chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Erythema, Fatigue, Headache, Injection site induration
Clinical narrative: Circle of inflammation at the injection site; Mild headache; Diarrhea; Lump at injection site; Arm soreness; arm weakness; Instant redness within 15 minutes; itching; Fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Arm soreness), LIMB DISCOMFORT (arm weakness), DIARRHOEA (Diarrhea), INJECTION SITE INFLAMMATION (Circle of inflammation at the injection site) and ERYTHEMA (Instant redness within 15 minutes) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy (Allergies to fillers and bonding agents.).    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness), LIMB DISCOMFORT (arm weakness), ERYTHEMA (Instant redness within 15 minutes), PRURITUS (itching), FATIGUE (Fatigue) and INJECTION SITE INDURATION (Lump at injection site). On 14-Jan-2021, the patient experienced DIARRHOEA (Diarrhea) and HEADACHE (Mild headache). On 21-Jan-2021, the patient experienced INJECTION SITE INFLAMMATION (Circle of inflammation at the injection site). On 15-Jan-2021, HEADACHE (Mild headache) had resolved. On 17-Jan-2021, DIARRHOEA (Diarrhea) had resolved. On 18-Jan-2021, PAIN IN EXTREMITY (Arm soreness) had not resolved, LIMB DISCOMFORT (arm weakness), PRURITUS (itching), FATIGUE (Fatigue) and INJECTION SITE INDURATION (Lump at injection site) had resolved. At the time of the report, INJECTION SITE INFLAMMATION (Circle of inflammation at the injection site) outcome was unknown and ERYTHEMA (Instant redness within 15 minutes) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.
Sex: F
Vaccine: COVID19
Symptoms: Injection site inflammation, Limb discomfort, Pain in extremity, Pruritus
Clinical narrative: Circle of inflammation at the injection site; Mild headache; Diarrhea; Lump at injection site; Arm soreness; arm weakness; Instant redness within 15 minutes; itching; Fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Arm soreness), LIMB DISCOMFORT (arm weakness), DIARRHOEA (Diarrhea), INJECTION SITE INFLAMMATION (Circle of inflammation at the injection site) and ERYTHEMA (Instant redness within 15 minutes) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy (Allergies to fillers and bonding agents.).    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness), LIMB DISCOMFORT (arm weakness), ERYTHEMA (Instant redness within 15 minutes), PRURITUS (itching), FATIGUE (Fatigue) and INJECTION SITE INDURATION (Lump at injection site). On 14-Jan-2021, the patient experienced DIARRHOEA (Diarrhea) and HEADACHE (Mild headache). On 21-Jan-2021, the patient experienced INJECTION SITE INFLAMMATION (Circle of inflammation at the injection site). On 15-Jan-2021, HEADACHE (Mild headache) had resolved. On 17-Jan-2021, DIARRHOEA (Diarrhea) had resolved. On 18-Jan-2021, PAIN IN EXTREMITY (Arm soreness) had not resolved, LIMB DISCOMFORT (arm weakness), PRURITUS (itching), FATIGUE (Fatigue) and INJECTION SITE INDURATION (Lump at injection site) had resolved. At the time of the report, INJECTION SITE INFLAMMATION (Circle of inflammation at the injection site) outcome was unknown and ERYTHEMA (Instant redness within 15 minutes) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: dizzy; A spontaneous report3w2aq was received from a 83-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced dizziness.  There is no previous reported medical history of the patient as such.  On 18th Jan at 07:00 pm, approximately nine hours after receiving the first  dose of mRNA-1273 (Lot number: 012L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection, the patient started feeling dizziness. The feeling was gone at around 03:00 am on 19th Jan, the following morning.   Action taken with mRNA-1273 in response to the events was not reported.   The event, feeling of dizziness were considered resolved on 19th Jan 2021.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: ache; headache; nausea; tiredness; injection site hot; injection site redness; injection site swell; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed injection site hot, injection site redness, injection site swell, headache, ache, nausea and tiredness.  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 05 Jan 2021 intramuscularly for prophylaxis of COVID-19 infection. The patient received their second of two planned doses of mRNA-1273 on 02 Feb 2021 intramuscularly for prophylaxis of COVID-19 infection.   Patient had a question on an adverse effect they had and wanted some information. She mentioned that she took her fist dose on 05 Jan 2021 and experienced injection hot, redness and swell. Second dose was on 02 Feb 2021, she experienced, headache, ache, nausea and tiredness. She mentioned that she followed up with her doctor. No further information provided.  No treatment information was provided for events.  Action taken with RNA-1273 in response to the event was unknown.  The outcome of the events was unknown.  The reporter did not provide an assessment for the events, injection site hot, injection site redness, injection site swell, headache, ache, nausea and tiredness.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain
