chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Vaccination site urticaria
Clinical narrative: Pain in my arm at injection site; Small red round spot with itchiness at the injection site; Small red round spot with itchiness at the injection site; It (injection site) was warm to touch; A spontaneous report was received from a consumer concerning himself, of age 44 years old, female who received Moderna's COVID-19 vaccine and experienced the events of "small red round spot with itchiness at the injection site", "pain in my arm at injection site" and "it (injection site) was warm to touch".  There were no medical history and concomitant medications reported.  On 26-Dec-2020, patient received their first of two planned doses of mRNA-1273 (Lot number was unknown) intramuscularly on the left arm for prophylaxis of COVID-19 infection.  On 27 Dec 2020, in the morning, the patient experienced pain in my arm at injection site, warm to touch, small red round spot at the injection site which has gotten bigger and itchiness at the injection site. No treatment was administered.  On 28 Dec 2020, the event, pain in my arm at injection site was resolved but, the red circle got bigger and it was still warm to touch. It is only slightly itchy. The patient did not take any treatment medications for the events.  Action taken with mRNA-1273 in response to the events were not reported.   The events small red round spot with itchiness at the injection site and It (injection site) was warm to touch were not resolved. The event pain in my arm at injection site was resolved on 28 Dec 2020.; Reporter's Comments: This case concerns a 44-year-old, female patient. The patient's medical history was not provided. The patient experienced non serious, expected event of injection site urticaria, erythema, pain,  and an unexpected event of injection site warmth. The event occurred 2 days after the first dose of mRNA-1273 administration. 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: Pyrexia
Clinical narrative: Fever/Elevated temperature; This spontaneous case was reported by a health care professional and describes the occurrence of PYREXIA (Fever/Elevated temperature) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (Fever/Elevated temperature). At the time of the report, PYREXIA (Fever/Elevated temperature) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 01-Feb-2021: The patient name and dose number were provided.; Sender's Comments: This case concerns a female patient of unknown age. The medical history is not provided. The patient experienced an expected non-serious event of Pyrexia approximately one day after receiving their first of two planned doses of mRNA-1273 (Lot unknown). Based on temporal association between the use of the product and the onset of the event, a causal relationship cannot be excluded and the event is considered possibly related to the vaccine.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: Migraine; A spontaneous report was received from a nurse, 42 year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a migraine.   The patient's medical history included migraine. No relevant concomitant medications were reported.   On 26 Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 27 Dec 2020, within 24 hours of vaccine administration, the patient developed a migraine. The patient stated that she had an appointment with her neurologist for a botulinum toxin injection on the day of the event but was advised by the doctor to report her side effects. The consumer stated being treated for migraines, but they have been cyclic/hormonal. Treatment information included sumatriptan, ibuprofen and caffeine, "all the usuals".    Action taken with mRNA-1273 in response to the event was not reported.  The event, migraine, was considered not resolved.; Reporter's Comments: This case concerns a 42-years-old female patient, with past medical history of migraine, who experienced a non-serious unexpected event of migraine. The events occurred 2 days after first dose of mRNA-1273, lot # 025J20A-2A. Treatment included sumatriptan, ibuprofen and caffeine.  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. Additional information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Tingling followed by numbness in tongue, mouth and throat; Tingling followed by numbness in tongue, mouth and throat; A spontaneous report was received from a consumer concerning a female patient of unknown age who was Moderna's COVID-19 vaccine (mRNA-1273) and experienced tingling in tongue, mouth and throat and numbness in tongue, mouth and throat.   There were no medical history and concomitant medications reported.  On an unreported date in 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On an unreported date in 2020, the patient reported experiencing tingling followed by numbness in tongue, mouth and throat upon administration of mRNA-1273.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events were unknown.  The outcomes of the events were unknown.; Reporter's Comments: This spontaneous report concerning a female patient of unknown age who experienced tingling in tongue, mouth and throat and numbness in tongue, mouth and throat. The events occurred the on an unknown date after the administration of the first dose of mRNA-1273 ((lot number unknown, expiration date unknown). Treatment provided and outcome are unknown. There is not enough information to assess the causal association between the event and the administration of mRNA-1273 vaccine as critical details such as the duration date of dosing and onset of the events was not provided. Main field defaults to possibly related'
