chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Cannot use her right arm (worsening arm pain); A spontaneous report was received from a consumer concerning a 58-year-old, female patient, who received Moderna's COVID-19 Vaccine and experienced can't use right arm, arm begin to sore and was getting worse.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 30 Dec 2020, Wednesday at 8 AM, prior to the onset of event, the patient received their first of two planned doses of mRNA-1273 (Batch number: 025L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 30 Dec 2020, Wednesday the patient experienced can't use right arm, arm begin to sore and was getting worse.  Treatment for event can't use right arm, arm begin to sore and was getting worse included muscle relaxant, heat-ice pack, pain medication and acetylsalicylic acid.  Action taken with mRNA-1273 in response to the event can't use right arm, arm begin to sore and was getting worse was not reported.  The outcome of the event can't use right arm, arm begin to sore and was getting worse was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper
Clinical narrative: stomach cramp; A spontaneous report was received from a consumer concerning a 80 year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced stomach cramps.    The patient's medical history was not provided. No relevant concomitant medications were reported.    On 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (039K20A) intramuscularly for prophylaxis of COVID-19 infection.   On 31 Dec 2020, the patient began to experience stomach cramps. The cramps were ongoing, but getting better, as reported by the patient. Treatment for this event included paracetamol (one at last night and one today morning).    Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event was considered recovering/resolving.; 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: Headache, Migraine
Clinical narrative: headache; migraine; A spontaneous report was received from a consumer who was a 61-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1272) and who experienced headache and migraine.     The patient's medical history was not provided. No relevant concomitant medications were reported.    On 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (039K20-2A) intramuscularly for prophylaxis of COVID-19 infection.   On 31 Dec 2020, the patient began to experience a headache then a migraine. No treatment information was reported.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the events, headache and migraine, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Dizziness, Headache, Neck pain, Palpitations
Clinical narrative: heart racing; abdomen pain; vomiting; neck pain; headache; dizziness; injection site pain; fever; A spontaneous report was received from a consumer concerning herself, a 51-year-old, female patient who received Moderna's Covid-19 Vaccine (mRNA-1273) and who experienced her heart racing, pain in abdomen area, vomiting, neck pain, severe headache, dizziness, pain at injection site and fever of 100.9.   The patient's medical history included being diagnosed with Covid-19 in Sep 2020. Concomitant product use was not provided by the reporter.   On 31 Dec 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number 025J20A) intramuscularly for prophylaxis of COVID-19 infection.   The patient reported (translated by husband) that she is not feeling well due to symptoms occurring after taking the Moderna Covid-19 vaccine. She received the vaccine the day before and started experiencing heart racing, pain in abdomen area, vomiting, neck pain, severe headache, dizziness, pain at injection site, and fever of 100.9.   Treatment for the event included tramadol for a severe headache.   Action taken with mRNA-1273 in response to the events was unknown.   The outcomes of the events,  heart racing, pain in abdomen area, vomiting, neck pain, severe headache, dizziness, pain at injection site and fever of 100.9, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain, Vomiting
Clinical narrative: heart racing; abdomen pain; vomiting; neck pain; headache; dizziness; injection site pain; fever; A spontaneous report was received from a consumer concerning herself, a 51-year-old, female patient who received Moderna's Covid-19 Vaccine (mRNA-1273) and who experienced her heart racing, pain in abdomen area, vomiting, neck pain, severe headache, dizziness, pain at injection site and fever of 100.9.   The patient's medical history included being diagnosed with Covid-19 in Sep 2020. Concomitant product use was not provided by the reporter.   On 31 Dec 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number 025J20A) intramuscularly for prophylaxis of COVID-19 infection.   The patient reported (translated by husband) that she is not feeling well due to symptoms occurring after taking the Moderna Covid-19 vaccine. She received the vaccine the day before and started experiencing heart racing, pain in abdomen area, vomiting, neck pain, severe headache, dizziness, pain at injection site, and fever of 100.9.   Treatment for the event included tramadol for a severe headache.   Action taken with mRNA-1273 in response to the events was unknown.   The outcomes of the events,  heart racing, pain in abdomen area, vomiting, neck pain, severe headache, dizziness, pain at injection site and fever of 100.9, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Lower respiratory tract infection, Malaise, Vaccination site lymphadenopathy, Vaccination site pain