Clinical narrative: ache; headache; nausea; tiredness; injection site hot; injection site redness; injection site swell; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed injection site hot, injection site redness, injection site swell, headache, ache, nausea and tiredness.  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 05 Jan 2021 intramuscularly for prophylaxis of COVID-19 infection. The patient received their second of two planned doses of mRNA-1273 on 02 Feb 2021 intramuscularly for prophylaxis of COVID-19 infection.   Patient had a question on an adverse effect they had and wanted some information. She mentioned that she took her fist dose on 05 Jan 2021 and experienced injection hot, redness and swell. Second dose was on 02 Feb 2021, she experienced, headache, ache, nausea and tiredness. She mentioned that she followed up with her doctor. No further information provided.  No treatment information was provided for events.  Action taken with RNA-1273 in response to the event was unknown.  The outcome of the events was unknown.  The reporter did not provide an assessment for the events, injection site hot, injection site redness, injection site swell, headache, ache, nausea and tiredness.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Covid-19; A spontaneous report was received from a consumer concerning a 45- year old-male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced covid-19.  The patient's medical history was not provided.No relevant concomitant medications were reported.   On 26-Dec-2020,prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch 011J20A) intramuscularly on right arm for prophylaxis of COVID-19 infection.  On 21-Jan-2021,the patient tested positive (on pcr but negative on rapid test),he is asymptomatic. Laboratory data included,covid-19 PCR test positive and covid-19 rapid test negative,was provided.Treatment information was not provided.  Action taken with mRNA-1273 in response to the events  was unknown. The outcome of the event covid-19 was considered as unknown at the time of the report.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: fever around injection Site; Redness 2" around injection site; Case reference number MOD-2021-011252 is a spontaneous case report sent by a Non-Health Professional on 21-JAN-2021 00:00:00 , which refers to a Female aged 77 Years. At the time of the event the patient had Blood pressure. The following drugs are known to have been taken by the patient prior to the event: METOPROLOL and LOSARTAN.  On  09-JAN-2021, the patient received Moderna COVID-19 Vaccine  in the upper left arm  for COVID-19 vaccination. On 20-JAN-2021,  the patient developed Injection site redness and  and fever around injection Site .    The action taken for Moderna COVID-19 Vaccine was  Unknown on.The Non-Health Professional did not declare any relatedness between Redness 2 injection site and Moderna COVID-19 Vaccine.   The outcome of the event(s) was unknownot reported.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: extremely cold hands; warm feeling on face; spot grew to about the size of a baseball; warm to touch; red spot at the injection site; painful to touch; mild pain in her left arm; A report was received from a consumer who is patient's husband. The consumer reported that his wife, 41 years old female patient was participating in the mRNA-1273 Emergency Use Program and experienced Pain - Left Arm, Red - At Injection Site, Swelling - At Injection Site, Painful to Touch - At Injection Site, Warm to Touch - At Injection Site, Warm Feeling on Face, Extremely Cold Hands.  No relevant concomitant medications were reported.   The patient received their first planned dose of mRNA-1273 on 12-JAN-2021 in her Left upper arm.  The patient had some mild pain in her Left arm the same day she received the Moderna COVID-19 Vaccine. Also when she woke up on the day of 19-JAN-2021 with a Red Spot at the Injection Site and reported that it was Warm and Painful to Touch.   On 20-JAN-2021, the spot on her arm grew to about the Size of a Baseball and continued to be painful and hot to touch. The spot on her  arms has not changed from 20-JAN-2021 to today 21-JAN-2021 and reported that she developed a Warm Feeling on her Face and Extremely Cold Hands.  No treatment information was provided.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral coldness