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Polymerase chain reaction
Clinical narrative: Positive for COVID-19; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of COVID-19 (Positive for COVID-19) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2020, the patient experienced COVID-19 (Positive for COVID-19). The patient was treated with ASA ongoing since an unknown date at a dose of UNK daily; MULTIVITAMINS [VITAMINS NOS] ongoing since an unknown date at a dose of UNK daily and STEROIDS ongoing since an unknown date at a dose of UNK daily. At the time of the report, COVID-19 (Positive for COVID-19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Dec-2020, Polymerase chain reaction: (Positive) Patient tested positive for COVID-19.     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 experienced symptoms headache, muscle ache, loss of smell, loss of taste. Concomitant medications details were not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 29-Mar-2021: The patient's current condition, symptoms, event outcome and treatment information were provided.; Sender's Comments: Based on lack of biological implausibility  the event is assessed as unlikely related to mRNA-1273.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Pain, Pyrexia, Tenderness
Clinical narrative: slight fever; chills; Diarrhea; Feeling Achy; shakes; left side tender to touch; This spontaneous case was reported by a nurse and describes the occurrence of PYREXIA (slight fever), CHILLS (chills), DIARRHOEA (Diarrhea), PAIN (Feeling Achy) and TREMOR (shakes) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in October 2020.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced PYREXIA (slight fever), CHILLS (chills), DIARRHOEA (Diarrhea), PAIN (Feeling Achy), TREMOR (shakes) and TENDERNESS (left side tender to touch). At the time of the report, PYREXIA (slight fever), CHILLS (chills), DIARRHOEA (Diarrhea), PAIN (Feeling Achy), TREMOR (shakes) and TENDERNESS (left side tender to touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 30-Dec-2020: Follow-up received on 31 Mar 2021 included no new information; Reporter's Comments: A spontaneous report concerns a 22-year-old, female patient, who experienced non-serious events of slight fever, chills, shakes, diarrhea, "feeling achy", and left side tenderness. The event occurred 1 day after the administration of the first dose of the mRNA-1273 vaccine (Lot #: unknown, expiration date-unknown). No treatment was provided, and outcome was unknown. Based on the information provided, which indicates a temporal association between the reported events and the administration of mRNA-1273 vaccine, a causal association cannot be excluded. Fever and chills are consistent with the known safety profile of mRNA-1273 vaccine.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: slight fever; chills; Diarrhea; Feeling Achy; shakes; left side tender to touch; This spontaneous case was reported by a nurse and describes the occurrence of PYREXIA (slight fever), CHILLS (chills), DIARRHOEA (Diarrhea), PAIN (Feeling Achy) and TREMOR (shakes) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in October 2020.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced PYREXIA (slight fever), CHILLS (chills), DIARRHOEA (Diarrhea), PAIN (Feeling Achy), TREMOR (shakes) and TENDERNESS (left side tender to touch). At the time of the report, PYREXIA (slight fever), CHILLS (chills), DIARRHOEA (Diarrhea), PAIN (Feeling Achy), TREMOR (shakes) and TENDERNESS (left side tender to touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 30-Dec-2020: Follow-up received on 31 Mar 2021 included no new information; Reporter's Comments: A spontaneous report concerns a 22-year-old, female patient, who experienced non-serious events of slight fever, chills, shakes, diarrhea, "feeling achy", and left side tenderness. The event occurred 1 day after the administration of the first dose of the mRNA-1273 vaccine (Lot #: unknown, expiration date-unknown). No treatment was provided, and outcome was unknown. Based on the information provided, which indicates a temporal association between the reported events and the administration of mRNA-1273 vaccine, a causal association cannot be excluded. Fever and chills are consistent with the known safety profile of mRNA-1273 vaccine.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia, Paraesthesia oral
Clinical narrative: Tingling in feet and toes; Numbness in feet / Numbness in toes; Left side of mouth tingling; This spontaneous report was received from a consumer of age 25 years old, female who was participating in the mRNA-1273COVID-19 Vaccine,  Emergency Use Authorization Program and experienced multiple events of tingling in feet and toes, numbness in feet / numbness in toes and left side of mouth tingling.  The patient's medical history was not reported. No concomitant medications were reported.  On 30 Dec 2020, approximately 3 minutes earlier to the onset of the events, the patient received her first of two planned doses of mRNA-1273 (Lot number 011J20A) intramuscularly in the deltoid muscle of the left arm for prophylaxis of COVID-19 infection.  