chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Lymphadenopathy, Pain, Pain in extremity
Clinical narrative: Whole arm is hurting up to the breast/arm is sore; Has a mild swelling; Achy symptoms/is in pain; Really bad headache; Lymph nodes are swollen next to the armpit; Chills; A spontaneous report, was received from a physician (patient), concerning herself, a 67 years-old female patient, unknown race and ethnicity, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced whole arm is hurting up to the breast/arm is sore (pain in extremity), has a mild swelling (peripheral swelling), achy symptoms/is in pain (pain), really bad headache (headache), lymph nodes are swollen next to the armpit (lymphadenopathy), and chills.  The patient's medical history was not provided. The patient's historical vaccine included flu shot which was two months ago on an unknown date in Nov 2020. No concomitant medications were reported.  On 05 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: Unknown) intramuscularly in left arm for prophylaxis of COVID-19 infection.   On 06 Jan 2021, the patient experienced that the whole arm was hurting up to the breast, lymph nodes are swollen next to the armpit, mild swelling, is in pain, really bad headache (the patient took caffeine for it), achy symptoms and chills. The patient stated that is usually pain in the injection site when gets a vaccine but not like this, including the whole arm. The patient has headache, which was difficult to deal with, chills too (on going), and the arm was sored still, the whole arm. No treatment was administered for the events.   Action taken with second dose of mRNA-1273 in response to the events was not provided.  The outcome for the events, whole arm is hurting up to the breast/arm is sore and chills were considered as not recovered, and that of events has a mild swelling, achy symptoms/is in pain, really bad headache and lymph nodes are swollen next to the armpit were 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: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Whole arm is hurting up to the breast/arm is sore; Has a mild swelling; Achy symptoms/is in pain; Really bad headache; Lymph nodes are swollen next to the armpit; Chills; A spontaneous report, was received from a physician (patient), concerning herself, a 67 years-old female patient, unknown race and ethnicity, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced whole arm is hurting up to the breast/arm is sore (pain in extremity), has a mild swelling (peripheral swelling), achy symptoms/is in pain (pain), really bad headache (headache), lymph nodes are swollen next to the armpit (lymphadenopathy), and chills.  The patient's medical history was not provided. The patient's historical vaccine included flu shot which was two months ago on an unknown date in Nov 2020. No concomitant medications were reported.  On 05 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: Unknown) intramuscularly in left arm for prophylaxis of COVID-19 infection.   On 06 Jan 2021, the patient experienced that the whole arm was hurting up to the breast, lymph nodes are swollen next to the armpit, mild swelling, is in pain, really bad headache (the patient took caffeine for it), achy symptoms and chills. The patient stated that is usually pain in the injection site when gets a vaccine but not like this, including the whole arm. The patient has headache, which was difficult to deal with, chills too (on going), and the arm was sored still, the whole arm. No treatment was administered for the events.   Action taken with second dose of mRNA-1273 in response to the events was not provided.  The outcome for the events, whole arm is hurting up to the breast/arm is sore and chills were considered as not recovered, and that of events has a mild swelling, achy symptoms/is in pain, really bad headache and lymph nodes are swollen next to the armpit were 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: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Hot vaccination area; Itchy vaccination area; Little swollen vaccination area; Red vaccination area; A spontaneous report was received from a consumer, concerning herself, an 84-year-old, female patient, who received Moderna's COVID-19 vaccine and experienced hot, itchy, little swollen and red at vaccination area.  The patient's medical history provided by the reporter included diabetes and hypertension. Concomitant medications reported included pressure pills, diabetes pills and liquid removal pills.  On 05-Jan-2021, approximately 7 days prior to the onset of events, the patient received the first of two planned doses of mRNA-1273 vaccine (lot# unknown) intramuscularly in the right arm (dominant arm) for prophylaxis of COVID-19 infection.   The patient reported that, she did not present with any reactions after the shot of vaccine on 05-Jan-2021. But, however, on 12-Jan-2021 at 08:00 PM, the patient developed itchy, red, hot, and a little swollen at vaccination area, which were most annoying. Reporter also stated that these symptoms were continued except for itchy and was less swollen. Treatment for the event included acetaminophen and icepack application.  Action taken with mRNA-1273 in response to the events were not reported.  The outcome of the events, hot vaccination area and red vaccination area were considered unknown. The outcome of the event, little swollen vaccination area was considered resolving at the time of this report. The outcome of the event, itchy vaccination area was considered resolved on an unspecified date in Jan-2021.; Reporter's Comments: A spontaneous report concerns an 84-year-old, female patient, who experienced hot, itchy, little swollen and red at vaccination area. The events occurred 7 days after the administration of the first dose of the mRNA-1273 vaccine (Lot #: unknown, expiration date-unknown). Treatment provided included acetaminophen and icepack application and outcome is unknown.  Based on the information provided, which indicates a temporal association and local reactions at the site of administration of mRNA-1273 vaccine, a causal association cannot be excluded. Injection site itchy, injection site redness and swelling are consistent with the known safety profile of mRNA-1273 vaccine.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema
Clinical narrative: Arm was sore; Red,  2x2 circle on my arm; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Arm was sore) and VACCINATION SITE ERYTHEMA (Red,  2x2 circle on my arm) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    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 PAIN IN EXTREMITY (Arm was sore) and VACCINATION SITE ERYTHEMA (Red,  2x2 circle on my arm). At the time of the report, PAIN IN EXTREMITY (Arm was sore) and VACCINATION SITE ERYTHEMA (Red,  2x2 circle on my arm) 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 included warm soak  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.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: red spot on her arm is 3 inches in diameter; arm started to feel sore; arm hurts and aches; red spot is swollen; headache; her arm feels itchy at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (red spot on her arm is 3 inches in diameter), INJECTION SITE PAIN (arm started to feel sore; arm hurts and aches), INJECTION SITE SWELLING (red spot is swollen), HEADACHE (headache) and INJECTION SITE PRURITUS (her arm feels itchy at injection site) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) (unknown route) 1 dosage form. On 06-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (red spot on her arm is 3 inches in diameter), INJECTION SITE PAIN (arm started to feel sore; arm hurts and aches), INJECTION SITE SWELLING (red spot is swollen), HEADACHE (headache) and INJECTION SITE PRURITUS (her arm feels itchy at injection site). At the time of the report, INJECTION SITE ERYTHEMA (red spot on her arm is 3 inches in diameter), INJECTION SITE PAIN (arm started to feel sore; arm hurts and aches), INJECTION SITE SWELLING (red spot is swollen), HEADACHE (headache) and INJECTION SITE PRURITUS (her arm feels itchy at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) 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 did not allow further contact; 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: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure before pregnancy
Clinical narrative: Pregnant and received Moderna; This spontaneous prospective pregnancy case was reported by an other health care professional and describes the occurrence of MATERNAL EXPOSURE BEFORE PREGNANCY (Pregnant and received Moderna) in a 39-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011220A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy (Live, full-term birth) on 26-Sep-2017. Concurrent medical conditions included Fish allergy and Latex allergy. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Allergy, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 06-Dec-2020 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was in June 2020 and the estimated date of delivery was 21-Mar-2021. On 06-Dec-2020, the patient experienced MATERNAL EXPOSURE BEFORE PREGNANCY (Pregnant and received Moderna). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 06-Dec-2020, MATERNAL EXPOSURE BEFORE PREGNANCY (Pregnant and received Moderna) 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.   The patient has a prior use of alcohol once a month and stopped in Jan-2020. The estimated date of conception was Jul-2020. The patient received prenatal care. No treatment information was provided.  Case comment: This is a case of product exposure during pregnancy with no associated AEs for this 39-year-old female. 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 39-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling, Vaccination site urticaria, Vaccination site warmth
Clinical narrative: Injection site was large; Injection site redness; Injection site warmth; Arm was itchy; Hives on arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Arm was itchy), VACCINATION SITE URTICARIA (Hives on arm), VACCINATION SITE SWELLING (Injection site was large), VACCINATION SITE ERYTHEMA (Injection site redness) and VACCINATION SITE WARMTH (Injection site warmth) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    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 VACCINATION SITE PRURITUS (Arm was itchy) and VACCINATION SITE URTICARIA (Hives on arm). On 08-Jan-2021, the patient experienced VACCINATION SITE SWELLING (Injection site was large), VACCINATION SITE ERYTHEMA (Injection site redness) and VACCINATION SITE WARMTH (Injection site warmth). At the time of the report, VACCINATION SITE PRURITUS (Arm was itchy) and VACCINATION SITE ERYTHEMA (Injection site redness) was resolving and VACCINATION SITE URTICARIA (Hives on arm), VACCINATION SITE SWELLING (Injection site was large) and VACCINATION SITE WARMTH (Injection site warmth) 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 erythema, Vaccination site reaction
Clinical narrative: injection site reaction; It is red; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE REACTION (injection site reaction) and VACCINATION SITE ERYTHEMA (It is red) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jan-2021, the patient experienced VACCINATION SITE REACTION (injection site reaction) and VACCINATION SITE ERYTHEMA (It is red). At the time of the report, VACCINATION SITE REACTION (injection site reaction) and VACCINATION SITE ERYTHEMA (It is red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient's medical history was not provided. Concomitant product use was not provided.  No treatment information was provided.   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.
