chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Oral mucosal exfoliation, Stomatitis, Swollen tongue, Throat irritation
Clinical narrative: 2 bruises on the arm which showed a round thing; Body was lethargic; Kept misplacing her things; Couldn't sleep for 3days/2nights; Neck pain but was just a little bit now; Swollen tongue; Raw mouth; Throat burning; Gums were peeling; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (2 bruises on the arm which showed a round thing), STOMATITIS (Raw mouth), THROAT IRRITATION (Throat burning), ORAL MUCOSAL EXFOLIATION (Gums were peeling) and LETHARGY (Body was lethargic) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced STOMATITIS (Raw mouth), THROAT IRRITATION (Throat burning), ORAL MUCOSAL EXFOLIATION (Gums were peeling) and SWOLLEN TONGUE (Swollen tongue). On an unknown date, the patient experienced CONTUSION (2 bruises on the arm which showed a round thing), LETHARGY (Body was lethargic), AMNESIA (Kept misplacing her things), INSOMNIA (Couldn't sleep for 3days/2nights) and NECK PAIN (Neck pain but was just a little bit now). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, CONTUSION (2 bruises on the arm which showed a round thing), STOMATITIS (Raw mouth), THROAT IRRITATION (Throat burning), ORAL MUCOSAL EXFOLIATION (Gums were peeling), LETHARGY (Body was lethargic), AMNESIA (Kept misplacing her things), INSOMNIA (Couldn't sleep for 3days/2nights), NECK PAIN (Neck pain but was just a little bit now) and SWOLLEN TONGUE (Swollen tongue) 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.   Concomitant product use was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Ventricular extrasystoles
Clinical narrative: Premature ventricular contractions; This spontaneous case was reported by a health care professional and describes the occurrence of VENTRICULAR EXTRASYSTOLES (Premature ventricular contractions) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second 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 VENTRICULAR EXTRASYSTOLES (Premature ventricular contractions). At the time of the report, VENTRICULAR EXTRASYSTOLES (Premature ventricular contractions) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication details not provided. Treatment medication details not provided.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Erythema, Pruritus, Rash macular
Clinical narrative: feels itchy, feet, legs and lower back itch after getting out of the shower; little red spots on arms; knees feel like on fire and red in color; knees feel like on fire and red in color; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (feels itchy, feet, legs and lower back itch after getting out of the shower), RASH MACULAR (little red spots on arms), ERYTHEMA (knees feel like on fire and red in color) and ARTHRALGIA (knees feel like on fire and red in color) 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 Hives. Concurrent medical conditions included Sensitive skin.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (feels itchy, feet, legs and lower back itch after getting out of the shower), RASH MACULAR (little red spots on arms), ERYTHEMA (knees feel like on fire and red in color) and ARTHRALGIA (knees feel like on fire and red in color). At the time of the report, PRURITUS (feels itchy, feet, legs and lower back itch after getting out of the shower), RASH MACULAR (little red spots on arms), ERYTHEMA (knees feel like on fire and red in color) and ARTHRALGIA (knees feel like on fire and red in color) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Red patches around the injection site; bumps around the injection site; itching around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red patches around the injection site), SWELLING (bumps around the injection site) and PRURITUS (itching around the injection site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced ERYTHEMA (Red patches around the injection site), SWELLING (bumps around the injection site) and PRURITUS (itching around the injection site). At the time of the report, ERYTHEMA (Red patches around the injection site), SWELLING (bumps around the injection site) and PRURITUS (itching around the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.    Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Lymphadenopathy, Myalgia
Clinical narrative: muscle aches; Joint pain; Swollen lymph nodes; Headache; Sore arm; Chills; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), CHILLS (Chills), NAUSEA (Nausea), MYALGIA (muscle aches) and ARTHRALGIA (Joint pain) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), CHILLS (Chills), NAUSEA (Nausea) and HEADACHE (Headache). On 28-Mar-2021, the patient experienced MYALGIA (muscle aches), ARTHRALGIA (Joint pain) and LYMPHADENOPATHY (Swollen lymph nodes). At the time of the report, PAIN IN EXTREMITY (Sore arm), CHILLS (Chills), NAUSEA (Nausea), MYALGIA (muscle aches), ARTHRALGIA (Joint pain), LYMPHADENOPATHY (Swollen lymph nodes) and HEADACHE (Headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. The patient did not receive any treatment medications.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity
Clinical narrative: muscle aches; Joint pain; Swollen lymph nodes; Headache; Sore arm; Chills; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), CHILLS (Chills), NAUSEA (Nausea), MYALGIA (muscle aches) and ARTHRALGIA (Joint pain) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), CHILLS (Chills), NAUSEA (Nausea) and HEADACHE (Headache). On 28-Mar-2021, the patient experienced MYALGIA (muscle aches), ARTHRALGIA (Joint pain) and LYMPHADENOPATHY (Swollen lymph nodes). At the time of the report, PAIN IN EXTREMITY (Sore arm), CHILLS (Chills), NAUSEA (Nausea), MYALGIA (muscle aches), ARTHRALGIA (Joint pain), LYMPHADENOPATHY (Swollen lymph nodes) and HEADACHE (Headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. The patient did not receive any treatment medications.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Tested positive of Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive of Covid-19) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive of Covid-19). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive of Covid-19) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant information use was not reported.  Treatment information was not provided.    Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Events Outcome: from unknown to recovered updated.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Night sweats
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (really bad night sweats), FATIGUE (extreme tiredness) and CHILLS (Chills) 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 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced NIGHT SWEATS (really bad night sweats), FATIGUE (extreme tiredness) and CHILLS (Chills). At the time of the report, NIGHT SWEATS (really bad night sweats), FATIGUE (extreme tiredness) and CHILLS (Chills) outcome was unknown. The patient reported that she was waking up with wet spots on her bed sheet and she woke up 4-5 times a night to wipe sweat off her arms, chest, and legs. She was on her menstrual cycle and never had issues with night sweats before. She denied of taking any medications. She had not checked her temperature during those episodes. Concomitant medications were not provided. This case was linked to MOD-2021-064267.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Erythema, Peripheral swelling, Rash
Clinical narrative: Her arm was still swollen; Leg on her left side has a rash; Rash look like a big tick tack toe; Arm is red; Under her arm pit is swollen; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY MASS (Under her arm pit is swollen), PERIPHERAL SWELLING (Her arm was still swollen), RASH (Leg on her left side has a rash), RASH (Rash look like a big tick tack toe) and ERYTHEMA (Arm is red) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for COVID-19 vaccination.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced AXILLARY MASS (Under her arm pit is swollen), RASH (Leg on her left side has a rash), RASH (Rash look like a big tick tack toe) and ERYTHEMA (Arm is red). On 24-Mar-2021, the patient experienced PERIPHERAL SWELLING (Her arm was still swollen). At the time of the report, AXILLARY MASS (Under her arm pit is swollen), PERIPHERAL SWELLING (Her arm was still swollen), RASH (Leg on her left side has a rash), RASH (Rash look like a big tick tack toe) and ERYTHEMA (Arm is red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant included Blood pressure medication were noted. No treatment information were provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Follow up received on 13-MAY-2021 Included No new Significant Information
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Insomnia, Myalgia
Clinical narrative: sleepless; pain 7 out of 10; fatigue; headache; muscle ache; nausea; fever; Joint Pain; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (sleepless), PAIN (pain 7 out of 10), FATIGUE (fatigue), HEADACHE (headache) and MYALGIA (muscle ache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0Z1R21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included COPD and Asthma. Concomitant products included ALBUTEROL [SALBUTAMOL], GUAIFENESIN (MUCINEX), CALCIUM CARBONATE (TUMS [CALCIUM CARBONATE]) and OMEPRAZOLE for an unknown indication.    On 30-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INSOMNIA (sleepless), PAIN (pain 7 out of 10), FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle ache), NAUSEA (nausea), PYREXIA (fever) and ARTHRALGIA (Joint Pain). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 2 doses 4 to 6 hours. At the time of the report, INSOMNIA (sleepless), PAIN (pain 7 out of 10), FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle ache), NAUSEA (nausea), PYREXIA (fever) and ARTHRALGIA (Joint Pain) had not resolved.            Other concomitant medications included advir.