chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Limb discomfort, Vaccination site rash
Clinical narrative: Red rash over injection site; Right upper arm typical discomfort after vaccination; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of LIMB DISCOMFORT (Right upper arm typical discomfort after vaccination) and VACCINATION SITE RASH (Red rash over injection site) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced LIMB DISCOMFORT (Right upper arm typical discomfort after vaccination). On an unknown date, the patient experienced VACCINATION SITE RASH (Red rash over injection site). At the time of the report, LIMB DISCOMFORT (Right upper arm typical discomfort after vaccination) and VACCINATION SITE RASH (Red rash over injection site) 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 medications were provided No treatment information provided; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 96.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Influenza like illness
Clinical narrative: Flu like symptoms; Dizzy; Headache; Chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), DIZZINESS (Dizzy), HEADACHE (Headache) and CHILLS (Chills) in a 96-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included DABIGATRAN ETEXILATE MESILATE (PRADAXA) and CALCIUM for an unknown indication.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), DIZZINESS (Dizzy), HEADACHE (Headache) and CHILLS (Chills). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), DIZZINESS (Dizzy), HEADACHE (Headache) and CHILLS (Chills) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for the symptoms included Tylenol.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Chills, Myalgia, Nausea
Clinical narrative: congestion in her chest and throat; Body aches; Vomiting; Nausea; Chills; Fever; dosn't feel good; lost her sense of taste and smell; loss of taste; A spontaneous report was received from a 56-year-old female consumer who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed fever, chills, nausea, vomiting, body aches, not feeling good, loss of taste and congestion in her chest and throat.    The patient's medical history, as provided by the reporter, included COVID-19 infection in November 2020.  Concomitant product use was not provided.  On 05 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 05 Jan 2021, approximately nine and a half hours after the vaccine was administered, the patient experienced fever, chills, nausea, vomiting, body aches and loss of taste and smell. Later, she experienced some congestion in her chest and throat. Treatment for the event included paracetamol.    Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, fever, chills, nausea, vomiting, and body aches, were considered resolving. The outcome of the events, loss of taste and smell, were considered resolved. The outcome of the events, congestion in her throat and chest, were considered unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Respiratory tract congestion, Vaccination complication, Vomiting
Clinical narrative: congestion in her chest and throat; Body aches; Vomiting; Nausea; Chills; Fever; dosn't feel good; lost her sense of taste and smell; loss of taste; A spontaneous report was received from a 56-year-old female consumer who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed fever, chills, nausea, vomiting, body aches, not feeling good, loss of taste and congestion in her chest and throat.    The patient's medical history, as provided by the reporter, included COVID-19 infection in November 2020.  Concomitant product use was not provided.  On 05 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 05 Jan 2021, approximately nine and a half hours after the vaccine was administered, the patient experienced fever, chills, nausea, vomiting, body aches and loss of taste and smell. Later, she experienced some congestion in her chest and throat. Treatment for the event included paracetamol.    Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, fever, chills, nausea, vomiting, and body aches, were considered resolving. The outcome of the events, loss of taste and smell, were considered resolved. The outcome of the events, congestion in her throat and chest, were considered unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Headache, Thirst, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: very thirsty like she has cotton mouth; pain in the lower left backside above her hipbone; swelling in the arm site; red splotches; itchy; severe headaches; This spontaneous case was reported by a consumer and describes the occurrence of THIRST (very thirsty like she has cotton mouth), BACK PAIN (pain in the lower left backside above her hipbone), VACCINATION SITE SWELLING (swelling in the arm site), VACCINATION SITE ERYTHEMA (red splotches) and VACCINATION SITE PRURITUS (itchy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced THIRST (very thirsty like she has cotton mouth), BACK PAIN (pain in the lower left backside above her hipbone), VACCINATION SITE SWELLING (swelling in the arm site), VACCINATION SITE ERYTHEMA (red splotches), VACCINATION SITE PRURITUS (itchy) and HEADACHE (severe headaches). At the time of the report, THIRST (very thirsty like she has cotton mouth), BACK PAIN (pain in the lower left backside above her hipbone), VACCINATION SITE SWELLING (swelling in the arm site), VACCINATION SITE ERYTHEMA (red splotches), VACCINATION SITE PRURITUS (itchy) and HEADACHE (severe headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: very thirsty like she has cotton mouth; pain in the lower left backside above her hipbone; swelling in the arm site; red splotches; itchy; severe headaches; This spontaneous case was reported by a consumer and describes the occurrence of THIRST (very thirsty like she has cotton mouth), BACK PAIN (pain in the lower left backside above her hipbone), VACCINATION SITE SWELLING (swelling in the arm site), VACCINATION SITE ERYTHEMA (red splotches) and VACCINATION SITE PRURITUS (itchy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced THIRST (very thirsty like she has cotton mouth), BACK PAIN (pain in the lower left backside above her hipbone), VACCINATION SITE SWELLING (swelling in the arm site), VACCINATION SITE ERYTHEMA (red splotches), VACCINATION SITE PRURITUS (itchy) and HEADACHE (severe headaches). At the time of the report, THIRST (very thirsty like she has cotton mouth), BACK PAIN (pain in the lower left backside above her hipbone), VACCINATION SITE SWELLING (swelling in the arm site), VACCINATION SITE ERYTHEMA (red splotches), VACCINATION SITE PRURITUS (itchy) and HEADACHE (severe headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Maternal exposure during pregnancy, Pregnancy test
Clinical narrative: Received vaccine while 32.1 week pregnant; Arm soreness at injection site; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Received vaccine while 32.1 week pregnant) and INJECTION SITE PAIN (Arm soreness at injection site) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 28-May-2020 and the estimated date of delivery was 04-Mar-2021. On 08-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Received vaccine while 32.1 week pregnant) and INJECTION SITE PAIN (Arm soreness at injection site). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-second week of the pregnancy.  On 08-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Received vaccine while 32.1 week pregnant) had resolved. At the time of the report, INJECTION SITE PAIN (Arm soreness at injection site) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Jun-2020, Pregnancy test: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were provided. No treatment information provided.; Reporter's Comments: This is a case of product exposure during pregnancy with  associated AEs for this 30-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy .Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Itchy in the injection site; Swelling around injection site; Redness around the injection site; Pain around injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchy in the injection site), VACCINATION SITE SWELLING (Swelling around injection site), VACCINATION SITE ERYTHEMA (Redness around the injection site) and VACCINATION SITE PAIN (Pain around injection site) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20-2A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included SALBUTAMOL (ALBUTEROL HFA), FLUTICASONE FUROATE (ARNUITY ELLIPTA) and ETONOGESTREL (NEXPLANON) for an unknown indication.    On 27-Dec-2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Dec-2020, the patient experienced VACCINATION SITE SWELLING (Swelling around injection site), VACCINATION SITE ERYTHEMA (Redness around the injection site) and VACCINATION SITE PAIN (Pain around injection site). On 03-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy in the injection site). On 30-Dec-2020, VACCINATION SITE SWELLING (Swelling around injection site) and VACCINATION SITE ERYTHEMA (Redness around the injection site) had resolved. On 04-Jan-2021, VACCINATION SITE PRURITUS (Itchy in the injection site) had resolved. At the time of the report, VACCINATION SITE PAIN (Pain around injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Pregnant patient received the 1st dose of the Moderna Covid 19 vaccine.; This spontaneous prospective pregnancy case was reported by a physician and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient received the 1st dose of the Moderna Covid 19 vaccine.) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 611L(2 or Z)OA) for COVID-19 vaccination.     Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 07-Jan-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 28-Apr-2021. On 07-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient received the 1st dose of the Moderna Covid 19 vaccine.). On 07-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient received the 1st dose of the Moderna Covid 19 vaccine.) 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.   No treatment information was provided.  Company Comment : This is a case of product exposure during pregnancy with no associated AEs for this 29-year-old female. without any associated AEs.  