chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: blood pressure increased; Really bad headache; Felt drained; Sick to stomach; Arms felt like they were 50 pounds; Felt kind of funny; felt sick/felt terrible; Little discomfort in arm; Fever; A spontaneous report  was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and had experienced fever (pyrexia), discomfort in arm  pain, felt terrible and sick, drained, sick to stomach, really bad headache, arms felt like they were 50 pounds, and felt kind of funny.  The patient's medical history and concomitant product use were not provided by the reporter.  On 28 Dec 2020, the same day as the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot #: 037K20A) intramuscularly for prophylaxis of COVID-19 infection.  On 28 Dec 2020, the first night after receiving the vaccine, the patient reported they had a little fever, little discomfort in arm and felt sick and terrible.  The patient's temperature was 99.5 and 100 degrees Fahrenheit. On 29 Dec 2020, patient  felt ok.  However, on 30 Dec 2020, the patient continued to run a fever, felt sick and drained, had a really bad headache, sick to her stomach,  arms felt like they weighed 50 pounds, and they felt kind of funny.  At one point the patient's blood pressure was 186/106 and had been high on and off since being vaccinated.  At the time of the report, the patient stated that while they were feeling better, they are still experiencing these symptoms.    Action taken with mRNA-1273 in response to the events was not provided/unknown.  The outcome of the events, had a little fever, little discomfort in arm, felt terrible and sick, drained, sick to stomach, really bad headache, arms felt like they were 50 pounds, and felt kind of funny, 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: Coronavirus test, SARS-CoV-2 test positive
Clinical narrative: Tested positive for COVID; A spontaneous report was received from a pharmacist concerning a patient was participating in the mRNA-1273 Emergency Use the patient was positive for tested positive for COVID.   The patient's medical history was not provided. No relevant concomitant medications were reported.   The patient received their first of two planned doses of mRNA-127 intramuscularly in the for prophylaxis of COVID-19 infection. The pharmacist then reported the patient and was not positive for COVID but guess the next day the result came back from the last time they did their test as positive.  No treatment information was provided.   The seriousness criteria for event was non-serious.  Action taken with mRNA-1273 in response to the event(s) was not reported.  The event, was not positive for COVID but guess the next day the result came back from the last time they did their test as positive, was considered unknown.~; Reporter's Comments: Based on the current available information, the mRNA-1723 does not contain a virus capable of causing infection and with the occurrence of Covid-19 infection after vaccination, this event is assessed as unlikely related to mRNA-1273.
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: received the vaccine and is currently 14 weeks pregnant; A spontaneous report was received from a 34 year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and is currently 14 weeks pregnant.  As provided by the reporter, the patient had no history of allergies to medications or food, and no history of alcohol, nicotine or marijuana intake. The patient had no family history of congenital anomalies/genetic disease. The patient had no previous pregnancy history.  Concomitant medications taken during pregnancy included prenatal vitamins minerals nos, vitamins nos and acetylsalicylic acid.   The expected due date was estimated as 27 Jun 2021.   On 28 Dec 2020, at 10:12 am, the patient received their first of two planned doses of mRNA-1273 intramuscularly (lot :026L20A) in her right arm for prophylaxis of COVID-19 infection while currently 14 weeks pregnant. The patient reported no side effects to vaccine.  Action taken with mRNA-1273 vaccine was unknown.  The outcome of the event of vaccine exposure during pregnancy was considered unknown; Reporter's Comments: This is a case of vaccine exposure during pregnancy with no associated AEs for this 34 year old female who is 14 weeks pregnant. Patient will continue to be contacted for further monitoring of AEs during the pregnancy
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Got COVID-19, chills cold to the bone, coughing at work; A spontaneous report was received from a 48-year-old female consumer who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed COVID-19.    The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 28 Dec 2020, prior to the onset of the event, the patient received her  first of two planned doses of mRNA-1273 (Lot 037K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On an unknown date after receiving the vaccine, the patient experienced chills, cold to the bone and coughing at work. She then tested positive for COVID-19. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, developed COVID-19, was considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Pain assessment
