chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: 2x2 in redness at the site of injection; Itching at the site of injection; Pain at site of injection; Muscle sore (not severe); A spontaneous report was received from a nurse concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced multiple events of pain at the injection site, muscle sore, 2x2 in redness at the site of injection and itching at the site of injection.  The patient's medical history included difficulty breathing. The concomitant medications reported included levocetirizine.   On 23 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot# 011J20A). On the same day, the experienced pain at the injection site and muscle sore. The treatment information included paracetamol.  On 31 Dec 2020, the patient experienced 2x2 in redness at the site of injection and itching at the site of injection. The reporter stated, the patient took a missed dose of levocetirizine.   The Action taken with mRNA-1273 in response to the events was No change. The date of return for second dose is 20 Jan 2021.  The outcome for the events, 2x2 in redness at the site of injection and itching at the site of injection 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: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: Arm is still swollen; Arm  is still very red; A spontaneous report was received from a non-health professional concerning a consumer of unknown age and gender, who received Moderna's COVID-19 vaccine and developed an arm that was swollen and red.   The patient's medical history was not provided. No relevant concomitant medications were reported.  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: unknown) for prophylaxis of COVID-19 infection.     On 22 Dec 2020, after receiving the mRNA-1273 vaccination, the patient's arm began to swell and red. The patient reported, on 31 Dec 2020, the arm was still swollen and very red. No treatment information was provided.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.    The outcome for the events, arm that was swollen and red, were considered not recovered.  The reporter's assessment of causality for the events was not provided.; 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. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Pain, Pyrexia
Clinical narrative: diarrhea; fever; Body is aching; headache; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine and experienced diarrhea, fever, body aches and headache.   The patient's medical history was not provided. No relevant concomitant medications were reported.  On 30 Dec 2020, approximately 9 hours prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.   On 30 Dec 2020, the patient started to feel "super sick" with diarrhea, fever, body aches and headache. No treatment information was reported.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, diarrhea, fever, body aches and headache, 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: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by an other health care professional and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 32-year-old female patient (gravida 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     The patient's past medical history included Spontaneous abortion in April 2010. Family history included Cardiac disorder (Paternal Side) since an unknown date. Concurrent medical conditions included Drug allergy (Omeprazole), Acid reflux (esophageal) since 2019, Food allergy (sweet potato), Fish allergy (Fish) and Food allergy (Mustard). Concomitant products included FAMOTIDINE, PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 23-Nov-2020 and the estimated date of delivery was 30-Aug-2021. On 30-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fifth week of the pregnancy.  On 30-Dec-2020, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Dec-2020, Pregnancy: 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.   Reporter did not allow further contact; Reporter's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 32-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Malaise, Vaccination site pain
Clinical narrative: Not feeling great; Really sore arm; Patient is pregnant; A spontaneous report, was received from a consumer (patient), a 37 years-old female patient, unknown race and ethnicity, who received Moderna's COVID-19 Vaccine (mRNA-1273), and experienced not feeling great (malaise), really sore arm (injection site pain), and patient is pregnant (exposure during pregnancy).  The patient's medical history was not provided. No relevant concomitant medications were reported.   The patient received their first of two doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of Covid-19 infection on 30-Dec-2020 while pregnant. The due date was estimated as 27-Jun-2021.   On 30 Dec 2020, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (Batch number: 025J20-2A), intramuscularly in left arm for the prophylaxis of COVID-19 infection.  On 31-Dec-2020, the patient woke up in the morning with a really sore arm and was not feeling great. The patient was feeling a lot better by 03 30 pm on the same day.  The patent was pregnant and was exposed to vaccine. The patient's estimated due date was 27 Jun 2021. The patient took paracetamol for the adverse events.   Action taken with second dose of mRNA-1273 in response to the events was not reported.  The events, really sore arm and was not feeling great, were reported as recovering/resolving, and that of patient is pregnant was recovered on 30 Dec 2020.; Reporter's Comments: This is a case of product exposure during pregnancy for this 37-year-old female. Patient experienced malaise and vaccination site pain. 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.  Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Chills, Dizziness, Pyrexia
