chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site ulcer
Clinical narrative: a little bit of redness; painful to touch; superficial skin ulcer; A spontaneous report was received on 28 Dec 2020, from a 47 year old male patient who is also a radiologist. The patient is a participating in the mRNA-1273 Emergency Use Program and experienced a superficial skin ulcer, a little bit of redness, and painful to touch with the use of mRNA-1273.    There was no medical history provided. Concomitant medication included olmesartan.  On 22 Dec 2020 the patient received the first of two planned doses of mRNA-1273 (Lot # 039K20A) intramuscularly, in the left deltoid, for prophylaxis of COVID-19 infection.  On 22 Dec 2020, the patient experienced the non-serious event of painful to touch, on 24 Dec 2020 the patient experienced a little bit of redness, and on 25 Dec 2020, the patient noticed a superficial skin ulcer. It was noted that all reported events were at the injection site and the patient felt the administration was intramuscularly but may not have been deep enough into the muscle. Additionally, he described the area as a superficial ulcer, with no drainage, which initially had been painful and nownot painful at all. He also notes the ulcer had not been there on the 24th when he removed his band-aid. At the time of this report, the ulcer was no longer painful to touch, but ulceration has stayed the same size. He noted it looked like it was trying to heal for the last two days. There were no other symptoms associated with the events. The patient spoke with other physicians, but the event has not been reported to his physician. The patient did not take anything to treat the reported events.  There were no relevant laboratory tests provided.  Action taken with mRNA-1273 in response to the events of superficial skin ulcer, a little bit of redness, and painful to touch was not reported.   The events of superficial skin ulcer and a little bit of redness were recovering at the time of this report. The event of painful to touch was reported as resolved.   Causality was not provided for the events of superficial skin ulcer, a little bit of redness, and painful to touch.; Reporter's Comments: This case concerns a 47-year-old male patient, who experienced non-serious expected events of Injection site pain and Injection site erythema, and no-serious unexpected event of Injection site ulcer. The event of Injection site pain occurred on the same date after first dose of mRNA-1273, lot # 039K20A. The Injection site erythema  and Injection site ulcer occurred approximately 2 days and 3 days respectively after first dose of mRNA-1273, lot # 039K20A. No treatment  was taken 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.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; A spontaneous report was received from consumer concerning a female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a headache.  The patient's medical history was not provided. No relevant concomitant medications were reported.  The patient received their first of two planned doses of mRNA-1273 on 28 Dec 2020 intramuscularly for prophylaxis of COVID-19 infection.  On 28 Dec 2020, the consumer called asking if she could take aspirin for her headache.   Treatment for the event included aspirin.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, headache, was unknown.; Reporter's Comments: This case concerns a female patient on unknown age who experienced an expected non-serious event of Headache. The event occurred on the same day after receiving first dose of mRNA-1273, (lot # unknown). Treatment for the event included aspirin. 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 and the event is considered possibly related to the vaccine.
