chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: Large red area around the injection site, right arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Large red area around the injection site, right arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0AD8418 and 036A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (Large red area around the injection site, right arm). At the time of the report, VACCINATION SITE ERYTHEMA (Large red area around the injection site, right arm) outcome was unknown. Not Provided          Patient has been applying Alcohol rubs. No relevant concomitant medications were reported.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discomfort, Vaccination site induration, Vaccination site pain
Clinical narrative: little hard ball at the injection site; a bit painful to touch; discomfort at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOMFORT (discomfort at the injection site), VACCINATION SITE INDURATION (little hard ball at the injection site) and VACCINATION SITE PAIN (a bit painful to touch) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced VACCINATION SITE DISCOMFORT (discomfort at the injection site). On 08-Apr-2021, the patient experienced VACCINATION SITE INDURATION (little hard ball at the injection site) and VACCINATION SITE PAIN (a bit painful to touch). At the time of the report, VACCINATION SITE DISCOMFORT (discomfort at the injection site), VACCINATION SITE INDURATION (little hard ball at the injection site) and VACCINATION SITE PAIN (a bit painful to touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.   Treatment information was not provided.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Injection site hypoaesthesia
Clinical narrative: started to cough after second dose; hand numb in injection arm; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (started to cough after second dose) and INJECTION SITE HYPOAESTHESIA (hand numb in injection arm) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 038A21A) for COVID-19 vaccination.     Concurrent medical conditions included Exposure to COVID-19 (Relatives tested positive for COVID today) since 07-Apr-2021.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced COUGH (started to cough after second dose) and INJECTION SITE HYPOAESTHESIA (hand numb in injection arm). At the time of the report, COUGH (started to cough after second dose) had resolved and INJECTION SITE HYPOAESTHESIA (hand numb in injection arm) outcome was unknown.            No concomitant medications were provided No treatment medications were provided   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Follow up received on 10-MAY-2021, contains information such as event outcome has changed.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Disorientation, Gait disturbance, Myalgia, Vaccination site pain
Clinical narrative: disoriented; staggering around house; arm hurt- unable to raise it or lay on it; body aches; This spontaneous case was reported by a consumer and describes the occurrence of DISORIENTATION (disoriented), GAIT DISTURBANCE (staggering around house), VACCINATION SITE PAIN (arm hurt- unable to raise it or lay on it) and MYALGIA (body aches) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 011A21A) for COVID-19 vaccination.     Concurrent medical conditions included Liver failure (Stage 4 Liver failure).   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced DISORIENTATION (disoriented), GAIT DISTURBANCE (staggering around house), VACCINATION SITE PAIN (arm hurt- unable to raise it or lay on it) and MYALGIA (body aches). The patient was treated with TRAMADOL at a dose of 1 dosage form. At the time of the report, DISORIENTATION (disoriented), GAIT DISTURBANCE (staggering around house), VACCINATION SITE PAIN (arm hurt- unable to raise it or lay on it) and MYALGIA (body aches) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Apr-2021, Body temperature: up by 2 degrees (High) up by 2 degrees.         No concomitant medications were provided Patients treatment medication reported was tramadol.   This case was linked to US-MODERNATX, INC.-MOD-2021-071162 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-071162:First Dose
Sex: U
Vaccine: COVID19
Symptoms: Fall, Product dose omission issue
Clinical narrative: patient fell and has been in rehab; unable to get their 2nd dose within the 42 day window; This spontaneous case was reported by a nurse and describes the occurrence of FALL (patient fell and has been in rehab) and PRODUCT DOSE OMISSION ISSUE (unable to get their 2nd dose within the 42 day window) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FALL (patient fell and has been in rehab) and PRODUCT DOSE OMISSION ISSUE (unable to get their 2nd dose within the 42 day window). At the time of the report, FALL (patient fell and has been in rehab) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (unable to get their 2nd dose within the 42 day window) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment and concomitant information were provided by the reporter.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Rash, Rash erythematous