On 30 Dec 2020, two to three minutes after the injection, the patient experienced tingling and numbness in left foot and toes. She started to walk around bit but the feeling persisted. A few minutes later the same tingling and numbness in right foot and toes developed. After ten minutes, the patient experienced tingling in her left lip. The patient was then treated with Benadryl and taken to the emergency medical technician (EMT) to be monitored. After 35 minutes and having the patient's vitals checked twice the patient was cleared to go. The patient informed that after she left the site she did not experienced any tingling or numbness.  The Action taken with mRNA-1273 Vaccine in response to the events was not reported.   The outcome for the events, tingling and numbness in left foot and toes, tingling and numbness in right foot and toes and tingling in my left lip were considered recovered/ resolved on the same date.  The reporter did not provide an assessment for the events.; Reporter's Comments: This case concerns a 25-year-old, female patient,  who experienced  non-serious unexpected events of Paraesthesia  and Hypoaesthesia extremities and Paraesthesia oral  left side . The events of Paraesthesia  and Hypoaesthesia extremities and Paraesthesia oral  left side , occurred 1 day (same day) after first dose of mRNA-1273, COVID-19 Vaccine lot # 011J20A. Treatment included Benadryl. Based on the current available information and temporal association between the use of the product and onset of the events a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during breast feeding
Clinical narrative: breastfeeding; A spontaneous report was received from 28 year old female patient who is also a nurse. The patient is a participating in the mRNA-1273 Emergency Use Program and experienced breastfeeding with the use of mRNA-1273.    Medical history included allergy to vancomycin, sulfa, and bees. Concomitant medications included Prenatal vitamins (nos).  On 28 Dec 2020, the patient received the first of two planned doses of mRNA-1273 (Lot # unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 27 Dec 2020, the patient, experienced the non-serious event of breastfeeding. The patient reports she had the vaccine and is currently breastfeeding. There was no treatment information provided.  There were no relevant laboratory tests provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome for the reported event of breastfeeding was unknown at the time of this report.  Causality was not provided for the event of breastfeeding.; Reporter's Comments: This report refers to a case of Maternal exposure during breastfeeding for mRNA-1273, lot # unknown.  There were no reported AEs associated with this case.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Exposure during pregnancy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Exposure during pregnancy). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Exposure during pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not reported . Treatment history was not reported .; Reporter's Comments: This is a case of product exposure during pregnancy with no associated AEs for this unknown age female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Body Aches; A spontaneous report was received from a consumer concerning a 19 year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced body aches.    The patient's medical history was not provided. No relevant concomitant medications were reported.   On 30 Dec 2020, approximately 24 hours prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 intramuscularly prophylaxis of COVID-19 infection.   On 31 Dec 2020, the patient began to experience body aches. Reporter also expressed that the patient was exposed to someone who tested positive for COVID-19 one day prior to vaccination. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event was not reported.; Reporter's Comments: This case concerns a 19 year-old, female patient, who experienced events of  body aches. The events occurred the next day after the first and last dose of mRNA-1273 vaccine administration. 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 and the events are assessed as possibly related.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Headache; sore arm; A spontaneous report was received from a consumer himself, a 48-year-old, male who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced headache and sore arm.   There were no medical history and concomitant medications reported.  On 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot 011J02A) intramuscularly for prophylaxis of COVID-19 infection.   On 31 Dec 2020, patient experienced a headache and sore arm. There was no treatment information provided.   Action taken with mRNA-1273 in response to the events headache and sore arm was not reported.   The outcome of the events headache and sore arm was unknown.; Reporter's Comments: This case concerns a 48 year old male who received their first of two planned doses of mRNA-1273 (Lot 011J02A) intramuscularly for prophylaxis of COVID-19 infection and experienced non serious listed event of headache and non-serious unlisted event of sore arm. 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 and the events are possibly related.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Injection site pain