Clinical narrative: Some soreness in the arm at the injection site; A spontaneous report was received from a physician concerning a, 49-year-old, female consumer who received Moderna's COVID-19 vaccine and developed soreness in the arm at the injection site.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 06 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 06 Jan 2021, after she received the vaccine, the patient experienced soreness in the arm at the injection site. The soreness on the pain scale of 6 out of 10 severity. No treatment information was reported.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The outcome for the events, soreness in the arm at the injection site, 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. Further information has been requested
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Investigation, Pruritus
Clinical narrative: left side of the lip felt numb; Itchy all over the body; A spontaneous report was received from a consumer concerning a, 67-year-old, female patient who received Moderna's COVID-19 vaccine and when returning her left side of the lip felt numb which went away in a moment, then she got itchy all over the body.   The patients past medical history included. Concomitant medications included Ambien 10 mg daily, Carvedilol 12.5 mg split twice a day, Lipitor 40 mg, Baby aspirin daily, cyclobenzaprine, Zeaden 10 mg, oxybutinin, Timolol eye drop and other eye drop. At the time of the event the patient reported she was allergic to "some things".  On 30 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J208) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On an unknown date, Patient states that when vaccinated yesterday she had to wait one hour in the health care center and when returning her left side of the lip felt numb which went away in a moment, then she got "itchy all over the body" and she was still "itchy" today too. Itchy severity was 8/10 (yesterday) and 3/10 (today). No treatment information was reported.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome for the event, lip felt numb was resolved on 06 Jan 2021. Th outcome of the event, Itchy the whole body was considered as not resolved.; Reporter's Comments: This case concerns a 67-year-old female who experienced NS unexpected events of Hypoaesthesia oral and Pruritus. Event onset occurred 8 days after the first dose of mRNA-1273. Treatment not reported. Hypoaesthesia oral resolved, but pruritus ongoing. 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: Injection site erythema, Injection site pruritus, Injection site warmth, Pain in extremity, Peripheral swelling
Clinical narrative: Swollen arm; Little warm; Itches really bad; Red spot at the injection site, Red area about size of a pea; Sore arm; A spontaneous report was received from a 35 year old, female consumer who was participating in the mRNA-1273 Program and experienced red area on her arm, sore and swollen arm, injection site redness, warmth and itchiness.   The patient's medical history, as provided by the reporter, included hypertension, increased cholesterol asthma, and low estrogen. Concomitant medications reported included atorvastatin, estradiol, fremanezumab vfrm, oxymetazoline hydrochloride, omeprazole, HCTZ, and betamethasone.    On 5 Jan 2021prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot 025J20A) intramuscularly in the arm for prophylaxis of COVID-19 infection.   On 5 Jan 2021, after receiving the vaccine, the patient experienced a red area on her arm about the size of a pea and arm soreness. On 6 Jan 2021, the patient experienced swollen arm and an increasing in size red spot at the injection site. Patient reports the red spot is warm and itches really bad. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, experienced red area on her arm, sore and swollen arm, injection site redness, warmth and itchiness, were considered unknown.  Follow up:  Follow-up received on 07 Jan 2021 included updated symptoms to include sore and swollen arm, increasing in size red spot at the injection site and warmth. Also added concomitant medications estradiol, fremanezumab vfrm, and oxymetazoline hydrochloride.; 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: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Facial discomfort, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: left arm and left hand numbness/left side of her face went numb; she could feel the nerve that goes from her eye to the corner of her mouth tightened up; Tongue either went numb or was swollen; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (left arm and left hand numbness/left side of her face went numb), FACIAL DISCOMFORT (she could feel the nerve that goes from her eye to the corner of her mouth tightened up) and HYPOAESTHESIA ORAL (Tongue either went numb or was swollen) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced HYPOAESTHESIA (left arm and left hand numbness/left side of her face went numb), FACIAL DISCOMFORT (she could feel the nerve that goes from her eye to the corner of her mouth tightened up) and HYPOAESTHESIA ORAL (Tongue either went numb or was swollen). On 08-Jan-2021, HYPOAESTHESIA (left arm and left hand numbness/left side of her face went numb), FACIAL DISCOMFORT (she could feel the nerve that goes from her eye to the corner of her mouth tightened up) and HYPOAESTHESIA ORAL (Tongue either went numb or was swollen) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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: M
Vaccine: COVID19
Symptoms: COVID-19, Headache, Pyrexia, SARS-CoV-2 test
