chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea
Clinical narrative: more fatigued; nauseous; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (more fatigued) and NAUSEA (nauseous) 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) 1 dosage form. On an unknown date, the patient experienced FATIGUE (more fatigued) and NAUSEA (nauseous). At the time of the report, FATIGUE (more fatigued) and NAUSEA (nauseous) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site urticaria
Clinical narrative: itching; hives in the same area of the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itching) and VACCINATION SITE URTICARIA (hives in the same area of the injection) 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 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (itching) and VACCINATION SITE URTICARIA (hives in the same area of the injection). At the time of the report, VACCINATION SITE PRURITUS (itching) and VACCINATION SITE URTICARIA (hives in the same area of the injection) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Sex: M
Vaccine: COVID19
Symptoms: Injection site haemorrhage
Clinical narrative: Bleeding after injection; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE HAEMORRHAGE (Bleeding after injection) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A, 028L20A) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE HAEMORRHAGE (Bleeding after injection). At the time of the report, INJECTION SITE HAEMORRHAGE (Bleeding after injection) outcome was unknown. Unknown          The patient was worried that he did not receive the full dose. The  liquid coming out was more pink than red, so he thought that part of the vaccine was mixed with the blood. Concomitant medications were not provided. Treatment information was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: Itching; Redness; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching) and ERYTHEMA (Redness) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 291201A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced PRURITUS (Itching) and ERYTHEMA (Redness). At the time of the report, PRURITUS (Itching) and ERYTHEMA (Redness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Pyrexia
Clinical narrative: Chest discomfort when breathing; Fever at 102.6; This spontaneous case was reported by a nurse and describes the occurrence of CHEST DISCOMFORT (Chest discomfort when breathing) and PYREXIA (Fever at 102.6) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced CHEST DISCOMFORT (Chest discomfort when breathing) and PYREXIA (Fever at 102.6). At the time of the report, CHEST DISCOMFORT (Chest discomfort when breathing) and PYREXIA (Fever at 102.6) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications included blood pressure medications. Treatment information was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: small rash at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (small rash at the injection site) 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 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced VACCINATION SITE RASH (small rash at the injection site). At the time of the report, VACCINATION SITE RASH (small rash at the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: itchy huge rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (itchy huge rash) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC), ARIPIPRAZOLE (ABILIFY), CLONAZEPAM and OLANZAPINE (ZYPREXA) for an unknown indication.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced RASH PRURITIC (itchy huge rash). At the time of the report, RASH PRURITIC (itchy huge rash) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not reported.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Ear pain, Headache, Pyrexia
Clinical narrative: Very very weak; Headache; Fever; Throwing up; Earache; Diarrhea; A spontaneous report was received from a Consumer concerning a 80-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced headache, earache, fever, throwing up, diarrhea, very very weak.  The patient's medical history was not provided. Concomitant medications reported were Blood Pressure medicine.  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: 012M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 28 Jan 2021, the patient experienced headache, earache, fever, throwing up, diarrhea. On 1 Feb 2021, the patient experienced the events very very weak.  Treatment details included Tylenol.  Action taken with mRNA-1273 in response to the events was unknown.   On 30 Jan 2021 the outcome of headache, earache, fever, throwing up and diarrhea was resolved.  The outcome of very very weak was not recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Very very weak; Headache; Fever; Throwing up; Earache; Diarrhea; A spontaneous report was received from a Consumer concerning a 80-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced headache, earache, fever, throwing up, diarrhea, very very weak.  