chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Tested positive for Covid; A spontaneous report  was received from a healthcare professional (pharmacist) concerning a female patient of unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events tested positive for Covid/ SARS-CoV-2 test positive.  The patient's medical history included Urinary tract infection, in the hospital, patient got plasma and antibiotics for Urinary tract infection. Concomitant medications reported were Metformin for drug use for unknown indication.  On 20 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 29 Jan 2021, the patient experienced the event(s) tested positive for Covid.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event, tested positive for Covid was unknown.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance
Clinical narrative: Couldn't walk; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (Couldn't walk) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included LETROZOLE, LEVOTHYROXINE and AMLODIPINE for an unknown indication.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On an unknown date, the patient experienced GAIT DISTURBANCE (Couldn't walk). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency.   At the time of the report, GAIT DISTURBANCE (Couldn't walk) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Patient's concomitant medication included Bendsarthan.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Malaise, Pain, Thirst
Clinical narrative: pain that felt like two golf balls; really thirsty; Felt immune system compromised; bad shivering; tired; This spontaneous case was reported by a patient and describes the occurrence of PAIN (pain that felt like two golf balls), THIRST (really thirsty), MALAISE (Felt immune system compromised), CHILLS (bad shivering) and FATIGUE (tired) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced PAIN (pain that felt like two golf balls), THIRST (really thirsty), MALAISE (Felt immune system compromised), CHILLS (bad shivering) and FATIGUE (tired). At the time of the report, PAIN (pain that felt like two golf balls), THIRST (really thirsty), MALAISE (Felt immune system compromised), CHILLS (bad shivering) and FATIGUE (tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. The patient took no treatment.   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: No new information
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Constipation, Eructation, Nausea
Clinical narrative: Soreness everywhere; Chills; fever; Constant belching; Joint pain; Nausea; Constipation; A spontaneous report was received from a (Consumer) concerning a- 71 years old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Soreness everywhere, chills, fever, constant belching, constipation, joint pain and nausea. The patient's medical history not reported. No relevant concomitant medications were reported.   On 22 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch:013M20A) unknown route and site for prophylaxis of COVID-19 infection. On 21 Feb 2021, the patient experienced Soreness everywhere, chills, fever, constant belching, constipation, joint pain and nausea. Laboratory details not provided. Treatment was taken as Advil and diazepam. Action taken with mRNA-1273 in response to the events was not reported.  At the time of this report, the outcome of the events were Not Recovered/ Not Resolving.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Soreness everywhere; Chills; fever; Constant belching; Joint pain; Nausea; Constipation; A spontaneous report was received from a (Consumer) concerning a- 71 years old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Soreness everywhere, chills, fever, constant belching, constipation, joint pain and nausea. The patient's medical history not reported. No relevant concomitant medications were reported.   On 22 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch:013M20A) unknown route and site for prophylaxis of COVID-19 infection. On 21 Feb 2021, the patient experienced Soreness everywhere, chills, fever, constant belching, constipation, joint pain and nausea. Laboratory details not provided. Treatment was taken as Advil and diazepam. Action taken with mRNA-1273 in response to the events was not reported.  At the time of this report, the outcome of the events were Not Recovered/ Not Resolving.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Hypoaesthesia oral, Lip swelling, Paraesthesia, Paraesthesia oral