Clinical narrative: Positive for COVID; Headache; lowgrade fever; A spontaneous report was received from a consumer concerning a male patient who received Moderna's COVID-19 vaccine and experienced headache, low-grade fever and a positive COVID-19 test.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 01 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (011J20A) intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, the patient started to experience headache and low-grade fever. It was reported that he had just received results of positive COVID-19 test. The date of test was not reported.  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 events headache and fever, a causal relationship cannot be excluded. The event Covid-19 is assessed as unlikely related to COVID-19 vaccine as the patient may have contracted the infection before receiving the vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Red mark; The spot were the vaccine was injected at is still sore; A spontaneous report was received from a consumer concerning a 49-year old, female patient who received Moderna's COVID-19 vaccine and experienced injection site soreness and a red mark at injection site.    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 (037K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 23 Dec 2020, the patient began to experience soreness at the site of injection. The spot was sore to touch. One to two days later, the patient reports the appearance of a red mark at the injection site approximately 2.5 inches long and 1 inch wide. No treatment information was provided.   Action taken with mRNA-1273 in response to the events is not applicale.   The outcome of the events, injection site soreness and injection site redness 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: Aphasia, Asthenia, Chills, Decreased appetite, Headache
Clinical narrative: Slept for 22 hours; Weakness; No appetite; Low blood pressure; Could not talk; Hot flashes; Fast heart rate; Lethargy; Pain in arm; Weird Headache; Swollen Lymph nodes; Chills; Nausea; Fever; A spontaneous report was received from a 29-year-old, female nurse, consumer who received Moderna's COVID-19 vaccine and experienced swollen lymph nodes, pain in arm, lethargy, weird headache, chills, hot flashes, nausea, fever, low blood pressure, fast heart rate, weakness, could not talk, no appetite, slept for 22hrs.    The patient's medical history was not provided. No relevant concomitant medications were reported.  On 29th 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 in the left arm deltoid for prophylaxis of COVID-19 infection.  After receiving the vaccine, the patient experienced swollen lymph nodes, pain in arm, lethargy, weird headache, chills, hot flashes, nausea, fever, low blood pressure, fast heart rate, weakness, could not talk, no appetite, slept for 22hrs.  Treatment for the events included Excedrin which helped with the headache.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The outcome for the events were not reported..; Reporter's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Hot flush, Hypersomnia, Hypotension, Lethargy
Clinical narrative: Slept for 22 hours; Weakness; No appetite; Low blood pressure; Could not talk; Hot flashes; Fast heart rate; Lethargy; Pain in arm; Weird Headache; Swollen Lymph nodes; Chills; Nausea; Fever; A spontaneous report was received from a 29-year-old, female nurse, consumer who received Moderna's COVID-19 vaccine and experienced swollen lymph nodes, pain in arm, lethargy, weird headache, chills, hot flashes, nausea, fever, low blood pressure, fast heart rate, weakness, could not talk, no appetite, slept for 22hrs.    The patient's medical history was not provided. No relevant concomitant medications were reported.  On 29th 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 in the left arm deltoid for prophylaxis of COVID-19 infection.  After receiving the vaccine, the patient experienced swollen lymph nodes, pain in arm, lethargy, weird headache, chills, hot flashes, nausea, fever, low blood pressure, fast heart rate, weakness, could not talk, no appetite, slept for 22hrs.  Treatment for the events included Excedrin which helped with the headache.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The outcome for the events were not reported..; Reporter's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Nausea, Pyrexia, Vaccination site pain
Clinical narrative: Slept for 22 hours; Weakness; No appetite; Low blood pressure; Could not talk; Hot flashes; Fast heart rate; Lethargy; Pain in arm; Weird Headache; Swollen Lymph nodes; Chills; Nausea; Fever; A spontaneous report was received from a 29-year-old, female nurse, consumer who received Moderna's COVID-19 vaccine and experienced swollen lymph nodes, pain in arm, lethargy, weird headache, chills, hot flashes, nausea, fever, low blood pressure, fast heart rate, weakness, could not talk, no appetite, slept for 22hrs.    The patient's medical history was not provided. No relevant concomitant medications were reported.  On 29th 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 in the left arm deltoid for prophylaxis of COVID-19 infection.  After receiving the vaccine, the patient experienced swollen lymph nodes, pain in arm, lethargy, weird headache, chills, hot flashes, nausea, fever, low blood pressure, fast heart rate, weakness, could not talk, no appetite, slept for 22hrs.  Treatment for the events included Excedrin which helped with the headache.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The outcome for the events were not reported..; Reporter's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Fatigue, Headache, Nasal dryness
