chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Eye irritation, Feeling abnormal, Illness, Limb discomfort
Clinical narrative: body ache especially at the back; eyes burn; bloodshot eyes; joint soreness; arm soreness; feverish; looks when he is sick; felt miserable; A spontaneous report was received from a consumer concerning a 60 year-old, male patient participating in the mRNA-1273 Emergency Use Program and experienced body ache (especially at the back), eyes burn, bloodshot eyes, joint soreness, arm soreness, feverish (no fever), looking sick and felt miserable.   The patient's medical history was not provided. No relevant concomitant medications were reported.  On 24 Dec 2020, approximately 2-3 hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 24 Dec 2020, the patient experienced body ache (especially at the back), burning eyes, bloodshot (red) eyes, joint soreness, and arm pain. It was reported that the patient was feverish but had no fever. The reporter described that the patient "looks the way he looks when he is sick", felt miserable, but denied chills. Treatment for the events included ibuprofen, 2 or 3 times to alleviate the pain, but it did not seem to really help.   Action taken with mRNA-1273 in response to the events was not reported.   The events, body ache (especially at the back), eyes burn, bloodshot eyes, joint soreness, arm soreness, feverish (no fever), looking sick and felt miserable, were considered recovering/resolving.  The reporter did not provide assessment of the events in relation to study drug.; Reporter's Comments: This case concerns a 60 year old male who experienced non-serious unexpected events of body ache, eyes burn, bloodshot eyes, looking sick and felt miserable and non-serious expected events of arthralgia, arm soreness, and pyrexia.  The events occurred with 2-3 hours after first dose of mRNA-1273 administration.  Treatment for the events included ibuprofen, and all events were resolving at the time of this report. Based on the current available information and temporal association between the use of mRNA-1273 and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Ocular hyperaemia, Pain, Pyrexia
Clinical narrative: body ache especially at the back; eyes burn; bloodshot eyes; joint soreness; arm soreness; feverish; looks when he is sick; felt miserable; A spontaneous report was received from a consumer concerning a 60 year-old, male patient participating in the mRNA-1273 Emergency Use Program and experienced body ache (especially at the back), eyes burn, bloodshot eyes, joint soreness, arm soreness, feverish (no fever), looking sick and felt miserable.   The patient's medical history was not provided. No relevant concomitant medications were reported.  On 24 Dec 2020, approximately 2-3 hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 24 Dec 2020, the patient experienced body ache (especially at the back), burning eyes, bloodshot (red) eyes, joint soreness, and arm pain. It was reported that the patient was feverish but had no fever. The reporter described that the patient "looks the way he looks when he is sick", felt miserable, but denied chills. Treatment for the events included ibuprofen, 2 or 3 times to alleviate the pain, but it did not seem to really help.   Action taken with mRNA-1273 in response to the events was not reported.   The events, body ache (especially at the back), eyes burn, bloodshot eyes, joint soreness, arm soreness, feverish (no fever), looking sick and felt miserable, were considered recovering/resolving.  The reporter did not provide assessment of the events in relation to study drug.; Reporter's Comments: This case concerns a 60 year old male who experienced non-serious unexpected events of body ache, eyes burn, bloodshot eyes, looking sick and felt miserable and non-serious expected events of arthralgia, arm soreness, and pyrexia.  The events occurred with 2-3 hours after first dose of mRNA-1273 administration.  Treatment for the events included ibuprofen, and all events were resolving at the time of this report. Based on the current available information and temporal association between the use of mRNA-1273 and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm is killing her this morning; A spontaneous report was received from  a nurse on 28 Dec 2020 concerning an adult female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced arm is killing her this morning with the use of mRNA-1273.    There was no medical history or concomitant medications provided.  On 27 Dec 2020, the patient received the first of two planned doses of mRNA-1273 (Lot # 026L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 28 Dec 2020, the patient, experienced the non-serious event of arm is killing her this morning. There was no treatment information provided.  There were no relevant laboratory tests provided.  Action taken with mRNA-1273 in response to the event of arm is killing her this morning was not reported.   The outcome of the event was unknown,.; Reporter's Comments: This case concerns a female patient, who experienced event of arm is killing her this morning. The event occurred the next day after the first and last dose of mRNA-1273 vaccine administration. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded and the events are assessed as possibly related.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Bad reaction; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a very bad reaction.  The patient's medical history was not provided. No concomitant medications were reported.  