Clinical narrative: Tingling in her chest; distaste in her mouth; tingling of the tongue and lips, they actually became swollen and after a certain point, it became numb; tingling of the tongue and lips, they actually became swollen and after a certain point, it became numb; tingling of the tongue and lips, they actually became swollen and after a certain point, it became numb; tingling of the tongue and lips, they actually became swollen and after a certain point, it became numb; chest tightness; A spontaneous report was received from a consumer concerning, a 65-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced tingling and tightening of chest/paraesthesia, chest discomfort, tingling of tongue and lips/ paraesthesia oral, additional taste in their mouth/ taste disorder, lips and tongue began to swell/swollen lips, swollen tongue and tongue and lips eventually became numb/hypoaesthesia oral.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 28 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 010M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On the same day, immediately after receiving the vaccine the patient had tingling of tongue and lips and also experienced tingling and tightening of chest. After two hours of vaccine lips and tongue began to swell and later the patient's tongue and lips eventually became numb. The patient also felt an additional taste in their mouth  On the same day, four hours after receiving the vaccine, the patient reported their tingling and tightness went away.  The patient was scheduled for their second dose on 25 Feb 2021 and contacted their doctor on 22 Feb 2021 to determine if patient should take the vaccine.  No treatment information was provided for the event.  Action taken with mRNA-1273 in response to the event(s) was not reported.  The outcome of the events tingling and tightening of chest, tingling of tongue and lips, additional taste in their mouth, lips and tongue began to swell and tongue and lips eventually became numb were considered resolved at the time of this report.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Swollen tongue, Taste disorder
Clinical narrative: Tingling in her chest; distaste in her mouth; tingling of the tongue and lips, they actually became swollen and after a certain point, it became numb; tingling of the tongue and lips, they actually became swollen and after a certain point, it became numb; tingling of the tongue and lips, they actually became swollen and after a certain point, it became numb; tingling of the tongue and lips, they actually became swollen and after a certain point, it became numb; chest tightness; A spontaneous report was received from a consumer concerning, a 65-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced tingling and tightening of chest/paraesthesia, chest discomfort, tingling of tongue and lips/ paraesthesia oral, additional taste in their mouth/ taste disorder, lips and tongue began to swell/swollen lips, swollen tongue and tongue and lips eventually became numb/hypoaesthesia oral.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 28 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 010M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On the same day, immediately after receiving the vaccine the patient had tingling of tongue and lips and also experienced tingling and tightening of chest. After two hours of vaccine lips and tongue began to swell and later the patient's tongue and lips eventually became numb. The patient also felt an additional taste in their mouth  On the same day, four hours after receiving the vaccine, the patient reported their tingling and tightness went away.  The patient was scheduled for their second dose on 25 Feb 2021 and contacted their doctor on 22 Feb 2021 to determine if patient should take the vaccine.  No treatment information was provided for the event.  Action taken with mRNA-1273 in response to the event(s) was not reported.  The outcome of the events tingling and tightening of chest, tingling of tongue and lips, additional taste in their mouth, lips and tongue began to swell and tongue and lips eventually became numb were considered resolved at the time of this report.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Pain, Pyrexia
Clinical narrative: Fatigue; Diarrhoea; Fever (101.3); Chills; Body aches; tches but not too much; blotchy rash on injection site down arm about 6 inches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (tches but not too much), VACCINATION SITE RASH (blotchy rash on injection site down arm about 6 inches), FATIGUE (Fatigue), DIARRHOEA (Diarrhoea) and PYREXIA (Fever (101.3)) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Allergic to Codeine). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (tches but not too much) and VACCINATION SITE RASH (blotchy rash on injection site down arm about 6 inches). On 08-Mar-2021, the patient experienced DIARRHOEA (Diarrhoea), PYREXIA (Fever (101.3)), CHILLS (Chills) and PAIN (Body aches). On 09-Mar-2021, the patient experienced FATIGUE (Fatigue). On 10-Mar-2021, DIARRHOEA (Diarrhoea), PYREXIA (Fever (101.3)), CHILLS (Chills) and PAIN (Body aches) had resolved. At the time of the report, VACCINATION SITE PRURITUS (tches but not too much), VACCINATION SITE RASH (blotchy rash on injection site down arm about 6 inches) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash
Clinical narrative: Fatigue; Diarrhoea; Fever (101.3); Chills; Body aches; tches but not too much; blotchy rash on injection site down arm about 6 inches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (tches but not too much), VACCINATION SITE RASH (blotchy rash on injection site down arm about 6 inches), FATIGUE (Fatigue), DIARRHOEA (Diarrhoea) and PYREXIA (Fever (101.3)) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Allergic to Codeine). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (tches but not too much) and VACCINATION SITE RASH (blotchy rash on injection site down arm about 6 inches). On 08-Mar-2021, the patient experienced DIARRHOEA (Diarrhoea), PYREXIA (Fever (101.3)), CHILLS (Chills) and PAIN (Body aches). On 09-Mar-2021, the patient experienced FATIGUE (Fatigue). On 10-Mar-2021, DIARRHOEA (Diarrhoea), PYREXIA (Fever (101.3)), CHILLS (Chills) and PAIN (Body aches) had resolved. At the time of the report, VACCINATION SITE PRURITUS (tches but not too much), VACCINATION SITE RASH (blotchy rash on injection site down arm about 6 inches) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Exposure during pregnancy, Pregnancy test, Ultrasound foetal
Clinical narrative: Pregnant; Sore arm; A spontaneous report was received from a consumer concerning a 32-year old pregnant female patient who experienced exposure to vaccine during pregnancy and a sore arm.   The patient's medical history was not provided. Concomitant medication provided mentions prenatal vitamins.   The patient received their first of two planned doses of mRNA-1273 (Batch number:014M20A) on 25 Feb 2021 for prophylaxis of COVID-19 infection.  Patient got a positive pregnancy test on 03 Jan 2021. Her last menstrual period was 06 Dec 2020, and estimated date of conception was not provided. The patients estimated due date is 16 Sep 2021. On 25 Feb 2021, the pregnant patient was exposed to the mRNA-1273 vaccine. She would like to be enrolled to the pregnancy registry.  On 25 Feb 2021, after the vaccination, the patient reported she experienced a sore arm. Treatment information was not provided. Action taken with mRNA-1273 in response to the event is not mentioned.  The outcome of the event, [sore arm] was considered unknown.
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate increased, Pharyngeal swelling
Clinical narrative: trouble breathing; swelling in my throat; rapid heart rate; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (trouble breathing), PHARYNGEAL SWELLING (swelling in my throat) and HEART RATE INCREASED (rapid heart rate) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, the patient experienced DYSPNOEA (trouble breathing), PHARYNGEAL SWELLING (swelling in my throat) and HEART RATE INCREASED (rapid heart rate). At the time of the report, DYSPNOEA (trouble breathing) and PHARYNGEAL SWELLING (swelling in my throat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. Treatment medications was not provided.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Musculoskeletal chest pain, Vaccination complication
Clinical narrative: Report AE from second vaccine/Had and every other symptom on fact sheet; Pain in rib; Pain all the way pain down spine; Pain in Knee; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Report AE from second vaccine/Had and every other symptom on fact sheet), MUSCULOSKELETAL CHEST PAIN (Pain in rib), BACK PAIN (Pain all the way pain down spine) and ARTHRALGIA (Pain in Knee) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 027L20A,) for COVID-19 vaccination.     The patient's past medical history included Open heart surgery. Concomitant products included LORAZEPAM and ESCITALOPRAM for an unknown indication.   On 05-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced VACCINATION COMPLICATION (Report AE from second vaccine/Had and every other symptom on fact sheet), MUSCULOSKELETAL CHEST PAIN (Pain in rib), BACK PAIN (Pain all the way pain down spine) and ARTHRALGIA (Pain in Knee). On 09-Feb-2021, VACCINATION COMPLICATION (Report AE from second vaccine/Had and every other symptom on fact sheet), MUSCULOSKELETAL CHEST PAIN (Pain in rib), BACK PAIN (Pain all the way pain down spine) and ARTHRALGIA (Pain in Knee) had resolved.            There was no treatment taken for symptoms Action taken with mRNA-1273 in response to the events was  not applicable    Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Patient age, gender, medical history entered. In products tab, first and second vaccination lot number, anatomical position and date of second vaccination updated. Concomitant Products updated. New events back pain, musculoskeletal chest pain, arthralgia, vaccination complication entered and outcome of events updated.
