chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: sore; redness; itchhing; A spontaneous report was received from a consumer concerning a 31-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273)  experienced sore, itching, redness 3 inches in diameter that went away and came back on the 9th day.  The patient's medical history was not reported. Concomitant medication Ajovy,Botox  were reported for drug use for unknown indication.  On 13-jan-2021 prior to the onset of the events, the patient received her first of two planned doses of mRNA-1273 (Lot number: 012L20A) for prophylaxis of COVID-19 infection.    On an unknown date patient experienced sore, itching, redness 3 inches in diameter that went away and came back on the 9th day.   The patient was treated for the event with ibuprofen and prednisone.  The action taken for Moderna COVID-19 Vaccine was not reported.     At the time of this report, the outcome of the events redness,sore and itching is 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: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: arm sore at the injection site; vaccination site pain; redness about the size of a quarter; A spontaneous report was received from a Health care professional concerning a 78 year-old female patient who received Moderna's COVID-19 vaccine(mRNA-1273) and experienced events of vaccination site erythema, vaccination site swelling, and vaccination site pain.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 10-Jan-2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (batch unknown) in the left arm for prophylaxis of COVID-19 infection.   On 10-Jan-2021, the patient experienced injection site redness about the size of a quarter.  On 07-Feb-2021, prior to the onset of the events, the patient received the second of two planned doses of mRNA-1273 (Batch no:010M20A) in the left arm for prophylaxis of COVID-19 infection.  On 07-Feb-2021, the patient experienced sore arm at the injection site, slight swelling, and discomfort upon moving his arm away from the body. No Treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.  The Outcome of event was not Reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: hot; red; Rash on left arm that is itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (hot), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE PRURITUS (Rash on left arm that is itchy) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029120A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical History reported).    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, the patient experienced VACCINATION SITE WARMTH (hot), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE PRURITUS (Rash on left arm that is itchy). At the time of the report, VACCINATION SITE WARMTH (hot), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE PRURITUS (Rash on left arm that is itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Laboratory details provided. No concomitant information was reported. Treatment information was not reported.   Reporter did not allow further contact; 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: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Induration, Pain, Pain in extremity, Rhinorrhoea
Clinical narrative: Nose is runny; Aches all over; Feels tired; Pus coming out of the arm from injection site; arm was sore; Hardness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was sore), VACCINATION SITE PUSTULE (Pus coming out of the arm from injection site), RHINORRHOEA (Nose is runny), PAIN (Aches all over) and INDURATION (Hardness) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0026052) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COPD, Cirrhosis of liver, Heart disease, unspecified and COVID-19 in October 2020. Concurrent medical conditions included Allergy (allergy to Humira). Concomitant products included TADALAFIL, OXYBUTYNIN and AZITHROMYCIN for an unknown indication.    On 22-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 PAIN IN EXTREMITY (arm was sore) and INDURATION (Hardness). On 24-Jan-2021, the patient experienced VACCINATION SITE PUSTULE (Pus coming out of the arm from injection site). On 25-Jan-2021, the patient experienced RHINORRHOEA (Nose is runny), PAIN (Aches all over) and FATIGUE (Feels tired). At the time of the report, PAIN IN EXTREMITY (arm was sore), VACCINATION SITE PUSTULE (Pus coming out of the arm from injection site), RHINORRHOEA (Nose is runny), PAIN (Aches all over), INDURATION (Hardness) and FATIGUE (Feels tired) outcome was unknown.        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 medication reported   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: Non-significant information
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pustule
Clinical narrative: Nose is runny; Aches all over; Feels tired; Pus coming out of the arm from injection site; arm was sore; Hardness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was sore), VACCINATION SITE PUSTULE (Pus coming out of the arm from injection site), RHINORRHOEA (Nose is runny), PAIN (Aches all over) and INDURATION (Hardness) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0026052) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COPD, Cirrhosis of liver, Heart disease, unspecified and COVID-19 in October 2020. Concurrent medical conditions included Allergy (allergy to Humira). Concomitant products included TADALAFIL, OXYBUTYNIN and AZITHROMYCIN for an unknown indication.    On 22-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 PAIN IN EXTREMITY (arm was sore) and INDURATION (Hardness). On 24-Jan-2021, the patient experienced VACCINATION SITE PUSTULE (Pus coming out of the arm from injection site). On 25-Jan-2021, the patient experienced RHINORRHOEA (Nose is runny), PAIN (Aches all over) and FATIGUE (Feels tired). At the time of the report, PAIN IN EXTREMITY (arm was sore), VACCINATION SITE PUSTULE (Pus coming out of the arm from injection site), RHINORRHOEA (Nose is runny), PAIN (Aches all over), INDURATION (Hardness) and FATIGUE (Feels tired) outcome was unknown.        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 medication reported   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: Non-significant information
