chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Nausea, Vomiting
Clinical narrative: Really really bad Abdominal Cramping; Diarrhea; feels very weak; Nausea; Throwing up; Sore arm; Ranging Headache; A spontaneous report was received from a 23-year-old, female consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events, ranging headache, sore arm, throwing up, diarrhea, nausea, really really bad abdominal cramping, and feels very weak.  The patients' medical history was not provided. Concomitant medications included escitalopram, buspirone and etonogestrel implant.  On 23 Dec 2020 at 13:30 approximately one hour prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 vaccine intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 23 Dec 2020 after vaccination, the patient experienced ranging headache and soreness on her arm. She had severe abdominal cramping in middle of the night.   On the morning of 24 Dec 2020 she began having diarrhea, nausea, really, really bad abdominal cramping and took 2 naproxen and warm bath after which she felt little better, but threw up immediately after. She also reported having to get up and down to go to the bathroom, but all that was coming out was water. She denied a fever. The patient attempted to go to urgent care during morning hours, but because she was experiencing COVID symptoms, healthcare provider stated they could not help her until she provided a negative COVID test result. The patient reported to have self-treated for her symptoms but continued to feel weak. Treatment for the events included naproxen and bismuth subsalicylate.  The event, ranging headache was considered resolved on 24 Dec 2020. The outcome of events, really really bad abdominal cramping, diarrhea, throwing up, feels very weak, and nausea, were considered not resolved. The outcome of the event, sore arm, was unknown.  Action taken with mRNA-1273 in response to the events was not provided.; Reporter's Comments: This case concerns a 23-year-old, female subject, who experienced a non-serious unexpected event of abdominal pain, diarrhea, asthenia and expected event of nausea, vomiting, injection site pain and headache. The event of headache and injection site pain within few hours after the first dose of mRNA-1273 (Lot# unknown) administration. The events of nausea, vomiting, abdominal pain, diarrhea and asthenia occurred 1 day 10 hrs. after the first dose of mRNA-1273 administration. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Headache, Joint stiffness, Malaise, Pyrexia
Clinical narrative: Felt like a truck ran over him; Headaches; Temperature of 101 degrees; Stiffness in joints; A spontaneous report was received from a 73-year-old, male patient, participating in the mRNA-1273 Emergency Use Program who experienced headaches, a temperature of 101 degrees, stiffness in joints and felt like a truck ran over him.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 23 Dec 2020 at 9 am, approximately 24 hours 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 the morning of 24 Dec 2020, the patient felt "like a truck ran over him." He experienced headaches, a temperature of 101 degrees and stiffness in joints. The patient stated he did not experience vomiting and no allergic reaction such as trouble in breathing. Treatment for the event, headache, included paracetamol.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, felt like a truck ran over him, headaches, a temperature of 101 degrees and stiffness in joints were not reported.; Reporter's Comments: This case concerns a 73 year old male patient who experienced a non-serious unexpected event of Malaise, and non-serious expected events of Headache, Pyrexia, and Joint stiffness. The events occurred approximately 24 hours after first dose of mRNA-1273 administration. Very limited information regarding the events has been provided at this time. Based on temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: A little tenderness and redness at the injection site; A little tenderness and redness at the injection site; A spontaneous report was received from a nurse who was a 31-year-old, female patient who received Moderna's COVID-19 vaccine and experienced a little tenderness and redness at the injection site.   The patient's medical history was not provided. Concomitant medications were not reported.   On 23 Dec 2020, prior to the onset of the symptoms, the patient received her first of two planned doses of mRNA-1273 (Lot number: 037K20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   On 23 Dec 2020, she experienced a little tenderness and redness at the injection site, but she reported that that was normal for her after receiving any vaccine. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events, a little tenderness and redness at the injection site, was not reported.; Reporter's Comments: This case concerns a 31-year-old female patient who experienced the events of Injection site pain and Injection site erythema, occurring on the same day when the first dose of mRNA-1273 vaccine was administered. Because the location of the events matched the injection site and there was a temporal association between the onset of the events and the administration of the drug, the events are assessed as possibly related to mRNA-1273.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Dysgeusia, Feeling abnormal, Headache
