chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Erythema, Pruritus, Rash
Clinical narrative: Itchy; Rash; Redness spreading down to the elbow; Redness of arm; A spontaneous report was received from a reporter like consumer concerning a 77 yr old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events redness in her arm, which is itchy and is slowly "going down" to the elbow. The patient was under treatment for immunosuppression. Concomitant medications reported include medication for immunocompromised. On 16th Jan 2021, prior to the onset of the events, the patient received the first of the two planned doses of mRNA-1273 (lot/batch-026L20A) in the anatomical location for prophylaxis of of COVID-19 infection. On 23rd Jan 2021 the patient experienced events like rash and itchy, redness spreading down to the elbow.. Laboratory details were not provided. No treatment information was provided. Action taken with mRNA-1273 in response to the events were not reported
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: rash all over the body; Swelling massively in injection site; itching; burning; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash all over the body), VACCINATION SITE SWELLING (Swelling massively in injection site), VACCINATION SITE PRURITUS (itching) and VACCINATION SITE PAIN (burning) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 14-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 RASH (rash all over the body), VACCINATION SITE SWELLING (Swelling massively in injection site), VACCINATION SITE PRURITUS (itching) and VACCINATION SITE PAIN (burning). At the time of the report, RASH (rash all over the body), VACCINATION SITE SWELLING (Swelling massively in injection site), VACCINATION SITE PRURITUS (itching) and VACCINATION SITE PAIN (burning) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medications were not provided. Treatment details Benadryl. Upon internal review on 04-Aug-21, the age was corrected 63 years.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Rash on injection site; Injection site is warm to touch; Swelling on injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash on injection site), VACCINATION SITE WARMTH (Injection site is warm to touch) and VACCINATION SITE SWELLING (Swelling on injection site) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 15-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 RASH (Rash on injection site), VACCINATION SITE WARMTH (Injection site is warm to touch) and VACCINATION SITE SWELLING (Swelling on injection site). At the time of the report, VACCINATION SITE RASH (Rash on injection site), VACCINATION SITE WARMTH (Injection site is warm to touch) and VACCINATION SITE SWELLING (Swelling on injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rash macular
Clinical narrative: spots around the left eye; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and RASH MACULAR (spots around the left eye) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 28-Jan-2021, the patient experienced RASH MACULAR (spots around the left eye). At the time of the report, PAIN IN EXTREMITY (Sore arm) and RASH MACULAR (spots around the left eye) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product information was not provided. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 10-Jul-2021: Follow-up contains non significant  information.
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness around injection site; Swelling around injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (Redness around injection site) and INJECTION SITE SWELLING (Swelling around injection site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE ERYTHEMA (Redness around injection site) and INJECTION SITE SWELLING (Swelling around injection site). At the time of the report, INJECTION SITE ERYTHEMA (Redness around injection site) and INJECTION SITE SWELLING (Swelling around injection site) 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   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: NNI confirmed
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Sore at injection site; Red circle at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Sore at injection site) and INJECTION SITE ERYTHEMA (Red circle at injection site) in a 68-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 16-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 INJECTION SITE PAIN (Sore at injection site) and INJECTION SITE ERYTHEMA (Red circle at injection site). At the time of the report, INJECTION SITE PAIN (Sore at injection site) and INJECTION SITE ERYTHEMA (Red circle at injection site) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Follow up document was attached on 08-Jun-2021, in which Event outcome was updated to recovered.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: extreme pain in arm/extreme pain in my lower leg on the same side that I got the vaccine/really painful; leg is asleep; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (extreme pain in arm/extreme pain in my lower leg on the same side that I got the vaccine/really painful) and HYPOAESTHESIA (leg is asleep) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (extreme pain in arm/extreme pain in my lower leg on the same side that I got the vaccine/really painful) and HYPOAESTHESIA (leg is asleep). At the time of the report, PAIN IN EXTREMITY (extreme pain in arm/extreme pain in my lower leg on the same side that I got the vaccine/really painful) and HYPOAESTHESIA (leg is asleep) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. Treatment information was not available. The patient reported that she did not have any other symptoms but it was really painful. She felt like her leg was asleep but with a lot of pain. Like she could push on an area that made it hurt even more. The patient reported that according to her, symptoms were definitely related to vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: No new information was received