On 23 Dec 2020, the patient received her first of two planned doses of mRNA-1273 (Lot: unknown, Exp. unknown). On the same day, the patient experienced the very bad reaction and was being sent to the emergency room (ER).   No treatment information was provided.   The Action taken with mRNA-1273 in response to the event was unknown.  The outcome for the event, having a very bad reaction was considered unknown.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives; A spontaneous report was received from a nurse concerning a 40 year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed hives.   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 # 026L208) on 23 Dec 2020.  On 23 Dec 2020, unknown amount of time from the time of vaccination prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (LOT # 026L208) intramuscularly (injection site not provided) prophylaxis of COVID-19 infection.   The nurse reported after receiving the mRNA-1273 vaccine the patient developed hives which started at the injection site.   Treatment for the event included diphenhydramine 25 mg orally. The nurse reported the hives disappeared after taking the diphenhydramine. The nurse reported at 23 hours post vaccination, the hives reappeared all over the patient's body.   Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the event was unknown.; Reporter's Comments: This case concerns 40-year-old female patient, who experienced a non-serious unexpected event of urticaria, which started at injection site.  The event occurred at the same day of the first dose of mRNA-1273 vaccine. Treatment included diphenhydramine orally and the event resolved, however reappeared again The event was assessed as related to mRNA-1273 vaccine due to temporal association.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Back pain, Chills, Cough
Clinical narrative: Can't smell; Can't taste; Chills; Fever; Neck pain; Back pain; Sore throat; Nasal congestion; Runny nose; Cough; A report was received from a physician concerning a 43-year old, female patient and experienced nasal congestion, runny nose, fever, chills, cough, sore throat, back pain, neck pain, can't smell and can't taste.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 21 Dec 2020, approximately 4 days prior to the onset of the events, nasal congestion, runny nose, fever, chills, cough, sore throat, back pain, neck pain, and 5 days prior to the onset of the events, can't smell and can't taste, the patient received their first of two planned doses of mRNA-1273 (BATCH #011J20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 22 Dec 2020, the patient was exposed to her COVID-19 positive daughter. On 25 Dec 2020, the patient began to experience nasal congestion, runny nose, fever, chills, cough, sore throat, back pain, neck pain. On 26 Dec 2020, the subject reported no longer being able to taste or smell. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcomes of the events, nasal congestion, runny nose, fever, chills, cough, sore throat, back pain, neck pain, can't smell and can't taste, were unknown.   The reporter did not provide an assessment for the events, nasal congestion, runny nose, fever, chills, cough, sore throat, back pain, neck pain, can't smell and can't taste.; Reporter's Comments: This case concerns a 43 year old female who experienced non-serious unexpected events of congestion, runny nose, cough, sore throat, back pain, neck pain, can't smell and can't taste and non-serious expected events of fever and chills. The events occurred 4 days after first dose of mRNA-1273, followed one day later by loss of taste and smell.  No treatment information was 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.
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Neck pain, Oropharyngeal pain, Pyrexia, Rhinorrhoea
Clinical narrative: Can't smell; Can't taste; Chills; Fever; Neck pain; Back pain; Sore throat; Nasal congestion; Runny nose; Cough; A report was received from a physician concerning a 43-year old, female patient and experienced nasal congestion, runny nose, fever, chills, cough, sore throat, back pain, neck pain, can't smell and can't taste.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 21 Dec 2020, approximately 4 days prior to the onset of the events, nasal congestion, runny nose, fever, chills, cough, sore throat, back pain, neck pain, and 5 days prior to the onset of the events, can't smell and can't taste, the patient received their first of two planned doses of mRNA-1273 (BATCH #011J20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 22 Dec 2020, the patient was exposed to her COVID-19 positive daughter. On 25 Dec 2020, the patient began to experience nasal congestion, runny nose, fever, chills, cough, sore throat, back pain, neck pain. On 26 Dec 2020, the subject reported no longer being able to taste or smell. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcomes of the events, nasal congestion, runny nose, fever, chills, cough, sore throat, back pain, neck pain, can't smell and can't taste, were unknown.   The reporter did not provide an assessment for the events, nasal congestion, runny nose, fever, chills, cough, sore throat, back pain, neck pain, can't smell and can't taste.; Reporter's Comments: This case concerns a 43 year old female who experienced non-serious unexpected events of congestion, runny nose, cough, sore throat, back pain, neck pain, can't smell and can't taste and non-serious expected events of fever and chills. The events occurred 4 days after first dose of mRNA-1273, followed one day later by loss of taste and smell.  No treatment information was 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.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Headache, Injection site haemorrhage, Injection site pain, Joint swelling
