chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vertigo, Visual impairment
Clinical narrative: Could feel the heat coming of my arm; injection site muscle constricting; Injection site nerve pain; Throat also starting to swell; Arm swelling which progressed over the week,Arm doubled in size; Arm welted and itchy; Allergic reaction; fever; lymph node swell; redness at injection site; nausea; visual disturbance and distortions; seems like room was spinning; hardness near injection site; This spontaneous case was reported by a consumer and describes the occurrence of VISUAL IMPAIRMENT (visual disturbance and distortions), VERTIGO (seems like room was spinning), HYPERSENSITIVITY (Allergic reaction), VACCINATION SITE INDURATION (hardness near injection site) and LYMPHADENOPATHY (lymph node swell) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT).    On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Dec-2020, the patient experienced VISUAL IMPAIRMENT (visual disturbance and distortions), VERTIGO (seems like room was spinning), VACCINATION SITE INDURATION (hardness near injection site), LYMPHADENOPATHY (lymph node swell), VACCINATION SITE ERYTHEMA (redness at injection site) and NAUSEA (nausea). On 24-Dec-2020, the patient experienced HYPERSENSITIVITY (Allergic reaction). On 23-Dec-2020, VISUAL IMPAIRMENT (visual disturbance and distortions), VERTIGO (seems like room was spinning), VACCINATION SITE INDURATION (hardness near injection site), LYMPHADENOPATHY (lymph node swell) and VACCINATION SITE ERYTHEMA (redness at injection site) had resolved. At the time of the report, HYPERSENSITIVITY (Allergic reaction) outcome was unknown and NAUSEA (nausea) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       This case concerns a 27-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot 025J20-2A), and who experienced the listed events of lymphadenopathy, nausea, injection site erythema, and injection site swelling, and the  unlisted events of visual impairment, motion sickness, and seems like room was spinning.  The events were considered possibly related to the vaccine due to the temporal relationship and the known safety profile.   Most recent FOLLOW-UP information incorporated above includes: On 05-Jan-2021: No specific follow-up information recorded. On 31-Mar-2021: HCP information added; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Pyrexia
Clinical narrative: Fever; feeling warm; Left arm is a littl ebit sore; A report was received from a health care professional concerning a patient of age 37 years old, male who was participating in the mRNA-1273 Emergency Use Program and experienced multiple events of left arm is a little bit sore and feeling warm.  The patient's medical history was not provided. No concomitant medications were reported.  On 23 Dec 2020, the patient received their first of two planned doses of mRNA-1273. Soon after, the patient experienced left arm is a little bit sore and feeling warm. No treatment was administered.    Action taken with mRNA-1273 in response to the events was not reported.   The outcome for the events, left arm is a little bit sore and feeling warm were unknown.  The reporter did not provide an assessment for the events.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Pyrexia
Clinical narrative: Low grade fever; Severe arm pain in injection arm; A spontaneous report was received from a nurse concerning a female patient who received Moderna's COVID-19 Vaccine and experienced a low grade fever and severe arm pain in injection arm.   The patient's medical history included COVID-19. No relevant concomitant medications were reported.  On 23 Dec 2020, approximately one day prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the arm for prophylaxis of COVID-19 infection.   On 24 Dec 2020, the patient experienced a low grade fever and severe arm pain in injection arm. No treatment for the events was reported.    The outcome of events, a low grade fever and severe arm pain in injection arm, were not reported.   Action taken with mRNA-1273 in response to the events was not reported.; Reporter's Comments: This case concerns a female patient, who experienced a non-serious expected event of pyrexia and injection site pain. Event occurred 1 day after first dose of mRNA-1273 (Lot# Unknown) vaccine 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.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20.2A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use on 26-Apr-2020.    On 23-Dec-2020 at 1:20 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 26-Apr-2020 and the estimated date of delivery was 31-Jan-2021. On 23-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-fourth week of the pregnancy.  