Clinical narrative: extremely cold hands; warm feeling on face; spot grew to about the size of a baseball; warm to touch; red spot at the injection site; painful to touch; mild pain in her left arm; A report was received from a consumer who is patient's husband. The consumer reported that his wife, 41 years old female patient was participating in the mRNA-1273 Emergency Use Program and experienced Pain - Left Arm, Red - At Injection Site, Swelling - At Injection Site, Painful to Touch - At Injection Site, Warm to Touch - At Injection Site, Warm Feeling on Face, Extremely Cold Hands.  No relevant concomitant medications were reported.   The patient received their first planned dose of mRNA-1273 on 12-JAN-2021 in her Left upper arm.  The patient had some mild pain in her Left arm the same day she received the Moderna COVID-19 Vaccine. Also when she woke up on the day of 19-JAN-2021 with a Red Spot at the Injection Site and reported that it was Warm and Painful to Touch.   On 20-JAN-2021, the spot on her arm grew to about the Size of a Baseball and continued to be painful and hot to touch. The spot on her  arms has not changed from 20-JAN-2021 to today 21-JAN-2021 and reported that she developed a Warm Feeling on her Face and Extremely Cold Hands.  No treatment information was provided.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Headache, Pain in extremity, Vaccination site erythema, Vaccination site pain
Clinical narrative: really hot/hot to the touch; arm was really sore again; raised red; hurts; massive headache; arm was sore; A spontaneous report was received from a consumer concerning a 53 year old female patient who received Modern's COVID-19 vaccine (mRNA-1273) who experienced arm was sore/pain in arm, arm was really sore again/pain in arm, raised red/vaccination site erythema, really hot/ hot to the touch/vaccination site warmth, hurts/vaccination site pain, massive headache/headache.  The patient's medical history and concomitant medication were not reported.  On 15Jan2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 028L20A) in left arm for prophylaxis of COVID-19 infection.  On 19Jan2021, the patient experienced arm was sore. On 26Jan2021, the patient arm was really sore again, raised red, really hot/ hot to the touch, hurts, massive headache. No Laboratory details provided.  Advil was given as treatment for the events.  Action taken with mRNA-1273 in response to the events was not reported.  At the time of this report, the outcome of the event arm was sore is recovered on 21Jan2021. At the time of this report, the outcome of the event arm was really sore again, raised red, really hot/ hot to the touch, hurts, massive headache is unknown.  The consumer assessed the event arm was sore, arm was really sore again, raised red, really hot/ hot to the touch, hurts, massive headache were not reported.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: really hot/hot to the touch; arm was really sore again; raised red; hurts; massive headache; arm was sore; A spontaneous report was received from a consumer concerning a 53 year old female patient who received Modern's COVID-19 vaccine (mRNA-1273) who experienced arm was sore/pain in arm, arm was really sore again/pain in arm, raised red/vaccination site erythema, really hot/ hot to the touch/vaccination site warmth, hurts/vaccination site pain, massive headache/headache.  The patient's medical history and concomitant medication were not reported.  On 15Jan2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 028L20A) in left arm for prophylaxis of COVID-19 infection.  On 19Jan2021, the patient experienced arm was sore. On 26Jan2021, the patient arm was really sore again, raised red, really hot/ hot to the touch, hurts, massive headache. No Laboratory details provided.  Advil was given as treatment for the events.  Action taken with mRNA-1273 in response to the events was not reported.  At the time of this report, the outcome of the event arm was sore is recovered on 21Jan2021. At the time of this report, the outcome of the event arm was really sore again, raised red, really hot/ hot to the touch, hurts, massive headache is unknown.  The consumer assessed the event arm was sore, arm was really sore again, raised red, really hot/ hot to the touch, hurts, massive headache were not reported.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Injection site pain