Clinical narrative: bleed at the injection site; having problems with her knees; Sore arm; headache; gait a little unstable; A spontaneous report was received from a healthcare facility staff member concerning a 50-year-old, female patient who was participating in the mRNA-1273 Emergency Use Program and who experienced having problems with her knees, began to bleed at the injection site, her arm was sore, had a headache, swelling in her knees and gait a little unstable.   The patient's medical history included elevated cholesterol and thyroid disorder.  The Products known to have been used by the patient, within two weeks prior to the event, included pravastatin, levothyroxine sodium, turmeric, vitamin D, vitamin B1, ferrous sulfate and combination calcium + vitamin D3.   The patient received their first of two planned doses of mRNA-1273 (LOT # 011J20A) on 23-Dec-2020 intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   Patient received the Moderna vaccine on 23-Dec-2020.  After the injection, she began having problems with her knees.  She also experienced bleeding and soreness at the injection site.  Additionally, she reported a headache.  The arm soreness, which she treated with over-the-counter Advil, resolved after 2 days, however, she reported an increase in knee swelling, left greater than right.  She stated that her knees were not painful but that they felt heavy as if there was fluid in them.  She said the swelling was also causing her gait to be a little unstable. Patient denies history of knee issues.  She admitted to taking over-the-counter Aleve with no resolution of swelling.   Treatment for the event included over-the-counter Advil and Aleve.   There was no change planned to the dosing schedule of mRNA-1273 in response to the events, having problems with her knees, began to bleed at the injection site, her arm was sore, had a headache, swelling in her knees and gait a little unstable.  The event, her arm was sore, was considered recovered/resolved.    The outcome of the events, having problems with her knees, began to bleed at the injection site, had a headache, swelling in her knees and gait a little unstable, was not reported.   The reporter did not provide an assessment for the events, having problems with her knees, began to bleed at the injection site, her arm was sore, had a headache, swelling in her knees and gait a little unstable.; Reporter's Comments: This case concerns a 50-year-old, female patient with medical history of elevated cholesterol and thyroid disorder, who experienced NS, expected event of injection site pain, headache and unexpected event of injection site bleeding, joint swelling and gait disturbance. The events occurred the day the first dose of mRNA-1273 (LOT # 011J20A) was administered. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Ear pain
Clinical narrative: left ear throbbing pain; sharp pain on right ear; A spontaneous report was received from a health care provider who received Moderna's COVID-19 vaccine (mRNA-1273) and had left ear throbbing pain and sharp pain on right ear.  The patient's medical history was not provided. Concomitant medications included Synthroid, Rosuvastatin, and Candesartan.  The patient received their first of two planned doses of mRNA-1273 (Batch # 026L20A) on 26 Dec 2020 intramuscularly for prophylaxis of COVID-19 infection.   On 26 Dec 2020, the patient experienced a throbbing pain on her left ear and a sharp pain on her right ear after 45 minutes.  The patient took Tylenol as an intervention to the pain.  Action taken with mRNA-1273 in response to the event was not reported.  The events, left ear throbbing pain and sharp pain on right ear, were unknown.; Reporter's Comments: This case concerns a patient of unknown age and gender. The patient's medical history was not provided. The patient experienced a non serious, unexpected event of ear pain. The event occurred the day the first dose of mRNA-1273 (Batch # 026L20A) was administered. Very limited information regarding this event has been provided at this time.  Based on temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: A spontaneous report (United States) was received from  a consumer concerning a 40-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced headache and fatigue.  The patient's medical history was not provided.  No relevant concomitant medications were reported.  The patient received their first of two planned doses of mRNA-1273 (Batch # 025l20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection on 27 Dec 2020.  On 27 Dec 2020, the patient experienced headache and fatigue after receiving the vaccine.  No treatment information was provided as per patient she has not taken any medications.   There was no change planned in the dosing schedule of mRNA-1273 in response to the event.  The events, headache and fatigue, were not recovered/resolved.; Reporter's Comments: This case concerns a 40-year-old female patient on unknown age who experienced expected non-serious events of Headache and Fatigue. The events occurred on the same day after receiving first dose of mRNA-1273, (lot # 025l20A). No treatment was given for the events. Based on the current available information and temporal association between the use of the product and onset of the events a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Cold sweat, Feeling hot, Hyperhidrosis, Micturition urgency