Clinical narrative: Mild soreness in my left arm at the site of injection (deltoid); Moderately-bad headache; A spontaneous report was received from a 51-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced mild soreness in his left arm at the site of injection (deltoid) and a moderately bad headache.  Relevant medical history included migraines. No relevant concomitant medications were reported.   On 30 Dec 2020 at 11:30am, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011J20A) intramuscularly in the arm for prophylaxis of COVID-19 infection.   On 31 Dec 2020, the patient woke up with mild soreness in his left arm at the site of injection along with a moderately-bad headache. The patient mentioned he is prone to migraines so the headache may be unrelated to the vaccine. Otherwise he "felt normal".  Treatment information was not provided.    Action taken with mRNA-1273 in response to the reported events were not reported.   The outcome of events mild soreness in his left arm at the site of injection (deltoid) and a moderately bad headache were unknown.; Reporter's Comments: A spontaneous report concerns a 51-year-old, male patient, who experienced mild soreness in his left arm at the site of injection (deltoid) and a moderately bad headache. The events occurred the following day after the administration of the first dose of mRNA-1273 ((lot number 011J20A, expiration date unknown). Treatment provided and outcome are unknown. The reported events are temporally associated with administration of mRNA-1273 vaccine  and  consistent with the known safety profile of vaccine , hence a causal association cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Positive Covid results; A spontaneous report was received from a health care travel agency employee, concerning a patient who was participating in the mRNA-1273 Emergency Use Program and experienced the event positive Covid results.  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-1273 on 29 Dec 2020.   The reporter stated that the patient had received the Covid vaccine on 29 Dec 2020. On 30 Dec 2020, the patient received positive Covid results. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, positive Covid results, was considered not resolved.; Reporter's Comments: This case concerns a patient of unknown age and gender. The patient's medical history was not provided.  The patient experienced an unexpected event of positive COVID test 2 days after the first dose of mRNA-1273 was administered. Very limited information regarding this event has been provided at this time.  Further information has been requested. The event is assessed as unlikely related to mRNA-1273.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Rash
Clinical narrative: Rash on stomach which is now on back; Nausea; Headache; A spontaneous report was received from a 63 year old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a rash on stomach which is now on back, headache and nausea.   The patient's medical history, as provided by the reporter, included breast cancer (BRCA) 2 positive. Concomitant medications reported included oral chemotherapy.  On 23 Dec 2020, the patient received her first of two planned doses of mRNA-1273 (Lot number 011J20A) , intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On unknown date in Dec 2020 patient experienced a headache and nausea.   On 25 Dec 2020 she woke up with rash on stomach which is now on her back. Treatment for the event included ibuprofen and antihistamine.   Action taken with mRNA-1273 in response to the events was not provided.  The reported events of rash on stomach which is now on back, headache, nausea were considered not resolved.; Reporter's Comments: This case concerns a 63 year old, female with a history of BRCA2 positive (breast cancer), who experienced a serious unexpected event of rash and an expected event of nausea and headache. The event occurred 1 day after first dose of mRNA-1273 (Lot# 011J20A) administration. The subject is on oral chemotherapy for breast cancer (name of the medication not provided) and treatment for the event included Advil and antihistamine. 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: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pain, Pyrexia
Clinical narrative: Pain; Chills; Headache; Ran a fever; A spontaneous report was received from a healthcare professional concerning 41-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pain, chills, headache and ran fever.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 24 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (011J20A), intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 24 Dec 2020, the patient complained of pain, chills, headache and fever. After the first dose, she developed fever. The vitals included temperature readings at 101 degrees. Later in the evening, her temperature was recorded at 102 degrees.   On 25 Dec 2020, the temperature readings of 100.5 degrees was reported.   Treatment of symptoms included acetaminophen.  Action taken with mRNA-1273 in response to the events was not reported.    The outcome of the events pain, chills, headache and ran fever were not resolved.; Reporter's Comments: This case concerns a 41-year-old, female, patient, who experienced an expected non-serious events of Myalgia, Chills, Headache, and Pyrexia. The events occurred on the same day after first dose of mRNA-1273 (lot # 011J20A). Treatment included Tylenol for her symptoms. Based on the current available information and temporal association between the use of the product and onset of the events a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Injection site pain, Myalgia