Clinical narrative: General unwell; Chest cold; Lymph node swollen; Painful in right arm pit; A spontaneous report was received from a consumer who was also the patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced generally unwell, chest cold, lymph node swollen, and pain in the right arm pit.   The patient's medical history was not provided. No relevant concomitant medications were reported.  On 28 Dec 2020, the patient received the first of two planned doses of mRNA-1273 in the right deltoid for prophylaxis of COVID-19 infection.   On an unknown date, the patient experienced being generally unwell, chest cold, swollen lymph nodes, and pain in right arm pit.    The treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, being generally unwell, chest cold, lymph node swollen, and pain in the right arm pit, was considered not 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 events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Ear discomfort, Feeling hot, Headache
Clinical narrative: Hot all over/bottom of feet were on fire; Left ear popped; Felt very sick/felt bad; Lethargic; Vomiting; Severe headache; Fever; Chills; A spontaneous report was received from a female patient who received Moderna's COVID-19 Vaccine and experienced hot all over/bottom of feet were on fire (feeling hot), felt very sick/felt bad (malaise), left ear popped (ear discomfort), severe headache, was lethargic, vomiting, fever (pyrexia), and chills.  The patient's reported medical history included COVID-19 (April 2020).  A COVID antibody test on 24 Nov 2020 showed she still had antibodies.  No relevant concomitant medications were reported.   On 31 Dec 2020, the patient received the first of two planned doses of mRNA-1273 intramuscularly for COVID-19 for infection prophylaxis.  On 01 Jan 2021, the patient was hot all over, felt very sick, her left ear popped, she had a severe headache, she was lethargic, was vomiting, had a fever and chills. She stated that her body temperature was 101.1.  On 02 Jan 2021, the patient felt bad, her temperature was 103.0, she had a severe headache, and the bottom of her feet were on fire. She also reported that she had lethargy, chills, and stated, "it felt like I had COVID again."   On 02 Jan 2021, the patient did not vomit and she felt much better, but was still lethargic.   Treatment for the events was not reported.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event, vomiting, was considered resolved on an unknown date January 2020. The outcome of the events, hot all over/bottom of feet were on fire, felt very sick/felt bad, left ear popped, severe headache, fever, and chills were resolving.  The event of lethargic was considered not resolved at the time of this report.; Reporter's Comments: This case concerns a female who experienced with NS events of unexpected malaise, lethargy, feeling hot, ear discomfort and expected fever, chills, headache, vomiting.  Event onset occurred on Day 2 after the first dose of mRNA-1273. Treatment not reported. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Malaise, Pyrexia, SARS-CoV-2 antibody test, Vomiting
Clinical narrative: Hot all over/bottom of feet were on fire; Left ear popped; Felt very sick/felt bad; Lethargic; Vomiting; Severe headache; Fever; Chills; A spontaneous report was received from a female patient who received Moderna's COVID-19 Vaccine and experienced hot all over/bottom of feet were on fire (feeling hot), felt very sick/felt bad (malaise), left ear popped (ear discomfort), severe headache, was lethargic, vomiting, fever (pyrexia), and chills.  The patient's reported medical history included COVID-19 (April 2020).  A COVID antibody test on 24 Nov 2020 showed she still had antibodies.  No relevant concomitant medications were reported.   On 31 Dec 2020, the patient received the first of two planned doses of mRNA-1273 intramuscularly for COVID-19 for infection prophylaxis.  On 01 Jan 2021, the patient was hot all over, felt very sick, her left ear popped, she had a severe headache, she was lethargic, was vomiting, had a fever and chills. She stated that her body temperature was 101.1.  On 02 Jan 2021, the patient felt bad, her temperature was 103.0, she had a severe headache, and the bottom of her feet were on fire. She also reported that she had lethargy, chills, and stated, "it felt like I had COVID again."   On 02 Jan 2021, the patient did not vomit and she felt much better, but was still lethargic.   Treatment for the events was not reported.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event, vomiting, was considered resolved on an unknown date January 2020. The outcome of the events, hot all over/bottom of feet were on fire, felt very sick/felt bad, left ear popped, severe headache, fever, and chills were resolving.  