chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Light fever; Slight chills; A spontaneous report was received from a consumer and concerned a female patient (age unspecified) who was administered Moderna's COVID-19 vaccine (mRNA-1273) and developed light fever and slight chills.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 04 Jan 2021, approximately 6 hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch unknown) intramuscularly for prophylaxis of COVID-19 infection.   On 04 Jan 2021, approximately 6 hours after receiving the vaccine, the patient developed a light fever and slight chills.   No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, light fever and slight chills was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: Headache; Temperature of 102; A spontaneous report was received concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced headache and temperature of 102 (pyrexia).   The patient's medical history was not reported. No relevant concomitant medications were reported.   On 05 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot #:unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 06 Jan 2021, the patient began to experience a headache and temperature of 102F.  No treatment information was reported.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events was unknown/not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness in her arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness in her arm) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 05-Jan-2021 at 9:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced VACCINATION SITE PAIN (Soreness in her arm). At the time of the report, VACCINATION SITE PAIN (Soreness in her arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Influenza like illness, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: it was warm and raised; A large lymph node above her collar bone; an itchy spot the size of a quarter; the rash started again; supraclavicular lymphadenopathy; an itchy spot the size of a quarter; sore arm; flu like symptoms; A spontaneous report  was received from a female consumer of an unknown who received Moderna's COVID-19 Vaccine, and who experienced being mild sore arm, itchy spot the size of a quarter that night (reported in case MOD-2021-01036), flu-like symptoms, low grade temperature that went away and then came back, a large area on my shoulder, it was warm and raised.and a supraclavicular lymphadenopathy.  The patient's medical history was not provided. Concomitant medications were not provided by the reporter.   The patient received her first of two planned doses of mRNA-1273 (LOT number not provided) on an unspecified day last week intramuscularly in the for prophylaxis of COVID-19 infection.  On 05 Jan 2021, a female patient reported that after she received her first of the Moderna COVID-19 vaccination last week, she experienced being mild sore, had a low-grade temperature that went away and then came back, and had a large lymph node above her collar bone.  On that day, she was seen by her health care professional (HCP).   Treatment for the events were not provided.  At the time of the report no additional information was provided.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome for the events, being mild sore arm, itchy spot the size of a quarter that night (reported in case MOD-2021-01036), flu-like symptoms, low grade temperature that went away and then came back, a large area on my shoulder, it was warm and raised. and a supraclavicular lymphadenopathy.were unknown.   The causality assessment was not provided by the reporter.; Reporter's Comments: This case concerns a 48-year-old female who had NS events of unexpected influenza like illness, injection site warmth, pain in extremity, and expected injection site pruritus, injection site rash, injection site swelling, lymphadenopathy. Event onset the same day as first dose mRNA-1273. Treatment not reported. Outcomes unknown. 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: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth, Lymphadenopathy, Pain in extremity
Clinical narrative: it was warm and raised; A large lymph node above her collar bone; an itchy spot the size of a quarter; the rash started again; supraclavicular lymphadenopathy; an itchy spot the size of a quarter; sore arm; flu like symptoms; A spontaneous report  was received from a female consumer of an unknown who received Moderna's COVID-19 Vaccine, and who experienced being mild sore arm, itchy spot the size of a quarter that night (reported in case MOD-2021-01036), flu-like symptoms, low grade temperature that went away and then came back, a large area on my shoulder, it was warm and raised.and a supraclavicular lymphadenopathy.  The patient's medical history was not provided. Concomitant medications were not provided by the reporter.   The patient received her first of two planned doses of mRNA-1273 (LOT number not provided) on an unspecified day last week intramuscularly in the for prophylaxis of COVID-19 infection.  