chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Musculoskeletal discomfort, Pyrexia, Sinus disorder
Clinical narrative: shortness of breath; tightness across her chest; soreness around her check and back of neck; sinus issues; sneezing; no appetite; tiredness; left arm began to hurt; chills; headache; felt an elevated body temperature, temperature of 99.8 degrees Fahrenheit; A spontaneous report was received from a pharmacist who was also 67-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a headache, her left arm began to hurt, felt an elevated body temperature, measured temperature of 99.8 degrees Fahrenheit, chills, tiredness, no appetite, shortness of breath, tightness across the chest, soreness around her chest and back of neck, sinus issues and sneezing.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 05 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot: 011J20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 05 Jan 2021, 8 hours post injection, the patient developed headache, her left arm began to hurt, felt an elevated body temperature, measured temperature of 99.8 degrees Fahrenheit, chills and tiredness. On 06 Jan 2021, the patient stated that she slept all day. On 07 Jan 2021, she experienced shortness of breath, tightness across her chest, soreness around her chest and back of neck, sinus issues, sneezing, productive blowing of her nose. On 08 Jan 2021, the patient stated that when she woke up, she felt completely back to her normal self. Treatment included pseudoephedrine hydrochloride and ibuprofen.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the events, headache, her left arm began to hurt, felt an elevated body temperature, measured temperature of 99.8 degrees Fahrenheit, chills, tiredness, no appetite, shortness of breath, tightness across the chest, soreness around her chest and back of neck, sinus issues and sneezing, were considered resolved on 08 Jan 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Sneezing
Clinical narrative: shortness of breath; tightness across her chest; soreness around her check and back of neck; sinus issues; sneezing; no appetite; tiredness; left arm began to hurt; chills; headache; felt an elevated body temperature, temperature of 99.8 degrees Fahrenheit; A spontaneous report was received from a pharmacist who was also 67-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a headache, her left arm began to hurt, felt an elevated body temperature, measured temperature of 99.8 degrees Fahrenheit, chills, tiredness, no appetite, shortness of breath, tightness across the chest, soreness around her chest and back of neck, sinus issues and sneezing.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 05 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot: 011J20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 05 Jan 2021, 8 hours post injection, the patient developed headache, her left arm began to hurt, felt an elevated body temperature, measured temperature of 99.8 degrees Fahrenheit, chills and tiredness. On 06 Jan 2021, the patient stated that she slept all day. On 07 Jan 2021, she experienced shortness of breath, tightness across her chest, soreness around her chest and back of neck, sinus issues, sneezing, productive blowing of her nose. On 08 Jan 2021, the patient stated that when she woke up, she felt completely back to her normal self. Treatment included pseudoephedrine hydrochloride and ibuprofen.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the events, headache, her left arm began to hurt, felt an elevated body temperature, measured temperature of 99.8 degrees Fahrenheit, chills, tiredness, no appetite, shortness of breath, tightness across the chest, soreness around her chest and back of neck, sinus issues and sneezing, were considered resolved on 08 Jan 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Swelling of eyelid
Clinical narrative: Swollen eyelids; Sore arm; A spontaneous report was received from a consumer, concerning herself, a 80-year-old female patient, who received Moderna's COVID-19 vaccine and developed swollen eye lids and a sore arm.    The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 08-Jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot number 025L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 09-Jan-2021, the patient woke up with swollen eye lids and a sore arm. The patient did not take any treatment medication; however, her symptoms were improving.   Action taken with mRNA-1273 in response to the events were not reported.   The outcome of the events, swollen eye lids and a sore arm were considered resolving at the time of this report.; Reporter's Comments: This case concerns an 80 year old, female patient, who experienced a non-serious unexpected event of swelling of eyelid, and non-serious expected event of pain in extremity. The events occurred 2 days after first dose of mRNA-1273, lot # 025L20A. No treatment was administered, and the event appeared to be improving. 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. Additional information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Injection site swelling, Injection site warmth, Limb discomfort, Pain in extremity
