chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in a female patient of an unknown age (gravida 1, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. The patient's last menstrual period was on 05-Jan-2021 and the estimated date of delivery was 06-Oct-2021. On 20-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  second week of the pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant) 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.    Treatment information was not provided.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Palpitations, Pyrexia
Clinical narrative: felt like she was "going to pass-out"; heart palpitations; nauseous; fever (about 100 degrees); This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (felt like she was "going to pass-out"), PALPITATIONS (heart palpitations), NAUSEA (nauseous) and PYREXIA (fever (about 100 degrees)) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Macular degeneration.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2021, the patient experienced DIZZINESS (felt like she was "going to pass-out"), PALPITATIONS (heart palpitations), NAUSEA (nauseous) and PYREXIA (fever (about 100 degrees)). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIZZINESS (felt like she was "going to pass-out"), PALPITATIONS (heart palpitations), NAUSEA (nauseous) and PYREXIA (fever (about 100 degrees)) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Dyspnoea, Headache, Influenza like illness
Clinical narrative: Covid-19; shortness of breath; headache; flu-like symptoms; body aches; fever of 101; chills; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), DYSPNOEA (shortness of breath), COVID-19 (Covid-19), MYALGIA (body aches) and PYREXIA (fever of 101) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms), MYALGIA (body aches), PYREXIA (fever of 101) and CHILLS (chills). On 10-Feb-2021, the patient experienced DYSPNOEA (shortness of breath) and HEADACHE (headache). On 11-Feb-2021, the patient experienced COVID-19 (Covid-19). On 02-Jan-2021, INFLUENZA LIKE ILLNESS (flu-like symptoms), MYALGIA (body aches), PYREXIA (fever of 101) and CHILLS (chills) had resolved. At the time of the report, DYSPNOEA (shortness of breath), COVID-19 (Covid-19) and HEADACHE (headache) 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 relevant concomitant medication reported.  Patient took Tylenol and Ibuprofen for treatment.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: Covid-19; shortness of breath; headache; flu-like symptoms; body aches; fever of 101; chills; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), DYSPNOEA (shortness of breath), COVID-19 (Covid-19), MYALGIA (body aches) and PYREXIA (fever of 101) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms), MYALGIA (body aches), PYREXIA (fever of 101) and CHILLS (chills). On 10-Feb-2021, the patient experienced DYSPNOEA (shortness of breath) and HEADACHE (headache). On 11-Feb-2021, the patient experienced COVID-19 (Covid-19). On 02-Jan-2021, INFLUENZA LIKE ILLNESS (flu-like symptoms), MYALGIA (body aches), PYREXIA (fever of 101) and CHILLS (chills) had resolved. At the time of the report, DYSPNOEA (shortness of breath), COVID-19 (Covid-19) and HEADACHE (headache) 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 relevant concomitant medication reported.  Patient took Tylenol and Ibuprofen for treatment.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Palpitations, SARS-CoV-2 test negative
Clinical narrative: hot flashes; palpitations; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of PALPITATIONS (palpitations) and HOT FLUSH (hot flashes) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039KorR0A and 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Sulfa), Drug allergy (TRAZADONE), Food allergy (GLUTEN & DAIRY SENSITIVE) and Allergy to animal (CATS). Concomitant products included CALCIUM for Osteopenia, VITAMIN D [VITAMIN D NOS], VITAMIN E [VITAMIN E NOS], MULTIVITAMIN [VITAMINS NOS] and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Dec-2020, the patient experienced PALPITATIONS (palpitations). On an unknown date, the patient experienced HOT FLUSH (hot flashes). At the time of the report, PALPITATIONS (palpitations) and HOT FLUSH (hot flashes) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jan-2021, SARS-CoV-2 test negative: negative (Negative) Covid-19 test-Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient had post menopausal for over 17 years.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Moderna ADR form
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Headache, Injection site pain
Clinical narrative: back pain; pain at injection site; slight headache; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back pain), INJECTION SITE PAIN (pain at injection site) and HEADACHE (slight headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergy to diclofenac reported.).    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, the patient experienced BACK PAIN (back pain), INJECTION SITE PAIN (pain at injection site) and HEADACHE (slight headache). At the time of the report, BACK PAIN (back pain), INJECTION SITE PAIN (pain at injection site) and HEADACHE (slight headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported. No Treatments were reported.   This case was linked to MOD-2021-068634 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Headache, Hypoaesthesia, Insomnia
