chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Sinusitis
Clinical narrative: Congested toward one side of face; Sinus infection; A Spontaneous report was received from a consumer concerning a 31 year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed a sinus infection and congestion.   The patient's medical history and relevant concomitant medications were Azithromycin.   On 26 Dec 2020, approximately five days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 31 Dec 2020, The patient experienced a sinus infection.  On 05 Jan 2021, she was feeling congested. Treatment for the event included Azithromycin.  Action taken with mRNA-1273 in response to the events was not reported .   The outcome of the event(s) sinus infection and congestion were unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Joint stiffness, Limb discomfort, Pruritus, Rash
Clinical narrative: Wrist is stiff; Minor itch on upper neck and front part of abdomen; Localized rash to her upper neck and front part of abdomen; Swelling to the point of feeling it was arthritic pain all way down to the fingertips; Feeling like arthritic pain; Sore at the injection site; Sore from injection site to the fingertips; A spontaneous report was received from a consumer concerning a female patient of an unknown age, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sore at the injection site, sore from injection site to the fingertips, swelling to the point of feeling it was arthritic pain all way down to the fingertips, feeling like arthritic pain, wrist is stiff, localized rash to her upper neck and front part of abdomen and minor itch on upper neck and front part of abdomen.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 30 Dec 2020 the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) via unknown route for prophylaxis of COVID-19 infection.   A consumer called to report she had received the Moderna's  COVID-19 vaccine on 30 Dec 2020 at 2:45pm. Later than evening, 7 hours post injection, was sore at the injection site to the point it "woke me up". The next morning, she stated she was sore from the injection site to the fingertips, sore and swelling to the point of feeling it was arthritic pain all the way down to her fingertips, currently feeling that way. Wrist is stiff, cannot take lid off. On Friday morning she stated she had a localized rash to her upper neck and front part of abdomen, it did itch (minor itch), similar to a sunburn type of reaction. It resolved after taking Claritin D.   Treatment for the event Localized rash to her upper neck and front part of abdomen and Minor itch on upper neck and front part of abdomen included Claritin D.   Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events, Sore at the injection site, Sore from injection site to the fingertips, swelling to the point of feeling it was arthritic pain all way down to the fingertips, Feeling like arthritic pain and Wrist is stiff were considered unknown. The outcome of the events, Localized rash to her upper neck and front part of abdomen and Minor itch on upper neck and front part of abdomen, were considered as recovered/resolved.; Reporter's Comments: Based on the information provided which includes a strong temporal association between the reported events and administration of mRNA-1273 vaccine, an excluding any other etiology, a causal association cannot be excluded. Vaccination site pain, injection site swelling, rash and arthralgia are consistent with the known safety profile of the vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: Wrist is stiff; Minor itch on upper neck and front part of abdomen; Localized rash to her upper neck and front part of abdomen; Swelling to the point of feeling it was arthritic pain all way down to the fingertips; Feeling like arthritic pain; Sore at the injection site; Sore from injection site to the fingertips; A spontaneous report was received from a consumer concerning a female patient of an unknown age, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sore at the injection site, sore from injection site to the fingertips, swelling to the point of feeling it was arthritic pain all way down to the fingertips, feeling like arthritic pain, wrist is stiff, localized rash to her upper neck and front part of abdomen and minor itch on upper neck and front part of abdomen.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 30 Dec 2020 the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) via unknown route for prophylaxis of COVID-19 infection.   A consumer called to report she had received the Moderna's  COVID-19 vaccine on 30 Dec 2020 at 2:45pm. Later than evening, 7 hours post injection, was sore at the injection site to the point it "woke me up". The next morning, she stated she was sore from the injection site to the fingertips, sore and swelling to the point of feeling it was arthritic pain all the way down to her fingertips, currently feeling that way. Wrist is stiff, cannot take lid off. On Friday morning she stated she had a localized rash to her upper neck and front part of abdomen, it did itch (minor itch), similar to a sunburn type of reaction. It resolved after taking Claritin D.   