The patient was treated with MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) ongoing since an unknown date at an unspecified dose and frequency. On 23-Dec-2020, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-May-2020, Pregnancy test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) to be not applicable.; Reporter's Comments: This case concerns a 32 year-old, female patient, who is 34 weeks pregnant who experienced an event of exposure during pregnancy after receiving her first dose of COVID-19 vaccine. No adverse events were reported.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: low grade fever; A spontaneous report (United States)  was received from a nurse concerning a male nurse who was participating in the mRNA-1273 Emergency Use Program and experienced the event of low grade fever.  The patient's medical history included COVID. No concomitant medications were reported.  On 21 Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 22 Dec 2020, the patient experienced low grade fever. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome for the event low grade fever was considered recovered/resolved on 23 Dec 2020.  The reporter did not provide an assessment for the event.; 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.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Pain, Pyrexia
Clinical narrative: Body aches; Feeling feverish; Chills; Nausea; A spontaneous report (United States) was received from a physician concerning a female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced feeling feverish, chills, body aches, and nausea.    The patient's medical history was not provided. No relevant concomitant medications were reported.    On 23 Dec 2020 at approximately noon, the patient received her first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On 23 Dec 2020 after receiving vaccine the patient started feeling feverish, has chills, body aches, and nausea. The reporter stated that the symptoms had continued the morning of 24 Dec 2020.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The events, feeling feverish, chills, body aches, and nausea, were considered not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: Slight fever; Headache that started on top of head; A spontaneous report was received from a healthcare facility staff member, who was also a 66 year-old female patient, who received Moderna's COVID-19 Vaccine, and experienced slight fever and headache.    The patient's medical history was not provided. Concomitant product use was not provided.    On 23 Dec 2020, approximately 4 hours prior to the onset of symptoms, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the upper left arm for prophylaxis of COVID-19 infection. After four hours, the patient developed a slight fever. That evening, she developed a headache that started on top of her head.  On 24 Dec 2020, the fever subsided, and the headache lessened. Treatment information was not provided.  Action taken with mRNA-1273 in response to the events, slight fever and headache, was not reported.   The event, slight fever, was considered resolved on 24 Dec 2020. The outcome of the event, headache, was considered recovering.; Reporter's Comments: This case concerns a 66-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot unknown),  and who experienced the non-serious listed events of fever and headache.  Based on the current available information and temporal association between the use of the product and the onset of event on the day of vaccination, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Fever; A spontaneous report was received from a consumer, who was also a female patient, who received Moderna's COVID-19 Vaccine and experienced the event: patient has fever of 100.7 after taking COVID vaccine.  The patient's medical history included COVID. No concomitant medications were reported.  On 23 Dec 2020, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273.   On 24 Dec 2020, the patient experienced the event, patient has fever of 100.7 after taking COVID vaccine. No treatment information was reported.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome for the event, patient has fever of 100.7 after taking COVID vaccine, was unknown.; Reporter's Comments: This case concerns a female patient with medical history of COVID-19, who received their first of two planned doses of mRNA-1273 (Lot unknown),  and who experienced the non-serious listed event of fever.  Based on the current available information and temporal association between the use of the product and the onset of the event, a causal relationship cannot be excluded and the event was considered possibly related to the vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue; A spontaneous report was received from a consumer who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced fatigue.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On an unknown date, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, the patient experienced fatigue. Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not provided.   The outcome of the event, fatigue, was unknown.; Reporter's Comments: This case concerns a female patient, who experienced a non-serious expected event of fatigue. The event occurred on an unspecified date after first dose of mRNA-1273, lot # unknown. Treatment details were 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.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Injection site movement impairment, Injection site pain, Peripheral swelling, Rash pustular