Clinical narrative: Chills; Joint pain; Headache; soreness in her arm injection site; A Spontaneous case report was received from a consumer who was a 68 year old female patient who has received first dose of Moderna COVID-19 Vaccine(mRNA-1273) on her right arm on 20-JAN-2021.She experienced chills,joint pain,headache and soreness in her arm. at injection site.No past medical history  and treatment was provided.The outcome of the patient is unknown.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Glucose tolerance test, Ultrasound scan
Clinical narrative: Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnancy) in a 34-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy (low birth weight) on 04-Sep-2018. Concurrent medical conditions included Allergy to antibiotic (Amoxicillin, Penicillin.). Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81) for Low birth weight baby, DOXYLAMINE SUCCINATE, PYRIDOXINE HYDROCHLORIDE (DICLEGIS) for Morning sickness, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy.    On 21-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 18-Jun-2020 and the estimated date of delivery was 01-Apr-2021. On 21-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-first week of the pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (Pregnancy) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Sep-2020, Ultrasound scan: unknown (Inconclusive) Unknown. On 19-Nov-2020, Ultrasound scan: unknown (Inconclusive) Unknown. On 23-Dec-2020, Glucose tolerance test: unknown (Inconclusive) Unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 04-Sep-2018, patient had a previous pregnancy that ended with live, full-term birth and had the complication of low birth weight.  The patient reports prior use of alcohol 1-2 drinks/week.  Company Comment: This is a case of product exposure during pregnancy with no associated AEs for this 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 female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: diagnosed with COVID; A spontaneous report was received from a consumer concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and he got possitive with COVID-19.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 31-12-2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.  The patient told he only had symptoms for couple of days. The symptoms are not given by the patient.  Laboratory details are not provided.   The patient didn't take any medication.  Action taken with mRNA-1273 in response to the events was not reported.   The events are not resolved .  At the time of this report, the outcome of the event was not resolved.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Chromaturia, Pain in extremity
Clinical narrative: Dark urine; Arm pain; A spontaneous report was received from a consumer (caregiver) concerning her mother, a 78-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced dark urine/chromaturia and arm pain/pain in extremity.  The patient's medical history, as provided by the reporter, included allergy to sulfurs and lung cancer. Concomitant medications reported included bp medication, cholesterol medication and cancer pill.   On 13 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) through unknown route of administration in the upper left arm for prophylaxis of COVID-19 infection.   On 13 Jan 2021, the patient experienced dark urine and arm pain.  Lab details were not provided by the reporter.  Treatment for the events were unknown.  Action taken with mRNA-1273 in response to the events were not reported.   The outcome of the events dark urine and arm pain were unknown.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Pain in extremity
Clinical narrative: feels cold; absolutely shivering; Sore Arm; A spontaneous report was received from a consumer concerning a 60 years old, male patient who developed Sore Arm/ Pain in extremity , absolutely shivering/ Chills , feels cold/ Nasopharyngitis.    The patient's medical history was not provided. Additional suspected products included Metformin, Dertin, Omeprazole, Insulin, Aspirin, Vitamin D.    The patient received their first of two planned doses of mRNA-1273 (Batch number not provided) on 20-Jan-2021. On 20-Jan-2021, approximately few hours prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection.    Patient had a sore arm last night and today he is absolutely shivering, he has three blankets on and still feels cold. Treatment information was unknown.    Action taken with mRNA-1273 in response to the event(s) was not provided.  The outcome of the events were unknown.