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Swelling of the upper limb; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling of the upper limb) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    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 PERIPHERAL SWELLING (Swelling of the upper limb). At the time of the report, PERIPHERAL SWELLING (Swelling of the upper limb) 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. No treatment information was provided.  Case 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.; 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: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: contracted Covid; A spontaneous report was received from a pharmacist concerning a, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed COVID-19.   The patient's medical history was not provided. No relevant concomitant medications were reported.  It was unknown when the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   Pharmacist reported their patient got the vaccine and then contracted COVID-19. She wondered if the patient could get the second vaccine. Call back was made to reporter on 07 Jan 2021.  No treatment information was provided.  Action taken with RNA-1273 in response to the event was unknown.  The outcome of the event was unknown.; Reporter's Comments: Although limited information has been provided as dosing details for mRNA-1273 and onset date of the event was not provided, based on the etiology of COVID-19 and the established information about the mRNA-1273 vaccine, a causal association between the event and the product use is assessed as unlikely.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Pain in extremity
Clinical narrative: Pain; Sore arm; Headache; Fatigue; A spontaneous report was received from a 35-year-old, female consumer who received Moderna's COVID-19 vaccine and experienced headache, pain, sore arm and fatigue.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 06 Jan 2021 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011L20A) for prophylaxis of COVID-19 infection.   On 06 Jan 2021, after receiving the vaccine, the patient experienced headache, pain, sore arm and fatigue. Treatment for the events was Ibuprofen.   Action taken with the second dose of mRNA-1273 in response to the event was not reported.   The outcome for the events is Recovering/resolving.; 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: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Lymph node pain
Clinical narrative: Sore arm; Sore lymph node under jaw; This spontaneous case was reported by a health care professional and describes the occurrence of LIMB DISCOMFORT (Sore arm) and LYMPH NODE PAIN (Sore lymph node under jaw) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     The patient's past medical history included Root canal procedure. Concomitant products included AMOXICILLIN from 05-Jan-2021 to an unknown date for Root canal procedure.    On 22-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LIMB DISCOMFORT (Sore arm) and LYMPH NODE PAIN (Sore lymph node under jaw). At the time of the report, LIMB DISCOMFORT (Sore arm) and LYMPH NODE PAIN (Sore lymph node under jaw) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. This spontaneous case was reported by a health care professional and describes the occurrence of LIMB DISCOMFORT (Sore arm) and LYMPH NODE PAIN (Sore lymph node under jaw) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     The patient's past medical history included Root canal procedure. Concomitant products included AMOXICILLIN from 05-Jan-2021 to an unknown date for Root canal procedure.    On 22-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LIMB DISCOMFORT (Sore arm) and LYMPH NODE PAIN (Sore lymph node under jaw). At the time of the report, LIMB DISCOMFORT (Sore arm) and LYMPH NODE PAIN (Sore lymph node under jaw) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  No treatment information was provided.  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.; 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.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: Redness at the site of injection; Swollen injection site; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of   in a 35-year-old male 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 event (No reported medical history.).    On 28-Dec-2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment for the event included loratadine.  Case 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.; 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: Dizziness, Nausea, Vision blurred
