chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity, Vaccination site erythema, Vaccination site irritation, Vaccination site pruritus
Clinical narrative: When I scratch the itch, the pain and soreness is back; Irritation in the injection arm; Itching at injection site; Redness at injection arm; Soreness at injection shoulder; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (When I scratch the itch, the pain and soreness is back), VACCINATION SITE IRRITATION (Irritation in the injection arm), ARTHRALGIA (Soreness at injection shoulder), VACCINATION SITE PRURITUS (Itching at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection arm) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No medical reported history provided by the reporter.  Concomitant products included VITAMINS NOS for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced ARTHRALGIA (Soreness at injection shoulder). On 18-Mar-2021, the patient experienced PAIN IN EXTREMITY (When I scratch the itch, the pain and soreness is back), VACCINATION SITE IRRITATION (Irritation in the injection arm), VACCINATION SITE PRURITUS (Itching at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection arm). On 13-Mar-2021, ARTHRALGIA (Soreness at injection shoulder) had resolved. At the time of the report, PAIN IN EXTREMITY (When I scratch the itch, the pain and soreness is back), VACCINATION SITE IRRITATION (Irritation in the injection arm), VACCINATION SITE PRURITUS (Itching at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection arm) outcome was unknown.        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.   treatment to the events not provided.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Pyrexia, Vaccination site nodule
Clinical narrative: Back Ache; Nodule on Injection Site (Egg Size); Chills; fever; This spontaneous case was reported by a nurse and describes the occurrence of BACK PAIN (Back Ache), VACCINATION SITE NODULE (Nodule on Injection Site (Egg Size)), CHILLS (Chills) and PYREXIA (fever) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced BACK PAIN (Back Ache), VACCINATION SITE NODULE (Nodule on Injection Site (Egg Size)), CHILLS (Chills) and PYREXIA (fever). In February 2021, BACK PAIN (Back Ache), VACCINATION SITE NODULE (Nodule on Injection Site (Egg Size)), CHILLS (Chills) and PYREXIA (fever) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   ? No treatment information was provided. ?The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Illness, Pyrexia
Clinical narrative: sick; couldn't go to work; fever and chills; fever and chills; This spontaneous case was reported by an other health care professional and describes the occurrence of ASTHENIA (couldn't go to work), ILLNESS (sick), CHILLS (fever and chills) and PYREXIA (fever and chills) 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 COVID-19 in March 2020. Concurrent medical conditions included Hot flashes and Asthma.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced CHILLS (fever and chills) and PYREXIA (fever and chills). On 05-Mar-2021, the patient experienced ASTHENIA (couldn't go to work). On 07-Mar-2021, the patient experienced ILLNESS (sick). On 08-Mar-2021, ASTHENIA (couldn't go to work), ILLNESS (sick), CHILLS (fever and chills) and PYREXIA (fever and chills) 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.   Concomitant medications include medication for hot flashes. Treatment details included Anti-nausea medication.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Cough, Headache, Pain
Clinical narrative: tinge of a headache; aching all over body; fever of 101.1; cough; weakness; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (tinge of a headache), PAIN (aching all over body), PYREXIA (fever of 101.1), COUGH (cough) and ASTHENIA (weakness) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 11M20A) 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) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEADACHE (tinge of a headache), PAIN (aching all over body), PYREXIA (fever of 101.1), COUGH (cough) and ASTHENIA (weakness). At the time of the report, HEADACHE (tinge of a headache), PAIN (aching all over body), PYREXIA (fever of 101.1), COUGH (cough) and ASTHENIA (weakness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.1 (High) 101.1.         Concomitant product use was not provided by the reporter. Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not Applicable.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: tinge of a headache; aching all over body; fever of 101.1; cough; weakness; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (tinge of a headache), PAIN (aching all over body), PYREXIA (fever of 101.1), COUGH (cough) and ASTHENIA (weakness) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 11M20A) 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) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEADACHE (tinge of a headache), PAIN (aching all over body), PYREXIA (fever of 101.1), COUGH (cough) and ASTHENIA (weakness). At the time of the report, HEADACHE (tinge of a headache), PAIN (aching all over body), PYREXIA (fever of 101.1), COUGH (cough) and ASTHENIA (weakness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.1 (High) 101.1.         Concomitant product use was not provided by the reporter. Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not Applicable.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Bone swelling, Feeling abnormal, Lymphadenopathy, Malaise, Tenderness