Clinical narrative: Generalize itching (face and scalp); anorexia; nausea; mild headache; fatigue; insomnia; numbness on legs; Throat swollen up; This spontaneous case was reported by a physician and describes the occurrence of PHARYNGEAL SWELLING (Throat swollen up), PRURITUS (Generalize itching (face and scalp)), DECREASED APPETITE (anorexia), NAUSEA (nausea) and HEADACHE (mild headache) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PHARYNGEAL SWELLING (Throat swollen up). On 11-Feb-2021, the patient experienced DECREASED APPETITE (anorexia), NAUSEA (nausea), HEADACHE (mild headache), FATIGUE (fatigue), INSOMNIA (insomnia) and HYPOAESTHESIA (numbness on legs). On 15-Feb-2021, the patient experienced PRURITUS (Generalize itching (face and scalp)). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at a dose of UNK dosage form; PARACETAMOL (TYLENOL) at a dose of UNK dosage form; PEPTIDE LOPHE at a dose of UNK dosage form and MULTIVITAMINS & MINERALS PLUS LUTEIN at a dose of UNK dosage form. At the time of the report, PHARYNGEAL SWELLING (Throat swollen up), PRURITUS (Generalize itching (face and scalp)), DECREASED APPETITE (anorexia), NAUSEA (nausea), HEADACHE (mild headache), FATIGUE (fatigue), INSOMNIA (insomnia) and HYPOAESTHESIA (numbness on legs) 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.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pharyngeal swelling, Pruritus
Clinical narrative: Generalize itching (face and scalp); anorexia; nausea; mild headache; fatigue; insomnia; numbness on legs; Throat swollen up; This spontaneous case was reported by a physician and describes the occurrence of PHARYNGEAL SWELLING (Throat swollen up), PRURITUS (Generalize itching (face and scalp)), DECREASED APPETITE (anorexia), NAUSEA (nausea) and HEADACHE (mild headache) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PHARYNGEAL SWELLING (Throat swollen up). On 11-Feb-2021, the patient experienced DECREASED APPETITE (anorexia), NAUSEA (nausea), HEADACHE (mild headache), FATIGUE (fatigue), INSOMNIA (insomnia) and HYPOAESTHESIA (numbness on legs). On 15-Feb-2021, the patient experienced PRURITUS (Generalize itching (face and scalp)). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at a dose of UNK dosage form; PARACETAMOL (TYLENOL) at a dose of UNK dosage form; PEPTIDE LOPHE at a dose of UNK dosage form and MULTIVITAMINS & MINERALS PLUS LUTEIN at a dose of UNK dosage form. At the time of the report, PHARYNGEAL SWELLING (Throat swollen up), PRURITUS (Generalize itching (face and scalp)), DECREASED APPETITE (anorexia), NAUSEA (nausea), HEADACHE (mild headache), FATIGUE (fatigue), INSOMNIA (insomnia) and HYPOAESTHESIA (numbness on legs) 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.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Lip swelling, Pain in extremity, Pyrexia
Clinical narrative: fever; Lips like has botox/both lips/Swollen lips; Little headache; Little pain in the arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Little pain in the arm), LIP SWELLING (Lips like has botox/both lips/Swollen lips), HEADACHE (Little headache) and PYREXIA (fever) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (Allergy to tetracycline.).    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced PAIN IN EXTREMITY (Little pain in the arm) and HEADACHE (Little headache). On 13-Feb-2021, the patient experienced LIP SWELLING (Lips like has botox/both lips like Miss Pinky/Swollen lips). On 14-Feb-2021, the patient experienced PYREXIA (fever). The patient was treated with ACETAMINOPHEN for Fever, at a dose of UNK dosage form; LORATADINE (CLARITIN [LORATADINE]) ongoing since an unknown date at a dose of UNK, q12h and ACETAMINOPHEN for Pain in arm, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Little pain in the arm), HEADACHE (Little headache) and PYREXIA (fever) outcome was unknown and LIP SWELLING (Lips like has botox/both lips like Miss Pinky/Swollen lips) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Feb-2021, Body temperature: 102.4 (High) high.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication include Vitamins. Treatment information included  popsicles.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Malaise, Myalgia, Pyrexia