Clinical narrative: bone pain; feels dizzy; fever of 102; chills; A spontaneous report was received from a healthcare professional concerning a 40 year old, female patient who received Moderna's Covid-19 vaccine (mRNA-1273) and developed feeling dizzy, fever of 102, chills and bone pain.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   The patient received their first of two planned doses of mRNA-1273 (Lot # 025J20-2A) on 30 Dec 2020 in the left deltoid intramuscularly for prophylaxis of COVID-19 infection.   Nurse called to report she had received the COVID-19 vaccine on 30 Dec 2020 in her left deltoid. She reported feeling dizzy, fever of 102, chills and bone pain 12 hours after receiving the vaccine. She reported taking ibuprofen and had no symptoms the next morning.   Treatment for the event included ibuprofen.   Action taken with mRNA-1273 in response to the events was not provided.   The event, feeling dizzy, fever of 102, chills and bone pain, was considered resolved on 31 Dec 2020.   The reporter did not provide an assessment of the event, feeling dizzy, fever of 102, chills and bone pain.; Reporter's Comments: Based on the current available information and a strong temporal association between the use of the product, the known safety profile of the vaccine and the start date of the reported events, a causal relationship with the events cannot be excluded. Fever and chills are consistent with the known safety profile of mRNA-1273.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Not that painful; A spontaneous report was received from a consumer, who was a 42-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and it was painful.   The patient's medical history was not provided. Relevant concomitant medications were reported included sildenafil.  On 30 Dec 2020, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 31 Dec 2020, the pain began the same day of injection. The patient's pain was not that painful. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, not that painful, 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.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: Quite miserable; A spontaneous report was received from a consumer concerning for a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and felt quite miserable.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.    On 29 Dec 2020, the patient received her first of two planned doses of mRNA-1273 (Batch # 026L20A) intramuscularly in her left deltoid for prophylaxis of COVID-19 infection.   On 30 Dec 2020, the patient felt quite miserable. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not provided.  The outcome for the event quite miserable 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.
Sex: F
Vaccine: COVID19
Symptoms: Eye pruritus, Headache, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: runny nose; itchy eyes; tender throat; severe headache; A report was received from a consumer concerning a 53-year old, female patient who was participating in the mRNA-1273 Emergency Use Program and experienced severe headache, runny nose, itchy eyes and tender throat.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 24 Dec 2020, approximately 1 day prior to the onset of the event, severe headache, and 2 days prior to the onset of the events, runny nose, itchy eyes and tender throat, the patient received their first of two planned doses of mRNA-1273 (BATCH # 037K20A) intramuscularly in the hip for prophylaxis of COVID-19 infection.  On 25 Dec 2020, the patient had a severe headache and took Tylenol. On 26 Dec 2020, her headache was not resolved and she started to have runny nose, itchy eyes and tender throat. Symptoms were ongoing. Treatment for the event included Tylenol.   Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events were unknown.   The reporter did not provide an assessment for the events, headache, runny nose, itchy eyes and tender throat.; 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. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Headache, Musculoskeletal stiffness, Pain, Pyrexia