Sex: F
Vaccine: COVID19
Symptoms: Infective thrombosis
Clinical narrative: immunothrombosis; A spontaneous report  was received from a Consumer concerning a  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the serious, medically significant event of infective thrombosis.  The patient's medical history was not provided. No relevant concomitant medications were reported. On unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection.    On an unknown date, The patient experienced immunothrombosis ( medically significant)  No treatment information was provided.    Action taken with mRNA-1273 in response to the events was not reported.; Reporter's Comments: This case concerns a patient, who experienced a serious unexpected event of infective thrombosis, after receiving 2nd dose of mRNA- 1273 (Lot# unknown). Very limited information regarding this event has been provided at this time. There are no contact details, so no further information has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Tested positive for COVID19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID19) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced COVID-19 (Tested positive for COVID19). At the time of the report, COVID-19 (Tested positive for COVID19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Jan-2021, COVID-19: positive (Positive) Tested positive for COVID-19 after receiving the first dose of the Moderna vaccine.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.   Reporter did not allow further contact.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: pregnancy; A spontaneous pregnancy report  was received from other healthcare Professional concerning a 32 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273).  The patient's medical history, as provided by the reporter,  included one prior pregnancy. The first pregnancy ended on 15 Nov, 2017 with full term birth of the child. No history of pregnancy complications and infant abnormalities.   The patient's medical history also included allergy to Darvocet and demeral.  No concomitant medications were reported.  On 13 Feb 2021, the patient received her first of two planned doses of mRNA-1273 (lot/batch no. 031L20A) intramuscularly in her left arm for prophylaxis of COVID-19 infection.  The patient's last menstrual period was on 20 Aug, 2020.  The estimated date of conception was not provided and the delivery due date was estimated as 27 May 2021.  On 13 Feb 2021, the patient was exposed to mRNA-1273 vaccine. She would like to be enrolled in the pregnancy registry. No treatment information was provided.  The outcome of the event, exposure to vaccine during pregnancy, was  unknown.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Injection site erythema, Injection site pruritus, Injection site rash, Injection site urticaria
Clinical narrative: hives at injection site; itchy at injection site; rash at injection site; red at injection site; chills; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE URTICARIA (hives at injection site), INJECTION SITE PRURITUS (itchy at injection site), INJECTION SITE RASH (rash at injection site), INJECTION SITE ERYTHEMA (red at injection site) and CHILLS (chills) in a female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 15-Jan-2021, the patient experienced INJECTION SITE URTICARIA (hives at injection site), INJECTION SITE PRURITUS (itchy at injection site), INJECTION SITE RASH (rash at injection site), INJECTION SITE ERYTHEMA (red at injection site) and CHILLS (chills). At the time of the report, INJECTION SITE URTICARIA (hives at injection site), INJECTION SITE PRURITUS (itchy at injection site), INJECTION SITE RASH (rash at injection site), INJECTION SITE ERYTHEMA (red at injection site) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.     As per client, MI error in DOB capture No concomitant medication were given. No treatment information were provided by the reporter.   This case was linked to MOD-2021-227044 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling
Clinical narrative: swollen lips; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (swollen lips) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021 at 12:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced LIP SWELLING (swollen lips). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency. At the time of the report, LIP SWELLING (swollen lips) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: no new information.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Heart rate, Muscular weakness, Product dose omission issue
Clinical narrative: Missed dose; Muscles felt weak; Legs felt weak; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Muscles felt weak), ASTHENIA (Legs felt weak) and PRODUCT DOSE OMISSION ISSUE (Missed dose) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced MUSCULAR WEAKNESS (Muscles felt weak) and ASTHENIA (Legs felt weak). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed dose). At the time of the report, MUSCULAR WEAKNESS (Muscles felt weak) and ASTHENIA (Legs felt weak) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Missed dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: went up (High) went up. On an unknown date, Heart rate: rapid heartbeat (High) Rapid heartbeat.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information were reported.   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Follow up received included reporter contact details, patient age updated, lab details added, event details updated.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Decreased appetite, Fatigue, Headache