Clinical narrative: injection site soreness; 101.5 degree fever; headache; joint pain; muscle pain; fatigue; A report was received from a consumer concerning a patient, 22 years old, male and experienced multiple events of injection site soreness, 101.5 F fever, headache, joint pain, muscle pain and fatigue.  The patient's medical history was not provided. No Concomitant medications were reported.  On 26 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot # 026L20A).   On 27 Dec 2020, the patient experienced injection site soreness, 101.5 F fever, headache, joint pain, muscle pain and fatigue. No treatment information was reported. On the same day, the body temperature of the patient was 101.5 degrees Fahrenheit.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome for the events, injection site soreness, 101.5 F fever, headache, joint pain, muscle pain and fatigue was unknown.  The reporter did not provide an assessment for the events.; Reporter's Comments: This case concerns a 22-years-old male patient, who experienced a non-serious expected event of injection site pain, pyrexia, headache, arthralgia, myalgia, and fatigue. The events occurred 2 days after first dose of mRNA-1273, lot # 026L20A.  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.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: injection site soreness; 101.5 degree fever; headache; joint pain; muscle pain; fatigue; A report was received from a consumer concerning a patient, 22 years old, male and experienced multiple events of injection site soreness, 101.5 F fever, headache, joint pain, muscle pain and fatigue.  The patient's medical history was not provided. No Concomitant medications were reported.  On 26 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot # 026L20A).   On 27 Dec 2020, the patient experienced injection site soreness, 101.5 F fever, headache, joint pain, muscle pain and fatigue. No treatment information was reported. On the same day, the body temperature of the patient was 101.5 degrees Fahrenheit.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome for the events, injection site soreness, 101.5 F fever, headache, joint pain, muscle pain and fatigue was unknown.  The reporter did not provide an assessment for the events.; Reporter's Comments: This case concerns a 22-years-old male patient, who experienced a non-serious expected event of injection site pain, pyrexia, headache, arthralgia, myalgia, and fatigue. The events occurred 2 days after first dose of mRNA-1273, lot # 026L20A.  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: Headache, Nausea, Vomiting
Clinical narrative: Headache; Nausea; Vomiting; A spontaneous report was received from a consumer concerning a female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events, headache, nausea , vomiting.  The patients' medical history was not provided. No concomitant medications list was provided.  On 23 Dec 2020, prior to the onset of symptoms, patient received the first of two planned doses of mRNA-1273 for the prophylaxis of COVID -19 infection.  On 25 Dec 2020 the patient started experiencing headache, nausea, vomiting.   Treatment for the reported events were not provided.  Action taken with planned  second dose of  mRNA-1273 in response  to the events was not provided.  Outcome of the events, headache, nausea and vomiting, was not reported.; Reporter's Comments: This case concerns a female, patient of unknown age, who experienced expected non-serious events of Headache, Nausea, and Vomiting. The events occurred approximately two days after first dose of mRNA-1273, (lot # unknown). Treatment information was not provided. Based on the current available information and temporal association between the use of the product and onset of the events a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Paraesthesia oral
Clinical narrative: Numbness of lips; Tingling of the tongue.; A spontaneous report was received from a nurse concerning, a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed numbness of lips and tingling of the tongue .  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-1273 (Lot 037K20A) on 26 Dec 2020 intramuscularly for prophylaxis of COVID-19 infection. Forty minutes after administration, the patient started to experience numbness on her lips and tingling of the tongue. Treatment and duration of symptoms information was not provided.    Action taken with mRNA-1273 in response to the event was not reported.  The outcome of event was not reported.; Reporter's Comments: This case concerns a female patient, who experienced a non-serious unexpected event of hypoaesthesia oral and paraesthesia oral. The events occurred 1 day (approximately 40 min.) after first dose of mRNA-1273, lot # 037K20A.  No treatment was administered, and the event was ongoing.  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: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Minor soreness in the arm; A spontaneous report was received from a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and had minor soreness in his arm  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-1273 on 23 Dec 2020 intramuscularly for prophylaxis of COVID-19 infection. On 23 Dec 2020, the patient had a sore arm and did not take any medications.  He drank lots of water and noted that he always had minor soreness in the arm after every vaccine he has received.  On 24 Dec 2020, the event resolved.   Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, minor soreness in the arm, was resolved.; Reporter's Comments: This case concerns male patient of unknown age, who experienced a non-serious expected event of pain in arm. The event occurred at the same day of the first dose of mRNA-1273 vaccine. Patient reported drinking a lot of water and noted that he always had minor soreness in the arm after every vaccine he has received. The event resolved the day after.  The event was assessed as related to mRNA-1273 due to temporal association.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Dyspnoea, Fatigue, Headache