Clinical narrative: Body ache; Fever; Headache; I was stuck in my right arm; I am really worried about symptoms; A report was received from a healthcare professional concerning a 30-year old, female patient who experienced fever, headache, body ache, I was stuck in my right arm and I am really worried about my symptoms.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 23 Dec 2020, approximately 1 day and 10 hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (BATCH # 037K20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 24 Dec 2020 at about 10 am, the patient began to feel a fever, headache, body ache, stuck in right arm and really worried about her symptoms. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, fever, headache, body ache, I was stuck in my right arm and I am really worried about my were unknown.   The reporter did not provide an assessment for the events, fever, headache, body ache, I was stuck in my right arm and I am really worried about my symptoms.; Reporter's Comments: This case concerns a 30-year-old female who experienced NS unexpected events of musculoskeletal stiffness, pain, anxiety and NS expected events of fever, headache.  The events occurred 2 days after 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 discomfort, Arthralgia, Fatigue
Clinical narrative: Left shoulder soreness; Stomach discomfort; Tiredness; 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 left shoulder soreness, stomach discomfort and tiredness.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 28 Dec 2020, prior to onset of the events left shoulder soreness, stomach discomfort and tiredness, the patient received their dose of mRNA-1273 (lot/batch number: unknown) for prophylaxis of COVID-19 infection.    On 28 Dec 2020, the patient started having some side effects. The patient experienced left shoulder soreness, stomach discomfort and tiredness. No treatment information reported.   Action taken with mRNA-1273 in response to the events was not provided.  The outcome of event stomach discomfort was recovered on 28 Dec 2020. The outcome of events left shoulder soreness and tiredness was not provided.; 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. Further information has been requested.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Palpitations, Tachycardia
Clinical narrative: Heart rate up to 122; Still have Heart palpitations; A spontaneous report was received from a 30 year old, female nurse who developed heart palpitations (palpitations) and resting heart rate up to 122 (tachycardia),    The patient's medical history was not provided. No relevant concomitant medications were reported.   On 29 Dec 2020, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot# 025J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 30 Dec 2020, the patient began to experience heart palpitations and her resting heart rate was up to 122.   On 31 Dec 2020, her heart rate was back to normal but was still having heart palpitations. On follow up call 06 Jan 2021, patient stated her heart palpitations have not ended.    Treatment for the event included urgent care visit, Holter monitor in place and cardiologist visit scheduled 19 Jan 2021.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event, heart palpitations (palpitations) was not recovered. The outcome of the event, resting heart rate up to 122 (tachycardia), was resolved on 31 Dec 2020.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Feeling abnormal, Vaccination site pain
Clinical narrative: Not feeling great; Sore arm; pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (pregnancy), FEELING ABNORMAL (Not feeling great) and VACCINATION SITE PAIN (Sore arm) in a 37-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Pregnancy (Live, full term birth) on 08-Oct-2018. Concurrent medical conditions included Fruit allergy, Allergy to nuts, Latex allergy, Gestational diabetes and Hypertension (Chronic). Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE], VITAMIN D NOS and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for an unknown indication.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 30-Dec-2020, the patient experienced EXPOSURE DURING PREGNANCY (pregnancy). On 31-Dec-2020, the patient experienced FEELING ABNORMAL (Not feeling great) and VACCINATION SITE PAIN (Sore arm). The patient was treated with PARACETAMOL (TYLENOL) for Discomfort, at an unspecified dose and frequency. On 30-Dec-2020, EXPOSURE DURING PREGNANCY (pregnancy) had resolved. At the time of the report, FEELING ABNORMAL (Not feeling great) and VACCINATION SITE PAIN (Sore arm) had not 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.   Patient Estimated due date was reported as June-2021 . Lab data included Ultrasound .  Company Comment: This is a case of product exposure during pregnancy with no associated AEs for this 37-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy. Based on the current available information and temporal association between the use of the product and the start date of the events (vaccination site pain and feeling abnormal), a causal relationship cannot be excluded.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 37-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy. Based on the current available information and temporal association between the use of the product and the start date of the events (vaccination site pain and feeling abnormal), a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Arm was tender; A spontaneous report was received from a healthcare professional concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced tenderness.  The patient's medical history was not provided. C oncomitant medications were Tylenol and aspirin 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/batch: 011-J20A) intramuscularly in the Left arm for prophylaxis of COVID-19 infection.  