Clinical narrative: Terrible headaches; Loss of appetite (could not eat or drink for 2 days), lost interest in sweets; Fatigue; Chills; Fever 101-103; This spontaneous pregnancy case was reported by a health care professional and describes the occurrence of DECREASED APPETITE (Loss of appetite (could not eat or drink for 2 days), lost interest in sweets), FATIGUE (Fatigue), CHILLS (Chills), PYREXIA (Fever 101-103) and HEADACHE (Terrible headaches) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 023MA) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (allergic to Benadryl).   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 04-Feb-2021, the patient experienced DECREASED APPETITE (Loss of appetite (could not eat or drink for 2 days), lost interest in sweets), FATIGUE (Fatigue), CHILLS (Chills) and PYREXIA (Fever 101-103). On 09-Feb-2021, the patient experienced HEADACHE (Terrible headaches). On 13-Feb-2021, HEADACHE (Terrible headaches) was resolving. At the time of the report, DECREASED APPETITE (Loss of appetite (could not eat or drink for 2 days), lost interest in sweets) outcome was unknown and FATIGUE (Fatigue), CHILLS (Chills) and PYREXIA (Fever 101-103) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Feb-2021, COVID-19: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Treatment information included paracetamol.  Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: Follow up received on 20-may-2021,patient demographic details updated ,ADR with significant info. 1st and 2nd dose details; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Terrible headaches; Loss of appetite (could not eat or drink for 2 days), lost interest in sweets; Fatigue; Chills; Fever 101-103; This spontaneous pregnancy case was reported by a health care professional and describes the occurrence of DECREASED APPETITE (Loss of appetite (could not eat or drink for 2 days), lost interest in sweets), FATIGUE (Fatigue), CHILLS (Chills), PYREXIA (Fever 101-103) and HEADACHE (Terrible headaches) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 023MA) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (allergic to Benadryl).   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 04-Feb-2021, the patient experienced DECREASED APPETITE (Loss of appetite (could not eat or drink for 2 days), lost interest in sweets), FATIGUE (Fatigue), CHILLS (Chills) and PYREXIA (Fever 101-103). On 09-Feb-2021, the patient experienced HEADACHE (Terrible headaches). On 13-Feb-2021, HEADACHE (Terrible headaches) was resolving. At the time of the report, DECREASED APPETITE (Loss of appetite (could not eat or drink for 2 days), lost interest in sweets) outcome was unknown and FATIGUE (Fatigue), CHILLS (Chills) and PYREXIA (Fever 101-103) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Feb-2021, COVID-19: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Treatment information included paracetamol.  Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: Follow up received on 20-may-2021,patient demographic details updated ,ADR with significant info. 1st and 2nd dose details; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Pregnancy test, Ultrasound scan, Vaccination site pain
Clinical narrative: 28 weeks pregnant; soreness in her arm; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (28 weeks pregnant) and VACCINATION SITE PAIN (soreness in her arm) in a 32-year-old female patient (gravida 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy (Miscarried at 10 weeks) on 25-Feb-2020. Concurrent medical conditions included Wasp sting. Concomitant products included DESOGESTREL for Contraception.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 29-Jul-2020 and the estimated date of delivery was 05-May-2021. On 12-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (28 weeks pregnant) and VACCINATION SITE PAIN (soreness in her arm). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-eighth week of the pregnancy.  On 12-Feb-2021, EXPOSURE DURING PREGNANCY (28 weeks pregnant) had resolved. On 13-Feb-2021, VACCINATION SITE PAIN (soreness in her arm) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Aug-2020, Pregnancy test: Positive. On 10-Sep-2020, Ultrasound scan: typical 6 weeks. On 06-Oct-2020, Ultrasound scan: typical 10 weeks. On 16-Dec-2021, Ultrasound scan: typical 20 weeks.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications include Full circle prenatal and full circle fish oil for prenatal vitamin use. No treatment information was provided.; Sender's Comments: This is a case of product exposure during pregnancy with an associated AE of for this 32-year-old female. 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: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Paraesthesia oral, Swelling face
Clinical narrative: driving home and it was about 25 to 30 minutes after the shot that the upper lip was tingling and puffy; the upper lip was tingling and puffy; cheek was puffy and hot; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (driving home and it was about 25 to 30 minutes after the shot that the upper lip was tingling and puffy), LIP SWELLING (the upper lip was tingling and puffy) and SWELLING FACE (cheek was puffy and hot) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced PARAESTHESIA ORAL (driving home and it was about 25 to 30 minutes after the shot that the upper lip was tingling and puffy), LIP SWELLING (the upper lip was tingling and puffy) and SWELLING FACE (cheek was puffy and hot). At the time of the report, PARAESTHESIA ORAL (driving home and it was about 25 to 30 minutes after the shot that the upper lip was tingling and