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Erythema, Fatigue, Lymphadenopathy, Ocular hyperaemia
Clinical narrative: Eyes were red; Raised from shoulder to elbow; Left arm was red; Itching; Lymph n odes on both side of her neck were swollen; Tired; several Asthma attacks; Arm was sore; A spontaneous report was received from a Reporter like HCP  concerning a 40 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events such as sore left arm, Tired, Reaction to the vaccine, very tired, several asthma attacks, swollen lymph nodes on both side of her neck, Red eyes, Red and raised left arm from shoulder to elbow, itching left arm from shoulder to elbow, extremely tired.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 15-01-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 batch no:027L20A  intramuscularly in the Anatomical location for prophylaxis of COVID-19 infection.  On 5th, 15th and 20th , The patient experienced the events such as sore left arm, Tired, Reaction to the vaccine, very tired, several asthma attacks, swollen lymph nodes on both side of her neck, Red eyes, Red and raised left arm from shoulder to elbow, itching left arm from shoulder to elbow, extremely tired.  Laboratory details are not provided.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The events are still not resolved.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: Eyes were red; Raised from shoulder to elbow; Left arm was red; Itching; Lymph n odes on both side of her neck were swollen; Tired; several Asthma attacks; Arm was sore; A spontaneous report was received from a Reporter like HCP  concerning a 40 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events such as sore left arm, Tired, Reaction to the vaccine, very tired, several asthma attacks, swollen lymph nodes on both side of her neck, Red eyes, Red and raised left arm from shoulder to elbow, itching left arm from shoulder to elbow, extremely tired.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 15-01-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 batch no:027L20A  intramuscularly in the Anatomical location for prophylaxis of COVID-19 infection.  On 5th, 15th and 20th , The patient experienced the events such as sore left arm, Tired, Reaction to the vaccine, very tired, several asthma attacks, swollen lymph nodes on both side of her neck, Red eyes, Red and raised left arm from shoulder to elbow, itching left arm from shoulder to elbow, extremely tired.  Laboratory details are not provided.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The events are still not resolved.
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Vaccination site warmth
Clinical narrative: Redness; Warm injection site; A spontaneous report was received from a Physician concerning his patient, of unknown age and sex who developed redness/erythema, warm injection site/vaccination site warmth.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.     The patients received their first of two planned doses of mRNA-1273 (Batch number: unknown) on unknown date in unknown injection site for prophylaxis of COVID-19 infection.   The patients developed redness, very warm injection site reaction after 8-10 days of receiving 1st shot of Moderna COVID vaccine. Treatment of the event was not provided.   Action taken with mRNA-1273 in response to the event(s) was not provided/unknown.  The outcome of the event(s) redness and warm injection site was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation
Clinical narrative: throat had a tickle in it, felt funny; A spontaneous report was received from a healthcare professional (Pharmacist) concerning a female patient who was in her late 30's, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced tickle in her throat(felt funny).  The patient's medical history, as provided by the reporter, included exercise-induced asthma, but does not take any medications for it (hadn't had to use a rescue inhaler for almost a year).  On 15 Jan 2021, approximately five to ten minutes prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.    On observing the event she was given  two puffs of albuterol inhaler and felt better. After 15 minutes her throat was doing it again. They gave her oral Benadryl 25mg. The staff took her to the emergency room and gave low dose oral prednisone for three days and a single oral dose of famotidine.  Action taken with mRNA-1273 in response to the events was not reported.    The events, tickling in throat were considered resolved after two days.   The reporter considered it as a anxiety-type reaction as she came to the vaccination site alone.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Confusional state, Fatigue, Headache, Hyperhidrosis