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction
Clinical narrative: adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (adverse reaction) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (adverse reaction). At the time of the report, ADVERSE REACTION (adverse reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant and treatment information were not provided.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pruritus
Clinical narrative: Itching on ears, necks and all over body; Pain; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching on ears, necks and all over body) and PAIN (Pain) in an 84-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 (medical history not reported.).    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Itching on ears, necks and all over body) and PAIN (Pain). At the time of the report, PRURITUS (Itching on ears, necks and all over body) and PAIN (Pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal
Clinical narrative: was more like a brain fog; Dizziness; A spontaneous report (United States) was received from a consumer concerning, a female patient of an unknown age who received Moderna (mRNA-1273) vaccine and experienced lots of dizziness/dizziness and more like brain fog / feeling abnormal.  The patient's medical history provided included the patient received both the first and second of their planned doses of mRNA-1273. Concomitant product use was unknown by the reporter.  The patient received both the first and second of their planned doses of mRNA-1273 (Lot number: unknown for both) via unknown route for prophylaxis of COVID-19 infection. The patient experienced events from both the doses.  Post receiving the first dose of (mRNA-1273) vaccine the patient experienced lots of dizziness, which more felt like brain fog. The patient was able to do stuff but still felt dizzy.  The patient experienced more fatigued after the second dose of mRNA. It has been 3 weeks still patient felt dizzy in doing stuffs. Treatment information was unknown.  Action taken with mRNA-1273 in response to the event(s) was Not applicable.  The outcome of the events, experienced lots of dizziness more like brain fog, can do stuff but it still felt dizzy were not resolved at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia
Clinical narrative: loss of taste; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (loss of taste) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced AGEUSIA (loss of taste). At the time of the report, AGEUSIA (loss of taste) outcome was unknown.            No concomitant medications reported by investigator.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Inappropriate schedule of product administration
Clinical narrative: Inappropriate schedule of vaccine; Woozy; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIZZINESS (Woozy) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included METRONIDAZOLE for an unknown indication.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Jan-2021, the patient experienced DIZZINESS (Woozy). On 19-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine). On 19-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine) had resolved. At the time of the report, DIZZINESS (Woozy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ALLOPURINOL, ENTECAVIR, INDAPAMIDE, LOSARTAN POTASSIUM (LOSARTIN), METOPROLOL and NIFEDIPINE for an unknown indication.   On 16-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 25-Feb-2021, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown.      No treatment information was provided.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Itching on chest and arms; Beginning of rash; This spontaneous case was reported by a pharmacist and describes the occurrence of PRURITUS (Itching on chest and arms) and RASH (Beginning of rash) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history). Concurrent medical conditions included Allergy (sulfa allergy).    On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 26-Feb-2021, the patient experienced PRURITUS (Itching on chest and arms) and RASH (Beginning of rash). At the time of the report, PRURITUS (Itching on chest and arms) and RASH (Beginning of rash) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysgeusia, Fatigue, Heart rate increased, Nasal congestion
Clinical narrative: heart rate is usually normal at 58 - 60, but right now it is 85; stuffy nose; dizziness; really tired; fever of 101.5F; weird metallic taste in her mouth; Tender Injection Site; Swollen Injection Site; Red rash on the injection site (5" X 3"); Hot to the touch Injection Site; A Little Sore Injection Site,arm is very sore; A little Red Injection Site; This spontaneous case was reported by a health care professional and describes the occurrence of INJECTION SITE PAIN (A Little Sore Injection Site,arm is very sore), INJECTION SITE ERYTHEMA (A little Red Injection Site), INJECTION SITE PAIN (Tender Injection Site), INJECTION SITE SWELLING (Swollen Injection Site) and INJECTION SITE RASH (Red rash on the injection site (5" X 3")) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 