INJECTION SITE SWELLING (Right arm swollen) and INJECTION SITE PAIN (slight pain on the left arm after the vaccination) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided. No treatment medication were provided.   This case was linked to MOD-2021-079539, MOD-2021-079539.   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Live follow up received on 16-Apr-2021: Event related information added. On 11-Jul-2021: Updated event outcome from unknown to recovered resolved
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Oropharyngeal discomfort, Pharyngeal hypoaesthesia, Stomatitis, Vaccination site erythema
Clinical narrative: throat numb; throat tingly; mouth numb; mouth tingly; arm very warm to touch; arm swollen up; arm very red; This spontaneous case was reported by an other health care professional and describes the occurrence of PHARYNGEAL HYPOAESTHESIA (throat numb), OROPHARYNGEAL DISCOMFORT (throat tingly), HYPOAESTHESIA ORAL (mouth numb), STOMATITIS (mouth tingly) and VACCINATION SITE WARMTH (arm very warm to touch) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included HCTZ, OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) and ESTRADIOL (VIVELLE [ESTRADIOL]) for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced PHARYNGEAL HYPOAESTHESIA (throat numb), OROPHARYNGEAL DISCOMFORT (throat tingly), HYPOAESTHESIA ORAL (mouth numb), STOMATITIS (mouth tingly), VACCINATION SITE WARMTH (arm very warm to touch), VACCINATION SITE SWELLING (arm swollen up) and VACCINATION SITE ERYTHEMA (arm very red). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) ongoing from 20-Jan-2021 at a dose of 1 dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) from 20-Jan-2021 to 22-Jan-2021 for Numbness, at a dose of 25 mg. On 24-Jan-2021, PHARYNGEAL HYPOAESTHESIA (throat numb), OROPHARYNGEAL DISCOMFORT (throat tingly), HYPOAESTHESIA ORAL (mouth numb), STOMATITIS (mouth tingly), VACCINATION SITE WARMTH (arm very warm to touch), VACCINATION SITE SWELLING (arm swollen up) and VACCINATION SITE ERYTHEMA (arm very red) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 20 Jan 2021, the patient reported her arm started to swell and she has numbness and tingling in her mouth, neck and throat.  On 24 Jan 2021 she recovered from the events of  swelling, numbness and tingling in her mouth, neck and throat .   This case was linked to MOD-2021-237552.   Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: Follow-up information received on 25 JUN 2021, updated patient demography and concomitant medications.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: throat numb; throat tingly; mouth numb; mouth tingly; arm very warm to touch; arm swollen up; arm very red; This spontaneous case was reported by an other health care professional and describes the occurrence of PHARYNGEAL HYPOAESTHESIA (throat numb), OROPHARYNGEAL DISCOMFORT (throat tingly), HYPOAESTHESIA ORAL (mouth numb), STOMATITIS (mouth tingly) and VACCINATION SITE WARMTH (arm very warm to touch) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included HCTZ, OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) and ESTRADIOL (VIVELLE [ESTRADIOL]) for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced PHARYNGEAL HYPOAESTHESIA (throat numb), OROPHARYNGEAL DISCOMFORT (throat tingly), HYPOAESTHESIA ORAL (mouth numb), STOMATITIS (mouth tingly), VACCINATION SITE WARMTH (arm very warm to touch), VACCINATION SITE SWELLING (arm swollen up) and VACCINATION SITE ERYTHEMA (arm very red). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) ongoing from 20-Jan-2021 at a dose of 1 dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) from 20-Jan-2021 to 22-Jan-2021 for Numbness, at a dose of 25 mg. On 24-Jan-2021, PHARYNGEAL HYPOAESTHESIA (throat numb), OROPHARYNGEAL DISCOMFORT (throat tingly), HYPOAESTHESIA ORAL (mouth numb), STOMATITIS (mouth tingly), VACCINATION SITE WARMTH (arm very warm to touch), VACCINATION SITE SWELLING (arm swollen up) and VACCINATION SITE ERYTHEMA (arm very red) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 20 Jan 2021, the patient reported her arm started to swell and she has numbness and tingling in her mouth, neck and throat.  On 24 Jan 2021 she recovered from the events of  swelling, numbness and tingling in her mouth, neck and throat .   This case was linked to MOD-2021-237552.   Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: Follow-up information received on 25 JUN 2021, updated patient demography and concomitant medications.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue, Headache, Vaccination site pain