Clinical narrative: Swelling in her left arm; Cannot move her left elbow due to the swelling and severe pain; Severe pain in left arm; blisters on hand, neck; pustules on neck and left arm; A few blisters on her hand and neck, progressively gotten worse; A spontaneous report was received from a nurse reporting on behalf of herself, a 39 year old female patient who developed blisters on her hand and neck which then spread into larger pustules on her neck and at the injection site (on her left arm). She reported that the pustules itch however there is no fluid drainage. Additionally, she developed swelling and pain in left arm and is unable to move her arm due to the swelling and pain.   The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included baby aspirin and clopidogrel.   On 24-Dec-2020, approximately one day prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot #011j20a) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 25-Dec-2020, she developed blisters on her hand and neck. The blisters have spread and advanced to larger pustules on her neck and left arm at the injection site. She reported that the pustules itch but are not draining fluid. Additionally, she developed swelling in her left arm and cannot move her left elbow due to the swelling and severe pain. Treatment for the event included oral diphenhydramine.   Action taken with mRNA-1273 in response to the events was not provided.   The outcomes of the events were not reported.; Reporter's Comments: This case concerns a 39-year-old, female patient. The patient's medical history was not provided. The patient experienced an unexpected event of blisters, Pustular rash, injection site joint movement impairment and expected event of injection site pain and swelling of arm. The event occurred 1 day after the first dose of mRNA-1273 (Lot #011j20a) 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.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Received the Moderna vaccine this morning and is pregnant; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Received the Moderna vaccine this morning and is pregnant) in a 28-year-old female patient (gravida 3, para 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20-2A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (Socially). Family history included Cancer. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Vitamin supplementation.    On 28-Dec-2020 at 7:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 11-Jul-2020 and the estimated date of delivery was 17-Apr-2021. On 28-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Received the Moderna vaccine this morning and is pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-fourth week of the pregnancy.  On 28-Dec-2020, MATERNAL EXPOSURE DURING PREGNANCY (Received the Moderna vaccine this morning and is 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.; Sender's Comments: This case concerns a 28-year-old, female G3P2 with medical history of prior social alcohol use who reported pregnancy. The first day of the patient's last menstrual period was on 11 Jul 2020. In August of 2020, the patient had a positive pregnancy test and the patient received mRNA-1273 on 28 December 2020. The estimated date of conception was unknown, and the due date was estimated as 17 April 2021.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: fatigue; a little headache; chills; muscle pain; joint pain; a little bit of fever; This spontaneous report was received from a male consumer who was participating in mRNA-1273 and experienced the events, fatigue, a little headache, chills, muscle pains, joint pain, a little bit of fever.  The patient's medical history and concomitant medications were not provided.  On 23-Dec-2020 the patient received the first of the two planned doses of mRNA-1273 for the prophylaxis of COVID-19.  On an unspecified date, the patient experienced fatigue, a little headache, chills, muscle pains, joint pain after receiving the mRNA-1273 vaccine. He did not experience any nausea, vomiting or intestinal distress. The patient thought of experiencing a little bit of fever based on the way he feels, but temperature was not confirmed.  No medication was taken by the patient for the events.  Action taken with mRNA-1273 vaccine in relation to events was not provided.  