Clinical narrative: didn't feel good; felt run down - feels tired, need to take nap; Headache; Achy; had low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (didn't feel good), FATIGUE (felt run down - feels tired, need to take nap), PYREXIA (had low grade fever), HEADACHE (Headache) and MYALGIA (Achy) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Thyroid operation (She undergone procedure 4 months ago, still having thyroid problems and taking medication for it.).    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced PYREXIA (had low grade fever). On an unknown date, the patient experienced MALAISE (didn't feel good), FATIGUE (felt run down - feels tired, need to take nap), HEADACHE (Headache) and MYALGIA (Achy). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 26-Jan-2021, PYREXIA (had low grade fever) had resolved. At the time of the report, MALAISE (didn't feel good), FATIGUE (felt run down - feels tired, need to take nap), HEADACHE (Headache) and MYALGIA (Achy) 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.   No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 12-Jun-2021: Follow up information received on 12-JUN-2021 and contains no new information.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test, Ultrasound scan
Clinical narrative: Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a health care professional and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 35-year-old female patient (gravida 4, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 030L20A) for COVID-19 vaccination.     The patient's past medical history included Spontaneous abortion on 02-Jan-2017, Spontaneous abortion on 12-Jun-2017 and Pregnancy on 12-Jun-2018. Concurrent medical conditions included Drug allergy (Morphine).   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 15-May-2020 and the estimated date of delivery was 06-Mar-2021. On 20-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-ninth week of the pregnancy.  At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jun-2020, Pregnancy test: positive (Positive) Positive. On 10-Jul-2020, Ultrasound scan: normal (normal) normal. On 10-Oct-2020, Ultrasound scan: normal (normal) normal. On 02-Feb-2021, Ultrasound scan: normal (normal) normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications reported. No treatment information was provided. Action taken with mRNA-123 is not applicable. The patient's estimated date of conception was reported as 01-JUN-2020.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: arm got red, had a little heat; arm got red, had a little heat; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (arm got red, had a little heat) and INJECTION SITE WARMTH (arm got red, had a little heat) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included Breast cancer (history of breast cancer 20 years ago) and Lymph node excision (lymph nodes removed 20 years ago).    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (arm got red, had a little heat) and INJECTION SITE WARMTH (arm got red, had a little heat). At the time of the report, INJECTION SITE ERYTHEMA (arm got red, had a little heat) and INJECTION SITE WARMTH (arm got red, had a little heat) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.    No treatment information provided.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test
Clinical narrative: COVID-19; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of COVID-19 (COVID-19) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). The patient was treated with ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (CITRAMAX FORTE) for COVID-19, at a dose of UNK dosage form; ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for COVID-19, at a dose of UNK dosage form and ANTIBIOTICS for COVID-19, at a dose of UNK dosage form. At the time of the report, COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody 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.   No Concomitant medications reported.  Patient was treated with isolation as well.   This case was linked to US-MODERNATX, INC.-MOD-2021-065849, US-MODERNATX, INC.-MOD-2021-014845 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-065849:Reporter's co-worker wife case (female patient) US-MODERNATX, INC.-MOD-2021-014845:Reporter's case, female patient
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: extreme fatigue; headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FATIGUE (extreme fatigue) and HEADACHE (headache) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) 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 FATIGUE (extreme fatigue) and HEADACHE (headache). At the time of the report, FATIGUE (extreme fatigue) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. The patient spoke to the physician and everything was fine and it was taken care of. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: No new information