Clinical narrative: weakness; lightheadness/dizziness; Headache; fatigue; pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), DIZZINESS (lightheadness/dizziness), HEADACHE (Headache), FATIGUE (fatigue) and VACCINATION SITE PAIN (pain in arm) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included TIA (It was a slight blood clot that disappeared after 30 minutes and he was released from the hospital after two days of observation.) on 06-Dec-2020 and Clot blood. Concurrent medical conditions included Migraine headache, Blood pressure and Cholesterol. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) for Cholesterol, METOPROLOL for Hypertension, RIVAROXABAN (XARELTO) and CLOPIDOGREL BISULFATE (PLAVIX) for Thrombus.   On 22-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (weakness), DIZZINESS (lightheadness/dizziness), HEADACHE (Headache), FATIGUE (fatigue) and VACCINATION SITE PAIN (pain in arm). At the time of the report, ASTHENIA (weakness), DIZZINESS (lightheadness/dizziness), HEADACHE (Headache), FATIGUE (fatigue) and VACCINATION SITE PAIN (pain in arm) had resolved.            Treatment information were not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: TCR form includes Outcome of the events as resolved.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Carpal tunnel syndrome, Injection site pain
Clinical narrative: Wrist became inflammed and in pain, dr said flare of carpal tunnel now in both wrists, but worse on left arm; Joint pain in arm and shoulder-left side; Injection site soreness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CARPAL TUNNEL SYNDROME (Wrist became inflammed and in pain, dr said flare of carpal tunnel now in both wrists, but worse on left arm), INJECTION SITE PAIN (Injection site soreness) and ARTHRALGIA (joint pain in arm and shoulder-left side) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced INJECTION SITE PAIN (Injection site soreness). On an unknown date, the patient experienced CARPAL TUNNEL SYNDROME (Wrist became inflammed and in pain, dr said flare of carpal tunnel now in both wrists, but worse on left arm) and ARTHRALGIA (joint pain in arm and shoulder-left side). At the time of the report, CARPAL TUNNEL SYNDROME (Wrist became inflammed and in pain, dr said flare of carpal tunnel now in both wrists, but worse on left arm), INJECTION SITE PAIN (Injection site soreness) and ARTHRALGIA (joint pain in arm and shoulder-left side) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used included blood thinner. The week following vaccination, the patient wrists became inflamed and in pain. Their doctor said it was flare up of carpal tunnel, which is now in both wrists, but worse in the left arm. Treatment for the events included ice. No prescription medications were provided. The patient has recovered with no problems.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Follow-up information was received and processed the same time as initial report. Follow-up information from the patient indicated they recovered.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling, Pyrexia, Vaccination site pain
Clinical narrative: Swelling in arm; Redness; Fever; Injection site is hurting really bad; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling in arm), ERYTHEMA (Redness), PYREXIA (Fever) and VACCINATION SITE PAIN (Injection site is hurting really bad) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012m20a) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ALPRAZOLAM (XANAX) and ENOXAPARIN SODIUM (CLEXANE) for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE PAIN (Injection site is hurting really bad). On an unknown date, the patient experienced PERIPHERAL SWELLING (Swelling in arm), ERYTHEMA (Redness) and PYREXIA (Fever). At the time of the report, PERIPHERAL SWELLING (Swelling in arm), ERYTHEMA (Redness), PYREXIA (Fever) and VACCINATION SITE PAIN (Injection site is hurting really bad) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       The patient post receiving their first dose of vaccine stated their left arm at injection site was hurting really bad.  On 20-Apr-2021, the patient reported that they experienced swelling in arm, redness and fever post receiving the first dose of vaccine.  Reportedly, the patient took the second dose on 04-Mar-2021. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Follow-up was received on 20-Apr-2021 and added additional events experienced after first dose. Updated the Action taken. Included second dose date in I-narrative supplement.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Feeling chills all day; This spontaneous case was reported by an other and describes the occurrence of CHILLS (Feeling chills all day) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 30-Jan-2021, the patient experienced CHILLS (Feeling chills all day). At the time of the report, CHILLS (Feeling chills all day) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash
Clinical narrative: Itchy at the point of injection; Slight rash at the point of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchy at the point of injection) and VACCINATION SITE RASH (Slight rash at the point of injection) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 206L20A) for COVID-19 vaccination.     No medical history was provided by reporter.  No concomitant medication reported.     On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy at the point of injection) and VACCINATION SITE RASH (Slight rash at the point of injection). On 27-Jan-2021, VACCINATION SITE RASH (Slight rash at the point of injection) had resolved. At the time of the report, VACCINATION SITE PRURITUS (Itchy at the point of injection) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product use was reported. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Additional information added on 24JUN2021 contains non significant information. Patient had concerns about the form and how to provide more information if needed.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: 2 raised bumps on her arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (2 raised bumps on her arm at the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced VACCINATION SITE SWELLING (2 raised bumps on her arm at the injection site). At the time of the report, VACCINATION SITE SWELLING (2 raised bumps on her arm at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.      No relevant concomitant medications were reported.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: Reaction to the shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Reaction to the shot) 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 (Reaction to the shot). At the time of the report, VACCINATION SITE REACTION (Reaction to the shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Treatment information was not provided.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chills, Hypotension, Lymphadenopathy, Pyrexia
Clinical narrative: Low blood pressure; Swelling on lymph nodes; Fever; Sore arm; Chills; Fast heart beating; This spontaneous case was reported by a consumer and describes the occurrence of HYPOTENSION (Low blood pressure), LYMPHADENOPATHY (Swelling on lymph nodes), PYREXIA (Fever), VACCINATION SITE PAIN (Sore arm) and CHILLS (Chills) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced HYPOTENSION (Low blood pressure), LYMPHADENOPATHY (Swelling on lymph nodes), PYREXIA (Fever), VACCINATION SITE PAIN (Sore arm), CHILLS (Chills) and TACHYCARDIA (Fast heart beating). At the time of the report, HYPOTENSION (Low blood pressure), LYMPHADENOPATHY (Swelling on lymph nodes), PYREXIA (Fever), VACCINATION SITE PAIN (Sore arm), CHILLS (Chills) and TACHYCARDIA (Fast heart beating) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2019, COVID-19: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment medications were provided.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Tachycardia, Vaccination site pain
Clinical narrative: Low blood pressure; Swelling on lymph nodes; Fever; Sore arm; Chills; Fast heart beating; This spontaneous case was reported by a consumer and describes the occurrence of HYPOTENSION (Low blood pressure), LYMPHADENOPATHY (Swelling on lymph nodes), PYREXIA (Fever), VACCINATION SITE PAIN (Sore arm) and CHILLS (Chills) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced HYPOTENSION (Low blood pressure), LYMPHADENOPATHY (Swelling on lymph nodes), PYREXIA (Fever), VACCINATION SITE PAIN (Sore arm), CHILLS (Chills) and TACHYCARDIA (Fast heart beating). At the time of the report, HYPOTENSION (Low blood pressure), LYMPHADENOPATHY (Swelling on lymph nodes), PYREXIA (Fever), VACCINATION SITE PAIN (Sore arm), CHILLS (Chills) and TACHYCARDIA (Fast heart beating) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2019, COVID-19: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment medications were provided.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Lymphadenopathy, Tenderness
Clinical narrative: On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced TENDERNESS (Tenderness), CHILLS (Chills) and LYMPHADENOPATHY (Lymph nodes swelling under the right arm). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] 25-Jan-2021 for Adverse event, at a dose of 500 milligram once a day. At the time of the report, TENDERNESS (Tenderness) and CHILLS (Chills) outcome was unknown and LYMPHADENOPATHY (Lymph nodes swelling under the right arm) 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.   No concomitant medications were provided.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Back pain, Chills, Dizziness, Headache
