chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Feeling abnormal, Headache
Clinical narrative: pains; she feels so sick; She started to fade, she started to feel heavy working with the patients; Achy everywhere; Headache; Chills; Feeling tired; Fever 103F; This spontaneous case was reported by a health care professional and describes the occurrence of PAIN (pains), ILLNESS (she feels so sick), FEELING ABNORMAL (She started to fade, she started to feel heavy working with the patients), MYALGIA (Achy everywhere) and HEADACHE (Headache) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced PAIN (pains), ILLNESS (she feels so sick), FEELING ABNORMAL (She started to fade, she started to feel heavy working with the patients), MYALGIA (Achy everywhere), HEADACHE (Headache), CHILLS (Chills), FATIGUE (Feeling tired) and PYREXIA (Fever 103F). The patient was treated with PARACETAMOL (TYLENOL) for Pyrexia, at an unspecified dose and frequency. On 05-Feb-2021, PYREXIA (Fever 103F) had resolved. At the time of the report, PAIN (pains), ILLNESS (she feels so sick), FEELING ABNORMAL (She started to fade, she started to feel heavy working with the patients), MYALGIA (Achy everywhere), HEADACHE (Headache), CHILLS (Chills) and FATIGUE (Feeling tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Feb-2021, Body temperature: high (High) 103F. On 05-Feb-2021, Body temperature: high (High) 101F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Significant FU received on 12 Jul 2021, reporter information, lab data, outcome of event(pyrexia), new event :feeling abnormal updated.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Myalgia, Pain, Pyrexia
Clinical narrative: pains; she feels so sick; She started to fade, she started to feel heavy working with the patients; Achy everywhere; Headache; Chills; Feeling tired; Fever 103F; This spontaneous case was reported by a health care professional and describes the occurrence of PAIN (pains), ILLNESS (she feels so sick), FEELING ABNORMAL (She started to fade, she started to feel heavy working with the patients), MYALGIA (Achy everywhere) and HEADACHE (Headache) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced PAIN (pains), ILLNESS (she feels so sick), FEELING ABNORMAL (She started to fade, she started to feel heavy working with the patients), MYALGIA (Achy everywhere), HEADACHE (Headache), CHILLS (Chills), FATIGUE (Feeling tired) and PYREXIA (Fever 103F). The patient was treated with PARACETAMOL (TYLENOL) for Pyrexia, at an unspecified dose and frequency. On 05-Feb-2021, PYREXIA (Fever 103F) had resolved. At the time of the report, PAIN (pains), ILLNESS (she feels so sick), FEELING ABNORMAL (She started to fade, she started to feel heavy working with the patients), MYALGIA (Achy everywhere), HEADACHE (Headache), CHILLS (Chills) and FATIGUE (Feeling tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Feb-2021, Body temperature: high (High) 103F. On 05-Feb-2021, Body temperature: high (High) 101F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Significant FU received on 12 Jul 2021, reporter information, lab data, outcome of event(pyrexia), new event :feeling abnormal updated.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Diarrhoea, Fatigue, Feeling hot, Heart rate increased
Clinical narrative: back has hurt every day since receiving the vaccine; entire body hurt; extremely fatigued, "it felt like someone get me with a Mack truck"; was smoldering hot; heart rate was raising; DIARRHEA; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (DIARRHEA), FEELING HOT (was smoldering hot), HEART RATE INCREASED (heart rate was raising), BACK PAIN (back has hurt every day since receiving the vaccine) and MYALGIA (entire body hurt) in an 86-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.     The patient's past medical history included No adverse event .  Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN), VITAMIN D NOS and CALCIUM for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced DIARRHOEA (DIARRHEA). On 21-Jan-2021, the patient experienced FEELING HOT (was smoldering hot) and HEART RATE INCREASED (heart rate was raising). On an unknown date, the patient experienced BACK PAIN (back has hurt every day since receiving the vaccine), MYALGIA (entire body hurt) and FATIGUE (extremely fatigued, "it felt like someone get me with a Mack truck"). At the time of the report, DIARRHOEA (DIARRHEA), FEELING HOT (was smoldering hot), HEART RATE INCREASED (heart rate was raising), BACK PAIN (back has hurt every day since receiving the vaccine), MYALGIA (entire body hurt) and FATIGUE (extremely fatigued, "it felt like someone get me with a Mack truck") was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included Statin ( Cholesterol ), 3 Heart Medication. No treatment information provided   Reporter did not allow further contact
