chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: malaise; covid arm; low grade fever/low grade temperature/normal temperature is 97.8, on sunday he recorded 100.2; body aches; (arm) swollen; (arm) it had redness; headache; chills; joint pain; pain that night/still sore to the touch; itch; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (malaise), VACCINATION SITE REACTION (covid arm), PAIN (pain that night/still sore to the touch), PRURITUS (itch) and PERIPHERAL SWELLING ((arm) swollen) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058E21A, 003AZ1A and 030L(Z)0A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included METOPROLOL, TIMOLOL and CYANOCOBALAMIN (B12 [CYANOCOBALAMIN]) for an unknown indication.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Sep-2021, the patient experienced PAIN (pain that night/still sore to the touch) and PRURITUS (itch). On 12-Sep-2021, the patient experienced PERIPHERAL SWELLING ((arm) swollen), ERYTHEMA ((arm) it had redness), HEADACHE (headache), CHILLS (chills) and ARTHRALGIA (joint pain). On an unknown date, the patient experienced MALAISE (malaise), VACCINATION SITE REACTION (covid arm), PYREXIA (low grade fever/low grade temperature/normal temperature is 97.8, on sunday he recorded 100.2) and MYALGIA (body aches). At the time of the report, MALAISE (malaise), VACCINATION SITE REACTION (covid arm), PAIN (pain that night/still sore to the touch), PRURITUS (itch), PERIPHERAL SWELLING ((arm) swollen), ERYTHEMA ((arm) it had redness), PYREXIA (low grade fever/low grade temperature/normal temperature is 97.8, on sunday he recorded 100.2), HEADACHE (headache), CHILLS (chills), ARTHRALGIA (joint pain) and MYALGIA (body aches) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was provided.  Patient was taking vitamins and supplements.   Patient received the 3rd dose. It was not clarified if the caller was immunocompromised or not.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Dry skin, Pigmentation disorder, Pruritus, Thermal burn
Clinical narrative: Itching; Big burn; Skin is dry and rough; Big old bruise burn back of the leg; Big old mark; This spontaneous case was reported by a consumer and describes the occurrence of DRY SKIN (Skin is dry and rough), CONTUSION (Big old bruise burn back of the leg), PIGMENTATION DISORDER (Big old mark), PRURITUS (Itching) and THERMAL BURN (Big burn) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-2021, the patient experienced PRURITUS (Itching). In September 2021, the patient experienced DRY SKIN (Skin is dry and rough), CONTUSION (Big old bruise burn back of the leg), PIGMENTATION DISORDER (Big old mark) and THERMAL BURN (Big burn). At the time of the report, DRY SKIN (Skin is dry and rough), CONTUSION (Big old bruise burn back of the leg), PIGMENTATION DISORDER (Big old mark), PRURITUS (Itching) and THERMAL BURN (Big burn) 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.   Concomitant product use was not provided by the reporter.   No treatment information was provided. Patient reported adverse events that are skin was dry, big old bruise burn back of the leg, skin is rough, big old mark, big burn, itching. The location was clarified left kneecap, where she bend her leg. Patient states the itching started the night of the vaccination.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Insomnia, Magnetic resonance imaging head, Tinnitus
