chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Injection site pruritus, Pain, Pyrexia
Clinical narrative: mild fever; mild chills; mild body aches; swelling at injection site; itching at injection site; redness at injection site; redness traveling down the arm; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (mild fever), CHILLS (mild chills), PAIN (mild body aches), VACCINATION SITE SWELLING (swelling at injection site) and INJECTION SITE PRURITUS (itching at injection site) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, the patient experienced PYREXIA (mild fever), CHILLS (mild chills), PAIN (mild body aches), VACCINATION SITE SWELLING (swelling at injection site), INJECTION SITE PRURITUS (itching at injection site), VACCINATION SITE ERYTHEMA (redness at injection site) and ERYTHEMA (redness traveling down the arm). At the time of the report, PYREXIA (mild fever), CHILLS (mild chills), PAIN (mild body aches), VACCINATION SITE SWELLING (swelling at injection site), INJECTION SITE PRURITUS (itching at injection site), VACCINATION SITE ERYTHEMA (redness at injection site) and ERYTHEMA (redness traveling down the arm) outcome was unknown. Not Provided          No concomitant medications were provided.   This case was linked to MOD-2021-066573 (Patient Link).
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: mild fever; mild chills; mild body aches; swelling at injection site; itching at injection site; redness at injection site; redness traveling down the arm; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (mild fever), CHILLS (mild chills), PAIN (mild body aches), VACCINATION SITE SWELLING (swelling at injection site) and INJECTION SITE PRURITUS (itching at injection site) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, the patient experienced PYREXIA (mild fever), CHILLS (mild chills), PAIN (mild body aches), VACCINATION SITE SWELLING (swelling at injection site), INJECTION SITE PRURITUS (itching at injection site), VACCINATION SITE ERYTHEMA (redness at injection site) and ERYTHEMA (redness traveling down the arm). At the time of the report, PYREXIA (mild fever), CHILLS (mild chills), PAIN (mild body aches), VACCINATION SITE SWELLING (swelling at injection site), INJECTION SITE PRURITUS (itching at injection site), VACCINATION SITE ERYTHEMA (redness at injection site) and ERYTHEMA (redness traveling down the arm) outcome was unknown. Not Provided          No concomitant medications were provided.   This case was linked to MOD-2021-066573 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Felt Horrible for 3 days; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Felt Horrible for 3 days) 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.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced MALAISE (Felt Horrible for 3 days). At the time of the report, MALAISE (Felt Horrible for 3 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication was not provided.No concomitant medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-089606, US-MODERNATX, INC.-MOD-2021-083018 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-089606:Crosslinked case US-MODERNATX, INC.-MOD-2021-083018:crosslinked case
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (light headache) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No reported medical history.  Concomitant products included LEVOTHYROXINE, FLUOXETINE, ATORVASTATIN and supplements for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced HEADACHE (light headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 24-Mar-2021, HEADACHE (light headache) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-089646 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-089646:Dose 2
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: FLU LIKE SYMPTOMS; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (FLU LIKE SYMPTOMS) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  Concurrent medical conditions included Hypertension and Type 2 diabetes mellitus.   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, the patient experienced INFLUENZA LIKE ILLNESS (FLU LIKE SYMPTOMS). At the time of the report, INFLUENZA LIKE ILLNESS (FLU LIKE SYMPTOMS) outcome was unknown.     No concomitant medications were provided.  No treatments were provided,  This case was linked to MOD-2021-087587.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Feeling hot, Gait disturbance, Limb discomfort, Pain
Clinical narrative: hot arm; discomfort; swollen arm; could not run; right leg felt like small stings; arm felt uncomfortable.; pain in her arm; normal pain of vaccination during the day; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (arm felt uncomfortable.), GAIT DISTURBANCE (could not run), PAIN (right leg felt like small stings), FEELING HOT (hot arm) and DISCOMFORT (discomfort) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and 003BB21A) 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) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 22-Apr-2021, the patient experienced LIMB DISCOMFORT (arm felt uncomfortable.), PAIN (right leg felt like small stings), PAIN IN EXTREMITY (pain in her arm) and VACCINATION SITE PAIN (normal pain of vaccination during the day). On 23-Apr-2021, the patient experienced GAIT DISTURBANCE (could not run), FEELING HOT (hot arm), DISCOMFORT (discomfort) and PERIPHERAL SWELLING (swollen arm). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at a dose of UNK dosage form and EPHEDRINE at a dose of UNK dosage form. On 22-Apr-2021, PAIN (right leg felt like small stings) and VACCINATION SITE PAIN (normal pain of vaccination during the day) had resolved. At the time of the report, LIMB DISCOMFORT (arm felt uncomfortable.), GAIT DISTURBANCE (could not run), FEELING HOT (hot arm), DISCOMFORT (discomfort), PERIPHERAL SWELLING (swollen arm) and PAIN IN EXTREMITY (pain in her arm) outcome was unknown.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Vaccination site pain