Treatment for the event Localized rash to her upper neck and front part of abdomen and Minor itch on upper neck and front part of abdomen included Claritin D.   Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events, Sore at the injection site, Sore from injection site to the fingertips, swelling to the point of feeling it was arthritic pain all way down to the fingertips, Feeling like arthritic pain and Wrist is stiff were considered unknown. The outcome of the events, Localized rash to her upper neck and front part of abdomen and Minor itch on upper neck and front part of abdomen, were considered as recovered/resolved.; Reporter's Comments: Based on the information provided which includes a strong temporal association between the reported events and administration of mRNA-1273 vaccine, an excluding any other etiology, a causal association cannot be excluded. Vaccination site pain, injection site swelling, rash and arthralgia are consistent with the known safety profile of the vaccine.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Palpitations, Tinnitus
Clinical narrative: Palpitations; Ringing in the ears; Sore arm; A spontaneous report was received from a nurse concerning a 56-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced palpitations, ringing in the ears/tinnitus and sore arm/pain in extremity.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 30 Dec 2020, prior to the onset of the events, the patient received their dose of mRNA-1273 (Batch Number: 039K20-2A) in the right arm for prophylaxis of COVID-19 infection.  On 30 Dec 2020, the patient experienced palpitations and ringing in the ears for about three minutes. On the same day, the patient experienced sore arm that lasted for 48 hours.   Treatment details included ibuprofen.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, palpitations and ringing in the ears was resolved on 30 Dec 2020. The outcome of the event sore arm was resolved on 31 Dec 2020.; Reporter's Comments: Based on the information provided which includes a strong temporal association between the reported events and administration of mRNA-1273 vaccine, an excluding any other etiology, a causal association cannot be excluded
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site warmth
Clinical narrative: Injection site warm; Injection site hardness; Injection site redness; A spontaneous report was received from a 36-year-old, female consumer who received Moderna's COVID-19 vaccine and experienced injection site redness, site warm to touch and hardness.  The patient's medical history was not provided. Concomitant medications are Wellbutrin and Doxycycline for Unknown indications.  On 22 Dec 2020 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number:011J20A) in the left arm for prophylaxis of COVID-19 infection at Hospital.  On 28 Dec 2020, after receiving the vaccine, the patient experienced injection site reaction on the left arm, injection site redness, site warm to touch and hardness. Treatment for the events were Benadryl and Pepcid.   On 05 Jan 2021 patient reported the treatment was not helping and the left upper arm is red and warm to touch. Treatment for the event is Unknown.  Action taken with the second dose of mRNA-1273 in response to the event was not applicable.  The outcome for the events is Not recovered/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: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Itchy; It's very red; Painful; Swelling at the insertion site in her arm; A spontaneous report was received from a non-health professional concerning a 78-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed itching (vaccination site pruritic), pain (vaccination site pain), swelling (vaccination site swelling), and redness (vaccination site erythema) at the injection site.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 30 Dec 2020, approximately seven days prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.    On 06 Jan 2021, the patient developed swelling at the insertion site. It was very red, painful, swollen, and itchy. No treatment information for the event was provided.   Action taken with the second dose of mRNA-1273 in response to the event was not reported.    The outcome for the events, itching, pain, swelling, and redness at the injection site, 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 event, a causal relationship cannot be excluded.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Heart rate increased, Insomnia, Nausea