Clinical narrative: Ear situation became almost unbearable; Lost a week of sleep because of the buzzing sound and how bad it was,then it started getting better hearing came back; Lost a week of sleep because of the buzzing sound and how bad it was; This spontaneous case was reported by a patient and describes the occurrence of EAR DISCOMFORT (Ear situation became almost unbearable), TINNITUS (Lost a week of sleep because of the buzzing sound and how bad it was,then it started getting better hearing came back) and INSOMNIA (Lost a week of sleep because of the buzzing sound and how bad it was) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011AZ1A and 0L0M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced EAR DISCOMFORT (Ear situation became almost unbearable), TINNITUS (Lost a week of sleep because of the buzzing sound and how bad it was,then it started getting better hearing came back) and INSOMNIA (Lost a week of sleep because of the buzzing sound and how bad it was). The patient was treated with PREDNISONE on 16-Mar-2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, EAR DISCOMFORT (Ear situation became almost unbearable) and TINNITUS (Lost a week of sleep because of the buzzing sound and how bad it was,then it started getting better hearing came back) was resolving and INSOMNIA (Lost a week of sleep because of the buzzing sound and how bad it was) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging head: normal (normal) Normal.         No concomitant products were reported. The patient stated that the prednisone worked for her, and her hearing came back. Also stated that she had an antigen test done in August 2021, and her level was greater than 20.She thinks she had a very strong immune response to the Moderna COVID19 Vaccine, which is why that happened in her ear. she also stated that was a total nightmare what she went through for a period of about 6 weeks. She states she wants to get a booster because of her age. She states that the medical community is clueless as far as the vaccine because the information that has come out - even on medical journals - is sometimes conflicting and confusing.   This case was linked to MOD-2021-039504 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: vaccine stored in fridge over 12 hours, at approved temperature and given to patients; vaccine stored in fridge over 12 hours; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine stored in fridge over 12 hours, at approved temperature and given to patients) and PRODUCT STORAGE ERROR (vaccine stored in fridge over 12 hours) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine stored in fridge over 12 hours, at approved temperature and given to patients) and PRODUCT STORAGE ERROR (vaccine stored in fridge over 12 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccine stored in fridge over 12 hours, at approved temperature and given to patients) and PRODUCT STORAGE ERROR (vaccine stored in fridge over 12 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products were reported. No treatment drugs were reported
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Limb discomfort, Migraine
Clinical narrative: migraine; body aches; arm ache; arm felt heavy; strong headache; chills; fever of 100.2°F; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (migraine), PAIN (body aches), PAIN IN EXTREMITY (arm ache), LIMB DISCOMFORT (arm felt heavy) and HEADACHE (strong headache) in a 48-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.     Concurrent medical conditions included Cancer (cancer remission) and Immunocompromised (immune system is very low.). Concomitant products included ALENDRONATE SODIUM (ALENDRONATE), CALCIUM, COLECALCIFEROL (CALCIUM +D3), ASCORBIC ACID (VITAMINS C), MULTIVITAMINS [VITAMINS NOS] and VITAMIN B12 NOS for an unknown indication.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Feb-2021, the patient experienced MIGRAINE (migraine), PAIN (body aches), PAIN IN EXTREMITY (arm ache), LIMB DISCOMFORT (arm felt heavy), HEADACHE (strong headache), CHILLS (chills) and PYREXIA (fever of 100.2°F). On 22-Feb-2021, MIGRAINE (migraine), PAIN (body aches), LIMB DISCOMFORT (arm felt heavy), HEADACHE (strong headache), CHILLS (chills) and PYREXIA (fever of 100.2°F) had resolved. On 23-Feb-2021, PAIN IN EXTREMITY (arm ache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Feb-2021, Body temperature: 100.2°f (High) fever of 100.2°F.         The treatment information was unknown   This case was linked to MOD-2021-320164 (Patient Link).