Clinical narrative: Not feeling well, general malaise; Swelling on right Scapula; Uncomfortable feeling on right groin, felt blah; Left side clavicle area has large swollen glands; Left side glands are tender to touch; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Not feeling well, general malaise), TENDERNESS (Left side glands are tender to touch), BONE SWELLING (Swelling on right Scapula), FEELING ABNORMAL (Uncomfortable feeling on right groin, felt blah) and LYMPHADENOPATHY (Left side clavicle area has large swollen glands) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to metals (Allergic to nickel). Concomitant products included MISOPROSTOL, OMEPRAZOLE, VALPROATE SEMISODIUM (DEPAKOTE), MELATONIN, DIPHENHYDRAMINE and SUMATRIPTAN SUCCINATE (IMITREX DF) for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced TENDERNESS (Left side glands are tender to touch) and LYMPHADENOPATHY (Left side clavicle area has large swollen glands). On 17-Mar-2021, the patient experienced MALAISE (Not feeling well, general malaise), BONE SWELLING (Swelling on right Scapula) and FEELING ABNORMAL (Uncomfortable feeling on right groin, felt blah). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MALAISE (Not feeling well, general malaise), TENDERNESS (Left side glands are tender to touch), BONE SWELLING (Swelling on right Scapula), FEELING ABNORMAL (Uncomfortable feeling on right groin, felt blah) and LYMPHADENOPATHY (Left side clavicle area has large swollen glands) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Headache, Pyrexia
Clinical narrative: weakness; fever/chills; fever; headaches; fatigue, tiredness; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), CHILLS (fever/chills), PYREXIA (fever), HEADACHE (headaches) and FATIGUE (fatigue, tiredness) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M02A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (last year). Concurrent medical conditions included Hypercholesteremia and Hypertension.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced ASTHENIA (weakness), CHILLS (fever/chills), PYREXIA (fever), HEADACHE (headaches) and FATIGUE (fatigue, tiredness). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ASTHENIA (weakness), CHILLS (fever/chills), PYREXIA (fever), HEADACHE (headaches) and FATIGUE (fatigue, tiredness) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) POSITIVE.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   patient says that she feels like "she got Covid-19." Reports history of Covid-19 last year. She wants to know how long are these symptoms going to last.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: weakness; fever/chills; fever; headaches; fatigue, tiredness; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), CHILLS (fever/chills), PYREXIA (fever), HEADACHE (headaches) and FATIGUE (fatigue, tiredness) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M02A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (last year). Concurrent medical conditions included Hypercholesteremia and Hypertension.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced ASTHENIA (weakness), CHILLS (fever/chills), PYREXIA (fever), HEADACHE (headaches) and FATIGUE (fatigue, tiredness). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ASTHENIA (weakness), CHILLS (fever/chills), PYREXIA (fever), HEADACHE (headaches) and FATIGUE (fatigue, tiredness) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) POSITIVE.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   patient says that she feels like "she got Covid-19." Reports history of Covid-19 last year. She wants to know how long are these symptoms going to last.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Myalgia, Pyrexia, SARS-CoV-2 test
Clinical narrative: Dizzy spells; Cold chills; Muscle aches; Fever; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy spells), CHILLS (Cold chills), MYALGIA (Muscle aches) and PYREXIA (Fever) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 026B21A) for COVID-19 vaccination.     The patient's past medical history included Muscle ache (muscle ache due to past accident).   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced DIZZINESS (Dizzy spells), CHILLS (Cold chills), MYALGIA (Muscle aches) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency; GUAIFENESIN (MUCINEX) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. On 08-Mar-2021, CHILLS (Cold chills), MYALGIA (Muscle aches) and PYREXIA (Fever) had resolved. On 15-Mar-2021, DIZZINESS (Dizzy spells) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Mar-2021, SARS-CoV-2 test: negative (Negative) tested negative for covid-19.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications provided ice pack was used for treatment.   This case was linked to MOD-2021-116387.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Added demographic details(DOB), Added event(pyrexia), treatment drug and updated event stop date
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia, Tremor