The event of lethargic was considered not resolved at the time of this report.; Reporter's Comments: This case concerns a female who experienced with NS events of unexpected malaise, lethargy, feeling hot, ear discomfort and expected fever, chills, headache, vomiting.  Event onset occurred on Day 2 after the first dose of mRNA-1273. Treatment not reported. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: Itchy rash around nose and forehead; A spontaneous report was received from a consumer concerning a male patient of unknown age, who received Moderna's COVID-19 vaccine (mRNA-1273)  experienced itchy rash around his nose and forehead.  The patient's medical history was not provided.  No relevant concomitant medications were reported.   On 29 Dec 2020, approximately 3 days prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot# 039K20A) intramuscularly for prophylaxis of COVID-19 infection.  On 01 Jan 2021, the patient developed itchy rash around his nose and forehead. Treatment for the event included Benadryl, but saw no changes on the rash.   Action taken with mRNA-1273 in response to the event as not reported.  The outcome of the event 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 event, a causal relationship cannot be excluded.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Tenderness, Vaccination site pain, Vaccination site swelling
Clinical narrative: Arm was tender; Pain in the injection site; Swelling in the injection site; A spontaneous report, was received from a consumer (patient), a 35 years-old female patient, unknown race and ethnicity, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced arm was tender (tenderness), pain in the injection site (injection site pain), and swelling in the injection site (injection site swelling).  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 24 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot# 037K20A), intramuscularly in the arm for prophylaxis of COVID-19 infection.   On 24 Dec 2020, after administration of the vaccine, the patient experienced pain and swelling on the injection site and arm was tender. No treatment information was provided.   Action taken with second dose of mRNA-1273 in response to the events was not reported.   The outcome of the events, arm was tender, pain in the injection site, and swelling in the injection site, were considered as not recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Lymphadenopathy, Rash, Skin tightness, Vaccination site warmth
Clinical narrative: Skin is tight; Skin is hot; Rash on my whole left shoulder; Lymph nodes under my arm are painful; Lymph nodes under my arm are swollen; A report was received from a consumer concerning a 37-year old, female patient who was participating in the mRNA-1273 Emergency Use Program and experienced rash on my whole left shoulder, skin is tight, skin is hot, lymph nodes under my arm are swollen and lymph nodes under my arm are painful.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 28 Dec 2020, approximately 3 days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection.  31 Dec 2020 and a little bit on 01 Jan 2021, the patient had a rash on her whole shoulder, noticed the skin was tight and hot, and the lymph nodes under her arm were swollen and painful. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  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 event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Night sweats
Clinical narrative: Night sweats; A report was received from a consumer concerning an anonymous female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced night sweats.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 30-Dec-2020, approximately 3 days prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 02-Jan-2021, the patient experience night sweats. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event was unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time. No further follow-up information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm soreness; A spontaneous report was received from other health professional concerning a 51-year-old, female consumer who received Moderna's COVID-19 vaccine and developed soreness in her arm.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 04 Jan 2021 at 07:15AM, prior to the onset of the events, the patient received their first of two doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.     On 04 Jan 2021, after receiving her vaccination, the patient began to develop soreness on her left arm. Treatment for the event included ice massage on her arm.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome for the events, soreness in her arm, was unknown.   The reporter's assessment of causality for the event was not provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria, Vaccination site pain