The patient's medical history was not provided. Concomitant medications reported were Blood Pressure medicine.  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: 012M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 28 Jan 2021, the patient experienced headache, earache, fever, throwing up, diarrhea. On 1 Feb 2021, the patient experienced the events very very weak.  Treatment details included Tylenol.  Action taken with mRNA-1273 in response to the events was unknown.   On 30 Jan 2021 the outcome of headache, earache, fever, throwing up and diarrhea was resolved.  The outcome of very very weak was not recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Productive cough
Clinical narrative: A little cough with phlegm; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCTIVE COUGH (A little cough with phlegm) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced PRODUCTIVE COUGH (A little cough with phlegm). On 31-Jan-2021, PRODUCTIVE COUGH (A little cough with phlegm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient states he takes medicine for his blood pressure (not specified), cholesterol (not specified) and also an anti-acid (not specified). No concomitant medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Patient declined consent for further follow up.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M2DA) 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 30-Jan-2021, the patient experienced DIARRHOEA (Diarrhea). At the time of the report, DIARRHOEA (Diarrhea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On the night of 30-Jan-2021, the patient experienced diarrhoea (watery stools) twice. Concomitant medications were not provided. Treatment information was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Dizziness, Headache
Clinical narrative: weakness; dizziness; stomach pain; headache; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), DIZZINESS (dizziness), ABDOMINAL PAIN UPPER (stomach pain) and HEADACHE (headache) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced ASTHENIA (weakness), DIZZINESS (dizziness), ABDOMINAL PAIN UPPER (stomach pain) and HEADACHE (headache). At the time of the report, ASTHENIA (weakness), DIZZINESS (dizziness), ABDOMINAL PAIN UPPER (stomach pain) and HEADACHE (headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. No treatment was received by the patient.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: Redness around where the shot was given; A spontaneous report was received from a Consumer concerning a 80-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273).   The patient's medical history was not provided. No relevant concomitant medications were reported.  On 19 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch: 032L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 28 Jan 2021, 9 days after vaccination the patient noticed a red circle which enlarged up to 5 inches, no pain or itch. The nurse taking care of the patient complained that the lesion is fading away.   Treatment details not reported.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event erythema at vaccination site was resolving.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site mass, Vaccination site erythema
Clinical narrative: Bruise in the injection site; Hard lump; redness at either side of the injection; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE BRUISING (Bruise in the injection site), INJECTION SITE MASS (Hard lump) and VACCINATION SITE ERYTHEMA (redness at either side of the injection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On 26-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE BRUISING (Bruise in the injection site), INJECTION SITE MASS (Hard lump) and VACCINATION SITE ERYTHEMA (redness at either side of the injection). At the time of the report, INJECTION SITE BRUISING (Bruise in the injection site), INJECTION SITE MASS (Hard lump) and VACCINATION SITE ERYTHEMA (redness at either side of the injection) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Vaccination site erythema
Clinical narrative: a red swelling for 3 daysand  It has a red ring around it, a good probably like 5 inches; my arm swelled up again; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (a red swelling for 3 daysand  It has a red ring around it, a good probably like 5 inches) and PERIPHERAL SWELLING (my arm swelled up again) 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.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (a red swelling for 3 daysand  It has a red ring around it, a good probably like 5 inches) and PERIPHERAL SWELLING (my arm swelled up again). At the time of the report, VACCINATION SITE ERYTHEMA (a red swelling for 3 daysand  It has a red ring around it, a good probably like 5 inches) and PERIPHERAL SWELLING (my arm swelled up again) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Decreased appetite, Diarrhoea, Weight decreased