The outcome of the events fatigue, chills, little headache, muscle pain, joint pain, a little bit of fever was not provided.; Reporter's Comments: This case concerns a male subject of unknown age, who experienced a non-serious expected event of fatigue, headache, chills, myalgia, arthralgia and fever. All events occurred at unspecified time after the first dose of mRNA-1273 vaccine. Treatment for reported, as well as outcome were not reported. All events were assessed as possibly related to mRNA-1273 vaccine; however additional information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fatigue; a little headache; chills; muscle pain; joint pain; a little bit of fever; This spontaneous report was received from a male consumer who was participating in mRNA-1273 and experienced the events, fatigue, a little headache, chills, muscle pains, joint pain, a little bit of fever.  The patient's medical history and concomitant medications were not provided.  On 23-Dec-2020 the patient received the first of the two planned doses of mRNA-1273 for the prophylaxis of COVID-19.  On an unspecified date, the patient experienced fatigue, a little headache, chills, muscle pains, joint pain after receiving the mRNA-1273 vaccine. He did not experience any nausea, vomiting or intestinal distress. The patient thought of experiencing a little bit of fever based on the way he feels, but temperature was not confirmed.  No medication was taken by the patient for the events.  Action taken with mRNA-1273 vaccine in relation to events was not provided.  The outcome of the events fatigue, chills, little headache, muscle pain, joint pain, a little bit of fever was not provided.; Reporter's Comments: This case concerns a male subject of unknown age, who experienced a non-serious expected event of fatigue, headache, chills, myalgia, arthralgia and fever. All events occurred at unspecified time after the first dose of mRNA-1273 vaccine. Treatment for reported, as well as outcome were not reported. All events were assessed as possibly related to mRNA-1273 vaccine; however additional information has been requested.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hot flush, Hyperhidrosis, Hypoaesthesia
Clinical narrative: Left arm numbness; Left arm feels heavy; right hand numbness (feels like carpal tunnel on steroids); Left hand numbness (feels like carpal tunnel on steriods); shaky hands; tingling in legs; weakness left hand; Hot flushes; EXTREME SWEATING; FREQUENT URINATION; FATIGUE; HEADACHE; Sore arm; Nausea; Crummy feet and hands; A spontaneous report was received from a physician concerning a 53 year old, female patient who developed a sore arm, fatigue, headache, nausea, frequent urination, extreme sweating, hot flushes, and crummy feet and hands.    The patient's medical history included anaphylaxis. Concomitant product use was not provided by the reporter.   The patient received their first of two planned doses of mRNA-1273 on 23 Dec 2020. On 23 Dec 2020, approximately 1 day prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot #039K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 24 Dec 2020 the patient had a sore arm, fatigue, headache, nausea, frequent urination, and extreme sweating. The patient also reported that she had hot flushes and started to feel crummy on her feet and hands. Treatment for the event included paracetamol for headache, which subsided. Other symptoms were ongoing at time of the report.   On 07 Jan 2021, the patient reported more symptoms which include Left arm numbness, left arm feels heavy, right hand numbness (feels like carpal tunnel on steroids,) left hand numbness (feels like carpal tunnel on steroids,) shaky hands, tingling in legs, and weakness in left hand. It was also reported that all the original symptoms from 24 Dec 2020 have resolved.   Action taken with mRNA-1273 in response to the event(s) was not provided/unknown.   The event, headache was considered resolved on 24 Dec 2020. The outcome of the events sore arm, fatigue, nausea, frequent urination, extreme sweating, hot flushes, and crummy feet and hands were reported as resolved.  The events, Left arm numbness, left arm feels heavy, right hand numbness (feels like carpal tunnel on steroids,) left hand numbness (feels like carpal tunnel on steroids,) shaky hands, tingling in legs, and weakness in left hand are reported as not resolved.; Reporter's Comments: This case concerns a 53-year-old female who had NS unexpected pain, pain in extremity, hypoesthesia, tremor, restless legs, muscular weakness, limb discomfort, pollakiuria, hyperhidrosis, hot flush, and NS expected fatigue, headache, nausea. Event onset occurred 1 day after the first dose of mRNA-1273. Treatment included paracetamol. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Muscular weakness, Nausea, Pain, Pain in extremity
