chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal discomfort, Pain, Vaccination site pain
Clinical narrative: general achiness (malaise); Flu like symptoms; Headache; Soreness in same arm of vaccine; His joints hurt; Was having difficulty swallowing; Feels like something stuck in his throat; Feels achy all over; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHAGIA (Was having difficulty swallowing), OROPHARYNGEAL DISCOMFORT (Feels like something stuck in his throat), PAIN (Feels achy all over), MALAISE (general achiness (malaise)) and INFLUENZA LIKE ILLNESS (Flu like symptoms) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) 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 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jan-2021, the patient experienced DYSPHAGIA (Was having difficulty swallowing), OROPHARYNGEAL DISCOMFORT (Feels like something stuck in his throat), PAIN (Feels achy all over), ARTHRALGIA (His joints hurt) and VACCINATION SITE PAIN (Soreness in same arm of vaccine). On 04-Jan-2021, the patient experienced HEADACHE (Headache). On 06-Jan-2021, the patient experienced MALAISE (general achiness (malaise)) and INFLUENZA LIKE ILLNESS (Flu like symptoms). At the time of the report, DYSPHAGIA (Was having difficulty swallowing), OROPHARYNGEAL DISCOMFORT (Feels like something stuck in his throat), PAIN (Feels achy all over), MALAISE (general achiness (malaise)), INFLUENZA LIKE ILLNESS (Flu like symptoms), ARTHRALGIA (His joints hurt), HEADACHE (Headache) and VACCINATION SITE PAIN (Soreness in same arm of vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment for the event included acetaminophen and omeprazole.  This case concerns a 64 Y/O M with nonserious unexpected influenza like illness, malaise, pain, oropharyngeal discomfort, dysphagia and expected vaccination site pain, arthralgia and headache.  Event onset Day 6 after first dose mRNA-1273. Treated with acetaminophen and omeprazole. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Reporter's Comments: This case concerns a 64 Y/O M with nonserious unexpected influenza like illness, malaise, pain, oropharyngeal discomfort, dysphagia and expected vaccination site pain, arthralgia and headache.  Event onset Day 6 after first dose mRNA-1273. Treated with acetaminophen and omeprazole. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Myalgia, Nausea, Neck pain
Clinical narrative: Neck is sore and hurts; Headache; 101.0 F temperature; Body aches; Nauseous; After the vaccination, she felt a little sore; A spontaneous report was received from a 68-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and felt a little sore, her neck is sore and hurts, has a headache, a 101 F temperature, body aches and feels a little nauseous.    The patient's medical history was not provided. No relevant concomitant medications were reported.   On 05 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 05 Jan 2021, after administration, the patient felt sore.  On 06 Jan 2021, the patient stated she feels "more sore", her neck is sore and hurts. She has a headache, and a 101 F temperature. She mentioned that she hardly runs a temperature when sick. Upon call back, she reports that she still has body aches, pain, and feels a little nauseous. No treatment information was provided.   On 06-JAN-2021 laboratory details included body temperature which was 101°F.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome for events, felt a little sore, headache, a 101 F temperature, were unknown.   The outcome for events, her neck is sore and hurts, body aches and feels a little nauseous, were 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 event, a causal relationship cannot be excluded.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site discomfort
Clinical narrative: Neck is sore and hurts; Headache; 101.0 F temperature; Body aches; Nauseous; After the vaccination, she felt a little sore; A spontaneous report was received from a 68-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and felt a little sore, her neck is sore and hurts, has a headache, a 101 F temperature, body aches and feels a little nauseous.    The patient's medical history was not provided. No relevant concomitant medications were reported.   On 05 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 05 Jan 2021, after administration, the patient felt sore.  On 06 Jan 2021, the patient stated she feels "more sore", her neck is sore and hurts. She has a headache, and a 101 F temperature. She mentioned that she hardly runs a temperature when sick. Upon call back, she reports that she still has body aches, pain, and feels a little nauseous. No treatment information was provided.   On 06-JAN-2021 laboratory details included body temperature which was 101°F.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome for events, felt a little sore, headache, a 101 F temperature, were unknown.   The outcome for events, her neck is sore and hurts, body aches and feels a little nauseous, were 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 event, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: vaccine reaction; A spontaneous report was received from a healthcare professional concerning a patient of an unknown age and gender, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vaccine reaction.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date, the patient received their first of two planned doses of mRNA-1273 (Lot number: Unknown) via unknown route for prophylaxis of COVID-19 infection.   On an unknown date, the patient experienced vaccine reaction. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event is considered unknown.; 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: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test