Clinical narrative: Shaking; Chills; Temperature spike to 103.7 fever; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shaking), CHILLS (Chills) and PYREXIA (Temperature spike to 103.7 fever) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TREMOR (Shaking), CHILLS (Chills) and PYREXIA (Temperature spike to 103.7 fever). The patient was treated with PARACETAMOL ( acetaminophen) (TYLENOL) at an unspecified dose and frequency. At the time of the report, TREMOR (Shaking), CHILLS (Chills) and PYREXIA (Temperature spike to 103.7 fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103.7 (High) 103.7.         No concomitant medication were provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Telephone contact report received on 28-JUL-2021 in which lab data added. Events outcome were updated.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, COVID-19, Headache, Hypersomnia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach cramping), ASTHENIA (feels very weak), HYPERSOMNIA (sleeping all day), COVID-19 (feels like covid again) and PYREXIA (Fever for two days) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (She got Covid in Dec) in December 2019.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced PYREXIA (Fever for two days). On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (stomach cramping), ASTHENIA (feels very weak), HYPERSOMNIA (sleeping all day), COVID-19 (feels like covid again) and HEADACHE (really bad headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ABDOMINAL PAIN UPPER (stomach cramping), ASTHENIA (feels very weak), HYPERSOMNIA (sleeping all day), COVID-19 (feels like covid again), PYREXIA (Fever for two days) and HEADACHE (really bad headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medications are provided. second dose is scheduled on 14Apr2021.  patient feels like she has COVID again which she had in December and called out of work both days.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach cramping), ASTHENIA (feels very weak), HYPERSOMNIA (sleeping all day), COVID-19 (feels like covid again) and PYREXIA (Fever for two days) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (She got Covid in Dec) in December 2019.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced PYREXIA (Fever for two days). On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (stomach cramping), ASTHENIA (feels very weak), HYPERSOMNIA (sleeping all day), COVID-19 (feels like covid again) and HEADACHE (really bad headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ABDOMINAL PAIN UPPER (stomach cramping), ASTHENIA (feels very weak), HYPERSOMNIA (sleeping all day), COVID-19 (feels like covid again), PYREXIA (Fever for two days) and HEADACHE (really bad headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medications are provided. second dose is scheduled on 14Apr2021.  patient feels like she has COVID again which she had in December and called out of work both days.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was sore), VACCINATION SITE WARMTH (hot), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE SWELLING (puffy) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027421A) for COVID-19 vaccination. Concomitant products included DESVENLAFAXINE SUCCINATE (PRISTIQ), STRESS B COMPLEX [AMINOBENZOIC ACID;ASCORBIC ACID; BIOTIN; CALCIUM PANTOTHENATE; CHOLINE BITARTRATE; CYANOCOBALAMIN; FOLIC ACID; INOSITOL; NICOTINIC ACID; PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;ROSA CANINA;THIAMINE MONONITRATE], CLONAZEPAM and APOAEQUORIN (PREVAGEN [APOAEQUORIN]) for an unknown indication. On 09-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm was sore). On 18-Mar-2021, the patient experienced VACCINATION SITE WARMTH (hot), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE SWELLING (puffy). At the time of the report, PAIN IN EXTREMITY (arm was sore), VACCINATION SITE WARMTH (hot), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE SWELLING (puffy) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Event outcome and treatment details were not reported.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pyrexia
Clinical narrative: Dizziness; Fever; This spontaneous case was reported by a nurse and describes the occurrence of DIZZINESS (Dizziness) and PYREXIA (Fever) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037k20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced DIZZINESS (Dizziness) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 13-Feb-2021, DIZZINESS (Dizziness) and PYREXIA (Fever) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  second dose was given to the deltoid muscle (unknown arm)
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: patient who received 0.13 mL, 1/4 of a dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (patient who received 0.13 mL, 1/4 of a dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .13 ml. On an unknown date, the patient experienced INCORRECT DOSE ADMINISTERED (patient who received 0.13 mL, 1/4 of a dose). At the time of the report, INCORRECT DOSE ADMINISTERED (patient who received 0.13 mL, 1/4 of a dose) had resolved. Not Provided      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 medication reported.  Treatment information not provided.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: COVID arm; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE REACTION (COVID arm) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (COVID arm). At the time of the report, VACCINATION SITE REACTION (COVID arm) 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 medication was reported Treatment information was not provided.