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: facial redness; injection site warmth; tenderness; swelling; This spontaneous case was reported by a nurse and describes the occurrence of ERYTHEMA (facial redness), INJECTION SITE WARMTH (injection site warmth), INJECTION SITE PAIN (tenderness) and INJECTION SITE SWELLING (swelling) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included HYALURONIC ACID, LIDOCAINE (RESTYLANE L) from 11-Jan-2021 to an unknown date for Skin cosmetic procedure.    On 26-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced ERYTHEMA (facial redness). 27-Jan-2021, the patient experienced INJECTION SITE WARMTH (injection site warmth), INJECTION SITE PAIN (tenderness) and INJECTION SITE SWELLING (swelling). The patient was treated with METHYLPREDNISOLONE (MEDROL DOSEPAK) at an unspecified dose and frequency. On 01-Feb-2021, ERYTHEMA (facial redness), INJECTION SITE WARMTH (injection site warmth), INJECTION SITE PAIN (tenderness) and INJECTION SITE SWELLING (swelling) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the event was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Body temperature increased, Nausea, Pain in extremity
Clinical narrative: stomach sick; nausea; left arm hurting; corporal temperature of 99.6F; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (left arm hurting), BODY TEMPERATURE INCREASED (corporal temperature of 99.6F), ABDOMINAL DISCOMFORT (stomach sick) and NAUSEA (nausea) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L2OA) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced PAIN IN EXTREMITY (left arm hurting) and BODY TEMPERATURE INCREASED (corporal temperature of 99.6F). On 17-Jan-2021, the patient experienced ABDOMINAL DISCOMFORT (stomach sick) and NAUSEA (nausea). The patient was treated with PARACETAMOL (TYLENOL) 16-Jan-2021 at a dose of UNK dosage form. On 17-Jan-2021, BODY TEMPERATURE INCREASED (corporal temperature of 99.6F) had resolved. On 18-Jan-2021, PAIN IN EXTREMITY (left arm hurting), ABDOMINAL DISCOMFORT (stomach sick) and NAUSEA (nausea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient takes blood pressure medication regularly.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: itchy rash at her lower legs; small patches at the bottom of both of her legs round her ankles; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (itchy rash at her lower legs) and RASH (small patches at the bottom of both of her legs round her ankles) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     Concomitant products included LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) and CALAMINE for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced RASH PRURITIC (itchy rash at her lower legs) and RASH (small patches at the bottom of both of her legs round her ankles). At the time of the report, RASH PRURITIC (itchy rash at her lower legs) and RASH (small patches at the bottom of both of her legs round her ankles) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. The patient took Benadryl 2(diphenhydramine) 5mg, calamine topical to alleviate the symptoms.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperhidrosis, Myalgia, Pain
Clinical narrative: sweating; Pain; Chills; Body ache; head ache; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating), PAIN (Pain), CHILLS (Chills), MYALGIA (Body ache) and HEADACHE (head ache) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced HYPERHIDROSIS (sweating), PAIN (Pain), CHILLS (Chills), MYALGIA (Body ache) and HEADACHE (head ache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HYPERHIDROSIS (sweating), PAIN (Pain), CHILLS (Chills), MYALGIA (Body ache) and HEADACHE (head ache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator   Most recent FOLLOW-UP information incorporated above includes: On 02-Mar-2021: follow up received on 02-Mar-2021 included vaccine details has been updated.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain
Clinical narrative: Pain; Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), CHILLS (Chills) and HEADACHE (Headache) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (Pain), CHILLS (Chills) and HEADACHE (Headache). At the time of the report, PAIN (Pain), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.   No treatment information for the events was provided.   This case was linked to MOD21-13175, MOD21-13172 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  MOD21-13175:Crosslinked: Same reporter MOD21-13172:Crosslinked: Same reporter
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Fatigue, Headache, Nausea
Clinical narrative: shaking all over; sick on stomach; arm extremely sore; chills; headache; so tired; nausea; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shaking all over), ABDOMINAL DISCOMFORT (sick on stomach), PAIN IN EXTREMITY (arm extremely sore), CHILLS (chills) and HEADACHE (headache) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Blood pressure high and COVID-19. Concomitant products included POTASSIUM, CARVEDILOL, FUROSEMIDE, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), TELMISARTAN, DOXAZOSIN MESYLATE, CLONIDINE HCL, SIMVASTATIN, ASCORBIC ACID, ZINC SULFATE (VITAMIN C & ZINK) and VITAMIN D2 for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced TREMOR (shaking all over), ABDOMINAL DISCOMFORT (sick on stomach), PAIN IN EXTREMITY (arm extremely sore), CHILLS (chills), HEADACHE (headache), FATIGUE (so tired) and NAUSEA (nausea). At the time of the report, TREMOR (shaking all over), ABDOMINAL DISCOMFORT (sick on stomach), PAIN IN EXTREMITY (arm extremely sore), CHILLS (chills), HEADACHE (headache), FATIGUE (so tired) and NAUSEA (nausea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Tremor