Clinical narrative: Left arm numbness; Left arm feels heavy; right hand numbness (feels like carpal tunnel on steroids); Left hand numbness (feels like carpal tunnel on steriods); shaky hands; tingling in legs; weakness left hand; Hot flushes; EXTREME SWEATING; FREQUENT URINATION; FATIGUE; HEADACHE; Sore arm; Nausea; Crummy feet and hands; A spontaneous report was received from a physician concerning a 53 year old, female patient who developed a sore arm, fatigue, headache, nausea, frequent urination, extreme sweating, hot flushes, and crummy feet and hands.    The patient's medical history included anaphylaxis. Concomitant product use was not provided by the reporter.   The patient received their first of two planned doses of mRNA-1273 on 23 Dec 2020. On 23 Dec 2020, approximately 1 day prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot #039K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 24 Dec 2020 the patient had a sore arm, fatigue, headache, nausea, frequent urination, and extreme sweating. The patient also reported that she had hot flushes and started to feel crummy on her feet and hands. Treatment for the event included paracetamol for headache, which subsided. Other symptoms were ongoing at time of the report.   On 07 Jan 2021, the patient reported more symptoms which include Left arm numbness, left arm feels heavy, right hand numbness (feels like carpal tunnel on steroids,) left hand numbness (feels like carpal tunnel on steroids,) shaky hands, tingling in legs, and weakness in left hand. It was also reported that all the original symptoms from 24 Dec 2020 have resolved.   Action taken with mRNA-1273 in response to the event(s) was not provided/unknown.   The event, headache was considered resolved on 24 Dec 2020. The outcome of the events sore arm, fatigue, nausea, frequent urination, extreme sweating, hot flushes, and crummy feet and hands were reported as resolved.  The events, Left arm numbness, left arm feels heavy, right hand numbness (feels like carpal tunnel on steroids,) left hand numbness (feels like carpal tunnel on steroids,) shaky hands, tingling in legs, and weakness in left hand are reported as not resolved.; Reporter's Comments: This case concerns a 53-year-old female who had NS unexpected pain, pain in extremity, hypoesthesia, tremor, restless legs, muscular weakness, limb discomfort, pollakiuria, hyperhidrosis, hot flush, and NS expected fatigue, headache, nausea. Event onset occurred 1 day after the first dose of mRNA-1273. Treatment included paracetamol. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pollakiuria, Restless legs syndrome, Tremor
Clinical narrative: Left arm numbness; Left arm feels heavy; right hand numbness (feels like carpal tunnel on steroids); Left hand numbness (feels like carpal tunnel on steriods); shaky hands; tingling in legs; weakness left hand; Hot flushes; EXTREME SWEATING; FREQUENT URINATION; FATIGUE; HEADACHE; Sore arm; Nausea; Crummy feet and hands; A spontaneous report was received from a physician concerning a 53 year old, female patient who developed a sore arm, fatigue, headache, nausea, frequent urination, extreme sweating, hot flushes, and crummy feet and hands.    The patient's medical history included anaphylaxis. Concomitant product use was not provided by the reporter.   The patient received their first of two planned doses of mRNA-1273 on 23 Dec 2020. On 23 Dec 2020, approximately 1 day prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot #039K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 24 Dec 2020 the patient had a sore arm, fatigue, headache, nausea, frequent urination, and extreme sweating. The patient also reported that she had hot flushes and started to feel crummy on her feet and hands. Treatment for the event included paracetamol for headache, which subsided. Other symptoms were ongoing at time of the report.   On 07 Jan 2021, the patient reported more symptoms which include Left arm numbness, left arm feels heavy, right hand numbness (feels like carpal tunnel on steroids,) left hand numbness (feels like carpal tunnel on steroids,) shaky hands, tingling in legs, and weakness in left hand. It was also reported that all the original symptoms from 24 Dec 2020 have resolved.   Action taken with mRNA-1273 in response to the event(s) was not provided/unknown.   The event, headache was considered resolved on 24 Dec 2020. The outcome of the events sore arm, fatigue, nausea, frequent urination, extreme sweating, hot flushes, and crummy feet and hands were reported as resolved.  The events, Left arm numbness, left arm feels heavy, right hand numbness (feels like carpal tunnel on steroids,) left hand numbness (feels like carpal tunnel on steroids,) shaky hands, tingling in legs, and weakness in left hand are reported as not resolved.; Reporter's Comments: This case concerns a 53-year-old female who had NS unexpected pain, pain in extremity, hypoesthesia, tremor, restless legs, muscular weakness, limb discomfort, pollakiuria, hyperhidrosis, hot flush, and NS expected fatigue, headache, nausea. Event onset occurred 1 day after the first dose of mRNA-1273. Treatment included paracetamol. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Tremor