Patient will continue to be contacted for further monitoring of AEs during the pregnancy.; Reporter's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 29-year-old female. without any associated AEs.  Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: Urinary tract infection; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (Urinary tract infection) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 012L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Jan-2021, the patient experienced URINARY TRACT INFECTION (Urinary tract infection). At the time of the report, URINARY TRACT INFECTION (Urinary tract infection) 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 medications were not reported. No treatment information was provided.  Company Comment: This case concerns a 69-year-old female who experienced NS unexpected event of urinary tract infection.  Event onset occurred the same day as the first dose of mRNA-1273. Treatment not reported. Event outcome unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Reporter's Comments: This case concerns a 69-year-old female who experienced NS unexpected event of urinary tract infection.  Event onset occurred the same day as the first dose of mRNA-1273. Treatment not reported. Event outcome unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: a little ache in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (a little ache in the injection site) 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 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced VACCINATION SITE PAIN (a little ache in the injection site). On 07-Jan-2021, VACCINATION SITE PAIN (a little ache in the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment medications were reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site warmth
Clinical narrative: Warmth at the injection site; Induration at the injection site; Erythema at the injection site; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE WARMTH (Warmth at the injection site), VACCINATION SITE INDURATION (Induration at the injection site) and VACCINATION SITE ERYTHEMA (Erythema at the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (Warmth at the injection site), VACCINATION SITE INDURATION (Induration at the injection site) and VACCINATION SITE ERYTHEMA (Erythema at the injection site). At the time of the report, VACCINATION SITE WARMTH (Warmth at the injection site), VACCINATION SITE INDURATION (Induration at the injection site) and VACCINATION SITE ERYTHEMA (Erythema at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication details not reported by the reporter. Treatment details not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 25-Mar-2021: Updated outcome of the events from unknown to recovered.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Itch; red blanches and blotches around injection site; a little swelling on the blanches; Headache; pain at the injection site, very sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itch), VACCINATION SITE ERYTHEMA (red blanches and blotches around injection site), VACCINATION SITE SWELLING (a little swelling on the blanches), VACCINATION SITE PAIN (pain at the injection site, very sore arm) and HEADACHE (Headache) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for an unreported indication: SHINGRIX (shingles) and PERTUSSIS VACCINE. Concomitant products included HYDROCHLOROTHIAZIDE and FAMOTIDINE for an unknown indication.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jan-2021, the patient experienced VACCINATION SITE PAIN (pain at the injection site, very sore arm). On 11-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itch), VACCINATION SITE ERYTHEMA (red blanches and blotches around injection site), VACCINATION SITE SWELLING (a little swelling on the blanches) and HEADACHE (Headache). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Vaccination site erythema, Vaccination site swelling, Vaccination site pruritus and Vaccination site pain, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (Itch) had not resolved and VACCINATION SITE ERYTHEMA (red blanches and blotches around injection site), VACCINATION SITE SWELLING (a little swelling on the blanches), VACCINATION SITE PAIN (pain at the injection site, very sore arm) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       On 11-Jan-2021, the patient rubbed her arm with her sponge and noticed it was very itchy, rubbed it a little bit and looked at it closer and noticed red blotches and was swollen around the injection area. It had been a week and still itchy, could feel it through her shirt. It just felt a little strange, like heavy.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: pain in her arm; Pretty bad fever; Chills; Lower body aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in her arm), PYREXIA (Pretty bad fever), CHILLS (Chills) and MYALGIA (Lower body aches) 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 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (pain in her arm), PYREXIA (Pretty bad fever), CHILLS (Chills) and MYALGIA (Lower body aches). At the time of the report, PAIN IN EXTREMITY (pain in her arm), PYREXIA (Pretty bad fever), CHILLS (Chills) and MYALGIA (Lower body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Paraesthesia oral, Pruritus, Vaccination site urticaria