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: back has hurt every day since receiving the vaccine; entire body hurt; extremely fatigued, "it felt like someone get me with a Mack truck"; was smoldering hot; heart rate was raising; DIARRHEA; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (DIARRHEA), FEELING HOT (was smoldering hot), HEART RATE INCREASED (heart rate was raising), BACK PAIN (back has hurt every day since receiving the vaccine) and MYALGIA (entire body hurt) in an 86-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.     The patient's past medical history included No adverse event .  Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN), VITAMIN D NOS and CALCIUM for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced DIARRHOEA (DIARRHEA). On 21-Jan-2021, the patient experienced FEELING HOT (was smoldering hot) and HEART RATE INCREASED (heart rate was raising). On an unknown date, the patient experienced BACK PAIN (back has hurt every day since receiving the vaccine), MYALGIA (entire body hurt) and FATIGUE (extremely fatigued, "it felt like someone get me with a Mack truck"). At the time of the report, DIARRHOEA (DIARRHEA), FEELING HOT (was smoldering hot), HEART RATE INCREASED (heart rate was raising), BACK PAIN (back has hurt every day since receiving the vaccine), MYALGIA (entire body hurt) and FATIGUE (extremely fatigued, "it felt like someone get me with a Mack truck") was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included Statin ( Cholesterol ), 3 Heart Medication. No treatment information provided   Reporter did not allow further contact
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnant; This spontaneous pregnancy case was reported by a health care professional and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 15-Dec-2020 and the estimated date of delivery was 21-Sep-2021. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  second week of the pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   patient uses unspecified prenatal vitamins as concomitant medications.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 30-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Came down with COVID; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of COVID-19 (Came down with COVID) in a  patient of an unknown age and gender 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Came down with COVID). At the time of the report, COVID-19 (Came down with COVID) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) PCR and rapid tests were positive.     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.   The doctor reported his patient got the first does of Moderna and about 4-5 days later, came down with COVID. Episode of COVID has resolved and the patient is asymptomatic.  No concomitant medication and treatment medication were reported.   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: The physician reported, his patient never got the Moderna Vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue
Clinical narrative: sore shoulder; feels tired; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (sore shoulder) and FATIGUE (feels tired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No relevant medical history).    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 ARTHRALGIA (sore shoulder) and FATIGUE (feels tired). At the time of the report, ARTHRALGIA (sore shoulder) and FATIGUE (feels tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitants were provided.  treatment medications were reported ice pack.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Received the first dose of the Moderna Covid-19 vaccine and contracted Covid afterwards; A spontaneous report was received from other healthcare professional concerning a patient of an unknown age and gender who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced covid after first dose of the moderna covid-19 vaccine.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection.  On an unknown date, after the first dose of the Moderna Covid-19 vaccine and the patient had contracted covid afterwards. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not provided.  The outcome of event received the first dose of the moderna covid-19 vaccine and contracted covid afterwards was not provided.; Reporter's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: 3 inch diameter rash around the original injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (3 inch diameter rash around the original injection site) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 UNK. On 05-Feb-2021, the patient experienced VACCINATION SITE RASH (3 inch diameter rash around the original injection site). At the time of the report, VACCINATION SITE RASH (3 inch diameter rash around the original injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Non significant follow up received on 05-MAY-2021, No new information
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Diarrhoea, Dizziness, Headache, Nausea
Clinical narrative: felt dizzy; diarrhea; No appetite; Headache; Nausea; A spontaneous report was received from a Consumer concerning a 53-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced headache, nausea, felt dizzy, diarrhea and no appetite.  The patient's medical history was not provided. No relevant concomitant medications were reported.  The caller reported contracted COVID-19 on October 2020 it was mild, nothing terribly bad.  No relevant lab data was provided by the reporter.  On 25 Jan 2021, prior to the onset of the events the patient received the first of two planned doses of mRNA-1273 (lot/batch: 041L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced headache, nausea, felt dizzy, diarrhea, no appetite, The symptoms on the patient lasted longer, head ache and nausea affected the patient the most.  Treatment details included Tylenol.  Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date the outcome of events was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test