Clinical narrative: shaking all over; sick on stomach; arm extremely sore; chills; headache; so tired; nausea; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shaking all over), ABDOMINAL DISCOMFORT (sick on stomach), PAIN IN EXTREMITY (arm extremely sore), CHILLS (chills) and HEADACHE (headache) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Blood pressure high and COVID-19. Concomitant products included POTASSIUM, CARVEDILOL, FUROSEMIDE, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), TELMISARTAN, DOXAZOSIN MESYLATE, CLONIDINE HCL, SIMVASTATIN, ASCORBIC ACID, ZINC SULFATE (VITAMIN C & ZINK) and VITAMIN D2 for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced TREMOR (shaking all over), ABDOMINAL DISCOMFORT (sick on stomach), PAIN IN EXTREMITY (arm extremely sore), CHILLS (chills), HEADACHE (headache), FATIGUE (so tired) and NAUSEA (nausea). At the time of the report, TREMOR (shaking all over), ABDOMINAL DISCOMFORT (sick on stomach), PAIN IN EXTREMITY (arm extremely sore), CHILLS (chills), HEADACHE (headache), FATIGUE (so tired) and NAUSEA (nausea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: Redness at injection site; tenderness at injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE PAIN (tenderness at injection site) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     Concomitant products included CANDESARTAN CILEXETIL (ATACAND), ATORVASTATIN CALCIUM (LIPITOR), NAPHAZOLINE HYDROCHLORIDE (EYE DROPS [NAPHAZOLINE HYDROCHLORIDE]), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), PARACETAMOL (TYLENOL) and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE PAIN (tenderness at injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Redness at injection site) had not resolved and VACCINATION SITE PAIN (tenderness at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore arm). At the time of the report, VACCINATION SITE PAIN (Sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   Treatment information was not provided.   This case was linked to MOD21-13007, MOD21-13175 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: No specific follow-up information recorded.; Sender's Comments:  MOD21-13007:Crosslinked: Same reporter MOD21-13175:Crosslinked: Same reporter
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Geriatric assessment, Pain in extremity, Rash, Vaccination site pain
Clinical narrative: Sore Arm; Rash; "His arm hurts a lot"; Potential Adverse Event because is a Special Population (Geriatric); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore Arm), RASH (Rash), PAIN IN EXTREMITY ("His arm hurts a lot") and GERIATRIC ASSESSMENT (Potential Adverse Event because is a Special Population (Geriatric)) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore Arm), RASH (Rash), PAIN IN EXTREMITY ("His arm hurts a lot") and GERIATRIC ASSESSMENT (Potential Adverse Event because is a Special Population (Geriatric)). At the time of the report, VACCINATION SITE PAIN (Sore Arm), RASH (Rash), PAIN IN EXTREMITY ("His arm hurts a lot") and GERIATRIC ASSESSMENT (Potential Adverse Event because is a Special Population (Geriatric)) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD21-13007, MOD21-13172 (E2B Linked Report).; Sender's Comments:  MOD21-13007:Crosslinked: Same reporter MOD21-13172:Crosslinked: Same reporter
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Headache, Nausea
Clinical narrative: severe headache; terrible stomach pain; nausea; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (terrible stomach pain), NAUSEA (nausea) and HEADACHE (severe headache) 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 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2021, the patient experienced ABDOMINAL PAIN UPPER (terrible stomach pain) and NAUSEA (nausea). On 17-Jan-2021, the patient experienced HEADACHE (severe headache). At the time of the report, ABDOMINAL PAIN UPPER (terrible stomach pain), NAUSEA (nausea) and HEADACHE (severe headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Headache, Nausea, Pain in extremity
Clinical narrative: not feeling myself; sore arm; bad headache; nausea; chills; low grade fever; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arm), HEADACHE (bad headache), NAUSEA (nausea), CHILLS (chills) and PYREXIA (low grade fever) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm), HEADACHE (bad headache), NAUSEA (nausea), CHILLS (chills) and PYREXIA (low grade fever). On 26-Jan-2021, the patient experienced FEELING ABNORMAL (not feeling myself). On 26-Jan-2021, PAIN IN EXTREMITY (sore arm), NAUSEA (nausea), CHILLS (chills) and PYREXIA (low grade fever) had resolved. At the time of the report, HEADACHE (bad headache) had not resolved and FEELING ABNORMAL (not feeling myself) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   Treatment medication included  Tylenol. But it was not working..