Clinical narrative: Feeling stiff jaw; Woke up with no smell or taste; Woke up with no smell or taste; Little headache; Feels metal taste in her mouth; Feeling very weird; Throat feel like Novocain is wearing off; A spontaneous report was received from a consumer who was a female patient, who experienced feels metal taste in her mouth, feeling stiff jaw, throat feel like novocaine is wearing off, little headache, woke up with no smell or taste and was feeling very weird.  The patient's medical history included seasonal allergies and penicillin allergy. No concomitant medications were provided.  On 23 Dec 2020 at 14:00, the patient received her first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection and experienced little headache.  On 23 Dec 2020, she had a little headache.    On an unspecified date in Dec 2020, she felt a metallic taste in her mouth and her throat felt like novocaine was wearing off, like she went to the dentist. She was feeling very weird  On 24 Dec 2020, the patient woke up with no smell or taste and had felt jaw stiffness for about two hours. Unspecified symptoms subsided. She stated that she believed her symptoms could be due to the fact that she could be anxious. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not provided  The outcome for the events, feels metal taste in her mouth, feeling stiff jaw, throat feel like novocaine is wearing off, little headache, woke up with no smell or taste and was feeling very weird, was not provided.; Reporter's Comments: This case concerns a female patient who received their first of two planned doses of mRNA-1273 (Lot unknown),  and who experienced the listed event of Headache and the unlisted events of Dysgeusia, Joint stiffness, Oropharyngeal discomfort, Anosmia, Ageusia, and Feeling abnormal.  The events were considered possibly related to the vaccine due to the temporal relationship with the onset on the day of dosing, however the events might be explained by the patient's report of being anxious.
Sex: F
Vaccine: COVID19
Symptoms: Joint stiffness, Oropharyngeal discomfort
Clinical narrative: Feeling stiff jaw; Woke up with no smell or taste; Woke up with no smell or taste; Little headache; Feels metal taste in her mouth; Feeling very weird; Throat feel like Novocain is wearing off; A spontaneous report was received from a consumer who was a female patient, who experienced feels metal taste in her mouth, feeling stiff jaw, throat feel like novocaine is wearing off, little headache, woke up with no smell or taste and was feeling very weird.  The patient's medical history included seasonal allergies and penicillin allergy. No concomitant medications were provided.  On 23 Dec 2020 at 14:00, the patient received her first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection and experienced little headache.  On 23 Dec 2020, she had a little headache.    On an unspecified date in Dec 2020, she felt a metallic taste in her mouth and her throat felt like novocaine was wearing off, like she went to the dentist. She was feeling very weird  On 24 Dec 2020, the patient woke up with no smell or taste and had felt jaw stiffness for about two hours. Unspecified symptoms subsided. She stated that she believed her symptoms could be due to the fact that she could be anxious. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not provided  The outcome for the events, feels metal taste in her mouth, feeling stiff jaw, throat feel like novocaine is wearing off, little headache, woke up with no smell or taste and was feeling very weird, was not provided.; Reporter's Comments: This case concerns a female patient who received their first of two planned doses of mRNA-1273 (Lot unknown),  and who experienced the listed event of Headache and the unlisted events of Dysgeusia, Joint stiffness, Oropharyngeal discomfort, Anosmia, Ageusia, and Feeling abnormal.  The events were considered possibly related to the vaccine due to the temporal relationship with the onset on the day of dosing, however the events might be explained by the patient's report of being anxious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Injection site pain, Musculoskeletal stiffness, Nausea