Clinical narrative: feeling sick to his stomach; diarrhea; lost 15 pounds; can't eat; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (feeling sick to his stomach), DIARRHOEA (diarrhea), WEIGHT DECREASED (lost 15 pounds) and DECREASED APPETITE (can't eat) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025320A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy and Blood pressure high. Concomitant products included LEVOTHYROXINE, OLODATEROL HYDROCHLORIDE, TIOTROPIUM BROMIDE MONOHYDRATE (STIOLTO RESPIMAT), SALBUTAMOL (ALBUTEROL HFA), PANTOPRAZOLE and LOSARTAN for an unknown indication.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced ABDOMINAL PAIN UPPER (feeling sick to his stomach), DIARRHOEA (diarrhea), WEIGHT DECREASED (lost 15 pounds) and DECREASED APPETITE (can't eat). At the time of the report, ABDOMINAL PAIN UPPER (feeling sick to his stomach), DIARRHOEA (diarrhea), WEIGHT DECREASED (lost 15 pounds) and DECREASED APPETITE (can't eat) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Myalgia, Nasopharyngitis, Tenderness
Clinical narrative: woke up sweating; got cold; sore arm; headache; right arm was a little tender; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (right arm was a little tender), HYPERHIDROSIS (woke up sweating), NASOPHARYNGITIS (got cold), MYALGIA (sore arm) and HEADACHE (headache) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     The patient's past medical history included Bone disorder. Concurrent medical conditions included Drug allergy (erythromycin, Cipro and sulfa). Concomitant products included VITAMINS NOS and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication.    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced TENDERNESS (right arm was a little tender). On 01-Feb-2021, the patient experienced HYPERHIDROSIS (woke up sweating), NASOPHARYNGITIS (got cold), MYALGIA (sore arm) and HEADACHE (headache). On 03-Feb-2021, TENDERNESS (right arm was a little tender), HYPERHIDROSIS (woke up sweating), NASOPHARYNGITIS (got cold), MYALGIA (sore arm) and HEADACHE (headache) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication include acetaminophen and Ibuprofen.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia, Vaccination site pain
Clinical narrative: sore right arm; Fever; Nausea; Muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore right arm), PYREXIA (Fever), NAUSEA (Nausea) and MYALGIA (Muscle aches) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (required hospitalization) in November 2020. Concurrent medical conditions included Asthma and Adhesive tape allergy. Concomitant products included OMALIZUMAB (XOLAIR) for Asthma.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 27-Jan-2021, the patient experienced VACCINATION SITE PAIN (sore right arm), PYREXIA (Fever), NAUSEA (Nausea) and MYALGIA (Muscle aches). At the time of the report, VACCINATION SITE PAIN (sore right arm), PYREXIA (Fever), NAUSEA (Nausea) and MYALGIA (Muscle aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not reported.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Cough, Diarrhoea, Dizziness, Fatigue, Headache
Clinical narrative: Dizzy; Nauseous; tired; Diarrhea; Headache; Sore throat; cough; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), COUGH (cough), DIARRHOEA (Diarrhea), DIZZINESS (Dizzy) and HEADACHE (Headache) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat) and COUGH (cough). On 26-Jan-2021, the patient experienced DIARRHOEA (Diarrhea) and HEADACHE (Headache). On 30-Jan-2021, the patient experienced DIZZINESS (Dizzy), NAUSEA (Nauseous) and FATIGUE (tired). On 26-Jan-2021, OROPHARYNGEAL PAIN (Sore throat) and COUGH (cough) had resolved. On 01-Feb-2021, DIARRHOEA (Diarrhea) had resolved. At the time of the report, DIZZINESS (Dizzy), HEADACHE (Headache), NAUSEA (Nauseous) and FATIGUE (tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included Mylanta.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Oropharyngeal pain
Clinical narrative: Dizzy; Nauseous; tired; Diarrhea; Headache; Sore throat; cough; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), COUGH (cough), DIARRHOEA (Diarrhea), DIZZINESS (Dizzy) and HEADACHE (Headache) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat) and COUGH (cough). On 26-Jan-2021, the patient experienced DIARRHOEA (Diarrhea) and HEADACHE (Headache). On 30-Jan-2021, the patient experienced DIZZINESS (Dizzy), NAUSEA (Nauseous) and FATIGUE (tired). On 26-Jan-2021, OROPHARYNGEAL PAIN (Sore throat) and COUGH (cough) had resolved. On 01-Feb-2021, DIARRHOEA (Diarrhea) had resolved. At the time of the report, DIZZINESS (Dizzy), HEADACHE (Headache), NAUSEA (Nauseous) and FATIGUE (tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included Mylanta.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: sore; fever; chill; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (sore), PYREXIA (fever) and CHILLS (chill) 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 22-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 PAIN (sore), PYREXIA (fever) and CHILLS (chill). At the time of the report, PAIN (sore), PYREXIA (fever) and CHILLS (chill) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Rhinorrhoea