Clinical narrative: I got COVID symptoms; Back Ache; Dizzy; Stomach Ache; sore arm; muscle aches; chills; head ache for 2 days; This spontaneous case was reported by a consumer and describes the occurrence of SUSPECTED COVID-19 (I got COVID symptoms), BACK PAIN (Back Ache), DIZZINESS (Dizzy), ABDOMINAL PAIN UPPER (Stomach Ache) and PAIN IN EXTREMITY (sore arm) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Jan-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced SUSPECTED COVID-19 (I got COVID symptoms), BACK PAIN (Back Ache), DIZZINESS (Dizzy), ABDOMINAL PAIN UPPER (Stomach Ache), PAIN IN EXTREMITY (sore arm), MYALGIA (muscle aches), CHILLS (chills) and HEADACHE (head ache for 2 days). On 28-Jan-2021, SUSPECTED COVID-19 (I got COVID symptoms), BACK PAIN (Back Ache), DIZZINESS (Dizzy), ABDOMINAL PAIN UPPER (Stomach Ache), PAIN IN EXTREMITY (sore arm), MYALGIA (muscle aches), CHILLS (chills) and HEADACHE (head ache for 2 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment medications were provided
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Suspected COVID-19
Clinical narrative: I got COVID symptoms; Back Ache; Dizzy; Stomach Ache; sore arm; muscle aches; chills; head ache for 2 days; This spontaneous case was reported by a consumer and describes the occurrence of SUSPECTED COVID-19 (I got COVID symptoms), BACK PAIN (Back Ache), DIZZINESS (Dizzy), ABDOMINAL PAIN UPPER (Stomach Ache) and PAIN IN EXTREMITY (sore arm) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Jan-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced SUSPECTED COVID-19 (I got COVID symptoms), BACK PAIN (Back Ache), DIZZINESS (Dizzy), ABDOMINAL PAIN UPPER (Stomach Ache), PAIN IN EXTREMITY (sore arm), MYALGIA (muscle aches), CHILLS (chills) and HEADACHE (head ache for 2 days). On 28-Jan-2021, SUSPECTED COVID-19 (I got COVID symptoms), BACK PAIN (Back Ache), DIZZINESS (Dizzy), ABDOMINAL PAIN UPPER (Stomach Ache), PAIN IN EXTREMITY (sore arm), MYALGIA (muscle aches), CHILLS (chills) and HEADACHE (head ache for 2 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment medications were provided
Sex: F
Vaccine: COVID19
Symptoms: Skin reaction
Clinical narrative: skin reaction; This spontaneous case was reported by a consumer and describes the occurrence of SKIN REACTION (skin reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history provided).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On an unknown date, the patient experienced SKIN REACTION (skin reaction). At the time of the report, SKIN REACTION (skin reaction) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information was provided
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Fatigue, Feeling cold
Clinical narrative: really tired; stomach issue; really bad cramps; diarrhea; alot of body ache; low grade fever; chills; Freezing; hardly work; cold; This spontaneous case was reported by a consumer and describes the occurrence of FREEZING PHENOMENON (Freezing), GAIT DISTURBANCE (hardly work), FEELING COLD (cold), ABDOMINAL PAIN UPPER (stomach issue) and MUSCLE SPASMS (really bad cramps) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for an unknown indication. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product MELATONIN for an unknown indication.    Concomitant products included ENALAPRILAT (VASOTEC [ENALAPRILAT]), HYDROCHLOROTHIAZIDE, FAMOTIDINE, APIXABAN (ELIQUIS) and METOPROLOL for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started MELATONIN (unknown route) at an unspecified dose. On 26-Jan-2021, the patient experienced FREEZING PHENOMENON (Freezing), GAIT DISTURBANCE (hardly work), FEELING COLD (cold), MYALGIA (alot of body ache), PYREXIA (low grade fever) and CHILLS (chills). On 31-Jan-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach issue), MUSCLE SPASMS (really bad cramps) and DIARRHOEA (diarrhea). On an unknown date, the patient experienced FATIGUE (really tired). At the time of the report, FREEZING PHENOMENON (Freezing), GAIT DISTURBANCE (hardly work), FEELING COLD (cold), ABDOMINAL PAIN UPPER (stomach issue), MUSCLE SPASMS (really bad cramps), DIARRHOEA (diarrhea), MYALGIA (alot of body ache), PYREXIA (low grade fever), CHILLS (chills) and FATIGUE (really tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitant medications include Vitamin C and Vitamin D. Treatment medications were not provided.