Clinical narrative: noticed welt on left arm, very itchy; Noticed welt on left arm; lips kinda tingled; achiness since date of injection, barely noticeable; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (lips kinda tingled), PAIN (achiness since date of injection, barely noticeable), PRURITUS (noticed welt on left arm, very itchy) and VACCINATION SITE URTICARIA (Noticed welt on left arm) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced PARAESTHESIA ORAL (lips kinda tingled) and PAIN (achiness since date of injection, barely noticeable). On 07-Jan-2021, the patient experienced PRURITUS (noticed welt on left arm, very itchy) and VACCINATION SITE URTICARIA (Noticed welt on left arm). On 30-Dec-2020, PARAESTHESIA ORAL (lips kinda tingled) had resolved. At the time of the report, PAIN (achiness since date of injection, barely noticeable), PRURITUS (noticed welt on left arm, very itchy) and VACCINATION SITE URTICARIA (Noticed welt on left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   Treatment details were not reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site rash, Vaccination site warmth
Clinical narrative: Warm to touch on the arm vaccine was administered; Rash on the arm vaccine was administered; 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 VACCINATION SITE WARMTH (Warm to touch on the arm vaccine was administered) and VACCINATION SITE RASH (Rash on the arm vaccine was administered) 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 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (Warm to touch on the arm vaccine was administered) and VACCINATION SITE RASH (Rash on the arm vaccine was administered). At the time of the report, VACCINATION SITE WARMTH (Warm to touch on the arm vaccine was administered) and VACCINATION SITE RASH (Rash on the arm vaccine was administered) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided.  No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: swelling at the injection site; site became very itchy; tenderness; redness; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (tenderness), ERYTHEMA (redness), INJECTION SITE SWELLING (swelling at the injection site) and INJECTION SITE PRURITUS (site became very itchy) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 30-Dec-2020, the patient experienced INJECTION SITE PAIN (tenderness) and ERYTHEMA (redness). On 06-Jan-2021, the patient experienced INJECTION SITE SWELLING (swelling at the injection site) and INJECTION SITE PRURITUS (site became very itchy). At the time of the report, INJECTION SITE PAIN (tenderness) and ERYTHEMA (redness) had resolved and INJECTION SITE SWELLING (swelling at the injection site) and INJECTION SITE PRURITUS (site became very itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Treatment medication included ibuprofen.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during breast feeding, Vaccination site erythema, Vaccination site inflammation, Vaccination site pruritus
Clinical narrative: breastfeeding 5 months; Red inflammation" with 2 inches wide; Little itchy; Red inflammation" with 2 inches wide; This spontaneous case was reported by an other health care professional and describes the occurrence of MATERNAL EXPOSURE DURING BREAST FEEDING (breastfeeding 5 months), VACCINATION SITE INFLAMMATION (Red inflammation" with 2 inches wide), VACCINATION SITE PRURITUS (Little itchy) and VACCINATION SITE ERYTHEMA (Red inflammation" with 2 inches wide) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024JQ0A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced VACCINATION SITE INFLAMMATION (Red inflammation" with 2 inches wide), VACCINATION SITE PRURITUS (Little itchy) and VACCINATION SITE ERYTHEMA (Red inflammation" with 2 inches wide). On 13-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (breastfeeding 5 months). On 12-Jan-2021, VACCINATION SITE INFLAMMATION (Red inflammation" with 2 inches wide), VACCINATION SITE PRURITUS (Little itchy) and VACCINATION SITE ERYTHEMA (Red inflammation" with 2 inches wide) had resolved. At the time of the report, MATERNAL EXPOSURE DURING BREAST FEEDING (breastfeeding 5 months) 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.   Reporter did not allow further contact; Sender's Comments: This is a case of product exposure during breastfeeding with associated AEs of vaccination site inflammation, vaccination site erythema, vaccination site pruritus. Patient will continue to be contacted for further monitoring of AEs. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Fever; Chills; Some nausea; Achy on arm; A spontaneous report was received from an other health care professional, concerning himself, a 26-year-old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fever, chills, some nausea and achy on arm.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 08-Jan-2021 at 11:30AM, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (lot number 031K20A) intramuscularly in his left arm for prophylaxis of COVID-19.  