Clinical narrative: Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 27-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.  Concurrent medical conditions included Hypothyroidism. Concomitant products included LEVOTHYROXINE for Hypothyroidism, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 02-Jul-2020 and the estimated date of delivery was 08-Apr-2021. On 09-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the twenty-seventh week of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 09-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.  DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Jul-2020, Pregnancy test: positive (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.  Estimated date of conception 16-Jul-2020. No treatment information provided.  Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 27-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Sex: U
Vaccine: COVID19
Symptoms: Injection site pain, Injection site warmth, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Redness; Swelling; Itching; Pain in the arm; Heat in the arm; A spontaneous report was received from a nurse concerning an unknown patient who received Moderna's COVID-19 vaccine and experienced redness, swelling, itching, pain in the arm, and heat in the arm.    The patient's medical history was not provided. No relevant concomitant medications were reported.   On 23 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (lot: unknown) intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, the patient reported redness, swelling, itching, pain in the arm and heat in the arm. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events 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 event, a causal relationship cannot be excluded
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test
Clinical narrative: Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 31-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (Prior use was occasional.). Concurrent medical conditions included Lichen planus since 2015. Concomitant products included VITAMIN D NOS, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) and PROGESTERONE for an unknown indication, FOLIC ACID (FOLATE).    On 22-Dec-2020 at 2:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 06-Dec-2020 and the estimated date of delivery was 12-Sep-2021. On 22-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  second week of the pregnancy.  On 22-Dec-2020, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Dec-2020, Pregnancy test: positive (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.   The results of Beta HCG and Progesterone Lab test performed in Dec 2020 and Jan 2021 was unknown. Date of estimated date of conception was 21Dec2020.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 31-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID-19; A spontaneous report was received from a physician concerning a 54-year old, male patient who received Moderna's COVID-19 vaccine and tested positive for COVID-19.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 23 Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   On 30 Dec 2020, the patient tested positive for COVID-19 after being exposed to the virus by a family member. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event was unknown.; Reporter's Comments: Based on the current available information and the mechanism of action of mRNA-1237 vaccine, the event of COVID-19 is assessed as unlikely related. The history of patient being exposed to the virus by a family member confounds causality.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Nausea
Clinical narrative: Nausea; Lightheadedness; Fatigue; Headache; A spontaneous report was received from a consumer who was a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced nausea, lightheadedness, fatigue and headache.  The patient's medical history was not provided. No concomitant medications were reported.  On 29 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, the patient experienced nausea, lightheadedness, fatigue and headache. No treatment information was reported.   Action taken with mRNA-1273 in response to the events was not provided.  The outcome for the events, nausea, lightheadedness, fatigue and headache was unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Vaccinated while pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccinated while pregnant) in a 36-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included Social alcohol drinker from 2005 to 14-Sep-2020. Concurrent medical conditions included Sleep disorder (Stable at conception) since 2016. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy, AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for Sleep disorder.    On 05-Jan-2021 at 9:20 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 19-Aug-2020 and the estimated date of delivery was 26-May-2021. On 05-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccinated while pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twentieth week of the pregnancy.  On 05-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Vaccinated while pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.   Company Comment: This is a case of product exposure during pregnancy with no associated AEs for this 36-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jan-2021: Internal review on 20JUL2021 resulted in updates to pregnancy details.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 36-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (pregnant) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included Adverse event (No reported medical history).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. In 2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (pregnant). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient's medical history was not provided. Concomitant product use was not provided by the reporter  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.; Reporter's Comments: 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.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Pain in extremity