Clinical narrative: felt dizzy; diarrhea; No appetite; Headache; Nausea; A spontaneous report was received from a Consumer concerning a 53-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced headache, nausea, felt dizzy, diarrhea and no appetite.  The patient's medical history was not provided. No relevant concomitant medications were reported.  The caller reported contracted COVID-19 on October 2020 it was mild, nothing terribly bad.  No relevant lab data was provided by the reporter.  On 25 Jan 2021, prior to the onset of the events the patient received the first of two planned doses of mRNA-1273 (lot/batch: 041L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced headache, nausea, felt dizzy, diarrhea, no appetite, The symptoms on the patient lasted longer, head ache and nausea affected the patient the most.  Treatment details included Tylenol.  Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date the outcome of events was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Dyspnoea, Pain, Pyrexia, Throat tightness
Clinical narrative: Abdominal pain (left rib); Body ache; Fever; Problem breathing, shortness of breath and it was hard to breath; Throat was closing; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Problem breathing, shortness of breath and it was hard to breath), THROAT TIGHTNESS (Throat was closing), ABDOMINAL PAIN (Abdominal pain (left rib)), PAIN (Body ache) and PYREXIA (Fever) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No medical history was reported.     On 13-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 DYSPNOEA (Problem breathing, shortness of breath and it was hard to breath). 13-Jan-2021, the patient experienced THROAT TIGHTNESS (Throat was closing). On 15-Jan-2021, the patient experienced ABDOMINAL PAIN (Abdominal pain (left rib)), PAIN (Body ache) and PYREXIA (Fever). The patient was treated with FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, DYSPNOEA (Problem breathing, shortness of breath and it was hard to breath), THROAT TIGHTNESS (Throat was closing), ABDOMINAL PAIN (Abdominal pain (left rib)), PAIN (Body ache) and PYREXIA (Fever) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications also included unspecified antihistamine. Concomitant medications included natural supplements for seasonal allergies.   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Follow-up received on 20-APR-2021 included: No new information
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: Shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath) in a 56-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 COVID-19 in March 2020. Concurrent medical conditions included Latex allergy.    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 DYSPNOEA (Shortness of breath). At the time of the report, DYSPNOEA (Shortness of breath) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment information provided
Sex: F
Vaccine: COVID19
Symptoms: Injection site mass, Vaccination site erythema, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: It's about the size area of an orange puffed out; Not real hot but kind of hot; it is red; Having a little itching just around the site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Not real hot but kind of hot), INJECTION SITE MASS (It's about the size area of an orange puffed out), VACCINATION SITE PRURITUS (Having a little itching just around the site) and VACCINATION SITE ERYTHEMA (it is red) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Having a little itching just around the site). On 29-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Not real hot but kind of hot) and VACCINATION SITE ERYTHEMA (it is red). On an unknown date, the patient experienced INJECTION SITE MASS (It's about the size area of an orange puffed out). At the time of the report, VACCINATION SITE WARMTH (Not real hot but kind of hot), INJECTION SITE MASS (It's about the size area of an orange puffed out), VACCINATION SITE PRURITUS (Having a little itching just around the site) and VACCINATION SITE ERYTHEMA (it is red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       This case concerns a female of unknown age with NS unexpected events of vaccination site mass, vaccination site warmth and NS expected events of vaccination site erythema, vaccination site pruritus.  Event onset 8 days after the first dose of mRNA-1273. Treatment not reported. Event outcome 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.; Sender's Comments: This case concerns a female of unknown age with NS unexpected events of vaccination site mass, vaccination site warmth and NS expected events of vaccination site erythema, vaccination site pruritus.  Event onset 8 days after the first dose of mRNA-1273. Treatment not reported. Event outcome 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.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Pyrexia