Clinical narrative: Hands were shaky; Feeling loopy (spacey)/Didn't feel right; Chills; Feeling fatigued; A spontaneous report was received from a consumer concerning a 47 year old, female patient participating in a program and experienced chills, fatigue, shaky hands, feeling loopy (spacey), and did not feel right.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 23 Dec 2020, approximately 24 hours prior to the onset of the events, the patient received her first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 24 Dec 2020, the patient reported that she started to feel chills, fatigued and loopy (spacey), and didn't feel right. She also reported hands were shaky earlier in the day, but were not shaky at the time of report.    No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, chills, fatigue, feeling loopy (spacey) and did not feel right were not reported. The outcome of the event shaky hands was reported recovered/resolved on 24 Dec 2020.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Testing postive for COVID-19; A report was received from a consumer, a 32 year old adult female, who was participating in the mRNA-1273 Emergency Use Program and experienced the event testing positive for COVID-19.  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.   On 28 Dec 2020, the patient reported that they had received the vaccine on 23 Dec 2020 and now were testing 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, testing positive for COVID-19, was considered not resolved.  The reporter did not provide an assessment for the event, testing positive for COVID-19.; Reporter's Comments: This case concerns a 32 year old female with unknown medical history, who experienced a non serious unexpected event of " tested positive for COVID-19"  after receiving the first dose of mRNA-1273. Details of the event are not reported.  Based on the available information and the close temporal association with mRNA-1273 administration, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy, Pain in extremity, Peripheral swelling
Clinical narrative: left arm swelled up; left arm hurt; headache; left gland swollen; A spontaneous report was received from a health care professional concerning a patient of age 63 years old, female who received Moderna's COVID-19 vaccine and experienced multiple events of left arm hurt (Pain in extremity), left arm swelled up (Peripheral swelling), left gland swollen (Lymphadenopathy) and headache.  The patient's medical history was not provided. No concomitant medications were reported.  On 28-Dec-2020, the patient received their second of two planned doses of mRNA-1273 (Lot number was unknown) intramuscularly for prophylaxis of COVID-19 infection. After receiving the vaccine, the patient experienced left arm hurt, left arm swelled up, left gland swollen and headache. Treatment for the events included Tylenol. The patient took Tylenol and her headache subsided. The patient's arm still hurts and is swollen but is starting to go down and the left gland is still swollen but is also starting to go down.  The Action taken with mRNA-1273 in response to the events was not reported.   The outcome for the events, left arm hurt (Pain in extremity), left arm swelled up (Peripheral swelling) and left gland swollen (Lymphadenopathy) was considered as recovering/resolving and for headache its considered as recovered on 28-Dec-2020.; Reporter's Comments: This case concerns a 63-year-old, female patient. The patient's medical history was not provided. The patient experienced a non serious event of lymphadenopathy, headache, pain and swelling of arm. The event occurred after the administration of the first dose of mRNA-1273. 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: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Paraesthesia, Vaccination site anaesthesia
Clinical narrative: Feeling numbness at site of injection; Finger tingling; Feeling sweaty (Hot); A spontaneous report was received from a nurse, concerning a 52-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced numbness at vaccine site of injection, finger tingling and feeling sweaty (hot).  The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included sertraline hydrochloride, multivitamins, vitamin D, vitamin B12, collagen and flaxseed oil.    On 28-Dec-2020, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number: 026L20A) intramuscularly in her right arm for prophylaxis of COVID-19 infection.  The nurse reported that within 30 minutes after receiving the vaccination, the patient stated that the arm where she got the injection was feeling in numbness and that her finger was tingling. The nurse reported that there was no redness or swelling. The reporter stated that the patient felt hot (sweaty). No treatment was given.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of the events, numbness at vaccine site of injection, finger tingling, and feeling sweaty (hot), were 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 events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia, Nausea, Pain