Clinical narrative: arm is extremely sore; sniffles; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm is extremely sore) and RHINORRHOEA (sniffles) 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 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm is extremely sore) and RHINORRHOEA (sniffles). At the time of the report, PAIN IN EXTREMITY (arm is extremely sore) and RHINORRHOEA (sniffles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.    Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dizziness, Myalgia, Pain in extremity
Clinical narrative: Sore arm; fever (102.6 F); Chills; joint ache; bodyache; vomiting; dizzines; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PYREXIA (fever (102.6 F)), CHILLS (Chills), ARTHRALGIA (joint ache) and MYALGIA (bodyache) in a 76-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 Migraine. Concomitant products included OXYCODONE HYDROCHLORIDE, OXYCODONE TEREPHTHALATE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]) for Migraine.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), PYREXIA (fever (102.6 F)), CHILLS (Chills), ARTHRALGIA (joint ache), MYALGIA (bodyache), VOMITING (vomiting) and DIZZINESS (dizzines). On 30-Jan-2021, PAIN IN EXTREMITY (Sore arm), PYREXIA (fever (102.6 F)), CHILLS (Chills), ARTHRALGIA (joint ache), MYALGIA (bodyache), VOMITING (vomiting) and DIZZINESS (dizzines) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication included acetaminophen.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Sore arm; fever (102.6 F); Chills; joint ache; bodyache; vomiting; dizzines; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PYREXIA (fever (102.6 F)), CHILLS (Chills), ARTHRALGIA (joint ache) and MYALGIA (bodyache) in a 76-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 Migraine. Concomitant products included OXYCODONE HYDROCHLORIDE, OXYCODONE TEREPHTHALATE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]) for Migraine.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), PYREXIA (fever (102.6 F)), CHILLS (Chills), ARTHRALGIA (joint ache), MYALGIA (bodyache), VOMITING (vomiting) and DIZZINESS (dizzines). On 30-Jan-2021, PAIN IN EXTREMITY (Sore arm), PYREXIA (fever (102.6 F)), CHILLS (Chills), ARTHRALGIA (joint ache), MYALGIA (bodyache), VOMITING (vomiting) and DIZZINESS (dizzines) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication included acetaminophen.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rash erythematous, Rash pruritic
Clinical narrative: slight rash that became red and itchy; slight rash that became red and itchy; some soreness and pain in the injection arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (some soreness and pain in the injection arm), RASH ERYTHEMATOUS (slight rash that became red and itchy) and RASH PRURITIC (slight rash that became red and itchy) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced PAIN IN EXTREMITY (some soreness and pain in the injection arm). On 27-Jan-2021, the patient experienced RASH ERYTHEMATOUS (slight rash that became red and itchy) and RASH PRURITIC (slight rash that became red and itchy). At the time of the report, PAIN IN EXTREMITY (some soreness and pain in the injection arm) and RASH PRURITIC (slight rash that became red and itchy) outcome was unknown and RASH ERYTHEMATOUS (slight rash that became red and itchy) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication included lotion.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Swelling, Vaccination site induration, Vaccination site warmth
Clinical narrative: swelling from her elbow to her shoulder; red; hot; hard; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swelling from her elbow to her shoulder), ERYTHEMA (red), VACCINATION SITE WARMTH (hot) and VACCINATION SITE INDURATION (hard) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013LZ0A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced SWELLING (swelling from her elbow to her shoulder), ERYTHEMA (red), VACCINATION SITE WARMTH (hot) and VACCINATION SITE INDURATION (hard). At the time of the report, SWELLING (swelling from her elbow to her shoulder), ERYTHEMA (red), VACCINATION SITE WARMTH (hot) and VACCINATION SITE INDURATION (hard) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The pharmacist advised the patient to consult her doctor and discuss if it would be ok to take corticosteroids after the second shot.
