chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Muscle tightness, Vaccination site pain
Clinical narrative: Fatigue; Tightness in the left jawand  left neck; Chills; Pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TIGHTNESS (Tightness in the left jawand  left neck), CHILLS (Chills), VACCINATION SITE PAIN (Pain at injection site) and FATIGUE (Fatigue) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-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 MUSCLE TIGHTNESS (Tightness in the left jawand  left neck), CHILLS (Chills) and VACCINATION SITE PAIN (Pain at injection site). On 30-Jan-2021, the patient experienced FATIGUE (Fatigue). At the time of the report, MUSCLE TIGHTNESS (Tightness in the left jawand  left neck), CHILLS (Chills), VACCINATION SITE PAIN (Pain at injection site) and FATIGUE (Fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. The patient did not receive any treatment medications.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Follow-up received on 24-06-2021: No new information
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: Pain in the injection site; a 6*3 inch red spot in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain in the injection site) and VACCINATION SITE ERYTHEMA (a 6*3 inch red spot in the injection site) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 18-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 PAIN (Pain in the injection site) and VACCINATION SITE ERYTHEMA (a 6*3 inch red spot in the injection site). The patient was treated with PARACETAMOL (TYLENOL) for Vaccination site pain and Vaccination site erythema, at an unspecified dose and frequency; IBUPROFEN (ADVIL [IBUPROFEN]) for Vaccination site erythema and Vaccination site pain, at an unspecified dose and frequency and CORTISONE for Vaccination site pain and Vaccination site erythema, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Pain in the injection site) and VACCINATION SITE ERYTHEMA (a 6*3 inch red spot in the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Shoulder is extremely sore; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Shoulder is extremely sore) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Rotator cuff injury.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced ARTHRALGIA (Shoulder is extremely sore). The patient was treated with IBUPROFEN for Shoulder soreness, at an unspecified dose and frequency. At the time of the report, ARTHRALGIA (Shoulder is extremely sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site warmth, Vaccination site discolouration, Vaccination site pain
Clinical narrative: injection site hot; injection site discoloured; injection site  red; injection site sore; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (injection site hot), VACCINATION SITE DISCOLOURATION (injection site discoloured), INJECTION SITE ERYTHEMA (injection site  red) and VACCINATION SITE PAIN (injection site sore) 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 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jan-2021, the patient experienced INJECTION SITE WARMTH (injection site hot), VACCINATION SITE DISCOLOURATION (injection site discoloured), INJECTION SITE ERYTHEMA (injection site  red) and VACCINATION SITE PAIN (injection site sore). At the time of the report, INJECTION SITE WARMTH (injection site hot), VACCINATION SITE DISCOLOURATION (injection site discoloured), INJECTION SITE ERYTHEMA (injection site  red) and VACCINATION SITE PAIN (injection site sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product information was not provided. Treatment information was not reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 10-Jul-2021: Follow-up received on 10-JUL-2021 and contains non significant information
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Myalgia, Pain in extremity
Clinical narrative: arm became sore; muscle pain; joint pain; fatigue; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (arm became sore), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and FATIGUE (fatigue) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-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 PAIN IN EXTREMITY (arm became sore), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and FATIGUE (fatigue). At the time of the report, PAIN IN EXTREMITY (arm became sore), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and FATIGUE (fatigue) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were not provided. No concomitant medications were not provided.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Discomfort, Dizziness, Headache