Clinical narrative: Fatigue; Chills; Shaking; Body aches; Muscle pain; Nausea; Initial MOD-2020-001401  A report was received from a physician concerning a male patient of unknown age and race participating in the mRNA-1273 Emergency Use Program and experienced fatigue, tiredness, muscle pain, body aches, chills, shaking, feeling cold, nausea, achy, and the verbatim term of "felt run down".  The patient's medical history was not provided.  No relevant concomitant medications were reported.   On 23 December 2020 at 4pm prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (BATCH# 011J20A) by injection for prophylaxis of COVID-19 infection.     Patient experienced fatigue, tiredness, muscle pain, body aches, chills, shaking, feeling cold, nausea, achy, and the verbatim term of "felt run down", on the same day as the injection start date. It is unknown if patient has recovered from the events. No treatment was administered to treat the events.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events fatigue, tiredness, muscle pain, body aches, chills, shaking, feeling cold, nausea, achy, and the verbatim term of "felt run down" was not reported.   The causality assessment of the reported events fatigue, tiredness, muscle pain, body aches, chills, shaking, feeling cold, nausea, achy, and the verbatim term of "felt run down", is unknown to the study drug.; Reporter's Comments: This case concerns a male patient of unknown age. The patient's medical history was not provided. The patient experienced the expected event of fatigue, myalgia, chills, nausea and unexpected event of Pain, tremors, feeling cold and feeling abnormal. The event occurred the day the first dose of mRNA-1273 (BATCH# 011J20A) was administered. 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: Tremor
Clinical narrative: Fatigue; Chills; Shaking; Body aches; Muscle pain; Nausea; Initial MOD-2020-001401  A report was received from a physician concerning a male patient of unknown age and race participating in the mRNA-1273 Emergency Use Program and experienced fatigue, tiredness, muscle pain, body aches, chills, shaking, feeling cold, nausea, achy, and the verbatim term of "felt run down".  The patient's medical history was not provided.  No relevant concomitant medications were reported.   On 23 December 2020 at 4pm prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (BATCH# 011J20A) by injection for prophylaxis of COVID-19 infection.     Patient experienced fatigue, tiredness, muscle pain, body aches, chills, shaking, feeling cold, nausea, achy, and the verbatim term of "felt run down", on the same day as the injection start date. It is unknown if patient has recovered from the events. No treatment was administered to treat the events.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events fatigue, tiredness, muscle pain, body aches, chills, shaking, feeling cold, nausea, achy, and the verbatim term of "felt run down" was not reported.   The causality assessment of the reported events fatigue, tiredness, muscle pain, body aches, chills, shaking, feeling cold, nausea, achy, and the verbatim term of "felt run down", is unknown to the study drug.; Reporter's Comments: This case concerns a male patient of unknown age. The patient's medical history was not provided. The patient experienced the expected event of fatigue, myalgia, chills, nausea and unexpected event of Pain, tremors, feeling cold and feeling abnormal. The event occurred the day the first dose of mRNA-1273 (BATCH# 011J20A) was administered. 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: Maternal exposure during pregnancy
Clinical narrative: Patient is pregnant; This 32-year old, female subject was participating in a Program and became pregnant.   The patient's medical history, was not reported. The pregnancy history of the patient included 1 prior pregnancy: no additional pregnancy or infant details provided. No concomitant medications were reported.   The patient received their first of two planned doses of mRNA-1273 on 29 Dec 2020. The date the patient had a positive pregnancy test was not reported. The patient is reported to be 5 weeks pregnant. The due date was estimated as 06 Sep 2021.   Action taken with mRNA-1273 in response to the event(s) was not reported.   No additional pregnancy details were provided from the reporter.  Patient gave consent for Safety to Follow-up.; Reporter's Comments: This case concerns a 32-year-old female G2P1 who reported Maternal exposure during pregnancy. The subject took first dose of vaccination while she is 5 weeks pregnant. Estimated Due Date is 06/Sep/2021.