On 05 Jan 2021, a female patient reported that after she received her first of the Moderna COVID-19 vaccination last week, she experienced being mild sore, had a low-grade temperature that went away and then came back, and had a large lymph node above her collar bone.  On that day, she was seen by her health care professional (HCP).   Treatment for the events were not provided.  At the time of the report no additional information was provided.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome for the events, being mild sore arm, itchy spot the size of a quarter that night (reported in case MOD-2021-01036), flu-like symptoms, low grade temperature that went away and then came back, a large area on my shoulder, it was warm and raised. and a supraclavicular lymphadenopathy.were unknown.   The causality assessment was not provided by the reporter.; Reporter's Comments: This case concerns a 48-year-old female who had NS events of unexpected influenza like illness, injection site warmth, pain in extremity, and expected injection site pruritus, injection site rash, injection site swelling, lymphadenopathy. Event onset the same day as first dose mRNA-1273. Treatment not reported. Outcomes unknown. 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: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Feeling tired; A spontaneous report was received from a consumer concerning a 72 year-old male patient who was administered Moderna's COVID-19 vaccine (mRNA-1273) and developed fatigue.  The patient's medical history included COVID-19 infection. Concomitant product use was not provided.   On 05-JAN-2021, the patient received his first of two planned doses of mRNA-1273 (lot#: unknown) intramuscularly for the prophylaxis of COVID-19 infection.   The patient's wife called to report that he was fine the day of vaccination but started feeling tired the next day; 06-JAN-2021. 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: 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: Body temperature, Fatigue, Injection site pain, Myalgia, Pyrexia
Clinical narrative: muscular pain; fever 100.4; fatigue; disproportionate pain at the injection site; runny nose; A spontaneous  report was received from a Health Care Professional concerning a 57-year-old female who received  the  Moderna mRNA-1273 Vaccine and experienced fatigue, had a lot of muscular pain, a fever of 100 degree Fahrenheit, runny nose and a disproportionate pain at the injection site.  The patient history included removal of her thyroid. The date of this procedure was unknown. In the 2 weeks prior to receiving the vaccine she stated she took levothyroxine, dosage and frequency unknown.  On 29 Dec 2020, the patient received the first of two planned doses of mRNA-1273 (lot number: unknown) through an intramuscular route in the left (non dominant) arm for COVID-19 infection prophylaxis.  On 29 Dec 2020, the patient experienced fatigue, had a lot of muscular pain and a fever of 100 degree Fahrenheit. The patient also experienced runny nose and a disproportionate pain at the injection site. The patient was treated with ibuprofen round the clock for 2 days   Action taken with the second does of mRNA-1273 is unknown.  The outcome of the events, fatigue, had a lot of muscular pain, a fever of 100 degree Fahrenheit, runny nose and a disproportionate pain at the injection site were considered as unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: muscular pain; fever 100.4; fatigue; disproportionate pain at the injection site; runny nose; A spontaneous  report was received from a Health Care Professional concerning a 57-year-old female who received  the  Moderna mRNA-1273 Vaccine and experienced fatigue, had a lot of muscular pain, a fever of 100 degree Fahrenheit, runny nose and a disproportionate pain at the injection site.  The patient history included removal of her thyroid. The date of this procedure was unknown. In the 2 weeks prior to receiving the vaccine she stated she took levothyroxine, dosage and frequency unknown.  On 29 Dec 2020, the patient received the first of two planned doses of mRNA-1273 (lot number: unknown) through an intramuscular route in the left (non dominant) arm for COVID-19 infection prophylaxis.  On 29 Dec 2020, the patient experienced fatigue, had a lot of muscular pain and a fever of 100 degree Fahrenheit. The patient also experienced runny nose and a disproportionate pain at the injection site. The patient was treated with ibuprofen round the clock for 2 days   Action taken with the second does of mRNA-1273 is unknown.  The outcome of the events, fatigue, had a lot of muscular pain, a fever of 100 degree Fahrenheit, runny nose and a disproportionate pain at the injection site were considered as unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Swelling, Tenderness