Clinical narrative: Fast heart rate; body aches; couldn't sleep; chills; Nausea; bad headache; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Fast heart rate), PAIN (body aches), INSOMNIA (couldn't sleep), CHILLS (chills) and NAUSEA (Nausea) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K202A KJ) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Had it bad).    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 HEART RATE INCREASED (Fast heart rate), PAIN (body aches), INSOMNIA (couldn't sleep), CHILLS (chills), NAUSEA (Nausea) and HEADACHE (bad headache). On 06-Jan-2021, HEART RATE INCREASED (Fast heart rate), PAIN (body aches), INSOMNIA (couldn't sleep), CHILLS (chills), NAUSEA (Nausea) and HEADACHE (bad 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.   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: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Fast heart rate; body aches; couldn't sleep; chills; Nausea; bad headache; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Fast heart rate), PAIN (body aches), INSOMNIA (couldn't sleep), CHILLS (chills) and NAUSEA (Nausea) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K202A KJ) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Had it bad).    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 HEART RATE INCREASED (Fast heart rate), PAIN (body aches), INSOMNIA (couldn't sleep), CHILLS (chills), NAUSEA (Nausea) and HEADACHE (bad headache). On 06-Jan-2021, HEART RATE INCREASED (Fast heart rate), PAIN (body aches), INSOMNIA (couldn't sleep), CHILLS (chills), NAUSEA (Nausea) and HEADACHE (bad 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.   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: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation, Throat tightness
Clinical narrative: Throat tightness; Scratchy throat; A spontaneous report was received from a consumer concerning a 35-year-old, female patient who experienced throat tightness and scratchy throat.   The patient's medical history, as provided by the reporter, included allergies to the flu shot and  food allergies of wheat, corn, and citrus.  No relevant concomitant medications were reported.   On 05 Jan 2021, the patient received her first of two planned doses of mRNA-1273 (025L20A) intramuscularly in the right deltoid for prophylaxis of COVID-19 infection.   On 05 Jan 2021, During her 15-minute waiting period after the injection, the patient began to experience throat tightness and scratchy throat. The patient was assisted in the emergency bay area and monitored for severe reaction symptoms.   No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, throat tightness and throat irritation 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.
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Pain in extremity, Pruritus, Swelling
Clinical narrative: armpit pain; hurts to put her arm by her side; swelling; itchy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (hurts to put her arm by her side) 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 30-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 PAIN IN EXTREMITY (hurts to put her arm by her side). At the time of the report, PAIN IN EXTREMITY (hurts to put her arm by her side) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's medical history was not provided. No concomitant medications were reported.  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   This case was linked to US-MODERNATX, INC.-MOD-2021-002594 (E2B Linked Report).; 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 US-MODERNATX, INC.-MOD-2021-002594:
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes
Clinical narrative: Fever blister; A spontaneous report was received from a consumer concerning a 62-year-old, female patient who received Moderna's Covid-19 vaccine (mRNA-1273) and developed a fever blister.  The patient's medical history included fever blisters and high blood pressure. Concomitant Products known to have been used by the patient, within two weeks prior to the event, included lisinopril.  The patient received their first of two planned doses of mRNA-1273 (Lot number 025L20A) on 03 Jan 2021 in the left arm for prophylaxis of COVID-19 infection.   A consumer called to report she had received the Moderna COVID-19 vaccine on 03 Jan 2021 and got a fever blister on 05 Jan 2021.  Treatment for the event was not provided.    Action taken with mRNA-1273 in response to the eventswas not provided.   The outcome of the event, fever blister, considered as unknown.  The reporter did not provide an assessment of the event, fever blister.; Reporter's Comments: Based on the information provided which includes a strong temporal association between the reported events and administration of mRNA-1273 vaccine, an excluding any other etiology, a causal association cannot be excluded
Sex: M
Vaccine: COVID19
Symptoms: Synovitis