Clinical narrative: whole arm started to ache as if she was writing too much (shoulder to her hand); there is still mild itchy; red, raised rash at the injection site that was warm or hot to the touch; rash continued to grow and extending from 4cm above the elbow to above the shoulder on the injection side of the arm and started to wrap around the other side of the arm but never engulfing the entire arm; This spontaneous case was reported by a health care professional and describes the occurrence of RASH ERYTHEMATOUS (red, raised rash at the injection site that was warm or hot to the touch), RASH (rash continued to grow and extending from 4cm above the elbow to above the shoulder on the injection side of the arm and started to wrap around the other side of the arm but never engulfing the entire arm), PAIN IN EXTREMITY (whole arm started to ache as if she was writing too much (shoulder to her hand)) and PRURITUS (there is still mild itchy) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     Concomitant products included CICLOSPORIN (RESTASIS), DOXYCYCLINE, VITAMIN D3, CYANOCOBALAMIN, FOLIC ACID (VITAMIN B12 & FOLIC ACID), ZINC and IBUPROFEN for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced RASH ERYTHEMATOUS (red, raised rash at the injection site that was warm or hot to the touch), RASH (rash continued to grow and extending from 4cm above the elbow to above the shoulder on the injection side of the arm and started to wrap around the other side of the arm but never engulfing the entire arm) and PRURITUS (there is still mild itchy). On 05-Apr-2021, the patient experienced PAIN IN EXTREMITY (whole arm started to ache as if she was writing too much (shoulder to her hand)). On 06-Apr-2021, RASH ERYTHEMATOUS (red, raised rash at the injection site that was warm or hot to the touch), RASH (rash continued to grow and extending from 4cm above the elbow to above the shoulder on the injection side of the arm and started to wrap around the other side of the arm but never engulfing the entire arm) and PAIN IN EXTREMITY (whole arm started to ache as if she was writing too much (shoulder to her hand)) had resolved. At the time of the report, PRURITUS (there is still mild itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment included Ice gel pack and Ibuprofen 200mg (2 tablets) for a total of 3 times
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Flushing, Vaccination site bruising, Vaccination site haemorrhage
Clinical narrative: bruising at injection site; faced turned red; face flushed; bled; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE HAEMORRHAGE (bled), VACCINATION SITE BRUISING (bruising at injection site), ERYTHEMA (faced turned red) and FLUSHING (face flushed) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017b21a) for COVID-19 vaccination.     Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.   On 08-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, the patient experienced VACCINATION SITE HAEMORRHAGE (bled), ERYTHEMA (faced turned red) and FLUSHING (face flushed). On 08-Apr-2021, the patient experienced VACCINATION SITE BRUISING (bruising at injection site). On 06-Apr-2021, ERYTHEMA (faced turned red) and FLUSHING (face flushed) had resolved. On 08-Apr-2021, VACCINATION SITE HAEMORRHAGE (bled) had resolved. At the time of the report, VACCINATION SITE BRUISING (bruising at injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events was not Applicable. treatment information not provided   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Follow up received on 10-MAY-2021, contains non significant information such as, added contact details.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Nervousness, Rash macular, Vaccination site erythema, Vaccination site pain
Clinical narrative: Warmness; Itchiness at injection site; Redness at injection; Injection site was hurting; red dot showed up; Nervous; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (red dot showed up), NERVOUSNESS (Nervous), FEELING HOT (Warmness), VACCINATION SITE PRURITUS (Itchiness at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced RASH MACULAR (red dot showed up) and NERVOUSNESS (Nervous). On an unknown date, the patient experienced FEELING HOT (Warmness), VACCINATION SITE PRURITUS (Itchiness at injection site), VACCINATION SITE ERYTHEMA (Redness at injection) and VACCINATION SITE PAIN (Injection site was hurting). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; CLINDAMYCIN at an unspecified dose and frequency; ACETAMINOPHEN at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. On 01-Apr-2021, RASH MACULAR (red dot showed up) had resolved. At the time of the report, NERVOUSNESS (Nervous), FEELING HOT (Warmness), VACCINATION SITE PRURITUS (Itchiness at injection site), VACCINATION SITE ERYTHEMA (Redness at injection) and VACCINATION SITE PAIN (Injection site was hurting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication taken by the patient included thyroid medicines, blood pressure pills. Treatment activities for event was done with  Sulphur based medication, cold pack,  cold compress and some antibiotics .   