Clinical narrative: Bad diarrhea; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of   in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L2O4) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter.  Treatment information was not provided/unknown.   Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site cellulitis, Vaccination site mass, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: lump the size of a dime at the injection site at first; lump is warm to the touch; cellulitis; injection site area is itchy; A spontaneous case report was received from a health care professional, concerning herself who was 56 year-old female patient, who was administered Moderna's COVID-19 vaccine (mRNA-1273) and developed vaccination site mass, vaccination site pruritus, vaccination site warmth, and vaccination site cellulitis.   lump the size of a dime at the injection site at first, could see the injection site,injection site area is itchy,lump is the size of a mandarin ,lump is warm to the touch ,cellulitis .  The patient's medical history and concomitant medications were not provided. Concomitant medications included rivaroxaban, multivitamin, and vitamin B-complex.  0n 30-DEC-2020 , prior to the onset of the events, the patient received her first of two planned doses of mRNA-1273 (batch number: 026L20A) intramuscularly in the left arm for the prophylaxis of COVID-19 infection.  On 06-JAN-2021, the injection site area was itchy. On 07-JAN-2021, at the injection site the lump was the size of a dime/mandarin, was warm to the touch, and was reportedly cellulitis. The patient was going to urgent care for treatment.  Action taken with mRNA-1273 in response to the events was not reported.   The  outcomes of the events, vaccination site mass, Vaccination site pruritus, vaccination site warmth, and vaccination site cellulitis, 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.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Nausea, Pain, Pyrexia
Clinical narrative: Fever 103F; Nausea; chills; Body aches; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PYREXIA (Fever 103F), NAUSEA (Nausea), CHILLS (chills) and PAIN (Body aches) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: VACCINES (vaccine). Concomitant products included METOPROLOL and PANTOPRAZOLE for an unknown indication.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever 103F), NAUSEA (Nausea), CHILLS (chills) and PAIN (Body aches). At the time of the report, PYREXIA (Fever 103F), NAUSEA (Nausea), CHILLS (chills) and PAIN (Body aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, Body temperature: 103 °F.     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.; 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: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Asthenia, Diarrhoea, Dizziness, Headache
Clinical narrative: side effects-almost like flu; bad abdominal pain; diarrhea; lack of energy; dizziness; headache; arm sore; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in September 2020.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced HEADACHE (headache). On 06-Jan-2021, 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.   Concomitant product use was not provided by the reporter. Treatment of the events included Advil (ibuprofen) and Aleve (naproxen).  This case concerns an 82-year-old female with NS events of unexpected pain in extremity, influenza like illness, asthenia, abdominal pain, diarrhea, dizziness and expected headache. Arm pain onset Day 1 after first dose mRNA-1273, followed by other events on Day 2. Treatment not reported. Events resolved, except asthenia ongoing. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.; Reporter's Comments: This case concerns an 82-year-old female with NS events of unexpected pain in extremity, influenza like illness, asthenia, abdominal pain, diarrhea, dizziness and expected headache. Arm pain onset Day 1 after first dose mRNA-1273, followed by other events on Day 2. Treatment not reported. Events resolved, except asthenia ongoing. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Pain in extremity
Clinical narrative: side effects-almost like flu; bad abdominal pain; diarrhea; lack of energy; dizziness; headache; arm sore; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in September 2020.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced HEADACHE (headache). On 06-Jan-2021, 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.   Concomitant product use was not provided by the reporter. Treatment of the events included Advil (ibuprofen) and Aleve (naproxen).  This case concerns an 82-year-old female with NS events of unexpected pain in extremity, influenza like illness, asthenia, abdominal pain, diarrhea, dizziness and expected headache. Arm pain onset Day 1 after first dose mRNA-1273, followed by other events on Day 2. Treatment not reported. Events resolved, except asthenia ongoing. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.; Reporter's Comments: This case concerns an 82-year-old female with NS events of unexpected pain in extremity, influenza like illness, asthenia, abdominal pain, diarrhea, dizziness and expected headache. Arm pain onset Day 1 after first dose mRNA-1273, followed by other events on Day 2. Treatment not reported. Events resolved, except asthenia ongoing. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia
Clinical narrative: Fatigued; Achy muscles; Chills; A spontaneous report was received from a 35-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and resulted in fatigue, ache muscles, and chills.  The patient's medical history was not provided. Concomitant medications were not reported.  On 30 DEC 2020, the patient received their first of two planned doses of mRNA-1273 with unknown batch number for prophylaxis of COVID-19 infection.  On 31 DEC 2020, the patient experienced fatigue, ache muscles and chills.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of fatigue, ache muscles, and chills, were considered unknown.; 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: Erythema, Feeling hot, Pain in extremity, Pruritus, Swelling
Clinical narrative: Redness; Swelling; Itching; Pain in arm; Heat in arm; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of   in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Dec-2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.        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 case was linked to US-MODERNATX, INC.-MOD-2021-003300, US-MODERNATX, INC.-MOD-2021-003306 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 22-Mar-2021:  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-2021-003300: US-MODERNATX, INC.-MOD-2021-003306:
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Myalgia, Nausea, Vaccination site erythema
Clinical narrative: Myalgia; Left arm was really red; Left arm was hot; left arm was swollen to the size of a baseball; Achy joints; Really tired; Nausea due to the pain; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of MYALGIA (Myalgia) in a 45-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 reported medical history.).    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Myalgia). At the time of the report, MYALGIA (Myalgia) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided 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 start date of the events, a causal relationship cannot be excluded.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 07-Jan-2021: No specific follow-up information recorded.; 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: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: Myalgia; Left arm was really red; Left arm was hot; left arm was swollen to the size of a baseball; Achy joints; Really tired; Nausea due to the pain; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of MYALGIA (Myalgia) in a 45-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 reported medical history.).    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Myalgia). At the time of the report, MYALGIA (Myalgia) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided 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 start date of the events, a causal relationship cannot be excluded.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 07-Jan-2021: No specific follow-up information recorded.; 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: 60.0
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Pruritus, Swelling, Vaccination site warmth
Clinical narrative: Pain in arm; Swelling; Itching; Redness; Heat in arm; A spontaneous report was received from an nurse concerning a 60 years old, unspecified gender patient who experienced redness, swelling, itching, pain in the arm and heat in the arm.   The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.  On 23 Dec 2020, prior to the onset of the symptoms, the patient received their first/second (not specified) of two planned doses of mRNA-1273 (Batch number not provided) for prophylaxis of COVID-19 infection.   The patient experienced redness, swelling, itching, pain in the arm and heat in the arm all since an unknown date.  Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the redness, swelling, itching, pain in the arm and heat in the arm 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.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-003307:
Sex: F
Vaccine: COVID19
Symptoms: Anosmia, Nasal discomfort, Taste disorder, Vaccination site pain
Clinical narrative: unable to smell; taste was off; injection site was sore; nose was tingly; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine and experienced injection site soreness, nose tingling, loss of smell, and altered taste.    The patient's medical history was not provided. No relevant concomitant medications were reported.   On 05 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 05 Jan 2021, the patient experienced soreness at the injection site. A short while after the vaccine, her nose began to feel tingly. Later that evening (8:30 pm), the patient was unable to smell the Crystal Light she was drinking and the taste was off. On 06 Jan 2021, she reported having to be close to her coffee to smell it. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events was unknown/not reported; Reporter's Comments: This case concerns a female of unknown age who experienced nonserious events of unexpected nasal discomfort, anosmia, taste disorder and expected vaccination site pain. Event onset the same day as the first dose of mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Anxiety, Body temperature, Fatigue, Headache
Clinical narrative: Body aches; fever of 100.6F; abdominal pain; headaches; fatigue; anxiety; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of PAIN (Body aches), PYREXIA (fever of 100.6F), ABDOMINAL PAIN (abdominal pain), HEADACHE (headaches) and FATIGUE (fatigue) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse effect.    On 03-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jan-2021, the patient experienced PAIN (Body aches), PYREXIA (fever of 100.6F), ABDOMINAL PAIN (abdominal pain), HEADACHE (headaches), FATIGUE (fatigue) and ANXIETY (anxiety). At the time of the report, PAIN (Body aches), HEADACHE (headaches), FATIGUE (fatigue) and ANXIETY (anxiety) had not resolved and PYREXIA (fever of 100.6F) and ABDOMINAL PAIN (abdominal pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jan-2021, Body temperature (100.6-Unknown): Fahrenheit.     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.   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.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jan-2021: No specific follow-up information recorded.; 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: Pain, Pyrexia