puffy), LIP SWELLING (the upper lip was tingling and puffy) and SWELLING FACE (cheek was puffy and hot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Itching at the injection site; Patient started experiencing pain, itching, and redness at the injection site on the day of vaccination, and now the redness size increased from the size of a penny to a silver dollar coin; Redness at the injection site increased from the size of a penny to a silver dollar coin; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (Itching at the injection site), INJECTION SITE PAIN (Patient started experiencing pain, itching, and redness at the injection site on the day of vaccination, and now the redness size increased from the size of a penny to a silver dollar coin) and INJECTION SITE ERYTHEMA (Redness at the injection site increased from the size of a penny to a silver dollar coin) in a 78-year-old female patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced INJECTION SITE PRURITUS (Itching at the injection site), INJECTION SITE PAIN (Patient started experiencing pain, itching, and redness at the injection site on the day of vaccination, and now the redness size increased from the size of a penny to a silver dollar coin) and INJECTION SITE ERYTHEMA (Redness at the injection site increased from the size of a penny to a silver dollar coin). At the time of the report, INJECTION SITE PRURITUS (Itching at the injection site), INJECTION SITE PAIN (Patient started experiencing pain, itching, and redness at the injection site on the day of vaccination, and now the redness size increased from the size of a penny to a silver dollar coin) and INJECTION SITE ERYTHEMA (Redness at the injection site increased from the size of a penny to a silver dollar coin) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drugs were reported. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: No new information was reported.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash; A spontaneous report was received from a consumer concerning a patient of unknown age and gender who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events rash.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection.  On an unknown date, nine days after receiving the vaccine the patient experienced the event rash.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event rash was unknown.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Dizziness, Headache
Clinical narrative: Dizziness; weakness; Fever 101.5 F; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), ASTHENIA (weakness), PYREXIA (Fever 101.5 F), CHILLS (Chills) and HEADACHE (Headache) 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 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced DIZZINESS (Dizziness), ASTHENIA (weakness), PYREXIA (Fever 101.5 F), CHILLS (Chills) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 18-Feb-2021, DIZZINESS (Dizziness), ASTHENIA (weakness), PYREXIA (Fever 101.5 F), CHILLS (Chills) and HEADACHE (Headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Feb-2021, Body temperature: 101.5f 101.5F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.   This case was linked to MOD-2021-243218 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Non-Significant follow up appended to AER
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Dizziness; weakness; Fever 101.5 F; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), ASTHENIA (weakness), PYREXIA (Fever 101.5 F), CHILLS (Chills) and HEADACHE (Headache) 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 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced DIZZINESS (Dizziness), ASTHENIA (weakness), PYREXIA (Fever 101.5 F), CHILLS (Chills) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 18-Feb-2021, DIZZINESS (Dizziness), ASTHENIA (weakness), PYREXIA (Fever 101.5 F), CHILLS (Chills) and HEADACHE (Headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Feb-2021, Body temperature: 101.5f 101.5F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.   This case was linked to MOD-2021-243218 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Non-Significant follow up appended to AER
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Feeling hot, Myalgia
Clinical narrative: pain on both arms; Warm on both arms, thorax and abdomen warm; 38 C of fever; Chills; Muscular pain; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain on both arms), FEELING HOT (Warm on both arms, thorax and abdomen warm), PYREXIA (38 C of fever), CHILLS (Chills) and MYALGIA (Muscular pain) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 025J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (fatigue, hair loose, join and muscular pain, diarrhea intermittent) in March 2020. Concurrent medical conditions included Asthma. Concomitant products included MULTIVITAMINS [VITAMINS NOS] and STEROIDS for an unknown indication.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced PAIN IN EXTREMITY (pain on both arms), FEELING HOT (Warm on both arms, thorax and abdomen warm), PYREXIA (38 C of fever), CHILLS (Chills), MYALGIA (Muscular pain) and ARTHRALGIA (Joint pain). The patient was treated with CEFALEXIN MONOHYDRATE (KEFLEX [CEFALEXIN MONOHYDRATE]) for Adverse event, at a dose of UNK dosage form. On 05-Feb-2021, PAIN IN EXTREMITY (pain on both arms), CHILLS (Chills), MYALGIA (Muscular pain) and ARTHRALGIA (Joint pain) outcome was unknown and FEELING HOT (Warm on both arms, thorax and abdomen warm) and PYREXIA (38 C of fever) had resolved. Possible    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Feb-2021, Body temperature: 38 (High) 38°C  fever.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.   This case was linked to MOD-2021-006536 (Patient Link).