18-Jan-2021, the patient experienced INJECTION SITE PAIN (A Little Sore Injection Site,arm is very sore) and INJECTION SITE ERYTHEMA (A little Red Injection Site). On 01-Feb-2021, the patient experienced INJECTION SITE PAIN (Tender Injection Site), INJECTION SITE SWELLING (Swollen Injection Site), INJECTION SITE RASH (Red rash on the injection site (5" X 3")) and INJECTION SITE WARMTH (Hot to the touch Injection Site). On 15-Feb-2021, the patient experienced PYREXIA (fever of 101.5F), DYSGEUSIA (weird metallic taste in her mouth), NASAL CONGESTION (stuffy nose), DIZZINESS (dizziness) and FATIGUE (really tired). On an unknown date, the patient experienced HEART RATE INCREASED (heart rate is usually normal at 58 - 60, but right now it is 85). On 20-Jan-2021, INJECTION SITE PAIN (A Little Sore Injection Site,arm is very sore) and INJECTION SITE ERYTHEMA (A little Red Injection Site) outcome was unknown. At the time of the report, INJECTION SITE PAIN (Tender Injection Site), INJECTION SITE SWELLING (Swollen Injection Site), INJECTION SITE RASH (Red rash on the injection site (5" X 3")), INJECTION SITE WARMTH (Hot to the touch Injection Site), PYREXIA (fever of 101.5F), DYSGEUSIA (weird metallic taste in her mouth), NASAL CONGESTION (stuffy nose), DIZZINESS (dizziness) and FATIGUE (really tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site erythema, Vaccination site pain, Vaccination site rash, Vaccination site swelling
Clinical narrative: heart rate is usually normal at 58 - 60, but right now it is 85; stuffy nose; dizziness; really tired; fever of 101.5F; weird metallic taste in her mouth; Tender Injection Site; Swollen Injection Site; Red rash on the injection site (5" X 3"); Hot to the touch Injection Site; A Little Sore Injection Site,arm is very sore; A little Red Injection Site; This spontaneous case was reported by a health care professional and describes the occurrence of INJECTION SITE PAIN (A Little Sore Injection Site,arm is very sore), INJECTION SITE ERYTHEMA (A little Red Injection Site), INJECTION SITE PAIN (Tender Injection Site), INJECTION SITE SWELLING (Swollen Injection Site) and INJECTION SITE RASH (Red rash on the injection site (5" X 3")) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 18-Jan-2021, the patient experienced INJECTION SITE PAIN (A Little Sore Injection Site,arm is very sore) and INJECTION SITE ERYTHEMA (A little Red Injection Site). On 01-Feb-2021, the patient experienced INJECTION SITE PAIN (Tender Injection Site), INJECTION SITE SWELLING (Swollen Injection Site), INJECTION SITE RASH (Red rash on the injection site (5" X 3")) and INJECTION SITE WARMTH (Hot to the touch Injection Site). On 15-Feb-2021, the patient experienced PYREXIA (fever of 101.5F), DYSGEUSIA (weird metallic taste in her mouth), NASAL CONGESTION (stuffy nose), DIZZINESS (dizziness) and FATIGUE (really tired). On an unknown date, the patient experienced HEART RATE INCREASED (heart rate is usually normal at 58 - 60, but right now it is 85). On 20-Jan-2021, INJECTION SITE PAIN (A Little Sore Injection Site,arm is very sore) and INJECTION SITE ERYTHEMA (A little Red Injection Site) outcome was unknown. At the time of the report, INJECTION SITE PAIN (Tender Injection Site), INJECTION SITE SWELLING (Swollen Injection Site), INJECTION SITE RASH (Red rash on the injection site (5" X 3")), INJECTION SITE WARMTH (Hot to the touch Injection Site), PYREXIA (fever of 101.5F), DYSGEUSIA (weird metallic taste in her mouth), NASAL CONGESTION (stuffy nose), DIZZINESS (dizziness) and FATIGUE (really tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: heart rate is usually normal at 58 - 60, but right now it is 85; stuffy nose; dizziness; really tired; fever of 101.5F; weird metallic taste in her mouth; Tender Injection Site; Swollen Injection Site; Red rash on the injection site (5" X 3"); Hot to the touch Injection Site; A Little Sore Injection Site,arm is very sore; A little Red Injection Site; This spontaneous case was reported by a health care professional and describes the occurrence of INJECTION SITE PAIN (A Little Sore Injection Site,arm is very sore), INJECTION SITE ERYTHEMA (A little Red Injection Site), INJECTION SITE PAIN (Tender Injection Site), INJECTION SITE SWELLING (Swollen Injection Site) and INJECTION SITE RASH (Red rash on the injection site (5" X 3")) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 18-Jan-2021, the patient experienced INJECTION SITE PAIN (A Little Sore Injection Site,arm is very sore) and INJECTION SITE ERYTHEMA (A little Red Injection Site). On 01-Feb-2021, the patient experienced INJECTION SITE PAIN (Tender Injection Site), INJECTION SITE SWELLING (Swollen Injection Site), INJECTION SITE RASH (Red rash on the injection site (5" X 3")) and INJECTION SITE WARMTH (Hot to the touch Injection Site). On 15-Feb-2021, the patient experienced PYREXIA (fever of 101.5F), DYSGEUSIA (weird metallic taste in her mouth), NASAL CONGESTION (stuffy nose), DIZZINESS (dizziness) and FATIGUE (really tired). On an unknown date, the patient experienced HEART RATE INCREASED (heart rate is usually normal at 58 - 60, but right now it is 85). On 20-Jan-2021, INJECTION SITE PAIN (A Little Sore Injection Site,arm is very sore) and INJECTION SITE ERYTHEMA (A little Red Injection Site) outcome was unknown. At the time of the report, INJECTION SITE PAIN (Tender Injection Site), INJECTION SITE SWELLING (Swollen Injection Site), INJECTION SITE RASH (Red rash on the injection site (5" X 3")), INJECTION SITE WARMTH (Hot to the touch Injection Site), PYREXIA (fever of 101.5F), DYSGEUSIA (weird metallic taste in her mouth), NASAL CONGESTION (stuffy nose), DIZZINESS (dizziness) and FATIGUE (really tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Feeling abnormal, Myalgia, Rash vesicular