Clinical narrative: tested positive for Covid; Fever 102; Chills; Her arm also felt sore at the injection site; Headache; Strange Sensation; Light Headed; inside of her nose was really dry; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (Strange Sensation), DIZZINESS (Light Headed), NASAL DRYNESS (inside of her nose was really dry), SARS-COV-2 TEST POSITIVE (tested positive for Covid) and HEADACHE (Headache) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced DISCOMFORT (Strange Sensation), DIZZINESS (Light Headed), NASAL DRYNESS (inside of her nose was really dry), HEADACHE (Headache) and VACCINATION SITE PAIN (Her arm also felt sore at the injection site). On 12-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for Covid), PYREXIA (Fever 102) and CHILLS (Chills). At the time of the report, DISCOMFORT (Strange Sensation), DIZZINESS (Light Headed), NASAL DRYNESS (inside of her nose was really dry), SARS-COV-2 TEST POSITIVE (tested positive for Covid), HEADACHE (Headache), PYREXIA (Fever 102), CHILLS (Chills) and VACCINATION SITE PAIN (Her arm also felt sore at the injection site) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jan-2021, Body temperature: 102 (High) fever. On 12-Jan-2021, SARS-CoV-2 test: positive (abnormal) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal dryness, Pyrexia, SARS-CoV-2 test, SARS-CoV-2 test positive, Vaccination site pain
Clinical narrative: tested positive for Covid; Fever 102; Chills; Her arm also felt sore at the injection site; Headache; Strange Sensation; Light Headed; inside of her nose was really dry; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (Strange Sensation), DIZZINESS (Light Headed), NASAL DRYNESS (inside of her nose was really dry), SARS-COV-2 TEST POSITIVE (tested positive for Covid) and HEADACHE (Headache) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced DISCOMFORT (Strange Sensation), DIZZINESS (Light Headed), NASAL DRYNESS (inside of her nose was really dry), HEADACHE (Headache) and VACCINATION SITE PAIN (Her arm also felt sore at the injection site). On 12-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for Covid), PYREXIA (Fever 102) and CHILLS (Chills). At the time of the report, DISCOMFORT (Strange Sensation), DIZZINESS (Light Headed), NASAL DRYNESS (inside of her nose was really dry), SARS-COV-2 TEST POSITIVE (tested positive for Covid), HEADACHE (Headache), PYREXIA (Fever 102), CHILLS (Chills) and VACCINATION SITE PAIN (Her arm also felt sore at the injection site) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jan-2021, Body temperature: 102 (High) fever. On 12-Jan-2021, SARS-CoV-2 test: positive (abnormal) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, SARS-CoV-2 test
Clinical narrative: Tested positive for covid-19; Tiredness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 (Tested positive for covid-19) and FATIGUE (Tiredness) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J202A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced FATIGUE (Tiredness). On 25-Jan-2021, the patient experienced COVID-19 (Tested positive for covid-19). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event NOS, at an unspecified dose and frequency and NAPROXEN SODIUM (ALEVE) for Adverse event NOS, at an unspecified dose and frequency. At the time of the report, COVID-19 (Tested positive for covid-19) and FATIGUE (Tiredness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jan-2021, SARS-CoV-2 test: positive (Positive) Other.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.; Sender's Comments: Very limited information regarding these events has been provided at this time. The patient probably experienced asymptomatic COVID-19 infection before being administered with the mRNA-1273 vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Pre-existing condition improved
Clinical narrative: some shakiness in her left arm and hand which stopped for a few days after receiving the first dose of vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRE-EXISTING CONDITION IMPROVED (some shakiness in her left arm and hand which stopped for a few days after receiving the first dose of vaccine) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Arm injury (She walked around the corner into the kitchen where her arm caught on an electric wheel chair and injured that arm.). Concurrent medical conditions included Shakiness, Depression and Tremor limb (started after she was taking care of her son who had cancer) since 2013.    On 15-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 PRE-EXISTING CONDITION IMPROVED (some shakiness in her left arm and hand which stopped for a few days after receiving the first dose of vaccine). At the time of the report, PRE-EXISTING CONDITION IMPROVED (some shakiness in her left arm and hand which stopped for a few days after receiving the first dose of vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Additionally after receiving the vaccine she has felt good, rested up, and like the depression she had was gone. She also felt that she could have gotten up and walked, though she was bedridden. Concomitant medications were not provided. The patient did not receive any treatment medications.