On 09-Jan-2021, the patient woke up at 01:00AM with a fever, chills, some nausea (maybe from eating late) and achy on arm. Hence, he took paracetamol as treatment for events.    Action taken with mRNA-1273 in response to the events were not reported.   The outcome for the events, fever, chills, some nausea and achy on arm were unknown.; Reporter's Comments: A spontaneous report concerns a 26-year-old male patient, who experienced fever, chills, some nausea and achy on arm. The event occurred 1 day after the administration of the first dose of the mRNA-1273 vaccine (Lot #: 031K20A, expiration date-unknown). Treatment included paracetamol and outcome is unknown. Based on the information provided, which includes a temporal association between the reported events and the administration of mRNA-1273 vaccine, a causal association cannot be excluded. The events of fever, chills, some nausea are consistent with the known safety profile of mRNA-1273 vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: Itchy rash on her arm that is rectangular with 2 inches on each side; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Itchy rash on her arm that is rectangular with 2 inches on each side) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 24-Dec-2020,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH PRURITIC (Itchy rash on her arm that is rectangular with 2 inches on each side). At the time of the report, RASH PRURITIC (Itchy rash on her arm that is rectangular with 2 inches on each side) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information was not provided.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal distension
Clinical narrative: bloated stomach; A spontaneous report was received from a consumer (reporting on self) concerning a male patient of unspecified age, who received Moderna's Covid-19 vaccine (mRNA-1273) and experienced bloated stomach/PT: abdominal distension.    The patient's medical history was not provided.    Concomitant product use was not provided by the reporter.    On 07 Jan 2021, prior to the onset of the symptoms, the patient received their first/second (not specified) of two planned doses of mRNA-1273 (Batch number not provided) in left arm  for prophylaxis of COVID-19 infection.    On 08 Jan 2021, in the morning the patient woke up with a bloated stomach. The patient had treated the event with two GAS-X tablets and the symptoms were ongoing.    Action taken with mRNA-1273 in response to the event was not reported.  Outcome of the event of bloated stomach was not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia, Nausea, Vaccination site pain
Clinical narrative: Injection site was painful; Nauseous; overall body aches; Severe chills; overall fatigue; A spontaneous report was received from a consumer who is a 61-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced severe chills, body aches, overall fatigue, nauseous and  injection site pian  The patient's medical history included rheumatoid arthritis, COVID-19. No concomitant product use was reported.  On 04 Jan 2021, the patient received her first of two planned doses of mRNA-1273 (Lot number: 039K20-2A) in the right arm intramuscularly for prophylaxis of COVID-19 infection.   On 04 Jan 2021, the same day as the vaccination, the patient reported she had severe chills, body aches, and was overall fatigued.   On 05 Jan 2021 and 06 Jan 2021, the patient reported she was not able to work due to her symptoms.  On 07 Jan 2021, the patient reported she was nauseated and fatigued. She stated her injection site was so painful she was unable to lay down on it at night. She also reported she had arthritis in her shoulders but was not sure if that was related to her rheumatoid arthritis.   Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events, severe chills, body aches, overall fatigue, nauseous, injection site pain  were considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Injection site discomfort
Clinical narrative: localized minor discomfort at the site of injection; chills; Extreme Fatigue; A spontaneous report was received from a nurse, a 54 year-old female patient who received Moderna's COVID-19 Vaccine and experienced chills, extreme fatigue, and localized minor discomfort at the site of injection.  The patient's medical history included Covid-19. No relevant concomitant medications were reported.   On 28 Dec 2020, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (batch 0261.20A) intramuscularly for COVID-19 infection prophylaxis.   On 28 Dec 2020, after receiving the vaccine, the patient experienced some side effects. She stated that these side effects included chills, extreme fatigue, and localized minor discomfort at the site of injection. Treatment for the events included paracetamol, 1000 mg and ibuprofen, 100 mg.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, chills, extreme fatigue, localized minor discomfort at the site of injection, was considered resolved on 29 Dec 2020.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Injection site swelling, Injection site warmth, Mobility decreased, Vaccination site pain