Clinical narrative: muscle aches; chills; rash on their arm and their chest, with little hives or vesicles that now have started to dry up; sensation of being like in a fog like state, mentally for 24-48 hours; skin would get red as a lobster, like a skin flushing, that came and went for 48 hours; rash on their arm and their chest, with little hives or vesicles that now have started to dry up; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of RASH VESICULAR (rash on their arm and their chest, with little hives or vesicles that now have started to dry up), FEELING ABNORMAL (sensation of being like in a fog like state, mentally for 24-48 hours), ERYTHEMA (skin would get red as a lobster, like a skin flushing, that came and went for 48 hours), VACCINATION SITE RASH (rash on their arm and their chest, with little hives or vesicles that now have started to dry up) and MYALGIA (muscle aches) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced RASH VESICULAR (rash on their arm and their chest, with little hives or vesicles that now have started to dry up), FEELING ABNORMAL (sensation of being like in a fog like state, mentally for 24-48 hours), ERYTHEMA (skin would get red as a lobster, like a skin flushing, that came and went for 48 hours) and VACCINATION SITE RASH (rash on their arm and their chest, with little hives or vesicles that now have started to dry up). On an unknown date, the patient experienced MYALGIA (muscle aches) and CHILLS (chills). At the time of the report, RASH VESICULAR (rash on their arm and their chest, with little hives or vesicles that now have started to dry up), FEELING ABNORMAL (sensation of being like in a fog like state, mentally for 24-48 hours), ERYTHEMA (skin would get red as a lobster, like a skin flushing, that came and went for 48 hours), VACCINATION SITE RASH (rash on their arm and their chest, with little hives or vesicles that now have started to dry up), MYALGIA (muscle aches) and CHILLS (chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: muscle aches; chills; rash on their arm and their chest, with little hives or vesicles that now have started to dry up; sensation of being like in a fog like state, mentally for 24-48 hours; skin would get red as a lobster, like a skin flushing, that came and went for 48 hours; rash on their arm and their chest, with little hives or vesicles that now have started to dry up; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of RASH VESICULAR (rash on their arm and their chest, with little hives or vesicles that now have started to dry up), FEELING ABNORMAL (sensation of being like in a fog like state, mentally for 24-48 hours), ERYTHEMA (skin would get red as a lobster, like a skin flushing, that came and went for 48 hours), VACCINATION SITE RASH (rash on their arm and their chest, with little hives or vesicles that now have started to dry up) and MYALGIA (muscle aches) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced RASH VESICULAR (rash on their arm and their chest, with little hives or vesicles that now have started to dry up), FEELING ABNORMAL (sensation of being like in a fog like state, mentally for 24-48 hours), ERYTHEMA (skin would get red as a lobster, like a skin flushing, that came and went for 48 hours) and VACCINATION SITE RASH (rash on their arm and their chest, with little hives or vesicles that now have started to dry up). On an unknown date, the patient experienced MYALGIA (muscle aches) and CHILLS (chills). At the time of the report, RASH VESICULAR (rash on their arm and their chest, with little hives or vesicles that now have started to dry up), FEELING ABNORMAL (sensation of being like in a fog like state, mentally for 24-48 hours), ERYTHEMA (skin would get red as a lobster, like a skin flushing, that came and went for 48 hours), VACCINATION SITE RASH (rash on their arm and their chest, with little hives or vesicles that now have started to dry up), MYALGIA (muscle aches) and CHILLS (chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) and CHILLS (Chills) 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 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 09-Feb-2021, the patient experienced PYREXIA (fever) and CHILLS (Chills).   At the time of the report, PYREXIA (fever) and CHILLS (Chills) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: NNI
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Chills, Headache, Pain in extremity, Pyrexia