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: sleepless; pain 7 out of 10; fatigue; headache; muscle ache; nausea; fever; Joint Pain; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (sleepless), PAIN (pain 7 out of 10), FATIGUE (fatigue), HEADACHE (headache) and MYALGIA (muscle ache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0Z1R21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included COPD and Asthma. Concomitant products included ALBUTEROL [SALBUTAMOL], GUAIFENESIN (MUCINEX), CALCIUM CARBONATE (TUMS [CALCIUM CARBONATE]) and OMEPRAZOLE for an unknown indication.    On 30-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INSOMNIA (sleepless), PAIN (pain 7 out of 10), FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle ache), NAUSEA (nausea), PYREXIA (fever) and ARTHRALGIA (Joint Pain). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 2 doses 4 to 6 hours. At the time of the report, INSOMNIA (sleepless), PAIN (pain 7 out of 10), FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle ache), NAUSEA (nausea), PYREXIA (fever) and ARTHRALGIA (Joint Pain) had not resolved.            Other concomitant medications included advir.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pyrexia, Vaccination site pain
Clinical narrative: Fever (98F); headache; pain on injection site on the very same night; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever (98F)), HEADACHE (headache) and VACCINATION SITE PAIN (pain on injection site on the very same night) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030MZ0ALLD073121) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced PYREXIA (Fever (98F)), HEADACHE (headache) and VACCINATION SITE PAIN (pain on injection site on the very same night). The patient was treated with PARACETAMOL (TYLENOL) on 02-Mar-2021 for Adverse event, at an unspecified dose and frequency and IBUPROFEN on 02-Mar-2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever (98F)), HEADACHE (headache) and VACCINATION SITE PAIN (pain on injection site on the very same night) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Mar-2021, Body temperature: 98f (Inconclusive) 98F.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medications were not provided.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Vertigo
Clinical narrative: Vertigo; Dizziness; Slight Frog; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo), DIZZINESS (Dizziness) and FEELING ABNORMAL (Slight Frog) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B21A and 024M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN, LISINOPRIL, MULTIVITAMINS [VITAMINS NOS], VITAMIN C [ASCORBIC ACID], IBUPROFEN and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced FEELING ABNORMAL (Slight Frog). On 28-Mar-2021, the patient experienced DIZZINESS (Dizziness). On 29-Mar-2021, the patient experienced VERTIGO (Vertigo). At the time of the report, VERTIGO (Vertigo), DIZZINESS (Dizziness) and FEELING ABNORMAL (Slight Frog) outcome was unknown.            Other concomitant medications included cholesterol and blood pressure medications. Treatment information was not reported.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: he received the 2nd dose on day 35 after the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (he received the 2nd dose on day 35 after the 1st dose) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (he received the 2nd dose on day 35 after the 1st dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (he received the 2nd dose on day 35 after the 1st dose) had resolved. Not Provided          Concomitant medications were not provided. Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Event verbatim updated
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Flushing, Pruritus
Clinical narrative: At 28 mins after 1st dose, her mouth got itchy; cheeks were flushed; Her BP went up about 20-30 points of her normal BP; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (At 28 mins after 1st dose, her mouth got itchy), FLUSHING (cheeks were flushed) and BLOOD PRESSURE INCREASED (Her BP went up about 20-30 points of her normal BP) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma. Concomitant products included ACYCLOVIR [ACICLOVIR] and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 05-Mar-2021, the patient experienced PRURITUS (At 28 mins after 1st dose, her mouth got itchy), FLUSHING (cheeks were flushed) and BLOOD PRESSURE INCREASED (Her BP went up about 20-30 points of her normal BP). At the time of the report, PRURITUS (At 28 mins after 1st dose, her mouth got itchy), FLUSHING (cheeks were flushed) and BLOOD PRESSURE INCREASED (Her BP went up about 20-30 points of her normal BP) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitant medication was oral chemo therapy. Treatment medication included diphenhydramine hydrochloride and asthma inhaler.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Balance disorder, Chills, Eating disorder, Fatigue