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: migraine; body aches; arm ache; arm felt heavy; strong headache; chills; fever of 100.2°F; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (migraine), PAIN (body aches), PAIN IN EXTREMITY (arm ache), LIMB DISCOMFORT (arm felt heavy) and HEADACHE (strong headache) in a 48-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.     Concurrent medical conditions included Cancer (cancer remission) and Immunocompromised (immune system is very low.). Concomitant products included ALENDRONATE SODIUM (ALENDRONATE), CALCIUM, COLECALCIFEROL (CALCIUM +D3), ASCORBIC ACID (VITAMINS C), MULTIVITAMINS [VITAMINS NOS] and VITAMIN B12 NOS for an unknown indication.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Feb-2021, the patient experienced MIGRAINE (migraine), PAIN (body aches), PAIN IN EXTREMITY (arm ache), LIMB DISCOMFORT (arm felt heavy), HEADACHE (strong headache), CHILLS (chills) and PYREXIA (fever of 100.2°F). On 22-Feb-2021, MIGRAINE (migraine), PAIN (body aches), LIMB DISCOMFORT (arm felt heavy), HEADACHE (strong headache), CHILLS (chills) and PYREXIA (fever of 100.2°F) had resolved. On 23-Feb-2021, PAIN IN EXTREMITY (arm ache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Feb-2021, Body temperature: 100.2°f (High) fever of 100.2°F.         The treatment information was unknown   This case was linked to MOD-2021-320164 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chest pain, Heart rate, Interchange of vaccine products, Myalgia
Clinical narrative: constant burning on chest; Patient has sore throat; little bumps on back of my throat; uncomfortable gastric; both arm got sore; Jansen COVID-19 vaccine given to her on 1June2021 and 4Sep2021 the moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PHARYNGEAL SWELLING (little bumps on back of my throat), ABDOMINAL DISCOMFORT (uncomfortable gastric), CHEST PAIN (constant burning on chest), OROPHARYNGEAL PAIN (Patient has sore throat) and INTERCHANGE OF VACCINE PRODUCTS (Jansen COVID-19 vaccine given to her on 1June2021 and 4Sep2021 the moderna vaccine) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was reported.  Concomitant products included VITAMIN D NOS, VITAMIN C [ASCORBIC ACID], VITAMIN A [RETINOL] and TOCOPHEROL (VITAMIN E [TOCOPHEROL]) for an unknown indication.    On 04-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jun-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Jansen COVID-19 vaccine given to her on 1June2021 and 4Sep2021 the moderna vaccine). On 05-Sep-2021, the patient experienced PHARYNGEAL SWELLING (little bumps on back of my throat), ABDOMINAL DISCOMFORT (uncomfortable gastric) and MYALGIA (both arm got sore). On an unknown date, the patient experienced CHEST PAIN (constant burning on chest) and OROPHARYNGEAL PAIN (Patient has sore throat). On 01-Jun-2021, INTERCHANGE OF VACCINE PRODUCTS (Jansen COVID-19 vaccine given to her on 1June2021 and 4Sep2021 the moderna vaccine) had resolved. At the time of the report, PHARYNGEAL SWELLING (little bumps on back of my throat), ABDOMINAL DISCOMFORT (uncomfortable gastric), CHEST PAIN (constant burning on chest), OROPHARYNGEAL PAIN (Patient has sore throat) and MYALGIA (both arm got sore) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Sep-2021, Heart rate: high (High) fast heartbeat.     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 has reported that she also had Jansen COVID-19 vaccine given to her on 1-June-2021. No treatment information was reported.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pharyngeal swelling
Clinical narrative: constant burning on chest; Patient has sore throat; little bumps on back of my throat; uncomfortable gastric; both arm got sore; Jansen COVID-19 vaccine given to her on 1June2021 and 4Sep2021 the moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PHARYNGEAL SWELLING (little bumps on back of my throat), ABDOMINAL DISCOMFORT (uncomfortable gastric), CHEST PAIN (constant burning on chest), OROPHARYNGEAL PAIN (Patient has sore throat) and INTERCHANGE OF VACCINE PRODUCTS (Jansen COVID-19 vaccine given to her on 1June2021 and 4Sep2021 the moderna vaccine) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was reported.  Concomitant products included VITAMIN D NOS, VITAMIN C [ASCORBIC ACID], VITAMIN A [RETINOL] and TOCOPHEROL (VITAMIN E [TOCOPHEROL]) for an unknown indication.    