Clinical narrative: hives all over the body; soreness on her left arm; A spontaneous report was received from a non-health professional concerning a female consumer, of unknown age, who received Moderna's COVID-19 vaccine and developed hives and soreness on her left arm.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 26 Dec 2020, prior to the onset of the events, the patient received their first of two doses of mRNA-1273 (Lot number: 026L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.     On 26 Dec 2020, after receiving her vaccination, the patient began to develop soreness on her left arm. On 2 Jan 2021, she developed hives all over the body. Treatment for the event included prednisone for her hives.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome for the events, hives and soreness on her left arm, was unknown.   The reporter's assessment of causality for the event was not provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Muscle spasms
Clinical narrative: leg cramping; swelling at injection site; itching at the injection site; red at the injection site; injection site hardness; A spontaneous report was received from a healthcare professional (an emergency medical technician) who was also a 55-year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) experienced leg cramping (muscle spasms), swelling at injection site, injection site itching, injection site redness, and injection site hardness (injection site induration).   The patient's medical history was not provided. Concomitant medications included prazosin, lamotrigin, bupropion, metoprolol, propylthiouracil, hydroxyzine, cyanocobalamin, adreset, and oxicell.  On 24 Dec 2020, approximately 2 days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number 026L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 26 Dec 2020, the patient experienced itching, hardness, swelling, and redness at the injection site. The redness was initially the size of a 50-cent coin, then doubled in size to the diameter of a coffee cup. The patient also reported experiencing leg cramping (date not provided).   Treatment for the events included a hot compress and diphenhydramine hydrochloride.  Action taken with mRNA-1273 in response to the events was not reported.  The outcomes of the events of itching and swelling at injection site and leg cramping were unknown.  The event of redness at the injection site was resolving.  The event of hardness at the injection site was not resolved at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events a causal relationship cannot be excluded.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-054857:CROSS LINKED WITH 1 CASE
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Chills, Discomfort, Heart rate, Heart rate increased
Clinical narrative: Sore; Chills; Hypertension; heart rate increased; A spontaneous report was received from a consumer concerning a 55 year old, female patient who received Moderna's Covid-19 vaccine (mRNA-1273) and experienced blood pressure increased, heart rate increased, chills, and discomfort.  The patient's medical history included hypertension. Products known to have been used by the patient, within two weeks prior to the event, included metoprolol.  The patient received their first of two planned doses of mRNA-1273 (Lot # not provided) on 31 Dec 2020 for prophylaxis of COVID-19 infection.   On 03 Jan 2021, consumer called to report her heart rate-136, blood pressure-145/74, chills experienced on 31 Dec 2020, and sore on 01 Jan 2021.   Treatment for the event included metoprolol.   Action taken with mRNA-1273 in response to the events was not provided.   The event, blood pressure increased, heart rate increased, chills, and discomfort, were considered as unknown.  The reporter did not provide an assessment of the event, blood pressure increased, heart rate increased, chills, and discomfort.; 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: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension
Clinical narrative: Sore; Chills; Hypertension; heart rate increased; A spontaneous report was received from a consumer concerning a 55 year old, female patient who received Moderna's Covid-19 vaccine (mRNA-1273) and experienced blood pressure increased, heart rate increased, chills, and discomfort.  The patient's medical history included hypertension. Products known to have been used by the patient, within two weeks prior to the event, included metoprolol.  The patient received their first of two planned doses of mRNA-1273 (Lot # not provided) on 31 Dec 2020 for prophylaxis of COVID-19 infection.   On 03 Jan 2021, consumer called to report her heart rate-136, blood pressure-145/74, chills experienced on 31 Dec 2020, and sore on 01 Jan 2021.   Treatment for the event included metoprolol.   Action taken with mRNA-1273 in response to the events was not provided.   The event, blood pressure increased, heart rate increased, chills, and discomfort, were considered as unknown.  The reporter did not provide an assessment of the event, blood pressure increased, heart rate increased, chills, and discomfort.; 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, Chills, Decreased appetite, Dizziness, Fatigue