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: severe allergic reaction; A spontaneous report was received from a health care professional, concerning a patient of unknown age and gender, who received Moderna's COVID-19 vaccine and experienced severe allergic reaction.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.    On an unknown date, approximately 15 minutes prior to the onset of symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number: Unknown) for prophylaxis of COVID-19 infection.   On an unknown date, the patient experienced a severe allergic reaction. The symptoms were discovered during the 15 minute post-vaccination observation period. The patient had no prior history of anaphylactic reactions. Treatment information was not provided. The patient was advised not to receive second dose of COVID-19 vaccine.  The action taken in response to the event was not reported.  The event severe allergic reaction was considered recovered/resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Myalgia, SARS-CoV-2 test
Clinical narrative: Covid-19; Muscle Pain; A report was received from a healthcare facility staff member concerning 53 year old female patient who was participating in the mRNA-1273 Emergency Use Program and experienced muscle pain and positive COVID-19 test.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 28 Dec 2020 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot: 011-J20A) intramuscularly in the right deltoid for prophylaxis of COVID-19 infection.   On 29 Dec 2020, patient developed muscle pain and received a positive COVID-19 test.   No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, muscle pain and positive COVID-19 test, were not reported  The reporter did not provide an assessment for the events.; Reporter's Comments: Based on the natural history of COVID-19, and the established information about the mRNA-1273 vaccine, a causal association between the event of tested positive for COVID and the product use is assessed as unlikely.  Based on the information provided, event most likely pre-existed vaccine administration.  The event of myalgia is consistent with the known safety profile of mRNA-1273 vaccine,  hence a causal relationship with the events cannot be excluded.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test
Clinical narrative: Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 36-year-old female patient (gravida 3, para 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included Spontaneous abortion in October 2018 and Hernia (As a child). Family history included Family history of cardiovascular disorder, Diabetes and Rheumatoid arthritis. Concurrent medical conditions included Penicillin allergy. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from 30-Jun-2018 to an unknown date for Pregnancy.    On 29-Dec-2020 at 1:15 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 22-Jul-2020 and the estimated date of delivery was 27-Apr-2021. On 29-Dec-2020 at 1:15 PM, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-second week of the pregnancy. The vaginal delivery occurred on Apr-2021, which was reported as Full-term. For neonate 1, The outcome was reported as Delivered NOS. It was a full term vaginal delivery without any complications, mother didn't experience any problems during delivery. There were no perinatal complications for the infant. There were no identified fetal/infant abnormalities on delivery and no identified infant abnormalities at 1 month post partum. On 29-Dec-2020 at 1:15 PM, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Aug-2020, Pregnancy test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medications information not reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Follow Up received on 08-JUN-2021 Contains Pregnancy Outcome Information and Updated date of Pregnancy Test, Updated start date and Route of administration of Concomitant Medications.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Sluggishness, Vaccination site pain
Clinical narrative: Sluggish; headache; Arm pain at site of injection; A spontaneous report was received from a nurse concerning a 43 year-old, female patient participating in the mRNA-1273 Program and experienced feeling sluggish, arm pain at site of injection, headache.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 28 Dec 2020, the same day as the onset of the events, the patient received their first of two planned doses of mRNA-1273 (025J20A) for prophylaxis of COVID-19 infection.   On 28 Dec 2020 the patient began to feel sluggish and experience arm pain at the site of injection. She also reported a headache that is improving with self-treatment. Treatment for the event included paracetamol.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events feeling sluggish and arm pain at site of injection were unknown/not reported. The outcome of the event, headache, was considered recovering/resolving.; 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.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: She received the Moderna vaccine #1 today in her left upper arm; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of EXPOSURE DURING PREGNANCY (She received the Moderna vaccine #1 today in her left upper arm) in a 41-year-old female patient (gravida 6) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included Miscarriage (three times) and Alcohol use (Occasionally, prior to pregnancy.). Concomitant products included LEVOTHYROXINE from 15-Jul-2020 to an unknown date for Prophylaxis.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 20-Mar-2021. On 29-Dec-2020, the patient experienced EXPOSURE DURING PREGNANCY (She received the Moderna vaccine #1 today in her left upper arm). On 29-Dec-2020, EXPOSURE DURING PREGNANCY (She received the Moderna vaccine #1 today in her left upper arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient had alcohol occasionally, prior to pregnancy.; Reporter's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 41-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Influenza like illness