Clinical narrative: A sudden urge to urinate; Tingling sensation; Felt warm; Feet were sweaty; Hands clammy; Anxious; Antsy; A spontaneous report was received from a pharmacy intern concerning herself, a 34-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a sudden urge to urinate (Micturition urgency), tingling sensation (Paraesthesia), feeling warm (Feeling hot), sweaty feet (Hyperhydrosis), clammy hands (Cold sweat), anxiety and feeling antsy (Restlessness).   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 24-Dec-20, approximately 3 hours prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (037A20-A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On the same date, a few minutes after the vaccination she was standing up and felt a sudden urge to urinate and a tingling sensation. She did not feel light headed but felt warm. She checked her temperature at the pharmacy, and it was fine. At the pharmacy she sat down and was feeling warm. Her feet were sweaty so she took her shoes off and the feeling went away in 15 to 20 minutes. The patient went home and was still feeling the same way again: warm and hands clammy. She walks around and feels the coolness of the house, but still feels clammy. She checked her axillary temperature and it was 98.5 degrees Fahrenheit. She also feels anxious and antsy. She stated that she is going to reach out to her doctor for treatment advice.  Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was unknown.   The outcome of the event sweaty feet resolved 15-20 minutes after the patient removed her shoes, and the outcome of the events sudden urge to urinate, tingling sensation, feeling warm, clammy hands, anxiety and feeling antsy were not reported.; Reporter's Comments: This case concerns a 34 year old female patient, who experienced the non-serious unlisted events of sudden urge to urinate, tingling sensation, feeling warm, sweaty feet, clammy hands, anxiety, and feeling antsy . The events occurred on the same day after receiving the first dose of mRNA-1273 vaccine.  Based on the current available information and temporal association between vaccination and the onset of events on the same day, a causal relationship cannot be excluded.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Restlessness, Thermometry
Clinical narrative: A sudden urge to urinate; Tingling sensation; Felt warm; Feet were sweaty; Hands clammy; Anxious; Antsy; A spontaneous report was received from a pharmacy intern concerning herself, a 34-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a sudden urge to urinate (Micturition urgency), tingling sensation (Paraesthesia), feeling warm (Feeling hot), sweaty feet (Hyperhydrosis), clammy hands (Cold sweat), anxiety and feeling antsy (Restlessness).   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 24-Dec-20, approximately 3 hours prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (037A20-A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On the same date, a few minutes after the vaccination she was standing up and felt a sudden urge to urinate and a tingling sensation. She did not feel light headed but felt warm. She checked her temperature at the pharmacy, and it was fine. At the pharmacy she sat down and was feeling warm. Her feet were sweaty so she took her shoes off and the feeling went away in 15 to 20 minutes. The patient went home and was still feeling the same way again: warm and hands clammy. She walks around and feels the coolness of the house, but still feels clammy. She checked her axillary temperature and it was 98.5 degrees Fahrenheit. She also feels anxious and antsy. She stated that she is going to reach out to her doctor for treatment advice.  Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was unknown.   The outcome of the event sweaty feet resolved 15-20 minutes after the patient removed her shoes, and the outcome of the events sudden urge to urinate, tingling sensation, feeling warm, clammy hands, anxiety and feeling antsy were not reported.; Reporter's Comments: This case concerns a 34 year old female patient, who experienced the non-serious unlisted events of sudden urge to urinate, tingling sensation, feeling warm, sweaty feet, clammy hands, anxiety, and feeling antsy . The events occurred on the same day after receiving the first dose of mRNA-1273 vaccine.  Based on the current available information and temporal association between vaccination and the onset of events on the same day, a causal relationship cannot be excluded.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Lymphadenopathy, Pain in extremity