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Vaccination site pain
Clinical narrative: Right Knee Pain; Sore Left Arm (Injection Site); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore Left Arm (Injection Site)) and ARTHRALGIA (Right Knee Pain) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced VACCINATION SITE PAIN (Sore Left Arm (Injection Site)). On an unknown date, the patient experienced ARTHRALGIA (Right Knee Pain). At the time of the report, VACCINATION SITE PAIN (Sore Left Arm (Injection Site)) and ARTHRALGIA (Right Knee Pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Treatment medication was not reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Sinus headache
Clinical narrative: Sinus Headache; Condition worsened; A spontaneous report was received from a Consumer concerning a 69 year-old male patient who received Modern's COVID-19 vaccine (mRNA-1273) and experienced sinus headache and condition worsened.  The patient's medical history include regular sinus headaches.  No concomitant medication are reported.   On 08-Feb-2021, patient received the first of two planned doses of mRNA-1273 (lot/batch: 013M20A) in left arm for prophylaxis of COVID-19 infection.  .  On 08-Feb-2021, the patient experienced the event of sinus headache.  No Laboratory details provided.  No treatment medication has been provided.  Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of the events, sinus headache, and condition worsened, 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: 41.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: contracted covid; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (contracted covid) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (contracted covid). At the time of the report, SARS-COV-2 TEST POSITIVE (contracted covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Jan-2021, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment and concomitant medicines were not provided  Action taken with mRNA-1273 in response to the event was unknown; Reporter's Comments: Based on reporter's causality the event is assessed as unlikely related to mRNA-1273. The event of COVID-19 virus test positive is unlikely related to mRNA-1273 since the vaccine does not contain virus capable of causing infection.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness in left arm, felt a soreness sensation; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness in left arm, felt a soreness sensation) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 029L20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy and Blood pressure. Concomitant products included LISINOPRIL for Blood pressure high, IBUPROFEN and VITAMINS NOS.   On 26-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 22-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 ml. On 26-Dec-2020, the patient experienced VACCINATION SITE PAIN (Soreness in left arm, felt a soreness sensation). On 28-Dec-2020, VACCINATION SITE PAIN (Soreness in left arm, felt a soreness sensation) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided.   This case was linked to MOD-2021-078689 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: Non-Significant: Reporters email contact information has been updated.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: Diagnosed with covid, positive test result; Fever; Cough; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Diagnosed with covid, positive test result), PYREXIA (Fever) and COUGH (Cough) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) 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 26-Jan-2021, the patient experienced COUGH (Cough). On 26-Jan-2021 at 6:00 PM, the patient experienced PYREXIA (Fever). On 27-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Diagnosed with covid, positive test result). On 27-Jan-2021, PYREXIA (Fever) had resolved. On 28-Jan-2021, COUGH (Cough) had resolved. At the time of the report, SARS-COV-2 TEST POSITIVE (Diagnosed with covid, positive test result) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jan-2021, SARS CoV2 test: positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered SARS-COV-2 TEST POSITIVE (Diagnosed with covid, positive test result) to be not related. No further causality assessments were provided for PYREXIA (Fever) and COUGH (Cough).    Treatment included Tylenol, cough medicine
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included Tylenol
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Influenza like illness, Pain