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Injection site redness; Injection site swelling; Injection site soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Injection site redness), VACCINATION SITE SWELLING (Injection site swelling) and VACCINATION SITE PAIN (Injection site soreness) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 0024M20A) 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) (unknown route) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Injection site redness), VACCINATION SITE SWELLING (Injection site swelling) and VACCINATION SITE PAIN (Injection site soreness). At the time of the report, VACCINATION SITE ERYTHEMA (Injection site redness), VACCINATION SITE SWELLING (Injection site swelling) and VACCINATION SITE PAIN (Injection site soreness) had not resolved. Not Provided          No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not applicable.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: Injection site is red rash; red rash orange in size; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Injection site is red rash) and VACCINATION SITE RASH (red rash orange in size) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. O4M20A) for COVID-19 vaccination.     no medical information provided.  Concomitant products included FENOFIBRATE, HYDROCHLOROTHIAZIDE (DICHLOTRIDE [HYDROCHLOROTHIAZIDE]) and CALCIUM LEVOMEFOLATE (METHYL FOLATE) for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced VACCINATION SITE RASH (Injection site is red rash) and VACCINATION SITE RASH (red rash orange in size). At the time of the report, VACCINATION SITE RASH (Injection site is red rash) and VACCINATION SITE RASH (red rash orange in size) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       treatment information not provided.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Hot at injection site/warm at injection site; Itchy at injection site; Fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot at injection site/warm at injection site), VACCINATION SITE PRURITUS (Itchy at injection site) and PYREXIA (Fever) 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 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Hot at injection site/warm at injection site), VACCINATION SITE PRURITUS (Itchy at injection site) and PYREXIA (Fever). At the time of the report, VACCINATION SITE WARMTH (Hot at injection site/warm at injection site), VACCINATION SITE PRURITUS (Itchy at injection site) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Vaccination site pain
Clinical narrative: Headache; Sore Arm; Chills; This spontaneous case was reported by a nurse and describes the occurrence of HEADACHE (Headache), VACCINATION SITE PAIN (Sore Arm) and CHILLS (Chills) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced HEADACHE (Headache), VACCINATION SITE PAIN (Sore Arm) and CHILLS (Chills). At the time of the report, HEADACHE (Headache), VACCINATION SITE PAIN (Sore Arm) and CHILLS (Chills) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication information was provided.  Action taken with mRNA-1273 in response to the drug was not applicable.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Not Provided      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.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Nausea, Vomiting
Clinical narrative: Back Ache; Nausea; Vomiting; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of BACK PAIN (Back Ache), NAUSEA (Nausea) and VOMITING (Vomiting) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 immunisation.     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) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced BACK PAIN (Back Ache), NAUSEA (Nausea) and VOMITING (Vomiting). In February 2021, BACK PAIN (Back Ache), NAUSEA (Nausea) and VOMITING (Vomiting) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
Sex: M
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) 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 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced CHILLS (Chills). At the time of the report, CHILLS (Chills) outcome was unknown.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.  The concomitant medications and treatment details were not provided.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Pyrexia
Clinical narrative: fever; dizziness; headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), DIZZINESS (dizziness) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid cancer.    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 PYREXIA (fever), DIZZINESS (dizziness) and HEADACHE (headache). At the time of the report, PYREXIA (fever), DIZZINESS (dizziness) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient was taking unspecified concomitants for thyroid cancer.  The patient experienced dizziness, headaches, and fever following her dose and was taken by the rescue squad to the emergency room for her symptoms. She was not admitted to the hospital but was discharged from the emergency room after receiving a steroid injection for her symptoms.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Arm itching really bad; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Arm itching really bad) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No medical history was provided by reporter.     On 15-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 PRURITUS (Arm itching really bad). At the time of the report, PRURITUS (Arm itching really bad) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 08-May-2021: TCR