This case was linked to MOD-2021-074928 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: Follow up information was received and concomitant medication, new event , treatment medications were updated.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: Warmness; Itchiness at injection site; Redness at injection; Injection site was hurting; red dot showed up; Nervous; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (red dot showed up), NERVOUSNESS (Nervous), FEELING HOT (Warmness), VACCINATION SITE PRURITUS (Itchiness at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced RASH MACULAR (red dot showed up) and NERVOUSNESS (Nervous). On an unknown date, the patient experienced FEELING HOT (Warmness), VACCINATION SITE PRURITUS (Itchiness at injection site), VACCINATION SITE ERYTHEMA (Redness at injection) and VACCINATION SITE PAIN (Injection site was hurting). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; CLINDAMYCIN at an unspecified dose and frequency; ACETAMINOPHEN at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. On 01-Apr-2021, RASH MACULAR (red dot showed up) had resolved. At the time of the report, NERVOUSNESS (Nervous), FEELING HOT (Warmness), VACCINATION SITE PRURITUS (Itchiness at injection site), VACCINATION SITE ERYTHEMA (Redness at injection) and VACCINATION SITE PAIN (Injection site was hurting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication taken by the patient included thyroid medicines, blood pressure pills. Treatment activities for event was done with  Sulphur based medication, cold pack,  cold compress and some antibiotics .   This case was linked to MOD-2021-074928 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: Follow up information was received and concomitant medication, new event , treatment medications were updated.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Did not receive the Second dose after 35 days; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Did not receive the Second dose after 35 days) 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 29-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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Did not receive the Second dose after 35 days). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Did not receive the Second dose after 35 days) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment information not provided.
Sex: F
Vaccine: COVID19
Symptoms: Eye infection, Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurt a little) and EYE INFECTION (developed an eye infection) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm hurt a little) and EYE INFECTION (developed an eye infection). At the time of the report, PAIN IN EXTREMITY (arm hurt a little) and EYE INFECTION (developed an eye infection) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment information was not provided. This case was linked to MOD-2021-071224.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder due to general medical condition, insomnia type, Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of SLEEP DISORDER DUE TO GENERAL MEDICAL CONDITION, INSOMNIA TYPE (Insomnia due to pain and tenderness), the first episode of VACCINATION SITE PAIN (extreme pain and tenderness at the injection site of her left arm) and the second episode of VACCINATION SITE PAIN (extreme pain and tenderness at the injection site of her left arm) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 036A21A) for COVID-19 vaccination.     The patient's past medical history included Bladder cancer (patient was diagnosed with bladder cancer five years ago), Sleep restless (patient is a restless sleeper.) since an unknown date and Cancer surgery (three surgeries to remove numerous tumors).   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 07-Apr-2021, the patient experienced SLEEP DISORDER DUE TO GENERAL MEDICAL CONDITION, INSOMNIA TYPE (Insomnia due to pain and tenderness), the first episode of VACCINATION SITE PAIN (extreme pain and tenderness at the injection site of her left arm) and the second episode of VACCINATION SITE PAIN (extreme pain and tenderness at the injection site of her left arm). At the time of the report, SLEEP DISORDER DUE TO GENERAL MEDICAL CONDITION, INSOMNIA TYPE (Insomnia due to pain and tenderness) and the last episode of VACCINATION SITE PAIN (extreme pain and tenderness at the injection site of her left arm) outcome was unknown.    No concomitant medications were provided. No treatment medications were provided. Per patient the day after receiving the vaccine she felt fine and went shopping. During her shopping experience she did lift two cases of water. That evening, she started to feel extreme pain and tenderness at the injection site of her left arm. Patient reported after 1st dose she had no symptoms. It was injected in Right arm.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: exceeded 35 day interval between doses; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (exceeded 35 day interval between doses) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Chemotherapy (Patient was undergoing chemotherapy and therefore could not receive his second dose which was scheduled for 20Mar2021.) since an unknown date. Concurrent medical conditions included Lymphoma (Diffuse b-cell lymphoma).    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (exceeded 35 day interval between doses). On 08-Apr-2021, PRODUCT DOSE OMISSION ISSUE (exceeded 35 day interval between doses) had resolved. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant medication included chemotherapy  Treatment medication was not provided   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Follow up received on 10-MAY-2021: Email id, past medical history were updated On 10-May-2021: follow up received: No new information