On 04-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jun-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Jansen COVID-19 vaccine given to her on 1June2021 and 4Sep2021 the moderna vaccine). On 05-Sep-2021, the patient experienced PHARYNGEAL SWELLING (little bumps on back of my throat), ABDOMINAL DISCOMFORT (uncomfortable gastric) and MYALGIA (both arm got sore). On an unknown date, the patient experienced CHEST PAIN (constant burning on chest) and OROPHARYNGEAL PAIN (Patient has sore throat). On 01-Jun-2021, INTERCHANGE OF VACCINE PRODUCTS (Jansen COVID-19 vaccine given to her on 1June2021 and 4Sep2021 the moderna vaccine) had resolved. At the time of the report, PHARYNGEAL SWELLING (little bumps on back of my throat), ABDOMINAL DISCOMFORT (uncomfortable gastric), CHEST PAIN (constant burning on chest), OROPHARYNGEAL PAIN (Patient has sore throat) and MYALGIA (both arm got sore) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Sep-2021, Heart rate: high (High) fast heartbeat.     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 has reported that she also had Jansen COVID-19 vaccine given to her on 1-June-2021. No treatment information was reported.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, Vaccination site pain
Clinical narrative: fever of 99; sore arm at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm at injection site) and PYREXIA (fever of 99) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Sep-2021, the patient experienced PYREXIA (fever of 99). In September 2021, the patient experienced VACCINATION SITE PAIN (sore arm at injection site). At the time of the report, VACCINATION SITE PAIN (sore arm at injection site) and PYREXIA (fever of 99) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Sep-2021, Body temperature: 99 (High) fever of 99.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product information was not provided.  Treatment information was not provided.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Myalgia, Pain in extremity, Vaccination site pain
Clinical narrative: body was painful like getting the flu; all the arm hurt/all the arm was very sore; body aches/body was painful like getting the flu; injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (body was painful like getting the flu), PAIN IN EXTREMITY (all the arm hurt/all the arm was very sore), MYALGIA (body aches/body was painful like getting the flu) and VACCINATION SITE PAIN (injection site pain) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cancer (remission) and Immunocompromised (immune system is very low). Concomitant products included ALENDRONATE SODIUM (ALENDRONATE), CALCIUM, COLECALCIFEROL (CALCIUM +D3), VITAMIN C [ASCORBIC ACID], MULTIVITAMINS [VITAMINS NOS] and VITAMIN B12 NOS for an unknown indication.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Sep-2021, the patient experienced INFLUENZA LIKE ILLNESS (body was painful like getting the flu), PAIN IN EXTREMITY (all the arm hurt/all the arm was very sore) and VACCINATION SITE PAIN (injection site pain). 14-Sep-2021, the patient experienced MYALGIA (body aches/body was painful like getting the flu). At the time of the report, INFLUENZA LIKE ILLNESS (body was painful like getting the flu), PAIN IN EXTREMITY (all the arm hurt/all the arm was very sore), MYALGIA (body aches/body was painful like getting the flu) and VACCINATION SITE PAIN (injection site pain) outcome was unknown.            Patient states if getting the third dose before 8 months have gone by from the second dose my counteract the effect of the previous one. This case pertains to patient 1.  Treatment details was not reported .    This case was linked to MOD-2021-320155.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Hurt a little bit on my left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Hurt a little bit on my left arm) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE, ATORVASTATIN CALCIUM (LIPITOR), OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]), METOPROLOL and VITAMINS NOS for an unknown indication.    On 25-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 PAIN IN EXTREMITY (Hurt a little bit on my left arm). At the time of the report, PAIN IN EXTREMITY (Hurt a little bit on my left arm) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Relevant concomitant medications included Ellipta.  No treatment information was provided.   This case was linked to MOD-2021-320261, MOD-2021-320262 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Asthenia, COVID-19, Chest pain, Decreased appetite
Clinical narrative: Sick for a long while; Thinks she might have covid; Chest hurts; Stomach is bad; Can't eat much; Doesn't have the same energy; Fevers on and off; Tired throughout the day; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick for a long while), COVID-19 (Thinks she might have covid), CHEST PAIN, ABDOMINAL DISCOMFORT, and DECREASED APPETITE (Can't eat much) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (Sick for a long while), COVID-19 (Thinks she might have covid), CHEST PAIN, ABDOMINAL DISCOMFORT, DECREASED APPETITE (Can't eat much), ASTHENIA, PYREXIA, and FATIGUE. At the time of the report, ILLNESS (Sick for a long while), COVID-19 (Thinks she might have covid), CHEST PAIN, ABDOMINAL DISCOMFORT, DECREASED APPETITE (Can't eat much), ASTHENIA, PYREXIA and FATIGUE outcome was unknown.            No concomitants are provided. No treatment drug information was provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Illness, Pyrexia