Clinical narrative: Dizziness; Nausea; red rash that covers her neck, abdomen and underarm; rash that appears like a sunburn and blotchy; Severe arm soreness; No appetite; Chills; Headache; Muscle ache; Severe fatigue; temp of 100F; A report was received from a healthcare facility staff member concerning a 51-year old, female patient who was participating in the mRNA-1273 Program and experienced severe fatigue, muscle ache, headache, chills, severe arm soreness, no appetite, red rash that covers her neck, abdomen and underarm that appears like a sunburn and blotchy, severe headache that starts from the base of the neck to the top of her head, nausea, and dizziness.  The patient's medical history, as provided by the reporter, included migraines and breast cancer. Concomitant medications reported included ascorbic acid, betacarotene, biotin, calcium carbonate, calcium pantothenate, calcium phosphate dihydrate, chromic chloride, colecalciferol, copper sulfate, cyanocobalamin, dl-alpha tocopheryl acetate, ferrous fumarate, folic acid, lycopene, magnesium oxide heavy, manganese sulfate monohydrate, nicotinamide, phytomenadione, potassium iodide, pyridoxine hydrochloride, retinol acetate, riboflavin, sodium selenate, thiamine mononitrate, xantofyl, zinc oxide, colecalciferol, and tamoxifen.  On 29 Dec 2020, approximately 0-3 days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 29 Dec 2020, in the afternoon, the patient started to feel severe fatigue, muscle ache, heache, chills, and experienced sever arm soreness, temp of 100 F and no appetite through the night. On 31 Dec 2020, her headache became severe, and she experienced chills, a blotchy, and a red rash that covers her neck, abdomen and underarm that appears like a sunburn. On 01 Jan 2021, the rash was still evident, she had no appetite, a sever headache that started at the base of her neck to the top of her head, nausea, and dizziness. On 03 Jan 2020, the patient reported all symptoms were still the same. The patient reported that despite taking pain killers and migraine medication, the pain persisted. Treatment for the event included ibuprofen on 29 Dec 2020, paracetamol every 6-7 hours, and Imitrex on 30 Dec 2020 and 01 Jan 2021.   Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events were unknown.; Reporter's Comments: This case concerns a female of unknown age with NS events of unexpected dizziness, decreased appetite, rash erythematous, rash macular, pain in extremity and expected fatigue, fever, chills, headache, myalgia, nausea.  Event onset on Day 2 after the first dose of mRNA-1273. Treated with ibuprofen, paracetamol, Imitrex. 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.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Dizziness; Nausea; red rash that covers her neck, abdomen and underarm; rash that appears like a sunburn and blotchy; Severe arm soreness; No appetite; Chills; Headache; Muscle ache; Severe fatigue; temp of 100F; A report was received from a healthcare facility staff member concerning a 51-year old, female patient who was participating in the mRNA-1273 Program and experienced severe fatigue, muscle ache, headache, chills, severe arm soreness, no appetite, red rash that covers her neck, abdomen and underarm that appears like a sunburn and blotchy, severe headache that starts from the base of the neck to the top of her head, nausea, and dizziness.  The patient's medical history, as provided by the reporter, included migraines and breast cancer. Concomitant medications reported included ascorbic acid, betacarotene, biotin, calcium carbonate, calcium pantothenate, calcium phosphate dihydrate, chromic chloride, colecalciferol, copper sulfate, cyanocobalamin, dl-alpha tocopheryl acetate, ferrous fumarate, folic acid, lycopene, magnesium oxide heavy, manganese sulfate monohydrate, nicotinamide, phytomenadione, potassium iodide, pyridoxine hydrochloride, retinol acetate, riboflavin, sodium selenate, thiamine mononitrate, xantofyl, zinc oxide, colecalciferol, and tamoxifen.  On 29 Dec 2020, approximately 0-3 days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 29 Dec 2020, in the afternoon, the patient started to feel severe fatigue, muscle ache, heache, chills, and experienced sever arm soreness, temp of 100 F and no appetite through the night. On 31 Dec 2020, her headache became severe, and she experienced chills, a blotchy, and a red rash that covers her neck, abdomen and underarm that appears like a sunburn. On 01 Jan 2021, the rash was still evident, she had no appetite, a sever headache that started at the base of her neck to the top of her head, nausea, and dizziness. On 03 Jan 2020, the patient reported all symptoms were still the same. The patient reported that despite taking pain killers and migraine medication, the pain persisted. Treatment for the event included ibuprofen on 29 Dec 2020, paracetamol every 6-7 hours, and Imitrex on 30 Dec 2020 and 01 Jan 2021.   Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events were unknown.; Reporter's Comments: This case concerns a female of unknown age with NS events of unexpected dizziness, decreased appetite, rash erythematous, rash macular, pain in extremity and expected fatigue, fever, chills, headache, myalgia, nausea.  Event onset on Day 2 after the first dose of mRNA-1273. Treated with ibuprofen, paracetamol, Imitrex. 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.