Clinical narrative: body aches; Fatigue; flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), FATIGUE (Fatigue) and INFLUENZA LIKE ILLNESS (flu like symptoms) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (body aches), FATIGUE (Fatigue) and INFLUENZA LIKE ILLNESS (flu like symptoms). At the time of the report, PAIN (body aches) had not resolved and FATIGUE (Fatigue) and INFLUENZA LIKE ILLNESS (flu like symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment information provided.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 08-Feb-2021, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown.        Treatment medication were not provided. Action taken with mRNA-1273 in response to the event was not applicable; 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.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: injection site was red; injection site was itchy; injection site was burn; injection site was swollen; A spontaneous report was received from a consumer concerning 65-year -old, male patient who was administered Moderna's COVID-19 vaccine.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 22-JAN-2021 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot Number: 032L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On  22-JAN-2021 the patient experienced the events injection site was red, injection site was itchy, injection site was burn, injection site was swollen. Treatment medication included alcohol swab.  Action taken with the second dose of mRNA-1273 vaccine was not reported.  The outcome of events injection site was red, injection site was itchy, injection site was burn, injection site was swollen 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: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Migraine, Vaccination site erythema, Vaccination site inflammation, Vaccination site pain
Clinical narrative: Injection site inflammation; Injection site itchy; Injection site red; Injection site sore to touch and Sore arm; migraine; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (migraine), VACCINATION SITE INFLAMMATION (Injection site inflammation), VACCINATION SITE PRURITUS (Injection site itchy), VACCINATION SITE ERYTHEMA (Injection site red) and VACCINATION SITE PAIN (Injection site sore to touch and Sore arm) in a 43-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 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 15-Jan-2021, the patient experienced HEADACHE (Headache). On 16-Jan-2021, the patient experienced MIGRAINE (migraine). On an unknown date, the patient experienced VACCINATION SITE INFLAMMATION (Injection site inflammation), VACCINATION SITE PRURITUS (Injection site itchy), VACCINATION SITE ERYTHEMA (Injection site red) and VACCINATION SITE PAIN (Injection site sore to touch and Sore arm). The patient was treated with PARACETAMOL (TYLENOL) for Migraine, at an unspecified dose and frequency. At the time of the report, MIGRAINE (migraine) and HEADACHE (Headache) had not resolved and VACCINATION SITE INFLAMMATION (Injection site inflammation), VACCINATION SITE PRURITUS (Injection site itchy), VACCINATION SITE ERYTHEMA (Injection site red) and VACCINATION SITE PAIN (Injection site sore to touch and Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: Injection site inflammation; Injection site itchy; Injection site red; Injection site sore to touch and Sore arm; migraine; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (migraine), VACCINATION SITE INFLAMMATION (Injection site inflammation), VACCINATION SITE PRURITUS (Injection site itchy), VACCINATION SITE ERYTHEMA (Injection site red) and VACCINATION SITE PAIN (Injection site sore to touch and Sore arm) in a 43-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 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 15-Jan-2021, the patient experienced HEADACHE (Headache). On 16-Jan-2021, the patient experienced MIGRAINE (migraine). On an unknown date, the patient experienced VACCINATION SITE INFLAMMATION (Injection site inflammation), VACCINATION SITE PRURITUS (Injection site itchy), VACCINATION SITE ERYTHEMA (Injection site red) and VACCINATION SITE PAIN (Injection site sore to touch and Sore arm). The patient was treated with PARACETAMOL (TYLENOL) for Migraine, at an unspecified dose and frequency. At the time of the report, MIGRAINE (migraine) and HEADACHE (Headache) had not resolved and VACCINATION SITE INFLAMMATION (Injection site inflammation), VACCINATION SITE PRURITUS (Injection site itchy), VACCINATION SITE ERYTHEMA (Injection site red) and VACCINATION SITE PAIN (Injection site sore to touch and Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Lethargy, Pyrexia
Clinical narrative: Lethargic; Tired; temperarure high as 102.8F and 102.9F and Sunday as high as 102.4F and 102.6F; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LETHARGY (Lethargic), FATIGUE (Tired) and PYREXIA (temperarure high as 102.8F and 102.9F and Sunday as high as 102.4F and 102.6F) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced LETHARGY (Lethargic), FATIGUE (Tired) and PYREXIA (temperarure high as 102.8F and 102.9F and Sunday as high as 102.4F and 102.6F). At the time of the report, LETHARGY (Lethargic), FATIGUE (Tired) and PYREXIA (temperarure high as 102.8F and 102.9F and Sunday as high as 102.4F and 102.6F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, Body temperature: 102.8f and 102.9f (High) 102.8F and 102.9F. On 21-Jan-2021, Body temperature: 102.4f and 102.6f (High) high as 102.4F and 102.6F..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On unknown date, Lab tests included COVID, flu, pneumonia, and UTI - all returned negative. No Concomitant medications were provided Treatment medication included an IV in the hospital
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Injection site pain
Clinical narrative: Arm Pain Near Injection Site; Fatigue; Joint pain; A spontaneous report was received from a female consumer concerning a72 year old male patient, who received  Moderna covid 19 vaccine and experienced Arm Pain Near the Injection Site, Joint Pain, and Fatigue.  Patient's medical history is unknown.  On 5 Jan 2021 the patient received first dose of mRNA-1273, in the left upper arm.  On 2 Feb 2021 prior to the onset of the events, the patient received second dose of mRNA-1273(Lot #: 025L20A) injection intramuscularly in the left upper arm for prophylaxis of covid 19 infection.  On 3 Feb 2021 the patient experienced onset of symptoms. These symptoms include Arm Pain Near the Injection Site, Joint Pain, and Fatigue. the consumer is self medicating with "Tylenol", to try and help alleviate the symptoms.  The symptoms seemed to have gone away by 04 FEB 2021.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site induration, Vaccination site rash, Vaccination site warmth