Clinical narrative: Had synovitis secondary to the Moderna COVID19 vaccine; A spontaneous report was received from a pharmacist concerning a male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced synovitis.  The patient's medical history, as provided by the reporter, included had 2 artificial knees. No relevant concomitant medications were reported.  On an unspecified date, the patient received their dose of mRNA-1273 (Batch Number: Unknown) for prophylaxis of COVID-19 infection.  On an unspecified date, the patient experienced synovitis secondary to the Moderna COVID19 vaccine.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, synovitis secondary to the Moderna COVID19 vaccine was not reported.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time. Critical details such as the dosing date, onset date of the event is lacking. The patient's has a significant history of  2 artificial knees. Further information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Lymphadenopathy
Clinical narrative: Itching; Redness; Swelling; Lymphadenopathy; A spontaneous report was received from a nurse concerning two patients of an unknown age and gender who received Moderna's COVID-19 Vaccine (mRNA-1273 ) and who experienced redness, swelling, itching and lymphadenopathy.   The patient's medical history was not provided. No relevant concomitant medications were not provided.  On an unknown date, prior to onset of the events, the patient received their dose of mRNA-1273 (lot/batch number: unknown) for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced delayed local reactions to Moderna COVID-19 vaccine including redness, swelling, itching and lymphadenopathy. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events redness, swelling, itching and lymphadenopathy was not reported.; 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: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: When receiving the vaccine he complained of having soreness; A spontaneous report was received from a male consumer, age unknown who received Moderna's COVID-19 vaccine and experienced soreness when receiving the vaccine.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On unknown date prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 039K20A) in the right deltoid for prophylaxis of COVID-19 infection.   After receiving the vaccine, the patient experienced soreness. Treatment for the event is Unknown.  The second dose of mRNA-1273 was scheduled for 26 Jan2021.  The outcome for the event is Unknown.  The reporter did not provide causality for the event.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test
Clinical narrative: Pregnancy; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) in a 37-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 23-Jul-2020 and the estimated date of delivery was 01-May-2021. On 02-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-third week of the pregnancy.  On 02-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2020, Pregnancy test: positive (Positive) positive.     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 relevant concomitant medications were reported. No treatment information was provided. She had one previous pregnancy on 29 Sep 2017 and had vaginal wall hematoma during delivery requiring blood transfusion and the pregnancy was live and full term birth.    Company Comment  This is a case of product exposure during pregnancy with no associated adverse events for this 37-year-old female. Patient will continue to be contacted for further monitoring of adverse events during the pregnancy
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Drug exposure during pregnancy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history was provided by the reporter. On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 20-Jun-2021. On 05-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Drug exposure during pregnancy). On 05-Jan-2021, EXPOSURE DURING PREGNANCY (Drug exposure during pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Company Comment  This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Sex: F
Vaccine: COVID19
Symptoms: Neuralgia
Clinical narrative: burning nerve pain in her left arm, left shoulder, and her chest/neurological symptoms; A spontaneous report was received from a physician (reporting on self) concerning a 38-year-old female patient who was administered Moderna's COVID-19 vaccine (mRNA-1273) and experienced burning nerve pain in her left arm, left shoulder, and her chest/neurological symptoms (neuralgia).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 31 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot Number: 037K20A) Intramuscular, in her left arm for the prophylaxis of COVID-19 infection.  On 02 Jan 2021, the patient experienced neurological symptoms on the side where she got the injection.  It felt like a burning nerve pain on her left arm, left shoulder, and chest.  On 06 Jan 2021, the patient was treated with Motrin (Ibuprofen).  Action taken with mRNA-1273 in response to the event was not reported.  Outcome of the event of burning nerve pain in her left arm, left shoulder, and her chest/neurological symptoms (neuralgia) was not recovered.; 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: Injection site erythema