Clinical narrative: Sick for a long while; Thinks she might have covid; Chest hurts; Stomach is bad; Can't eat much; Doesn't have the same energy; Fevers on and off; Tired throughout the day; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick for a long while), COVID-19 (Thinks she might have covid), CHEST PAIN, ABDOMINAL DISCOMFORT, and DECREASED APPETITE (Can't eat much) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (Sick for a long while), COVID-19 (Thinks she might have covid), CHEST PAIN, ABDOMINAL DISCOMFORT, DECREASED APPETITE (Can't eat much), ASTHENIA, PYREXIA, and FATIGUE. At the time of the report, ILLNESS (Sick for a long while), COVID-19 (Thinks she might have covid), CHEST PAIN, ABDOMINAL DISCOMFORT, DECREASED APPETITE (Can't eat much), ASTHENIA, PYREXIA and FATIGUE outcome was unknown.            No concomitants are provided. No treatment drug information was provided.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Decreased appetite, Feeling abnormal, Headache, Nausea
Clinical narrative: No appetite; Very painful body aches; Felt really crappy; A little nausea; Fever up to 101 degrees F; Headache; Sore arm; This spontaneous case was reported by an other health professional and describes the occurrence of DECREASED APPETITE (No appetite), PAIN (Very painful body aches), PAIN IN EXTREMITY (Sore arm), FEELING ABNORMAL (Felt really crappy) and NAUSEA (A little nausea) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in March 2021.    On 13-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Sep-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and HEADACHE (Headache). On 14-Sep-2021, the patient experienced DECREASED APPETITE (No appetite). 14-Sep-2021, the patient experienced PAIN (Very painful body aches), FEELING ABNORMAL (Felt really crappy), NAUSEA (A little nausea) and PYREXIA (Fever up to 101 degrees F). The patient was treated with PARACETAMOL (TYLENOL) in September 2021 for Fever, at an unspecified dose and frequency; IBUPROFEN in September 2021 for Fever, at an unspecified dose and frequency and MENTHOL (BIOFREEZE PAIN RELIEVING) in September 2021 for General body pain, at an unspecified dose and frequency. At the time of the report, DECREASED APPETITE (No appetite), PAIN (Very painful body aches), PAIN IN EXTREMITY (Sore arm), FEELING ABNORMAL (Felt really crappy), NAUSEA (A little nausea) and HEADACHE (Headache) outcome was unknown and PYREXIA (Fever up to 101 degrees F) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Sep-2021, Body temperature: 101 (High) Fever up to 101 degrees F.     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 reported.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: No appetite; Very painful body aches; Felt really crappy; A little nausea; Fever up to 101 degrees F; Headache; Sore arm; This spontaneous case was reported by an other health professional and describes the occurrence of DECREASED APPETITE (No appetite), PAIN (Very painful body aches), PAIN IN EXTREMITY (Sore arm), FEELING ABNORMAL (Felt really crappy) and NAUSEA (A little nausea) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in March 2021.    On 13-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Sep-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and HEADACHE (Headache). On 14-Sep-2021, the patient experienced DECREASED APPETITE (No appetite). 14-Sep-2021, the patient experienced PAIN (Very painful body aches), FEELING ABNORMAL (Felt really crappy), NAUSEA (A little nausea) and PYREXIA (Fever up to 101 degrees F). The patient was treated with PARACETAMOL (TYLENOL) in September 2021 for Fever, at an unspecified dose and frequency; IBUPROFEN in September 2021 for Fever, at an unspecified dose and frequency and MENTHOL (BIOFREEZE PAIN RELIEVING) in September 2021 for General body pain, at an unspecified dose and frequency. At the time of the report, DECREASED APPETITE (No appetite), PAIN (Very painful body aches), PAIN IN EXTREMITY (Sore arm), FEELING ABNORMAL (Felt really crappy), NAUSEA (A little nausea) and HEADACHE (Headache) outcome was unknown and PYREXIA (Fever up to 101 degrees F) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Sep-2021, Body temperature: 101 (High) Fever up to 101 degrees F.     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 reported.