Clinical narrative: itchy; swelling; Redness; Tenderness; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness), TENDERNESS (Tenderness), PRURITUS (itchy) and SWELLING (swelling) 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 30-Dec-2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced ERYTHEMA (Redness) and TENDERNESS (Tenderness). On 06-Jan-2021, the patient experienced PRURITUS (itchy) and SWELLING (swelling). At the time of the report, ERYTHEMA (Redness), TENDERNESS (Tenderness), PRURITUS (itchy) and SWELLING (swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications was reported. Treatment information was not provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MODERNATX, INC.-MOD-2021-002594 (E2B Linked Report). This case was linked to MOD-2021-003744, MOD-2021-002594, MOD-2021-002925 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. MODERNATX, INC.-MOD-2021-002594:
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pruritus
Clinical narrative: Vaccination site erythema; Vaccination site induration; Vaccination site pruritus; A spontaneous report was received from a patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed itching, erythema and very mild induration.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 26 Dec 2020, 10 days prior to the onset of events, the patient received the first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On 05 Jan 2021, the patient was experiencing itching, erythema and very mild induration. No treatment information was provided.  Action taken with mRNA-1273 was unknown.  The outcomes of the events, itching, erythema, and very mild induration, 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: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Migraine, Myalgia, Pyrexia
Clinical narrative: Migraine; Muscle aches; fatigue; fever; A spontaneous report was received from a female patient, nurse, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced migraine, muscle aches, fatigue and fever.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 29 Dec 2020, at 2pm, the patient received their first of two planned doses of mRNA-1273 (Lot: unknown) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection . On 30 Dec 2020, at 4am, the patient experienced migraine, muscle aches, fatigue, and fever. She measured for fever that evening at 102.7 Fahrenheit. Her symptoms lasted for 48 hours before resolving.  The patient mentioned that she took naproxen as treatment, without improvement.    Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the events, migraine, muscle aches, fatigue, and fever, were considered resolved on 01 Jan 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Arm soreness the size of a half dollar area at the injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PAIN (Arm soreness the size of a half dollar area at the injection site) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy in 2017.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2021, the patient experienced VACCINATION SITE PAIN (Arm soreness the size of a half dollar area at the injection site). At the time of the report, VACCINATION SITE PAIN (Arm soreness the size of a half dollar area at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   The patient had not taken any treatment medication. No relevant concomitant medications were reported.   This case was linked to MOD-2021-070116 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Apr-2021: Follow up received on 05-APR-2021. Outcome updated and history 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 event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Feeling cold, Feeling hot, Headache
Clinical narrative: Body aches; Arm was sore; Couldn't lift arm; Body feeling hot; Extremeties feeling cold; Couldn't sleep; Chills / shivering really bad; Headache; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of PAIN (Body aches), PAIN IN EXTREMITY (Arm was sore), MOBILITY DECREASED (Couldn't lift arm), FEELING HOT (Body feeling hot) and FEELING COLD (Extremeties feeling cold) in a 44-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 Migraine headache.  On 05-Jan-2021 at 8:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021 at 3:00 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (Headache). On 05-Jan-2021 at 8:00 PM, the patient experienced PAIN (Body aches), PAIN IN EXTREMITY (Arm was sore), MOBILITY DECREASED (Couldn't lift arm), FEELING HOT (Body feeling hot), FEELING COLD (Extremeties feeling cold), INSOMNIA (Couldn't sleep) and CHILLS (Chills / shivering really bad). On 06-Jan-2021 at 3:00 AM, INSOMNIA (Couldn't sleep) outcome was unknown. At the time of the report, PAIN (Body aches), PAIN IN EXTREMITY (Arm was sore), MOBILITY DECREASED (Couldn't lift arm), FEELING HOT (Body feeling hot), FEELING COLD (Extremeties feeling cold) and CHILLS (Chills / shivering really bad) outcome was unknown and HEADACHE (Headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Jan-2021, Body temperature: Low and normal.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  Treatment included ibuprofen.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Mobility decreased, Pain, Pain in extremity