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: not feeling myself; sore arm; bad headache; nausea; chills; low grade fever; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arm), HEADACHE (bad headache), NAUSEA (nausea), CHILLS (chills) and PYREXIA (low grade fever) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm), HEADACHE (bad headache), NAUSEA (nausea), CHILLS (chills) and PYREXIA (low grade fever). On 26-Jan-2021, the patient experienced FEELING ABNORMAL (not feeling myself). On 26-Jan-2021, PAIN IN EXTREMITY (sore arm), NAUSEA (nausea), CHILLS (chills) and PYREXIA (low grade fever) had resolved. At the time of the report, HEADACHE (bad headache) had not resolved and FEELING ABNORMAL (not feeling myself) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   Treatment medication included  Tylenol. But it was not working..
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 036B21A) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol and Hypertension since 2010. Concomitant products included CHLORTHALIDONE for Blood pressure, EZETIMIBE for Cholesterol, OMEPRAZOLE for Indigestion, VITAMIN D3 and CYANOCOBALAMIN (B12-VITAMIN) for an unknown indication.   On 06-Jan-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021 at 11:00 AM, 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 COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.      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) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 18-Apr-2021: Follow-up was received included Medical History was updated and Concomitant Medicines were added.information regarding dose 2 has been added
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypoaesthesia, Migraine, Myalgia, Paraesthesia
Clinical narrative: improved to normal soreness; fatigued; numb like pins and needles; tingly all day; migraine; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numb like pins and needles), PARAESTHESIA (tingly all day), MIGRAINE (migraine), MYALGIA (improved to normal soreness) and FATIGUE (fatigued) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced HYPOAESTHESIA (numb like pins and needles), PARAESTHESIA (tingly all day), MIGRAINE (migraine) and FATIGUE (fatigued). On 05-Jan-2021, the patient experienced MYALGIA (improved to normal soreness). On 05-Jan-2021, HYPOAESTHESIA (numb like pins and needles) and PARAESTHESIA (tingly all day) had resolved, MIGRAINE (migraine) and FATIGUE (fatigued) outcome was unknown. At the time of the report, MYALGIA (improved to normal soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Exposure via breast milk
Clinical narrative: Exposure via breast milk; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE VIA BREAST MILK (Exposure via breast milk) in a female patient of an unknown age exposed to mRNA-1273 (Moderna COVID-19 Vaccine) , while the mother received the product for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the mother received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 11-Jan-2021, the patient was diagnosed with EXPOSURE VIA BREAST MILK (Exposure via breast milk). At the time of the report, EXPOSURE VIA BREAST MILK (Exposure via breast milk) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were provided by reporter.  No treatment was reported.; Sender's Comments: This is a case of product exposure during breastfeeding with no associated AEs. Patient will continue to be contacted for further monitoring of AEs
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: decent skin reaction at site of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (decent skin reaction at site of injection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 04-Jan-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 VACCINATION SITE REACTION (decent skin reaction at site of injection). At the time of the report, VACCINATION SITE REACTION (decent skin reaction at site of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper
Clinical narrative: a little pain in stomach; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (a little pain in stomach) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     Concurrent medical conditions included Headache. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for Heart disorder, VITAMIN D3 for an unknown indication.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced ABDOMINAL PAIN UPPER (a little pain in stomach). At the time of the report, ABDOMINAL PAIN UPPER (a little pain in stomach) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: No specific follow-up information recorded.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Light Headed; A spontaneous report was received from a consumer, concerning a 23 year old female patient, who received Moderna's COVID-19 vaccine and experienced light headedness/ Dizziness.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 28 JAN 2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (batch number- 043L20A) via intramuscular route for COVID-19 infection prophylaxis. The patient felt light headed 10 minutes after the vaccine administration.  No treatment medication was reported.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the event, light headedness/ Dizziness was considered to be unknown at the time of this report.  Based on comment, light headedness/ Dizziness