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Have not received second dose (>35 days have passed)/first dose on 28Jul2021; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Have not received second dose (>35 days have passed)/first dose on 28Jul2021) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Have not received second dose (>35 days have passed)/first dose on 28Jul2021). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Have not received second dose (>35 days have passed)/first dose on 28Jul2021) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided. List of concomitant medication were not given.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: Slight fever; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Slight fever) and FATIGUE (Fatigue) 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-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (Slight fever) and FATIGUE (Fatigue). At the time of the report, PYREXIA (Slight fever) and FATIGUE (Fatigue) outcome was unknown.            The patient is reporter's mother and had received booster vaccine 5 days ago.  No concomitant medication were provided.  No treatment medication were provided.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Hypoaesthesia, Illness, Slow speech
Clinical narrative: I've been sick for a long time; Kind of numb; like I have Bell's palsy, paralyze some part of my face, the right side/ I have paralyze some part of my face/started on my left (side) then it moved over to my right (side); I can't form my words; This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (like I have Bell's palsy, paralyze some part of my face, the right side/ I have paralyze some part of my face/started on my left (side) then it moved over to my right (side)) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided.  Concomitant products included OXYCODONE for Back pain, METOPROLOL, HYDROCHLOROTHIAZIDE and GABAPENTIN for an unknown indication.    On 10-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Sep-2021, the patient experienced BELL'S PALSY (like I have Bell's palsy, paralyze some part of my face, the right side/ I have paralyze some part of my face/started on my left (side) then it moved over to my right (side)) (seriousness criterion medically significant) and SLOW SPEECH (I can't form my words). On an unknown date, the patient experienced ILLNESS (I've been sick for a long time) and HYPOAESTHESIA (Kind of numb). At the time of the report, BELL'S PALSY (like I have Bell's palsy, paralyze some part of my face, the right side/ I have paralyze some part of my face/started on my left (side) then it moved over to my right (side)) had not resolved and ILLNESS (I've been sick for a long time), SLOW SPEECH (I can't form my words) and HYPOAESTHESIA (Kind of numb) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient taking medication for pressure as a concomitant.  Patient reported that she experienced paralyze some part of her face, the right side. It started on her left side then it moved over to her right side. The paralysis started on 14Sep2021 and it is still ongoing.  Company comment: This case concerns a 54 year old female who experienced serious unexpected event of Bell's palsy 4 days after the receiving the first dose of the Moderna vaccine. No medical history provided. Dechallenge is unknown and rechallenge is not applicable.  The benefit-risk relationship is not affected by this report for the Moderna vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 15-Sep-2021: Additional information received on 15-Sep-2021 which updated events and concomitant products.; Sender's Comments: This case concerns a 54 year old female who experienced serious unexpected event of Bell's palsy 4 days after the receiving the first dose of the Moderna vaccine. No medical history provided. Dechallenge is unknown and rechallenge is not applicable.  The benefit-risk relationship is not affected by this report for the Moderna vaccine.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: I got Covid 9/9/21; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (I got Covid 9/9/21) 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) (unknown route) 1 dosage form. On 09-Sep-2021, the patient experienced COVID-19 (I got Covid 9/9/21). At the time of the report, COVID-19 (I got Covid 9/9/21) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant medication information were provided. No treatment information were provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Nipple pain, Pain in extremity, Peripheral swelling, Skin irritation