Clinical narrative: Nausea; Dizziness; Blurred vision; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea), DIZZINESS (Dizziness) and VISION BLURRED (Blurred vision) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was reported).    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2021, the patient experienced NAUSEA (Nausea), DIZZINESS (Dizziness) and VISION BLURRED (Blurred vision). At the time of the report, NAUSEA (Nausea), DIZZINESS (Dizziness) and VISION BLURRED (Blurred vision) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea), DIZZINESS (Dizziness) and VISION BLURRED (Blurred vision) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was reported).    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2021, the patient experienced NAUSEA (Nausea), DIZZINESS (Dizziness) and VISION BLURRED (Blurred vision). At the time of the report, NAUSEA (Nausea), DIZZINESS (Dizziness) and VISION BLURRED (Blurred vision) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.  Company comment: Based on the current available information and temporal association between the use of the product and the onset date of the reported 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 onset date of the reported events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain, Headache, Myalgia, Pyrexia
Clinical narrative: Bad abdominal pain; Fever; Headache; Aches; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of ABDOMINAL PAIN (Bad abdominal pain), PYREXIA (Fever), HEADACHE (Headache) and MYALGIA (Aches) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No adverse event).    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 05-Jan-2021, the patient experienced PYREXIA (Fever), HEADACHE (Headache) and MYALGIA (Aches). On 06-Jan-2021, the patient experienced ABDOMINAL PAIN (Bad abdominal pain). At the time of the report, ABDOMINAL PAIN (Bad abdominal pain), PYREXIA (Fever), HEADACHE (Headache) and MYALGIA (Aches) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   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 did not allow further contact; 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: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Itching at injection site; Redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itching at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site) in a 56-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 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 06-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itching at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site). At the time of the report, VACCINATION SITE PRURITUS (Itching at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Arthralgia, COVID-19, Nasal congestion
Clinical narrative: stuffy nose and feels like she has to sneeze all the time, but can't; Tested positive for COVID-19; I lost my sense of taste; I lost my sense of smell; Body aches; Joint pain; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (Tested positive for COVID-19), AGEUSIA (I lost my sense of taste), ANOSMIA (I lost my sense of smell), PAIN (Body aches) and ARTHRALGIA (Joint pain) 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.     The patient's past medical history included No adverse event (No reported medical history.).    On 27-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jan-2021, the patient experienced AGEUSIA (I lost my sense of taste), ANOSMIA (I lost my sense of smell), PAIN (Body aches) and ARTHRALGIA (Joint pain). On 04-Jan-2021, the patient experienced COVID-19 (Tested positive for COVID-19). On 07-Jan-2021, the patient experienced NASAL CONGESTION (stuffy nose and feels like she has to sneeze all the time, but can't). At the time of the report, COVID-19 (Tested positive for COVID-19), AGEUSIA (I lost my sense of taste), ANOSMIA (I lost my sense of smell), PAIN (Body aches), ARTHRALGIA (Joint pain) and NASAL CONGESTION (stuffy nose and feels like she has to sneeze all the time, but can't) 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.   No treatment information was provided.  Very limited information regarding these events has been provided at this time. The patient probably experienced asymptomatic COVID-19 infection before being administered with the mRNA-1273 vaccine.; Sender's Comments: Very limited information regarding these events has been provided at this time. The patient probably experienced asymptomatic COVID-19 infection before being administered with the mRNA-1273 vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: stuffy nose and feels like she has to sneeze all the time, but can't; Tested positive for COVID-19; I lost my sense of taste; I lost my sense of smell; Body aches; Joint pain; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (Tested positive for COVID-19), AGEUSIA (I lost my sense of taste), ANOSMIA (I lost my sense of smell), PAIN (Body aches) and ARTHRALGIA (Joint pain) 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.     The patient's past medical history included No adverse event (No reported medical history.).    On 27-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jan-2021, the patient experienced AGEUSIA (I lost my sense of taste), ANOSMIA (I lost my sense of smell), PAIN (Body aches) and ARTHRALGIA (Joint pain). On 04-Jan-2021, the patient experienced COVID-19 (Tested positive for COVID-19). On 07-Jan-2021, the patient experienced NASAL CONGESTION (stuffy nose and feels like she has to sneeze all the time, but can't). At the time of the report, COVID-19 (Tested positive for COVID-19), AGEUSIA (I lost my sense of taste), ANOSMIA (I lost my sense of smell), PAIN (Body aches), ARTHRALGIA (Joint pain) and NASAL CONGESTION (stuffy nose and feels like she has to sneeze all the time, but can't) 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.   No treatment information was provided.  Very limited information regarding these events has been provided at this time. The patient probably experienced asymptomatic COVID-19 infection before being administered with the mRNA-1273 vaccine.; Sender's Comments: Very limited information regarding these events has been provided at this time. The patient probably experienced asymptomatic COVID-19 infection before being administered with the mRNA-1273 vaccine.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Nasopharyngitis, Productive cough, SARS-CoV-2 test positive