Clinical narrative: Sweating; fever 101.8F; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating) and PYREXIA (fever 101.8F) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0320L20A) for COVID-19 vaccination.     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 HYPERHIDROSIS (Sweating) and PYREXIA (fever 101.8F). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HYPERHIDROSIS (Sweating) and PYREXIA (fever 101.8F) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were 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 events, a causal relationship cannot be excluded.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site warmth, Pruritus, Urticaria
Clinical narrative: red hives, it grewdiameter of an orange; hotness; redness; itchy; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (red hives, it grewdiameter of an orange), INJECTION SITE WARMTH (hotness), ERYTHEMA (redness) and PRURITUS (itchy) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included EPINEPHRINE (EPIPEN) for Allergy, SALBUTAMOL (SALBUTEROL) for an unknown indication.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced URTICARIA (red hives, it grewdiameter of an orange), INJECTION SITE WARMTH (hotness), ERYTHEMA (redness) and PRURITUS (itchy). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and CORTISONE for Adverse event, at an unspecified dose and frequency. On 14-Jan-2021, URTICARIA (red hives, it grewdiameter of an orange), INJECTION SITE WARMTH (hotness), ERYTHEMA (redness) and PRURITUS (itchy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Follow-up received on 05 May 2021 included no new information.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: Fatigue; Temperature of 99.4; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) and PYREXIA (Temperature of 99.4) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced FATIGUE (Fatigue) and PYREXIA (Temperature of 99.4). At the time of the report, FATIGUE (Fatigue) and PYREXIA (Temperature of 99.4) outcome was unknown.            No concomitant medications were provided No treatment information provided
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore Arm Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore Arm Injection Site) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) 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 VACCINATION SITE PAIN (Sore Arm Injection Site). On 23-Jan-2021, VACCINATION SITE PAIN (Sore Arm Injection Site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant Concomitant medications were reported.   No Treatment information for the event was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Feb-2021 and was forwarded to Moderna on 05-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore Arm Injection Site) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) 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 VACCINATION SITE PAIN (Sore Arm Injection Site). On 23-Jan-2021, VACCINATION SITE PAIN (Sore Arm Injection Site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant Concomitant medications were reported.   No Treatment information for the event was provided.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Ear swelling, Swelling
Clinical narrative: Outer front part of her ear felt swollen; it was uncomfortable; It spread down to her neck /And to her eyebrows; This spontaneous case was reported by a consumer and describes the occurrence of EAR SWELLING (Outer front part of her ear felt swollen), EAR DISCOMFORT (it was uncomfortable) and SWELLING (It spread down to her neck /And to her eyebrows) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History Information was reported.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 20-Feb-2021, the patient experienced EAR SWELLING (Outer front part of her ear felt swollen), EAR DISCOMFORT (it was uncomfortable) and SWELLING (It spread down to her neck /And to her eyebrows). At the time of the report, EAR SWELLING (Outer front part of her ear felt swollen), EAR DISCOMFORT (it was uncomfortable) and SWELLING (It spread down to her neck /And to her eyebrows) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-257310, MOD-2021-257310 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow up  received, Event outcome updated.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache, Myalgia
Clinical narrative: Weakness; Body Aches; Headaches; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), MYALGIA (Body Aches), HEADACHE (Headaches) and CHILLS (Chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 04-Feb-2021, the patient experienced ASTHENIA (Weakness), MYALGIA (Body Aches), HEADACHE (Headaches) and CHILLS (Chills). At the time of the report, ASTHENIA (Weakness), MYALGIA (Body Aches), HEADACHE (Headaches) and CHILLS (Chills) outcome was unknown.            no concomitants were reported no treatment medications were reported.   Reporter did not allow further contact
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Heart rate, Hyperhidrosis