Clinical narrative: hot arm; discomfort; swollen arm; could not run; right leg felt like small stings; arm felt uncomfortable.; pain in her arm; normal pain of vaccination during the day; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (arm felt uncomfortable.), GAIT DISTURBANCE (could not run), PAIN (right leg felt like small stings), FEELING HOT (hot arm) and DISCOMFORT (discomfort) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and 003BB21A) 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) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 22-Apr-2021, the patient experienced LIMB DISCOMFORT (arm felt uncomfortable.), PAIN (right leg felt like small stings), PAIN IN EXTREMITY (pain in her arm) and VACCINATION SITE PAIN (normal pain of vaccination during the day). On 23-Apr-2021, the patient experienced GAIT DISTURBANCE (could not run), FEELING HOT (hot arm), DISCOMFORT (discomfort) and PERIPHERAL SWELLING (swollen arm). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at a dose of UNK dosage form and EPHEDRINE at a dose of UNK dosage form. On 22-Apr-2021, PAIN (right leg felt like small stings) and VACCINATION SITE PAIN (normal pain of vaccination during the day) had resolved. At the time of the report, LIMB DISCOMFORT (arm felt uncomfortable.), GAIT DISTURBANCE (could not run), FEELING HOT (hot arm), DISCOMFORT (discomfort), PERIPHERAL SWELLING (swollen arm) and PAIN IN EXTREMITY (pain in her arm) outcome was unknown.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received the Moderna vaccine 14 days apart.; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the Moderna vaccine 14 days apart.) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037D21A and 037D21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the Moderna vaccine 14 days apart.). On 23-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the Moderna vaccine 14 days apart.) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: light headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (light headache) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 001C21A) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included LEVOTHYROXINE, FLUOXETINE and ATORVASTATIN for an unknown indication.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced HEADACHE (light headache). At the time of the report, HEADACHE (light headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitant medicine: Supplements Treatment Tylenol tablets different strength, Tylenol liquid and heating of muscles by warmer.   This case was linked to US-MODERNATX, INC.-MOD-2021-089631 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-089631:
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Headache, Pain, Peripheral swelling, Pyrexia
Clinical narrative: Back ache; Felt a whole pain; Fever; Headache is killing me; Arm was swollen a bit; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm was swollen a bit), BACK PAIN (Back ache), PAIN (Felt a whole pain), PYREXIA (Fever) and HEADACHE (Headache is killing me) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C2119) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient mentioned that she had COVID back in January).    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced PERIPHERAL SWELLING (Arm was swollen a bit). On 23-Apr-2021, the patient experienced BACK PAIN (Back ache), PAIN (Felt a whole pain), PYREXIA (Fever) and HEADACHE (Headache is killing me). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 650 milligram every four hours. At the time of the report, PERIPHERAL SWELLING (Arm was swollen a bit), BACK PAIN (Back ache), PAIN (Felt a whole pain), PYREXIA (Fever) and HEADACHE (Headache is killing me) 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.   Treatment Patient drinks water to treat symptoms
Sex: U
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: 3 persons felt dizziness after vaccination; 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 DIZZINESS (3 persons felt dizziness after vaccination) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (3 persons felt dizziness after vaccination). At the time of the report, DIZZINESS (3 persons felt dizziness after vaccination) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant and treatment medication was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-089271, US-MODERNATX, INC.-MOD-2021-089661 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-089271:Reporter case US-MODERNATX, INC.-MOD-2021-089661:Wife case
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 039A21A) for COVID-19 vaccination.     No past medical history was provided by reporter.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on 16-Mar-2021 and the estimated date of delivery was 21-Dec-2021. On 07-Apr-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  On 07-Apr-2021, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved. Not Provided          Concomitant medications included medicine for birth control. Treatment details was not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: LMP date provided