Clinical narrative: Spot that looks like a ring higher up from where the vaccine was given; Swollen at injection site; Itchy rash; Arm was sore; Arm was hot to touch on the site of injection; Arm was very painful; A spontaneous report was received from 31 year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced burning sensation all over the arm, itchy rash, arm was very painful and sore, she was not able to lift anything, arm was hot to touch on the site of the injection, a little swollen, rash bigger, and a spot that looks like a ring higher up from where the vaccine was given.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 31 Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly (lot number 011L220A) on her left arm for prophylaxis of COVID-19 infection.    On 31 Dec 2020, the day of administration, the patient started to experience burning sensation all over the arm. She stated that it turned into an itchy rash at night. On an unknown date, her arm was very painful and sore, she was not able to lift anything. Her arm was hot to touch on the site of the injection and a little swollen. On an unknown date, she stated that the soreness is no longer there, but the pain is. She mentions that the rash bigger, and a spot that looks like a ring higher up from where the vaccine was given. Treatment include cetirizine hydrochloride, which helped ease the effects a little.   Action taken with mRNA-1273 vaccine is not applicable.  The outcome of the events, soreness, was resolved. The outcome of events, burning sensation all over the arm, itchy rash, arm was very painful, she was not able to lift anything, arm was hot to touch on the site of the injection, a little swollen, rash bigger, and a spot that looks like a ring higher up from where the vaccine was given, 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: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: Spot that looks like a ring higher up from where the vaccine was given; Swollen at injection site; Itchy rash; Arm was sore; Arm was hot to touch on the site of injection; Arm was very painful; A spontaneous report was received from 31 year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced burning sensation all over the arm, itchy rash, arm was very painful and sore, she was not able to lift anything, arm was hot to touch on the site of the injection, a little swollen, rash bigger, and a spot that looks like a ring higher up from where the vaccine was given.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 31 Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly (lot number 011L220A) on her left arm for prophylaxis of COVID-19 infection.    On 31 Dec 2020, the day of administration, the patient started to experience burning sensation all over the arm. She stated that it turned into an itchy rash at night. On an unknown date, her arm was very painful and sore, she was not able to lift anything. Her arm was hot to touch on the site of the injection and a little swollen. On an unknown date, she stated that the soreness is no longer there, but the pain is. She mentions that the rash bigger, and a spot that looks like a ring higher up from where the vaccine was given. Treatment include cetirizine hydrochloride, which helped ease the effects a little.   Action taken with mRNA-1273 vaccine is not applicable.  The outcome of the events, soreness, was resolved. The outcome of events, burning sensation all over the arm, itchy rash, arm was very painful, she was not able to lift anything, arm was hot to touch on the site of the injection, a little swollen, rash bigger, and a spot that looks like a ring higher up from where the vaccine was given, 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: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Myalgia, Nausea
Clinical narrative: arm pain; Body ache; joint pain; Fever; Chills; muscle pain; headache; nausea; A spontaneous report was received from a medical assistant who is a 43 year old, female patient who experienced fever, body ache, chills, muscle pain, joint pain, arm pain, headache, and nausea.   The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter.   On 02 Jan 2021, approximately 15 and a half hours prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number 037K20A) intramuscularly in the right deltoid for prophylaxis of COVID-19 infection.   The patient reported that she received the vaccine on 02 Jan 2021 at  08:30 AM, at midnight, she experienced fever, body ache, chills, muscle pain, joint pain, arm pain, headache, and nausea. Symptoms were still present when reported the next day. Treatment for the event included paracetamol (2, 500mg) on 03 Jan 2021.  Action taken with mRNA-1273 in response to the event(s) was not provided/unknown.   The outcome of the events, fever, body ache, chills, muscle pain, joint pain, arm pain, headache, and nausea was not known/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: Pain, Pain in extremity, Pyrexia