Clinical narrative: Pain tenderness of arm at rest, pain when left arm is moved; Swollen left lymph node; swollen left armpit extending to the chest region and pain; A spontaneous report was received from a consumer concerning a 28-year old, female patient who experienced swollen left arm pit extending to the chest region, pain tenderness of arm at rest, pain when left arm is moved, slight pain in right arm around lymph node not as bad as left, and swollen left lymph node.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 22 DEC 2020, approximately five days prior to the onset of symptoms, the patient received their first of two planned doses of mRNA-1273 (LOT/BATCH# 011J20A) in the left arm for prophylaxis of COVID-19 infection.   On 27 DEC 2020, the patient started to experience swollen left lymph node, swollen left arm pit extending to the chest region, pain tenderness of arm at rest, pain when left arm is moved, and slight pain in the right arm around lymph node not as bad as left. The events were progressive at time of reporting. mRNA-1273 (LOT/BATCH# 011J20A). The patient did not take any treatment for the events. Action taken with mRNA-1273 in response to the events was not reported.   The events swollen left arm pit extending to the chest region, pain tenderness of arm at rest, pain when left arm is moved, slight pain in right arm around lymph node not as bad as left, and swollen left lymph node were considered ongoing.  The reporter did not provide an assessment for the events swollen left arm pit extending to the chest region, pain tenderness of arm at rest, pain when left arm is moved, slight pain in right arm around lymph node not as bad as left, and swollen left lymph node.; Reporter's Comments: This case concerns a 28-year-old, female patient. The patient's medical history was not provided. The patient experienced NS expected event of axillary lymph node, lymphadenopathy, pain in arm and unexpected event of pain in right arm. The events occurred 6 days after the administration of the first dose of mRNA-1273 (LOT/BATCH# 011J20A). The patient did not take any treatment for the events. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during breast feeding
Clinical narrative: Breast feeding; A spontaneous report was received from a 43 year old, female, patient, who received Moderna's COVID-19 vaccine (mRNA-1273) while breastfeeding.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 24 Dec 2020, the patient received her first of two planned doses of mRNA-1272 intramuscularly for prophylaxis of COVID-19 infection.  On 24 Dec 2020, the patient called to report that she was breastfeeding. She reported no symptoms and consented to follow-up with safety or a health care professional.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome for the event, breast feeding, was unknown.; Reporter's Comments: This case concerns a 43-year-old, female patient. The patient's medical history was not provided. The patient reported that she was breastfeeding. The date of birth of the baby was unknown. The patient had an event of exposure during breast feeding after receiving the first dose of mRNA-1273.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Fatigue, Influenza like illness, Pyrexia
Clinical narrative: Fever  that typically stayed around 100.5; felt very weak; A little more tired than normal; Flu like symotoms; A report was received from a physician concerning a 60-year old, female patient who was participating in the mRNA-1273 a Program and experienced fever that typically stayed around 100.5, felt very weak, flu-like symptoms, and more tired than normal.   The patient's medical history, as provided by the reporter, included anxiety and COVID. Concomitant medications reported included fluoxetine.   On 23 Dec 2020, approximately 12 hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (BATCH #025J202) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 24 Dec 2020, approximately 12 hours following vaccine administration, around 6 or 7 am, the patient began to experience "flu-like symptoms". She reported feeling a little more tired than normal, felt very weak, and had a fever staying around 100.5 °F. She took her temperature every few hours from 24 Dec 2020 to 25 Dec 2020, with the highest temperature being 101°F. The patient reported laying around for 48 hours and felt better. Treatment for the event included Tylenol and an unspecified non-steroidal anti-inflammatory drug (NSAID).   Action taken with mRNA-1273 in response to the events was not reported.  The events, fever that typically stayed around 100.5, was considered resolved on 25 Dec 2020. The events, felt very weak, flu-like symptoms, and more tired than normal, were considered resolved on 26 Dec 2020.   The reporter did not provide an assessment for the events, fever that typically stayed around 100.5, felt very weak, flu-like symptoms, and more tired than normal.; Reporter's Comments: This case concerns a 60-year old, female patient with medical history of anxiety and COVID, who experienced NS, expected events of pyrexia and fatigue and unexpected events of asthenia and influenza-like symptoms. The events occurred 7 hours after the administration of mRNA-1273 (BATCH #025J202). The patient reported laying around for 48 hours and felt better. Treatment for the event included Tylenol and an unspecified non-steroidal anti-inflammatory drug (NSAID). 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: Pruritus
Clinical narrative: Itching; A spontaneous report was received from a physician concerning a 59-year-old female patient participating in the mRNA-1273 who experienced itching.   The patient's medical history, as provided by the reporter included shellfish allergy, arthritis, allergic rhinitis, chronic back and shoulder pain.  No relevant concomitant medications were reported.   On 27 Dec 2020, approximately 8 hours 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 27 Dec 2020, the patient experienced itching. After self-treatment, she continues to itch, but it was getting better. Treatment for the event included methyprednisolone acetate and diphenhydramine hydrochloride.   Action taken with mRNA-1273 in response to the event was not reported.   The event, itching, was considered recovering/resolving.; Reporter's Comments: This case concerns a 59-year-old female patient with a relevant  medical history of shellfish allergy and allergic rhinitis, who experienced a non-serious unexpected event of pruritus. The event occurred approximately 8 hours after receiving the first dose of mRNA-1273, lot # unknown). Treatment for the event included methyprednisolone acetate and diphenhydramine hydrochloride. Based on the current available information and temporal association between the use of the product and onset of the event a causal relationship cannot be excluded. Of note, the patient's medical history of shellfish allergy and allergic rhinitis are considered as risk factors.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Dry throat, Fatigue, Feeling hot