Clinical narrative: She doesn't feel like eating; She is not steady on her feet; As of now, she feels fatigued; Back pain; pain in hands, wrists, and ankles; At night, she started with chills; After an hour of receiving 2nd dose, she had a painful arm; Headache; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back pain), PAIN IN EXTREMITY (pain in hands, wrists, and ankles), EATING DISORDER (She doesn't feel like eating), BALANCE DISORDER (She is not steady on her feet) and CHILLS (At night, she started with chills) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Thyroid disorder NOS and Glaucoma.   On 30-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced BACK PAIN (Back pain), PAIN IN EXTREMITY (pain in hands, wrists, and ankles), CHILLS (At night, she started with chills), VACCINATION SITE PAIN (After an hour of receiving 2nd dose, she had a painful arm) and HEADACHE (Headache). On 31-Mar-2021, the patient experienced EATING DISORDER (She doesn't feel like eating), BALANCE DISORDER (She is not steady on her feet) and FATIGUE (As of now, she feels fatigued). At the time of the report, BACK PAIN (Back pain), PAIN IN EXTREMITY (pain in hands, wrists, and ankles), EATING DISORDER (She doesn't feel like eating), BALANCE DISORDER (She is not steady on her feet), CHILLS (At night, she started with chills), VACCINATION SITE PAIN (After an hour of receiving 2nd dose, she had a painful arm), HEADACHE (Headache) and FATIGUE (As of now, she feels fatigued) outcome was unknown.            Concomitant medications include Thyroid medication, glaucoma drops, anti-depressant.  No treatment information was reported.     Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Follow-up Telephone Contact Report (TCR) received on 13-May-2021 contains No new information
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Vaccination site pain
Clinical narrative: She doesn't feel like eating; She is not steady on her feet; As of now, she feels fatigued; Back pain; pain in hands, wrists, and ankles; At night, she started with chills; After an hour of receiving 2nd dose, she had a painful arm; Headache; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back pain), PAIN IN EXTREMITY (pain in hands, wrists, and ankles), EATING DISORDER (She doesn't feel like eating), BALANCE DISORDER (She is not steady on her feet) and CHILLS (At night, she started with chills) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Thyroid disorder NOS and Glaucoma.   On 30-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced BACK PAIN (Back pain), PAIN IN EXTREMITY (pain in hands, wrists, and ankles), CHILLS (At night, she started with chills), VACCINATION SITE PAIN (After an hour of receiving 2nd dose, she had a painful arm) and HEADACHE (Headache). On 31-Mar-2021, the patient experienced EATING DISORDER (She doesn't feel like eating), BALANCE DISORDER (She is not steady on her feet) and FATIGUE (As of now, she feels fatigued). At the time of the report, BACK PAIN (Back pain), PAIN IN EXTREMITY (pain in hands, wrists, and ankles), EATING DISORDER (She doesn't feel like eating), BALANCE DISORDER (She is not steady on her feet), CHILLS (At night, she started with chills), VACCINATION SITE PAIN (After an hour of receiving 2nd dose, she had a painful arm), HEADACHE (Headache) and FATIGUE (As of now, she feels fatigued) outcome was unknown.            Concomitant medications include Thyroid medication, glaucoma drops, anti-depressant.  No treatment information was reported.     Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Follow-up Telephone Contact Report (TCR) received on 13-May-2021 contains No new information
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Feeling abnormal, Headache
Clinical narrative: foggy brain; couldn't drive; Vomited once; really tired; headache; weak muscles; fever of 103; chills; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (weak muscles), FEELING ABNORMAL (foggy brain), IMPAIRED DRIVING ABILITY (couldn't drive), PYREXIA (fever of 103) and CHILLS (chills) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced MUSCULAR WEAKNESS (weak muscles), PYREXIA (fever of 103), CHILLS (chills) and HEADACHE (headache). On an unknown date, the patient experienced FEELING ABNORMAL (foggy brain), IMPAIRED DRIVING ABILITY (couldn't drive), VOMITING (Vomited once) and FATIGUE (really tired). The patient was treated with PARACETAMOL (TYLENOL) on 19-Mar-2021 for Fever, at an unspecified dose and frequency. At the time of the report, MUSCULAR WEAKNESS (weak muscles), FEELING ABNORMAL (foggy brain), IMPAIRED DRIVING ABILITY (couldn't drive), PYREXIA (fever of 103), CHILLS (chills), VOMITING (Vomited once), FATIGUE (really tired) and HEADACHE (headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Mar-2021, Body temperature: 103 (High) 103.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient tested negative for COVID and the flu. Concomitant medications were not provided.