Clinical narrative: Anxiety; chills; headache; fever; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), ANXIETY (Anxiety), CHILLS (chills), HEADACHE (headache) and PYREXIA (fever) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm), CHILLS (chills), HEADACHE (headache) and PYREXIA (fever). On an unknown date, the patient experienced ANXIETY (Anxiety). At the time of the report, PAIN IN EXTREMITY (sore arm), ANXIETY (Anxiety), CHILLS (chills), HEADACHE (headache) and PYREXIA (fever) outcome was unknown.            Concomitant medication information was not reported. Treatment information as not reported. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) is considered as not applicable.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Exposure during pregnancy
Clinical narrative: Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of   in a 25-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 032L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No past medical history not provided) and Pregnancy (Pregnancy end date, Live full term birth  1 previous pregnancy) on 24-Apr-2018. Concomitant products included FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) for Allergy, ESCITALOPRAM OXALATE (LEXAPRO) for Anxiety, DOXYLAMINE SUCCINATE, PYRIDOXINE HYDROCHLORIDE (DICLEGIS) for Morning sickness, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-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 30-Sep-2020 and the estimated date of delivery was 07-Jul-2021. The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-first week of the pregnancy.  Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2021, Blood test: was carrier for genetic disease with lip accumulat (Inconclusive) was carrier for genetic disease with lip accumulation.         On an unspecified date the patient had a normal ultrasound and anatomy scan,
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dysphonia, Hypersomnia, Tremor
Clinical narrative: Body tremor/body shakes without temperature/her hands very shaky; Coughing; Creaky sounding voice; Slept alot that day; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Feb-2021 and was forwarded to Moderna on 26-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DYSPHONIA (Creaky sounding voice), HYPERSOMNIA (Slept alot that day), COUGH (Coughing) and TREMOR (Body tremor/body shakes without temperature/her hands very shaky) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for an unknown indication.     Concurrent medical conditions included Myasthenia gravis.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, the patient experienced DYSPHONIA (Creaky sounding voice) and HYPERSOMNIA (Slept alot that day). On 23-Feb-2021, the patient experienced COUGH (Coughing). On 24-Feb-2021, the patient experienced TREMOR (Body tremor/body shakes without temperature/her hands very shaky). At the time of the report, DYSPHONIA (Creaky sounding voice), HYPERSOMNIA (Slept alot that day) and COUGH (Coughing) outcome was unknown and TREMOR (Body tremor/body shakes without temperature/her hands very shaky) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  The patient's medical condition of myasthenia gravis and advanced age are contributing factors.   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 event, a causal relationship cannot be excluded.  The patient's medical condition of myasthenia gravis and advanced age are contributing factors.
Sex: M
Vaccine: COVID19
Symptoms: Depression, Fatigue, Insomnia
Clinical narrative: Worse depression; Insomnia; Tiredness; A spontaneous report was received from a consumer concerning, a male patient of an unspecified age, who received Moderna's COVID-19 vaccine (mRNA-1273) and developed worse depression, tiredness, and insomnia.  The patient's medical history included depression. Concomitant product use was not provided by the reporter.   On 19 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 026L20A) for prophylaxis of COVID-19 infection.   On 16 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Lot number: 011M20A) for prophylaxis of COVID-19 infection.   On an unknown date, after vaccination patient developed worse depression, tiredness, and insomnia.   No laboratory details were provided.  Treatment information for the event was not provided by the reporter.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  On an unknown date, the outcome of the events, worse depression, tiredness, and insomnia, were considered unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: enlarged lymp nodes in left clavicle; A spontaneous report was received from a Consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events enlarged lymph nodes in her left clavicle.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: Detail Batch Number) intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, patient experienced enlarged lymph nodes in her left clavicle.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.  On an unknown date the outcome of events, enlarged lymph nodes in her left clavicle was not reported.