Clinical narrative: Diarrhea; Pain from injection site up to her neck; Neck feels stiff; Body chills; Pain at the injection site; Nausea; Vomiting; Feels like she's running a fever temperature; A spontaneous report was received from a consumer, who was also a 34-year-old, female patient, who received Moderna's COVID-19 Vaccine and experienced body chills, pain at the injection site, pain from the injection site up to her neck, neck stiffness, nausea, vomiting, diarrhea, and feeling like she's running a temperature.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 23 Dec 2020, approximately one day 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 24 Dec 2020 at 6:00 am, the patient began to experience body chills, pain at the injection site, pain from the injection site up to her neck, neck stiffness, nausea, vomiting, diarrhea, and feeling like she's running a temperature. Patient reported that symptoms are ongoing and progressing.  Treatment for the event included ondansetron for nausea.   Action taken with mRNA-1273 in response to the events was not reported.   The events, body chills, pain at the injection site, pain from the injection site up to her neck, neck stiffness, nausea, vomiting, diarrhea, and feeling like she's running a temperature, were considered not recovered/not resolved.; Reporter's Comments: This case concerns a 34-years-old, female subject, who experienced a non-serious unexpected event of diarrhea, and non-serious expected events of neck pain, musculoskeletal stiffness, chills, injection site pain, nausea, vomiting, and pyrexia. The events occurred one day after first dose of mRNA-1273. The treatment medication included ondansetron. 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: Neck pain, Pyrexia, Vomiting
Clinical narrative: Diarrhea; Pain from injection site up to her neck; Neck feels stiff; Body chills; Pain at the injection site; Nausea; Vomiting; Feels like she's running a fever temperature; A spontaneous report was received from a consumer, who was also a 34-year-old, female patient, who received Moderna's COVID-19 Vaccine and experienced body chills, pain at the injection site, pain from the injection site up to her neck, neck stiffness, nausea, vomiting, diarrhea, and feeling like she's running a temperature.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 23 Dec 2020, approximately one day 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 24 Dec 2020 at 6:00 am, the patient began to experience body chills, pain at the injection site, pain from the injection site up to her neck, neck stiffness, nausea, vomiting, diarrhea, and feeling like she's running a temperature. Patient reported that symptoms are ongoing and progressing.  Treatment for the event included ondansetron for nausea.   Action taken with mRNA-1273 in response to the events was not reported.   The events, body chills, pain at the injection site, pain from the injection site up to her neck, neck stiffness, nausea, vomiting, diarrhea, and feeling like she's running a temperature, were considered not recovered/not resolved.; Reporter's Comments: This case concerns a 34-years-old, female subject, who experienced a non-serious unexpected event of diarrhea, and non-serious expected events of neck pain, musculoskeletal stiffness, chills, injection site pain, nausea, vomiting, and pyrexia. The events occurred one day after first dose of mRNA-1273. The treatment medication included ondansetron. 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: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cold sweat, Dizziness, Fatigue, Headache
Clinical narrative: Fatigue; Headache; Body Aches; Chills; Hot Sweats; Cold sweats; Warm to touch; Dizziness; A spontaneous/solicited report was received from a physician concerning a, 24 year old, male patient who was participating in the mRNA-1273 Emergency Use Program and who experienced fatigue, headache, dizziness, body aches, chills, hot and cold sweats, and warm to touch. The patient indicated that he had Covid-19 in April 2020 and has antibodies.  The patient denies having any chronic medical history and is not taking any relevant concomitant medications.  On 26 Dec 2020, approximately one day prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the shoulder for prophylaxis of COVID-19 infection.   On 27 Dec 2020, the patient experienced fatigue, headache, dizziness, body aches, chills, hot and cold sweats, and warm to touch. Treatment for the events included paracetamol. He took Tylenol 1000mg 2 doses yesterday after receiving the vaccine and one dose of Tylenol 1000mg this morning. He was in a hurry to hang up, agent did not ask for Lot number.  The outcome of the events were not provided.   Action taken with mRNA-1273 in response to the events was not reported.   The reporter did not provide a causality assessment for the events, fatigue, headache, dizziness, body aches, chills, hot and cold sweats, and warm to touch.  Consent received to save callers information in our database, email information to him and for safety to follow up with him; Reporter's Comments: This case concerns a 24-years-old male patient, with past medical history of COVID-19 disease (April 2020) with antibodies, who experienced a non-serious unexpected event of pain, hyperhidrosis, cold sweat, skin warm, and dizziness, and non-serious expected event of fatigue, headache, and chills. All the events occurred 2 days after first dose of mRNA-1273, lot # unknown. Treatment included Tylenol 1,000mg.  Based on the current available information and temporal association between the use of the product and onset of the event a causal relationship cannot be excluded.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Pain, Skin warm