Age: 93.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue
Clinical narrative: kind of lost the appetite; seemed weakened; A spontaneous report was received from a Healthcare Professional concerning a 93-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events kind of lost the appetite, seemed weakened.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 15 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch: 013L20A) for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the events kind of lost the appetite . On an unknown date, the patient experienced the events seemed weakened.  Treatment details included Extra hydrocort tablet.  Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date the outcome of events include, kind of lost the appetite, seemed weakened was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever of 102-104 for 31 hours.; A spontaneous report was received from a consumer concerning a 28-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fever of 102-104 for 31 hours.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 13 Jan 2021, prior to the onset of the event the patient received their first of two planned doses of mRNA-1273 (lot batch: Unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 13 Jan 2021, an hour after the vaccine, the patient experienced the event Fever of 102-104 for 31 hours..  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   On an unknown date the outcome of event fever of 102-104 for 31 hours was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Asthenia, COVID-19, Cough
Clinical narrative: covid positive; fever; really nauseous; generally exhausted; super weak; lost my sense of taste and smell; lost my sense of taste and smell; a really disgusting wet cough which has become dry; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (super weak), ANOSMIA (lost my sense of taste and smell), AGEUSIA (lost my sense of taste and smell), COUGH (a really disgusting wet cough which has become dry) and COVID-19 (covid positive) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) 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 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jan-2021, the patient experienced ASTHENIA (super weak), ANOSMIA (lost my sense of taste and smell), AGEUSIA (lost my sense of taste and smell), COUGH (a really disgusting wet cough which has become dry), PYREXIA (fever), NAUSEA (really nauseous) and FATIGUE (generally exhausted). On 29-Jan-2021, the patient experienced COVID-19 (covid positive). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form and GUAIFENESIN (MUCINEX) at a dose of 1 dosage form. At the time of the report, ASTHENIA (super weak), ANOSMIA (lost my sense of taste and smell), AGEUSIA (lost my sense of taste and smell), COUGH (a really disgusting wet cough which has become dry), COVID-19 (covid positive), PYREXIA (fever), NAUSEA (really nauseous) and FATIGUE (generally exhausted) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Pyrexia, SARS-CoV-2 test
Clinical narrative: covid positive; fever; really nauseous; generally exhausted; super weak; lost my sense of taste and smell; lost my sense of taste and smell; a really disgusting wet cough which has become dry; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (super weak), ANOSMIA (lost my sense of taste and smell), AGEUSIA (lost my sense of taste and smell), COUGH (a really disgusting wet cough which has become dry) and COVID-19 (covid positive) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) 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 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jan-2021, the patient experienced ASTHENIA (super weak), ANOSMIA (lost my sense of taste and smell), AGEUSIA (lost my sense of taste and smell), COUGH (a really disgusting wet cough which has become dry), PYREXIA (fever), NAUSEA (really nauseous) and FATIGUE (generally exhausted). On 29-Jan-2021, the patient experienced COVID-19 (covid positive). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form and GUAIFENESIN (MUCINEX) at a dose of 1 dosage form. At the time of the report, ASTHENIA (super weak), ANOSMIA (lost my sense of taste and smell), AGEUSIA (lost my sense of taste and smell), COUGH (a really disgusting wet cough which has become dry), COVID-19 (covid positive), PYREXIA (fever), NAUSEA (really nauseous) and FATIGUE (generally exhausted) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Coronavirus test, Cough, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: Tested positive for Covid-19; A temperature 99.1; A little cough; A spontaneous report was received from a Consumer concerning a 79-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events a cough, fever, Covid-19 infection.  The patient's medical history was not provided. Concomitant medications reported were Toprolol XL, Amlodipine Valsartan, Losartan, Amaryl, Dexilant, Citrical plus D, Multivitamin, Vitamin D, Actonel, Zetia, Tricor, Metformin  for unknown indication.  On 12 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (unknown batch number) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 18 Jan 2021, the patient experienced the events a little cough and had fever of temperature 99.1. The patient was reported to be tested positive for Covid-19.  Treatment details included BAM Infusion, Z-Pak and another antibiotics and steroids and cough medicine.  Action taken with mRNA-1273 in response to the events was not reported.   On 29 Jan 2021 the outcome of events, cough, fever and Covid-19 infection was not reported.; Reporter's Comments: The event of Covid-19 infection is unlikely to be related to Moderna's Covid 19 vaccine. Based on the current available information and temporal association between the use of the product and the start date of the events of cough and fever, a causal relationship cannot be excluded.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: Little sore at injection site; Redness around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Little sore at injection site) and VACCINATION SITE ERYTHEMA (Redness around the injection site) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K2OA) for COVID-19 vaccination.     Concurrent medical conditions included Back pain. Concomitant products included MORPHINE for Back injury.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced VACCINATION SITE PAIN (Little sore at injection site) and VACCINATION SITE ERYTHEMA (Redness around the injection site). At the time of the report, VACCINATION SITE PAIN (Little sore at injection site) and VACCINATION SITE ERYTHEMA (Redness around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 18-Apr-2021: Patient declined consent for further follow up