Clinical narrative: Groggy; Sore all over; Nauseous; Headache; Major fatigue; Chills; Could not sleep; Sweats; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Could not sleep), HYPERHIDROSIS (Sweats), SOMNOLENCE (Groggy), MYALGIA (Sore all over) and NAUSEA (Nauseous) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced INSOMNIA (Could not sleep), HYPERHIDROSIS (Sweats), MYALGIA (Sore all over), NAUSEA (Nauseous), HEADACHE (Headache), FATIGUE (Major fatigue) and CHILLS (Chills). On 04-Feb-2021, the patient experienced SOMNOLENCE (Groggy). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at a dose of 1 dosage form and PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 05-Feb-2021, INSOMNIA (Could not sleep), HYPERHIDROSIS (Sweats), SOMNOLENCE (Groggy), MYALGIA (Sore all over), NAUSEA (Nauseous), HEADACHE (Headache), FATIGUE (Major fatigue) and CHILLS (Chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Feb-2021, Heart rate: 95-105 (High) 95-105 bpm and 120-130 (High) 120-130. On 04-Feb-2021, Heart rate: 50-60 (normal) 50-60 beats per minute.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication includes BC Powder.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Follow-up information received on 29-jun-2021 contains event Groggy was updated.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Myalgia, Nausea, Somnolence
Clinical narrative: Groggy; Sore all over; Nauseous; Headache; Major fatigue; Chills; Could not sleep; Sweats; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Could not sleep), HYPERHIDROSIS (Sweats), SOMNOLENCE (Groggy), MYALGIA (Sore all over) and NAUSEA (Nauseous) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced INSOMNIA (Could not sleep), HYPERHIDROSIS (Sweats), MYALGIA (Sore all over), NAUSEA (Nauseous), HEADACHE (Headache), FATIGUE (Major fatigue) and CHILLS (Chills). On 04-Feb-2021, the patient experienced SOMNOLENCE (Groggy). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at a dose of 1 dosage form and PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 05-Feb-2021, INSOMNIA (Could not sleep), HYPERHIDROSIS (Sweats), SOMNOLENCE (Groggy), MYALGIA (Sore all over), NAUSEA (Nauseous), HEADACHE (Headache), FATIGUE (Major fatigue) and CHILLS (Chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Feb-2021, Heart rate: 95-105 (High) 95-105 bpm and 120-130 (High) 120-130. On 04-Feb-2021, Heart rate: 50-60 (normal) 50-60 beats per minute.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication includes BC Powder.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Follow-up information received on 29-jun-2021 contains event Groggy was updated.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Blood urine present, Vaccination site pain
Clinical narrative: Pee blood pretty bad; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD URINE PRESENT (Pee blood pretty bad) and VACCINATION SITE PAIN (Sore arm) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     The patient's past medical history included Prostate induration.    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 VACCINATION SITE PAIN (Sore arm). On 04-Feb-2021, the patient experienced BLOOD URINE PRESENT (Pee blood pretty bad). On 04-Feb-2021, BLOOD URINE PRESENT (Pee blood pretty bad) had resolved. At the time of the report, VACCINATION SITE PAIN (Sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Non significant follow up received on 21-MAY-2021, no new information
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vertigo, Vomiting
Clinical narrative: vomits; vertigo/spinning; headache; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (vertigo/spinning), HEADACHE (headache) and VOMITING (vomits) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History Information was reported.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), OMEPRAZOLE and VITAMINS NOS for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced VERTIGO (vertigo/spinning) and HEADACHE (headache). On an unknown date, the patient experienced VOMITING (vomits). At the time of the report, VERTIGO (vertigo/spinning), HEADACHE (headache) and VOMITING (vomits) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Feb-2021 and was forwarded to Moderna on 22-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (vertigo/spinning), HEADACHE (headache) and VOMITING (vomits) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History Information was reported.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), OMEPRAZOLE and VITAMINS NOS for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced VERTIGO (vertigo/spinning) and HEADACHE (headache). On an unknown date, the patient experienced VOMITING (vomits). At the time of the report, VERTIGO (vertigo/spinning), HEADACHE (headache) and VOMITING (vomits) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Pyrexia, Vaccination site pain