Clinical narrative: Covid rapid test positive; Dry throat - same symptom as you would have when the humidity in the house is not; dry nose - same symptom as you would have when the humidity in the house is not; scratchy throat; Scratchy nose; Feels hot; Feels tired; Chills; A spontaneous report was received from a consumer concerning a 34 year-old, female patient participating in the mRNA-1273 Emergency Use Program and experienced dry throat and nose, scratchy throat and nose, chills, feeling hot, and tired. Patient also experienced a positive COVID-19 rapid test.   The patient's medical history included "cancer treatment last year". Concomitant medications reported included phentermine, bupropion hydrochloride, and neratinb maleate.    On 23 Dec 2020, approximately three 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.   On 26 Dec 2020, the patient started to have a dry, scratchy nose and throat (noted as "the same symptom as you would have when the humidity in the house is not enough"), chills, felt hot and tired. The patient denies cough, fever and loss of taste. On 27 Dec 2020, the patient has a positive COVID rapid test. The repeat test was also positive. Treatment for the event included paracetamol, ibuprofen, dextromethorphan hydrobromide/doxylamine succinate/ephedrine sulfate/ethanol/paracetamol, and dextromethorphan hydrobromide/ guaifenesin/paracetamol/pseudoephedrine hydrochloride.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, dry throat and nose, scratchy throat and nose, chills, feeling hot, and tired, was unknown/not reported. The outcome of the event, positive COVID-19 rapid test, was considered resolved.   The reporter did not provide assessment of the event in relation to study drug.; Reporter's Comments: This case concerns a 34 year old female with medical history of neratinib for cancer experienced nonserious unexpected events of dry throat and nose, scratchy throat and nose, feeling hot, and COVID-19 (positive COVID-19 rapid test) and nonserious expected events of chills and fatigue. The events occurred 3 days after first dose of mRNA-1273 administration, and were treated with paracetamol, ibuprofen, dextromethorphan, doxylamine, ephedrine, guaifenesin, and pseudoephedrine.  The events remained ongoing at the time of this report. Based on the available information and temporal association between the use of mRNA-1273 and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Nasal discomfort, Nasal dryness, Oropharyngeal discomfort, SARS-CoV-2 test
Clinical narrative: Covid rapid test positive; Dry throat - same symptom as you would have when the humidity in the house is not; dry nose - same symptom as you would have when the humidity in the house is not; scratchy throat; Scratchy nose; Feels hot; Feels tired; Chills; A spontaneous report was received from a consumer concerning a 34 year-old, female patient participating in the mRNA-1273 Emergency Use Program and experienced dry throat and nose, scratchy throat and nose, chills, feeling hot, and tired. Patient also experienced a positive COVID-19 rapid test.   The patient's medical history included "cancer treatment last year". Concomitant medications reported included phentermine, bupropion hydrochloride, and neratinb maleate.    On 23 Dec 2020, approximately three 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.   On 26 Dec 2020, the patient started to have a dry, scratchy nose and throat (noted as "the same symptom as you would have when the humidity in the house is not enough"), chills, felt hot and tired. The patient denies cough, fever and loss of taste. On 27 Dec 2020, the patient has a positive COVID rapid test. The repeat test was also positive. Treatment for the event included paracetamol, ibuprofen, dextromethorphan hydrobromide/doxylamine succinate/ephedrine sulfate/ethanol/paracetamol, and dextromethorphan hydrobromide/ guaifenesin/paracetamol/pseudoephedrine hydrochloride.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, dry throat and nose, scratchy throat and nose, chills, feeling hot, and tired, was unknown/not reported. The outcome of the event, positive COVID-19 rapid test, was considered resolved.   The reporter did not provide assessment of the event in relation to study drug.; Reporter's Comments: This case concerns a 34 year old female with medical history of neratinib for cancer experienced nonserious unexpected events of dry throat and nose, scratchy throat and nose, feeling hot, and COVID-19 (positive COVID-19 rapid test) and nonserious expected events of chills and fatigue. The events occurred 3 days after first dose of mRNA-1273 administration, and were treated with paracetamol, ibuprofen, dextromethorphan, doxylamine, ephedrine, guaifenesin, and pseudoephedrine.  The events remained ongoing at the time of this report. Based on the available information and temporal association between the use of mRNA-1273 and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chills, Cough, Oropharyngeal pain, Pain