Clinical narrative: Being confused; having cold chills; fever; nausea; Lot of headache; Arm was hurting; I couldn't sleep all night; sweating a lot; Fatigue; A spontaneous report was received from a 62-years-old male patient concerning himself who received Modern's COVID-19 vaccine (mRNA-1273) and experienced arm hurting, couldn´t sleep at all night, sweating a lot, having cold chills, suppose  had a fever, nausea , chills and fatigue, being confused and having lot of headaches.  The patient's medical history was provided. as diabetes. No relevant concomitant medications reported.  On 19 Jan 2021, prior to the onset of the events, the patient received the first dose of two planned doses of mRNA-1273 (lot/batch:011L20A) via unknown route of administration and unknown anatomical location for prophylaxis of COVID-19 infection.   On 19 Jan 2021, the patient developed arm hurting, couldn´t sleep at all night, sweating a lot, having cold chills.   On 20 Jan 2021, patient experienced suppose had a fever, nausea, chills and fatigue, being confused and having lot of headaches.  Treatment information provided was Tylenol (acetaminophen).  Action taken with mRNA-1273 in response to the events was not reported.  At the time of the report, the outcome of events arm hurting, couldn´t sleep at all night, sweating a lot, having cold chills, suppose  had a fever, nausea , chills and fatigue, being confused was unknown and having lot of headache was considered recovered.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Being confused; having cold chills; fever; nausea; Lot of headache; Arm was hurting; I couldn't sleep all night; sweating a lot; Fatigue; A spontaneous report was received from a 62-years-old male patient concerning himself who received Modern's COVID-19 vaccine (mRNA-1273) and experienced arm hurting, couldn´t sleep at all night, sweating a lot, having cold chills, suppose  had a fever, nausea , chills and fatigue, being confused and having lot of headaches.  The patient's medical history was provided. as diabetes. No relevant concomitant medications reported.  On 19 Jan 2021, prior to the onset of the events, the patient received the first dose of two planned doses of mRNA-1273 (lot/batch:011L20A) via unknown route of administration and unknown anatomical location for prophylaxis of COVID-19 infection.   On 19 Jan 2021, the patient developed arm hurting, couldn´t sleep at all night, sweating a lot, having cold chills.   On 20 Jan 2021, patient experienced suppose had a fever, nausea, chills and fatigue, being confused and having lot of headaches.  Treatment information provided was Tylenol (acetaminophen).  Action taken with mRNA-1273 in response to the events was not reported.  At the time of the report, the outcome of events arm hurting, couldn´t sleep at all night, sweating a lot, having cold chills, suppose  had a fever, nausea , chills and fatigue, being confused was unknown and having lot of headache was considered recovered.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Lethargy, Pyrexia, Vaccination site erythema, Vaccination site induration
Clinical narrative: lethargic; hot; slight fever, up by 1 degree; chilled; the arm started to itch like crazy; it was red; swollen; hard; A spontaneous report was received from a reporter concerning a 71-year-old, female patient, participating in the who received Moderna's COVID-19 vaccine (mRNA-1273) Emergency Use Program  who and experienced  lethargy, chills, fever, vaccination site pruritus, vaccination site erythema, vaccination site swelling, vaccination site warmth, vaccination site induration.   The patient's medical history, was not  provided by the reporter. There were no  Concomitant medications reported.   The patient received their first of two planned dose of mRNA-1273 on 09jan2021. On 09jan2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 039K2014)  in the right arm for prophylaxis of COVID-19 infection.     Initially after receiving mRNA-1273, the patient experienced lethargy, chills, fever up by 1 degree.        Action taken with mRNA-1273 in response to the events was not reported.     The events, lethargy, chills, fever   were considered resolved.   The reporter did not provide an assessment for the .events lethargy, chills, fever, vaccination site pruritus, vaccination site erythema, vaccination site swelling, vaccination site warmth, vaccination site induration.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: lethargic; hot; slight fever, up by 1 degree; chilled; the arm started to itch like crazy; it was red; swollen; hard; A spontaneous report was received from a reporter concerning a 71-year-old, female patient, participating in the who received Moderna's COVID-19 vaccine (mRNA-1273) Emergency Use Program  who and experienced  lethargy, chills, fever, vaccination site pruritus, vaccination site erythema, vaccination site swelling, vaccination site warmth, vaccination site induration.   The patient's medical history, was not  provided by the reporter. There were no  Concomitant medications reported.   The patient received their first of two planned dose of mRNA-1273 on 09jan2021. On 09jan2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 039K2014)  in the right arm for prophylaxis of COVID-19 infection.     Initially after receiving mRNA-1273, the patient experienced lethargy, chills, fever up by 1 degree.        Action taken with mRNA-1273 in response to the events was not reported.     The events, lethargy, chills, fever   were considered resolved.   The reporter did not provide an assessment for the .events lethargy, chills, fever, vaccination site pruritus, vaccination site erythema, vaccination site swelling, vaccination site warmth, vaccination site induration.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Maternal exposure during pregnancy, Myalgia