Sex: F
Vaccine: COVID19
Symptoms: Impaired driving ability, Muscular weakness, Pyrexia, Vomiting
Clinical narrative: foggy brain; couldn't drive; Vomited once; really tired; headache; weak muscles; fever of 103; chills; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (weak muscles), FEELING ABNORMAL (foggy brain), IMPAIRED DRIVING ABILITY (couldn't drive), PYREXIA (fever of 103) and CHILLS (chills) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced MUSCULAR WEAKNESS (weak muscles), PYREXIA (fever of 103), CHILLS (chills) and HEADACHE (headache). On an unknown date, the patient experienced FEELING ABNORMAL (foggy brain), IMPAIRED DRIVING ABILITY (couldn't drive), VOMITING (Vomited once) and FATIGUE (really tired). The patient was treated with PARACETAMOL (TYLENOL) on 19-Mar-2021 for Fever, at an unspecified dose and frequency. At the time of the report, MUSCULAR WEAKNESS (weak muscles), FEELING ABNORMAL (foggy brain), IMPAIRED DRIVING ABILITY (couldn't drive), PYREXIA (fever of 103), CHILLS (chills), VOMITING (Vomited once), FATIGUE (really tired) and HEADACHE (headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Mar-2021, Body temperature: 103 (High) 103.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient tested negative for COVID and the flu. Concomitant medications were not provided.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site warmth, Musculoskeletal disorder, Myalgia, Pain in extremity
Clinical narrative: R arm hot to touch; R arm hurts; R arm she has like a chicken egg/Swelling in arm after 2nd dose; side effects from the 2nd dose. She says it was like she had duck eggs all up and down her arms; she says picking things up has been a nightmare; R arm of injection red; Knots in arm after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (R arm hot to touch), PAIN IN EXTREMITY (R arm hurts), PERIPHERAL SWELLING (R arm she has like a chicken egg/Swelling in arm after 2nd dose), SKIN DISORDER (side effects from the 2nd dose. She says it was like she had duck eggs all up and down her arms) and MUSCULOSKELETAL DISORDER (she says picking things up has been a nightmare) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Breast cancer (Breast cancer survivor). Concurrent medical conditions included Allergy NOS (Allergies to medicines) and Idiopathic thrombocytopenic purpura (turned black, Says the radiation caused her body to attack its own cells and cause the ITP). Concomitant products included ELTROMBOPAG OLAMINE (PROMACTA), POTASSIUM CHLORIDE, METOPROLOL TARTRATE, LOVASTATIN, PANTOPRAZOLE SODIUM ANHYDROUS and VITAMIN D NOS for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INJECTION SITE WARMTH (R arm hot to touch), PAIN IN EXTREMITY (R arm hurts), PERIPHERAL SWELLING (R arm she has like a chicken egg/Swelling in arm after 2nd dose), SKIN DISORDER (side effects from the 2nd dose. She says it was like she had duck eggs all up and down her arms), MUSCULOSKELETAL DISORDER (she says picking things up has been a nightmare), INJECTION SITE ERYTHEMA (R arm of injection red) and MYALGIA (Knots in arm after 2nd dose). At the time of the report, INJECTION SITE WARMTH (R arm hot to touch), PAIN IN EXTREMITY (R arm hurts), SKIN DISORDER (side effects from the 2nd dose. She says it was like she had duck eggs all up and down her arms), MUSCULOSKELETAL DISORDER (she says picking things up has been a nightmare), INJECTION SITE ERYTHEMA (R arm of injection red) and MYALGIA (Knots in arm after 2nd dose) outcome was unknown and PERIPHERAL SWELLING (R arm she has like a chicken egg/Swelling in arm after 2nd dose) was resolving.            No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: significant followup On 08-Jul-2021: Follow up included no new information.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Skin disorder
Clinical narrative: R arm hot to touch; R arm hurts; R arm she has like a chicken egg/Swelling in arm after 2nd dose; side effects from the 2nd dose. She says it was like she had duck eggs all up and down her arms; she says picking things up has been a nightmare; R arm of injection red; Knots in arm after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (R arm hot to touch), PAIN IN EXTREMITY (R arm hurts), PERIPHERAL SWELLING (R arm she has like a chicken egg/Swelling in arm after 2nd dose), SKIN DISORDER (side effects from the 2nd dose. She says it was like she had duck eggs all up and down her arms) and MUSCULOSKELETAL DISORDER (she says picking things up has been a nightmare) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Breast cancer (Breast cancer survivor). Concurrent medical conditions included Allergy NOS (Allergies to medicines) and Idiopathic thrombocytopenic purpura (turned black, Says the radiation caused her body to attack its own cells and cause the ITP). Concomitant products included ELTROMBOPAG OLAMINE (PROMACTA), POTASSIUM CHLORIDE, METOPROLOL TARTRATE, LOVASTATIN, PANTOPRAZOLE SODIUM ANHYDROUS and VITAMIN D NOS for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INJECTION SITE WARMTH (R arm hot to touch), PAIN IN EXTREMITY (R arm hurts), PERIPHERAL SWELLING (R arm she has like a chicken egg/Swelling in arm after 2nd dose), SKIN DISORDER (side effects from the 2nd dose. She says it was like she had duck eggs all up and down her arms), MUSCULOSKELETAL DISORDER (she says picking things up has been a nightmare), INJECTION SITE ERYTHEMA (R arm of injection red) and MYALGIA (Knots in arm after 2nd dose). At the time of the report, INJECTION SITE WARMTH (R arm hot to touch), PAIN IN EXTREMITY (R arm hurts), SKIN DISORDER (side effects from the 2nd dose. She says it was like she had duck eggs all up and down her arms), MUSCULOSKELETAL DISORDER (she says picking things up has been a nightmare), INJECTION SITE ERYTHEMA (R arm of injection red) and MYALGIA (Knots in arm after 2nd dose) outcome was unknown and PERIPHERAL SWELLING (R arm she has like a chicken egg/Swelling in arm after 2nd dose) was resolving.            No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: significant followup On 08-Jul-2021: Follow up included no new information.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Blister, Chills, Lethargy, Pain in extremity, Pyrexia
Clinical narrative: Blisters/ scabs are now healed where they wouldn't before.; Chills; fever range 101; Lethargy; Rash; aches; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER, CHILLS, PYREXIA, LETHARGY, and RASH in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012120A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Bladder cancer.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient experienced BLISTER, CHILLS, PYREXIA, LETHARGY, RASH, and PAIN IN EXTREMITY. The patient was treated with TYLENOL for Adverse event, at an unspecified dose and frequency. At the time of the report, BLISTER, CHILLS, PYREXIA, LETHARGY, RASH, and PAIN IN EXTREMITY outcome was unknown. Not Provided.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above On 13-May-2021.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Blisters/ scabs are now healed where they wouldn't before.; Chills; fever range 101; Lethargy; Rash; aches; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER, CHILLS, PYREXIA, LETHARGY, and RASH in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012120A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Bladder cancer.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient experienced BLISTER, CHILLS, PYREXIA, LETHARGY, RASH, and PAIN IN EXTREMITY. The patient was treated with TYLENOL for Adverse event, at an unspecified dose and frequency. At the time of the report, BLISTER, CHILLS, PYREXIA, LETHARGY, RASH, and PAIN IN EXTREMITY outcome was unknown. Not Provided.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above On 13-May-2021.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Mass, Vaccination site pain
Clinical narrative: feeling something weird, a lump on the left side of her neck between shoulder and neck; tender at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of MASS (feeling something weird, a lump on the left side of her neck between shoulder and neck) and VACCINATION SITE PAIN (tender at the injection site) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039AZ1A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced VACCINATION SITE PAIN (tender at the injection site). On 30-Mar-2021, the patient experienced MASS (feeling something weird, a lump on the left side of her neck between shoulder and neck). At the time of the report, MASS (feeling something weird, a lump on the left side of her neck between shoulder and neck) and VACCINATION SITE PAIN (tender at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: a little fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced FATIGUE. On 31-Mar-2021, FATIGUE had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: swelling in the foot (right); This spontaneous case was reported by a physician and describes the occurrence of PERIPHERAL SWELLING (swelling in the foot (right)) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     Concurrent medical conditions included Depression. Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT) for Depression.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced PERIPHERAL SWELLING (swelling in the foot (right)). At the time of the report, PERIPHERAL SWELLING (swelling in the foot (right)) 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 treatment products reported. Patient has swelling in the right foot. It does not hurt and did not have a fever. Consent for safety follow up given. Consent for safety follow up with health care professional given.   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Follow up information was received on 13 May 2021 in which fax number was updated.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Speech disorder