Clinical narrative: She has light red circle where they gave her the shot; A spontaneous report was received from a consumer concerning a female patient who was participating in the mRNA-1273 Emergency Use Program and experienced injection site redness.  The patient's medical history was not provided.  Concomitant medications were not reported.  On an unknown date, the patient received their first of two planned doses of mRNA-1273 for the prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced a light red circle where she received the shot that was about 4-5 inches in size. Treatment information was not provided.  Action taken for the event was not reported.  The outcome of the event, injection site redness, was considered not recovered.; Reporter'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.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Itchiness at the injection site; Redness at the injection site; Soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (Itchiness at the injection site), INJECTION SITE ERYTHEMA (Redness at the injection site) and INJECTION SITE PAIN (Soreness at the injection site) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) 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) 1 dosage form. On 30-Dec-2020, the patient experienced INJECTION SITE PAIN (Soreness at the injection site). On 05-Jan-2021, the patient experienced INJECTION SITE PRURITUS (Itchiness at the injection site) and INJECTION SITE ERYTHEMA (Redness at the injection site). At the time of the report, INJECTION SITE PRURITUS (Itchiness at the injection site), INJECTION SITE ERYTHEMA (Redness at the injection site) and INJECTION SITE PAIN (Soreness at the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.  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: Abdominal pain, Ageusia, Anosmia, Body temperature, COVID-19
Clinical narrative: Cough; Congestion; Diagnosed with COVID-19; Loss of smell; Loss of taste; Headache; Chills; Nausea; Fever; Abdominal pain; This spontaneous case was reported by a consumer and describes the occurrence of RESPIRATORY TRACT CONGESTION (Congestion), COUGH (Cough), ANOSMIA (Loss of smell) and AGEUSIA (Loss of taste) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J202A) 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) (Intramuscular) 1 dosage form. On 01-Jan-2021, the patient experienced ANOSMIA (Loss of smell) and AGEUSIA (Loss of taste). On an unknown date, the patient experienced RESPIRATORY TRACT CONGESTION (Congestion) and COUGH (Cough). At the time of the report, RESPIRATORY TRACT CONGESTION (Congestion), COUGH (Cough), ANOSMIA (Loss of smell) and AGEUSIA (Loss of taste) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Dec-2020, Body temperature: 100.5 °F and 100.7 °F. On 01-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and the mechanism of action of mRNA-1237 vaccine, the events of COVID-19, headache, chills, abdominal pain, nausea, fever, loss of smell, loss of taste, cough and congestion are assessed as unlikely related. The patient, being a medical professional has high occupational risk for COVID-19 infection.; Reporter's Comments: Based on the current available information and the mechanism of action of mRNA-1237 vaccine, the events of COVID-19, headache, chills, abdominal pain, nausea, fever, loss of smell, loss of taste, cough and congestion are assessed as unlikely related. The patient, being a medical professional has high occupational risk for COVID-19 infection.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Headache, Nausea, Pyrexia
Clinical narrative: Cough; Congestion; Diagnosed with COVID-19; Loss of smell; Loss of taste; Headache; Chills; Nausea; Fever; Abdominal pain; This spontaneous case was reported by a consumer and describes the occurrence of RESPIRATORY TRACT CONGESTION (Congestion), COUGH (Cough), ANOSMIA (Loss of smell) and AGEUSIA (Loss of taste) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J202A) 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) (Intramuscular) 1 dosage form. On 01-Jan-2021, the patient experienced ANOSMIA (Loss of smell) and AGEUSIA (Loss of taste). On an unknown date, the patient experienced RESPIRATORY TRACT CONGESTION (Congestion) and COUGH (Cough). At the time of the report, RESPIRATORY TRACT CONGESTION (Congestion), COUGH (Cough), ANOSMIA (Loss of smell) and AGEUSIA (Loss of taste) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Dec-2020, Body temperature: 100.5 °F and 100.7 °F. On 01-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and the mechanism of action of mRNA-1237 vaccine, the events of COVID-19, headache, chills, abdominal pain, nausea, fever, loss of smell, loss of taste, cough and congestion are assessed as unlikely related. The patient, being a medical professional has high occupational risk for COVID-19 infection.; Reporter's Comments: Based on the current available information and the mechanism of action of mRNA-1237 vaccine, the events of COVID-19, headache, chills, abdominal pain, nausea, fever, loss of smell, loss of taste, cough and congestion are assessed as unlikely related. The patient, being a medical professional has high occupational risk for COVID-19 infection.