Clinical narrative: Body aches; fever of 100.6F; abdominal pain; headaches; fatigue; anxiety; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of PAIN (Body aches), PYREXIA (fever of 100.6F), ABDOMINAL PAIN (abdominal pain), HEADACHE (headaches) and FATIGUE (fatigue) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse effect.    On 03-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jan-2021, the patient experienced PAIN (Body aches), PYREXIA (fever of 100.6F), ABDOMINAL PAIN (abdominal pain), HEADACHE (headaches), FATIGUE (fatigue) and ANXIETY (anxiety). At the time of the report, PAIN (Body aches), HEADACHE (headaches), FATIGUE (fatigue) and ANXIETY (anxiety) had not resolved and PYREXIA (fever of 100.6F) and ABDOMINAL PAIN (abdominal pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jan-2021, Body temperature (100.6-Unknown): Fahrenheit.     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.   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.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jan-2021: No specific follow-up information recorded.; 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: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Limb discomfort, Muscular weakness, Paraesthesia, Tremor
Clinical narrative: left arm real numb, right and left hand numbness; left arm feels heavy; shaky hand; tingling in legs; weakness in left hand; This spontaneous case was reported by a physician and describes the occurrence of   in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 23-Dec-2020, the patient received first 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 medication was not 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 MOD-2020-001375 (Patient Link).; 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: Genetic counselling, Glucose tolerance test, Maternal exposure during pregnancy, Ultrasound Doppler
Clinical narrative: Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a female patient of an unknown age (gravida 3, para 1) 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 MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 15-Feb-2021. On 06-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). On 06-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Dec-2020, Ultrasound Doppler: not provided (Inconclusive) Not provided. On an unknown date, Genetic counselling: normal (normal) Normal. On an unknown date, Glucose tolerance test: normal (normal) Normal.     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.   Company Comment:  This is a case of product exposure during pregnancy with no associated AEs for this female whos age was not reported. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female whos age was not reported. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore in the injection site; A spontaneous report was received from a dietician concerning a 26-years-old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sore in the injection site/vaccination site pain.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 05 Jan 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (batch Number: 011L20A) intramuscularly in the arm for prophylaxis of COVID-19 infection.  On 05 Jan 2021, the patient experienced sore in the injection site. On 06 Jan 2021, the patient's arm looks better but symptom was still ongoing. The patient did not receive any treatment.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome for the event sore at the injection site was not resolved (still ongoing).; 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, SARS-CoV-2 test
Clinical narrative: Tested positive for covid; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of COVID-19 (Tested positive for covid) 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 reported medical event.).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Tested positive for covid). At the time of the report, COVID-19 (Tested positive for covid) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: unknown (Positive) Tested positive for covid 2 days later..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications and treatment information were not provided   Based on the current available information and the mechanism of action of mRNA-1237 vaccine, the event of COVID-19 is assessed as unlikely related.   Reporter did not allow further contact; Reporter's Comments: Based on the current available information and the mechanism of action of mRNA-1237 vaccine, the event of COVID-19 is assessed as unlikely related.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature increased, Fatigue, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: Weakness; Tiredness, exhaustion; Low grade fever 99-100F; Circumscribed rash at injection site which looked like a cellulitis infection; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE CELLULITIS (Circumscribed rash at injection site which looked like a cellulitis infection) 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 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 CELLULITIS (Circumscribed rash at injection site which looked like a cellulitis infection). At the time of the report, VACCINATION SITE CELLULITIS (Circumscribed rash at injection site which looked like a cellulitis infection) outcome was unknown.  DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Jan-2021, Body temperature increased: 99° to 100° f (High) High. On 11-Jan-2021, SARS-CoV-2 test negative: negative (Negative) Negative.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.