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Headache, Injection site nodule, Peripheral swelling, Rash
Clinical narrative: warm arm; swollen arm; rash is itchy at times; red arm; "horseshoe" shaped rash around site of administration; "bad" headache, is unsure if headache is related to vaccination; "hard nodule" below injection site; not sure if the dose was administered in muscle, dose was administered about three inches belowshoulder; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE NODULE ("hard nodule" below injection site), WRONG TECHNIQUE IN DEVICE USAGE PROCESS (not sure if the dose was administered in muscle, dose was administered about three inches belowshoulder), VACCINATION SITE WARMTH (warm arm), PERIPHERAL SWELLING (swollen arm) and RASH PRURITIC (rash is itchy at times) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced WRONG TECHNIQUE IN DEVICE USAGE PROCESS (not sure if the dose was administered in muscle, dose was administered about three inches belowshoulder). On 01-Apr-2021, the patient experienced INJECTION SITE NODULE ("hard nodule" below injection site), VACCINATION SITE WARMTH (warm arm), PERIPHERAL SWELLING (swollen arm), RASH PRURITIC (rash is itchy at times), ERYTHEMA (red arm), RASH ("horseshoe" shaped rash around site of administration) and HEADACHE ("bad" headache, is unsure if headache is related to vaccination). On 26-Mar-2021, WRONG TECHNIQUE IN DEVICE USAGE PROCESS (not sure if the dose was administered in muscle, dose was administered about three inches belowshoulder) had resolved. On 08-Apr-2021, HEADACHE ("bad" headache, is unsure if headache is related to vaccination) had resolved. At the time of the report, INJECTION SITE NODULE ("hard nodule" below injection site), VACCINATION SITE WARMTH (warm arm), PERIPHERAL SWELLING (swollen arm), RASH PRURITIC (rash is itchy at times), ERYTHEMA (red arm) and RASH ("horseshoe" shaped rash around site of administration) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided Patient treated her symptoms with diphenhydramine(oral), hydrocortisone (topical) per recommendation of her local pharmacist. patient also took acetaminophen to relieve headache. Patient reports the rash has diminished in severity, but is still present. Patient reports headache has resolved as of 8Apr2021
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic, Vaccination site warmth, Wrong technique in device usage process
Clinical narrative: warm arm; swollen arm; rash is itchy at times; red arm; "horseshoe" shaped rash around site of administration; "bad" headache, is unsure if headache is related to vaccination; "hard nodule" below injection site; not sure if the dose was administered in muscle, dose was administered about three inches belowshoulder; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE NODULE ("hard nodule" below injection site), WRONG TECHNIQUE IN DEVICE USAGE PROCESS (not sure if the dose was administered in muscle, dose was administered about three inches belowshoulder), VACCINATION SITE WARMTH (warm arm), PERIPHERAL SWELLING (swollen arm) and RASH PRURITIC (rash is itchy at times) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced WRONG TECHNIQUE IN DEVICE USAGE PROCESS (not sure if the dose was administered in muscle, dose was administered about three inches belowshoulder). On 01-Apr-2021, the patient experienced INJECTION SITE NODULE ("hard nodule" below injection site), VACCINATION SITE WARMTH (warm arm), PERIPHERAL SWELLING (swollen arm), RASH PRURITIC (rash is itchy at times), ERYTHEMA (red arm), RASH ("horseshoe" shaped rash around site of administration) and HEADACHE ("bad" headache, is unsure if headache is related to vaccination). On 26-Mar-2021, WRONG TECHNIQUE IN DEVICE USAGE PROCESS (not sure if the dose was administered in muscle, dose was administered about three inches belowshoulder) had resolved. On 08-Apr-2021, HEADACHE ("bad" headache, is unsure if headache is related to vaccination) had resolved. At the time of the report, INJECTION SITE NODULE ("hard nodule" below injection site), VACCINATION SITE WARMTH (warm arm), PERIPHERAL SWELLING (swollen arm), RASH PRURITIC (rash is itchy at times), ERYTHEMA (red arm) and RASH ("horseshoe" shaped rash around site of administration) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided Patient treated her symptoms with diphenhydramine(oral), hydrocortisone (topical) per recommendation of her local pharmacist. patient also took acetaminophen to relieve headache. Patient reports the rash has diminished in severity, but is still present. Patient reports headache has resolved as of 8Apr2021