Clinical narrative: arm pain; Body ache; joint pain; Fever; Chills; muscle pain; headache; nausea; A spontaneous report was received from a medical assistant who is a 43 year old, female patient who experienced fever, body ache, chills, muscle pain, joint pain, arm pain, headache, and nausea.   The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter.   On 02 Jan 2021, approximately 15 and a half hours prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number 037K20A) intramuscularly in the right deltoid for prophylaxis of COVID-19 infection.   The patient reported that she received the vaccine on 02 Jan 2021 at  08:30 AM, at midnight, she experienced fever, body ache, chills, muscle pain, joint pain, arm pain, headache, and nausea. Symptoms were still present when reported the next day. Treatment for the event included paracetamol (2, 500mg) on 03 Jan 2021.  Action taken with mRNA-1273 in response to the event(s) was not provided/unknown.   The outcome of the events, fever, body ache, chills, muscle pain, joint pain, arm pain, headache, and nausea was not known/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: Dry mouth, Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: large area with red lesions at the injection site; Area at the injection site is very hot; area at injection site is itchy; large area with red lesions at the injection site; Arm was tender to the touch; dry mouth; arm was a little painful; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (arm was a little painful) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no historical event reported). Concomitant products included METOPROLOL, DILTIAZEM (DILTIAZEM ER), ACETYLSALICYLIC ACID (ASPIRIN 81), MULTIVITAMIN [VITAMINS NOS], MAGNESIUM and VITAMIN D3 for an unknown indication.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced PAIN IN EXTREMITY (arm was a little painful). At the time of the report, PAIN IN EXTREMITY (arm was a little painful) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Skin lesion
Clinical narrative: large area with red lesions at the injection site; Area at the injection site is very hot; area at injection site is itchy; large area with red lesions at the injection site; Arm was tender to the touch; dry mouth; arm was a little painful; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (arm was a little painful) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no historical event reported). Concomitant products included METOPROLOL, DILTIAZEM (DILTIAZEM ER), ACETYLSALICYLIC ACID (ASPIRIN 81), MULTIVITAMIN [VITAMINS NOS], MAGNESIUM and VITAMIN D3 for an unknown indication.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced PAIN IN EXTREMITY (arm was a little painful). At the time of the report, PAIN IN EXTREMITY (arm was a little painful) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: itching; sore arm; bump at injection site; swelling and redness at injection site; swelling and redness at injection site; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PRURITUS (itching), VACCINATION SITE PAIN (sore arm), VACCINATION SITE MASS (bump at injection site), VACCINATION SITE SWELLING (swelling and redness at injection site) and VACCINATION SITE ERYTHEMA (swelling and redness at injection site) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20-A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On 24-Dec-2020 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (itching), VACCINATION SITE PAIN (sore arm), VACCINATION SITE MASS (bump at injection site), VACCINATION SITE SWELLING (swelling and redness at injection site) and VACCINATION SITE ERYTHEMA (swelling and redness at injection site). At the time of the report, VACCINATION SITE PRURITUS (itching), VACCINATION SITE PAIN (sore arm), VACCINATION SITE MASS (bump at injection site), VACCINATION SITE SWELLING (swelling and redness at injection site) and VACCINATION SITE ERYTHEMA (swelling and redness at injection site) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Company comment: 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.   Reporter did not allow further contact; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Condition aggravated, Dysgeusia, Dysphonia, Flushing
Clinical narrative: Severe headache; Nausea; feels like when she catches a cold; Throat feels funny; Voice is scratchy; Cheeks flush/rosy; Feels sluggish; Iron/chemical taste in mouth; Feels like she does when she's catching a cold; Symptoms getting worse as the day goes on; Arm was really sore; 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 sore arm, severe headache, throat feels funny, voice was scratchy, cheeks flush/rosy, nausea, feels sluggish, an iron/chemical taste in the mouth and feels like she was catching a cold.   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 (Batch No: 011J20A) in the left arm for prophylaxis of COVID-19 infection.  