Clinical narrative: Body aches; Arm was sore; Couldn't lift arm; Body feeling hot; Extremeties feeling cold; Couldn't sleep; Chills / shivering really bad; Headache; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of PAIN (Body aches), PAIN IN EXTREMITY (Arm was sore), MOBILITY DECREASED (Couldn't lift arm), FEELING HOT (Body feeling hot) and FEELING COLD (Extremeties feeling cold) in a 44-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 Migraine headache.  On 05-Jan-2021 at 8:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021 at 3:00 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (Headache). On 05-Jan-2021 at 8:00 PM, the patient experienced PAIN (Body aches), PAIN IN EXTREMITY (Arm was sore), MOBILITY DECREASED (Couldn't lift arm), FEELING HOT (Body feeling hot), FEELING COLD (Extremeties feeling cold), INSOMNIA (Couldn't sleep) and CHILLS (Chills / shivering really bad). On 06-Jan-2021 at 3:00 AM, INSOMNIA (Couldn't sleep) outcome was unknown. At the time of the report, PAIN (Body aches), PAIN IN EXTREMITY (Arm was sore), MOBILITY DECREASED (Couldn't lift arm), FEELING HOT (Body feeling hot), FEELING COLD (Extremeties feeling cold) and CHILLS (Chills / shivering really bad) outcome was unknown and HEADACHE (Headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Jan-2021, Body temperature: Low and normal.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  Treatment included ibuprofen.; 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: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site swelling, Lip swelling, Pain
Clinical narrative: lip swelling; Severe body aches; Swelling at the injection site; Injection site pain; A spontaneous report was received from a nurse who was a 61-year-old, female patient who received Moderna's COVID-19 Vaccine, and who experienced swelling at the injection site, injection site pain, severe body aches and lip swelling.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 30-Dec-2020, the same day as onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (LOT 025J2O2A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 30-Dec-2020, she experienced swelling and pain at the injection site and on 31-Dec-2020, she reported severe body aches.  All symptoms resolved by 02-Jan-2021.  Additionally, on 01-Jan-2021, she reported that she had lip swelling that lasted for eight hours. Patient wished to know the efficacy of the vaccine if she did not get the second dose. Treatment included ibuprofen for body aches.    Action taken with mRNA-1273 in response to the events was not provided.   The events, swelling at the injection site and injection site pain, severe body aches and lip swelling, were considered recovered/resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pain
Clinical narrative: Feel a little achy; Chills; Headache; A spontaneous report  was received from a male patient who was administered Moderna's COVID-19 vaccine (mRNA-1273) and developed pain, chills, and headache.  The patient's medical history and concomitant medications were not reported.   On 30-DEC-2020, six days prior to the onset of the events, the patient received his first of two planned doses of mRNA-1273 (batch number: 011L20A) intramuscularly in the left arm for the prophylaxis of COVID-19 infection.   On 04-JAN-2021, the patient developed chills, headache, and felt a little achy which lasted for one day. Treatment included paracetamol.   Action taken with mRNA-1273 in response to the events was not reported.   The outcomes of the events, pain, chills, and headache, were resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Myalgia
Clinical narrative: lymphadenopathy neck; lymphadenopathy neck and axillary area; Achiness; This spontaneous case was reported by a nurse and describes the occurrence of LYMPHADENOPATHY (lymphadenopathy neck), LYMPHADENOPATHY (lymphadenopathy neck and axillary area) and MYALGIA (Achiness) 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, the patient experienced LYMPHADENOPATHY (lymphadenopathy neck), LYMPHADENOPATHY (lymphadenopathy neck and axillary area) and MYALGIA (Achiness). At the time of the report, LYMPHADENOPATHY (lymphadenopathy neck), LYMPHADENOPATHY (lymphadenopathy neck and axillary area) and MYALGIA (Achiness) was resolving.        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 medications details were not reported by the reporter. Treatment details was not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jan-2021: case was not valid until 22-Jan-2021; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Injection site erythema, Vaccination site nodule, Vaccination site pain
Clinical narrative: a raised, firm area about 1X1 inch; red spot below the injection site; Feeling a little tired; Soreness in arm; A spontaneous report was received from a healthcare facility staff member (United States) concerning a 52-year-old, male patient who was participating in the mRNA-1273 Emergency Use Program and who experienced soreness in my arm, a red spot below the injection site, a raised, firm area about 1 x 1 inches and feeling a little tired.    The patient's medical history was not provided. Concomitant product use was not provided by the reporter   The patient received their first of two planned doses of mRNA-1273 (LOT# 039K20A) on 28-Dec-2020 intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   Patient reported receiving the Moderna vaccine on 28-Dec-2020 in the left deltoid. He stated the he initially experienced arm soreness which resolved by 29-Dec-2020. On 05-Jan-2021, he stated that he noticed a red spot below the injection site along with a firm, raised area measuring about 1 x 1 inch and he also reported feeling a little tired.   