Sex: M
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: Experiencing side effect; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (Experiencing side effect) in a male 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 26-Jan-2021, the patient experienced ADVERSE EVENT (Experiencing side effect). At the time of the report, ADVERSE EVENT (Experiencing side effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Very limited information regarding the event has been provided at this time and is insufficient for causality assessment. Further information has been requested.; Sender's Comments: Very limited information regarding the event has been provided at this time and is insufficient for causality assessment. Further information has been requested.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, Vaccination site pain
Clinical narrative: fever; body aches; sore arm; A spontaneous report was received from a consumer concerning a 42-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events flu like symptoms (fever, sore arm, and body ache).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 26 Jan 2021, prior to the onset of the events the patient received their last of two planned doses of mRNA-1273 (lot batch: 038K20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 26 Jan 2021, the patient experienced the events flu like symptoms (fever sore arm, and body ache) and was treated with ibuprofen.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events flu like symptoms was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea, Vaccination site pain, Vaccination site pruritus
Clinical narrative: diarrhea; red rash on the injection arm; injection arm hurts; nausea; A spontaneous report was received from a Consumer concerning a 76-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events red rash on the injection arm, injection arm hurts, nausea and diarrhea.  The patient's medical history include hypertension and chronic kidney disease. Concomitant medications reported were Blood pressure medication, Simvastatin, Pantoprazole, Vitamins, drugs used for unknown indication.  On 29 Jan 2021, prior to the onset of the events the patient received their last of two planned doses of mRNA-1273 (lot batch: 037R20A) for prophylaxis of COVID-19 infection.  On 29 Jan 2021, the patient experienced the events red rash on the injection arm. injection arm hurts, nausea and diarrhea.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, red rash on the injection arm, injection arm hurts, nausea and diarrhea was not reported.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site erythema, Vaccination site rash
Clinical narrative: Itching; It started getting red; Big rash looking around the injection area; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching), VACCINATION SITE ERYTHEMA (It started getting red) and VACCINATION SITE RASH (Big rash looking around the injection area) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037V20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-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 PRURITUS (Itching), VACCINATION SITE ERYTHEMA (It started getting red) and VACCINATION SITE RASH (Big rash looking around the injection area). At the time of the report, PRURITUS (Itching) had resolved, VACCINATION SITE ERYTHEMA (It started getting red) was resolving and VACCINATION SITE RASH (Big rash looking around the injection area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient reported that the rash started in a quarter size, and every day it got bigger and bigger and became almost 6" across. He saw it on TV news that it was called the COVID arm, which is a reaction to the injection. He put ice pack on it drank a lot of water. Concomitant medications were not provided.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Vaccination site pain
Clinical narrative: flu like symptoms; pain and soreness on site of injection; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms) and VACCINATION SITE PAIN (pain and soreness on site of injection) in a 70-year-old female 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 01-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms) and VACCINATION SITE PAIN (pain and soreness on site of injection). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms) and VACCINATION SITE PAIN (pain and soreness on site of injection) 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.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chills, Headache, Influenza like illness, Injection site pain
Clinical narrative: started to feel chills, headaches, body aches, felt like he had a fever; started to feel chills, headaches, body aches, felt like he had a fever; Had all flu like symptoms; Tested positive for Covid-19; started to feel chills, headaches, body aches, felt like he had a fever; started to feel chills, headaches, body aches, felt like he had a fever; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (sore arm), CHILLS (started to feel chills, headaches, body aches, felt like he had a fever), HEADACHE (started to feel chills, headaches, body aches, felt like he had a fever), MYALGIA (started to feel chills, headaches, body aches, felt like he had a fever) and PYREXIA (started to feel chills, headaches, body aches, felt like he had a fever) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included PARACETAMOL (TYLENOL) and PARACETAMOL (TYLENOL) for an unknown indication.