On 04 Jan 2021, After receiving the vaccine, she stated that her arm was really sore. On 05 Jan 2021, the patient woke up with a severe headache. The patient experienced sore arm, severe headache, throat feels funny, voice was scratchy, cheeks flush/rosy, nausea, feels sluggish, an iron/chemical taste in the mouth and feels like she was catching a cold. The patient stated that the symptoms seem to be getting worse as the day goes on. The patient also stated she was in contact with several COVID positive individuals before being vaccinated but two separate COVID tests came back negative, however she was feeling sick the week prior to getting vaccinated. Treatment for the event included migraine medication.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events experienced sore arm, throat feels funny, severe headache, voice is scratchy, cheeks flush/rosy, nausea, feels sluggish, an iron/chemical taste in the mouth and feels like she's catching a cold 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 these events, a causal relationship cannot be excluded.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Influenza like illness, Nasopharyngitis, Nausea, Oropharyngeal discomfort
Clinical narrative: Severe headache; Nausea; feels like when she catches a cold; Throat feels funny; Voice is scratchy; Cheeks flush/rosy; Feels sluggish; Iron/chemical taste in mouth; Feels like she does when she's catching a cold; Symptoms getting worse as the day goes on; Arm was really sore; 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 sore arm, severe headache, throat feels funny, voice was scratchy, cheeks flush/rosy, nausea, feels sluggish, an iron/chemical taste in the mouth and feels like she was catching a cold.   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 (Batch No: 011J20A) in the left arm for prophylaxis of COVID-19 infection.  On 04 Jan 2021, After receiving the vaccine, she stated that her arm was really sore. On 05 Jan 2021, the patient woke up with a severe headache. The patient experienced sore arm, severe headache, throat feels funny, voice was scratchy, cheeks flush/rosy, nausea, feels sluggish, an iron/chemical taste in the mouth and feels like she was catching a cold. The patient stated that the symptoms seem to be getting worse as the day goes on. The patient also stated she was in contact with several COVID positive individuals before being vaccinated but two separate COVID tests came back negative, however she was feeling sick the week prior to getting vaccinated. Treatment for the event included migraine medication.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events experienced sore arm, throat feels funny, severe headache, voice is scratchy, cheeks flush/rosy, nausea, feels sluggish, an iron/chemical taste in the mouth and feels like she's catching a cold 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 these events, a causal relationship cannot be excluded.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Sluggishness, Vaccination site pain
Clinical narrative: Severe headache; Nausea; feels like when she catches a cold; Throat feels funny; Voice is scratchy; Cheeks flush/rosy; Feels sluggish; Iron/chemical taste in mouth; Feels like she does when she's catching a cold; Symptoms getting worse as the day goes on; Arm was really sore; 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 sore arm, severe headache, throat feels funny, voice was scratchy, cheeks flush/rosy, nausea, feels sluggish, an iron/chemical taste in the mouth and feels like she was catching a cold.   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 (Batch No: 011J20A) in the left arm for prophylaxis of COVID-19 infection.  On 04 Jan 2021, After receiving the vaccine, she stated that her arm was really sore. On 05 Jan 2021, the patient woke up with a severe headache. The patient experienced sore arm, severe headache, throat feels funny, voice was scratchy, cheeks flush/rosy, nausea, feels sluggish, an iron/chemical taste in the mouth and feels like she was catching a cold. The patient stated that the symptoms seem to be getting worse as the day goes on. The patient also stated she was in contact with several COVID positive individuals before being vaccinated but two separate COVID tests came back negative, however she was feeling sick the week prior to getting vaccinated. Treatment for the event included migraine medication.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events experienced sore arm, throat feels funny, severe headache, voice is scratchy, cheeks flush/rosy, nausea, feels sluggish, an iron/chemical taste in the mouth and feels like she's catching a cold 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 these events, a causal relationship cannot be excluded.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dehydration, Fatigue, Nausea, Vomiting