Clinical narrative: hard close to the injection site; warm to the touch close to the injection site; Red rash close to the injection site; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm to the touch close to the injection site), VACCINATION SITE INDURATION (hard close to the injection site), MYALGIA (Muscle pain) and VACCINATION SITE RASH (Red rash close to the injection site) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026l20a) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced MYALGIA (Muscle pain). On 24-Jan-2021, the patient experienced VACCINATION SITE WARMTH (warm to the touch close to the injection site) and VACCINATION SITE RASH (Red rash close to the injection site). On an unknown date, the patient experienced VACCINATION SITE INDURATION (hard close to the injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 19-Jan-2021, MYALGIA (Muscle pain) had resolved. At the time of the report, VACCINATION SITE WARMTH (warm to the touch close to the injection site), VACCINATION SITE INDURATION (hard close to the injection site) and VACCINATION SITE RASH (Red rash close to the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Somnolence
Clinical narrative: Slept longer; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Slept longer) and FATIGUE (Tiredness) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03L20A) 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 22-Jan-2021, the patient experienced FATIGUE (Tiredness). On 23-Jan-2021, the patient experienced SOMNOLENCE (Slept longer). On 24-Jan-2021, FATIGUE (Tiredness) had resolved. At the time of the report, SOMNOLENCE (Slept longer) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Pregnant.    On 11-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 an unknown date and the estimated date of delivery was 07-Oct-2021. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). At the time of the report, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) 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 considered EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) to be not related.    No concomitant information was reported. Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 12-Feb-2021: No specific follow-up information recorded.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Vaccination site discharge
Clinical narrative: leaked out of injection site; Tired; nausea; headache; A spontaneous report was received by a health care professional concerning a female patient of an unknown age, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced felt tired, nausea, headaches and after the shot some of the dose leaked from the injection site.  The patient's medical history was not provided by the reporter. Concomitant product use was not reported.  On 26 Dec 2020, prior to the onset of the events, the patient received first dose of mRNA-1273 (Lot number unknown) for prophylaxis of COVID-19 infection. After first dose the patient experienced nausea, headache, and felt tired.  On an unknown date, the patient received second dose of mRNA-1273 (Lot number unknown). After second dose the patient developed no reaction at all, but some of the dose leaked out of the injection site.  Action taken with mRNA-1273 in response to the events was not reported.  The outcomes of the events felt tired, nausea, headaches, and after the shot some of the dose leaked from the injection site were unknown.; Reporter's Comments: This report refers to a case of dose leaked out of the injection site for mRNA-1273, lot # unknown. Based on the current available information and temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: pain at injection site; A spontaneous report was received from a consumer concerning a 66-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced injection site pain  The patient's medical history was not provided by the reporter.  Concomitant product use was not reported.  On 14 Jan 2021, prior to the onset of symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot #: 0013L20A) intramuscularly for prophylaxis of COVID-19 infection.    The patient's symptoms included pain at injection. Treatment included acetaminophen (one a day), warm cloth and cold compress.   The patient received both scheduled doses of mRNA-1273 therefore, action taken with the drug in response to the events is not applicable.  The outcome of the events, injection site pain, was unknown.; Reporter's Comments: The reported event is consistent with the known safety profile of mRNA-1273 vaccine and temporarily associated with the product use, hence a causal relationship cannot be excluded.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain, Pruritus
Clinical narrative: Itch; Pain; Redness; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itch), PAIN (Pain) and ERYTHEMA (Redness) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) 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) (unknown route) 1 dosage form. On 20-Jan-2021, the patient experienced PRURITUS (Itch), PAIN (Pain) and ERYTHEMA (Redness). At the time of the report, PRURITUS (Itch), PAIN (Pain) and ERYTHEMA (Redness) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator  No treatment medications provided by the reporter.    Most recent FOLLOW-UP information incorporated above includes: On 17-Apr-2021: Follow-up received included No new Information