On unknown date, the patient experienced arm tenderness.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not provided.   At the time of this report, the outcome of the event arm tenderness was unknown.; Reporter's Comments: This case concerns a female patient,  who experienced non-serious expected event of injection site pain left arm after vaccination on that arm .The event of injection site pain left arm occurred after the first dose of mRNA-1273, COVID -19 Vaccine. Based on the current available information and temporal association between the use of the product and onset of the event ,  a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Itching on the injection site (left arm); swelling on the injection site (left arm); 2 lymph nodes on right side of her neck; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itching on the injection site (left arm)), VACCINATION SITE SWELLING (swelling on the injection site (left arm)) and LYMPHADENOPATHY (2 lymph nodes on right side of her neck) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itching on the injection site (left arm)), VACCINATION SITE SWELLING (swelling on the injection site (left arm)) and LYMPHADENOPATHY (2 lymph nodes on right side of her neck). At the time of the report, VACCINATION SITE PRURITUS (Itching on the injection site (left arm)), VACCINATION SITE SWELLING (swelling on the injection site (left arm)) and LYMPHADENOPATHY (2 lymph nodes on right side of her neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. The patient put ice on injection site due to swelling and itching.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia, Vaccination complication
Clinical narrative: Symptoms from high temperature; Body chills; Long lasting side effects; A spontaneous report was received from a nurse concerning a female patient , of unknown age, who experienced long lasting side effects (vaccination complication), symptoms from high body temperature(pyrexia), and body chills (chills).   The patient's medical history was not provided. Concomitant product use was unknown.  On unknown date, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.  The patient reported symptoms from high temperature and body chills. The patient stated that she can't take it anymore. The patient experienced long lasting side effects for 3 days (since 30 Dec 2020). Treatment information was unknown.   Action taken with mRNA-1273 in response to the events was not unknown.   The outcome for the events of long lasting side effects (vaccination complication), symptoms from high body temperature (pyrexia), and body chills (chills)was considered as 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: Injection site bruising, Injection site swelling
Clinical narrative: Bruising where vaccine was administered; Swelling where vaccine was administered; A spontaneous report was received from a consumer, regarding herself, afemale patient of unspecified age, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced swelling and bruising where the vaccine was administered.   The patient's medical history was not provided. Concomitant medications were not reported.     On 23-Dec-2020, approximately 9 days 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 01-Jan-2021, the patient developed swelling and bruising around the area where the vaccine was administered. No treatment information was provided.  Action taken with mRNA-1273 in response to the events were not reported.   The outcome of the events, swelling and bruising where vaccine was administered were not reported.; Reporter's Comments: This case concerns a female patient who received their first of two planned doses of mRNA-1273 (Lot unknown), and who experienced the non-serious listed event of Injection site swelling and the non-serious unlisted event of Injection site bruising.  The events occurred 10 days after the first dose of vaccine. Based on the current available information and temporal association between the use of the product and the onset of events after vaccination, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased, Fatigue, Headache, Pain
Clinical narrative: Blood sugar has been rising after the vaccine; Increase in soreness; Mild headache; Fatigue; A spontaneous report was received from a consumer concerning himself, a 68-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) experienced increased blood sugar/Blood glucose increased, mild headache, increase in soreness/Pain and fatigue.   The patient's current condition included diabetes. Concomitant medication included insulin.  On 02 Jan 2021, approximately 2 hours prior to the onset of the symptoms, the patient received one of two planned doses of mRNA-1273 (Lot number unknown) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 02 Jan 2021, a couple hours after his vaccine, he had a mild headache, an increase in soreness and fatigue. On 03 Jan 2021, the patient's blood sugar had been rising after receiving the vaccine. Prior to receiving the vaccine, his blood glucose was 118 and 3 hours after, his blood sugar increased and he had to increase his insulin dose. Additional treatment information was not provided.   Action taken with mRNA-1273 in response to the events was not provided.   The event, blood sugar increasing, was considered resolved at the time of this report. The outcomes of the events mild headache, increase in soreness and fatigue 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 events, a causal relationship cannot be excluded.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, Vaccination site pain