Clinical narrative: Dehydration; Very weak; 8-10 hours of nausea and vomiting; 8-10 hours of nausea and vomiting; Very tired; This spontaneous case was reported by a consumer and describes the occurrence of DEHYDRATION (Dehydration), ASTHENIA (Very weak), NAUSEA (8-10 hours of nausea and vomiting), VOMITING (8-10 hours of nausea and vomiting) and FATIGUE (Very tired) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Cholesterol. Concomitant products included LOSARTAN for Blood pressure high, ATORVASTATIN CALCIUM (AVASTATIN) for High cholesterol.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jan-2021, the patient experienced DEHYDRATION (Dehydration), ASTHENIA (Very weak), NAUSEA (8-10 hours of nausea and vomiting), VOMITING (8-10 hours of nausea and vomiting) and FATIGUE (Very tired). The patient was treated with PARACETAMOL, PROMETHAZINE HYDROCHLORIDE (PHENARGAN PLUS) ongoing since an unknown date at a dose of 50 mg. On 01-Jan-2021, DEHYDRATION (Dehydration), ASTHENIA (Very weak), NAUSEA (8-10 hours of nausea and vomiting), VOMITING (8-10 hours of nausea and vomiting) and FATIGUE (Very tired) had resolved.        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.   Additional concomitant medication included HRT. Reportedly the patient was able to hold broth, tea and biscuits. The next morning patient felt nice as if nothing had happened.   This case was linked to MOD-2021-079534 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Mar-2021: FUP obtained included: new events and concomitant medications.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events,  a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Oropharyngeal pain, Pain, Pain in extremity
Clinical narrative: Sore throat; Feeling sick; Strep throat; Chills; Soreness in arm; Body aches; Feeling weird; Fever 100.8 F; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness in arm), PAIN (Body aches), FEELING ABNORMAL (Feeling weird), OROPHARYNGEAL PAIN (Sore throat) and VACCINATION COMPLICATION (Feeling sick) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported.    On 21-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In December 2020, the patient experienced FEELING ABNORMAL (Feeling weird) and PYREXIA (Fever 100.8 F). On 22-Dec-2020, the patient experienced PAIN IN EXTREMITY (Soreness in arm) and PAIN (Body aches). On 31-Dec-2020, the patient experienced CHILLS (Chills). On 01-Jan-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat) and VACCINATION COMPLICATION (Feeling sick). In January 2021, the patient experienced PHARYNGITIS STREPTOCOCCAL (Strep throat). At the time of the report, PAIN IN EXTREMITY (Soreness in arm), PAIN (Body aches), FEELING ABNORMAL (Feeling weird), OROPHARYNGEAL PAIN (Sore throat), VACCINATION COMPLICATION (Feeling sick), PHARYNGITIS STREPTOCOCCAL (Strep throat), CHILLS (Chills) and PYREXIA (Fever 100.8 F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pharyngitis streptococcal: positive.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter.   Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 18-Jan-2021: Description of events.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Pharyngitis streptococcal, Pyrexia, Vaccination complication
Clinical narrative: Sore throat; Feeling sick; Strep throat; Chills; Soreness in arm; Body aches; Feeling weird; Fever 100.8 F; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness in arm), PAIN (Body aches), FEELING ABNORMAL (Feeling weird), OROPHARYNGEAL PAIN (Sore throat) and VACCINATION COMPLICATION (Feeling sick) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported.    On 21-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In December 2020, the patient experienced FEELING ABNORMAL (Feeling weird) and PYREXIA (Fever 100.8 F). On 22-Dec-2020, the patient experienced PAIN IN EXTREMITY (Soreness in arm) and PAIN (Body aches). On 31-Dec-2020, the patient experienced CHILLS (Chills). On 01-Jan-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat) and VACCINATION COMPLICATION (Feeling sick). In January 2021, the patient experienced PHARYNGITIS STREPTOCOCCAL (Strep throat). At the time of the report, PAIN IN EXTREMITY (Soreness in arm), PAIN (Body aches), FEELING ABNORMAL (Feeling weird), OROPHARYNGEAL PAIN (Sore throat), VACCINATION COMPLICATION (Feeling sick), PHARYNGITIS STREPTOCOCCAL (Strep throat), CHILLS (Chills) and PYREXIA (Fever 100.8 F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pharyngitis streptococcal: positive.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter.   Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 18-Jan-2021: Description of events.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Tested positive for COVID one week later; A spontaneous report was received from a health professional concerning a patient, of unknown gender and age, who received Moderna's COVID-19 vaccine and tested positive for COVID one week later.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On an unspecified date, prior to the onset of the event, the patient received their first dose of mRNA-1273 (Lot/batch number: unknown) for prophylaxis of COVID-19 infection.     One week after receiving the vaccine, the patient tested positive for COVID-19. No treatment information was provided.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.    The outcome for the event of a positive for COVID test was not reported.; Reporter's Comments: Based on the current available information and the mechanism of action of mRNA-1273 vaccine, the event of positive for SARS-CoV-2, are assessed as unlikely related.