Clinical narrative: speaking was completely gargled and couldn't speak; arm soreness in her right arm; This spontaneous case was reported by a physician and describes the occurrence of SPEECH DISORDER (speaking was completely gargled and couldn't speak) and PAIN IN EXTREMITY (arm soreness in her right arm) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     The patient's past medical history included Congenital heart disease NOS (surgery age 2) on 19-Mar-2001. Concurrent medical conditions included Drug allergy (Multiple sensitivities to meds and foods) since 19-Mar-2001, Allergy NOS (Lacks both of a a type of cyp enzymes) and Food allergy (Multiple sensitivities to meds and foods) since 19-Mar-2001. Concomitant products included ETHINYLESTRADIOL, NORETHISTERONE ACETATE (LOESTRIN) from 03-Jan-2020 to an unknown date, VITAMIN D3 from 01-Jan-2006 to an unknown date, PROBIOTIC 10 from 01-Jan-2016 to an unknown date, SPIRONOLACTONE from 02-Jan-2020 to an unknown date and VALACICLOVIR HYDROCHLORIDE (VALTREX) from 01-Jan-2020 to an unknown date for an unknown indication.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced SPEECH DISORDER (speaking was completely gargled and couldn't speak) and PAIN IN EXTREMITY (arm soreness in her right arm). On 31-Mar-2021, SPEECH DISORDER (speaking was completely gargled and couldn't speak) had resolved. At the time of the report, PAIN IN EXTREMITY (arm soreness in her right arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Follow up received on 17-MAY-2021, patient demographic details and concomitant medication was added.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Injection site pain, Vertigo
Clinical narrative: vertigo; balance loss; dizziness and lightheadedness; arm soreness at injection site/"it hurts" when touched or arm raised above the shoulder; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (vertigo), BALANCE DISORDER (balance loss), DIZZINESS (dizziness and lightheadedness) and INJECTION SITE PAIN (arm soreness at injection site/"it hurts" when touched or arm raised above the shoulder) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     Concurrent medical conditions included Vertigo. Concomitant products included DIAZEPAM for Vertigo.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced INJECTION SITE PAIN (arm soreness at injection site/"it hurts" when touched or arm raised above the shoulder). On 09-Mar-2021, the patient experienced VERTIGO (vertigo), BALANCE DISORDER (balance loss) and DIZZINESS (dizziness and lightheadedness). The patient was treated with DIAZEPAM at a dose of quarter tablet. On 14-Mar-2021, VERTIGO (vertigo), BALANCE DISORDER (balance loss) and DIZZINESS (dizziness and lightheadedness) had resolved. At the time of the report, INJECTION SITE PAIN (arm soreness at injection site/"it hurts" when touched or arm raised above the shoulder) had resolved.        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 medications also included cholesterol medication.  Patient developed symptoms of arm soreness at injection site on 06-MAR-2021 Saturday and 07-MAR-2021 Sunday. Also mentioned as "it hurts" when touched or arm raised above the shoulder. By Monday midnight and Tuesday early morning i.e. on 09-MAR-2021, patient started to experience symptoms like, vertigo, balance loss, dizziness, and lightheadedness. All these symptoms lasted for 5 days and now no symptoms persisting. Patient did quote " This is not the typical vertigo symptom I would experiences often."
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Pain in extremity
Clinical narrative: little dizziness; little sore arm; little nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (little dizziness), PAIN IN EXTREMITY (little sore arm) and NAUSEA (little nausea) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     The patient's past medical history included Stroke. Previously administered products included for Tuberculosis immunisation: VACCINE BCG (Her arm blistered up.) in 2005. Past adverse reactions to the above products included Swollen arm with VACCINE BCG.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced NAUSEA (little nausea). On 16-Mar-2021, the patient experienced DIZZINESS (little dizziness) and PAIN IN EXTREMITY (little sore arm). On 17-Mar-2021, DIZZINESS (little dizziness) and NAUSEA (little nausea) had resolved. At the time of the report, PAIN IN EXTREMITY (little sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications not reported.  Follow-up information received on 12-Apr-2021 included a new event, stop dates for two events and outcome for two events.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: Major narrative update