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Inappropriate schedule of product administration
Clinical narrative: second dose of Moderna COVID-19 Vaccine delayed almost 75 days apart; Got Shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Got Shingles) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose of Moderna COVID-19 Vaccine delayed almost 75 days apart) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN and ATORVASTATIN CALCIUM (LIPITOR) for Cholesterol, HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN HCT) and AMLODIPINE for Hypertension, LEVOTHYROXINE for Thyroid disorder NOS.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced HERPES ZOSTER (Got Shingles). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose of Moderna COVID-19 Vaccine delayed almost 75 days apart). The patient was treated with GABAPENTIN at a dose of 100 milligram; VALACICLOVIR HYDROCHLORIDE (VALACYCLOVIR HCL) at a dose of 1 g and ALUMINIUM CHLOROHYDRATE, METHYLPREDNISOLONE ACETATE, SULFUR (MEDROL COMP) at an unspecified dose and frequency. At the time of the report, HERPES ZOSTER (Got Shingles) was resolving and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose of Moderna COVID-19 Vaccine delayed almost 75 days apart) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment details included Gabapentin 100mg, valacyclovir 1gm, medrol dose pack.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: New event added
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Nausea, Vomiting
Clinical narrative: Residual effects /SOB; Nausea; Vomiting; This spontaneous case was reported by an other health care professional and describes the occurrence of DYSPNOEA (Residual effects /SOB), NAUSEA (Nausea) and VOMITING (Vomiting) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 012L20A) for COVID-19 vaccination.     The patient's past medical history included Shoulder operation (Patient had right shoulder surgery over 10 years ago). Concurrent medical conditions included Contrast media allergy. Concomitant products included RALOXIFENE HYDROCHLORIDE (EVISTA) for Bone disorder NOS.   On 14-Jan-2021 at 4:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021 at 4:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced NAUSEA (Nausea) and VOMITING (Vomiting). On an unknown date, the patient experienced DYSPNOEA (Residual effects /SOB). At the time of the report, DYSPNOEA (Residual effects /SOB) outcome was unknown and NAUSEA (Nausea) and VOMITING (Vomiting) had resolved with sequelae.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.   This case was linked to MOD-2021-027190 (Patient Link).
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: received 1st doses while pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (received 1st doses while pregnant) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No medical history was provided.  Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) and MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 23-Aug-2021. On 15-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (received 1st doses while pregnant). On 15-Feb-2021, EXPOSURE DURING PREGNANCY (received 1st doses while pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: mild body aches; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (mild body aches) and FATIGUE (fatigue) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 011M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced PAIN (mild body aches) and FATIGUE (fatigue). On 16-Mar-2021, PAIN (mild body aches) and FATIGUE (fatigue) had resolved.            No concomitant products were reported.  Treatment medication included Tylenol once in a day.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: a red area around where she got the shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (a red area around where she got the shot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (a red area around where she got the shot). At the time of the report, VACCINATION SITE ERYTHEMA (a red area around where she got the shot) outcome was unknown.            Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: 3 persons felt dizziness after vaccination; 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 DIZZINESS (3 persons felt dizziness after vaccination) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (3 persons felt dizziness after vaccination). At the time of the report, DIZZINESS (3 persons felt dizziness after vaccination) outcome was unknown. Not Provided    No concomitant and treatment details were provided.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-089650, US-MODERNATX, INC.-MOD-2021-089271 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-089650:Wife case US-MODERNATX, INC.-MOD-2021-089271:Reporter case
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: swollen lymph node; This spontaneous case was reported by a nurse and describes the occurrence of LYMPHADENOPATHY (swollen lymph node) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form(s). On an unknown date, the patient experienced LYMPHADENOPATHY (swollen lymph node). At the time of the report, LYMPHADENOPATHY (swollen lymph node) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No  concomitant medical  provided by the reporter. No treatment information provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2021-089616 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-089616:
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: a "little pain in the arm" at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (a "little pain in the arm" at the injection site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included IBUPROFEN (ADVIL [IBUPROFEN]) for an unknown indication.    On 22-Apr-2021, 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 (a "little pain in the arm" at the injection site). At the time of the report, VACCINATION SITE PAIN (a "little pain in the arm" at the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  It was reported that the patient took Advil 2 hours prior to the vaccination.  It was unknown if the IM injection was given into the left or right deltoid.   Reporter did not allow further contact
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Blood pressure measurement, Cold sweat, Diplopia, Headache
Clinical narrative: headache; stomach ache; rash on chin and ear; blurred vision double vision fleeting; blurred vision double vision fleeting; weak in knees; nausea; clammy; sweating; This spontaneous case was reported by a consumer and describes the occurrence of COLD SWEAT (clammy), HYPERHIDROSIS (sweating), ABDOMINAL PAIN UPPER (stomach ache), VISION BLURRED (blurred vision double vision fleeting) and DIPLOPIA (blurred vision double vision fleeting) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced COLD SWEAT (clammy), HYPERHIDROSIS (sweating), VISION BLURRED (blurred vision double vision fleeting), DIPLOPIA (blurred vision double vision fleeting), MUSCULAR WEAKNESS (weak in knees) and NAUSEA (nausea). On 25-Mar-2021, the patient experienced RASH (rash on chin and ear). On 29-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach ache). On 30-Mar-2021, the patient experienced HEADACHE (headache). The patient was treated with NEBIVOLOL HYDROCHLORIDE (BYSTOLIC) on 19-Apr-2021 for Blood pressure management, at an unspecified dose and frequency. At the time of the report, COLD SWEAT (clammy), HYPERHIDROSIS (sweating), ABDOMINAL PAIN UPPER (stomach ache), VISION BLURRED (blurred vision double vision fleeting), DIPLOPIA (blurred vision double vision fleeting), MUSCULAR WEAKNESS (weak in knees), RASH (rash on chin and ear), HEADACHE (headache) and NAUSEA (nausea) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Apr-2021, Polymerase chain reaction: negative (Negative) Negative. On an unknown date, Blood pressure measurement: abnormal mmHg (abnormal) Blood Pressure reading 202/107, 172/94 mmHg (abnormal) 172/94, 120/82 mmHg (abnormal) 120/82 and 160/90 mmHg (abnormal) 160/90.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Relevant concomitant medications was reported.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Muscular weakness, Nausea, Polymerase chain reaction, Rash
Clinical narrative: headache; stomach ache; rash on chin and ear; blurred vision double vision fleeting; blurred vision double vision fleeting; weak in knees; nausea; clammy; sweating; This spontaneous case was reported by a consumer and describes the occurrence of COLD SWEAT (clammy), HYPERHIDROSIS (sweating), ABDOMINAL PAIN UPPER (stomach ache), VISION BLURRED (blurred vision double vision fleeting) and DIPLOPIA (blurred vision double vision fleeting) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced COLD SWEAT (clammy), HYPERHIDROSIS (sweating), VISION BLURRED (blurred vision double vision fleeting), DIPLOPIA (blurred vision double vision fleeting), MUSCULAR WEAKNESS (weak in knees) and NAUSEA (nausea). On 25-Mar-2021, the patient experienced RASH (rash on chin and ear). On 29-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach ache). On 30-Mar-2021, the patient experienced HEADACHE (headache). The patient was treated with NEBIVOLOL HYDROCHLORIDE (BYSTOLIC) on 19-Apr-2021 for Blood pressure management, at an unspecified dose and frequency. At the time of the report, COLD SWEAT (clammy), HYPERHIDROSIS (sweating), ABDOMINAL PAIN UPPER (stomach ache), VISION BLURRED (blurred vision double vision fleeting), DIPLOPIA (blurred vision double vision fleeting), MUSCULAR WEAKNESS (weak in knees), RASH (rash on chin and ear), HEADACHE (headache) and NAUSEA (nausea) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Apr-2021, Polymerase chain reaction: negative (Negative) Negative. On an unknown date, Blood pressure measurement: abnormal mmHg (abnormal) Blood Pressure reading 202/107, 172/94 mmHg (abnormal) 172/94, 120/82 mmHg (abnormal) 120/82 and 160/90 mmHg (abnormal) 160/90.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Relevant concomitant medications was reported.