Clinical narrative: body ache; dizziness; having hard time breathing; body chills; very fatigue; headache; injection site pain; A spontaneous report was received from a non-HCP concerning a 36-year old, male patient who experienced body ache, dizziness, having hard time breathing, body chills, very fatigue, headache, and injection site pain.   The patient's medical history was not provided by the reporter. Concomitant product use was not provided by the reporter.   On 23 DEC 2020, the patient received one of two planned doses of mRNA-1273 (LOT/BATCH# 011J20A) intramuscularly in the Left Deltoid for prophylaxis of COVID-19 infection.   On 23 DEC 2020, the patient experienced body chill, headache, very fatigue, body ache, dizziness, injection site pain, and having a hard time breathing. Treatment for the events included 400mg ibuprofen  Action taken with mRNA-1273 in response to the events was not reported.   The events very fatigue, injection site pain, and having a hard time breathing were considered not recovered/not resolved.  The events body ache, dizziness, and body chill were considered recovered/resolved on 24 DEC 2020.   The event headache was considered recovered/resolved on 25 DEC 2020  The reporter did not provide an assessment for the events body ache, dizziness, having hard time breathing, body chills, very fatigue, headache, and injection site pain.; Reporter's Comments: This case concerns a 36-year-old, male patient. The patient's medical history was not provided. The patient experienced the non serious, unexpected event of body ache, dyspnea, dizziness and, expected event of chills, fatigue, headache and injection site pain. The event occurred the day the patient received one of the two doses of mRNA-1273 (LOT/BATCH# 011J20A). 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: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Pain
Clinical narrative: body ache; dizziness; having hard time breathing; body chills; very fatigue; headache; injection site pain; A spontaneous report was received from a non-HCP concerning a 36-year old, male patient who experienced body ache, dizziness, having hard time breathing, body chills, very fatigue, headache, and injection site pain.   The patient's medical history was not provided by the reporter. Concomitant product use was not provided by the reporter.   On 23 DEC 2020, the patient received one of two planned doses of mRNA-1273 (LOT/BATCH# 011J20A) intramuscularly in the Left Deltoid for prophylaxis of COVID-19 infection.   On 23 DEC 2020, the patient experienced body chill, headache, very fatigue, body ache, dizziness, injection site pain, and having a hard time breathing. Treatment for the events included 400mg ibuprofen  Action taken with mRNA-1273 in response to the events was not reported.   The events very fatigue, injection site pain, and having a hard time breathing were considered not recovered/not resolved.  The events body ache, dizziness, and body chill were considered recovered/resolved on 24 DEC 2020.   The event headache was considered recovered/resolved on 25 DEC 2020  The reporter did not provide an assessment for the events body ache, dizziness, having hard time breathing, body chills, very fatigue, headache, and injection site pain.; Reporter's Comments: This case concerns a 36-year-old, male patient. The patient's medical history was not provided. The patient experienced the non serious, unexpected event of body ache, dyspnea, dizziness and, expected event of chills, fatigue, headache and injection site pain. The event occurred the day the patient received one of the two doses of mRNA-1273 (LOT/BATCH# 011J20A). Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Maternal exposure during pregnancy
Clinical narrative: Slight headache; Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of HEADACHE (Slight headache) and MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) in a 30-year-old female patient (gravida 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Pregnancy.    On 26-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 19-Feb-2021. On 26-Dec-2020, the patient experienced HEADACHE (Slight headache) and MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. On 26-Dec-2020, HEADACHE (Slight headache) and MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.; Reporter's Comments: This case concerns a 30-year-old female patient who experienced headache. The patient also was 32 weeks pregnant during the administration of mRNA-1273. The last menstrual period, method of contraception and date of conception was unknown. The patient's pregnancy due date was 21-Feb-2021.  The patient experienced NS, expected event of headache  the day the first dose of mRNA-1273 was administered.  Treatment for the event included Tylenol. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives on my arm; A spontaneous report was received from a consumer concerning a 55-year-old, male, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced hives on his arm.  