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Erythema, Lip swelling, Rash, Vasculitis
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VASCULITIS (vasculitis), ASTHMA (flare ups with asthma), LIP SWELLING (swelling in lips), RASH (rash on face) and ERYTHEMA (face is red) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination. The patient's past medical history included Asthma since an unknown date. On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced VASCULITIS (vasculitis), ASTHMA (flare ups with asthma), LIP SWELLING (swelling in lips), RASH (rash on face) and ERYTHEMA (face is red). At the time of the report, VASCULITIS (vasculitis), ASTHMA (flare ups with asthma), LIP SWELLING (swelling in lips), RASH (rash on face) and ERYTHEMA (face is red) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not provided. Treatment medications included prednisone and albuterol inhaler.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Chills, Dizziness, Headache, Heart rate
Clinical narrative: dizziness; general head and body pain like when she had Covid in January 2021; her whole body inflammation; hand inflammation; feet inflammation; chills; general head and body pain like when she had Covid in January 2021; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Apr-2021 and was forwarded to Moderna on 08-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), PAIN (general head and body pain like when she had Covid in January 2021), INFLAMMATION (her whole body inflammation), INFLAMMATION (hand inflammation) and INFLAMMATION (feet inflammation) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Had Covid in January 2021) in January 2021.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced DIZZINESS (dizziness), PAIN (general head and body pain like when she had Covid in January 2021), INFLAMMATION (her whole body inflammation), INFLAMMATION (hand inflammation), INFLAMMATION (feet inflammation), CHILLS (chills) and HEADACHE (general head and body pain like when she had Covid in January 2021). At the time of the report, DIZZINESS (dizziness), PAIN (general head and body pain like when she had Covid in January 2021), INFLAMMATION (her whole body inflammation), INFLAMMATION (hand inflammation), INFLAMMATION (feet inflammation), CHILLS (chills) and HEADACHE (general head and body pain like when she had Covid in January 2021) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Mar-2021, Blood pressure measurement: (High) elevated. On 04-Mar-2021, Heart rate: 110 (High) elevated heartrate.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medications were provided No treatment medications were provided   This case was linked to US-MODERNATX, INC.-MOD-2021-071207 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-071207:Case for Second dose
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Pain
Clinical narrative: dizziness; general head and body pain like when she had Covid in January 2021; her whole body inflammation; hand inflammation; feet inflammation; chills; general head and body pain like when she had Covid in January 2021; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Apr-2021 and was forwarded to Moderna on 08-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), PAIN (general head and body pain like when she had Covid in January 2021), INFLAMMATION (her whole body inflammation), INFLAMMATION (hand inflammation) and INFLAMMATION (feet inflammation) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Had Covid in January 2021) in January 2021.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced DIZZINESS (dizziness), PAIN (general head and body pain like when she had Covid in January 2021), INFLAMMATION (her whole body inflammation), INFLAMMATION (hand inflammation), INFLAMMATION (feet inflammation), CHILLS (chills) and HEADACHE (general head and body pain like when she had Covid in January 2021). At the time of the report, DIZZINESS (dizziness), PAIN (general head and body pain like when she had Covid in January 2021), INFLAMMATION (her whole body inflammation), INFLAMMATION (hand inflammation), INFLAMMATION (feet inflammation), CHILLS (chills) and HEADACHE (general head and body pain like when she had Covid in January 2021) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Mar-2021, Blood pressure measurement: (High) elevated. On 04-Mar-2021, Heart rate: 110 (High) elevated heartrate.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medications were provided No treatment medications were provided   This case was linked to US-MODERNATX, INC.-MOD-2021-071207 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-071207:Case for Second dose
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Pain, Pyrexia