Clinical narrative: Sore breast; Sore nipples; Severe irritated sore nipples; Swelling in the arm; Patient had sore arm; This spontaneous case was reported by a consumer and describes the occurrence of BREAST PAIN (Sore breast), NIPPLE PAIN (Sore nipples), SKIN IRRITATION (Severe irritated sore nipples), PERIPHERAL SWELLING (Swelling in the arm) and PAIN IN EXTREMITY (Patient had sore arm) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination.     Concurrent medical conditions included Acid reflux (esophageal). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), FLUOXETINE HYDROCHLORIDE (PROZAC), ASCORBIC ACID (VITAMIN C PLUS [ASCORBIC ACID]), COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), IRON, MAGNESIUM and CYANOCOBALAMIN (B12-VITAMIIN) for an unknown indication.   On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Sep-2021, the patient experienced PERIPHERAL SWELLING (Swelling in the arm) and PAIN IN EXTREMITY (Patient had sore arm). On 14-Sep-2021, the patient experienced BREAST PAIN (Sore breast), NIPPLE PAIN (Sore nipples) and SKIN IRRITATION (Severe irritated sore nipples). On 12-Sep-2021, PERIPHERAL SWELLING (Swelling in the arm) and PAIN IN EXTREMITY (Patient had sore arm) had resolved. At the time of the report, BREAST PAIN (Sore breast), NIPPLE PAIN (Sore nipples) and SKIN IRRITATION (Severe irritated sore nipples) outcome was unknown.            Concomitant medication included acid reflux pill which the patient used to take when she had acid reflux.  Treatment medications were not administered by the patient and no further treatment information was provided.   This case was linked to MOD-2021-320224 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Sep-2021: Follow up document received and patient's date of birth was updated.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: had some reaction to the first shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (had some reaction to the first shot) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (had some reaction to the first shot). At the time of the report, VACCINATION COMPLICATION (had some reaction to the first shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant Medications were provided by the reporter  No Treatment Information were provided by the reporter
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: Sore arm; Real tired; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm) and FATIGUE (Real tired) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination.     Concurrent medical conditions included Acid reflux (esophageal). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), FLUOXETINE HYDROCHLORIDE (PROZAC), VITAMIN B12 [VITAMIN B12 NOS], MULTIVITAMIN [VITAMINS NOS], VITAMIN C [ASCORBIC ACID], VITAMIN D NOS, MAGNESIUM and IRON for an unknown indication.    On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 2021, the patient experienced VACCINATION SITE PAIN (Sore arm) and FATIGUE (Real tired). At the time of the report, VACCINATION SITE PAIN (Sore arm) and FATIGUE (Real tired) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medication also included acid reflux pill when she has acid reflux. Treatment information was not provided.   This case was linked to MOD-2021-320212 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Sep-2021: Updated patient date of birth.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria, Vaccination complication
Clinical narrative: immediate reaction, within 2 minutes of receiving the vaccine; 3 welts developed on her left arm and 1 welt on her right arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (immediate reaction, within 2 minutes of receiving the vaccine) and URTICARIA (3 welts developed on her left arm and 1 welt on her right arm) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Aug-2021, the patient experienced VACCINATION COMPLICATION (immediate reaction, within 2 minutes of receiving the vaccine). 18-Aug-2021, the patient experienced URTICARIA (3 welts developed on her left arm and 1 welt on her right arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Welts, at an unspecified dose and frequency. On 19-Aug-2021, URTICARIA (3 welts developed on her left arm and 1 welt on her right arm) had resolved. At the time of the report, VACCINATION COMPLICATION (immediate reaction, within 2 minutes of receiving the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was not on any concomitant medications.   The patient did not have an anaphylactic reaction due to the vaccination.   The patient was scheduled to receive her 2nd dose on 15-Sep-2021. The patient mentioned that per CDC, the recommendation for anyone experiencing an allergic reaction to the vaccine was to not receive another dose.  It was not reported if the patient received any corrective treatment for the event vaccination adverse reaction.