Clinical narrative: Loss of smell; Loss of taste; Sore throat; Dry mucus lining in nose; Fever; Slight headache; Fatigue; A spontaneous report was received from a consumer concerning a 63-year-old male who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a fever, slight headache, fatigue, sore throat, dry mucus lining in nose, loss of smell, and loss of taste.   The patient's medical history was not provided. No relevant concomitant medications were reported.  On 28 Dec 2020 at 04:30 pm, approximately one day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 026L2O14) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 26 Dec 2020, prior to receiving the vaccine, the patient had a negative COVID test.   On 29 Dec 2020, he developed a fever, slight headache and fatigue.   On 30 Dec 2020, he experienced a sore throat and dry mucous lining in his nose.   On 31 Dec 2020, the fever subsided but the patient lost his smell and taste. The patient wanted to know if these symptoms were common. Treatment for the event of headache included Tylenol (acetaminophen).   Action taken with mRNA-1273 in response to the event was not reported.  The event fever was considered resolved on 31 Dec 2020. The outcome of the event(s) slight headache, fatigue, sore throat, dry mucus lining in nose, loss of smell and loss of taste 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: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: Loss of smell; Loss of taste; Sore throat; Dry mucus lining in nose; Fever; Slight headache; Fatigue; A spontaneous report was received from a consumer concerning a 63-year-old male who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a fever, slight headache, fatigue, sore throat, dry mucus lining in nose, loss of smell, and loss of taste.   The patient's medical history was not provided. No relevant concomitant medications were reported.  On 28 Dec 2020 at 04:30 pm, approximately one day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 026L2O14) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 26 Dec 2020, prior to receiving the vaccine, the patient had a negative COVID test.   On 29 Dec 2020, he developed a fever, slight headache and fatigue.   On 30 Dec 2020, he experienced a sore throat and dry mucous lining in his nose.   On 31 Dec 2020, the fever subsided but the patient lost his smell and taste. The patient wanted to know if these symptoms were common. Treatment for the event of headache included Tylenol (acetaminophen).   Action taken with mRNA-1273 in response to the event was not reported.  The event fever was considered resolved on 31 Dec 2020. The outcome of the event(s) slight headache, fatigue, sore throat, dry mucus lining in nose, loss of smell and loss of taste 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: Dyspnoea, Fatigue, Myalgia
Clinical narrative: Fatigue; Muscle pain; Breathing problem; A spontaneous report, was received from a consumer (patient), concerning herself, a 78 years-old female patient, unknown race and ethnicity, who received Moderna's COVID-19 vaccine (mRNA-1273), and experienced breathing problem (dyspnea), fatigue, and muscle pain (myalgia).    The patient's medical history included asthma, high blood pressure, atrial fibrillation, and colitis. Concomitant medications include budesonide/formoterol fumarate, albuterol, an unknown medication for atrial fibrillation, an unknown medication for hypertension, an unknown medication for colitis, and a statin medication.  On 31 Dec 2020, 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 right arm for prophylaxis of COVID-19 infection.   On 02 Jan 2021, the patient had a breathing problem. Despite her asthma, the patient states that she usually doesn't get this out of breath. She checked her airflow and it was in the yellow zone. She increased her asthma medication and started prednisone the next day in response to airflow being in a lower zone. The patient has some fatigue, however she related that to her asthma. She also reported muscle pain, but she said this was caused by her statin medication.  Treatment for the events included prednisone. 30 mg daily for 5 days.   Action taken with second dose of mRNA-1273 in response to the events was not reported.   The outcome of the events, breathing problem, fatigue, and muscle pain 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 of dyspnea, fatigue, and myalgia, a causal relationship cannot be excluded. However, patient's medical history of asthma may have been contributory for dyspnea.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia, Tremor
Clinical narrative: Fever; Chills; Shakes; A spontaneous report was received from a consumer concerning a male patient who received Moderna (mRNA-1273) and experienced fever, chills and shakes.    The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter.   The patient received their first of two planned doses of mRNA-1273 (Lot number unknown) on an unknown date intramuscularly for prophylaxis of COVID-19 infection.   The patient's wife called (04 Jan 2021) to report that her husband had received the covid-19 shot on Saturday and still has fever, chills, and shakes that they have been able to control with Ibuprofen.   Treatment for the event included ibuprofen.    Action taken with mRNA-1273 in response to the events was unknown.   The outcome of the events fever, chills, and shakes 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: Blister, Headache, Pain in extremity, Pyrexia