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Warm to the touch; Little swollen; Tender/pain; A spontaneous report was received from a consumer, concerning herself, a 49-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced warm to the touch/ vaccination site warmth, little swollen/ vaccination site swelling, tender/pain/ vaccination site pain.    The patient's medical history was not provided.  Concomitant product use included allergy pill every day.  On 27 Dec 2020, approximately eight days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 026L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.    On 04 Jan 2021, after receiving the vaccine, the patient reported that it was little swollen, tender, pain and warm to the touch. Treatment information was not provided.    Action taken with mRNA-1273 in response to the events were not provided.  The outcome of the events, warm to the touch, little swollen, tender/pain were 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.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Ultrasound scan
Clinical narrative: Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 28-Jun-2021. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Ultrasound scan: normal (normal) Ultrasound-Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       At the time of this report, patient had no complications during this pregnancy.  Patient was scheduled to get the second dose of Moderna vaccine on 28-Jan-2021.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 43-year-old female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Headache, Myalgia, Nausea, Rash pruritic
Clinical narrative: difficulty in breathing; Itching, hives; nauseated; headache; achiness in her muscles; A spontaneous report was received from a healthcare provider (HCP) concerning a female patient of unknown age  who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced feeling nauseated/Nausea, difficulty in breathing/Dyspnea, itching and hives/ Rash pruritic, headache/Headache and achiness in her muscles/Myalgia.  The patient's medical history was not provided. No concomitant medications were reported.  On 28 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.   An hour after receiving the vaccine the patient experienced feeling nauseated, difficulty in breathing, itching, hives, headache and achiness in her muscles. The patient was rushed to the emergency room (ER) and treated with epinephrine, steroids, benadry, & pepsin.   Action taken with mRNA-1273 in response to the events was not applicable.  The outcome for the events, feeling nauseated, difficulty in breathing, itching, hives, headache and achiness in her muscles was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Body temperature increased, Cough, Fatigue
Clinical narrative: Loss of taste; Loss of smell; Cough; Sinus pressure; Extreme fatigue; Headache; Temp of 99.8; Tested positive for COVID-19; This spontaneous case was reported by a health care professional and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19), BODY TEMPERATURE INCREASED (Temp of 99.8), ANOSMIA (Loss of smell), COUGH (Cough) and PARANASAL SINUS DISCOMFORT (Sinus pressure) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for an unknown indication. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 07-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19). On 08-Jan-2021, the patient experienced BODY TEMPERATURE INCREASED (Temp of 99.8). On 11-Jan-2021, the patient experienced ANOSMIA (Loss of smell), COUGH (Cough), PARANASAL SINUS DISCOMFORT (Sinus pressure), FATIGUE (Extreme fatigue) and HEADACHE (Headache). On 08-Jan-2021, BODY TEMPERATURE INCREASED (Temp of 99.8) had resolved. At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19), ANOSMIA (Loss of smell), COUGH (Cough), PARANASAL SINUS DISCOMFORT (Sinus pressure), FATIGUE (Extreme fatigue) and HEADACHE (Headache) outcome was unknown.        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 information was not provided.  Based on the current available information and temporal association between the use of the product and the start date of the events( Fatigue, headache elevated temp) , a causal relationship cannot be excluded. However, the event of COVID-19 is Unlikely related to mRNA-1273. Further information has been requested   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events( Fatigue, headache elevated temp) , a causal relationship cannot be excluded. However, the event of COVID-19 is Unlikely related to mRNA-1273. Further information has been requested
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Paranasal sinus discomfort, SARS-CoV-2 test positive