Clinical narrative: Fatigue; Achy; Pregnant; This spontaneous prospective pregnancy case was reported by a patient and describes the occurrence of FATIGUE (Fatigue), MYALGIA (Achy) and MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A and 032L20A) for COVID-19 vaccination.     Concurrent medical conditions included Latex allergy. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 15-Jun-2021. On 31-Dec-2020, the patient experienced FATIGUE (Fatigue), MYALGIA (Achy) and MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). The patient was treated with PARACETAMOL (TYLENOL) for Adverse reaction, at a dose of 1 dosage form. On 31-Dec-2020, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved. At the time of the report, FATIGUE (Fatigue) and MYALGIA (Achy) outcome was unknown.            The patient had established prenatal care. Number of fetuses was reported as 1.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Decreased appetite, Feeling abnormal, Headache, Limb discomfort
Clinical narrative: body aches; Severe Arm Pain; could not lift her arm; Could not shower for 2 days; Could not eat for 2 days; caused a flare up of auto immune disease; Still not feeling normal; severe headaches; A spontaneous report was received from a consumer concerning a 58-female patient, who received Moderna COVID-19 vaccine (mRNA-1273) and experienced severe headache , body aches, severe arm pain so that she could not lift her arm and it caused a flare up of auto immune disease and could not shower or eat for 2 days. The patient's medical history was not provided. Relevant concomitant medications include Dupixent and Prednisone was reported. On 12-jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273(lot number : 039K20A) intramuscularly on left upper arm  for the prophylaxis of COVID-19 infection. On 13-jan-2021, the patient experienced severe headache , body aches, severe arm pain so that she could not lift her arm and it caused a flare up of auto immune disease and could not shower or eat for 2 days. No treatment information was provided . Action taken with mRNA-1273 in response to the events was not reported. At the time of report, the outcome of the events severe headache , body aches, severe arm pain so that she could not lift her arm and it caused a flare up of auto immune disease and could not shower or eat for 2 days was unknown.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Pain, Pain in extremity
Clinical narrative: body aches; Severe Arm Pain; could not lift her arm; Could not shower for 2 days; Could not eat for 2 days; caused a flare up of auto immune disease; Still not feeling normal; severe headaches; A spontaneous report was received from a consumer concerning a 58-female patient, who received Moderna COVID-19 vaccine (mRNA-1273) and experienced severe headache , body aches, severe arm pain so that she could not lift her arm and it caused a flare up of auto immune disease and could not shower or eat for 2 days. The patient's medical history was not provided. Relevant concomitant medications include Dupixent and Prednisone was reported. On 12-jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273(lot number : 039K20A) intramuscularly on left upper arm  for the prophylaxis of COVID-19 infection. On 13-jan-2021, the patient experienced severe headache , body aches, severe arm pain so that she could not lift her arm and it caused a flare up of auto immune disease and could not shower or eat for 2 days. No treatment information was provided . Action taken with mRNA-1273 in response to the events was not reported. At the time of report, the outcome of the events severe headache , body aches, severe arm pain so that she could not lift her arm and it caused a flare up of auto immune disease and could not shower or eat for 2 days was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Redness at the injection site; Itchiness on her arm at the injection site; Pain in wrist on the same arm; A spontaneous case report (united states) was received from a consumer, concerning female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) experienced redness and itchiness on her arm at the injection site and pain in wrist on the same arm.  The patient's medical history not provided by the reporter. Concomitant medications were not reported.  On unknown date, patient received their first of two planned doses of mRNA-1273 (Lot/Batch: unknown) for prophylaxis of COVID-19 infection.   On unknown date, patient experienced redness and itchiness on her arm at the injection site and pain in wrist on the same arm. Treatment information was not provided   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of event experienced for redness and itchiness on her arm at the injection site and Pain in wrist was unknown.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pyrexia