Clinical narrative: Hard to lift arm; elevated heart rate; warm; little bit of swelling at the injection site; Super painful; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MOBILITY DECREASED (Hard to lift arm), HEART RATE INCREASED (elevated heart rate), INJECTION SITE WARMTH (warm), INJECTION SITE SWELLING (little bit of swelling at the injection site) and VACCINATION SITE PAIN (Super painful) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included No adverse effect.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2021, the patient experienced MOBILITY DECREASED (Hard to lift arm), HEART RATE INCREASED (elevated heart rate), INJECTION SITE WARMTH (warm), INJECTION SITE SWELLING (little bit of swelling at the injection site) and VACCINATION SITE PAIN (Super painful). At the time of the report, MOBILITY DECREASED (Hard to lift arm), HEART RATE INCREASED (elevated heart rate), INJECTION SITE WARMTH (warm), INJECTION SITE SWELLING (little bit of swelling at the injection site) and VACCINATION SITE PAIN (Super painful) had not 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.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Acne, Vaccination site erythema, Vaccination site induration, Vaccination site pruritus
Clinical narrative: side of the injection was itch; side of the injection was red; side of injection was hard; Pimples in the left arm; This spontaneous case was reported by a consumer and describes the occurrence of ACNE (Pimples in the left arm), VACCINATION SITE PRURITUS (side of the injection was itch), VACCINATION SITE ERYTHEMA (side of the injection was red) and VACCINATION SITE INDURATION (side of injection was hard) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. O37KZOA) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced ACNE (Pimples in the left arm). On 06-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (side of the injection was itch), VACCINATION SITE ERYTHEMA (side of the injection was red) and VACCINATION SITE INDURATION (side of injection was hard). On 01-Jan-2021, ACNE (Pimples in the left arm) had resolved. At the time of the report, VACCINATION SITE PRURITUS (side of the injection was itch), VACCINATION SITE ERYTHEMA (side of the injection was red) and VACCINATION SITE INDURATION (side of injection was hard) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment for the event included an unknown topical cream and ibuprofen.   Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: a red circle that was two inches around the site, is puffed out, and is itchy.; knees have been achy; a red circle that was two inches around the site, is puffed out, and is itchy.; injection site had a 1.5 inch red circle around it and was a little elevated; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (a red circle that was two inches around the site, is puffed out, and is itchy.), ARTHRALGIA (knees have been achy), VACCINATION SITE SWELLING (a red circle that was two inches around the site, is puffed out, and is itchy.) and VACCINATION SITE ERYTHEMA (injection site had a 1.5 inch red circle around it and was a little elevated) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Benzocaine).    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Dec-2020, the patient experienced VACCINATION SITE ERYTHEMA (injection site had a 1.5 inch red circle around it and was a little elevated). On 05-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (a red circle that was two inches around the site, is puffed out, and is itchy.), ARTHRALGIA (knees have been achy) and VACCINATION SITE SWELLING (a red circle that was two inches around the site, is puffed out, and is itchy.). At the time of the report, VACCINATION SITE PRURITUS (a red circle that was two inches around the site, is puffed out, and is itchy.), ARTHRALGIA (knees have been achy), VACCINATION SITE SWELLING (a red circle that was two inches around the site, is puffed out, and is itchy.) and VACCINATION SITE ERYTHEMA (injection site had a 1.5 inch red circle around it and was a little elevated) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        No relevant concomitant medications were reported Treatment for the events included Tylenol and ice.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: Welt like rash below the site of the injection, looks like a little island; A spontaneous report was received from a healthcare professional concerning a 36-year-old, female patient who experienced welt like rash below the injection site and looks like island / PT: vaccination site rash.   The patient's medical history was not provided.    Concomitant product use was not provided.   On 28 Dec 2020, prior to the onset of the symptoms, the patient received the first/second (not specified) of two planned doses of mRNA-1273 (Batch number not provided) for prophylaxis of COVID-19 infection.    On date 07 Jan 2021, the patient experienced the event welt like rash below the injection site and looks like island.  Treatment information was not provided.    Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the event welt like rash below the injection site and looks like island was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.