Sex: F
Vaccine: COVID19
Symptoms: Freezing phenomenon, Gait disturbance, Muscle spasms, Myalgia, Pyrexia
Clinical narrative: really tired; stomach issue; really bad cramps; diarrhea; alot of body ache; low grade fever; chills; Freezing; hardly work; cold; This spontaneous case was reported by a consumer and describes the occurrence of FREEZING PHENOMENON (Freezing), GAIT DISTURBANCE (hardly work), FEELING COLD (cold), ABDOMINAL PAIN UPPER (stomach issue) and MUSCLE SPASMS (really bad cramps) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for an unknown indication. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product MELATONIN for an unknown indication.    Concomitant products included ENALAPRILAT (VASOTEC [ENALAPRILAT]), HYDROCHLOROTHIAZIDE, FAMOTIDINE, APIXABAN (ELIQUIS) and METOPROLOL for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started MELATONIN (unknown route) at an unspecified dose. On 26-Jan-2021, the patient experienced FREEZING PHENOMENON (Freezing), GAIT DISTURBANCE (hardly work), FEELING COLD (cold), MYALGIA (alot of body ache), PYREXIA (low grade fever) and CHILLS (chills). On 31-Jan-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach issue), MUSCLE SPASMS (really bad cramps) and DIARRHOEA (diarrhea). On an unknown date, the patient experienced FATIGUE (really tired). At the time of the report, FREEZING PHENOMENON (Freezing), GAIT DISTURBANCE (hardly work), FEELING COLD (cold), ABDOMINAL PAIN UPPER (stomach issue), MUSCLE SPASMS (really bad cramps), DIARRHOEA (diarrhea), MYALGIA (alot of body ache), PYREXIA (low grade fever), CHILLS (chills) and FATIGUE (really tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitant medications include Vitamin C and Vitamin D. Treatment medications were not provided.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Vaccination site swelling
Clinical narrative: swelling of a lymph node in my armpit; hard swollen area about 2 inches below the injection site.; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (swelling of a lymph node in my armpit) and VACCINATION SITE SWELLING (hard swollen area about 2 inches below the injection site.) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     Concomitant products included PARACETAMOL (TYLENOL) and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced LYMPHADENOPATHY (swelling of a lymph node in my armpit) and VACCINATION SITE SWELLING (hard swollen area about 2 inches below the injection site.). At the time of the report, LYMPHADENOPATHY (swelling of a lymph node in my armpit) and VACCINATION SITE SWELLING (hard swollen area about 2 inches below the injection site.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were not provided.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID-19; A Spontaneous report was received from a consumer concerning an unknown-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced covid-19.  The patient's medical history, was not provided .The Concomitant medications were not  reported .  On an unknown day , prior to the onset of the events, the patient received their first dose of two planned doses of mRNA-1273 (Lot number: Batch number not provided) intramuscularly  in an unknown location for prophylaxis of COVID-19 infection.  On an unknown day, patient developed covid-19 positive. No further information was reported.  The treatment information was not  reported.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event covid-19 was considered as unknown.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: injection site pain and sore arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (injection site pain and sore arm) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037620A and 011J20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   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) (unknown route) dosage was changed to 1 dosage form. On 05-Jan-2021, the patient experienced INJECTION SITE PAIN (injection site pain and sore arm). At the time of the report, INJECTION SITE PAIN (injection site pain and sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD21-021617 (E2B Linked Report).; Sender's Comments:  MOD21-021617:Crosslink
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Cold chill; This spontaneous case was reported by a patient and describes the occurrence of CHILLS (Cold chill) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 6039K209) for COVID-19 vaccination.     The patient's past medical history included Bronchitis. Concurrent medical conditions included Allergy (Allergic to grass and mold.).    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced CHILLS (Cold chill). At the time of the report, CHILLS (Cold chill) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Pyrexia, Rash erythematous, Vaccination site warmth
Clinical narrative: Red Rash Near the Injection Site; Hot Rash Near the Injection Site; Fever; Nausea; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Red Rash Near the Injection Site), VACCINATION SITE WARMTH (Hot Rash Near the Injection Site), PYREXIA (Fever), NAUSEA (Nausea) and FATIGUE (Fatigue) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced PYREXIA (Fever), NAUSEA (Nausea) and FATIGUE (Fatigue). On 24-Jan-2021, the patient experienced RASH ERYTHEMATOUS (Red Rash Near the Injection Site) and VACCINATION SITE WARMTH (Hot Rash Near the Injection Site). On 23-Jan-2021, PYREXIA (Fever), NAUSEA (Nausea) and FATIGUE (Fatigue) had resolved. On 28-Jan-2021, RASH ERYTHEMATOUS (Red Rash Near the Injection Site) and VACCINATION SITE WARMTH (Hot Rash Near the Injection Site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products use was not provided by the reporter.  Patient reported taking Antihistamines, to try and help alleviate the symptoms.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: severe itching at the site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (severe itching at the site) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (severe itching at the site). At the time of the report, VACCINATION SITE PRURITUS (severe itching at the site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment medications were reported.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Mobility decreased, Pain in extremity, Peripheral swelling, Vaccination site erythema