Clinical narrative: flu like symptoms; Developed COVID-19; A spontaneous report was received from a consumer concerning her friend a female patient of unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and developed Covid-19 and flu like symptoms.  The patient's medical history was not provided. No concomitant medications were reported.  On an unknown date, the patient received their first of two planned doses of mRNA-1273 (Lot# unknown, Exp. unknown).   On an unknown date, the patient developed Covid-19 and flu like symptoms. No treatment information was reported.  The Action taken with mRNA-1273 in response to the events was unknown.  The outcome for the events, Covid-19 and flu like symptoms was unknown.  The reporter did not provide an assessment for the events.; Reporter's Comments: This case concerns a female of unknown age who developed Covid-19 and flu like symptoms on an unknown date and in addition, patient received vaccine on unknown date. Very limited information regarding these events has been provided at this time.  Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Myalgia, Oropharyngeal pain, Pyrexia, Restlessness
Clinical narrative: Restless through the night,did not sleep well,feels like hit by a truck; Sinus drainage; Throat was sore; arm feeling tender; Fever of 102.7 F; A spontaneous report was received from a nurse concerning a female patient of 56 years old, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sinus drainage, sore throat, restlessness, myalgia and pyrexia.  The patient's medical history was not provided.  No relevant concomitant medications were reported.   On 29 Dec 2020, at 1 pm, prior to the onset of events, the patient received their first of two planned dose of mRNA-1273 (Lot number: unknown) vaccine intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 29 Dec 2020, couple of hours later, patient experienced sinus drainage, sore throat, patient woke up her arm feeling tender, fever of 102.7 F, restless through the night, did not sleep well, felt like hit by a truck.  Treatment information for the event was not reported. On 29-DEC-2020 the body temperature of the patient was 102.7 degree F.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The outcome of the event sinus drainage, sore throat, restlessness, myalgia and pyrexia was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Upper-airway cough syndrome
Clinical narrative: Restless through the night,did not sleep well,feels like hit by a truck; Sinus drainage; Throat was sore; arm feeling tender; Fever of 102.7 F; A spontaneous report was received from a nurse concerning a female patient of 56 years old, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sinus drainage, sore throat, restlessness, myalgia and pyrexia.  The patient's medical history was not provided.  No relevant concomitant medications were reported.   On 29 Dec 2020, at 1 pm, prior to the onset of events, the patient received their first of two planned dose of mRNA-1273 (Lot number: unknown) vaccine intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 29 Dec 2020, couple of hours later, patient experienced sinus drainage, sore throat, patient woke up her arm feeling tender, fever of 102.7 F, restless through the night, did not sleep well, felt like hit by a truck.  Treatment information for the event was not reported. On 29-DEC-2020 the body temperature of the patient was 102.7 degree F.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The outcome of the event sinus drainage, sore throat, restlessness, myalgia and pyrexia was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dysphagia, Fatigue, Hypoaesthesia, Insomnia
Clinical narrative: Felt tired; Felt anxious; Face was numb; Face was tingling; Problems sleeping; Lips were tingling; Trouble swallowing; Lips started to swell; A spontaneous report was received from a female nurse patient, of unknown age who received Moderna's COVID-19 vaccine (mRNA-1273)  experienced Felt tired, Felt anxious, Face was numb, Face was tingling, Problems sleeping, Lips were tingling, Trouble swallowing and Lips started to swell.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 29-Dec-2020, approximately one day prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (lot: unknown) for prophylaxis of COVID-19 infection.  On 30-Dec-2020, the patient began feeling tired, felt anxious, her face was numb and tingling, had problems sleeping, her lips were tingling and swollen, and she had trouble swallowing.  Treatment included diphenhydramine.  She "wasn't sure if her problems with the sleep had to do with her taking diphendramine".  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Paraesthesia, Paraesthesia oral