Treatment information was not provided.   Action taken with mRNA-1273 in response to the events, soreness in my arm, a red spot below the injection site, a raised, firm area about 1 x 1 inches and feeling a little tired, was not provided.   The event, soreness in my arm, was considered recovered/resolved. The outcome of the events, a red spot below the injection site, a raised, firm area about 1 x 1 inches and feeling a little tired, was not reported.   The reporter did not provide a causality assessment of the events, soreness in my arm, a red spot below the injection site, a raised, firm area about 1 x 1 inches and feeling a little tired; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Blister, Chills, Fatigue, Headache
Clinical narrative: Upset stomach; skin lesions that turn into blisters might be Shingles; Skin lesions that turns to blister on her back and around belly button; Headache; Nausea; Chills; Muscle pain; Fatigue; Temparature of 99.5; A spontaneous report was received from a consumer, who was 42-year-old, female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced headache, nausea, upset stomach, muscle pain, fatigue, chills, fever 99.5 Fahrenheit(F), skin lesions and blisters on her back and around belly button, which could be shingles.  The patient's medical history was not provided by the reporter.  No relevant concomitant medications were reported.  On 30 DEC 2020, the patient received their first two planned doses of mRNA-1273 (batch number: unknown) for prophylaxis of COVID-19 infection.  On 30 DEC 2020, patient experienced headache, nausea, upset stomach, muscle pain, fatigue, chills and fever 99.5 F. The patient stated that the skin lesions on her back and around belly button had turned into blisters. The patient consulted her physician who prescribed acyclovir (for provisional shingles) and an unspecified ointment.   Treatment for the events included acetaminophen, acyclovir and an unspecified ointment.   Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of events, headache, nausea, upset stomach, muscle pain, fatigue, chills, fever, were considered resolved on 30 DEC 2020.  The outcome of events, skin lesions, blisters on her back and around belly button and shingles 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.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia, Skin lesion
Clinical narrative: Upset stomach; skin lesions that turn into blisters might be Shingles; Skin lesions that turns to blister on her back and around belly button; Headache; Nausea; Chills; Muscle pain; Fatigue; Temparature of 99.5; A spontaneous report was received from a consumer, who was 42-year-old, female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced headache, nausea, upset stomach, muscle pain, fatigue, chills, fever 99.5 Fahrenheit(F), skin lesions and blisters on her back and around belly button, which could be shingles.  The patient's medical history was not provided by the reporter.  No relevant concomitant medications were reported.  On 30 DEC 2020, the patient received their first two planned doses of mRNA-1273 (batch number: unknown) for prophylaxis of COVID-19 infection.  On 30 DEC 2020, patient experienced headache, nausea, upset stomach, muscle pain, fatigue, chills and fever 99.5 F. The patient stated that the skin lesions on her back and around belly button had turned into blisters. The patient consulted her physician who prescribed acyclovir (for provisional shingles) and an unspecified ointment.   Treatment for the events included acetaminophen, acyclovir and an unspecified ointment.   Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of events, headache, nausea, upset stomach, muscle pain, fatigue, chills, fever, were considered resolved on 30 DEC 2020.  The outcome of events, skin lesions, blisters on her back and around belly button and shingles 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.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Cough, Dizziness, Ear pain, Fatigue
Clinical narrative: Shooting pain in ear; Cough; Colds; Lightheaded; 2 distinct tender lumps above left collarbone; Redness in the injection site; Head really hurt; Fever (100.6 F); Fatigue; A spontaneous report was received from a consumer who was a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced multiple events of fatigue, shooting pain in the ear, head really hurt, redness in the injection site, 2 distinct tender lumps above her left collarbone, fever (100.6 F), cough, colds and lightheaded.  The patient's medical history was not provided. No concomitant medications were reported   On 28 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 206L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 29 Dec 2020, the patient experienced fatigue that continued for two more days.   