Clinical narrative: COVID test on 12Jan2021, which came back positive; Developed a cold; Productive cough; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of NASOPHARYNGITIS (Developed a cold), PRODUCTIVE COUGH (Productive cough) and COVID-19 (COVID test on 12Jan2021, which came back positive) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 immunization.     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 07-Jan-2021, the patient experienced NASOPHARYNGITIS (Developed a cold) and PRODUCTIVE COUGH (Productive cough). On 12-Jan-2021, the patient experienced COVID-19 (COVID test on 12Jan2021, which came back positive). At the time of the report, NASOPHARYNGITIS (Developed a cold), PRODUCTIVE COUGH (Productive cough) and COVID-19 (COVID test on 12Jan2021, which came back positive) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jan-2021, SARS-CoV-2 test positive: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided No treatment details were provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dizziness, Fatigue, Nausea
Clinical narrative: slightly itchy; Red area has expanded to about 3 - 3.5 inches; Warm to the touch; redness suddenly appeared at the injection site; Sore; Tired; Chills; Nauseous; Hot and cold chills; arm swelled (hard bump); tired; Joint pain; Dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), VACCINATION SITE WARMTH (Warm to the touch), VACCINATION SITE PRURITUS (slightly itchy), NAUSEA (Nauseous) and CHILLS (Hot and cold chills) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included VITAMINS NOS, ESTROGENS CONJUGATED (PREMARIN), DOXYCYCLINE, OMEPRAZOLE and LEVOTHYROXINE for an unknown indication.    On 11-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 DIZZINESS (Dizzy), NAUSEA (Nauseous), CHILLS (Hot and cold chills), VACCINATION SITE SWELLING (arm swelled (hard bump)), FATIGUE (tired) and ARTHRALGIA (Joint pain). On 18-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Warm to the touch), VACCINATION SITE ERYTHEMA (redness suddenly appeared at the injection site), VACCINATION SITE PAIN (Sore), FATIGUE (Tired) and CHILLS (Chills). On 20-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (slightly itchy) and VACCINATION SITE ERYTHEMA (Red area has expanded to about 3 - 3.5 inches). On 15-Jan-2021, DIZZINESS (Dizzy), NAUSEA (Nauseous), CHILLS (Hot and cold chills), VACCINATION SITE SWELLING (arm swelled (hard bump)), FATIGUE (tired) and ARTHRALGIA (Joint pain) had resolved. At the time of the report, VACCINATION SITE WARMTH (Warm to the touch), VACCINATION SITE PRURITUS (slightly itchy), VACCINATION SITE ERYTHEMA (redness suddenly appeared at the injection site), VACCINATION SITE PAIN (Sore), FATIGUE (Tired), CHILLS (Chills) and VACCINATION SITE ERYTHEMA (Red area has expanded to about 3 - 3.5 inches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment related information has been reported.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: slightly itchy; Red area has expanded to about 3 - 3.5 inches; Warm to the touch; redness suddenly appeared at the injection site; Sore; Tired; Chills; Nauseous; Hot and cold chills; arm swelled (hard bump); tired; Joint pain; Dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), VACCINATION SITE WARMTH (Warm to the touch), VACCINATION SITE PRURITUS (slightly itchy), NAUSEA (Nauseous) and CHILLS (Hot and cold chills) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included VITAMINS NOS, ESTROGENS CONJUGATED (PREMARIN), DOXYCYCLINE, OMEPRAZOLE and LEVOTHYROXINE for an unknown indication.    On 11-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 DIZZINESS (Dizzy), NAUSEA (Nauseous), CHILLS (Hot and cold chills), VACCINATION SITE SWELLING (arm swelled (hard bump)), FATIGUE (tired) and ARTHRALGIA (Joint pain). On 18-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Warm to the touch), VACCINATION SITE ERYTHEMA (redness suddenly appeared at the injection site), VACCINATION SITE PAIN (Sore), FATIGUE (Tired) and CHILLS (Chills). On 20-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (slightly itchy) and VACCINATION SITE ERYTHEMA (Red area has expanded to about 3 - 3.5 inches). On 15-Jan-2021, DIZZINESS (Dizzy), NAUSEA (Nauseous), CHILLS (Hot and cold chills), VACCINATION SITE SWELLING (arm swelled (hard bump)), FATIGUE (tired) and ARTHRALGIA (Joint pain) had resolved. At the time of the report, VACCINATION SITE WARMTH (Warm to the touch), VACCINATION SITE PRURITUS (slightly itchy), VACCINATION SITE ERYTHEMA (redness suddenly appeared at the injection site), VACCINATION SITE PAIN (Sore), FATIGUE (Tired), CHILLS (Chills) and VACCINATION SITE ERYTHEMA (Red area has expanded to about 3 - 3.5 inches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment related information has been reported.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Anxiety, Chills, Dizziness, Headache