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: pain on both arms; Warm on both arms, thorax and abdomen warm; 38 C of fever; Chills; Muscular pain; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain on both arms), FEELING HOT (Warm on both arms, thorax and abdomen warm), PYREXIA (38 C of fever), CHILLS (Chills) and MYALGIA (Muscular pain) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 025J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (fatigue, hair loose, join and muscular pain, diarrhea intermittent) in March 2020. Concurrent medical conditions included Asthma. Concomitant products included MULTIVITAMINS [VITAMINS NOS] and STEROIDS for an unknown indication.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced PAIN IN EXTREMITY (pain on both arms), FEELING HOT (Warm on both arms, thorax and abdomen warm), PYREXIA (38 C of fever), CHILLS (Chills), MYALGIA (Muscular pain) and ARTHRALGIA (Joint pain). The patient was treated with CEFALEXIN MONOHYDRATE (KEFLEX [CEFALEXIN MONOHYDRATE]) for Adverse event, at a dose of UNK dosage form. On 05-Feb-2021, PAIN IN EXTREMITY (pain on both arms), CHILLS (Chills), MYALGIA (Muscular pain) and ARTHRALGIA (Joint pain) outcome was unknown and FEELING HOT (Warm on both arms, thorax and abdomen warm) and PYREXIA (38 C of fever) had resolved. Possible    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Feb-2021, Body temperature: 38 (High) 38°C  fever.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.   This case was linked to MOD-2021-006536 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site coldness, Vaccination site erythema, Vaccination site hypersensitivity, Vaccination site pruritus
Clinical narrative: Itching; Delayed cutaneous hypersensitivity; Swell up; Up to 3 in with light reddish mark; severe itching; Feeling an intense cold stream going through my arm immediately after the shot was given; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE COLDNESS (Feeling an intense cold stream going through my arm immediately after the shot was given), VACCINATION SITE PRURITUS (Itching), VACCINATION SITE HYPERSENSITIVITY (Delayed cutaneous hypersensitivity), VACCINATION SITE SWELLING (Swell up) and VACCINATION SITE ERYTHEMA (Up to 3 in with light reddish mark) in a 60-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 information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced VACCINATION SITE COLDNESS (Feeling an intense cold stream going through my arm immediately after the shot was given) and PRURITUS (severe itching). On 15-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itching), VACCINATION SITE HYPERSENSITIVITY (Delayed cutaneous hypersensitivity), VACCINATION SITE SWELLING (Swell up) and VACCINATION SITE ERYTHEMA (Up to 3 in with light reddish mark). On 10-Feb-2021, PRURITUS (severe itching) was resolving. At the time of the report, VACCINATION SITE COLDNESS (Feeling an intense cold stream going through my arm immediately after the shot was given), VACCINATION SITE PRURITUS (Itching), VACCINATION SITE HYPERSENSITIVITY (Delayed cutaneous hypersensitivity), VACCINATION SITE SWELLING (Swell up) and VACCINATION SITE ERYTHEMA (Up to 3 in with light reddish mark) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.    Most recent FOLLOW-UP information incorporated above includes: On 18-Feb-2021: New events added On 01-Apr-2021: FUP received on this date included no new information. On 26-Apr-2021: FUP received on this date included no new information.; Reporter's Comments: Based on the information provided which includes a temporal association and the established safety profile of mRNA-1273 vaccine, a causal association between the event of headache and the product use cannot be excluded. Vaccination site redness, itching and swelling are consistent with the known safety profile of the vaccine.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Itching; Delayed cutaneous hypersensitivity; Swell up; Up to 3 in with light reddish mark; severe itching; Feeling an intense cold stream going through my arm immediately after the shot was given; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE COLDNESS (Feeling an intense cold stream going through my arm immediately after the shot was given), VACCINATION SITE PRURITUS (Itching), VACCINATION SITE HYPERSENSITIVITY (Delayed cutaneous hypersensitivity), VACCINATION SITE SWELLING (Swell up) and VACCINATION SITE ERYTHEMA (Up to 3 in with light reddish mark) in a 60-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 information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced VACCINATION SITE COLDNESS (Feeling an intense cold stream going through my arm immediately after the shot was given) and PRURITUS (severe itching). On 15-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itching), VACCINATION SITE HYPERSENSITIVITY (Delayed cutaneous hypersensitivity), VACCINATION SITE SWELLING (Swell up) and VACCINATION SITE ERYTHEMA (Up to 3 in with light reddish mark). On 10-Feb-2021, PRURITUS (severe itching) was resolving. At the time of the report, VACCINATION SITE COLDNESS (Feeling an intense cold stream going through my arm immediately after the shot was given), VACCINATION SITE PRURITUS (Itching), VACCINATION SITE HYPERSENSITIVITY (Delayed cutaneous hypersensitivity), VACCINATION SITE SWELLING (Swell up) and VACCINATION SITE ERYTHEMA (Up to 3 in with light reddish mark) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.    