Clinical narrative: Fever 100.7 F; Tenderness at site of injection; A spontaneous report received from a physician who was a 48-year old, female patient who was participating in the mRNA-1273 Program and developed fever of 100.7 and tenderness at sight on injection.  The patient's medical history included COVID-19. No relevant concomitant medications were reported.   On 02 Jan 2021, approximately 0 days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number 026L20A) intramuscularly for prophylaxis of COVID-19 infection.  On the night of 02 Jan 2021, the patient began to experience a fever of 100.7 degrees and tenderness at the injection site. She had no other symptoms. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcomes of the events, fever of 100.7 and tenderness at sight on injection were considered as 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.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site warmth
Clinical narrative: Localized rash at injection site that is "red", "warm" and "tender"; Localized rash at injection; Localized rash at injection site that is "red", "warm" and "tender"; Localized rash at injection site that is "red"; Soreness in left arm; A spontaneous report was received from a consumer concerning a 39-year-old, female patient, who received Moderna's COVID-19 Vaccine and experienced soreness in left arm, localized rash at injection site that is red, warm and tender.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 23 Dec 2020, approximately 24 hours prior to the onset of the events, the patient received their dose of mRNA-1273 (Batch number: Unknown) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 24 Dec 2020, the patient experienced soreness in left arm. On 31 Dec 2020, Thursday the patient experienced localized rash at injection site that is red, warm and tender.  Treatment for events localized rash at injection site that is red, warm and tender included Benadryl and hydrocortisone.  Action taken with mRNA-1273 in response to the events soreness in left arm, localized rash at injection site that is red, warm and tender was not reported.  The outcome of the events soreness in left arm, localized rash at injection site that is red, warm and tender was not reported.; Reporter's Comments: Based on the current available information and a strong temporal association between the use of the product, the known safety profile of the vaccine and the start date of the reported events, a causal relationship with the events cannot be excluded
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discomfort, Vaccination site erythema, Vaccination site pain
Clinical narrative: Mild arm soreness / Tenderness at injection site; Redness at injection site; Arm felt heavy; A spontaneous report was received from a nurse concerning herself, a 36 old, female patient who experienced mild arm soreness [Injection site pain], her arm felt heavy [Vaccination site discomfort], redness at the injection site [vaccination site erythema] and tenderness at the injection site [vaccination site pain].  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 28-Dec-2020, immediately prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 28-Dec-2020, immediately after receiving the vaccine, the patient experienced some mild arm soreness at the injection site which went away. On 03-Jan-2021, the patient reported that her arm felt heavy. She experienced redness and tenderness at the injection site. The redness and tenderness were continuing at the time of the report and she believes the redness was spreading. Treatment for the events included ibuprofen and ice packs.   Action taken with mRNA-1273 in response to the events was not provided.   The event tenderness at the injection site [vaccination site pain] resolved on 28-Dec-2020. The events of redness at the injection site [vaccination site erythema] were not resolved as of the time of this report.   The event, Vaccination site pain beginning on 28-Dec-2020 was resolved on 28-Dec-2020. The events of redness and tenderness at the injection site were not resolved as of the time of this report. The outcome of the event, arm felt heavy, 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: Fatigue, Feeling of body temperature change, Nausea, Sneezing, Vomiting
Clinical narrative: sneezing; feeling hot and cold; Not being able to keep anything down; fatigue; Nausea; A spontaneous report was received from a healthcare professional concerning a 22 year-old, female patient who received Moderna's COVID-19 vaccine and experienced  nausea, vomiting, fatigue, sneezing and fatigue, sneezing and feeling of hot and cold.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 03 Jan 2021, 7 days after vaccination, the patient began to feel fatigue, sneezing a lot and feeling hot and cold with nausea and vomiting.  Treatment for the event included dimenhydrinate.     Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events 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.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Palpitations