Clinical narrative: Loss of taste; Loss of smell; Cough; Sinus pressure; Extreme fatigue; Headache; Temp of 99.8; Tested positive for COVID-19; This spontaneous case was reported by a health care professional and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19), BODY TEMPERATURE INCREASED (Temp of 99.8), ANOSMIA (Loss of smell), COUGH (Cough) and PARANASAL SINUS DISCOMFORT (Sinus pressure) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for an unknown indication. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 07-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19). On 08-Jan-2021, the patient experienced BODY TEMPERATURE INCREASED (Temp of 99.8). On 11-Jan-2021, the patient experienced ANOSMIA (Loss of smell), COUGH (Cough), PARANASAL SINUS DISCOMFORT (Sinus pressure), FATIGUE (Extreme fatigue) and HEADACHE (Headache). On 08-Jan-2021, BODY TEMPERATURE INCREASED (Temp of 99.8) had resolved. At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19), ANOSMIA (Loss of smell), COUGH (Cough), PARANASAL SINUS DISCOMFORT (Sinus pressure), FATIGUE (Extreme fatigue) and HEADACHE (Headache) outcome was unknown.        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 information was not provided.  Based on the current available information and temporal association between the use of the product and the start date of the events( Fatigue, headache elevated temp) , a causal relationship cannot be excluded. However, the event of COVID-19 is Unlikely related to mRNA-1273. Further information has been requested   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events( Fatigue, headache elevated temp) , a causal relationship cannot be excluded. However, the event of COVID-19 is Unlikely related to mRNA-1273. Further information has been requested
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Nausea
Clinical narrative: Feeling hot; Nausea; A spontaneous report was received concerning a 56-year old, male patient who received Moderna's COVID-19 vaccine and experienced nausea and feeling hot.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 05 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (025L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   On 05 Jan 2021, during his 15-minute waiting period after the injection, the patient began to experience nausea and feeling hot. The patient was assisted in the emergency bay area and monitored for severe reaction symptoms. The patient drank water and was feeling better within a few minutes.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, nausea and feeling hot, were considered as recovering.; 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.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Vaccination site erythema, Vaccination site oedema
Clinical narrative: Headache; Body Aches and Pains; Redness at the injection site; Edema at the injection site; A spontaneous report was received from a physician concerning herself, a 48-year old, female patient who received Moderna's COVID-19 vaccine and experienced redness and edema at the injection site, body aches and pains and headache.    The patient's medical history was not provided. The patient's concomitant drug included Diabetes medication for Diabetes.   On 31 Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 02 Jan 2021, the patient began to have redness and edema at the injection site. On 04 Jan 2021, the patient began to have body aches and pains. On 05 Jan 2021, she reports having a headache.    Treatment for the events included naproxen sodium.  Action taken with mRNA-1273 in response to the events was not reported.   The events, redness and edema at the injection site, body aches and pains and headache, were 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 events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: Muscle aches all over; Extremely horrible headaches; A spontaneous report was received from a consumer concerning a female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced headaches and muscle aches.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 31 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: 025J20-2A) for prophylaxis of COVID-19 infection.  On 01 Jan 2021, after receiving Moderna COVID-19 Vaccine the patient experienced extremely horrible, awful, debilitating headaches for two and a half days followed by muscle aches all over as if  someone beat with a baseball bat.  Treatment for the events included 2 pills of paracetamol every 6 hours.  Action taken with mRNA-1273 in response to the events was not reported.  The events, headaches and muscle aches, were considered resolved on 03 Jan 2021.; 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.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: I am 27 weeks pregnant; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (I am 27 weeks pregnant) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 04-Aug-2020 and the estimated date of delivery was date. On 04-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (I am 27 weeks pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-second week of the pregnancy.  On 04-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (I am 27 weeks pregnant) had resolved.        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.   Company Comment: This is a case of product exposure during pregnancy with no associated AEs for this 32-year-old female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 32-year-old female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.