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Anosmia, Arthralgia, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: positive COVID-19; runny nose; loss of smell; Sore arm; A spontaneous report was received from a pharmacist concerning a 39-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events sore arm, runny nose, a little loss of smell, tested positive for Covid-19.  The patient's medical history was not provided. No relevant concomitant medications were reported. Other unspecified medications included Nexium for unknown use.  On 11 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 left arm for prophylaxis of COVID-19 infection.  On 11 Jan 2021, the patient experienced the events sore arm . On 25 Jan 2021, the patient experienced the events runny nose and a little loss of smell. On 29 Jan 2021, the patient reported tested positive for Covid-19.  Treatment for the events was not reported. Action taken with mRNA-1273 in response to the events was not reported.   On 2 Feb 2021, the outcome of the events sore arm, runny nose and loss of smell were reported to be resolved. On 2 Feb 2021 the outcome of the event tested positive for Covid-19 was not reported.; 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. Based on mechanism of action of mRNA -1273 vaccine, the event COVID-19 is assessed as unlikely related to mRNA-1273
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site warmth
Clinical narrative: 2nd dose hot red spot on arm; 2nd dose baseball size sore spot; 2nd dose red hot spot on arm; A spontaneous report  was received from a Healthcare Professional concerning a 65-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events hot spot on arm, red spot on arm  and baseball size sore spot on arm.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unspecified date, the patient received their first of two planned doses of mRNA-1273 (unknown batch number) for prophylaxis of COVID-19 infection. The adverse events reported to the first dose included swelling in arm and red arm.  On an unspecified date, the patient received their first of two planned doses of mRNA-1273 (unknown batch number) for prophylaxis of COVID-19 infection. The adverse events reported to the second dose included hot spot on arm, red spot on arm  and baseball size sore spot on arm. The patient reported to have taken medications Advil and Tylenol prior to second dose of vaccination. Treatment details were not provided.  Action taken with mRNA-1273 in response to the events was not reported.   On 3 Feb 2021, the outcome of events hot spot on arm, red spot on arm  and baseball size sore spot on arm were not reported.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Injection site pain
Clinical narrative: Arm tenderness; fatigue; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Arm tenderness), FATIGUE (fatigue) and ARTHRALGIA (joint pain) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 25-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE PAIN (Arm tenderness), FATIGUE (fatigue) and ARTHRALGIA (joint pain). At the time of the report, INJECTION SITE PAIN (Arm tenderness), FATIGUE (fatigue) and ARTHRALGIA (joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       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. Further information has been requested.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Pruritus, Rash erythematous
Clinical narrative: Big red circle on her arm, sore and itchy, its like a rash; SWOLLEN ARM; ITCHINESS; SORENESS IN ARM; A spontaneous report was received from a Consumer concerning a 41 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events, soreness in the arm, itchiness, big red circle on her arm, sore and itchy, its like a rash, swollen arm. The patient's medical history was not provided. Concomitant medications reported were Dayquil, Nightquil for drug use for unknown indication. On 24 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot batch: 042L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 24 Jan 2021, the patient experienced the events, soreness in the arm. itchiness. On 1 Feb 2021, the patient experienced the events, big red circle on her arm. sore and itchy, its like a rash, swollen arm. Treatment details included Antihistamine - Benadryl Action taken with mRNA-1273 in response to the events, soreness in the arm, itchiness, big red circle on her arm, sore and itchy, its like a rash, swollen arm was not reported.   On an unknown date the outcome of events include, soreness in the arm, itchiness, big red circle on her arm, sore and itchy, its like a rash, swollen arm was not reported.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Feeling cold
Clinical narrative: Could not get warm; Diarrhea; Extreme Chills; A spontaneous report was received from a healthcare professional concerning a 77-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events extreme chills, could not get warm and diarrhea.  The patient's medical history included as asthma. Concomitant medications reported were Dulera Inhaler,  Albuterol Nebulizer.  On 31 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 000UM20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 1 Feb 2021, the patient experienced extreme chills. could not get warm, diarrhea.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of all events were considered resolved on 2 Feb 2021.; Reporter's Comments: Based on the current available information which includes a temporal association between the use of the product and the start date of the reported events, a causal relationship with the event cannot be excluded.  Chills is consistent with the known safety profile of the vaccine.