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Rash macular
Clinical narrative: Dizziness; Nausea; red rash that covers her neck, abdomen and underarm; rash that appears like a sunburn and blotchy; Severe arm soreness; No appetite; Chills; Headache; Muscle ache; Severe fatigue; temp of 100F; A report was received from a healthcare facility staff member concerning a 51-year old, female patient who was participating in the mRNA-1273 Program and experienced severe fatigue, muscle ache, headache, chills, severe arm soreness, no appetite, red rash that covers her neck, abdomen and underarm that appears like a sunburn and blotchy, severe headache that starts from the base of the neck to the top of her head, nausea, and dizziness.  The patient's medical history, as provided by the reporter, included migraines and breast cancer. Concomitant medications reported included ascorbic acid, betacarotene, biotin, calcium carbonate, calcium pantothenate, calcium phosphate dihydrate, chromic chloride, colecalciferol, copper sulfate, cyanocobalamin, dl-alpha tocopheryl acetate, ferrous fumarate, folic acid, lycopene, magnesium oxide heavy, manganese sulfate monohydrate, nicotinamide, phytomenadione, potassium iodide, pyridoxine hydrochloride, retinol acetate, riboflavin, sodium selenate, thiamine mononitrate, xantofyl, zinc oxide, colecalciferol, and tamoxifen.  On 29 Dec 2020, approximately 0-3 days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 29 Dec 2020, in the afternoon, the patient started to feel severe fatigue, muscle ache, heache, chills, and experienced sever arm soreness, temp of 100 F and no appetite through the night. On 31 Dec 2020, her headache became severe, and she experienced chills, a blotchy, and a red rash that covers her neck, abdomen and underarm that appears like a sunburn. On 01 Jan 2021, the rash was still evident, she had no appetite, a sever headache that started at the base of her neck to the top of her head, nausea, and dizziness. On 03 Jan 2020, the patient reported all symptoms were still the same. The patient reported that despite taking pain killers and migraine medication, the pain persisted. Treatment for the event included ibuprofen on 29 Dec 2020, paracetamol every 6-7 hours, and Imitrex on 30 Dec 2020 and 01 Jan 2021.   Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events were unknown.; Reporter's Comments: This case concerns a female of unknown age with NS events of unexpected dizziness, decreased appetite, rash erythematous, rash macular, pain in extremity and expected fatigue, fever, chills, headache, myalgia, nausea.  Event onset on Day 2 after the first dose of mRNA-1273. Treated with ibuprofen, paracetamol, Imitrex. 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.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain, Pyrexia
Clinical narrative: Red soreness; Red soreness; Fever; A spontaneous report was received from a consumer concerning an unknown age, female patient, who received Moderna's COVID-19 Vaccine and experienced red soreness and fever.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 30 Dec 2020, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (Batch number: Unknown) for prophylaxis of COVID-19 infection.  On 01 Jan 2021, the patient experienced red soreness and fever.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events red soreness and fever was not reported.  The outcome of the events of red soreness and fever was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Pain, Pain in extremity
Clinical narrative: Arm was sore; Had body aches; Low energy and fatigue; Low energy and fatigue; A spontaneous report was received from a consumer(Healthcare Professional) concerning a 61-year-old, female patient, who received Moderna's COVID-19 Vaccine and experienced arm was sore, had body aches, low energy and fatigue.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 30 Dec 2020, Wednesday, the patient received their first of two planned doses of mRNA-1273 (Batch Number: Unknown) in the left arm for prophylaxis of COVID-19 infection.  On 30 Dec 2020, the patient experienced arm was sore (gone by 01 Jan 2021), body aches, low energy and fatigue.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events arm was sore, had body aches, low energy and fatigue was not reported.  The outcome of the event arm was sore was reported resolved. The outcome of the events body aches, low energy and fatigue was not reported.; Reporter's Comments: Based on the current available information and a strong temporal association between the use of the product, the known safety profile of the vaccine and the start date of the reported events, a causal relationship with the events cannot be excluded. Fatigue is consistent with the known safety profile of mRNA-1273.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dark circles under eyes, Ear discomfort, Erythema, Eye pruritus