Clinical narrative: Not Able to Work; Body Aches; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (Not Able to Work) and PAIN (Body Aches) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced DISCOMFORT (Not Able to Work) and PAIN (Body Aches). On 28-Jan-2021, DISCOMFORT (Not Able to Work) and PAIN (Body Aches) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: 100f (High) 100F.         No concomitant medications were provided No treatment medications were provided   This case was linked to .-MOD-2021-071228 (E2B Linked Report).; Sender's Comments:  MOD-2021-071228:crosslink case
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Dyskinesia, Injection site pain, Muscle discomfort, Neck pain, Rash
Clinical narrative: the muscle is rejecting the vaccine; a rash on his forearm in a straight line; little black holes about every 1/4 inch on either side; bicep started involuntarily contracting with extreme pain; radiated up to his neck and down to his hand; site of the injection was painful; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INJECTION SITE PAIN (site of the injection was painful), NECK PAIN (radiated up to his neck and down to his hand), DYSKINESIA (bicep started involuntarily contracting with extreme pain), SKIN REACTION (little black holes about every 1/4 inch on either side) and MUSCLE DISCOMFORT (the muscle is rejecting the vaccine) in a 71-year-old male 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 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced INJECTION SITE PAIN (site of the injection was painful). On 20-Mar-2021, the patient experienced NECK PAIN (radiated up to his neck and down to his hand). On 29-Mar-2021, the patient experienced DYSKINESIA (bicep started involuntarily contracting with extreme pain). On 04-Apr-2021, the patient experienced SKIN REACTION (little black holes about every 1/4 inch on either side) and RASH (a rash on his forearm in a straight line). On an unknown date, the patient experienced MUSCLE DISCOMFORT (the muscle is rejecting the vaccine). At the time of the report, INJECTION SITE PAIN (site of the injection was painful), NECK PAIN (radiated up to his neck and down to his hand), DYSKINESIA (bicep started involuntarily contracting with extreme pain), SKIN REACTION (little black holes about every 1/4 inch on either side), MUSCLE DISCOMFORT (the muscle is rejecting the vaccine) and RASH (a rash on his forearm in a straight line) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient reports taking acetaminophen(T ylenol). He went to his orthopedist yesterday, who said that the best explanation for his symptoms is that "the muscle is rejecting the vaccine." He has an appointment with his primary care, internist, this afternoon.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Skin reaction
Clinical narrative: the muscle is rejecting the vaccine; a rash on his forearm in a straight line; little black holes about every 1/4 inch on either side; bicep started involuntarily contracting with extreme pain; radiated up to his neck and down to his hand; site of the injection was painful; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INJECTION SITE PAIN (site of the injection was painful), NECK PAIN (radiated up to his neck and down to his hand), DYSKINESIA (bicep started involuntarily contracting with extreme pain), SKIN REACTION (little black holes about every 1/4 inch on either side) and MUSCLE DISCOMFORT (the muscle is rejecting the vaccine) in a 71-year-old male 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 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced INJECTION SITE PAIN (site of the injection was painful). On 20-Mar-2021, the patient experienced NECK PAIN (radiated up to his neck and down to his hand). On 29-Mar-2021, the patient experienced DYSKINESIA (bicep started involuntarily contracting with extreme pain). On 04-Apr-2021, the patient experienced SKIN REACTION (little black holes about every 1/4 inch on either side) and RASH (a rash on his forearm in a straight line). On an unknown date, the patient experienced MUSCLE DISCOMFORT (the muscle is rejecting the vaccine). At the time of the report, INJECTION SITE PAIN (site of the injection was painful), NECK PAIN (radiated up to his neck and down to his hand), DYSKINESIA (bicep started involuntarily contracting with extreme pain), SKIN REACTION (little black holes about every 1/4 inch on either side), MUSCLE DISCOMFORT (the muscle is rejecting the vaccine) and RASH (a rash on his forearm in a straight line) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient reports taking acetaminophen(T ylenol). He went to his orthopedist yesterday, who said that the best explanation for his symptoms is that "the muscle is rejecting the vaccine." He has an appointment with his primary care, internist, this afternoon.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Product dose omission issue