On the early morning of 04 Jan 2020, the patient experienced shooting pain in the ear, head really hurt, redness in the injection site which she noticed was an oval shaped measuring bout 3-3.5x4 inches, 2 distinct tender lumps above her left collarbone, fever (100.6 F), cough, colds and lightheaded. Treatment for the events included paracetamol for the ear pain and headache.  On 05 Jan 2020, the patient reported that the redness in the injection site got bigger and was the size of her palm. She still had cough and colds. It was also noted that she might be scheduled for a Covid-19 test.  Action taken with mRNA-1273 in response to the events was not provided.  The event, fatigue, was considered resolved on 31 Dec 2020.  The events, shooting pain in the ear, head really hurt and fever (100.6 F) and lightheaded was considered resolved on 04 Jan 2020.  The outcome for the events, redness in the injection site, 2 distinct tender lumps above her left collarbone, cough and  colds was 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.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy, Nasopharyngitis, Pyrexia, Vaccination site erythema
Clinical narrative: Shooting pain in ear; Cough; Colds; Lightheaded; 2 distinct tender lumps above left collarbone; Redness in the injection site; Head really hurt; Fever (100.6 F); Fatigue; A spontaneous report was received from a consumer who was a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced multiple events of fatigue, shooting pain in the ear, head really hurt, redness in the injection site, 2 distinct tender lumps above her left collarbone, fever (100.6 F), cough, colds and lightheaded.  The patient's medical history was not provided. No concomitant medications were reported   On 28 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 206L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 29 Dec 2020, the patient experienced fatigue that continued for two more days.   On the early morning of 04 Jan 2020, the patient experienced shooting pain in the ear, head really hurt, redness in the injection site which she noticed was an oval shaped measuring bout 3-3.5x4 inches, 2 distinct tender lumps above her left collarbone, fever (100.6 F), cough, colds and lightheaded. Treatment for the events included paracetamol for the ear pain and headache.  On 05 Jan 2020, the patient reported that the redness in the injection site got bigger and was the size of her palm. She still had cough and colds. It was also noted that she might be scheduled for a Covid-19 test.  Action taken with mRNA-1273 in response to the events was not provided.  The event, fatigue, was considered resolved on 31 Dec 2020.  The events, shooting pain in the ear, head really hurt and fever (100.6 F) and lightheaded was considered resolved on 04 Jan 2020.  The outcome for the events, redness in the injection site, 2 distinct tender lumps above her left collarbone, cough and  colds was 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: U
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: reaction in the site at the arm; A spontaneous report was received from a 66 year-old patient who was administered Moderna's COVID-19 vaccine (mRNA-1273) and developed a vaccination site reaction.  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 a cholesterol medication.  On 28-DEC-2020, 9 days prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (lot#: unknown) intramuscularly in the left arm for the prophylaxis of COVID-19 infection.   On 05-JAN-2021, the patient developed a reaction at the injection site on the left arm. Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not provided.   The outcome of the event, vaccination site reaction, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: Adverse event; A spontaneous report was received from a healthcare professional concerning a patient (age and gender unspecified) who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced adverse event.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On an unspecified date, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) at unknown injection site for prophylaxis of COVID-19 infection.  On 4 Jan 2021, the patient experienced adverse event.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of event of adverse event was unknown.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: Runny nose; Slight cough; Tested positive for COVID-19; A spontaneous report was received from a nurse concerning a 91-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and tested positive for COVID-19, and experienced runny nose and slight cough.   The patient's medical history was not provided. No concomitant medications were reported.  On 28 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) via unknown route at unknown anatomical location for prophylaxis of COVID-19 infection.   On 03 Jan 2021, the patient tested positive for COVID-19 by PCR analysis and also experienced runny nose and slight cough.   No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not provided.  The outcome for the events, tested positive for COVID-19, runny nose and slight cough was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test, Ultrasound scan