Clinical narrative: Fatigue; Headache; Body Aches; Chills; Hot Sweats; Cold sweats; Warm to touch; Dizziness; A spontaneous/solicited report was received from a physician concerning a, 24 year old, male patient who was participating in the mRNA-1273 Emergency Use Program and who experienced fatigue, headache, dizziness, body aches, chills, hot and cold sweats, and warm to touch. The patient indicated that he had Covid-19 in April 2020 and has antibodies.  The patient denies having any chronic medical history and is not taking any relevant concomitant medications.  On 26 Dec 2020, approximately one day prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the shoulder for prophylaxis of COVID-19 infection.   On 27 Dec 2020, the patient experienced fatigue, headache, dizziness, body aches, chills, hot and cold sweats, and warm to touch. Treatment for the events included paracetamol. He took Tylenol 1000mg 2 doses yesterday after receiving the vaccine and one dose of Tylenol 1000mg this morning. He was in a hurry to hang up, agent did not ask for Lot number.  The outcome of the events were not provided.   Action taken with mRNA-1273 in response to the events was not reported.   The reporter did not provide a causality assessment for the events, fatigue, headache, dizziness, body aches, chills, hot and cold sweats, and warm to touch.  Consent received to save callers information in our database, email information to him and for safety to follow up with him; Reporter's Comments: This case concerns a 24-years-old male patient, with past medical history of COVID-19 disease (April 2020) with antibodies, who experienced a non-serious unexpected event of pain, hyperhidrosis, cold sweat, skin warm, and dizziness, and non-serious expected event of fatigue, headache, and chills. All the events occurred 2 days after first dose of mRNA-1273, lot # unknown. Treatment included Tylenol 1,000mg.  Based on the current available information and temporal association between the use of the product and onset of the event a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Felt feverish; Vaccination arm hurt too much to sleep on; A spontaneous report was received from a consumer concerning a female patient, who was also a nurse, who received Moderna's COVID-19 Vaccine and experienced feeling feverish and the arm in which she received the vaccination hurt too much to sleep on it.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 24 Dec 2020, approximately one day prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection.   The patient, a nurse, reported that she received the vaccine on 24 Dec 2020 and felt fine. On 25 Dec 2020 the patient verbally told the reporter that she felt feverish (not confirmed via thermometer) and that the arm in which she received the vaccination (left arm) hurt too much to sleep on it. Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not provided/unknown.; Reporter's Comments: This case concerns a female patient who experienced events of feeling feverish and the arm in which she received the vaccination hurt too much to sleep on it, following administration of first of two planned doses of mRNA-1273. Very limited information regarding the events has been provided at this time. Based on temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Fatigue
Clinical narrative: Red spot on her arm; Fatigue; Chills; A spontaneous report was received from a 60-year-old, female patient who was also a nurse and received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events, red spot on her arm, fatigue and chills.  The patient's medical history was not provided. Concomitant medications were not reported.  On 23 Dec 2020 prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 vaccine intramuscularly for prophylaxis of COVID-19 infection. After vaccination, the patient reported experiencing a red spot on her arm, fatigue and chills.The patient reported she gets the same side effects with the flu vaccine but said this was more. Treatment given for the events was not reported.  The events, red spot on arm and fatigue, were considered not resolved. The event, chills, was considered resolved on 24 Dec 2020.  Action taken with mRNA-1273 in response to the events was not provided.; Reporter's Comments: This case concerns a 60-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot unknown), and experienced the listed events of fatigue and chills and the unlisted event of erythema. The events were considered related to the vaccine due to the temporal relationship with onset on day of dosing.