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Diarrhoea, Dizziness, Fatigue, Feeling hot
Clinical narrative: she had neck and back cramps; she had back cramps; itching; hot arm; swollen arm; can't move her arm; tiredness; vomiting; diarrhea; terrible headache; can't sleep; dizziness; everything hurts; her lungs hurt; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (she had neck and back cramps), BACK PAIN (she had back cramps), PRURITUS (itching), FEELING HOT (hot arm) and PERIPHERAL SWELLING (swollen arm) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included GABAPENTIN and DULOXETINE for an unknown indication.    On 10-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 MUSCLE SPASMS (she had neck and back cramps), BACK PAIN (she had back cramps), PRURITUS (itching), FEELING HOT (hot arm), PERIPHERAL SWELLING (swollen arm), LIMB DISCOMFORT (can't move her arm), FATIGUE (tiredness), VOMITING (vomiting), DIARRHOEA (diarrhea), HEADACHE (terrible headache), INSOMNIA (can't sleep), DIZZINESS (dizziness), PAIN (everything hurts) and PULMONARY PAIN (her lungs hurt). At the time of the report, MUSCLE SPASMS (she had neck and back cramps), BACK PAIN (she had back cramps), PRURITUS (itching), FEELING HOT (hot arm), PERIPHERAL SWELLING (swollen arm), LIMB DISCOMFORT (can't move her arm), FATIGUE (tiredness), VOMITING (vomiting), DIARRHOEA (diarrhea), HEADACHE (terrible headache), INSOMNIA (can't sleep), DIZZINESS (dizziness), PAIN (everything hurts) and PULMONARY PAIN (her lungs hurt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Insomnia, Limb discomfort, Muscle spasms, Pain
Clinical narrative: she had neck and back cramps; she had back cramps; itching; hot arm; swollen arm; can't move her arm; tiredness; vomiting; diarrhea; terrible headache; can't sleep; dizziness; everything hurts; her lungs hurt; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (she had neck and back cramps), BACK PAIN (she had back cramps), PRURITUS (itching), FEELING HOT (hot arm) and PERIPHERAL SWELLING (swollen arm) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included GABAPENTIN and DULOXETINE for an unknown indication.    On 10-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 MUSCLE SPASMS (she had neck and back cramps), BACK PAIN (she had back cramps), PRURITUS (itching), FEELING HOT (hot arm), PERIPHERAL SWELLING (swollen arm), LIMB DISCOMFORT (can't move her arm), FATIGUE (tiredness), VOMITING (vomiting), DIARRHOEA (diarrhea), HEADACHE (terrible headache), INSOMNIA (can't sleep), DIZZINESS (dizziness), PAIN (everything hurts) and PULMONARY PAIN (her lungs hurt). At the time of the report, MUSCLE SPASMS (she had neck and back cramps), BACK PAIN (she had back cramps), PRURITUS (itching), FEELING HOT (hot arm), PERIPHERAL SWELLING (swollen arm), LIMB DISCOMFORT (can't move her arm), FATIGUE (tiredness), VOMITING (vomiting), DIARRHOEA (diarrhea), HEADACHE (terrible headache), INSOMNIA (can't sleep), DIZZINESS (dizziness), PAIN (everything hurts) and PULMONARY PAIN (her lungs hurt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus, Pulmonary pain, Vomiting
Clinical narrative: she had neck and back cramps; she had back cramps; itching; hot arm; swollen arm; can't move her arm; tiredness; vomiting; diarrhea; terrible headache; can't sleep; dizziness; everything hurts; her lungs hurt; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (she had neck and back cramps), BACK PAIN (she had back cramps), PRURITUS (itching), FEELING HOT (hot arm) and PERIPHERAL SWELLING (swollen arm) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included GABAPENTIN and DULOXETINE for an unknown indication.    On 10-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 MUSCLE SPASMS (she had neck and back cramps), BACK PAIN (she had back cramps), PRURITUS (itching), FEELING HOT (hot arm), PERIPHERAL SWELLING (swollen arm), LIMB DISCOMFORT (can't move her arm), FATIGUE (tiredness), VOMITING (vomiting), DIARRHOEA (diarrhea), HEADACHE (terrible headache), INSOMNIA (can't sleep), DIZZINESS (dizziness), PAIN (everything hurts) and PULMONARY PAIN (her lungs hurt). At the time of the report, MUSCLE SPASMS (she had neck and back cramps), BACK PAIN (she had back cramps), PRURITUS (itching), FEELING HOT (hot arm), PERIPHERAL SWELLING (swollen arm), LIMB DISCOMFORT (can't move her arm), FATIGUE (tiredness), VOMITING (vomiting), DIARRHOEA (diarrhea), HEADACHE (terrible headache), INSOMNIA (can't sleep), DIZZINESS (dizziness), PAIN (everything hurts) and PULMONARY PAIN (her lungs hurt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Malaise, Nausea
Clinical narrative: Bad headache; nausea; extremely fatigue; feeling sick; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Bad headache), NAUSEA (nausea), FATIGUE (extremely fatigue) and MALAISE (feeling sick) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced HEADACHE (Bad headache), NAUSEA (nausea), FATIGUE (extremely fatigue) and MALAISE (feeling sick). The patient was treated with PARACETAMOL (TYLENOL) for Paracetamol, at an unspecified dose and frequency. At the time of the report, HEADACHE (Bad headache), NAUSEA (nausea), FATIGUE (extremely fatigue) and MALAISE (feeling sick) was resolving. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication information not provided. Treatment medication include Tylenol.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Incorrect route of product administration, Malaise, Vaccination site pain