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: headache; stomach ache; rash on chin and ear; blurred vision double vision fleeting; blurred vision double vision fleeting; weak in knees; nausea; clammy; sweating; This spontaneous case was reported by a consumer and describes the occurrence of COLD SWEAT (clammy), HYPERHIDROSIS (sweating), ABDOMINAL PAIN UPPER (stomach ache), VISION BLURRED (blurred vision double vision fleeting) and DIPLOPIA (blurred vision double vision fleeting) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced COLD SWEAT (clammy), HYPERHIDROSIS (sweating), VISION BLURRED (blurred vision double vision fleeting), DIPLOPIA (blurred vision double vision fleeting), MUSCULAR WEAKNESS (weak in knees) and NAUSEA (nausea). On 25-Mar-2021, the patient experienced RASH (rash on chin and ear). On 29-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach ache). On 30-Mar-2021, the patient experienced HEADACHE (headache). The patient was treated with NEBIVOLOL HYDROCHLORIDE (BYSTOLIC) on 19-Apr-2021 for Blood pressure management, at an unspecified dose and frequency. At the time of the report, COLD SWEAT (clammy), HYPERHIDROSIS (sweating), ABDOMINAL PAIN UPPER (stomach ache), VISION BLURRED (blurred vision double vision fleeting), DIPLOPIA (blurred vision double vision fleeting), MUSCULAR WEAKNESS (weak in knees), RASH (rash on chin and ear), HEADACHE (headache) and NAUSEA (nausea) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Apr-2021, Polymerase chain reaction: negative (Negative) Negative. On an unknown date, Blood pressure measurement: abnormal mmHg (abnormal) Blood Pressure reading 202/107, 172/94 mmHg (abnormal) 172/94, 120/82 mmHg (abnormal) 120/82 and 160/90 mmHg (abnormal) 160/90.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Relevant concomitant medications was reported.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: headache; Developed injection arm soreness after receiving Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) and VACCINATION SITE PAIN (Developed injection arm soreness after receiving Moderna vaccine) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache) and VACCINATION SITE PAIN (Developed injection arm soreness after receiving Moderna vaccine). At the time of the report, HEADACHE (headache) and VACCINATION SITE PAIN (Developed injection arm soreness after receiving Moderna vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-089696, US-MODERNATX, INC.-MOD-2021-089717 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-089696:Crosse linked
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Product temperature excursion issue, Vaccination site pain
Clinical narrative: some soreness; some stiffness; I am concerned that I received the 2nd dose from a facility that had a power outage; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (some soreness), MUSCULOSKELETAL STIFFNESS (some stiffness) and PRODUCT TEMPERATURE EXCURSION ISSUE (I am concerned that I received the 2nd dose from a facility that had a power outage) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 030B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced VACCINATION SITE PAIN (some soreness), MUSCULOSKELETAL STIFFNESS (some stiffness) and PRODUCT TEMPERATURE EXCURSION ISSUE (I am concerned that I received the 2nd dose from a facility that had a power outage). At the time of the report, VACCINATION SITE PAIN (some soreness), MUSCULOSKELETAL STIFFNESS (some stiffness) and PRODUCT TEMPERATURE EXCURSION ISSUE (I am concerned that I received the 2nd dose from a facility that had a power outage) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Dyspepsia, Fatigue, Mass
Clinical narrative: tightness in chest that feels like she needs to belch; chest pain that is increasing; arm extremely sore like being hit with a damn ton of bricks; slight knot in arm; extremely tired; nauseated; indigestion; This spontaneous case was reported by a consumer and describes the occurrence of DYSPEPSIA (indigestion), CHEST DISCOMFORT (tightness in chest that feels like she needs to belch), CHEST PAIN (chest pain that is increasing), PAIN IN EXTREMITY (arm extremely sore like being hit with a damn ton of bricks) and MASS (slight knot in arm) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included UBROGEPANT (UBRELVY) and TOPIRAMATE (TOPAMAX) for Migraine, MULTIVITAMIN & MINERAL for an unknown indication.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced DYSPEPSIA (indigestion), PAIN IN EXTREMITY (arm extremely sore like being hit with a damn ton of bricks), MASS (slight knot in arm), FATIGUE (extremely tired) and NAUSEA (nauseated). On 23-Apr-2021 at 4:00 PM, the patient experienced CHEST DISCOMFORT (tightness in chest that feels like she needs to belch). 23-Apr-2021 at 4:00 PM, the patient experienced CHEST PAIN (chest pain that is increasing). At the time of the report, DYSPEPSIA (indigestion) and NAUSEA (nauseated) was resolving and CHEST DISCOMFORT (tightness in chest that feels like she needs to belch), CHEST PAIN (chest pain that is increasing), PAIN IN EXTREMITY (arm extremely sore like being hit with a damn ton of bricks), MASS (slight knot in arm) and FATIGUE (extremely tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Medical history reported.   Patient self treated with acetaminophen, ibuprofen, and ranitidine.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity
Clinical narrative: tightness in chest that feels like she needs to belch; chest pain that is increasing; arm extremely sore like being hit with a damn ton of bricks; slight knot in arm; extremely tired; nauseated; indigestion; This spontaneous case was reported by a consumer and describes the occurrence of DYSPEPSIA (indigestion), CHEST DISCOMFORT (tightness in chest that feels like she needs to belch), CHEST PAIN (chest pain that is increasing), PAIN IN EXTREMITY (arm extremely sore like being hit with a damn ton of bricks) and MASS (slight knot in arm) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included UBROGEPANT (UBRELVY) and TOPIRAMATE (TOPAMAX) for Migraine, MULTIVITAMIN & MINERAL for an unknown indication.