Sex: F
Vaccine: COVID19
Symptoms: Injection site reaction
Clinical narrative: Injection site reaction that has spread beyond an inch of the injection location; A spontaneous report was received from a nurse concerning a, 33-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced injection site reaction that has spread beyond an inch of the injection location.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On the afternoon of 22 Dec 2020, less than 24 hours prior to the onset of the symptoms, the patient received her first of two planned doses of mRNA-1273 intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   On an unspecified date in Dec 2020, less than 24 hours after receiving the injection, the patient experienced an injection site reaction that had spread beyond an inch of the injection location. No treatment for the event was received, but she was advised to ice the area.    The outcome of the event, injection site reaction that has spread beyond an inch of the injection location, was considered not resolved.     Action taken with mRNA-1273 in response to the event was not reported.  The reporter assessed the event, injection site reaction that has spread beyond an inch of the injection location, as related to study drug.; Reporter's Comments: This case concerns a 33-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot unknown), and who experienced the listed event of injection site reaction. The event was considered possibly related to the vaccine due to the known safety profile and the temporal relationship with onset within 24 hours of dosing.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain
Clinical narrative: Sore arm where received injection; Feeling fatigued; A report was received from a Moderna employee concerning a male patient participating in the mRNA-1273 Program and experienced as sore arm and feeling fatigue.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 27 Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the arm for prophylaxis of COVID-19 infection.   Sometime after the vaccine on 27 Dec 2020, the patient experienced a sore where he received the injection and was also feeling fatigued. Specific onset date is unknown. No treatment information was provided.   Action taken with mRNA-1273 in response to the event(s) was not reported.   The outcome of the events, sore arm and feeling fatigue, was not reported.; Reporter's Comments: This case concerns a male patient of unknown age. The patient experienced non-serious expected events of Injection site pain and Fatigue at unknown date after receiving their first of two planned doses of mRNA-1273 (Lot unknown).  Based on the current available information and temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: pregnant; A spontaneous report was received from a 34 year old , female health care professional, who while participating in the mRNA-1273 Emergency use program  became pregnant.  The patients' medical history included slight asthma and allergy to Sulsa antibiotics. The patient's previous pregnancy history included live, full term birth on 23 NOV 2018 with no complications. There is No family history of congenital anomalies/genetic disease in relation to patient. There is no history of alcohol, nicotine, marijuana or other illicit substances.  Concomitant medications reported as taken since conception included  OTC multivitamins for immunity.  On 27 DEC 2020, prior to awareness of pregnancy ,the patient received the first of the two planned doses of mRNA -1273 intramuscularly in left deltoid for prophylaxis of COVID-19 infection.The first day of the patient's last menstrual period was on 22 NOV 2020.The  due date was estimated on 29 AUG 2021.The estimated date of conception was not reported.  The  date on which relevant tests performed to detect pregnancy was unknown.  Action taken with the second dose of mRNA-1273 was unknown.; Reporter's Comments: This case concerns a 34-year-old female G2P1, who reported pregnancy. Last menstrual period was 22-Nov-2020. Method of contraception was unknown.  The date of conception and the type of pregnancy test used for pregnancy determination was not provided. Estimated Due Date is 29-AUG-2021.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Electrocardiogram
Clinical narrative: Chest pain; A spontaneous report was received from a non-health care professional concerning a 51 year old, female patient while participating in the mRNA-1273 Emergency use program and experienced chest pain.  The patient's medical history included allergy to hydrocodone bitartrate /acetaminophen. No relevant concomitant medications were reported.   On 23 DEC 2020, prior to the onset of symptoms, patient received the first of two planned doses of mRNA-1273 intramuscularly in the left arm for the prophylaxis of COVID -19 infection.She was monitored for 15 minutes. After this, she returned to her desk and approximately 10 minutes later she experienced chest pain. The pain lasted five to six minutes and the patient went to the Emergency room (ER). At the ER they performed an electrocardiogram. No treatment information was provided.  The event, chest pain, was considered resolved on 23 DEC 2020.  Action taken with planned second dose of mRNA-1273 in response to the event was not provided.; Reporter's Comments: This case concerns a female patient who experienced the event of chest pain, occurring about 30 minutes following administration of the first dose of mRNA-1273 vaccine. Based on the limited available information, a definitive assessment with regards to a drug: event-causal association cannot be provided at this time. However, due to the temporal association between the onset of the event and the administration of the drug, a causal relationship cannot be excluded. Hence, the event is assessed as possibly related to mRNA-1273.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Vein discolouration