Sex: F
Vaccine: COVID19
Symptoms: Respiratory tract congestion, SARS-CoV-2 test
Clinical narrative: Cough; Congestion; Diagnosed with COVID-19; Loss of smell; Loss of taste; Headache; Chills; Nausea; Fever; Abdominal pain; This spontaneous case was reported by a consumer and describes the occurrence of RESPIRATORY TRACT CONGESTION (Congestion), COUGH (Cough), ANOSMIA (Loss of smell) and AGEUSIA (Loss of taste) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J202A) 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) (Intramuscular) 1 dosage form. On 01-Jan-2021, the patient experienced ANOSMIA (Loss of smell) and AGEUSIA (Loss of taste). On an unknown date, the patient experienced RESPIRATORY TRACT CONGESTION (Congestion) and COUGH (Cough). At the time of the report, RESPIRATORY TRACT CONGESTION (Congestion), COUGH (Cough), ANOSMIA (Loss of smell) and AGEUSIA (Loss of taste) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Dec-2020, Body temperature: 100.5 °F and 100.7 °F. On 01-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and the mechanism of action of mRNA-1237 vaccine, the events of COVID-19, headache, chills, abdominal pain, nausea, fever, loss of smell, loss of taste, cough and congestion are assessed as unlikely related. The patient, being a medical professional has high occupational risk for COVID-19 infection.; Reporter's Comments: Based on the current available information and the mechanism of action of mRNA-1237 vaccine, the events of COVID-19, headache, chills, abdominal pain, nausea, fever, loss of smell, loss of taste, cough and congestion are assessed as unlikely related. The patient, being a medical professional has high occupational risk for COVID-19 infection.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Hypersensitivity, Musculoskeletal stiffness, Neck pain, Pain
Clinical narrative: Diagnosed it to have allergy; Neck pain all her shoulder; Feeling pain on left side of body; Little bit pain on her right arm; Left shoulder/arm feels like she got shot in left arm; Pain behind her left ear going down her neck; Neck was kind of stiff and cant move neck easily; A spontaneous report was received from a 51-year-old, female consumer who received Moderna's COVID-19 vaccine and experienced pain on the left side of the body, behind her left ear going down her neck, neck pain all her shoulder and little bit on her right arm, neck little stiff and can't move the neck easily, left shoulder/arm feels like she got shot in the left arm and allergy.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 04 Jan 2021 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 039K20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 04 Jan 2021, after receiving the vaccine, the patient experienced pain on the left side of the body, behind her left ear going down her neck, neck pain all her shoulder and little bit on her right arm, neck little stiff and can't move the neck easily, left shoulder/arm feels like she got shot in the left arm. Went to a clinic and saw a Nurse and was treated with Methyl Prednisone, Benadryl and Cetirizine. Nurse diagnosed the events as allergy.   Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The outcome for the events is 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: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Diagnosed it to have allergy; Neck pain all her shoulder; Feeling pain on left side of body; Little bit pain on her right arm; Left shoulder/arm feels like she got shot in left arm; Pain behind her left ear going down her neck; Neck was kind of stiff and cant move neck easily; A spontaneous report was received from a 51-year-old, female consumer who received Moderna's COVID-19 vaccine and experienced pain on the left side of the body, behind her left ear going down her neck, neck pain all her shoulder and little bit on her right arm, neck little stiff and can't move the neck easily, left shoulder/arm feels like she got shot in the left arm and allergy.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 04 Jan 2021 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 039K20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 04 Jan 2021, after receiving the vaccine, the patient experienced pain on the left side of the body, behind her left ear going down her neck, neck pain all her shoulder and little bit on her right arm, neck little stiff and can't move the neck easily, left shoulder/arm feels like she got shot in the left arm. Went to a clinic and saw a Nurse and was treated with Methyl Prednisone, Benadryl and Cetirizine. Nurse diagnosed the events as allergy.   Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The outcome for the events is 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: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Headache, Pain, Palpitations
Clinical narrative: hives; body aches; shortness of breath; heart was racing; Fever; chills; headache; A spontaneous  was received from a healthcare facility staff member (United States) who was a 27-year-old, female patient who received Moderna's COVID-19 Vaccine, and who experienced fevers, chills, body aches, broke out in hives, headache, shortness of breath and her heart was racing.   The patient's medical history included a positive diagnosis of COVID-19 on 19-Jul-2020 for which she remained quarantined for approximately three weeks.  Concomitant product use was not provided by the reporter.   On 01-Jan-2021, approximately 3 days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (LOT unknown) intramuscularly for prophylaxis of COVID-19 infection.   Patient received her Moderna vaccine on 01-Jan-2021.  She reported that 32 hours after receiving her injection, on 03-Jan-2021, that she experienced chills, body aches and that she broke out in hives.  