The patients' medical history included diabetes, hypertension and cholesterol and takes medications for these. However, the list of concomitant medications was not provided.  On 26 Dec 2020, prior to the onset of symptoms, patient received the first of two planned doses of mRNA-1273 (BATCH: -026L20A) for the prophylaxis of COVID -19 infection. On 26 Dec 2020 he experienced hives on his arm.  Treatment for the hives on his arm was not provided.   Action taken with planned second dose of mRNA-1273 in response to the event was not provided.  The outcome of the event, hives on arm was not provided.; Reporter's Comments: This case concerns a 55-year-old male, patient, who experienced an unexpected non-serious event of Urticaria. The event occurred on the same day  after receiving the first dose of mRNA-1273, lot # 026L20A. Treatment information was not provided. 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 and the event is considered possibly related to the vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Skin irritation, Vertigo
Clinical narrative: 2 bouts of vertigo; nose a little sore and irritated; Rash on nose; A spontaneous report was received from a physician concerning a 55-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced rash on nose, nose a little sore and irritated, and 2 bouts of vertigo.  The patient's medical history was not provided. Concomitant medications reported included estradiol and progesterone.  On 23 Dec 2020, approximately 2 hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (BATCH #025J20A) intramuscularly for prophylaxis of COVID-19 infection.  On 23 Dec 2020, within 2 hours of vaccine administration, the patient reported developing a small rash that came up as a blister, on her nose. She used clindamycin ointment on the area and the rash resolved the same day. The patient reported that the area is now sore and irritated. On 26 Dec 2020, the patient reported experiencing 2 bouts of vertigo at 10:30 pm, which she says is unusual for her.   Treatment for the event included topical clindamycin ointment.   Action taken with mRNA-1273 in response to the events was not reported.  The event, rash on nose, was considered resolved on 23 Dec 2020. The event, 2 bouts of vertigo, was considered resolved on 26 Dec 2020. The outcome of the event, nose a little sore and irritated, was unknown.; Reporter's Comments: This case concerns a 55 year old female with unknown medical history who experienced the nonserious unlisted events of vertigo, rash, and skin irritation. The event of vertigo occurred 3 days after the first dose of mRNA-1273, rash the same day as mRNA-1273, and skin irritation occurred 2 days after mRNA-1273.  Based on the current available information and close 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: Maternal exposure during pregnancy, Rash
Clinical narrative: itchy rash on left side of the face; Pregnant; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of RASH (itchy rash on left side of the face) and MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.    No Medical History information was reported.    On 27-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 27-Dec-2020, the patient experienced RASH (itchy rash on left side of the face) and MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash face, at an unspecified dose and frequency. On 27-Dec-2020, RASH (itchy rash on left side of the face) was resolving and MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not reported. Treatment information was not provided.; Reporter's Comments: This case concerns a female, who experienced a non-serious expected event of Rash and non-serious unexpected event of Exposure during pregnancy. The event of Rash occurred same day as the first dose of the mRNA-1273 administration which started resolving with treatment with Diphenhydramine.   Based on the current available information and temporal association between the use of the product and the start date of the Rash, a causal relationship cannot be excluded.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Anosmia, COVID-19, Hypogeusia
Clinical narrative: Diminished taste; Diminished smell; A spontaneous report was received from a physician concerning a 67-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and who experienced diminished taste and smell.   The patient's medical history included an ongoing respiratory issue causing a cough. Concomitant product use was not provided by the reporter   On 23-Dec-2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 24-Dec-2020, one day after receiving his injection, patient experienced diminished taste and smell but by 25-Dec-2020, he was back to baseline.  A negative Covid test was conducted on an undisclosed date.  Additionally, the patient reported that he has a chronic cough related to an ongoing respiratory issue.   Treatment information was not provided.  Patient was advised to consult his physician.   Action taken with mRNA-1273 in response to the events was not provided.  The events diminished taste and smell were resolved.; Reporter's Comments: This case concerns a 67-year-old male, patient, who experienced  unexpected non-serious events of diminished taste and smell. The events occurred approximately one day after receiving first dose of mRNA-1273, (lot # unknown). Treatment information was not provided. Based on the current available information and temporal association between the use of the product and onset of the events a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.