Most recent FOLLOW-UP information incorporated above includes: On 18-Feb-2021: New events added On 01-Apr-2021: FUP received on this date included no new information. On 26-Apr-2021: FUP received on this date included no new information.; Reporter's Comments: Based on the information provided which includes a temporal association and the established safety profile of mRNA-1273 vaccine, a causal association between the event of headache and the product use cannot be excluded. Vaccination site redness, itching and swelling are consistent with the known safety profile of the vaccine.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Injection site erythema, Pain, Pain in extremity
Clinical narrative: red hot feverish skin at injection site; swollen left arm; raised skin like if you cut an orange in half; pain in left arm; fatigue; achiness; rash; tingling; fever; Loss of appetite; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (red hot feverish skin at injection site), PERIPHERAL SWELLING (swollen left arm), SKIN SWELLING (raised skin like if you cut an orange in half), PAIN IN EXTREMITY (pain in left arm) and FATIGUE (fatigue) in a 78-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.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (red hot feverish skin at injection site), PERIPHERAL SWELLING (swollen left arm), SKIN SWELLING (raised skin like if you cut an orange in half), PAIN IN EXTREMITY (pain in left arm), FATIGUE (fatigue), PAIN (achiness), RASH (rash), PARAESTHESIA (tingling), PYREXIA (fever) and DECREASED APPETITE (Loss of appetite). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency and CALAMINE at an unspecified dose and frequency. At the time of the report, INJECTION SITE ERYTHEMA (red hot feverish skin at injection site), PERIPHERAL SWELLING (swollen left arm), SKIN SWELLING (raised skin like if you cut an orange in half), PAIN IN EXTREMITY (pain in left arm), FATIGUE (fatigue), PAIN (achiness), RASH (rash), PARAESTHESIA (tingling), PYREXIA (fever) and DECREASED APPETITE (Loss of appetite) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant medication were provided by reporter  No treatment was reported   This case was linked to MOD-2021-223931 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: significant follow-up added
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Peripheral swelling, Pyrexia, Rash, Skin swelling
Clinical narrative: red hot feverish skin at injection site; swollen left arm; raised skin like if you cut an orange in half; pain in left arm; fatigue; achiness; rash; tingling; fever; Loss of appetite; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (red hot feverish skin at injection site), PERIPHERAL SWELLING (swollen left arm), SKIN SWELLING (raised skin like if you cut an orange in half), PAIN IN EXTREMITY (pain in left arm) and FATIGUE (fatigue) in a 78-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.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (red hot feverish skin at injection site), PERIPHERAL SWELLING (swollen left arm), SKIN SWELLING (raised skin like if you cut an orange in half), PAIN IN EXTREMITY (pain in left arm), FATIGUE (fatigue), PAIN (achiness), RASH (rash), PARAESTHESIA (tingling), PYREXIA (fever) and DECREASED APPETITE (Loss of appetite). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency and CALAMINE at an unspecified dose and frequency. At the time of the report, INJECTION SITE ERYTHEMA (red hot feverish skin at injection site), PERIPHERAL SWELLING (swollen left arm), SKIN SWELLING (raised skin like if you cut an orange in half), PAIN IN EXTREMITY (pain in left arm), FATIGUE (fatigue), PAIN (achiness), RASH (rash), PARAESTHESIA (tingling), PYREXIA (fever) and DECREASED APPETITE (Loss of appetite) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant medication were provided by reporter  No treatment was reported   This case was linked to MOD-2021-223931 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: significant follow-up added
Sex: F
Vaccine: COVID19
Symptoms: Coronavirus infection
Clinical narrative: Covid; This spontaneous case was reported by a consumer and describes the occurrence of CORONAVIRUS INFECTION (Covid) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CORONAVIRUS INFECTION (Covid). At the time of the report, CORONAVIRUS INFECTION (Covid) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication information was provided.  No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Follow-up received on 24-JUL-2021 included no new information.