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Glucose tolerance test, Group B streptococcus neonatal sepsis, Maternal exposure during pregnancy, Pregnancy test, Ultrasound scan
Clinical narrative: Got vaccine while pregnant; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Got vaccine while pregnant) in a 27-year-old female patient (gravida 1, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 014M20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy and Drug allergy. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Vitamin supplementation.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 10-Jul-2020 and the estimated date of delivery was 16-Apr-2021. On 10-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Got vaccine while pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirtieth week of the pregnancy. The patient had a vaginal delivery which occurred on an unknown date, which was reported as Full-term. For neonate 1, the birth weight was 3460 grams (7lbs 10oz) with an APGAR score of 8 and 9 at (1, 5 minutes). The outcome was reported as Delivered NOS. Perinatal complication for the infant included jaundice, bilirubin in high risk zone. slow weight gain was observed after the 1 month post-partum. Length was 51.44 cm and head circumference was  34.93 cm. At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Got vaccine while pregnant) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Aug-2020, Pregnancy test: positive (Positive) Positive. On 08-Aug-2021, Group B streptococcus neonatal sepsis: positive (Positive) Positive (26 Mar 2021). On an unknown date, Glucose tolerance test: normal (normal) Normal. On an unknown date, Ultrasound scan: normal (normal) Normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medications were not reported. Infant abnormalities at 1- month post partum included slow weight gain.   This case was linked to MOD-2021-232123, MOD-2021-232123 (Parent-Child Link).   See case MOD-2021-232123,MOD-2021-232123 for details regarding the child case.  Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Follow up received on 22-JUN-2021 patient demographic details medical history and lab data was updated,perinatal complications, pregnancy outcome. was updated second dose information was updated
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Dizziness, Lip swelling, Migraine
Clinical narrative: rash on lips, down to chin; lips swelling; face so itchy; muscles are so painful; fingers with the arthritis in it, so painful; fingers with the arthritis in it , inflammed yesterday; dizzy; my heart, I had other medical things so they kept me longer; Migraine; A spontaneous report was received from a 60-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced face is so itchy, rash on lips, down to chin and is swollen, dizzy, migraine, my heart, "had other medical things so they kept me longer", fingers with the arthritis in it, they're really inflamed and so painful and muscles are so painful.   The patient's medical history included arthritis, autoimmune diagnosis, multiple sclerosis, bladder and high blood pressure. Concomitant medications included unknown medication for multiple sclerosis, migraine, bladder and high blood pressure.  On 10 Feb 2021, at 5:30pm, the patient received their first of two planned doses of mRNA-1273 (Lot: 031M20A) intramuscularly in left arm for prophylaxis of COVID-19 infection.  On 10 Feb 2021, the patient reported when she received the vaccine, she stated she "was so dizzy, my heart, I had other medical things so they kept me longer." She also mentioned that her fingers with the arthritis in it, were really inflamed and so painful. She stated that her muscles are so painful, but that seemed to subside, but now the rash. I don't know.   On 12 Feb 2021, upon call back from the agent, the patient mentioned that the facility kept her longer, after administration, since she had an autoimmune diagnosis and is allergic to many meds. She also reported having a migraine the evening of 10 Feb 2021, an immediate migraine which lingered into 11 Feb 2021, that she treated with unknown migraine medicine. That her face is so itchy, that she has a rash on her lips, down to my chin, and it is swollen. She took a couple of diphenhydramine hydrochloride this morning as treatment.  She stated that she has not contacted her doctor yet as he doesn't work on Fridays.   Action taken with mRNA-1273 in response to the events was not provided/unknown.  The outcome of the events, face is so itchy, rash on lips, down to chin and is swollen, dizzy, migraine, my heart, "had other medical things so they kept me longer", fingers with the arthritis in it, they're really inflamed and so painful, were unknown.  The event, muscle pain, was considered recovered/resolved, date 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; Sender's Comments:  MOD-2021-013579:same reporter, different patient
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pruritus, Rash, Vaccination complication