Clinical narrative: Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) in a female patient of an unknown age (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J202A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use and In vitro fertilization on 29-Nov-2020. Concomitant products included PROGESTERONE from 29-Nov-2020 to an unknown date and ESTRADIOL (ESTROGEN) from 17-Nov-2020 to an unknown date for Pregnancy, ACETYLSALICYLIC ACID, ASCORBIC ACID (ASPIRIN [ACETYLSALICYLIC ACID;ASCORBIC ACID]) from 17-Nov-2020 to an unknown date and PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] for an unknown indication.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 22-Aug-2021. On 28-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy). On 28-Dec-2020, MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Nov-2020, Ultrasound scan: unknown (Inconclusive) unknown. On 16-Dec-2020, Pregnancy test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This is a case of product exposure during pregnancy with no associated AEs for this female of unspecified age. Patient will continue to be contacted for further monitoring of AEs during the pregnancy; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female of unspecified age. Patient will continue to be contacted for further monitoring of AEs during the pregnancy
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: Injection site was swollen, size like a mosquito bite; Rash local to the injection site; Itching at injection site; A spontaneous report was received from a healthcare professional concerning a 41-year-old female patient who experienced itching at the injection site, injection site swelling and rash local to the injection site.  The patient's medical history was not provided. The patient is not currently taking any medications.   On an unknown date, approximately 7 days prior to the onset of symptoms, the patient received the first of two planned doses of mRNA-1273 (Lot number unknown) intramuscularly in her left upper arm for prophylaxis of COVID-19 infection.   On 04 Jan 2021 approximately 7 days after receiving the vaccine, the patient started having itching at the injection site. The injection site swollen and appears to be the size of a mosquito bite. She also had a rash that was local to the injection site and occasionally itches.   The patient has not received any treatment for the events.    Action taken with mRNA-1273 in response to the events was not provided.   The outcomes of the events were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Dyspnoea, Nausea, Pyrexia, Vomiting
Clinical narrative: Shortness of breath; Nausea; Vomiting; Fever of 102; A spontaneous report was received from a male consumer of unknown age, who was also the patient, who received Moderna's COVID-19 vaccine and experienced shortness of breath, nausea, vomiting, and fever of 102.   The patient's medical history was not provided. Concomitant medications were not provided by the reporter.   On 03 Jan 2021, approximately two days prior to the onset of symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number: Unknown) for prophylaxis of COVID-19 infection.   On 05 Jan 2021, the patient experienced nausea, vomiting, shortness of breath, and fever of 102. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was unknown.  The outcome for the events experienced shortness of breath, nausea, vomiting, and fever of 102 was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events two days after vacciination, a causal relationship cannot be excluded. Further information has been requested
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Light rash behind left ear; This spontaneous case was reported by a patient and describes the occurrence of RASH (Light rash behind left ear) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Light rash behind left ear). At the time of the report, RASH (Light rash behind left ear) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient's medical history was not provided. No relevant concomitant medications were reported.  No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.   Reporter did not allow further contact; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Moderna Covid-19 vaccine while pregnant; A spontaneous report was received from a healthcare professional concerning herself, a female patient of unspecified age who received Moderna's COVID-19 Vaccine and was pregnant/Exposure during pregnancy.  The patient's medical and pregnancy history was not provided. No concomitant medications were reported.  On an unknown date, the patient received the first dose of mRNA-1273 for prophylaxis of COVID-19 infection.   The date of the patient's positive pregnancy test and first day of the last menstrual period were not reported. The estimated date of conception and due date were not reported.  Action taken with mRNA-1273 was not applicable.  The outcome of the event Moderna Covid-19 vaccine while pregnant was recovered.; Reporter's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female of unspecified age. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.