Clinical narrative: Palpitations; Headache; This spontaneous case was reported by a patient and describes the occurrence of PALPITATIONS (Palpitations) and HEADACHE (Headache) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma, Hypertension and Sulfonamide allergy. Concomitant products included HYDROCHLOROTHIAZIDE and LISINOPRIL for Hypertension, SERTRALINE for an unknown indication.    On 28-Dec-2020 at 6:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Dec-2020 at 6:45 AM, the patient experienced PALPITATIONS (Palpitations) and HEADACHE (Headache). At the time of the report, PALPITATIONS (Palpitations) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of the events within 30 minutes after vaccination, a causal relationship cannot be excluded. Further information has been requested; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events within 30 minutes after vaccination, a causal relationship cannot be excluded. Further information has been requested
Sex: F
Vaccine: COVID19
Symptoms: Dysphonia, Headache, Oropharyngeal pain, Pain, Vaccination site pain
Clinical narrative: Sore throat; Scratchy voice; Body aches; pain on the injection site; Headache; A spontaneous report was received from a 35-year-old healthcare professional, who was also the patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pain on the injection site, headache, body aches, sore throat, and scratchy voice.   The patient's medical history was not provided.  No concomitant medications were reported.  On 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Batch #025L20A) intramuscularly in her right deltoid for prophylaxis of COVID-19 infection.   On 30 Dec 2020, patient experienced pain on the injection site and a headache which resolved on 31 Dec 2020.  On 01 Jan 2021, the patient started having body aches.  On 02 Jan 2021, the patient experienced sore throat and scratchy voice.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, pain on the injection site and headache, was recovered/resolved on 31 Dec 2020.  The outcome of the events, body aches, sore throat, and scratchy voice, was not recovered/resolved.; Reporter's Comments: This case concerns a 35-year-old female who had nonserious events of unexpected Oropharyngeal pain and dysphonia and expected headache, pain, injection site pain.  Event onset occurred the same day as the first dose of mRNA-1273. Based on 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 upper, Back pain, Dizziness, Nausea
Clinical narrative: intense gastric pain; nausea; back pain; felt lightheaded; A spontaneous report was received from a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced intense stomach pain, intense gastric pain, nausea, back pain, and felt lightheaded.  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: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, thirty-nine hours post injection, the patient stated that she experienced about one hour of intense stomach pain, intense gastric pain, nausea, back pain, and felt lightheaded. She mentioned after the hour she felt fine. No treatment information was provided.   Action taken with mRNA-1273 in response to the events is not applicable.  The outcome of the events, intense stomach pain, intense gastric pain, nausea, back pain, and felt light headed, were 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: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Diarrhoea, Feeling cold, Nausea, Vaccination site pain
Clinical narrative: diarrhea; back pain; feeling constantly cold; nausea; injection site pain; A spontaneous report was received from a pharmacist concerning a 47-year-old patient, who was also the patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced injection site pain, backpain, diarrhea, nausea, and feeling constantly cold.   The patient's medical history was not provided.  Concomitant medications included Bystolic and Lexapro.  On 26 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot# 037K20A) in the right deltoid for prophylaxis of COVID-19 infection.   On 26 Dec 2020, the patient experienced injection site pain after taking the vaccine until 29 Dec 2020.  On 02 Jan 2021, the patient experienced backpain, diarrhea, nausea, and feeling constantly cold.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event, injection site pain, was recovered on 29 Dec 2020.  The outcome of the events, backpain, diarrhea, nausea, and feeling constantly cold, was considered 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 events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Injection site pain, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID-19; The day she received the vaccine she had sore arm.; A spontaneous report was received from a 57-year-old health care professional, who was also the patient, who received Moderna's COVID-19 vaccine and experienced a positive COVID test and injection site pain.  The patient's medical history included a negative test for COVID-19 on 29 Dec 2020.  No concomitant medications were reported.  