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jan-2021, the patient experienced INJECTION SITE PAIN (sore arm). On 23-Jan-2021, the patient experienced HEADACHE (started to feel chills, headaches, body aches, felt like he had a fever). On an unknown date, the patient experienced CHILLS (started to feel chills, headaches, body aches, felt like he had a fever), MYALGIA (started to feel chills, headaches, body aches, felt like he had a fever), PYREXIA (started to feel chills, headaches, body aches, felt like he had a fever), INFLUENZA LIKE ILLNESS (Had all flu like symptoms) and COVID-19 (Tested positive for Covid-19). At the time of the report, INJECTION SITE PAIN (sore arm), CHILLS (started to feel chills, headaches, body aches, felt like he had a fever), HEADACHE (started to feel chills, headaches, body aches, felt like he had a fever), MYALGIA (started to feel chills, headaches, body aches, felt like he had a fever), PYREXIA (started to feel chills, headaches, body aches, felt like he had a fever), INFLUENZA LIKE ILLNESS (Had all flu like symptoms) and COVID-19 (Tested positive for Covid-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.        No treatment information was provided.    Reporter did not allow further contact
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: started to feel chills, headaches, body aches, felt like he had a fever; started to feel chills, headaches, body aches, felt like he had a fever; Had all flu like symptoms; Tested positive for Covid-19; started to feel chills, headaches, body aches, felt like he had a fever; started to feel chills, headaches, body aches, felt like he had a fever; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (sore arm), CHILLS (started to feel chills, headaches, body aches, felt like he had a fever), HEADACHE (started to feel chills, headaches, body aches, felt like he had a fever), MYALGIA (started to feel chills, headaches, body aches, felt like he had a fever) and PYREXIA (started to feel chills, headaches, body aches, felt like he had a fever) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included PARACETAMOL (TYLENOL) and PARACETAMOL (TYLENOL) for an unknown indication.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jan-2021, the patient experienced INJECTION SITE PAIN (sore arm). On 23-Jan-2021, the patient experienced HEADACHE (started to feel chills, headaches, body aches, felt like he had a fever). On an unknown date, the patient experienced CHILLS (started to feel chills, headaches, body aches, felt like he had a fever), MYALGIA (started to feel chills, headaches, body aches, felt like he had a fever), PYREXIA (started to feel chills, headaches, body aches, felt like he had a fever), INFLUENZA LIKE ILLNESS (Had all flu like symptoms) and COVID-19 (Tested positive for Covid-19). At the time of the report, INJECTION SITE PAIN (sore arm), CHILLS (started to feel chills, headaches, body aches, felt like he had a fever), HEADACHE (started to feel chills, headaches, body aches, felt like he had a fever), MYALGIA (started to feel chills, headaches, body aches, felt like he had a fever), PYREXIA (started to feel chills, headaches, body aches, felt like he had a fever), INFLUENZA LIKE ILLNESS (Had all flu like symptoms) and COVID-19 (Tested positive for Covid-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.        No treatment information was provided.    Reporter did not allow further contact
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: Tiredness and Fatigue; body aches; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of FATIGUE (Tiredness and Fatigue) and PAIN (body aches) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A and 011M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-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 FATIGUE (Tiredness and Fatigue) and PAIN (body aches). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) for Fatigue, at an unspecified dose and frequency and VITAMINS NOS for Tiredness, at an unspecified dose and frequency. At the time of the report, FATIGUE (Tiredness and Fatigue) and PAIN (body aches) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment details included Tylenol extra strength and vitamins.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: felt like a tetanus shot and was painful; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (felt like a tetanus shot and was painful) in a male 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,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (felt like a tetanus shot and was painful). At the time of the report, PAIN IN EXTREMITY (felt like a tetanus shot and was painful) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site warmth
Clinical narrative: heat in right arm; itching in right ram; A spontaneous report was received from a consumer concerning a 63-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced heat in right arm and itching in right arm.  The patient's medical history was not provided. No relevant concomitant medications were reported.  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: 025L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 25 Jan 2021, the patient experienced the events heat in right arm where she got vaccinated and itching.  In the evening it will get more itchy and then go away while she sleeps. It is slowly going away.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Redness and swelling; Redness and swelling; Itchy at the Injection area; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchy at the Injection area), VACCINATION SITE ERYTHEMA (Redness and swelling) and VACCINATION SITE SWELLING (Redness and swelling) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029620A - 029C20A not sure) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE for an unknown indication.    On 22-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 VACCINATION SITE PRURITUS (Itchy at the Injection area). On 31-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness and swelling) and VACCINATION SITE SWELLING (Redness and swelling). On 03-Feb-2021, VACCINATION SITE ERYTHEMA (Redness and swelling) and VACCINATION SITE SWELLING (Redness and swelling) had resolved. At the time of the report, VACCINATION SITE PRURITUS (Itchy at the Injection area) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Exposure via breast milk