Clinical narrative: fever; chills; body aches; cough; Positive COVID-19 test; sore throat; A spontaneous report was received from a deputy health officer concerning a male patient participating in the mRNA-1273 Emergency Use Program and experienced sore throat, fever, chills, body aches and cough. The patient also tested positive for COVID-19.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 26 Dec 2020, approximately 24 hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 27 Dec 2020, the patient was not feeling well after vaccination and had developed sore throat overnight. He was given a COVID-19 rapid test and results returned negative. On 28 Dec 2020, the patient woke up with fever, body aches, chills and cough. He was given a second COVID-19 rapid test and the results returned positive. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The event, positive COVID-19 test, was considered resolved. The outcome of the events, sore throat, fever, chills, body aches and cough was unknown/not reported.; Reporter's Comments: This case concerns a male of unknown age who experienced the nonserious unexpected events of sore throat, cough, and COVID-19, and nonserious expected events of fever, chills, and body aches.  The sore throat occurred within 1 day after the first dose of RNA-1273, and the events of fever, body aches, chills, cough, and a positive COVID-19 test occurred 2 days after mRNA-1273 administration.  Based on the current available information and temporal association between the use of mRNA-1273 and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: fever; chills; body aches; cough; Positive COVID-19 test; sore throat; A spontaneous report was received from a deputy health officer concerning a male patient participating in the mRNA-1273 Emergency Use Program and experienced sore throat, fever, chills, body aches and cough. The patient also tested positive for COVID-19.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 26 Dec 2020, approximately 24 hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 27 Dec 2020, the patient was not feeling well after vaccination and had developed sore throat overnight. He was given a COVID-19 rapid test and results returned negative. On 28 Dec 2020, the patient woke up with fever, body aches, chills and cough. He was given a second COVID-19 rapid test and the results returned positive. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The event, positive COVID-19 test, was considered resolved. The outcome of the events, sore throat, fever, chills, body aches and cough was unknown/not reported.; Reporter's Comments: This case concerns a male of unknown age who experienced the nonserious unexpected events of sore throat, cough, and COVID-19, and nonserious expected events of fever, chills, and body aches.  The sore throat occurred within 1 day after the first dose of RNA-1273, and the events of fever, body aches, chills, cough, and a positive COVID-19 test occurred 2 days after mRNA-1273 administration.  Based on the current available information and temporal association between the use of mRNA-1273 and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Itchy hives; Rash all over body; A spontaneous report was received from a health care professional concerning a 20-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) experienced multiple events of rash all over body and itchy hives.  The patient's medical history was not provided. No concomitant medications were reported.  On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot# 026O20A, Exp. unknown). On the same day, patient experienced rash all over body and itchy hives. The treatment information included Benadryl. Symptoms did not subside after taking Benadryl. It was confirmed that the patient was not pregnant.   The Action taken with mRNA-1273 in response to the events was unknown.   The outcome for the events, rash all over body and itchy hives was not resolved.; Reporter's Comments: This case concerns a 20-year-old, female patient, who experienced a non-serious unexpected event of urticaria and non-serious expected event of rash. The events occurred 1 day (3 Hrs.) after first dose of mRNA-1273, lot # 026O20A. Treatment included Benadryl. Based on the current available information and temporal association between the use of the product and onset of the events a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during breast feeding
Clinical narrative: vaccine while breast feeding an 18 month old baby; A spontaneous report was received from a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) experienced exposure via breast milk.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot #039K20A) intramuscularly, in her left arm, for prophylaxis of COVID-19 infection.  On 28 Dec 2020, after vaccine administration, the patient received the vaccine without considering that she was breastfeeding an 18 month old baby. The patient stated she did not experience any side effects and has not breastfed the baby by the time of the call.   Action taken with mRNA-1273 in response to the event was not reported.  The event, exposure via breast milk, was considered unknown.; Reporter's Comments: This case concerns a female patient who received their first of two planned doses mRNA-1273 (Lot number 039K20A) while breastfeeding an 18 month old baby, with no associated adverse events.