Clinical narrative: Weird sinus pain behind sinuses; Dark circles under her eyes; Headache; Joint pain in hips; Sensation of something moving through her body; Discomfort in left ear; Face was totally red; Sharp needle prick-like pain in Left and Right hand; Severe prickly feeling of tongue; Severe pain in tongue; Severely itchy eyes; Glassy eyes; Half her bottom lip swelled; Swollen face; A spontaneous report was received from a consumer concerning a 61-years-old, female patient who received Moderna's COVID-19 Vaccine, and who experienced sensation of something moving through her body, discomfort in left ear, face began to feel weird, face was totally red, sharp needle prick-like pain in left and Right hand, severe prickly feeling of tongue, serve pain in tongue, severely itchy eyes, glassy eyes, half her bottom lip swelled, swollen face, headache, joint pain in hips, dark circles under her eyes, looks like she aged 10 years and weird sinus pain behind sinuses.  The patient's medical history included chemical sensitivity. Concomitant medication provided was Kenalog.   On 31 Dec 2020, approximately 6-8 minutes prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.    On 31 Dec 2020, the patient stated experiencing sensation of something moving through her body, discomfort in left ear, face began to feel weird, face was totally red, sharp needle prick-like pain in left and Right hand, severe prickly feeling of tongue, serve pain in tongue, severely itchy eyes, glassy eyes, half her bottom lip swelled, swollen face, headache, and joint pain in hips. On 02 Jan 2021, the patient reported dark circles under her eyes, looks like she aged 10 years and weird sinus pain behind sinuses.  Treatment for the events included loratadine.   Action taken with mRNA-1273 in response to the events was unknown.   The events, sensation of something moving through her body, discomfort in left ear, face began to feel weird, sharp needle prick-like pain in left and R hand, severe prickly feeling of tongue, serve pain in tongue, severely itchy eyes, glassy eyes, half her bottom lip swelled, swollen face, headache and joint pain in hips were considered recovered/resolved on 31 Dec 2020.   The event face was totally red was considered recovered/resolved on 02 Jan 2021.  The outcome of the event's dark circles under her eyes, looks like she aged 10 years and weird sinus pain behind sinuses was not reported/unknown.; Reporter's Comments: Based on the information provided which includes a strong temporal association between the reported events and administration of mRNA-1273 vaccine, an excluding any other etiology, a causal association cannot be excluded. Nausea is consistent with the known safety profile of the vaccine
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Glassy eyes, Glossodynia, Headache, Lip swelling, Pain
Clinical narrative: Weird sinus pain behind sinuses; Dark circles under her eyes; Headache; Joint pain in hips; Sensation of something moving through her body; Discomfort in left ear; Face was totally red; Sharp needle prick-like pain in Left and Right hand; Severe prickly feeling of tongue; Severe pain in tongue; Severely itchy eyes; Glassy eyes; Half her bottom lip swelled; Swollen face; A spontaneous report was received from a consumer concerning a 61-years-old, female patient who received Moderna's COVID-19 Vaccine, and who experienced sensation of something moving through her body, discomfort in left ear, face began to feel weird, face was totally red, sharp needle prick-like pain in left and Right hand, severe prickly feeling of tongue, serve pain in tongue, severely itchy eyes, glassy eyes, half her bottom lip swelled, swollen face, headache, joint pain in hips, dark circles under her eyes, looks like she aged 10 years and weird sinus pain behind sinuses.  The patient's medical history included chemical sensitivity. Concomitant medication provided was Kenalog.   On 31 Dec 2020, approximately 6-8 minutes prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.    On 31 Dec 2020, the patient stated experiencing sensation of something moving through her body, discomfort in left ear, face began to feel weird, face was totally red, sharp needle prick-like pain in left and Right hand, severe prickly feeling of tongue, serve pain in tongue, severely itchy eyes, glassy eyes, half her bottom lip swelled, swollen face, headache, and joint pain in hips. On 02 Jan 2021, the patient reported dark circles under her eyes, looks like she aged 10 years and weird sinus pain behind sinuses.  Treatment for the events included loratadine.   Action taken with mRNA-1273 in response to the events was unknown.   The events, sensation of something moving through her body, discomfort in left ear, face began to feel weird, sharp needle prick-like pain in left and R hand, severe prickly feeling of tongue, serve pain in tongue, severely itchy eyes, glassy eyes, half her bottom lip swelled, swollen face, headache and joint pain in hips were considered recovered/resolved on 31 Dec 2020.   The event face was totally red was considered recovered/resolved on 02 Jan 2021.  The outcome of the event's dark circles under her eyes, looks like she aged 10 years and weird sinus pain behind sinuses was not reported/unknown.; Reporter's Comments: Based on the information provided which includes a strong temporal association between the reported events and administration of mRNA-1273 vaccine, an excluding any other etiology, a causal association cannot be excluded. Nausea is consistent with the known safety profile of the vaccine