Clinical narrative: Veins on top of his biceps turned dark purple; Hhoulder soreness; A spontaneous report was received from a consumer who was a 25-year old, male patient, who received Moderna's COVID-19 vaccine and experienced veins on top of his biceps turned dark purple  The patient's medical history included soreness usually occurs when he gets his flu vaccine. The patient was not taking any concomitant medications.   On 23 DEC 2020 at 10:00, approximately 12 hours prior to the onset of the events, the patient received his first of two planned doses of mRNA-1273 intramuscularly in the left shoulder for prophylaxis of COVID-19 infection.   On 23 DEC 2020 around 22:00 to 23:00, the patient noticed the veins on top of his biceps turned dark purple and he had shoulder soreness for the next two days. He noted that the soreness normally occurs when he gets his flu vaccine. The patient was not taking any treatment for the events.   Action taken with mRNA-1273 in response to the events was not reported.    The event, veins on top of his biceps turned dark purple, was considered resolved on 25 DEC 2020. The outcome of the event, shoulder soreness, was not reported.; Reporter's Comments: This case concerns a 25 year old male subject who experienced a non-serious expected event of vein discoloration. The event occurred the same day, approximately 1 hour, of vaccination. 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: Epistaxis, Fatigue, Headache
Clinical narrative: Slight headache; Feeling tired; Slight blood on her nose; A spontaneous report was received from consumer concerning a female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced slight blood on her nose, slight headache, and feeling tired.    There was no medical history or concomitant medications provided.  On 24 Dec 2020, the patient received the first of two planned doses of mRNA-1273 (Lot # unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 26 Dec 2020, the patient, experienced the non-serious event of slight blood on her nose. Additionally, she was experiencing the non-serious events of slight headache and feeling tired on unknown date. It was noted the patient wiped her nose with a tissue and saw the slight blood. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the events slight blood on her nose, slight headache, and feeling tired was unkown.; Reporter's Comments: This case concerns a female patient of unknown age, who experienced an unexpected non-serious event of Epistaxis and expected non-serious events of Headache and Fatigue. The event of Epistaxis occurred approximately two days after receiving first dose of mRNA-1273, (lot # unknown). The events of Headache and Fatigue occurred at unknown date after receiving first dose of mRNA-1273, (lot # unknown). Treatment information was not provided. Based on the current available information and temporal association between the use of the product and onset of the events a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Heart rate increased, Hypoaesthesia, Injection site swelling
Clinical narrative: Both my hands numb; both my feet numb; lightheaded; shortness of breath; feel like i was going to faint; heart was beating fast; injection site swollen; A report was received from a physician concerning a female patient who was participating in the mRNA-1273 Emergency Use Program and experienced the events both my hands numb, both my feet numb, lightheaded, shortness of breath, feel like I was going to faint, heart was beating fast and injection site swollen.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 27 Dec 2020, around 11:15 or 11:30 am, approximately 0 days 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 reported experiencing numbness in both hands and feet, lightheadedness, shortness of breath, feeling like she was going to faint, and increased heart rate following vaccine administration. She was given oral Benadryl for her symptoms. Around 7:00 pm that night, the patient experienced a reoccurrence of numbness and took Benadryl again before going to sleep.   On 29 Dec 2020, the patient reported feeling better but was still experiencing injection site swelling. She plans to do a skin allergy test and inquired about the vaccine ingredients.   Treatment for the event included oral Benadryl.   Action taken with mRNA-1273 in response to the events was not reported.  The events, both my hands numb, both my feet numb, lightheaded, shortness of breath, feel like I was going to faint, heart was beating fast, were considered resolved on 29 Dec 2020. The outcome of the event, injection site swollen, was unknown.  The reporter did not provide an assessment for the events, both my hands numb, both my feet numb, lightheaded, shortness of breath, feel like I was going to faint, heart was beating fast and injection site swollen.; Reporter's Comments: This case concerns a female patient of unknown age. The patient's medical history was not provided. The patient experienced NS, unexpected events of Dizziness, increased heart rate, dyspnea, Pre syncope, hypoaesthesia of hands and feet and expected event of injection site swelling. The events of  Dizziness, increased heart rate, dyspnea, Pre syncope, hypoaesthesia of hands and feet occurred in 15 minutes after the first dose of mRNA-1273 was administered and injection site swelling occurred on an unknown date. Treatment for the event included oral Benadryl. 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: Presyncope