Clinical narrative: became sick within 7-9 days of getting the vaccine and currently in rehab center; unable to get their 2nd dose within the 42 day window; This spontaneous case was reported by a nurse and describes the occurrence of ILLNESS (became sick within 7-9 days of getting the vaccine and currently in rehab center) and PRODUCT DOSE OMISSION ISSUE (unable to get their 2nd dose within the 42 day window) 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 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (became sick within 7-9 days of getting the vaccine and currently in rehab center) and PRODUCT DOSE OMISSION ISSUE (unable to get their 2nd dose within the 42 day window). At the time of the report, ILLNESS (became sick within 7-9 days of getting the vaccine and currently in rehab center) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (unable to get their 2nd dose within the 42 day window) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided No treatment medications were provided
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort
Clinical narrative: Had a little bit of discomfort in her right arm; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Had a little bit of discomfort in her right arm) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 036B21A) for COVID-19 vaccination.     The patient's past medical history included Heart valve replacement (Mechanical heart valve.). Concomitant products included WARFARIN SODIUM for Heart valve replacement.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced LIMB DISCOMFORT (Had a little bit of discomfort in her right arm). At the time of the report, LIMB DISCOMFORT (Had a little bit of discomfort in her right arm) had resolved. Not Provided          Treatment details included band-aid's placement after the first dose.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Gingival discolouration, Gingival erythema, Gingival pain, Lichen planus, Noninfective gingivitis
Clinical narrative: Lichen Planus; reddish, inflammed gums; reddish, inflammed gums; White spots; it would burn; covid mouth; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LICHEN PLANUS (Lichen Planus), NONINFECTIVE GINGIVITIS (reddish, inflammed gums), GINGIVAL ERYTHEMA (reddish, inflammed gums), GINGIVAL DISCOLORATION (White spots) and GINGIVAL PAIN (it would burn) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 04-Mar-2021, the patient experienced LICHEN PLANUS (Lichen Planus), NONINFECTIVE GINGIVITIS (reddish, inflammed gums), GINGIVAL ERYTHEMA (reddish, inflammed gums), GINGIVAL DISCOLORATION (White spots), GINGIVAL PAIN (it would burn) and ORAL DISORDER (covid mouth). At the time of the report, LICHEN PLANUS (Lichen Planus), NONINFECTIVE GINGIVITIS (reddish, inflammed gums), GINGIVAL ERYTHEMA (reddish, inflammed gums), GINGIVAL DISCOLORATION (White spots), GINGIVAL PAIN (it would burn) and ORAL DISORDER (covid mouth) outcome was unknown. Not Provided          No concomitant medications reported. Patient reports her dentist diagnosed her with "Lichen Planus" and gave her an oral wash, spray and gel to help treat the pain and swelling. Patient reports one of the medications was Stella Life.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Oral disorder
Clinical narrative: Lichen Planus; reddish, inflammed gums; reddish, inflammed gums; White spots; it would burn; covid mouth; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LICHEN PLANUS (Lichen Planus), NONINFECTIVE GINGIVITIS (reddish, inflammed gums), GINGIVAL ERYTHEMA (reddish, inflammed gums), GINGIVAL DISCOLORATION (White spots) and GINGIVAL PAIN (it would burn) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 04-Mar-2021, the patient experienced LICHEN PLANUS (Lichen Planus), NONINFECTIVE GINGIVITIS (reddish, inflammed gums), GINGIVAL ERYTHEMA (reddish, inflammed gums), GINGIVAL DISCOLORATION (White spots), GINGIVAL PAIN (it would burn) and ORAL DISORDER (covid mouth). At the time of the report, LICHEN PLANUS (Lichen Planus), NONINFECTIVE GINGIVITIS (reddish, inflammed gums), GINGIVAL ERYTHEMA (reddish, inflammed gums), GINGIVAL DISCOLORATION (White spots), GINGIVAL PAIN (it would burn) and ORAL DISORDER (covid mouth) outcome was unknown. Not Provided          No concomitant medications reported. Patient reports her dentist diagnosed her with "Lichen Planus" and gave her an oral wash, spray and gel to help treat the pain and swelling. Patient reports one of the medications was Stella Life.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site rash, Vaccination site urticaria
Clinical narrative: it's itching; it's like a bee hive; rash a little under the injection area; it's a big red area; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (it's itching), VACCINATION SITE URTICARIA (it's like a bee hive), VACCINATION SITE RASH (rash a little under the injection area) and VACCINATION SITE ERYTHEMA (it's a big red area) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy. Concomitant products included VITAMINS NOS, VITAMIN D [VITAMIN D NOS] and CALCIUM for an unknown indication.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (it's itching), VACCINATION SITE URTICARIA (it's like a bee hive), VACCINATION SITE RASH (rash a little under the injection area) and VACCINATION SITE ERYTHEMA (it's a big red area). At the time of the report, VACCINATION SITE PRURITUS (it's itching), VACCINATION SITE URTICARIA (it's like a bee hive), VACCINATION SITE RASH (rash a little under the injection area) and VACCINATION SITE ERYTHEMA (it's a big red area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.