Clinical narrative: Felt tired; Felt anxious; Face was numb; Face was tingling; Problems sleeping; Lips were tingling; Trouble swallowing; Lips started to swell; A spontaneous report was received from a female nurse patient, of unknown age who received Moderna's COVID-19 vaccine (mRNA-1273)  experienced Felt tired, Felt anxious, Face was numb, Face was tingling, Problems sleeping, Lips were tingling, Trouble swallowing and Lips started to swell.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 29-Dec-2020, approximately one day prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (lot: unknown) for prophylaxis of COVID-19 infection.  On 30-Dec-2020, the patient began feeling tired, felt anxious, her face was numb and tingling, had problems sleeping, her lips were tingling and swollen, and she had trouble swallowing.  Treatment included diphenhydramine.  She "wasn't sure if her problems with the sleep had to do with her taking diphendramine".  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on my chest up to my neck; A spontaneous report was received from a consumer who of unknown age and gender who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced a red rash on my chest up to my neck/rash.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On an unspecified date, approximately 6 hours prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) for prophylaxis of COVID-19 infection.  The next day after vaccination, patient had a red rash on chest up to neck about 6 hours after vaccination rashes resolve on its own.  Treatment for the event included some allergy medicine not specified.  Action taken with mRNA-1273 in response to the event was not provided.  The events, red rash on chest up to neck, was considered recovered on an unspecified date.; 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: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Hyperhidrosis, Migraine, Myalgia
Clinical narrative: Feeling Horrible; Sweating; Severe Migraine; Chills; Nausea; Muscle pain all over; A spontaneous report was received from a consumer concerning a 35 year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273)  experienced feeling horrible, sweating, chills, severe migraine, and muscle pain.   The patient's medical history was not provided. No relevant concomitant medications were reported   On 29 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (037K20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   On 30 Dec 2020, the patient reports waking up feeling horrible, sweating, chills, severe migraine, and muscle pain all over. Treatment for the events included ibuprofen.   Action taken with mRNA-1273 in response to the events was not reported.    The outcome of the event was unknown.; Reporter's Comments: This case concerns a 35-year-old female who had NS unexpected events of migraine, feeling abnormal, hyperhidrosis, and NS expected events of nausea, chills, myalgia.  Event onset occurred Day 2 after the first dose of mRNA-1273. Treatment with ibuprofen. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Feeling Horrible; Sweating; Severe Migraine; Chills; Nausea; Muscle pain all over; A spontaneous report was received from a consumer concerning a 35 year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273)  experienced feeling horrible, sweating, chills, severe migraine, and muscle pain.   The patient's medical history was not provided. No relevant concomitant medications were reported   On 29 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (037K20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   On 30 Dec 2020, the patient reports waking up feeling horrible, sweating, chills, severe migraine, and muscle pain all over. Treatment for the events included ibuprofen.   Action taken with mRNA-1273 in response to the events was not reported.    The outcome of the event was unknown.; Reporter's Comments: This case concerns a 35-year-old female who had NS unexpected events of migraine, feeling abnormal, hyperhidrosis, and NS expected events of nausea, chills, myalgia.  Event onset occurred Day 2 after the first dose of mRNA-1273. Treatment with ibuprofen. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Headache, Limb discomfort, Nausea, Pain
Clinical narrative: Mild nausea; Feeling hot; Intermittent left face tingling; discomfort on the left arm; Mild headache; mild achiness all over her body; A spontaneous report was received from a consumer concerning a 56 year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) experienced multiple events of felt hot, mild headache, intermittent left face tingling, discomfort on left arm, mild achiness all over her body and mild nausea.  The patient's medical history included, fibromyalgia, traumatic brain injury (right side, occipital), 2 large thyroid nodules and osteopenia. The concomitant medications included fosamax and calcium, colecalciferol for unknown indication.  On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot# unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On the same day, the patient experienced felt hot, mild headache, intermittent left face tingling, discomfort on left arm and mild achiness all over her body.  On 29 Dec 2020, the patient experienced mild nausea. The treatment information included Motrin.  The action taken with mRNA-1273 in response to the events was unknown.  The outcome for the event, felt hot was considered recovered/resolved on 28 Dec 2020.   The outcome for the events, mild headache, intermittent left face tingling, discomfort on left arm, mild achiness all over her body and mild nausea was considered as not recovered/not resolved.; Reporter's Comments: This case concerns a 56-year-old female who experienced NS unexpected events of limb discomfort, paraesthesia, and feeling hot and NS expected events of headache, pain, nausea.  