Clinical narrative: Fatigue; Headache; Chills; Mild fever; A spontaneous report was received from 83 years old female patient of unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fatigue, headache, chills and mild fever.  Medical history was not reported.  Concomitant medication was not reported.  On an unknown date, prior to the onset of the events fatigue, headache, chills and mild fever, the patient received their first of two planned doses of mRNA-1273 (lot/batch: O11L01A) via unknown route in unknown anatomical location for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced events fatigue, headache, chills and mild fever.  Laboratory details was not provided.  Treatment medication included acetaminophen and aspirin at an unknown dose and frequency via an unknown route for fever.  Action taken with mRNA-1273 in response to the events fatigue, headache, chills and mild fever was not provided.  The outcome of the events fatigue, headache, chills and mild fever was not provided and the outcome of the event mild fever was recovered on an unknown date.  The reporter did not provide the assessment of the events fatigue, headache, chills and mild fever to study drug.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: Redness on the shoulder from the injection side; Swollen shoulder; A spontaneous report was received from the consumer,79 years old female has developed redness on the shoulder from the injection side, as well as the swollen shoulder from her 1st dose of Moderna.Patients medical history was unknown. Patients concomitant medication was unknown.S he has received  COVID-19 Vaccine on January 13, 2021.She wanted to know whether it will impact her ability to get her 2nd dose of COVID-19 Vaccine.The event has not recovered.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: arm started itching at vaccination site; became red at the vaccination site; swollen at the vaccination site; A spontaneous report  was received from a consumer (patient) concerning an 65-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced arm started itching at vaccination site, became red at the vaccination site and swollen at the vaccination site.  No medical history was provided. No relevant concomitant medications were reported.  On 11-Jan-2021, 8 days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 026L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 19-Jan-2021, the patient experienced arm started itching at vaccination site, became red at the vaccination site and swollen at the vaccination site.   Treatment information included patient took Hydrocortisone, Benadryl.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, arm started itching at vaccination site, became red at the vaccination site and swollen at the vaccination site were unknown.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site warmth
Clinical narrative: Red splotch at injection site. Bigger than a 50 cent piece and not perfectly round, has some; Felt a little Warm at Injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Red splotch at injection site. Bigger than a 50 cent piece and not perfectly round, has some) and VACCINATION SITE WARMTH (Felt a little Warm at Injection site) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L208) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red splotch at injection site. Bigger than a 50 cent piece and not perfectly round, has some) and VACCINATION SITE WARMTH (Felt a little Warm at Injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Red splotch at injection site. Bigger than a 50 cent piece and not perfectly round, has some) and VACCINATION SITE WARMTH (Felt a little Warm at Injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness on the Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness on the Injection Site) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced VACCINATION SITE PAIN (Soreness on the Injection Site). At the time of the report, VACCINATION SITE PAIN (Soreness on the Injection Site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: a little bit of a rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (a little bit of a rash) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On an unknown date, the patient experienced VACCINATION SITE RASH (a little bit of a rash). At the time of the report, VACCINATION SITE RASH (a little bit of a rash) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Malaise, Pyrexia
Clinical narrative: Not feeling good; headache; chills; kind of fever; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Not feeling good), HEADACHE (headache), CHILLS (chills) and PYREXIA (kind of fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced MALAISE (Not feeling good), HEADACHE (headache), CHILLS (chills) and PYREXIA (kind of fever). On 21-Jan-2021, MALAISE (Not feeling good), HEADACHE (headache), CHILLS (chills) and PYREXIA (kind of fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 29.0
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 consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 29-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy (Live, full-term birth High blood pressure towards the end) on 24-Jun-2018, Blood pressure high and Alcohol use (3-5 times a week) on 28-Aug-2020. Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) and VITAMINS NOS for an unknown indication.    On 01-Feb-2021, 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 28-Jul-2020 and the estimated date of delivery was 12-May-2021. On 01-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-seventh week of the pregnancy.  On 01-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Aug-2020, Pregnancy test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medications were not provided.  Lab tests include ULTRASOUND(normal), GLUCOSE TESTING(normal), GENETIC TESTING(normal) on an unknown date .  No treatment information was provided.