Clinical narrative: Feels uncomfortable; Pain came back into shoulder joint; Tenderness in her tissue; Agonizing painful joint (rate it 20 for 10); Vaccine given on the given on the hardest part of the muscle and very high/liquid has gone to her joint rather than to the muscle/sensation felt like needle went into the joint and not the muscle/believes the shot was given incorrectly; A spontaneous report (United States) was received from a consumer who was also a 65-years-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) on the hardest part of the muscle and very high; liquid has gone to her joint rather than to the muscle; sensation felt like needle went into the joint and not the muscle; believes the shot was given incorrectly/incorrect route of product administration and who experienced feels uncomfortable/malaise, agonizing painful joint (rate it 20 for 10); pain came back into shoulder joint/arthralgia and tenderness in her tissue/vaccination site pain.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 17 Mar 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 002B21A (via an unknown route) intramuscularly in the hardest part of the muscle for prophylaxis of COVID-19 infection.  On 17 Mar 2021, the patient received vaccine in the hardest part of the muscle and patient believes that the shot was given too high when administered. Patient stated that patient did not feel the needle go in, the sensation felt like the needle went into the joint and not the muscle. She added that it took 3.5 days for the severe pain to go away, but the day before reporting the pain woke patient from sleep. Patient described tenderness in tissue and the pain came back into shoulder joint was feeling uncomfortable. Patient believes the shot was given incorrectly.   Treatment for the event included advil for agonizing painful joint (rate it 20 for 10).  Action taken with mRNA-1273 in response to the events was not provided.  The events, Vaccine given on the given on the hardest part of the muscle and very high/liquid has gone to her joint rather than to the muscle/sensation felt like needle went into the joint and not the muscle/believes the shot was given incorrectly, was recovered on 17 Feb 2021 and the event agonizing painful joint (rate it 20 for 10) was recovered on 20 Feb 2021. The outcome of other reported events was not reported.; Sender's Comments:  MOD21-063203:MI Report
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Disorientation, Headache, Vaccination site pain
Clinical narrative: disorientation; Persistent headache; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of DISORIENTATION (disorientation), HEADACHE (Persistent headache) and VACCINATION SITE PAIN (sore arm) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) 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) (unknown route) 1 dosage form. On 07-Mar-2021, the patient experienced DISORIENTATION (disorientation), HEADACHE (Persistent headache) and VACCINATION SITE PAIN (sore arm). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Headache, Disorientation and Vaccination site pain, at an unspecified dose and frequency. At the time of the report, DISORIENTATION (disorientation) and VACCINATION SITE PAIN (sore arm) outcome was unknown and HEADACHE (Persistent headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications details were not reported by the reporter.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Bone pain, Myalgia, Pain
Clinical narrative: Temperature of 101; body aches; Bone hurts; Muscle Pain; This spontaneous case was reported by a consumer and describes the occurrence of BODY TEMPERATURE INCREASED (Temperature of 101), PAIN (body aches), BONE PAIN (Bone hurts) and MYALGIA (Muscle Pain) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BODY TEMPERATURE INCREASED (Temperature of 101), PAIN (body aches), BONE PAIN (Bone hurts) and MYALGIA (Muscle Pain). At the time of the report, BODY TEMPERATURE INCREASED (Temperature of 101), PAIN (body aches), BONE PAIN (Bone hurts) and MYALGIA (Muscle Pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 (High) Temperature of 101.         Action taken with mRNA-1273 Moderna COVID-19 Vaccination was Not applicable.  No Concomitant medication was provided.  No Treatment medication was provided.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash
Clinical narrative: red rash at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE RASH (red rash at injection site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced INJECTION SITE RASH (red rash at injection site). On 14-Mar-2021, INJECTION SITE RASH (red rash at injection site) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication and treatment medication was not reported.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Vaccination site erythema
Clinical narrative: injection site turned red; chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and VACCINATION SITE ERYTHEMA (injection site turned red) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 19-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 CHILLS (chills) and VACCINATION SITE ERYTHEMA (injection site turned red). At the time of the report, CHILLS (chills) and VACCINATION SITE ERYTHEMA (injection site turned red) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient reported no past medical history or concurrent medical conditions. No treatment medications or concomitant medications reported.