Event onset occurred the same day as the first dose of mRNA-1273. Treatment included Motrin. Events resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Mild nausea; Feeling hot; Intermittent left face tingling; discomfort on the left arm; Mild headache; mild achiness all over her body; A spontaneous report was received from a consumer concerning a 56 year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) experienced multiple events of felt hot, mild headache, intermittent left face tingling, discomfort on left arm, mild achiness all over her body and mild nausea.  The patient's medical history included, fibromyalgia, traumatic brain injury (right side, occipital), 2 large thyroid nodules and osteopenia. The concomitant medications included fosamax and calcium, colecalciferol for unknown indication.  On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot# unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On the same day, the patient experienced felt hot, mild headache, intermittent left face tingling, discomfort on left arm and mild achiness all over her body.  On 29 Dec 2020, the patient experienced mild nausea. The treatment information included Motrin.  The action taken with mRNA-1273 in response to the events was unknown.  The outcome for the event, felt hot was considered recovered/resolved on 28 Dec 2020.   The outcome for the events, mild headache, intermittent left face tingling, discomfort on left arm, mild achiness all over her body and mild nausea was considered as not recovered/not resolved.; Reporter's Comments: This case concerns a 56-year-old female who experienced NS unexpected events of limb discomfort, paraesthesia, and feeling hot and NS expected events of headache, pain, nausea.  Event onset occurred the same day as the first dose of mRNA-1273. Treatment included Motrin. Events resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Developed shingles; A spontaneous report was received from a consumer, concerning his wife, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced shingles.    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 number unknown) intramuscularly for prophylaxis of COVID-19 infection.  On unknown date in Dec 2020, after vaccine administration, the patient developed shingles.   Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, shingles, was unknown.; Reporter's Comments: This case concerns a female patient experienced a non-serious unexpected event of herpes zoster. The event occurred on unknown date in Dec 2020 after first dose of the study medication administration on 28 Dec 2020.  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.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Fever of 100-101; A spontaneous report was received from a female consumer name and age unknown who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a fever of 100-101.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 29 Dec 2020, approximately one day prior to the onset of the event, the patient received her first of two planned doses of mRNA-1273  intramuscularly for prophylaxis of COVID-19 infection.   On 30 Dec 2020, the patient called to report that she is having a fever of 100-101 and asked what temperatures she should be concerned about.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, fever of 100-101, was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: 27 weeks pregnant; This spontaneous prospective pregnancy case was reported by a patient and describes the occurrence of EXPOSURE DURING PREGNANCY (27 weeks pregnant) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 30-Dec-2020, the patient experienced EXPOSURE DURING PREGNANCY (27 weeks pregnant). The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 30-Dec-2020, EXPOSURE DURING PREGNANCY (27 weeks pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Reporter's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Tested positive after taking vaccine; A spontaneous report was received from a 47-year-old female patient who is also a healthcare professional who experienced testing positive after taking vaccine with the use of mRNA-1273.   Medical history included being Immunocompromised and Multiple Sclerosis. There were no concomitant medications used by the patient.    On 30 Dec 2020, the patient received the first of two planned doses of mRNA-1273 (Batch # 025L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 31 Dec 2020, the patient had a positive COVID-19 test with a Rapid lab kit.  The second test was positive as well. Additionally, the patient did a third test using PCR on 31 Dec 2021. On 05 Jan 2021, the patient still had not received results as her sample had been lost. She was administered another test on 06 Jan 2021 and results were still pending. On 08 Jan 2021, the patient was advised her PCR test was negative. There was no treatment information provided.  Action taken with mRNA-1273 in response to the event, tested positive for the vaccine, was not provided.  The outcome for the event, tested positive for the vaccine, was recovered/resolved.; Reporter's Comments: Based on reporter's causality the event is assessed as unlikely related to mRNA-1273. The event of positive COVID-19 test with a Rapid lab kit is unlikely related to mRNA-1273 since the vaccine does not contain virus capable of producing a positive test result.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: pain in arm; A spontaneous report was received from a consumer concerning a female patient who received mRNA-1273 and experienced pain in her arm (Pain in extremity).  The patient's medical history and concomitant product use were not provided/unknown by the reporter.  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 in Dec 2020, the patient reported experiencing pain in her arm.  She asked if she could use ibuprofen for treatment, but it is unknown if ibuprofen was administered.  At the time of the report the outcome for the event was unknown.   Action taken with mRNA-1273 in response to the event was not provided/unknown.  The outcome of the event was unknown/not reported.   The reporter did not provide causality for the event.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Rash pruritic, Skin tightness