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced DYSPEPSIA (indigestion), PAIN IN EXTREMITY (arm extremely sore like being hit with a damn ton of bricks), MASS (slight knot in arm), FATIGUE (extremely tired) and NAUSEA (nauseated). On 23-Apr-2021 at 4:00 PM, the patient experienced CHEST DISCOMFORT (tightness in chest that feels like she needs to belch). 23-Apr-2021 at 4:00 PM, the patient experienced CHEST PAIN (chest pain that is increasing). At the time of the report, DYSPEPSIA (indigestion) and NAUSEA (nauseated) was resolving and CHEST DISCOMFORT (tightness in chest that feels like she needs to belch), CHEST PAIN (chest pain that is increasing), PAIN IN EXTREMITY (arm extremely sore like being hit with a damn ton of bricks), MASS (slight knot in arm) and FATIGUE (extremely tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Medical history reported.   Patient self treated with acetaminophen, ibuprofen, and ranitidine.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Pain in extremity
Clinical narrative: sore left arm; Headache; dizziness; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (Headache), DIZZINESS (dizziness) and PAIN IN EXTREMITY (sore left arm) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002b21a) 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) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced HEADACHE (Headache) and DIZZINESS (dizziness). On 26-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore left arm). On 25-Mar-2021, HEADACHE (Headache) and DIZZINESS (dizziness) outcome was unknown. On 28-Mar-2021, PAIN IN EXTREMITY (sore left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Treatment medication was provided by the reporter. No concomitant medication was provided by the reporter. No lab data was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2021-089330 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-089330:Husband Case
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: Other patients had side effects after Moderna vaccine; 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 ADVERSE DRUG REACTION (Other patients had side effects after Moderna vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced ADVERSE DRUG REACTION (Other patients had side effects after Moderna vaccine). At the time of the report, ADVERSE DRUG REACTION (Other patients had side effects after Moderna vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided. No treatment medications provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-089398 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-089398:
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Dyspnoea, Illness
Clinical narrative: Get dizzy; So weak to lift my arms/ cannot walk because he is to weak; Trouble breathing/ shortness of breath; So sick now i don't think i'm gonna make it; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 30-Mar-2021. The most recent information was received on 21-May-2021 and was forwarded to Moderna on 21-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (So weak to lift my arms/ cannot walk because he is to weak), DYSPNOEA (Trouble breathing/ shortness of breath), ILLNESS (So sick now i don't think i'm gonna make it) and DIZZINESS (Get dizzy) 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) (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 23-Apr-2021, the patient experienced ASTHENIA (So weak to lift my arms/ cannot walk because he is to weak), DYSPNOEA (Trouble breathing/ shortness of breath) and ILLNESS (So sick now i don't think i'm gonna make it). On an unknown date, the patient experienced DIZZINESS (Get dizzy). At the time of the report, ASTHENIA (So weak to lift my arms/ cannot walk because he is to weak), ILLNESS (So sick now i don't think i'm gonna make it) and DIZZINESS (Get dizzy) outcome was unknown and DYSPNOEA (Trouble breathing/ shortness of breath) had not resolved.            Concomitant product use was not provided by the reporter. The patient stated that the breathing is getting better but not so good. Treatment information included goes twice a week for breathing therapy.  The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Follow up received  includes additional event, updated outcome of the event, dosage details (received 2 shots) and narrative were updated. On 06-Aug-2021: Followup Received includes : updated patients home Address received.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Vaccination site rash
Clinical narrative: Rash on the arm of the injection and back; Felling winded; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash on the arm of the injection and back) and DYSPNOEA (Felling winded) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced VACCINATION SITE RASH (Rash on the arm of the injection and back) and DYSPNOEA (Felling winded). At the time of the report, VACCINATION SITE RASH (Rash on the arm of the injection and back) and DYSPNOEA (Felling winded) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-089559 (Patient Link).
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: headache; little nausea; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) and NAUSEA (little nausea) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) 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 19-Mar-2021, the patient experienced HEADACHE (headache) and NAUSEA (little nausea). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 19-Mar-2021, HEADACHE (headache) and NAUSEA (little nausea) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   This case was linked to MOD-2021-089710 (Patient Link).