Clinical narrative: She has a feeling inside that something is wrong; bowels are a little abnormal; Nausea; headache; dizziness; chills; low grade fever of about 100° F; Vaccination site pain; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 15-Jan-2021 and was forwarded to Moderna on 15-Jan-2021.    This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of CHILLS (chills), PYREXIA (low grade fever of about 100° F), HEADACHE (headache), DIZZINESS (dizziness) and ANXIETY (She has a feeling inside that something is wrong) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013C20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported.).    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced CHILLS (chills), PYREXIA (low grade fever of about 100° F) and VACCINATION SITE PAIN (Vaccination site pain). On 14-Jan-2021, the patient experienced HEADACHE (headache), DIZZINESS (dizziness) and NAUSEA (Nausea). On 15-Jan-2021, the patient experienced ABDOMINAL DISCOMFORT (bowels are a little abnormal). On an unknown date, the patient experienced ANXIETY (She has a feeling inside that something is wrong). On 15-Jan-2021, PYREXIA (low grade fever of about 100° F) outcome was unknown. At the time of the report, CHILLS (chills), DIZZINESS (dizziness), ANXIETY (She has a feeling inside that something is wrong), VACCINATION SITE PAIN (Vaccination site pain), ABDOMINAL DISCOMFORT (bowels are a little abnormal) and NAUSEA (Nausea) outcome was unknown and HEADACHE (headache) 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 included Tylenol for fever which helped, cold compress for sore arm, heat for chills.; 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: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Vaccination site pain
Clinical narrative: She has a feeling inside that something is wrong; bowels are a little abnormal; Nausea; headache; dizziness; chills; low grade fever of about 100° F; Vaccination site pain; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 15-Jan-2021 and was forwarded to Moderna on 15-Jan-2021.    This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of CHILLS (chills), PYREXIA (low grade fever of about 100° F), HEADACHE (headache), DIZZINESS (dizziness) and ANXIETY (She has a feeling inside that something is wrong) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013C20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported.).    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced CHILLS (chills), PYREXIA (low grade fever of about 100° F) and VACCINATION SITE PAIN (Vaccination site pain). On 14-Jan-2021, the patient experienced HEADACHE (headache), DIZZINESS (dizziness) and NAUSEA (Nausea). On 15-Jan-2021, the patient experienced ABDOMINAL DISCOMFORT (bowels are a little abnormal). On an unknown date, the patient experienced ANXIETY (She has a feeling inside that something is wrong). On 15-Jan-2021, PYREXIA (low grade fever of about 100° F) outcome was unknown. At the time of the report, CHILLS (chills), DIZZINESS (dizziness), ANXIETY (She has a feeling inside that something is wrong), VACCINATION SITE PAIN (Vaccination site pain), ABDOMINAL DISCOMFORT (bowels are a little abnormal) and NAUSEA (Nausea) outcome was unknown and HEADACHE (headache) 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 included Tylenol for fever which helped, cold compress for sore arm, heat for chills.; 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: SARS-CoV-2 test, SARS-CoV-2 test false positive
Clinical narrative: Tested positive for COVID; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST FALSE POSITIVE (Tested positive for COVID) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. O11J2OA) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2021, the patient experienced SARS-COV-2 TEST FALSE POSITIVE (Tested positive for COVID). At the time of the report, SARS-COV-2 TEST FALSE POSITIVE (Tested positive for COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: It was itching; It was swollen; It was hurting; Started to turn red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (It was itching), VACCINATION SITE SWELLING (It was swollen), VACCINATION SITE PAIN (It was hurting) and VACCINATION SITE ERYTHEMA (Started to turn red) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No medical history provided by the reporter.  Concomitant products included CITALOPRAM, SIMVASTATIN, TIZANIDINE HYDROCHLORIDE (TIZADINE), MULTIVITAMIN [VITAMINS NOS], CALCIUM, VITAMIN D NOS, VITAMIN C [ASCORBIC ACID], COBAMAMIDE (VITAMIN B12 [COBAMAMIDE]) and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Started to turn red). On 13-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (It was itching), VACCINATION SITE SWELLING (It was swollen) and VACCINATION SITE PAIN (It was hurting). At the time of the report, VACCINATION SITE PRURITUS (It was itching) had resolved and VACCINATION SITE SWELLING (It was swollen), VACCINATION SITE PAIN (It was hurting) and VACCINATION SITE ERYTHEMA (Started to turn red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information provided was histacort cream.  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 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.