Clinical narrative: Skin rash, itchiness; Skin tightening; A spontaneous report was received from a physician concerning, a 34 year old, male patient who received Moderna Covid-19 vaccine (mRNA-1273) and developed a skin rash, itchiness and skin tightening.   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 number: 011J20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection on 22 Dec 2020.   On 28 Dec 2020, the patient started experiencing a skin rash, itchiness and skin tightening.   Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of skin rash, itchiness, skin tightening and condition worsened were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity, Lacrimation increased, Rhinorrhoea, Sneezing
Clinical narrative: Sneezing; Runny nose; Runny eyes; One of the worst allergy attacks in awhile; A spontaneous report was received from consumer concerning a male patient who received Moderna's COVID-19 vaccine and experienced an allergy flare up, sneezing, runny nose and runny eyes.    The patient's medical history included unspecified allergies. No relevant concomitant medications were reported.   On 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 31 Dec 2020, the patient describes his reaction as "one of the worst allergy attacks in a while." The patient experiences sneezing, runny nose and runny eye. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event(s)  allergy flare up, sneezing, runny nose and runny eyes were unknown.; Reporter's Comments: This case concerns a male of unknown age who experienced NS events of unexpected sneezing lacrimation, increased, rhinorrhoea and expected hypersensitivity.  Event onset occurred on Day 2 after the first dose of mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: My wife got the shot. It is very painful for her.; A spontaneous report was received from a consumer concerning a 41-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vaccination site pain.  The patient's medical history was not provided. No concomitant medications were reported.  On 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot# Unknown). On the same day, the patient experienced pain. No treatment information was reported.   The reporter stated that on 30 Dec 2020, the same day of the injection, the pain began. The caller stated that the patient couldn't sleep because of the pain.  The action taken with mRNA-1273 in response to the events was unknown.  At the time of the report, the outcome for the event, pain, was considered not recovered/not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Vaccination site erythema, Vaccination site lymphadenopathy, Vaccination site rash, Vaccination site urticaria
Clinical narrative: red mark at injection site; blotchy hives around injection site that are itchy at times; lymph nodes by her shoulder and armpit/outer breast area are swollen, tough; lymph nodes by her shoulder and armpit/outer breast area are sore; bumps on her shoulder area, neck and arm; A spontaneous report was received from a consumer concerning a 25 year old, female patient who received Moderna's COVID-19 vaccine and experienced bumps on her left shoulder area, neck and arm, red mark at the injection site, blotchy hives at the injection site, swollen, tough, and sore lymph nodes by her shoulder and armpit/outer breast.   The patient's medical history was not provided. Concomitant medications reported included ethinyl estradiol/norgestimate.    On 22 Dec 2020, the patient received her first of two planned doses of mRNA-1273 (039K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 27 Dec 2020, the patient noticed bums on her left shoulder area, neck and left arm. The bumps worsed on 30 Dec 2020. On 31 Dec 2020, the patient reported a red mark at the injection site and blotchy hives around the area that are itchy at times. She also has lymph nodes by her shoulder and armpit/ outer breast area that are swollen, tough and sore. Treatment for the event included paracetamol.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events was unknown/not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: soreness of the arm for 48 hours; A spontaneous report was received from a healthcare professional concerning a female consumer who received Moderna's COVID-19 vaccine and developed soreness of the arm for 48 hours.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 29 Dec 2020, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.     On 29 Dec 2020, after the patient received the vaccine, she developed soreness of the arm. She states the soreness has lasted for 48 hours. Treatment for the events included ibuprofen.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.    The outcome for the event, soreness of the arm for 48 hours was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Fatigue, Myalgia, Nausea