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Sensation of foreign body, Sinus pain, Swelling face, Tongue rough
Clinical narrative: Weird sinus pain behind sinuses; Dark circles under her eyes; Headache; Joint pain in hips; Sensation of something moving through her body; Discomfort in left ear; Face was totally red; Sharp needle prick-like pain in Left and Right hand; Severe prickly feeling of tongue; Severe pain in tongue; Severely itchy eyes; Glassy eyes; Half her bottom lip swelled; Swollen face; A spontaneous report was received from a consumer concerning a 61-years-old, female patient who received Moderna's COVID-19 Vaccine, and who experienced sensation of something moving through her body, discomfort in left ear, face began to feel weird, face was totally red, sharp needle prick-like pain in left and Right hand, severe prickly feeling of tongue, serve pain in tongue, severely itchy eyes, glassy eyes, half her bottom lip swelled, swollen face, headache, joint pain in hips, dark circles under her eyes, looks like she aged 10 years and weird sinus pain behind sinuses.  The patient's medical history included chemical sensitivity. Concomitant medication provided was Kenalog.   On 31 Dec 2020, approximately 6-8 minutes prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.    On 31 Dec 2020, the patient stated experiencing sensation of something moving through her body, discomfort in left ear, face began to feel weird, face was totally red, sharp needle prick-like pain in left and Right hand, severe prickly feeling of tongue, serve pain in tongue, severely itchy eyes, glassy eyes, half her bottom lip swelled, swollen face, headache, and joint pain in hips. On 02 Jan 2021, the patient reported dark circles under her eyes, looks like she aged 10 years and weird sinus pain behind sinuses.  Treatment for the events included loratadine.   Action taken with mRNA-1273 in response to the events was unknown.   The events, sensation of something moving through her body, discomfort in left ear, face began to feel weird, sharp needle prick-like pain in left and R hand, severe prickly feeling of tongue, serve pain in tongue, severely itchy eyes, glassy eyes, half her bottom lip swelled, swollen face, headache and joint pain in hips were considered recovered/resolved on 31 Dec 2020.   The event face was totally red was considered recovered/resolved on 02 Jan 2021.  The outcome of the event's dark circles under her eyes, looks like she aged 10 years and weird sinus pain behind sinuses was not reported/unknown.; Reporter's Comments: Based on the information provided which includes a strong temporal association between the reported events and administration of mRNA-1273 vaccine, an excluding any other etiology, a causal association cannot be excluded. Nausea is consistent with the known safety profile of the vaccine
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Pain, Pyrexia
Clinical narrative: COVID 19 Diagnosis; body ache; fever; A spontaneous report was received from a physician concerning a 44 year old, female patient who experienced fever and body ache.  The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter.   On 22 Dec 2020, approximately 9 days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number unknown) intramuscularly in the for prophylaxis of COVID-19 infection.   The physician called to report that one of the nurses got the Moderna Covid-19 vaccine on 22 Dec 2020 and early in the morning of 31 Dec 2020, started having Covid-19 symptoms to include fever and body ache. She was tested and the results were positive. Treatment information was not provided/unknown.   Action taken with mRNA-1273 in response to the events was not provided/unknown.   The outcome of the events fever and body ache were unknown/not reported.   The reporter did not provide causality for the events fever and body ache; Reporter's Comments: This case concerns a 44-year-old female who "started having COVID-19 symptoms" and reported NS events of unexpected SARS-CoV-2 test positive (COVID-19), pain and expected pyrexia. Event onset occurred on Day 10 after the first dose of mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.