Clinical narrative: Blisters around the nose and mouth; Pain in the back of the head; Arm was a little sore; Very Very high fever; A spontaneous report was received from a consumer concerning a of an unknown age, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273)  and experienced high fever, blisters around her nose and mouth, arm was a little sore, and pain in the back of the head.   The patient's medical history and relevant concomitant medications were not 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 left arm for prophylaxis of COVID-19 infection.   On 01 Jan 2021, the patient's arm was a little sore and developed a fever.  On 04 Jan 2021 the patient developed blisters around her nose and mouth and pain in the back of her head.  The patient took ibuprofen to treat the events.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events blisters around her nose and mouth, and pain in the back of her head were not reported. The outcome of the events arm was a little sore and fever were considered 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.
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Dysgeusia, Headache
Clinical narrative: Tasting metal; Headaches; General side effects; A spontaneous report was received from a consumer concerning of an unknown age,female patient, who received Moderna's COVID-19 vaccine and experienced tasting metal, headache and other general side effects.    The patient's medical history was not provided. No relevant concomitant medications were reported.   On 31 Dec 2020, the patient received their first of two planned doses of mRNA-1273 via unknown route for prophylaxis of COVID-19 infection.   On an unknown date, the patient experienced a metallic taste, along with having headaches and other unspecified side effects. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of the events, tasting metal, headache and other general side effects 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: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: Itching all over her body; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PRURITUS (Itching all over her body) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced VACCINATION SITE PRURITUS (Itching all over her body). At the time of the report, VACCINATION SITE PRURITUS (Itching all over her body) 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.   Company comment: This case concerns a 52-year-old female who experienced a nonserious unexpected event of pruritus without associated rash.  Event onset occurred the same day as the first dose of mRNA-1273. Treatment not reported. Event ongoing. 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 52-year-old female who experienced a nonserious unexpected event of pruritus without associated rash.  Event onset occurred the same day as the first dose of mRNA-1273. Treatment not reported. Event ongoing. 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: Chest discomfort, Cough, Fatigue, Headache, Lethargy
Clinical narrative: Lethargic; Headaches; Feeling tired; Some occasional cough; Pressure on chest; A spontaneous report was received from a 46 year-old female patient who was administered Moderna's COVID-19 vaccine (mRNA-1273) and developed cough, headache, chest discomfort, fatigue, and lethargy.   The patient's medical history and concomitant medications were not reported.  On 31-DEC-2020, prior to the onset of the events, the patient received her first of two planned doses of mRNA-1273 (lot number: unknown) intramuscularly in the left arm for the prophylaxis of COVID-19 infection.  On 31-DEC-2020, the patient developed headaches, some occasional cough, pressure on the chest, feeling of tiredness, and lethargy. Treatment information was unknown.   Action taken with mRNA-1273 in response to the events was not reported.  The outcomes of the events, cough, headache, chest discomfort, fatigue, and lethargy, 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 events, a causal relationship cannot be excluded.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Headache, Pain, Pain in extremity, Pruritus
Clinical narrative: Itchy at the  injection site; Redness at the  injection site; Sore arm at the injection site; Itching under belly button and arm pit; Arm felt warm; Body ache; Fever; Headache; Arm soreness; A spontaneous report was received from a other health care professional, concerning herself, a 26-year-old female patient, who received Moderna's COVID-19 vaccine and experienced arm soreness/ pain in extremity, body ache/ pain, itching under belly button and arm pit/ pruritus, arm felt warm/ feeling hot, itchy at the  injection site/ vaccination site pruritus, redness at the  injection site/ vaccination site erythema, sore arm at the injection site/ vaccination site pain, fever/ pyrexia and headache.  The patient's medical history was not provided. No relevant concomitant medications were provided.   