Clinical narrative: vaccine exposure via breast milk; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE VIA BREAST MILK (vaccine exposure via breast milk) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    MEDICAL HISTORY (Parent): No medical history was provided by reporter.     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 EXPOSURE VIA BREAST MILK (vaccine exposure via breast milk). At the time of the report, EXPOSURE VIA BREAST MILK (vaccine exposure via breast milk) outcome was unknown.            No Concomitant medication were provided by reporter  No treatment was reported
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction
Clinical narrative: Adverse reaction to vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (Adverse reaction to vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 to vaccine). At the time of the report, ADVERSE REACTION (Adverse reaction to vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.        No relevant concomitant medications were reported  No treatment information was provided.   Reporter did not allow further contact
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash erythematous
Clinical narrative: It is not itchy; appeared a reddish rush on patient´s torso, stomach, back, face, around her neck and her chest; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (appeared a reddish rush on patient´s torso, stomach, back, face, around her neck and her chest) and PRURITUS (It is not itchy) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     The patient's past medical history included Red rash. Concomitant products included allergy medication since, nasal spray every morning, Claritin for congestion and MONTELUKAST SODIUM (SINGULAIR) for an unknown indication.    On 31-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced RASH ERYTHEMATOUS (appeared a reddish rush on patient´s torso, stomach, back, face, around her neck and her chest). On an unknown date, the patient experienced PRURITUS (It is not itchy). At the time of the report, RASH ERYTHEMATOUS (appeared a reddish rush on patient´s torso, stomach, back, face, around her neck and her chest) and PRURITUS (It is not itchy) outcome was unknown. Not Provided          Treatment details included No   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Skin discolouration
Clinical narrative: large dark spot on the top of her hand.; as if "I hit my hand and got a large bruise on it."; resembles a large bruise when you hit yourself.; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISCOLOURATION (large dark spot on the top of her hand.), CONTUSION (as if "I hit my hand and got a large bruise on it.") and CONTUSION (resembles a large bruise when you hit yourself.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced SKIN DISCOLOURATION (large dark spot on the top of her hand.), CONTUSION (as if "I hit my hand and got a large bruise on it.") and CONTUSION (resembles a large bruise when you hit yourself.). At the time of the report, SKIN DISCOLOURATION (large dark spot on the top of her hand.), CONTUSION (as if "I hit my hand and got a large bruise on it.") and CONTUSION (resembles a large bruise when you hit yourself.) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Cough, Headache, Pyrexia
Clinical narrative: allergic reaction of itchy red bumps on body and head; chills; fever; bad headaches and got worse; cough; chest congestion; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), PYREXIA (fever), HEADACHE (bad headaches and got worse), COUGH (cough) and CHEST DISCOMFORT (chest congestion) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced CHILLS (chills), PYREXIA (fever), HEADACHE (bad headaches and got worse), COUGH (cough) and CHEST DISCOMFORT (chest congestion). On an unknown date, the patient experienced RASH PRURITIC (allergic reaction of itchy red bumps on body and head). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency. On 09-Jan-2021, CHILLS (chills), HEADACHE (bad headaches and got worse), COUGH (cough) and CHEST DISCOMFORT (chest congestion) had resolved. At the time of the report, PYREXIA (fever) and RASH PRURITIC (allergic reaction of itchy red bumps on body and head) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.    Most recent FOLLOW-UP information incorporated above includes: On 27-Jan-2021: No specific follow-up information recorded.
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: allergic reaction of itchy red bumps on body and head; chills; fever; bad headaches and got worse; cough; chest congestion; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), PYREXIA (fever), HEADACHE (bad headaches and got worse), COUGH (cough) and CHEST DISCOMFORT (chest congestion) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced CHILLS (chills), PYREXIA (fever), HEADACHE (bad headaches and got worse), COUGH (cough) and CHEST DISCOMFORT (chest congestion). On an unknown date, the patient experienced RASH PRURITIC (allergic reaction of itchy red bumps on body and head). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency. On 09-Jan-2021, CHILLS (chills), HEADACHE (bad headaches and got worse), COUGH (cough) and CHEST DISCOMFORT (chest congestion) had resolved. At the time of the report, PYREXIA (fever) and RASH PRURITIC (allergic reaction of itchy red bumps on body and head) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.    Most recent FOLLOW-UP information incorporated above includes: On 27-Jan-2021: No specific follow-up information recorded.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus, Rash