She also stated that on the same day she had a headache, shortness of breath and that her heart was racing.  On an undisclosed date, she reported that the hives went away along with the shortness of breath and fever.  She wanted to know if it was safe to receive the second dose.   Treatment for the event included diphenhydramine for the hives and shortness of breath per her primary physician's recommendation.   Action taken with mRNA-1273 in response to the events, fevers, chills, body aches, broke out in hives, headache, shortness of breath and her heart was racing, was unknown.    The events, fevers, broke out in hives and shortness of breath, were considered recovered/resolved.   The outcome of the events, chills, body aches, headache and her heart was racing, were not reported. 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: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Urticaria
Clinical narrative: hives; body aches; shortness of breath; heart was racing; Fever; chills; headache; A spontaneous  was received from a healthcare facility staff member (United States) who was a 27-year-old, female patient who received Moderna's COVID-19 Vaccine, and who experienced fevers, chills, body aches, broke out in hives, headache, shortness of breath and her heart was racing.   The patient's medical history included a positive diagnosis of COVID-19 on 19-Jul-2020 for which she remained quarantined for approximately three weeks.  Concomitant product use was not provided by the reporter.   On 01-Jan-2021, approximately 3 days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (LOT unknown) intramuscularly for prophylaxis of COVID-19 infection.   Patient received her Moderna vaccine on 01-Jan-2021.  She reported that 32 hours after receiving her injection, on 03-Jan-2021, that she experienced chills, body aches and that she broke out in hives.  She also stated that on the same day she had a headache, shortness of breath and that her heart was racing.  On an undisclosed date, she reported that the hives went away along with the shortness of breath and fever.  She wanted to know if it was safe to receive the second dose.   Treatment for the event included diphenhydramine for the hives and shortness of breath per her primary physician's recommendation.   Action taken with mRNA-1273 in response to the events, fevers, chills, body aches, broke out in hives, headache, shortness of breath and her heart was racing, was unknown.    The events, fevers, broke out in hives and shortness of breath, were considered recovered/resolved.   The outcome of the events, chills, body aches, headache and her heart was racing, were not reported. 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: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Injection site hot to the touch; Injection site area is itchy; Injection site area is red; Injection site pain; A spontaneous report was received from a nurse who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced injection site pain/vaccination site pain, injection site area is red/vaccination site erythema, injection site area is itchy/vaccination site pruritus, and injection site area is hot to the touch/vaccination site warmth.   The patient's medical history was not provided. Concomitant medications reported included Synthroid (levothyroxine sodium) and hydrochlorothiazide.  On 23 Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly (batch unknown) in the left deltoid for prophylaxis of COVID-19 infection.   On 23 Dec 2020, the patient received the vaccine and felt some injection site pain, which she didn't find abnormal.   On 05 Jan 2021, she woke up and the injection site was red, itchy and hot to the touch.No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, injection site area is red, injection site area is itchy, and injection site area is hot to the touch was not resolved.  The outcome for the event, injection site pain 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.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Itchy in the area around the immunization; swelling in the area around the immunization; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE PRURITUS (Itchy in the area around the immunization) and VACCINATION SITE SWELLING (swelling in the area around the immunization) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J2Q-2A) 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) (unknown route) 1 dosage form. On 06-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy in the area around the immunization) and VACCINATION SITE SWELLING (swelling in the area around the immunization). At the time of the report, VACCINATION SITE PRURITUS (Itchy in the area around the immunization) and VACCINATION SITE SWELLING (swelling in the area around the immunization) 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 was taken in response to the events.  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: Dizziness, Fatigue
Clinical narrative: Light headedness; Fatigue; A spontaneous report was received from a consumer concerning a 64-years-old female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced light headedness and fatigue.  The patient's medical history was not provided. Concomitant medications were not reported.  On 01 JAN 2021, the patient received their first two planned doses of mRNA-1273 (Batch number: 011L20A) intramuscularly in her left arm for prophylaxis of COVID-19 infection.  On 03 JAN 2021, the patient experienced light headedness and fatigue.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of light headedness and fatigue, were considered 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.