Clinical narrative: Pain in the stomach; Body aches; Nausea; Fatigue; Chills; A report was received from a consumer concerning a 67 year old  female  who was participating in the mRNA-1273 Emergency Use Program and experienced nausea, fatigue, chills, body aches, and pain in the stomach.  The patient's medical history was not provided. Concomitant medications included gabapentin, modafinil, buspirone, tofacitinib citrate, potassium, flecainide, levothyroxine, rosuvastatin, duloxetine, pantoprazole, ondansetron, metoprolol, and vitamin D. The patient also reported using Ticamidint, Busviront and Hydroxychloridium but they cannot be coded.  On 28 Dec 2020, prior to the onset of the events,  the patient received their first of two planned doses of mRNA-1273 (lot 025L20A) for prophylaxis of COVID-19 infection.  On 31 Dec 2020, the patient experienced nausea, fatigue, chills, body aches, and pain in the stomach. She had no fever and no rash. Treatment for the events included Tylenol (acetaminophen) and Thinner (to be confirmed) gum for the nausea.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome for the events of nausea, fatigue, chills, body aches and pain in the stomach were considered as unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Neck injury
Clinical narrative: neck injury; A report was received from a consumer concerning a patient who was participating in the mRNA-1273  Program and experienced neck injury.  The patient's medical history, as provided by the reporter, included heart issues. No relevant concomitant medications were reported.   On 23 Dec 2020, approximately 3 days prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On 26 Dec 2020, the patient had a neck injury. Treatment for the event included a 4 mg dose of methylprednisolone from 6x/day on day one, 5x/day on day 2, 4x/day on day 3, and 2x/day on day 4.  Action taken with mRNA-1273 in response to the event was not reported.  The event, neck injury, was considered resolved on 29 Dec 2020.   The reporter did not provide an assessment for the event, neck injury.; Reporter's Comments: Very limited information regarding the events has been provided at this time and is insufficient for causality assessment. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: warm; The same arm doesn't hurt but it is warm, itching, red and the size of a golf ball; The same arm doesn't hurt but it is warm, itching, red and the size of a golf ball.; Soreness and redness in the arm she got the vaccine; Soreness and redness in the arm she got the vaccine; A spontaneous report was received from a female healthcare facility staff member, who received Moderna's COVID-19 vaccine (mRNA-127and experienced  soreness and redness in the arm where vaccine was given then developed swelling, golf ball size, warm, itchy, redness which looks like a mild sunburn one week later.   The patient's medical history was not provided. Concomitant medications reported included levothyroxine sodium, rosuvastatin calcium and losartan.  On 22 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273(Batch number: unknown) intramuscularly in the arm for prophylaxis of COVID-19 infection.   Patient reported initial soreness and redness in the arm where she got the vaccine at which lasted for a day and went away. Patient then reports one week later, the same arm developed swelling, golf ball size, warm, itchy, redness which looks like mild sunburn. Treatment for the event included diphenhydramine cream, cold compress, and ibuprofen.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, soreness, and redness in the arm where vaccine was given then developed swelling, golf ball size, warm, itchy, redness which looks like a mild sunburn one week later were not reported.  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 events, a causal relationship cannot be excluded.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Bronchitis
Clinical narrative: Has bronchitis; A spontaneous report was received from a consumer concerning a 67-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced bronchitis.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 29 Dec 2020, prior to the onset of the event, the patient received their dose of mRNA-1273 (Batch Number: 025S20A or 025520A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced bronchitis.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event bronchitis was not reported.; Reporter's Comments: Very limited information regarding the event has been provided at this time and is insufficient for causality assessment. Further information has been requested.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pain, Pyrexia, Vomiting
Clinical narrative: Body ache; headache; vomitted; Fever; A report was received from a consumer concerning a 48-year old, female patient who experienced fever, vomiting, body ache and headache.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 30 Dec 2020, approximately 0 days hours prior to the onset of the events, fever, headache and body ache, and 1 day prior to the event vomiting, the patient received their first of two planned doses of mRNA-1273 (LOT# 025L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 30 Dec 2020 at 10:00 pm, the patient had a fever of 38.36 or 38.6, body and headache. On 31 Dec 2020 at 04:00 am, the subject reported vomiting. She took diclofenac when she went to bed the night of 30 Dec 2020, and Tylenol on the morning of 31 Dec 2020 after which she reported feeling better. Treatment for the event included diclofenac and Tylenol.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event were unknown.   The reporter did not provide an assessment for the events, fever, vomiting, body ache and headache.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.