Clinical narrative: rash on lips, down to chin; lips swelling; face so itchy; muscles are so painful; fingers with the arthritis in it, so painful; fingers with the arthritis in it , inflammed yesterday; dizzy; my heart, I had other medical things so they kept me longer; Migraine; A spontaneous report was received from a 60-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced face is so itchy, rash on lips, down to chin and is swollen, dizzy, migraine, my heart, "had other medical things so they kept me longer", fingers with the arthritis in it, they're really inflamed and so painful and muscles are so painful.   The patient's medical history included arthritis, autoimmune diagnosis, multiple sclerosis, bladder and high blood pressure. Concomitant medications included unknown medication for multiple sclerosis, migraine, bladder and high blood pressure.  On 10 Feb 2021, at 5:30pm, the patient received their first of two planned doses of mRNA-1273 (Lot: 031M20A) intramuscularly in left arm for prophylaxis of COVID-19 infection.  On 10 Feb 2021, the patient reported when she received the vaccine, she stated she "was so dizzy, my heart, I had other medical things so they kept me longer." She also mentioned that her fingers with the arthritis in it, were really inflamed and so painful. She stated that her muscles are so painful, but that seemed to subside, but now the rash. I don't know.   On 12 Feb 2021, upon call back from the agent, the patient mentioned that the facility kept her longer, after administration, since she had an autoimmune diagnosis and is allergic to many meds. She also reported having a migraine the evening of 10 Feb 2021, an immediate migraine which lingered into 11 Feb 2021, that she treated with unknown migraine medicine. That her face is so itchy, that she has a rash on her lips, down to my chin, and it is swollen. She took a couple of diphenhydramine hydrochloride this morning as treatment.  She stated that she has not contacted her doctor yet as he doesn't work on Fridays.   Action taken with mRNA-1273 in response to the events was not provided/unknown.  The outcome of the events, face is so itchy, rash on lips, down to chin and is swollen, dizzy, migraine, my heart, "had other medical things so they kept me longer", fingers with the arthritis in it, they're really inflamed and so painful, were unknown.  The event, muscle pain, was considered recovered/resolved, date 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; Sender's Comments:  MOD-2021-013579:same reporter, different patient
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Vaccination site pain
Clinical narrative: pregnancy; after first dose, her arm was sore; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (pregnancy) and VACCINATION SITE PAIN (after first dose, her arm was sore) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 028L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE].   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 01-Oct-2021. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (pregnancy) and VACCINATION SITE PAIN (after first dose, her arm was sore). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (pregnancy) had resolved and VACCINATION SITE PAIN (after first dose, her arm was sore) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not reported. Treatment information was not provided.; Reporter's Comments: This is a case of product exposure during pregnancy with associated non-serious adverse events of soreness of arm, chills and low grade temperature for this 29-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Exposure during pregnancy, Glucose tolerance test, Pregnancy test, Ultrasound antenatal screen
Clinical narrative: Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma (Well Controlled, No changes.) since 01-Jan-1993 and Alcohol use (5 drinks per week) since 29-Mar-2021. Concomitant products included OMEPRAZOLE from an unknown date to 26-Mar-2021 for Heartburn, HYDROXYZINE for Insomnia.    On 11-Feb-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 20-Jun-2020 and the estimated date of delivery was 31-Mar-2021. On 11-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-third week of the pregnancy. The vaginal delivery occurred which was reported as Full-term. For neonate 1, the birth weight was 3033 grams (6lbs 11oz) with an APGAR score of 8 and 9 at (1, 5 minutes). The outcome was reported as Delivered NOS. Infant details: Length : 20.25in Sex: Male. On 11-Feb-2021, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Jan-2020, Glucose tolerance test: normal (normal) Normal. On 05-Jan-2020, Ultrasound antenatal screen: normal (normal) Normal. On 18-Jul-2020, Pregnancy test: positive (Positive) Positive. On 31-Aug-2020, Blood test: normal (normal) Normal, Rh, HIV,CBC, Standard  screen.. On 10-Nov-2020, Ultrasound antenatal screen: normal (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No abnormalities identified for the infant.  No treatment medications provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Significant follow up which contains pregnancy outcome details, concomitant medications and medical history updated.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a pharmacist and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 34-year-old female patient (gravida 4, para 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 026L20A) for COVID-19 vaccination.     The patient's past medical history included Miscarriage in June 2016. Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] and 4-STEARYLAMINO-PHENYL-TRIMETHYLAM. METILSULF. for an unknown indication.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on 22-Dec-2020 and the estimated date of delivery was 28-Sep-2021. On 12-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  seventh week of the pregnancy.  On 12-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided by the reporter. It was reported that she found out she was pregnant on 8 Feb 2021. She was having the dating ultrasound on 15 Feb 2021. On 08 Feb 2021 she had positive pregnancy test. She had 3 previous pregnancies. On  Jun 2016 had spontaneous abortion and gave live and full-term birth. The bedside ultrasound was performed on 08 Feb 2021.