Sex: F
Vaccine: COVID19
Symptoms: Migraine with aura, Swelling of eyelid
Clinical narrative: Swollen eyelids; Migraine with aura; A spontaneous report was received from a Nurse of a 55-year-old female was participating in the mRNA-1273 Emergency Use Program and developed migraine aura and swollen eyelids.   The patient's medical history, as provided by the reporter, included anemia, migraine, sciatica, seasonal spring and fall allergies and ADHD. Concomitant medications reported were gabapentin, amfetamine aspartate/ amfetamine sulfate/ dexamfetamine saccharate/ dexamfetamine sulfate and certirizine hydrochloride.    On 24 Dec 2020, 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 (Lot# unknow).   On 24 Dec 2020, within 20-40 minutes post vaccine administration, the patient began to experience migraine aura. The patient then experienced bilateral eyelid swelling 3.5 hours post vaccine administration. Swelling and migraine worsened throughout the day so patient sought treatment in the emergency room by midnight. Patient reports all symptoms are improving.    Treatment for the event included methylprednisolone, diphenhydramine, and prednisone taper.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events migraine aura and swollen eyelids was reported as recovering.  The reporter did not provide an assessment for the events.; Reporter's Comments: This case concerns a 55-year-old female patient with a medical history of migraine and seasonal allergies who experienced non-serious unexpected events of Migraine with aura and Swelling of eyelid. The events occurred 1 day (same day) after receiving the first dose of mRNA-1273, lot # unknown. Treatment included methylprednisolone, diphenhydramine, and prednisone taper. Based on the current available information and temporal association between the use of the product and onset of the events a causal relationship cannot be excluded. Of note, patient's previous history of migraine and seasonal allergies are considered risk factors to the occurrence of the events.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Dyspnoea, Fatigue, Feeling abnormal, Injection site paraesthesia
Clinical narrative: Horrendous reaction; Left arm injection site tingling; Felt tired; Back pain; Ran a fever; Congested; Left arm injection site still feels hot to touch; had vomiting; lingering shortness of breath; A spontaneous report was received from a consumer 71-year-old, female patient who was participating in the mRNA-1273 Emergency Use Program and experienced horrendous reaction, left arm injection site tingling, felt tired, back pain, ran a fever, vomiting, congested, left arm injection site still feels hot to touch and lingering shortness of breath.  The patient's medical history included Covid-19 approximately two weeks prior to receiving the injection.  Concomitant product use was not provided by the reporter.   The patient received their first of two planned doses of mRNA-1273 on 23-Dec-2020 intramuscularly in the left arm for prophylaxis of COVID-19 infection.   Patient reported that she had a horrendous reaction after receiving the Moderna vaccine (mRNA-1273) on 23-Dec-2020.  She stated that on that day, her left arm tingled and she felt tired.  During the night, she stated that she had back pain, ran a fever, vomited and was congested.  The patient said that although she experienced these symptoms for 3 days, she did notice some improvement over the course of the 3 days.  As of 28-Dec-2020, she reported that her left shoulder, the injection site, still felt hot to the touch and that she still had some lingering shortness of breath.    Treatment information was not provided.  Action taken with mRNA-1273 in response to the events, horrendous reaction, left arm injection site tingling, felt tired, back pain, ran a fever, vomiting, congested, left arm injection site still feels hot to touch and lingering shortness of breath, was not provided.  The outcome of the events, horrendous reaction, left arm injection site tingling, felt tired, back pain, ran a fever, vomiting, congested was reported as recovering and for left arm injection site still feels hot to touch and lingering shortness of breath was reported as not recovered.; Reporter's Comments: This case concerns a 71-year-old female patient with medical history of recent COVID-19, who received their first of two planned doses of mRNA-1273 (Lot unknown), and who experienced the non-serious listed events of fatigue, fever, and vomiting, and the non-serious unlisted events of horrendous reaction, left arm injection site tingling, back pain, nasal congestion, injection site warmth, and lingering shortness of breath.  Based on the current available information and temporal association between the use of the product and the onset of events on the day of vaccination, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.