On 27 DEC 2020, the patient received their first of two planned doses of mRNA-1273 vaccine (batch# 037K20A) via unknown route in the left arm for prophylaxis of COVID-19 infection.   On 27 Dec 2020, immediately after vaccination, the patient developed an arm soreness. On 28 Dec 2020 patient also experienced body ache, fever, headache and her arm felt warm. On 31 Dec 2020, additionally patient experienced itching under her belly button and arm pit. On 04 Jan 2021 she developed sore arm, redness and itchy at the injection site. No treatment was taken as of now and symptoms are ongoing at the time of this report..  The outcome of events arm soreness, body ache, itching under belly button and arm pit, arm felt warm, itchy at the injection site, redness at the  injection site, sore arm at the injection site, fever and headache were not resolved at the time of this report.; Reporter's Comments: Based on the information provided which includes a strong temporal association between the reported events and administration of mRNA-1273 vaccine, an excluding any other etiology, a causal association cannot be excluded. itchy at the injection site, redness at the injection site, sore arm at the injection site, fever and headache are consistent with the known safety profile of the vaccine.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Itchy at the  injection site; Redness at the  injection site; Sore arm at the injection site; Itching under belly button and arm pit; Arm felt warm; Body ache; Fever; Headache; Arm soreness; A spontaneous report was received from a other health care professional, concerning herself, a 26-year-old female patient, who received Moderna's COVID-19 vaccine and experienced arm soreness/ pain in extremity, body ache/ pain, itching under belly button and arm pit/ pruritus, arm felt warm/ feeling hot, itchy at the  injection site/ vaccination site pruritus, redness at the  injection site/ vaccination site erythema, sore arm at the injection site/ vaccination site pain, fever/ pyrexia and headache.  The patient's medical history was not provided. No relevant concomitant medications were provided.   On 27 DEC 2020, the patient received their first of two planned doses of mRNA-1273 vaccine (batch# 037K20A) via unknown route in the left arm for prophylaxis of COVID-19 infection.   On 27 Dec 2020, immediately after vaccination, the patient developed an arm soreness. On 28 Dec 2020 patient also experienced body ache, fever, headache and her arm felt warm. On 31 Dec 2020, additionally patient experienced itching under her belly button and arm pit. On 04 Jan 2021 she developed sore arm, redness and itchy at the injection site. No treatment was taken as of now and symptoms are ongoing at the time of this report..  The outcome of events arm soreness, body ache, itching under belly button and arm pit, arm felt warm, itchy at the injection site, redness at the  injection site, sore arm at the injection site, fever and headache were not resolved at the time of this report.; Reporter's Comments: Based on the information provided which includes a strong temporal association between the reported events and administration of mRNA-1273 vaccine, an excluding any other etiology, a causal association cannot be excluded. itchy at the injection site, redness at the injection site, sore arm at the injection site, fever and headache are consistent with the known safety profile of the vaccine.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash; This spontaneous report was received from a physician concerning a patient of unknown age and gender who received Moderna's COVID-19 vaccine and experienced a rash.   The patient's medical history was not provided. Concomitant Medications were not reported.   On 04 Jan 2021, the patient received a dose of mRNA-1273 (batch number Unknown) via unknown route for prophylaxis of COVID-19 infection.  On 04 Jan 2021, the patient experienced rash.  The physician was seeing multiple patients and was extremely rushed. The physician also stated that the patient also had fillers  The action taken for Moderna COVID-19 Vaccine was not reported.   The outcome of rash 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 rash, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, SARS-CoV-2 test positive
Clinical narrative: Tested positive for COVID; Tired; Just body aches; This spontaneous case was reported by a health care professional and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for COVID), FATIGUE (Tired) and MYALGIA (Just body aches) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2020, the patient experienced FATIGUE (Tired) and MYALGIA (Just body aches). On 04-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for COVID). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for COVID), FATIGUE (Tired) and MYALGIA (Just body aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Jan-2021, SARS-CoV-2 test positive: postiive.     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 concerns a patient of unknown age and gender who experienced non serious events of unexpected SARS-CoV-2 test positive and expected fatigue and myalgia.  Event onset 3 days after the first dose of mRNA-1273, followed by SARS-CoV-2 test positive on Day 8. 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.; Reporter's Comments: This case concerns a patient of unknown age and gender who experienced nonserious events of unexpected SARS-CoV-2 test positive and expected fatigue and myalgia.  