Sex: M
Vaccine: COVID19
Symptoms: Lip erythema, Lip swelling
Clinical narrative: some lip swelling; Lip swelling and redness; A spontaneous report was received from a pharmacist and concerns a male patient, of unspecified age who experienced lip swelling and redness.  The patient's medical history was not provided. No concomitant medications were provided.  On 23 Dec 2020, the patient received his first of two planned doses of mRNA-1273 (Batch number and route; unknown) for prophylaxis of COVID-19 infection.   On 23 Dec 2020, the patient reported Lip swelling and redness. He denied experiencing any difficulty in breathing. Additionally, he denied any history of allergies or anaphylaxis. The patient went to the ER and received with oral diphenhydramine.  Action taken with mRNA-1273 in response to lip swelling and redness was not provided  The outcome for the events lip swelling and redness was not provided.; Reporter's Comments: This case concerns a male subject of unknown age and unknown medical history, who experienced nonserious unexpected events of lip swelling and lip erythema with in 1 day of the first dose of mRNA-1273. In the ER, he received only oral diphenhydramine. Both events were reported as resolved/recovered at the time of this report.  Based on the close temporal association between the use of the product and the start date of the event/s, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Cough, Headache, Musculoskeletal stiffness, Pain
Clinical narrative: Neck Stiffness; Body sore; Sore at Injection Site; tenperature at 100.4 F; Mild cough; Back ache; Headache; A report was received from a 57-year-old, female patient, participating in the mRNA-1273 Emergency Use Program who experienced a mild cough, back aches, a headache, neck stiffness, her body was sore, soreness at the injection site and a temperature of 100.4 degrees Fahrenheit.    The patient's medical history included tow prior episodes of COVID-19 on  26 Nov2020 and 16Dec2020.  No relevant concomitant medications were reported.   On 28 Dec 2020 at 1:30pm, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the arm for prophylaxis of COVID-19 infection.   On 28 Dec 2020, the patient had a mild cough during work, but felt otherwise asymptomatic until returning home from work, when she experienced a back ache. The patient stated that the back aches are common for her.  At 10pm that night, she noticed a headache. On the morning of 29 Dec 2020, she experienced neck stiffness, her body was sore, soreness at the injection site and took her temperature at 100.4 degrees Fahrenheit. Treatment was unknown.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, mild cough, back aches, a headache, neck stiffness, her body was sore, soreness at the injection site and a temperature of 100.4 degrees Fahrenheit were not resolved.     The reporter did not provide an assessment for the events.; Reporter's Comments: Company comment: This case concerns a 57 year old female, with relevant medical history of 2 prior episodes of COVID-19 on 25Nov2020 and 15Dec2020, who experienced nonserious events of cough, back aches, a headache, neck stiffness, her body was sore, soreness at the injection site pain and fever the same day she received her first dose of mRNA-1273.  Details of prior events of COVID-19 (25Nov2020 and 16Dec2020) were not reported.  Treatment of the events and event outcomes were not reported. Based on the current available information and temporal association between the use of the product and the start date of the event(s), a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: Neck Stiffness; Body sore; Sore at Injection Site; tenperature at 100.4 F; Mild cough; Back ache; Headache; A report was received from a 57-year-old, female patient, participating in the mRNA-1273 Emergency Use Program who experienced a mild cough, back aches, a headache, neck stiffness, her body was sore, soreness at the injection site and a temperature of 100.4 degrees Fahrenheit.    The patient's medical history included tow prior episodes of COVID-19 on  26 Nov2020 and 16Dec2020.  No relevant concomitant medications were reported.   On 28 Dec 2020 at 1:30pm, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the arm for prophylaxis of COVID-19 infection.   On 28 Dec 2020, the patient had a mild cough during work, but felt otherwise asymptomatic until returning home from work, when she experienced a back ache. The patient stated that the back aches are common for her.  At 10pm that night, she noticed a headache. On the morning of 29 Dec 2020, she experienced neck stiffness, her body was sore, soreness at the injection site and took her temperature at 100.4 degrees Fahrenheit. Treatment was unknown.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, mild cough, back aches, a headache, neck stiffness, her body was sore, soreness at the injection site and a temperature of 100.4 degrees Fahrenheit were not resolved.     The reporter did not provide an assessment for the events.; Reporter's Comments: Company comment: This case concerns a 57 year old female, with relevant medical history of 2 prior episodes of COVID-19 on 25Nov2020 and 15Dec2020, who experienced nonserious events of cough, back aches, a headache, neck stiffness, her body was sore, soreness at the injection site pain and fever the same day she received her first dose of mRNA-1273.  Details of prior events of COVID-19 (25Nov2020 and 16Dec2020) were not reported.  Treatment of the events and event outcomes were not reported. Based on the current available information and temporal association between the use of the product and the start date of the event(s), a causal relationship cannot be excluded.