Clinical narrative: Weakness; Soreness in the arm at the injection site; Chills all night long; A little fever; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), VACCINATION SITE PAIN (Soreness in the arm at the injection site), CHILLS (Chills all night long) and PYREXIA (A little fever) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 012M20A) 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 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced ASTHENIA (Weakness), CHILLS (Chills all night long) and PYREXIA (A little fever). 04-Feb-2021, the patient experienced VACCINATION SITE PAIN (Soreness in the arm at the injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 05-Feb-2021, CHILLS (Chills all night long) and PYREXIA (A little fever) had resolved. At the time of the report, ASTHENIA (Weakness) and VACCINATION SITE PAIN (Soreness in the arm at the injection site) outcome was unknown.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Muscle spasms, Pain in extremity
Clinical narrative: both of her calves are very sore; Headache; Very very sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Very very sore arm), MUSCLE SPASMS (both of her calves are very sore) and HEADACHE (Headache) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     NO Medical History Information was reported.  Concomitant products included VITAMINS NOS for an unknown indication.    On 29-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced PAIN IN EXTREMITY (Very very sore arm) and HEADACHE (Headache). On 05-Feb-2021, the patient experienced MUSCLE SPASMS (both of her calves are very sore). On 29-Jan-2021, PAIN IN EXTREMITY (Very very sore arm) and HEADACHE (Headache) had resolved. At the time of the report, MUSCLE SPASMS (both of her calves are very sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reported relevant Concomitant medications including statins for unknown indications.   No Treatment information for the event was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Feb-2021 and was forwarded to Moderna on 06-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Very very sore arm), MUSCLE SPASMS (both of her calves are very sore) and HEADACHE (Headache) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     NO Medical History Information was reported.  Concomitant products included VITAMINS NOS for an unknown indication.    On 29-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced PAIN IN EXTREMITY (Very very sore arm) and HEADACHE (Headache). On 05-Feb-2021, the patient experienced MUSCLE SPASMS (both of her calves are very sore). On 29-Jan-2021, PAIN IN EXTREMITY (Very very sore arm) and HEADACHE (Headache) had resolved. At the time of the report, MUSCLE SPASMS (both of her calves are very sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reported relevant Concomitant medications including statins for unknown indications.   No Treatment information for the event was provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth, Pain in extremity, Rash, Vaccination site rash, Vaccination site swelling
Clinical narrative: warm to touch; 10 DAYS LATER DEVELOPED RED OVAL SHAPE PATCH ITCHY RASH AT THE SITE OF THE INJECTION; RED RASH SPREADS FROM SHOULDER TO ELBOW; SWOLLEN AND GETTING BIGGER; SORE ARM FOR 2 DAYS; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (SORE ARM FOR 2 DAYS), INJECTION SITE WARMTH (warm to touch), RASH (10 DAYS LATER DEVELOPED RED OVAL SHAPE PATCH ITCHY RASH AT THE SITE OF THE INJECTION), VACCINATION SITE RASH (RED RASH SPREADS FROM SHOULDER TO ELBOW) and VACCINATION SITE SWELLING (SWOLLEN AND GETTING BIGGER) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Colitis and Osteoporosis. Concomitant products included DENOSUMAB (PROLIA) for Osteoporosis, BUDESONIDE, LOPERAMIDE HYDROCHLORIDE (LOMOTIL [LOPERAMIDE HYDROCHLORIDE]), LOPERAMIDE HYDROCHLORIDE (IMODIUM), ESTRADIOL, VITAMIN D3, VITAMIN B12 NOS, BIOTIN and LIFITEGRAST (XIIDRA) for an unknown indication.    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 (SORE ARM FOR 2 DAYS). On 30-Jan-2021, the patient experienced INJECTION SITE WARMTH (warm to touch), RASH (10 DAYS LATER DEVELOPED RED OVAL SHAPE PATCH ITCHY RASH AT THE SITE OF THE INJECTION), VACCINATION SITE RASH (RED RASH SPREADS FROM SHOULDER TO ELBOW) and VACCINATION SITE SWELLING (SWOLLEN AND GETTING BIGGER). On 22-Jan-2021, PAIN IN EXTREMITY (SORE ARM FOR 2 DAYS) had resolved. At the time of the report, INJECTION SITE WARMTH (warm to touch), RASH (10 DAYS LATER DEVELOPED RED OVAL SHAPE PATCH ITCHY RASH AT THE SITE OF THE INJECTION), VACCINATION SITE RASH (RED RASH SPREADS FROM SHOULDER TO ELBOW) and VACCINATION SITE SWELLING (SWOLLEN AND GETTING BIGGER) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Email ID added On 08-Jul-2021: Follow-up information contains reporter details updated, medical history and concomitant medications were added.
Age: 77.0
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 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included DIAZEPAM (VALIUM) and VITAMIN D NOS for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced DIARRHOEA (Diarrhea). On 30-Jan-2021, DIARRHOEA (Diarrhea) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reported Concomitant medications including Blood pressure and Allergy pill.  It was reported that, the diarrhea was not severe enough for the patient to report to physician. It lasted for only one day. She was not sure if it was from the vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Event description was updated.