Event onset 3 days after the first dose of mRNA-1273, followed by SARS-CoV-2 test positive on Day 8. 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: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Itchiness at injection site; redness at injection site; Swelling at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchiness at injection site), VACCINATION SITE ERYTHEMA (redness at injection site) and VACCINATION SITE SWELLING (Swelling at injection site) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K202A) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction (No Medical History Received).    On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Dec-2020, the patient experienced VACCINATION SITE PRURITUS (Itchiness at injection site), VACCINATION SITE ERYTHEMA (redness at injection site) and VACCINATION SITE SWELLING (Swelling at injection site). On 01-Jan-2021, VACCINATION SITE PRURITUS (Itchiness at injection site), VACCINATION SITE ERYTHEMA (redness at injection site) and VACCINATION SITE SWELLING (Swelling at injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Malaise, Myalgia
Clinical narrative: Not feeling good; Fatigue; headache; Chills; soreness; fever; A spontaneous report was received from a consumer concerning a 76-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced not feeling good, fatigue, headache, chills, soreness and fever.  The patient's medical history included having COVID-19 in December 2020. Concomitant product use was not provided.  On 04 Jan 2021, the patient received their first dose of mRNA-1273 (Lot number unknown) in his left arm for prophylaxis of COVID-19 infection.   On 05 Jan 2021, The patient experienced symptoms of not feeling well with fatigue, headache, soreness, chills all day and then had a fever that evening. No treatment information were provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event(s) not feeling good, fatigue, headache, chills, soreness and fever 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 these events, a causal relationship cannot be excluded.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: Not feeling good; Fatigue; headache; Chills; soreness; fever; A spontaneous report was received from a consumer concerning a 76-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced not feeling good, fatigue, headache, chills, soreness and fever.  The patient's medical history included having COVID-19 in December 2020. Concomitant product use was not provided.  On 04 Jan 2021, the patient received their first dose of mRNA-1273 (Lot number unknown) in his left arm for prophylaxis of COVID-19 infection.   On 05 Jan 2021, The patient experienced symptoms of not feeling well with fatigue, headache, soreness, chills all day and then had a fever that evening. No treatment information were provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event(s) not feeling good, fatigue, headache, chills, soreness and fever 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 these events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site pain
Clinical narrative: 4 in by 3 in lump at the injection site along with redness; Soreness at injection site; Felt pain, soresness at injection site; A spontaneous report was received from a health care professional concerning of an unknown age female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pain, soreness at injection site and 4 in by 3 in lump at the injection site along with redness.   The patient's medical history included drug allergy to NSAIDs. No relevant concomitant medications were reported.   On 26 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot: unknown) via unknown route for prophylaxis of COVID-19.  On 26 Dec 2020, the patient stated she felt pain and soreness at injection site. On 04 Jan 2021, ten day later, the patient noticed 4 in by 3 in lump at the injection site along with redness. The lump was firm to touch.  No treatment information provided.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome for the event, pain and soreness at injection site, was resolved.  The outcome for the events, 4 in by 3 in lump at the injection site along with redness, was unknown; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: Severe Headache; Low grade fever; A spontaneous report was received from a 57 year old female consumer who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced low-grade fever and severe headache.  The patient's medical history was not provided. Concomitant medication use was not provided by the reporter.  On 30 Dec 2020, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection.   On 03 Jan 2021,  the patient developed a low-grade fever (temperature was not reported). On 04 Jan 2021 she began to experience severe headaches. The intensity and severity of the fever and headache before and after treatment, was not provided. The patient was due for her second dose of vaccine on 28 Jan 2021. However, the patient would like to be informed regarding the implications of her symptoms.  The patient reported to have taken Acetaminophen, Ibuprofen, and Naproxen to treat her symptoms.   Action taken with mRNA-1273 in response to the events, headache and fever, was not provided.  The outcome of the events low grade fever and severe headaches was unknown at the time of this report.; 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.