Sex: U
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: Muscle spasms; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Muscle spasms) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCLE SPASMS (Muscle spasms). At the time of the report, MUSCLE SPASMS (Muscle spasms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant information was reported. No treatment information was reported.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: received first dose on 04apr21 and still did not get the second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (received first dose on 04apr21 and still did not get the second dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (received first dose on 04apr21 and still did not get the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (received first dose on 04apr21 and still did not get the second dose) had resolved.            Concomitant medication was not provided. Treatment medication  was not provided .
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Fatigue, Nausea, Pyrexia
Clinical narrative: Bell's palsy; Low grade fever; Felt tired; Nauseous; This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (Bell's palsy), PYREXIA (Low grade fever), FATIGUE (Felt tired) and NAUSEA (Nauseous) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 039K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced PYREXIA (Low grade fever), FATIGUE (Felt tired) and NAUSEA (Nauseous). On 14-May-2021, the patient experienced BELL'S PALSY (Bell's palsy). The patient was treated with PREDNISONE for Bell's palsy, at an unspecified dose and frequency. On 06-Feb-2021, PYREXIA (Low grade fever), FATIGUE (Felt tired) and NAUSEA (Nauseous) had resolved. At the time of the report, BELL'S PALSY (Bell's palsy) was resolving.            No relevant concomitant medications were reported. Patient had Bell's palsy and was brought to ER and stayed for less than 24 hours. As per doctors, the event Bell's palsy wasn't related to the vaccine. Treatment for the events included anti-viral medication and eye drops.  Company comment: This case concerns a 75 year old female patient, with no relevant medical history, who experienced the expected event of Bell's palsy. The event occurred approximately 4 months after the second dose of Spikevax. The benefit-risk relation of Spikevax is not affected by this report. Event of Bell's Palsy was automatically upgraded as a Serious event. However, based on information available and as per medical criteria was classified as Non-serious.   Most recent FOLLOW-UP information incorporated above includes: On 15-Sep-2021: Follow up received contains no new information.; Sender's Comments: This case concerns a 75 year old female patient, with no relevant medical history, who experienced the expected event of Bell's palsy. The event occurred approximately 4 months after the second dose of Spikevax. The benefit-risk relation of Spikevax is not affected by this report. Event of Bell's Palsy was automatically upgraded as a Serious event. However, based on information available and as per medical criteria was classified as Non-serious.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Headache, Pyrexia
Clinical narrative: I looked at my arm and the hole area is red and hot; I looked at my arm and the hole area is red and hot; Terrible headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (I looked at my arm and the hole area is red and hot), ERYTHEMA (I looked at my arm and the hole area is red and hot), HEADACHE (Terrible headache) and PYREXIA (Fever) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Bone density abnormal. Concomitant products included ABALOPARATIDE (TYMLOS) for Bone density abnormal.    On 13-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Sep-2021, the patient experienced HEADACHE (Terrible headache) and PYREXIA (Fever). On 15-Sep-2021, the patient experienced FEELING HOT (I looked at my arm and the hole area is red and hot) and ERYTHEMA (I looked at my arm and the hole area is red and hot). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 15-Sep-2021, PYREXIA (Fever) had resolved. At the time of the report, FEELING HOT (I looked at my arm and the hole area is red and hot) and ERYTHEMA (I looked at my arm and the hole area is red and hot) outcome was unknown and HEADACHE (Terrible headache) was resolving.            it was reported that reported reaction was not life threatening and at the time of report headache come and go, but not deadly as it was.