Clinical narrative: Both my hands numb; both my feet numb; lightheaded; shortness of breath; feel like i was going to faint; heart was beating fast; injection site swollen; A report was received from a physician concerning a female patient who was participating in the mRNA-1273 Emergency Use Program and experienced the events both my hands numb, both my feet numb, lightheaded, shortness of breath, feel like I was going to faint, heart was beating fast and injection site swollen.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 27 Dec 2020, around 11:15 or 11:30 am, approximately 0 days 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 reported experiencing numbness in both hands and feet, lightheadedness, shortness of breath, feeling like she was going to faint, and increased heart rate following vaccine administration. She was given oral Benadryl for her symptoms. Around 7:00 pm that night, the patient experienced a reoccurrence of numbness and took Benadryl again before going to sleep.   On 29 Dec 2020, the patient reported feeling better but was still experiencing injection site swelling. She plans to do a skin allergy test and inquired about the vaccine ingredients.   Treatment for the event included oral Benadryl.   Action taken with mRNA-1273 in response to the events was not reported.  The events, both my hands numb, both my feet numb, lightheaded, shortness of breath, feel like I was going to faint, heart was beating fast, were considered resolved on 29 Dec 2020. The outcome of the event, injection site swollen, was unknown.  The reporter did not provide an assessment for the events, both my hands numb, both my feet numb, lightheaded, shortness of breath, feel like I was going to faint, heart was beating fast and injection site swollen.; Reporter's Comments: This case concerns a female patient of unknown age. The patient's medical history was not provided. The patient experienced NS, unexpected events of Dizziness, increased heart rate, dyspnea, Pre syncope, hypoaesthesia of hands and feet and expected event of injection site swelling. The events of  Dizziness, increased heart rate, dyspnea, Pre syncope, hypoaesthesia of hands and feet occurred in 15 minutes after the first dose of mRNA-1273 was administered and injection site swelling occurred on an unknown date. Treatment for the event included oral Benadryl. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; A spontaneous report was received from a consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced COVID-19.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On an unknown date, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.    On an unknown date, after receiving the first vaccine dose, the patient came down with COVID-19.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event was not reported.; Reporter's Comments: This case concerns a patient who experienced a non-serious unexpected event of COVID-19, which occurred after first dose of mRNA-1273 administration. Very limited information regarding the event has been provided at this time. Based on temporal association between the use of the product and the onset of the event, a causal relationship cannot be excluded.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Feeling hot, Hyperhidrosis, Taste disorder
Clinical narrative: being hot; sweaty; weird taste in mouth; A spontaneous report was received from a nurse concerning a 54-year-old, female patient and who experienced being hot, sweaty and a weird taste in her mouth.  The patient's medical history included high blood pressure and a positive Covid-19 test on 28-Dec-2020. Products known to have been used by the patient, within two weeks prior to the event, included birth control and high blood pressure medication.    The patient received their first of two planned doses of mRNA-1273 (LOT # 011J20A) on 26-Dec-2020 intramuscularly in the right arm for prophylaxis of COVID-19 infection.  Patient stated that she received the Moderna vaccine on 26-Dec-2020.  She had a negative Covid-19 test on 24-Dec-2020 and was asymptomatic prior to vaccine administration.  After she received the vaccine, patient reported being hot, sweaty and had a weird taste in her mouth.  Additionally, she reported a positive Covid-19 test on 28-Dec-2020.  She was in quarantine for 10 days.   Treatment information was not provided.   Action taken with mRNA-1273 in response to the events, being hot, sweaty and weird taste in mouth, was not provided.  The outcome of the events, being hot, sweaty and weird taste in mouth, was not reported   The reporter did not provide an assessment for the events, being hot, sweaty and weird taste in mouth.; Reporter's Comments: This case concerns a 54-year-old, female, patient, who experienced non-serious unexpected events of Feeling hot, hyperhidrosis and taste disorder. The events occurred after receiving first dose of mRNA-1273, lot # 011J20A. Treatment information was not provided. Based on the current available information and temporal association between the use of the product and onset of the events a causal relationship cannot be excluded and the events are considered possibly related to the vaccine. Of note, patient reporting being Covid-19 positive after vaccination is considered a confounder.