On 28 Dec 2020, the patient tested negative for COVID-19.    On 29 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Batch number 025620A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 29 Dec 2020, the patient experienced injection site pain after getting vaccinated.    On 02 Jan 2021, the patient experienced COVID-19 with symptoms including runny nose and a little cough.  On 04 Jan 2021, the patient tested positive for COVID-19.  No treatment information has been provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, a positive COVID test and injection site pain, was not recovered/resolved.; Reporter's Comments: This case concerns a 53-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot 025620A), and who experienced the non-serious unlisted event of COVID-19 and the non-serious listed event of Injection site pain. Based on the known safety profile and temporal association between the use of the product and the onset of the event Injection site pain on the day of vaccination, a causal relationship cannot be excluded and the event is assessed as possibly related to the vaccine.  Based on the absence of COVID-19 virus capable of causing infection in the vaccine, the event of COVID-19 is assessed as unlikely related to the vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea
Clinical narrative: headache; chills; nausea; A spontaneous report was received from a consumer concerning a female patient who was participating in the mRNA-1273 Emergency Use Program and who experienced headache, chills and nausea.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   The patient received their first of two planned doses of mRNA-1273 on 31-Dec-2020 intramuscularly in the for prophylaxis of COVID-19 infection.   Patient received the Moderna vaccine on 31-Dec-2020 at approximately 0815.  On 01-Jan-2021, she reported that she began to experience headache, chills and nausea.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events, headache, chills and nausea, was not provided.  The outcome of the events, headache, chills and nausea, were considered as 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: M
Vaccine: COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: Itchiness on right outer thigh; Red lines on right outer thigh; A spontaneous report was received from a consumer concerning himself, a male patient of unknown age, who developed itchiness of the right outer thigh [Pruritis] and red lines of right outer thigh [Erythema].   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 30-Dec-2020, one day prior to the onset of the symptoms, the patient received one of two planned doses of mRNA-1273 (037K20A) intramuscularly in an unknown injection site for prophylaxis of COVID-19 infection.   The patient reported he started to experience itchiness on the right outer thigh and observed four red lines on the same thigh approximately 3 inches in length.  Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was not provided.   The outcomes of the events 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.
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Body temperature, Chills, Fatigue, Pain
Clinical narrative: loss of taste; Temperature reading of 99 degrees; body aches; chills; fatigue; A report was received from a pharmacist concerning a male patient who was participating in the mRNA-1273 Emergency Use Program and developed fatigue, body aches, loss of taste, chills, and temperature of 99 degrees.   The patient's medical history, as provided by the reporter, included cancer and type II diabetes. No relevant concomitant medications were reported.   On 30 Dec 2020, approximately one day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot number 025J20-2A) intramuscularly in the right deltoid for prophylaxis of COVID-19 infection.   The patient began feeling fatigue on 31 Dec 2020.  ON 02 Jan 2021 he had a temperature of 99 degrees, body aches, chills, and loss of taste.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events fatigue, body aches, loss of taste, chills, and temperature of 99 degrees were not reported.  Reporter causality for the events was not provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: loss of taste; Temperature reading of 99 degrees; body aches; chills; fatigue; A report was received from a pharmacist concerning a male patient who was participating in the mRNA-1273 Emergency Use Program and developed fatigue, body aches, loss of taste, chills, and temperature of 99 degrees.   The patient's medical history, as provided by the reporter, included cancer and type II diabetes. No relevant concomitant medications were reported.   On 30 Dec 2020, approximately one day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot number 025J20-2A) intramuscularly in the right deltoid for prophylaxis of COVID-19 infection.   The patient began feeling fatigue on 31 Dec 2020.  ON 02 Jan 2021 he had a temperature of 99 degrees, body aches, chills, and loss of taste.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events fatigue, body aches, loss of taste, chills, and temperature of 99 degrees were not reported.  Reporter causality for the events was not provided.; 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.