Clinical narrative: even when try to lay down the arm ,i can not because of the pain, jumpmed on mysleep because I leaned on it; arm is pinkish,; her left arm very swollen; can not move left arm; it is so sore/ it hurts only when moving the arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (her left arm very swollen), MOBILITY DECREASED (can not move left arm), PAIN IN EXTREMITY (it is so sore/ it hurts only when moving the arm), LIMB DISCOMFORT (even when try to lay down the arm ,i can not because of the pain, jumpmed on mysleep because I leaned on it) and VACCINATION SITE ERYTHEMA (arm is pinkish,) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     The patient's past medical history included Cancer (had cancer some years ago, and her doctor told her, not to have vaccines in that arm.).    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced PERIPHERAL SWELLING (her left arm very swollen), MOBILITY DECREASED (can not move left arm), PAIN IN EXTREMITY (it is so sore/ it hurts only when moving the arm) and VACCINATION SITE ERYTHEMA (arm is pinkish,). On 05-Feb-2021, the patient experienced LIMB DISCOMFORT (even when try to lay down the arm ,i can not because of the pain, jumpmed on mysleep because I leaned on it). The patient was treated with PARACETAMOL (TYLENOL) on 04-Feb-2021 for Adverse event following immunisation, at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (her left arm very swollen), MOBILITY DECREASED (can not move left arm), PAIN IN EXTREMITY (it is so sore/ it hurts only when moving the arm), LIMB DISCOMFORT (even when try to lay down the arm ,i can not because of the pain, jumpmed on mysleep because I leaned on it) and VACCINATION SITE ERYTHEMA (arm is pinkish,) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications taken regularly included sleeping pill at night, iron pill and infusions every 3 weeks for the anemia   Reporter did not allow further contact
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Eating disorder, Headache, Nausea, Pain
Clinical narrative: Tingly on her face; Could not eat.; Every part of her body hurt; Chills; Headache; Nauseous; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Feb-2021 and was forwarded to Moderna on 05-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingly on her face), EATING DISORDER (Could not eat.), PAIN (Every part of her body hurt), CHILLS (Chills) and HEADACHE (Headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced PARAESTHESIA (Tingly on her face), EATING DISORDER (Could not eat.), PAIN (Every part of her body hurt), CHILLS (Chills), HEADACHE (Headache) and NAUSEA (Nauseous). On 03-Feb-2021, PARAESTHESIA (Tingly on her face) had resolved. On 05-Feb-2021, EATING DISORDER (Could not eat.), PAIN (Every part of her body hurt), CHILLS (Chills) and NAUSEA (Nauseous) had resolved. At the time of the report, HEADACHE (Headache) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  Treatment details included Tylenol and  Motrin.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Tingly on her face; Could not eat.; Every part of her body hurt; Chills; Headache; Nauseous; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Feb-2021 and was forwarded to Moderna on 05-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingly on her face), EATING DISORDER (Could not eat.), PAIN (Every part of her body hurt), CHILLS (Chills) and HEADACHE (Headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced PARAESTHESIA (Tingly on her face), EATING DISORDER (Could not eat.), PAIN (Every part of her body hurt), CHILLS (Chills), HEADACHE (Headache) and NAUSEA (Nauseous). On 03-Feb-2021, PARAESTHESIA (Tingly on her face) had resolved. On 05-Feb-2021, EATING DISORDER (Could not eat.), PAIN (Every part of her body hurt), CHILLS (Chills) and NAUSEA (Nauseous) had resolved. At the time of the report, HEADACHE (Headache) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  Treatment details included Tylenol and  Motrin.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Skin irritation
Clinical narrative: hot skin all over body; prickly skin all over body; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FEELING HOT (hot skin all over body) and SKIN IRRITATION (prickly skin all over body) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Allergic reaction (I usually get this allergic reaction to medications/vaccination and get prednisone. I can't take prednisone with this.) since an unknown date. Concurrent medical conditions included Allergy NOS (I have lots of allergies).    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING HOT (hot skin all over body) and SKIN IRRITATION (prickly skin all over body). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event following immunisation, at an unspecified dose and frequency. At the time of the report, FEELING HOT (hot skin all over body) and SKIN IRRITATION (prickly skin all over body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were given    Reporter did not allow further contact