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: a little soreness; Vaccination site pain; A spontaneous report was received from a consumer and his wife on 29 Dec 2020. This case concerns a 77 year old male patient. The patient is a participating in the mRNA-1273 Emergency Use Program and experienced a little soreness with the use of mRNA-1273.    There was no medical history or concomitant medications provided.  On 28 Dec 2020 the patient received the first of two planned doses of mRNA-1273 (Lot # 309K209) intramuscularly, in the right deltoid, for prophylaxis of COVID-19 infection.  On 28 Dec 2020, approximately five hours after receiving the vaccine, the patient experienced the non-serious event a little soreness, with no additional symptoms. It was noted that the patient and his wife were "doing well and pleasantly surprised", after vaccination. The patient did not take anything to treat the arm pain.  There were no relevant laboratory tests provided.  Action taken with mRNA-1273 in response to the event of a little soreness was not reported.   The outcome for the reported event of a little soreness was unknown 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 onset date of the events, a causal relationship cannot be excluded.; Sender's Comments:  MOD20-02092:
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pain in extremity, Pyrexia
Clinical narrative: Severe Arm Pain; Severe Leg Pain; Low grade Temp 99.5; A report was received from a 44 white female consumer and leg pain and low grade temperature 99.5.    The patient's medical history, as provided by the reporter, included previous COVID-19 infection, anxiety and depression. Concomitant medications reported included asa, sertraline hydrochloride and alprazolam.   The patient received their first of two planned doses of mRNA-1273 on 28 Dec 2020 intramuscularly in the left arm for prophylaxis of COVID-19 infection.   After the vaccine, the patient developed severe arm and leg pain and low grade temperature 99.5.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event(s) was not reported.   The outcome of the events were unknown.    The reporter did not provide an assessment for the events.; 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: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache
Clinical narrative: I felt dizzy; Headache; A spontaneous report was received from a nurse concerning herself, a 34-year-old, female patient who received Moderna's COVID-19 vaccine and felt dizzy and had a headache.  There were no medical history and concomitant medications reported.  On 29-Dec-2020, the patient received their first of two planned doses of mRNA-1273 (Lot # 037K208) intramuscularly in the arm for prophylaxis of COVID-19 infection.   On 29-Dec-2020, 15 minutes following the injection, while she walked to the parking lot, she began to feel dizzy and had a headache.  Action taken with mRNA-1273 in response to the events of dizziness and headache was not provided.   The outcome of the events dizziness and headache was unknown.; Reporter's Comments: This case concerns a 34-year-old, female, patient, who experienced an unexpected non-serious event of Dizziness and an expected non-serious event of Headache. The events occurred one day (same day) after receiving the first dose of mRNA-1273, lot # 037K208. Treatment information was not provided. Based on the current available information and temporal association between the use of the product and onset of the events a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; mild tenderness; A spontaneous report was received from a 42-year-old, female, consumer (nurse) who received Moderna's COVID-19 vaccine and experienced the event "a sore arm; mild tenderness".  The patient's medical history, as provided by the reporter, included rheumatoid arthritis, osteoarthritis, diabetes and hypothyroidism. Concomitant medications reported included levothyroxine sodium, dulaglutide, insulin glargine and upadacitinib.  The patient received their first of two planned doses of mRNA-1273 on 28 Dec 2020 for prophylaxis of COVID-19 infection.  On 29 Dec 2020, the consumer called to report a "sore arm but no sorer than any other vaccine, just mild tenderness". She stated that she has medical conditions which she takes medications for and thought it would be valuable information. She consented to being contacted, along with her health care provider. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event sore arm; mild tenderness was not reported.   The reporter assessed the event sore arm; mild tenderness as related to study drug.; Reporter's Comments: This case concerns a 42-year-old, female patient with medical history of rheumatoid arthritis, diabetes and hypothyroidism, who experienced an expected event of pain in arm. The event occurred 1 day after the first dose of mRNA-1273 administration. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Extreme headache; Fatigue; A spontaneous report was received from a 35-year-old, female consumer who received Moderna's COVID-19 vaccine and experienced extreme headache and fatigue.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 04 Jan 2021 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number:037K20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.      On 04 Jan 2021, after receiving the vaccine, the patient experienced extreme headache and fatigue. Treatment for the events included acetaminophen and ibuprofen. The headache has not gone away, and she is not stressing about the fatigue.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.    The outcome for the events, headache was not recovered and outcome of fatigue are unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.