Clinical narrative: first day rash; super itchy; swollen; delayed rash; This spontaneous case was reported by a patient and describes the occurrence of RASH (first day rash), PRURITUS (super itchy), PERIPHERAL SWELLING (swollen) and RASH (delayed rash) in a 30-year-old male patient 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 an unknown date, the patient experienced RASH (first day rash), PRURITUS (super itchy), PERIPHERAL SWELLING (swollen) and RASH (delayed rash). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ITCH) at an unspecified dose and frequency. At the time of the report, RASH (first day rash), PRURITUS (super itchy), PERIPHERAL SWELLING (swollen) and RASH (delayed rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Peripheral swelling, Pruritus
Clinical narrative: Red/ redness keeps spreading/redness/is 11 ½ cm x 20 ½ cm; Swollen/swelling is 8 ½ cm x 5 cm; Itching; Hot to the touch; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red/ redness keeps spreading/redness/is 11 ½ cm x 20 ½ cm), PERIPHERAL SWELLING (Swollen/swelling is 8 ½ cm x 5 cm), PRURITUS (Itching) and FEELING HOT (Hot to the touch) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy.    On 17-Jan-2021 at 8:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2021, the patient experienced ERYTHEMA (Red/ redness keeps spreading/redness/is 11 ½ cm x 20 ½ cm), PERIPHERAL SWELLING (Swollen/swelling is 8 ½ cm x 5 cm), PRURITUS (Itching) and FEELING HOT (Hot to the touch). At the time of the report, ERYTHEMA (Red/ redness keeps spreading/redness/is 11 ½ cm x 20 ½ cm) and PERIPHERAL SWELLING (Swollen/swelling is 8 ½ cm x 5 cm) had not resolved and PRURITUS (Itching) and FEELING HOT (Hot to the touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The relevant concomitant medications were also not provided. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash
Clinical narrative: rash on her arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE RASH (rash on her arm at the injection site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-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 INJECTION SITE RASH (rash on her arm at the injection site). The patient was treated with HYDROCORTISONE (BACTINE [HYDROCORTISONE]) at an unspecified dose and frequency. On 30-Jan-2021, INJECTION SITE RASH (rash on her arm at the injection site) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vaccination site pain
Clinical narrative: Pain at injection site; Dizziness; This spontaneous case was reported by a nurse and describes the occurrence of DIZZINESS (Dizziness) and VACCINATION SITE PAIN (Pain at injection site) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included Vertigo. Concomitant products included MECLIZINE [MECLOZINE] 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 06-Jan-2021, the patient experienced DIZZINESS (Dizziness). On 07-Jan-2021, the patient experienced VACCINATION SITE PAIN (Pain at injection site). On 12-Jan-2021, VACCINATION SITE PAIN (Pain at injection site) had resolved. At the time of the report, DIZZINESS (Dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment details was not provided.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Contusion, Discomfort, Erythema, Pain in extremity
Clinical narrative: uncomfortable; redness; itch was persistent; looks like a bruise; burning sensation: irritated, bigger red blotchy rim; arm was sore; arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (burning sensation: irritated, bigger red blotchy rim), DISCOMFORT (uncomfortable), CONTUSION (looks like a bruise), PAIN IN EXTREMITY (arm was sore) and ERYTHEMA (redness) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm was sore) and VACCINATION SITE PAIN (arm was sore). On 23-Jan-2021, the patient experienced BURNING SENSATION (burning sensation: irritated, bigger red blotchy rim). On 26-Jan-2021, the patient experienced CONTUSION (looks like a bruise). On an unknown date, the patient experienced DISCOMFORT (uncomfortable), ERYTHEMA (redness) and PRURITUS (itch was persistent). On 14-Jan-2021, PAIN IN EXTREMITY (arm was sore) and VACCINATION SITE PAIN (arm was sore) had resolved. At the time of the report, BURNING SENSATION (burning sensation: irritated, bigger red blotchy rim), DISCOMFORT (uncomfortable), CONTUSION (looks like a bruise), ERYTHEMA (redness) and PRURITUS (itch was persistent) 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.   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.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site pain
Clinical narrative: uncomfortable; redness; itch was persistent; looks like a bruise; burning sensation: irritated, bigger red blotchy rim; arm was sore; arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (burning sensation: irritated, bigger red blotchy rim), DISCOMFORT (uncomfortable), CONTUSION (looks like a bruise), PAIN IN EXTREMITY (arm was sore) and ERYTHEMA (redness) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm was sore) and VACCINATION SITE PAIN (arm was sore). On 23-Jan-2021, the patient experienced BURNING SENSATION (burning sensation: irritated, bigger red blotchy rim). On 26-Jan-2021, the patient experienced CONTUSION (looks like a bruise). On an unknown date, the patient experienced DISCOMFORT (uncomfortable), ERYTHEMA (redness) and PRURITUS (itch was persistent). On 14-Jan-2021, PAIN IN EXTREMITY (arm was sore) and VACCINATION SITE PAIN (arm was sore) had resolved. At the time of the report, BURNING SENSATION (burning sensation: irritated, bigger red blotchy rim), DISCOMFORT (uncomfortable), CONTUSION (looks like a bruise), ERYTHEMA (redness) and PRURITUS (itch was persistent) 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.   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.